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Three-dimensional structure made of material containing polyhydroxyalkanoate, kit for preparation of bone filling material, and intramedullary nail

A polyhydroxyalkanoate and filling material technology, applied in the field of intramedullary nails, can solve the problems of inability to meet bending, tensile strength, damage to body tissue, bone adhesion, etc., and achieve excellent biodegradation properties, The effect of promoting bone regeneration and improving bending strength

Inactive Publication Date: 2017-05-10
NAGOYA UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This resin has excellent strength and can quickly ensure bone strength, but this material cannot be directly bonded to the bone, and it emits heat to nearly 90 degrees during curing, which affects the surrounding tissues. (3) Cured methacrylic acid Methyl methacrylate is too hard, so if it is used for patients whose bones are inherently fragile, there is a problem in that it induces fractures in parts that are weaker than cured methyl methacrylate for the bones around the site where it is used.
[0010] However, when filling bone cement into the fracture site, it is necessary to seamlessly infiltrate the viscous bone cement paste into every corner of the irregularly shaped bone marrow cavity. The sheath of the above-mentioned Patent Document 1 is made of collagen, polyester fiber, polylactic acid Made of other materials, lack of flexibility, so there is a problem with the adhesion to the bone
[0011] In addition, since the bioabsorbable material described in Patent Document 2 and the three-dimensional structure described in Patent Document 3 are not excellent in extensibility, they cannot withstand the pressure when the bone cement paste is injected, and the bone cement is removed from the The three-dimensional structure leaks, and as a result, there are problems that it may flow into blood vessels, and it is difficult to fill the bone cement paste with viscosity into every corner of the bone
[0012] Moreover, the intramedullary nails such as the structural framework described in the above-mentioned patent document 1 are mostly made of metal, and if the bone is fractured again after surgery, the metal will fly out of the bone from the fracture site and damage the body tissue. possibility of
[0013] On the other hand, if intramedullary nails are not used in surgery on the fracture site, and only calcium phosphate bone cement with osteoconductivity is filled, the bone cement lacks elasticity in the cured state, and may be caused by bending, stretching, Risk of fracture due to stress such as compression
For example, when calcium phosphate-based bone cement is used for the fracture site (vertebrae) of a patient with vertebral compression fracture due to osteoporosis, if a high pressure is applied to the cured calcium phosphate-based bone cement, it cannot sufficiently Maintain long-term mechanical strength, it is difficult to maintain the desired shape stably
Therefore, although there is known a bone filling material in which curly fibers are dispersed in calcium phosphate bone cement, it still cannot satisfy bending and tensile strength (see Patent Document 4).

Method used

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  • Three-dimensional structure made of material containing polyhydroxyalkanoate, kit for preparation of bone filling material, and intramedullary nail
  • Three-dimensional structure made of material containing polyhydroxyalkanoate, kit for preparation of bone filling material, and intramedullary nail
  • Three-dimensional structure made of material containing polyhydroxyalkanoate, kit for preparation of bone filling material, and intramedullary nail

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] 2 g of PHA-18 was dissolved in chloroform so that the PHA concentration became 6% by weight. At this time, the viscosity of the solution was 2.8 Pa·s. 10 mL of the above solution was put into a glass syringe. Roll aluminum foil on a grounded rotating drum to act as a collector. Install a 22G injection needle, apply a voltage of 10kV, make the needle part positively charged, extrude at 0.35mm / min, spin on the collector, and produce a non-woven fabric with a thickness of 0.1mm. The fiber diameter is about 10 μm. The melting point and glass transition temperature of the obtained nonwoven fabric were measured using a differential scanning calorimeter. As a result, the melting point was 130°C and the glass transition temperature was -20°C.

Embodiment 2

[0105] 4 g of PHA-18L was dissolved in chloroform so that the PHA concentration became 6% by weight. At this time, the viscosity of the solution was 2.8 Pa·s. 10 mL of the above solution was put into a glass syringe. 1.5 L of ethanol was filled into a 400×200×40 mm plastic pan, and a grounded stainless steel plate with a diameter of 10 mm sank to the bottom. A 22G injection needle was attached to the syringe, and a voltage of 10 kV was applied to positively charge the needle portion, extruded at 0.35 mm / min, and spun in ethanol. The floating fibers were recovered with tweezers, placed on filter paper, and dried at room temperature. The diameter of the fibers is about 10 μm. The melting point and glass transition temperature of the obtained spongy substance were measured using a differential scanning calorimeter, and the melting point was 130°C, and the glass transition temperature was -20°C.

Embodiment 3

[0113] Silicone resin was poured into a glass bottle with a diameter of 15 mm and a length of 50 mm and cured while the bottle was tilted, thereby making a model of an uneven shape in which the silicone resin was tilted from the entire bottom of the bottle to one end of the cap. Then, the non-woven fabric prepared in the above-mentioned Example 1 was made into a bag shape, installed at the front end of the injection syringe in BIOPEX-R (Advanced Flowset), and the root was tied with silk thread to fix it. Prepare the BIOPEX paste according to the attached instructions except that the stirring method and filling method are set to 6 mL set and liquid volume 4.0 mL. Next, an injection syringe equipped with a nonwoven fabric was inserted into the non-uniform shape model prepared as above, and the prepared BIOPEX was injected using a syringe in a fixed amount (set).

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Abstract

The present invention provides a material for preventing bone cement from leaking out of bone when bone cement is filled into a fracture site. By using a three-dimensional structure made of a material containing polyhydroxyalkanoate when filling bone cement into a fracture site, it is possible to prevent bone cement from leaking out of the bone.

Description

[0001] technical field [0002] The invention relates to a three-dimensional structure made of a material containing polyhydroxyalkanoate, a kit for preparing a bone filling material, and an intramedullary nail, which are suitable for treating brittle bones caused by osteoporosis. Background technique [0003] Along with the aging of society, osteoporosis and fragility fractures have been increasing in recent years. Femoral neck fractures occur 150,000 times a year, requiring 250 billion yen in medical expenses, and a considerable part of them are fragility fractures that occur even if they do not fall. Fragility fractures do not cause dislocation in the initial stage (due to displacement or bending of the bone after the fracture, resulting in visible deformation at the fracture site), but dislocation gradually occurs, and eventually high-involvement and expensive surgical operations have to be performed. [0004] As a surgical operation on the fracture site, the following me...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/00A61L31/00
CPCA61L31/06A61L2430/02C08L67/04A61B17/8808A61L24/0015A61L24/06
Inventor 平田仁西塚隆伸夏目唯弘春日敏宏
Owner NAGOYA UNIVERSITY
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