Resorbable Bone Hemostat Polymer Composition

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Solution Overview

Problem

Current bone hemostat products are inadequate in controlling bleeding during surgical procedures, as they either fail to effectively manage bone bleeding or require preparation and warming, which can complicate surgical processes and hinder bone healing.

Innovation Solution

Development of biocompatible, resorbable, and soluble polymer compositions, including polyoxyethylene-polyoxypropylene block copolymers, natural polymers like gelatin and chitosan, and ceramic particles, formulated as pastes or dough-like materials that can be applied directly to bleeding bones without prior preparation, providing controlled hemostasis and promoting bone regeneration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bone wax is used to control bleeding, then bleeding is stopped, but the material is not resorbable and requires removal

Engineering Contradiction:
Improvehemostatic effectivenessVSAvoidmaterial resorbability
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The invention changes the chemical composition parameters of bone hemostat materials from non-resorbable (traditional bone wax) to resorbable polymers with controlled degradation rates. The patent specifies polymers with molecular weights and compositions that provide both immediate hemostatic effectiveness and subsequent resorption within 30 days, resolving the contradiction between stopping bleeding and requiring removal.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses composite material formulations combining multiple polymer components with different resorption rates and properties. The patent describes compositions containing blends of resorbable polymers, ceramics, and other biocompatible materials that work together to provide immediate hemostasis while ensuring complete resorption, eliminating the need for surgical removal.

Inventive Principle:
Principle #40Composite materials

2Reliability

If synthetic bone hemostasis materials are used, then bleeding control is improved, but preparation and warming are required

Engineering Contradiction:
Improvebleeding controlVSAvoidsurgical procedure simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention modifies the physical state parameters of the bone hemostat material by formulating it as a pre-warmed paste or impregnated gauze that is ready for immediate application. The patent specifies materials that maintain stable viscosity and applicability at body temperature without requiring additional warming steps, thus improving ease of operation while maintaining bleeding control effectiveness.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the hemostat remains in place long enough to achieve stable hemostasis, then bleeding is controlled, but it may interfere with bone healing

Engineering Contradiction:
Improvehemostasis stabilityVSAvoidmaterial persistence
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The invention precisely controls the degradation time parameter of the resorbable polymer materials to match the bone healing timeline. The patent specifies polymers with molecular weights and compositions that maintain structural integrity for 24-72 hours to ensure stable hemostasis, then gradually resorb within 30 days, providing a window for bone healing without long-term interference.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates a dynamic material system that transitions from a stable, structure-providing state during the acute hemostasis phase to a gradually degrading state that clears as bone heals. The patent describes materials whose mechanical properties and degradation rates are engineered to provide temporary support then naturally disappear, adapting to the different phases of bone repair.

Inventive Principle:
Principle #15Dynamics

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 compositions effectively control bleeding, resist irrigation, and remain in place long enough to achieve stable hemostasis, allowing for normal bone healing and regeneration, while being absorbed by the body within 30 days, and can be used as carriers for medications to reduce inflammation.

Implementation Method 1

polymer compositions or blends... that after application to a bleeding bone surface or site will remain in place temporarily

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

a carrier comprising a means for achieving reverse phase thermodynamic characteristics when mixed with the alloplastic material

Methodology Applied
Scientific EffectReverse phase thermodynamics: Phase Change

Implementation Method 3

synthetic, resorbable, or soluble (e.g. water soluble) polymers that after application... will then disappear or disperse away from the treatment area within a few days

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Implementation Method 4

resorbable... polymers... will then disappear or disperse away from the treatment area within a few days

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentEP3878483B1Compositons for bone hemostasis, and methods for their manufacture
Publication Date: 2023.08.09 BAXTER INT INC
  • EP3878483B1 patent drawingFigure 1
  • EP3878483B1 patent drawingFigure 2
  • EP3878483B1 patent drawingFigure 3

AI summary

The present invention relates to a biocompatible composition for use as a bone hemostat, wherein the composition comprises an oxazoline polymer, water present within a range from 20% to 45% by weight of the composition, and a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight (Mw) within a range from 9800 to 16300 g/mol; said biocompatible composition for use in inhibiting or controlling bleeding from a bone, wherein said composition is administered to the bone of a patient; and a method of manufacturing a biocompatible composition for use in treating a bone of a patient, wherein the method comprises mixing said biocompatible composition.