Phospholipid Putty for Bone Graft Handling

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Solution Overview

Problem

The handling of loose synthetic bone graft substitutes during surgery, such as MicroFuse Granules, poses challenges due to their loose nature and difficulty in containment at the implantation site, which affects the efficiency of bone regeneration procedures.

Innovation Solution

Development of phospholipid-based carrier compositions incorporating polymer components like Pluronic F127 and soybean-derived phospholipids, which form a putty or paste-like consistency, effectively holding granules, powders, or particulates together, enhancing handling and facilitating bone regeneration by providing a biocompatible, resorbable matrix.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If loose synthetic bone graft substitutes (e.g., MicroFuse Granules) are used, then bone regeneration is supported, but handling and containment at implantation site becomes difficult

Engineering Contradiction:
Improvebone regeneration supportVSAvoidhandling and containment
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent combines synthetic bone graft substitute granules with a phospholipid-based carrier material to create a composite putty formulation. This composite approach allows the granules to maintain their osteopromotive properties while the carrier material provides improved handling characteristics, moldability, and containment capabilities at the implantation site.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The phospholipid-based carrier acts as an intermediary material that facilitates the handling and delivery of synthetic bone graft granules. The carrier material temporarily holds the granules in a moldable putty form during surgery, enabling precise placement and containment, then gradually resorbs to leave the granules in situ for bone regeneration.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If a carrier material is added to improve handling, then handling and containment improve, but the complexity of the composition increases

Engineering Contradiction:
Improvehandling and containmentVSAvoidcomposition complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent utilizes temperature-dependent parameter changes of the phospholipid-based carrier material. The carrier transitions from a solid or semi-solid state at room temperature to a moldable putty state at body temperature, enabling easy handling and containment during surgery without requiring complex formulation or additional components.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The phospholipid-based carrier material undergoes a phase transition from a less mobile state to a more moldable state at body temperature, facilitating improved handling and containment properties during implantation while maintaining compositional simplicity. This phase change eliminates the need for complex stabilization mechanisms.

Inventive Principle:
Principle #36Phase transitions

3Duration of action of stationary object

If the carrier resorbs quickly to leave graft materials, then handling of resorbable material is simplified, but the timing of graft material availability may be affected

Engineering Contradiction:
Improvecarrier resorption timeVSAvoidgraft material availability
Core Design Contradiction:
Duration of action of stationary objectVSDuration of action of moving object

Solution Approach 1:

The patent segments the bone graft system into two distinct functional components: a temporarily acting phospholipid-based carrier that resorbs quickly to simplify handling and clear the site, and permanently acting synthetic bone graft granules that remain to provide prolonged osteopromotive support. This segmentation allows each component to optimize its duration of action independently.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The phospholipid-based carrier performs preliminary actions during surgery by providing immediate moldability, containment, and placement facilitation. As it gradually resorbs over time, it clears the site while the synthetic granules are already in position to provide prolonged bone regeneration support, ensuring proper timing of graft material availability.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP2747751B1Biodegradable putty compositions and implant devices, methods, and kits relating to the same
Publication Date: 2020.02.26 GLOBUS MEDICAL INC
  • EP2747751B1 patent drawingFigure 1~2
  • EP2747751B1 patent drawingFigure 3
  • EP2747751B1 patent drawingFigure 4

AI summary

Phospholipid-based compositions and implant devices, methods and kits include such compositions or components thereof. A polymer component such as a poloxamer or PEG component and a phospholipid component, such as a Phosal. The compositions may include at least one additional component, such as granules, powder and/or particulates. The compositions may further include one or more bone graft materials and/or active ingredients. The compositions may be used on their own or incorporated on or in a surgical implant.