Soft Tissue Anchor for Prosthetic Valve Fixation
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Solution Overview
Problem
Current cardiac prosthetic anchoring technologies face challenges in securely attaching heart valve prosthetics, particularly in mitral valve replacements, due to structural inconsistencies and the lack of effective securement methods that do not require invasive procedures, leading to potential damage to surrounding tissues and inconsistent deployment depths.
Innovation Solution
A proprietary anchoring technology using TCAT (Trans-catheter Anchoring Technology) with a deployment mechanism and self-tensioning anchors that ensure constant contact with heart tissues, even during cardiac cycles, and a compliant valve design with varying rigidity for improved sealing and support, allowing for minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical techniques are used to attach a prosthesis to bone, then the prosthesis can be securely fixed, but the procedure requires extensive incisions, retraction of soft tissue, and removal of bone, resulting in significant scarring and poor cosmetic results
Solution Approach 1:
The patent introduces a soft tissue anchor as an intermediary component that bridges the prosthesis and the underlying bone without requiring direct bone exposure. The anchor is implanted through a small incision in the soft tissue, allowing the prosthesis to be attached while minimizing damage to the skin and underlying structures, thus reducing scarring and improving cosmetic results.
Solution Approach 2:
The fixation system is divided into separate functional components: a prosthesis attachment component, a soft tissue anchor, and a bone anchor. This segmentation allows each component to be optimized for its specific function while enabling minimally invasive implantation. The soft tissue anchor acts as an intermediate layer that separates the prosthesis from direct bone contact, reducing the need for extensive bone removal and soft tissue disruption.
2Reliability
If conventional techniques are used to attach a prosthesis to soft tissue, then the prosthesis can be secured, but the procedure requires extensive incisions and retraction of soft tissue, resulting in significant scarring
Solution Approach 1:
The soft tissue anchor serves as a mediator that simplifies the surgical procedure by providing a dedicated attachment point within the soft tissue. Instead of requiring extensive incisions and retraction to directly secure the prosthesis to the bone, the anchor is implanted through a small incision and provides a secure attachment point, thereby reducing surgical complexity and improving ease of operation.
Solution Approach 2:
The soft tissue anchor is implanted and secured to the bone before the prosthesis is attached. This preliminary action creates a ready-made attachment point that simplifies the subsequent prosthesis installation, reducing the need for complex soft tissue manipulation and extensive incisions during the main procedure.
3Reliability
If a prosthesis is attached directly to bone, then secure fixation is achieved, but the procedure requires removal of bone and retraction of soft tissue, resulting in poor cosmetic results
Solution Approach 1:
The soft tissue anchor acts as an intermediary that preserves the integrity of the soft tissue and bone by providing a secure attachment point without requiring direct exposure or removal of these structures. The anchor is implanted through a small incision, minimizing disruption to the natural anatomy and preserving the cosmetic appearance while still achieving secure prosthesis fixation.
Solution Approach 2:
The soft tissue anchor is designed to be implanted at a specific location within the soft tissue, creating a localized attachment point that provides sufficient fixation strength without requiring widespread bone removal or soft tissue disruption. This localized approach preserves the surrounding tissue integrity and maintains the natural appearance of the area.
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
The solution enables reliable and secure attachment of prosthetic valves with reduced invasiveness, faster recovery times, and minimized health risks by maintaining constant contact with heart tissues and adapting to the irregular shapes of implant sites, thus overcoming the limitations of existing technologies.
Implementation Method 1
The bone anchor may be engaged to the bone in any suitable manner, e.g., by penetrating the bone, by engaging a porous structure in the bone, or by engaging an expandable structure in the bone
Implementation Method 2
The soft tissue anchor may be engaged to the soft tissue by friction, by adhesion, or by mechanical interlocking
Implementation Method 3
The soft tissue anchor may be engaged to the soft tissue by friction, by adhesion, or by mechanical interlocking
Implementation Method 4
A prosthesis may be affixed to soft tissue by engaging a soft tissue anchor to the soft tissue and engaging the prosthesis to the soft tissue anchor
Data Source
AI summary
Systems and methods recited herein provide for affixation of a prosthetic valve to surrounding tissue, by at least one anchor and an anchor deployment device. The prosthetic valve device may be compliant with native tissue and may receive the at least one anchor in at least one anchor receptacle to affix the prosthetic valve to native tissue. The anchor may include a distal tip, a proximal head, and a tension component, such that upon deployment into tissue the tension component is situated in a tensioned state to exert a pulling force on the distal end of the anchor.