JPH053913A - Artificial composite biomaterial - Google Patents

Abstract

PURPOSE:To provide an artificial composite biomaterial having an enclosing membrane body by which an artifical hard-tissue biomaterial part (artificial bone part) is enclosed and which is liable to be absorbed by an organism when it is fixed inside the organism. CONSTITUTION:An artificial bone part 12 is enclosed by an enclosing membrane body 13 which has been formed making the main component of polyglycolic acid without being joined to it to constitute an aritificial composite biomaterial 11.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to an artificial biomaterial. More particularly, the present invention relates to artificial hard tissue materials for replacement or filling, especially artificial bone materials.

[0002]

2. Description of the Related Art Generally, in the human body or other animal body,
When there is bone damage due to illness or trauma, or bone resection due to surgery due to malignant tumor development,
This bone damage part or excision part has been replaced or filled with other parts of the living body by autologous bone. Recently, replacement or filling of artificial bone tissue (hereinafter referred to as artificial bone) has been performed for the above-mentioned bone damage part or excision part.

However, the replacement or filling with artificial bone has many problems in practice. For example, when a surgical operation is performed on a malignant tumor of the sternum, a part of the sternum obtained by surgery is replaced with artificial bone. However, conventionally,
Since the consideration and measures for maintaining the function of the sternoclavicular joint were not adequately performed, dislocation, deviation, fistula formation of the sternoclavicular joint after surgery, pain, or cosmetic defect may occur. Was having problems.

In another example, in the case of a malignant tumor of the bone around the knee, the artificial knee joint is often used after the tumor is resected by preserving the affected limb. However, since the surrounding soft tissue is also removed, the swing joint becomes a problem, and a hinge-type artificial knee joint has been conventionally used. However, even if the oscillating joint could be prevented, it was remarkably different from the movement of the knee joint, and there were many complications such as fracture of the artificial joint, loosening, and fistula formation. Moreover, the normal bone had to be largely resected, and the surgical invasion was great. The multicentric artificial knee joint that has been recently used instead of this causes the occurrence of a swaying joint because the peripheral soft tissue is removed,
There was a problem that it was difficult to use because it was functionally bad.

As another example, after excising a bone tumor part,
Artificial bones made of ceramics, etc.
When suturing and fixing tendons, ligaments, or other tissues with metal wires, silk threads, or other suture materials, there is a problem that the artificial bone is easily damaged or the fixed artificial bone is easily dislocated. .

[0006] In order to solve the above problems, it has been attempted to use an inclusion film body for encapsulating an artificial bone part and suture-fixing it to a living body. A cloth or film made of polyester or polytetrafluoroethylene has been used as such an inclusion membrane, but these synthetic organic materials have a problem that they are difficult to be absorbed by the living body for a long period of time and easily cause inflammation. is there.

[0007]

DISCLOSURE OF THE INVENTION The present invention replaces bone in a living body with an artificial living body tissue material (artificial bone), or
When filling, remove only the affected area, lesion area, damaged area,
Insert artificial bone into this part and fix it tightly, firmly and stably, without causing dislocation or deviation in joints,
In addition, joint function can be preserved as much as possible by easily anchoring muscle tendons firmly without forming fistulas, causing pain, or forming cosmetic defects. It is intended to provide an artificial biomaterial that does not cause inflammation by being absorbed into the living body within a relatively short period of time and that does not cause the wear piece to deviate from the outside.

[0008]

The present invention has succeeded in solving the above-mentioned problems by using a film body made of polyglycolic acid as an inclusion film body.

The artificial biocomposite material of the present invention has an artificial hard tissue material part (artificial bone part) formed in a desired shape and size, and encapsulating the artificial bone part, and having polyglycolic acid as a main structure. It comprises a clathrate film formed as a component. In the present invention, the artificial bone includes an artificial joint. Further, in the material of the present invention, the artificial bone part may be formed of a substrate and a coating layer that covers the substrate.

[0010]

An example of the artificial biocomposite material of the present invention is shown in FIGS. 1 and 2. The artificial biocomposite material shown in FIGS. 1 and 2 is used for partial replacement of a femur and is composed of an artificial bone part 1 and an inclusion membrane body 2. The artificial bone part 1 is composed of a hollow disk-shaped core part 1a and a hollow projecting part 1c extending above and below the core part 1a with the hollow part 1b held in between. This artificial bone part 1 is contained in a tubular clathrate membrane 2.

