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EP-4735099-A1 - NEURAL ELECTRODE AND RELATED METHODS

EP4735099A1EP 4735099 A1EP4735099 A1EP 4735099A1EP-4735099-A1

Abstract

An electrode device and related methods of use and manufacture are described. The electrode can be configured to be securely mounted to a patient's nerve and so that individual contacts are put in electrical communication with individual nerves in a nerve bundle.

Inventors

  • SADDOW, Stephen Edward
  • MILLER, Timothy David
  • WESTON, MARK

Assignees

  • University of South Florida
  • Biologic Input Output Systems, Inc.

Dates

Publication Date
20260506
Application Date
20240627

Claims (20)

  1. What is claimed is: 1. An implantable peripheral nerve system comprising: a probe comprising: a panel including an electrical contact that is positioned on a surface of the panel; a shank coupled to and extending from the panel, the shank including an electrode contact, the electrode contact being electrically coupled to the electrical contact; a housing having an inner surface defining a cavity, the cavity being sized to house the panel of the probe while the shank extends from the cavity outside of the housing; and wherein the probe is adapted to engage a peripheral nerve of a subject thereby electrically connecting the peripheral nerve to the electrode contact of the shank.
  2. 2. The system of claim 1, wherein when the probe is positioned within the cavity of the housing, the housing constrains movement of the probe relative to the housing.
  3. 3. The system of claim 1, wherein the housing includes an opening at a bottom of the housing; and wherein when the probe is positioned within the cavity of the housing, the shank extends through the opening of the housing.
  4. 4. The system of claim 1, wherein the panel includes a concave portion; wherein the opening includes a concave region that aligns with the concave portion of the panel, when the probe is positioned within the cavity of the housing.
  5. 5. The system of claim 1, wherein the housing includes a mechanical stop that engages with the panel of the probe to prevent movement of the panel past the mechanical stop.
  6. 6. The system of claim 5, wherein the mechanical stop is an extension that extends into an opening of the housing in which the shank extends through. QB\90496165.4 43
  7. 7. The system of claim 1, wherein the electrical contact of the probe is exposed when the probe is positioned within the housing; and further comprising a cable configured to be coupled to the panel, such that when the cable is coupled to the panel, the cable electrically couples to the electrical contact of the probe.
  8. 8. The system of claim 1, further comprising a cable with a boot coupled to an end of the cable; wherein the housing includes a cut-out or recess that exposes the electrical contact when the probe is positioned within the housing; and wherein the boot mechanically engages with the housing thereby coupling the cable to the housing to secure the cable to the housing and electrically couple the electrical contact to the cable.
  9. 9. The system of claim 1, wherein the probe, the housing, and the cable are configured to be implanted within a subject.
  10. 10. The system of claim 1, wherein the electrical contact is a first electrical contact, the shank is a first shank, and the electrode contact is a first electrode contact; wherein the panel includes a second electrical contact that is positioned on the surface of the panel; and wherein the probe includes a second shank coupled to and extending from the panel, the shank including a second electrode contact, the second electrode contact being electrically coupled to the second electrical contact. QB\90496165.4 44
  11. 11. An implantable peripheral nerve system comprising: a probe comprising: a panel including an electrical contact that is positioned on a surface of the panel; a shank coupled to and extending from the panel, the shank including an electrode contact, the electrode contact being electrically coupled to the electrical contact; a housing having an inner surface defining a cavity, the cavity being sized to house the panel of the probe while the shank extends from the cavity outside of the housing; a support adapted to engage with a peripheral nerve of a subject, the support having a slot sized to house the housing with the probe therein, wherein when the housing is inserted into the support, the support constrains movement of the housing relative to the support; and wherein the probe is adapted to engage a peripheral nerve of a subject thereby electrically connecting the peripheral nerve to the electrode contact of the shank.
  12. 12. The system of claim 11, wherein the support includes a collar that is configured to surround the peripheral nerve of the subject; and wherein the slot is positioned on top of the collar.
  13. 13. The system of claim 1, further comprising a lock that when engaged constrains movement of the housing relative to the support.
  14. 14. The system of claim 13, wherein the support includes the lock and the lock includes one or more feet that contact the housing to block movement of the housing.
  15. 15. The system of claim 12, wherein the probe, the housing, and the support are configured to be implanted within a subject. QB\90496165.4 45
  16. 16. An implantable neural device comprising: a probe comprising: a panel having a length; a first shank coupled to and extending from the panel, the first shank including a first electrode contact, the first shank having a length that is greater than the length of the panel; a second shank coupled to and extending from the panel, the second shank including a second electrode contact, the second shank having a length that is greater than the length of the panel; and wherein the probe is adapted to engage a peripheral nerve of a subject thereby electrically connecting the peripheral nerve to at least one of the first shank or the second shank.
  17. 17. The device of claim 16, wherein a ratio of the length of the panel to the length of the first shank is greater than or equal to about 1; wherein a ratio of the length of the panel to the length of the first shank is greater than or equal to about 1.4; or wherein a ratio of the length of the panel to the length of the first shank is greater than or equal to about 1.7.
  18. 18. The device of claim 16, wherein the probe is adapted to engage a peripheral nerve bundle of a subject thereby electrically connecting a first peripheral nerve fiber of the peripheral nerve bundle to the first shank and electrically connecting a second peripheral nerve fiber of the peripheral nerve bundle to the second shank.
  19. 19. The device of claim 16, wherein a thickness of the panel is substantially the same as a thickness of the first shank and a thickness of the second shank.
  20. 20. The device of claim 16, wherein the first shank and the second shank are integrally formed with the panel. QB\90496165.4 46

