WO2024145228A2 - Electrical connectors for implantable devices - Google Patents

Electrical connectors for implantable devices Download PDF

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Publication number
WO2024145228A2
WO2024145228A2 PCT/US2023/085728 US2023085728W WO2024145228A2 WO 2024145228 A2 WO2024145228 A2 WO 2024145228A2 US 2023085728 W US2023085728 W US 2023085728W WO 2024145228 A2 WO2024145228 A2 WO 2024145228A2
Authority
WO
WIPO (PCT)
Prior art keywords
feedthrough
lead
compliant
electrical connector
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2023/085728
Other languages
French (fr)
Other versions
WO2024145228A3 (en
Inventor
Kevin VERZAL
David DIEKEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Inspire Medical Systems Inc
Original Assignee
Inspire Medical Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Inspire Medical Systems Inc filed Critical Inspire Medical Systems Inc
Publication of WO2024145228A2 publication Critical patent/WO2024145228A2/en
Publication of WO2024145228A3 publication Critical patent/WO2024145228A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/3611Respiration control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551Spinal or peripheral nerve electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3752Details of casing-lead connections

Definitions

  • FIG. 2 illustrates a front view schematically representing a patient’s body to which example devices may be applied.
  • FIG. 3 illustrates a control portion
  • FIGS. 6A-6D illustrate various views of an example device including an electrical connector.
  • FIGS. 7A-7F illustrate various views of another example device including an electrical connector.
  • FIGS. 9A-9D illustrate various views of yet another example device including an electrical connector.
  • FIGS. 10A-10D illustrate various views of yet another example device including an electrical connector.
  • FIGS. 14A-14D illustrate various views of yet another example device including an electrical connector.
  • the at least one conductive element 30 may comprise, or be part of, an electrical connector for transmitting power and/or signals to another device.
  • the at least one conductive element 30 is electrically connected to the power and/or circuitry of the first element 22 through the at least one wire 28 and the electrical connector 26.
  • second element 24 may support a plurality of conductive elements 30 (e.g., 2, 3, 4, 5, 6, 7, 8, or more) that are electrically connected to the power and/or circuitry of first element 22 through a plurality of wires 28 and the electrical connector 26.
  • the stimulation electrode arrangements of FIGS. 1 B-1 C provide examples of a relatively high number of independently controllable conductive elements (e.g. electrodes), which in turn may dictate a relatively high density connection of independent conductive elements of lead body 42 to a first element, such as first element 22 in FIG. 1A.
  • the benefit of a high density connection of independent conductive elements between the lead body 42 and the first element 22 may be heightened in examples in which the first element 22 and lead 24 together comprise a medical device sized and shaped for chronic implantation in a head-and-neck region of a patient or other compact region of the body.
  • a reduced size arrangement may comprise (or sometimes be referred to as) a microstimulator, which may or may not be implanted in a head- and-neck region of a patient (or other compact region of the body).
  • the first element 22 may comprise at least a power element, stimulation circuitry, and a wireless communication element to communicate power, stimulation information, and/or data between the first element 22 and a device external to the arrangement 20 (which may be external to the patient’s body or merely external to the first element 22 (and lead 28).
  • FIG. 1 D illustrates an example device 70 including a first element 22 and a second element 74.
  • device 70 includes at least some of substantially the same features as device 50 of FIG. 1 A, except that second element 74 of device 70 includes two wires 28a, 28b (and associated respective conductive elements 30a, 30b) instead of just one wire 28 and one conductive element 30.
  • Second element 74 may include a first portion (e.g., proximal portion) including an electrical connector 26, at least one first wire 28a, and at least one first conductive element 30a on an opposite second portion (e.g., first distal portion) of the second element 74.
  • Second element 74 may also include at least one second wire 28b opposite to the at least one first wire 28a, and at least one second conductive element 30b on an opposite third portion (e.g., second distal portion) of the second element 74.
  • the at least one wires 28a, 28b and the at least one conductive elements 30a, 30b may have substantially the same features as the at least one wire 28 and the at least one conductive element 30 described with reference to FIG. 1A.
  • wire 28b, element 30b) are positioned to be in sensing relation to other target tissues (e.g. respiratory tissues) to facilitate stimulation therapy for treating sleep disordered breathing (e.g. obstructive sleep apnea).
  • the other target tissues may comprise a phrenic nerve and/or diaphragm muscle to sense respiration and/or other physiologic parameters suitable to facilitate stimulation therapy for treating sleep disordered breathing (e.g. obstructive sleep apnea).
  • leads are illustrated as extending from opposing sidewalls of the electrical connector 26, in some examples, the leads may extend from the same sidewall of electrical connector 26, from adjacent sidewalls (e.g., perpendicular sidewalls) of electrical connector 26, and/or from the end wall of the electrical connector 26 (e.g., top surface of 26 in FIG. 1 D).
  • second element 74 may include more than two leads (e.g., 3, 4, 6, etc.) extending from the electrical connector 26.
  • FIG. 1 E illustrates an example device 80 including a first element 22 and a pair of second elements 74a, 74b.
  • device 80 includes at least some of substantially the same features as device 70 of FIG. 1 D, except that the respective second elements 74a, 74b of device 70 are connected to opposite ends 23a, 23b of the first element 22 which may provide greaterflexibility in positioning the respective leads (28a, 30b; 28b, 30b) of elements 74a, 74b relative to target tissues which are located in opposite directions from a location at which the first element 22 may be anchored within the patient’s body.
  • FIG. 1 F illustrates an example device 80 including a first element 22 and a second element 24.
  • device 80 includes at least some of substantially the same features as device 20 of FIG. 1 A (or FIGS. 1 B-1 E), except that instead of the at least one wire 28 extending perpendicular (e.g., 90°) to the long axis 53 of the first element 22, in device 80 the at least one wire 28 extends at an angle theta (0) relative to the long axis 53 of the first element 22.
  • the angle theta (0) may be within a range between 0° and 90° (e.g., 10°, 20°, 30°, 45°, 60°, 80°). While device 80 illustrated in FIG.
  • the stimulation element 117 may comprise part of an external component/device such as, but not limited to, the external component comprising a pulse generator (e.g., stimulation/control circuitry), power supply (e.g., rechargeable, non-rechargeable), and/or other components.
  • the external component comprising a pulse generator (e.g., stimulation/control circuitry), power supply (e.g., rechargeable, non-rechargeable), and/or other components.
  • a portion of the stimulation element 117 may be implantable and a portion of the stimulation element 1 17 may be external to the patient.
  • the various sensing element(s) 128 and/or stimulation element(s) 117 implanted in the patient’s body may be in wireless communication (e.g., connection 137) with at least one external element 150.
  • the external element(s) 150 may be implemented via a wide variety of formats such as, but not limited to, at least one of the formats 151 including a patient support 152 (e.g., bed, chair, sleep mat, other), wearable elements 154 (e.g., finger, wrist, head, neck, shirt), noncontact elements 156 (e.g., watch, camera, mobile device, other), and/or other elements 158.
  • a patient support 152 e.g., bed, chair, sleep mat, other
  • wearable elements 154 e.g., finger, wrist, head, neck, shirt
  • noncontact elements 156 e.g., watch, camera, mobile device, other
  • other elements 158 e.g., watch, camera, mobile device, other
  • the external element(s) 150 may comprise one or more different modalities 170 such as (but not limited to) a sensing portion 171 , stimulation portion 172, power portion 174, communication portion 176, and/or other portion 178.
  • the different portions 171 , 172, 174, 176, 178 may be combined into a single physical structure (e.g., package, arrangement, assembly), may be implemented in multiple different physical structures, and/or with just some of the different portions 171 , 172, 174, 176, 178 combined together in a single physical structure.
  • FIG. 4D illustrates a plan view of yet another example electrical connector 200d for a device, such as a pulse generator.
  • Electrical connector 200d includes feedthrough posts 204 either protruding from the external surface 203 of the housing 202, flush with external surface 203 of the housing 202, or recessed with respect to the external surface 203 of the housing 202.
  • the feedthrough posts 204 are arranged in a two-dimensional array.
  • FIG. 6D illustrates a partial cross-sectional view of the device 300a with the electrical connector 322 of the lead 320 connected to the electrical connector 220a on the device 300a.
  • the mounting screw receivers 240 and 328 act as alignment features to align the electrical connector 322 on the proximal portion of the lead 320 with the electrical connector 220a.
  • the electrical connectors 220a and 322 may include additional mounting posts and/or recesses to align the components.
  • FIG. 7A illustrates a side view and FIG. 7B illustrates a plan view of another example device 300b.
  • Device 300b includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 220b electrically connected to the pulse generator 302.
  • the electrical connector 220b also includes mounting screw receivers 240.
  • FIG. 7C illustrates a plan view
  • FIG. 7D illustrates a cross-sectional view of an interposer 340.
  • Interposer 340 includes a plurality of amorphous compliant contacts 224, a compliant electrically insulating material 250, an insulating layer 226, and mounting screw receivers 344.
  • the compliant electrically insulating material 250 surrounds the plurality of amorphous compliant contacts 224 and mounting screw receivers 344.
  • FIG. 11 A illustrates a side view of another example device 400c.
  • Device 400c includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 460 electrically connected to the pulse generator 302.
  • device 400c includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the external surface 203 of the housing 202.
  • Electrical connector 460 includes a portion 422 electrically connected to the plurality of feedthrough posts 204, a lead 424 permanently connected to the portion 422 on a first end of the lead, and a female connector 462 within a connector housing 464 permanently connected to the lead 424 on a second end of the lead.
  • female connector 462 includes a plurality of parallel hollow cylindrical contacts 466 arranged within a circular housing 464.
  • the circular housing 464 includes an alignment feature 468 (e.g., a notch) for aligning the female connector 462 with a male connector of a lead to be described below with reference to FIGS. 11 D and 11 E.
  • Each hollow cylindrical contact 466 corresponds to a respective feedthrough post 204 and is electrically connected to the stimulation circuitry of the pulse generator 302.
  • female connector 462 includes eight hollow cylindrical contacts 466
  • device 400c includes a respective eight feedthrough posts 204.
  • device 400c may include less than eight hollow cylindrical contacts 466 or more than eight hollow cylindrical contacts 466, and device 400c may include a respective equal number of feedthrough posts 204.
  • the electrical connector 510 also includes mounting screw receivers 516 as illustrated in FIG. 12B and a compliant electrically insulating material 514 surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 512.
  • the compliant electrically insulating material 514 is directly attached (e.g., glued, adhered, overmolded) to the external surface 203 of the housing 202.
  • the compliant electrically insulating material 514 may be directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 512 either in addition to or alternatively to being directly attached to the external surface 203 of the housing 202.
  • the compliant electrically insulating material 514 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
  • Each mounting screw receiver 516 may be flush with the external surface 203 of the housing 202 and extend into the housing 202 and/or may protrude from the external surface 203 of the housing 202.
  • a first mounting screw receiver 516 is arranged to the left of the center of the single line (e.g., column) of feedthrough posts 204 and respective amorphous compliant contacts 224
  • a second mounting screw receiver 516 is arranged to the right of the center of the single line of feedthrough posts 204 and respective amorphous compliant contacts 224.
  • the electrical connector 510 may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the feedthrough posts 204 and the respective amorphous compliant contacts 224.
  • the compliant electrically insulating material 544a and 544b contacts the external surface 203 of the housing 202 and the proximal portion (e.g., the connector housing 556 of the electrical connector 552) of the lead 550 to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the proximal portion of the lead 550.
  • the compliant electrically insulating material 544a and 544b may compress when the screw is engaged.
  • FIG. 14A illustrates a side view
  • FIG. 14B illustrates a plan view of another example device 600.
  • Device 600 includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 610 electrically connected to the pulse generator 302. As shown in the cross-sectional view of FIG.
  • the electrical connector 610 includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the housing 202.
  • the plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 14D, or separate from the housing 202 (e.g., 512 of FIG. 12C).
  • the electrical connector 610 also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612 as shown in FIG. 14D. In this example, as shown in FIG.
  • the electrical connector 610 includes eight feedthrough posts 204 and respective amorphous compliant contacts 224 arranged in two lines.
  • the electrical connector 610 may include less than eight feedthrough posts 204 or more than eight feedthrough posts 204 and respective amorphous compliant contacts 224, and feedthrough posts 204 and respective amorphous compliant contacts 224 may have another suitable arrangement, such as previously described and illustrated with reference to FIGS. 4B-4E.
  • FIG. 14C illustrates a plan view of a lead 620.
  • Lead 620 includes an electrical connector 622 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 622, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires.
  • the electrical connector 622 includes a plurality of contact pads 624, a connector housing 626, and mounting screw receivers 630.
  • the contact pads 624 may be flush with a recessed surface 628 of the connector housing 626, such that inner sidewalls 629 of the connector housing 626 surround the contact pads 624.
  • Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 620 through wires 324.
  • Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 610 to electrically connect the stimulation circuitry to the conductive elements of the lead 620.
  • Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 610 to secure the connector housing 626 to the electrical connector 610 using screws 632 as shown in FIG. 14D.
  • the compliant electrically insulating material 634 contacts insulating material block 612 of the electrical connector 610 and the proximal portion (e.g., the inner sidewalls 629 of the connector housing 626 of the electrical connector 622) of the lead 620 to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 610 and the proximal portion of the lead 620.
  • the compliant electrically insulating material 634 may deflect when the electrical connector 622 is connected to the electrical connector 610.
  • the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 620 via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively.
  • the proximal portion (e.g., electrical connector 622) of the lead 620 extends perpendicular to a long axis of the pulse generator 302.
  • FIG. 15A illustrates a cross-sectional view of an electrical connector 652a of a lead 650a connected to an electrical connector 640a on a device, such as device 600 of FIG. 14A.
  • the electrical connector 640a includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry (not shown) and extending through the housing 202.
  • the plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 15A, or separate from the housing 202 (e.g., 512 of FIG. 12C).
  • the feedthrough posts 204 may be recessed with respect to the surface of the insulating material block 612.
  • the electrical connector 640a also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612. Each amorphous compliant contact 224 may protrude from the insulating material block 612.
  • the electrical connector 640a also includes mounting screw receivers 614.
  • the electrical connector 640a may also include a compliant electrically insulating material 642a surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 612.
  • the compliant electrically insulating material 642a is directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 612 and the surface 203 of the housing 202 and includes a single triangular shaped ring of compliant electrically insulating material.
  • the compliant electrically insulating material 642a may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
  • Lead 650a includes an electrical connector 652a on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 652a, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires.
  • the electrical connector 652a includes a plurality of contact pads 624, a connector housing 656a, and mounting screw receivers 630.
  • the contact pads 624 may be flush with a recessed surface 658a of the connector housing 656a, such that inner sidewalls 659a of the connector housing 656a surround the contact pads 624.
  • Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 650a through wires 324.
  • Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 640a to electrically connect the stimulation circuitry to the conductive elements of the lead 650a.
  • Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 640a to secure the connector housing 656a to the electrical connector 640a using screws 632.
