Hemostasis Valve Seal Deflection Under Pressure

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Solution Overview

Problem

Existing hemostasis valves struggle to maintain a fluid-tight seal under varying pressures, leading to potential leakage during medical procedures.

Innovation Solution

The design incorporates a hemostasis valve with a seal member that shifts between open and sealed configurations, featuring a plunger with an inner tubular region and a specific clearance distance between the seal member and the plunger's distal end, allowing the seal member to deflect and maintain the sealed configuration under pressures of 80-250 pounds per square inch.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the seal member is designed to shift between open and sealed configurations, then the valve can control fluid flow, but the seal member may leak under varying pressures

Engineering Contradiction:
Improveseal integrityVSAvoidpressure range
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The seal member is designed to dynamically shift between open and sealed configurations, and the inner tubular region is positioned to allow the seal member to deflect into contact with it under pressure. This dynamic adjustment enables the seal to adapt to varying pressure conditions while maintaining integrity.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The clearance distance between the inner tubular region and the seal member is specifically designed (0.1 to 5 millimeters) to allow the seal member to deflect into contact with the inner tubular region when exposed to pressures of 552-1724 kPa (80-250 psi). This parameter optimization ensures the seal maintains integrity across the required pressure range.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the seal member deflects into contact with the inner tubular region under pressure, then leakage is prevented, but the clearance distance requires precise manufacturing

Engineering Contradiction:
Improveleakage preventionVSAvoidclearance distance
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The clearance distance is specified as a range (0.1 to 5 millimeters, or more specifically 0.3 to 2 millimeters) rather than a single value, providing manufacturing tolerance that balances precision requirements with practical manufacturability while ensuring proper seal deflection under pressure.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the plunger is designed with an inner tubular region spaced from the seal member, then the seal can deflect to maintain sealing, but the plunger structure becomes more complex

Engineering Contradiction:
Improveseal performanceVSAvoidplunger structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The plunger is segmented into an inner tubular region and an outer structure, with the inner tubular region serving as a separate functional element that the seal member can deflect against. This segmentation allows the seal to maintain contact under pressure while keeping the overall plunger structure relatively simple.

Inventive Principle:
Principle #1Segmentation

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 design effectively prevents backflow and leakage of fluids at higher pressures, enhancing the performance of the first seal member and maintaining a sealed configuration even under elevated pressures.

Implementation Method 1

the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3595767B1Hemostasis valves and methods for making and using hemostasis valves
Publication Date: 2025.06.18 BOSTON SCI MEDICAL DEVICE LTD
  • EP3595767B1 patent drawingFigure 1
  • EP3595767B1 patent drawingFigure 2
  • EP3595767B1 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 proximal end region. A cartridge may be at least partially disposed within the proximal end region. The cartridge may include a seal member. The seal member may be designed to shift between an open configuration and a sealed configuration. A plunger, having an inner tubular region and a distal end, may be coupled to the proximal end region of the main body. The distal end of the inner tubular region may be spaced a clearance distance from a proximal end of the seal member so that when the seal member is in the sealed configuration and exposed to pressures of 80-250 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.