AU2024316429A1

AU2024316429A1 - Methods and systems for pain management and testing thereof

Info

Publication number: AU2024316429A1
Application number: AU2024316429A
Authority: AU
Inventors: Sanjay Sinha
Original assignee: Gate Science Inc
Current assignee: Gate Science Inc
Priority date: 2023-07-28
Filing date: 2024-07-29
Publication date: 2026-03-12
Also published as: WO2025029752A2; WO2025029752A3

Abstract

Inventions and embodiments of the present disclosure provide, systems and methods for treating pain. In some embodiments, the system includes a catheter including a proximal end, a distal end, and electrodes. The system includes a catheter locking device arranged near the proximal end of the catheter and, via rotation, projects tines for locking the catheter. The system includes a housing affixed to the proximate end of the catheter and an injection port including a through-channel having a proximal end with a luer-lock. The system includes a needle having a lumen and that inserts, into the catheter's lumen, a proximal end that mates with the luer-lock, and a distal end that protrudes past the catheter's distal end when inserted within the catheter's lumen. The system includes a pulse generator configured to provide electric pulses to the electrodes, configured by a program on a computing device connected to external pulse generator.

Description

METHODS AND SYSTEMS FOR PAIN MANAGEMENT AND TESTING THEREOF

RELATED APPLICATIONS

[0001] The subject application claim priority to and benefit of U.S. provisional application no. 63/516,458 filed on July 28, 2024, the entire disclosure of which is incorporated herein by reference in its entirety.

FIELD

[0002] The present disclosure generally relates to the field of medical devices for pain management, and in particular, the present disclosure is related to methods and systems for pain management and nerve stimulation and testing thereof.

BACKGROUND

[0003] Catheter systems and devices are medical devices designed to provide relief and alleviate discomfort in patients undergoing various procedures, such as, for example, surgeries or chronic pain management. Some current technologies for management of pain or discomfort rely on systemic administration of medications, which can lead to side effects, such as sedation and respiratory depression. Local anesthetics, which can be commonly used through epidurals or nerve blocks, can be limited in duration, requiring repeated injections. A medical device for delivery of anesthesia and analgesia for an extended period of time and providing pain relief is needed.

SUMMARY

[0004] In some embodiments, a system for treating pain using a pain management (PM) system is presented which includes a catheter including a proximal end, a distal end, at least two electrodes located at the distal end thereof, and a lumen. The system can further include a catheter locking device arranged near the distal end of the catheter, proximal to electrodes (in some embodiments), and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient. In some embodiments, the system further includes a housing affixed to and arranged near the proximate end of the catheter, an injection port including a through-channel having a proximal end with luer-lock (for example), the injection port can be located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter. In some embodiments, an end (e.g., distal end proximal end) can also include a tip.

[0005] In some embodiments, the system further includes a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter. In some embodiments, at least one pulse generator is provided and arranged within the housing (in some embodiments) and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes. The pulse generator can include communications means configured to communicate with an external control device.

[0006] In some embodiments, a method for treating pain using a pain management (PM) system is provided. The PM system can include a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof and a lumen, a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, at least one pulse generator affixed to the catheter and configured to provide at least a first set of electric pulses at a designated rate, frequency, voltage and current to the at least the two electrodes and optionally to the distal end of the needle from an external nerve stimulator, and an application program operable on a computing device for controlling at least the pulse generator. The application program is configured to cause the computing device to display a touch interface for controlling upper and lower stimulation current thresholds, frequency, and pulse duration for the pulse generator. Accordingly, the method includes inserting the distal end of the needle and catheter through the skin of the patient towards a target nerve under ultrasound or X-ray guidance, where the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain. The method further includes guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve, and eliciting a twitch response of the muscle to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator. The external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle. The method further includes hydrodissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%, resulting in the formation of a hydro-dissected pocket, sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket, removing the needle from the lumen of the catheter, and establishing communications between the pulse generator and the computing device. Via the touchscreen display interface, adjusting one or more parameters of the pulse generator and thereafter causing the pulse generator to deliver the first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the surgical site. The method can also optionally, upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the first set of electrical pulses, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter.

[0007] In some embodiments, a method for treating pain using a pain management (PM) system, where the PM system includes a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, an injection port, and a lumen, a catheter locking device arranged proximal to the electrodes on the catheter and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient, a housing affixed to and arranged near the proximate end of the catheter, the injection port including a through-channel having a proximal end with luer-lock, the injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter, a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, at least one pulse generator arranged within the housing and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes and optionally to the distal end of the needle, communications means configured to communicate with an external control device, and an application program operable on a computing device for controlling at least the pulse generator. At least one of the lumen of the catheter and the lumen of the needle is configured to receive at least one of a dextrose solution, a saline solution, an anesthetic, and the application program is configured to cause the computing device to display a touch interface for controlling upper and lower stimulation current thresholds, frequency, and pulse duration for the pulse generator.

[0008] In such embodiments, the method includes preparing the insertion site to receive the distal end of the catheter and needle, where preparing comprises cleaning the insertion site and shaving any hair present, optionally preparing a sterile field on a mayo stand or surgical table for placement of the system thereon, inserting the needle within the lumen of the catheter from an opening in the proximal end of the injection port, where the needle is in electrical communication with an external nerve stimulator. The external nerve stimulator can be configured to deliver a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle. The method further includes connecting a tube to a proximal end of the through channel, connecting a syringe containing a 2-10% dextrose solution to the tube, flushing the lumen of the tube and lumen of the needle so as to remove air therein using the syringe containing the 2-10% dextrose solution, establishing communications between the computing device and the pulse generator via the communications means by turning on the pulse generator and thereafter, turning off the pulse generator, treating the skin at the insertion site with chi orohexi dine or suitable skin disinfectant, anesthetizing the skin at the insertion site, inserting the distal end of the needle and catheter (catheter-over needle unit) through the anesthetized skin towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve, eliciting a twitch response of the muscle innervated by the target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, hydrodissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 2-10%, resulting in the formation of a hydro-dissected pocket, unlocking the proximal end of the needle from the luer-lock, sliding the catheter between 0.1 to 3.0 cm into the hydrodissected pocket removing the needle from the lumen of the catheter, rotating the catheter in a first direction so as to deploy the one or more tines in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site, activating the pulse generator; establishing communications with the computing device, sealing the insertion site using a surgical glue, applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing closing the injection port with a clave, connecting a syringe to the injection port via the clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block, capping the clave with a swab-cap, turning off the pulse generator, conducting surgery at the surgical site, after surgery, activating the pulse generator, and establishing communications between the pulse generator and the computing device. Via the touchscreen display interface: selecting or adjusting the polarity of the electrodes, selecting or adjusting any and all of the pulse duration and pulse frequency, setting upper and lower stimulation current thresholds, selecting the at least two electrodes for use in delivering the electric pulses, and initiating or stopping pulse delivery.

[0009] In such embodiments: the scale of current delivery is between 1-100, wherein a setting of 1 corresponds to a pulse delivery imperceptible by the patient, the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale, the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain, and depending upon the status of the delivery of pulses, the touchscreen display radiates a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery, and activating the pulse generator upon the patient feeling pain in and/or around the surgical site. Optionally, upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, stopping the delivery of pulses via the computing device, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter. Administering can include removing the swabcap off the clave, uncapping a syringe filled with a prescribed amount of the drug, connecting the syringe to the clave, delivering the prescribed amount of the drug via the clave, and capping the clave with a new SwabCap. In some such embodiments, upon the delivery of a set of electrical pulses of a maximum current and the delivery of a plurality of bolus doses of anesthetic is not adequately addressing pain, the patient may ingest prescribed amount of pain, and upon the cessation of pain from the patient requiring the catheter system: removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed, rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient, and pulling the catheter out from the patient such that the catheter is completely removed from the patient. [0010] In some embodiments, a system for treating pain using a pain management (PM) system, the PM system is provided and includes a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, an injection port, and a lumen, a catheter locking device arranged proximal to the electrodes on the catheter and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient, a housing affixed to and arranged near the proximate end of the catheter, the injection port including a through-channel having a proximal end with luer-lock, the injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter, a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, and at least one pulse generator arranged within the housing and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes and communications means configured to communicate with an external control device.

[0011] In some embodiments, a method of testing or otherwise evaluating a system for treating pain using a pain management (PM) system for use on patients, the method includes inserting a distal end of a needle and a distal end of a catheter through a skin of a patient, so as to test a system for treating pain using a pain management (PM) system, towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve, eliciting a twitch response of a muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle, and hydrodissecting the target nerve from surrounding tissue by injecting a dextrose solution, resulting in the formation of a hydro-dissected pocket. The method can also include, via a touchscreen display interface, adjusting one or more parameters of the pulse generator, causing the pulse generator to deliver a first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the specific designated surgical site, and optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic via the catheter.

[0012] In some embodiments, a method for treating pain using a pain management (PM) system includes inserting a distal end of a needle and a distal end of a catheter through a skin of a patient (catheter-over-needle insertion technique) towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve, eliciting a twitch response of a muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, where the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle. The method also includes hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution, resulting in the formation of a hydro-dissected pocket, and via a touchscreen display interface, adjusting one or more parameters of the pulse generator. The method still further includes causing the pulse generator to deliver a first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the specific designated surgical site, and optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic via the catheter.

[0013] The above noted method embodiments, can also include one and or another of the following structures, steps, function, functionality, or clarifications (and if not mutually exclusive, in some embodiments, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of), yielding yet further embodiments of the present disclosure:

- the catheter includes the at least two electrodes located at the distal end of the catheter and a lumen;

- the pulse generator is affixed to the catheter and configured to provide the first set of electric pulses at a designated frequency, pulse duration, voltage and current to at least two electrodes of the catheter and optionally to the distal end of the needle; an application program operable on a computing device is configured to control the pulse generator, the application program further configured to cause the computing device to display the touch interface for controlling upper and lower stimulation current thresholds for the pulse generator; sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket; removing the needle from the lumen of the catheter; establishing communications between the pulse generator and the computing device; and hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%.

[0014] In some embodiments, a method for testing or otherwise evaluating a pain management (PM) system includes providing a PM system including a catheter, a needle, a housing is affixed to and arranged near a proximate end of the catheter, a first injection port arranged on the catheter including a through-channel that has a proximal end with a luer-lock, a second injection port located at or near the proximal end of the through-channel and having a distal end affixed to a proximal end of the catheter, and an external pulse generator nerve stimulator and/or an external pulse generator. Prior to testing or otherwise evaluating the PM system, the following may be optionally prepared: (1) an insertion site to receive a distal end of the catheter and a distal end of the needle, and (2) a sterile field on a mayo stand or surgical table for placement of the system thereon. The method can include inserting the needle within a lumen of the catheter from an opening in a proximal end of the first injection port of the catheter, wherein the needle is in electrical communication with an external nerve stimulator, and connecting (1) a tube to a proximal end of the needle that is in communication with a needle lumen thereof, and (2) a syringe or other source containing or in fluid communication with a dextrose solution to the tube. The method can further include flushing a lumen of the tube and a lumen of the needle so as to remove air therein optionally using the syringe, testing or otherwise establishing communications between a computing device operating an application program and the external pulse generator via a communications means by turning the pulse generator on and when desired, turning the pulse generator off, inserting the distal end of the needle and catheter through the skin of a patient towards a target nerve under ultrasound or X- ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve, eliciting a twitch response of the muscle innervated by the target nerve via the external pulse generator or the external nerve stimulator to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, hydro-dissecting the target nerve from surrounding tissue by injecting a hydro-dissecting solution resulting in the formation of a hydro-dissected pocket, sliding or otherwise inserting the catheter over the needle in the hydrodissected pocket adjacent to the target nerve, rotating the catheter in a first direction so as to deploy one or more tines of the distal end of the catheter in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site and removing the needle from the catheter, and connecting a syringe to the injection port via a clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block.

[0015] In some embodiments, a method for of treating pain with a pain management (PM) system is provided and includes prior to treating pain, optionally preparing (1) an insertion site to receive a distal end of a catheter and a distal end of a needle, and (2) a sterile field on a mayo stand or surgical table for placement of a PM system thereon. The method further includes inserting the needle within a lumen of the catheter from an opening in a proximal end of a first injection port of the catheter, wherein the needle is in electrical communication with an external nerve stimulator, and connecting (1) a tube to a proximal end of the needle that is in communication with a needle lumen thereof, and (2) a syringe or other source containing or in fluid communication with a dextrose solution to the tube. The method further includes flushing a lumen of the tube and the lumen of the needle so as to remove air therein optionally using a/the syringe, establishing communications between a computing device operating an application program and the external pulse generator and/or an external nerve stimulator via a communications means by turning the external pulse generator and/or external nerve stimulator on and when desired, turning the external pulse generator and/or external nerve stimulator off, inserting the distal end of the needle and catheter through the skin of a patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve, eliciting a twitch response of the muscle innervated by the target nerve via the external pulse generator or the external nerve stimulator to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, hydro- dissecting the target nerve from surrounding tissue by injecting a hydro-dissecting solution resulting in the formation of a hydro-dissected pocket, sliding or otherwise inserting the catheter over the needle in the hydro-dissected pocket adjacent to the target nerve, rotating the catheter in a first direction so as to deploy one or more tines of the distal end of the catheter in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site and removing the needle from the catheter, and connecting a syringe to the injection port via a clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block.

