JP2000245822A - Composite reinforced calcium phosphate artificial bone and manufacture thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an artificial bone which has good biocompatibility and higher strength, and which can be independently used for an area in which strength is required, and can be easily manufactured during operation. SOLUTION: A composite reinforced calcium phosphate artificial bone has a porous calcium phosphate artificial bone arranged in the peripheral part in contact with bones and paste-like calcium phosphate in this artificial bone. Further, the porous calcium phosphate artificial bone comprises a mixture of one or a plurality among hydroxyapatite, apatite containing carbon, α- tricalcium phosphate, β-tricalcium phosphate, tetracalcium phosphate. Moreover, in a method of manufacturing the composite reinforced calcium phosphate artificial bone, the paste-like calcium phosphate in which calcium phosphate is used as a main component of powder and water is used as a main component of liquid, and these are ground to form paste when using. The resulting paste- like calcium phosphate is used.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a composite reinforced calcium phosphate artificial bone for medical use and a method for producing the same.

[0002]

2. Description of the Related Art Conventionally, artificial bones made of calcium phosphate, mainly hydroxyapatite, have been used. These are mainly composed of calcium phosphate-based ceramics such as tricalcium phosphate in addition to hydroxyapatite.
Widely used in orthopedic, neurosurgery and oral surgery. These artificial bones made of calcium phosphate are usually porosity with a porosity of about 30 to 70%, and are designed with the expectation that living tissue will enter the pores and be integrated.

[0003]

However, the conventional artificial bone made of calcium phosphate is usually a porous material having a porosity of about 30 to 70%, and therefore has relatively low strength. There is a problem in that it cannot be used or must be used in combination with other fixtures such as metal. Therefore, the present inventors have conducted various studies on the above-mentioned problems, and as a result, by providing a void inside the calcium phosphate artificial bone, it is possible to prevent the invasion and integration of living tissue into the pores of the artificial bone. It has high strength, and it has been found that a composite-reinforced calcium phosphate artificial bone can be produced very easily even at a site where strength is required, and that a calcium phosphate artificial bone that can be used alone can be obtained. The present invention has been accomplished.

[0004] Therefore, the first problem to be solved by the present invention is that it has good biocompatibility, has high strength, and can be used alone at a site where strength is required.
An object of the present invention is to provide a composite reinforced calcium phosphate artificial bone. A second problem to be solved by the present invention is to provide a method for producing a composite reinforced calcium phosphate artificial bone which can be produced by an extremely simple method at the time of surgery.

[0005]

The above objects of the present invention can be achieved by the following inventions.

(1) A composite-strengthened calcium phosphate artificial bone characterized in that it has a porous calcium phosphate artificial bone disposed in a peripheral portion in contact with the bone and paste calcium phosphate inside the artificial bone. (2) The porous calcium phosphate artificial bone is composed of one or more of a hydroxyapatite, a carbonate-containing apatite, α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium phosphate. 2. The composite reinforced calcium phosphate artificial bone according to the above item 1, which is characterized in that: (3) A method for producing a composite reinforced calcium phosphate artificial bone, comprising: arranging a porous calcium phosphate artificial bone having a void therein at a peripheral portion in contact with the bone, and pouring the paste calcium phosphate into the void to reinforce the artificial bone. (4) The porous calcium phosphate artificial bone comprises one or a mixture of hydroxyapatite, carbonate-containing apatite, α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium phosphate. 4. The method for producing a composite-strengthened calcium phosphate artificial bone according to the above item 3, which is characterized in that: (5) The composite reinforcement, wherein the paste-like calcium phosphate is composed of calcium phosphates as a main component of powder and water as a main component of liquid, and these are kneaded when used to form a paste. A method for producing a calcium phosphate artificial bone, wherein the main components of the powder are each of α-tricalcium phosphate or tetracalcium phosphate alone and a mixture thereof, and α-tricalcium phosphate and tetracalcium phosphate are used. A mixture of calcium hydrogen phosphate and / or calcium dihydrogen phosphate, a mixture of α-type tricalcium phosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate, tetracalcium phosphate and calcium hydrogen phosphate and / or
Or the mixture with calcium dihydrogen phosphate, the method for producing a composite-strengthened calcium phosphate artificial bone according to the above item 3 or 4, wherein:

[0007] The composite-reinforced calcium phosphate artificial bone of the present invention is characterized by having a porous calcium phosphate artificial bone disposed in a peripheral portion in contact with the bone and paste calcium phosphate inside the artificial bone. By having the pasty calcium phosphate inside the artificial bone, biocompatibility is good, and, and has high strength,
This has an excellent effect that it can be used alone in a part where strength is required.

