Adjustable Ribbon Frame Mitral Valve Implant
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Solution Overview
Problem
Existing implantable medical devices for mitral insufficiency often suffer from unintended contact with the cardiac wall due to their size, reducing their efficacy in restoring the mitral valve to its native configuration.
Innovation Solution
A low-profile implant with an adjustable annular frame, comprising a ribbon-shaped elongate body and anchor housings, which allows for customization of the circumference through a gear-based adjustment mechanism, minimizing contact with cardiac tissue and ensuring secure anchoring around the valve annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional annuloplasty implant is used to restore the mitral valve configuration, then the valve annulus can be supported and reshaped, but the implant size causes unintended contact with the cardiac wall, reducing efficacy
Solution Approach 1:
The implant employs an adjustable circumference mechanism that allows the annuloplasty ring to be resized after deployment. The elongate body can be translated through the anchor housing to modify the ring's circumference, enabling dynamic adaptation to the patient's anatomy and reducing contact with cardiac walls while maintaining effective valve support.
Solution Approach 2:
The implant utilizes a gear-based adjustment mechanism that changes the physical parameter of circumference. By engaging the gear with grooves on the elongate body, the system can translate the body through the anchor housing, thereby changing the ring's circumference from an initial larger size to a reduced final size that minimizes cardiac wall contact.
2Object-affected harmful factors
If the implant size is reduced to minimize cardiac wall contact, then the risk of unintended contact decreases, but the structural integrity and anchoring capability may be compromised
Solution Approach 1:
The implant is divided into distinct functional components: multiple anchor housings distributed around the annulus, an elongate body passing through them, and a gear mechanism for adjustment. This segmentation allows the anchors to provide distributed structural support and anchoring capability while the adjustable ring portion can be sized to minimize cardiac wall contact.
Solution Approach 2:
The implant transitions from a fixed-size structure to a dynamically adjustable one. The gear mechanism enables post-deployment resizing of the ring, allowing the system to achieve both strong anchoring (through secure anchor placement) and minimal cardiac wall contact (through reduced final circumference).
3Object-affected harmful factors
If an adjustable circumference mechanism is added to the implant, then the implant can be customized to reduce cardiac wall contact, but the device complexity increases
Solution Approach 1:
The adjustment functionality is merged into the existing anchor housing structure. The gear mechanism is integrated within the anchor housing, and the elongate body serves dual purposes as both the structural ring component and the element that is adjusted through translation. This merging reduces overall device complexity compared to having separate adjustment components.
Solution Approach 2:
The elongate body serves multiple functions: it forms the annuloplasty ring structure, it engages with the gear for circumference adjustment, and it translates through the anchor housing to effect the size change. This multi-functionality reduces the need for additional specialized components, thereby limiting the increase in device complexity.
Data Source
AI summary
A low profile implant, system and method of deployment includes a frame comprising an elongate body having ends that overlap to form an annular configuration of the frame. A circumference of the frame may be modified by varying an extent of the overlap between the ends of the elongate body. The elongate structure may extend through a sleeve of a number of respective anchor housings of the implant along a first axis, and anchors may be deployed through bores in the anchor housings along a second axis to secure the anchor housings to tissue. The implant may be deployed about and anchored to a valve annulus, and the circumference of the frame, and associated anchored tissue, may be adjusted to reconfigure the valve annulus.