Heart Valve Delivery Catheter Safety Button for Controlled Valve Release
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current delivery catheters for prosthetic heart valves lack precise release mechanisms, leading to potential errors in positioning the valve within the native annulus and causing trauma to the body channels during deployment and withdrawal.
Innovation Solution
The catheter assembly features a handle design with two rotatable control knobs and a safety button, allowing for precise control of the distal tip, including a slotted tip for breaching the heart apex and sleeves for retaining and releasing the prosthetic valve, ensuring accurate deployment and withdrawal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a simple delivery catheter design is used, then the device complexity is reduced, but the positioning precision of the prosthetic valve deteriorates
Solution Approach 1:
The delivery catheter is divided into multiple functional segments: a handle assembly with control knobs for operator manipulation, a shaft for delivery, a distal tip assembly with sleeves for valve retention and release, and an introducer sheath for initial access. This segmentation allows each component to be optimized for its specific function while maintaining overall system precision.
Solution Approach 2:
The catheter incorporates dynamic control mechanisms including rotatable control knobs that enable precise angular adjustment of the distal tip, and a safety button that provides controlled release of the prosthetic valve. These dynamic elements allow the operator to make real-time adjustments to achieve accurate positioning.
2Measurement precision
If a precise release mechanism is added to improve valve positioning, then the positioning precision is improved, but the device complexity increases
Solution Approach 1:
The safety button acts as an intermediary control element between the operator and the valve release mechanism. It provides a simple, intuitive interface that triggers a predetermined sequence of release actions, reducing the cognitive load on the operator while ensuring precise and consistent valve deployment.
Solution Approach 2:
The release mechanism is designed to automatically execute the valve deployment sequence once the safety button is activated. The system self-regulates the release process through pre-configured mechanical linkages and spring-loaded components, eliminating the need for complex manual manipulation during the critical release phase.
3Force
If the distal tip is made sharp for breaching the heart apex, then the penetration capability is improved, but the trauma to the body channels increases
Solution Approach 1:
The distal tip is pre-formed with a sharp, slotted configuration that facilitates clean breaching of the heart apex. The slots in the tip structure allow controlled tissue separation and reduce the risk of uncontrolled tearing, enabling effective penetration while minimizing collateral damage to surrounding tissues.
Solution Approach 2:
The sharp, penetrating quality is localized specifically to the distal tip of the catheter, while the remainder of the catheter shaft maintains a smooth, compliant structure. This localized differentiation allows the tip to effectively breach tissue barriers without transmitting excessive force or causing trauma along the entire catheter length.
4Ease of operation
If control knobs are added for precise manipulation, then the ease of operation is improved, but the device complexity increases
Solution Approach 1:
The control knobs are designed to perform multiple functions: they control the angular orientation of the distal tip, regulate the advancement of the catheter shaft, and in conjunction with the safety button, control the valve release sequence. This multi-functionality reduces the number of separate controls needed while maintaining comprehensive operational precision.
Data Source
Figure 1
Figure 2
Figure 3
AI summary
Valve delivery catheter assemblies (100) 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 (102), an introducer sheath (116), and a distal tip assembly (104). The handle assembly can include a fixed main handle (108) and two or more rotating handles (110,112) that allow a user to control the distal tip assembly of the catheter. A safety button (1403) 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.