Implant Tissue Protection Tool for Crimping
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Solution Overview
Problem
Medical devices like stents and prosthetic valves face issues during crimping due to design features such as large outflow frame cells or wide leaflets, leading to pinching and damage, which affects their durability and functionality.
Innovation Solution
An implant tissue protection tool with an outer portion and protrusions is used to surround and protect tissue layers, preventing them from passing through openings during crimping by pushing radially inward, thus minimizing pinching and damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the medical device is crimped to facilitate delivery through a delivery device with smaller radial dimensions, then the device can be successfully delivered to the implantation site, but the tissue layers (e.g., leaflets) become pinched and damaged between struts
Solution Approach 1:
A protection tool is introduced as an intermediary component between the tissue layer and the strut during crimping. The tool includes an outer portion that surrounds the tissue layer and protrusions that extend into the openings to push the tissue layer away from the strut, preventing direct contact and pinching while allowing the crimping process to proceed
Solution Approach 2:
The protection tool is applied to the medical device before crimping begins. The outer portion is positioned around the tissue layer and the protrusions are placed in the openings prior to applying crimping force, so that the protective action starts before the harmful pinching can occur
2Force
If the crimping force is increased to ensure proper compression of the medical device, then the device achieves its final profile for delivery, but the risk of leaflet pinching and cuts increases
Solution Approach 1:
The protection tool acts as a mediator that allows high crimp forces to be applied to the medical device without transmitting those forces directly to the tissue layer. The outer portion and protrusions distribute the mechanical stress, enabling sufficient compression while protecting the leaflets from damage
Solution Approach 2:
The protection tool provides beforehand cushioning by positioning itself between the tissue layer and the strut before crimping begins. The protrusions in the openings act as cushioning elements that prevent direct transmission of crimping forces to the leaflets, reducing the risk of pinching and cuts
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
The tool effectively prevents tissue layer pinching and damage during crimping, enhancing the long-term durability and functionality of medical devices by ensuring they are not caught between struts, allowing for successful implantation without compromising the device's integrity.
Implementation Method 1
the at least one protrusion being configured to minimize occurrence of the at least one tissue layer of the medical device passing through at least one opening defined at least in part by two or more struts of the medical device during crimping of the medical device by a crimping device
Data Source
AI summary
Novel tools and techniques are provided for implementing protection of at least one tissue layer of a medical device or implant during crimping of the medical device or implant. In various embodiments, an implant tissue protection tool may include an outer portion configured to surround one or more outer segments of at least one tissue layer of a medical device to be implanted into a body of a subject and at least one protrusion (which may be affixed to a surface of the outer portion) configured to minimize or prevent occurrence (or likelihood of occurrence) of the at least one tissue layer (in some cases, leaflet material, or the like) of the medical device passing through at least one opening defined by a frame structure of the medical device during crimping of the medical device by a crimping device in preparation for implantation into the body of the subject.