Variable Diameter Tubular Structure for Biomedical Introducers
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Solution Overview
Problem
Current introducer devices for biomedical applications require frequent replacement due to fixed diameters, leading to increased surgical time, tissue trauma, and bleeding, as they cannot easily adjust to varying diameters without applying radial force.
Innovation Solution
A variable diameter tubular structure made from an extruded and thermoformed polymeric material with sliding walls and a resilient sheath, allowing for expansion without external force and returning to original diameter when not in use, facilitating use as an introducer device with adjustable diameter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed diameter introducer device is used, then the device structure is simple and easy to manufacture, but multiple devices are required for different diameter needs, increasing surgical time and tissue trauma
Solution Approach 1:
The introducer device incorporates a dynamic diameter adjustment mechanism where the tube can transition between a collapsed low-diameter state and an expanded high-diameter state. This is achieved through a structure with radially movable walls that can be pushed outward by a dilator, allowing the same device to adapt to different diameter requirements during surgical procedures.
Solution Approach 2:
The device employs a nested configuration where the adjustable diameter tube is positioned within a dilator assembly. The tube can be inserted through the dilator in a collapsed state, then expanded to its full diameter by the dilator's pushing action, creating a compact nested structure that provides multiple functionality.
2Productivity
If multiple fixed diameter introducer devices are used, then each device has a specific fixed function, but the number of devices and operations increases, extending surgical time
Solution Approach 1:
The introducer device is designed as a universal multi-functional tool that can serve multiple purposes: it can be used in a collapsed state for initial insertion through small punctures, then expanded to different diameter configurations to accommodate various catheters and medical devices, eliminating the need for multiple separate introducers of different fixed diameters.
Solution Approach 2:
The dynamic diameter adjustment capability allows a single device to replace multiple fixed-diameter devices. The tube can be expanded or collapsed as needed during the surgical procedure, providing versatility and reducing the time required to switch between different introducer devices for different instrument sizes.
3Object-affected harmful factors
If frequent introducer device replacement is performed, then the fixed diameter limitation is addressed, but tissue trauma and bleeding time increase
Solution Approach 1:
The dynamic diameter adjustment mechanism allows the introducer to be expanded in-situ without removal, minimizing tissue manipulation. The tube walls can be pushed radially outward by the dilator to achieve the required diameter, and then maintained in that expanded state, avoiding repeated puncture and insertion trauma associated with exchanging multiple fixed-diameter devices.
Solution Approach 2:
The device is prepared in a collapsed low-diameter state for initial insertion through the puncture site, minimizing insertion trauma. Once inside the vessel, the tube is then expanded to the required diameter using the dilator, separating the insertion phase from the expansion phase to minimize tissue trauma while achieving the necessary diameter adaptability.
4Ease of manufacture
If an extruded and thermoformed tube with sliding walls is used, then the tube can be easily enlarged without radial force, but the manufacturing process becomes more complex
Solution Approach 1:
The manufacturing process utilizes parameter changes in the polymeric material, specifically employing extrusion to create the basic tube structure and then thermoforming to shape the radially movable wall sections. These thermal and mechanical parameter changes during manufacturing create the desired sliding wall mechanism that allows easy enlargement without requiring complex radial forcing mechanisms during use.
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
This solution reduces the need for multiple introducer devices, minimizes surgical and bleeding times, and decreases tissue trauma by allowing for adjustable diameters, enhancing surgical procedures and reducing vessel wall trauma.
Implementation Method 1
The present invention provides a plastics material tube having a variable diameter which may be advantageously used in the medical field
Implementation Method 2
a variable diameter tubular structure made from an extruded and thermoformed polymeric material with sliding walls and a resilient sheath, allowing for expansion without external force and returning to original diameter when not in use
Data Source
AI summary
A plastics material variable diameter tubular structure for a biomedical use has a diameter which increases as the structure is subjected to an inner force, and returns to a starting diameter in a rest condition of the structure, the tubular structure being advantageously used for making a body of a vascular introducer device.