[0016] The above noted method embodiments, can also include one and or another of the following structures, steps, function, functionality, or clarifications (and if not mutually exclusive, in some embodiments, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of), yielding yet further embodiments of the present disclosure: preparing the insertion site further comprises cleaning the insertion site and shaving any hair present;

- the external nerve stimulator is configured to deliver a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle;

- the syringe or other source contains a 2-10% dextrose solution;

- the method further includes treating the skin at the insertion site with chlorohexidine and anesthetizing the skin at the insertion site; hydro-dissecting the target nerve further includes hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%; sealing the insertion site using a surgical glue; applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing; closing the injection port with a clave; capping the clave with a swab-cap; conducting surgery at the surgical site; after surgery, activating the external pulse generator; - via a touchscreen display interface of the computing device, selecting or adjusting the polarity of the electrodes, selecting or adjusting any and all of the pulse duration and pulse frequency, setting upper and lower stimulation current thresholds, selecting the at least two electrodes for use in delivering the electric pulses, and/or initiating or stopping pulse delivery;

- the scale of current delivery is between 1-100, wherein a setting of 1 corresponds to a pulse delivery imperceptible by the patient;

- the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale;

- the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain and corresponds to a 100 on the 1-100 scale; depending upon the status of the delivery of pulses, the touchscreen display radiates a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery; activating the pulse generator upon the patient feeling pain in and/or around the surgical site or source of pain;

- upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by one or more pulses provided by the external nerve stimulator: o administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter, administering can include removing the swabcap off the clave, uncapping a syringe pre- filled with a prescribed amount of the drug, connecting the syringe to the clave, and delivering the prescribed amount of the drug via the clave; and capping the clave with a new SwabCap; upon the delivery of a set of pulses of a maximum current and the delivery of a plurality of bolus doses not adequately addressing pain of the patient, the patient can ingest a prescribed amount of pain medication tablets; - upon the cessation of pain from the patient requiring the catheter system: removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed, rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient, and pulling the catheter out from the patient such that the catheter Is completely removed from the patient.

[0017] In some embodiments, a method for treating pain using a pain management (PM) system, the PM system includes a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, an injection port, and a lumen, a catheter locking device arranged proximal to the electrodes on the catheter and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient, a housing affixed to and arranged near the proximate end of the catheter, the injection port including a through-channel having a proximal end with luer-lock, the injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter, a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, at least one pulse generator arranged within the housing and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes and optionally to the distal end of the needle, communications means configured to communicate with an external control device, and an application program operable on a computing device for controlling at least the pulse generator. In some such embodiments, at least one of the lumen of the catheter and the lumen of the needle is configured to receive at least one of a dextrose solution, a saline solution, an anesthetic, and the application program is configured to cause the computing device to display a touch interface for controlling upper and lower stimulation current thresholds, frequency, and pulse duration for the pulse generator.

[0018] Accordingly, the method can include preparing the insertion site to receive the distal end of the catheter and needle and inserting the needle within the lumen of the catheter from an opening in the proximal end of the injection port. The method can also include one and or another of the following structures, steps, function, functionality, or clarifications (and if not mutually exclusive, in some embodiments, a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of), yielding yet further embodiments of the present disclosure:

- the needle is in electrical communication with an external nerve stimulator,

- the external nerve stimulator is configured to deliver a current of between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; connecting a tube to a proximal end of the through channel; connecting a syringe containing a 2-10% dextrose solution to the tube; flushing the lumen of the tube and lumen of the needle so as to remove air therein using the syringe containing the 2-10% dextrose solution; establishing communications between the computing device and the pulse generator via the communications means by turning on the pulse generator and thereafter, turning off the pulse generator;

- treating the skin at the insertion site with chlorohexidine or suitable skin disinfectant; anesthetizing the skin at the insertion site; inserting the distal end of the needle and catheter (catheter-over needle unit) through the anesthetized skin towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve; eliciting a twitch response of the muscle innervated by the target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 2-10%, resulting in the formation of a hydro-dissected pocket; unlocking the proximal end of the needle from the luer-lock; sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket removing the needle from the lumen of the catheter; rotating the catheter in a first direction so as to deploy the one or more tines in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site; activating the pulse generator; establishing communications with the computing device; sealing the insertion site using a surgical glue; applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing; closing the injection port with a clave; connecting a syringe to the injection port via the clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block; capping the clave with a swab-cap;

- turning off the pulse generator; conducting surgery at the surgical site; after surgery, activating the pulse generator; establishing communications between the pulse generator and the computing device;

- via the touchscreen display interface: o selecting or adjusting the polarity of the electrodes, o selecting or adjusting any and all of the pulse duration and pulse frequency; o setting upper and lower stimulation current thresholds; o selecting the at least two electrodes for use in delivering the electric pulses; and/or o initiating or stopping pulse delivery,

- the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale; - the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain; depending upon the status of the delivery of pulses, the touchscreen display radiates a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery; activating the pulse generator upon the patient feeling pain in and/or around the surgical site;

- upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse; stopping the delivery of pulses via the computing device; administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter, administering can include: o removing the swabcap off the clave, uncapping a syringe filled with a prescribed amount of the drug; o connecting the syringe to the clave; o delivering the prescribed amount of the drug via the clave; capping the clave with a new SwabCap; o upon the delivery of a set of electrical pulses of a maximum current and the delivery of a plurality of bolus doses of anesthetic is not adequately addressing pain, the patient may ingest prescribed amount of pain, and/or o upon the cessation of pain from the patient requiring the catheter system: removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed; rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient; and pulling the catheter out from the patient such that the catheter is completely removed from the patient.

[0019] These and other embodiments, inventions, and objects and advantages thereof, will become even more clear by reference to the figures, a brief description of which is below, and following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 is a block diagram illustrating system for anesthesia delivery and nerve stimulation for pain management, according to some embodiment.

[0021] FIG. 2 is a block diagram illustrating a computing device compatible in the system of FIG. 1, according to some embodiments.

[0022] FIG. 3 is a flow diagram of a method for anesthesia delivery and nerve stimulation for pain management, according to some embodiment.

[0023] FIG. 4 is a flow diagram of another method for anesthesia delivery and nerve stimulation for pain management, according to some embodiment.

[0024] FIG. 5 is a schematic illustration of the system of FIG. 1, according to some embodiment.

[0025] FIG. 6 is a schematic illustration of a catheter compatible in the system of FIG. 1, according to some embodiment.

[0026] FIG. 7 is an illustrative representation of a placement of the catheter compatible in the system of FIG. 1, according to some embodiment.

[0027] FIG. 8 is a schematic illustration of an assembly of a needle compatible with the in the system of FIG. 1, according to some embodiment.

[0028] FIG. 9 is a schematic illustration of a pulse generator compatible in the system of FIG. 1, according to some embodiment.

[0029] FIGs. 10A-10B, illustrates example representations of a mobile application for communicating with a pulse generator compatible in the system of FIG. 1, according to some embodiment.

[0030] FIG. 11 illustrates example representations of ultrasound images of injected anesthetic solutions absorbed at an injection site within one to two hours, according to some embodiment.

[0031] FIG. 12 illustrates an example representation of the system of FIG. 1 in action on nerve fibers, according to some embodiment.

[0032] FIG. 13 is a flow diagram of another method for anesthesia delivery and nerve stimulation for pain management, according to some embodiment.

[0033] FIG. 14 is a flow diagram of another method for anesthesia delivery and nerve stimulation for pain management, according to some embodiment. DETAILED DESCRIPTION

[0034] In some embodiments, a system is provided which is configured to deliver prolonged anesthesia and analgesia and nerve stimulation for pain management during any of the preoperative, perioperative and post-operative period in upper and lower extremities and other locations of the body. In some cases, the system can deliver prolonged anesthesia, analgesia and/or nerve stimulation for pain management for days (in some embodiments, up to 30 or more days). In some implementations, the system can deliver anesthesia and analgesia for up to 72 hours and peripheral nerve stimulation for symptomatic relief of post-surgical, post- traumatic or chronic pain for up to 30 days. In some embodiments, the system can include a device for placement next to peripheral nerves and nerve plexuses of a patient.

[0035] FIG. 1 is a block diagram illustrating system 100 for anesthesia delivery and nerve stimulation for pain management, according to some embodiment. The system 100 can include a catheter 110, a needle 120, a catheter locking device 130, a pulse generator 140, and/or a computing device 101. The computing device 101 can include a processor 102 and a memory 103 operatively coupled to the processor 102. The computing device 101 can also include a touch interface 104 and an application program 105 operatively coupled to the processor 102 and/or the memory 103.

[0036] The memory 103 can store instructions that can cause processor 102 to execute modules, processes, programs, devices, and/or functions such as, for example, for displaying a touch interface 104 for controlling upper and lower stimulation current thresholds for the pulse generator 140. In some implementations, the memory 103 can also store programs and/or applications associated with an operating system (e.g., power management, memory allocation, etc.). In some implementations, the application program 105 can be operable on the computing device 101 for controlling the pulse generator 140. In some cases, the application program 105 can be configured to cause the computing device 101 to display the touch interface 104 (on a screen) for controlling upper and lower stimulation current thresholds, pulse duration and frequency for the pulse generator 140.

[0037] The catheter 110 can include a proximal end 111, a distal end 112, one or more electrodes 113, a lumen 114, a leur-lock 115, and/or an injection port 116. In some implementations, the catheter 110 can include at least two electrodes 113 located at the distal end 112 and the lumen 114. In some implementations, a housing 117 can be affixed to and/or arranged the proximal to the electrodes 113 on the catheter 110. The injection hub 116 can include a through-channel having a proximal end with the leur-lock 115. In some cases, the injection port 116 can be located at or near the proximal end of the through-channel and the distal end 112 can be affixed to the proximal end 111 of the catheter 110.

[0038] The catheter locking device 130 can include one or more fixation tines 131 (also referred to herein as "tines"). Embodiments related to the fixation tines can be found in PCT application no. PCT/US2024/013542, the entire disclosure of which is incorporated by reference herein in its entirety. In some implementations, the catheter locking device 130 can be arranged near the proximal end 111 of the catheter 110 and configured, via rotation, to project one or more tines 131 for locking the catheter 110 in place relative to a tissue of a patient.

[0039] The needle 120 can include a proximal end 121, a distal end 122, a lumen 124, and a leur-lock 125. In some implementations, the needle 120 can be configured for removable insertion into the lumen 114 of the catheter 110. The proximal end 121 of the needle 120 can be configured to mate and/or lock with the leur-lock 125 of the needle 120. The distal end 122 of the needle 120 can be configured to protrude past the distal end 112 of the catheter 110 when inserted within the lumen 114 of the catheter.

[0040] The pulse generator 140 can be configured to generate electrical pulses 141. In some implementations, the system 100 can include at least one pulse generator. The pulse generator 140 can be arranged within the housing 117 and configured to provide at least a first set of electrical pulses 141 at a designated frequency, pulse duration, and current to the at least the two electrodes 113. In some implementations, the pulse generator 140 can include or be electorally coupled to an external nerve stimulator (also referred to herein as "external stimulator" see ref. no. 508, FIG. 5) that is configured to manage and/or control the electrical pulses 141 to be used for nerve stimulation.

[0041] In some embodiments, the distal end 122 of the needle 120 and the distal end 112 of the catheter 110 can be inserted through a skin of a patient towards a target nerve under ultrasound or X-ray guidance. The skin at the insertion site of the patient can be treated with chlorohexidine, and/or the skin can be anesthetized at the insertion site.

[0042] In some cases, the nerve can correspond to communicating nerve impulses to and from a specific designated surgical site or source of pain in the patient. In some implementations, the distal end 112 of the catheterllO can be guided such that the distal end 122 of the needle 120 is adjacent to a muscle or tissue of the patient and that is proximate to the target nerve.

[0043] In some implementations, the system can include functionality to elicit a twitch response of the muscle to confirm that the distal end 112 of the catheter 110 is located in a suitable position to provide neuromodulation to the target nerve. In some cases, such twitch responses can be elicited via electrical communication between the distal end 122 of the needle 120 and an external nerve stimulator (which can be, in some embodiments, the external nerve stimulator, and/or a separate electrical providing device, together “electrical pulse means”) electrically connected to the proximal end 121 of needle 120. Accordingly, electrical pulses can be delivered via the distal end 122 of the needle 120, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end 122 of the needle 120.

