Neuro-Adaptive Implantable Cardioverter-Defibrillator (ICD) System
Legal Citation
Summary of the Inventive Concept
A next-generation ICD system that leverages neural interfaces, machine learning, and wearable technology to provide personalized, adaptive, and minimally invasive cardioverter-defibrillator therapy.
Background and Problem Solved
The original patent disclosed an implantable cardioverter-defibrillator (ICD) system with a substernal pacing lead. However, this system has limitations, including the need for invasive surgical procedures, limited adaptability to individual patient needs, and suboptimal power management. The new inventive concept addresses these limitations by introducing a neuro-adaptive ICD system that integrates neural interfaces, machine learning, and wearable technology to provide more effective, comfortable, and personalized therapy.
Detailed Description of the Inventive Concept
The neuro-adaptive ICD system comprises a wearable ICD device, a defibrillation lead with a proximal portion coupled to the wearable ICD device and a distal portion having a defibrillation electrode, and a power management system for optimizing power consumption and extending battery life. The system also includes a neural interface for detecting cardiac neural signals and adapting therapy accordingly, and a machine learning module for analyzing patient-specific data and predicting optimal therapy parameters. The wearable ICD device can be modular, with interchangeable therapy modules for providing different therapy modalities, and wirelessly communicate with a patient's electronic health record.
Novelty and Inventive Step
The new claims introduce a paradigm shift in ICD technology by incorporating neural interfaces, machine learning, and wearable technology to provide personalized, adaptive, and minimally invasive cardioverter-defibrillator therapy. This represents a significant departure from the original patent's limitations and provides a more effective, comfortable, and patient-centric solution.
Alternative Embodiments and Variations
Alternative embodiments of the neuro-adaptive ICD system could include different neural interface configurations, such as implantable or external sensors, and varying levels of machine learning complexity. The system could also be adapted for use in other medical applications, such as cardiac resynchronization therapy or atrial fibrillation treatment.
Potential Commercial Applications and Market
The neuro-adaptive ICD system has significant commercial potential in the cardiac rhythm management market, with potential applications in hospitals, clinics, and home healthcare settings. The system's wearable and modular design could also expand the market to include patients who were previously ineligible for ICD therapy due to surgical risks or other contraindications.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical Device Technology, specifically Implantable Cardiac Rhythm Management Devices, requiring advanced electrical engineering, biomedical engineering, and medical device design expertise with knowledge of cardiac electrophysiology and implantable electronic systems
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device designer with advanced degree, 5-10 years experience in cardiac rhythm management technologies, familiar with implantable cardioverter-defibrillator design, neural signal processing, and emerging medical technology integration strategies
Obviousness Rationale
A PHOSITA would recognize that the PTD represents a predictable evolution of ICD technology by integrating emerging technologies like machine learning and neural interfaces into an existing subcutaneous ICD framework. The core functional elements of the source patent remain consistent, with the PTD introducing incremental technological enhancements that would be considered obvious extensions of known medical device design principles. The variations represent logical technological progressions using standard engineering design methodologies.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,779 |
|---|---|
| Title | Implantable cardioverter-defibrillator (ICD) system including substernal pacing lead |
| Assignee(s) | Medtronic, Inc. |