VAGUS NERVE STIMULATION SCREENING TEST

• US 20150241447A1
• Filed: 02/24/2015
• Published: 08/27/2015
• Est. Priority Date: 11/17/2009
• Status: Active Application

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Ralph J. Zitnik
• Inventors: Zitnik, Ralph J., Levine, Jacob A.
• Application Number:
  US14/630,613
• Publication Number:
  US 20150241447A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0048 Detecting, measuring or recording by applying mechanical forces or stimuli A61B5/021, A61B5/4884 and A61B9/00 take precedence
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: G01N 2333/52 Assays involving cytokines
• CPC Class Codes: G01N 2333/525 Tumor necrosis factor [TNF]
• CPC Class Codes: G01N 2333/5412 IL-6
• CPC Class Codes: G01N 2333/545 IL-1
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 2800/7095 Inflammation
• CPC Class Codes: G01N 33/505 involving T-cells
• CPC Class Codes: G01N 33/5052 involving B-cells
• CPC Class Codes: G01N 33/6863 Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
• CPC Class Codes: G01N 33/6869 Interleukin

Abstract

A diagnostic screening test can be used to identify candidates for implantable vagus nerve stimulation devices. An analyte, such as a cytokine or inflammatory molecule, can be measured both before and after vagus nerve stimulation in order to determine the responsiveness of the patient. VNS can be delivered noninvasively or minimally invasively using short term electrical or mechanical stimulation.

Claims

1. A method for screening a patient for responsiveness to vagus nerve stimulation, the method comprising:

measuring a baseline level of an analyte;

stimulating the vagus nerve after the step of measuring the baseline level of the analyte;

measuring a post stimulation level of the analyte;

comparing the post stimulation level of the analyte to the baseline level of the analyte; and

determining whether the patient is a suitable candidate for an implantable vagus nerve stimulation device based on the step of comparing the post stimulation level of the analyte to the baseline level of the analyte.

2. The method of claim 1, wherein the step of stimulating the vagus nerve is done noninvasively.

3. The method of claim 2, wherein the step of stimulating the vagus nerve is done with transcutaneous electrical stimulation.

4. The method of claim 2, wherein the step of stimulating the vagus nerve is done with mechanical stimulation.

5. The method of claim 1, wherein the step of stimulating the vagus nerve comprises stimulating the auricular branch of the vagus nerve.

6. The method of claim 1, wherein the step of stimulating the vagus nerve comprises stimulating a cervical portion of the vagus nerve.

7. The method of claim 6, further comprising:

introducing an electrode intravascularly via percutaneous puncture; and

positioning the electrode at a cervically located blood vessel proximate the vagus nerve.

8. The method of claim 6, further comprising:

introducing an electrode into the carotid sheath; and

positioning the electrode within the carotid sheath such that the electrode is proximate the vagus nerve.

9. The method of claim 6, further comprising:

placing an electrode of a transcutaneous electrical nerve stimulation device on the patient'"'"'s skin over the cervical vagus nerve.

10. The method of claim 1, further comprising:

introducing an expandable element intravascularly;

positioning the expandable element within a cervically located blood vessel proximate the vagus nerve; and

stimulating the vagus nerve by expanding the expandable element.

11. The method of claim 1, wherein the analyte is selected from the group consisting of cytokines and inflammatory mediators.

12. The method of claim 1, wherein the step of stimulating the vagus nerve comprises stimulating a cervical portion of the vagus nerve with a noninvasive form of stimulation selected from the group consisting of transcutaneous ultrasound energy, transcutaneous magnetic energy and transcutaneous RF energy.

13. A method for screening a patient for responsiveness to vagus nerve stimulation, the method comprising:

collecting a first sample of cells from the patient;

stimulating the vagus nerve after the step of collecting the first sample of cells from the patient;

collecting a second sample of cells from the patient, the second sample collected after the step of stimulating the vagus nerve;

inducing release of an analyte from the first sample and the second sample;

comparing the release of the analyte from the first sample with the release of analyte from the second sample; and

determining whether the patient is a suitable candidate for an implantable vagus nerve stimulation device based on the step of comparing the release of the analyte from the first sample with the release of analyte from the second sample.

14. A method for screening a patient for responsiveness to vagus nerve stimulation, the method comprising:

measuring a baseline level of an analyte from a first sample obtained before vagus nerve stimulation;

measuring a post stimulation level of the analyte from a second sample obtained after vagus nerve stimulation;

comparing the post stimulation level of the analyte to the baseline level of the analyte; and

determining whether the patient is a suitable candidate for an implantable vagus nerve stimulation device based on the step of comparing the post stimulation level of the analyte to the baseline level of the analyte.

15. The method of claim 14, wherein the analyte is selected from the group consisting of cytokines and inflammatory mediators.

16. The method of claim 14, wherein the patient is a suitable candidate for the implantable vagus nerve stimulation device when the post stimulation level of the analyte shows at least a predetermined reduction to the baseline level of the analyte.

17. The method of claim 16, wherein the predetermined reduction is at least 10%.

18. The method of claim 14, wherein the patient is a suitable candidate for the implantable vagus nerve stimulation device when the post stimulation level of the analyte shows at least a predetermined increase to the baseline level of the analyte.

19. The method of claim 18, wherein the predetermined increase is at least 10%.

20. A method for screening a patient for responsiveness to vagus nerve stimulation, the method comprising:

inducing release of an analyte from a first sample and a second sample, wherein the first sample comprises cells taken from the patient before vagus nerve stimulation and the second sample comprises cells taken from the patient after vagus nerve stimulation;

comparing the release of the analyte from the first sample with the release of analyte from the second sample; and

determining whether the patient is a suitable candidate for an implantable vagus nerve stimulation device based on the step of comparing the release of the analyte from the first sample with the release of analyte from the second sample.

21. The method of claim 20, wherein the analyte is selected from the group consisting of cytokines and inflammatory mediators.

22. The method of claim 20, wherein the step of inducing release of the analyte comprises adding to the first sample and the second sample an inducing agent selected from the group consisting of bacterial lipopolysaccharide, Toll-like receptor activators, fragments of complement molecules, and activating antibodies directed against T cell or B cell surface receptors.

23. The method of claim 20, wherein the patient is a suitable candidate for the implantable vagus nerve stimulation device when the release of the analyte from the second sample shows at least a predetermined reduction to the release of the analyte from the first sample.

24. The method of claim 23, wherein the predetermined reduction is at least 10%.

25. The method of claim 20, wherein the patient is a suitable candidate for the implantable vagus nerve stimulation device when the release of the analyte from the second sample shows at least a predetermined increase to the release of the analyte from the first sample.

26. The method of claim 25, wherein the predetermined increase is at least 10%.