Description

NEURAL ELECTRODE AND RELATED METHODS CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of and priority to U.S. Provisional Application No.63/511,101, filed June 29, 2023, which is incorporated by reference in its entirety. TECHNICAL FIELD [0002] The present disclosure generally relates to medical devices and more specifically to apparatus and related methods for an implantable neural electrode. BACKGROUND [0003] Implantable neural interfaces (INIs) are devices configured to connect with the human nervous system through electrical means. Advantageously, such devices allow electrical recording and stimulation of the nervous system and can contribute to developing effective treatments for various nervous system diseases (e.g., chronic pain, arrythmia, Parkinson’s, Alzheimer’s, and poliomyelitis). [0004] However, the materials used for conventional INIs (e.g., silicon and noble metals) suffer from many limitations. For example, due to a relatively low impedance and small detection window, noble metals and silicon-based INIs have limited application during neural stimulation. Additionally, long-term implantable performance with such devices is poor due to the foreign body response, loss of target neurons, and scar formation (i.e., gliosis). In some instances, a base material, such as Si, has been known to make contact with the neural environment and trigger the body’s immune system response. In some instances, this has led to undesirable device encapsulation with glial scar tissue resulting in reduced device performance and patient discomfort. [0005] Furthermore, metals can introduce irreversible dissolution during neurostimulation, which can cause undesirable damage to the human body. Accordingly, new implantable device materials for biomedical applications are desirable. [0006] With rapid improvements in bionic limbs (prosthetic hands, arms and legs) new challenges arise in the efficient and transparent operation of these advanced devices. Electromyography (EMG) sensors can be used to detect and measure electrical signals in a patient’s muscle, however, this does not allow for specific neural interfacing. Performance QB\90496165.4 1 using these sensors is limited due to the large number of neural signals that are picked up, sometimes all at the same time. In addition, this type of interface does not lend itself to accurate and effective neural stimulation, for instance to individual nerves, and thus bionic limb feedback signals cannot be fed back to the user. A solution is desired that allows for an increase in the number of individual neural recording/stimulation points that are available, along with reliable, long-term electrode implantation in the peripheral nervous system (PNS). Such a device would preferably improve the number of bionic limb degrees of freedom possible, and also both reduce latency and improve accuracy, as contemporary interfaces require a software algorithm and lengthy training to assess and estimate the patient’s intent. [0007] Microelectrode (MEA) arrays, developed for use in the central nervous system (CNS), are known, but available devices are not suitable for long-term implantation in the peripheral nervous system (PNS). Reliability of implanted devices can be affected by a variety of factors, including the degradation of the implant itself, the immune response, and patient motion in an in-vivo environment. SUMMARY [0008] In some embodiments of the present disclosure, an implantable neural device is provided for placement in the body of a patient for transmitting electrical signals. The device can include a probe that has one or more elongated electrode shanks, which can be formed from silicon carbide, extending from a panel. The electrode shanks can include one or more electrode traces that can electrically couple a respective electrode contact. The electrode shanks can be adapted and sized to engage one or more peripheral nerves such that the electrode contacts can electrically couple with the nerve. The surface of the probe can be covered in a silicon carbide coating that can act as an insulator, for instance an amorphous silicon carbide coating with the electrode tip contact uncovered to allow for electrical coupling to the neural environment. [0009] In some embodiments, an implantable neural device can include signal control electronics attached to the at least one elongated electrode shank and in communication with the at least one electrode contact. [0010] In some embodiments, an implantable neural device a plurality of elongated electrode shanks can be arranged into a matrix. [0011] In some embodiments, an implantable neural device matrix can be a two- dimensional matrix. [0012] In some embodiments, an implantable neural device matrix can be a three- dimensional matrix. QB\90496165.4 2 [0013] In some embodiments, each shank can have a plurality of electrode traces, each electrode trace can be configured to electrically couple a respective