Another example of the artificial biocomposite material of the present invention is shown in FIGS. 3 and 4. The artificial biocomposite material shown in FIGS. 3 and 4 is also used for partial replacement of the femur and is composed of the artificial bone part 1 and the clathrate membrane 2. The artificial bone portion 1 is formed of a base body 1d and a coating layer 1e, and the base body 1d includes a hollow disk-shaped core portion 1a and its hollow portion 1b.
Hollow protrusion 1 extending above and below the core 1a
It consists of c. The coating layer 1e is formed so as to cover the side surfaces of the core portion 1a and the hollow protruding portion 1c of the base body 1d. In this way, the artificial bone part 1 having the double structure is contained in the tubular inclusion membrane body 2.

An artificial biocomposite material as shown in FIGS. 1, 2, 3 and 4 is used for in-vivo femoral diaphysis (long bone).
The artificial bone portion is fixed by inserting it into the resection portion or the defect portion and inserting the hollow protruding portion 1c with or without the covering layer of the artificial bone portion into the bone marrow cavity of the upper and lower living bones to be joined, A portion of the clathrate that extends from the core portion 1a with or without the coating layer of the artificial bone portion 1 surrounds the outside of the long bone, and this portion is sewn to the long bone. And also firmly sew the surrounding muscles.

Another example of the artificial biocomposite material of the present invention is shown in FIG. Artificial biocomposite material 3 shown in FIG.
Is an artificial sternum material 4 and an inclusion film body 5 which covers the artificial sternum material and is made of a synthetic fiber (for example, polyester fiber) cloth or a porous polytetrafluoroethylene sheet. Further, such an artificial biocomposite material,
For example, the artificial sternum material 4 shown in FIG. 5 may be used as a substrate and a coating layer is formed on the surface thereof.

Thus, the artificial biocomposite material of the present invention is
By the clathrate membrane, not only the bone portion but also the surrounding muscles, tendons and other soft tissues (peritoneum, joint capsule, periosteum, etc.) are securely sutured and fixed. For example, as shown in FIG. 6, the artificial biocomposite material 11 is composed of an artificial bone part 12 having a predetermined shape and dimensions, and an inclusion membrane body 13 covering the artificial bone part 12, and the artificial bone part 12 has a main body. It has a portion 14 and a protrusion 15. The protrusion 15 of the artificial bone portion 12 of such a composite material 11 is inserted into the cut portion 16 of the cut biological bone, and the artificial bone portion 12 and the surrounding of the biological bone are covered with the inclusion membrane body 13, Both ends,
Suture to the muscle (unfixed) around the bone.

In the artificial biocomposite material of the present invention, the artificial bone portion or its substrate is at least one selected from ceramics, carbon, metals (including alloys), and hard organic synthetic resins in a desired shape and size. It is formed as the main structural component. As the ceramic for forming the artificial bone portion or the substrate for forming the artificial bone portion, for example, one made of at least one selected from alumina (Al ₂ O ₃ ), zirconia (ZrO ₂ ) and calcium phosphate is used. Examples of the metal for forming the artificial bone portion or the base body thereof include stainless steel, titanium, tantalum, titanium alloys, nickel-
At least one selected from chromium alloys, nickel-chromium-cobalt alloys, cobalt-chromium-molybdenum alloys and the like is used.

Further, as a hard organic material for forming an artificial bone portion or a base body thereof, a high density polyethylene resin,
A resin made of at least one selected from polytetrafluoroethylene resin, polymethyl acrylate resin, polyester resin and silicone resin is used.

The material forming the artificial bone portion or the substrate thereof may be a porous material or a non-porous material.
For example, a porous calcium phosphate sintered body is used as a material for forming an artificial bone part for an artificial biocomposite material of the present invention or a substrate forming the same.

The synthetic calcium phosphate used for such purposes has a molar ratio of calcium to phosphorus of 1.30 to 1.80.
In particular, calcium phosphate having a molar ratio of calcium to phosphorus within the range of 1.60 to 1.70 (Ca
₃ (PO ₄ ) ₂ ], and hydroxyapatite [Ca ₁₀ (P
O ₄ ) ₆ (OH) ₂ ] is preferable, and further, calcium phosphate synthesized by the sol-gel method and freeze-dried is particularly preferable.

