Pivotable Heart Valve Sewing Ring for Tissue Protection
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Solution Overview
Problem
Conventional heart valve sewing rings face challenges in achieving a secure and reliable implantation due to varying annulus contours and the risk of puncturing native tissue, while also requiring complex suturing procedures and limited orifice size.
Innovation Solution
A pivotable sewing ring design that allows for outward movement from the stent, enabling easier isolation from tissue leaflets, increased orifice size, and simplified manufacturing and implantation by using a suture-permeable insert ring and fabric cover that pivots between stable positions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of moving object
If a conventional fixed sewing ring is used, then the valve structure is simple, but the orifice size is limited and the risk of tissue puncture is high
Solution Approach 1:
The sewing ring is designed to be pivotable relative to the stent, transitioning from a fixed to a dynamic structure. This allows the sewing ring to move outward during implantation to isolate from tissue leaflets, reducing puncture risk, while maintaining a compact profile when retracted
Solution Approach 2:
The sewing ring can be positioned in a retracted state nested against the stent during storage and implantation, minimizing the profile. During suturing, it pivots outward to provide working space, then returns to the nested position
2Area of moving object
If a larger sewing ring is used to increase orifice size, then the valve orifice area increases, but the outer diameter of the valve increases
Solution Approach 1:
The pivotable sewing ring creates dynamic spatial separation between the orifice-defining stent and the suturing platform. This allows the orifice to be maximized without permanently increasing the valve's outer diameter, as the sewing ring only extends during implantation operations
3Length of stationary object
If the sewing ring is made smaller to reduce outer diameter, then the outer diameter decreases, but the ease of suturing and access to the annulus is reduced
Solution Approach 1:
The sewing ring provides a compact profile during storage and implantation, then dynamically extends outward during suturing to provide adequate working space and access to the annulus. This temporal separation of functions maintains small outer diameter while ensuring ease of operation when needed
4Productivity
If conventional suturing methods are used with a fixed sewing ring, then the implantation procedure is straightforward, but the time and skill required are significant
Solution Approach 1:
The pivotable sewing ring simplifies the suturing process by automatically providing better isolation from tissue leaflets and improved access to the annulus. This reduces the skill level and time required for suturing, increasing implantation productivity without significantly increasing device complexity
Data Source
AI summary
A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. The sewing ring may have a compliant insert having a celled construction defined by outer walls and inner ribs. A method of implantation, and a method of assembly of the heart valve is also provided.