Split Funnel Crimping for Prosthetic Valves With Non-Crimped Parts
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Solution Overview
Problem
Conventional crimping devices are limited in their ability to effectively crimp medical devices such as stents and prosthetic valves, especially those made from rigid materials, and lack portability and mechanical advantage, particularly for devices with expanded diameters greater than 29 mm, due to their size and weight, and cannot accommodate medical devices with non-crimped components.
Innovation Solution
The development of crimping devices with crimping jaws driven by mechanisms out of the plane of crimping, such as axial motion perpendicular to the crimping plane, and the use of sloped guiderails or conical surfaces to actuate the jaws, allowing for radial compression and improved access to the medical device, along with funnel-shaped designs and rotating rollers to crimp medical devices while allowing non-crimped components to remain in their original configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If conventional crimping devices with in-plane mechanisms are used, then the device structure is simple, but the device size and weight increase for larger diameter stents (over 29 mm), reducing portability
Solution Approach 1:
The patent transitions from in-plane crimping mechanisms to out-of-plane mechanisms. The crimping jaws are driven by axial motion perpendicular to the crimping plane, allowing the mechanism to achieve the same crimping function with a more compact footprint. This dimensional change enables portability for large-diameter stents without proportionally increasing device weight
2Device complexity
If static conical tube method is used for crimping, then the device structure is simple, but it is ineffective for stents formed from rigid or stiff materials
Solution Approach 1:
The patent replaces the static conical tube with dynamic crimping jaws that can change diameter. The jaws are driven by axial motion to move radially inward, creating a dynamic crimping action that can adapt to rigid materials. This dynamic mechanism provides controlled radial compression that is effective for both easily deformable and rigid stent materials
Solution Approach 2:
The invention uses axial motion (out of the crimping plane) to drive radial crimping forces. This out-of-plane actuation mechanism allows the crimping jaws to effectively compress rigid stent materials by converting axial displacement into radial compression, overcoming the limitations of static conical tubes
3Ease of operation
If conventional in-plane crimping mechanisms are used, then the mechanism fits within the crimping plane, but the device size and weight increase, reducing portability
Solution Approach 1:
The patent positions the crimping jaw drive mechanism out of the crimping plane by using axial motion. This allows the actuation components to be arranged along the longitudinal axis rather than within the radial crimping plane, significantly reducing the device footprint and improving portability while maintaining full crimping functionality
4Device complexity
If conventional crimping devices are used, then the device structure is straightforward, but they cannot accommodate medical devices with non-crimped components
Solution Approach 1:
The patent creates selective access zones within the crimping device. The out-of-plane mechanism allows certain regions of the medical device to be exposed or accessible during crimping, enabling non-crimped components to be accommodated while other portions are crimped. This local differentiation in crimping action provides versatility for complex medical devices with mixed crimped and non-crimped features
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
These crimping devices provide enhanced mechanical advantage, portability, and the ability to crimp a wider range of medical devices, including those with expanded diameters greater than 29 mm, while allowing for proper positioning and alignment of components that are not crimped, thereby improving the crimping process and device delivery.
Implementation Method 1
The sloped guiderails can be configured to provide mechanical advantage in converting axial motion to radial crimping motion
Implementation Method 2
a plurality of crimping jaws secured to an outer annular frame positioned adjacent an external surface of an inner annular frame... Movement of the inner frame with respect to the outer frame along the longitudinal axis of the stent causes the crimping jaws to move closer together, thereby reducing the diameter of the stent
Data Source
AI summary
A crimping system for a prosthetic heart valve comprises a split funnel comprising an elongated annular body having an enlarged insertion end, a narrower outlet end, and a central opening extending along a central longitudinal axis of the split funnel, between the insertion end and the outlet end. The body comprises first and second slots extending axially along opposite sides of the body from the outlet end toward the insertion end, the first and second slots defining first and second split portions of the body extending circumferentially between the first and second slots on opposite sides of the central opening. The crimping device is configured to crimp a prosthetic heart valve moving axially through the central opening from the insertion end to the outlet end while allowing portions of the prosthetic heart valve to protrude through the first and second slots and remain in an expanded configuration.