JPS61170471A - Bone prosthetic molded body - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] [Industrial application field].

TECHNICAL FIELD The present invention relates to a bone prosthesis molded body, and particularly to a human body.

A bone prosthesis made of a sintered porous body of a calcium phosphate compound formed into a shape that can be adapted to bone defects, bone voids, fractures, defects resulting from removal of bone tumors, aging areas, etc. of living organisms such as animals. This invention relates to a molded article.

[Prior art]

Calcium phosphate compounds, such as hydroxyapatite and its solid solutions, have good affinity with living organisms and are useful as medical materials, such as substitute materials for bones or tooth roots, or prosthetic materials. Japanese Patent No. 54841 discloses a material for filling bone defects and voids using an apatite-type crystal structure calcium phosphate compound powder.

Further, Japanese Patent Application Laid-Open No. 166843/1984 discloses a bone defect and void filler made of a porous body of a calcium phosphate compound. The pores contained in this porous body of calcium phosphate compound have a maximum pore diameter of 3.00 mm and a minimum pore diameter of 0.05 mm, and have a shape and size that allows the bone-forming components of the living body to easily enter. It forms a continuous three-dimensional network structure.

[Problems with conventional technology]

However, the above-mentioned conventional calcium phosphate compound ceramic materials tend to deform over time after performing surgical operations such as fillings and prosthetics, or due to the hardness of the soft tissue near the filling or prosthetic part. This caused problems such as the abnormality being forced to be removed.

In addition, methyl methacrylate-based adhesive cement has traditionally been used as bone cement to fix artificial bones or joints made from metal or ceramic materials in vivo; Cement contains a small amount of unreacted monomer, which may dissolve in the living body and harm the living tissue, causing fever9, loosening of fixation at the surgical site, or complications from complications, so it is not satisfactory. There wasn't.

In general, in the treatment of hard tissue defects in living organisms, such as excision of bone tumors or defects caused by external bone damage, it is most preferable to promote natural healing.1 Replacement with artificial materials or prosthetics is not necessarily preferable. No, even if artificial bone cement is used to fill or prosthetize in a living body, it is possible that such bone cement will eventually be eaten away by the living body and natural living tissue will regenerate in its place to complete the fixation. This is the most desirable thing. In this case, it is important that the rate at which bone cement is replaced by living tissue (turnover rate) is appropriate; if the turnover rate is too fast, it may cause local damage such as inflammation.
This can lead to complications such as the development of cancer. In addition, if the turnover rate is low and bone cement remains in the body for a long period of time, deformation of local living tissue (bone) and hardening of nearby soft tissues may occur, which may require surgical excision. There is.

In order to address the above-mentioned problems, it is important that bone cement inserted into a living body can satisfy the requirements for inducing, replacing, and replacing living tissue at the cellular level. In other words, it appropriately promotes the activation of bone mass cells (osteoclast-oplasts) in living tissues, and promotes the invasion and development of collagen fibers that promote the hardening of bone-destructive cells (osteocrusts) and soft tissues, as well as the hardening of bone tissue. It is important not to inhibit the infiltration of red blood cells and body fluids and the development of capillaries.

In order to meet the above requirements, the bone cement inserted into a living body must have good affinity for the living body, especially bioresponsibility, and be effective in activating desired cells. It provides a good living space for growth, prevents the invasion of unwanted cells, and collagen m! It is necessary to be able to prevent the hardening of bone tissue due to abnormal development of a.

The object of the present invention is to treat fractures in living organisms such as humans and animals.

It is an object of the present invention to provide a bone prosthesis molded body made of a porous sintered body of a calcium phosphate compound formed into a shape that can be fitted and filled into bone defects, bone voids, and bone tumor resection sites.

[Technical means to solve problems]

The bone prosthesis molded body of the present invention is made of a sintered body of a calcium phosphate compound, and the inside of the sintered body contains one or more 1-600
It has pores with a pore diameter of microns and micro-void passages that communicate these pores with the external space, and is suitable for use in bone fractures, bone defects, bone voids, and bone tumors in the human body and animals. It is molded into a shape that can be adapted to the excised and aging parts of the body.

[Detailed description of the invention]

The calcium phosphate compound used in the present invention is CaHP
O* C113(PO4) 2 Cas (PO4)30H Ca40(PO4)z Calo (PO4)b (OH)2CaPa0+t Ca (PO3) 2 Ca2P20p Ca (H2PO4)2 11H20 etc. are the main components, and hydroxyapatite It includes a group of compounds called. Hydroxyapatite has the composition formula Ca
s CPO5) 30H or Cago (PO4)
The basic component is a compound having 6 (OH) 2, and a portion of the CaIIt component is Sr, Ba, Mg, Fe.
, A.M., Y., and La.

It may be substituted with one or more of Na, H, etc.,
Also, a part of the (Po4) component is ■04.

It may be substituted with one or more of BO3, SOa, CO3, 51g4, etc., and further, a part of the (OH) component may be substituted with one or more of F, C1,0, CO3, etc. Hydroxyapatite may be a normal crystal or a homomorphic solid solution.

It may be either a substitutional solid solution or an interstitial solid solution, and may contain stoichiometric lattice defects.

Generally, the calcium phosphate compound used in the present invention has an atomic ratio of calcium (Ca) to phosphorus (P) (Ca/P).
is preferably within the range of 1.30 to 1.80,
More preferably, it is within the range of 1.60-1.67.

The calcium phosphate compound used in the present invention is tricalcium phosphate (Ca:+ (PO4) 2).

Hydroxyapatite (Ca5 (PO4) 30H
) and Cago CPO5)b (OH)2 are preferred, and those synthesized by the sol-gel method and freeze-dried are particularly preferred, and the calcium phosphate compound is 800
It is preferably sintered at a temperature of ~1450°C, and the sintering temperature is more preferably 850~1250°C.

