Pre-loaded Stent Graft Delivery with Split Sheath Access
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Solution Overview
Problem
Existing stent graft delivery devices face challenges when dealing with branch vessels adjacent to the main artery, as they can be occluded by the stent graft, potentially causing permanent damage, and require additional side branch grafts and catheterization for access.
Innovation Solution
A pre-loaded stent graft delivery device with a guide wire catheter, handle assembly, and access sheaths with longitudinal splits, allowing for the deployment of side branch grafts through fenestrations in the main stent graft while maintaining access without occluding branch vessels, utilizing a tri-lumen catheter and sheath with splits for retraction and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stent graft is deployed in the main artery, then the aneurism or damaged portion is bridged and protected, but the branch vessels may be occluded causing permanent damage
Solution Approach 1:
The stent graft is segmented with fenestrations that allow separate access to branch vessels. The delivery device is also segmented with multiple access sheaths that can independently catheterize different branch vessels while the main stent graft protects the primary artery, thus resolving the contradiction between main artery protection and branch vessel patency
Solution Approach 2:
Access sheaths serve as intermediary devices that pass through the fenestrations of the main stent graft to reach and catheterize branch vessels. These intermediaries allow selective deployment of side branch grafts without compromising the main artery protection or causing branch vessel occlusion
2Adaptability or versatility
If fenestrations are added to the stent graft to access branch vessels, then branch vessel access is enabled, but additional side branch grafts and catheterization procedures are required
Solution Approach 1:
The invention merges the main stent graft deployment with pre-loaded access sheaths and side branch grafts into a single integrated delivery device. This combination allows simultaneous or sequential deployment of the main graft and side branch grafts through the same access points, reducing the number of separate procedures and devices needed while maintaining adaptability for branch vessel access
3Ease of operation
If multiple access sheaths are pre-loaded in the delivery device, then side branch graft deployment is facilitated, but the device structure becomes more complex
Solution Approach 1:
The delivery device employs a nested structure where access sheaths are positioned within side ports of the manifold, which itself is integrated into the handle assembly. The main stent graft and side branch grafts are nested within the delivery catheter system, allowing multiple components to be compactly arranged while maintaining ease of deployment through coordinated retraction and expansion movements
Data Source
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AI summary
Disclosed is a pre-loaded stent graft delivery device having a guide wire catheter and a handle (101) including a multi-port manifold with access ports, where an access sheath extends from each access port. A sheath (106) is disposed coaxially around the guide wire catheter and includes two splits that enable the retraction of the sheath while the access sheaths are disposed within the respective access port of the manifold. Also disclosed is a pre-loaded stent graft delivery device (100) comprising a manifold (314), three access sheaths (318,322,326), a tri-lumen catheter (319), and a sheath (306). The manifold has three access ports and a central aperture (350). The three access ports (312, 316, 320) extend distally from the central aperture (350). The tri-lumen catheter (319) extends proximally from the manifold (314) and comprises three auxiliary lumens (392, 394, 396) therethrough. Each access sheath (318, 322, 326) extends through a corresponding auxiliary lumen (392, 394, 396) within the tri-lumen catheter (319). The sheath (306) is disposed coaxially over the tri-lumen catheter (319). The sheath (306) has at least three longitudinal splits formed along a portion of the length of the sheath (306). Each split is aligned with a corresponding access sheath (318, 322, 326) such that the sheath (306) can be at least partially retracted over the access sheaths (318, 322, 326).