Dynamic Flexible Spindle for Transcatheter Delivery
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Solution Overview
Problem
Current transcatheter delivery devices face challenges in navigating tortuous anatomy, particularly the aortic arch, due to the rigidity of the spindle, which affects prosthesis deployment accuracy and flexibility during navigation and deployment.
Innovation Solution
A dynamically flexible spindle with selectively stiffening or flexible properties, utilizing spine wires that can be retracted or advanced within lumens to adjust rigidity, allowing for precise navigation and accurate deployment of the stented prosthesis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the spindle is made rigid to improve prosthesis deployment accuracy, then deployment precision is improved, but the ability to navigate tortuous anatomy deteriorates
Solution Approach 1:
The spindle's rigidity is made dynamic rather than static. During navigation, the spindle remains flexible to navigate tortuous anatomy. During deployment, the spindle becomes rigid to ensure accurate prosthesis positioning. This temporal separation of flexibility and rigidity resolves the contradiction between navigability and deployment precision.
Solution Approach 2:
The physical parameter of rigidity is changed based on procedural needs. The spindle transitions from a flexible state during navigation to a rigid state during deployment. This parameter change allows the same component to satisfy both contradictory requirements at different stages of the procedure.
2Ease of operation
If the spindle is made flexible to improve navigation through tortuous anatomy, then navigability is improved, but prosthesis deployment accuracy deteriorates
Solution Approach 1:
The spindle transitions from a flexible state during navigation to a rigid state during deployment. This dynamic property change ensures that the spindle can navigate tortuous anatomy when flexible, then maintain precise positioning when rigid during prosthesis deployment.
Solution Approach 2:
The rigidity parameter of the spindle is adjusted based on procedural requirements. The spindle is flexible during navigation to access difficult anatomical locations, then becomes rigid during deployment to ensure accurate prosthesis placement. This parameter adjustment resolves the trade-off between navigability and precision.
3Stability of the object's composition
If a rigid spindle is used to maintain stability during prosthesis deployment, then deployment stability is improved, but the ability to conform to complex vascular geometry deteriorates
Solution Approach 1:
The spindle's mechanical properties are made dynamic, allowing it to be flexible during navigation to conform to vascular geometry, then stable and rigid during deployment. This temporal separation resolves the contradiction between adaptability to anatomy and stability during the deployment process.
Data Source
AI summary
The present disclosure provides a delivery device including an inner shaft assembly including an inner shaft having a proximal end and a distal end and a lumen. The inner shaft further includes a spindle connected to the distal end of the inner shaft and the spindle includes a body and a side lumen offset with respect to a central axis of the spindle. The delivery device further includes a spine wire that can slide within both the lumen of the inner shaft and the side lumen of the spindle. Additional lumens and spine wires can be provided. The disclosure further includes methods of using the delivery devices of the disclosure for delivery a stented prosthesis, for example.