  • the mounting screw receivers 614 and 630 and insulating material block 612 and connector housing 656a act as alignment features to align the electrical connector 652a on the proximal portion of the lead 650a with the electrical connector 640a.
  • Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 656a.
  • the compliant electrically insulating material 642a contacts insulating material block 612 of the electrical connector 640a, the external surface 203 of the housing 202, and the proximal portion (e.g., the inner sidewalls 659a of the connector housing 656a of the electrical connector 652a) of the lead 650a to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 640a and the proximal portion of the lead 650a.
  • the compliant electrically insulating material 642a may compress when the screws 632 are tightened.
  • the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 650a via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively.
  • FIG. 15B illustrates a cross-sectional view of an electrical connector 652b of a lead 650b connected to an electrical connector 640b on a device, such as device 600 of FIG. 14A.
  • the electrical connector 640b includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry (not shown) and extending through the housing 202.
  • the plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 15B, or separate from the housing 202 (e.g., 512 of FIG. 12C).
  • the feedthrough posts 204 may be recessed with respect to the surface of the insulating material block 612.
  • the electrical connector 640b also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612. Each amorphous compliant contact 224 may protrude from the insulating material block 612.
  • the electrical connector 640b also includes mounting screw receivers 614.
  • the electrical connector 640b may also include a compliant electrically insulating material 642b surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 612, and compliant electrically insulating material 644 between (e.g., surrounding) each individual amorphous compliant contact 224.
  • the compliant electrically insulating material 642b is directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 612 and the surface 203 of the housing 202 and includes two ridges extending from a single triangular shaped base portion ring of compliant electrically insulating material.
  • compliant electrically insulating material 642b illustrated in FIG. 15B includes two ridges
  • compliant electrically insulating material 642b may include a single ridge or more than two ridges.
  • the compliant electrically insulating material 644 may be directly attached (e.g., glued, adhered, overmolded) to the insulating material block 612 or part of an interposer (e.g. , 340 of FIGS. 7C and 7D).
  • the compliant electrically insulating material 642b and 644 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
  • Lead 650b includes an electrical connector 652b on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 652b, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires.
  • the electrical connector 652b includes a plurality of contact pads 624, a connector housing 656b, and mounting screw receivers 630.
  • the contact pads 624 may be recessed with respect to a recessed surface 658b of the connector housing 656b, such that portions of amorphous compliant contacts 224 extend into the connector housing 656b to electrically contact the contact pads 624.
  • the recessed surface 658b is surrounded by inner sidewalls 659b of the connector housing 656b.
  • the inner sidewalls 659b are angled with respect to the recessed surface 658b (e.g., the angle between the recessed surface 658b and the inner sidewalls 656b is greater than about 90 degrees and less than about 170 degrees).
  • Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 650b through wires 324.
  • Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 640b to electrically connect the stimulation circuitry to the conductive elements of the lead 650b.
  • Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 640b to secure the connector housing 656b to the electrical connector 640b using screws 632.
  • the mounting screw receivers 614 and 630 and insulating material block 612 and connector housing 656b act as alignment features to align the electrical connector 652b on the proximal portion of the lead 650b with the electrical connector 640b.
  • Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 656b.
  • the compliant electrically insulating material 642b contacts insulating material block 612 of the electrical connector 610, the external surface 203 of the housing 202, and the proximal portion (e.g., the inner walls 659b of the connector housing 656b of the electrical connector 652b) of the lead 650b to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 640b and the proximal portion of the lead 650b.
  • the compliant electrically insulating material 642b and/or 644 may compress when the screws 632 are tightened.
  • the compliant electrically insulating material 644 contacts insulating material block 612 and the surface 658b of the connector housing 656b to form seals between the electrical connector 640b and the portion of the lead 650b between the amorphous compliant contacts 224.
  • the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 650b via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively.
  • FIG. 15C illustrates a cross-sectional view of an electrical connector 652c of a lead 650c connected to an electrical connector 640c on a device, such as device 600 of FIG. 14A.
  • the electrical connector 640c includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry (not shown) and extending through the housing 202.
  • the plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 15C, or separate from the housing 202 (e.g., 512 of FIG. 12C).
  • the feedthrough posts 204 may be flush with the surface of the electrically insulating material block 612.
  • the electrical connector 640c also includes a plurality of deflectable contacts 222 (e.g., leaf springs), where each deflectable contact 222 is electrically connected to a respective feedthrough post 204.
  • the electrical connector 640c also includes mounting screw receivers 614.
  • the electrical connector 640c may also include a compliant electrically insulating material 634 surrounding the plurality of feedthrough posts 204, the deflectable contacts 222, and the insulating material block 612, and compliant electrically insulating material 644 between (e.g., surrounding) each individual deflectable contact 222.
  • the compliant electrically insulating material 634 is directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 612 and includes two rings of compliant electrically insulating material.
  • the compliant electrically insulating material 634 may include a single ring of compliant electrically insulating material or more than two rings of compliant electrically insulating material.
  • the compliant electrically insulating material 644 may be directly attached (e.g., glued, adhered, overmolded) to the insulating material block 612 or part of an interposer (e.g. , 340 of FIGS. 7C and 7D).
  • the compliant electrically insulating material 634 and 644 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, polyurethane/silicone blend, or another suitable material.
  • Lead 650c includes an electrical connector 652c on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 652c, and a plurality of conductive elements (e.g., 30 of FIG.
  • the electrical connector 652c includes a plurality of contact pads 624, a connector housing 656c, and mounting screw receivers 630.
  • the contact pads 624 may be flush with a recessed surface 658c of the connector housing 656c, such that inner sidewalls 659c of the connector housing 656c surround the contact pads 624.
  • the inner sidewalls 659c are perpendicular to the recessed surface 658c.
  • Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 650c through wires 324.
  • Each contact pad 624 corresponds to a respective deflectable contact 222 of the electrical connector 640c to electrically connect the stimulation circuitry to the conductive elements of the lead 650c.
  • Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 640c to secure the connector housing 656c to the electrical connector 640c using screws 632.
  • the mounting screw receivers 614 and 630 and insulating material block 612 and connector housing 656c act as alignment features to align the electrical connector 652c on the proximal portion of the lead 650c with the electrical connector 640c.
  • Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 656c.
  • the compliant electrically insulating material 634 contacts insulating material block 612 of the electrical connector 610 and the proximal portion (e g., the inner walls 659c of the connector housing 656c of the electrical connector 652c) of the lead 650c to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 640c and the proximal portion of the lead 650c.
  • the compliant electrically insulating material 634 and/or 644 may compress when the screws 632 are tightened.
  • the compliant electrically insulating material 644 contacts insulating material block 612 and the surface 658c of the connector housing 656c to form seals between the electrical connector 640b and the portion of the lead 650b between the deflectable contacts 222.
  • the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 650c via the feedthrough posts 204, deflectable contacts 222, contact pads 624, and wires 324, respectively.
  • FIG. 16A illustrates a side view and FIG. 16B illustrates a plan view of another example device 700.
  • Device 700 includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 710 electrically connected to the pulse generator 302.
  • the electrical connector 710 includes a plurality of hollow cylindrical contacts 714 electrically connected to the stimulation circuitry and extending through the external surface 203 of the housing 202.
  • the plurality of hollow cylindrical contacts 714 may extend through an electrically insulating material block 712 (e.g., a ceramic material block) and may protrude from the electrically insulating material block 712.
  • the plurality of hollow cylindrical contacts 714 may be coated with a medical-grade Parylene, which is known to be biocompatible.
  • the electrical connector 710 includes eight hollow cylindrical contacts 714 arranged in two lines (e.g., two rows). In other examples, the electrical connector 710 may include less than eight hollow cylindrical contacts 714 or more than eight hollow cylindrical contacts 714, and hollow cylindrical contacts 714 may have another suitable arrangement, such as previously described and illustrated with reference to FIGS. 4A-4E.
  • the electrical connector 710 also includes mounting screw receivers 716.
  • a first mounting screw receiver 716 is arranged to the left of the center of the two lines (e.g., two rows) of hollow cylindrical contacts 714, and a second mounting screw receiver 716 is arranged to the right of the center of the two lines of hollow cylindrical contacts 714.
  • the electrical connector 710 may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the hollow cylindrical contacts 714.
  • FIG. 16C is a plan view and FIG. 16D is a side view of an example elastomeric septum 720.
  • FIG. 16E is a front view of an example septum clamp 730.
  • Septum clamp 730 includes a frame 732 and an opening 734 extending through the frame 732.
  • the frame 732 includes two curved portions 736 corresponding to mounting screw receivers 716.
  • Septum clamp 730 is configured to be placed over elastomeric septum 720, such that the frame 732 contacts the outer portion 722 of the elastomeric septum 720.
  • the opening 734 of the septum clamp 730 is configured to receive the inner portion 724 of the elastomeric septum 720, such that the frame 732 surrounds the inner portion 724.
  • the contact pins 744 protrude from a recessed surface 748 of the connector housing 746, such that inner sidewalls 749 of the connector housing 746 surround the contact pins 744. The inner sidewalls 749 are perpendicular to the recessed surface 748.
  • Each contact pin 744 is electrically connected to a respective conductive element on the distal end of the lead 740 through wires 324.
  • Each contact pin 744 corresponds to a respective hollow cylindrical contact 714 of the electrical connector 710 to electrically connect the stimulation circuitry to the conductive elements of the lead 740.
  • the base of each contact pin 744 (which does not extend into a respective hollow cylindrical contact 714) may be coated with a medical-grade Parylene (or other non-conductive coating), which is known to be biocompatible.
  • Each mounting screw receiver 750 corresponds to a respective mounting screw receiver 716 of the electrical connector 710 and the curved portion 736 of the septum clamp 730 to secure the connector housing 746 to the electrical connector 710 using screws 752 as shown
  • FIG. 16H illustrates a partial cross-sectional view of the device 700 with the electrical connector 742 of the lead 740 connected to the electrical connector 710 on the device 700.
  • the mounting screw receivers 716 and 750, the curved portions 736 of septum clamp 730, and insulating material block 712 and connector housing 746 act as alignment features to align the electrical connector 742 on the proximal portion of the lead 740 with the electrical connector 710.
  • Elastomeric septum 720 is arranged between the female connector 710 and the male connector 742, such that the plurality of contact pins 744 of the male connector 742 penetrate the elastomeric septum 720.
  • the elastomeric septum 720 (and Parylene or other non-conductive coating) provides effective isolation between adjacent contact pins 744, even if the male connector 742 is connected to the female connector 710 in a wet environment.
  • the elastomeric septum 720 (and Parylene or other non-conductive coating) prevents the development of short-circuits between the contact pins 744 due to fluid ingress during the device lifetime.
  • Septum clamp 730 is between the elastomeric septum and the male connector 740.
  • the Elastomeric septum 720 forms a seal (e.g., electrically isolating seal, hermetic seal) between the male connector 742 and the female connecter 710 and between each of the plurality of contact pins 744 and respective hollow cylindrical contacts 714.
  • a seal e.g., electrically isolating seal, hermetic seal
  • the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 740 via the hollow cylindrical contacts 714, contact pins 744, and wires 324, respectively.
  • the proximal portion (e.g., electrical connector 742) of the lead 740 extends perpendicular to a long axis of the pulse generator 302.
  • FIG. 17A illustrates a cross-sectional view of the electrical connectors 622 and 680 prior to connecting the electrical connectors
  • FIG. 17B illustrates a cross-sectional view of the electrical connectors 622 and 680 after connecting the electrical connectors.
  • Lead 620 includes electrical connector 622 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 622, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires.
  • the electrical connector 622 includes a plurality of contact pads 624, a connector housing 626, and mounting screw receivers 630.
  • the contact pads 624 may be flush with a recessed surface 628 of the connector housing 626, such that inner sidewalls 629 of the connector housing 626 surround the contact pads 624. The inner sidewalls 629 are perpendicular to the recessed surface 628.
  • Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 620 through wires 324.
  • Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 680 to electrically connect the stimulation circuitry to the conductive elements of the lead 620.
  • the electrical connector 680 includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the housing 202.
  • the plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 17A and 17B, or separate from the housing 202 (e.g., 512 of FIG. 12C).
  • the feedthrough posts 204 may be recessed with respect to the surface of the insulating material block 612.
  • Electrical connector 680 also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612. Each amorphous compliant contact 224 may protrude from the insulating material block 612.
  • the electrical connector 680 also includes mounting screw receivers 614. Each mounting screw receiver 614 corresponds to a respective mounting screw receiver 630 of the electrical connector 622 to secure the connector housing 626 to the electrical connector 680 using screws 632.
  • the electrical connector 680 may also include a compliant electrically insulating material 682 surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 612.
  • the compliant electrically insulating material 682 is directly attached (e.g., glued, adhered, overmolded) to the external surface 203 of the housing 202 and includes a single ring of compliant electrically insulating material.
  • the compliant electrically insulating material 682 prior to connecting the electrical connector 622 to the electrical connector 680, has a first height as indicated at 684. As shown in FIG.
  • the compliant electrically insulating material 682 is compressed to have a second height as indicated at 686.
  • the compliant electrically insulating material 682 may be compressed by up to about 20 percent or more to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the electrical connector 622 (e.g., surface 628).
  • the compression of the compliant electrically insulating material 682 is set by the height of sidewalls 629 of the electrical connector 622 also indicated by 686 as the screws 632 are tightened.
  • the compliant electrically insulating material 682 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
  • the mounting screw receivers 614 and 630, compliant electrically insulating material 682, and connector housing 626 act as alignment features to align the electrical connector 622 on the proximal portion of the lead 620 with the electrical connector 680.
  • Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 626.
  • the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 620 via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively.

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Abstract

An implantable medical device includes a first element and a second element. The second element is electrically connected to the first element via an electrical connector. The second element includes at least one conductive element.

Description

ELECTRICAL CONNECTORS FOR IMPLANTABLE DEVICES
Background
[0001] A significant portion of the population suffers from various medical conditions, some of which may be treated using an implantable medical device. In some instances, an implantable medical device may include separate components, which are connected prior to or during implantation within the patient.
Brief Description of the Drawings
[0002] FIG. 1A illustrate example devices including a first element.
[0003] FIGS. 1 B-1C illustrate example elements including an array of conductive elements.
[0004] FIGS. 1 D-1 F illustrate example devices including a first element and a second element.
[0005] FIG. 2 illustrates a front view schematically representing a patient’s body to which example devices may be applied.
[0006] FIG. 3 illustrates a control portion.
[0007] FIGS. 4A-4E illustrate various views of example electrical connectors for a device.
[0008] FIGS. 5A and 5B illustrate cross-sectional views of example electrical connectors for a device.
[0009] FIGS. 6A-6D illustrate various views of an example device including an electrical connector.
[0010] FIGS. 7A-7F illustrate various views of another example device including an electrical connector.
[0011] FIGS. 8A-8G illustrate various views of yet another example device including an electrical connector.
[0012] FIGS. 9A-9D illustrate various views of yet another example device including an electrical connector. [0013] FIGS. 10A-10D illustrate various views of yet another example device including an electrical connector.