[0044] In some implementations, the target nerve from surrounding tissue of the patient can be hydro-dissected by an injection of a dextrose solution between, for example, 3 - 10%, resulting in the formation of a hydro-dissected pocket of fluid. In some cases, the catheter can be slid between, for example, 0.1 to 3.0 cm into the hydro-dissected pocket. In some cases, the needle 120 can be removed from the lumen 114 of the catheter 110. Communication between the pulse generator 140 and the computing device 101 can be established. The communication established between the computing device 101 and the pulse generator 140 can be established and/or tested/evaluated by turning the pulse generator 140 on, and thereafter, turning off the pulse generator 140 (i.e., after use).

[0045] In some embodiments, via the touch interface 104 (or touchscreen display interface), a user (e.g., doctor, nurse, medical professional, etc.) can adjust one or more parameters of the pulse generator 140. In some cases, the pulse generator 140 delivers the first set of electrical pulses 141 in accordance with the one or more parameters upon the patient feeling pain in and/or around the surgical site. In some cases, the user can optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the electrical pulse 141, administer at least one bolus dose of a prescribed amount of at least one of a local anesthetic solution and an adjuvant or narcotic (together "drug") via the catheter 110.

[0046] In some embodiments, a user (e.g., doctor, nurse, medical professional, etc.) can prepare an insertion site of the patient such that the patient can receive, at the insertion site, the distal end 112 of the catheter 110 and the distal end 122 of the needle 120. In some cases, preparing can include cleaning the insertion site and shaving any hair present around the insertion site of the patient. In some cases, the user can prepare a sterile field on a mayo stand or surgical table for placement of the system 100 including, including the catheter 110 and the needle 120. One of skill in the art will understand that a “mayo stand” (a small, movable stand or table configured to hold instruments and supplies during surgery) and a “surgical table” (a table for holding and retaining a patient in place during surgery) are well known structures used in medical procedures/surgery.

[0047] In some embodiments, the needle 120 can be inserted within the lumen 115 of the catheter 110 from an opening in the proximal end of the injection port 116. A tube can be connected to the proximal end of the through-channel of the injection hub 116. In some cases, a syringe containing, for example, 2-10% dextrose solution can be connected to the tube. In some cases, a lumen and the lumen 124 of the needle 120 can be flushed as to remove air therein using the syringe. In some cases, the syringe can be connected to the injection port 116 via the clave and a local anesthetic solution can be injected through the catheter 110 so as to deliver the anesthetic solution to the target nerve (in some embodiments, the syringe can create a primary nerve block). Note, one of skill in the art is very familiar with medical syringes for withdrawing, injecting/dispensing and transferring fluids, as well as a clave (a device for connection between systems and/or devices, e.g., IV spikes) and a swab cap.

[0048] In some embodiments, the proximal end 121 of the needle 120 can be unlocked from the leur-lock 125. The catheter 110 can be slid between, for example, 0.1 to 3.0 cm into the hydro-dissected pocket. The needle 120 can be removed from the lumen 114 of the catheter 110. In some embodiments, the pulse generator 140 can be activated by the user or the patient. The pulse generator 140 can establish communication with the computing device 101 such that the upper and lower stimulation current thresholds for the pulse generator 140 can be established via the touch interface 104 displayed by the computing device 101.

[0049] In some embodiments, the catheter 110 can be rotated in a first direction so as to deploy the one or more tines 131 in the tissue of the patient at the insertion site to substantially anchor the catheter 110 in place within the tissue proximate the insertion site. In some cases, the insertion site can be sealed using a surgical glue. In some cases, a waterproof dressing can be applied to cover the insertion site, wherein the housing 117 and the injection port 116 can be arranged outside the waterproof dressing. In some cases, the injection port 116 can be closed with a clave. In some embodiments, the clave can be capped with a swab-cap. The pulse generator 140 can then be turned off and surgery can be conducted at the surgical site (according to some embodiments). After surgery, the pulse generator 140 can be activated, which can be accomplished by a user (e.g., doctor, nurse, medical professional, etc.) via the touchscreen display interface 104. The interface can also be used, in some embodiments, to adjust polarity of the electrodes 113, selecting or adjusting any and all of the pulse duration and pulse frequency, setting upper and lower stimulation current thresholds, selecting the at least two electrodes 113 for use in delivering the electric pulses, and/or initiating or stopping pulse delivery. One of skill in the art is very familiar with the structures which correspond to a clave and a swab cap.

[0050] In some embodiments, the scale of current delivery can be between, for example, 1- 100, 1-90, 1-80, 1-70, 1-60, 1-50, 1-40, 1-30, 1-20, 1-10, and ranges therebetween. In some embodiments, a setting of 1 corresponds to a pulse delivery imperceptible or barely perceptible by the patient. In some cases, a lower stimulation current threshold can be determined by initiating pulses at a lower current and/or at a first setting, and gradually increasing the current up to a second setting (or subsequent settings) at which the patient can initially feel one or more pulses. In some cases, the upper stimulation current threshold can be determined by increasing the current setting from the second setting to a third setting (or subsequent settings) at which the patient experiences discomfort or pain. In some cases, the pulse duration and frequency settings of the pulse generator 140 can be changed to change the morphology of the electrical pulse 141 before establishing the lower stimulation current and upper stimulation current. Depending upon the status of the delivery of pulses, the touchscreen display interface 104 can radiate a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery.

[0051] In some embodiments, the pulse generator 140 and/or the nerve stimulator can be activated upon the patient feeling pain in and/or around the surgical site of the patient. Optionally, upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the electrical pulse, at least one bolus does of a prescribed amount of at least one of a local anesthetic and an adjuvant or narcotic (e.g., drug) via the catheter 110 can be administered. In some embodiments, administering the drug can include removing the swab-cap (e.g., SwabCap®) off the clave, uncapping a syringe filled with a prescribed amount of the drug, connecting the syringe to the clave, delivering the prescribed amount of the drug via the clave, and capping the clave with a new SwabCap® should the delivery of a set of pulses of a maximum current and the delivery of a plurality of bolus not adequately addressing pain of the patient; optionally, the method can include ceasing the delivery of electrical pulses 141 from the pulse generator 140 (or the nerve stimulator) and, in some embodiments, ingesting a prescribed amount of pain medication, and/or the like.

[0052] In some cases, upon the cessation of pain from the patient, the waterproof dressing can be removed, the skin and the insertion site of the patient can be cleaned such that the surgical glue is removed, so that the catheter 110 can be rotated in second direction that is opposite to the first direction such that the tines 131 can collapse and release the catheter 110 from the tissue of the patient. Thereafter, the catheter 110 can be pulled out and completely removed from the patient, and/or the like.

[0053] FIG. 2 is a block diagram illustrating system 200 of a computing device 201 compatible in the system 100 of FIG. 1, according to some embodiments. The system 200 can also include an input device 220, an output device 222, a portable computer readable storage media 226, and/or a network 230. As shown in FIG. 2, the computing device 201 can include one or more processor(s) 202 (e.g., microprocessors, CPUs, GPUs, etc.), one or more computer- readable RAMs 204, one or more computer-readable ROMs 206, one or more computer readable storage media 208, device drivers 212, read/write drive or interface 214, network adapter or interface 216, and/or the like and interconnected over a communications fabric. In some cases, the network adapter 216 can communicate with the network 230. In some implementations, the communications fabric can be implemented with any architecture designed for passing data and/or control information between processors (such as microprocessors, communications and network processors, etc.), system memory, peripheral devices, and any other hardware components within a system.

[0054] In some implementations, the computing device 201 can include one or more operating systems 210 and one or more application programs 211 configured to perform embodiments described herein, can be stored on one or more of the computer readable storage media 208 for execution by one or more of the processor(s) 202 via one or more of the respective RAMs 204 (which typically include cache memory). In some implementations, the processor(s) 202 can be consistent with the processor 102 of FIG. 1. In some embodiments, each of the computer readable storage media 208 may be a magnetic disk storage device of an internal hard drive, CD-ROM, DVD, memory stick, magnetic tape, magnetic disk, optical disk, a semiconductor storage device such as RAM, ROM, EPROM, flash memory or any other computer-readable medium (e.g., a tangible storage device) that can store a computer program and digital information. [0055] In some implementations, the computing device 201 can also include a read/write (R/W) drive or interface 214 to read from and write to one or more portable computer readable storage media 226. In some implementations, the application programs 211 can be stored on one or more of the portable computer readable storage media 226, read via the respective R/W drive or interface 214 and loaded into the respective computer readable storage media 208. In some implementations, the computing device 201 can also include a network adapter or interface 216, such as a Transmission Control Protocol (TCP)/Internet Protocol (IP) adapter card or wireless communication adapter (such as a 4G wireless communication adapter using Orthogonal Frequency Division Multiple Access (OFDMA) technology). For example, application programs 211 can be downloaded to the computing device 201 from an external computer or external storage device via a network (for example, the Internet, a local area network or other wide area network or wireless network) and network adapter or interface 216. From the network adapter or interface 216, the programs can be loaded onto computer readable storage media 208. In some implementations, the network 230 can include copper wires, optical fibers, wireless transmission, routers, firewalls, switches, gateway computers and/or edge servers. In some implementations, the computing device 201 can also include one or more output devices or interfaces 220 (e.g., a display screen), and one or more input devices or interfaces 222 (e.g., keyboard, keypad, mouse or pointing device, touchpad). For example, device drivers 212 can interface to output devices or interfaces 220 for imaging, to input devices or interfaces 222 for user input or user selection (e.g., via pressure or capacitive sensing), and so on. The device drivers 212, R/W drive or interface 214 and network adapter or interface 216 can also include hardware and software (stored on computer readable storage media 208 and/or ROM 206).

[0056] FIG. 3 is a flow diagram of a method 300 for anesthesia delivery and nerve stimulation for pain management, according to some embodiment. In some embodiments, the steps of the method 300 can be performed by a user (e.g., doctor, nurse, medical professional, etc.). In some embodiments, the method 300 can be performed using the system of FIG. 1. At 305, the method 300 includes inserting a distal end of a needle and a distal end of a catheter through a skin of a patient towards a target nerve under ultrasound or X-ray guidance. The target nerve can correspond to communicating nerve impulses to and from a specific designated surgical site.

[0057] At 310, the method 300 includes guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve. In some embodiments, the method 300 can also include guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve.

[0058] At 315, the method 300 includes eliciting a twitch response of the muscle to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve. The twitch response can be elicited via electrical communication between the distal end of the needle and an external nerve stimulator. In some cases, the external nerve stimulator can be configured to deliver, via the distal end of the needle, a current between 1.0- 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle.

[0059] At 320, the method 300 includes hydro-dissecting the target nerve from surrounding tissue using a dextrose solution of between 3-10%, resulting in the formation of a hydro-dissected pocket. In some instances, the hydro-dissected pocket can include a hydrodissected pocket of fluid.

[0060] At 325, the method 300 can include sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket. At 330, the method 300 includes removing the needle from the lumen of the catheter. At 335, the method 300 includes establishing communication between the pulse generator and a computing device. At 340, the method 300 includes, via a touchscreen display interface (for example) of the computing device, adjusting one or more parameters of the pulse generator. At 345, the method 300 includes causing the pulse generator to deliver a first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the specific designated surgical site.

[0061] At 3500, the method 300 includes optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the first set of electrical pulses, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter. FIG. 4 is a flow diagram of another method 400 for anesthesia delivery and nerve stimulation for pain management, according to some embodiment. In some embodiments, the steps of the method 400 can be performed by a user (e.g., doctor, nurse, medical professional, etc.). In some embodiments, the method 400 can be performed using the system of FIG. 1. At 405, the method 400 includes preparing (1) an insertion site to receive a distal end of a catheter and a distal end of a needle and (2) a sterile field on a mayo stand or surgical table for placement of the system thereon, a housing is affixed to and arranged near the proximate end of the catheter, an injection port of the catheter including the through-channel that has a proximal end with luer-lock. The injection port can be located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter. In some implementations, the preparing can include cleaning the insertion site and shaving any hair present.

[0062] At 410, the method 400 includes inserting the needle within a lumen of the catheter from an opening in a proximal end of a hub of the catheter, wherein the needle is in electrical communication with a pulse generator or an external nerve stimulator. In some implementations, external nerve stimulator can be configured to deliver a current between 1.0- 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle. In some implementations, the needle can be connected to the external nerve simulator.

[0063] At 415, the method 400 includes connecting (1) a tube to a proximal end of a through- channel of the hub and (2) a syringe containing a dextrose solution to the tube. In some implementations, the syringe can contain a 2-10% dextrose solution. At 420, the method 400 includes flushing a lumen through the tube and a lumen of the needle so as to remove air therein using the syringe. At 425, the method 400 includes testing or otherwise establishing communications between a computing device operating an application program and the pulse generator via the communications means by turning on the pulse generator and thereafter, turning off the pulse generator. In some embodiments, the method 400 can also include treating the skin at the insertion site with chlorohexidine or a suitable skin disinfectant and anesthetizing the skin at the insertion site or source of pain.

