Coordinated Trigeminal and Vagal Nerve Stimulation for Hemostasis in Diverse Medical Applications
Legal Citation
Summary of the Inventive Concept
This inventive concept expands the core technology of coordinated trigeminal and vagal nerve stimulation to novel medical applications, including robotic-assisted surgery, bleeding disorders, traumatic brain injury, childbirth, and dialysis, providing a non-invasive, effective, and real-time controlled approach to reduce bleeding and improve patient outcomes.
Background and Problem Solved
The original patent disclosed methods and apparatuses for reducing bleeding via coordinated trigeminal and vagal nerve stimulation, primarily focusing on treating bleeding in a subject. However, the original patent's scope was limited to general bleeding prevention and treatment. This inventive concept addresses the need for more specialized and targeted approaches to bleeding reduction in various medical fields, where uncontrolled bleeding can lead to severe complications and even death.
Detailed Description of the Inventive Concept
The new inventive concept comprises a range of novel applications and use cases, including: (1) reducing post-operative bleeding in robotic-assisted surgery by applying coordinated trigeminal and vagal nerve stimulation during the surgical procedure; (2) controlling bleeding in patients with bleeding disorders using a wearable device and real-time bleeding metrics; (3) treating bleeding-related complications in patients with traumatic brain injury by tailoring the stimulation to the patient's specific injury and bleeding profile; (4) reducing bleeding during childbirth using a vaginal probe and adjusting the stimulation based on the patient's bleeding rate and uterine contraction patterns; and (5) reducing bleeding in patients undergoing dialysis by adjusting the stimulation based on the patient's blood flow rate and fluid removal rate. These applications leverage the core technology's ability to provide real-time controlled bleeding reduction, enhancing patient safety and outcomes in diverse medical contexts.
Novelty and Inventive Step
The new claims introduce novel and non-obvious applications of the coordinated trigeminal and vagal nerve stimulation technology, expanding its scope beyond general bleeding prevention and treatment. The inventive step lies in the specific adaptations and customizations of the technology to address distinct bleeding challenges in various medical fields, demonstrating a significant departure from the original patent's scope and limitations.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include variations in the wearable device design, electrode configurations, and stimulation protocols tailored to specific medical applications. Additionally, the technology could be integrated with other bleeding reduction methods, such as pharmacological interventions or surgical techniques, to create hybrid approaches. These variations would ensure broad conceptual coverage and flexibility in adapting the technology to diverse medical contexts.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in various medical industries, including surgical robotics, bleeding disorder management, traumatic brain injury treatment, obstetrics, and dialysis. The technology's ability to reduce bleeding and improve patient outcomes could lead to widespread adoption in hospitals, clinics, and medical centers, generating substantial revenue and market growth opportunities.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Biomedical engineering, specifically neurostimulation techniques for physiological regulation, with expertise in electrical nerve stimulation, medical device design, and hemostatic interventions
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device researcher with advanced degrees, understanding of neural stimulation principles, knowledge of nerve anatomy, and experience designing targeted electrical stimulation protocols for physiological modulation
Obviousness Rationale
The published technical disclosure represents predictable extensions of the source patent's core technology by applying coordinated trigeminal and vagal nerve stimulation to specific medical contexts. A person having ordinary skill would recognize that the fundamental nerve stimulation mechanism disclosed in US 11857788 could be systematically adapted to various bleeding scenarios by modifying electrode placement, stimulation parameters, and control algorithms. The variations demonstrate routine engineering design choices that leverage the established neurological intervention framework.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,788 |
|---|---|
| Title | Methods and apparatuses for reducing bleeding via coordinated trigeminal and vagal nerve stimulation |
| Assignee(s) | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH |