Delivery System Projections for Prosthetic Heart Valve Positioning
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Solution Overview
Problem
Current prosthetic heart valve delivery systems face challenges in visualization and positioning due to the need for substantial contrast medium exposure and increased risk, particularly when using valves without control arms, which can result in a larger profile and reduced control during procedures.
Innovation Solution
Incorporating a support arm structure or projections on the delivery system rather than the prosthetic heart valve itself, allowing for tactile feedback and reduced reliance on fluoroscopy, enabling better control and alignment of the valve within the patient's heart, and accommodating various types of prosthetic heart valves, including those without control arms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If projections or control arms are attached to the prosthetic heart valve, then retention and positioning control are improved, but the profile of the prosthetic heart valve increases making the delivery system larger
Solution Approach 1:
The patent extracts the control function from the prosthetic heart valve itself and relocates it to the delivery system. Projections are attached to the delivery catheter rather than the valve, allowing the valve to maintain a compact profile while the delivery system provides the control arms functionality during implantation.
Solution Approach 2:
Instead of attaching control elements to the valve (traditional approach), the patent inverts the arrangement by attaching control projections to the delivery system. This reversal allows the valve to remain small while the delivery system provides positioning control.
2Measurement precision
If fluoroscopy is used to locate and align the prosthetic heart valve, then positioning accuracy is improved, but contrast medium exposure and patient risk increase
Solution Approach 1:
The projections on the delivery system provide tactile feedback to the operator during implantation, allowing direct physical sensing of valve position and alignment with native heart structures. This haptic feedback reduces reliance on fluoroscopic imaging and contrast medium.
Solution Approach 2:
The patent replaces optical imaging (fluoroscopy) with a mechanical sensing system. The projections physically interact with native heart structures, allowing the operator to feel and determine positioning through tactile cues rather than visual imaging.
3Adaptability or versatility
If the delivery system is designed to work with prosthetic heart valves without control arms, then versatility is improved, but control and manipulation during the procedure become more difficult
Solution Approach 1:
The delivery system is designed with integrated projections that provide control functionality regardless of whether the attached prosthetic valve has its own control arms. This universal design allows the same delivery system to effectively implant various valve types by providing control projections when needed.
Data Source
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AI summary
Delivery systems for delivering medical devices and prosthetic heart valves in a patient's body are disclosed. The delivery system may include a catheter-based delivery system. The delivery system may include a tip, a capsule, an inner sheath, and a projection. The delivery system may include an outer sheath and a handle. The delivery system may be configured to be actuated via an actuator disposed on the handle. The projection may include an arm portion and a feeler portion. The feeler portion may include an indentation. The delivery system may be configured to correctly position a medical device or prosthetic heart valve.