Portable percutaneous assemblies, systems and methods for providing highly selective functional or therapeutic neuromuscular stimulation

• US 7,120,499 B2
• Filed: 02/12/2004
• Issued: 10/10/2006
• Est. Priority Date: 02/12/2004
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: NDI Medical, LLC
• Inventors: Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Primary Examiner(s): Pezzuto, Robert
• Assistant Examiner(s): JOHNSON, SHEVON ELIZABETH
• Application Number:
  US10/777,771
• Publication Number:
  US 20050182455A1
• Time in Patent Office: 971 Days
• Field of Search: 607 48- 49, 607/128, 607/144, 607/148, 607/115, 607/2, 607/149, 607/46, 128/907, 606/44, 606/41
• US Class Current: 607/48
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: Y10S 128/907 Acupuncture

Abstract

Neuromuscular stimulation assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles or nerves inside the body and stimulus generators or recording instruments mounted on the surface of the skin outside the body.

Claims

1. A neuromuscular stimulation assembly comprising

at least one electrode sized and configured for implantation in a targeted neural or muscular tissue region,

a percutaneous lead electrically coupled to the electrode and including an exposed region adapted to be projecting through an external skin surface,

a carrier sized and configured to be worn on the external skin surface,

circuitry carried on-board the carrier configured to generate a stimulation pulse,

a communication bay carried on-board the carrier that is electrically coupled to the circuitry, the communication bay being sized and configured to establish a communication link between the circuitry and an external device, the communication bay also being sized and configured to hold a power source, and

an electrode connection element carried on-board the carrier that is electrically coupled to the circuitry, the electrode connection element being sized and configured to electrically engage at least a portion of the exposed region of the lead to electrically couple the electrode to the circuitry to percutaneously apply the stimulation pulse to the tissue region.

4. An assembly according to claim 1 or 2

wherein the power source comprises a battery.

2. A neuromuscular stimulation assembly comprising

at least one electrode sized and configured for implantation in a targeted neural or muscular tissue region,

a percutaneous lead electrically coupled to the electrode and including an exposed region adapted to be projecting through an external skin surface,

a carrier sized and configured to be worn on the external skin surface,

circuitry carried on-board the carrier configured to generate a stimulation pulse,

a communication bay carried on-board the carrier that is electrically coupled to the circuitry, the communication bay being sized and configured to establish a communication link between the circuitry and an external device, the communication bay also being sized and configured to hold a power source that can be released and replaced, and

an electrode connection element carried on-board the carrier that is electrically coupled to the circuitry, the electrode connection element being sized and configured to electrically engage at least a portion of the exposed region of the lead to electrically couple the electrode to the circuitry to percutaneously apply the stimulation pulse to the tissue region.

3. An assembly according to clean 2

further including instructions prescribing the release and replacement of the power source according to a preset schedule.

5. A neuromuscular stimulation assembly comprising

at least one electrode sized and configured for implantation in a targeted neural or muscular tissue region,

a percutaneous lead electrically coupled to the electrode and including an exposed region adapted to be projecting through an external skin surface,

a carrier sized and configured to be worn on the external skin surface,

circuitry carried on-board the carrier configured to generate a stimulation pulse, the circuitry including programmable code that governs generation of the stimulation pulse,

a communication bay carried on-board the carrier that is electrically coupled to the circuitry, the communication bay being sized and configured to establish a communication link between the circuitry and an external device to program the programmable code, the communication bay also being sized and configured to hold a power source, and

an electrode connection element carried on-board the carrier that is electrically coupled to the circuitry, the electrode connection element being sized and configured to electrically engage at least a portion of the exposed region of the lead to electrically couple the electrode to the circuitry to percutaneously apply the stimulation pulse to the tissue region.

6. An assembly according to claim 5

wherein the communication bay is also sized and configured to hold a power source that can be released and replaced.

7. An assembly according to claim 6

further including instructions prescribing the release and replacement of the power source according to a preset schedule.

8. An assembly according to claim 5 or 6

wherein the power source comprises a battery.

9. A neuromuscular stimulation assembly comprising

at least one electrode sized and configured for implantation in a targeted neural or muscular tissue region,

a percutaneous lead electrically coupled to the electrode and including an exposed region adapted to be projecting through an external skin surface,

a carrier sized and configured to be worn on the external skin surface,

circuitry carried on-board the carrier configured to generate a stimulation pulse,

an electronics bay carried on-board the carrier that is sized and configured to hold the circuitry for selective release from the carrier, and

an electrode connection element carried on-board the carrier that is electrically coupled to the circuitry, the electrode connection element being sized and configured to electrically engage at least a portion of the exposed region of the lead to electrically couple the electrode to the circuitry to percutaneously apply the stimulation pulse to the tissue region.

10. A neuromuscular stimulation assembly comprising

at least one electrode sized and configured for implantation in a targeted neural or muscular tissue region,

a percutaneous lead electrically coupled to the electrode and including an exposed region adapted to be projecting through an external skin surface,

a carrier sized and configured to be worn on the external skin surface,

a region carried on-board the carrier sized and configured to adhere the carrier to the external skin surface and to accommodate selective detachment of the carrier from the external skin surface,

circuitry carried on-board the carder configured to generate a stimulation pulse, and

an electrode connection element carried on-board the carrier that is electrically coupled to the circuitry, the electrode connection element being sized and configured to electrically engage at least a portion of the exposed region of the lead to electrically couple the electrode to the circuitry to percutaneously apply the stimulation pulse to the tissue region.

