Access Sheath With Rotating Seal For Transcatheter Valve Delivery
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Solution Overview
Problem
Existing transcatheter mitral valve implantation methods are invasive and challenging due to the need for multiple catheters and difficulties in maintaining hemostasis during the procedure.
Innovation Solution
A delivery system comprising an access sheath with an inner lumen for catheters and a handle with a seal to provide hemostatic access, along with a sheath bending component for improved maneuverability, allowing for efficient delivery of valve prostheses through interchangeable catheters and maintaining hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If multiple catheters are interchanged during the procedure, then the valve prosthesis can be delivered, but the complexity of the procedure increases and maintaining hemostasis becomes challenging
Solution Approach 1:
The access sheath is designed with a universal hub structure that can accommodate multiple catheter types through interchangeable seals. The hub receives multiple seals with different lumen configurations, allowing a single access sheath to support various catheters for different procedural stages (access, valve delivery, anchoring), thereby reducing the need for multiple dedicated catheters and simplifying the overall procedure
Solution Approach 2:
The access sheath system is segmented into modular components: the access sheath body, interchangeable seals with different lumens, and various catheters. This segmentation allows each component to be optimized for its specific function while enabling flexible reconfiguration during the procedure. The separable design permits easy exchange of seals and catheters through the same access sheath, maintaining procedural simplicity
2Reliability
If a seal is provided in the access sheath to maintain hemostasis, then bleeding is controlled, but the structure becomes more complex
Solution Approach 1:
The seal system incorporates dynamic elements including a rotatable hub that can be rotated to different positions, and a push-button mechanism that can be actuated to release the seal. This dynamic design allows the seal to be engaged and disengaged as needed, providing reliable hemostasis control while maintaining operational simplicity through intuitive mechanical controls
Solution Approach 2:
The seal mechanism is designed to be self-regulating through its mechanical design. The push-button release system allows the operator to easily open the seal when needed, and the hub's rotational positioning automatically aligns the catheter lumen with the seal opening. This self-service design reduces the need for complex control systems while maintaining reliable hemostasis
3Ease of operation
If the access sheath is made steerable, then maneuverability is improved, but the device complexity increases
Solution Approach 1:
A steerable catheter is introduced as an intermediary element that passes through the access sheath. The steerable catheter contains its own actuation mechanism (such as a wire or robotic control) that allows it to be maneuvered independently of the access sheath. This intermediary approach allows the access sheath to remain relatively simple while still achieving steerable delivery of the valve prosthesis through the controlled movement of the inner catheter
Data Source
AI summary
Delivery systems for delivering a valve prosthesis into the heart. A delivery system includes an access sheath configured to enter the patient's body and/or heart. The access sheath includes an inner lumen for accommodating one or more delivery catheters carrying one or more parts of the valve prosthesis. The access sheath may include a handle for controlling interchangeable access to the inner lumen of the access sheath. The handle may be configured to provide a hemostatic seal between an outer environment and the inner lumen of the access sheath. In some cases, a bending component is configured to bend the access sheath to facilitate entry of the access sheath into the patient's body.