The porous calcium phosphate sinter can be manufactured as follows. For example, calcium phosphate (100 parts by weight) is uniformly mixed with spherical organic synthetic resin particles having a particle size of 1 to 600 μm (0 to 70 parts by weight) and organic polymer fibers having a diameter of 1 to 30 μm (1 to 5 parts by weight). Then, this mixture is molded into a molded product having a desired shape and size, and this molded product is
The organic synthetic resin particles and the organic polymer fibers are thermally decomposed and removed by heating at a temperature of 00 to 800 ° C. to obtain a porous molded article. Next, the porous molded product is fired at a temperature of 800 to 1350 ° C, preferably 1000 to 1350 ° C. This porous sintered body is cut into a desired shape and size.

Particles made of polypropylene resin, polymethylmethacrylate resin, polystyrene resin, etc. are used as the organic synthetic resin particles for the porous molded article, and animal hair, silk fiber, cellulose fiber, polyester are used as the organic polymer fibers. Fibers, polyolefin fibers and the like can be used.

The porous calcium phosphate sinter produced as described above has a large number of spherical independent pores having a diameter of 1 to 600 μm and a large number of capillary void passages having a diameter of 1 to 30 μm. The spherical independent holes are connected to each other and to the external space by the capillary void passages. It is preferable that the pores have a spherical shape or a substantially spherical shape and that they are uniformly distributed in the sintered body.

Such pores serve as a space for bone cells to recognize the field as an osteoblast and to provide a space for activation, that is, a cell recognition site (cell habitation space) for bone repair. Bone cells are very fond of staying in a spherical space with a specific curvature, and their pore size is 1-60.
It is preferably 0 μm, and more preferably in the range of 10 to 300 μm. Further, when the pores are spherical or almost spherical, the mechanical strength of the obtained porous body increases. Capillary void passages with a pore size of 1 to 30 μm allow selective entry of osteoclasts, osteoblasts, body fluids, leukocytes, etc., but prevent the invasion of large-sized collagen fibers and macrophages, thereby causing abnormal growth of collagen fibers. In addition, it is possible to prevent the occurrence of pseudo-joint inflamed surroundings and cancer. The cells and the like that have penetrated into the pores are highly apt to stay in the pores of this size, and can promote the control of the regeneration rate of bone, the control of bone resorption, and the induction of new bone.

When the artificial biocomposite material of the present invention comprises a substrate, an artificial bone portion composed of a coating layer, and an inclusion membrane, such an artificial biocomposite material is listed in, for example, Table 1 And various embodiments as shown in FIG. However, the artificial biocomposite material of the present invention is not limited to such an embodiment.

[Table 1]

In the composite material of the present invention, the clathrate membrane containing the artificial bone portion is extremely effective for stably fixing the composite material in the living body. Here, the term “encapsulated” means a state in which most of the artificial bone part is contained in the space defined by the clathrate membrane, and one part of the artificial bone part, for example, a part of the coating layer, is exposed to the external space. Alternatively, a part of the inner surface of the clathrating membrane and a part of the outer surface of the artificial bone part may be slightly separated from each other. The clathrate is
It may have any shape such as a sheet, a tube and a bag.

The main structural component of the clathrate is polyglycolic acid, which may be made from fibers consisting of it in the form of sheets such as wovens, knits, felts, reticulates and nonwoven webs. It may be configured. This clathrate comprising polyglycolic acid remains in the living body during the healing period, is then hydrolyzed in the living body, and is completely absorbed by the living body.

The clathrate film is preferably stretchable in the vertical and horizontal directions, and depending on the desired stretching requirements,
The structure and configuration, or the processing method, such as stretching, and the conditions thereof are selected. For example, it is required that the vertical and horizontal stretches have the same stretchability, or that the stretchability of one of the vertical and horizontal stretches is greater than that of the other. For example, it is necessary that the elongation in the vertical direction is smaller than that in the horizontal direction and the contraction in the vertical direction is larger than that in the horizontal direction, or the expansion in the vertical direction is small and the contraction in the vertical direction is large. There are cases.

The polyglycolic acid film used as the main structural component of the clathrate film may be a fiber cloth, a net, a nonwoven web or the like. When a knitted fabric is used as the clathrate, it preferably has a structure in which the elongation in the lengthwise direction is small and the shrinkage or tightening is large, particularly when it is in the shape of a tube. Such an inclusion membrane, an artificial ligament covering an artificial bone portion, an artificial joint capsule,
It is effective as a material for forming artificial fascia, artificial periosteum and the like, and is particularly preferable for artificial load joints.