[0064] At 430, the method 400 includes inserting the distal end of the needle and catheter (catheter-over needle unit) through a skin of a patient towards a target nerve under ultrasound or X-ray guidance. The target nerve can correspond to communicating nerve impulses to and from a specific designated surgical site. At 435, the method 400 includes guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve. At 440, the method 400 includes eliciting a twitch response of the muscle innervated by the target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve.

[0065] At 445, the method 400 includes hydro-dissecting the target nerve from surrounding tissue via a dextrose solution resulting in the formation of a hydro-dissected pocket. In some implementations, hydro-dissecting the target nerve from surrounding tissue can include hydrodissecting the target nerve by injecting the dextrose solution of between 2 - 10%. In some embodiments, the method 400 can also include unlocking the proximal end of the needle from the luer-lock, sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket, removing the needle from the lumen of the catheter, activating the pulse generator, and/or establishing communications with the computing device.

[0066] At 450, the method 400 includes rotating the catheter in a first direction so as to deploy the one or more tines in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site. In some implementations, the method 400 can include activating the pulse generator (and/or nerve stimulator) and establishing communications with the computing device. In some embodiments, the method 400 can also include sealing the insertion site using a surgical glue, applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing, and/or closing the injection port with a clave.

[0067] At 455, the method 400 includes connecting a syringe to the injection port via a clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block. In some embodiments, the method 400 can also include capping the clave with a swab-cap, turning off the pulse generator, conducting surgery at the surgical site, after surgery, activating the pulse generator, and/or establishing communications between the pulse generator and the computing device. At 460, the method 400 includes establishing communications between the pulse generator and the computing device. In some cases, establishing communications between the pulse generator and the computing device includes establishing communications between the nerve stimulator and the computing device.

[0068] In some embodiments the method 400 can include, via a touchscreen display interface of the computing device (for example), selecting or adjusting the polarity of the electrodes, selecting or adjusting any and all of the pulse duration and pulse frequency, setting upper and lower stimulation current thresholds, selecting the at least two electrodes for use in delivering the electric pulses, and initiating or stopping pulse delivery. In some implementations, the scale of current delivery can be between 1-100, where a setting of 1 corresponds to a pulse delivery imperceptible by the patient. In some cases, the lower stimulation current threshold can be determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses. In some embodiments, the lower stimulation current threshold can correspond approximately to a 20 on the 1-100 scale (for example, and according to some embodiments). In some implementations, the upper stimulation current threshold can be determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain. Depending upon the status of the delivery of pulses, the touchscreen display interface can radiate a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery. In some implementations, the pulse generator can be activated upon the patient feeling pain in and/or around the surgical site.

[0069] In some embodiments, optionally, upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the electrical pulse, can administer at least one bolus dose of a prescribed amount of at least one of a local anesthetic solution and an adjuvant (together "drug") via the catheter. In some cases, administering the at least one bolus dose can include removing the swab-cap (e.g., SwabCap®) off the clave, uncapping a syringe filled with a prescribed amount of the drug, connecting the syringe to the clave, delivering the prescribed amount of the drug via the clave, and capping the clave with a new SwabCap®. In some implementations, upon the delivery of a set of electrical pulses of a maximum current and the delivery of a plurality of bolus doses of anesthetic is not adequately addressing pain of the patient.

[0070] In some embodiments, upon the cessation of pain from the patient requiring the catheter system, the method 400 can also include removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed, rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient, and/or pulling the catheter out from the patient such that the catheter is completely removed from the patient.

[0071] FIG. 5 is a schematic illustration of the system of FIG. 1, according to some embodiment. As shown in FIG. 5, system 500 can be or include a pain management system as described herein. In some cases, the pain management system can include an anchoring apparatus. In some cases, the system 500 can also be referred to as a "relay system” (“relay system” and “pain management system” can be used interchangeably throughout the subject disclosure). The relay system 500 can include a catheter assembly 505 (also referred to as a "catheter", or “catheter needle” assembly 501 (also referred to as a "needle") and/or a gatekeeper application (in some embodiments, 501 may simply be a tube having a proximal end for connection to a fluid source and a distal end for connection to the pulse generator. Accordingly, in some embodiments, the system can also include a connector and/or injection port 501a (which can be a “first” or a “second” injection port depending upon use or description), and a connector and/or injection port 503a (which can be a “first” or a “second” injection port depending upon use or description). In some embodiments of the present disclosure, a pain management system corresponding to those disclosed in PCT publication no. WO/2022/221452A1 (“the ‘452 PCT”) can be used or pain management systems similar thereto or components thereof (mixed with components of the subject disclosure), and in some embodiments, electrode arrangement as disclosed in the ‘452 PCT.

[0072] In some embodiments, the catheter assembly 505 can be integrated into an externally placed pulse generator 504. In some instances, an active needle assembly 501 can serve as a guide to place the catheter assembly 505 at a target nerve site of a patient. The gatekeeper app can be or include, for example, a software application that can be deployed on mobile devices in which a user (e.g., doctor, physician, nurse, medical professional, etc.) can program the pulse generator 504 to control the intensity of nerve stimulation (or peripheral nerve stimulation) for the patient via generated pulses.

[0073] In some embodiments, the relay system can also include a connection for an external stimulator 508 (which can also be the external pulse generator 504), a leur-lock connector 503, fixation-tines 506 (also referred to as "tines"), and/or stimulation electrodes 507 (also referred to as "electrodes").

[0074] In some embodiments, the relay system 500 can utilizes two modes of analgesia to address a full acute pain episode following surgery: 1) neuromodulation via percutaneous electrical stimulation; and 2) local delivery of anesthetic solution (Sodium channel blockade). In some cases, the catheter assembly 505 can be inserted into a tissue and/or subcutaneous tissue using, for example, a catheter-over-needle technique, and a tip or end of the catheter (where the stimulation electrodes 507 reside) can be placed adjacent to a target nerve of the patient using guided ultrasound. In some implementations, once a minimum and/or maximum stimulation current thresholds have been measured and programmed into the gatekeeper app, a bolus of local anesthetic injection can be administered to create a primary conduction nerve block. The local anesthetic solution can bathe the nerves of the patient, and molecules of the local anesthetic solution can attach to the sodium-potassium channel to induce a conduction nerve block. This blockade at the molecular (receptor) site can persist for 16-24 hours with a long-acting local anesthetic solution. In some cases, the excess local anesthetic solution at the site of injection can be absorbed and removed very quickly by the blood supply to the perineural tissues. In some cases, signals causing stimulation can pass through the connection 502 for external stimulator 508. [0075] In some implementations, the leur-lock connector 503 (also referred to as a "leur-lock") can be a mechanism used to securely connect the needle assembly 501, the external pulse generator 504, the catheter assembly 505, and/or an external simulator. In some cases, the leur-lock connector 503 can include a male and female fitting with interlocking threads that create a tight seal when twisted together. The leur-lock connector 503 can allow for easy and reliable connections between various devices and ensuring leak-free fluid transfer.

[0076] In some embodiments, the fixation-tines 506 can be or include, for example small, flexible extensions or protrusions located near a distal end of the catheter assembly 505. In some cases, the fixation-tines 506 can be designed to help secure the catheter assembly 505 in place once it is inserted into the body of a patient. The fixation-tines 506 can be typically made of a flexible material, such as, for example, silicone, and have a slightly curved shape. The fixation- tines 506 can be gently pressed against the surrounding tissue, anchoring the catheter assembly 505 and preventing it from unintended movement or dislodgement.

[0077] In some embodiments, the duration of the primary conduction nerve block can usually last 18-24 hours for long-acting agents such as, for example, Bupivacaine® or Ropivacaine®. This conduction block can control the severe pain that is experienced in the first 24 hours after surgery. At the time of discharge from a recovery room (3-6 hours after surgery), the pulse generator 504 can be turned "ON" at 25th percentile current intensity within the minimum and maximum stimulation current range.

[0078] As the primary conduction nerve block wears off (resolves), in some embodiments, neuromodulation via electrical stimulation can continue to provide post-operative analgesia for up to 30 days. The patient, in some embodiments, has the ability to dial up or down the intensity of stimulation to match the pain levels via the gatekeeper app. For instance, if the patient experiences transient episodes of severe break-through pain within the 72 hours, the patient or user can inject 3mL bolus of Bupivacaine 0.25% via the relay system to induce a conduction block and control the pain. At the time of discharge from the recovery room, both modalities of conduction nerve block and peripheral nerve stimulation (neuromodulation) can be used concurrently influencing the nerve. Subsequently, if 3 mL bolus of Bupivacaine 0.25% is injected, concurrent use cab occur until the effect of the 3 mL bolus dissipates. In some cases, the patient can be sent home with three (3) prefilled syringes with Bupivacaine® or Ropivacaine® that is provided by a healthcare facility. In some cases, syringes can be compatible with a Convenience Kit® devices and the proximal port of the catheter assembly 505. In some cases, these are not part of the relay system 500 but can be used with the relay system 500 to achieve its intended use.

[0079] In some embodiments, to ensure safe use of the relay system 500, the relay system 500 can be inserted using universal barrier precautions. For instance, an anesthesiologist can mask, cap, gown, and glove after washing hands. The skin of a patient can be prepped with chlorhexidine 2% solution and draped in sterile fashion. The ultrasound transducer can be enclosed in a sterile sleeve. The site of skin puncture can be sealed with wound closure adhesive (2-Octyl 2-cyanoacry-late). The injection port of the catheter assembly 505 can be connected via luer-lock 503 with, for example, a MicroClave® clear neutral connector and capped with Swab Cap®. The relay system 500 can be covered by a chlorohexidine impregnated Tegaderm®. In some embodiments, to ensure safe use of the relay system 500 in- hospital/surgical-center and at home, a dressing can be placed over the access site to prevent infection. The relay system 500 can include a convenience kit (procedure support tray) which can include FDA- cleared devices and can be used in accordance with the FDA-cleared labeling. For example, the FDA-cleared devices can include a Swab Cap (Excelsior Medical Corp.®) having a 510(k) clearance K1309975, a MicroClave® Clear Neutral Connector (ICU Medical, Inc.®) having a 510(k) clearance ofK090189, and Tegaderm (3M®) having a 510(k) clearance ofK200835.

[0080] In some embodiments, the relay system 500 can utilize two modes of analgesia to address the full acute pain episode following surgery: neuromodulation induced by peripheral nerve electrical stimulation and local delivery of anesthetic solution (Sodium channel blockade). Both can be well established and in extensive clinical. For instance, neuromodulation can disrupt the transmission of pain signal to higher brain centers. Pain signals, originating in the periphery, are transmitted via small-diameter nerves C fibers and Ao fibers, to the Dorsal Horn of spinal cord where these fibers synapse with secondary neurons that transmit the sensation of pain to higher centers of the nervous system. Neuromodulation can block this synaptic transmission through the activation of the large, fast A fibers in the nerve trunk with electrical stimulation. The activity of A fiber in the Dorsal Horn can have an inhibitory effect on synaptic activity of C fibers and Ao fibers, effectively disrupting the propagation of pain signals to higher centers (Gate Theory). Using neuromodulation, the relay system 500 can activate A fibers to inhibit propagation of pain signals to the higher brain centers. [0081] In addition to the use of neuromodulation, the relay system 500 can utilize the delivery of local anesthetic solution. These solutions (Bupivacaine or Ropivacaine) work by inactivating molecular channels (sodium-potassium pump) in the neuronal membrane. The signaling mechanism (the action potential) does not propagate, and the pain signal is not delivered to higher centers. FIG. 6 is a schematic illustration of a catheter 600 compatible in the system of FIG. 1, according to some embodiment. The catheter 600 (or catheter assembly). The catheter 600 can include a catheter hub 601 (e.g., injection port), a strain relief 602, a catheter body 603, fixation-tins 604 and/or electrodes 606.

[0082] In some embodiments, the catheter 600 can be composed of a flexible conduction catheter made of PEBAX®, with three electrodes 606 at the distal end of the catheter 600. A custom fixation-tine structure (also made of PEBAX®), can be proximal to an end of the catheter 600. The electrodes 606 can be connected to an electrical pulse generator as described herein and can have a reversible polarity of cathode and anode. In some implementations, the electrodes 605 can be placed adjacent to a target nerve 701 of a patient for neuromodulation, which can be shown in FIG. 7. In some implementations, the fixation-tines 604 can be intended to prevent catheter migration. The fixation-tines 604 can remain in a collapsed position upon insertion and deployed when the catheter 600 (or proximal catheter) is rotated counterclockwise. At the time of removal, a proximal end of the catheter 600 can be rotated clockwise continuously to collapse the tines, while the catheter 600 is slowly withdrawn from tissue of the patient. In some implementations, a conduction catheter can also have a proximal injection port (catheter hub 601) and a distal exit port at the end of the catheter 600. The distal end of the catheter 600 can be positioned adjacent to the nerve such that local anesthetic solution injected through the catheter hub 601 induces a conduction nerve block.

