Articulatable Tissue Anchor System for Mitral Annulus Reshaping
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Solution Overview
Problem
Current percutaneous methods for treating mitral regurgitation, such as mitral annuloplasty, face challenges in applying forces from the correct directions to effectively reshape the mitral annulus, leading to inadequate control of valve leakage and limited adjustability during procedures, which complicates the minimally invasive correction of mitral valve dysfunction.
Innovation Solution
A medical device system comprising a kit with tissue anchors and a percutaneously deployable implant member that can be configured to apply forces from various directions, featuring a plurality of tissue anchors, guide lines, and an implant member with articulable segments and stops to secure and reshape the mitral valve annulus, allowing for precise adjustment and anchoring within the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous deployment is used to minimize invasiveness, then patient recovery time and surgery risk are reduced, but device complexity and difficulty of positioning increase significantly
Solution Approach 1:
The implant member is divided into multiple articulable segments that can be independently positioned and oriented. Each segment can be controlled to achieve the desired final configuration, allowing the device to be delivered through a narrow catheter and then assembled in situ within the body.
Solution Approach 2:
The implant member is designed to be nested within a catheter sheath for delivery. The segments are configured to fit within the limited space of the catheter during delivery, then deployed and articulated to their final configuration after insertion into the target site.
2Object-affected harmful factors
If percutaneous deployment is used to minimize invasiveness, then patient recovery time is reduced, but positioning accuracy and operational difficulty increase
Solution Approach 1:
The implant member features articulable segments that can be dynamically adjusted and repositioned after deployment. This allows the operator to fine-tune the positioning and orientation of each segment to achieve optimal alignment with the mitral annulus, compensating for the lack of direct visual contact during the procedure.
3Reliability
If traditional mitral annuloplasty is performed to correct valve leakage, then valve function is improved, but invasiveness and surgery complexity increase
Solution Approach 1:
The invention replaces the traditional open-heart surgical approach with a percutaneous mechanical system. Instead of requiring direct surgical access to the heart, the implant member is delivered through a catheter and uses mechanical articulation of segments to achieve the annuloplasty effect, thereby reducing invasiveness while maintaining therapeutic efficacy.
4Shape
If the implant member is made rigid to affect annulus shape, then reshaping capability is improved, but deliverability percutaneously deteriorates
Solution Approach 1:
The implant member is segmented into multiple articulable sections that can be compacted for delivery through a narrow catheter. Once deployed, the segments can be articulated and positioned to form the desired rigid or semi-rigid structure for shaping the mitral annulus, thus resolving the conflict between deliverability and shape control capability.
Data Source
AI summary
A tissue anchor system includes a plurality of elongated members pivotally coupled by a pivot member and at least one coupler coupled to at least one of the elongated members between a pivot point and an end of the elongated member which coupler is operable to secure the elongated members in a configuration that securely couples the tissue anchor to tissue.