[0014] FIGS. 11A-11 F illustrate various views of yet another example device including an electrical connector.
[0015] FIGS. 12A-12E illustrate various views of yet another example device including an electrical connector.
[0016] FIGS. 13A-13D illustrate various views of yet another example device including an electrical connector.
[0017] FIGS. 14A-14D illustrate various views of yet another example device including an electrical connector.
[0018] FIGS. 15A-15C illustrate cross-sectional views of yet another example electrical connectors for a device.
[0019] FIGS. 16A-16H illustrate various views of yet another example device including an electrical connector.
[0020] FIGS. 17 A and 17B illustrate cross-sectional views of yet another example electrical connector for a device.
[0021] FIG. 18 illustrates one example of a device implanted in a patient.
Detailed Description
[0022] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific examples in which the disclosure may be practiced. It is to be understood that other examples may be utilized and structural or logical changes may be made without departing from the scope of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense. It is to be understood that features of the various examples described herein may be combined, in part or whole, with each other, unless specifically noted otherwise.
[0023] At least some examples of the present disclosure are directed to devices for diagnosis, therapy, and/or other care of medical conditions. At least some examples may include implantable devices and/or methods including use of implantable devices.
[0024] At least some of the example devices and/or example methods may relate to sleep disordered breathing (SDB) care, which may include monitoring, diagnosis, and/or stimulation therapy. In some examples, SDB care devices may include electrical connectors to removably electrically connect an SDB care device to a lead including at least one electrode for delivering therapy and/or for sensing, or including at least one conductive element for power transmission and/or for signal transmission.
[0025] These examples, and additional examples, are further described in association with at least FIGS. 1A-18.
[0026] FIG. 1A illustrates an example device 20 including a first element 22 and a second element 24. First element 22 may include a power source (e.g., battery) and circuitry (e.g., a control portion and/or other circuitry), which may be used for a variety of purposes within the patient’s body. Second element 22 may include a first portion (e.g., proximal portion) including an electrical connector 26, at least one wire 28 (e.g. conductor), and at least one conductive element 30 on an opposite second portion (e.g., distal portion) of the second element 24.
[0027] The at least one conductive element 30 may comprise, or be part of, an electrical connector for transmitting power and/or signals to another device. The at least one conductive element 30 is electrically connected to the power and/or circuitry of the first element 22 through the at least one wire 28 and the electrical connector 26. In some examples, second element 24 may support a plurality of conductive elements 30 (e.g., 2, 3, 4, 5, 6, 7, 8, or more) that are electrically connected to the power and/or circuitry of first element 22 through a plurality of wires 28 and the electrical connector 26.
[0028] In some examples, the at least one conductive element 30 may provide an electrical connection to a third element such that the second element 24 may communicate power and/or signals (e.g., control, data, etc.) between the first element 22 and the third element.
[0029] With this in mind, the circuitry of the first element 22 may support a wide variety of functions, such as stimulation, sensing, communication, patient management, and the like. Among other examples, the first element 22 may comprise a stimulation element (e.g., pulse generator) and the second element 24 may comprise a lead. The circuitry of the first element 22 (e.g. acting as a stimulation element) may include stimulation circuitry for delivering therapy (e.g., applying electrical stimulation to an upper airway patency-related tissue of a patient) via the lead (e.g., 24) and/or directly at/through the first element 22. Alternatively, the first element 22 may comprise a sensing element comprising sensing circuitry for obtaining sensing signals in relation to some physiologic aspect within the patient’s body via the lead and/or directly at/through the first element 22. In some such examples, the first element 22 may comprise a combination of stimulation circuitry and sensing circuitry (and other forms of circuitry such as, but not limited to, communication, antenna, power, control, patient management, etc.) and support both stimulation and/or sensing via second element 24 (e.g., lead) and/or via directly at/through the first element 22. [0030] In some examples, the at least one conductive element 30 may include at least one electrode (e.g., stimulation electrode and/or sensing electrode). The at least one conductive element 30 (e.g., cuff electrode) is electrically connected to stimulation circuitry and/or sensing circuitry of first element 22 through the at least one wire 28 and the electrical connector 26. In a manner to that previously noted, in some examples, lead 24 may support a plurality of conductive elements 30 (e.g., 2, 3, 4, 5, 6, 7, 8, or more) that are electrically connected to stimulation circuitry and/or sensing circuitry of first element 22 through a plurality of wires 28 and the electrical connector 26. As further described later, the electrical connector 26 may comprise a plurality of connection points corresponding to the plurality of conductive elements 30 (and/or number of wires 28).
[0031] In some examples, the second element 24 (e.g., lead) including electrical connector 26 and the at least one wire 28, may extend perpendicular to the long axis of the first element 22. First element 22 may be a headerless device, such that electrical connector 26 of lead 24 is directly connected to a housing of first element 22. Electrical connections of first element 22 (e.g., metal pins) may extend through a wall of the housing of first element 22 to electrically connect circuitry of the first element to electrical connector 26. Electrical connector 26 may be removably electrically connected to first element 22.
[0032] FIG. 1 B is a side plan view schematically representing an example arrangement 40 in which stimulation electrode arrangement 50 (e.g. stimulation electrodes supported on a carrier) is in stimulating relation to a target tissue 41 , such as an upper airway patency-related tissue. The target tissue 41 may comprise a nerve, muscle, and/or neuromuscular junction (e.g. motor point) of the nerve and muscle. In some examples, the nerve may comprise a hypoglossal nerve, an infrahyoid-muscle (IHM)-innervating nerve, and/or other nerve related to increasing and/or maintaining upper airway patency. In some examples, the muscle may comprise a genioglossus muscle, an infrahyoid strap muscle, and/or other muscle relate to increasing and/or maintaining upper airway patency. In some examples, the target tissue may comprise pelvic tissues (e.g. nerves, muscles, neuromuscular junctions) involved in treating pelvic disorders such as, but not limited to, urinary and/or fecal incontinence. At least some additional target tissues are described in association with at least FIG. 2.
[0033] In some examples, the stimulation electrode arrangement 50 comprises one example implementation of the at least one conductive element 30 of FIG. 1A.
[0034] The stimulation electrode arrangement 50 may be secured in pressing contact with the target tissue 41 or may be secured in close proximity to, but spaced apart from, the target tissue 41. In some examples, stimulation electrode arrangement 50 extends from, and/or is supported on, a distal portion 44 of a lead body 42 with lead body 42 providing one example implementation of the wire 28 in the example of FIG. 1 A. In some examples, stimulation electrode arrangement 50 comprises a plurality of spaced apart electrodes 56 (e.g. ring electrodes) arranged on a support 57 in a linear array 55. It will be understood that the support may take various forms (e.g. cuff, paddle, etc.) and/or various shapes, while the electrodes 56 may take forms other than a ring electrode. Moreover, in some examples, the stimulation electrode arrangement 50 may comprise a fewer or greater number of electrodes than the number (e.g. 8) of electrodes 56 shown in FIG. 1 B. [0035] FIG. 1C is a side plan view schematically representing an example arrangement 61 in which stimulation electrode arrangement 60 is adapted to be in stimulating relation to a target tissue, as in FIG. 1 B. In some examples, the stimulation electrode arrangement 60 may comprise at least some of substantially the same features and attributes as stimulation electrode arrangement 50 in FIG. 1 B, except comprising a linear array 65 of spaced apart split ring electrodes 66 instead of ring electrodes 56 in FIG. 1 B.
[0036] Among other features, the stimulation electrode arrangements of FIGS. 1 B-1 C provide examples of a relatively high number of independently controllable conductive elements (e.g. electrodes), which in turn may dictate a relatively high density connection of independent conductive elements of lead body 42 to a first element, such as first element 22 in FIG. 1A. The benefit of a high density connection of independent conductive elements between the lead body 42 and the first element 22 may be heightened in examples in which the first element 22 and lead 24 together comprise a medical device sized and shaped for chronic implantation in a head-and-neck region of a patient or other compact region of the body. In such arrangements, due to the reduced size of the medical device, the available space for making a relatively high number of independent electrical connections between conductive elements of a lead 24 and corresponding conductive contacts of a first element 22 may be significantly reduced. In some such examples, a reduced size arrangement may comprise (or sometimes be referred to as) a microstimulator, which may or may not be implanted in a head- and-neck region of a patient (or other compact region of the body). As such, as further described later, in some example implementations (of a microstimulator) the first element 22 may comprise at least a power element, stimulation circuitry, and a wireless communication element to communicate power, stimulation information, and/or data between the first element 22 and a device external to the arrangement 20 (which may be external to the patient’s body or merely external to the first element 22 (and lead 28).
[0037] Among other reasons, some example second elements (e.g. element 30) may provide a relatively high number of conductive elements (e.g. stimulation electrodes) to expedite, and/or increase the effectiveness of, locating a preferred stimulation site along a target tissue (e.g. nerve) at which efficacious stimulation therapy (and/or efficacious sensing) may be performed. Similarly, the relatively high number of conductive elements also may enhance selective stimulation of particular fascicles within a nerve/nerve branch which innervate target muscles/functions. In addition, or alternatively, the relatively high number of conductive elements (e.g. electrodes) also may enable use of multiple different stimulation vectors, which might otherwise not be possible when fewer electrodes are provided on a lead.
[0038] FIG. 1 D illustrates an example device 70 including a first element 22 and a second element 74. In some examples, device 70 includes at least some of substantially the same features as device 50 of FIG. 1 A, except that second element 74 of device 70 includes two wires 28a, 28b (and associated respective conductive elements 30a, 30b) instead of just one wire 28 and one conductive element 30. Second element 74 may include a first portion (e.g., proximal portion) including an electrical connector 26, at least one first wire 28a, and at least one first conductive element 30a on an opposite second portion (e.g., first distal portion) of the second element 74. Second element 74 may also include at least one second wire 28b opposite to the at least one first wire 28a, and at least one second conductive element 30b on an opposite third portion (e.g., second distal portion) of the second element 74. The at least one wires 28a, 28b and the at least one conductive elements 30a, 30b may have substantially the same features as the at least one wire 28 and the at least one conductive element 30 described with reference to FIG. 1A.
[0039] Using two at least one wires 28a, 28b and two corresponding at least one conductive elements 30a, 30b, (e.g., two leads) enables dividing a plurality of wires and corresponding conductive elements between the leads to either reduce the number of wires and corresponding conductive elements for each lead compared to using a single lead (e.g., FIG. 1 A) and/or to enable stimulation and/or sensing at two spaced apart locations within a patient.
[0040] For instance, in some examples, the device 70 may be implanted in a lower portion of a head-and-neck region, such as superior to the clavicle or the manubrium, at which one lead (e.g. wire 28a, element 30a) may extend to be in stimulating relation to an infrahyoid strap muscle (and/or an infrahyoid muscle (IHM)-innervating nerve distal to the ansa cervicalis nerve loop. The other lead (e.g. wire 28b, element 30b) may extend to be in stimulating relation to other target tissues related to treating sleep disordered breathing (SDB) including obstructive sleep apnea. However, in some examples, the other lead (e.g. wire 28b, element 30b) are positioned to be in sensing relation to other target tissues (e.g. respiratory tissues) to facilitate stimulation therapy for treating sleep disordered breathing (e.g. obstructive sleep apnea). In some examples, the other target tissues may comprise a phrenic nerve and/or diaphragm muscle to sense respiration and/or other physiologic parameters suitable to facilitate stimulation therapy for treating sleep disordered breathing (e.g. obstructive sleep apnea).
[0041] In some examples, the sensed respiration may be used for providing closed loop stimulation in which a timing of the stimulation is based on the sensed respiratory information. However, in some examples, the stimulation may be an open loop stimulation (e.g. in which stimulation timing is not based on sensed respiration) and the sensed respiratory information may be used for other purposes to facilitate SDB treatment. Of course, the two lead arrangement is not limited to use with the above-mentioned stimulation and sensing targets.
[0042] While the leads (e.g., 28a/30a and 28b/30b) are illustrated as extending from opposing sidewalls of the electrical connector 26, in some examples, the leads may extend from the same sidewall of electrical connector 26, from adjacent sidewalls (e.g., perpendicular sidewalls) of electrical connector 26, and/or from the end wall of the electrical connector 26 (e.g., top surface of 26 in FIG. 1 D). In addition, while two leads are illustrated in FIG. 1 D as extending from the electrical connector 26, in some examples, second element 74 may include more than two leads (e.g., 3, 4, 6, etc.) extending from the electrical connector 26.
[0043] FIG. 1 E illustrates an example device 80 including a first element 22 and a pair of second elements 74a, 74b. In some examples, device 80 includes at least some of substantially the same features as device 70 of FIG. 1 D, except that the respective second elements 74a, 74b of device 70 are connected to opposite ends 23a, 23b of the first element 22 which may provide greaterflexibility in positioning the respective leads (28a, 30b; 28b, 30b) of elements 74a, 74b relative to target tissues which are located in opposite directions from a location at which the first element 22 may be anchored within the patient’s body.
[0044] FIG. 1 F illustrates an example device 80 including a first element 22 and a second element 24. In some examples, device 80 includes at least some of substantially the same features as device 20 of FIG. 1 A (or FIGS. 1 B-1 E), except that instead of the at least one wire 28 extending perpendicular (e.g., 90°) to the long axis 53 of the first element 22, in device 80 the at least one wire 28 extends at an angle theta (0) relative to the long axis 53 of the first element 22. In some examples, the angle theta (0) may be within a range between 0° and 90° (e.g., 10°, 20°, 30°, 45°, 60°, 80°). While device 80 illustrated in FIG. 1 F includes one lead (e.g., 28), in some examples, device 80 may include more than one lead (e.g., 28a/30a and 28b/30b of FIG. 1 D) and each lead may be connected at an angle relative to the long axis 53 of the first element 22. In some such examples, the angle theta (0) for each lead may be the same or different and each lead may extend from the same sidewall of electrical connector 26, from adjacent sidewalls (e.g., perpendicular sidewalls) of electrical connector 26, and/or from the end wall of the electrical connector 26 (e.g., top surface of 26 in FIG. 1 F).FIG. 2 is a block diagram schematically representing a patient’s body 100, including example target portions 110-134 at which at least some example sensing element(s) and/or stimulation elements may be employed to implement at least some examples of the present disclosure.
