Helical Guide Prosthesis for Controlled Transcatheter Delivery
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Solution Overview
Problem
Existing transcatheter delivery systems for prosthetic heart valves face challenges such as large delivery profiles, limited device tracking, and uncontrolled deployment, which can complicate the minimally invasive implantation of prosthetic heart valves.
Innovation Solution
The system employs a prosthesis with a stent frame and a helical track formed by guides, which is used in conjunction with a delivery device featuring a helical elongated member. This configuration allows for a reduced delivery profile, improved tracking, and controlled deployment of the prosthetic heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional transcatheter delivery system is used, then the prosthetic heart valve can be delivered, but the delivery profile is large which complicates minimally invasive implantation
Solution Approach 1:
The prosthesis is nested within a delivery catheter in a compressed state, with the stent frame crimped around a balloon portion and the valve structure contained within the stent frame. This nesting allows the large prosthesis to be delivered through a small catheter profile, enabling minimally invasive implantation through peripheral vessels.
Solution Approach 2:
The delivery system transitions from a compressed delivery state to an expanded deployed state. The stent frame is compressed during delivery and then expanded upon deployment at the target site, allowing the prosthesis to achieve its functional size only when needed, thereby reducing the delivery profile while maintaining the ability to provide a large valve at the implantation site.
2Measurement precision
If a conventional delivery system is used, then the prosthesis can be delivered, but device tracking is limited reducing precision of valve placement
Solution Approach 1:
The delivery catheter and prosthesis components incorporate radiopaque markers and imaging features that enable visualization under fluoroscopic and other imaging modalities. These markers allow the operator to track the position and orientation of the delivery system and prosthesis during navigation and deployment, ensuring precise valve placement at the target site.
3Ease of operation
If a conventional delivery system is used, then the prosthesis can be delivered, but deployment is uncontrolled which complicates the procedure
Solution Approach 1:
The prosthesis is pre-compressed within the delivery catheter and positioned at the target site before deployment. The compressed state is maintained during navigation, and deployment is initiated only when the prosthesis is correctly positioned. This preliminary positioning in a controlled compressed state allows for precise placement before the expansion action is taken.
Solution Approach 2:
The delivery system incorporates imaging guidance and position sensing that provides real-time feedback to the operator during navigation and deployment. This feedback allows the operator to monitor the position of the prosthesis and adjust as needed, ensuring controlled and accurate deployment at the intended target site.
4Ease of operation
If the prosthesis is made shorter to improve maneuverability, then maneuverability improves, but the structural integrity and support may be compromised
Solution Approach 1:
The stent frame employs a curved or angled configuration rather than a straight design, with the distal end positioned at an angle relative to the proximal end. This curved geometry provides structural strength and radial support while accommodating the shorter length needed for improved maneuverability through tortuous vasculature. The curvature distributes mechanical stresses more effectively than a straight design would in a compressed state.
Data Source
AI summary
A prosthesis includes a stent frame, a valve structure positioned within the stent frame, and a plurality of guides spaced apart in series along a helical track. Each guide of the plurality of guides comprises a distinct opening. Methods also provide at least a portion of a helical elongated member being received within a plurality of corresponding openings of a plurality of guides formed by a track of a prosthesis to radially compress at least a portion of the prosthesis from a radially expanded arrangement to a radially compressed arrangement.