Furthermore, one or more pores having a pore diameter of 1 to 600 microns are formed inside the bone prosthesis molded article according to the present invention, and these pores communicate with the external space through a microscopic pore passage. The diameter of this fine void passage is preferably in the range of 1 to 30 microns, more preferably in the range of 1 to 20 microns, and the inner hole in the 1 & shape body preferably has a pearl or similar shape, In addition, when a plurality of these pores are present, it is preferable that they are uniformly distributed within the molded body.When the ceramic material is implanted in a living body, these pores will cause bone mass cells.

It provides a living space for biologically activating bone regenerating cells. Bone regenerating cells and the like very much prefer to be anchored in these pores, especially in spherical pores. For this purpose, the pore diameter of the pores must be in the range of 1 to 600 microns, preferably 10 to 300 microns. It is not possible to provide a good living space.

If the shape of the pores is a pearl or a spherical shape similar to this,
The resulting porous material has high mechanical strength.

Therefore, when this bone prosthesis molded body is implanted in a living body, until it is returned over by new bone,
It can maintain and control high mechanical strength and adhesive strength.

The micro-void passages in the bone prosthesis T171 molded body communicate at least the pores with the external space of the molded body, and through these passages, the bone phagocytes, bone regenerating cells, red blood cells9 body fluids, etc. can freely flow. It can penetrate into porous bodies, and the development of capillaries is promoted. For this reason, the diameter of this fine void passage is preferably in the range of 1 to 30 microns, more preferably in the range of 1 to 20 microns. It is difficult to enter the capillary-like void passages in the porous body,
Abnormal development of collagen fibers and hardening of bone tissue can be prevented. That is, in the bone prosthesis molded article according to the present invention, the fine void passages also have the function of a biofilter.

When the diameter of the fine void passage is smaller than H chron,
It may be difficult for bone mass cells, bone regenerating cells, red blood cells, etc. to enter the porous body, and if the size exceeds 30 microns, it will allow the invasion and development of destroyed cells and collagen fibers, thus inhibiting bone regeneration. However, the bone prosthesis molded article according to the present invention may also lead to hardening of the regenerated bone tissue or the tissues in its vicinity.
The sintered porous molded body made of a calcium phosphate compound used in the bone prosthesis molded body according to the present invention can be produced by various methods. Various aspects of the manufacturing method of the present invention will be described below.

(t) Too many parts by weight Egg white is whipped to form a large number of bubbles with a pore size of 1 to 600 microns, and the egg white foam is 30 to 12
0 parts by weight of calcium phosphate compound powder, and molded into the shape shown in FIGS. 1 to 52 by pouring this mixture into a mold of a desired shape, and the molded mixture was heated at a temperature of 120 to 150°C. heating to a temperature of 500 to 700°C to carbonize the albumen, then heating to a temperature of 800 to 1350°C in an oxygen-containing atmosphere to burn off the char. It can also be produced by sintering the calcium phosphate compound powder.

In this case, the egg white curing and heating step can be carried out at a temperature increase rate of 5 to 10° C./minute in an atmosphere having a relative humidity of 30 to 70%.

Further, the calcium phosphate compound powder may be 0.05 to 10
Preferably, the particles have a particle size of microns.

(2) 100 parts by weight of egg white is whipped to form a large number of bubbles with a pore size of 1 to 600 microns, and this egg white foam and 30
- 120 parts by weight of calcium phosphate compound powder and 1 to 5 parts by weight of organic fibers having a length of 5 cm or less and a diameter of 1 to 30 microns are mixed;
The molded mixture is heated to a temperature of 120-150°C to harden the albumen, and then heated to a temperature of 500-700"O to carbonize the albumen and fibers. 800-13 in an oxygen-containing atmosphere.
It can be produced by heating to a temperature of 50° C. to burn off the carbide and sinter the calcium phosphate compound powder.

In this case, it is preferable that the organic fiber is an animal fiber, silk fiber, cellulose fiber, and/or organic synthetic fiber, and the length of the organic fiber is 1 micron to 5 m.

(3) 20 to 300 parts by weight of sublimable solid material powder having a particle size of 1 to 600 microns is mixed with 100 parts by weight of calcium phosphate compound powder, and this mixture is shaped into the desired shape (Fig. The molded product is heated to a temperature of 300 to 500°C to remove the sublimable substance by sublimation, and then heated to a temperature of 800 to 1350°C to form the calcium phosphate. It can be manufactured by sintering compound powder.

In this case, the calcium phosphate compound is 0.05 to 1O
The sublimable solid substance has a particle size of microns,
Preferably, the material is selected from camphor, camphor, naphthalene, and mixtures of two or more of these.

(4) 20 to 300 parts by weight of sublimable solid substance powder having a particle size of 1 to 600 microns, and 1 to 5 parts by weight of organic fibers having a length of 5 mm or less and a diameter of 1 to 30 microns; The mixture is mixed with 100 parts by weight of a calcium phosphate compound, and the mixture is shaped into the desired shape (the shape shown in FIGS. 1 to 52).
This molded product is heated to a temperature of 200 to 800°C to sublimate and remove the sublimable substance and carbonize the organic fiber, and then heated to a temperature of 800 to 800°C in an oxygen-containing atmosphere.
It can be manufactured by heating to a temperature of 350° C. to burn off the carbide and sinter the calcium phosphate compound powder.

In this case, the organic fiber is animal fiber, silk fiber, cellulose fiber and/or organic synthetic fiber,
It is preferable that the organic fiber has a length of 1 micron to 5 mm.

(5) 25 to 380 parts by weight of organic synthetic resin particles having a particle size of 1 to 600 microns are mixed with 100 parts by weight of a calcium phosphate compound, and the mixture is shaped into the desired shape (as shown in Figures 1 to 52). shape), the obtained molded product is heated to a temperature of 200 to 800°C to remove the organic synthetic resin particles by thermal decomposition, and then heated to 80°C in an oxygen-containing atmosphere.
By heating to a temperature of 0-1350℃.

It can be manufactured by sintering the calcium phosphate compound powder.

