3D Printed Bone Composite Using Fibrinogen and Thrombin

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Solution Overview

Problem

Current bone grafting methods, such as autologous and allografts, face limitations including surgical risks, sterility concerns, and limitations in shape and size, while synthetic substitutes lack immediate mechanical support and are not suitable for wrapping or resurfacing bone.

Innovation Solution

A multi-part composition for 3D printing of bone composites comprising fibrinogen, thrombin, and a pharmaceutically acceptable hydrogel mixed with biocompatible inorganic materials, allowing for precise and sterile fabrication of bone constructs with osteoconductive, osteoinductive, and osteogenic properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If autologous bone grafts are harvested from the patient, then viable bone tissue is obtained with osteoconductive and osteogenic properties, but additional surgery is required and risks of infection, blood loss and compromised structural integrity at the donor site increase

Engineering Contradiction:
Improvebone graft viabilityVSAvoidsurgical risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent creates a synthetic copy of viable bone tissue using 3D printing technology. The composition replicates the functional properties of autologous bone (osteoconductive, osteoinductive, and osteogenic capabilities) without requiring harvesting from the patient's body. The printed bone composite serves as an artificial counterpart that mimics the biological functionality of natural bone tissue.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent changes the physical and chemical parameters of the bone graft material by using a multi-part composition system. The composition includes fibrinogen, thrombin, and inorganic materials with specific viscosity ranges (1-300 Pa·s at 0.1 s⁻¹ shear rate) that enable 3D printing while providing mechanical support. These parameter changes allow the material to transition from a printable state to a structurally supportive state.

Inventive Principle:
Principle #35Parameter changes

2Strength

If load bearing allograft bones are extracted from cadavers, then structural support is provided without harvesting from living donors, but issues around sterility, suitability and long-term supply persist

Engineering Contradiction:
Improvestructural supportVSAvoidsterility and supply consistency
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent enables self-service in bone graft production by creating an on-demand 3D printing system. The multi-part composition can be printed into custom shapes and sizes specifically tailored to each patient's defect, eliminating the need to rely on available allograft sizes. The system serves itself by generating exactly what is needed, when it is needed, in the required quantity and form.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent changes the physical state and mechanical properties of the bone composite through controlled composition formulation. The material transitions from a viscous printable state (1-300 Pa·s viscosity) to a solid load-bearing structure after printing, providing immediate structural support while maintaining sterility through controlled manufacturing conditions.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If synthetic bone substitute materials are used, then a pliable raw material is obtained that can be readily remodelled and reshaped, but immediate mechanical support and suitability for wrapping or resurfacing bone are not provided

Engineering Contradiction:
Improveremodelling capabilityVSAvoidmechanical support
Core Design Contradiction:
Ease of manufactureVSStrength

Solution Approach 1:

The patent introduces dynamic properties to the bone substitute material through its multi-part composition system. The material exhibits shear-thinning behavior where viscosity changes with applied stress, allowing it to be easily extruded during 3D printing (low viscosity under shear) and then set into a rigid structural form (high viscosity at rest). This dynamic response enables both ease of manufacture and immediate mechanical support.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent utilizes parameter changes in the material's rheological properties to resolve the contradiction. The composition is formulated with specific viscosity characteristics (1-300 Pa·s at 0.1 s⁻¹) that allow it to flow during printing but maintain structural integrity afterward. The inorganic materials provide immediate mechanical strength while the hydrogel matrix allows for remodeling capability.

Inventive Principle:
Principle #35Parameter changes

4Manufacturing precision

If 3D printing technology is used to fabricate bone constructs, then precise and accurate shapes can be obtained according to surgeon's specification, but the material must maintain mechanical integrity and provide structural support

Engineering Contradiction:
Improveshape accuracyVSAvoidmechanical integrity
Core Design Contradiction:
Manufacturing precisionVSStrength

Solution Approach 1:

The patent employs composite materials combining organic and inorganic components to achieve both printability and mechanical strength. The composition includes fibrinogen and thrombin (organic components enabling biological functionality) combined with inorganic materials (providing mechanical strength and rigidity). This composite structure allows the material to be precisely printed while maintaining the structural integrity required for load-bearing applications.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent utilizes parameter changes in the material's rheological and mechanical properties to enable both precise printing and structural support. The viscosity is controlled within specific ranges (1-300 Pa·s at 0.1 s⁻¹ shear rate) to ensure accurate extrusion and shape fidelity during 3D printing, while the composition formulation ensures the printed structure maintains mechanical integrity and provides load-bearing capability.

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

Enables the accurate and precise printing of bone structures with desirable mechanical properties, providing load-bearing support and a non-toxic environment for biologically active materials, addressing the limitations of traditional bone grafts by offering customizable and sterile bone constructs.

Implementation Method 1

a first part comprising fibrinogen in a pharmaceutically acceptable carrier; a second part comprising thrombin in a pharmaceutically acceptable carrier

Methodology Applied
Scientific EffectCoagulation: Coagulation

Implementation Method 2

a third part comprising a pharmaceutically acceptable hydrogel mixed with at least one biocompatible inorganic material

Methodology Applied
Scientific EffectGel: Gel

Data Source

PatentUS20230355841A1Bone composite and compositions for preparing same
Publication Date: 2023.11.09 GRIFOLS WORLDWIDE OPERATIONS
  • US20230355841A1 patent drawing
  • US20230355841A1 patent drawing
  • US20230355841A1 patent drawing

AI summary

Bone Composite and Compositions, particularly multicomponent or multipart compositions, are for the preparation of bone constructs for use in trauma, or cancer patients for example. The multipart compositions are based around combinations of fibrinogen, thrombin, hydrogels and calcium/phosphorous salts. The multipart compositions are capable of being printed to yield bone constructs using a 3D printing process to produce accurate and precise bone constructs of a desired geometry.