Segmented Hemostasis Valve Seal for High-Pressure Leakage Prevention

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Solution Overview

Problem

Current medical devices, such as hemostasis valves, face challenges in effectively preventing fluid leakage during medical procedures, especially when dealing with high-pressure fluids, and existing manufacturing methods may not provide sufficient sealing or durability under varying pressures.

Innovation Solution

A hemostasis valve design featuring a main body with a threaded proximal end, a nut, and a plunger, along with a cartridge containing a seal member secured by a mechanical bond, such as crimping, which includes a central seal region and a peripheral leg region to engage the seal holding area, enhancing the seal's ability to withstand pressures and prevent leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional seal member is used in a hemostasis valve, then the device structure remains simple, but the seal fails under high-pressure fluid conditions

Engineering Contradiction:

Improvesealing performanceVSAvoidvalve structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The seal member is divided into multiple distinct regions: a central seal region for primary sealing contact and a peripheral leg region for secondary sealing and structural support. This segmentation allows each region to be optimized for its specific function, enabling the seal to withstand high pressures while maintaining a manageable overall structure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the seal member are given different structural properties - the central seal region has optimized dimensions for sealing contact while the peripheral leg region has specific thickness and geometry for engagement with the seal holding area. This local differentiation of properties enables effective sealing under high pressure without requiring the entire structure to be overly complex or robust.

Inventive Principle:

Principle #3Local quality

2Reliability

If the seal member axial thickness is increased to prevent leakage, then sealing performance improves, but the cartridge engagement and overall device dimensions are compromised

Engineering Contradiction:

Improvefluid-tight sealVSAvoidseal member axial thickness

Core Design Contradiction:

ReliabilityVSLength of stationary object

Solution Approach 1:

The seal member thickness is segmented into functional zones: the central seal region has sufficient axial thickness (0.1016-0.508 cm) to prevent fluid leakage under pressure, while the peripheral leg region has reduced thickness (0.00254-0.0508 cm) to enable proper engagement with the seal holding region of the cartridge, achieving both sealing and compatibility goals.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The seal member exhibits local variation in thickness - thicker in the central seal region where pressure resistance is critical, and thinner in the peripheral leg region where engagement with the cartridge is needed. This local quality differentiation allows the seal to maintain fluid-tight integrity without excessive overall dimensions.

Inventive Principle:

Principle #3Local quality

3Reliability

If a mechanical bond (crimp) is used to secure the seal member, then sealing durability under pressure improves, but manufacturing complexity increases

Engineering Contradiction:

Improveseal durabilityVSAvoidseal attachment process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The seal member's peripheral leg region is designed as a distinct engagement structure that can be separately crimped to the cartridge. This segmentation allows the crimping operation to be focused on a specific, well-defined region rather than the entire seal member, simplifying the manufacturing process while still achieving durable attachment.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The peripheral leg region is pre-formed with geometry optimized for crimping engagement before the actual crimping operation. This preliminary preparation of the engagement structure enables a more straightforward and reliable crimping process, improving seal durability without proportionally increasing manufacturing complexity.

Inventive Principle:

Principle #10Preliminary action

4Adaptability or versatility

If the peripheral leg region thickness is reduced for better engagement, then cartridge compatibility improves, but structural strength may be compromised

Engineering Contradiction:

Improvecartridge engagementVSAvoidperipheral region strength

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The peripheral leg region is designed with locally optimized thickness (0.00254-0.0508 cm) that provides sufficient structural strength for engagement with the cartridge seal holding region, while being thin enough to ensure proper fit and compatibility. The central seal region maintains greater thickness for strength where needed, creating local quality differentiation that satisfies both engagement and strength requirements.

Inventive Principle:

Principle #3Local quality

Data Source

PatentEP3595764B1Hemostasis valves and methods for making and using hemostasis valves

Publication Date: 2024.10.09 BOSTON SCI MEDICAL DEVICE LTD

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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 including a seal member. The cartridge may have a proximal member, a distal member, and may define a seal holding region. The seal member may have an axial thickness of about 0.04 to about 0.2 inches. The seal member may be secured within the seal holding region by a mechanical bond.