Methods for peripheral nerve stimulation

• US 10,173,060 B2
• Filed: 09/29/2017
• Issued: 01/08/2019
• Est. Priority Date: 06/02/2014
• Status: Active Grant

• Current Assignee: Cala Health, Inc.
• Original Assignee: Cala Health, Inc.
• Inventors: Wong, Serena HanYing, Rosenbluth, Kathryn H., Hamner, Samuel, Chidester, Paula, Delp, Scott L., Sanger, Terence D., Klein, David
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/721,480
• Publication Number:
  US 20180021576A1
• Time in Patent Office: 466 Days
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0496 characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives
• CPC Class Codes: A61N 1/36 for stimulation
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A peripheral nerve stimulator can be used to stimulate a peripheral nerve to treat essential tremor, Parkinsonian tremor, and other forms of tremor. The stimulator can have electrodes that are placed circumferentially around the patient'"'"'s wrist or arm. Specific nerves in the wrist or arm can be targeted by appropriate spacing of the electrodes. Positioning the electrodes on generally opposing sides of the target nerve can result in improved stimulation of the nerve. The stimulation pattern may alternate between the nerves. Improved stimulation algorithms can incorporate tremor feedback, external data, predictive adaptation, and long-term monitoring data.

Claims

1. A transcutaneous method of stimulating at least one nerve in an arm or wrist of a patient, the method comprising:

placing a circumferential band comprising a first electrode and a second electrode around the patient'"'"'s arm or wrist, the electrodes configured to be in a configuration such that in a transverse cross-sectional plane of the arm or wrist there is a 90 degree to 180 degree angle between a line extending between a first nerve and the first electrode and a line extending between the first nerve and the second electrode, the first nerve selected from the patient'"'"'s median, radial and ulnar nerves, wherein the first and second electrodes are spaced a predetermined distance apart, wherein the band consists of two or three stimulation electrodes and one or more additional components operably connected to the band that are not stimulation electrodes; and

delivering a first electrical stimulus between the first and second electrodes to preferentially stimulate the first nerve, the first electrical stimulus generated from a pulse generator.

2. The method of claim 1, wherein the band comprises a third electrode spaced a predetermined distance apart from the first and second electrodes such that there is a 90 degree to 180 degree angle between a line extending between a second nerve and the first electrode and a line extending between the second nerve and the third electrode, the second nerve selected from the patient'"'"'s median, radial and ulnar nerves.

3. The method of claim 2, further comprising delivering a second electrical stimulus from the first electrode and the third electrode to stimulate the second nerve, the second electrical stimulus generated from the pulse generator.

4. The method of claim 2, wherein the first nerve is the median nerve and the second nerve is the radial nerve.

5. The method of claim 3, further comprising temporally offsetting the first electrical stimulus from the second electrical stimulus by a period of time.

6. The method of claim 3, wherein the first electrical stimulus and the second electrical stimulus comprise patterned stimuli.

7. The method of claim 6, wherein the first electrical stimulus and the second electrical stimulus comprise burst stimuli.

8. The method of claim 3, wherein the first electrical stimulus and the second electrical stimulus comprise waveforms with ramped amplitudes.

9. The method of claim 1, wherein the band is operatively connected to a housing enclosing a sensor, and the method further comprises measuring one or more physiologic characteristics of the patient.

10. The method of claim 9, further comprising adjusting the first electrical stimulus based upon the measured physiologic characteristic.

11. The method of claim 1, wherein the first electrical stimulus has a duration between 20 and 60 minutes.

12. The method of claim 1,

wherein the first electrical stimulus and the second electrical stimulus comprise patterned stimuli,

wherein the band comprises a third electrode spaced a predetermined distance apart from the first and second electrodes such that there is a 90 degree to 180 degree angle between a line extending between a second nerve and the first electrode and a line extending between the second nerve and the third electrode, the second nerve selected from the patient'"'"'s median, radial and ulnar nerves,

wherein the method further comprises:

delivering a second electrical stimulus from the first electrode and the third electrode to excite the second nerve, the second electrical stimulus generated from the pulse generator;

measuring one or more physiologic characteristics of the patient using a sensor;

temporally offsetting the first electrical stimulus from the second electrical stimulus by a period of time; and

adjusting the first electrical stimulus based upon the measured physiologic characteristic.

13. The method of claim 1, wherein the one or more additional components that are not stimulation electrodes comprise an electrically conductive wire.

14. The method of claim 1, wherein the one or more additional components that are not stimulation electrodes comprise a fastener.

15. The method of claim 1, wherein the one or more additional components that are not stimulation electrodes comprise an adjustable ring or buckle.

