Branched Medical Device Introducer with Splitting Sheath
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional introducer assemblies for deploying medical devices in vessels are complex and require multiple percutaneous access points or secondary procedures for branched devices, such as stent grafts, due to the need to deploy different parts of the device into separate vessels or lumens.
Innovation Solution
An introducer assembly with a double protective sheath system and a splitting mechanism, where the distal sheath is split to expose the branch element first, allowing for the deployment of a branched medical device in a single procedure without multiple access points, using a cutting element and a drive element like a wire or string to facilitate the splitting process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional introducer assemblies are used for branched medical devices, then deployment in separate vessels requires multiple percutaneous access points, but this increases procedural complexity and patient trauma
Solution Approach 1:
The patent combines multiple sheath functions into a single integrated introducer assembly. The distal sheath and proximal sheath work together as a unified system to deploy both the main body and branch of the medical device through a single percutaneous access point, eliminating the need for separate access points and reducing procedural complexity.
Solution Approach 2:
The introducer assembly is segmented into functional zones: a distal sheath for initial device containment and a proximal sheath for controlled release. This segmentation allows the branch element to be deployed first through selective sheath retraction, followed by the main body, enabling complex branched device deployment through a single access point.
2Reliability
If multiple percutaneous access points are used for deploying branched devices, then complete device deployment is achieved, but vessel wall trauma increases
Solution Approach 1:
The patent merges multiple access points into a single percutaneous entry. The introducer assembly delivers both the main body and branch of the branched medical device through one access point, reducing the number of punctures and minimizing vessel wall trauma while ensuring complete device deployment.
3Manufacturing precision
If secondary procedures are performed for branched device deployment, then proper positioning is achieved, but procedure time increases
Solution Approach 1:
The introducer assembly is pre-configured with the branched medical device in a compressed state, with the branch element positioned within the distal sheath and the main body extending proximally. This preliminary arrangement allows both elements to be deployed simultaneously through a single procedure, achieving accurate positioning without requiring secondary procedures or extended procedure time.
4Adaptability or versatility
If complex introducer assemblies with individual elements for different device parts are used, then branched device deployment is enabled, but device complexity and procedure complexity increase
Solution Approach 1:
The introducer assembly is designed as a universal system that can deploy both the main body and branch of branched medical devices through a single integrated structure. The distal sheath and proximal sheath perform multiple functions: containing the compressed device, enabling selective branch deployment, and facilitating main body release, thereby reducing overall system complexity while maintaining versatility.
Data Source
Figure 1
Figure 2.1~2.5
Figure 3A~3C
AI summary
An introducer assembly (10) includes a distal sheath (20) and a proximal sheath (22). A splitting element (50) is located at a proximal end (38) of the distal sheath (20) and is arranged to split the distal sheath (20) in a distal direction, so as to deploy first a branch element (32) of a medical device (30) and thereafter the distal end of the medical device (30). The proximal sheath (22) can then be retracted to release the proximal end of the medical device (30). Deployment of the medical device from the branch element (32) first enables accurate positioning of the branch element (32) prior to deployment of the main body portion (40) of the medical device.