Catheter Distal Tip Polymer Elastomer Lamination
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Solution Overview
Problem
Current clot retrieval devices face challenges in navigating tortuous blood vessels and effectively removing clots due to issues with catheter design, such as delamination at the distal tip, which affects deliverability and functionality.
Innovation Solution
The development of a clot capture catheter with a distal tip section comprising multiple layers of materials, including an inner layer of polymer material and outer layers of elastomeric material, which are laminated together to prevent delamination and enhance flexibility and deliverability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional funnel mouth catheters are used, then the catheter can be delivered to the target site, but delamination occurs at the distal tip section preventing effective clot removal
Solution Approach 1:
The catheter distal tip section uses a composite structure with an inner layer of polymer material (e.g., PTFE) and an outer layer of elastomeric material (e.g., polyurethane). This composite design combines the low friction properties of polymer with the flexibility and durability of elastomer, creating a stable bonded interface that prevents delamination while maintaining catheter functionality for clot removal.
Solution Approach 2:
The invention changes the material parameters of the catheter layers, specifically using a polymer inner layer with low coefficient of friction and an elastomeric outer layer with appropriate durometer hardness. This parameter optimization ensures proper adhesion between layers while maintaining the mechanical properties needed for effective operation in tortuous vessels.
2Ease of operation
If the catheter is made flexible to navigate tortuous vessels, then deliverability improves, but the catheter profile becomes too large for small target vessels
Solution Approach 1:
The catheter employs local quality differentiation where the distal tip section has a reduced profile compared to the proximal shaft. The multi-layer construction at the tip allows for a smaller outer diameter while maintaining flexibility, enabling the catheter to navigate tortuous vessels and access small target vessels like the distal ICA without being too bulky.
Solution Approach 2:
The catheter is segmented into distinct functional zones: a proximal shaft portion and a distal tip section with different dimensional characteristics. The distal tip section is specifically designed with reduced profile and optimized flexibility to navigate the neurovascular bed, while the proximal portion maintains structural integrity for manipulation.
3Area of stationary object
If the catheter is designed with a reduced profile for small vessels, then deliverability to target sites improves, but the catheter lacks the flexibility needed for tortuous vessels
Solution Approach 1:
The distal tip section uses a composite construction with an inner polymer layer providing structural support and an outer elastomeric layer providing flexibility. This allows the catheter to maintain a reduced profile for accessing small vessels while the elastomeric outer layer ensures sufficient flexibility to navigate tortuous vascular paths.
Solution Approach 2:
The catheter employs flexible thin film layers, particularly the elastomeric outer layer at the distal tip, which provides the necessary flexibility and compliance to navigate tortuous vessels. The thin film construction allows the catheter to bend and conform to the vascular anatomy without compromising the reduced profile design.
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 improved catheter design effectively prevents delamination, allowing for better navigation through tortuous vessels and enhanced capability to remove clots, thereby improving the success rate of intravascular medical treatments.
Implementation Method 1
an inner layer comprising a polymer material disposed within the tubular support and an outer layer comprising an elastomeric material disposed over the tubular support
Implementation Method 2
The first layer and the third layer can be joined at the distal end of the distal tip section
Implementation Method 3
The inner surface of the inner layer and second layer can be chemically etched. The outer surface and at least a distal portion of the inner surface of the second layer is chemically etched
Data Source
AI summary
A clot capture catheter that includes an elongate tubular shaft and a distal tip section that extends distally from the elongate tubular shaft. The elongate tubular shaft includes a proximal end, a distal end, a lumen, and a tubular support which includes an inner layer comprising a polymer material disposed within the tubular support and an outer layer comprising an elastomeric material disposed over the tubular support. The distal tip section includes a first layer and a third layer comprising an elastomeric material, and a second layer comprising a polymer material.