IP Library Granted Patent US 11,857,778
Granted Patent B2
US 11,857,778 · App. 16/962,810 · Granted Jan 2, 2024

Systems and methods for treating inflammatory bowel disease through peripheral nerve stimulation

Inventors: Samuel Richard Hamner (San Francisco, CA); Erika Kristine Ross (San Mateo, CA); Kathryn H. Rosenbluth (San Francisco, CA)
Assignee: Cala Health, Inc.
A61N1/0456A61N1/323A61N1/36007A61N1/36031A61N1/36034A61N1/36036
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Quick Facts
Patent No.
US 11,857,778
App. No.
16/962,810
Granted
Jan 2, 2024
Kind
B2
Abstract

Systems and methods for treating symptoms of an inflammatory gastrointestinal disease in a patient with transcutaneous stimulation of a peripheral nerve are disclosed. The method can include any number of positioning a first peripheral nerve effector on the patient's skin to stimulate the peripheral nerve of the patient, delivering a first electrical nerve stimulation signal transcutaneously to the peripheral nerve through the first peripheral nerve effector, and modifying at least one brain or spinal cord autonomic feedback loop relating to release of neurotransmitters from the autonomic nervous system that modulate synthesis of inflammatory biomarkers and reduce inflammation relating to the inflammatory gastrointestinal disease.

Claims (43)

1. A method for treating symptoms of an inflammatory gastrointestinal disease in a patient with transcutaneous stimulation of a peripheral nerve comprising:

positioning a first peripheral nerve effector on the patient's skin to stimulate the peripheral nerve of the patient;

delivering a first electrical nerve stimulation signal transcutaneously to the peripheral nerve through the first peripheral nerve effector;

receiving an input relating to activation of the first peripheral nerve;

calculating one or more features from the input relating to activation at least based in part on a nerve conduction velocity of the first peripheral nerve;

adjusting an electrical stimulation parameter based on one or more features of the nerve conduction velocity of the first peripheral nerve to selectively activate a first preselected nerve fiber type; and

delivering the adjusted electrical stimulation pattern via an electrical nerve stimulation signal through the first peripheral nerve effector to affect at least one brain or spinal cord autonomic feedback loop relating to release of neurotransmitters from an autonomic nervous system that modulate synthesis of inflammatory biomarkers and reduce inflammation relating to the inflammatory gastrointestinal disease.

2. The method of claim 1 , further comprising:

positioning a second peripheral nerve effector on the patient's skin to stimulate a second peripheral nerve of the patient;

delivering a second electrical nerve stimulation signal transcutaneously to a second peripheral nerve through the second peripheral nerve effector;

adjusting an electrical stimulation parameter based on one or more features of a nerve conduction velocity of the second peripheral nerve to selectively activate a second preselected nerve fiber type; and

modifying at least one brain or spinal cord autonomic feedback loop relating to release of neurotransmitters from the autonomic nervous system that modulate synthesis of inflammatory biomarkers and reduce inflammation relating to the inflammatory gastrointestinal disease.

3. The method of claim 1 , wherein the preselected nerve fiber type is selected from the group consisting of: A-alpha, A-beta, A-delta, A-gamma, and B fibers.

4. The method of claim 1 , wherein adjusting the electrical stimulation parameter comprises adjusting at least one of a pulse width or a pulse duration of the electrical stimulation to within about 10% of a chronaxie of the first preselected nerve fiber type.

5. The method of claim 1 , wherein adjusting the electrical stimulation parameter comprises adjusting at least one of a pulse width or a pulse duration of the electrical stimulation to within about 5% of a chronaxie of the first preselected nerve fiber type.

6. The method of claim 1 , wherein adjusting the electrical stimulation parameter comprises adjusting at least one of a pulse width or a pulse duration of the electrical stimulation to about a chronaxie of the first preselected nerve fiber type.

7. The method of claim 1 , wherein the nerve conduction velocity is measured orthodromic ally.

8. The method of claim 1 , wherein the nerve conduction velocity is measured antidromic ally.

9. The method of claim 2 , wherein the first peripheral nerve and the second peripheral nerve do not directly innervate abdominal organs.

