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Publication Number
US-11173307-B2
Publication Date
2021-11-16
Expiration Date
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.
Core Innovation
The invention concerns pre-implantation assessment for vagus nerve stimulation (VNS) in patients with inflammatory disorders. It uses the relationship between toxin-associated inflammatory cytokine responses in patient blood to inform whether VNS implantation is appropriate. The supplied content identifies lipopolysaccharide as a toxin example and describes dose-response analysis as a basis for classifying likely responders and non-responders.
The supplied content does not include the patent's background section, so the problem stated there is not explicitly described. It reports that slope analysis distinguished four of five non-responders in a study, and that the screening result can guide implantation. The content also refers to candidate mechanical, transcutaneous electrical, and minimally invasive stimulators, and to observations involving C-reactive protein, immune cells, and IL-7.
Claims Coverage
The supplied relevant claim identifies one independent claim with two inventive features. Its coverage links a comparative inflammatory-cytokine response in pre-implantation patient blood to treatment of an inflammatory disorder with VNS.
Comparative cytokine-response assessment
The claim assesses inflammatory cytokine responses associated with different toxin concentrations in patient blood collected before VNS implantation. Further procedural detail is omitted.
Response-based VNS implantation
The claim provides for VNS implantation when the cytokine response associated with the higher toxin concentration exceeds the response associated with the lower concentration by a threshold.
The independent claim covers pre-implantation comparison of toxin-associated cytokine responses and uses the comparison to determine whether VNS is used to treat the patient's inflammatory disorder.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Use of vagus nerve stimulation to treat a patient having an inflammatory disorder, with pre-implantation blood screening used to inform the implantation decision.
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