Soft tissue fixation

Abstract

Presented herein are techniques for securing / fixing implantable medical devices in a recipient using soft tissue. As described further below, implantable medical devices in accordance with certain embodiments presented herein include one or more suture zones that enable a surgeon to suture the implantable medical device to soft tissue of the recipient and, accordingly, at least temporarily secure the implantable medical devices at a selected location in the recipient. After the implantable medical device is sutured to the tissue, soft tissue growth can further secure or stabilize the implantable medical device in the recipient.

Description

Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1SOFT TISSUE FIXATIONBACKGROUNDField of the Invention[ooot] The present invention relates generally to soft tissue fixation of implantable medical devices.Related Art

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY

[0004] In one aspect, an implantable medical device is provided. The implantable medical comprises: an implantable housing; an implantable coil spaced from the implantable housing via a transition region, wherein the implantable coil is electrically connected to components in the implantable housing via one or more wires passing through the transition region; and an encapsulation layer disposed around at least the implantable coil and the transition region,Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 wherein the encapsulation layer includes one or more suture zones configured to facilitate suturing of the implantable medical device to tissue of a recipient.

[0005] In another aspect, a method is provided. The method comprises: forming a skin flap in a head of a recipient; inserting an implantable medical device under the skin flap such that a part of the implantable medical device remains externally visible; and securing the externally visible part of the implantable medical device to soft tissue of the head of the recipient.

[0006] In another aspect, a method is provided. The method provides: providing a medical device comprising an implantable housing and an implantable coil spaced from the implantable housing via a transition region; forming a skin flap in a recipient; implanting the medical device under the skin flap such that only the transition region is visible; and suturing the transition region to tissue of the recipient.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:

[0008] FIG. 1 is a diagram illustrating an active transcutaneous bone conduction device in accordance with embodiments presented herein;

[0009] FIG. 2 is a diagram illustrating another active transcutaneous bone conduction device in accordance with embodiments presented herein;[ooto] FIG. 3 is a diagram illustrating a further active transcutaneous bone conduction device in accordance with embodiments presented herein;[ooit] FIG. 4 is a diagram illustrating a further active transcutaneous bone conduction device in accordance with embodiments presented herein;

[0012] FIG. 5A is a top view diagram illustrating a further active transcutaneous bone conduction device in accordance with embodiments presented herein;

[0013] FIG. 5B is a side view of the active transcutaneous bone conduction device of FIG. 5A;

[0014] FIG. 6A is a top view diagram illustrating a further active transcutaneous bone conduction device in accordance with embodiments presented herein;

[0015] FIG. 6B is a side view of the active transcutaneous bone conduction device of FIG.6A;Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1

[0016] FIG. 7A is a top view diagram illustrating a further active transcutaneous bone conduction device in accordance with embodiments presented herein;

[0017] FIG. 7B is a side view of the active transcutaneous bone conduction device of FIG. 7A;

[0018] FIGs. 8A, 8B, 8C, 8D, 8E, 8H, 8G, 8H are a series of diagrams illustrating a surgical procedure, in accordance with embodiments presented herein;

[0019] FIG 9 is a flowchart of a method in accordance with embodiments presented herein;

[0020] FIG 10 is a flowchart of a method in accordance with embodiments presented herein;

[0021] FIG. 11A is a schematic diagram illustrating a cochlear implant system with which aspects of the techniques presented herein can be implemented;

[0022] FIG. 1 IB is a side view of a recipient wearing a sound processing unit of the cochlear implant system of FIG. 11A; and

[0023] FIG. 12 is a schematic diagram illustrating a vestibular stimulator system with which aspects of the techniques presented herein can be implemented.DETAILED DESCRIPTION

[0024] Presented herein are techniques for securing / fixing implantable medical devices in a recipient using soft tissue. As described further below, implantable medical devices in accordance with certain embodiments presented herein include one or more suture zones that enable a surgeon to suture the implantable medical device to soft tissue of the recipient and, accordingly, at least temporarily secure the implantable medical devices at a selected location in the recipient. After the implantable medical device is sutured to the tissue, soft tissue growth can further secure or stabilize the implantable medical device in the recipient..

[0025] There are a number of different types of implantable medical devices with which embodiments of the present invention can be implemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific implantable medical device in the form of an active transcutaneous bone conduction device. However, it is to be appreciated that the techniques presented herein may also be partially or fully implemented by any of a number of different types of devices, including other types of hearing devices. As used herein, the term “hearing device” is to be broadly construed as any deviceAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 that acts on an acoustical perception of an individual, including to improve perception of sound signals, to reduce perception of sound signals, etc. In particular, a hearing device can deliver sound signals to a user in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc., and / or can operate to suppress all or some sound signals. As such, a hearing device can be a device for use by a hearing-impaired person (e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy device systems, combinations or variations thereof, etc.), a device for use by a person with normal hearing (e.g., consumer devices that provide audio streaming, consumer headphones, earphones, and other listening devices), a hearing protection device, etc. In other examples, the techniques presented herein can be implemented by, or used in conjunction with, various other implantable medical devices, such as visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and / or treating epileptic events), sleep apnea devices, electroporation devices, etc.

