IP Library Granted Patent US 12,251,560
Granted Patent B1
US 12,251,560 · App. 16/993,085 · Granted Mar 18, 2025

Connection quality determination for wearable neurostimulation systems

Inventors: Sami Balbaky (San Jose, CA); Samuel Richard Hamner (San Francisco, CA)
Assignee: Cala Health, Inc.
A61N1/08A61N1/36142A61N1/36175A61N2001/083
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Quick Facts
Patent No.
US 12,251,560
App. No.
16/993,085
Granted
Mar 18, 2025
Kind
B1
Abstract

Systems, devices, and methods for electrically stimulating peripheral nerve(s) to treat various disorders are disclosed, as well as signal processing systems and methods for enhancing diagnostic and therapeutic protocols relating to the same.

Claims (40)

1. A wearable neurostimulation device for transcutaneously stimulating one or more peripheral nerves of a user, the device comprising:

circuitry for generating electric stimulation signals;

a plurality of electrodes configured to emit the electric stimulation signals; and

one or more hardware processors configured to:

measure a plurality of electromagnetic characteristics across at least two of the plurality of electrodes,

wherein the at least two of the plurality of electrodes comprises a first electrode and a second electrode,

wherein the plurality of electromagnetic characteristics comprises a first electromagnetic characteristic of the first electrode, and

wherein the plurality of electromagnetic characteristics comprises a second electromagnetic characteristic of the second electrode;

determine a plurality of connection quality indicators based on the first electromagnetic characteristic and the second electromagnetic characteristic, said connection quality indicators corresponding to a degree of connection between the first electrode and the second electrode with skin of the user;

maintain one or more counters for the plurality of connection quality indicators over a time window based on repeated measurements of the plurality of electromagnetic characteristics within the time window;

wherein maintaining one or more counters for the plurality of connection quality indicators comprises determining if at least one of the one or more counters crosses a threshold within the time window; and

change an operating characteristic of the wearable neurostimulation device if at least one of the one or more counters has crossed the threshold within the time window;

wherein the one or more hardware processors are capable of determining the plurality of connection quality indicators based on the plurality of electromagnetic characteristics.

2. The wearable neurostimulation device of claim 1 , wherein the one or more hardware processors are configured to reset the one or more counters after the time window has elapsed.

3. The wearable neurostimulation device of claim 1 , wherein the one or more hardware processors are configured to maintain therapy during the time window where at least one of the plurality of connection quality indicators indicate a weak connection and where at least one of the plurality of connection quality indicators has not crossed the threshold.

4. The wearable neurostimulation device of claim 1 , wherein the electromagnetic characteristic comprises impedance.

5. The wearable neurostimulation device of claim 1 , wherein the electromagnetic characteristic comprises voltage mismatch.

6. The wearable neurostimulation device of claim 1 , wherein the electromagnetic characteristic comprises a pulse shape determination.

7. The wearable neurostimulation device of claim 1 , wherein the operating characteristic includes stimulation settings.

8. The wearable neurostimulation device of claim 1 , wherein the changing the operating characteristic includes generating an alert.

9. The wearable neurostimulation device of claim 1 , wherein each of the plurality of electromagnetic characteristics is configured to enable an independent determination of the connection quality indicator independent of at least one other determination of the connection quality indicator.

10. A wearable neurostimulation device for transcutaneously stimulating one or more peripheral nerves of a user, the device comprising:

circuitry for generating electric stimulation signals;

a plurality of electrodes configured to emit the electric stimulation signals; and

one or more hardware processors configured to:

determine a first electromagnetic characteristic across a first electrode of the plurality of electrodes and a second electromagnetic characteristic across a second electrode of the plurality of electrodes;

determine a first connection quality indicator, corresponding to connection between the first electrode of the plurality of electrodes and skin of the user, based on the determined electromagnetic characteristic;

determine a second connection quality indicator, corresponding to connection between the second electrode of the plurality of electrodes and skin of the user, based on the determined electromagnetic characteristic;

maintain a first counter corresponding to the first connection quality indicator over a time window, wherein the first counter can increase or decrease during the time window based on the connection quality indicator;

maintain a second counter corresponding to the second connection quality indicator over a time window, wherein the first counter can increase or decrease during the time window based on the connection quality indicator; and

change an operating characteristic of the wearable neurostimulation device based on either the first counter or the second counter exceeding a threshold.

11. The wearable neurostimulation device of claim 10 , wherein the electromagnetic characteristic comprises impedance.

12. The wearable neurostimulation device of claim 10 , wherein electromagnetic characteristic comprises voltage mismatch.

13. The wearable neurostimulation device of claim 10 , wherein electromagnetic characteristic comprises a pulse shape determination.

14. The wearable neurostimulation device of claim 10 , wherein the operating characteristic includes stimulation settings.

15. The wearable neurostimulation device of claim 10 , wherein the changing the operating characteristic includes generating an alert.

16. The wearable neurostimulation device of claim 10 , wherein the one or more hardware processors is configured to determine a plurality of electromagnetic characteristics across the plurality of electrodes, wherein each of the plurality of electromagnetic characteristics is configured to enable an independent determination of the connection quality indicator.

17. The wearable neurostimulation device of claim 16 , wherein the one or more hardware processors is configured to determine a plurality of connection quality indicators based on the determined plurality of electromagnetic characteristics.

18. The wearable neurostimulation device of claim 17 , wherein the one or more hardware processors is configured to track the determined plurality of connection quality indicators over a time period.

19. The wearable neurostimulation device of claim 18 , wherein the operating characteristic is only changed when at least one of the determined plurality of connection quality indicators exceed a threshold over the time period.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Feb 25, 2026
From: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
To: CALA HEALTH, INC.
Reel/Frame 073890/0716 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2026
From: CALA HEALTH, INC.
To: TRINITY CAPITAL INC.
Reel/Frame 074971/0532 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 11, 2023
From: BALBAKY, SAMI; HAMNER, SAMUEL RICHARD
To: CALA HEALTH, INC.
Reel/Frame 065188/0566 →
CORRECTIVE ASSIGNMENT TO CORRECT THE THE CORRESPONDENT NAME PREVIOUSLY RECORDED AT REEL: 006005 FRAME: 0030. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 3, 2022
From: CALA HEALTH, INC.
To: CALA HEALTH, INC.
Reel/Frame 061069/0675 →
CHANGE OF ADDRESS Recorded Apr 12, 2022
From: CALA HEALTH, INC.
To: CALA HEALTH, INC.
Reel/Frame 060005/0030 →
SECURITY INTEREST Recorded Jul 15, 2021
From: CALA HEALTH, INC.
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 056862/0017 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 25, 2021
From: BALBAKY, SAMI; HAMNER, SAMUEL RICHARD
To: CALA HEALTH, INC.
Reel/Frame 056668/0955 →