Portable assemblies, systems, and methods for providing functional or therapeutic neurostimulation

• US 20070123952A1
• Filed: 11/10/2006
• Published: 05/31/2007
• Est. Priority Date: 02/12/2004
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: NDI Medical, LLC
• Inventors: Thrope, Geoffrey, Strother, Robert, Pack, Danny, Galecki, Steven, Mrva, Joseph
• Granted Patent: US 8,086,318 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: H01M 50/213 adapted for cells having curved cross-section, e.g. round or elliptic H01M50/209, H01M50/216 take precedence
• CPC Class Codes: Y02E 60/10 Energy storage using batteries

Abstract

Neurostimulation 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 or carried outside the body. Neurostimulation assemblies, systems, and methods may include a carrier and a removable electronics pod, the electronics pod including stimulation generation circuitry, a power input bay to hold a disposable power source, and user interface components. The assemblies, systems, and methods are adapted to provide coordinated neurostimulation to multiple regions of the body.

Claims

1. A neurostimulation assembly comprising

at least one electrode,

a carrier sized and configured to be worn by a user,

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

a power input bay carried on-board the electronics pod that is electrically coupled to the circuitry, the power input bay being sized and configured to accept a disposable power source.

2. An assembly according to claim 1

wherein the disposable power source includes circuitry to electronically store information about the power source.

3. An assembly according to claim 2

wherein the power source circuitry includes non-volatile memory.

4. An assembly according to claim 1

wherein the electronics pod circuitry includes non-volatile memory to electronically store information about the power source.

5. An assembly according to claim 2

wherein the electronically stored information is selected from a group comprising power source usage data, a unique power source identification, and power source capacity.

6. An assembly according to claim 4

wherein the electronically stored information is selected from a group comprising power source usage data, a unique power source identification, and power source capacity.

7. An assembly according to claim 1

further including an adhesive region on the carrier to temporarily secure the carrier to an external skin surface during use.

8. An assembly according to claim 7

The adhesive region further including a surface return electrode.

22. A method of evaluating whether a person will respond to electrical stimulation of a nerve to reduce a bladder dysfunction comprising using the assembly defined in claim 1.

9. A neurostimulation assembly comprising

at least one electrode,

a carrier sized and configured to be worn by a user, and

an electronics pod carried on-board the carrier, the electronics pod including circuitry configured to generate a stimulation pulse to the electrode, a user interface adapted to allow user input to the circuitry to adjust the stimulation pulse, and a visual output of neurostimulation assembly information.

10. An assembly according to claim 9

wherein the electronics pod is removably carried on-board the carrier.

11. An assembly according to claim 9

further including a power input bay carried on-board the electronics pod that is electrically coupled to the circuitry, the power input bay being sized and configured to accept a disposable power source.

12. An assembly according to claim 9

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

13. An assembly according to claim 9

wherein the visual output comprises a display carried on-board the electronics pod.

14. An assembly according to claim 9

wherein the visual output is provided by an illumination source that illuminates at least a portion of the electronics pod.

15. A neurostimulation system comprising

a carrier sized and configured to be worn by a user, the carrier including circuitry configured to generate a stimulation pulse, an electronics pod sized and configured to hold a disposable power source 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 is adapted to be 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 power source according to a prescribed power source replacement regime, the prescribed power source replacement regime comprising the replacement of the disposable power source on a prescribed repeated basis, similar to administering a pill under a prescribed pill-based medication regime, and

a supply of power sources provided in an organizer that includes one or more disposable power sources for each day or period of the prescribed power source replacement regime.

16. A system according to claim 15

wherein the organizer is in the form of a daily pill case that includes one or more compartments to hold one or more disposable power sources for each day or period of the prescribed power source replacement regime.

17. A neurostimulation assembly comprising

at least one electrode,

a carrier sized and configured to be worn by a user, the carrier including stimulation circuitry configured to generate a stimulation pulse to the electrode, and

a disposable power source releasably coupled to the stimulation circuitry, the disposable power source comprising a housing, a battery positioned within the housing, and power source circuitry positioned within the housing, the power source circuitry adapted to store information about the power source.

18. An assembly according to claim 17

further including a power input bay carried on-board the carrier that is electrically coupled to the stimulation circuitry, the power input bay being sized and configured to accept the disposable power source.

19. A neurostimulation assembly comprising

at least one electrode,

a carrier sized and configured to be worn by a user,

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

the circuitry including an illumination source adapted to create a glowing appearance of at least a portion of the cover to provide a visual feedback of neurostimulation assembly information to the user.

20. An assembly according to claim 19

wherein the electronics pod is removably carried on-board the carrier.

21. An assembly according to claim 19

wherein the glowing appearance is selected from a group comprising blinking or pulsing configurations, illumination brightness, changing colors, or any combination.

23. A method of providing neurostimulation to tissue comprising

providing a neurostimulation assembly, the neurostimulation assembly comprising a carrier sized and configured to be worn by a user, the carrier including circuitry configured to generate a stimulation pulse, an electronics pod sized and configured to hold a disposable power source 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 a supply of power sources provided in an organizer that includes one or more disposable power sources for each day or period of the prescribed power source replacement regime,

placing one of the power sources in the electronics pod to power the circuitry, and

operating the neurostimulation circuitry to apply the stimulation pulse to the targeted tissue region.

24. A method according to claim 23

wherein the organizer is in the form of a daily pill case that includes one or more compartments to hold one or more disposable power sources for each day or other prescribed interval of the prescribed power source replacement regime.

25. A kit of devices to provide neurostimulation to a targeted tissue region, the kit comprising,

a stimulation electrode sized and configured to be implanted in the targeted tissue region,

a neurostimulation assembly sized and configured to be worn by a user, the neurostimulation assembly sized and configured to hold a disposable power source,

a lead to couple the stimulation electrode to the neurostimulation assembly,

a supply of power sources provided in an organizer that includes one or more disposable power sources for each day or period of the prescribed power source replacement regime, and

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