[0026] As noted, FIG. 1 is a schematic diagram illustrating a bone conduction device 100 that can be secured in a recipient in accordance with embodiments presented herein. The bone conduction device 100 includes an external component 102 and an implantable component 104. The bone conduction device 100 of FIG. 1 is referred to as an “active” transcutaneous bone conduction device because the implantable component 104 includes a subcutaneously implanted actuator / transducer (i.e., the active vibration generation component is implanted within the recipient, rather than positioned externally). The bone conduction device 100 of FIG. 1 is also referred to as a “transcutaneous” device because the device includes the external component 102 that provides data for use in stimulating the hearing of a recipient. As such, bone conduction device 100 is sometimes referred to herein as an active transcutaneous bone conduction device.

[0027] The external component 102 is directly or indirectly attached to the body of the recipient and typically comprises an external coil 108 and, generally, a magnet (not shown in FIG. 1) fixed relative to the external coil 108. The external component 102 also comprises one or more sound input elements 112 (e.g., microphones, telecoils, etc.) for receiving sound signals, and a sound processing unit 106. The sound processing unit 106 is electrically connected to the external coil 108 via a cable or lead 110.Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1

[0028] In the embodiment of FIG. 1, the sound processing unit 106 is a behind-the-ear sound processing unit. The sound processing unit 106 may include, for example, a power source (not shown in FIG. 1) and a sound processor (also not shown in FIG. 1). The sound processor is configured to process electrical signals generated by the sound input element 112.

[0029] FIG. 1 illustrates an example in which bone conduction device 100 includes an external component 102 with an external sound processor. It is to be appreciated that the use of an external component is merely illustrative and that the techniques presented herein may be used in arrangements having an implanted sound processor, an implanted microphone, and / or an implanted power source (battery). It is also to be appreciated that the individual components referenced herein, e.g., sound input elements, the sound processor, etc., may be distributed across more than one device, e.g., two bone conduction devices, and indeed across more than one type of device, e.g., a bone conduction device and a consumer electronic device or a remote control of the bone conduction device.

[0030] The implantable component 104 comprises an internal coil 116 and, generally, a magnet fixed relative to the internal coil 116. The magnets adjacent to the external coil 108 and the internal coil 116 facilitate the operational alignment of the external and implantable coils. The operational alignment of the coils enables the external coil 108 to transcutaneously transmit / receive power and data to / from the internal coil 116. More specifically, in certain examples, external coil 108 transmits electrical signals (e.g., power and data) to internal coil 116 via a transcutaneous radio frequency (RF) link 114. External coil 108 and internal coil 116 are typically wire antenna coils comprised of multiple turns of electrically insulated singlestrand or multi-strand platinum or gold wire. The electrical insulation of internal coil 116 is provided by a flexible silicone molding. It is to be appreciated that various other types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, may be used to transfer the power and / or data from external component 102 to implantable component 104 and that FIG. 1 illustrates only one example arrangement.

[0031] The internal coil 116 is electrically connected to an electronics assembly (not shown in FIG. 1) that is embedded within an actuator assembly 120 via a lead (e.g., two-wire lead) 124. In certain embodiments, the actuator assembly 120 includes a piezoelectric actuator (not shown in FIG. 1) configured to deliver mechanical output forces (vibration) to the recipient’s hard tissue (e.g., bone or other tissue). More specifically, the electronics assembly uses the data received from the external component 102 to generate actuator drive signals. When delivered to the piezoelectric actuator, the actuator drive signals cause the piezoelectric actuator to generate vibration signals (vibration) that are transferred through a recipient’s tissue and / orAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 bone to the cochlea, thereby causing generation of nerve impulses that result in the perception of the sound signals received by the sound input element 112.

[0032] As shown, the implantable component 104 comprises suture zones 119. As described further below, the suture zones 119 provide dedicated areas / regions on the implantable component 104 for use in suturing the implantable component to soft tissue (e.g., muscle, tissue, fat, etc.) of the recipient. Also as described below, the suture zones 119 are structural arrangements in the implantable component 104 (e.g., in an encapsulation layer) that enable the surgeon to readily pass sutures through and / or around portions of the implantable component with damaging the implantable component.

[0033] It is to be appreciated that an active transcutaneous device in accordance with embodiments of the present invention may have a number of different arrangements. For example, FIG. 2 illustrates an alternative arrangement for an active transcutaneous bone conduction device 200 where a different external component 202 operates with the implantable component 104. Whereas FIG. 1 illustrates a behind-the-ear (BTE) external component 102, FIG. 2 illustrates use of an off-the-ear (OTE) external component 202. The OTE external 202 operates similar to the external component 102, the sound input elements, sound processor, external coil, and external magnet (all not shown in FIG. 2) are disposed within (or adjacent to) the same housing configured to be worn at the same location as where an external coil is traditionally located.

[0034] FIG. 3 illustrates an embodiment of an implantable component (implantable medical device) 304 in accordance with embodiments presented herein comprising suture zones in the form of arcuate members 306. More specifically, in the embodiment of FIG. 3, the implantable component 304 comprises an internal coil 316 and, generally, a magnet 317 fixed relative to the internal coil 316. The internal coil 316 is electrically connected to an electronics assembly 322 embedded within an actuator assembly 320 via one or more wires 325. In certain embodiments, the actuator assembly 320 includes a piezoelectric actuator 323 configured to deliver mechanical output forces (vibration) to the recipient’s hard tissue (e.g., bone or other tissue).

