SYSTEMS AND METHODS FOR TEMPORARY, INCOMPLETE, BI-DIRECTIONAL, ADJUSTABLE ELECTRICAL NERVE BLOCK

• US 20140324129A1
• Filed: 04/30/2014
• Published: 10/30/2014
• Est. Priority Date: 04/30/2013
• Status: Abandoned Application

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Franke, Manfred, Epur, Ashritha, Kaufmann, Benjamin
• Application Number:
  US14/266,027
• Publication Number:
  US 20140324129A1
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• 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 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

One aspect of the present disclosure relates to a system that can provide an incomplete nerve block to a patient. In some instances, the incomplete nerve block can be bi-directional. In other instances, the incomplete nerve block can be adjustable. The system can include a waveform generator that can provide temporary electrical nerve conduction block to a nerve using an electrode. The electrode can include at least one contact. The temporary electrical nerve conduction block can block conduction in less than 100% of the fibers within the nerve located in close proximity to or being surrounded by the electrode. The temporary electrical nerve conduction block does not cause intentional damage to neural tissue as mode of action to achieve the incomplete nerve block. A complete recovery of nerve conduction can be expected post application of the incomplete nerve block.

Claims

1. A method for providing a bi-directional, incomplete nerve block to a patient, comprising the steps of:

providing an adjustable temporary electrical nerve conduction block to a nerve using an electrode,

wherein the temporary electrical nerve block is adjusted on demand and on the spot; and

blocking conduction in less than 100% of the fibers within the nerve located in close proximity to or being surrounded by the electrode without causing intentional damage of neural tissue as mode of action to achieve the incomplete nerve block during application of the electrical nerve conduction block,

wherein a complete recovery of nerve conduction is expected within seconds post application of the incomplete nerve block.

2. The method of claim 1, wherein the step of blocking the conduction further comprises at least one of:

blocking the conduction in large fibers within the nerve while permitting conduction in small fibers within the nerve;

blocking the conduction in small fibers within the nerve while permitting conduction in large fibers within the nerve;

blocking the conduction in efferent fibers within the nerve while permitting conduction in afferent fibers within the nerve;

blocking the conduction in afferent fibers within the nerve while permitting conduction in efferent fibers within the nerve;

blocking the conduction in sympathetic fibers within the nerve while permitting conduction in parasympathetic fibers within the nerve; and

blocking the conduction in parasympathetic fibers within the nerve while permitting conduction in sympathetic fibers within the nerve.

3. The method of claim 1, wherein the electrical signal comprises a high frequency electric alternating current (HFAC) waveform, a kilohertz HFAC (KHFAC) waveform, a charge-balanced direct current (CBDC) waveform, or a multi-phased direct current (MPDC) waveform.

4. The method of claim 1, wherein the step of blocking the conduction further comprises blocking the conduction in at least 10% and not more than 90% of the fibers within the nerve.

5. The method of claim 1, wherein the electrode comprises a plurality of contacts;

and

wherein at least one of the plurality of contacts delivers the electrical signal to a portion of the nerve to incompletely block conduction within the portion of the nerve.

6. The method of claim 5, wherein a second one of the plurality of contacts delivers a second electrical signal to a second portion of the nerve to generate action potentials in fibers within the second portion of the nerve and

wherein the second portion of the nerve at least one of overlaps the first portion of the nerve and is separate from the first portion of the nerve.

7. The method of claim 1, further comprising adjusting a parameter of the electrical signal to block conduction within a different number of fibers within the nerve.

8. The method of claim 1, wherein the step of providing the adjustable temporary electrical nerve conduction block to the nerve further comprises the steps of:

receiving, by a system comprising a processor, an input altering a parameter of an electrical signal corresponding to the electrical nerve conduction block;

altering, by the system, the parameter of the electrical signal; and

providing, by the system, the altered electrical signal to the electrode for the electrical nerve conduction block.

9. The method of claim 8, wherein the input is related to at least one of a plurality of predefined alterations of the parameter of the electrical signal.

