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Inorganic salt-protein composite medical instrument

A technology of medical devices and inorganic salts, applied in the field of medical devices, can solve problems such as adverse effects of protein functions and difficulties in obtaining expected results, and achieve the effects of avoiding aseptic manufacturing methods, inhibiting inactivation, and reducing costs

Pending Publication Date: 2021-11-26
CELL MEDICINE +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, it is considered that when it is intended to obtain effects such as tissue regeneration by using a protein that is not recognized as a foreign body by the administered or transplanted animal, it is considered that it is not recognized as a foreign body due to unnatural molecular changes caused by radiation sterilization. Binding to the receptor, etc., will adversely affect the function of the protein, and it is difficult to obtain the expected effect

Method used

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  • Inorganic salt-protein composite medical instrument
  • Inorganic salt-protein composite medical instrument
  • Inorganic salt-protein composite medical instrument

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0198] Example 1: Cell Proliferation Activity After Radiation Sterilization of External Fixation Pins Coated with FGF-2-Encapsulated Apatite

[0199] Titanium internal fixation pins used in fracture fixation were coated with an inorganic salt solid embedded with FGF-2 having cell proliferation activity, and the whole was sterilized by ionizing radiation to examine whether FGF-2 had cell proliferation activity.

[0200] Contains 4.89mM Ca ions, 1.28mM Phosphate ions, 6.13mM K ions, 138.8mM Na ions, 0.23mM Mg ions, 136.6mM Cl ions, 15.09mM HCO 3 An unstable calcium phosphate supersaturated solution that is ionic and has a pH of 7.8, and can crystallize calcium phosphate by spontaneous nucleation in about 4-5 hours even if it is placed directly at 37°C (the unstable calcium phosphate supersaturated solution is related to the patent document 19 different fluids). Fibroblast growth factor-2 (FGF-2) was added to the unstable calcium phosphate supersaturated solution at concentratio...

example 2

[0206] Example 2: Cell Proliferation Activity After Radiation Sterilization of External Fixation Pins Coated with FGF-2 Adsorbed Apatite

[0207] Titanium internal fixation pins used in fracture fixation were coated with an inorganic salt solid adsorbed with FGF-2 having cell proliferation activity, and the whole was sterilized by ionizing radiation to examine whether FGF-2 had cell proliferation activity.

[0208] Using the same unstable calcium phosphate supersaturated solution as in Example 1, a supersaturated calcium phosphate solution without FGF-2 was prepared, and 6 or 8 titanium internal fixation pins (Synthes, Inc. Cell Drill 4.0 / 3.0mmTi, 20mm-80mm) was dipped in it for 48 hours to make Ap pins coated with apatite on the surface. This Ap pin was dipped in supersaturated calcium phosphate containing 12 μg / ml FGF-2 for a few seconds, frozen at -18°C, and adsorbed apatite FGF-2 coated with FGF-2-adsorbed apatite ( Adsorbs ApFGF) pins. Under exactly the same conditions...

example 3

[0213] Example 3: Cell Proliferation Activity After Radiation Sterilization of External Fixation Pins Coated with FGF-2-Encapsulated Gelatin

[0214]Dip the same titanium internal fixation pin as in Example 1 for a few seconds in a 1% gelatin solution containing 4 μg / ml of FGF-2, freeze at -18°C, and prepare a pin coated with FGF-2-embedded gelatin (Gelatin FGF). Under exactly the same conditions as in Example 1, vacuum drying, γ-ray irradiation or non-irradiation, storage, and evaluation of cell growth activity were performed at room temperature. The operation of applying FGF-2-embedded gelatin, irradiating or not irradiating γ rays, and measuring the proliferation rate was repeated four times.

[0215] Table 3 shows the number of gelatin FGF pins judged to be "active" in 4 replicates. also, image 3 The value of the measured proliferation rate is shown.

[0216] [table 3]

[0217]

[0218] As shown in Table 3, in 4 experiments, 13 / 13 gamma-ray irradiated group and 13...

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Abstract

A medical instrument configured such that an inorganic salt solid such as an apatite having a peptide hormone, or the like, embedded therein is disposed in such a manner as to coat a metal, or the like, wherein the inorganic salt solid is provided via controlled delayed co-precipitation in a labile supersaturated calcium phosphate solution, or the like, and the medical instrument is exposed to a dose of ionizing radiation that is sufficient to sterilize the medical instrument.

Description

technical field [0001] The present invention relates to a medical device having resistance to sterilization by ionizing radiation, comprising a crystalline inorganic salt or an amorphous solid of an inorganic salt (hereinafter, sometimes simply referred to as "inorganic salt solid" in this specification) and having biologically active protein. [0002] More specifically, the present invention relates to a medical device for use in mammals including humans, the medical device comprising an inorganic salt-based solid embedding biological substances that are not recognized as foreign by the animal. The active protein is sterilized by ionizing radiation while maintaining the biological activity of the protein, taking advantage of ionizing radiation sterilization resistance obtained by embedding. Background technique [0003] Embedding is a term used in pathology. Embedding refers to embedding and solidifying the living tissue as the object of pathological examination in curabl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61C8/00A61F2/28A61B17/70A61B17/72A61B17/86A61L27/02A61L27/04A61L27/06A61L27/10A61L27/12A61L27/20A61L27/22A61L27/24A61L27/30A61L27/32A61L27/36A61L27/54A61L27/58
CPCA61L27/10A61L27/32A61L27/54A61F2/28A61B17/72A61L27/06A61L27/042A61L27/045A61L27/425A61L2300/414A61L2300/236A61L31/022A61L31/026A61L31/086A61L31/123A61L31/16A61L2430/02A61L2430/24A61L27/12A61L29/02A61L29/106A61L29/123A61L29/16A61L2420/02A61L2420/06A61L2420/04A61F2/30767A61F2002/3093A61F2310/00796A61F2310/00976A61B17/866A61L27/227A61L33/0011A61C8/00A61B17/86A61B17/70A61L2/0035A61L2/007A61L2300/252A61L2300/606A61L2300/62A61L2202/21A61L2202/24
Inventor 大野忠夫安永茉由伊藤敦夫十河友小林文子
Owner CELL MEDICINE