Retractable Flat-Wire Coupling for Controlled Heart Valve Deployment
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Solution Overview
Problem
Existing transcatheter delivery systems for heart valve prostheses face complications such as vessel trauma, inaccurate placement, coronary artery obstruction, and paravalvular leakage due to large delivery profiles and curved anatomy, which current technologies have not adequately addressed.
Innovation Solution
A delivery system utilizing retractable flat wires as a coupling and deployment mechanism, comprising an outer sheath, an elongate tube with wires, and self-expanding frames, where the wires are woven through the frames to couple and deploy the prosthesis, allowing controlled and predictable expansion and repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a large delivery profile is used to deliver the prosthesis, then the prosthesis can be delivered through the vasculature, but vessel trauma occurs due to the large size
Solution Approach 1:
The prosthesis is divided into multiple segments or sections that can be collapsed together during delivery and separated after deployment. The delivery system includes a delivery catheter with a delivery balloon that can inflate to expand the prosthesis segments into their final configuration, allowing the prosthesis to traverse the vasculature in a compressed state and then expand to the required size at the implantation site
Solution Approach 2:
The prosthesis is nested within the delivery catheter in a collapsed or compressed state during delivery. The delivery catheter acts as a container that holds the prosthesis in a reduced profile configuration, allowing it to pass through the vasculature without causing trauma. Once positioned at the target site, the prosthesis is deployed from the nested configuration into its expanded functional state
2Ease of operation
If percutaneous delivery is used to reduce invasiveness, then patient safety is improved, but inaccurate placement and conduction disturbances may occur
Solution Approach 1:
The delivery system incorporates feedback mechanisms such as radiopaque markers, imaging guidance integration, and position-sensing elements that provide real-time information about the prosthesis location and orientation during percutaneous delivery. This feedback allows the operator to make precise adjustments to ensure accurate placement while maintaining the minimally invasive percutaneous approach
Solution Approach 2:
The delivery system is designed to pre-position the prosthesis accurately within the delivery catheter before insertion, and includes preliminary alignment features and positioning mechanisms that ensure the prosthesis is correctly oriented and located before it is deployed at the target site, thereby preventing placement errors while maintaining percutaneous access
3Adaptability or versatility
If the delivery catheter is advanced through highly curved anatomy, then percutaneous access is achieved, but vessel trauma and conduction disturbances occur
Solution Approach 1:
The delivery catheter is designed with dynamic, flexible characteristics that allow it to adapt to highly curved anatomical pathways. The catheter includes flexible segments, shape-memory materials, or actively controllable bending sections that can be dynamically adjusted to navigate complex vascular anatomy, enabling percutaneous access to difficult-to-reach targets while minimizing trauma through smooth, adaptable navigation rather than rigid forceful insertion
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
The system enables precise and controlled deployment of heart valve prostheses, reducing vessel trauma and paravalvular leakage by minimizing delivery profile and ensuring accurate placement, thus enhancing procedural safety and efficacy.
Implementation Method 1
self-expanding first and second frames disposed in series within a distal portion of the outer sheath component
Data Source
Figure 1~1A
Figure 2~4
Figure 5~6
AI summary
A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component (106) defining a lumen therethrough, an elongate tube (136) having at least two flat wires (146) longitudinally extending from a distal end thereof, and self-expanding first and second frames (102, 104) disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.