Tiltable Heart Valve Holder for Precise Mitral Alignment
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Solution Overview
Problem
The challenge in implanting prosthetic mitral valves is the entanglement of commissure posts with pre-installed sutures, which is difficult to detect due to limited visibility during minimally-invasive procedures, complicating the sizing and alignment of the valve.
Innovation Solution
The use of a removable bioprosthetic heart valve assembly with a holder that includes a maneuvering system for aligning the valve frame with the abutment ring, and a sizer for determining the appropriate size of the annulus, facilitating precise implantation and alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Weight of moving object
If minimally-invasive access approach is used, then patient trauma is reduced, but visibility of surgical field is limited
Solution Approach 1:
The commissure posts include visibility features such as radiopaque markers or colored indicators that allow the surgeon to visually detect the position and status of the posts during minimally-invasive procedures, compensating for the limited visibility of the surgical field
Solution Approach 2:
The holder assembly acts as an intermediary tool that provides mechanical guidance and alignment features, enabling the surgeon to properly position the valve without direct visual access to the deep surgical field
2Device complexity
If commissure posts are delivered close to pre-installed sutures, then valve delivery is simplified, but entanglement of posts with sutures occurs
Solution Approach 1:
The holder assembly extracts or separates the commissure posts from direct contact with the sutures during delivery, maintaining a controlled distance between the posts and suture loop to prevent entanglement while simplifying the overall delivery procedure
Solution Approach 2:
The holder pre-positions the commissure posts in a controlled manner before they enter the annulus, ensuring they are properly oriented and spaced to avoid entanglement with pre-installed sutures
3Productivity
If surgeon cannot visually detect entanglement, then procedure speed is maintained, but implantation accuracy is compromised
Solution Approach 1:
Radiopaque markers or visibility features on the commissure posts enable visual detection of entanglement through fluoroscopic imaging or direct visualization, allowing the surgeon to maintain both procedure speed and implantation accuracy
4Ease of manufacture
If multiple sutures and small components are manipulated in tight spaces, then valve implantation is achieved, but surgical complexity increases
Solution Approach 1:
The holder assembly merges multiple functions (alignment, positioning, and guidance of commissure posts) into a single integrated tool, reducing the number of separate manipulation steps required and simplifying the surgical procedure
Data Source
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AI summary
In certain embodiments, an implantation accessory for placement at a heart valve annulus location of a patient's heart, the annulus having a first axis, the implantation accessory comprising: a first surface; a second axis perpendicular to the first surface; and, a maneuvering system for aligning the first axis and the second axis. In certain embodiments, a removable bioprosthetic heart valve assembly for implantation into an abutment ring attached at a heart valve annulus location of a patient's heart, the abutment ring having a first axis, the removable bioprosthetic heart valve assembly includes a bioprosthetic valve for coupling to the abutment ring and a holder. The holder, detachably coupled to the bioprosthetic valve, includes a first surface, a second axis perpendicular to the first surface, and a maneuvering system for aligning the first axis and the second axis. Methods of implantation are also disclosed.