In this case, the calcium phosphate compound powder is 0.05 to
Preferably, it has a particle size of 10 microns;
Further, the particle size of the organic synthetic resin spherical particles is 10 to 300.
It is preferable that the organic synthetic resin is within the micron range, and furthermore, it is preferable that the organic synthetic resin is at least one selected from polymethyl methacrylate, polypropylene, and polystyrene.

(8) 25 to 380 parts by weight of organic synthetic resin particles having a particle size of 1 to 600 microns, and 1 to 5 parts by weight of am pyramids having a length of 51 layers or less and a diameter of 1 to 30 microns, It is mixed with 100 parts by weight of calcium phosphate compound powder, the obtained mixture is press-molded into a desired shape (the shape shown in FIGS. 1 to 52), and the obtained molded product is
Heating to a temperature of 00°C to thermally decompose and remove the synthetic resin and carbonize the organic fibers, and then heating to a temperature of 800 to 1350°C in an oxygen-containing atmosphere to burn and remove the carbide. , # can be produced by sintering calcium phosphate compound powder.

In this case, it is preferable that the organic fiber is selected from animal fibers, silk fibers, cellulose fibers and/or organic synthetic fibers, and the organic fibers have a length of 1 micron to 5 cm. It is preferable if there is, and furthermore,
It is preferable that the particle size of the organic synthetic resin ff1 particles is within the range of 10 to 300 microns.

(7) 25 to 380 parts by weight of organic synthetic resin particles having a particle size of 1 to 600 microns and 2 to 5 parts by weight of sublimable solid material particles having a particle size of 1 to 600 microns; The mixture obtained by mixing with the calcium phosphate compound powder of
The synthetic resin particles are removed by thermal decomposition by heating to a temperature of 00°C, and the sublimable material particles are removed by sublimation, and then heated to a temperature of 800 to 1350°C in an oxygen-containing atmosphere to remove the phosphoric acid. It can be manufactured by sintering calcium compound powder.

In this case, it is preferable that the sublimable substance is selected from camphor, camphor, naphthalene, and a mixture of two or more thereof. Furthermore, it is preferable that the particle size of the organic synthetic resin particles is within the range of lθ to 300 microns. - (8) 25 to 380 parts by weight of organic synthetic resin particles having a particle size of 1 to 600 microns and 2 to 5 parts by weight of 1 to 60 microns;
sublimable solid material particles having a particle size of 0 microns;
5 parts by weight of organic fibers having a length of 5 mm or less and a diameter of 1 to 30 microns are mixed with 100 parts by weight of calcium phosphate compound powder, and the resulting mixture is shaped into the desired shape (first
The obtained molded product is heated to a temperature of 200 to 800°C to remove the organic synthetic resin particles by thermal decomposition, and the sublimable material particles are removed by sublimation. , and can be produced by carbonizing the organic fiber and then heating it to a temperature of 800 to 1350°C in an oxygen-containing atmosphere to burn off the carbide and sinter the calcium phosphate compound powder. .

In this case, the particle size of the organic synthetic resin spherical particles is 10 to 3
It is suitable if it is within the range of 00 microns,
Further, it is preferable that the organic fiber has a length of 1 micron to 5 mm.

In detail, the method for manufacturing the bone prosthesis molded article according to the present invention is as follows: For example, a sublimable solid material powder having a particle size of 1 to 600 microns is mixed with the remaining amount of calcium phosphate compound powder, and this mixture is mixed at high speed. The mixture containing the sublimable solid substance is stirred repeatedly while being heated with an alcohol medium using a stirrer, and then the mixture containing the sublimable solid substance is applied to bone defects, bone voids, fractures, resection sites of bone tumors, and aging bones of living organisms such as humans and animals. It is molded by placing it in a mold with a shape that can be adapted to the parts etc. (shown in Figures 1 to 52), extrusion molding, CIPJi shape, press molding and rubber press molding, drying and heating at 300 to 500 °C. The sublimable solid substance is removed by sublimation, and the first
It is produced by heating and sintering at a temperature of 50°C, preferably 850-1250°C.

The calcium phosphate compound powder used in the above production method preferably has a particle size of 0.05 to 10 microns. Particularly preferable calcium phosphate compound powders include:
It is preferable to include a plate-shaped crystal part, and SEM
According to observation results based on scanning electron microscopy (scanning electron microscope), less than 30% of powder particles have a particle size of 11 chrome or more, and 70%
Preferably, the particles have a particle size distribution such that the particle size is 1 micron or less.

In addition, the sublimable solid substance powder is contained in the bone prosthesis molded body at 1 to 6
There is no particular limitation on the type as long as it is used to form pores with a desired size of 0.00 microns, easily sublimes at a temperature of 200 to 800°C, and leaves virtually no residue. The type is selected from camphor, camphor, naphthalene, and mixtures of two or more of these. The mixture is heated to a temperature of 200 to 800°C, preferably 120°C.
When heated for ~180 minutes, the sublimable substance sublimates and escapes to form pores, but at this time, the fine powder of the sublimable substance sublimates and escapes from the pores, forming microvoid passages that communicate with the outside of the porous body. Ru. Further, microscopic void spaces are also formed that communicate between the holes.

Next, the molded product is further heated at 800 to 1450°C, preferably at 85°C.
The calcium phosphate compound powder is sintered by heating to 0 to 1200°C, preferably for 1 to 3 hours.

In the method using the above sublimable substance powder, 1 to 5 parts by weight of organic fibers having a length of 1 micron to 5 mm and a diameter of 1 to 30 microns are added and mixed with 100 parts by weight of the calcium phosphate compound powder. Such a mixture may be heated to a temperature of 200-800°C, preferably 120-800°C.
If heated for 180 minutes, the sublimable substance sublimates and escapes, and the organic fibers are carbonized.Next, if heated to a temperature of 800 to 1450°C, preferably for 1 to 3 hours, the carbide is burned out and a calcium phosphate compound is formed. The powder is sintered.

In this method, the incorporation of organic fibers is effective in ensuring the formation of capillary-like void passages having a diameter of 1 to 30 microns. This miscellaneous condition is the same as that for both speeds.