The inclusion membrane used in the present invention is wrapped around an artificial bone portion (including an artificial joint portion) or wraps the artificial bone portion, so that it is used as a bone muscle, tendon, ligament or other soft part. It becomes easy to fix the artificial bone part in place by suturing it to the tissue, and also to bear part of the load applied to the artificial bone part to reduce and distribute the load to the artificial bone part, and It is possible to prevent crushing and necrosis due to the load of. Further, when the biomaterial is damaged, it is possible to prevent the fragments and wear fragments from discretely deviating from the living body.

Such an effect of the clathrate membrane enables the artificial biocomposite material of the present invention to be used for a load joint. The artificial bone portion used in the present invention may contain at least one selected from the group consisting of an osteoinductive protein impregnated in or coated with its main structural component and a collagen inducing substance. In this case, the artificial bone portion The main structural component of is a porous body, for example, a porous calcium phosphate sinter, and is preferably impregnated with the above substance. Thus, the bone-inducing protein and the collagen-inducing substance contained in the artificial bone portion promote the formation and induction of new bone and collagen.

The clathrate membrane used in the present invention may contain at least one kind selected from an osteoinductive protein and a collagen inducing substance, which is impregnated into or coated with the polyglycolic acid membrane. Thus, the osteoinductive protein and the collagen inducer contained in the inclusion membrane promote the induction and formation of new bone.

When the clathrate membrane of the present invention is a mesh fabric made of polyglycolic acid fiber, biological soft tissue penetrates through the micropores or meshes and is directly made of an artificial bone portion, for example, a porous calcium phosphate sintered body. An artificial bone part which is in contact with the artificial bone part or its coating layer and is made of such a material,
Or, since the coating layer has a very good biocompatibility, it exerts a very good effect of accepting a soft tissue in the living body, and chondrocytes infiltrate into the artificial bone portion made of a porous calcium phosphate sintered body or the surface of the coating layer. Then, cartilage can be formed there. Therefore, the artificial biocomposite material of the present invention can be firmly fixed to a living body.

Even when the artificial bone portion is composed of a base and a coating layer, the base contains a high-strength metal (including alloy) or a ceramic sintered body (alumina, zirconia, HAP, etc.). The artificial bone part has a sufficiently high strength. Further, the covering layer of the artificial bone part can receive invasion of the soft tissue of the living body and form bone tissue.

The effects of the present invention as described above are exerted to a higher degree by using the clathrate membrane body of the present invention containing polyglycolic acid as a main constituent, thereby stabilizing and fixing the artificial biocomposite material to the living body. The mobility of the part can be improved.

In the present invention, the collagen fibrous tissue enters the micropores of the artificial biomaterial of the present invention with the progress of the operation to reinforce the strength, so that the function of a permanent artificial joint capsule can be expected. In this case, the size of the pores, expansion and contraction of the clathrate, adjustment of the membrane, for example, the thickness of the cloth, and the like, by applying a substance that actively induces fibroblasts, or by allowing it to soak, An excellent permanent artificial joint that can be stably fixed can be obtained.

As an example of the present invention, an artificial joint material containing a polyglycolic acid fiber cloth as an inclusion membrane has undergone resection surgery due to neoplastic diseases such as tumors (mainly malignant tumors), and the supporting tissues around the joints have been lost. Can also be used in cases. Also artificial joints [stainless steel, titanium alloys, other metals,
By combining high density polyethylene resin (HDP) such as ceramics) with biomaterials (hydroxyapatite, stainless steel, titanium alloys, other metals, HDP),
Dislocation and deviation can be prevented and joint stability and support can be obtained.

According to the invention, individual joint movements (sliding,
Braking) is not disturbed as much as possible, there is no pain and cosmetically excellent post-operative results are obtained.

In the artificial biocomposite material of the present invention, since the artificial bone part is wrapped with the polyglycolic acid clathrate, a stable supporting force for the artificial bone part can be obtained, and the separated ligament around the joint, Muscles and tendons can be easily anchored to the artificial biomaterial of the present invention, and thus the stability, supportability and motility of joints are significantly improved.

