Malleable Demineralized Bone Putty for Shape Retention
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Solution Overview
Problem
Existing malleable bone compositions struggle to maintain position and consistency in treating osseous defects and bone voids, particularly when formulated as pastes or putties, due to lack of effective retention and molding capabilities.
Innovation Solution
A malleable demineralized bone composition is developed, comprising two portions of cortical bone: one made from cut pieces ground into particles and the other from long thin shavings, both freeze-dried and demineralized, mixed with gelatin formed by autoclaving sterile water, creating a cohesive and moldable paste with a specific particle size ratio and gelatin volume ratio.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If collagen or gelatinous materials are added to formulate malleable paste or putty, then the composition becomes moldable and easy to apply, but the composition loses its ability to stay in position and maintain consistency
Solution Approach 1:
The invention segments the bone material into two distinct portions: ground cortical bone particles (first portion) and shaved cortical bone particles (second portion). This segmentation allows each portion to contribute different functional properties - the ground particles provide structural framework while the shaved particles form gelatin that acts as a setting agent, resolving the contradiction between malleability and position retention.
Solution Approach 2:
The invention creates a composite material system combining two different bone particle forms with specific size distributions. The composite structure of ground particles (1-4mm cut pieces ground to <1000 microns) and shaved particles (ground to <150 microns) that form gelatin provides both the ease of application and the position retention capability that single-material formulations cannot achieve.
2Ease of operation
If the composition is formulated as a flowable paste, then it can be easily applied and molded, but it cannot maintain its shape and position in the bone defect
Solution Approach 1:
The invention utilizes parameter changes in the physical state of the composition. The shaved bone particles undergo autoclaving to transform from dry particles to gelatin form, creating a temperature and moisture-dependent setting system. This allows the composition to be moldable at room temperature while maintaining shape retention after setting, resolving the contradiction between moldability and shape retention.
Solution Approach 2:
The invention exploits phase transitions in the bone material. The autoclaving process induces a phase transition where shaved bone particles transform into gelatin, creating a setting reaction that locks the molded shape in place. This phase transition mechanism enables the composition to transition from a moldable state to a shape-retaining state, solving the contradiction between ease of molding and shape maintenance.
3Strength
If larger particles are used in the composition, then the structural framework is stronger, but the composition becomes less moldable and harder to apply
Solution Approach 1:
The invention applies local quality by assigning different particle size characteristics to different functional roles. The first portion (ground particles <1000 microns) provides the structural framework with appropriate strength, while the second portion (shaved particles ground to <150 microns) provides the gelatin-forming capability for malleability. This local differentiation of particle properties resolves the contradiction between structural strength and ease of operation.
Solution Approach 2:
By segmenting the bone material into two portions with different particle size specifications, the invention allows each segment to optimize for its specific function. The ground particles segment maintains structural integrity while the shaved particles segment ensures moldability, eliminating the need to compromise between strength and ease of application that would occur with a single particle size distribution.
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 composition forms a cohesive, moldable paste that retains shape in saline and can be easily molded, addressing the challenge of maintaining position and consistency in bone repair applications, with enhanced osteoinductive properties for new bone growth.
Implementation Method 1
The pieces are freeze-dried and then ground into particles
Implementation Method 2
the mixture is autoclaved under heat and pressure to form a gelatin
Data Source
AI summary
A malleable demineralized bone composition consists of cortical bone made from a first portion and a second portion. The first portion of cortical bone is made from cut pieces freeze dried then ground into particles and demineralized then freeze-dried. The second portion of cortical bone is shaved into shavings. The shavings are long thin strips subjected to freeze-drying. The freeze-dried shavings are ground and demineralized and then freeze-dried. A volume of the second portion is placed in a solution of sterile water to create a mixture, the water volume being twice the second portion, the mixture is autoclaved under heat and pressure to form a gelatin, and the first portion is mixed with the gelatin to form a malleable putty or paste.