Hemostatic Device Double-Layer Inflation Portion

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Solution Overview

Problem

Existing hemostatic devices require manual operation to reduce compressing force on puncture sites, which can lead to vascular occlusion and increased effort for healthcare professionals, as they rely on fluid decompression to manage pressure over time.

Innovation Solution

A hemostatic device with a double-layer inflation portion, where the first layer is made of a thermosetting elastomer with high gas permeability and the second layer is made of a thermoplastic resin, allowing gas to be discharged over time through gap portions, maintaining strength and reducing compressive force without manual intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the inflation portion is configured to include material which stretches with the lapse of time, then the decompressing operation can be saved time and effort, but the thickness of the inflation portion becomes thinner and strength is compromised

Engineering Contradiction:
Improvedecompressing operationVSAvoidstrength of the inflation portion
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The inflation portion is divided into two distinct layers: a first layer made of stretching material that gradually expands to reduce compressing force, and a second layer made of non-stretching material that maintains structural strength and thickness. This segmentation allows each layer to perform its specific function without compromising the other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention uses a composite structure combining two different materials with complementary properties: a stretching material (e.g., elastomer) for automatic decompression and a non-stretching material (e.g., thermoplastic resin) for maintaining strength. The combination enables both automatic pressure reduction and structural integrity to coexist.

Inventive Principle:
Principle #40Composite materials

2Reliability

If the inflation portion strongly compresses the puncture site for a long time, then hemostasis is maintained, but vascular occlusion may occur

Engineering Contradiction:
Improvehemostasis maintenanceVSAvoidvascular occlusion
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The compressing force is made dynamic rather than static. The first layer automatically increases in volume over time, causing the compressing force to gradually decrease. This dynamic adjustment maintains effective hemostasis initially while automatically preventing harmful prolonged compression that could cause vascular occlusion.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The inflation portion performs automatic decompression through the stretching property of the first layer, eliminating the need for manual intervention. The system self-regulates the compressing force over time, transitioning from strong compression for hemostasis to reduced compression to prevent vascular occlusion.

Inventive Principle:
Principle #25Self-service

3Object-affected harmful factors

If manual decompression is performed periodically, then vascular occlusion can be prevented, but increased effort is required from healthcare professionals

Engineering Contradiction:
Improvevascular occlusion preventionVSAvoideffort for healthcare professionals
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The first layer of the inflation portion automatically performs the decompression function through its inherent stretching property. The material gradually expands over time, reducing internal pressure and compressing force without requiring healthcare professionals to connect syringes or perform manual decompression operations.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The manual mechanical decompression operation (using syringes to discharge fluid) is replaced by the intrinsic physical property of the stretching material. The automatic volume increase of the first layer substitutes for the manual fluid discharge mechanism, eliminating the need for periodic medical intervention.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 device effectively reduces compressive force on puncture sites over time, preventing vascular occlusion and minimizing the need for manual decompression, thus reducing the burden on healthcare professionals while maintaining the strength of the inflation portion.

Implementation Method 1

The first layer is formed of a material which has a larger gas permeation amount per unit area than a material for forming the second layer

Methodology Applied
Scientific EffectGas permeation: Permeation

Implementation Method 2

The second layer has a gap portion which can expose the outer surface of the first layer outward from the second layer in a state where the inflation portion is inflated

Methodology Applied
Scientific EffectPhysical exposure through gap:

Implementation Method 3

The inflation portion has a first layer formed of a thermosetting elastomer and a second layer which covers an outer surface of the first layer

Methodology Applied
Scientific EffectComposite material structure: Composite Materials

Data Source

PatentUS10575859B2Hemostatic device
Publication Date: 2020.03.03 TERUMO KK
  • US10575859B2 patent drawing
  • US10575859B2 patent drawing
  • US10575859B2 patent drawing

AI summary

A hemostatic device includes a band for being wrapped around a wrist W, securing means for securing the band in a state where the band is wrapped around the wrist, and an inflation portion disposed on an inner peripheral surface of the band, and that is inflated by injecting gas. The inflation portion has a first layer and a second layer which covers an outer surface of the first layer. The first layer is formed of a material which has a larger gas permeation amount per unit area than a material for forming the second layer. The second layer has gap portions which can expose the outer surface of the first layer outward from the second layer in a state where the inflation portion is inflated.