IP Library Granted Patent US 10,695,569
Granted Patent B2
US 10,695,569 · App. 15/411,933 · Granted Jun 30, 2020

Control of vagal stimulation

Inventors: Jacob A. Levine (West Hempstead, NY); Michael A. Faltys (Valencia, CA); Jesse M. Simon (Los Angeles, CA)
Assignee: SetPoint Medical Corporation
A61N1/36135A61B5/02405A61B5/0456A61B5/4035A61B5/4836A61B5/7257A61N1/3606A61N1/36053A61N1/3756A61N1/37205A61N1/0556A61N1/3787A61N1/37247
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Quick Facts
Patent No.
US 10,695,569
App. No.
15/411,933
Granted
Jun 30, 2020
Kind
B2
Abstract

Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.

Claims (23)

1. A method for treating inflammation in a subject, the method comprising:

measuring a first level of memory T regulatory cells in the subject;

applying a first stimulation to the subject's vagus nerve;

measuring a second level of memory T regulatory cells in the subject after the first stimulation; and

applying a second stimulation to the subject's vagus nerve based on the first and second levels of memory T regulatory cells measured.

2. The method of claim 1 , further comprising comparing the first level of memory T regulatory cells to the second level of memory T regulatory cells.

3. The method of claim 1 , wherein the second stimulation is greater than the first stimulation by at least a predetermined amount in one or more of: the frequency of stimulation, the duration of stimulation, the burst duration, the amplitude of electrical stimulation, and the peak-to-peak voltage of the stimulation.

4. The method of claim 1 , wherein the second stimulation is less than the first stimulation by at least a predetermined amount in one or more of: the frequency of stimulation, the duration of stimulation, the burst duration, the amplitude of electrical stimulation, and the peak-to-peak voltage of the stimulation.

5. The method of claim 3 , wherein the predetermined amount is 10 percent.

6. The method of claim 4 , wherein the predetermined amount is 10 percent.

7. The method of claim 1 , wherein applying the second stimulation to the subject's vagus nerve comprises applying electrical stimulation from an implanted microstimulator.

8. The method of claim 1 , wherein applying the first stimulation to the subject's vagus nerve comprises applying a non-invasive stimulation to the subject's vagus nerve.

9. The method of claim 1 , wherein measuring a first level of memory T regulatory cells comprises determining a level of CD4+CD25+CD127LowCD45RO+ cells in a sample of blood from the subject.

10. The method of claim 1 , wherein measuring a first level of memory T regulatory cells comprises determining a level of expression of FOXP3 in a sample of blood from the subject.

11. The method of claim 1 , wherein applying the first stimulation to the subject's vagus nerve comprises applying a minimally-invasive stimulation to the subject's vagus nerve.

12. The method of claim 11 , wherein the minimally-invasive stimulation comprises stimulation from a needle electrode.

13. A method of setting a dosage level for electrically stimulating a subject's vagus nerve for treating inflammation, the method comprising:

measuring a baseline level of memory T regulatory cells in a sample of the subject's blood;

applying a first stimulation to the subject's vagus nerve;

measuring a post-stimulation level of memory T regulatory cells in a sample of the patient's blood taken after applying the first stimulation to the subject's vagus nerve;

comparing the baseline level of memory T regulatory cells to the post-stimulation level;

adjusting at least one parameter of the first stimulation based on the baseline level of memory T regulatory cells and the post-stimulation level of memory T regulatory cells; and

applying a second stimulation to the subject's vagus nerve using the adjusted at least one parameter.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2017
From: LEVINE, JACOB A.; FALTYS, MICHAEL A.; SIMON, JESSE M.
To: SETPOINT MEDICAL CORPORATION
Reel/Frame 041950/0511 →
Continuity (5)
Provisional Application 62281135 · Jan 20, 2016
Provisional Application 62286950 · Jan 25, 2016
Provisional Application 62286957 · Jan 25, 2016
Provisional Application 62340950 · May 24, 2016
Related Publication 20170203103A1 · Jul 20, 2017
Cited By (12)
US 12,220,579 US 12,290,695 US 12,296,169 US 12,343,535 US 12,383,741 US 12,402,826 US 12,444,497 US 12,465,768 US 12,472,368 US 12,533,531 US 12,582,819 US 12,649,059