Vagus nerve stimulation pre-screening test
AssigneeSetPoint Medical Corporation
InventorsJacob A. Levine, Ralph J. Zitnik
Life of this patent
Estimating the term…
Abstract
Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.
Claims23
An in vitro method for screening a patient for responsiveness to vagus nerve stimulation to treat an inflammatory disorder, the method comprising:
- obtaining a sample of blood taken from the patient prior to stimulation of the patient's vagus nerve;
- challenging the sample of blood with a first concentration of toxin;
- obtaining a second sample of blood taken from the patient prior to stimulation of the patient's vagus nerve;
- challenging a second sample of blood with a second concentration of toxin that is at least 2 times the first concentration;
- determining an amount of inflammatory cytokine released in response to the second concentration of toxin compared to the inflammatory cytokine released in response to the first concentration of toxin;
- and
- outputting an indication that the patient is a responder or a non-responder for vagus nerve stimulation based on the amount of inflammatory cytokine released.
An in vitro method for screening a patient for responsiveness to vagus nerve stimulation, the method comprising:
- obtaining a sample of blood taken from the patient prior to stimulation of the patient's vagus nerve;
- challenging the sample of blood with LPS at a first concentration of LPS;
- measuring a level of an inflammatory cytokine that is released in response to the LPS challenge at the first concentration of LPS;
- challenging the sample of blood with LPS at a second concentration of LPS that is at least 5 times the first concentration of LPS;
- measuring a level of the inflammatory cytokine that is released in response to the LPS challenge at the second concentration of LPS;
- and
- determining a response curve based on the level of the inflammatory cytokine that is released in response to the LPS challenges at the first concentration of LPS and the second concentration of LPS;
- comparing the determined response curve to a cutoff;
- and
- determining whether the patient is suitable for vagus nerve stimulation based on the comparison of the determined response curve to the cutoff.
A method for screening a patient for responsiveness to vagus nerve stimulation, the method comprising:
- measuring a baseline level of C-reactive protein (CRP) in a sample of blood taken from the patient;
- stimulating the vagus nerve;
- measuring a post-stimulation level of CRP in a sample of blood taken after the vagus nerve has been stimulated;
- comparing the post-stimulation level of CRP to the baseline level of CRP;
- and
- indicating if the patient is a suitable candidate for an implantable vagus nerve stimulation device based on the comparison of the post-stimulation level of CRP to the baseline level of CRP.
Dependencies are inferred from the claim text.