Transcatheter Implant Delivery With Swivel Alignment and Resheathing
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Solution Overview
Problem
Existing transcatheter techniques for delivering and deploying expandable stents to heart valves face challenges in engaging, loading, translating, repositioning, resheathing, and deploying the stent within the heart chamber efficiently.
Innovation Solution
The use of a self-expandable implant made from superelastic materials like Nitinol or titanium alloys, with a swivel body and hinge block mechanism, allows for precise deployment and repositioning of the stent within the heart chamber, utilizing a delivery cable and pusher catheter system for controlled expansion and alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a self-expandable implant with swivel body and hinge block mechanism is used, then deployment precision and repositioning capability are improved, but device complexity increases
Solution Approach 1:
The implant is divided into multiple functional segments including a swivel body portion and a hinge block mechanism. The swivel body allows rotational movement for orientation adjustment, while the hinge block provides controlled expansion and repositioning capability. This segmentation enables precise deployment through independent control of each functional component.
Solution Approach 2:
The implant incorporates dynamic elements including a swivel body that can rotate to adjust orientation, and a hinge block mechanism that enables controlled expansion and repositioning. These dynamic features allow the implant to adapt its configuration during deployment to achieve precise positioning while managing the complexity through controlled mobility.
2Adaptability or versatility
If superelastic materials like Nitinol are used, then flexibility and repositioning capability are improved, but manufacturing complexity increases
Solution Approach 1:
The implant utilizes superelastic materials such as Nitinol that exhibit unique stress-strain characteristics. These materials can undergo large deformations and return to their original shape, enabling the implant to be compressed for delivery through catheters and then self-expand at the target site. The superelastic property allows for repositioning capability while the material's inherent properties simplify the manufacturing process compared to traditional metallic alloys.
Solution Approach 2:
The implant employs superelastic Nitinol material that combines elastic properties with shape memory characteristics. This composite material behavior allows the implant to maintain flexibility for repositioning while providing sufficient structural support. The use of established superelastic materials leverages existing manufacturing processes, reducing overall manufacturing complexity despite the advanced material properties.
3Object-affected harmful factors
If the stent is delivered percutaneously via transcatheter techniques, then invasiveness is reduced, but control during delivery and deployment becomes more difficult
Solution Approach 1:
The self-expandable implant is nested within a delivery catheter system that provides remote control capabilities. The implant is compressed and contained within the catheter for percutaneous delivery through blood vessels to the heart valve. Once positioned, the implant is deployed by manipulating the catheter, allowing control during delivery and deployment while maintaining the benefits of minimally invasive percutaneous access.
Solution Approach 2:
The delivery catheter acts as an intermediary between the operator and the implant during percutaneous delivery. The catheter system provides mechanical control and support for the implant throughout the delivery process, enabling precise positioning and controlled deployment. This intermediary mechanism allows the operator to maintain control over the implant despite the constraints of percutaneous access through small incisions.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables efficient and controlled delivery and deployment of the stent within the heart chamber, ensuring proper positioning and alignment of the stent, even after withdrawal of the delivery cable, thereby enhancing the effectiveness of transcatheter valve replacement procedures.
Implementation Method 1
a self-expandable implant made from superelastic materials like Nitinol or titanium alloys
Data Source
AI summary
Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing.