Catheter Handle Segmentation for Valve Placement Precision
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Solution Overview
Problem
Current heart valve delivery catheters lack a precise release mechanism, leading to potential errors in positioning prosthetic valves during implantation, and they do not adequately minimize trauma to the expanded valve and body channels during withdrawal.
Innovation Solution
A delivery catheter with a handle design featuring two or more rotatable control knobs for precise manipulation of the distal tip, allowing for controlled release and withdrawal of the prosthetic valve, including a slotted tip for breaching the heart and sleeves for retaining and releasing the valve, minimizing trauma and ensuring accurate placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
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 handle assembly is segmented into multiple independent control knobs (first control knob, second control knob, third control knob) that can be rotated independently. Each control knob manipulates a separate delivery shaft (first delivery shaft, second delivery shaft, third delivery shaft), allowing precise independent control of different catheter components. This segmentation enables fine-tuned positioning of the distal tip and control of valve release without requiring complex integrated mechanisms.
Solution Approach 2:
The delivery shafts are designed to be rotatable and movable relative to each other, transforming the static handle into a dynamic control system. The first delivery shaft can rotate independently, the second delivery shaft can move distally and proximally, and the third delivery shaft can rotate independently. This dynamic capability allows the operator to precisely adjust the distal tip position and control valve deployment timing, achieving accurate valve placement while maintaining a relatively simple overall device structure.
2Loss of time
If the distal tip is withdrawn quickly through the expanded valve, then the procedure time is reduced, but the trauma to the body channels and valve increases
Solution Approach 1:
The second delivery shaft is designed with distal and proximal movement capability, allowing the operator to dynamically control the withdrawal speed and direction. The shaft can be moved distally to deploy the valve and then proximally to withdraw it. This dynamic control enables a gradual, controlled withdrawal process that minimizes mechanical trauma to the body channels and the newly implanted valve, while still completing the procedure efficiently.
3Adaptability or versatility
If the valve is released early during delivery, then the positioning flexibility is improved, but the risk of misplacement increases
Solution Approach 1:
The valve release mechanism is segmented and distributed across multiple delivery shafts rather than being controlled by a single mechanism. The first delivery shaft controls initial positioning, the second delivery shaft controls valve release timing, and the third delivery shaft provides additional positioning control. This segmented control system allows the operator to progressively adjust the valve position and only release when optimal placement is achieved, thereby maintaining positioning flexibility while ensuring placement accuracy.
Solution Approach 2:
The multi-shaft control system provides inherent feedback to the operator. By independently manipulating each delivery shaft and observing the corresponding changes in catheter and valve position, the operator can continuously assess placement accuracy and make real-time adjustments before final valve release. This feedback mechanism reduces the risk of misplacement while preserving the ability to adjust positioning as needed.
Data Source
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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. In one embodiment, a catheter assembly according to the present invention includes 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 valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.