Resilient Tip Prosthetic Valve Sizer for Annular Conformity
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Solution Overview
Problem
Current prosthetic heart valve sizing tools, typically made of rigid materials, fail to accurately match the size and contour of varying patient-specific heart valve annuli, leading to difficulties in selecting the appropriate prosthetic valve during surgery due to their inflexible nature and inability to conform to the anatomical features.
Innovation Solution
A prosthetic heart valve sizer with a resilient tip and a sizer body made of a more flexible material, designed to replicate the flexibility and shape of the prosthetic heart valve, allowing for accurate and reproducible assessment of fit within the patient's anatomy, including a handle and a sewing ring that mimics the prosthetic valve's flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If rigid plastic sizers are used to measure valve opening size, then the sizer structure is simple and easy to manufacture, but the sizer cannot accurately conform to the varying contour and flexibility requirements of patient-specific heart valve annuli
Solution Approach 1:
The sizer is divided into a rigid body portion (providing structural stability and size reference) and a separate resilient tip portion (providing flexibility and contour adaptation). This segmentation allows each part to perform its specialized function, improving measurement accuracy without requiring the entire device to be complex and flexible.
Solution Approach 2:
Different portions of the sizer have different material properties: the body is made of rigid plastic for structural integrity, while the tip is made of resilient material for conforming to annular contours. This local differentiation of material quality enables the sizer to simultaneously maintain structural simplicity while achieving accurate anatomical conformity at the critical measurement interface.
2Adaptability or versatility
If rigid sizers are used during surgery, then the device is easy to handle and insert, but the sizer cannot accurately replicate the flexibility and shape of actual prosthetic heart valves
Solution Approach 1:
The sizer is divided into a rigid body portion (providing structural stability and size reference) and a separate resilient tip portion (providing flexibility and contour adaptation). This segmentation allows each part to perform its specialized function, improving measurement accuracy without requiring the entire device to be complex and flexible.
Solution Approach 2:
The material properties of the sizer tip are changed to be more resilient and flexible, matching the physical characteristics of actual prosthetic heart valve materials. This parameter change in material flexibility allows the sizer to accurately replicate how the actual valve will behave in the annulus, improving adaptability while the rigid body maintains ease of handling.
3Reliability
If multiple rigid sizers of different sizes are used to determine proper valve fit, then each sizer can be简单地 manufactured, but the selection process is time-consuming and may lead to inaccurate size selection
Solution Approach 1:
The material properties of the sizer tip are changed to be more resilient and flexible, matching the physical characteristics of actual prosthetic heart valve materials. This parameter change in material flexibility allows the sizer to accurately replicate how the actual valve will behave in the annulus, improving adaptability while the rigid body maintains ease of handling.
Solution Approach 2:
The traditional mechanical trial-and-error method of fitting rigid sizers is replaced by a more accurate resilient tip design that naturally conforms to the annular geometry. This substitution provides more reliable size assessment in a single attempt, reducing the need for multiple sizing trials and decreasing surgical time.
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 sizer enables precise evaluation of the heart valve annulus, facilitating the selection of the appropriate prosthetic valve size and implantation technique, reducing surgical time and minimizing tissue damage, while ensuring a proper fit and function of the prosthetic valve.
Implementation Method 1
a resilient tip (40) extending from a post (30) of the sizer body (110). The resilient tip (40) includes a material different from and more flexible than a material of the sizer body (110)
Data Source
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AI summary
Various embodiments of a prosthetic valve sizer and a method that utilizes such valve sizer are disclosed. In one or more embodiments, the prosthetic valve sizer can include a sizer body including an annular base (130) and a post (130) extending from the annular base. The prosthetic valve sizer can also include a resilient tip (140) extending from the post of the sizer body. The resilient tip can include a material different from and more flexible than a material of the sizer body.