Removable Inner Sheath for Intravascular IMD Deployment
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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 current methods for intravascular deployment of IMDs are used, then the procedure can be completed, but the procedure is invasive and carries risk of damage or improper placement
Solution Approach 1:
The delivery system is divided into multiple segments including an outer sheath, inner sheath, deployment catheter, and coupling modules. This segmentation allows each component to perform its specific function independently, enabling precise control during deployment while minimizing trauma to the vasculature through a modular, less invasive structure.
Solution Approach 2:
The patent employs a nested configuration where the deployment catheter is positioned within the inner sheath, which is itself within the outer sheath. This nested doll structure allows for compact delivery through narrow vasculature while enabling sequential deployment of components, reducing invasiveness and improving placement precision through controlled staged release.
2Object-affected harmful factors
If remote deployment techniques are implemented, then minimally invasive access is achieved, but the complexity of the delivery system increases
Solution Approach 1:
The coupling modules are designed with universal functionality to perform multiple operations: mechanical coupling between sheaths, alignment verification, and controlled release mechanisms. This multi-functionality reduces the number of separate components needed, thereby managing system complexity while enabling remote minimally invasive deployment capabilities.
Solution Approach 2:
The inner sheath acts as an intermediary component between the outer delivery system and the implantable medical device. It provides a controlled interface for device release while maintaining the nested structure, allowing remote deployment without requiring direct manipulation of the device itself, thus balancing invasiveness reduction with manageable system complexity.
3Manufacturing precision
If precise placement is achieved through multiple sheaths and coupling modules, then placement accuracy improves, but the device complexity increases
Solution Approach 1:
The coupling modules are pre-configured with alignment features and engagement mechanisms that automatically ensure proper positioning when components are assembled. This preliminary action of pre-setting alignment parameters reduces the need for complex real-time adjustments during deployment, improving placement accuracy while managing overall system complexity through intelligent pre-design.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables minimally invasive, precise, and secure deployment of IMDs within the vasculature, reducing the risk of damage and improving placement accuracy, thereby enhancing the effectiveness of medical procedures.
Implementation Method 1
The inflatable member is selectively inflatable from a proximal end of the inner sheath. The inflatable member is configured to substantially fill the inner lumen and close-off the distal opening of the outer sheath when inflated.
Data Source
AI summary
In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device, the kit comprising an outer sheath, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with a tapered distal end. The inner sheath is slidable within the inner lumen of the outer sheath and is selectably removable from the inner lumen of the outer sheath by sliding the inner sheath out of the proximal opening of the outer sheath. The kit includes an elongated deployment receptacle including a deployment bay slidable within the inner lumen of the outer sheath when the inner sheath is not within the inner lumen of the outer sheath. The deployment bay carries an implantable medical device through the inner lumen of the outer sheath and facilitates deployment of the implantable medical device from the distal end of the outer sheath.