Triphasic Bone Cement Kit for Controlled Resorption and Strength
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Solution Overview
Problem
Current synthetic bone repair materials do not possess ideal functional characteristics, such as a desirable resorption rate, high mechanical strength, ease of handling, osteoconductivity, and a workable set time, especially when used with additives.
Innovation Solution
A particulate composition comprising calcium sulfate hemihydrate powder, calcium phosphate granules with a porous morphology, and a brushite-forming calcium phosphate mixture, which forms a hardened triphasic cement upon mixing with an aqueous solution, providing good mechanical strength and a controlled resorption rate.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If calcium sulfate cement is used for bone repair, then good mechanical strength and ease of handling are achieved, but the resorption rate is too rapid
Solution Approach 1:
The patent combines calcium sulfate hemihydrate (providing mechanical strength and ease of handling) with calcium phosphate granules (providing controlled resorption rate). This composite material resolves the contradiction by integrating two materials with complementary properties: calcium sulfate for immediate structural support and calcium phosphate for sustained, controlled degradation matching bone regeneration rates.
2Reliability
If hydroxyapatite is used for bone repair, then excellent biocompatibility and osteoconductivity are achieved, but the resorption rate is extremely slow
Solution Approach 1:
The patent incorporates hydroxyapatite particles within the calcium sulfate-calcium phosphate composite matrix. This creates local regions of excellent biocompatibility and osteoconductivity where hydroxyapatite contacts bone tissue, while the overall composite maintains an optimal resorption rate through the calcium phosphate component. The local quality principle allows simultaneous achievement of high biocompatibility and controlled resorption.
3Reliability
If bone graft cement contains biological additives, then osteoinductivity and biological activity are improved, but the setting time becomes unacceptably long
Solution Approach 1:
The patent uses calcium sulfate hemihydrate instead of traditional calcium sulfate dihydrate, which fundamentally changes the setting reaction kinetics. The hemihydrate form reacts more rapidly with water to form dihydrate, providing a faster setting time that accommodates the inclusion of biological additives like growth factors or bone marrow aspirate without extending the working time excessively.
4Reliability
If autologous cancellous bone is used for bone repair, then osteogenic capacity and non-immunogenicity are maximized, but donor site morbidity and trauma occur
Solution Approach 1:
The patent creates an intermediary material that mimics the beneficial properties of autologous bone (osteoconductivity, porosity, biocompatibility) without requiring harvesting from the patient. The calcium sulfate-calcium phosphate-hydroxyapatite composite serves as a synthetic substitute that provides structural support and facilitates bone regeneration without the harmful effects of donor site morbidity associated with autograft harvesting.
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 bone graft substitute cement exhibits high mechanical strength, facilitates the development of high-quality bone at the site of bone defects, and maintains acceptable handling characteristics, while also setting quickly and being capable of hardening in the presence of biological additives.
Implementation Method 1
comprising a calcium sulfate hemihydrate powder, a porous-tricalcium phosphate component, and a brushite-forming calcium phosphate mixture
Implementation Method 2
a porous-tricalcium phosphate component
Implementation Method 3
a brushite-forming calcium phosphate mixture
Data Source
AI summary
Disclosed are kits for preparing a reactive graft material and injecting the graft material into a patient. Kits may include a first syringe containing a first powdered component and a second syringe containing a second powdered component that is reactive with the first powdered component when the first and second powdered components are dispersed in a diluent solution. The kits may further include a vial sealed by a septum and containing the diluent solution. A syringe connector may be included that has a connector at each end configured to make a fluidic connection to, respectively, the first syringe and the second syringe, and also comprises a passageway adapted to allow fluid to pass between the syringes when the syringes are both fluidically connected to the syringe connector. A vial adapter comprising a connector adapted for fluidically connecting to at least one of the first syringe and the second syringe, a passageway adapted to allow fluid to pass from the vial into a syringe fluidically connected to the connector of the vial adapter, and a spike in fluidic communication with the passageway of the vial adapter may be included. The spike is adapted for piercing the septum of the vial. Certain kits also contain one or more needles for delivery of the graft material to a site within a body of a patient.