Crimping Kit Angular Positioning for Heart Valve
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Solution Overview
Problem
Crimping implantable medical devices, such as heart valve prostheses, is a delicate and complex process that often risks damaging the device due to direct manipulation, and achieving accurate angular positioning is challenging with existing devices.
Innovation Solution
A kit and crimping apparatus with a holder member and angular indicia that supports the medical device, allowing for precise angular positioning without direct contact, featuring radially contractible portions and a crimping opening that facilitates safe and accurate crimping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the practitioner adjusts the angular position of the implantable medical device within the crimping orifice by contacting and manipulating the implantable device directly, then the angular positioning can be achieved, but there is a risk of damaging the implantable medical device
Solution Approach 1:
The holder member acts as an intermediary tool between the practitioner's hands and the implantable medical device. It features external manipulation surfaces and engagement structures that allow the practitioner to adjust and secure the angular position of the device without directly contacting the device itself, thereby eliminating the risk of damage while maintaining positioning accuracy
2Reliability
If the holder member extends axially clear of the radially contractible axial portion, then unimpeded radial contraction is permitted, but the holder member complexity increases
Solution Approach 1:
The holder member is segmented into distinct functional zones: a proximal section that extends axially clear of the radially contractible portion to permit unimpeded crimping, and a distal section that interfaces with the device. This segmentation allows each zone to perform its specific function optimally without unnecessary complexity in other areas
3Measurement precision
If angular indicia are provided on the crimping apparatus, then angular positioning can be achieved, but the device complexity increases
Solution Approach 1:
Angular indicia in the form of visual markers or color-coded indicators are provided on the holder member and/or crimping apparatus. These indicators allow the practitioner to quickly and accurately determine the angular position of the implantable medical device without adding complex mechanical positioning mechanisms, thereby maintaining simplicity while improving measurement precision
Data Source
AI summary
A kit for facilitating crimping of a prosthetic heart valve for implantation at an aortic valve site in a human heart, the aortic valve site including a plurality of valve sinuses, the kit comprising a prosthetic aortic heart valve having a tubular structure and a first central axis including an anchoring structure comprising an annular outflow member, an annular inflow member, and a plurality of axial connection formations arranged in pairs angularly distributed around the central axis, and a plurality of leaflets coupled to the anchoring structure and adapted to substantially allow blood flow in a first direction and to substantially prevent blood flow in a second direction. The kit further includes a holder member comprising a first disc support member that includes a central hub and a plurality of bridge elements, wherein the hub and the bridge elements extend axially from opposite sides of the disc support member; and a second ring support member that includes receptacles for coupling with the bridge elements, and a plurality of finger formations protruding axially from the ring member and extending lengthwise along at least a portion of the prosthetic aortic heart valve.