Re-entry Catheter Deflectable Struts Stabilization
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Solution Overview
Problem
Current re-entry catheters face challenges in navigating through occluded vessels, particularly in creating a passageway from a subintimal area back to the true lumen, due to difficulties in maintaining rotational orientation, stiffness, and flexibility, which complicates procedures like percutaneous transluminal coronary angioplasty and stent delivery.
Innovation Solution
A re-entry catheter design featuring an elongated outer tubular member with deflectable struts made from nickel-titanium alloy, an actuating member to radially expand the struts, and a lateral port for advancing a guidewire or cannula, allowing for stabilization and support while forming a passageway from the subintimal area to the true lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the catheter is made sufficiently flexible to navigate tortuous vasculature, then trackability is improved, but stiffness and pushability deteriorate
Solution Approach 1:
The catheter shaft is divided into multiple articulated segments that can flex relative to each other, allowing the catheter to navigate tortuous vasculature while maintaining overall structural integrity and pushability through the segmented construction
Solution Approach 2:
The catheter incorporates composite materials with varying mechanical properties along its length, providing flexible distal portions for navigation while maintaining stiffer proximal portions for pushability and torque transmission
2Manufacturing precision
If the catheter tip is stabilized to maintain rotational orientation for passageway formation, then re-entry precision is improved, but flexibility and trackability deteriorate
Solution Approach 1:
The catheter is segmented into a flexible distal portion for navigation and a stabilized proximal portion for precise re-entry, with articulation points that allow the flexible section to move independently while the proximal section maintains rotational stability
Solution Approach 2:
The catheter incorporates a rotatable component that allows independent rotation of the distal tip relative to the proximal shaft, enabling the tip to maintain orientation for passageway formation while the shaft remains flexible for navigation through tortuous vessels
3Strength
If the catheter is made stiffer to improve pushability and torque transmission, then stiffness is improved, but flexibility and ability to navigate tight bends deteriorate
Solution Approach 1:
The catheter shaft is divided into multiple articulated segments that can flex relative to each other, allowing the catheter to navigate tortuous vasculature while maintaining overall structural integrity and pushability through the segmented construction
Solution Approach 2:
Different portions of the catheter have different stiffness characteristics - the distal portion is more flexible for navigation while the proximal portion is stiffer for pushability, with transition zones that provide gradual mechanical property changes
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 catheter effectively facilitates the creation of a passageway into the true lumen by stabilizing the distal tip and providing sufficient stiffness and flexibility to navigate through tortuous vasculature, enhancing the success of interventions like angioplasty and stent delivery.
Implementation Method 1
a plurality of deflectable struts arranged longitudinally within the window, and an actuating member coaxially disposed within the outer tubular member, wherein proximal ends of the deflectable struts are operatively connected to a distal end of the actuating member, such that axial motion of the actuating member relative to the outer tubular member deflects the struts radially outward
Data Source
AI summary
This disclosure is directed to systems and methods for re-entering the true lumen of a vessel. The re-entry catheters employ deflectable struts to stabilize and support the distal tip in a subintimal location while a passageway back into the true lumen is formed. Re-entry to the true lumen can be effected with a cutting element or with a conventional guidewire.


