CN115120335A - A device for ultrasound-guided radiofrequency ablation of the prostate - Google Patents

Abstract

The invention discloses a prostate radio frequency ablation device under ultrasonic guidance, which comprises a catheter and a catheter which is arranged in the catheter in a run-through manner, wherein a plurality of radio frequency electrode needle guide channels are also arranged between the catheter and the catheter along the circumferential direction; the catheter is circumferentially provided with a radio frequency ablation electrode needle outlet which is communicated with a radio frequency electrode needle guide channel; ablation electrode needles are uniformly arranged in the radio frequency electrode needle guide channels; the ablation electrode needle comprises a radio frequency electrode needle and a nerve detection needle; the radio frequency electrode needle is connected with a variable radio frequency instrument, and the nerve detection needle is connected with a nerve real-time detector. The prostate radio-frequency ablation device has small damage during operation, can adjust the direction and the size of an ablation target area in real time, has accurate and controllable ablation range, monitors and protects nerves in real time during operation, reserves sexual nerves, controls urine function, does not damage important tissues such as blood vessels, sphincters and the like, and is simple and quick in operation.

Description

A device for ultrasound-guided radiofrequency ablation of the prostate

technical field

The invention relates to the technical field of medical devices, in particular to a device for radiofrequency ablation of the prostate under ultrasound guidance.

Background technique

Benign prostatic hyperplasia (BPH), or enlarged prostate, is one of the common diseases of middle-aged and elderly men. About 50% of men over 60 and 90% of men in their 70s and 80s have different degrees of benign prostatic hyperplasia. symptom. Due to the hyperplasia and hypertrophy of the prostate gland, BPH patients squeeze the urethra, which will cause symptoms such as difficulty urinating, frequent urination, poor urination, interrupted urination or weak urination, which has a great impact on daily activities and life well-being. As the condition worsens, urethral stones, bladder strain, urinary tract infections, and even kidney failure may occur. Prostate cancer (PCa) is also the most common non-cutaneous malignancy in men. According to the latest statistics, its morbidity accounts for 13.5% of male malignant tumors, and its mortality accounts for 6.7%. By 2040, PCa patients worldwide are expected to grow to nearly 2.3 million, with 740,000 deaths. The morbidity and mortality of PCa in Chinese males showed a significant upward trend.

In order to treat benign prostatic hyperplasia and prostate cancer, drug therapy or surgery is often used. Drug therapy is often ineffective. Surgery is divided into two categories: resection and thermal ablation. However, both types of surgery may cause damage to surrounding tissues, such as prostate nerves, stroma, blood vessels and connective tissue and urethral muscle tissue, which may result in permanent ejaculation disorders, impotence, and abnormal urinary continence. After ablation, the local area is not complete, causing problems such as continued blockage or tumor recurrence.

SUMMARY OF THE INVENTION

In view of the deficiencies in the prior art, the purpose of the present invention is to provide a device for ultrasound-guided radiofrequency ablation of the prostate, which solves the problem that the device in the prior art is likely to cause damage to surrounding tissues and incomplete ablation, resulting in continuous blockage. Problems with the presence or recurrence of the tumor.

In order to solve the above-mentioned technical problems, the present invention adopts the following technical solutions to achieve: a device for radiofrequency ablation of the prostate under ultrasound guidance, comprising a catheter and a catheter arranged in the catheter, and between the catheter and the catheter A plurality of radio frequency electrode needle guide channels are also arranged along the circumferential direction;

The catheter is provided with a radio frequency ablation electrode needle outlet along the circumferential direction, the number of the radio frequency ablation electrode needle outlet is the same as that of the radio frequency electrode needle guide channel, and the radio frequency ablation electrode needle outlet is communicated with the radio frequency electrode needle guide channel;

An ablation electrode needle is arranged in the guide channel of the radio frequency electrode needle, and the ablation electrode needle can be extended or retracted through the outlet of the radio frequency ablation electrode needle;

The ablation electrode needle includes a radio frequency electrode needle and a nerve probe needle connected to one end of the radio frequency electrode needle, and the nerve probe needle is arranged on the side close to the outlet of the radio frequency ablation electrode needle;

The radio frequency electrode needle is connected with a variable radio frequency instrument, and the nerve detection needle is connected with a nerve real-time detector.