[0083] In some embodiments, the strain relief 602 of the catheter 600 can include a component, feature, and/or mechanism designed to provide support and protect the catheter 600 from excessive stress or tension at the point where it connects to an external device or tubing. The strain relief 602 can typically be a flexible section or structure incorporated into the catheter 600. The strain relief 602 can be configured to help distribute forces and prevent strain or damage to the catheter 600 or catheter body 603 at the junction, which could occur due to pulling, bending, or twisting of the tubing.

[0084] FIG. 7 is an illustrative representation of a placement of the catheter compatible in the system of FIG. 1, according to some embodiment. As shown in FIG. 7, a catheter can be placed on a target nerve and electrodes of the catheter can be placed adjacent to the target nerve for neuromodulation.

[0085] FIG. 8 is a schematic illustration of an assembly of a needle compatible within the system of FIG. 1, according to some embodiment. A needle assembly 800 can include a needle 801, a needle coating 802, a luer-lock 803, a touch proof connector 804 (e.g., for connection to an external stimulator, see FIG. 5, ref. no. 508), a needle housing 805, an administrative tubing 806, and/or an end cap 807. The needle 801 can be a 304 stainless steel guide needle that is positioned inside a catheter as described herein, prior to relay system of FIG. 5 being inserted using "catheter-over-needle." In some implementations, ultrasound guidance can be used to direct a needle-catheter assembly towards a target nerve. In some instances, a clinician can use a combination of ultrasound guidance and nerve stimulator (external) to position the end of the needle 801 close to the nerve as is the case for conduction catheters. In some cases, if a nerve stimulator (e.g., pulse generator) is used, the needle 801 (which can include, and in some embodiments, preferably includes a lumen therein) can be connected to the nerve stimulator via 804a to deliver electrical pulses to evoke muscle twitches as the needle 801 approaches the target nerve. Once the end of the needle 801 is close to the target nerve, a 1-5 mL bolus of dextrose 5% solution can be injected to create a pocket of fluid around the target nerve. The catheter can subsequently be slid over the needle 801 to position the catheter 0.1 to 1.5 cm beyond the end of the needle 801 in the pocket of fluid next to the target nerve. Once the catheter is satisfactorily placed, the needle 801 can be, tines of the catheter can be deployed to hold the catheter in place and mitigate catheter migration. In some embodiments, the catheter can be left in place for up to 30 days (in some embodiments, longer).

[0086] FIG. 9 is a schematic illustration of a pulse generator 900 compatible in the system of FIG. 1, according to some embodiment. The pulse generator 900 can be configured to deliver an electrical signal of specific intensity, frequency, and pulse duration. The pulse generator 900 can be programmed to deliver electrical pulses for neuromodulation with a frequency between l-4999Hz, a pulse duration between 0.1-1.0ms, a current between 0. ImA-lOmA, a waveform that is biphasic rectangular with a positive and negative phase that is charge balanced, and/or the like. The pulse generator can include various connectors to be incorporated into the pain management system (e.g., 500, see FIG. 5), including a distal connector 902 and a proximal connector 904 (in some preferred embodiments, a through channel (partially shown as 906) is included to allow the fluid and electrical communication through the device (for example). [0087] In some implementations, once a catheter has been positioned in proximity to a target nerve of a patient, the pulse generator 900 can be configured to turn "ON." In some cases, the pulse generator 900 can have settings (e.g., default start settings) such as, for example, a current at 0 milli-Amperes, a frequency at 100 Hertz, a pulse duration of 0.1 milli-seconds, and/or the like.

[0088] In some implementations, the current (milli-amperes) can then be gradually increased until the patient first notices a paresthesia or "buzzing" sensation at the site of the catheter insertion or along the distribution of the target nerve or at the site of surgery. In some implementations, this can be defined as the Minimum Threshold Current (MTC). The current can then be increased further until the patient feels the paresthesia intensely (tolerable but not painful). This can be Maximal Stimulation Current (MSC) for the patient. The initial setting of the nerve stimulator or pulse generator 900 can be the 25-percentile between the MTC and MSC. The electrical pulse generator will be programmed so that the patient cannot dial a current above the MSC. Once the threshold currents are determined, local anesthetic can be injected through the catheter to induce a conduction nerve block to control the early severe post-operative pain.

[0089] FIGs. 10A-10B, illustrates example representations of a mobile application for communicating with the pain management system, and in particular (in some embodiments), communicating with the pulse generator; FIG. 10A, ref. nos. 1-6, show a number of screens illustrating, for example, initiating and confirming communication connection between the application/mobile device and the pain management system, and ref. no. 7 illustrating, for example, the status of the system. To this end, FIG. 10B is an enlargement of the screen no. 7, showing the various statuses of the system (e.g., wireless connection with the system, device status, device impedance, a section for proceeding with configuration of the pulse generator). The mobile application can be a gatekeeper app that is intended for use by a user (e.g., doctor, nurse, physician, etc.) to program the settings on the pulse generator, including the parameter limitations, and by the patient to adjust the amplitude of the stimulation within pre- set limits following discharge. The gatekeeper app can also display the battery life of the pulse generator. The gatekeeper app can also communicate with the pulse generator wireless through, for example, a Bluetooth connection. In some implementations, upon selecting the gatekeeper app on a mobile device, the gatekeeper app can automatically attempt to connect to the pulse generator. In some embodiments, a “success” message can be displayed on the mobile device when command was successfully sent to the mobile device. [0090] FIG. 11 illustrates example representations of ultrasound images of injected anesthetic solutions absorbed at an injection site within one to two hours, according to some embodiment. In some implementations, after placing the end of the catheter close to a target nerve, and the minimum threshold current and maximum stimulation current have been measured and recorded into the gatekeeper app, a bolus of local anesthetic injection can be administered to create a primary conduction nerve block. The local anesthetic solution can bathe the nerves and molecules of the local anesthetic solution attaches to the sodium- potassium channel and blocks it to induce a conduction nerve block. This blockade at the molecular (receptor) site can persist for 16-24 hours with long-acting local anesthetic solution. The excess local anesthetic solution at the site of injection can be absorbed and removed very quickly by the blood supply to the perineural tissues. In a case study, where Ropivacaine® 0.5% 20 mL was injected around the popliteal sciatic nerve, excess local anesthetic solution was completely reabsorbed that at the time of discharge (3 hours post-injection) as shown in FIG. 11. The duration of the primary conduction nerve block can usually last 18-24 hours for long- acting agents like Bupivacaine® or Ropivacaine®. This conduction block can control the severe pain that is experienced in the first 24 hours after surgery. In some implementations, at the time of discharge from the recovery room (3-6 hours after surgery), the external pulse generator can be turned "ON" at 25th percentile current intensity within the MTC and the MSC range.

[0091] As the primary conduction nerve block wears off (resolves) the neuromodulation can provide post-operative analgesia for up to 30 days. The patient has the ability to dial up or down the intensity of stimulation to match the pain levels via the gatekeeper app. If the patient experiences transient episodes of severe break-through pain, they can inject 3mL bolus of Bupivacaine® 0.25% to induce a conduction block and control the pain. A 3 mL bolus of Bupivacaine® 0.25% will typically last 2 hours.

[0092] At the time of discharge from recovery room, only conduction nerve block will be influencing the nerve and peripheral nerve stimulation (neuromodulation) will be ineffective as all the sodium-potassium channels will be blocked by the local anesthetic molecules. As the nerve block starts to wear off and sodium-potassium channel are unblocked, peripheral nerve stimulation will start influencing the nerve and at that time conduction block and nerve stimulation will be concurrently influencing the nerve. Once the conduction nerve block has completely resolved, only nerve stimulation will be influencing the nerve. Subsequently, if 3 mL bolus of Bupivacaine® 0.25% is injected, concurrent influence of conduction nerve block and nerve stimulation will occur till the effect of the 3 mL bolus dissipates. [0093] In some embodiments, the relay system of FIG. 5 can be intended for use up to 30 days after placement, but may be removed sooner, if the patient's pain is under control. Pain after surgery lasts for days to weeks after surgery. In a study, pain scores of patients (N=298) having general, orthopedic and urologic surgeries were followed prospectively. Fifty five percent (n=127) of the patients rated their worst pain experiences >4 on the NRS (0-10) at 48 hours, as well as 43% (n=91) at seven days and 34% (n=26) at three months after surgery. Patients who experience high levels of pain after surgeries are at increased risk of developing persistent pain after surgery and chronic opioid use. In other words, the relay system of FIG> 5 can be configured to block two different "gates" in the pain pathway (e.g., molecular gates and synaptic gates). The molecular gate can be controlled with conduction block and the synaptic gate can be controlled with neuromodulation. Both the molecular gate and the synaptic gate can be controlled by a single catheter positioned at the nerve trunk. This mode of action can be shown in FIG. 12.

[0094] FIG. 12 illustrates an example representation of the system of FIG. 1 in action on nerve fibers, according to some embodiment. In some cases, a required treatment to an individual using the relay system of FIG. 5 can be determined based on the type of surgery and severity of pain the patient is experiencing during recovery. For severe pain that is typically experienced in the first three days post-surgery (corresponding to a VAS score of "27), nerve blockade is required to address the patient's pain. For moderate pain that is typically experienced beyond the first three days post-surgery (VAS score of <7), management via neuromodulation alone is possible. The RELAY System offers the modalities to address both pain intensities.

[0095] FIG. 13 is a flow diagram of another method 1300 for anesthesia delivery and nerve stimulation for pain management, according to some embodiment. At 1305, the method 1300 includes inserting a distal end of a needle and a distal end of a catheter through a skin of a patient (catheter-over-needle insertion technique) towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve.

[0096] At 1310, the method 1300 includes eliciting a twitch response of a muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1- 0.5 msec to the distal end of the needle.

[0097] At 1315, the method 1300 includes hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution, resulting in the formation of a hydro- dissected pocket.

[0098] At 1320, the method 1300 includes, via a touchscreen display interface, adjusting one or more parameters of the pulse generator.

[0099] At 1325, the method 1300 includes causing the pulse generator to deliver a first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the specific designated surgical site. In some cases, the method 1400 can include activating the pulse generator upon the patient feeling pain in and/or around the surgical site or source of pain.

[00100] At 1330, the method 1300 includes optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic via the catheter.

[00101] FIG. 14 is a flow diagram of another method 1400 for anesthesia delivery and nerve stimulation for pain management, according to some embodiment. At 1405, the method 1400 includes preparing (1) an insertion site to receive a distal end of a catheter and a distal end of a needle and (2) a sterile field on a mayo stand or surgical table for placement of the system thereon, a housing is affixed to and arranged near the proximate end of the catheter, an injection port of the catheter including the through-channel that has a proximal end with luer-lock, an injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter. In some implementations, preparing the insertion site can include cleaning the insertion site and shaving any hair present.

[00102] At 1410, the method 1400 includes inserting the needle within a lumen of the catheter from an opening in a proximal end of an injection port of the catheter, wherein the needle is in electrical communication with an external nerve stimulator. In some implementations, the external nerve stimulator can be configured to deliver a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle. [00103] At 1415, the method 1400 includes connecting (1) a tube to a proximal end of the needle that is in communication with needle lumen and (2) a syringe containing a dextrose solution to the tube. In some cases, the syringe contains a 2-10% dextrose solution.

[00104] At 1420, the method 1400 includes flushing a lumen through the tube and a lumen of the needle so as to remove air therein using the syringe. In some cases, the method 1400 can include treating the skin at the insertion site with chlorohexidine and anesthetizing the skin at the insertion site.

[00105] At 1425, the method 1400 includes testing or otherwise establishing communications between a computing device operating an application program and the pulse generator via the communications means by turning on the pulse generator and thereafter, turning off the pulse generator.

[00106] At 1430, the method 1400 includes inserting the distal end of the needle and catheter through the skin of a patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain. At 1435, the method 1400 includes guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve.

[00107] At 1440, the method 1400 includes eliciting a twitch response of the muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve.

[00108] At 1445, the method 1400 includes hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution resulting in the formation of a hydrodissected pocket. In some cases, hydro-dissecting the target nerve can include hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%.

[00109] At 1450, the method 1400 includes rotating the catheter in a first direction so as to deploy the one or more tines in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site.

[00110] In some embodiments, the method 1400 can include sealing the insertion site using a surgical glue, applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing, and closing the injection port with a clave. In some cases, the method 1400 can also include capping the clave with a swab-cap (e.g., SwabCap®), turning off the pulse generator, conducting surgery at the surgical site, after surgery, activating the pulse generator, and establishing communications between the pulse generator and the computing device.

[00111] At 1455, the method 1400 includes connecting a syringe to the injection port via the clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve; the syringe to create the primary nerve block. At 1460, the method 1400 includes establishing communications between the pulse generator and the computing device.

[00112] In some embodiments, the method 1400 can include unlocking the proximal end of the needle from the luer-lock, sliding the catheter between 0.1 to 3.0 cm into the hydrodissected pocket, removing the needle from the lumen of the catheter, activating the pulse generator, and establishing communications with the computing device.