When mixing organic fibers or sublimable material powder with calcium phosphate compound powder, adding volatile lower alcohols such as methanol or ethanol not only makes it easier to obtain a homogeneous mixture, but also reduces the particle size of the sublimable material particles. control,
In addition, it is possible to improve the contact between the sublimable material particles and the organic fibers, thereby promoting the formation of microvoid passages communicating with the pores.

Another method for manufacturing the bone prosthesis molded body according to the present invention is to mix organic synthetic resin particles having a particle size of 1 to 600 microns with 100 parts by weight of calcium phosphate compound powder,
This mixture is molded into a desired shape (as shown in FIGS. 1 to 52) by a method similar to the method described above, and the resulting molded product is heated to a temperature of 200 to 800°C to form the organic synthetic resin particles. The method includes removing the calcium phosphate compound by thermal decomposition, and then heating the calcium phosphate compound powder to a temperature of 800 to 1450° C. in an oxygen-containing atmosphere to sinter the calcium phosphate compound powder.

The organic synthetic resin particles having a particle size of 1 to 600 microns used in the above method are effective for forming pores of 1 to 600 microns in the molded article. Regarding the types of organic synthetic resins.

Although there is no particular limitation as long as it thermally decomposes at a temperature of 200 to 400°C and escapes from the porous body, it is generally methyl methacrylate.

The above-mentioned organic synthetic resins selected from thermoplastic synthetic resins such as polypropylene and polystyrene, with methyl methacrylate being particularly preferred, have considerable hardness, so their particles may be mixed with calcium phosphate compound powder,
When this mixture is press-molded, the spherical particles are not deformed or crushed, and therefore, it is possible to form pores with a size and shape that exactly correspond to the size and shape of the particles used.

The mixture of organic synthetic resin spherical particles and calcium phosphate compound powder is placed in a mold that can create a shape that fits the bone defect site of the living body (shapes shown in FIGS. 1 to 52), or press-molded. After molding using a rubber press or other known method, heating is performed at a temperature of 200 to 500°C, preferably 300 to 350°C, for 120 to 180 minutes to thermally decompose and remove the organic synthetic resin particles. Holes are formed, and fine void passages extending from the holes are also formed.

Furthermore, this molded product was heated to 800 to 145 in an oxygen-containing atmosphere.
0°C, preferably 850-1250°C, preferably 1
Heat for ~3 hours to sinter the calcium phosphate compound powder. At this time, even if there is residual liquid from thermal decomposition of organic synthetic resin particles,
This is burnt off during sintering heating.

In the method using the organic synthetic resin particles, 100
For every part by weight of calcium phosphate compound powder, 1 to 5 parts by weight of organic fibers having a length of 1 micron-51 and a diameter of 1 to 30 microns can be added. The types and effects of this organic fiber are the same as described above.

Furthermore, in the method using the organic synthetic resin particles,
2 to 100 parts by weight of calcium phosphate compound powder
5 parts by weight of sublimable solid material particles having a particle size of 1 to 600 microns can be additionally incorporated. The type of this sublimable substance is the same as described above. In this method, the sublimable material particles have a particle size of 1 micron to 600 microns and are effective in forming capillary-like void passages.

Furthermore, in the method 2 using the organic synthetic resin particles, for 100 parts by weight of calcium phosphate compound powder,
Add 2 to 5 parts by weight of organic fibers with a length of 1 micron to 5 cm and a diameter of 1 to 30 microns, and 2 to 5 parts by weight of sublimable solid particles with a particle size of 1 micron to SOO microns. The types and effects of these organic fibers and sublimable solid particles that may be mixed are the same as described above.

The molded bone prosthesis according to the present invention can be molded by pouring into a mold, molding using a rubber press molding machine (pressing under static pressure of 2 kg/cm2 and leaving for about 10 minutes), or extrusion molding.

Next, the specific shape of the bone prosthesis molded body according to the present invention, which is molded by CIP method, hydrostatic press molding method, etc., will be explained.

The bone prosthesis molded body l shown in FIGS. 1, 3, and 5 is formed into a rectangular parallelepiped. The bone prosthesis molded body 2 shown in FIG. 2 is formed into a rectangular parallelepiped shape as a whole, and grooves 2 are formed on the top and bottom surfaces along the width direction so that it can be divided as needed along the length direction.
The bone prosthesis molded body 3 shown in FIG. 4 is formed into a rectangular parallelepiped, and grooves 4 and 5 are provided on the top and bottom surfaces along the length and width directions. The bone prosthesis molded body 6 shown in FIG. 6 is formed into a rectangular parallelepiped, and the top and bottom surfaces have grooves 6a, 6b, 6c in the length direction, width direction, and diagonal direction.
The bone prosthesis molded body 7 shown in FIG. 7 is formed as a flat plate with a square plane, and the bone prosthesis molded body 8 shown in FIG. The bone prosthesis molded body 9 shown is formed into a cube, the bone prosthesis molded body 1O shown in FIG. The prosthetic molded body 12 is formed into a disk shape. Further, the bone prosthesis molded body 13 shown in FIG. 13 is formed in the shape of a square member with a square cross section, and the bone prosthesis molded body 14 shown in FIG. 14 is similarly formed in the shape of a square member with a square cross section, but the upper and lower surfaces A plurality of grooves 14a and 14b are formed in the bone prosthesis molded body 15 shown in FIG. 15, which is formed into a square piece with a square cross section. However, a plurality of grooves 15a are formed on the upper surface, lower surface, and both side surfaces. The bone prosthesis molded body 16 shown in FIG.
The bone prosthesis molded body 17 shown in FIG. 7 is formed in the shape of a triangular prism having a right triangle cross section, and the bone prosthesis molded body 18 shown in FIG. 18 is formed in the shape of a quadrangular pyramid. Further, the bone prosthesis molded body 19 shown in FIG. 19 is formed in a hollow cylindrical shape, and the bone prosthesis molded body 20 shown in FIG. 20 is formed in a thick-walled cylindrical shape.
The bone prosthesis molded body 21 shown in FIG. 1 has a shape obtained by cutting a cylinder in the length direction, and the bone prosthesis molded body 22 shown in FIG.
is formed into a conical shape, and the bone prosthesis molded body 23 shown in FIG. 23 consists of a cylindrical portion 23a and a conical portion 23b.

