Recapture Sheath Funnel Segment for Heart Valve Delivery
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Solution Overview
Problem
Current transcatheter heart valve delivery systems lack the capability for accurate partial deployment and recapturing of stented prosthetic heart valves, leading to potential mispositioning and complications during percutaneous implantation due to the high radial expansion force of the prosthesis and limitations in the design of existing delivery sheaths.
Innovation Solution
A delivery system comprising an inner shaft assembly, a delivery sheath capsule, and a recapture sheath with a funnel segment that includes circumferentially spaced runners and a polymer overlay, allowing for the compression and recapturing of the stented prosthetic heart valve by transitioning between a natural and expanded condition to facilitate sliding over the partially deployed prosthesis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional delivery sheath is used to deliver the stented prosthetic heart valve, then the valve can be delivered through the catheter, but the system cannot achieve accurate partial deployment and recapturing of the prosthesis
Solution Approach 1:
The delivery system is divided into multiple functional components: a delivery catheter, a recapture catheter with a recapture balloon, and a deployment balloon. This segmentation allows independent control of delivery, recapture, and deployment functions, enabling partial deployment and recapturing capabilities that conventional single-catheter systems cannot achieve.
Solution Approach 2:
The recapture balloon acts as an intermediary mechanism between the delivery catheter and the prosthetic heart valve. By inflating the recapture balloon, the system creates a recapture zone that can capture and hold the valve in a compressed state, facilitating precise recapturing and repositioning without direct manual manipulation.
2Ease of operation
If the stented prosthetic heart valve is compressed for delivery in the catheter, then it can be delivered percutaneously, but the high radial expansion force makes recapturing difficult
Solution Approach 1:
The recapture balloon is designed to be inflated beforehand to create a cushioning recapture zone. This pre-inflated balloon provides a compliant surface that can accommodate the radial expansion force of the valve during recapturing, preventing damage to both the valve and the recapture mechanism while enabling smooth recapturing operations.
Solution Approach 2:
The system utilizes pneumatic pressure through the recapture balloon and deployment balloon to achieve recapturing and deployment functions. By controlling the inflation and deflation of these balloons, the system can generate the necessary forces to compress the valve for recapturing and then expand it for deployment, overcoming the high radial expansion force through controlled pneumatic pressure rather than direct mechanical compression.
3Productivity
If the prosthesis is incorrectly positioned relative to the native annulus, then deployment can proceed, but serious complications can result including leakage and dislodgement
Solution Approach 1:
The system enables preliminary positioning and evaluation before final deployment. The valve can be partially deployed and held in position by the recapture balloon, allowing the operator to verify positioning relative to the native annulus using imaging techniques. This preliminary action allows for correction of positioning errors before the valve is fully deployed, preventing complications such as leakage and dislodgement while maintaining efficient deployment procedures.
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 precise partial deployment and recapturing of the stented prosthetic heart valve, overcoming the challenges of radial force and mispositioning, thereby improving the safety and efficacy of percutaneous heart valve implantation procedures.
Implementation Method 1
the funnel segment is transitionable from a natural condition to an expanded condition in which the funnel segment has a funnel shape with a distally increasing diameter
Implementation Method 2
the runners provide a columnar strength to the funnel segment
Implementation Method 3
the overlay is bonded to the shaft, but is not bonded to at least the distal tips
Data Source
AI summary
A delivery device for percutaneously deploying a stented prosthetic heart valve. The device includes a delivery capsule and a recapture sheath. The capsule is configured to compressively retain the prosthesis. The recapture sheath includes a funnel segment having a plurality of circumferentially spaced runners and a polymer overlay. The runners are attached to a shaft and terminate at a distal tip. The overlay surrounds the runners, and is bonded to the shaft but not to at least the tips. The funnel segment is transitionable from a normal condition to an expanded condition forming a funnel shape with a distally increasing diameter, and self-transitionable back toward the normal condition. The funnel segment facilitates sliding of the capsule over a partially deployed region of the prosthesis as part of a recapturing operation. The runners provide columnar strength, with the overlay controlling a shape of the funnel segment.