Intravascular Implantable Medical Device Introduction Kit
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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 with various configurations, such as inflatable members, tapered ends, and deployment receptacles, to facilitate the intravascular implantation of IMDs, allowing for precise placement and secure fixation within the vasculature using expandable fixation elements and tether systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a surgical procedure is used for implantation, then the implantable medical device can be securely placed, but the procedure becomes invasive and complex
Solution Approach 1:
The delivery system is divided into separate functional components: an outer sheath for navigation, an inner sheath for device containment, and a deployment mechanism. This segmentation allows each component to perform its specific function independently, reducing overall procedural complexity while maintaining secure placement capability.
Solution Approach 2:
The inner sheath acts as an intermediary between the outer sheath and the implantable medical device. It provides a protected pathway for the device during delivery and serves as a platform for the deployment mechanism, enabling secure placement without requiring complex surgical procedures.
2Object-affected harmful factors
If a percutaneous delivery catheter is used, then the procedure becomes less invasive, but the deployment mechanism becomes more complex
Solution Approach 1:
The inner sheath is nested within the outer sheath, with the implantable medical device contained within the inner sheath. This nested configuration allows the delivery system to maintain a simple percutaneous delivery approach while incorporating a sophisticated deployment mechanism that activates only at the target site.
Solution Approach 2:
The inner sheath is pre-positioned within the outer sheath during the delivery phase, preparing the deployment mechanism in advance. This preliminary arrangement allows the deployment mechanism to be activated simply by retracting the inner sheath, avoiding the need for complex deployment procedures.
3Manufacturing precision
If the inner sheath is used to push the device through the outer sheath, then the device can be precisely placed, but the inner sheath must be precisely controlled
Solution Approach 1:
The inner sheath is designed to be self-contained with its own lumen and deployment mechanism. The deployment mechanism automatically activates when the inner sheath is retracted, eliminating the need for complex external control systems and simplifying the operator's task while maintaining precise placement.
Solution Approach 2:
The deployment mechanism replaces complex manual manipulation of the inner sheath with an automated mechanical system. When the inner sheath is retracted, the deployment mechanism automatically releases and deploys the implantable medical device, reducing the skill level required for precise control.
Data Source
AI summary
In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an inflatable member at its distal portion. The inflatable member is inflatable from a proximal end of the inner sheath to close-off the distal opening of the outer sheath when inflated. The inner sheath further includes a stopper proximally located relative to the inflatable member. The inflatable member is remotely controllable from a proximal end of the inner sheath to retract in a proximal direction towards the stopper. The inflatable member can be retracted in a proximal direction towards the stopper and past an implantable medical device positioned within a distal portion of the outer sheath.