Systems and methods for delivering neuroregenerative therapy

• US 10,589,089 B2
• Filed: 08/27/2019
• Issued: 03/17/2020
• Est. Priority Date: 10/25/2017
• Status: Active Grant

• Current Assignee: Epineuron Technologies Inc.
• Original Assignee: Epineuron Technologies Inc.
• Inventors: Willand, Michael Patrick, Aguirre, Sergio David
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US16/553,043
• Publication Number:
  US 20190381310A1
• Time in Patent Office: 203 Days
• Field of Search: None
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components

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.

Claims

1. A method of stimulating a target nerve of a subject, comprising:

during a verification phase, delivering stimulation energy having a first frequency to the target nerve via at least one electrode assembly, wherein the at least one electrode assembly comprises at least one electrode and a lead electrically coupled to the at least one electrode; and

during a therapeutic phase, delivering stimulation energy having a second frequency to the target nerve for a predetermined time period via the at least one electrode assembly;

wherein delivering stimulation energy during the verification phase is configured to confirm at least one condition, wherein the at least one condition comprises measurement of at least one electrical parameter at a location upstream to an injury site of the target nerve, wherein the at least one electrical parameter is associated with the target nerve;

wherein delivering stimulation energy to the subject during the therapeutic phase creates a regenerative effect to the target nerve;

wherein the second frequency is equal to or greater than the first frequency; and

wherein the lead of the at least one electrode assembly is configured to be advanced to or near the target nerve through a skin surface of the subject via a para-incisional pathway, wherein the para-incisional pathway is percutaneous and is separate of an opening of the skin surface related to the injury site of the target nerve of the subject.

2. The method of claim 1,

wherein the at least one electrical parameter comprises a detection of action potentials in the target nerve;

wherein the second frequency is 10 Hz to 100 Hz; and

wherein delivering stimulation energy during the verification phase is configured to activate an indicator as a confirmation of the at least one condition.

3. The method of claim 1, wherein the verification phase is a separate event from the therapeutic phase.

4. The method of claim 1, wherein the verification phase and the therapeutic phase comprise a single event.

5. The method of claim 1, wherein the at least one electrical parameter comprises a detection of action potentials in the target nerve.

6. The method of claim 1, wherein the at least one electrical parameter comprises current flow between anode and cathode electrodes.

7. The method of claim 1, wherein the at least one condition relates to motor or sensory responses of the subject.

8. The method of claim 1, wherein the at least one condition is that the at least one electrode assembly is contacting the target nerve.

9. The method of claim 1, wherein delivering stimulation energy during the verification phase is configured to activate an indicator confirming a confirmation of the at least one condition.

10. A method of stimulating a target nerve of a subject, comprising:

delivering confirmatory stimulation energy to the subject via at least one electrode assembly to confirm at least one condition, wherein the at least one electrode assembly comprises at least one electrode and a lead coupled to the at least one electrode; and

delivering therapeutic stimulation energy having a frequency to the subject for a predetermined time period via the at least one electrode assembly;

wherein delivering therapeutic stimulation energy to the subject at the frequency for the predetermined time period creates a regenerative effect to the target nerve;

wherein the frequency of the therapeutic stimulation energy is 10 Hz to 100 Hz;

wherein the at least one condition comprises measurement of at least one electrical parameter at a location upstream to an injury site of the target nerve, wherein the at least one electrical parameter is associated with the target nerve;

wherein the at least one condition comprises validation that a regenerative effect to the target nerve is being accomplished when delivering therapeutic stimulation energy; and

wherein the lead of the at least one electrode assembly is configured to be advanced to or near the target nerve through a skin surface of the subject via a para-incisional pathway, wherein the para-incisional pathway is percutaneous and is separate of an opening of the skin surface related to the injury site of the target nerve of the subject.

11. The method of claim 10, wherein the at least one condition comprises a measurement of action potentials in the target nerve.

12. The method of claim 10, wherein delivering confirmatory stimulation energy to confirm at least one condition is a separate event from delivering therapeutic stimulation energy to create a regenerative effect.

13. The method of claim 10, wherein delivering confirmatory stimulation energy to confirm at least one condition and delivering therapeutic stimulation energy to create a regenerative effect are a single event.

14. The method of claim 10, wherein the at least one condition comprises one or more of the following:

that the at least one electrode assembly is working, a measurement of current flow between anode and cathode electrodes, a measurement of motor or sensory responses, and that the at least one electrode assembly is contacting the target nerve.

15. A method of stimulating a target nerve of a subject, comprising:

delivering confirmatory stimulation energy to the subject via at least one electrode assembly to confirm at least one condition; and

delivering therapeutic stimulation energy having a frequency to the subject via the at least one electrode assembly;

wherein delivering therapeutic stimulation energy to the subject at the frequency for the predetermined time period creates a regenerative effect to the target nerve;

wherein the at least one condition comprises measurement of at least one electrical parameter associated with the target nerve, wherein measurement of the at least one electrical parameter occurs at a location upstream to an injury site of the target nerve;

wherein the at least one condition comprises validation that a regenerative effect to the target nerve is being accomplished when delivering therapeutic stimulation energy; and

wherein a lead of the at least one electrode assembly is configured to be advanced to or near the target nerve through a skin surface of the subject via a para-incisional pathway, wherein the para-incisional pathway is percutaneous and is separate of an opening of the skin surface related to the injury site of the target nerve of the subject.

16. The method of claim 15, wherein the at least one condition comprises a measurement of action potentials in the target nerve.

17. The method of claim 15, wherein delivering confirmatory stimulation energy to confirm at least one condition is a separate event from delivering therapeutic stimulation energy to create a regenerative effect.

18. The method of claim 15, wherein delivering confirmatory stimulation energy to confirm at least one condition and delivering therapeutic stimulation energy to create a regenerative effect are a single event.