The bone prosthesis molded body 24 shown in FIG. 24 is formed into a round shape as a whole, and the bone prosthesis molded body 25 shown in FIG. 25 has the same overall shape as the bone prosthesis molded body 24 shown in FIG. A bone prosthesis molded body 26 shown in FIG. 26 has a cylindrical portion 26a and a disc-shaped seven flange portion 26b provided at an intermediate portion of the cylindrical portion 26a. The bone prosthesis molded body 27 shown in FIG. 27 is formed into a wedge shape as a whole, with legs 27a having trapezoidal sides, and a head 27b having a substantially rectangular parallelepiped shape with a curved upper part. Consists of. The leg portion 27a is tapered downward. Also the 28th
The overall shape of the bone prosthesis molded body 28 shown in the figure is approximately the same as that of the bone prosthesis molded body 27 shown in FIG. It is formed in a shape that tapers downward. The bone prosthesis molded body 29.30 shown in FIGS. 29 and 30 is
It has the basic shape of the bone prosthesis molded body 27 shown in FIG. 27, and has holes 29a and 30a for passing prosthetic threads.
Several have been established. The bone prosthesis molded body 30 is formed to be wider than the bone prosthesis molded body 29.

The bone prosthesis molded bodies 31 and 32 shown in FIGS. 31 and 32 have the basic shape of the bone prosthesis molded body 29 shown in FIG. There is. These notches 31b and 32b are
1a, 32a (7) are provided at opposite sides of both ends 31c, 32c. In addition, the bone prosthesis molded body 3
2 is formed to be wider than the bone prosthesis molded body 31. In the bone prosthesis molded bodies 33 and 34 shown in FIGS. 33 and 34, the notches 33b and 34b are respectively
The notches 31c and 32c are the heads 33a and 3, respectively.
The bone prosthesis molded body 31 is provided on the opposite side of 4a.
and has the same configuration as the bone prosthesis molded body 32. The bone prosthesis molded body 34 is formed to be wider than the bone prosthesis molded body 33. The bone prosthesis molded bodies 35 and 36 shown in FIGS. 35 and 36 are different from the bone prosthesis molded body 28 shown in FIG.
having a basic shape, a hole 35a for passing a prosthetic thread,
Multiple 36a have been established.

The bone prosthesis molded bodies 37 and 38 shown in FIGS. 37 and 38 have holes 37b and 38b at both ends of the heads 37a and 38a.
is opened and the leg portion 37c is opened.

38c has three grooves 37d in its width direction.

38d, and is configured so that it can be cut and formed into a size according to the bone extraction site. Further, the bone prosthesis molded body 38 is formed to be wider than the bone prosthesis molded body 37. Bone prosthesis molded body 39 shown in FIGS. 39 and 40
The bone prosthesis molded body 40 has a basic shape of the bone prosthesis molded body 37 and the bone prosthesis molded body 38, and has grooves 39b with a plurality of holes 39a and 40a for passing prosthetic threads.

40b. In addition, the bone prosthesis molded body 4
0 is formed to be wider than the bone prosthesis molded body 39. The bone prosthesis molded body 41 and the bone prosthesis molded body 42 shown in FIGS.
1b.

42b. The bone prosthesis molded body 43 and the bone prosthesis molded body 44 shown in FIGS. 43 and 44 have cutout portions 43a and 44a provided on opposite sides of the bone prosthesis molded body 41 and the bone prosthesis molded body 42, respectively. Except for this, the structure is the same as that of the bone prosthesis molded body 41 and the bone prosthesis molded body 42.

The bone prosthesis molded body 45 and bone prosthesis molded body 46 shown in FIGS. 45 and 46 are the bone prosthesis molded body 37 and the bone prosthesis molded body 3.
Similarly to 8, holes 45b and 46b are provided in the heads 45a and 48a.
In addition, grooves 45d and 46d are provided in the leg portions 45c and 46c. No. 47 @ and No. 48
A bone prosthesis molded body 47 and a bone prosthesis molded body 48 shown in the figure have the same configuration as the bone prosthesis molded body 45 and bone prosthesis molded body 46, except that notches 47a and 48a are provided on opposite sides. It is. A bone prosthesis molded body 49 and a bone prosthesis molded body 50 shown in FIG. 49 and FIG. , 50a are provided.

The bone prosthesis molded body 51 and the bone prosthesis molded body 52 shown in FIGS. 51 and 52 are the same except that the notches 51a and 52a are provided on the opposite side of the bone prosthesis molded body 49 and 50. The composition is as follows.

In addition, bone prosthesis molded bodies 42, 44, 46, and 4g.

50.52 is a bone prosthesis molded body 41, 43, 45°47,
49 and 51, except that they are each formed to have a wider width than those of 49 and 51.

The specific shape of the bone prosthesis molded body according to the present invention is not limited to one or more shapes, and the design may be changed as appropriate.

Next, the essential parts of each of these bone prosthesis molded bodies 1 to 52 will be explained.

The bone prosthesis molded bodies 1 to 9 shown in FIGS. 1 to 9 can be appropriately used, for example, in a defective part of the iliac bone 53, as shown in FIGS. 53 (1) to (3).

In the figure, 5' indicates a section of the bone prosthesis molded body 5, and it can be used as a kind of spacer in any damaged part of any bone, not limited to the ilium. Also, Fig. 54 (1) -
As shown in (6).

Figures 1θ, 11, 16, 17, and ia.

Bone prosthesis molded bodies 10, 11.1B, and 17.1B shown in FIGS. 19, 20, 21, 22, and 23.

