Steerable Annuloplasty Ring Catheters for Precise Valve Repair
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Solution Overview
Problem
Ischemic heart disease causes mitral regurgitation due to dilatation of the mitral valve annulus, leading to increased stroke volume and decreased cardiac output, as the valve leaflets fail to coapt properly, necessitating a solution for repairing the dilated valve annulus.
Innovation Solution
An adjustable partial annuloplasty ring with flexible anchors is deployed using a steerable manipulator to anchor around the valve annulus, allowing for precise placement and contraction to tighten the annulus, combined with a multi-component tubular system for controlled delivery and orientation of the implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a rigid delivery catheter is used to maintain structural stability during delivery, then the delivery precision is improved, but the device complexity increases due to the need for multiple steerable segments and locking mechanisms
Solution Approach 1:
The catheter is divided into multiple steerable segments that can be independently controlled. Each segment contains steering wires that allow it to be deflected relative to the proximal segment, enabling precise positioning of the annuloplasty ring at the target location while maintaining overall catheter stability during delivery through the hierarchical segment structure.
Solution Approach 2:
The catheter employs a nested configuration where steerable segments are positioned within a proximal segment, and steering wires are contained within the wall of each segment. The annuloplasty ring is delivered within the catheter lumen, creating multiple levels of nesting that protect internal components while allowing selective deployment at the target site.
Solution Approach 3:
The catheter transitions from a rigid structure during delivery to a dynamic, steerable configuration at the target site. The steerable segments can be independently deflected using steering wires, and the annuloplasty ring can be deployed in a contracted or expanded state, allowing the system to adapt its configuration based on the procedural requirements.
2Ease of operation
If the annuloplasty ring is delivered in a contracted state through the catheter, then the ease of operation during delivery is improved, but the manufacturing precision requirements increase to ensure proper expansion and anchoring at the target site
Solution Approach 1:
The annuloplasty ring is designed to transition between contracted and expanded states. During delivery, it is maintained in a contracted state within the catheter lumen for ease of navigation. At the target site, it is deployed in an expanded state to provide the necessary structural support for anchoring, with the ability to adjust its configuration based on the specific procedural requirements.
Solution Approach 2:
The ring's configuration parameter changes from a contracted state during delivery to an expanded state at the target site. This parameter change allows the same device to serve multiple functions: easy delivery through the catheter and effective anchoring at the heart valve annulus, with the transition controlled by deployment mechanisms.
3Reliability
If multiple anchors are deployed through the ring wall to secure the ring to the heart valve, then the reliability of the implant is improved, but the device complexity increases due to the need for separate anchoring components and deployment mechanisms
Solution Approach 1:
The anchoring function is merged into the annuloplasty ring structure itself through the integration of anchors within the ring wall. The anchors are positioned within the ring and deployed through the ring wall to secure it to the heart valve annulus, combining the structural support and anchoring functions into a single integrated device rather than separate components.
Solution Approach 2:
The anchors are designed to be self-contained within the ring structure, with deployment mechanisms that allow them to be released and positioned independently. The ring structure itself provides the framework for anchor deployment, eliminating the need for separate anchoring devices and reducing overall system complexity.
Data Source
AI summary
Apparatus is provided for repairing a cardiac valve, the apparatus including a catheter sized for delivery through vasculature of a subject and an elongated and flexible annuloplasty structure having an annuloplasty structure axis. The annuloplasty structure is sized and configured for delivery to a heart of the subject through the catheter substantially along a catheter axis of the catheter while the annuloplasty structure axis is substantially parallel to the catheter axis. The apparatus also includes a plurality of anchors configured for delivery to a region of cardiac tissue from a proximal end of the catheter toward a distal end of the catheter and substantially along the annuloplasty structure axis and the catheter axis while at least a portion of the annuloplasty structure is within a delivery passage of the catheter. Other embodiments are also described.