Implant Tissue Protection Tool for Crimping
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Solution Overview
Problem
Medical devices, such as stents and prosthetic valves, are prone to tissue damage during crimping due to pinching of leaflets between struts, leading to durability issues and functionality problems during implantation.
Innovation Solution
An implant tissue protection tool with an outer portion and protrusions that surround the tissue layer, preventing it from passing through openings in the stent frame during crimping, thereby minimizing pinching and damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If crimping forces are applied to compress the medical device for delivery, then the device can be delivered through smaller catheters, but tissue layers become pinched between struts causing damage
Solution Approach 1:
A protection tool is introduced as an intermediary element between the crimping system and the tissue layers. This tool includes features such as protrusions or barriers that physically prevent tissue from being pinched between the struts during compression, allowing the crimping force to be applied without causing tissue damage
2Area of stationary object
If large outflow frame cells or openings are used in medical device design, then blood flow is improved, but tissue is more susceptible to pinching during crimping
Solution Approach 1:
The protection tool serves as a mediator that allows large frame cells to be used for improved blood flow while preventing the associated pinching risk during crimping. The tool's design features specifically target the openings to prevent tissue intrusion during compression
3Adaptability or versatility
If wide and long leaflets are used in prosthetic valves, then valve functionality is improved, but leaflet pinching occurs during crimping leading to peeling and cuts
Solution Approach 1:
The protection tool acts as a mediator during the crimping process, preventing wide and long leaflets from being caught between struts. This allows functional leaflet designs to be used while protecting them from mechanical damage that would compromise their durability
Solution Approach 2:
The protection tool is positioned on the device before crimping begins, establishing protective barriers in advance to prevent leaflet pinching during the subsequent compression process
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.