[0045] As shown in FIG. 2, the patient’s body 100 includes a head-and-neck portion 110, including head 112 and neck 1 14. Head 112 comprises cranial tissue, nerves, etc., and upper airway 116 (e.g., nerves, muscles, tissues), etc. As further shown in FIG. 2, the patient’s body 100 includes a torso 120, which includes various organs, muscles, nerves, other tissues, such as but not limited to those in pectoral region 122 (e.g., lungs 126, cardiac 127), abdomen 124, pelvic region 129 (e.g., urinary/bladder, anal, reproductive, etc.), and/or other regions (e.g., lower back, buttocks, axilla, etc.). As further shown in FIG. 2, the patient’s body 100 includes limbs 130, such as arms 132 and legs 134. [0046] It will be understood that various sensing elements (and/or stimulation elements) as described throughout the various examples of the present disclosure may be deployed within the various regions of the patient’s body 100 to sense and/or otherwise diagnose, monitor, treat a wide variety of physiologic conditions. Among other treatable conditions, the implantable medical device(s) may be used to treat sleep disordered breathing including but not limited to obstructive sleep apnea. In some such examples, a stimulation element 117 (e.g., pulse generator, lead, and/or associated stimulation electrode arrangements) may be located in or near the upper airway 116 for treating sleep disordered breathing and/or a sensing element 128 may be located anywhere within the neck 114 and/or torso 120 (or other body regions) to sense physiologic information for providing SDB care. A similar arrangement may be implanted for applying electrical stimulation therapy to other nerves (e.g., peripheral nerves) and muscles such as, but not limited to, nerves/muscles in the pelvic region to treat pelvic disorders like incontinence, whether urinary or fecal. Such disorders may include stress incontinence, urge incontinence, and the like.
[0047] In some examples, the stimulation element 117 and/or sensing element 118 may comprise an example implementation of, and/or at least some of substantially the same features as, the devices (20 in FIG. 1A; 40 in FIG. 1 B; 61 in FIG. 1C; 70 in FIG. 1 D; 80 in FIG. 1 E; and 90 in FIG. 1 F) of previous examples of the present disclosure and/or the devices, arrangements, etc. of the examples of FIGS. 3-18.
[0048] In some examples, at least a portion of the stimulation element 117 may comprise part of an implantable component/device, such as an implantable pulse generator (IPG) whether full sized or sized as a microstimulator. The implantable components (e.g., IPG, other) may comprise a stimulation/control circuit, a power supply (e.g., non-rechargeable, rechargeable), communication elements, and/or other components. In some examples, the stimulation element 117 also may comprise a stimulation electrode and/or stimulation lead connected to the implantable pulse generator.
[0049] In some examples, at least a portion of the stimulation element 117 may comprise part of an external component/device such as, but not limited to, the external component comprising a pulse generator (e.g., stimulation/control circuitry), power supply (e.g., rechargeable, non-rechargeable), and/or other components. In some examples, a portion of the stimulation element 117 may be implantable and a portion of the stimulation element 1 17 may be external to the patient.
[0050] Accordingly, as further shown in FIG. 2, the various sensing element(s) 128 and/or stimulation element(s) 117 implanted in the patient’s body may be in wireless communication (e.g., connection 137) with at least one external element 150.
[0051] As further shown in FIG. 2, in some examples, the external element(s) 150 may be implemented via a wide variety of formats such as, but not limited to, at least one of the formats 151 including a patient support 152 (e.g., bed, chair, sleep mat, other), wearable elements 154 (e.g., finger, wrist, head, neck, shirt), noncontact elements 156 (e.g., watch, camera, mobile device, other), and/or other elements 158.
[0052] As further shown in FIG. 2, in some examples, the external element(s) 150 may comprise one or more different modalities 170 such as (but not limited to) a sensing portion 171 , stimulation portion 172, power portion 174, communication portion 176, and/or other portion 178. The different portions 171 , 172, 174, 176, 178 may be combined into a single physical structure (e.g., package, arrangement, assembly), may be implemented in multiple different physical structures, and/or with just some of the different portions 171 , 172, 174, 176, 178 combined together in a single physical structure.
[0053] In some examples, the external power portion 174 and/or power components associated with stimulation element 117 (e.g., implantable portions) may comprise a rechargeable power element (e.g., supply, battery, circuitry elements) and/or non-rechargeable power elements (e.g., battery). In some examples, the external power portion 174 may comprise a power source by which a power component of the stimulation element 117 (e.g., implantable portions) may be recharged.
[0054] In some examples, the wireless communication portion 176 (e.g., connection/link at 137) may be implemented via various forms of radiofrequency communication and/or other forms of wireless communication, such as (but not limited to) magnetic induction telemetry, Bluetooth (BT), Bluetooth Low Energy (BLE), near infrared (NIF), near-field protocols, Wi-Fi, Ultra-Wideband (UWB), ultrasonic waves, and/or other short range or long range wireless communication protocols suitable for use in communicating between implanted components and external components in a medical device environment.
[0055] Examples are not so limited as expressed by other portion 178 via which other aspects of implementing medical care may be embodied in external element(s) 150 to relate to the various implanted and/or external components described above.
[0056] FIG. 3 schematically represents a control portion 190. In some examples, the control portion 190 may be part of a care engine or the like. Among other aspects, example methods and/or example devices may be implemented via the control portion 190. In some examples, the control portion 190 may be used to implement at least some of the various example devices and/or example methods of the present disclosure as described herein. In some examples, the control portion 190 may form part of, and/or be in communication with, the stimulation element (e.g., 117 in FIG. 2) or other implantable medical device (e.g., pulse generator or the like).
[0057] The following examples in association with FIGS. 4A-17B may comprise example implementations of, and/or at least some of substantially the same features as, the examples in association with at least FIGS. 1A-3, 18.
[0058] FIG. 4A illustrates a side view of an example electrical connector 200a for a device, such as a pulse generator or another device also including a power source and/or circuitry, as one example. It will be understood that references to a pulse generator, stimulation circuitry, sensing circuitry, etc. in the following examples throughout the remaining portions of the present disclosure may be applicable generally to, and for use with, any kind of implantable medical device, circuitry, etc.
[0059] Electrical connector 200a includes a plurality of feedthrough posts 204 protruding from a housing 202 of a pulse generator. The housing 202 may be made of an electrically conductive material, such as a metal (e.g., stainless steel, titanium, MP35N, nickel-alloys, Pt-lr, nitinol) and/or an electrically insulating material (e.g., ceramic, PEEK, polysulfone). The plurality of feedthrough posts 204 may be electrically isolated from each other. The plurality of feedthrough posts 204 are configured to be connected to a proximal portion of a lead to electrically connect at least one conductive element of a distal portion of the lead to circuitry (e.g., stimulation circuitry of a pulse generator). Each feedthrough post 204 includes an electrically conductive material, such as a metal (e.g., stainless steel, titanium, Pt-lr, Palladium, gold, MP35N, nickel-alloys, nitinol). In some examples, each feedthrough post 204 may be solid, and the electrical connector 200a may be a male connector configured to be connected to a female connector of the proximal portion of a lead. In other examples, each feedthrough post 204 may be hollow, and the electrical connector 200a may be a female connector configured to be connected to a male connector of the proximal portion of a lead. Each feedthrough post 204 may extend from an external surface 203 of the housing 202 as indicated at 206 within a range, for example, between flush with the surface and extending about 15.0 millimeters. The spacing between adjacent feedthrough posts 204 as indicated at 208 may be within a range, for example, between about 0.10 millimeters and about 5 millimeters. Each feedthrough post 204 may have a diameter or width as indicated at 210 within a range, for example, between about 0.05 millimeters and about 2.0 millimeters. In this example, the electrical connector 200a includes eight feedthrough posts 204 arranged in a single line. Thus, the area occupied by the eight feedthrough posts 204 could be as small as 0.05 millimeters by 1 .2 millimeters. In other examples, the electrical connector 200a may include another suitable number of feedthrough posts 204, such as 1 , 2, 3, 4, 5, 6, 7, 9, 10, or more, and they do not necessarily need to be arranged in a linear manner.
[0060] The dimensions and spacing of the feedthrough posts 204 described above may also be applicable to other contacts (e.g., contact pads, amorphous compliant contacts) and/or other arrangements and/or configurations of feedthrough posts 204 described below with reference to the following FIGS. 4B- 17B. [0061] FIG. 4B illustrates a plan view of another example electrical connector 200b for a device, such as a pulse generator. In one example, the electrical connector 200b is similar to the electrical connector 200a of FIG. 4A and includes feedthrough posts 204 protruding from the external surface 203 of the housing 202. In other examples, the feedthrough posts 204 may be flush with the external surface 203 of the housing 202, such that the posts 204 do not protrude from the external surface 203 of the housing 202. In yet other examples, the feedthrough posts 204 may be recessed with respect to the external surface 203 of the housing 202. The spacing between the feedthrough posts 204 as indicated at 208 and the diameter or width of each feedthrough post 204 as indicated at 210 may be similar to the values previously described with reference to FIG. 4A. While each feedthrough post 204 is illustrated as circular in the example of FIG. 4B, in other examples, each feedthrough post 204 may have another suitable shape, such as oval, square, rectangular, triangular, hexagonal, octagonal, etc. [0062] FIG. 4C illustrates a plan view of yet another example electrical connector 200c for a device, such as a pulse generator. Electrical connector 200c includes feedthrough posts 204 either protruding from the external surface 203 of the housing 202, flush with the external surface 203 of the housing 202, or recessed with respect to the external surface 203 of the housing 202. In this example, the feedthrough posts 204 are arranged in a two-dimensional array. A first subset (e.g., four) of feedthrough posts 204 are arranged in a first line 212a, and a second subset (e.g., another four) of feedthrough posts 204 are arranged in a second line 212b parallel to the first line 212a. Each feedthrough post 204 of the first subset of feedthrough posts is aligned with a respective feedthrough post 204 of the second subset of feedthrough posts in a direction perpendicular to the first line 212a and the second line 212b. While in this example, the electrical connector 200c includes eight feedthrough posts 204 arranged in a 2x4 array (thus occupying an area as small as 0.2 millimeters by 0.6 millimeters), in other examples, the electrical connector 200c may include a different number of feedthrough posts 204 arranged in, for example, a 2x2, 2x3, 3x3, 3x4, 4x4, etc. array. [0063] FIG. 4D illustrates a plan view of yet another example electrical connector 200d for a device, such as a pulse generator. Electrical connector 200d includes feedthrough posts 204 either protruding from the external surface 203 of the housing 202, flush with external surface 203 of the housing 202, or recessed with respect to the external surface 203 of the housing 202. In this example, the feedthrough posts 204 are arranged in a two-dimensional array. Similarly to the electrical connector 200c of FIG. 4C, the electrical connector 200d includes a first subset (e.g., four) of feedthrough posts 204 arranged in a first line 212a, and a second subset (e.g., another four) of feedthrough posts 204 arranged in a second line 212b parallel to the first line 212a. In this example, however, each feedthrough post 204 of the first subset of feedthrough posts 204 is offset to a respective feedthrough post 204 of the second subset of feedthrough posts 204 in a direction perpendicular to the first line 212a and the second line 212b.
[0064] FIG. 4E illustrates a front view of yet another example electrical connector 200e for a device, such as a pulse generator. Electrical connector 200e includes feedthrough posts 204 either protruding from the external surface 203 of the housing 202, flush with external surface 203 of the housing 202, or recessed with respect to the external surface 203 of the housing 202. In this example, the feedthrough posts 204 are arranged in a circle. While the electrical connector 200e illustrated in FIG. 4E includes eight feedthrough posts 204 arranged in a single circle, in other examples, the electrical connector 200e may include another suitable number of feedthrough posts 204, such as 2, 3, 4, 5, 6, 7, 9, 10, or more arranged in a single circle or two or more concentric circles.
[0065] FIG. 5A illustrates a cross-sectional view of an example electrical connector 220a for a device, such as a pulse generator. Electrical connector 220a includes a plurality of feedthrough posts 204 extending through a wall of the housing 202 and flush with an external surface 203 of the housing 202 (e.g., can). The wall of the housing 202 surrounding the feedthrough posts 204 includes an electrically insulating material, such as a ceramic material, glass, lead cement, PEEK, polysulfone, etc. The electrical connector 220a also includes a plurality of deflectable contacts 222. Each deflectable contact 222 is electrically connected (e.g., welded, conductive epoxy bond) to a respective feedthrough post 204 on the external surface 203 of the housing 202. Each deflectable contact 222 may include a leaf spring as illustrated in FIG. 5A or another suitable contact that can return to its original shape after being contacted, pressed, compressed, or otherwise deformed (e.g., coil spring, pogo pin, ball detent, radial spring, etc ). Each deflectable contact 222 is configured to be electrically connected to a corresponding contact of a proximal portion of a lead to electrically connect a conductive element of a distal portion of the lead to stimulation circuitry of the pulse generator. While two feedthrough posts 204 and respective deflectable contacts 222 are illustrated in FIG. 5A, the electrical connector 220a may include any suitable number (e.g., 3, 4, 5, 6, 7, 8, or more) of feedthrough posts 204 and respective deflectable contacts 222. The plurality of feedthrough posts 204 and respective deflectable contacts 222 of the electrical connector 220a may be arranged in any suitable manner (e.g., single line, two-dimensional array, circle, etc.), such as previously described and illustrated with reference to FIGS. 4B-4E. [0066] FIG. 5B illustrates a cross-sectional view of another example electrical connector 220b for a device, such as a pulse generator. Electrical connector 220b includes a plurality of feedthrough posts 204 extending through a wall of a housing 202 and flush with an external surface 203 of the housing 202. The electrical connector 220b also includes a plurality of amorphous compliant contacts 224 arranged within an insulating layer 226 on the external surface 203 of the housing 202. Each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 on the external surface 203 of the housing 202. In other examples, the feedthrough posts 204 may be recessed with respect to the external surface 203 of the housing 202, and each amorphous compliant contact 224 may be arranged within a respective recess, such that insulating layer 226 may be excluded.
[0067] Each amorphous compliant contact 224 may include a conductive polymer, such as a conductive silicone (e.g., carbon nanotubes mixed into silicone and held in suspension, carbon black, silver infused polymer), carbon nanotubes, carbon fiber, a graphene film, silver doping, a wire or another suitable material that can return to its original shape after being contacted, pressed, compressed, or otherwise deformed. In the example of the amorphous compliant contact being a wire, the wire may include a single gold-plated beryllium copper wire or a single gold-plated molybdenum wire randomly arranged to form a contact. In other examples, the wire may include nitinol, MP35N, stainless steel, or titanium. In some examples, each amorphous compliant contact includes a plurality of electrical pathways through the contact. Each amorphous compliant contact 224 is configured to be electrically connected to a corresponding contact of a proximal portion of a lead to electrically connect a conductive element of a distal portion of the lead to stimulation circuitry of the pulse generator. While two feedthrough posts 204 and respective amorphous compliant contacts 224 are illustrated in FIG. 5B, the electrical connector 220b may include any suitable number (e.g., 3, 4, 5, 6, 7, 8, or more) of feedthrough posts 204 and respective amorphous compliant contacts 224. The plurality of feedthrough posts 204 and respective amorphous compliant contacts 224 of the electrical connector 220b may be arranged in any suitable manner (e.g., single line, two-dimensional array, circle, etc.), such as previously described and illustrated with reference to FIGS. 4B-4E.
