Minimally Invasive Introducer Tool for Percutaneous Electrode Implantation
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Solution Overview
Problem
Current baroreflex activation therapy implantation methods require large incisions, general anesthesia, and suturing, which are invasive and costly, and are typically performed by surgeons, limiting accessibility and efficiency.
Innovation Solution
A minimally invasive system comprising an introducer tool with a dilator and carrier portion, and a lead with an electrode structure, allowing for ultrasound-guided delivery and fixation without sutures, enabling implantation by electrophysiologists and interventional cardiologists in a standard cathlab or hybrid cathlab, reducing the need for full cut-downs and general anesthesia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used for baroreflex activation therapy implantation, then reliable electrode placement on carotid artery is achieved, but large incisions, general anesthesia, and suturing are required which increase invasiveness and procedural complexity
Solution Approach 1:
The patent introduces a self-expanding carrier device as an intermediary tool that facilitates electrode placement without requiring traditional surgical exposure. The carrier device is delivered via catheter through a small incision, expands at the implantation site to provide stable positioning, and enables secure electrode attachment to the carotid artery using simple sutures or adhesives, thereby reducing procedural complexity while maintaining placement reliability
Solution Approach 2:
The implantation system is divided into separate functional components: a deliverable catheter, a self-expanding carrier device, and the electrode array. This segmentation allows each component to be optimized for its specific function and enables stepwise deployment, reducing the complexity of the overall procedure while ensuring reliable electrode placement
2Reliability
If traditional surgical implantation methods are used, then secure electrode fixation is achieved, but large incisions and suturing increase patient risk and procedural cost
Solution Approach 1:
The self-expanding carrier device serves as a mediator that provides a stable platform for electrode fixation. The carrier expands to engage the carotid artery geometry, allowing secure electrode attachment with minimal suturing through a small incision, thereby reducing procedural risks associated with large incisions and extensive suturing
Solution Approach 2:
The carrier device is designed to self-expand upon delivery to the implantation site, preliminarily establishing a stable fixation structure before the electrode is attached. This preliminary action creates a secure foundation that simplifies subsequent electrode fixation and reduces the need for extensive surgical intervention
3Ease of operation
If minimally invasive approaches are used, then procedural simplicity and reduced invasiveness are achieved, but specialized physician expertise and controlled settings are required
Solution Approach 1:
The implantation system is designed with universal features that allow it to be operated by electrophysiologists and interventional cardiologists using techniques they already possess. The catheter-based delivery and self-expanding carrier utilize familiar interventional procedures, making the technology accessible to a broader range of physicians while maintaining implantation simplicity
Data Source
AI summary
Devices and methods of use for introduction and implantation of an electrode as part of a minimally invasive technique. A system includes an introducer tool including a dilator portion, a carrier portion and a release mechanism, the dilator portion selectively engageable with the carrier portion. The system further includes a lead including a lead body and an electrode structure, the electrode structure including an active side with an electrode disposed thereon, and an inactive side with an element disposed thereon. The introducer tool is configured to be temporarily inserted into a patient over a guidewire, and a portion of the release mechanism is selectively engageable with the element of the electrode structure to retain the electrode structure to the introducer tool.