The present invention also has the following technical features:

The catheter includes a front-end catheter and a rear-end catheter that are coaxially connected, and a nano-drug layer is arranged on the outside of the front-end catheter.

An advance regulator is arranged on the rear end catheter, the advance regulator is connected with the ablation electrode needle, and the advance regulator is used to adjust the extension or retraction of the ablation electrode needle through the outlet of the radiofrequency ablation electrode needle.

A radio frequency needle length adjuster is also arranged on the back-end catheter, the radio frequency needle length adjuster is connected with the insulating sleeve layer sleeved on the ablation electrode needle, and the radio frequency needle length adjuster is used to adjust the insulating sleeve layer during ablation. position on the electrode needle.

The device for radiofrequency ablation of the prostate under ultrasound guidance also includes a cooling device;

The cooling device includes a cooling water channel arranged on the side of the RF electrode needle guide channel facing the catheter and a cold circulation power pump communicated with the cooling water channel;

The cooling water channel includes a water inlet pipe and a water outlet pipe arranged side by side, the water inlet pipe and the water outlet pipe are communicated near the outlet of the radiofrequency ablation electrode needle, and the water inlet pipe is pumped into sterile water through a cold circulation power pump, The water outlet pipe is communicated with the waste water recovery device.

Compared with the prior art, the present invention has the following technical effects:

(I) The radiofrequency ablation device for prostate of the present invention has little damage during operation, can adjust the direction and size of the ablation target area in real time, accurately and control the ablation range, and monitor the protective nerve, preserved nerve, and urinary continence function in real time during the operation. It does not damage important tissues such as blood vessels and sphincter, and the operation is simple and fast.

(II) The present invention has a simple structure, is convenient to use, and can greatly save manpower and material resources.

Description of drawings

Fig. 1 is the internal structure schematic diagram of the present invention;

Fig. 2 is the external structure schematic diagram of the present invention;

3 is a schematic cross-sectional view of the present invention;

4 is a schematic diagram of a specific use process of the present invention;

The meaning of each symbol in the attached drawing:

1- catheter; 2- catheter; 3- RF electrode needle guide channel; 4- RF ablation electrode needle outlet; 5- ablation electrode needle; 6- variable RF instrument; 7- nerve real-time detector; 8- advance adjustment 9-RF needle length regulator; 10-insulation jacket, 11-cooling device, 12-wastewater recovery device, 13-sterile water tank;,

1-1 front-end catheter, 1-2 back-end catheter, 1-3 nano drug layer;

5-1 RF electrode needle, 5-2 nerve probe needle;

11-1 cooling water channel, 11-2 cold circulation power pump;

11-1-1 water inlet pipe, 11-1-2 water outlet pipe;

The specific content of the present invention will be further explained in detail below in conjunction with the embodiments.

Detailed ways

Specific embodiments of the present invention are given below. It should be noted that the present invention is not limited to the following specific embodiments, and all equivalent transformations made on the basis of the technical solutions of the present application fall into the protection scope of the present invention.

The terms "upper", "lower", "front", "rear", "top", "bottom" and the like used in the present invention indicate the orientation or positional relationship only for the convenience of describing the present invention and simplifying the description, rather than indicating or It is implied that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and "inner" and "outer" refer to the inside and outside of the contour of the corresponding component, and the above terms should not be construed as limiting the invention.

In the present invention, the terms "installed", "connected", "connected", "fixed" and other terms should be understood in a broad sense unless otherwise stated, for example, it may be a fixed connection or a detachable connection It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal communication between the two elements or the interaction relationship between the two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

All components in the present invention, unless otherwise specified, are all known components in the prior art.