[0008] The porous calcium phosphate artificial bone used in the present invention may be a hydroxyapatite, a carbonate-containing apatite,
By using one or more of α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium mixture, the effects of the above-mentioned item 1 are further improved.

In the method for producing a composite-reinforced calcium phosphate artificial bone according to the present invention, a porous calcium phosphate artificial bone having a void therein is disposed in a peripheral portion in contact with the bone, and the calcium phosphate paste is poured into the void to reinforce the bone. By pouring paste-like calcium phosphate into the voids of the artificial bone, the artificial bone is strengthened, high strength is obtained, and thus, it can be used alone at the site where strength is required. Can be used.

[0010] In the third aspect of the present invention, the porous calcium phosphate artificial bone comprises one or more of hydroxyapatite, carbonate-containing apatite, α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium phosphate. By being composed of a plurality of mixtures, the effects of the above item 3 are more excellent.

In the invention described in the above item 3 or 4, the pasty calcium phosphate is composed of calcium phosphates as a main component of a powder and water as a main component of a liquid, and these are mixed when used. A method for producing a composite-strengthened calcium phosphate artificial bone, characterized in that the powder is mainly composed of α-tricalcium phosphate or tetracalcium phosphate alone or a mixture thereof. A mixture of α-tricalcium phosphate and tetracalcium phosphate with calcium hydrogen phosphate and / or calcium dihydrogen phosphate, a mixture of α-tricalcium phosphate with calcium hydrogen phosphate and / or calcium dihydrogen phosphate, By using either calcium tetraphosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate as a mixture Is an excellent manufacturing method capable of manufacturing a paste-like product by a simple method.

[0012]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments of the present invention will be described below in detail, but the present invention is not limited to the scope of these embodiments.

In the present invention, a porous calcium phosphate artificial bone is disposed in the peripheral portion in contact with the bone, and the paste calcium phosphate is disposed therein. The porous calcium phosphate artificial bone used in the present invention is manufactured from one or more of hydroxyapatite, carbonate-containing apatite, α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium phosphate. The prepared calcium phosphate artificial bone can be suitably used. The void inside the artificial bone can be provided at an arbitrary position, and therefore does not need to be at the center or the position of the center of gravity of the porous calcium phosphate artificial bone. The artificial bone can be reinforced by a method described later. It only has to be in the position.

As the paste-like calcium phosphate, it is preferable to use a hydraulic paste-like calcium phosphate which hardens in about 10 minutes at 37 ° C. by kneading a powder of calcium phosphates with a liquid agent containing water as a main component. (Japanese Unexamined Patent Publication (Kokai) No. 64-37445, "FC Report" Vol. 6 (1998), pp. 475-480, Japan Fine Ceramics Association). As the calcium phosphates, specifically, α-tricalcium phosphate, tetracalcium phosphate and the like are used as a main component of the powder and water is used as a main component of the liquid.

More specifically, the main component of the powder is α-tricalcium phosphate or tetracalcium phosphate alone or a mixture thereof, α-tricalcium phosphate, tetracalcium phosphate and calcium hydrogen phosphate And / or a mixture of calcium dihydrogen phosphate, a mixture of α-type tricalcium phosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate, tetracalcium phosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate The artificial calcium phosphate artificial bone which is any of the above mixtures is preferable. Further, the main component of the powder is preferably composed of α-tricalcium phosphate, tetracalcium phosphate, calcium dihydrogen phosphate and / or calcium hydrogen phosphate.

Here, the mixture of α-tricalcium phosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate is a mixture of α-tricalcium phosphate and calcium hydrogen phosphate, α-tricalcium phosphate A mixture of α-tricalcium phosphate, calcium hydrogen phosphate and calcium dihydrogen phosphate, and a mixture of tetracalcium phosphate and calcium hydrogen phosphate and / or dihydrogen phosphate The mixture with calcium,
A mixture of tetracalcium phosphate and calcium hydrogen phosphate,
A mixture of tetracalcium phosphate and calcium dihydrogen phosphate, a mixture of tetracalcium phosphate, calcium hydrogen phosphate and calcium dihydrogen phosphate, α-type tricalcium phosphate, tetracalcium phosphate and calcium hydrogenphosphate, and / or
Alternatively, a mixture of calcium dihydrogen phosphate is α-type phosphoric acid 3
Mixture of calcium, tetracalcium phosphate and calcium hydrogen phosphate, α-type tricalcium phosphate, mixture of tetracalcium phosphate and calcium dihydrogen phosphate, α-type phosphate 3
Any of a mixture of calcium, tetracalcium phosphate, calcium hydrogen phosphate, and calcium dihydrogen phosphate.

