Hemostatic Pad Using PEG Binder for Protein Adhesion

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Solution Overview

Problem

Current hemostatic pads containing lyophilized thrombin and fibrinogen on bioabsorbable scaffolds face challenges with improved wettability, reduced friability, and enhanced tissue adhesion and sealing properties.

Innovation Solution

A hemostatic pad comprising a bioabsorbable scaffolding material with lyophilized thrombin and fibrinogen powders, along with a polyethylene glycol (PEG) powder that bonds these proteins to the scaffold without fully enveloping them, improving wettability and adhesion while reducing friability through a manufacturing process involving suspension coating, evaporation, and heat treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If lyophilized thrombin and fibrinogen powders are disposed on bioabsorbable scaffold without binder, then the device structure remains simple, but the powders exhibit high friability and poor adhesion to the scaffold

Engineering Contradiction:
Improveadhesion strengthVSAvoiddevice structure
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

A polyethylene glycol (PEG) binder is introduced as an intermediary substance between the lyophilized thrombin and fibrinogen powders and the bioabsorbable scaffold. The PEG binder adheres to both the scaffold and the protein powders, creating strong interfacial bonding that prevents powder shedding during handling and cutting, while maintaining device structural integrity.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The device employs a composite structure combining the bioabsorbable scaffold, PEG binder, and lyophilized protein powders into a unified hemostatic pad system. This composite material approach integrates multiple functional components (structural support, adhesion, and hemostatic activity) into a single device that delivers improved performance without requiring complex assembly procedures.

Inventive Principle:
Principle #40Composite materials

2Strength

If lyophilized proteins are fully enveloped by binder material, then adhesion strength improves, but wettability decreases and reconstitution time increases

Engineering Contradiction:
Improveadhesion strengthVSAvoidreconstitution time
Core Design Contradiction:
StrengthVSLoss of time

Solution Approach 1:

The PEG binder is applied in a controlled manner to provide localized adhesion at the interface between the protein powders and the scaffold, rather than creating a thick uniform coating. This localized binding approach ensures strong attachment where needed while leaving the majority of the protein powder surfaces exposed and accessible to water, enabling rapid reconstitution when the device contacts blood or aqueous environments.

Inventive Principle:
Principle #3Local quality

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 solution enhances tissue adhesion and sealing properties, reduces friability, and improves wettability, leading to faster hemostasis and more effective wound closure.

Implementation Method 1

a polyethylene glycol powder that bonds the lyophilized thrombin powder and the lyophilized fibrinogen powder to the bioabsorbable scaffolding material

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

a manufacturing process involving suspension coating, evaporation, and heat treatment

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentUS9351883B2Hemostatic bioabsorbable device with polyethylene glycol binder
Publication Date: 2016.05.31 ETHICON INC
  • US9351883B2 patent drawing
  • US9351883B2 patent drawing
  • US9351883B2 patent drawing

AI summary

A hemostatic pad comprising a bioabsorbable scaffolding material; a lyophilized thrombin powder, a lyophilized fibrinogen powder, and a meltable binder powder, with all powders disposed on the bioabsorbable scaffolding material. A meltable binder such as PEG bonds the lyophilized thrombin powder and the lyophilized fibrinogen powder to the bioabsorbable scaffolding material for improved friability, wettability and performance in a use, such as for hemostatic treatment or sealing at a wound site.