Atraumatic Annuloplasty Components for Tissue-Safe Annulus Reduction
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Solution Overview
Problem
Existing implantable medical devices often cause tissue irritation and trauma due to anatomical variations among patients, leading to undesirable contact and potential complications such as thrombus formation.
Innovation Solution
The implantable annuloplasty device features atraumatic surfaces, including curved structures and shields, to minimize contact with tissue, and a slider mechanism for adjusting between collapsed and expanded configurations, reducing trauma and expanding the patient population that can be treated.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If an implantable device is designed with standard geometric features (flat surfaces, sharp edges), then manufacturing is simpler and device structure is less complex, but tissue trauma and irritation increase when the device contacts surrounding tissue
Solution Approach 1:
The patent applies curvature by replacing sharp edges and flat surfaces with rounded contours on the implantable device. Specifically, the device incorporates curved transition surfaces between parallel portions and rounded corners instead of sharp edges. This spherical/curved geometry reduces stress concentration and distributes contact forces more evenly across tissue surfaces, thereby minimizing tissue trauma and irritation while the device performs its anchoring function.
2Adaptability or versatility
If the device size and dimensions are fixed to accommodate anatomical variations among patients, then manufacturing precision is improved, but the device cannot be adapted to different patient anatomies, reducing versatility
Solution Approach 1:
The patent implements adjustability through sliders that can be repositioned along the struts of the annuloplasty ring. This dynamic configuration allows the device to be resized and reshaped after implantation to accommodate different anatomical variations among patients. The sliders enable the ring to transition between different circumferential dimensions and geometric configurations, providing versatility across patient populations while maintaining manufacturing precision for each fixed size option.
3Object-affected harmful factors
If the device is designed to minimize contact with surrounding tissue, then tissue irritation is reduced, but the device may lose stability and secure anchoring in the implant site
Solution Approach 1:
The patent applies local quality by differentiating between device surfaces that contact tissue and surfaces that anchor to tissue. The outer surfaces of the struts feature curved, atraumatic geometry to minimize irritation of surrounding cardiac tissue. In contrast, the inner surfaces incorporate anchors with barbs and engagement features designed to penetrate and secure firmly to the annulus tissue. This spatial differentiation of surface properties allows simultaneous achievement of tissue protection and secure anchoring.
Solution Approach 2:
The patent applies curvature to the outer surfaces of the device to reduce tissue irritation, while maintaining sharp, angular features on the anchors for secure engagement. The curved transition surfaces on the struts distribute contact forces evenly against the cardiac chamber wall, preventing pressure points and tissue erosion. This geometric differentiation between curved protective surfaces and angular anchoring surfaces resolves the contradiction between minimizing irritation and maximizing stability.
Data Source
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AI summary
Solutions for reducing irritation and/or trauma which may result upon contact of an implanted implantable device with tissue surrounding or adjacent to the implantable device. Various embodiments include features which allow a tangential or otherwise atraumatic contact of the implantable device with the tissue, in contrast with a sharper contact which may occur with prior art implantable devices. The broad principles are applicable to annuloplasty devices, and have other broader applications as well.