Enhanced Methods and Systems for Cranial Nerve Stimulation
Legal Citation
Summary of the Inventive Concept
Improved neuromodulation systems and methods for treating sleep disorders, breathing disorders, and other conditions by stimulating cranial nerves, with enhanced device fixation, real-time signal adjustment, bioactive coatings, and advanced monitoring capabilities.
Background and Problem Solved
The original patent disclosed methods for stimulating cranial nerves to treat various disorders. However, the existing approach has limitations, such as device migration, inadequate signal adjustment, and tissue inflammation. The new inventive concept addresses these limitations by introducing novel device fixation mechanisms, real-time signal adjustment, bioactive coatings, and advanced monitoring capabilities.
Detailed Description of the Inventive Concept
The enhanced system comprises a neuromodulation device housing configured for implantation in a cervical region of a patient, with a secure fixation mechanism to a digastric tendon, reducing migration or dislocation of the device housing. The system also includes a lead coated with a bioactive material that promotes neural tissue growth and reduces tissue inflammation. The method involves applying a neuromodulation signal to a cranial nerve target, with real-time adjustment based on sensed physiologic information about the patient. Additionally, a sensor is configured for implantation in a cervical region to detect changes in cranial nerve activity and transmit the information to an external controller, enabling real-time monitoring and adjustment of neuromodulation therapy. A minimally invasive surgical approach is used for device implantation, reducing patient trauma and recovery time.
Novelty and Inventive Step
The new claims introduce novel features, such as secure device fixation, real-time signal adjustment, bioactive coatings, and advanced monitoring capabilities, which are not present in the original patent. These features provide a significant improvement over the existing approach, enabling more effective and efficient treatment of sleep disorders, breathing disorders, and other conditions.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include variations in device design, such as different shapes or sizes, or alternative materials used for the bioactive coating. Additionally, the system could be adapted for use in different anatomical locations or for treating different conditions.
Potential Commercial Applications and Market
The enhanced neuromodulation system has significant commercial potential in the medical device industry, particularly in the fields of sleep medicine, respiratory medicine, and neurology. The system's advanced features and improved efficacy could lead to increased adoption and market share, with potential applications in hospitals, clinics, and private practices.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Biomedical engineering, specifically neuromodulation and implantable medical devices for neural stimulation, with expertise in cranial nerve intervention techniques and surgical implantation methods
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device specialist with advanced degrees in bioengineering, experience in neural stimulation technologies, understanding of minimally invasive surgical techniques, and knowledge of cranial nerve anatomy and physiological response mechanisms
Obviousness Rationale
A person skilled in the art would recognize that the PTD's variations represent predictable engineering improvements to the source patent's core neuromodulation approach. The disclosed enhancements like bioactive coatings, real-time signal adjustment, and improved fixation mechanisms are logical extensions of existing neural stimulation technologies that address known limitations in implantable medical devices. These modifications would be considered routine optimization strategies by a skilled practitioner seeking to improve device performance and patient outcomes.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,792 |
|---|---|
| Title | Methods for stimulation of cranial nerves |
| Assignee(s) | NuXcel2, L.L.C. |