Sutureless Heart Valve Attachment Using Swellable Anchoring Sleeve
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Solution Overview
Problem
Conventional heart valve replacement surgeries are invasive and risky, often requiring open-chest surgery and cardiopulmonary bypass, leading to significant morbidity and mortality, with challenges in achieving uniform contact between expandable valves and the annulus, particularly in highly calcified areas, resulting in paravalvular leakage.
Innovation Solution
A non-expandable or expandable prosthetic heart valve with an anchoring sleeve made of a material that swells upon absorption of body fluids, providing mechanical strength to anchor the valve to the annulus without the need for sutures, using a frame with a valve member and leaflets to ensure unidirectional blood flow, and optionally supplemented with barbs for additional anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional suture-based valve implantation is used, then secure attachment to annulus is achieved, but surgery time and patient trauma increase significantly
Solution Approach 1:
The invention removes the suture component from the implantation system entirely. The anchoring sleeve is designed to provide secure attachment to the annulus through direct mechanical engagement without requiring sutures, thereby eliminating the time-consuming suturing process while maintaining attachment security.
Solution Approach 2:
The anchoring sleeve serves as an intermediary component between the valve frame and the annulus. It provides a specialized interface that enables direct mechanical attachment, replacing the traditional suture-mediated connection and allowing for faster implantation while ensuring secure fixation.
2Object-affected harmful factors
If expandable valves are used to reduce surgery invasiveness, then open-chest surgery is avoided, but uniform contact with calcified annulus becomes difficult causing leakage
Solution Approach 1:
The anchoring sleeve features localized engagement structures such as barbs or gripping surfaces at specific locations to optimize contact with the annulus. This local quality enhancement ensures reliable attachment and uniform contact particularly in challenging calcified areas, preventing paravalvular leakage while maintaining the benefits of minimally invasive implantation.
3Object-affected harmful factors
If minimally invasive percutaneous delivery is used, then patient trauma is reduced, but anchoring reliability in highly calcified annulus decreases
Solution Approach 1:
The anchoring sleeve is constructed from composite materials or structures combining different properties - such as radiopaque materials for imaging visibility, biocompatible materials for tissue compatibility, and mechanically strong materials with barb or gripping features for reliable anchoring in calcified annulus. This composite approach enables minimally invasive delivery while ensuring sufficient anchoring strength.
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 anchoring sleeve allows for a more efficient and less invasive implantation procedure, reducing the time on extracorporeal circulation and minimizing the risk of complications by providing a secure attachment to the annulus, preventing migration and leakage, and enabling faster recovery.
Implementation Method 1
an anchoring sleeve which surrounds the frame and is at least partly made of a material that increases in size due to absorption of body fluids
Implementation Method 2
The anchoring sleeve comprises an inner swellable material enclosed within a cover
Data Source
AI summary
A prosthetic heart valve having an anchoring sleeve that changes shape when the valve is implanted and contacts the surrounding annulus to prevent migration of the valve. The heart valve may be non-expandable and the anchoring sleeve may provide the primary anchoring structure of the valve. Alternatively, the valve may be expandable wherein the anchoring sleeve supplements the inherent anchoring capacity of the valve structure. The anchoring sleeve is at least partly made of a material that increases in size, i.e., swells, due to absorption of body fluids. For instance, the anchoring sleeve may be formed of an inner material that swells upon contact with body fluids enclosed by a cover. The anchoring sleeve desirably changes shape to provide spaced apart annular flanges for securing the valve around a fibrous annulus. An anchoring sleeve for a prosthetic heart valve having an expandable frame surrounds a majority of the frame and may define an external hourglass configuration.