Collapsible Catheter Structure for Single-Sheath Multi-Device Access
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current percutaneous coronary intervention (PCI) procedures require multiple access points into the vasculature, leading to increased complications, contamination risks, and inefficiencies due to the need for multiple introducer sheaths and devices, particularly in cases involving vascular issues or complex procedures like CTO treatment.
Innovation Solution
A collapsible catheter system that allows multiple medical devices to be inserted through a single introducer sheath by varying its size to accommodate additional devices, using a flexible or rigid layer configuration or active deformation mechanisms to create an adjustable annular gap within the sheath.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple access points are used for device insertion, then more devices can be inserted into the vasculature, but the risk of complications and contamination increases
Solution Approach 1:
The patent implements nesting by placing multiple devices within a single introducer sheath. The first device is inserted through the sheath, and the second device is then passed alongside it within the same sheath lumen. This nested configuration allows multiple devices to access the vasculature through one entry point, reducing contamination risk while maintaining the ability to insert multiple devices.
Solution Approach 2:
The introducer sheath is designed as a universal access system that can accommodate multiple different types of medical devices simultaneously. The sheath's lumen is configured to receive and transport various devices (such as blood pumps and PCI devices) through a single access point, making the sheath multi-functional and eliminating the need for separate access sites for each device type.
2Device complexity
If a single introducer sheath is used for multiple devices, then access site management is simplified, but the sheath diameter must be large enough to accommodate all devices
Solution Approach 1:
The catheter incorporates a collapsible or expandable structure that can dynamically change its cross-sectional dimensions. When not in use, the catheter maintains a smaller profile to fit within the sheath alongside other devices. When needed, the catheter can be expanded or rigidized to perform its function, allowing the sheath to accommodate multiple devices without requiring an excessively large diameter.
Solution Approach 2:
The patent utilizes dimensional transformation by employing a catheter that can change from a compressed state during insertion to an expanded state during operation. This dimensional change allows the catheter to fit within the constrained space of the single sheath lumen during insertion, then occupy more space when deployed, effectively solving the space constraint problem.
3Adaptability or versatility
If devices are reduced in size to fit within a single sheath, then single-access insertion becomes possible, but device functionality may be compromised
Solution Approach 1:
The catheter employs dynamic structural changes, transitioning from a compressed delivery configuration to an expanded functional configuration. This allows the device to be small enough for single-sheath insertion while maintaining full functionality when deployed. The collapsible/expandable structure ensures that size reduction during insertion does not compromise operational capabilities.
Solution Approach 2:
The nested configuration allows the catheter to be positioned alongside other devices within the sheath without permanent size reduction. The catheter maintains its full functional dimensions when deployed in the vasculature, while only being compressed during the insertion phase within the constrained sheath space, thus preserving reliability.
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 single-access point insertion of multiple devices, reducing procedural complications, contamination risks, and access site management, while allowing for flexible device positioning and adaptation during procedures.
Implementation Method 1
the catheter frame is configured to deform from a first state, wherein the exterior circumference of the catheter in the first state defines a first annular gap between the exterior circumference and the inner circumference of the lumen, to a second state, wherein the exterior circumference of the catheter in the second state defines a second annular gap
Data Source
Figure 1A~1B
Figure 2~3
Figure 4
AI summary
An intravascular system includes an introducer sheath with fixed-diameter lumen, a medical device, and a catheter with a proximal end and a distal end coupled to the first medical device. When the catheter is positioned within the introducer sheath, an annular gap is formed between an exterior circumference of the catheter and an inner circumference of the lumen. The catheter is configured to take different dimensional configurations, such that the sizes of the catheter and the annular gap are variable. The variability of the size of the catheter allows another medical device to pass through the annular gap within the lumen. The catheter may change configurations passively as the second medical device is passed adjacently or by an active mechanism under a physician's control.