[0068] FIG. 6A illustrates a side view and FIG. 6B illustrates a plan view of an example device 300a. Device 300a includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 220a electrically connected to the pulse generator 302. In addition to the feedthrough posts 204 and the deflectable contacts 222 (e.g., leaf springs) as previously described and illustrated with reference to FIG. 5A, in this example, the electrical connector 220a also includes mounting screw receivers 240 and a compliant electrically insulating material 250 surrounding the plurality of feedthrough posts 204 and the deflectable contacts 222. In some examples as illustrated in FIG. 6B, the compliant electrically insulating material 250 also surrounds each of the individual feedthrough posts 204 and respective deflectable contacts 222 and each individual mounting screw receiver 240. The compliant electrically insulating material 250 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material. [0069] Each mounting screw receiver 240 may be flush with the external surface 203 of the housing 202 and extend into the housing 202 and/or may protrude from the external surface 203 of the housing 202. In the example illustrated in FIG. 6B, a first mounting screw receiver 240 is arranged to the left of a first line 212a of feedthrough posts 204, and a second mounting screw receiver 240 is arranged to the right of a second line 212b of feedthrough posts 204, such that the first mounting screw receiver 240 is arranged in a first corner of the electrical connector 220a and the second mounting screw receiver 240 is arranged in a second corner of the electrical connector 220a opposite to the first corner. In other examples, the electrical connector 220a may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the feedthrough posts 204. In the example illustrated in FIG. 6B, the first line 212a of feedthrough posts 204 is offset with respect to the second line 212b of feedthrough posts 204 by one feedthrough post 204, such that the first (e.g., leftmost) feedthrough post 204 in the first line 212a is aligned with the second (e.g., second from the left) feedthrough post 204 in the second line 212b in a direction perpendicular to the first line 212a and the second line 212b.
[0070] FIG. 6C illustrates a plan view of a lead 320. Lead 320 includes an electrical connector 322 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 322, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. Electrical connector 322 includes a plurality of contact pads 326, mounting screw receivers 328, and a connector housing 330. Each contact pad 326 includes an electrically conductive material, such as a metal (e.g., stainless steel, titanium, Pt-lr, MP35N, nickel- alloy , nitinol, platinum). The contact pads 326 may be flush with a surface 332 of the connector housing 330. Each contact pad 326 is electrically connected to a respective conductive element on the distal end of the lead 320 through wires 324. Each contact pad 326 corresponds to a respective deflectable contact 222 of the electrical connector 220a to electrically connect the stimulation circuitry to the conductive elements of the lead 320. In this example, each contact pad 326 is square shaped, and may have a width, for example, within a range between about 0.05 millimeters and about 5 millimeters. In other examples, each contact pad 326 may have another suitable shape, such as rectangular, circular, hexagonal, etc. Each mounting screw receiver 328 corresponds to a respective mounting screw receiver 240 of the electrical connector 220a to secure the connector housing 330 to the electrical connector 220a using screws.
[0071] FIG. 6D illustrates a partial cross-sectional view of the device 300a with the electrical connector 322 of the lead 320 connected to the electrical connector 220a on the device 300a. The mounting screw receivers 240 and 328 act as alignment features to align the electrical connector 322 on the proximal portion of the lead 320 with the electrical connector 220a. In some examples, the electrical connectors 220a and 322 may include additional mounting posts and/or recesses to align the components. The compliant electrically insulating material 250 contacts the external surface 203 of the housing 202 and the proximal portion (e.g., the surface 332 of the connector housing 330 of the electrical connector 322) of the lead 320 to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the proximal portion of the lead 320. With the electrical connector 322 of the lead 320 connected to the electrical connector 220a, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 320 via the feedthrough posts 204, deflectable contacts 222, contacts 326, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 322) of the lead 320 extends perpendicular to a long axis of the pulse generator 302.
[0072] FIG. 7A illustrates a side view and FIG. 7B illustrates a plan view of another example device 300b. Device 300b includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 220b electrically connected to the pulse generator 302. In addition to the feedthrough posts 204 as previously described and illustrated with reference to FIG. 5B, in this example, the electrical connector 220b also includes mounting screw receivers 240.
[0073] Each mounting screw receiver 240 may be flush with the external surface 203 of the housing 202 and extend into the housing 202 and/or may protrude from the external surface 203 of the housing 202. In this example as illustrated in FIG. 7B, a first mounting screw receiver 240 is arranged to the left of a first line 212a of feedthrough posts 204, and a second mounting screw receiver 240 is arranged to the right of a second line 212b of feedthrough posts 204, such that the first mounting screw receiver 240 is arranged in a first corner of the electrical connector 220b and the second mounting screw receiver 240 is arranged in a second corner of the electrical connector 220b opposite to the first corner. In other examples, the electrical connector 220b may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the feedthrough posts 204. In the example illustrated in FIG. 7B, the first line 212a of feedthrough posts 204 is offset with respect to the second line 212b of feedthrough posts 204 by one feedthrough post 204, such that the first (e.g., leftmost) feedthrough post 204 in the first line 212a is aligned with the second (e.g., second from the left) feedthrough post 204 in the second line 212b in a direction perpendicular to the first line 212a and the second line 212b.
[0074] FIG. 7C illustrates a plan view and FIG. 7D illustrates a cross-sectional view of an interposer 340. Interposer 340 includes a plurality of amorphous compliant contacts 224, a compliant electrically insulating material 250, an insulating layer 226, and mounting screw receivers 344. The compliant electrically insulating material 250 surrounds the plurality of amorphous compliant contacts 224 and mounting screw receivers 344. The compliant electrically insulating material 250 may also surround each of the individual amorphous compliant contacts 224 and each individual mounting screw receiver 344 on both a first surface of the interposer 340 (e.g., the top surface of the insulating layer 226) and on a second surface of the interposer 340 (e.g., the bottom surface of the insulating layer 226) opposite to the first surface. Each amorphous compliant contact 224 corresponds to a respective feedthrough post 204 of the electrical connector 220b. In this example, each amorphous compliant contact 224 is square shaped, and may have a width, for example, within a range between about 0.05 millimeters and about 5 millimeters. In other examples, each amorphous compliant contact 224 may have another suitable shape, such as rectangular, circular, hexagonal, etc. Each mounting screw receiver 344 corresponds to a respective mounting screw receiver 240 of the electrical connector 220b.
[0075] FIG. 7E illustrates a plan view of a lead 320. Lead 320 includes an electrical connector 322 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 322, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires. Electrical connector 322 includes a plurality of contact pads 326, mounting screw receivers 328, and a connector housing 330. The contact pads 326 may be flush, protrude, or be recessed with respect to a surface 332 of the connector housing 330. Each contact pad 326 is electrically connected to a respective conductive element on the distal end of the lead 320 through wires 324. Each contact pad 326 corresponds to a respective amorphous compliant contact 224 of the interposer 340 and a respective feedthrough post 204 of the electrical connector 220b to electrically connect the stimulation circuitry to the conductive elements of the lead 320. Each mounting screw receiver 328 corresponds to a respective mounting screw receiver 344 of the interposer 340 and a respective mounting screw receiver 240 of the electrical connector 220b to secure the connector housing 330 and the interposer 340 to the electrical connector 220b using screws.
[0076] FIG. 7F illustrates a partial cross-sectional view of the device 300b with the electrical connector 322 of the lead 320 and the interposer 340 connected to the electrical connector 220b on the device 300b. The mounting screw receivers 240, 344, and 328 act as alignment features to align the electrical connector 322 on the proximal portion of the lead 320 and the interposer 340 with the electrical connector 220b. In some examples, the electrical connectors 220b and 322 may include additional mounting posts and/or recesses to align the components. The compliant electrically insulating material 250 of the interposer 340 contacts the external surface 203 of the housing 202 and the proximal portion (e.g., the surface 332 of the connector housing 330 of the electrical connector 322) of the lead 320 to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the proximal portion of the lead 320. With the electrical connector 322 of the lead 320 connected to the electrical connector 220b via the interposer 340, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 320 via the feedthrough posts 204, amorphous compliant contacts 224, contacts 326, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 322) of the lead 320 extends perpendicular to a long axis of the pulse generator 302.
[0077] FIG. 8A illustrates a side view and FIG. 8B illustrates a plan view of another example device 300c. Device 300c includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 220b electrically connected to the pulse generator 302. In addition to the feedthrough posts 204 as previously described and illustrated with reference to FIG. 5B, in this example, the electrical connector 220b also includes mounting screw receivers 240.
[0078] Each mounting screw receiver 240 may be flush with the external surface 203 of the housing 202 and extend into the housing 202 and/or may protrude from the external surface 203 of the housing 202. In this example as illustrated in FIG. 8B, a first mounting screw receiver 240 is arranged to the left of a first line 212a of feedthrough posts 204, and a second mounting screw receiver 240 is arranged to the right of a second line 212b of feedthrough posts 204, such that the first mounting screw receiver 240 is arranged in a first corner of the electrical connector 220b and the second mounting screw receiver 240 is arranged in a second corner of the electrical connector 220b opposite to the first corner. In other examples, the electrical connector 220b may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the feedthrough posts 204. In the example illustrated in FIG. 8B, the first line 212a of feedthrough posts 204 is offset with respect to the second line 212b of feedthrough posts 204 by one feedthrough post 204, such that the first (e.g., leftmost) feedthrough post 204 in the first line 212a is aligned with the second (e.g., second from the left) feedthrough post 204 in the second line 212b in a direction perpendicular to the first line 212a and the second line 212b. [0079] FIG. 8C illustrates a plan view and FIG. 8D illustrates a cross-sectional view of an interposer 340 as previously described and illustrated with reference to FIGS. 7C and 7D. Interposer 340 includes a plurality of amorphous compliant contacts 224, a compliant electrically insulating material 250, an insulating layer 226, and mounting screw receivers 344. The compliant electrically insulating material 250 surrounds the plurality of amorphous compliant contacts 224 and mounting screw receivers 344. The compliant electrically insulating material 250 may also surround each of the individual amorphous compliant contacts 224 and each individual mounting screw receiver 344 on both a first surface of the interposer 340 (e.g., the top surface of the insulating layer 226) and on a second surface of the interposer 340 (e.g., the bottom surface of the insulating layer 226) opposite to the first surface. Each amorphous compliant contact 224 corresponds to a respective feedthrough post 204 of the electrical connector 220b. Each mounting screw receiver 344 corresponds to a respective mounting screw receiver 240 of the electrical connector 220b.
[0080] FIG. 8E illustrates a plan view of a lead 360. Lead 360 includes an electrical connector 362 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 362, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. Electrical connector 362 includes a plurality of contact pads 326, mounting screw receivers 328, and a connector housing 370. The contact pads 326 may be flush with a surface 372 of the connector housing 370. Each contact pad 326 is electrically connected to a respective conductive element on the distal end of the lead 360 through wires 324. Each contact pad 326 corresponds to a respective amorphous compliant contact 224 of the interposer 340 and a respective feedthrough post 204 of the electrical connector 220b to electrically connect the stimulation circuitry to the conductive elements of the lead 360. Each mounting screw receiver 328 corresponds to a respective mounting screw receiver 344 of the interposer 340 and a respective mounting screw receiver 240 of the electrical connector 220b.
[0081] FIG. 8F illustrates a plan view of a removable cap 380. Removable cap 380 includes mounting screw receivers 382. Each mounting screw receiver 382 corresponds to a respective mounting screw receiver 328 of the electrical connector 362, a respective mounting screw receiver 344 of the interposer 340, and a respective mounting screw receiver 240 of the electrical connector 220b to secure the removable cap 380, the connector housing 370 of the electrical connector 362 of the lead 360, and the interposer 340 to the electrical connector 220b using screws.
[0082] FIG. 8G illustrates a partial cross-sectional view of the device 300c with the removable cap 380, the electrical connector 362 of the lead 360, and the interposer 340 connected to the electrical connector 220b on the device 300c. The mounting screw receivers 240, 344, 328, and 382 act as alignment features to align the removable cap 380, the electrical connector 362 on the proximal portion of the lead 360, and the interposer 340 with the electrical connector 220b. In some examples, the electrical connectors 220b and 362 may include additional mounting posts and/or recesses to align the components. The compliant electrically insulating material 250 of the interposer 340 contacts the external surface 203 of the housing 202 and the proximal portion (e.g., the surface 372 of the connector housing 370 of the electrical connector 362) of the lead 360 to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the proximal portion of the lead 360. The removable cap 380 contacts the proximal end of the lead 360 on the surface of the connector housing 370 opposite to the surface 372 to secure the proximal portion of the lead 360 to the interposer 340 and to the housing 202. With the electrical connector 362 of the lead 360 connected to the electrical connector 220b via the interposer 340, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 360 via the feedthrough posts 204, amorphous compliant contacts 224, contacts 326, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 362) of the lead 360 extends perpendicular to a long axis of the pulse generator 302.
[0083] FIG. 9A illustrates a side view and FIG. 9B illustrates a plan view of another example device 400a. Device 400a includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and a plurality of electrical connectors 402 electrically connected to the pulse generator 302. Each electrical connector 402 is a female connector including a plurality of aligned hollow cylindrical contacts 406 within a connector housing 404. The connector housing 404 of each female connector 402 is directly attached to the housing 202 (e.g., the external surface 203 of the housing 202). Each hollow cylindrical contact 406 is electrically connected to the stimulation circuitry of the pulse generator 302. Each hollow cylindrical contact 406 may include an annular spring, a radial spring, or a plurality of leaf springs. In this example, device 400a includes four electrical connectors 402, and each electrical connector 402 includes two hollow cylindrical contacts 406 fora total of eight hollow cylindrical contacts 406. In other examples, device 400a may include less than four electrical connectors 402 or more than four electrical connectors 402, and each electrical connector 402 may include a single hollow cylindrical contact 406 or more than two hollow cylindrical contacts 406 for any suitable total number of hollow cylindrical contacts 406.
[0084] FIG. 9C illustrates a side view of one example of a lead 410. Lead 410 includes an electrical connector 412 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 412, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 412 is a male connector to removably slidably engage with a respective female connector 402. The electrical connector412 includes a plurality of aligned contacts 414 (e.g., cylindrical contacts) and a connector housing 416. Each contact 414 is electrically connected to a respective conductive element on the distal end of the lead 410 through wires 324. Each contact 414 corresponds to a respective hollow cylindrical contact 406 of an electrical connector 402 to electrically connect the stimulation circuitry to the conductive elements of the lead 410. For example, each contact 414 may include an annular depression or notch to engage the annular spring of a respective hollow cylindrical contact 406 and to provide mechanical retention in addition to electrical connection.
[0085] FIG. 9D illustrates the device 400a with electrical connectors 412 of the leads 410 engaged with electrical connectors 402. With the electrical connector 412 of each lead 410 connected to a respective electrical connector 402, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the leads 410 via the hollow cylindrical contacts 406, contacts 414, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 412) of the leads 410 extend in the direction of the long axis of the pulse generator 302.
