Articulating Valve Implant Holder for Sizing and Easy Detachment
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Solution Overview
Problem
Current surgical procedures for implanting prosthetic heart valves and annuloplasty rings face challenges such as suture tangling, limited visibility during implantation, inefficient sizing, and difficulty in detaching holders from implants, especially in minimally invasive procedures.
Innovation Solution
An articulating implant holder system with a modular handle assembly that includes a swivel, latch, and actuating cable, allowing for adjustable positioning and easy detachment, along with a system of sizer heads for precise sizing and implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a traditional fixed holder system is used for implanting prosthetic heart valves, then the implantation process is simplified, but suture tangling occurs and visibility during implantation is limited
Solution Approach 1:
The holder system is divided into multiple segments including a handle, shaft, articulating section, and head portion that can move independently. This segmentation allows the distal end to be positioned optimally while keeping the handle outside the body, reducing suture tangling and improving visibility without requiring a completely complex monolithic structure.
Solution Approach 2:
The holder incorporates an articulating mechanism with degrees of freedom that allows dynamic adjustment of the distal end position and orientation relative to the handle. This dynamic capability enables the surgeon to optimize the implantation angle and suture routing during the procedure, preventing suture tangling while maintaining operational simplicity.
2Object-affected harmful factors
If a minimally invasive approach is used for valve implantation, then patient trauma is reduced, but holder detachment from implant becomes difficult
Solution Approach 1:
The handle portion of the holder is extracted and positioned outside the patient's body through the minimally invasive access site, while only the essential implanting portion remains inside. This extraction allows the handle to serve as an external control mechanism that facilitates easy detachment of the implant from the holder by simply releasing the locking mechanism on the handle, solving the detachment difficulty while maintaining minimally invasive benefits.
3Manufacturing precision
If precise sizing is required for heart valve implantation, then implant accuracy is improved, but procedural time increases
Solution Approach 1:
Sizer heads with predetermined sizes are provided as separate components that can be attached to the holder before the actual implantation. The surgeon can quickly try different sizer heads to determine the correct size, and the selected sizer head remains attached during implantation, eliminating the need for separate sizing steps and reducing procedural time while maintaining precise sizing accuracy.
Solution Approach 2:
The holder is designed to accommodate multiple sizer heads of different sizes, allowing the same holder structure to be used for sizing and then for actual implantation. This multi-functionality eliminates the need for separate sizing instruments and procedures, reducing procedural time while maintaining the ability to achieve precise valve sizing.
Data Source
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AI summary
An articulating implant holder system for heart valve repair or replacement has an implant configured to be secured to a heart valve annulus, an implant holder secured to the implant, an articulating handle assembly comprising a handle, a swivel pivotably secured to the handle at a first location and a connector pivotably secured to the swivel at a second location, an actuating cable secured between the handle and the connector to cause the swivel to move from a first position to a second position, and a latch removably secured to the implant holder. A plurality of sizer heads are configured to correspond to different sizes of heart valve annuluses and each of the plurality of sizer heads has a latching feature. A latching feature of the swivel is configured to removably snap on to the latching feature of each of the plurality of sizer heads and is configured to permanently snap on to the latch.