Hemostasis Valve Threaded Assembly for Leak-Resistant Sealing

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current medical devices, such as hemostasis valves, face challenges in effectively preventing fluid leakage during medical procedures, particularly in intravascular use, where fluid under pressure can escape or leak from the device.

Innovation Solution

A method for assembling a hemostasis valve involves positioning a plunger along a threaded proximal end region of a main body, aligning a nut with an axial slot, and rotating it to engage with the threads, which secures a cartridge and seal members, ensuring a fluid-tight seal by adjusting the position of the plunger and nut to control the seal members.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If traditional hemostasis valves are assembled using gluing methods, then assembly is simplified, but reliability and ease of repair deteriorate due to permanent bonding and inability to adjust components

Engineering Contradiction:
Improveassembly simplicityVSAvoidconnection reliability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The hemostasis valve is divided into modular components (body, plunger, cartridge, seal members) connected through threaded interfaces rather than permanent bonds. This segmentation allows individual components to be separated, inspected, replaced, or adjusted while maintaining reliable connections through mechanical threading, resolving the contradiction between assembly simplicity and connection reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The valve employs dynamic, adjustable connections through threaded fasteners and movable plunger mechanisms rather than static glued joints. The threaded nut and bolt assembly allows for adjustable tightening and positioning, enabling the system to adapt to different assembly requirements and maintain reliability while preserving ease of disassembly and repair.

Inventive Principle:
Principle #15Dynamics

2Ease of manufacture

If hemostasis valves use fixed seal positions, then manufacturing is simplified, but reliability deteriorates due to inability to adjust for manufacturing variations and pressure conditions

Engineering Contradiction:
Improveassembly simplicityVSAvoidseal effectiveness
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The seal members are positioned on movable components (plunger and cartridge) rather than fixed locations in the body. The plunger can be adjusted axially to position the first seal member, and the cartridge can be positioned to locate the second seal member. This dynamic positioning allows adjustment to compensate for manufacturing tolerances and optimize sealing under different pressure conditions while maintaining straightforward assembly procedures.

Inventive Principle:
Principle #15Dynamics

3Device complexity

If hemostasis valves are designed as integrated units, then device complexity is reduced, but ease of repair deteriorates due to inability to replace individual components

Engineering Contradiction:
Improvestructural simplicityVSAvoidcomponent replaceability
Core Design Contradiction:
Device complexityVSEase of repair

Solution Approach 1:

The valve is designed as a segmented assembly of distinct components (body, plunger, cartridge, seal members) connected through standardized threaded interfaces. This modular structure maintains relative structural simplicity while enabling individual components to be independently removed, replaced, or repaired without affecting the entire device, directly resolving the contradiction between structural simplicity and component replaceability.

Inventive Principle:
Principle #1Segmentation

4Ease of repair

If mechanical fittings are used instead of gluing, then ease of repair improves, but device complexity increases due to additional assembly steps and components

Engineering Contradiction:
Improvecomponent replaceabilityVSAvoidassembly complexity
Core Design Contradiction:
Ease of repairVSDevice complexity

Solution Approach 1:

The threaded fastener system serves multiple functions simultaneously: it provides secure mechanical connection, enables adjustable positioning of components, allows for easy disassembly and reassembly, and maintains alignment through features like alignment tabs and slots. This multi-functionality reduces the need for separate alignment features and simplifies the overall assembly process despite using mechanical fittings rather than gluing.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP3595763B1Hemostasis valves and methods for making and using hemostasis valves
Publication Date: 2023.06.14 BOSTON SCI MEDICAL DEVICE LTD
  • EP3595763B1 patent drawingFigure 1
  • EP3595763B1 patent drawingFigure 2
  • EP3595763B1 patent drawingFigure 3

AI summary

Hemostasis valves and methods for making and using hemostasis valves are disclosed. An example method for assembling a hemostasis valve may include positioning a plunger along a threaded proximal end region of a main body. The threaded proximal end region may include one or more threads and an axial slot extending through the one or more threads. The method may also include advancing the plunger along the threaded proximal end region to a position where a proximal end of the plunger is disposed distally of at least a portion of the one or more threads and disposing a nut adjacent to the threaded proximal end region. The method may also include aligning an alignment tab of the nut with the axial slot, engaging the nut with the one or more threads while the alignment tab is aligned with the axial slot, and rotating the nut 45-270.