Transcatheter Mitral Annuloplasty Delivery System
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Solution Overview
Problem
Current methods for treating mitral regurgitation, such as annuloplasty, often result in asymmetrical cinching and uneven force distribution when securing an implant to the valve annulus, leading to potential dislodgment of anchors and incomplete annular stabilization.
Innovation Solution
A delivery system comprising a guide catheter with multiple lumens and an anchor delivery apparatus that allows for symmetrical cinching of an implant by tensioning cinching members from both ends, ensuring secure anchoring and reshaping of the valve annulus with a fabric or wire implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional single-end cinching methods are used to secure the implant, then the delivery system is simpler, but the cinching becomes asymmetrical and force distribution is uneven
Solution Approach 1:
The delivery system is divided into separate functional components: a guide catheter for positioning, an implant catheter for delivering the implant, and an anchor delivery apparatus for securing the implant. This segmentation allows each component to perform its specific function optimally while achieving symmetrical cinching through coordinated action of multiple components
Solution Approach 2:
The implant catheter is housed within the guide catheter, and the anchor delivery apparatus is integrated into the implant catheter structure. This nested configuration allows the complex delivery system to be compact and manageable while maintaining the capability for symmetrical, controlled implant deployment and cinching
2Reliability
If anchors are secured without symmetrical cinching, then the procedure is faster, but anchor dislodgment occurs and annular stabilization is incomplete
Solution Approach 1:
The implant is pre-positioned and anchored at multiple points around the valve annulus before the cinching operation. The guide catheter is advanced to the target location, the implant is deployed and anchored at predetermined positions, and only then is the cinching operation performed to apply symmetrical force. This preliminary anchoring ensures reliability while maintaining procedural efficiency
Solution Approach 2:
The system incorporates real-time positioning and anchoring verification through the guide catheter and anchor delivery apparatus, allowing the operator to confirm proper implant placement and anchor securing before finalizing the cinching operation. This feedback mechanism ensures reliable anchor stabilization while avoiding unnecessary procedural delays
3Shape
If force is applied unevenly during implant securing, then the anchoring process is simpler, but the valve annulus is not properly reshaped
Solution Approach 1:
The system deliberately introduces asymmetry in the anchoring process by using multiple anchors positioned at different locations around the valve annulus, with the guide catheter and anchor delivery apparatus allowing for precise, non-uniform placement. This controlled asymmetry in anchor positioning enables subsequent symmetrical cinching to achieve proper valve annulus reshaping while maintaining operational simplicity
Solution Approach 2:
The delivery system allows for dynamic adjustment of anchor positioning and cinching force application. The guide catheter can be positioned at various angles, the implant can be deployed at different locations, and the cinching force can be applied progressively and symmetrically. This dynamic capability achieves proper reshaping while keeping the operation straightforward through real-time adaptability
Data Source
AI summary
Aspects of the disclosure include systems and devices for delivering an annuloplasty implant and anchor delivery apparatus to a valve annulus. The systems and devices of the disclosure are configured to dispense and secure or anchor the implant to the valve annulus. Various implants of the disclosure include one or more cinching members that can be tensioned to reshape the valve annulus. Methods of deploying the implant, securing the implant to the valve annulus and reshaping the valve annulus are also disclosed.