Dual-Layer Absorbable Hemostatic Fabric

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Solution Overview

Problem

Existing medical hemostatic materials, such as those using oxidized cellulose, can degrade quickly and interfere with biologically active agents, failing to provide sustained hemostasis in surgical procedures, and none have described a dual-layered nonwoven fabric with varying densities for effective bleeding control.

Innovation Solution

A synthetic dual-layered nonwoven hemostatic matrix composed of polyglycolide/polylactide copolymer fibers with different densities, where each layer is compacted to specific thicknesses and densities, and secured via needle-punching, allowing for effective hemostasis without oxidized polysaccharides, and optionally incorporating thrombin or fibrinogen for enhanced bleeding control.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If oxidized cellulose based material is used as hemostatic dressing, then hemostatic effect is achieved, but the material degrades quickly and interferes with biologically active agents

Engineering Contradiction:
Improvehemostatic effectVSAvoidmaterial degradation time
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent employs a composite structure consisting of a nonwoven fabric layer and a woven or knitted fabric layer. The nonwoven layer provides immediate hemostatic effect through its absorbent properties, while the woven/knitted layer provides structural support and controlled degradation. This composite approach allows the material to maintain hemostatic effectiveness longer without interfering with biologically active agents, as the degradation rate is controlled by the composition and structure of the two different fabric layers.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the physical and chemical parameters of the hemostatic material by using different fiber compositions, densities, and layer configurations. By adjusting the density of each layer (first layer density different from second layer density) and the composition of fibers (natural vs synthetic, absorbable vs non-absorbable), the degradation rate and hemostatic effectiveness are optimized to work together rather than interfere with each other.

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If single-layer hemostatic fabric is used, then manufacturing is simple, but hemostatic effectiveness and tissue reinforcement are insufficient

Engineering Contradiction:
Improvefabric structureVSAvoidhemostatic effectiveness
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The hemostatic device is divided into two distinct fabric layers, each with specific functions. The first layer (nonwoven) is optimized for hemostatic activity and fluid absorption, while the second layer (woven or knitted) is optimized for structural reinforcement and tissue integration. This segmentation allows each layer to be manufactured using appropriate techniques for its specific function, then combined through needle punching to create a composite structure that achieves both hemostatic effectiveness and tissue reinforcement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from a single-layer two-dimensional structure to a multi-layer three-dimensional composite structure. By stacking and needle-punching together two different fabric layers with different densities and properties, the device gains enhanced functional capabilities in the vertical dimension, providing both immediate hemostasis and sustained tissue reinforcement without complicating the manufacturing process.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Strength

If high density fabric is used, then mechanical strength is improved, but fluid absorption and hemostatic action are reduced

Engineering Contradiction:
Improvemechanical strengthVSAvoidfluid absorption capacity
Core Design Contradiction:
StrengthVSQuantity of substance

Solution Approach 1:

The patent applies different density characteristics to different layers of the composite fabric. The first layer is designed with specific density optimized for fluid absorption and hemostatic action, while the second layer has different density optimized for mechanical strength and structural support. This local differentiation of density properties allows the overall device to achieve both high fluid absorption capacity and adequate mechanical strength simultaneously.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

By combining two fabric layers with different density characteristics, the patent creates a composite material that exhibits properties superior to either layer alone. The less dense layer provides fluid absorption pathways and hemostatic activity, while the more dense layer provides structural integrity, resulting in a composite that achieves both mechanical strength and fluid absorption capacity.

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 dual-layered matrix effectively controls mild to moderate bleeding, maintains tensile strength, and promotes natural tissue healing, outperforming traditional hemostatic materials by achieving hemostasis within a defined time frame and maintaining mechanical integrity over several days.

Implementation Method 1

The first absorbable fabric and second absorbable sheet can be needle-punched into each other to secure a nonwoven fabric matrix

Methodology Applied
Scientific EffectMechanical interlocking: Mechanical Force

Implementation Method 2

the second absorbable woven or knitted fabric comprises oxidized regenerated cellulose fibers

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 3

oxidized regenerated cellulose fibers

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 4

The first absorbable nonwoven fabric comprises fibers comprising aliphatic polyester polymers, copolymers or blends thereof

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentUS8329211B2Reinforced absorbable multi-layered fabric for hemostatic applications
Publication Date: 2012.12.11 ETHICON INC

AI summary

The present invention is directed to a synthetic fabric comprising a multi-layered nonwoven fabric made from staples of a polyglycolide/polylactide copolymer, each layer having a different density. The multi-layer fabric can be used as a reinforced absorbable hemostat medical device.