Prosthesis Delivery Handle Assembly for Sequential Deployment
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Solution Overview
Problem
Current prosthesis delivery systems lack controlled and sequential deployment mechanisms, leading to potential premature or incorrect deployment of prostheses during medical procedures, which can compromise the effectiveness and safety of the implantation process.
Innovation Solution
A prosthesis delivery device with a handle assembly that includes a rotatable inner cannula and a coaxial sheath, where a second handle is longitudinally movable to retract the sheath and allow sequential release of the prosthesis, with a rotary dial mechanism to prevent premature deployment and ensure each step is completed before proceeding to the next, facilitating controlled deployment of bifurcated stent grafts in the aorta.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a simple delivery system is used, then device complexity is reduced, but deployment control and safety deteriorate due to inability to prevent premature or incorrect deployment
Solution Approach 1:
The delivery system is segmented into distinct functional components: an outer sheath for containment, an inner cannula for prosthesis support, and a handle assembly with separate control mechanisms (second handle for sheath retraction, rotary dial for proximal release). This segmentation allows independent control of each deployment step, preventing premature or incorrect deployment while maintaining manageable system complexity.
Solution Approach 2:
The system requires preliminary actions in a specific sequence: first the second handle is actuated to retract the sheath and expose the prosthesis, then the rotary dial is rotated to release the proximal end. This preliminary sequencing ensures that sheath retraction is completed before proximal release can occur, preventing premature deployment and ensuring reliable controlled deployment.
2Reliability
If sequential deployment control is implemented, then deployment safety is improved, but device complexity increases due to multiple handles and control mechanisms
Solution Approach 1:
The handle assembly incorporates dynamic elements that change state based on deployment progress: the second handle transitions from a retracted to an extended position to enable sheath retraction, and the rotary dial transitions from a locked to an unlocked state to enable proximal release. These dynamic states provide intuitive feedback to the operator and enforce the correct deployment sequence without requiring complex electronic controls.
Solution Approach 2:
The inner cannula acts as an intermediary element between the handle assembly and the prosthesis. It receives rotational input from the rotary dial and transmits it to the proximal end of the prosthesis for release. This intermediary mechanism simplifies the overall system by providing a direct mechanical connection that eliminates the need for complex wire-based or electronic release systems.
3Productivity
If the sheath is retracted early to expose the prosthesis, then deployment speed is improved, but premature deployment risk increases
Solution Approach 1:
The system requires the preliminary action of actuating the second handle to retract the sheath before the prosthesis can be deployed. This preliminary step ensures that sheath retraction is intentionally completed by the operator before any release occurs, preventing accidental premature deployment while maintaining efficient deployment speed through direct mechanical coupling.
Solution Approach 2:
The deployment process is divided into distinct periodic stages: Stage 1 involves actuating the second handle to retract the sheath and expose the prosthesis, and Stage 2 involves rotating the rotary dial to release the proximal end. This periodic structure ensures that each stage is completed deliberately before proceeding to the next, controlling deployment timing while maintaining efficiency.
Data Source
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AI summary
A prosthesis delivery device and method of using the same is described. The delivery device comprises a rotatable inner cannula (310) extending from a proximal end to a distal end with a prosthesis releasably coupled to the proximal end. A delivery handle assembly is disposed at the distal end of the delivery device. The handle comprises a first handle disposed about the inner cannula (310), a rotary dial disposed about the rotatable inner cannula and a second handle disposed about at least a portion of the distal end of the first handle. The second handle is longitudinally moveable relative to the first handle between a first position wherein the sheath is coaxially disposed about the prosthesis and rotation of the rotary dial is prevented, and a second position wherein the sheath is retracted distally to expose at least a portion of the prosthesis and rotation of the dial is permitted.