Pivotable Baroreflex Electrode Placement Through Minimal Incisions
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Solution Overview
Problem
Existing baroreflex activation therapy procedures face challenges in efficiently positioning electrodes on the carotid sinus due to the need for precise alignment and frequent repositioning, which increases procedure time and requires large incisions, affecting battery life and patient comfort.
Innovation Solution
A minimally invasive electrode design with a monopolar electrode and a backing material, featuring a releasable pivotable interface, allows for precise positioning on a blood vessel surface using an implant tool, enabling efficient energy delivery and secure fixation with minimal incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional electrode positioning methods are used, then precise alignment can be achieved, but procedure time increases and requires large incisions
Solution Approach 1:
The electrode assembly is divided into separate components: a body portion and a distinct positioning mechanism. The body portion contains the electrode elements while the positioning mechanism includes features like a tail portion with engagement structures that can be independently manipulated during insertion and positioning operations.
Solution Approach 2:
The electrode assembly incorporates movable and adjustable components including a pivotable interface for repositioning, a tail portion that can be manipulated to engage with tissue, and a body portion that can be rotated or adjusted. These dynamic features allow the electrode to be positioned precisely and then secured in place, reducing the need for prolonged manipulation during the procedure.
2Measurement precision
If frequent repositioning is performed to achieve precise alignment, then electrode positioning accuracy improves, but procedure time increases
Solution Approach 1:
The electrode assembly is designed with pre-configured positioning features that are activated during insertion. The tail portion and engagement structures are prepared in advance to facilitate accurate positioning in a single operation, eliminating the need for frequent repositioning and adjustment during the procedure.
Solution Approach 2:
The patent replaces complex mechanical adjustment mechanisms with a simplified pivotable interface and engagement system. The electrode assembly uses a pivot joint and engagement features that allow for precise positioning through a single manipulation rather than multiple adjustment cycles, improving procedure efficiency.
3Ease of operation
If large incisions are made to accommodate electrode positioning, then electrode placement is facilitated, but patient comfort and aesthetic outcomes deteriorate
Solution Approach 1:
The electrode assembly features a nested configuration where the body portion can be inserted through a small incision while containing the electrode elements within its structure. The tail portion and engagement features are integrated within the body portion, allowing the entire assembly to be placed through a minimally invasive approach without requiring large incisions.
Solution Approach 2:
The electrode assembly incorporates a flexible body portion that can be maneuvered through a small incision and positioned against the target tissue. The flexible design allows the electrode to be inserted and adjusted through minimal tissue disruption, maintaining patient comfort and aesthetic outcomes while facilitating easy placement.
Data Source
AI summary
Devices and methods of use for introduction and implantation of an electrode as part of a minimally invasive 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. The electrode structure is near one end of the electrical lead, and includes a monopolar electrode, a backing material having an effective surface area larger than the electrode, and a releasable pivotable interface to mate with an implant tool. The electrode is configured for implantation on an outer surface of a blood vessel and the control system is programmed to deliver a baroreflex therapy via the monopolar electrode to a baroreceptor within a wall of the blood vessel.


