Systems for peripheral nerve stimulation

• US 10,179,238 B2
• Filed: 09/29/2017
• Issued: 01/15/2019
• 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:
  US15/721,475
• Publication Number:
  US 20180036535A1
• Time in Patent Office: 473 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. An external system for stimulating at least one nerve in a patient'"'"'s arm or wrist, the system comprising:

a pulse generator; and

a circumferential band configured to be secured to the patient'"'"'s arm or wrist and configured to be operably attached to the pulse generator, the band supporting a first and a second electrode in electrical communication with the pulse generator, the first and second electrodes being spaced on the band and configured to deliver electrical stimuli from the pulse generator to the patient to preferentially stimulate a first nerve selected from the patient'"'"'s median, radial or ulnar nerve, the first and second electrodes being arranged and configured 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 connecting the first nerve and the first electrode and a line connecting the first nerve and the second electrode, 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.

2. The system of claim 1, wherein the band supports a third electrode in electrical communication with the pulse generator, the first and third electrodes being spaced on the band so as to deliver electrical stimuli from the pulse generator to the patient to preferentially stimulate a second nerve selected from the patient'"'"'s median, radial or ulnar nerve, the first and third electrodes being arranged and configured 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 connecting the second nerve and the first electrode and a line connecting the second nerve and the third electrode, wherein the first nerve and the second nerve are different nerves.

3. The system of claim 2, wherein when the circumferential band is secured around the patient'"'"'s arm or wrist, the first electrode is positioned on a dorsal side of the patient'"'"'s arm or wrist, the second electrode is positioned on the ventral side of the patient'"'"'s arm or wrist, and the third electrode is positioned on the patient'"'"'s arm or wrist in between the first electrode and second electrode.

4. The system of claim 1, wherein the pulse generator is the only pulse generator, the system further comprising:

a switch matrix configured to switch the pulse generator between the first electrode and the second electrode.

5. The system of claim 2, further comprising a controller configured to deliver an alternating stimulation pattern from the pulse generator to the first electrode, second electrode, and third electrode.

6. The system of claim 5, wherein the stimulation pattern comprises an application of a plurality of alternating bursts of electrical stimulation delivered in a first pulse train to the first nerve selected from the patient'"'"'s median, radial or ulnar nerve, and a second pulse train delivered to a second, different nerve selected from the patient'"'"'s median, radial or ulnar nerve, wherein the first pulse train and the second pulse train are offset.

7. The system of claim 5, wherein the stimulation pattern comprises an application of a plurality of bursts of electrical stimulation, wherein each burst comprises a stimulation frequency between 50 Hz and 2,000 Hz, a pulse width between 50 microseconds and 1 millisecond, and a pulse shape selected from the group consisting of monophasic rectangular, biphasic asymmetric rectangular, and biphasic symmetric rectangular.

8. The system of claim 5, wherein the stimulation pattern comprises an application of a plurality of alternating bursts of electrical stimulation.

9. The system of claim 1, further comprising a sensor configured to measure a parameter of the patient.

10. The system of claim 9, further comprising a controller in communication with the pulse generator and the sensor.

11. The system of claim 10, wherein the controller is further programmed to adjust one or more parameters of the electrical stimuli based on the parameter of the patient.

12. The system of claim 1, wherein the band supports a third electrode in electrical communication with the pulse generator, the first and third electrodes being spaced on the band so as to deliver electrical stimuli from the pulse generator to the patient to preferentially stimulate a second nerve selected from the patient'"'"'s median, radial or ulnar nerve, the first and third electrodes being arranged and configured 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 connecting the second nerve and the first electrode and a line connecting the second nerve and the third electrode, wherein the first nerve and the second nerve are different nerves,

wherein when the circumferential band is secured around the patient'"'"'s arm or wrist, the first electrode is positioned on a dorsal side of the patient'"'"'s arm or wrist, the second electrode is positioned on the ventral side of the patient'"'"'s arm or wrist, and the third electrode is positioned on the patient'"'"'s arm or wrist in between the first electrode and second electrode,

wherein the system further comprises a switch matrix configured to switch the pulse generator between the first electrode and the second electrode,

wherein the system further comprises a controller configured to deliver an alternating stimulation pattern from the pulse generator to the first electrode, second electrode, and third electrode.

13. The external system of claim 1, wherein the one or more additional components, other than stimulation electrodes, comprise an electrically conductive wire.

