Implant Adapter for Baroreflex Mapping
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Solution Overview
Problem
Current implantable baroreflex therapy systems face challenges in performing a cost- and time-effective mapping procedure during the implantation of baroreflex activation devices, particularly due to the need for specialized equipment and the risk of infection associated with creating a pocket in the patient's chest for the implantable pulse generator.
Innovation Solution
A system and method that includes a control system within an implantable housing, an electrical lead, a monopolar electrode, and an implant adapter with a reference element, allowing for a mapping procedure to be conducted without fully implanting the housing, using a temporary reference element and adapter to determine the suitable implant location for the electrode, and then securing it before fully implanting the system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the implantable pulse generator housing is fully implanted to perform mapping procedure, then the mapping can be conducted with the actual device, but the risk of infection increases and procedure time increases
Solution Approach 1:
The system is divided into two separate components: a temporary reference element that can be implanted without the pulse generator housing, and the actual pulse generator housing. This segmentation allows the mapping procedure to be performed with only the essential reference element implanted, reducing infection risk while maintaining mapping accuracy.
Solution Approach 2:
The temporary reference element is implanted and used for mapping procedures before the actual pulse generator housing is implanted. This preliminary action allows all positioning and optimization to be completed with minimal implantation, reducing the window of vulnerability to infection.
2Measurement precision
If specialized equipment is used for mapping procedure, then mapping precision can be improved, but procedure cost increases
Solution Approach 1:
The temporary reference element serves multiple functions: it acts as a reference for mapping, provides electrical connection, and enables the use of existing pulse generator hardware for mapping procedures. This self-service approach eliminates the need for specialized mapping equipment, reducing procedure costs while maintaining precision.
3Productivity
If the electrode is positioned without preliminary mapping, then procedure time is reduced, but energy efficiency decreases
Solution Approach 1:
The mapping procedure is performed as a preliminary step using the temporary reference element before final implantation. This allows optimal electrode positioning to be established in advance, ensuring energy-efficient operation and extended battery life without compromising procedure speed.
Data Source
AI summary
Embodiments of the present invention generally pertain to devices and methods for use in conjunction with implanting a baroreflex therapy system which includes an implantable pulse generator and associated circuitry contained within a hermetically sealed housing, an elongate flexible electrical lead connectable to the housing, and a monopolar electrode structure coupled with the electrical lead. More specifically, the devices and methods of the present invention allow for a mapping procedure to be conducted as part of the implant procedure prior to fully implanting the baroreflex therapy system.