Cuttable Catheter Hub with Segmented Hemostasis Seal
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Solution Overview
Problem
Current catheter hemostasis valves and hubs face challenges in facilitating the removal of catheters from a patient's body while maintaining a medical lead in place, requiring improved sealing and reduced resistance during device insertion and removal.
Innovation Solution
A catheter hemostasis valve hub design featuring a tubular shell with varying thickness regions, a hemostasis seal with axial slits, and an end cap that retains the seal within the shell, allowing for smooth transition and reduced resistance during catheter removal, while maintaining a fluid seal and facilitating flushing and aspiration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hemostasis valve is coupled to the hub to control blood flow, then sealing effectiveness is improved, but resistance to device insertion and removal increases
Solution Approach 1:
The hemostasis seal is divided into multiple functional regions: a first region with a slit for device passage and a second region with varying thickness. The slit segment allows medical devices to pass through with reduced resistance, while the thicker second region maintains sealing effectiveness. This segmentation resolves the contradiction by creating distinct zones for different functions within the same seal structure.
Solution Approach 2:
The seal incorporates a first region with a slit having specific dimensional characteristics and a second region with different thickness properties. The slit region is optimized for low-friction device passage, while the thicker second region provides enhanced sealing. This local differentiation of properties allows the seal to simultaneously reduce insertion resistance and maintain reliable hemostasis.
2Strength
If the shell thickness is increased to improve structural strength, then strength is improved, but ease of cutting the hub decreases
Solution Approach 1:
The shell is divided into a first region with reduced thickness and a second region with greater thickness. The first region is specifically designed to be easier to cut, facilitating hub modification during procedures, while the second region maintains overall structural strength. This segmentation allows differential optimization of cutting ease and strength in different portions of the same component.
Solution Approach 2:
The shell incorporates a first region with thickness optimized for ease of cutting and a second region with increased thickness for structural strength. This local variation in thickness allows the hub to be easily cut where needed while maintaining sufficient overall strength to support the hemostasis valve and withstand operational forces.
3Ease of operation
If a hemostasis seal with axial slits is used to reduce insertion resistance, then ease of operation is improved, but sealing reliability may be compromised
Solution Approach 1:
The seal is segmented into a first region containing axial slits for device passage and a second region with enhanced thickness for sealing. The slitted first region reduces insertion resistance by allowing device passage through pre-formed openings, while the thicker second region compensates for any potential sealing compromises and maintains hemostatic reliability.
Solution Approach 2:
The seal features a first region with axial slits optimized for low-friction device insertion and a second region with increased thickness optimized for sealing reliability. This local differentiation allows the seal to simultaneously facilitate easy device insertion through the slitted region while maintaining reliable hemostasis through the thicker second region.
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 design enables efficient removal of catheters with a medical lead in place, reducing resistance and maintaining effective sealing, thus improving the ease and safety of medical procedures.
Implementation Method 1
The seal is disk-shaped and is composed of a thermoplastic styrenic elastomer... The seal is contained in a valve body and is compressed between a valve seat in the valve body and a cap connected to the valve body.
Implementation Method 2
The seal is composed of a thermoplastic styrenic elastomer, such as a styrene-ethylene/butylene-styrene block copolymer, of low durometer
Data Source
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AI summary
A catheter hemostasis valve hub for a catheter or introducer sheath has a generally tubular shell with a first region and a second region having a greater thickness than the first region, a pre-slit hemostasis seal within the shell, and an end cap to retain the hemostasis seal within the shell having a web section. The hub is easily cut or slit after introduction of the catheter without prior breaking.