US-12616832-B2 - Systems and methods for delivering neuroregenerative therapy

Abstract

Systems, devices and methods are disclosed for the treatment of injured peripheral nerves or other tissue using electrical stimulation. The systems can be used either in intraoperative or peri-operative settings and incorporate the use of either a plurality of monopolar electrodes with a patch used as return or a plurality of bipolar electrodes such as a cuff. The systems can provide hands-free delivery of electrical stimulation therapy over a predetermined set of time.

Inventors

• Michael Patrick Willand
• Sergio David Aguirre

Assignees

• EPINEURON TECHNOLOGIES INC.

Dates

Publication Date

20260505

Application Date

20220211

Claims (18)

1. 1 . A method of stimulating a target nerve in a subject, comprising: positioning at least one electrode assembly of a stimulation device adjacent the target nerve, wherein the at least one electrode is located along an electrode lead of the stimulation device; wherein the at least one electrode assembly is positioned adjacent the target nerve percutaneously; delivering stimulation energy to the target nerve of the subject having a first frequency via the at least one electrode to confirm at least one validation condition; delivering stimulation energy to the target nerve of the subject having a second frequency via the at least one electrode assembly, wherein delivering stimulation energy to the subject to create a regenerative effect to the target nerve; wherein stimulation energy to confirm at least one validation condition and to create a regenerative effect to the target nerve is provided by the same at least one electrode; and wherein the at least one electrode assembly is configured to be percutaneously removed from the subject through a percutaneous access point following the delivery of stimulation energy; and removing the at least one electrode assembly from the subject.
2. 2 . The method of claim 1 , wherein the second frequency is 1 Hz to 100 Hz; wherein the target nerve comprises a peripheral nerve; and wherein the stimulation device is configured to be removably secured to a skin surface of the subject using an adhesive patch.
3. 3 . The method of claim 1 , wherein the second frequency is 1 Hz to 100 Hz.
4. 4 . The method of claim 1 , wherein the second frequency is 10 Hz to 100 Hz.
5. 5 . The method of claim 1 , wherein the at least one electrode assembly comprises a bipolar electrode assembly.
6. 6 . The method of claim 1 , wherein delivering stimulation energy occurs intraoperatively.
7. 7 . The method of claim 1 , wherein delivering stimulation energy occurs postoperatively.
8. 8 . The method of claim 1 , wherein delivering stimulation energy to create a regenerative effect occurs for a particular time period.
9. 9 . The method of claim 8 , wherein the particular time period is 10 to 90 minutes.
10. 10 . The method of claim 1 , wherein positioning the at least one electrode assembly adjacent the target nerve is performed with assistance of an insertion tool.
11. 11 . The method of claim 1 , wherein the stimulation device is configured to be removably secured to a skin surface of the subject using an adhesive patch.
12. 12 . The method of claim 1 , further comprising modifying at least one operational parameter of the stimulation energy using at least one controller of the stimulation device.
13. 13 . The method of claim 1 , wherein the target nerve comprises a peripheral nerve.
14. 14 . A method of stimulating a target nerve in a subject, comprising: positioning at least one electrode assembly adjacent the target nerve; wherein the at least one electrode assembly is positioned adjacent the target nerve percutaneously; and delivering stimulation energy to the target nerve of the subject to confirm at least one validation condition; delivering stimulation energy to the target nerve of the subject via the at least one electrode assembly, wherein delivering stimulation energy to the subject creates a regenerative effect to the target nerve; wherein the at least one electrode assembly is configured to be percutaneously removed from the subject through a percutaneous access point following the delivery of stimulation energy; and removing the at least one electrode assembly from the subject.
15. 15 . The method of claim 14 , wherein delivering stimulation energy occurs intraoperatively.
16. 16 . The method of claim 14 , wherein delivering stimulation energy occurs postoperatively.
17. 17 . The method of claim 14 , wherein the at least one electrode assembly comprises a bipolar electrode assembly.