These pasty calcium phosphates are:
After curing, the structure changes to hydroxyapatite in the environment in the living body,
Eventually, it exhibits a compressive strength of 40 to 90 MPa, so that it can be used for parts requiring strength. On the other hand, since it changes to hydroxyapatite after curing, biocompatibility is good. In addition, the paste having fluidity before hardening penetrates into the pores of the porous artificial bone arranged around the same, and after the hardening, mechanically meshes with the paste to be integrated.

Next, a method for producing a composite-reinforced calcium phosphate artificial bone will be described. First, a porous calcium phosphate artificial bone having a void therein is prepared. The voids are filled with a means such as pouring or pushing paste-like calcium phosphate. This void has an opening large enough to easily fill the paste-like calcium phosphate on the surface, and the size of this opening is such that the filler can form a cured body that can withstand the required load. For example, in the case of a cylindrical void, the diameter is preferably 3 mmφ or more (the length direction varies depending on the size of the porous calcium phosphate artificial bone surrounding it). Conversely, the porous calcium phosphate artificial bone is not particularly limited, but preferably has a thickness (about 3 mm or more) that does not cause collapse of the wall surface while having the voids therein.

Here, in order to make the paste-like calcium phosphate into a paste, a powder of calcium phosphates and a liquid, preferably water, are kneaded to an appropriate viscosity (fluidity).
Before the obtained paste is hardened, it is poured or pressed into the space inside the porous calcium phosphate artificial bone to fix it. At this time, the amount and viscosity of the paste to be filled are appropriately adjusted in consideration of the size of the void portion and the strength required for the filling portion. The powder-liquid ratio when normally used is 10 to 100 parts by weight with respect to 100 parts by weight of the powder.

When the strength is required, the strength is naturally increased by kneading the mixture with a slightly higher powder-liquid ratio to increase the strength. When the opening for filling the paste is small, a slightly lower powder-liquid ratio is used. It is necessary to knead and pour a highly fluid paste. These operations can be easily performed by the surgeon during the operation. The operator holds the manufactured composite-enhanced calcium phosphate artificial bone for an appropriate time in consideration of the state of the replacement site (such as the amount of bleeding), and then refills the patient. If the amount of bleeding is large, it is necessary to wait and compensate after the calcium phosphate paste hardens to a certain extent. If it is not necessary, it is preferable to immediately compensate for it because the operation time can be shortened.

[Effect] The composite-reinforced calcium phosphate artificial bone of the present invention penetrates into pores and the like of the artificial bone before hardening because the internal voids are filled with paste-like calcium phosphate, and after hardening, the paste Calcium phosphate changes to hydroxyapatite, and mechanically meshes and integrates, so that high strength is obtained.

[0022]

EXAMPLES Hereinafter, the present invention will be described in more detail by way of examples, but the present invention is not limited thereto.

A porous apatite artificial bone manufactured by Mitsubishi Materials Corporation, "Bonfill Type HS (size 30 × 30 ×
10 mm) "(porosity 60%) 1
4 small pieces of × 13 × 10 mm (11, 12, 13, 1
Cut into 4). Next, three of these pieces (12, 1
Holes 2 each having a diameter of 4 mm were formed in the center of each of 3, 3) with a drill. Furthermore, two of these holes (13, 1
In 4), the pasty calcium phosphate 3 shown in Table 1 was poured. At this time, the mixing of the powder and the liquid was performed by adding 3.2 ml of the liquid to 10 g of the powder (Example 1) (c in FIG. 2) and 2.7 ml of the liquid.
(Example 2) (d in FIG. 2) The mixing was performed. After the paste 3 was poured, the mixture was allowed to stand in the air for 10 minutes, and then kept at 37 ° C. for 30 minutes. In Comparative Example 1, the above-mentioned cut piece was left as it is without making a hole (FIG. 2A), and in Comparative Example 2, a hole was made in the center of the above-mentioned cut piece.
The paste is not filled (FIG. 2b).

The composite-reinforced calcium phosphate artificial bone thus obtained is immersed in a physiological saline solution at 37 ° C. for 7 days.
Thereafter, it was taken out and the compression breaking load was measured. Table 2 shows the obtained results.

[0025]

[Table 1]

[Raw materials] α-type tricalcium phosphate: 3 mol of calcium hydroxide (manufactured by Kanto Chemical Co., Ltd.) is dissolved in 3 liters of water, and 2 mol of phosphoric acid (manufactured by Lhasa Industries) is gradually added dropwise thereto. Synthesized. Tetracalcium phosphate: 4 mol of calcium hydroxide (manufactured by Kanto Chemical Co., Ltd.) was dissolved in 3 liters of water, and 2 mol of phosphoric acid (manufactured by Lhasa Industries) was gradually added dropwise to synthesize. The materials used in Table 1 were calcium hydrogen phosphate (manufactured by Kanto Kagaku), sodium chondroitin sulfate (manufactured by Kanto Kagaku), and disodium succinate anhydrous (manufactured by Junsei Kagaku).