Example 1:

Following the above-mentioned technical scheme, as shown in Fig. 1-Fig. 4, a device for radiofrequency ablation of the prostate under ultrasound guidance comprises a catheter 1 and a catheter 2 that is arranged in the catheter 1, the catheter 1 and the catheter A plurality of RF electrode needle guide channels 3 are also arranged along the circumferential direction between the tubes 2;

The catheter 1 is provided with a radiofrequency ablation electrode needle outlet 4 along the circumferential direction, the number of the radiofrequency ablation electrode needle outlet 4 is the same as that of the radiofrequency electrode needle guide channel 3, and the radiofrequency ablation electrode needle outlet 4 is guided to the radiofrequency electrode needle. Channel 3 is connected;

An ablation electrode needle 5 is arranged in the radio frequency electrode needle guide channel 3, and the ablation electrode needle 5 can be extended or retracted through the radio frequency ablation electrode needle outlet 4;

The ablation electrode needle 5 includes a radio frequency electrode needle 5-1 and a nerve probe needle 5-2 connected to one end of the radio frequency electrode needle 5-1, and the nerve probe needle 5-2 is arranged near the radio frequency ablation electrode needle outlet 4. one side;

A variable radio frequency instrument 6 is connected to the radio frequency electrode needle 5-1, and a real-time nerve detector 7 is connected to the nerve detection needle 5-2.

When in use, first locate the bladder and prostate under the guidance of ultrasound, and slowly feed the catheter 1 from the urethra. Under the ultrasound positioning, it can be seen that the head end of the device enters the bladder, and the catheter 2 in the catheter 1 plays a role of catheterization; The radiofrequency ablation electrode needle outlet 4 is positioned to the prostate treatment target area (hyperplastic area or tumor area) by ultrasound;

The variable radio frequency instrument 6 is connected to the radio frequency electrode needle 5-1, the variable radio frequency instrument 6 is turned on, and the power of the radio frequency electrode needle 5-1 is adjusted by using the variable radio frequency instrument 6 according to the actual situation, and the ablation operation is performed on the prostate treatment target area. The setting of nerve probe 5-2 and real-time nerve probe 7 can monitor and protect nerves, preserved nerves, and urinary continence in real time during the operation, without damaging important tissues such as blood vessels and sphincter muscles, and the operation is simple and fast.

In this embodiment, there are four RF electrode needle guide channels 3, corresponding to four RF ablation electrode needle outlets 4 and four ablation electrode needles 5 arranged in the RF electrode needle guide channel 3, and the RF electrode needle guide channels 3 are spaced at intervals of 90 ° Arrangement; due to the uneven distribution of the size of the lesions, the length of the four ablation electrode needles 5 extending from the outlet 4 of the radiofrequency ablation electrode needles can be adjusted respectively to cope with different size and distribution of the lesions, and the direction and size of the ablation target area can be adjusted in real time. The size and the ablation range are precisely controllable;

As a kind of preference of this embodiment:

The catheter 1 includes a front-end catheter 1-1 and a rear-end catheter 1-2 that are coaxially connected, and a nano-drug layer 1-3 is arranged outside the front-end catheter 1-1.

The liquid medicine can be absorbed and penetrated into the nano-drug layers 1-3, which not only plays the role of local anesthesia, anti-inflammatory, etc., but also plays a lubricating role.

As a kind of preference of this embodiment:

The rear end catheter 1-2 is provided with a pusher regulator 8, which is connected to the ablation electrode needle 5, and the pusher adjuster 8 is used to adjust the ablation electrode needle 5 to pass the radiofrequency ablation electrode needle. Outlet 4 is extended or retracted.

The push adjuster 8 can be made of plastic or other insulating materials, and can be pushed by hand to adjust the "depth" of the ablation electrode needle 5 in the gland.

As a kind of preference of this embodiment:

The radio frequency needle length adjuster 9 is also arranged on the back-end catheter 1-2, and the radio frequency needle length adjuster 9 is connected with the insulating sheath 10 sleeved on the ablation electrode needle 5. The radio frequency needle length adjuster 9 is used to adjust the position of the insulating sheath layer 10 on the ablation electrode needle 5 .