16. A transcutaneous method of stimulating at least one nerve in an arm or wrist of a patient, the method comprising:

placing a band comprising a first electrode and a second electrode around the patient'"'"'s arm or wrist in a configuration such that in a transverse cross-sectional plane of the arm or wrist there is a 90 degree to 180 degree angle between a line extending between a first nerve in the patient'"'"'s arm or wrist and the first electrode and a line extending between the first nerve and the second electrode, wherein the first and second electrodes are configured to be spaced a predetermined distance apart, wherein the band consists of two or three stimulation electrodes and one or more additional components other than stimulation electrodes which are operably connected to the band

delivering a first electrical stimulus from the first and second electrodes to excite the first nerve, the first electrical stimulus generated from the pulse generator which is operably connected to the electrodes and the band.

17. The method of claim 16,

wherein the first electrical stimulus and the second electrical stimulus comprise patterned stimuli,

wherein the band comprises a third electrode spaced a predetermined distance apart from the first and second electrodes such that there is a 90 degree to 180 degree angle between a line extending between a second nerve and the first electrode and a line extending between the second nerve and the third electrode, the second nerve selected from the patient'"'"'s median, radial and ulnar nerves,

wherein the method further comprises:

delivering a second electrical stimulus from the first electrode and the third electrode to excite the second nerve, the second electrical stimulus generated from the pulse generator;

measuring one or more physiologic characteristics of the patient using a sensor;

temporally offsetting the first electrical stimulus from the second electrical stimulus by a period of time; and

adjusting the first electrical stimulus based upon the measured physiologic characteristic.

18. The method of claim 16, wherein the band comprises a third electrode spaced a predetermined distance apart from the first and second electrodes such that there is a 90 degree to 180 degree angle between a line extending between a second nerve and the first electrode and a line extending between the second nerve and the third electrode, the second nerve selected from the patient'"'"'s median, radial and ulnar nerves.

19. The method of claim 18, wherein the first electrical stimulus and the second electrical stimulus comprise burst stimuli.

20. The method of claim 18, wherein the first electrical stimulus and the second electrical stimulus comprise waveforms with ramped amplitudes.

21. The method of claim 16, wherein delivering the first electrical stimulus from the first and second electrodes further comprises signaling the pulse generator via a controller to deliver the electrical stimuli to preferentially excite the first nerve via the first and second electrodes to the patient.

22. The method of claim 16, wherein the one or more additional components other than stimulation electrodes comprise an electrically conductive wire.

23. The method of claim 16, wherein the one or more additional components other than stimulation electrodes comprise a fastener.

24. The method of claim 16, wherein the one or more additional components other than stimulation electrodes comprise an adjustable ring or buckle.

25. A transcutaneous method of stimulating at least one nerve in the arm or wrist of a patient, the method comprising:

determining a circumference of a patient'"'"'s wrist;

providing a band and housing having a predetermined circumferential spacing for a first electrode, a second electrode, and a third electrode, wherein the predetermined circumferential spacing is based on the determined circumference of the patient'"'"'s wrist, wherein the housing encloses a pulse generator configured to be in electrical communication with the first electrode, the second electrode, and the third electrode, wherein the band and housing are configured to be positioned on the wrist such that the first electrode is positioned along the midline of the dorsal side of the arm or wrist, the second electrode is positioned approximately along the midline of the ventral side of the arm or wrist, and the third electrode is positioned in between the first electrode and second electrode, wherein the first electrode and the second electrode form a first electrode pair and the first electrode and third electrode form a second electrode pair, wherein the band consists of two or three stimulation electrodes and one or more additional components operably connected to the band that are not stimulation electrodes;

stimulating a first nerve by delivering a first electrical stimulus between the first electrode pair; and

stimulating a second nerve by delivering a second electrical stimulus between the second electrode pair.

26. The method of claim 25, further comprising:

temporally offsetting the first electrical stimulus from the second electrical stimulus by a period of time; and

adjusting the first electrical stimulus based upon a measured physiologic characteristic,

wherein the first electrical stimulus and the second electrical stimulus comprise patterned stimuli,

wherein stimulating the first nerve further comprises signaling the pulse generator via a controller to deliver the electrical stimuli to preferentially stimulate the first nerve via the first electrode pair to the patient, and

wherein stimulating the second nerve further comprises signaling the pulse generator via the controller to deliver the electrical stimuli to preferentially stimulate the second nerve via the second electrode pair to the patient.

27. The method of claim 25, wherein the one or more additional components that are not stimulation electrodes comprise an electrically conductive wire.

28. The method of claim 25, wherein the one or more additional components that are not stimulation electrodes comprise a fastener.

29. The method of claim 25, wherein the one or more additional components that are not stimulation electrodes comprise an adjustable ring or buckle.