Variable Hemostasis Valve Rotatable Seal Mechanism

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Solution Overview

Problem

Existing hemostasis valves lack variable control over the strength of the seal, often resulting in unintended bleeding and fluid leakage during percutaneous medical procedures due to their inability to adapt to large or irregularly sized instruments and failure to form a fluid-tight seal.

Innovation Solution

A variable hemostasis valve with a rotatable, flexible tubular seal element made of elastomeric material that can be opened or closed to accommodate instruments of varying sizes, allowing for precise control over the seal pressure and orifice size through rotation, enabling full insertion and extraction of medical instruments while preventing fluid leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing hemostasis valves use flaps or zero-closure valves to control sealing, then the valve structure is simple, but the seal strength cannot be controlled and fluid leakage occurs

Engineering Contradiction:
Improveseal strength controlVSAvoidvalve structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies the dynamics principle by implementing a rotatable valve body that can transition between open and closed positions, allowing the seal strength to be dynamically adjusted. The valve body rotation mechanism enables the operator to control the degree of sealing by rotating to different positions, transforming a static flap-based system into a dynamic, controllable sealing system that adapts to different instrument sizes and sealing requirements.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent applies parameter changes by varying the rotational position of the valve body to change the sealing parameter. By rotating the valve body to different angles, the effective sealing area and seal pressure are adjusted, allowing control over seal strength. This parameter-based control replaces the binary open/closed state of traditional flaps with a continuous range of sealing intensities.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If traditional hemostasis valves are used, then the valve is always closed around instruments, but this causes interference with full insertion of instruments into the patient's body

Engineering Contradiction:
Improveinstrument insertionVSAvoidseal formation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies dynamics by making the valve body rotatable between open and closed positions. During instrument insertion, the valve body is rotated to the open position, eliminating interference and allowing full insertion. After insertion, the valve body is rotated to the closed position to form a seal. This dynamic positioning resolves the contradiction between ease of insertion and reliable sealing.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent applies preliminary action by opening the valve body before instrument insertion to facilitate easy placement. The valve is deliberately kept in the open state during the insertion phase, and only after the instrument is properly positioned is the valve rotated to the closed state to establish sealing. This sequential action ensures both easy insertion and reliable seal formation.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If hemostasis valves are closed to prevent bleeding, then sealing is achieved, but extraction of instruments becomes difficult

Engineering Contradiction:
ImprovesealingVSAvoidinstrument extraction
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies dynamics by enabling the valve body to rotate between closed and open positions. During instrument extraction, the valve body is rotated back to the open position, releasing the seal and allowing easy removal of the instrument. This dynamic reversibility resolves the contradiction between maintaining a secure seal during use and enabling easy extraction when needed.

Inventive Principle:
Principle #15Dynamics

4Adaptability or versatility

If existing valves do not adapt to large or irregularly sized instruments, then the valve structure remains fixed, but unintended leakage and bleeding occur

Engineering Contradiction:
Improveinstrument size adaptationVSAvoidvalve adaptability
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by using a rotatable valve body that can adjust its effective sealing area through rotation. The valve body's rotational movement allows it to adapt to different instrument sizes and shapes by changing the contact area and sealing pressure. This parameter-based adaptability enables a single valve design to handle various instrument dimensions without requiring multiple specialized valves.

Inventive Principle:
Principle #35Parameter changes

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 variable hemostasis valve provides a reliable, fluid-tight seal that can be easily opened and closed, adapting to different instrument sizes, thereby reducing bleeding and leakage during medical procedures, and maintaining a secure seal throughout the insertion and extraction process.

Implementation Method 1

The tubular seal element is made from a flexible tube of an elastomeric material that conforms and adapts to the shape of the various instruments that may be inserted therethrough

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP2696932B1Variable hemostasis valve and method of use
Publication Date: 2018.05.09 MEDTRONIC INC
  • EP2696932B1 patent drawingFigure 1A
  • EP2696932B1 patent drawingFigure 1B~1C
  • EP2696932B1 patent drawingFigure 1D

AI summary

A variable hemostasis valve (100) is disclosed that may be used during medical procedures to prevent blood loss while permitting the percutaneous introduction, operation, and removal of medical instruments. A flexible tubular seal element (110) is disclosed that is disposed within the variable hemostasis valve to provide a fluid- tight, adjustable seal. After insertion of a medical instrument (170) into the valve through at least a portion of the flexible tubular seal element, a proximal portion (112) of the valve housing may be rotated to cause the tension of the flexible tubular seal element to increase over the inserted medical instrument and engage the valve in a closed position. The proximal portion of the valve housing may then be rotated in an opposite direction to release the seal and return the tubular seal element to a relaxed lumen open position.