Color-Coded Delivery Handle for Precise Valve Shaft Curvature
Solution Overview
Problem
Existing prosthetic heart valve delivery systems face challenges in conforming to the geometry of native tissue, leading to undesirable shifting and paravalvular leakage during implantation.
Innovation Solution
The use of a delivery apparatus with a spine assembly that transmits torque from the handle to the shaft, an adjustment mechanism for curvature control, and an indicator for visual manipulation, along with a seal assembly for secure attachment, ensures precise placement and anchoring of prosthetic heart valves using a docking device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a delivery apparatus is used to implant prosthetic heart valves, then the valve can be delivered through vasculature to the implantation site, but the valve may shift and cause paravalvular leakage due to inability to conform to native tissue geometry
Solution Approach 1:
The delivery apparatus incorporates a spine assembly with multiple segments that can be independently adjusted to change the curvature and shape of the shaft. This dynamic adjustment capability allows the distal end of the shaft to conform to the specific geometry of the native tissue at the implantation site, thereby improving valve placement stability and reducing paravalvular leakage.
Solution Approach 2:
The spine assembly allows modification of geometric parameters (curvature, bending, shaping) of the shaft distal end to match the native tissue geometry. By changing these physical parameters, the delivery apparatus achieves better conformity with the target tissue, ensuring reliable valve implantation without shifting.
2Strength
If the shaft is made rigid for structural support, then it can maintain its shape during delivery, but it cannot conform to the curvature of native tissue at the implantation site
Solution Approach 1:
The spine assembly is divided into multiple segments that can be independently adjusted. This segmentation allows the shaft to maintain overall structural support while enabling local curvature changes at the distal end to conform to native tissue geometry, resolving the contradiction between rigidity and adaptability.
Solution Approach 2:
The spine assembly transitions from a fixed rigid structure to a dynamically adjustable structure. The segments can be modified during the procedure to change the curvature of the shaft distal end, allowing it to adapt to different tissue geometries while maintaining sufficient structural support for delivery.
3Ease of operation
If the handle is designed with simple controls for ease of operation, then it is easy to manipulate, but it cannot provide precise control over shaft curvature and positioning
Solution Approach 1:
The handle incorporates an indicator assembly with windows and indicators that provide visual feedback on the curvature and positioning of the shaft distal end. This feedback mechanism allows operators to precisely control shaft curvature while maintaining ease of operation through intuitive visual guidance during manipulation.
Data Source
AI summary
A handle for a prosthetic implant delivery apparatus includes a plurality of knobs configured to control corresponding mechanisms of the delivery apparatus. Each knob has a color that is visually distinct from other knobs to indicate a unique function. In some instances, each knob is operably coupled to an indicator viewable through a window of the handle, and the indicator shares the same color as the corresponding knob to convey a functional relationship. Rotation or manipulation of a knob causes a corresponding adjustment mechanism, such as a pull wire, to actuate a feature of the delivery apparatus, for example, to control flex in different regions of a delivery shaft. A method for delivering a prosthetic implant includes manipulating one or more colored knobs to adjust aspects of the delivery apparatus and observing movement of matching-colored indicators to verify operation prior to or during implant deployment.