Baroreflex Electrode Fixation for Minimally Invasive Implantation
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Solution Overview
Problem
Current baroreflex activation therapy systems face challenges in achieving robust fixation of electrode structures during minimally invasive implant procedures, leading to potential migration and reduced therapeutic effectiveness.
Innovation Solution
The use of passive and active fixation mechanisms, including barbs, coils, hooks, and hood structures, combined with rigid electrode designs, to secure the lead and electrode in place during implantation, along with improved delivery tools for tissue dissection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If minimally invasive implant procedures are used, then patient trauma and recovery time are reduced, but electrode fixation stability deteriorates
Solution Approach 1:
The fixation elements (barbs, hooks, coils) are designed to be dynamically deployable - compressed during minimally invasive delivery through the catheter, then expanded or engaged after positioning to provide secure fixation. This allows the system to transition from a low-profile delivery state to a high-fixation-stability deployed state, resolving the contradiction between minimally invasive access and stable fixation.
2Stability of the object's composition
If fixation mechanisms like barbs and hooks are added, then electrode stability improves, but device complexity increases
Solution Approach 1:
Multiple fixation mechanisms (barbs, hooks, coils, hoods) are integrated into a single unified electrode structure rather than being separate components. This merging approach provides multi-directional fixation stability while reducing the number of separate parts and assembly steps, thereby improving stability without proportionally increasing device complexity.
Solution Approach 2:
The electrode structure incorporates multi-functional elements that serve both therapeutic and fixation purposes. For example, the electrode body itself is designed with integrated fixation features, and some structures like the hood or coil serve both as anchoring mechanisms and as part of the overall electrode assembly, reducing the need for separate dedicated fixation components.
3Reliability
If rigid electrode designs are used, then fixation reliability improves, but ease of delivery through minimally invasive access deteriorates
Solution Approach 1:
The electrode structure exhibits dynamic mechanical properties - flexible and compressible during delivery to navigate through small access sites and the catheter, then becomes rigid and stable after deployment to ensure reliable fixation. This phase transition or mechanical transformation resolves the contradiction between deliverability and fixation reliability.
Solution Approach 2:
The rigid electrode structure with fixation elements is nested within a flexible delivery catheter during the delivery phase. The catheter protects and guides the rigid electrode through the minimally invasive access site, then the electrode is deployed from the catheter where it assumes its rigid fixation configuration. This nesting approach allows rigid structures to be delivered through flexible access paths.
Data Source
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AI summary
Devices and methods of use for introduction and implantation of an electrode structure for baroreflex activation therapy, as part of a minimally invasive implant technique. An implantable baroreflex activation system includes a control system having an implantable housing, an electrical lead, attachable to the control system, and an electrode structure. One or more of the electrical lead or electrode structure may include elements to improve fixation at a target implant location. Improvements to delivery tools associated with implant are also described.