11. A neuromuscular stimulation assembly comprising

at least one electrode sized and configured for implantation in a targeted neural or muscular tissue region,

a percutaneous lead electrically coupled to the electrode and including an exposed region adapted to be projecting through an external skin surface,

a carrier sized and configured to be worn on the external skin surface, the carrier comprises separable sections that can be manipulated to open the carrier to accommodate passage of the exposed region of the lead into electrical engagement with an electrode connection element and to close the carrier to capture the exposed region of the lead within the electrode connection element,

circuitry carried on-board the carrier configured to generate a stimulation pulse, and

the electrode connection element being carried on-board the carrier and electrically coupled to the circuitry, the electrode connection element being sized and configured to electrically engage at least a portion of the exposed region of the lead to electrically couple the electrode to the circuitry to percutaneously apply the stimulation pulse to the tissue region.

12. An assembly according to claim 11

wherein the electrode connection element comprises a trough to route the exposed region of the lead.

13. A neuromuscular stimulation assembly comprising

at least one electrode sized and configured for implantation in a targeted neural or muscular tissue region,

a percutaneous lead electrically coupled to the electrode and including an exposed region adapted to be projecting through art external skin surface,

a carrier sized and configured to be worn on the external skin surface,

circuitry carried on-board the carrier configured to generate a stimulation pulse, and

an electrode connection element carried on-board the carrier that is electrically coupled to the circuitry, the electrode connection element comprises a trough to route the exposed region of the lead, the electrode connection element being sized and configured to electrically engage at least a portion of the exposed region of the lead to electrically couple the electrode to the circuitry to percutaneously apply the stimulation pulse to the tissue region.

14. A neuromuscular stimulation system comprising

a carrier sized and configured to be worn on an external skin surface at or near a targeted neural or muscular region, the carrier including circuitry configured to generate a stimulation pulse, a power input bay sized and configured to hold a disposable battery for the circuitry that can be released and replaced for powering the circuitry, and an electrode connection element that is sized and configured to electrically engage an electrode lead for an electrode that has been percutaneously implanted in the targeted tissue region, to percutaneously apply the stimulation pulse to the targeted tissue region,

instructions furnished by a clinician or caregiver or physician prescribing the release and replacement of the disposable battery according to a prescribed battery replacement regime, the prescribed battery replacement regime comprising the replacement of the disposable battery on a prescribed repeated basis similar to administering a pill under a prescribed pill-based medication regime, and

a supply of disposable batteries, each batteries comprising a dose of power for the circuitry for administration according to the prescribed battery replacement regime.

15. A system according to claim 14

wherein the circuitry includes programmable code governing generation of the stimulation pulse.

16. A system according to claim 15

wherein the carrier includes means for establishing a communication link between the circuit and an external device to program the programmable code.

24. A system according to claim 14 or 21

wherein the prescribed battery replacement regime comprises the replacement of the disposable battery repeated at least on about a daily basis.

25. A system according to claim 14 or 21

wherein the prescribed battery replacement regime comprises the replacement of the disposable battery repeated at least on about a weekly basis.

17. A method for providing a neuromuscular stimulation function comprising

providing a neuromuscular stimulation system comprising a carrier sized and configured to be worn by an individual, the carrier including circuitry configured to generate a stimulation pulse, a power input bay sized and configured to hold a disposable battery for the circuitry that can be released and replaced for powering the circuitry, and an electrode connection element that is sized and configured to electrically engage an electrode lead for an electrode that has been percutaneously implanted in a targeted tissue region, to percutaneously apply the stimulation pulse to the targeted tissue region,

providing instructions furnished by a clinician or caregiver or physician prescribing the release and replacement of the disposable battery according to a prescribed battery replacement regime, the prescribed battery replacement regime comprising the replacement of the disposable battery on a prescribed repeated basis similar to administering a pill under a prescribed pill-based medication, and

providing a supply of disposable batteries, each battery comprising a close of power for the circuitry for administration according to the prescribed battery replacement regime.

18. A method according to claim 17 wherein the neuromuscular stimulation function includes a function selected from a group comprising (i) maintenance of muscle function;

(ii) tissue or bone regeneration;

(iii) continuous active motion therapy;

(iv) anti-scarring treatment;

(v) diagnostic assessment;

(vi) neuroplasticity therapy;

(vii) anti spasm therapy;

(viii) pain therapy;

(ix) post-surgical reconditioning;

(x) anti-thrombosis therapy; and

(xi) treatment of osteoporosis.

19. A method according to claim 17

wherein the prescribed battery replacement regime comprises the replacement of the disposable battery repeated at least on about a daily basis.

20. A method according to claim 17

wherein the prescribed battery replacement regime comprises the replacement of the disposable battery repeated at least on about a weekly basis.

21. A neuromuscular stimulation system comprising

a carrier sized and configured to be worn by an individual, the carrier including circuitry configured to generate a stimulation pulse, a power input bay sized and configured to hold a disposable battery for the circuitry that can be released and replaced for powering the circuitry, and an electrode connection element that is sized and configured to electrically engage an electrode lead for an electrode that has been percutaneously implanted in a targeted tissue region, to percutaneously apply the stimulation pulse to the targeted tissue region,

instructions furnished by a clinician or caregiver or physician prescribing the release and replacement of the disposable battery according to a prescribed battery replacement regime, the prescribed battery replacement regime comprising the replacement of the disposable battery on a prescribed repeated basis similar to administering a pill under a prescribed pill-based medication regime, and

a supply of disposable batteries, each battery comprising a dose of power for the circuitry for administration according to the prescribed battery replacement regime.

22. A system according to claim 21

wherein the circuitry includes programmable code governing generation of the stimulation pulse.

23. A system according to claim 22

wherein the carrier includes means for establishing a communication link between the circuitry and an external device to program the programmable code.