19.20, 21, and 22.23 can be used as appropriate depending on the damaged part of the femur 54, for example. Of these,
The bone prosthesis molded bodies 19, 20, and 26 are used by being inserted into the medullary cavity inside the bone when the humerus, femur, etc. are fractured. Moreover, it is not limited to the femur 54, but includes the clavicle, humerus, tibia, and fibula.

It can be used for other appropriate parts of the osteotomy. In particular, the bone prosthesis molded body 26 is used to connect bones in the event of a fracture. Further, the spherical bone prosthesis molded body 11 shown in FIG. 11 is formed in various diameters, for example, a small spherical shape is filled into the medullary cavity to induce the generation of new bone around it. Moreover, as shown in FIG. 54(2), the bone prosthesis molded bodies 11 and 21 can be used in combination. In this case, each bone prosthesis molded body 11.2
1 in combination, new bone formation can be induced more effectively.

As shown in FIG. 54, the bone prosthesis molded body 12 shown in FIG. 12 is used, for example, by being horizontally inserted and filled into a damaged site of the thoracic vertebrae 55, and can also be used in the lumbar vertebrae. Furthermore, FIG.

Bone prosthesis molded body 13°14.1 shown in Figs. 14 and 15
Step 5 fills the damaged parts of the cervical vertebrae 56 shown in Fig. 55 and the thoracic vertebrae 57 shown in Figs. 56 to 58 along the vertical direction of the vertebrae. In this case, the bone prosthesis molded body 14. Bone prosthesis molded body 1
5 can be used after being cut to an appropriate size depending on the scale of the injured area, that is, as shown in FIG. You can also do that. In addition, numeral 58 in Figure 1 is a joining tool for joining each thoracic vertebrae.

Moreover, the bone prosthesis molded bodies 29 to 52 shown in FIGS. 29 to 52 are applied to the defect site of the iliac bone 53, as represented by the bone prosthesis molded body 35 shown in FIG. 53(1). It is used by inserting and filling. That is, when a part of the ilium 53 is cut and used for surgery on other parts of the human body, animals, etc., it can also be used by filling the defective part after cutting. Moreover, it can also be used by filling a defect site generated in the iliac bone 53 itself. Also, Figure 24 and 2
The bone prosthesis molded body 24 and the bone prosthesis molded body 25 shown in FIG.
Like the above-mentioned bone prosthesis molded bodies, it can be used for the defective part of the container, but in particular, the bone prosthesis molded body 25 is used when an artificial heart, an artificial liver, a pacemaker, etc. are used, as shown in FIG. 60. , embedded in the skin 59, external electric wire 6
0 is disposed through the hole 61 of the bone prosthesis molded body 25, and can also be used as a protective ring for implantation into the skin.

Furthermore, although the present invention will be explained in detail based on Examples, the present invention is not limited to these Examples.

〔Example〕

By a known wet method, a phosphoric acid solution was added dropwise to a calcium hydroxide slurry to synthesize calcium phosphate with Ca/P=1.65, and after drying, a calcium phosphate powder of 150 microns or less was obtained. For 100g of this calcium phosphate, 5 to 30
37 g of polymethyl methacrylate resin with a particle size of 0 microns was mixed, and organic fibers with a diameter of 5 microns and a length of 10 microns were mixed at the same time, and this mixture was pre-temperature stirred using a high-speed stirrer using methanol as a medium. The mixture was repeatedly applied to create a mixture, poured into a mold that can be molded into a shape that can be extracted into the defective part of the iliac bone of a living body (the shape shown in Figure 29), and heated and dried. After that, the organic synthetic resin particles were removed by thermal decomposition to obtain a porous body having pores of 5 to 300 microns, which was further sintered at 1000°C for 1 hour to obtain a porous body with a pore size of 5 to 300 microns. A bone prosthesis molded body having micron pores was obtained.

This bone prosthesis molded article was used by filling a defective site in the iliac bone of a living body (human), and the induction of new bone by the molded article of the present invention was observed. Two weeks later, one operation was performed, and the progress of the prosthetic site in the ilium of the living body was observed. As a result, a large amount of induced new bone formation was observed. As a result of observation after 13 weeks, the prosthesis site was almost completely replaced by new bone, and the progress was good.

〔Effect of the invention〕

The bone prosthesis molded body according to the present invention has pores having a pore diameter of 1 to 600 microns, preferably 3 to 300 microns, and 1
The capillary void passageway has a diameter of ~30 microns, preferably 1-20 microns.

Since it can function as a biofilter, it prevents abnormal development due to the invasion of collagen m fibers, hardening of bone tissue due to the catalytic action of collagen fibers, and organic inhibition of new bone before the invasion of destructive cells into the capillary-like void passageway. make it difficult,
It is possible to prevent collagen fibers from becoming hard due to abnormal growth of collagen fibers, and selectively allow only bone mass cells, bone regenerating cells, red blood cells, and other body fluids to pass through. Further, pores having a specific pore diameter can promote activation of bone mass cells and bone regeneration cells at the cellular level.

Therefore, by using the bone prosthesis molded article according to the present invention, it is possible to promote the induction of new bone and promote bone return-over while maintaining good compatibility with the living body.

Furthermore, in the bone prosthesis molded article according to the present invention, each of the pores communicates with each other through a capillary cavity passage, and further, the pores and the external space of the bone prosthesis molded article according to the present invention communicate with each other through a capillary cavity passage. At the same time, the pores and the external space communicate with each other through capillary-like void passages, and the capillary-like void passages are extremely small, with a diameter of 1 to 30 microns, preferably 1 to 20 microns, which facilitates new bone formation. It can be effectively induced.