[0035] As shown, an encapsulation layer 318 is disposed around at least the internal coil 316 and the one or more wires 325 to form what is referred to herein as a coil region 310 and a neck or transition region 311. The encapsulation layer 318 is formed from a biocompatible material, such as silicone, which is configured to electrically isolate the internal coil 316 and the one or more wires 325 from the recipient’s tissue and body fluids. In certain embodiments, theAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 encapsulation layer 318 is disposed around only the internal coil 316 and the one or more wires 325 and joins a housing 327 of the actuator assembly 320. In other embodiments, the encapsulation layer 318 is disposed around the internal coil 316, the one or more wires 325, and the housing 327.

[0036] As noted, the implantable component 304 also includes suture zones in the form of arcuate members 306 that extend laterally from one or more areas of the encapsulation layer 318. In general, the arcuate members 306 each comprise strips of material (e.g., the same material as the encapsulation layer 318 or a different material) that form openings 307 at / around an outer edge of the implantable component 304. The openings 307 provide suture areas / points for sutures 329 to be attached to a recipient’s soft tissue so that the implantable component 304 can be secured to / in the recipient without the use of a bone-anchor. That is, the sutures 329 extend through the openings 307 and secure / attach the implantable component 304 to the recipient’s tissue.

[0037] In general, after implantation of the implantable component 304, the recipient is allowed to heal for a period of time before the implantable component is activated for use. While the recipient heals, natural processes will cause soft tissue to gradually secure the implantable component 304 within the recipient. As such, in certain examples, the sutures 329 added via the arcuate members 306 can be used to temporarily secure the implantable component 304 while the natural processes cause the soft tissue to permanently secure the implantable component. As such, in such embodiments, the sutures 329 can be temporary (e.g., absorbable) sutures. In other embodiments, the sutures 329 attached to the arcuate members 306 could be permanent sutures (e.g., nonabsorbable sutures) that can be used to, for example, prevent shifting / migration of the implantable component 304 during or after healing.

[0038] As used herein, reference to “permanent” fixation / securement or “permanently” fixing / securing an implantable component via soft tissue would be understood to refer to a fixation that is stable over an extended of period of time in the absence of surgical intervention. That is, permanent fixation / securement or permanently fixing / securing secures the implantable component at a desired implantable location but does not preclude the ability for a surgeon to potentially remove the implantable component from the recipient in the future.

[0039] FIG. 3 illustrates the presence of the arcuate members 306 at both the coil region 310 and the transition (neck) region 311. It is to be appreciated that this embodiment is merely illustrative and that the arcuate members 306 could be located only at the coil region 310 orAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 only at the transition region 311. The arcuate members 306 could also or alternatively be located at the actuator assembly 320.

[0040] In certain embodiments, the arcuate members 306 are unitary with the encapsulation layer 318 (e.g., formed with the encapsulation layer), while in other embodiments the arcuate members 306 are attached to the encapsulation layer 318. In addition, although this embodiment shows the arcuate members 306 integrated with (or attached to) an encapsulation layer 318, other implantable medical devices without an encapsulation layer could include arcuate members 306 integrated with (or attached to) different biocompatible materials to provide anchor points for the sutures to secure the implantable medical device to / in a recipient.

[0041] FIG. 4 illustrates an embodiment of an implantable component (implantable medical device) 404 in accordance with embodiments presented herein comprising suture zones in the form of apertures extending through the encapsulation layer 418. More specifically, in the embodiment of FIG. 4, the implantable component 404 comprises an internal coil 416 and, generally, a magnet 417 fixed relative to the internal coil 416. The internal coil 416 is electrically connected to an electronics assembly (not shown in FIG. 4) embedded within an actuator assembly 420 via one or more wires 425. In certain embodiments, the actuator assembly 420 includes a piezoelectric actuator (not shown in FIG. 4) configured to deliver mechanical output forces (vibration) to the recipient’s hard tissue (e.g., bone or other tissue).

[0042] As shown, an encapsulation layer 418 is disposed around at least the internal coil 416 and the one or more wires 425 to form a coil region 410 and a neck or transition region 411. The encapsulation layer 418 is formed from a biocompatible material, such as silicone, which is configured to electrically isolate the internal coil 416 and the one or more wires 425 from the recipient’s tissue and body fluids. In certain embodiments, the encapsulation layer 418 is disposed around only the internal coil 416 and the one or more wires 425 and joins a housing 427 of the actuator assembly 420. In other embodiments, the encapsulation layer 418 is disposed around the internal coil 416, the one or more wires 425, and the housing 427.