[0086] FIG. 10A illustrates a side view of another example device 400b. Device 400b includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 420 electrically connected to the pulse generator 302. As further illustrated in the plan view of FIG. 10B, device 400b includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the external surface 203 of the housing 202. The electrical connector 420 includes a portion 422 electrically connected to the plurality of feedthrough posts 204, a lead 424 permanently connected to the portion 422 on a first end of the lead, and a female connector 430 permanently connected to the lead 424 on a second end of the lead. Female connector 430 includes a plurality of aligned hollow cylindrical contacts 426 within a connector housing 428. Each hollow cylindrical contact 426 corresponds to a respective feedthrough post 204 and is electrically connected to the stimulation circuitry of the pulse generator 302. Each hollow cylindrical contact 426 may include an annular spring. In this example, female connector 430 includes eight hollow cylindrical contacts 426, and device 400b includes a respective eight feedthrough posts 204. In other examples, female connector 430 may include less than eight hollow cylindrical contacts 426 or more than eight hollow cylindrical contacts 426, and device 400b may include a respective equal number of feedthrough posts 204.
[0087] FIG. 10C illustrates a side view of one example of a lead 440. Lead 440 includes an electrical connector 442 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 442, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 442 is a male connector to removably slidably engage with the female connector 430. The electrical connector 442 includes a plurality of aligned contacts 444 (e.g., cylindrical contacts) and a connector housing 446. Each contact 444 is electrically connected to a respective conductive element on the distal end of the lead 440 through wires 324. Each contact 444 corresponds to a respective hollow cylindrical contact 426 of the electrical connector 420 to electrically connect the stimulation circuitry to the conductive elements of the lead 440. For example, each contact 444 may include an annular depression or notch to engage the annular spring of a respective hollow cylindrical contact 426.
[0088] FIG. 10D illustrates the device 400b with the electrical connector 442 of the lead 440 engaged with the electrical connector 420. With the male connector 442 of the lead 440 connected to the female connector 430, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 440 via the feedthrough posts 204, lead 424, hollow cylindrical contacts 426, contacts 444, and wires 324, respectively.
[0089] FIG. 11 A illustrates a side view of another example device 400c. Device 400c includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 460 electrically connected to the pulse generator 302. As further illustrated in the plan view of FIG. 11 B, device 400c includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the external surface 203 of the housing 202. Electrical connector 460 includes a portion 422 electrically connected to the plurality of feedthrough posts 204, a lead 424 permanently connected to the portion 422 on a first end of the lead, and a female connector 462 within a connector housing 464 permanently connected to the lead 424 on a second end of the lead. As illustrated in FIG. 11C, female connector 462 includes a plurality of parallel hollow cylindrical contacts 466 arranged within a circular housing 464. The circular housing 464 includes an alignment feature 468 (e.g., a notch) for aligning the female connector 462 with a male connector of a lead to be described below with reference to FIGS. 11 D and 11 E. Each hollow cylindrical contact 466 corresponds to a respective feedthrough post 204 and is electrically connected to the stimulation circuitry of the pulse generator 302. In this example, female connector 462 includes eight hollow cylindrical contacts 466, and device 400c includes a respective eight feedthrough posts 204. In other examples, device 400c may include less than eight hollow cylindrical contacts 466 or more than eight hollow cylindrical contacts 466, and device 400c may include a respective equal number of feedthrough posts 204.
[0090] FIG. 11 D illustrates a side view of one example of a lead 470. Lead 470 includes an electrical connector 472 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 472, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. Male connector 472 may removably slidably engage with the female connector 462. As further illustrated in the plan view of FIG. 11 E, the electrical connector 472 includes a plurality of contact pins 474 extending from a connector housing 476 and an alignment feature 478 (e.g., notch). Each contact pin 474 is electrically connected to a respective conductive element on the distal end of the lead 470 through wires 324. Each contact pin 474 corresponds to a respective hollow cylindrical contact 466 of the electrical connector 460 to electrically connect the stimulation circuitry to the conductive elements of the lead 470. Alignment feature 478 of male connector 472 corresponds to alignment feature 468 of female connector 462 for aligning the male connector 472 with the female connector 462.
[0091] FIG. 11 F illustrates the device 400c with the electrical connector 472 of the lead 470 engaged with the electrical connector 460. With the male connector 472 of the lead 470 connected to the female connector 462, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 470 via the feedthrough posts 204, lead 424, hollow cylindrical contacts 466, contact pins 474, and wires 324, respectively.
[0092] FIG. 12A illustrates a side view and FIG. 12B illustrates a plan view of another example device 500a. Device 500a includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 510 electrically connected to the pulse generator 302. As further illustrated in the cross-sectional view of FIG. 12C, the electrical connector 510 includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the housing 202. The plurality of feedthrough posts 204 extend through an electrically insulating material block 512 (e.g., a ceramic material block). The electrical connector 510 also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into the insulating material block 512 as shown in FIG. 12C. In this example, the electrical connector 510 includes eight feedthrough posts 204 and respective amorphous compliant contacts 224 arranged in a single line. In other examples, the electrical connector 510 may include less than eight feedthrough posts 204 or more than eight feedthrough posts 204 and respective amorphous compliant contacts 224, and the feedthrough posts 204 and the respective amorphous compliant contacts 224 may have another suitable arrangement, such as previously described and illustrated with reference to FIGS. 4C-4E.
[0093] The electrical connector 510 also includes mounting screw receivers 516 as illustrated in FIG. 12B and a compliant electrically insulating material 514 surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 512. In this example, the compliant electrically insulating material 514 is directly attached (e.g., glued, adhered, overmolded) to the external surface 203 of the housing 202. In other examples, the compliant electrically insulating material 514 may be directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 512 either in addition to or alternatively to being directly attached to the external surface 203 of the housing 202. The compliant electrically insulating material 514 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
[0094] Each mounting screw receiver 516 may be flush with the external surface 203 of the housing 202 and extend into the housing 202 and/or may protrude from the external surface 203 of the housing 202. In this example as illustrated in FIG. 12B, a first mounting screw receiver 516 is arranged to the left of the center of the single line (e.g., column) of feedthrough posts 204 and respective amorphous compliant contacts 224, and a second mounting screw receiver 516 is arranged to the right of the center of the single line of feedthrough posts 204 and respective amorphous compliant contacts 224. In other examples, the electrical connector 510 may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the feedthrough posts 204 and the respective amorphous compliant contacts 224.
[0095] FIG. 12D illustrates a plan view of another example lead 520. Lead 520 includes an electrical connector 522 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 522, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 522 includes a plurality of contact pads 524, a connector housing 526, and mounting screw receivers 530. The contact pads 524 may be flush with a recessed surface 528 of the connector housing 526, such that inner sidewalls 529 of the connector housing 526 surround the plurality of contacts 524. The inner sidewalls 529 are perpendicular to the recessed surface 528. Each contact pad 524 is electrically connected to a respective conductive element on the distal end of the lead 520 through wires 324. Each contact pad 524 corresponds to a respective amorphous compliant contact 224 of the electrical connector 510 to electrically connect the stimulation circuitry to the conductive elements of the lead 520. Each mounting screw receiver 530 corresponds to a respective mounting screw receiver 516 of the electrical connector 510 to secure the connector housing 526 to the electrical connector 510 using screws.
[0096] FIG. 12E illustrates a partial cross-sectional view of the device 500a with the electrical connector 522 of the lead 520 connected to the electrical connector 510 on the device 500a. The mounting screw receivers 516 and 530 and insulating material block 512 and connector housing 526 act as alignment features to align the electrical connector 522 on the proximal portion of the lead 520 with the electrical connector 510. The compliant electrically insulating material 514 contacts the external surface 203 of the housing 202 and the proximal portion (e.g., the connector housing 526 of the electrical connector 522) of the lead 520 to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the proximal portion of the lead 520. With the electrical connector 522 of the lead 520 connected to the electrical connector 510, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 520 via the feedthrough posts 204, amorphous compliant contacts 224, contacts 524, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 522) of the lead 520 extends perpendicular to a long axis of the pulse generator 302.
[0097] FIG. 13A illustrates a side view and FIG. 13B illustrates a plan view of another example device 500b. Device 500b includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 540 electrically connected to the pulse generator 302. The electrical connector 540 includes a plurality of amorphous compliant contacts 224 electrically connected to the stimulation circuitry (e.g., via feedthrough posts not shown) and extending from an electrically insulating material block 542 (e.g., a ceramic material block). In this example, the electrical connector 540 includes eight amorphous compliant contacts 224 arranged in a circle. In other examples, the electrical connector 540 may include less than eight amorphous compliant contacts 224 or more than eight amorphous compliant contacts 224, and the amorphous compliant contacts 224 may have another suitable arrangement.
[0098] The electrical connector 540 also includes a mounting screw receiver 546 as illustrated in FIG. 13B and a compliant electrically insulating material including an outer portion 544a surrounding the plurality of amorphous compliant contacts 224 and the insulating material block 542, and an inner portion 544b surrounding the mounting screw receiver 546. In this example, the compliant electrically insulating material 544a and 544b may be directly attached (e.g., glued, adhered, overmolded) to the external surface 203 of the housing 202. In other examples, the compliant electrically insulating material 544a and 544b may be directly attached (e.g., glued, adhered, overmolded) to the insulating material block 542 either in addition to or alternatively to being directly attached to the external surface 203 of the housing 202. The compliant electrically insulating material 544a and 544b may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
[0099] The mounting screw receiver 546 may be flush with the external surface 203 of the housing 202 and extend into the housing 202 and/or may protrude from the external surface 203 of the housing 202 into or through the insulating material block 542. In this example as illustrated in FIG. 13B, the mounting screw receiver 546 is arranged in the center of the amorphous compliant contacts 224. In other examples, the electrical connector 540 may include more than one mounting screw receiver, and the mounting screw receivers may have another suitable arrangement with respect to the amorphous compliant contacts 224.
[0100] FIG. 13C illustrates a plan view of a lead 550. Lead 550 includes an electrical connector 552 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 552, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 552 includes a plurality of contact pads 554, a connector housing 556, and a mounting screw receiver 560. The contact pads 554 may be flush with a recessed surface 558 of the connector housing 556, such that inner sidewalls 559 of the connector housing 556 surround the plurality of contacts 554. The inner sidewalls 559 are perpendicular to the recessed surface 558. Each contact pad 554 is electrically connected to a respective conductive element on the distal end of the lead 550 through wires 324. Each contact pad 554 corresponds to a respective amorphous compliant contact 224 of the electrical connector 540 to electrically connect the stimulation circuitry to the conductive elements of the lead 550. The mounting screw receiver 560 corresponds to the mounting screw receiver 546 of the electrical connector 540 to secure the connector housing 556 to the electrical connector 540 using a screw.
[0101] FIG. 13D illustrates a partial cross-sectional view of the device 500b with the electrical connector 552 of the lead 550 connected to the electrical connector 540 on the device 500b. The mounting screw receivers 546 and 560 and insulating material block 542 and connector housing 556 act as alignment features to align the electrical connector 552 on the proximal portion of the lead 550 with the electrical connector 540. The compliant electrically insulating material 544a and 544b contacts the external surface 203 of the housing 202 and the proximal portion (e.g., the connector housing 556 of the electrical connector 552) of the lead 550 to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the proximal portion of the lead 550. The compliant electrically insulating material 544a and 544b may compress when the screw is engaged. With the electrical connector 552 of the lead 550 connected to the electrical connector 540, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 550 via the amorphous compliant contacts 224, contacts 554, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 552) of the lead 550 extends perpendicular to a long axis of the pulse generator 302. [0102] FIG. 14A illustrates a side view and FIG. 14B illustrates a plan view of another example device 600. Device 600 includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 610 electrically connected to the pulse generator 302. As shown in the cross-sectional view of FIG. 14D, the electrical connector 610 includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the housing 202. The plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 14D, or separate from the housing 202 (e.g., 512 of FIG. 12C). The electrical connector 610 also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612 as shown in FIG. 14D. In this example, as shown in FIG. 14B, the electrical connector 610 includes eight feedthrough posts 204 and respective amorphous compliant contacts 224 arranged in two lines. In other examples, the electrical connector 610 may include less than eight feedthrough posts 204 or more than eight feedthrough posts 204 and respective amorphous compliant contacts 224, and feedthrough posts 204 and respective amorphous compliant contacts 224 may have another suitable arrangement, such as previously described and illustrated with reference to FIGS. 4B-4E.
[0103] As illustrated in FIGS. 14B and 14D, the electrical connector 610 also includes mounting screw receivers 614. In this example as illustrated in FIG. 14B, a first mounting screw receiver 614 is arranged to the left of the center of the two lines (e.g., rows) of feedthrough posts 204 and respective amorphous compliant contacts 224, and a second mounting screw receiver 614 is arranged to the right of the center of the two lines of feedthrough posts 204 and respective amorphous compliant contacts 224. In other examples, the electrical connector 610 may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the feedthrough posts 204 and the respective amorphous compliant contacts 224.
[0104] As illustrated in FIG. 14D, the electrical connector 610 may also include a compliant electrically insulating material 634 surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 612. In this example, the compliant electrically insulating material 634 is directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 612 and includes two rings of compliant electrically insulating material. In other examples, the compliant electrically insulating material 634 may include a single ring of compliant electrically insulating material or more than two rings of compliant electrically insulating material. The compliant electrically insulating material 634 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
[0105] FIG. 14C illustrates a plan view of a lead 620. Lead 620 includes an electrical connector 622 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 622, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 622 includes a plurality of contact pads 624, a connector housing 626, and mounting screw receivers 630. The contact pads 624 may be flush with a recessed surface 628 of the connector housing 626, such that inner sidewalls 629 of the connector housing 626 surround the contact pads 624. The inner sidewalls 629 are perpendicular to the recessed surface 628. Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 620 through wires 324. Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 610 to electrically connect the stimulation circuitry to the conductive elements of the lead 620. Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 610 to secure the connector housing 626 to the electrical connector 610 using screws 632 as shown in FIG. 14D.
[0106] FIG. 14D illustrates a cross-sectional view of the electrical connector 622 of the lead 620 connected to the electrical connector 610 on the device 600. The mounting screw receivers 614 and 630 and insulating material block 612 and connector housing 626 act as alignment features to align the electrical connector 622 on the proximal portion of the lead 620 with the electrical connector 610. Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 626. The compliant electrically insulating material 634 contacts insulating material block 612 of the electrical connector 610 and the proximal portion (e.g., the inner sidewalls 629 of the connector housing 626 of the electrical connector 622) of the lead 620 to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 610 and the proximal portion of the lead 620. The compliant electrically insulating material 634 may deflect when the electrical connector 622 is connected to the electrical connector 610. With the electrical connector 622 of the lead 620 connected to the electrical connector 610, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 620 via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 622) of the lead 620 extends perpendicular to a long axis of the pulse generator 302.
[0107] FIG. 15A illustrates a cross-sectional view of an electrical connector 652a of a lead 650a connected to an electrical connector 640a on a device, such as device 600 of FIG. 14A. The electrical connector 640a includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry (not shown) and extending through the housing 202. The plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 15A, or separate from the housing 202 (e.g., 512 of FIG. 12C). The feedthrough posts 204 may be recessed with respect to the surface of the insulating material block 612. The electrical connector 640a also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612. Each amorphous compliant contact 224 may protrude from the insulating material block 612. The electrical connector 640a also includes mounting screw receivers 614.