That is, when an existing bone is filled with a bone prosthesis molded article according to the present invention, not only is the particle size and shape of the pores incompletely controlled with the conventional 7-batite porous material, but also collagen fibers enter the pores. It is a fairly large hole. Therefore collagen m! Even if l enters and new bone is induced,
Collagen develops abnormally and becomes hard due to the catalytic effect of collagen fibers, which may cause inflammation around the implanted area or cause cancer. However, the bone prosthesis molded article according to the present invention As mentioned above, the diameter of the capillary void passage is 1 to 30 microns, preferably 1 to 2 microns.
Because it is extremely small at 0 microns, it can prevent the collagen mix from entering the capillary void passageway, prevent the hardening and hardening of collagen fibers, and also contain bone mass cells, bone regeneration cells, and red blood cells that are effective in inducing new bone formation. 9 Because only body fluids can selectively pass through, it is possible to form bones that are very soft at first, and then become harder as they move outward (same structure as natural bones of humans and animals, with a central Therefore, it has exactly the same structure as the natural bones of humans and animals, that is, the center of the bone has the shape of bone marrow and the outer periphery is organized bone. Since bone with increased bone density can be formed, strong new bone can be created with exactly the same structure as natural bone, unlike conventional apatite bone consisting only of hardened bone. This is because when the bone prosthesis molded article according to the present invention is embedded in an existing bone, the bone of the present invention is eaten away and disappears, and in its place, new bone with the same structure as natural bone is induced, even after long-term use. Strong and flexible bones that are completely non-toxic are formed.

Furthermore, the bone prosthesis molded body according to the present invention is a single human body.

It is molded into a shape that can be adapted to bone defects, bone voids, fractures, defects caused by resection of bone tumors, etc. in living organisms such as animals, so it can be easily filled into the bone defects, etc. This will further promote the induction and formation of new bone at the site, and will not waste the amount of bone prosthesis molded material used at the fracture site or other sites during surgery, and will also reduce the amount of bone prosthesis work. This can be done efficiently and in a short time.

Additionally, in the past, if a fracture occurred in any part of the body, a piece of bone for filling would be removed from another part (for example, the ilium) and then inserted and filled into the fractured part. However, when using the bone prosthesis molded article according to the present invention, it is possible to perform prosthesis of the fractured part without removing the bone. Therefore, not only is it possible to perform a surgical operation only once, but also the efficiency of the operation itself can be improved.

Furthermore, according to the present invention, bone prosthesis molded bodies of extremely wide variety of shapes can be formed and prepared in advance.
This also has the effect of making it possible to respond equally and quickly, regardless of urban or rural areas, when emergency surgery is required due to a traffic accident or sudden illness.

[Brief explanation of drawings]