[0043] As noted, the implantable component 404 also includes suture zones in the form of apertures 406 that extend through the encapsulation layer 418. In general, the apertures 406 extend from the anterior of the implantable component 404 through the encapsulation layer 418 and end after forming an opening in the posterior of the implantable component 404 such that the internal coil 416 and the one or more wires 425 remain electrically isolated from the recipient’s tissue and body fluids. The apertures 406 provide suture zones for sutures 429 to beAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 attached to a recipient’s soft tissue so that the implantable component 404 can be secured to / in the recipient without the use of a bone-anchor. That is, the sutures 429 extend through the apertures 406 and attach the implantable component 404 to the recipient’s tissue.

[0044] In general, after implantation of the implantable component 404, the recipient is allowed to heal for a period of time before the implantable component is activated for use. While the recipient heals, natural processes will cause soft tissue to gradually secure the implantable component 404. As such, in certain examples, the sutures 429 added via the apertures 406 can be used to temporarily secure the implantable component 404 while the natural processes form the soft tissue to secure the implantable component. As such, in these embodiments, the sutures 429 can be absorbable sutures. In other embodiments, the sutures 429 attached to the apertures 406 could be permanent sutures (e.g., nonabsorbable sutures) that can be used to, for example, prevent shifting / migration of the implantable component 404 during or after healing.

[0045] FIG. 4 illustrates the presence of the apertures 406 at both the coil region 410 and the transition (neck) region 411. It is to be appreciated that this embodiment is merely illustrative and that the apertures 406 could be located only at the coil region 410 or only at the transition region 411.

[0046] FIGs. 5A-5B illustrate an embodiment of an implantable component (implantable medical device) 504 in accordance with embodiments presented herein comprising suture zones in the form of apertures extending through the encapsulation layer 518. More specifically, FIG. 5A is a top view of an implantable medical device 504, while FIG. 5B is a cross-sectional side view of a portion of the implantable medical device 504. For ease of reference FIGs. 5A-5B will generally be described together.

[0047] In the embodiment of FIGs. 5A and 5B, the implantable component 504 comprises an internal coil 516 and, generally, a magnet 517 fixed relative to the internal coil 516. The internal coil 516 is electrically connected to an electronics assembly (not shown in FIGs. 5 A and 5B) embedded within an actuator assembly 520 via one or more wires 525. In certain embodiments, the actuator assembly 520 includes a piezoelectric actuator (not shown in FIGs. 5 A and 5B) configured to deliver mechanical output forces (vibration) to the recipient’s hard tissue (e.g., bone or other tissue).

[0048] As shown, an encapsulation layer 518 is disposed around at least the internal coil 516 and the one or more wires 525 to form a coil region 510 and a neck or transition region 511.Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1The encapsulation layer 518 is formed from a biocompatible material, such as silicone, which is configured to electrically isolate the internal coil 516 and the one or more wires 525 from the recipient’s tissue and body fluids. In certain embodiments, the encapsulation layer 518 is disposed around only the internal coil 516 and the one or more wires 525 and joins a housing 5 1 of the actuator assembly 520. In other embodiments, the encapsulation layer 518 is disposed around the internal coil 516, the one or more wires 525, and the housing 527.

[0049] As noted, the implantable component 504 also includes suture zones in the form of channels 506 disposed in an outer surface in the encapsulation layer 518. In this example, the channels 506 extend laterally across the implantable component 504. Further, the channels 506 are disposed in the encapsulation layer 518 such that the internal coil 516 and the one or more wires 525 remain electrically isolated from the recipient’s tissue and body fluids.

[0050] As shown, the channels 506 provide areas for sutures 529 to be attached to a recipient’s soft tissue so that the implantable component 504 can be secured to / in the recipient without the use of a bone-anchor. In particular, the sutures 529 extend across the channels 506 and attach the implantable component 504 to the recipient’s tissue. Similar to other embodiments, the sutures 529 can be temporary sutures or permanent sutures.

[0051] FIGs. 5A and 5B illustrates the presence of the channels 506 at the transition (neck) region 511. It is to be appreciated that this embodiment is merely illustrative and that the channels 506 could also or alternatively be located at the coil region 511 or actuator assembly 520.

[0052] FIG. 6 illustrates an embodiment of an implantable component (implantable medical device) 604 in accordance with embodiments presented herein comprising suture zones in the form of recesses disposed in the encapsulation layer 618. More specifically, FIG. 6A is a top view of the implantable medical device 604, while FIG. 6B is a cross-sectional side view from the perspective of a portion of the implantable medical device 604. For ease of reference FIGs. 6A-6B will generally be described together.

[0053] More specifically, in the embodiment of FIGs. 6A and 6B, the implantable component 604 comprises an internal coil 616 and, generally, a magnet 617 fixed relative to the internal coil 616. The internal coil 616 is electrically connected to an electronics assembly (not shown in FIGs. 6A and 6B) embedded within an actuator assembly 620 via one or more wires 625. In certain embodiments, the actuator assembly 620 includes a piezoelectric actuator (not shownAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 in FIGs. 6A and 6B) configured to deliver mechanical output forces (vibration) to the recipient’s hard tissue (e.g., bone or other tissue).