10. The method of claim 8, further comprising the steps of:

checking, by the system, whether the input alters the electrical waveform outside of a predefined safety boundary or a predefined efficacy boundary; and

accepting the input when the input alters the electrical waveform within the predefined safety boundary and the predefined efficacy boundary;

or

rejecting the input when the input alters the electrical waveform outside of the predefined safety boundary or the predefined efficacy boundary.

11. A system that provides a bi-directional, incomplete nerve block to a patient, the system comprising:

a waveform generator configured to modulate a parameter of an electrical waveform so that the electrical waveform is configured to temporarily block conduction in less than 100% of the fibers within a portion of a nerve in close proximity to the electrode; and

an electrode, electrically coupled to the waveform generator, located in proximity to the nerve and configured to deliver the electrical conduction block waveform to the nerve via at least one contact.

12. The system of claim 11, further comprising:

a control unit communicatively coupled to the waveform generator and being configured to receive an input that modulates the parameter of the electrical waveform;

wherein the waveform generator is configured to modulate the parameter of the electrical waveform based on the input.

13. The system of claim 12, wherein at least one of an amplitude, a frequency, a polarity, a time period, and a shape of the waveform is adjusted based on the input.

14. The system of claim 12, wherein the control unit is configured to reject the input when the input modulates the parameter of the electrical waveform outside of a predefined safety boundary or predefined efficacy boundary.

15. The system of claim 11, wherein the electrical waveform comprises at least one of a HFAC waveform, a KHFAC waveform, a CBDC waveform, and a MPDC waveform.

16. The system of claim 11, wherein the waveform generator is electrically coupled to the electrode via at least one of a wire and an indirect coupling comprising at least one of capacitive coupling or inductive coupling.

17. The system of claim 11, further comprising a feedback unit configured to detect at least one of a patient physiological parameter, a patient activity, a patient position, a patient acceleration, a time of day, and a relative position of the patient'"'"'s body, and to provide an input to the waveform generator adjusting the waveform in response to the detection.

18. The system of claim 11, further comprising a signal receiver located within the patient and coupled to the waveform generator, the signal receiver configured to provide the electrical waveform to the electrode;

wherein the waveform generator is located external to the patient.

19. The system of claim 11, wherein the electrode is a nerve shaping electrode, an electrode array, a spiral electrode, a cuff electrode, a Huntington style electrode, a co-linear placed spinal cord stimulation (SCS) or deep brain stimulation (DBS) electrode, a disk electrode, an intra-muscular electrode, or an intra-fascicular electrode.

20. A neural prosthesis comprising:

an external control unit configured to receive an input from a patient, the input modulating a parameter of an electrical waveform; and

a waveform generator configured to adjust the electrical waveform based on the input and provide the adjusted electrical waveform to a nerve of a patient;

wherein the electrical waveform is configured to provide a temporary, bi-directional, incomplete nerve block to the nerve at the electrode site.

21. The neutral prosthesis of claim 20, wherein the external control unit comprises a wireless transmitter and the waveform generator includes a receiver configured to receive a first signal from the wireless transmitter or a second signal from a sensor within the body;

wherein the external control unit is configured to wirelessly communicate the input to the waveform generator.

22. The neural prosthesis of claim 20, wherein the external control unit includes at least one predefined setting for the incomplete nerve block;

wherein the at least one predefined setting is stored in a memory of the external controller.

23. The neural prosthesis of claim 20, wherein the external controller comprises an external magnet and the input is a swipe of the magnet over the implanted waveform generator.

24. The neural prosthesis of claim 20, wherein the external control unit is configured to produce the input based on an activity level of the patient determined from an electroencephalogram (EEG), an electromyogram (EMG), an electrocardiogram (ECG), a breathing change, a pO₂ change, a pCO₂ change, an accelerometer measurement, a blood sugar change, a temperature change of the patient, or a specific time during the day/night cycle.

25. The neural prosthesis of claim 20, wherein the external control unit provides power to the waveform generator;

wherein power is not stored within the waveform generator; and

wherein the waveform generator is implanted within the patient.