14. The external system of claim 1, wherein the one or more additional components, other than stimulation electrodes, comprise a fastener.

15. The external system of claim 1, wherein the one or more additional components, other than stimulation electrodes, comprise an adjustable ring or buckle.

16. An external system for stimulating at least one nerve in an arm or wrist of a patient, the system comprising:

a pulse generator; and

an arm or wrist band configured to be operably connected to the pulse generator and securable to the patient'"'"'s arm or wrist, the band supporting a first and a second electrode in electrical communication with the pulse generator, the first and second electrodes being spaced on the band and configured to deliver electrical stimuli from the pulse generator to the patient to preferentially excite a first nerve selected from the patient'"'"'s median, radial or ulnar nerve, the first and second electrodes being arranged and configured 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 connecting the first nerve and the first electrode and a line connecting the first nerve and the second electrode, wherein the band consists of two or three stimulation electrodes one or more additional components, other than stimulation electrodes, which are operably connected to the band.

17. The system of claim 16, further comprising a housing comprising one or more depressible user input buttons, each button located on a side of the housing, and a broad bracing surface on the opposite side of the housing from each button.

18. The system of claim 17, wherein the first and second electrodes comprise hydrogels.

19. The system of claim 16, wherein the first and second electrodes comprise a conductive foam.

20. The system of claim 16, wherein the first and second electrodes comprise a conductive fabric.

21. The system of claim 16, wherein the band supports a third electrode in electrical communication with the pulse generator, the first and third electrodes being spaced on the band so as to deliver electrical stimuli from the pulse generator to the patient to preferentially excite a second nerve selected from the patient'"'"'s median, radial or ulnar nerve, the first and third electrodes being arranged and configured 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 connecting the second nerve and the first electrode and a line connecting the second nerve and the third electrode, wherein the first nerve and the second nerve are different nerves,

wherein when the band is secured around the patient'"'"'s arm or wrist, the first electrode is positioned on a dorsal side of the patient'"'"'s arm or wrist, the second electrode is positioned on the ventral side of the patient'"'"'s arm or wrist, and the third electrode is positioned on the patient'"'"'s arm or wrist in between the first electrode and second electrode,

wherein the system further comprises a switch matrix configured to switch the pulse generator between the first electrode and the second electrode,

wherein the system further comprises a controller configured to deliver an alternating stimulation pattern from the pulse generator to the first electrode, second electrode, and third electrode.

22. The external system of claim 16, wherein the system further comprises a controller configured to signal the pulse generator to deliver the electrical stimuli to preferentially excite the first nerve via the first and second electrodes to the patient.

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

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

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

26. A transcutaneous system for stimulating at least one nerve of the arm or wrist, the system comprising:

a circumferential band configured to be secured to the patient'"'"'s arm or wrist, the band supporting a first and a second electrode in electrical communication with a pulse generator configured to be operably connected to the band, the first and second electrodes being spaced apart on the band and configured to deliver electrical stimuli from the pulse generator to the patient to preferentially excite a first nerve selected from the patient'"'"'s median, radial or ulnar nerve, the first and second electrodes being arranged and configured 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 connecting the first nerve and the first electrode and a line connecting the first nerve and the second electrode, 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.

27. The system of claim 26, wherein the band supports a third electrode in electrical communication with a pulse generator, the first and third electrodes being spaced on the band so as to deliver electrical stimuli from the pulse generator to the patient to preferentially excite a second nerve selected from the patient'"'"'s median, radial or ulnar nerve, the first and third electrodes being arranged and configured 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 connecting the second nerve and the first electrode and a line connecting the second nerve and the third electrode, wherein the first nerve and the second nerve are different nerves,

wherein when the band is secured around the patient'"'"'s arm or wrist, the first electrode is positioned on a dorsal side of the patient'"'"'s arm or wrist, the second electrode is positioned on the ventral side of the patient'"'"'s arm or wrist, and the third electrode is positioned on the patient'"'"'s arm or wrist in between the first electrode and second electrode.

28. The external system of claim 26, wherein the one or more additional components, other than stimulation electrodes, comprise an electrically conductive wire.

29. The external system of claim 26, wherein the one or more additional components, other than stimulation electrodes, comprise a fastener.

30. The external system of claim 26, wherein the system further comprises a controller configured to signal the pulse generator to deliver the electrical stimuli to preferentially excite the first nerve via the first and second electrodes to the patient.