The RF needle length adjuster 9 is made of insulating material, and by pushing the RF needle length adjuster 9, the position of the insulating sheath 10 on the ablation electrode needle 5 can be changed, so as to adjust the size of the exposed metal part of the RF electrode needle 5-1, and the RF needle can be adjusted. Only the exposed metal part of the electrode needle 5-1 can perform work, and the larger the size of the metal part, the more charge it carries, and the more power it carries, and vice versa.

As a kind of preference of this embodiment:

The described device for ultrasound-guided radiofrequency ablation of the prostate further comprises a cooling device 11;

The cooling device 11 includes a cooling water channel 11-1 arranged on the side of the RF electrode needle guide channel 3 facing the urinary catheter 2 and a cold circulation power pump 11-2 communicating with the cooling water channel 11-1;

The cooling water channel 11-1 includes a water inlet pipe 11-1-1 and a water outlet pipe 11-1-1 arranged side by side, and the water inlet pipe 11-1-1 and the water outlet pipe 11-1-2 are close to the radio frequency. The ablation electrode needle outlet 4 is connected, the water inlet pipe 11-1-1 is pumped into sterile water through the cold cycle power pump 11-2, and the water outlet pipe 11-1-2 is communicated with the waste water recovery device 12.

The cold circulation power pump 11-2 can be communicated with the sterile water tank 13 or other water supply devices to pump sterile water or other cooling liquids into the cooling water channel 11-1.

The cooling device 11 ensures the safety of the non-target target area during the ablation operation. (The target area is only the enlarged prostate, and does not act on the urethra and bladder). The sterile water is pumped into the water inlet pipe 11-1-1 through the cold circulation power pump 11-2, and then enters the waste water recovery device 12 through the water outlet pipe 11-1-2 to complete the cooling.

The specific use process of this program is as follows:

1. Open the sterile suit and take out the device;

2. Disinfect the skin near the urethra and lay antibacterial towel;

3. Position the bladder and prostate under ultrasound guidance, and slowly feed the device from the urethra. Under ultrasound positioning, it can be seen that the tip of the device enters the bladder, and the device is only a urinary catheter when no ablation is performed. The front-end catheter 1-1 is provided with a nano-drug layer 1-3, which can absorb and penetrate the liquid drug, which not only plays the role of local anesthesia and anti-inflammatory, but also plays a lubricating role. Position the outlet 4 of the radiofrequency ablation electrode needle to the prostate treatment target area (hyperplastic area or tumor area) by ultrasound;

4. Due to irregular prostatic hypertrophy or the location of the tumor is not fixed, precise ablation can be performed at any time according to the treatment target direction in four directions by advancing the regulator 8 under ultrasound-guided positioning. As shown in Figure 4.

5. The device has four-direction push adjusters 8. At the end of the device, adjusting the device can determine the position (depth) of the ablation electrode needle 5 in the prostate, and in front of the push adjuster 8, there is a length adjustment of the radio frequency needle. The device 9 and the insulating sheath 10 covered on the ablation electrode needle 5 can adjust the power of the ablation electrode needle 5 in real time according to the size of the ablation target area.

6. The nerve probe 5-2, that is, the metal guide wire coaxial with the radio frequency electrode needle 5-1, is connected to the nerve real-time detector 7 to ensure the safety of nerve tissue such as the intraprostatic nerve during the ablation process.

7. The ablation electrode needle 5 is equipped with a cooling device 11 to ensure the safety of the non-target target area during the ablation operation. (The target area is only the enlarged prostate, and does not act on the urethra and bladder).

8. Before the ablation electrode needle 5 reaches the ablation target area, turn on the cooling device 11, adjust the variable radio frequency instrument 6, slowly increase the power from low power to high power, and at the same time pass the nerve real-time detector 7, pay attention to the prostate during ablation Nerve stimulation in vivo.

9. After the ablation operation is completed, the adjustable radio frequency instrument 6 is removed, and the cooling device 11 is subsequently kept turned on to ensure that the tissue around the ablation area returns to normal temperature.

