Flexible Plasma Films via Thrombin Pressure Clotting

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Solution Overview

Problem

Existing plasma-based films for medical applications are brittle and lack sufficient flexibility and mechanical strength, making them unsuitable for applications requiring pressure resistance and flexibility, such as hemostasis and anti-adhesion prevention.

Innovation Solution

Improving the flexibility and mechanical strength of plasma-based films by mixing blood plasma with excess thrombin and calcium, and applying pressure during the clotting process within a mold to create films with enhanced fold endurance and burst pressure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If plasma-based films are made using conventional clotting methods, then biocompatibility is improved, but mechanical strength and flexibility deteriorate

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidmechanical strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies parameter changes by modifying the clotting process parameters - specifically using excess thrombin (more than required for complete clotting) and applying pressure during clotting. This changes the physical state and structure of the plasma-based film, transforming it from brittle to flexible while maintaining biocompatibility. The pressure application during clotting creates a denser, more flexible matrix that retains the biological properties of plasma.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite structure within the plasma-based film by incorporating excess thrombin and applying pressure during the clotting process. This results in a heterogeneous material structure where the plasma matrix is reinforced with thrombin aggregates, creating a composite that combines the biocompatibility of plasma with the mechanical strength of the thrombin-reinforced structure.

Inventive Principle:
Principle #40Composite materials

2Reliability

If plasma-based films are made using conventional clotting methods, then biocompatibility is improved, but flexibility deteriorates

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidflexibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies parameter changes by modifying the clotting process parameters - specifically using excess thrombin (more than required for complete clotting) and applying pressure during clotting. This changes the physical state and structure of the plasma-based film, transforming it from brittle to flexible while maintaining biocompatibility. The pressure application during clotting creates a denser, more flexible matrix that retains the biological properties of plasma.

Inventive Principle:
Principle #35Parameter changes

3Strength

If fibers or fabrics are added to plasma-based films to improve mechanical properties, then pressure resistance is improved, but harmful factors increase due to partial biodegradability

Engineering Contradiction:
Improvepressure resistanceVSAvoidsurgery-induced adhesions
Core Design Contradiction:
StrengthVSObject-generated harmful factors

Solution Approach 1:

The patent extracts and removes the problematic embedded fibers and fabrics from the plasma-based film composition. Instead of adding non-biodegradable or partially biodegradable materials that cause adhesions, the invention relies solely on plasma and thrombin, which are completely biodegradable and integrate seamlessly with host tissues without causing foreign body reactions or adhesion formation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the material composition parameters by using 100% plasma-based materials with excess thrombin, eliminating the need for embedded fibers or fabrics. This parameter change maintains mechanical strength and pressure resistance through the plasma-thrombin matrix structure itself, while avoiding the harmful adhesion effects of foreign materials.

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 resulting flexible plasma-based films demonstrate improved flexibility, elasticity, and mechanical strength, enabling effective use as hemostats, anti-adhesive sheets, wound dressings, and in hernia repair, with characteristics such as a fold number of at least 1 and burst pressure ranging from 50 to 1000 mm Hg.

Implementation Method 1

mixing blood plasma with more than 2.5 International Units (IU) of thrombin per ml of plasma and/or with about 0.65 to 1.3 mg of calcium ions per ml of plasma to induce clotting of the plasma

Methodology Applied
Scientific EffectClotting: Coagulation

Data Source

PatentEP3701973B1Plasma-based films and methods for making and using the same
Publication Date: 2022.10.26 OCTAPHARMA AG
  • EP3701973B1 patent drawingFigure 1
  • EP3701973B1 patent drawingFigure 2
  • EP3701973B1 patent drawingFigure 3

AI summary

The present invention relates to plasma-based films and in particular to flexible plasma-based films. The invention further relates to and to methods of making and using the flexible plasma-based films. Embodiments of the invention have been particularly developed for making flexible plasma-based films useful as a hemostat in the treatment and/or prevention of mild to severe as well as arterial bleedings, as an anti-adhesive sheet to reduce or prevent development of surgery-induced adhesions, as a wound healing patch, as a wound dressing, or as a film useful in hernia repair. Embodiments of the invention will be described hereinafter with reference to these applications. However, it will be appreciated that the invention is not limited to this particular field of use.