[0054] As shown, an encapsulation layer 618 is disposed around at least the internal coil 616 and the one or more wires 625 to form a coil region 610 and a neck or transition region 611. The encapsulation layer 618 is formed from a biocompatible material, such as silicone, which is configured to electrically isolate the internal coil 616 and the one or more wires 625 from the recipient’s tissue and body fluids. In certain embodiments, the encapsulation layer 618 is disposed around only the internal coil 616 and the one or more wires 625 and joins a housing 6 1 of the actuator assembly 620. In other embodiments, the encapsulation layer 618 is disposed around the internal coil 616, the one or more wires 625, and the housing 627.

[0055] As noted, the implantable component 604 also includes suture zones in the form of recesses 606 disposed in the encapsulation layer 618. In general, the recesses 606 form relatively thinner areas of the encapsulation layer 618 that can be readily pierced by a surgeon during suturing. The recesses 606 are disposed in the encapsulation layer 618 such that the internal coil 616 and the one or more wires 625 remain electrically isolated from the recipient’s tissue and body fluids. As shown, sutures 629 extend through the recesses 606 and attach the implantable component 604 to the recipient’s tissue. Similar to other embodiments, the sutures 629 can be temporary sutures or permanent sutures.

[0056] FIGs. 6A and 6B illustrates the presence of the recesses 606 at the transition (neck) region 611. It is to be appreciated that this embodiment is merely illustrative and that the recesses 606 could also or alternatively be located at the coil region 611 or actuator assembly 620.

[0057] FIGs. 7A-7B illustrate an embodiment of an implantable component (implantable medical device) 704 in accordance with embodiments presented herein comprising suture zones in the form of apertures extending through the encapsulation layer 718. More specifically, FIG. 7A is a top view of an implantable medical device 704, while FIG. 7B is a cross-sectional side view of a portion of the implantable medical device 704. For ease of reference FIGs. 7A-7B will generally be described together.

[0058] In the embodiment of FIGs. 7A and 7B, the implantable component 704 comprises an internal coil 416 and, generally, a magnet 717 fixed relative to the internal coil 716. The internal coil 716 is electrically connected to an electronics assembly (not shown in FIGs. 7A and 7B) embedded within an actuator assembly 720 via one or more wires 725. In certainAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 embodiments, the actuator assembly 720 includes a piezoelectric actuator (not shown in FIGs. 7A and 7B) configured to deliver mechanical output forces (vibration) to the recipient’s hard tissue (e.g., bone or other tissue).

[0059] As shown, an encapsulation layer 718 is disposed around at least the internal coil 716 and the one or more wires 725 to form a coil region 710 and a neck or transition region 711. The encapsulation layer 718 is formed from a biocompatible material, such as silicone, which is configured to electrically isolate the internal coil 716 and the one or more wires 725 from the recipient’s tissue and body fluids. In certain embodiments, the encapsulation layer 718 is disposed around only the internal coil 716 and the one or more wires 725 and joins a housing 727 of the actuator assembly 720. In other embodiments, the encapsulation layer 718 is disposed around the internal coil 716, the one or more wires 725, and the housing 727.

[0060] As noted, the implantable component 704 also includes suture zones in the form of mechanical weaknesses 706 that extend through the encapsulation layer 718. In general, the mechanical weaknesses 706 extend from a top / proximal surface of the implantable component 704 through the encapsulation layer 718 and end at the bottom / distal surface of the implantable component 704 such that the internal coil 716 and the one or more wires 725 remain electrically isolated from the recipient’s tissue and body fluids. The mechanical weaknesses 706 can comprise, for example, a different type of grade of material (e.g., a different grade of silicone) that that can be readily pierced by a surgeon during suturing. As such, the mechanical weaknesses 706 allow sutures 729 to be passed through the implantable component 704 and attached to a recipient’s soft tissue so that the implantable component 704 can be secured to / in the recipient without the use of a bone-anchor. Similar to other embodiments, the sutures 729 can be temporary sutures or permanent sutures.

[0061] FIGs. 7A and 7B illustrate the presence of the mechanical weaknesses 706 at both the coil region 710 and the transition (neck) region 711. It is to be appreciated that this embodiment is merely illustrative and that the mechanical weaknesses 706 could be located only at the coil region 710 or only at the transition region 711.

[0062] In certain embodiments, the mechanical weaknesses 706 are unitary with the encapsulation layer 718 (e.g., formed with the encapsulation layer), while in other embodiments the mechanical weaknesses 706 are formed with a different material than the encapsulation layer 718. In addition, although this embodiment shows the mechanical weaknesses 706 integrated with (or attached to) an encapsulation layer 718, other implantableAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 medical devices without an encapsulation layer could include mechanical weaknesses 706 integrated with different biocompatible materials to provide anchor points for the sutures to secure the implantable medical device to / in a recipient.

[0063] FIGs. 8A-8H illustrate an example of a surgical procedure for implanting an implantable component 804 into a recipient. In general, the implantable medical component 804 is inserted subcutaneously into a pocket / skin flap 832 and secured thereto via the use of only soft tissue (e.g., no bone anchoring). In accordance with embodiments presented herein, the implantable medical component 804 is sutured to the recipient’s soft tissue (e.g., by suturing around one or more parts of the implantable medical component 804 or by suturing through one or more suture zones of the implantable medical component 804, if present).

