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

• US 20070032837A1
• Filed: 10/10/2006
• Published: 02/08/2007
• Est. Priority Date: 02/12/2004
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: NDI Medical, LLC
• Inventors: Thrope, Geoffrey, Strother, Robert, Mrva, Joseph
• Granted Patent: US 7,571,002 B2
• Time in Patent Office: Days
• 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 or worn or carried by the patient. The assemblies, systems, and methods include an electrode sized and configured for implantation in tissue, a percutaneous lead electrically coupled to the electrode, a carrier sized and configured to be carried by the patient and to hold a power source, an electronics pod removably carried on-board the carrier and including circuitry configured to generate a stimulation pulse, and an electrode connection element carried on-board the carrier that is electrically coupled to the electronics pod. Instructions furnished by a clinician or caregiver or physician prescribe the release and replacement of a disposable battery according to a prescribed battery replacement regime.

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 of a patient,

a carrier sized and configured to be carried by the patient, the carrier also being sized and configured to hold a power source,

an electronics pod removably carried on-board the carrier, the electronics pod including circuitry configured to generate a stimulation pulse, and

an electrode connection element carried on-board the carrier that is electrically coupled to the electronics pod, 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 electronics pod to percutaneously apply the stimulation pulse to the tissue region.

2. An assembly according to claim 1

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

3. An assembly according to claim 2

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

4. An assembly according to claim 1

wherein the power source comprises a battery.

5. An assembly according to claim 2

wherein the power source comprises a battery.

6. An assembly according to claim 1

wherein the circuitry includes programmable code that governs generation of the stimulation pulse.

7. An assembly according to claim 1

wherein the electronics pod carried on-board the carrier is sized and configured for selective release from the carrier.

8. An assembly according to claim 1

further including 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.

9. 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 a selectively releasable electronics pod having 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 battery comprising a dose of power for the circuitry for administration according to the prescribed battery replacement regime.

10. A system according to claim 9

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

11. A system according to claim 10

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

12. 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 a selectively releasable electronics pod having 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 regime, and

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

13. A method according to claim 12 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 12

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 12

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

14. A neuromuscular stimulation system comprising

a carrier sized and configured to be worn by an individual, the carrier including a selectively releasable electronics pod having 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.

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 circuitry and an external device to program the programmable code.

17. A system according to claim 9 or 14

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

18. A system according to claim 9 or 14

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