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

• US 7,571,002 B2
• Filed: 10/10/2006
• Issued: 08/04/2009
• 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): Layno; Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US11/545,339
• Publication Number:
  US 20070032837A1
• Time in Patent Office: 1,029 Days
• Field of Search: None
• 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 that can be released and replaced,

instructions prescribing the release and replacement of the power source according to a preset schedule,

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 power source comprises a battery.

3. An assembly according to claim 1

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

4. An assembly according to claim 3

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

5. 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.

6. 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.

7. An assembly according to claim 1

wherein the stimulation pulse provides a neuromuscular stimulation function, the neuromuscular stimulation function including 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.

8. An assembly according to claim 1

wherein the preset schedule comprises the replacement of the power source repeated at least on about a daily basis.

9. An assembly according to claim 1

wherein the preset schedule comprises the replacement of the power source repeated at least on about a weekly basis.

10. A method for providing a neuromuscular stimulation function, the method comprising:

providing a percutaneous lead having an exposed region, the lead electrically coupled to at least one electrode, the at least on electrode sized and configured for implantation in a targeted neural or muscular tissue region,

providing a carrier sized and configured to be carried by the patient, the carrier also being sized and configured to hold a power source that can be released and replaced, the carrier including 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 at least one electrode to the electronics pod to percutaneously apply the stimulation pulse to the targeted neural or muscular tissue region,

providing instructions prescribing the release and replacement of the power source according to a preset schedule,

implanting the at least one electrode through an external skin surface of a patient and into the targeted neural or muscular tissue region,

electrically engaging the portion of the exposed region of the lead to the electrode connection element to electrically couple the electrode to the electronics pod, and

activating the circuitry to generate a stimulation pulse to percutaneously apply the stimulation pulse to the targeted neural or muscular tissue region.

11. A method according to claim 10

wherein the power source comprises a battery.

12. A method according to claim 10

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

13. A method according to claim 12

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

14. A method according to claim 10

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

15. A method according to claim 10

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.

16. A method according to claim 10

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.

17. A method according to claim 10

wherein the preset schedule comprises the replacement of the power source repeated at least on about a daily basis.

18. A method according to claim 10

wherein the preset schedule comprises the replacement of the power source repeated at least on about a weekly basis.