[0064] The method begins at FIG. 8A where a surgeon creates an incision 831 (e.g., proximate to the posterior of the recipient’s ear (not shown in FIGs. 8A-H). In FIG. 8B, a pocket 832 is formed in the recipient’s subcutaneous tissue. In FIG. 8C a template 833 is inserted into the pocket 832 to confirm that the pocket is the correct size to fit the implantable medical component 804. As shown in FIG. 8D, if the pocket 832 is not the correct size to fit the implantable medical component 804, after testing the size of the pocket 832 with the template 833, the size of the pocket 832 is adjusted to accommodate the implantable medical component 804 in the correct position. FIG. 8E shows the verification of the correct pocket 832 size by fully inserting the template 833 subcutaneously into the newly formed pocket 832 proximate to the anterior of the recipient’s ear. FIG. 8F shows the insertion of the implantable medical device 804 in the correctly sized pocket 832 after the template 833 has been removed (not shown in FIGs. 8A-H).

[0065] FIG. 8G shows the fully inserted implantable medical device 804 in the pocket 832 prior to incision 831 closure. The implantable medical device 804 is then secured via subcutaneous sutures (not shown in FIGs 8A-8H). FIG. 8H shows the incision 831 after it has been closed and secured via sutures 834.

[0066] As noted, in accordance with embodiments presented herein, the implantable medical component 804 is secured to the recipient’s soft tissue via subcutaneous sutures. That is, the implantable medical component 804 is sutured to the recipient’s soft tissue before the incision 831 is closed. In accordance with certain embodiments presented herein, the implantable medical component 804 does not include any suture zones (as described above) and the surgeon can suture around one or more parts of the implantable medical component 804 (e.g., around aAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 neck or transition region). In other embodiments, the implantable medical component 804 includes one or more suture zones and the surgeon can suture through the one or more suture zones.

[0067] It would be appreciated if the surgical steps / operations shown in FIGs. 8A-8H are merely illustrative and techniques presented herein can be implemented while omitting one or more of the above steps or by adding one or more additional surgical steps. It also to be appreciated that the techniques presented herein could be implemented with different surgical methods.

[0068] FIG. 9 is a flowchart of one example surgical method 940 utilizing the soft tissue of a recipient to secure an implantable medical device subcutaneously. Method 940 begins at 941 where an opening / incision is created in the skin of the recipient to form a pocket / skin flap in the head of the recipient. At 942, the implantable medical device is inserted under the skin flap of the recipient such that only part of the device remains externally visible / exposed (e.g., visible through the incision in the recipient’s skin). At 943 the externally visible / exposed portion of the implantable medical device is sutured to the soft tissue of the recipient. In certain embodiments, the skin flap is tensioned to tighten the recipient’s soft tissue against the implantable medical device (e.g., before or after suturing). After the externally visible / exposed portion of the implantable medical device is sutured to the soft tissue of the recipient, the incision in the skin is closed (e.g., via additional sutures) such that entire implantable medical device is disposed subcutaneously (e.g., under the skin of the recipient).

[0069] FIG. 10 is a flowchart of another example surgical method 1040 wherein an implantable medical device with a coil spaced from the housing via a transition region is secured to a recipient’s soft tissue. Method 1040 begins at 1041 wherein an implantable medical device with a coil is spaced from the housing via a transition region is provided. At 1042 an opening is created in the skin of the recipient to form a pocket / skin flap. At 1043 the implantable medical device with a coil spaced from the housing via the transition region is inserted under the skin flap formed in the recipient such that only the transition region is visible. At 1044 the transition region is sutured to the recipient’s soft tissue. In certain embodiments, the transition region includes one or more suture zones, and the surgeon can suture the transition region to the recipient using the suture zones. In other embodiments, the surgeon can suture the transition region by suturing laterally around the transition region.Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1

[0070] As previously described, the technology disclosed herein can be applied in any of a variety of circumstances and with a variety of different devices. Example devices that can benefit from technology disclosed herein are described in more detail in FIGs. 11A-11B and FIG. 12. The techniques of the present disclosure can be applied to other devices, such as neurostimulators, cardiac pacemakers, cardiac defibrillators, sleep apnea management stimulators, seizure therapy stimulators, tinnitus management stimulators, and vestibular stimulation devices, as well as other medical devices that deliver stimulation to tissue. These different systems and devices can benefit from the technology described herein.

[0071] FIGs. 11A-1 IB illustrate an example cochlear implant system 1102 with which aspects of the techniques presented herein can be implemented. The cochlear implant system 1102 comprises an external component 1104 that is configured to be directly or indirectly attached to the body of the user, and an intemal / implantable component 1112 that is configured to be implanted in or worn on the head of the user. In the examples of FIGs. 11A-11B, the implantable component 1112 is sometimes referred to as a “cochlear implant.” FIG. 11A illustrates the cochlear implant 1112 implanted in the head 1154 of a user, while FIG. 1 IB is a schematic drawing of the external component 1104 worn on the head 1154 of the user. For ease of description, FIGs. 11A-1 IB will generally be described together.

