Prosthetic Valve Frame with Integral Sewing Cuff
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current prosthetic heart valves face challenges in securing attachment to the heart tissue, particularly in preventing tissue ingrowth around the frame while ensuring durable anchoring through the sewing cuff, which affects the longevity and functionality of the valve.
Innovation Solution
A prosthetic valve frame assembly with an integral sewing cuff is developed, where a fabric with elastomer-filled pores is sandwiched between the frame and a composite material, allowing the sewing cuff to extend beyond the frame base and facilitate tissue ingrowth only in specific areas, while discouraging it elsewhere to enhance durability and integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sewing cuff is attached to the periphery of the prosthetic valve body to anchor sutures to the heart annulus, then the prosthetic valve can be securely attached to the heart, but tissue may grow around the frame in unwanted areas compromising attachment durability
Solution Approach 1:
The fabric is applied selectively to specific portions of the frame where tissue ingrowth should be discouraged, while leaving other areas exposed to allow tissue ingrowth for anchoring. This localized application ensures tissue integration at critical attachment points while preventing encroachment on valve components, thereby resolving the contradiction between secure attachment and preventing unwanted tissue growth.
Solution Approach 2:
The frame is divided into multiple portions with different fabric application zones. The sewing cuff is attached to specific segmented areas of the frame periphery, allowing differential tissue interaction across different frame sections. This segmentation enables simultaneous tissue anchoring in some areas and protection from tissue encroachment in others.
2Strength
If the sewing cuff is made from cloth material with filler material, then the sewing cuff provides structural support for suture anchoring, but the attachment method requires multiple components increasing device complexity
Solution Approach 1:
The fabric is integrated directly onto the frame structure, merging the reinforcement function into the existing frame rather than adding a separate sewing cuff component. This integration maintains structural support capabilities while reducing the number of discrete components, thereby resolving the contradiction between strength and device complexity.
Solution Approach 2:
The fabric itself serves as a composite material providing both structural support and tissue interaction properties. By using the fabric's inherent strength characteristics, the design achieves sewing cuff functionality without requiring additional filler materials or separate structural components, reducing overall device complexity while maintaining strength.
3Strength
If the fabric is coupled to the frame with the frame inside surface in contact with the fabric, then the fabric provides reinforcement, but the manufacturing process requires precise alignment increasing manufacturing difficulty
Solution Approach 1:
The fabric is positioned and secured to the frame at predetermined locations during the assembly process, establishing correct alignment before final valve components are installed. This preliminary positioning ensures proper fabric-frame contact and reinforcement effectiveness while simplifying subsequent manufacturing steps, thereby resolving the contradiction between strength and manufacturing precision.
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
A prosthetic valve (100) for surgical placement with a sewing cuff (116) durably attached to a frame (110). The durability of the attachment is accomplished by sandwiching a fabric (112) between the frame (110) and a composite material (118). The fabric(112) extends beyond the frame base (140) to form a sewing cuff (116) that is integral to a frame assembly. The sewing cuff (116) facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.