Crimping Self-Expanding Devices While Maintaining Sterility
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Solution Overview
Problem
There are challenges in crimping self-expanding devices to an unexpanded configuration due to their geometry and the need to maintain sterility, which complicates their deployment in minimally invasive medical procedures.
Innovation Solution
The development of crimping devices with various crimping members such as sutures, wires, ribbons, and holding structures that can engage self-expanding devices to reduce them from an expanded to an unexpanded configuration, while being compatible with drug delivery systems and maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If crimping devices are used to reduce self-expanding devices to unexpanded configuration, then the self-expanding devices can be delivered through minimally invasive approaches, but the crimping process may compromise sterility or damage the device geometry
Solution Approach 1:
A sterile barrier or protective sheath is introduced as an intermediary between the crimping mechanism and the self-expanding device. This barrier allows the crimping action to be applied while maintaining sterility, preventing direct contact between non-sterile crimping components and the sterile medical device.
Solution Approach 2:
The self-expanding device is pre-coated or pre-prepared with sterile protective layers before crimping. This preliminary protective action ensures that when the crimping process begins, the sterility barrier is already in place, preventing contamination during the reduction process.
2Productivity
If crimping members are used to reduce self-expanding devices, then the device can be compressed to unexpanded configuration, but the crimping members may damage the device geometry or embedded drugs
Solution Approach 1:
The crimping members are designed with differentiated local properties - softer, more compliant surfaces contact the self-expanding device to apply crimping force, while harder, more rigid portions maintain structural integrity. This local quality differentiation allows efficient crimping without damaging the device geometry or embedded pharmaceutical agents.
Solution Approach 2:
The crimping members utilize changeable parameters such as elastic deformation or shape memory properties, allowing them to adapt their physical characteristics during the crimping process. This enables the members to apply sufficient force for compression while automatically adjusting to preserve the device's geometric precision and drug integrity.
3Ease of operation
If the crimping device includes holding structures and passage units, then the self-expanding device can be securely held and manipulated, but the device complexity increases
Solution Approach 1:
The holding structures and passage units are designed to serve multiple functions: they provide structural support, guide the crimping members, maintain sterility barriers, and facilitate device retrieval. This multi-functionality reduces the need for separate specialized components, thereby limiting the increase in overall device complexity while maintaining ease of operation.
Data Source
AI summary
Described here are devices and methods for crimping self-expanding devices. The crimping devices may be useful for crimping a variety of different self-expanding devices (whether such devices are biodegradable or bio-durable). The crimping devices may have crimping members to engage the self-expanding device to reduce the device from an expanding configuration to an unexpanded configuration. The crimping member may comprise or include a suture, wire, ribbon, guiding hoop, pusher, prong, holding bar, balloon, jaws, combinations thereof, or the like. The crimping devices may also include or comprise a holding structure to hold the self-expanding device in an unexpanded or expanded configuration.