[0072] In the examples of FIGs. 11A-11B, the external component 1104 comprises a sound processing unit 1106, an external coil (not shown in FIGs. 11A-1 IB), and generally, a magnet fixed relative to the external coil (not shown in FIGs. 11A-1 IB). The cochlear implant 1112 includes an implantable coil (not shown in FIGs. 11A-11B), an implant body (not shown in FIGs. 11A-11B), and an elongate stimulating assembly (not shown in FIGs. 11A-11B) configured to be implanted in the user’s cochlea. In one example, the sound processing unit 106 is an off-the-ear (OTE) sound processing unit, sometimes referred to herein as an OTE component, which is configured to send data and power to the implantable component 1112. In general, an OTE sound processing unit is a component having a generally cylindrically shaped housing (not shown in FIGs. 11A-11B) and which is configured to be magnetically coupled to the user’s head 1154 (e.g., includes an integrated external magnet 1150 configured to be magnetically coupled to an intemal / implantable magnet (not shown in FIGs. 11A-11B) in the implantable component 1112). The OTE sound processing unit 1106 also includes an integrated external (headpiece) coil (the external coil (not shown in FIGs. 11A-11B)) that is configured to be inductively coupled to the implantable coil (not shown in FIGs. 11A-1 IB).Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1

[0073] It is to be appreciated that the OTE sound processing unit 1106 is merely illustrative of the external devices that could operate with implantable component 1112. For example, in alternative examples, the external component 1104 may comprise a behind-the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear. A BTE sound processing unit comprises a housing that is shaped to be worn on the outer ear of the user. In certain examples, the BTE is connected to a separate external coil assembly via a cable, where the external coil assembly is configured to be magnetically and inductively coupled to the implantable coil (not shown in FIGs. 11A-1 IB), while in other embodiments the BTE includes a coil disposed in or on the housing worn on the outer ear of the user. It is also to be appreciated that alternative external components could be located in the user’s ear canal, worn on the body, etc.

[0074] Although the cochlear implant system 1102 includes the sound processing unit 1106 and the cochlear implant 1112, as described below, the cochlear implant 1112 can operate independently from the sound processing unit 1106, for at least a period, to stimulate the user. For example, the cochlear implant 1112 can operate in a first general mode, sometimes referred to as an “external hearing mode,” in which the sound processing unit 1106 captures sound signals which are then used as the basis for delivering stimulation signals to the user. The cochlear implant 1112 can also operate in a second general mode, sometimes referred as an “invisible hearing” mode, in which the sound processing unit 1106 is unable to provide sound signals to the cochlear implant 1112 (e.g., the sound processing unit 1106 is not present, the sound processing unit 1106 is powered-off, the sound processing unit 1106 is malfunctioning, etc.). As such, in the invisible hearing mode, the cochlear implant 1112 captures sound signals itself via implantable sound sensors and then uses those sound signals as the basis for delivering stimulation signals to the user. Further details regarding operation of the cochlear implant 1112 in the external hearing mode are provided below, followed by details regarding operation of the cochlear implant 1112 in the invisible hearing mode. It is to be appreciated that reference to the external hearing mode and the invisible hearing mode is merely illustrative and that the cochlear implant 1112 could also operate in alternative modes.

[0075] In FIG. 11A, the cochlear implant system 1102 is shown with an external device 1110,. The external device 1 110 is a computing device, such as a personal computer (e.g., laptop, desktop, tablet), a mobile phone (e.g., smartphone), a remote control unit, etc. The external device 1110 and the cochlear implant system 1102 (e.g., sound processing unit 1106 or the cochlear implant 1112) wirelessly communicate via a bi-directional communication link 1126.Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1The bi-directional communication link 1126 may comprise, for example, a short-range communication, such as Bluetooth link, Bluetooth Low Energy (BLE) link, a proprietary link, etc.

[0076] FIG. 12 illustrates an example vestibular stimulator system 1202, with which embodiments presented herein can be implemented. As shown, the vestibular stimulator system 1202 comprises an implantable component (vestibular stimulator) 1212 and an external device / component 1204 (e.g., external processing device, battery charger, remote control, etc.). The external device 1204 comprises a transceiver unit 1260. As such, the external device 1204 is configured to transfer data (and potentially power) to the vestibular stimulator 1212.

[0077] The vestibular stimulator 1212 comprises an implant body (main module) 1234, a lead region 1236, and a stimulating assembly 1216, all configured to be implanted under the skin / tissue (tissue) 1215 of the recipient. The implant body 1234 generally comprises a hermetically-sealed housing 1238 in which RF interface circuitry, one or more rechargeable batteries, one or more processors, and a stimulator unit are disposed. The implant body 1214 also includes an intemal / implantable coil 1214 that is generally external to the housing 1238, but which is connected to the transceiver via a hermetic feedthrough (not shown).

[0078] The stimulating assembly 1216 comprises a plurality of electrodes 1244(l)-(3) disposed in a carrier member (e.g., a flexible silicone body). In this specific example, the stimulating assembly 1216 comprises three (3) stimulation electrodes, referred to as stimulation electrodes 1244(1), 1244(2), and 1244(3). The stimulation electrodes 1244(1), 1244(2), and 1244(3) function as an electrical interface for delivery of electrical stimulation signals to the recipient’s vestibular system.