18. 18 . The method of claim 14 , wherein the stimulation device is configured to be removably secured to a skin surface of the subject using an adhesive patch.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 16/759,257, filed Apr. 24, 2020 and scheduled to issue on Feb. 15, 2022 as U.S. Pat. No. 11,247,045, which is a National Stage application in the United States of PCT Application PCT/US2018/057375, filed Oct. 24, 2018 and published on May 2, 2019 as PCT Publ. WO 2019/084182, which claims priority to U.S. Provisional Patent Application Nos. 62/577,141, filed Oct. 25, 2017, and 62/683,019, filed Jun. 11, 2018. The contents of all of the foregoing applications are incorporated by reference herein and made part of the present application in their entireties. FIELD This application relates generally to devices, systems and methods for locating and/or treating (e.g., regenerating, facilitating the treatment of, etc.) injured tissue, and more specifically, to devices, systems and methods that facilitate the regeneration of injured nerves (e.g., neuroregeneration). BACKGROUND Peripheral nerve injuries (PNI) are severely debilitating, affecting otherwise healthy patients by limiting their ability to perform activities of daily living. Peripheral nerve injuries may result from various etiologies, from complex trauma to iatrogenic and compressive neuropathies. However, despite various etiologies the mainstay to repair peripheral nerve damage is surgical repair of transected nerve ends or surgical release of compressed nerves. Unfortunately, even the best surgical procedures usually leave patients with marked deficits. Given the disability associated with PNI, a need clearly exists to improve outcomes. Currently, clinical treatment of injured peripheral nerves is primarily surgical, either releasing the source of nerve compression or reattaching the transected nerve directly or with grafting materials. Surgery permits nerve regrowth by re-establishing nerve continuity but functional recovery remains inadequate. Generally, nerves regenerate slowly (˜1 mm/day at their fastest) requiring long periods of time before reconnecting with denervated target muscle or sensory end-organs. The window of opportunity for nerve regeneration is short with the regenerative capacity of the injured neurons and the regenerative support of the distal nerve stump declining with time and distance. These factors together with the misdirection of regenerating nerves account for the frequent poor recovery. SUMMARY According to some embodiments, a system (and corresponding method) configured to deliver targeted electrical stimulation therapy to injured nerves is amenable to fit the needs of different injuries and clinical workflows, including different anatomical areas, injured nerves, nerve diameters, and types of nerve injury. The system can advantageously provide users with the ability to seamlessly interchange nerve interfaces to connect with and deliver neuroregenerative therapy (e.g., for neuroregeneration). The embodiments disclosed herein provide flexibility to users to apply neuroregenerative therapy prior to surgery, at the time of surgery, post-surgery, or a combination thereof, as desired or required. According to some embodiments, additionally, the systems and methods allow for confirmation that the stimulating electrodes are functioning correctly by providing a means to verify the integrity of the electrode and/or system either through a physical self-verification or automatic verification steps. This becomes advantageous in situations where motor nerves are transected and no physical response (e.g., no muscle contraction) is present or in situations where a pure sensory nerve is transected and there are no physical responses to begin with. This same verification method allows for safe and continuous delivery of neuroregenerative therapy by monitoring current flow through the electrodes. According to some embodiments, the systems and methods disclosed herein further allow users to perform nerve location tasks using the same or different nerve interfaces prior to commencing neuroregenerative therapy. The system is also configured to incorporate a single button that controls stimulus parameters, system modes, and therapy time providing an easy to use interface for a clinician minimizing training and complexity. According to some embodiments, a method of stimulating a target nerve of a subject comprises, during a first phase, delivering stimulation energy of a first frequency via at least one electrode assembly, and, during a second phase, delivering to the subject stimulation energy of a second frequency for a predetermined period via the at least one electrode assembly, wherein delivering stimulation energy to the subject during the second phase creates a regenerative effect (e.g., neuroregenerative effect) to the target nerve, and wherein delivering stimulation energy during the first phase is configured to confirm at least one validation condition. In some embodiments, the second frequency is greater than the first frequen