Dry Membrane Heart Valve for Reduced Delivery Profile
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Solution Overview
Problem
Current percutaneous heart valve replacement technologies face challenges due to the bulkiness of existing devices, which complicates delivery, especially in smaller arteries, and require time-consuming and costly hydration and mounting processes in the catheterization lab, limiting their availability and increasing procedural risks.
Innovation Solution
A 'dry' membrane heart valve system where the tissue leaflet assembly is prepared and folded in a dry state, attached to a frame, and pre-mounted on a catheter delivery system, allowing for direct implantation without hydration or crimping, reducing bulk and procedural complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If traditional hydrated membrane heart valves are used, then the tissue has adequate flexibility and strength for operation, but the device bulk increases and delivery profile enlarges
Solution Approach 1:
The patent changes the physical state parameter of the tissue from hydrated to dry, fundamentally altering its properties. Dry tissue has reduced volume and mass while maintaining structural integrity through cross-linking, enabling smaller delivery profiles while preserving functional strength after implantation
Solution Approach 2:
The tissue undergoes a phase transition from hydrated (wet) state to dry state for delivery, then transitions back to hydrated state upon implantation. This phase change enables compact storage and delivery while ensuring proper functionality in the physiological environment
2Ease of operation
If traditional hydrated membrane heart valves are used, then the tissue maintains flexibility for operation, but the device requires time-consuming hydration and mounting processes
Solution Approach 1:
The tissue is prepared in advance in a dry state with cross-linking to ensure flexibility and strength, eliminating the need for time-consuming hydration and mounting procedures during the catheterization lab procedure. The valve is pre-assembled and ready for immediate deployment
3Stability of the object's composition
If traditional hydrated membrane heart valves are used, then the tissue has adequate structural integrity, but the device complexity and cost increase
Solution Approach 1:
The patent applies chemical cross-linking to the dry tissue to enhance its structural integrity and stability. This cross-linking process creates strong bonds within the tissue matrix, ensuring adequate structural integrity without requiring complex hydration and mounting procedures, thereby reducing overall device complexity
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
This approach simplifies arterial insertion, reduces procedural time and complications, and expands the candidacy for patients with smaller arteries by providing a lower profile and more efficient delivery system for heart valve replacement.
Implementation Method 1
causing osmotic shocking of the section of tissue by performing multiple rinses of the section of tissue with distilled water
Implementation Method 2
the treated membrane tissue is dehydrated to produce a dehydrated membrane tissue having a water content of less than about 60% by weight
Data Source
AI summary
A prosthetic heart valve implantable by catheter without surgery includes a substantially “dry” membrane or tissue material. In at least one embodiment, the tissue is folded in a dry state to form a tissue leaflet assembly that is then attached to a frame to form an implantable prosthetic heart valve. Alternatively, one or more tissue leaflets are operatively associated with a frame to form an implantable prosthetic heart valve. The implantable prosthetic heart valve is subsequently pre-mounted on an integrated catheter delivery system. The catheter delivery system that includes the implantable prosthetic heart valve is then packaged and transported while the tissue remains dry. The implantable prosthetic heart valve, while remaining substantially dry, can then be implanted into the receiving patient.