[0079] The stimulating assembly 1216 is configured such that a surgeon can implant the stimulating assembly adjacent the recipient’s otolith organs via, for example, the recipient’s oval window. It is to be appreciated that this specific embodiment with three stimulation electrodes is merely illustrative and that the techniques presented herein may be used with stimulating assemblies having different numbers of stimulation electrodes, stimulating assemblies having different lengths, etc.

[0080] In operation, the vestibular stimulator 1212, the external device 1204, and / or another external device can be configured to implement the techniques presented herein. That is, the vestibular stimulator 1212, possibly in combination with the external device 1204 and / orAtty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 another external device, can include an evoked biological response analysis system, as described elsewhere herein.

[0081] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. In general, additional configurations can be used to practice the processes and systems herein and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.

[0082] This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.

[0083] As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and / or some aspects described can be excluded without departing from the methods and systems disclosed herein.

[0084] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.

[0085] Similarly, where steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1

[0086] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.

[0087] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments may be combined with another in any of a number of different manners.

Claims

Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1CLAIMSWhat is claimed is:

1. An implantable medical device, comprising: an implantable housing; an implantable coil spaced from the implantable housing via a transition region, wherein the implantable coil is electrically connected to components in the implantable housing via one or more wires passing through the transition region; and an encapsulation layer disposed around at least the implantable coil and the transition region, wherein the encapsulation layer includes one or more suture zones configured to facilitate suturing of the implantable medical device to tissue of a recipient.

2. The implantable medical device of claim 1, wherein the one or more suture zones are disposed in the encapsulation layer at the transition region.

3. The implantable medical device of claim 1, wherein the one or more suture zones are disposed in the encapsulation layer at the implantable coil.

4. The implantable medical device of claim 1, wherein the one or more suture zones are disposed in the encapsulation layer at the transition region and the implantable coil.

5. The implantable medical device of claim 1, 2, 3, or 4, wherein the encapsulation layer is further disposed around the implantable housing.

6. The implantable medical device of claim 1, 2, 3, or 4, wherein the one or more suture zones comprise one or more apertures extending through the encapsulation layer.

7. The implantable medical device of claim 1, 2, 3, or 4, wherein the one or more suture zones comprise one or more projections extending laterally from the encapsulation layer.Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC18. The implantable medical device of claim 7, wherein the one or more projections extending laterally from the encapsulation layer comprise arcuate members that form openings adjacent at least one of the transition region or at the implantable coil.

9. The implantable medical device of claim 7, wherein the one or more projections are unitary with the encapsulation layer.

10. The implantable medical device of claim 7, wherein the one or more projections are attached to the encapsulation layer.

11. The implantable medical device of claim 7, wherein the one or more projections comprises a different material than the encapsulation layer.

12. The implantable medical device of claim 1, 2, 3, or 4, wherein the one or more suture zones comprise one or more recesses in the encapsulation layer.

13. The implantable medical device of claim 12, wherein the one or more recesses are located in a portion of the transition region that does not include the one or more wires.

14. The implantable medical device of claim 1, 2, 3, or 4, wherein the one or more suture zones comprise one or more channels in the encapsulation layer.

15. The implantable medical device of claim 1, 2, 3, or 4, wherein the one or more suture zones comprise one or more mechanical weaknesses in the encapsulation layer.

16. The implantable medical device of claim 15, wherein the encapsulation layer is substantially formed from a first material, and wherein the one or more mechanical weaknesses comprise portions of the encapsulation layer formed from a second material, wherein the second material is relatively softer than the first material.

17. The implantable medical device of claim 1, 2, 3, or 4, wherein an implantable transducer is disposed in the implantable housing.

18. A method, comprising: forming a skin flap in a head of a recipient;Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC1 inserting an implantable medical device under the skin flap such that a part of the implantable medical device remains externally visible; and securing the externally visible part of the implantable medical device to soft tissue of the head of the recipient.

19. The method of claim 18, wherein securing the externally visible part of the implantable medical device to the soft tissue of the head of the recipient comprises: suturing the externally visible part of the implantable medical device to the soft tissue of the head of the recipient.

20. The method of claim 19, wherein suturing the externally visible part of the implantable medical device to the soft tissue of the head of the recipient comprises: suturing around visible part of the implantable medical device.

21. The method of claim 19, wherein the implantable medical device includes one or more suture zones disposed in visible part of the implantable medical device, and wherein suturing the visible part of the implantable medical device to the soft tissue of the head of the recipient comprises: suturing through the one or more suture zones.

22. The method of claim 18, 19, 20, or 21, further comprising: tensioning the skin flap.

23. A method, comprising: providing a medical device comprising an implantable housing and an implantable coil spaced from the implantable housing via a transition region; forming a skin flap in a recipient; implanting the medical device under the skin flap such that only the transition region is visible; and suturing the transition region to tissue of the recipient.

24. The method of claim 23, wherein suturing the transition region to tissue of the recipient comprises: suturing around the transition region.Atty. Docket No. 3065.0846i Client Ref. No. CID03887WOPC125. The method of claim 23, wherein the transition region includes one or more suture zones, and wherein suturing the transition region to tissue of the recipient comprises: suturing through the one or more suture zones.

26. The method of claim 23, 24, or 25, further comprising: tensioning the skin flap.

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