10. Since there is a puncture operation in the urethra, in order to avoid urinary tract infection, keep the device in the body, only for the role of a urinary catheter, and the nano-drug layer 1-3 contains drugs such as anti-inflammatory and pain relief, which can protect the urethra. Postoperative urethral safety. After the other signs returned to normal during the perioperative period, the whole set of the device was removed, and the postoperative treatment effect of the patient was evaluated by ultrasound.

The above are only preferred specific embodiments of the present invention, but the protection scope of the present invention is not limited to this. Changes or substitutions are all included within the protection scope of the present invention.

Claims (5)

1. a device for radiofrequency ablation of the prostate under ultrasound guidance, comprising a catheter (1) and a catheter (2) that is arranged in the catheter (1) through, it is characterized in that the catheter (1) and catheterization A plurality of radio frequency electrode needle guide channels (3) are also arranged along the circumferential direction between the tubes (2); The catheter (1) is provided with a radiofrequency ablation electrode needle outlet (4) in the circumferential direction, the number of the radiofrequency ablation electrode needle outlet (4) is the same as that of the radiofrequency electrode needle guide channel (3), and the radiofrequency ablation electrode The needle outlet (4) is communicated with the radio frequency electrode needle guide channel (3); An ablation electrode needle (5) is arranged in the radio frequency electrode needle guide channel (3), and the ablation electrode needle (5) can be extended or retracted through the radio frequency ablation electrode needle outlet (4); The ablation electrode needle (5) comprises a radio frequency electrode needle (5-1) and a nerve probe needle (5-2) connected to one end of the radio frequency electrode needle (5-1), and the nerve probe needle (5-2) ) is arranged on the side close to the outlet (4) of the radiofrequency ablation electrode needle; A variable radio frequency instrument (6) is connected to the radio frequency electrode needle (5-1), and a real-time nerve detector (7) is connected to the nerve detection needle (5-2). 2. The device for ultrasound-guided radiofrequency ablation of the prostate according to claim 1, wherein the catheter (1) comprises a front-end catheter (1-1) and a rear-end catheter (1-2) that are coaxially connected ), a nano-drug layer (1-3) is arranged on the outside of the front-end catheter (1-1). 3. The device for ultrasound-guided radiofrequency ablation of the prostate according to claim 2, characterized in that, an advance regulator (8) is arranged on the back-end catheter (1-2), and the advance regulator (8) is connected to the ablation electrode needle (5), and the advancing regulator (8) is used to adjust the ablation electrode needle (5) to extend or retract through the radiofrequency ablation electrode needle outlet (4). 4. The device for ultrasound-guided radiofrequency ablation of the prostate according to claim 2, wherein a radiofrequency needle length regulator (9) is also arranged on the back-end catheter (1-2), and the The radio frequency needle length adjuster (9) is connected with the insulating sleeve layer (10) sleeved on the ablation electrode needle (5), and the radio frequency needle length adjuster (9) is used for adjusting the insulating sleeve layer (10) in the ablation electrode needle ( 5) on the position. 5. The device for radiofrequency ablation of the prostate under ultrasound guidance according to claim 1, wherein the device for radiofrequency ablation of the prostate under ultrasound guidance further comprises a cooling device (11); The cooling device (11) comprises a cooling water channel (11-1) arranged on the side of the radio frequency electrode needle guide channel (3) facing the urinary catheter (2), and a cooling water channel (11-1) communicating with the cooling water channel (11-1). Circulating power pump (11-2); The cooling water channel (11-1) includes a water inlet pipe (11-1-1) and a water outlet pipe (11-1-1) arranged side by side, and the water inlet pipe (11-1-1) and the water outlet pipe (11-1-2) is communicated near the outlet (4) of the radiofrequency ablation electrode needle, and the water inlet pipe (11-1-1) is pumped into sterile water through the cold circulation power pump (11-2). The water outlet pipe (11-1-2) is communicated with the waste water recovery device (12).

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