Adjustable Mitral Annuloplasty Ring Delivery System
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Solution Overview
Problem
Current mitral valve annuloplasty procedures lack a reliable method for accurately sizing and reshaping prosthetic mitral annuloplasty rings, leading to potential complications such as mitral valve stenosis or undesirable leaflet coaptation due to the reliance on physician experience and the inability to make adjustments during implantation.
Innovation Solution
A delivery device and system for a prosthetic mitral annuloplasty ring featuring an adjustable member with internal threads, a driving member, and a connecting member that allows for resizing by engaging external and internal threads, enabling precise adjustment of the ring's size and shape during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional mitral valve annuloplasty rings are used without adjustment mechanisms, then the implantation procedure is simple, but the ring size and shape cannot be accurately matched to the patient's anatomy
Solution Approach 1:
The delivery device employs a nested structure where the adjustment member is positioned within the delivery device body, and adjustment components are housed within protective sheaths. This nesting allows the complex adjustment mechanism to be delivered through a relatively simple catheter system while maintaining the ability to perform precise size and shape adjustments during implantation.
Solution Approach 2:
The prosthetic ring incorporates an adjustment member with movable components that allow dynamic modification of the ring's size and shape after implantation. The delivery device includes movable adjustment components that can be operated remotely to change the ring configuration, transforming a static implant into a dynamically adjustable one.
2Measurement precision
If the prosthetic ring size is selected based on physician experience without measurement tools, then the device selection process is simple, but the accuracy of ring size selection is poor
Solution Approach 1:
The invention replaces subjective physician estimation with an objective mechanical measurement system. The delivery device incorporates measurement markings and adjustment mechanisms that provide quantifiable data on ring size and shape, allowing for precise matching to the patient's anatomy rather than relying on experiential judgment.
Solution Approach 2:
The delivery device allows for preliminary measurement and selection of the appropriate ring size and shape before final implantation. The adjustment mechanisms can be pre-configured based on pre-procedural imaging and measurements, and fine-tuned during the procedure, separating the measurement and selection phases from the actual implantation.
3Reliability
If the prosthetic ring size is too small, then the risk of mitral valve stenosis increases, but using a larger ring may cause undesirable leaflet coaptation
Solution Approach 1:
The adjustable ring system allows the surgeon to start with a larger ring size to prevent stenosis, then dynamically reduce the size during the procedure to achieve proper leaflet coaptation. This dynamic adjustment capability provides the safety margin of a larger initial size while enabling precision reduction to avoid coaptation problems.
Solution Approach 2:
The adjustment mechanism allows changing key geometric parameters of the ring (size, shape, curvature) after implantation. This enables the surgeon to optimize these parameters in real-time based on observed surgical outcomes, transforming fixed-parameter implants into variable-parameter systems that can be tailored to the specific patient anatomy.
4Ease of operation
If traditional annuloplasty rings without adjustment capabilities are used, then the implantation procedure is straightforward, but no secondary adjustment can be made during implantation
Solution Approach 1:
The delivery device serves as an intermediary between the surgeon and the implantable ring, providing adjustment capabilities without requiring direct manipulation of the ring itself. The adjustment mechanisms are mediated through the delivery device, allowing modifications to be made remotely while the ring remains in position, thus maintaining procedural simplicity while adding adaptability.
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
Enables accurate fitting and resizing of the prosthetic mitral annuloplasty ring to match the native mitral valve annulus, improving surgical outcomes by allowing for adjustments during the procedure, thus reducing complications like mitral valve stenosis and enhancing leaflet coaptation.
Implementation Method 1
The intermediate tube is provided with an external thread complementary to the internal thread of the adjustment member
Data Source
AI summary
A prosthetic mitral annuloplasty ring includes a wire, an adjustment member for changing a length of the wire and a jacketing annulus for adjusting a radial dimension of the mitral valve annuloplasty ring. The jacketing annulus is sleeved over the wire and forms, together with the adjustment member, a shape matching that of a native mitral valve annulus. After the prosthetic mitral annuloplasty ring is implanted by suturing in a conventional surgical procedure and the patient's heart starts to beat again, the adjustment member can be connected to the delivery device and the wire length therein can be adjusted by a rotating operation of the delivery device so that the mitral valve annuloplasty ring will be expanded or contracted until the prosthetic mitral annuloplasty ring perfectly fits the native mitral valve annulus in shape, effectively avoiding the problem of incomplete mitral leaflet coaptation.