Intravascular Implantable Medical Device Deployment Sheath System
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Solution Overview
Problem
Current methods for the intravascular deployment of implantable medical devices (IMDs) are invasive and lack efficient techniques for remote deployment, particularly in accessing and securing devices within the vasculature without causing damage or improper placement.
Innovation Solution
The use of a kit and method involving an elongated outer sheath and inner sheath system, with various configurations such as inflatable members, tapered ends, and deployment receptacles, to facilitate the precise placement and deployment of IMDs within the vasculature, including expandable fixation elements and tether systems for secure positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical procedures are used for implantation of IMDs, then secure placement and reliability are improved, but patient trauma and procedure invasiveness worsen
Solution Approach 1:
The implantation system is divided into separate components: an outer sheath for navigation, an inner sheath for device delivery, and a deployment mechanism. This segmentation allows the outer sheath to be withdrawn first, followed by controlled deployment of the IMD from the inner sheath, achieving secure placement without requiring open surgical procedures.
Solution Approach 2:
The sheath system acts as an intermediary tool that enables minimally invasive delivery of the IMD. The sheaths provide a protected pathway through the vasculature, allowing the IMD to be delivered and deployed remotely without direct surgical access to the implantation site.
2Object-affected harmful factors
If remote deployment techniques are used, then patient trauma is reduced, but deployment precision and control worsen
Solution Approach 1:
The inner sheath is nested within the outer sheath, with the IMD contained within the inner sheath. This nested configuration allows both sheaths to be navigated to the target site together, then the outer sheath is withdrawn while the inner sheath remains in place, providing a stable platform for precise remote deployment of the IMD.
Solution Approach 2:
The sheaths are pre-positioned and navigated to the target site before IMD deployment. The coupling modules are pre-assembled to ensure proper alignment, and the IMD is pre-loaded into the inner sheath. This preliminary preparation enables precise deployment when the outer sheath is withdrawn and the deployment mechanism is activated.
3Ease of operation
If coupling modules are used to connect sheaths, then assembly ease is improved, but device complexity worsens
Solution Approach 1:
The coupling modules enable dynamic assembly and disassembly of the sheath system. The first coupling module on the inner sheath can be connected to and disconnected from the mating coupling module on the outer sheath, allowing the system to be assembled for delivery and disassembled for device retrieval or replacement, balancing ease of operation with manageable complexity.
Data Source
AI summary
In one example, this disclosure is directed to a method for intravascular implantation of an implantable medical device comprising positioning a distal end of an elongated outer sheath forming an inner lumen adjacent a target site within a vasculature of a patient, and partially deploying an implantable medical device from the distal opening, wherein the implantable medical device includes an expandable fixation element. A portion of the expandable fixation element assumes an expanded position when the implantable medical device is partially deployed from the distal opening. The method including advancing the distal end of the outer sheath within the vasculature with the implantable medical device partially deployed from the distal opening, and monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection to determine when the size of the portion of the expandable fixation element corresponds to the size of the vasculature.