Hemostasis Bypass Valve Assembly for Low-Force Device Passage
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Solution Overview
Problem
Existing medical delivery devices face challenges with hemostasis valves that require significant force to pass medical devices, leading to potential contamination and damage due to pre-applied lubricants and increased risk of fluid leakage.
Innovation Solution
A delivery device with a hemostasis bypass assembly featuring a bypass tube actuated by a rotatable or axially translatable knob, allowing the bypass tube to traverse the hemostasis valve, reducing the force required to pass medical devices and minimizing contamination and leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hemostasis valve is used to maintain a fluid-tight seal, then fluid leakage is prevented, but significant force is required to pass medical devices through the valve
Solution Approach 1:
The system is divided into two pathways: a primary pathway through the hemostasis valve and a secondary bypass pathway. The bypass tube provides an alternative route that does not require passing through the restrictive valve structure, thereby reducing the force needed to deliver medical devices while the valve remains intact to maintain the fluid-tight seal.
Solution Approach 2:
The bypass tube acts as an intermediary element that mediates between the medical device and the hemostasis valve. By providing an alternative pathway, it allows the medical device to be delivered without directly interacting with the valve structure, thus reducing the force required while maintaining the valve's sealing function.
2Ease of operation
If pre-applied lubricants are used on the hemostasis valve to reduce friction, then ease of device passage is improved, but contamination risk increases
Solution Approach 1:
The lubrication function is extracted from the hemostasis valve itself and relocated to the bypass tube pathway. This allows the medical device to be lubricated and passed through the bypass tube without requiring lubricants on the hemostasis valve, thereby eliminating the contamination risk associated with pre-applied lubricants while maintaining ease of device passage.
Solution Approach 2:
The bypass tube serves as an intermediary pathway that separates the lubrication process from the hemostasis valve. By providing an alternative route that can be lubricated independently, it allows easy device passage without compromising the cleanliness and sterility of the hemostasis valve.
3Reliability
If a traditional hemostasis valve design is used, then fluid-tight sealing is maintained, but the structure complexity increases due to the need for high-force passage mechanisms
Solution Approach 1:
The delivery system is segmented into two distinct pathways: the original valve pathway and the new bypass pathway. This segmentation allows the bypass tube to handle the high-force passage requirement separately, enabling the hemostasis valve to maintain its simple fluid-tight sealing structure without the added complexity of high-force passage mechanisms.
Solution Approach 2:
The bypass tube acts as an intermediary structure that absorbs the mechanical stress and force requirements of device passage. This allows the hemostasis valve to maintain its simple, reliable sealing design without requiring complex reinforcement or additional mechanisms to handle high passage forces.
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 solution enables seamless passage of medical devices with reduced force, minimizing contamination and leakage, while maintaining a fluid-tight seal, thus enhancing the efficiency and reliability of medical device delivery.
Implementation Method 1
A wiper seal may be coupled to the hemostasis bypass assembly proximal to the hemostasis valve
Data Source
Figure 1
Figure 2
Figure 3A~3C
AI summary
A delivery device (10) may include a handle (100), a catheter sheath (600), and a hemostasis valve (240) positioned within the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube (380) coupled to an actuator (300). The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.