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A moldable biomaterial for bone regeneration

A biomaterial and biodegradation technology, applied in the field of biomaterials, can solve problems such as high cost, achieve the effect of reducing polymer content, reducing burden, and increasing porosity

Inactive Publication Date: 2008-12-24
SCIL TECH GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Manufacture is thus delicate and costly

Method used

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  • A moldable biomaterial for bone regeneration
  • A moldable biomaterial for bone regeneration
  • A moldable biomaterial for bone regeneration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0266] Example 1: Preparation of solid particle porous material coated with active agent

[0267] This example uses β-TCP coated particles as the solid porous material and rhGDF-5 as the active agent. Alternatives can be prepared similarly.

[0268] Raw materials must be sterilized in an appropriate manner. Initially 500 mg of β-TCP (500-1000 μm particle size) was placed in dry form in a 2R-glass. The rhGDF-5 stock solution (3.4 mg / ml in 10 mM HCl) was diluted to 0.54 μg / ml with the corresponding coating buffer. 475 µl of the rhGDF-5 solution obtained by the above method was pipetted onto β-TCP with a pipette and absorbed. The wet pellet was incubated at 25°C for 1 hour and then lyophilized. Other examples of coating β-TCP are described in WO03 / 043673 and PCT / EP2005 / 006204.

Embodiment 2

[0269] Example 2: Preparation of biodegradable paste material

[0270] Initial polymer (RG502H; PLGA; polymer composition: 48-52mol% D, L-lactide and 48-51mol% glycolide; intrinsic viscosity: 0.16-0.24dl / g, 25°C, 0.1% in CHCl 3 Medium; Boehringer, Ingelheim) was added to the necessary amount of organic solvent (PEG400) in a porcelain crucible. The two components are homogenized and heated at about 60°C until the polymer is completely dissolved in the organic solvent. Subsequently, an inorganic filler (beta-tricalcium phosphate powder) and optionally other excipients (eg, a degradation regulator such as carboxymethylcellulose sodium salt) are dispersed into the polymer solution.

Embodiment 3

[0271] Example 3: Moldable biomaterials hardened in situ comprising porous calcium-containing ceramics

[0272] The coated beta-tricalcium phosphate particles of Example 1 and the biodegradable paste material of Example 2 are mixed gently in a crucible, for example, with a sterile spoon, to form a viscous, moldable Material. Preparation of implant materials with different ratios (wt% / wt%) of β-TCP particles and polymer paste: a) β-TCP:polymer paste ratio of 1:1.3; b ) the ratio of β-TCP:polymer paste is 1:1.4; c) the ratio of β-TCP:polymer paste is 1:1.5; and d) the ratio of β-TCP:polymer paste is 1:1.7.

[0273] For all experiments requiring biodegradable paste material or moldable biomaterial in its post-hardened shape, the material was transferred to wells of a 48-well plate (250-300 mg per well). The well plates were then incubated in a bath containing PBS-buffer, where the temperature was fixed at 37°C. The bath takes 150min -1 The frequency is constantly vibrating. ...

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Abstract

The present invention is directed to a moldable biomaterial comprising a particulate solid porous material and a biodegradable paste material. The paste material and the particulate solid porous material form a matrix usable for the replacement or augmentation of bone. In various embodiments the matrix has a high structural integrity, which does not immediately or shortly after implantation collapse into an amorphous non-porous mass, maintains its porosity after implantation, shows biphasic degradation after implantation and / or has a good resistance against being washed out when it is appliedto a wet opened implant site. Active agents can be incorporated in the moldable biomaterial of the present invention, such as bone growth factors. Kits, implants, method of manufacturing as well as medicinal uses are also provided.

Description

technical field [0001] The present invention relates to a moldable biomaterial comprising particulate solid porous material and biodegradable paste material. [0002] The paste material and particulate solid porous material form a matrix for bone replacement or bone augmentation. In various embodiments, the matrix has a high degree of structural integrity, does not collapse into a non-porous mass with no defined morphology immediately or shortly after implantation, and remains porous after implantation, exhibiting Two-stage degradation and / or good wash-out resistance when the matrix is ​​applied to wet open graft sites. [0003] Active agents, such as bone growth factors, can be added to the moldable biomaterials of the invention. [0004] The invention also provides kits, implants, methods of manufacture and medical applications. Background technique [0005] Spinal fusion or spinal arthrodesis (eg, lumbar spinal fusion) is often performed as a "last resort" for patients...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/12A61L27/56
CPCA61L27/56A61L27/58A61L27/44A61L27/502A61L27/54A61L2430/02
Inventor 米夏埃多·西德勒克劳泽·黑勒布兰德安德烈斯·许茨萨布里纳·克吕格尔
Owner SCIL TECH GMBH
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