Personalized Peripheral Nerve Stimulation for Inflammatory Bowel Disease
Legal Citation
Summary of the Inventive Concept
A novel system and method for treating inflammatory bowel disease through personalized peripheral nerve stimulation, leveraging individual autonomic tone and inflammatory response profiles, real-time monitoring, and customized electrical stimulation signals.
Background and Problem Solved
The original patent disclosed systems and methods for treating inflammatory bowel disease through peripheral nerve stimulation. However, it had limitations in terms of individualized treatment and real-time adjustments. The new inventive concept addresses these limitations by incorporating patient-specific profiles, real-time monitoring, and customized electrical stimulation signals to provide more effective and efficient treatment.
Detailed Description of the Inventive Concept
The novel system comprises a stimulation device configured to deliver a customized electrical nerve stimulation signal to a specific peripheral nerve of a patient. The signal is based on the patient's individual autonomic tone and inflammatory response profile, which is monitored in real-time. The system can adjust the electrical stimulation parameters in response to changes in the patient's autonomic tone and inflammatory response profile. Additionally, the system can incorporate data from a patient's gut microbiome to further optimize the treatment. The method involves monitoring the patient's autonomic tone and inflammatory response profile, and adjusting the electrical stimulation parameters accordingly. The system can also access a database of patient profiles and corresponding optimal electrical stimulation parameters to provide personalized treatment.
Novelty and Inventive Step
The new claims introduce the concept of personalized peripheral nerve stimulation, which is novel and non-obvious compared to the original patent. The use of individual autonomic tone and inflammatory response profiles, real-time monitoring, and customized electrical stimulation signals provides a significant improvement over existing treatments.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different types of sensors to monitor the patient's autonomic tone and inflammatory response profile, such as heart rate variability sensors or cytokine level sensors. The system could also be adapted for use in treating other inflammatory diseases, such as rheumatoid arthritis or lupus.
Potential Commercial Applications and Market
The novel system and method have significant commercial potential in the treatment of inflammatory bowel disease, with an estimated market size of over $10 billion. The personalized approach could also be applied to other inflammatory diseases, expanding the market potential further.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Biomedical engineering, specifically neuromodulation and peripheral nerve stimulation for treating inflammatory diseases, requiring advanced knowledge of electrical stimulation parameters, neurophysiology, and medical device design
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device researcher with expertise in neurostimulation techniques, electrical signal design, and understanding of autonomic nervous system interactions with inflammatory responses
Obviousness Rationale
A person having ordinary skill in the art would recognize that personalizing nerve stimulation parameters based on individual patient physiological markers is a natural extension of existing peripheral nerve stimulation techniques. The source patent establishes foundational nerve stimulation methodology, while the PTD introduces predictable refinements in signal customization and real-time monitoring. These variations represent incremental improvements using standard engineering design approaches and known principles of personalized medical interventions.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,778 |
|---|---|
| Title | Systems and methods for treating inflammatory bowel disease through peripheral nerve stimulation |
| Assignee(s) | Cala Health, Inc. |