[0108] The electrical connector 640a may also include a compliant electrically insulating material 642a surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 612. In this example, the compliant electrically insulating material 642a is directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 612 and the surface 203 of the housing 202 and includes a single triangular shaped ring of compliant electrically insulating material. The compliant electrically insulating material 642a may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
[0109] Lead 650a includes an electrical connector 652a on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 652a, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 652a includes a plurality of contact pads 624, a connector housing 656a, and mounting screw receivers 630. The contact pads 624 may be flush with a recessed surface 658a of the connector housing 656a, such that inner sidewalls 659a of the connector housing 656a surround the contact pads 624. The inner sidewalls 659a are angled with respect to the recessed surface 658a (e.g., the angle between the recessed surface 658a and the inner sidewalls 656a is greater than about 90 degrees and less than about 170 degrees). Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 650a through wires 324. Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 640a to electrically connect the stimulation circuitry to the conductive elements of the lead 650a. Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 640a to secure the connector housing 656a to the electrical connector 640a using screws 632.
[0110] The mounting screw receivers 614 and 630 and insulating material block 612 and connector housing 656a act as alignment features to align the electrical connector 652a on the proximal portion of the lead 650a with the electrical connector 640a. Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 656a. The compliant electrically insulating material 642a contacts insulating material block 612 of the electrical connector 640a, the external surface 203 of the housing 202, and the proximal portion (e.g., the inner sidewalls 659a of the connector housing 656a of the electrical connector 652a) of the lead 650a to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 640a and the proximal portion of the lead 650a. The compliant electrically insulating material 642a may compress when the screws 632 are tightened. With the electrical connector 652a of the lead 650a connected to the electrical connector 640a, the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 650a via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively.
[0111] FIG. 15B illustrates a cross-sectional view of an electrical connector 652b of a lead 650b connected to an electrical connector 640b on a device, such as device 600 of FIG. 14A. The electrical connector 640b includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry (not shown) and extending through the housing 202. The plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 15B, or separate from the housing 202 (e.g., 512 of FIG. 12C). The feedthrough posts 204 may be recessed with respect to the surface of the insulating material block 612. The electrical connector 640b also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612. Each amorphous compliant contact 224 may protrude from the insulating material block 612. The electrical connector 640b also includes mounting screw receivers 614.
[0112] The electrical connector 640b may also include a compliant electrically insulating material 642b surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 612, and compliant electrically insulating material 644 between (e.g., surrounding) each individual amorphous compliant contact 224. In this example, the compliant electrically insulating material 642b is directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 612 and the surface 203 of the housing 202 and includes two ridges extending from a single triangular shaped base portion ring of compliant electrically insulating material. While compliant electrically insulating material 642b illustrated in FIG. 15B includes two ridges, in other examples, compliant electrically insulating material 642b may include a single ridge or more than two ridges. The compliant electrically insulating material 644 may be directly attached (e.g., glued, adhered, overmolded) to the insulating material block 612 or part of an interposer (e.g. , 340 of FIGS. 7C and 7D). The compliant electrically insulating material 642b and 644 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material.
[0113] Lead 650b includes an electrical connector 652b on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 652b, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 652b includes a plurality of contact pads 624, a connector housing 656b, and mounting screw receivers 630. The contact pads 624 may be recessed with respect to a recessed surface 658b of the connector housing 656b, such that portions of amorphous compliant contacts 224 extend into the connector housing 656b to electrically contact the contact pads 624. The recessed surface 658b is surrounded by inner sidewalls 659b of the connector housing 656b. The inner sidewalls 659b are angled with respect to the recessed surface 658b (e.g., the angle between the recessed surface 658b and the inner sidewalls 656b is greater than about 90 degrees and less than about 170 degrees). Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 650b through wires 324. Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 640b to electrically connect the stimulation circuitry to the conductive elements of the lead 650b. Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 640b to secure the connector housing 656b to the electrical connector 640b using screws 632.
[0114] The mounting screw receivers 614 and 630 and insulating material block 612 and connector housing 656b act as alignment features to align the electrical connector 652b on the proximal portion of the lead 650b with the electrical connector 640b. Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 656b. The compliant electrically insulating material 642b contacts insulating material block 612 of the electrical connector 610, the external surface 203 of the housing 202, and the proximal portion (e.g., the inner walls 659b of the connector housing 656b of the electrical connector 652b) of the lead 650b to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 640b and the proximal portion of the lead 650b. The compliant electrically insulating material 642b and/or 644 may compress when the screws 632 are tightened. The compliant electrically insulating material 644 contacts insulating material block 612 and the surface 658b of the connector housing 656b to form seals between the electrical connector 640b and the portion of the lead 650b between the amorphous compliant contacts 224. With the electrical connector 652b of the lead 650b connected to the electrical connector 640b, the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 650b via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively.
[0115] FIG. 15C illustrates a cross-sectional view of an electrical connector 652c of a lead 650c connected to an electrical connector 640c on a device, such as device 600 of FIG. 14A. The electrical connector 640c includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry (not shown) and extending through the housing 202. The plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 15C, or separate from the housing 202 (e.g., 512 of FIG. 12C). The feedthrough posts 204 may be flush with the surface of the electrically insulating material block 612. The electrical connector 640c also includes a plurality of deflectable contacts 222 (e.g., leaf springs), where each deflectable contact 222 is electrically connected to a respective feedthrough post 204. The electrical connector 640c also includes mounting screw receivers 614.
[0116] The electrical connector 640c may also include a compliant electrically insulating material 634 surrounding the plurality of feedthrough posts 204, the deflectable contacts 222, and the insulating material block 612, and compliant electrically insulating material 644 between (e.g., surrounding) each individual deflectable contact 222. In this example, the compliant electrically insulating material 634 is directly attached (e.g., glued, adhered, overmolded) to the sides of the insulating material block 612 and includes two rings of compliant electrically insulating material. In other examples, the compliant electrically insulating material 634 may include a single ring of compliant electrically insulating material or more than two rings of compliant electrically insulating material. The compliant electrically insulating material 644 may be directly attached (e.g., glued, adhered, overmolded) to the insulating material block 612 or part of an interposer (e.g. , 340 of FIGS. 7C and 7D). The compliant electrically insulating material 634 and 644 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, polyurethane/silicone blend, or another suitable material. [0117] Lead 650c includes an electrical connector 652c on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 652c, and a plurality of conductive elements (e.g., 30 of FIG. 1 A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 652c includes a plurality of contact pads 624, a connector housing 656c, and mounting screw receivers 630. The contact pads 624 may be flush with a recessed surface 658c of the connector housing 656c, such that inner sidewalls 659c of the connector housing 656c surround the contact pads 624. The inner sidewalls 659c are perpendicular to the recessed surface 658c. Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 650c through wires 324. Each contact pad 624 corresponds to a respective deflectable contact 222 of the electrical connector 640c to electrically connect the stimulation circuitry to the conductive elements of the lead 650c. Each mounting screw receiver 630 corresponds to a respective mounting screw receiver 614 of the electrical connector 640c to secure the connector housing 656c to the electrical connector 640c using screws 632.
[0118] The mounting screw receivers 614 and 630 and insulating material block 612 and connector housing 656c act as alignment features to align the electrical connector 652c on the proximal portion of the lead 650c with the electrical connector 640c. Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 656c. The compliant electrically insulating material 634 contacts insulating material block 612 of the electrical connector 610 and the proximal portion (e g., the inner walls 659c of the connector housing 656c of the electrical connector 652c) of the lead 650c to form a seal (e.g., electrically isolating seal, hermetic seal) between the electrical connector 640c and the proximal portion of the lead 650c. The compliant electrically insulating material 634 and/or 644 may compress when the screws 632 are tightened. The compliant electrically insulating material 644 contacts insulating material block 612 and the surface 658c of the connector housing 656c to form seals between the electrical connector 640b and the portion of the lead 650b between the deflectable contacts 222. With the electrical connector 652c of the lead 650c connected to the electrical connector 640c, the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 650c via the feedthrough posts 204, deflectable contacts 222, contact pads 624, and wires 324, respectively.
[0119] FIG. 16A illustrates a side view and FIG. 16B illustrates a plan view of another example device 700. Device 700 includes a pulse generator 302, a battery 304 electrically connected to the pulse generator 302, and an electrical connector 710 electrically connected to the pulse generator 302. The electrical connector 710 includes a plurality of hollow cylindrical contacts 714 electrically connected to the stimulation circuitry and extending through the external surface 203 of the housing 202. The plurality of hollow cylindrical contacts 714 may extend through an electrically insulating material block 712 (e.g., a ceramic material block) and may protrude from the electrically insulating material block 712. The plurality of hollow cylindrical contacts 714 may be coated with a medical-grade Parylene, which is known to be biocompatible. In this example, as shown in FIG. 16B, the electrical connector 710 includes eight hollow cylindrical contacts 714 arranged in two lines (e.g., two rows). In other examples, the electrical connector 710 may include less than eight hollow cylindrical contacts 714 or more than eight hollow cylindrical contacts 714, and hollow cylindrical contacts 714 may have another suitable arrangement, such as previously described and illustrated with reference to FIGS. 4A-4E.
[0120] As illustrated in FIG. 16B, the electrical connector 710 also includes mounting screw receivers 716. In this example, a first mounting screw receiver 716 is arranged to the left of the center of the two lines (e.g., two rows) of hollow cylindrical contacts 714, and a second mounting screw receiver 716 is arranged to the right of the center of the two lines of hollow cylindrical contacts 714. In other examples, the electrical connector 710 may include a single mounting screw receiver or more than two mounting screw receivers, and the mounting screw receiver(s) may have another suitable arrangement with respect to the hollow cylindrical contacts 714. [0121] FIG. 16C is a plan view and FIG. 16D is a side view of an example elastomeric septum 720. Elastomeric septum 720 includes an outer portion 722 and an inner portion 724. The inner portion 724 is connected to the outer portion 722 and offset with respect to the outer portion 722, such that the elastomeric septum 720 includes a recess. The recess is defined by the outer portion 722, which defines inner sidewalls of the recess, and the inner portion 724, which defines a surface of the recess extending between the inner sidewalls.
[0122] FIG. 16E is a front view of an example septum clamp 730. Septum clamp 730 includes a frame 732 and an opening 734 extending through the frame 732. The frame 732 includes two curved portions 736 corresponding to mounting screw receivers 716. Septum clamp 730 is configured to be placed over elastomeric septum 720, such that the frame 732 contacts the outer portion 722 of the elastomeric septum 720. The opening 734 of the septum clamp 730 is configured to receive the inner portion 724 of the elastomeric septum 720, such that the frame 732 surrounds the inner portion 724.
[0123] FIG. 16F illustrates a front plan view and FIG. 16G illustrates a back plan view of a lead 740. Lead 740 includes an electrical connector 742 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 742, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 742 includes a plurality of contact pins 744, a connector housing 746, and mounting screw receivers 750. The contact pins 744 protrude from a recessed surface 748 of the connector housing 746, such that inner sidewalls 749 of the connector housing 746 surround the contact pins 744. The inner sidewalls 749 are perpendicular to the recessed surface 748. Each contact pin 744 is electrically connected to a respective conductive element on the distal end of the lead 740 through wires 324. Each contact pin 744 corresponds to a respective hollow cylindrical contact 714 of the electrical connector 710 to electrically connect the stimulation circuitry to the conductive elements of the lead 740. The base of each contact pin 744 (which does not extend into a respective hollow cylindrical contact 714) may be coated with a medical-grade Parylene (or other non-conductive coating), which is known to be biocompatible. Each mounting screw receiver 750 corresponds to a respective mounting screw receiver 716 of the electrical connector 710 and the curved portion 736 of the septum clamp 730 to secure the connector housing 746 to the electrical connector 710 using screws 752 as shown in FIG. 16G.
[0124] FIG. 16H illustrates a partial cross-sectional view of the device 700 with the electrical connector 742 of the lead 740 connected to the electrical connector 710 on the device 700. The mounting screw receivers 716 and 750, the curved portions 736 of septum clamp 730, and insulating material block 712 and connector housing 746 act as alignment features to align the electrical connector 742 on the proximal portion of the lead 740 with the electrical connector 710. Elastomeric septum 720 is arranged between the female connector 710 and the male connector 742, such that the plurality of contact pins 744 of the male connector 742 penetrate the elastomeric septum 720. Thus, the elastomeric septum 720 (and Parylene or other non-conductive coating) provides effective isolation between adjacent contact pins 744, even if the male connector 742 is connected to the female connector 710 in a wet environment. In addition, the elastomeric septum 720 (and Parylene or other non-conductive coating) prevents the development of short-circuits between the contact pins 744 due to fluid ingress during the device lifetime. Septum clamp 730 is between the elastomeric septum and the male connector 740. The Elastomeric septum 720 forms a seal (e.g., electrically isolating seal, hermetic seal) between the male connector 742 and the female connecter 710 and between each of the plurality of contact pins 744 and respective hollow cylindrical contacts 714. With the electrical connector 742 of the lead 740 connected to the electrical connector 710, the stimulation circuitry of the pulse generator 302 is electrically connected to each conductive element of the lead 740 via the hollow cylindrical contacts 714, contact pins 744, and wires 324, respectively. In this example, the proximal portion (e.g., electrical connector 742) of the lead 740 extends perpendicular to a long axis of the pulse generator 302.
[0125] FIG. 17A illustrates a cross-sectional view of the electrical connectors 622 and 680 prior to connecting the electrical connectors, and FIG. 17B illustrates a cross-sectional view of the electrical connectors 622 and 680 after connecting the electrical connectors. Lead 620 includes electrical connector 622 on the proximal portion of the lead, a plurality of wires indicated at 324 electrically connected to the electrical connector 622, and a plurality of conductive elements (e.g., 30 of FIG. 1A) on the distal end of the lead and electrically connected to the plurality of wires. The electrical connector 622 includes a plurality of contact pads 624, a connector housing 626, and mounting screw receivers 630. The contact pads 624 may be flush with a recessed surface 628 of the connector housing 626, such that inner sidewalls 629 of the connector housing 626 surround the contact pads 624. The inner sidewalls 629 are perpendicular to the recessed surface 628. Each contact pad 624 is electrically connected to a respective conductive element on the distal end of the lead 620 through wires 324. Each contact pad 624 corresponds to a respective amorphous compliant contact 224 of the electrical connector 680 to electrically connect the stimulation circuitry to the conductive elements of the lead 620.
[0126] The electrical connector 680 includes a plurality of feedthrough posts 204 electrically connected to the stimulation circuitry and extending through the housing 202. The plurality of feedthrough posts 204 may extend through an electrically insulating material block 612 (e.g., a ceramic material block) integral with the housing 202, as shown in FIG. 17A and 17B, or separate from the housing 202 (e.g., 512 of FIG. 12C). The feedthrough posts 204 may be recessed with respect to the surface of the insulating material block 612. Electrical connector 680 also includes a plurality of amorphous compliant contacts 224, where each amorphous compliant contact 224 is electrically connected to a respective feedthrough post 204 and at least partially extends into insulating material block 612. Each amorphous compliant contact 224 may protrude from the insulating material block 612. The electrical connector 680 also includes mounting screw receivers 614. Each mounting screw receiver 614 corresponds to a respective mounting screw receiver 630 of the electrical connector 622 to secure the connector housing 626 to the electrical connector 680 using screws 632.