10. The method of claim 2 , wherein the first peripheral nerve and the second peripheral nerve are not within an abdomen.

11. The method of claim 2 , wherein the first peripheral nerve and the second peripheral nerve are not a cervical branch of a vagus nerve.

12. A wearable device for treating symptoms of an inflammatory gastrointestinal disease in a patient with transcutaneous stimulation of one or more peripheral nerves comprising:

a controller;

a first peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned on the skin to stimulate a first peripheral nerve of the patient;

a first sensor or data input source, comprising at least one sensing electrode configured to be positioned on the skin to measure activity of the first peripheral nerve;

wherein the controller comprises a processor and a memory for receiving feedback information from one or more sensors that, when executed by the processor, cause the device to:

calculate one or more features of nerve conduction velocity of the first peripheral nerve based at least in part on the feedback information of the first sensor;

adjust one or more parameters of a first electrical stimulus based at least in part one or more features of nerve conduction velocity to selectively activate or maximize activation of a preselected fiber type in the first peripheral nerve; and

deliver a first electrical stimulus to a first peripheral nerve through the first peripheral nerve effector to modify at least one brain or spinal cord autonomic feedback loop relating to release of neurotransmitters from an autonomic nervous system that modulate synthesis of inflammatory biomarkers and reduce inflammation relating to the inflammatory gastrointestinal disease.

13. The device of claim 12 , further comprising:

a second peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned on the skin to stimulate a second peripheral nerve of the patient;

a second sensor or data input source, comprising at least one sensing electrode configured to be positioned on the skin to measure activity of the second peripheral nerve;

wherein the controller comprises a processor and a memory for receiving the feedback information from one or more sensors that, when executed by the processor, cause the device to:

calculate one or more features of nerve conduction velocity of the second peripheral nerve based at least in part on the feedback information of the second sensor;

adjust one or more parameters of a second electrical stimulus based at least in part one or more features of nerve conduction velocity to selectively activate or maximize activation of a preselected fiber type in the second peripheral nerve; and

deliver a second electrical stimulus to a second peripheral nerve through the second peripheral nerve effector to modify at least one brain or spinal cord autonomic feedback loop relating to release of neurotransmitters from the autonomic nervous system that modulate synthesis of inflammatory biomarkers and reduce inflammation relating to the inflammatory gastrointestinal disease.

14. The device of claim 12 , wherein the preselected nerve fiber type is selected from the group consisting of: A-alpha, A-beta, A-delta, A-gamma, and B fibers.

15. The device of claim 12 , wherein the controller is configured adjust at least one of a pulse width or a pulse duration of the electrical stimulation to within about 10% of a chronaxie of the first preselected nerve fiber type.

16. The device of claim 12 , wherein the controller is configured adjust at least one of a pulse width or a pulse duration of the electrical stimulation to within about 10% of a chronaxie of the first preselected nerve fiber type.

17. The device of claim 12 , wherein the controller is configured adjust at least one of a pulse width or a pulse duration of the electrical stimulation to about a chronaxie of the first preselected nerve fiber type.

18. The device of claim 12 , wherein the device is configured such that the first peripheral nerve and the second peripheral nerve do not directly innervate abdominal organs.

19. The device of claim 12 , wherein the device is configured such that, wherein the first peripheral nerve and the second peripheral nerve are not within the abdomen.

20. The device of claim 12 , wherein the device is configured such that the first peripheral nerve and the second peripheral nerve are not a cervical branch of a vagus nerve.

Assignments (6)
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 29, 2024
From: HAMNER, SAMUEL RICHARD; ROSS, ERIKA KRISTINE; ROSENBLUTH, KATHRYN H.
To: CALA HEALTH, INC.
Reel/Frame 069063/0517 →
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 →
Cited By (8)
US 12,357,824 US 12,408,974 US 12,420,082 US 12,453,853 US 12,478,806 US 12,539,167 US 12,575,780 US 12,629,522