Heart Valve Holder Structure for Clear Sewing Ring Access
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Solution Overview
Problem
Existing heart valve holders obstruct visibility and accessibility during implantation, leading to suture entanglement, increased force requirements for removal, and potential paravalvular leakage due to suture remnants.
Innovation Solution
A valve holder with small feet engaging the sewing ring, spider-like legs, and a central hub with a winch-type suture gather module that provides unobstructed visibility and access, separate suture paths, and a predetermined break point to prevent suture remnants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional valve holder is used to hold the prosthetic valve during implantation, then the valve can be securely held and positioned, but the holder obstructs visibility and accessibility to the sewing ring and valve structures
Solution Approach 1:
The valve holder is divided into multiple separate components: a first holder component that engages the sewing ring and a second holder component that engages the valve body. These components can be positioned independently to minimize obstruction while maintaining secure valve holding during implantation procedures.
2Stability of the object's composition
If the holder structure is extended to provide stable valve support, then valve positioning stability is improved, but suture entanglement with the holder increases
Solution Approach 1:
The harmful feature of suture entanglement is eliminated by extracting the suture engagement function from the main holder body. Sutures are engaged directly with the valve and sewing ring structures, while the holder components serve only for positioning and support, preventing suture entanglement with the holder itself.
3Reliability
If the holder structure is made robust to ensure secure valve attachment, then attachment reliability is improved, but the force required for holder removal increases
Solution Approach 1:
The holder components are designed with dynamic engagement features that provide strong attachment during implantation but allow for controlled release. The engagement structures can be securely locked during positioning but are designed to be released with reduced force after the valve is firmly attached to the sewing ring.
4Strength
If the holder engages the sewing ring directly for secure attachment, then valve holding strength is improved, but suture remnants may remain in the patient after holder removal
Solution Approach 1:
The holder components are designed as temporary, disposable tools that are removed after serving their purpose. The engagement structures are designed to leave no remnants, with any temporary engagement elements being easily removable or biodegradable, ensuring no foreign materials remain in the patient after valve implantation.
Data Source
AI summary
Methods and apparatus for holding and maneuvering a valve during preparation and attachment to patient, providing increased visibility of the prosthetic valve and the sewing ring to prevent suture entanglement. A handle attachment is spaced from the valve for improved visibility of the sewing ring and the outlet end of the valve during attachment. Commissure posts are bent inward at the tips while preventing crashing of the commissure posts into each other causing damage. A release force needed to remove the holder and unthread the holder sutures is reduced. The holder and related methods can provide a kink free holder suture path to reduce suture entanglement and prevent damage to the implanted valve during holder removal by reducing the release force needed to remove the holder sutures by up to 30%.