Prosthetic Heart Valve Delivery Steering for Precise Positioning
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Solution Overview
Problem
Existing delivery devices for prosthetic heart valves have a large crimp profile, inhibiting advancement through the vasculature and compromising precision in positioning, and lack sufficient control mechanisms for accurate implantation.
Innovation Solution
A delivery apparatus with a handle, first and second shafts, and a steering assembly that allows for longitudinal motion and flexing of the second shaft relative to the first, enabling precise positioning and reduced profile for prosthetic valve deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the catheter assembly is designed with a smaller profile to facilitate advancement through the vasculature, then the ease of operation is improved, but the flexural strength of the catheter assembly is reduced
Solution Approach 1:
The catheter assembly is divided into multiple shafts (first shaft and second shaft) with different structural characteristics. The first shaft provides structural support while the second shaft accommodates the prosthetic valve, allowing each segment to be optimized for its specific function - the first shaft maintains strength while the second shaft achieves smaller profile.
Solution Approach 2:
The second shaft is disposed within the first shaft in a nested configuration. This nesting allows the prosthetic valve delivery system to achieve a smaller overall profile for vascular advancement while the outer first shaft maintains the necessary flexural strength and structural integrity.
2Adaptability or versatility
If the delivery device is made relatively long to reach the implantation site, then the adaptability is improved, but the manufacturing precision of valve positioning is worsened due to unwanted movement
Solution Approach 1:
The steering assembly enables dynamic control of the catheter's distal end through longitudinal motion and flexing. This dynamic capability allows the physician to adjust the positioning of the prosthetic valve in real-time during the procedure, compensating for the length of the delivery device and maintaining precise control over valve placement.
Solution Approach 2:
The steering assembly changes the physical parameters of the second shaft by inducing flexing and longitudinal motion. This allows the distal end of the catheter to be positioned independently from the handle, enabling precise valve placement despite the overall length of the delivery device.
3Ease of operation
If the catheter assembly is reduced in diameter to minimize profile, then the ease of operation is improved, but the flexural strength is reduced complicating advancement and positioning
Solution Approach 1:
The catheter is segmented into multiple functional shafts where the first shaft provides structural support and the second shaft provides flexibility and access. This segmentation allows the overall assembly to achieve a reduced diameter while maintaining the necessary mechanical properties for advancement and positioning through the vasculature.
Data Source
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AI summary
A delivery apparatus for implanting a prosthetic implant in a native lumen of the body includes a handle portion, and a first shaft extending from and movable relative to the handle portion. The first shaft has a proximal end portion coupled to the handle portion and a distal end portion. The delivery apparatus further includes a second shaft extending from the handle portion and coaxially disposed within the first shaft. The second shaft has a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic implant in a radially compressed state. The handle portion of the delivery apparatus also includes a steering assembly configured to move the first shaft longitudinally relative to the second shaft while concurrently flexing the second shaft.