Modular Hemostatic Valve Segmentation for High Pressure Sealing

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Solution Overview

Problem

Current hemostatic valve systems lack flexibility and structural integrity to handle large proximal fittings and cannot effectively manage high arterial pressures, limiting their use in procedures like coronary sinus pacemaker lead placement and exposing patients to blood loss and infection risks.

Innovation Solution

A modular hemostatic valve system with semi-cylindrical shells connected by living hinges, allowing for quick disassembly and featuring a sealing element that provides a double seal, enabling secure passage of medical devices through high-pressure environments while maintaining structural integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a large integral valve is attached to the proximal end of the introducer sheath, then sealing against blood flashback is improved, but the device cannot be adapted to work with different sheaths and intravascular devices

Engineering Contradiction:

Improvesealing effectivenessVSAvoidcompatibility with different devices

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The valve assembly is divided into separate components: a valve body that can be detached from the introducer sheath, allowing the valve to be reused with different sheaths and devices while maintaining effective sealing

Inventive Principle:

Principle #1Segmentation

2Ease of operation

If the valve and introducer are designed as an integral splittable system, then the valve can be removed with the introducer, but the system lacks flexibility and cannot be adapted to different procedures

Engineering Contradiction:

Improveremoval capabilityVSAvoidprocedural flexibility

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The valve body is designed as a separate detachable component from the introducer sheath, enabling independent removal and reuse of the valve with different sheath configurations to accommodate various procedural needs

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The valve assembly transitions from a fixed integral design to a dynamic configurable system where the valve body can be attached to or removed from different introducer sheaths based on procedural requirements

Inventive Principle:

Principle #15Dynamics

3Ease of operation

If the valve body is made of elastic material to allow fitting into the introducer sheath, then ease of insertion is improved, but structural integrity to negotiate tortuous bends is reduced

Engineering Contradiction:

Improveinsertion easeVSAvoidstructural integrity

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The valve body is segmented into multiple sections with living hinges that provide both flexibility for insertion and structural integrity for navigating tortuous anatomical paths

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The valve body utilizes flexible materials and thin-walled construction with reinforced hinge sections that allow bending and deformation during insertion while maintaining sufficient strength to negotiate tortuous vessel bends

Inventive Principle:

Principle #30Flexible shells and thin films

4Ease of manufacture

If a simple valve body shell is used, then manufacturing simplicity is improved, but sealing effectiveness under high arterial pressures is insufficient

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidsealing under pressure

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The valve body is constructed from multiple simple semi-cylindrical shells that are easy to manufacture but combine to form a pressure-resistant sealed structure capable of withstanding high arterial pressures

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The valve assembly combines simple elastic shell materials with additional sealing components and reinforcement structures to achieve effective sealing under high pressure while maintaining manufacturing simplicity

Inventive Principle:

Principle #40Composite materials

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 modular design effectively reduces blood leakage and prevents fluid exposure, ensuring superior sealing characteristics even under high arterial pressures, facilitating safer and more versatile medical procedures.

Implementation Method 1

featuring a sealing element that provides a double seal, enabling secure passage of medical devices through high-pressure environments

Methodology Applied

Scientific EffectSealing:

Implementation Method 2

The valve body may be made of two unconnected semi-cylindrical shells. When closed, the two shells may form an elongated hollow passageway therewithin

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 3

arterial pressures represent over a ten fold increase over that of the venous side, making sealing much more difficult

Methodology Applied

Scientific EffectPressure resistance: Pressure Increase

Data Source

PatentUS8790309B2Modular hemostatic valve

Publication Date: 2014.07.29 COOK MEDICAL TECHNOLOGIES LLC

AI summary

A modular hemostatic valve includes a splittable valve body. The splittable body defines a passageway. A sealing element is positioned in the passageway. The sealing element is configured to facilitate the passage of a first medical device, and the splittable valve body is configured to engage a second medical device.