1 to 52 are perspective views showing an example of the form of the bone prosthetic molded body according to the present invention, and FIGS. 53 (1) to (3) show the usage states of the bone prosthetic molded bodies 1 to 9 and 35. Explanatory drawings, FIGS. 54 (1) to (6) show the bone prosthesis molded body 1 according to the present invention.
0,11,16°17.18,19,20.21,22
, 23° 24.26, FIG. 55 is a plan view showing the bone prosthesis moldings 13, 14, 15 according to the present invention in use, and FIG. 56 is the bone prosthesis molding according to the present invention. FIG. 57 is a side view showing how the body 13 is used, FIG. 57 is a side view showing how the molded bone prosthesis 15 according to the invention is used, and FIG. 58 is a side view showing how the molded bone prosthesis 14 according to the invention is used. Fig. 59 is an explanatory view showing a case where the bone prosthesis molded body 15 according to the present invention is cut and formed and a part thereof is used, Fig. 60
．． FIG. 2 is an explanatory diagram showing a state in which a bone prosthesis molded body 61 according to the present invention is used as a protective ring for skin implantation. 1.2, 3.6-52... Bone prosthesis molded body patent applicant
Representative of Sumitomo Cement Co., Ltd. Patent attorney
Tsuchihashi Hao Figure 53 (1) Figure 53 II Figure 53 II Figure 54 Figure 54 vA Figure 54 Figure 54 m Figure 54 Figure 54 Figure 56 m 5511 Article 59 II Procedural amendment (method) % formula % 2, Title of the invention Bone prosthesis molding body 3, Relationship with the person making the amendment Patent applicant address 1, Kanda Mitoyo-cho, Chiyoda-ku, Tokyo Name Sumitomo Cement Co., Ltd. Representative Konno 11 Hikoji 4, Agent Address: 1-17-3-5 Toranomon, Minato-ku, Tokyo 105
, Date of amendment order: April 30, 1985 (shipment date)6, Number of inventions increased by amendment: None7, "Brief explanation of drawings" column of the specification subject to amendment and contents of drawing amendment 1 ) The statement "Figs. 1 to 52 are perspective views showing an example of the shape of the bone prosthesis molded body according to the present invention" in lines 17 to 18 on page 41 of the specification is corrected as follows. ``Figure 1 is a perspective view showing a case in which the bone prosthesis molded body according to the present invention is formed into a rectangular parallelepiped, and Figure 2 is a perspective view showing a case in which grooves are formed on the top and bottom surfaces of the bone prosthesis molded body having the shape shown in Figure 1. FIG. 3 is a perspective view showing a case where the bone prosthesis molded body according to the present invention is formed into a slightly wide rectangular parallelepiped, and FIG. 4 is a perspective view showing grooves on the top and bottom surfaces of the bone prosthesis molded body shown in FIG. FIG. 5 is a perspective view showing a case in which the bone prosthesis molded body according to the present invention is formed into a rectangular parallelepiped, and FIG. 6 shows the upper surface and A perspective view showing the case where a groove is formed on the bottom surface, FIG. 7 is a perspective view showing the case where the bone prosthesis molded body is formed into a flat plate with a square plane, and FIG. 8 is a perspective view showing the case where it is similarly formed into a rectangular parallelepiped. Figures 9 and 9 are perspective views showing the case in which it is similarly formed into a cube, Fig. 1O is a perspective view showing the case in which it is similarly formed in a cylindrical shape, and Fig. 11 is a perspective view showing the case in which it is similarly formed in a spherical shape. , FIG. 12 is a perspective view showing a case in which it is similarly formed into a disk shape, and FIG. 13 is a perspective view showing a case in which it is similarly formed in a rectangular shape with a square cross section.
FIG. 14 is a perspective view showing the case where grooves are formed on the upper and lower surfaces of the molded bone prosthesis shown in FIG. 13, and FIG. 15 is a perspective view showing the upper surface, lower surface, and both sides of the molded bone prosthesis shown in FIG. 13. A perspective view showing a case in which grooves are formed on a surface, FIG. 16 is a perspective view showing a case in which a groove is formed in a triangular prism shape with an isosceles triangular cross section, and FIG. 17 shows a case in which a triangular prism shape is formed in a right triangle cross section. FIG. 18 is a perspective view showing the case where it is formed into a square pyramid shape, FIG. 19 is a perspective view showing the case where it is formed into a hollow cylindrical shape, and FIG. 20 is a perspective view showing the case where it is formed into a thick cylindrical shape. 21 is a perspective view showing a cylinder formed into a shape cut in the length direction, FIG. 22 is a perspective view showing a case formed into a conical shape, and FIG. 23 is a cylindrical part and a conical part. FIG. 24 is a perspective view showing a case where the bone prosthesis is formed in a round shape as a whole, and FIG. 25 is a perspective view showing a case where an elongated hole is formed in the bone prosthesis molded body of FIG. 24. 26 is a perspective view showing a case where the bone prosthesis molded body according to the present invention is formed by a cylindrical part and a flange part, and FIG. FIG. 28 is a perspective view showing a case in which the bone prosthesis is formed in a tapered shape from the head to the legs. FIG. 29 is a perspective view showing a case in which the bone prosthesis molded body shown in FIG. Perspective view showing the case where a hole is opened for passage, No. 30
The figure is a perspective view showing the bone prosthesis molded body shown in Figure 29 in the basic shape and slightly wider, and Figure 31 is the bone prosthesis molded body shown in Figure 29 in the basic shape with notches at both ends of the head. 32 is a perspective view showing a case where the bone prosthesis molded body shown in FIG. 31 is formed into a basic shape with a slightly thicker width, and FIG. 33 is a perspective view showing the case where the bone prosthesis shown in FIG. 31 is formed. A perspective view showing a case where the prosthetic molded body has a basic shape and a notch is provided on the opposite side, and FIG. 34 shows a case where the bone prosthesis molded body shown in FIG. 32 has a basic shape and a notch is provided on the opposite side. FIG. 35 is a perspective view showing a case where the bone prosthesis molding shown in FIG. 28 is used as the basic shape and a hole is opened. FIG. 36 is a perspective view showing a case where the bone prosthesis molded body shown in FIG. 35 is formed with a slightly thicker width, FIG. Figure 38 is the third
FIG. 7 is a perspective view showing a case in which the bone prosthesis molded body shown in FIG. 37 is formed with a slightly thicker width; FIG. Figure 40 is the third
Figure 8 is a perspective view showing a case where holes are made in the legs of the bone prosthesis molded body shown in Figure 8, and Figure 41 is a perspective view showing a case where the bone prosthesis molded body shown in Figure 35 has a basic shape and a notch is provided in the head. A perspective view showing,
Fig. 42 is a perspective view showing the bone prosthesis molded body shown in Fig. 36 in the basic shape and a notch provided in the head, and Fig. 43 is a perspective view showing the case where the bone prosthesis molded body shown in Fig. 41 has a notch part opposite to that of the bone prosthesis molded body shown in Fig. 41. FIG. 44 is a perspective view showing the case where the bone prosthesis molded body shown in FIG. 42 is provided with the notch on the opposite side, and FIG. 45 is shown in FIG. 37. 46th perspective view showing the case where the bone prosthesis molded body has a basic shape and a notch is shown in the head
The figure is a perspective view showing the case where the bone prosthesis molded body shown in FIG. 38 has a basic shape and a notch is provided in the head, and FIG.
FIG. 48 is a perspective view showing a case where the notch is provided on the opposite side from the bone prosthesis molded body shown in FIG. 46, and FIG. FIG. 49 is a perspective view showing a case where a hole for passing a prosthetic thread is formed in the leg portion of the bone prosthesis molded body shown in FIG. 45;
FIG. 50 is a perspective view showing a case where a hole for passing a prosthetic thread is formed in the leg of the molded bone prosthesis shown in FIG. 46, and FIG. 51 is a perspective view of the molded bone prosthesis shown in FIG. 47. A perspective view showing a case where a hole for passing a prosthetic thread is formed in the leg, No. 5
Figure 2 is a perspective view showing a case where a hole for passing a prosthetic thread is opened in the leg of the bone prosthesis molded body shown in Figure 48.'' 2) Figures 1 to 52 are attached as separate drawings. Correct as shown below.

Claims (1)

[Scope of Claims] 1) Consisting of a sintered body of a calcium phosphate compound, the inside of the sintered body has one or more pores having a pore diameter of 1 to 600 microns, and these pores and the outside of the sintered body or It has micro-void passages that connect each cavity, and is formed into a shape that can be adapted to fill bone fractures, defects, voids, aging parts, resected parts of bone tumors, etc. of the human body and animals. Characteristic bone prosthesis molded body. 2) The bone prosthesis molded article according to claim 1, wherein the atomic ratio of calcium to phosphorus in the calcium phosphate compound is within the range of 1.30 to 1.80. 3) The bone prosthesis molded article according to claim 1, wherein the calcium phosphate compound is hydroxyapatite. 4) The molded bone prosthesis according to claim 1, wherein the pore diameter is within the range of 3 to 300 microns. 5) The molded bone prosthesis according to claim 1, wherein the diameter of the micro-void passage is within the range of 1 to 30 microns. 6) The sintered body of the calcium phosphate compound is 40 to 90%
Claim 1 characterized in that it has a porosity of
The bone prosthesis molded article described in Section 1. 7) The bone according to claim 1, characterized in that the sintered body of the calcium phosphate compound has a plurality of pores, and these pores communicate with each other through fine pore passages. Prosthetic molded body. 8) The bone prosthesis molded article according to claim 1, wherein the pores communicate with the outer space through micro-cavity passages. 9) The sintered body of the calcium phosphate compound is 800 to 14
The molded bone prosthesis according to claim 1, which is sintered at a temperature of 50°C.