[00113] In some embodiments, the method 1400 can also include, via a touchscreen display interface of the computing device, selecting or adjusting the polarity of the electrodes, selecting or adjusting any and all of the pulse duration and pulse frequency, setting upper and lower stimulation current thresholds, selecting the at least two electrodes for use in delivering the electric pulses, and initiating or stopping pulse delivery. In some implementations, the scale of current delivery is between 1-100, wherein a setting of 1 corresponds to a pulse delivery imperceptible by the patient. In some cases, the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale. In some cases, the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain and corresponds to a 100 on the 1-100 scale. Depending upon the status of the delivery of pulses, the touchscreen display can radiate a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery.

[00114] In some embodiments, wherein upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, the method 1400 can include administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter. In some cases, administering can include removing the swab-cap off the clave, uncapping a syringe pre-filled with a prescribed amount of the drug, connecting the syringe to the clave, delivering the prescribed amount of the drug via the clave, and capping the clave with a new swab-cap. In some implementations, upon the delivery of a set of pulses of a maximum current and the delivery of a plurality of bolus doses not adequately addressing pain of the patient, the patient can ingest a prescribed amount of pain medication tablets. In some implementations, upon the cessation of pain from the patient requiring the catheter system, the method 1400 can further include removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed, rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient, and pulling the catheter out from the patient such that the catheter is completely removed from the patient.

Examples.

[00115] Example 1 : A method for treating pain using a pain management (PM) system, the PM system includes: a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, and a lumen, a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, at least one pulse generator affixed to the catheter and configured to provide at least a first set of electric pulses at a designated rate, frequency, voltage and current to the at least the two electrodes and optionally to the distal end of the needle from an external nerve stimulator, and an application program operable on a computing device for controlling at least the pulse generator,

- wherein the application program is configured to cause the computing device to display a touch interface for controlling upper and lower stimulation current thresholds, frequency, and pulse duration for the pulse generator, the method includes: inserting the distal end of the needle and catheter through the skin of the patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve; eliciting a twitch response of the muscle to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%, resulting in the formation of a hydrodissected pocket; sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket; removing the needle from the lumen of the catheter; establishing communications between the pulse generator and the computing device; via the touchscreen display interface, adjusting one or more parameters of the pulse generator; causing the pulse generator to deliver the first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the surgical site; and optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the first set of electrical pulses, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter. [00116] Example 2: A method for treating pain using a pain management (PM) system, the PM system includes: a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, an injection port, and a lumen, a catheter locking device arranged proximal to the electrodes on the catheter and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient; a housing affixed to and arranged near the proximate end of the catheter, the injection port including a through-channel having a proximal end with luer-lock, the injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter; a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter; at least one pulse generator arranged within the housing and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes and optionally to the distal end of the needle, communications means configured to communicate with an external control device, and an application program operable on a computing device for controlling at least the pulse generator,

- where at least one of the lumen of the catheter and the lumen of the needle is configured to receive at least one of a dextrose solution, a saline solution, an anesthetic, and the application program is configured to cause the computing device to display a touch interface for controlling upper and lower stimulation current thresholds, frequency, and pulse duration for the pulse generator,

- the method comprising: preparing the insertion site to receive the distal end of the catheter and needle, wherein preparing comprises cleaning the insertion site and shaving any hair present; optionally preparing a sterile field on a mayo stand or surgical table for placement of the system thereon; inserting the needle within the lumen of the catheter from an opening in the proximal end of the injection port, wherein the needle is in electrical communication with an external nerve stimulator, where the external nerve stimulator is configured to deliver a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; connecting a tube to a proximal end of the through channel; connecting a syringe containing a 2-10% dextrose solution to the tube; flushing the lumen of the tube and lumen of the needle so as to remove air therein using the syringe containing the 2-10% dextrose solution; establishing communications between the computing device and the pulse generator via the communications means by turning on the pulse generator and thereafter, turning off the pulse generator; treating the skin at the insertion site with chlorohexidine or suitable skin disinfectant; anesthetizing the skin at the insertion site; inserting the distal end of the needle and catheter (catheter-over needle unit) through the anesthetized skin towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve; eliciting a twitch response of the muscle innervated by the target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 2-10%, resulting in the formation of a hydrodissected pocket; unlocking the proximal end of the needle from the luer-lock; sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket removing the needle from the lumen of the catheter; rotating the catheter in a first direction so as to deploy the one or more tines in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site; activating the pulse generator; establishing communications with the computing device; sealing the insertion site using a surgical glue; applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing; closing the injection port with a clave; connecting a syringe to the injection port via the clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block; capping the clave with a swab-cap; turning off the pulse generator; conducting surgery at the surgical site; after surgery, activating the pulse generator; establishing communications between the pulse generator and the computing device; via the touchscreen display interface:

■ selecting or adjusting the polarity of the electrodes,

■ selecting or adjusting any and all of the pulse duration and pulse frequency;

■ setting upper and lower stimulation current thresholds; selecting the at least two electrodes for use in delivering the electric pulses; and/or initiating or stopping pulse delivery, o where

■ the scale of current delivery is between 1-100, wherein a setting of 1 corresponds to a pulse delivery imperceptible by the patient,

■ the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale;

■ the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain; and

■ depending upon the status of the delivery of pulses, the touchscreen display radiates a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery; o activating the pulse generator upon the patient feeling pain in and/or around the surgical site, optionally: o upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse; o stopping the delivery of pulses via the computing device, o administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter, administering comprising removing the swabcap off the clave, uncapping a syringe filled with a prescribed amount of the drug, connecting the syringe to the clave, and delivering the prescribed amount of the drug via the clave; capping the clave with a new SwabCap; o upon the delivery of a set of electrical pulses of a maximum current and the delivery of a plurality of bolus doses of anesthetic is not adequately addressing pain, the patient may ingest prescribed amount of pain and upon the cessation of pain from the patient requiring the catheter system: removing the waterproof dressing, o cleaning the skin and the insertion site, such that the surgical glue is removed, o rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient; and o pulling the catheter out from the patient such that the catheter is completely removed from the patient.

[00117] Example 3: A system for treating pain using a pain management (PM) system, the PM system including: a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, an injection port, and a lumen, a catheter locking device arranged proximal to the electrodes on the catheter and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient; a housing affixed to and arranged near the proximate end of the catheter, the injection port including a through-channel having a proximal end with luer-lock, the injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter; a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, and at least one pulse generator arranged within the housing and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes and communications means configured to communicate with an external control device.

[00118] Example 4: A method for testing or otherwise evaluating a system for treating pain using a pain management (PM) system for use on patients, the method includes: inserting a distal end of a needle and a distal end of a catheter through a skin of a patient, so as to test a system for treating pain using a pain management (PM) system, towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve; eliciting a twitch response of a muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution, resulting in the formation of a hydro-dissected pocket;

- via a touchscreen display interface, adjusting one or more parameters of the pulse generator; causing the pulse generator to deliver a first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the specific designated surgical site; and optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic via the catheter.

[00119] Example 5: A method for treating pain using a pain management (PM) system including: inserting a distal end of a needle and a distal end of a catheter through a skin of a patient (catheter-over-needle insertion technique) towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve; eliciting a twitch response of a muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution, resulting in the formation of a hydro-dissected pocket;

[00120] Example 6: The method of examples 4 or 5, where the catheter includes the at least two electrodes located at the distal end of the catheter and a lumen.

[00121] Example 7: The method of any of examples 4-6, where the pulse generator is affixed to the catheter and configured to provide the first set of electric pulses at a designated frequency, pulse duration, voltage and current to at least two electrodes of the catheter and optionally to the distal end of the needle.

[00122] Example 8: The method of any of examples 4-7, wherein an application program operable on a computing device is configured to control the pulse generator, the application program further configured to cause the computing device to display the touch interface for controlling upper and lower stimulation current thresholds for the pulse generator.

[00123] Example 9: The method of any of example 4-8, where the method further includes sliding the catheter (in some embodiments, between 0.1 to 3.0 cm) into the hydro-dissected pocket; removing the needle from the lumen of the catheter, and/or establishing communications between the pulse generator and the computing device.

[00124] Example 10: The method of any of examples 4-9, where hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution (in some embodiments, between 3 - 10%). [00125] Example 11 : A method for testing or otherwise evaluating a pain management (PM) system comprising: providing a PM system including a catheter, a needle, a housing is affixed to and arranged near a proximate end of the catheter, a first injection port arranged on the catheter including a through-channel that has a proximal end with a luer-lock, a second injection port located at or near the proximal end of the through-channel and having a distal end affixed to a proximal end of the catheter, and an external pulse generator nerve stimulator and/or an external pulse generator; prior to testing or otherwise evaluating the PM system optionally preparing: o (1) an insertion site to receive a distal end of the catheter and a distal end of the needle, and o (2) a sterile field on a mayo stand or surgical table for placement of the system thereon, inserting the needle within a lumen of the catheter from an opening in a proximal end of the first injection port of the catheter, wherein the needle is in electrical communication with an external nerve stimulator; connecting: (1) a tube to a proximal end of the needle that is in communication with a needle lumen thereof, and (2) a syringe or other source containing or in fluid communication with a dextrose solution to the tube; flushing a lumen of the tube and a lumen of the needle so as to remove air therein optionally using the syringe;

- testing or otherwise establishing communications between a computing device operating an application program and the external pulse generator via a communications means by turning the pulse generator on and when desired, turning the pulse generator off; inserting the distal end of the needle and catheter through the skin of a patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve; eliciting a twitch response of the muscle innervated by the target nerve via the external pulse generator or the external nerve stimulator to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve; hydro-dissecting the target nerve from surrounding tissue by injecting a hydrodissecting solution resulting in the formation of a hydro-dissected pocket; sliding or otherwise inserting the catheter over the needle in the hydro-dissected pocket adjacent to the target nerve; rotating the catheter in a first direction so as to deploy one or more tines of the distal end of the catheter in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site and removing the needle from the catheter; and connecting a syringe to the injection port via a clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block.

[00126] Example 12: A method for of treating pain with a pain management (PM) system including: prior to treating pain, optionally preparing: (1) an insertion site to receive a distal end of a catheter and a distal end of a needle, and (2) a sterile field on a mayo stand or surgical table for placement of a PM system thereon, inserting the needle within a lumen of the catheter from an opening in a proximal end of a first injection port of the catheter, wherein the needle is in electrical communication with an external nerve stimulator; connecting (1) a tube to a proximal end of the needle that is in communication with a needle lumen thereof, and (2) a syringe or other source containing or in fluid communication with a dextrose solution to the tube; flushing a lumen of the tube and the lumen of the needle so as to remove air therein optionally using a/the syringe; establishing communications between a computing device operating an application program and the external pulse generator and/or an external nerve stimulator via a communications means by turning the external pulse generator and/or external nerve stimulator on and when desired, turning the external pulse generator and/or external nerve stimulator off; inserting the distal end of the needle and catheter through the skin of a patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve; eliciting a twitch response of the muscle innervated by the target nerve via the external pulse generator or the external nerve stimulator to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve; hydro-dissecting the target nerve from surrounding tissue by injecting a hydrodissecting solution resulting in the formation of a hydro-dissected pocket; sliding or otherwise inserting the catheter over the needle in the hydro-dissected pocket adjacent to the target nerve; rotating the catheter in a first direction so as to deploy one or more tines of the distal end of the catheter in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site and removing the needle from the catheter; and connecting a syringe to the injection port via a clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block.

[00127] Example 13: The method of examples 11 or 12, wherein preparing the insertion site further comprises cleaning the insertion site and shaving any hair present.

[00128] Example 14: The method of any of examples 11-13, wherein the external nerve stimulator is configured to deliver a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle.

[00129] Example 15: The method of any of examples 11-14, where the syringe or other source contains a 2-10% dextrose solution.

[00130] Example 16: The method of any of examples 11-15, where the method further includes treating the skin at the insertion site with chlorohexidine and anesthetizing the skin at the insertion site. [00131] Example 17: The method of any of examples 11-16, where hydro-dissecting the target nerve further includes hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%.

[00132] Example 18: The method of any of examples 11-17, where the method further includes sealing the insertion site using a surgical glue, applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing; and closing the injection port with a clave.

[00133] Example 19: The method of any of examples 11-18, where the method further includes capping the clave with a swab-cap, conducting surgery at the surgical site, and after surgery, activating the external pulse generator.

[00134] Example 20: The method of any of examples 11-19, wherein, via a touchscreen display interface of the computing device, the method further includes: selecting or adjusting the polarity of the electrodes, selecting or adjusting any and all of the pulse duration and pulse frequency; setting upper and lower stimulation current thresholds; and selecting the at least two electrodes for use in delivering the electric pulses; and initiating or stopping pulse delivery.

[00135] Example 21 : The method of any of examples 11-20, where the scale of current delivery is between 1-100, where a setting of 1 corresponds to a pulse delivery imperceptible by the patient, the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale, the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain and corresponds to a 100 on the 1-100 scale; and depending upon the status of the delivery of pulses, the touchscreen display radiates a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery.

