Heart Valve Delivery Catheter Handle for Precise Valve Positioning
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Solution Overview
Problem
Current heart valve delivery catheters lack precise release mechanisms, leading to inaccuracies in positioning prosthetic valves within the native annulus and potential trauma to the body channels during deployment and withdrawal.
Innovation Solution
The catheter design includes a handle assembly with two rotatable control knobs and a safety button, allowing for precise control of the distal tip and staged release of prosthetic valves, featuring a slotted tip for breaching the heart apex and sleeves for valve retention, minimizing trauma during deployment and withdrawal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a simple delivery catheter design is used, then device complexity is reduced, but positioning precision of the prosthetic valve deteriorates
Solution Approach 1:
The delivery catheter is divided into multiple functional segments: a control assembly with rotatable knobs for manipulating delivery shafts, a distal tip assembly with sleeves for valve retention, and an introducer sheath. This segmentation allows each component to perform its specific function independently, achieving precise positioning without requiring overall system complexity
Solution Approach 2:
The catheter incorporates preliminary positioning features including a slotted tip for accurate apex breaching, pre-positioned sleeves for valve retention, and control mechanisms that allow the operator to prepare the distal tip assembly before final valve deployment. These preliminary actions ensure accurate positioning is achieved before the critical deployment moment
2Productivity
If forceful deployment is used to deploy the prosthetic valve, then deployment speed is improved, but trauma to body channels increases
Solution Approach 1:
The catheter employs an introducer sheath as an intermediary protective element that guides the distal tip assembly and prosthetic valve through the body channels. The sheath protects the delicate valve structure during insertion and provides a smooth pathway for deployment, reducing trauma to surrounding tissues while maintaining efficient deployment speed
Solution Approach 2:
The design incorporates protective features beforehand, including the introducer sheath that cushions the valve during insertion and deployment, and a distal tip assembly that controls the release mechanism to prevent sudden forceful deployment. These cushioning measures are built into the system before the deployment action occurs
3Measurement precision
If precise release mechanisms are added to the catheter, then valve positioning accuracy is improved, but device complexity increases
Solution Approach 1:
The release mechanism is designed to be self-regulating through the interaction of control knobs, delivery shafts, and retaining sleeves. The operator's manipulation of the control knobs automatically translates to precise movement of the delivery shafts and controlled release from the sleeves, with the system's own components working together to achieve accurate positioning without requiring additional complex control systems
Data Source
AI summary
Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. Catheter assemblies according to the present invention can include a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A safety button can be included on the handle assembly to allow for precise and consistent positioning of the prosthetic valve in the body. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment.