Hemostasis Valve Cartridge Locking to Prevent Seal Distortion

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Solution Overview

Problem

Existing medical devices face challenges in effectively preventing fluid leakage, particularly blood leakage, during medical procedures due to the presence of fluid under pressure within body lumens, and existing hemostasis valves may not adequately limit rotational forces that can distort seals, leading to incomplete sealing.

Innovation Solution

A hemostasis valve design featuring a main body with recesses and a cartridge with projections that engage to limit rotational movement, coupled with a plunger mechanism to control seal engagement, ensuring secure sealing against fluid leakage by using materials like metals, polymers, and composites.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a hemostasis valve uses a cartridge with seal members to prevent fluid leakage, then sealing effectiveness is improved, but rotational forces can distort the seals leading to incomplete sealing

Engineering Contradiction:
Improvesealing effectivenessVSAvoidseal distortion
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The valve assembly is segmented into a stationary main body and a movable cartridge that can be independently positioned. The cartridge contains the seal members and can be advanced or retracted relative to the main body, allowing the seals to be engaged or disengaged from the flow path without rotating the entire valve assembly. This segmentation isolates the seals from rotational forces while maintaining sealing effectiveness.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The recesses in the main body are strategically positioned to receive and stabilize the cartridge in specific angular orientations. By creating localized engagement features at specific positions, the design ensures the cartridge maintains a fixed orientation that prevents seal distortion while allowing linear movement for sealing control.

Inventive Principle:
Principle #3Local quality

2Power

If a hemostasis valve allows high-pressure fluid infusion, then fluid delivery capability is improved, but fluid leakage prevention becomes more difficult

Engineering Contradiction:
Improvefluid delivery capabilityVSAvoidleakage prevention
Core Design Contradiction:
PowerVSReliability

Solution Approach 1:

The valve employs dynamic seal engagement where the cartridge can be advanced to engage seal members against sealing surfaces, creating a tight seal that withstands high fluid pressures. The plunger mechanism allows dynamic adjustment of seal position and contact pressure, enabling the seals to adapt to pressure changes and maintain reliable leakage prevention during high-pressure infusion.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The seal members are constructed from composite materials combining soft elastomeric sealing surfaces with harder structural supports. This composite construction allows the seals to deform slightly under high pressure to maintain contact with sealing surfaces while the structural support prevents excessive deformation that would cause failure or leakage.

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If the cartridge is freely movable within the main body, then operational flexibility is improved, but rotational movement can occur causing seal distortion

Engineering Contradiction:
Improveoperational flexibilityVSAvoidrotational stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The valve assembly is segmented into a stationary main body and a movable cartridge that can be independently positioned. The cartridge contains the seal members and can be advanced or retracted relative to the main body, allowing the seals to be engaged or disengaged from the flow path without rotating the entire valve assembly. This segmentation isolates the seals from rotational forces while maintaining sealing effectiveness.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The recesses in the main body are strategically positioned to receive and stabilize the cartridge in specific angular orientations. By creating localized engagement features at specific positions, the design ensures the cartridge maintains a fixed orientation that prevents seal distortion while allowing linear movement for sealing control.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3595766B1Hemostasis valves and methods for making and using hemostasis valves
Publication Date: 2025.07.02 BOSTON SCI MEDICAL DEVICE LTD
  • EP3595766B1 patent drawingFigure 1
  • EP3595766B1 patent drawingFigure 2
  • EP3595766B1 patent drawingFigure 3

AI summary

Hemostasis valves and methods for making and using hemostasis valves are disclosed. An example hemostasis valve may include a main body having a distal end region and a proximal end region. A first seal member may be disposed within the proximal end region of the main body. A cartridge may be at least partially disposed within the proximal end region of the main body. The cartridge may include a second seal member. The cartridge may have one or more projections formed thereon. The proximal end region of the main body may have one or more recesses formed therein. The one or more recesses may be designed to engage the one or more projections. A plunger may be coupled to the proximal end region of the main body.