[00136] Example 22: The method of any of examples 11-21, the method further includes activating the pulse generator upon the patient feeling pain in and/or around the surgical site or source of pain. [00137] Example 23: The method of any of examples 11-22, where upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by one or more pulses provided by the external nerve stimulator, the method further includes: administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter, administering including removing the swabcap off the clave, uncapping a syringe pre- filled with a prescribed amount of the drug; connecting the syringe to the clave; delivering the prescribed amount of the drug via the clave; and capping the clave with a new SwabCap, upon the delivery of a set of pulses of a maximum current and the delivery of a plurality of bolus doses not adequately addressing pain of the patient, the patient can ingest a prescribed amount of pain medication tablets, upon the cessation of pain from the patient requiring the catheter system: removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed, rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient, and pulling the catheter out from the patient such that the catheter Is completely removed from the patient.

General Considerations

[00138] It is to be noted that any one or more of the aspects and embodiments described herein can be conveniently implemented using one or more machines (e.g., one or more computing devices that are utilized as a user computing device for an electronic document, one or more server devices, such as a document server, etc.) programmed according to the teachings of the present specification. Appropriate software coding can readily be prepared by skilled programmers based on the teachings of the present disclosure. Aspects and implementations discussed above employing software and/or software modules can also include appropriate hardware for assisting in the implementation of the machine executable instructions of the software and/or software module.

[00139] Such software can be a computer program product that employs a machine-readable storage medium. A machine-readable storage medium can be any medium that is capable of storing and/or encoding a sequence of instructions for execution by a machine (e.g., a computing device) and that causes the machine to perform any one of the methodologies and/or embodiments described herein. Examples of a machine-readable storage medium include, but are not limited to, a magnetic disk, an optical disc (e.g., CD, CD-R, DVD, DVD-R, etc.), a magneto-optical disk, a read-only memory "ROM" device, a random-access memory "RAM" device, a magnetic card, an optical card, a solid-state memory device, an EPROM, an EEPROM, and any combinations thereof. A machine-readable medium, as used herein, is intended to include a single medium as well as a collection of physically separate media, such as, for example, a collection of compact discs or one or more hard disk drives in combination with a computer memory. As used herein, a machine-readable storage medium does not include transitory forms of signal transmission.

[00140] Such software can also include information (e.g., data) carried as a data signal on a data carrier, such as a carrier wave. For example, machine-executable information can be included as a data-carrying signal embodied in a data carrier in which the signal encodes a sequence of instruction, or portion thereof, for execution by a machine (e.g., a computing device) and any related information (e.g., data structures and data) that causes the machine to perform any one of the methodologies and/or embodiments described herein.

[00141] Examples of a computing device include, but are not limited to, an electronic book reading device, a computer workstation, a terminal computer, a server computer, a handheld device (e.g., a tablet computer, a smartphone, etc.), a web appliance, a network router, a network switch, a network bridge, any machine capable of executing a sequence of instructions that specify an action to be taken by that machine, and any combinations thereof. In one example, a computing device can include and/or be included in a kiosk.

[00142] All combinations of the foregoing concepts and additional concepts discussed here within (provided such concepts are not mutually inconsistent) are contemplated as being part of the subject matter disclosed herein. The terminology explicitly employed herein that also can appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.

[00143] The drawings are primarily for illustrative purposes and are not intended to limit the scope of the subject matter described herein. The drawings are not necessarily to scale; in some instances, various aspects of the subject matter disclosed herein can be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference characters generally refer to like features (e.g., functionally similar and/or structurally similar elements).

[00144] The entirety of this application (including the Cover Page, Title, Headings, Background, Summary, Brief Description of the Drawings, Detailed Description, Embodiments, Abstract, Figures, Appendices, and otherwise) shows, by way of illustration, various embodiments in which the embodiments can be practiced. The advantages and features of the application are of a representative sample of embodiments only and are not exhaustive and/or exclusive. Rather, they are presented to assist in understanding and teach the embodiments and are not representative of all embodiments. As such, certain aspects of the disclosure have not been discussed herein. That alternate embodiments cannot have been presented for a specific portion of the innovations or that further undescribed alternate embodiments can be available for a portion is not to be considered to exclude such alternate embodiments from the scope of the disclosure. It will be appreciated that many of those undescribed embodiments incorporate the same principles of the innovations and others are equivalent. Thus, it is to be understood that other embodiments can be utilized and functional, logical, operational, organizational, structural and/or topological modifications can be made without departing from the scope and/or spirit of the disclosure. As such, all examples and/or embodiments are deemed to be non-limiting throughout this disclosure.

[00145] Also, no inference should be drawn regarding those embodiments discussed herein relative to those not discussed herein other than it is as such for purposes of reducing space and repetition. For example, it is to be understood that the logical and/or topological structure of any combination of any program components (a component collection), other components and/or any present feature sets as described in the figures and/or throughout are not limited to a fixed operating order and/or arrangement, but rather, any disclosed order is exemplary and all equivalents, regardless of order, are contemplated by the disclosure.

[00146] The term "automatically" is used herein to modify actions that occur without direct input or prompting by an external source such as a user. Automatically occurring actions can occur periodically, sporadically, in response to a detected event (e.g., a user logging in), or according to a predetermined schedule.

[00147] The term "determining" encompasses a wide variety of actions and, therefore, "determining" can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, "determining" can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, "determining" can include resolving, selecting, choosing, establishing and the like.

[00148] The phrase "based on" does not mean "based only on," unless expressly specified otherwise. In other words, the phrase "based on" describes both "based only on" and "based at least on." [00149] The term "processor" should be interpreted broadly to encompass a general-purpose processor, a central processing unit (CPU), a microprocessor, a digital signal processor (DSP), a controller, a microcontroller, a state machine and so forth. Under some circumstances, a "processor" can refer to an application specific integrated circuit (ASIC), a programmable logic device (PLD), a field programmable gate array (FPGA), etc. The term "processor" can refer to a combination of processing devices, e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core or any other such configuration.

[00150] The term "memory" should be interpreted broadly to encompass any electronic component capable of storing electronic information. The term memory can refer to various types of processor-readable media such as random-access memory (RAM), read-only memory (ROM), non-volatile random-access memory (NVRAM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable PROM (EEPROM), flash memory, magnetic or optical data storage, registers, etc. Memory is said to be in electronic communication with a processor if the processor can read information from and/or write information to the memory. Memory that is integral to a processor is in electronic communication with the processor.

[00151] The terms "instructions" and "code" should be interpreted broadly to include any type of computer-readable statement s). For example, the terms "instructions" and "code" can refer to one or more programs, routines, sub-routines, functions, procedures, etc. "Instructions" and "code" can comprise a single computer-readable statement or many computer-readable statements.

[00152] The term "modules" can be, for example, distinct but interrelated units from which a program may be built up or into which a complex activity may be analyzed. A module can also be an extension to a main program dedicated to a specific function. A module can also be code that is added in as a whole or is designed for easy reusability.

[00153] Some embodiments described herein relate to a computer storage product with a non- transitory computer-readable medium (also can be referred to as a non-transitory processor- readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include transitory propagating signals per se (e.g., a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable). The media and computer code (also can be referred to as code) can be those designed and constructed for the specific purpose or purposes. Examples of non-transitory computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as Application-Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM) devices. Other embodiments described herein relate to a computer program product, which can include, for example, the instructions and/or computer code discussed herein.

[00154] Some embodiments and/or methods described herein can be performed by software (executed on hardware), hardware, or a combination thereof. Hardware modules can include, for example, a general-purpose processor, a field programmable gate array (FPGA), and/or an application specific integrated circuit (ASIC). Software modules (executed on hardware) can be expressed in a variety of software languages (e.g., computer code), including C, C++, Java™, Ruby, Visual Basic™, and/or other object-oriented, procedural, or other programming language and development tools. Examples of computer code include, but are not limited to, micro-code or micro-instructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter. For example, embodiments can be implemented using imperative programming languages (e.g., C, Fortran, etc.), functional programming languages (Haskell, Erlang, etc.), logical programming languages (e.g., Prolog), object-oriented programming languages (e.g., Java, C++, etc.) or other suitable programming languages and/or development tools. Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.

[00155] Various concepts can be embodied as one or more methods, of which at least one example has been provided. The acts performed as part of the method can be ordered in any suitable way. Accordingly, embodiments can be constructed in which acts are performed in an order different than illustrated, which can include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments. Put differently, it is to be understood that such features can not necessarily be limited to a particular order of execution, but rather, any number of threads, processes, services, servers, and/or the like that can execute serially, asynchronously, concurrently, in parallel, simultaneously, synchronously, and/or the like in a manner consistent with the disclosure. As such, some of these features can be mutually contradictory, in that they cannot be simultaneously present in a single embodiment. Similarly, some features are applicable to one aspect of the innovations, and inapplicable to others. [0138] In addition, the disclosure can include other innovations not presently described. Applicant reserves all rights in such innovations, including the right to embodiment such innovations, file additional applications, continuations, continuations-in-part, divisionals, and/or the like thereof. As such, it should be understood that advantages, embodiments, examples, functional, features, logical, operational, organizational, structural, topological, and/or other aspects of the disclosure are not to be considered limitations on the disclosure as defined by the embodiments or limitations on equivalents to the embodiments. Depending on the particular desires and/or characteristics of an individual and/or enterprise user, database configuration and/or relational model, data type, data transmission and/or network framework, syntax structure, and/or the like, various embodiments of the technology disclosed herein can be implemented in a manner that enables a great deal of flexibility and customization as described herein.

[00156] In some embodiments, especially those for treating individuals/patients for pain, correspond substantially to method for testing or otherwise evaluating one and/or another disclosed pain management systems for managing pain. Thus, each and every method disclosed herein can correspond to (and/or configured to) a testing/evaluating method for a pain management system (and in some embodiments, more or less steps/elements, then methods of treatment are provided). To this end, some of the currently claimed embodiments include testing/evaluating methods for pain management using one or another of the disclosed pain management systems.

[00157] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

[01] The indefinite articles "a" and "an," as used herein in the specification and in the embodiments, unless clearly indicated to the contrary, should be understood to mean "at least one." The terms “can” and “may” are used interchangeably in the present disclosure, and indicate that the referred to element, component, structure, function, functionality, objective, advantage, operation, step, process, apparatus, system, device, result, or clarification, has the ability to be used, included, or produced, or otherwise stand for the proposition indicated in the statement for which the term is used (or referred to) for a particular embodiment(s).

[00158] The phrase "and/or," as used herein in the specification and in the embodiments, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and/or" should be construed in the same fashion, i.e., "one or more" of the elements so conjoined. Other elements can optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and/or B", when used in conjunction with open-ended language such as "comprising" can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[00159] As used herein in the specification and in the embodiments, "or" should be understood to have the same meaning as "and/or" as defined above. For example, when separating items in a list, "or" or "and/or" shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of or "exactly one of," or, when used in the embodiments, "consisting of," will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e., "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of' "Consisting essentially of," when used in the embodiments, shall have its ordinary meaning as used in the field of patent law.

[00160] As used herein in the specification and in the embodiments, the phrase "at least one," in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements can optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently "at least one of A and/or B") can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[00161] In the embodiments, as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of and "consisting essentially of shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

What is currently claimed:

1. A method for treating pain using a pain management (PM) system, the PM system comprising: a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, and a lumen, a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, at least one pulse generator affixed to the catheter and configured to provide at least a first set of electric pulses at a designated rate, frequency, voltage and current to the at least the two electrodes and optionally to the distal end of the needle from an external nerve stimulator, and an application program operable on a computing device for controlling at least the pulse generator, wherein: the application program is configured to cause the computing device to display a touch interface for controlling upper and lower stimulation current thresholds, frequency, and pulse duration for the pulse generator, the method comprising: inserting the distal end of the needle and catheter through the skin of the patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve; eliciting a twitch response of the muscle to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%, resulting in the formation of a hydro-dissected pocket; sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket; removing the needle from the lumen of the catheter; establishing communications between the pulse generator and the computing device; via the touchscreen display interface, adjusting one or more parameters of the pulse generator; causing the pulse generator to deliver the first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the surgical site; and optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the first set of electrical pulses, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter.