[0027]

[Table 2]

As is clear from Table 2, it can be seen that the strength is clearly improved by combining the paste-like calcium phosphate (Examples 1 and 2). After the hardening, the poured calcium phosphate paste was firmly bonded to the surrounding porous calcium phosphate artificial bone (bonfill), and the boundary was continuously integrated.

[0029]

The composite-reinforced calcium phosphate artificial bone of the present invention has good biocompatibility, high strength, and high strength by having paste-like calcium phosphate inside the artificial bone. This has an excellent effect that it can be used alone also in the part where it is performed.

[0030] The porous calcium phosphate artificial bone used in the present invention may be a hydroxyapatite, a carbonate-containing apatite,
By using one or more of α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium mixture, the effects of the above-mentioned item 1 are further improved.

In the method for producing a composite-reinforced calcium phosphate artificial bone according to the present invention, the artificial bone is strengthened by pouring pasty calcium phosphate into the voids of the artificial bone, and high strength is obtained. Can be used alone also in the parts where is required.

[0032] The paste-like calcium phosphate is composed of calcium phosphates as a main component of a powder and water as a main component of a liquid. A method for producing a calcium phosphate artificial bone, wherein the main component of the powder is a simple substance of α-tricalcium phosphate or tetracalcium phosphate or a mixture thereof, and α-tricalcium phosphate, tetracalcium phosphate and phosphorus Mixture of calcium hydrogen oxyphosphate and / or calcium dihydrogen phosphate, mixture of α-type tricalcium phosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate, tetracalcium phosphate and calcium hydrogen phosphate and / or phosphoric acid By using any of the mixture with calcium dihydrogen, it is possible to produce a paste-like material by a very simple method at the time of surgery. It is a wear excellent manufacturing method.

[Brief description of the drawings]

FIG. 1 is a perspective view showing a porous calcium phosphate artificial bone used in the present invention.

FIG. 2 is a perspective view showing a test sample of the artificial bone of FIG. 1; FIG. 2A shows the artificial bone of Comparative Example 1, and FIG.
2 shows the artificial bone of Comparative Example 2, and FIG. 2C shows Example 1 of the composite reinforced calcium phosphate artificial bone, and FIG.
Is Example 2 of the composite reinforced calcium phosphate artificial bone.

[Explanation of symbols]

 Reference Signs List 1 Porous calcium phosphate artificial bone 11, 12, 13, 14 Artificial bone test piece 2 holes 3 Paste calcium phosphate (Example 1) 4 Paste calcium phosphate (Example 2)

 ──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 4C081 AB03 AC03 AC04 BA17 BB08 BC02 CD072 CE08 CE11 CF011 CF012 CF021 CF022 CF031 CF032 DA01 DA14 DB03 DC13 EA02 EA05

Claims (5)

[Claims] 1. A composite-strengthened calcium phosphate artificial bone comprising: a porous calcium phosphate artificial bone disposed in a peripheral portion in contact with a bone; and a paste-like calcium phosphate inside the artificial bone. 2. The porous calcium phosphate artificial bone comprises:
The composite reinforced type according to claim 1, comprising one or a mixture of hydroxyapatite, carbonate-containing apatite, α-type tricalcium phosphate, β-type tricalcium phosphate, and tetracalcium phosphate. Calcium phosphate artificial bone. 3. A composite reinforced calcium phosphate artificial bone characterized in that a porous calcium phosphate artificial bone having a void therein is disposed in a peripheral portion in contact with a bone, and paste calcium phosphate is poured into the void to strengthen the artificial bone. Method. 4. The porous calcium phosphate artificial bone comprises:
The composite reinforced type according to claim 3, comprising one or more of a hydroxyapatite, a carbonate-containing apatite, α-tricalcium phosphate, β-tricalcium phosphate, and tetracalcium phosphate. A method for producing a calcium phosphate artificial bone. 5. The paste-like calcium phosphate comprises calcium phosphates as a main component of a powder and water as a main component of a liquid, and is kneaded at the time of use to form a paste. A method for producing a composite-enhanced calcium phosphate artificial bone, wherein the main components of the powder are each of α-tricalcium phosphate or tetracalcium phosphate alone or a mixture thereof, α-tricalcium phosphate and phosphoric acid 4
Calcium and calcium hydrogen phosphate and / or phosphoric acid 2
Any of a mixture of calcium hydrogen phosphate, a mixture of α-tricalcium phosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate, and a mixture of tetracalcium phosphate and calcium hydrogen phosphate and / or calcium dihydrogen phosphate The method for producing a composite-strengthened calcium phosphate artificial bone according to claim 3 or 4, wherein: