Transcatheter Tissue Cutting System with Insulating Sheath
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Solution Overview
Problem
Transcatheter techniques for delivering prosthetic valves face challenges in accessing and positioning the valve correctly within the anatomy, with potential impact on surrounding tissue performance and patient health due to unwanted interactions.
Innovation Solution
A delivery system incorporating a tissue cutting system with a cutting element that can be coupled to a prosthetic valve, allowing for precise tissue cutting and adjustment, featuring a conductive cutting element with a protective cover and an outer sheath made of insulating or abrasion-resistant materials, which can be adjusted and deployed to facilitate implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If transcatheter techniques are used to deliver prosthetic valves, then patient trauma is minimized compared to surgical procedures, but challenges arise in properly accessing treatment regions and positioning the valve correctly
Solution Approach 1:
The delivery system is divided into multiple functional components including an outer sheath for navigation, a delivery device for positioning, and a tissue cutting system for preparation. This segmentation allows each component to be optimized for its specific function while working together to minimize trauma and improve positioning accuracy
Solution Approach 2:
The tissue cutting system is deployed before the prosthetic valve to pre-prepare the treatment site by cutting tissue. This preliminary action facilitates easier and more accurate positioning of the valve by removing tissue barriers and creating appropriate access pathways
2Manufacturing precision
If a tissue cutting system is added to the delivery device, then precise tissue cutting and positioning is enabled, but device complexity increases
Solution Approach 1:
The tissue cutting system is merged with the delivery device by coupling the cutting element to the delivery device or implant. This integration allows precise tissue cutting to be performed as part of the valve deployment process without requiring separate equipment, thereby enabling precision while managing complexity through consolidation
Solution Approach 2:
The delivery device is designed to perform multiple functions: navigating to the treatment site, positioning the prosthetic valve, and deploying the tissue cutting system. This multi-functionality reduces the need for separate specialized devices, achieving precise tissue cutting without proportionally increasing overall system complexity
3Productivity
If a conductive cutting element is used, then cutting performance is improved, but unwanted impact on surrounding tissue from electrical interaction may occur
Solution Approach 1:
The outer sheath is made of electrically insulating material at specific locations where it contacts or is near surrounding tissue, while the cutting element itself remains conductive for effective cutting. This localized differentiation of material properties allows high cutting efficiency at the cutting site while preventing unwanted electrical interaction with surrounding tissue through the insulating sheath
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 precise tissue cutting and minimizes unwanted tissue interaction, improving the positioning and performance of prosthetic valves during transcatheter procedures, thereby enhancing patient outcomes.
Implementation Method 1
the cutting element includes a body formed of conductive material
Implementation Method 2
the outer sheath comprises a thermally insulating material
Implementation Method 3
the outer sheath comprises an electrically insulating material
Data Source
AI summary
Systems and methods for cutting tissue using a transcatheter approach are disclosed. In some examples, the systems and methods are implemented as part of a delivery system that includes an implant with a support structure and a cutting element coupled to the support structure, such that the cutting element configured to cut tissue.