Heart Valve Prosthesis Delivery With Split Sheaths for Precise Placement
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Solution Overview
Problem
Conventional heart valve replacement surgeries are invasive and require lengthy recovery periods, while transcatheter approaches face challenges such as vessel damage, imprecise positioning, and complications like vascular damage and paravalvular leakage.
Innovation Solution
A delivery device with a reduced passing profile, allowing for transcatheter implantation of heart valve prostheses through a transvascular approach, featuring a two-part distal carrier assembly and tethering component to facilitate precise positioning and anchoring, minimizing vessel trauma and complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-heart surgery is used for valve replacement, then the valve can be replaced effectively, but the surgery is highly invasive and requires lengthy recovery
Solution Approach 1:
The delivery device is divided into multiple components including a catheter, delivery sheath, expansion balloon, and valve holder that can be separated and advanced independently through the vasculature to the heart valve location
Solution Approach 2:
The valve prosthesis is nested within the delivery device components in a compressed state, allowing it to pass through the catheter and sheath, then expand at the target location to replace the defective valve
2Object-affected harmful factors
If transcatheter approach is used for valve implantation, then invasiveness is reduced, but positioning precision and vessel damage risks increase
Solution Approach 1:
The delivery device incorporates radiopaque markers and imaging guidance capabilities that provide real-time feedback to the operator, enabling precise positioning of the valve prosthesis at the target location through fluoroscopic or echocardiographic guidance
Solution Approach 2:
The valve prosthesis is pre-mounted in the compressed state within the delivery device before the procedure, and the delivery system is pre-positioned in the vasculature, allowing for controlled deployment at the precise target location without manual manipulation during implantation
3Ease of operation
If the delivery device components are advanced separately, then maneuverability through tortuous vessels is improved, but device complexity increases
Solution Approach 1:
The delivery device is segmented into a catheter, delivery sheath, expansion balloon, and valve holder that can be advanced separately through the vasculature, with each component designed to navigate tortuous anatomy independently before assembling at the target site
Solution Approach 2:
The delivery device incorporates flexible, dynamically adaptable components including a compliant catheter and expandable sheath that can adjust to the geometry of the vasculature, allowing smooth navigation through tortuous vessels while maintaining structural integrity
Data Source
AI summary
A prosthetic heart valve prosthesis can be delivered to a patient's native valve sinus via a delivery system. The system includes a grasper component that engages a sinus locator of the prosthesis and proximal and distal sheaths that carry the mesh frame of the prosthesis. The proximal and distal sheaths can each hold at least a portion of the mesh frame. In a delivery configuration, the proximal and distal sheaths can be separated by a longitudinal gap that exposes a medial section of the mesh frame. The system can be actuated to expand the mesh frame within the sinus locator to sandwich native valve leaflets therebetween and thereafter disengage the grasper component from the sinus locator.