2. A method for treating pain using a pain management (PM) system, the PM system comprising: a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, an injection port, and a lumen, a catheter locking device arranged proximal to the electrodes on the catheter and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient; a housing affixed to and arranged near the proximate end of the catheter, the injection port including a through-channel having a proximal end with luer-lock, the injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter; a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter; at least one pulse generator arranged within the housing and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes and optionally to the distal end of the needle, communications means configured to communicate with an external control device, and an application program operable on a computing device for controlling at least the pulse generator, wherein: at least one of the lumen of the catheter and the lumen of the needle is configured to receive at least one of a dextrose solution, a saline solution, an anesthetic, and the application program is configured to cause the computing device to display a touch interface for controlling upper and lower stimulation current thresholds, frequency, and pulse duration for the pulse generator, the method comprising: preparing the insertion site to receive the distal end of the catheter and needle, wherein preparing comprises cleaning the insertion site and shaving any hair present; optionally preparing a sterile field on a mayo stand or surgical table for placement of the system thereon; inserting the needle within the lumen of the catheter from an opening in the proximal end of the injection port, wherein the needle is in electrical communication with an external nerve stimulator, wherein the external nerve stimulator is configured to deliver a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1- 0.5 msec to the distal end of the needle; connecting a tube to a proximal end of the through channel; connecting a syringe containing a 2-10% dextrose solution to the tube; flushing the lumen of the tube and lumen of the needle so as to remove air therein using the syringe containing the 2-10% dextrose solution; establishing communications between the computing device and the pulse generator via the communications means by turning on the pulse generator and thereafter, turning off the pulse generator; treating the skin at the insertion site with chlorohexidine or suitable skin disinfectant; anesthetizing the skin at the insertion site; inserting the distal end of the needle and catheter (catheter-over needle unit) through the anesthetized skin towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve; eliciting a twitch response of the muscle innervated by the target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 2-10%, resulting in the formation of a hydro-dissected pocket; unlocking the proximal end of the needle from the luer-lock; sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket removing the needle from the lumen of the catheter; rotating the catheter in a first direction so as to deploy the one or more tines in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site; activating the pulse generator; establishing communications with the computing device; sealing the insertion site using a surgical glue; applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing; closing the injection port with a clave; connecting a syringe to the injection port via the clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block; capping the clave with a swab-cap; turning off the pulse generator; conducting surgery at the surgical site; after surgery, activating the pulse generator; establishing communications between the pulse generator and the computing device; via the touchscreen display interface: selecting or adjusting the polarity of the electrodes, selecting or adjusting any and all of the pulse duration and pulse frequency; setting upper and lower stimulation current thresholds; selecting the at least two electrodes for use in delivering the electric pulses; and/or initiating or stopping pulse delivery, wherein the scale of current delivery is between 1-100, wherein a setting of 1 corresponds to a pulse delivery imperceptible by the patient, the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale; the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain; and depending upon the status of the delivery of pulses, the touchscreen display radiates a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery; activating the pulse generator upon the patient feeling pain in and/or around the surgical site, optionally: upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse; stopping the delivery of pulses via the computing device, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter, administering comprising: removing the swabcap off the clave, uncapping a syringe filled with a prescribed amount of the drug; connecting the syringe to the clave; delivering the prescribed amount of the drug via the clave; capping the clave with a new SwabCap; upon the delivery of a set of electrical pulses of a maximum current and the delivery of a plurality of bolus doses of anesthetic is not adequately addressing pain, the patient may ingest prescribed amount of pain; and upon the cessation of pain from the patient requiring the catheter system: removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed, rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient; and pulling the catheter out from the patient such that the catheter is completely removed from the patient.

3. A system for treating pain using a pain management (PM) system, the PM system comprising: a catheter including a proximal end, a distal end at least two electrodes located at the distal end thereof, an injection port, and a lumen, a catheter locking device arranged proximal to the electrodes on the catheter and configured, via rotation, to project one or more tines for locking the catheter in place relative to tissue of a patient; a housing affixed to and arranged near the proximate end of the catheter, the injection port including a through-channel having a proximal end with luer-lock, the injection port located at or near the proximal end of the through-channel, and a distal end affixed to a proximal end of the catheter; a needle having a lumen and configured for removable insertion into the lumen of the catheter, a proximal end configured to mate and lock with the luer-lock, and a distal end configured to protrude past the distal end of the catheter when inserted within the lumen of the catheter, and at least one pulse generator arranged within the housing and configured to provide at least a first set of electric pulses at a designated frequency, pulse duration, voltage and current to the at least the two electrodes and communications means configured to communicate with an external control device.

4. A method for testing or otherwise evaluating a system for treating pain using a pain management (PM) system for use on patients, the method comprising: inserting a distal end of a needle and a distal end of a catheter through a skin of a patient, so as to test a system for treating pain using a pain management (PM) system, towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve; eliciting a twitch response of a muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution, resulting in the formation of a hydro-dissected pocket; via a touchscreen display interface, adjusting one or more parameters of the pulse generator; causing the pulse generator to deliver a first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the specific designated surgical site; and optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic via the catheter.

5. A method for treating pain using a pain management (PM) system comprises: inserting a distal end of a needle and a distal end of a catheter through a skin of a patient (catheter-over-needle insertion technique) towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain, guiding the distal end of the catheter such that the distal end of the needle is adjacent to the target nerve; eliciting a twitch response of a muscle innervated by target nerve to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve, the twitch response elicited via electrical communication between the distal end of the needle and an external nerve stimulator, wherein the external nerve stimulator is configured to deliver, via the distal end of the needle, a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle; hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution, resulting in the formation of a hydro-dissected pocket; via a touchscreen display interface, adjusting one or more parameters of the pulse generator; causing the pulse generator to deliver a first set of electrical pulses in accordance with the one or more parameters upon the patient feeling pain in and/or around the specific designated surgical site; and optionally upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by the pulse, administering at least one bolus dose of a prescribed amount of at least one of an anesthetic via the catheter.

6. The method of claim 5, wherein the catheter includes the at least two electrodes located at the distal end of the catheter and a lumen.

7. The method of claim 5, wherein the pulse generator is affixed to the catheter and configured to provide the first set of electric pulses at a designated frequency, pulse duration, voltage and current to at least two electrodes of the catheter and optionally to the distal end of the needle.

8. The method of claim 5, wherein an application program operable on a computing device is configured to control the pulse generator, the application program further configured to cause the computing device to display the touch interface for controlling upper and lower stimulation current thresholds for the pulse generator.

9. The method of claim 5, wherein the method further comprises: sliding the catheter between 0.1 to 3.0 cm into the hydro-dissected pocket; removing the needle from the lumen of the catheter; and establishing communications between the pulse generator and the computing device.

10. The method of claim 5, wherein hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%.

11. A method for testing or otherwise evaluating a pain management (PM) system comprising: providing a PM system including: a catheter; a needle; a housing is affixed to and arranged near a proximate end of the catheter, a first injection port arranged on the catheter including a through-channel that has a proximal end with a luer-lock, a second injection port located at or near the proximal end of the through- channel and having a distal end affixed to a proximal end of the catheter; an external pulse generator nerve stimulator and/or an external pulse generator; prior to testing or otherwise evaluating the PM system optionally preparing:

(1) an insertion site to receive a distal end of the catheter and a distal end of the needle, and

(2) a sterile field on a mayo stand or surgical table for placement of the system thereon, inserting the needle within a lumen of the catheter from an opening in a proximal end of the first injection port of the catheter, wherein the needle is in electrical communication with an external nerve stimulator; connecting

(1) a tube to a proximal end of the needle that is in communication with a needle lumen thereof, and

(2) a syringe or other source containing or in fluid communication with a dextrose solution to the tube; flushing a lumen of the tube and a lumen of the needle so as to remove air therein optionally using the syringe; testing or otherwise establishing communications between a computing device operating an application program and the external pulse generator via a communications means by turning the pulse generator on and when desired, turning the pulse generator off; inserting the distal end of the needle and catheter through the skin of a patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve; eliciting a twitch response of the muscle innervated by the target nerve via the external pulse generator or the external nerve stimulator to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve; hydro-dissecting the target nerve from surrounding tissue by injecting a hydrodissecting solution resulting in the formation of a hydro-dissected pocket; sliding or otherwise inserting the catheter over the needle in the hydro-dissected pocket adjacent to the target nerve; rotating the catheter in a first direction so as to deploy one or more tines of the distal end of the catheter in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site and removing the needle from the catheter; and connecting a syringe to the injection port via a clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block.

12. A method for of treating pain with a pain management (PM) system comprising: prior to treating pain, optionally preparing:

(1) an insertion site to receive a distal end of a catheter and a distal end of a needle, and

(2) a sterile field on a mayo stand or surgical table for placement of a PM system thereon, inserting the needle within a lumen of the catheter from an opening in a proximal end of a first injection port of the catheter, wherein the needle is in electrical communication with an external nerve stimulator; connecting

(2) a syringe or other source containing or in fluid communication with a dextrose solution to the tube; flushing a lumen of the tube and the lumen of the needle so as to remove air therein optionally using a/the syringe; establishing communications between a computing device operating an application program and the external pulse generator and/or an external nerve stimulator via a communications means by turning the external pulse generator and/or external nerve stimulator on and when desired, turning the external pulse generator and/or external nerve stimulator off; inserting the distal end of the needle and catheter through the skin of a patient towards a target nerve under ultrasound or X-ray guidance, the target nerve corresponding to communicating nerve impulses to and from a specific designated surgical site or source of pain; guiding the distal end of the catheter such that the distal end of the needle is adjacent a muscle proximate the target nerve; eliciting a twitch response of the muscle innervated by the target nerve via the external pulse generator or the external nerve stimulator to confirm that the distal end of the catheter is located in a suitable position to provide neuromodulation to the target nerve; hydro-dissecting the target nerve from surrounding tissue by injecting a hydrodissecting solution resulting in the formation of a hydro-dissected pocket; sliding or otherwise inserting the catheter over the needle in the hydro-dissected pocket adjacent to the target nerve; rotating the catheter in a first direction so as to deploy one or more tines of the distal end of the catheter in tissue to substantially anchor the catheter in place within the tissue proximate the insertion site and removing the needle from the catheter; and connecting a syringe to the injection port via a clave and injecting a local anesthetic solution through the catheter so as to deliver the anesthetic solution to the target nerve to create a primary nerve block.

13. The method of claim 12, wherein preparing the insertion site further comprises cleaning the insertion site and shaving any hair present.

14. The method of claim 12, wherein the external nerve stimulator is configured to deliver a current between 1.0 - 2.0 mA at a frequency of between 2 and 4 Hz at a pulse duration between 0.1-0.5 msec to the distal end of the needle.

15. The method of claim 12, wherein the syringe or other source contains a 2-10% dextrose solution.

16. The method of claim 12, wherein the method further includes treating the skin at the insertion site with chlorohexidine and anesthetizing the skin at the insertion site.

17. The method of claim 12, wherein hydro-dissecting the target nerve further includes hydro-dissecting the target nerve from surrounding tissue by injecting a dextrose solution of between 3 - 10%.

18. The method of claim 12, wherein the method further comprises: sealing the insertion site using a surgical glue; applying a waterproof dressing to cover the insertion site, wherein the housing and injection port are arranged outside the dressing; and closing the injection port with a clave.

19. The method of claim 12, wherein the method further includes: capping the clave with a swab-cap; conducting surgery at the surgical site; and after surgery, activating the external pulse generator.

20. The method of claim 12, wherein, via a touchscreen display interface of the computing device, the method further comprises: selecting or adjusting the polarity of the electrodes, selecting or adjusting any and all of the pulse duration and pulse frequency; setting upper and lower stimulation current thresholds; and selecting the at least two electrodes for use in delivering the electric pulses; and initiating or stopping pulse delivery.

21. The method of claim 12, wherein: the scale of current delivery is between 1-100, wherein a setting of 1 corresponds to a pulse delivery imperceptible by the patient, the lower stimulation current threshold is determined by initiating pulses at a lower, first setting, and gradually increasing the current up to a second setting at which the patient can initially feel one or more pulses, the lower stimulation current threshold corresponding approximately to a 20 on the 1-100 scale; the upper stimulation current threshold is determined by increasing the current setting from the second setting to a third setting at which the patient experiences discomfort or pain and corresponds to a 100 on the 1-100 scale; and depending upon the status of the delivery of pulses, the touchscreen display radiates a particular color, including red for ongoing pulse delivery and gray for inactive pulse delivery.

22. The method of claim 12, wherein, the method further includes activating the pulse generator upon the patient feeling pain in and/or around the surgical site or source of pain.

23. The method of claim 12, wherein upon the patient experiencing pain within a predetermined time period after surgery which cannot be adequately addressed by one or more pulses provided by the external nerve stimulator, the method further comprises: administering at least one bolus dose of a prescribed amount of at least one of an anesthetic and a narcotic (together "drug") via the catheter, administering comprising: removing the swabcap off the clave, uncapping a syringe pre- filled with a prescribed amount of the drug; connecting the syringe to the clave; and delivering the prescribed amount of the drug via the clave; and capping the clave with a new SwabCap; upon the delivery of a set of pulses of a maximum current and the delivery of a plurality of bolus doses not adequately addressing pain of the patient, the patient can ingest a prescribed amount of pain medication tablets; upon the cessation of pain from the patient requiring the catheter system: removing the waterproof dressing, cleaning the skin and the insertion site, such that the surgical glue is removed, rotating the catheter in a second direction opposite to the first direction so such that the tines collapse and release the catheter from tissue of the patient, and pulling the catheter out from the patient such that the catheter Is completely removed from the patient.