[0127] The electrical connector 680 may also include a compliant electrically insulating material 682 surrounding the plurality of feedthrough posts 204, the amorphous compliant contacts 224, and the insulating material block 612. In this example, the compliant electrically insulating material 682 is directly attached (e.g., glued, adhered, overmolded) to the external surface 203 of the housing 202 and includes a single ring of compliant electrically insulating material. As shown in FIG. 17A, prior to connecting the electrical connector 622 to the electrical connector 680, the compliant electrically insulating material 682 has a first height as indicated at 684. As shown in FIG. 17B, after connecting the electrical connector 622 to the electrical connector 680, the compliant electrically insulating material 682 is compressed to have a second height as indicated at 686. The compliant electrically insulating material 682 may be compressed by up to about 20 percent or more to form a seal (e.g., electrically isolating seal, hermetic seal) between the external surface 203 of the housing 202 and the electrical connector 622 (e.g., surface 628). The compression of the compliant electrically insulating material 682 is set by the height of sidewalls 629 of the electrical connector 622 also indicated by 686 as the screws 632 are tightened. The compliant electrically insulating material 682 may include silocone, polyurethane, polyetheretherketone (PEEK), polysulfone, silicone/polyurethane blend, or another suitable material. [0128] As shown in FIG. 17B, the mounting screw receivers 614 and 630, compliant electrically insulating material 682, and connector housing 626 act as alignment features to align the electrical connector 622 on the proximal portion of the lead 620 with the electrical connector 680. Each mounting screw receiver 630 may include a recessed portion 631 for receiving the head of a respective screw 632, such that the head of the respective screw 632 does not protrude from the outer surface of the connector housing 626. With the electrical connector 622 of the lead 620 connected to the electrical connector 680, the stimulation circuitry of a pulse generator is electrically connected to each conductive element of the lead 620 via the feedthrough posts 204, amorphous compliant contacts 224, contact pads 624, and wires 324, respectively.
[0129] FIG. 18 illustrates a device 50 including a first element 22 and a second element 24 (e.g., lead) implanted in a patient, which may comprise at least some of substantially the same features as, and/or an example implementation of, the examples previously described in association with at least FIGS. 1A-3. In some examples, the first element 22 may comprise a stimulation portion (and/or sensing portion) which may be implanted in a head 112 or neck 114 region of the patient with the second element 24 (e.g., lead) extending perpendicular to the long-axis of the first element 22. By configuring the lead 24 to be arranged perpendicular to the long-axis of the first element 22, the lead 24 may be placed in the neck 114 without making a 90 degree turn in the wire(s) 28. Accordingly, surgical implantation of the lead 24 may be simplified and/or less stress may be applied to the wire(s) 28. Moreover, this generally perpendicular configuration may enhance the ability to anchor the first and second elements 22, 24 relative to non-nerve tissues within the head-and-neck region (112, 114). In some examples, such as shown in FIG. 18, the conductive element 30 (e.g., electrode portion) of the lead 24 may be aligned/positioned for stimulation of nerves innervating the infra-hyoid strap muscles. However, it will be understood that the first and second elements 22, 24 may be implanted in a wide variety of positions, orientations, etc. within the head-and-neck region (112, 114) or other body regions to be placed in stimulating relation to a wide variety of nerves, nerve branches, muscles, and/or combinations thereof. Device 50 may include any of the devices including any of the leads and electrical connectors previously described and illustrated with reference to FIGS. 4A-17B.
[0130] As previously described and illustrated with reference to FIGS. 6A, 7A, 8A, 9A, 10A, 11 A, 12A, 13A, 14A, and 16A, first element 22 (e.g., stimulation portion and/or sensing portion) may include a pulse generator 302 including a control portion 190 (FIG. 3) and a battery 304 for delivering therapy via the second element 24 (e.g., lead). The first element 22 may include an electrical connector 200a-200e (FIGS. 4A-4E), 220a-220b (FIGS. 5A-5B, 6A-6B, 7A-7B, 8A-8B), 402 (FIGS. 9A-9B), 420 (FIG. 10A), 460 (FIG. 11A), 510 (FIGS. 12A-12C), 540 (FIGS. 13A-13B), 610 (FIGS. 14A-14B, 14D), 640a-640c (FIGS. 15A-15C), 710 (FIGS. 16A-16B), or 680 (FIGS. 17A-17B). The second element 24 may include a proximal portion including an electrical connector 26, at least one wire 28, and at least one electrode 30 (e.g., stimulation electrode and/or sensing electrode) on a distal portion of the lead. The electrical connector 26 may include an electrical connector 320 (FIG. 6C), 322/340 (FIGS. 7C-7E), 362/340/380 (FIGS. 8C-8F), 410 (FIG. 9C), 440 (FIG. 10C), 472 (FIGS. 11 D-11 E), 520 (FIG. 12D), 550 (FIG. 13C), 620 (FIG. 140), 652a-652c (FIGS. 15A-15C), 742 (FIGS. 16F-16G), or 622 (FIGS. 17A-17B). The at least one electrode 30 (e.g., cuff electrode) is electrically connected to circuitry (e.g., stimulation circuitry) of first element 22 through the at least one wire 28 and the electrical connector 26. In some examples, lead 24 may support a plurality of electrodes 30 (e.g., 2, 3, 4, 5, 6, 7, 8, or more) that are electrically connected to circuitry of first element 22 through a plurality of wires 28 and the electrical connector 26, as previously described for example with reference to FIGS. 1 B-1 C and 4A-17B.
[0131] Although specific examples have been illustrated and described herein, a variety of alternate and/or equivalent implementations may be substituted for the specific examples shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific examples discussed herein.

Claims

1 . An implantable medical device comprising: a first element; and a second element electrically connected to the first element, the second element comprising at least one conductive element.
2. The device of claim 1 , wherein the first element is for implantation within a head and neck or pectoral region to apply the electrical stimulation to an upper airway patency related tissue via the second element.
3. The device of claim 1 , wherein the first element comprises circuitry, and wherein the at least one conductive element is in communication with the circuitry.
4. The device of claim 3, wherein the second element comprises: a lead including a proximal portion connected to the first element and a distal portion spaced apart from the first element.
5. The device of claim 4, wherein the proximal portion is removably connectable to the first element.
6. The device of claim 4, wherein the first element comprises: a housing defining an external surface; and at least one feedthrough post electrically connected to the circuitry and extending through the external surface of the housing, wherein the at least one feedthrough post is electrically connected to the respective at least one conductive element.
7. The device of claim 6, wherein the first element comprises: at least one deflectable contact electrically connected to the respective at least one feedthrough post.
8. The device of claim 4, wherein the first element comprises: a housing defining an external surface; at least one feedthrough post electrically connected to the circuitry; and at least one amorphous compliant contact electrically connected to the respective at least one feedthrough post, wherein the at least one amorphous compliant contact is electrically connected to the respective at least one conductive element.
9. The device of claim 8, wherein the at least one amorphous compliant contact comprises a conductive polymer.
10. The device of claim 8, wherein the at least one amorphous compliant contact comprises at least one of carbon nanotubes, carbon fiber, graphene films, or silver doping.
11. The device of claim 8, wherein the at least one amorphous compliant contact comprises a wire.
12. The device of claim 8, wherein the at least one amorphous compliant contact comprises a plurality of electrical pathways.
13. The device of claim 6, wherein the at least one conductive element comprises a plurality of conductive elements spaced apart from the first element, wherein the at least one feedthrough post comprises a plurality of feedthrough posts electrically connected to the circuitry and extending through the external surface of the housing, and wherein each feedthrough post of the plurality of feedthrough posts is electrically connected to a respective conductive element of the plurality of conductive elements.
14. The device of claim 13, wherein the first element comprises: a compliant electrically insulating material surrounding the plurality of feedthrough posts and contacting the external surface of the housing and the proximal portion of the lead forming a seal between the external surface of the housing and the proximal portion of the lead.
15. The device of claim 14, wherein the compliant electrically insulating material forms a first seal and a second seal between the external surface of the housing and the proximal portion of the lead.
16. The device of claim 15, wherein the first element comprises: a plurality of amorphous compliant contacts, each of the plurality of amorphous compliant contacts comprising a plurality of electrical pathways, and each of the plurality of amorphous compliant contacts electrically connected between a respective feedthrough post of the plurality of feedthrough posts and a respective conductive element of the plurality of conductive elements, wherein the first seal and the second seal surround the plurality of amorphous compliant contacts.
17. The device of claim 14, further comprising: at least one screw to removably connect the proximal portion of the lead to the housing and to compress the compliant electrically insulating material to form the seal.
18. The device of claim 17, wherein the proximal portion of the lead comprises features to control the compression distance of the compliant electrically insulating material.
19. The device of claim 4, wherein the distal portion of the lead supports the at least one conductive element, and wherein the at least one conductive element comprises at least one electrode.
20. The device of claim 4, wherein the distal portion of the lead comprises an electrical connector comprising the at least one conductive element.
21. The device of claim 4, wherein the at least one conductive element comprises a plurality of conductive elements spaced apart from the first element.
22. The device of claim 7, wherein the proximal portion of the lead comprises at least one contact pad contacting the respective at least one deflectable contact.
23. The device of claim 8, wherein the proximal portion of the lead comprises at least one contact pad contacting the respective at least one amorphous compliant contact.
24. The device of claim 13, further comprising: an interposer comprising a plurality of amorphous compliant contacts, wherein the proximal portion of the lead comprises a plurality of contact pads, and wherein each amorphous complient contact of the plurality of amorphous compliant contacts electrically connects each feedthrough post of the plurality of feedthrough posts to a respective contact pad of the plurality of contact pads.
25. The device of claim 24, wherein the interposer comprises a compliant electrically insulating material surrounding each amorphous compliant contact of the plurality of amorphous compliant contacts on a first surface of the interposer and on a second surface of the interposer opposite to the first surface.
26. The device of claim 14, wherein the compliant electrically insulating material surrounds each of the plurality of feedthrough posts.
27. The device of claim 14, wherein the compliant electrically insulating material comprises at least one of silocone, polyurethane, polyetheretherketone (PEEK), silicone/polyurethane blend, or polysulfone.
28. The device of claim 14, wherein the seal comprises a plurality of ridges.
29. The device of claim 4, wherein the proximal portion extends perpendicular to a long axis of the first element.
30. The device of claim 5, further comprising: at least one screw to removably connect the proximal portion to the first element.
31. The device of claim 5, wherein the the proximal portion comprises an alignment feature to align the proximal portion with the first element.
32. The device of claim 6, wherein the at least one feedthrough post comprises a proximal end electrically connected to the circuitry and a distal end protruding from the external surface of the housing.
33. The device of claim 6, wherein the at least one feedthrough post comprises a proximal end electrically connected to the circuitry and a distal end flush with the external surface of the housing.
34. The device of claim 13, wherein the plurality of feedthrough posts are arranged in a single line.
35. The device of claim 13, wherein the plurality of feedthrough posts comprises a first subset of feedthrough posts arranged in a first line and a second subset of feedthrough posts arranged in a second line parallel to the first line.
36. The device of claim 35, wherein each feedthrough post of the first subset of feedthrough posts is aligned with a respective feedthrough post of the second subset of feedthrough posts in a direction perpendicular to the first line and the second line.
37. The device of claim 35, wherein each feedthrough post of the first subset of feedthrough posts is offset to a respective feedthrough post of the second subset of feedthrough posts in a direction perpendicular to the first line and the second line.
38. The device of claim 13 wherein the plurality of feedthrough posts are arranged in a circle.
39. The device of claim 13, wherein the plurality of feedthrough posts are arranged in a two-dimensional array.
40. The device of claim 13, wherein a spacing between adjacent feedthrough posts of the plurality of feedthrough posts is greater than or equal to 0.125 millimeters.
41 . The device of claim 24, wherein the interposer is removably connected to the proximal portion of the lead and the plurality of feedthrough posts.
42. The device of claim 24, further comprising: a removable cap securing the proximal portion of the lead to the interposer and to the housing.
43. The device of claim 24, further comprising: a plurality of screws to removably connect the proximal portion of the lead and the interposer to the housing and to align the plurality of amorphous compliant contacts with the plurality of feedthrough posts and the plurality of contact pads.
44. The device of claim 24, wherein a spacing between adjacent amorphous compliant contacts of the plurality of amorpous compliant contacts is greater than or equal to 0.125 millimeters.
45. The device of claim 4, wherein the at least one conductive element comprises a plurality of conductive elements spaced apart from the first element, wherein the first element comprises at least one female connector comprising a plurality of aligned hollow cylindrical contacts, each of the plurality of hollow cylindrical contacts electrically connected to the circuitry, wherein the proximal portion of the lead comprises at least one male connector removably sliably engaged with the respective at least one female connector, the at least one male connector comprising a plurality of aligned contacts, each of the plurality of contacts of the at least one male connector electrically connected to a respective conductive element of the plurality of conductive elements and contacting a respective hollow cylindrical contact of the female connector.
46. The device of claim 45, wherein the first element comprises a housing, and wherein the female connector is directly attached to the housing.
47. The device of claim 45, wherein the first element comprises: a housing defining an external surface; a plurality of feedthrough posts electrically connected to the circuitry and extending through the external surface of the housing; and a further lead permanently connected between the plurality of feedthrough posts and the femal connector.
48. The device of claim 4, wherein the at least one conductive element comprises a plurality of conductive elements spaced apart from the first element, wherein the first element comprises a female connector comprising a plurality paralellel hollow cylindrical contacts, each of the plurality of hollow cylindrical contacts electrically connected to the circuitry, wherein the proximal portion of the lead comprises at least one male connector removably sliably engaged with the respective at least one female connector, the at least one male connector comprising a plurality of contact pins, each of the plurality of contact pins electrically connected to a respective conductive element of the plurality of conductive elements and inserted into a respective hollow cylindrical contact of the female connector.
49. The device of claim 48, wherein the first element comprises a housing, and wherein the female connector is dirrectly attached to the housing.
50. The device of claim 48, wherein the first element comprises: a housing defining an external surface; a plurality of feedthrough posts electrically connected to the circuitry and extending through the external surface of the housing; and a further lead permanently connected between the plurality of feedthrough posts and the female connector.
51 . The device of claim 48, further comprising: an elastomeric septum between the the female connector and the male connector such that the plurality of contact pins of the male connector penetrate the elastomeric septum.
52. The device of claim 51 , further comprising: a septum clamp between the elastomeric septum and the male connector.
PCT/US2023/085728 2022-12-28 2023-12-22 Electrical connectors for implantable devices Ceased WO2024145228A2 (en)

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US63/477,415 2022-12-28

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US7590451B2 (en) * 2005-10-31 2009-09-15 Medtronic, Inc. Axial lead connector for implantable medical devices
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US8140163B1 (en) * 2008-05-23 2012-03-20 Advanced Neuromodulation Systems, Inc. Implantable pulse generator and method of use
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