Further, when the material of the artificial bone part is broken, it is also possible to prevent the breakage of the material. Further, the function of other joint capsules is similar to the function of reducing frictional force due to secretion of synovial fluid and catabolizing waste products in the joint cavity. The artificial biomaterial (artificial joint capsule) of the present invention can have a function.

The reason for this is that when fibroblasts, or histiocytes or cells having a phagocytic capacity for leukocytes enter, the secretion of bone fluid and the catabolism of waste products can be performed, and the synovial fluid can be stored.
In addition, it is possible to prevent undesired effects on the living body, such as the separation of waste products and wear pieces of artificial bone members.

In addition, the inclusion film made of polyglycolic acid,
Bone morphogenetic protein (BMP) can be applied or impregnated to actively measure bone induction, and the stability and support of the artificial bone part made of metal, ceramics or the like can be enhanced. In addition, a filler made of metal, ceramics, etc. and a clathrate made of polyglycolic acid are combined and used in a portion other than the joint to fill the bone defect and voids, and the surrounding supporting tissues (periosteum, ligament, muscle). Anchor membranes can be anchored to the membranes and muscles and tendons) to improve the stability and support of artificial biomaterials.

[0041]

The present invention will be further described with reference to Examples. Example 1

A. Manufacture of artificial bones 0.3 mol / in 0.5 mol / l calcium hydroxide solution
One liter of phosphoric acid solution was gradually added dropwise, and the mixture was reacted with stirring until its pH reached 7.5. Hydroxyapatite with a calcium to phosphorus molar ratio of 1.66 was obtained. This product was collected by filtration and dried to obtain powdery hydroxyapatite. To 100 g of hydroxyapatite powder, 35 g of spherical polymethylmethacrylate resin particles having a diameter of 50 to 350 μm and 5 g of cellulose fiber (diameter 5 to 10 μm, length 0.5 mm),
The mixture was stirred with ethanol, and the ethanol was removed by evaporation. 7 to 10 g of this mixture was enclosed in a rubber balloon tube having a length of 15 cm and a diameter of 2 cm, and the mixture was molded under hydrostatic pressure (CIP) under a pressure of 500 kg / cm ² .

The obtained molded product was dried overnight at room temperature, then placed in an electric furnace and heated to 400 ° C. at a heating rate of 2 ° C./min to thermally decompose and remove polymethylmethacrylate particles and cellulose fibers. The temperature to 1150 ° C,
The molded product was baked at this temperature for 5 hours. The obtained porous calcium phosphate sintered body has a porosity of 40%,
The pores with a diameter of 40-210 μm are evenly distributed, and these are 4
They were communicated by a capillary void passage of -9 μm.

The porous molded body obtained as described above was used to form an artificial bone portion as shown in FIGS. 1 and 2 by using a cutter, a lathe and a drill. The core 1a of the artificial bone portion had an outer diameter of 10 mm, the hollow portion 1c had a diameter of 3 mm, and the hollow protruding portion had an outer diameter of 5 mm.

B. Formation of composite material Around the core portion 1a of the artificial bone portion, thickness 1 mm, width 3
1 and 2 of cm polyglycolic acid fiber mesh fabric (trademark: DEXON MESH, manufactured by Nippon Redery Co., Ltd.)
A composite material was obtained by winding as shown in FIG.

C. Animal experiment A part of the diaphysis of the femur of a dog was excised by a length of 8 mm, and the above composite material was inserted into this excision. First, the upper and lower hollow protrusions 1a in the composite material are inserted into the bone marrow cavities of both cut portions of the living bone (long bone), and the artificial bone portion is arranged between the both cut portions of the living bone, and the inclusion film The parts extending upward and downward from the core part 1a of the body are arranged so as to wrap around both cut parts of the living bone, and the clathrate membrane is tied to the peripheral surface of the cut part of the living bone with silk thread, and the clathrate The membrane body was firmly sutured to the surrounding muscle to immobilize the artificial bone part. Observation was continued for 26 weeks after this operation, but no inflammatory reaction was observed at the operation site. After that, the femur underwent surgery was taken out and observed. As a result, the clathrate membrane completely disappeared, and the periosteal tunic tissue was formed. Histological observation of a thin section of this part with an optical microscope revealed that new bone was formed at the interface between the artificial bone part and the living bone, and formation of osteone was observed in this new bone. The new bone and the artificial bone were integrally connected.

Example 2 The same operation as in Example 1 was repeated. However, the sintered porous calcium phosphate molded product was cut for an artificial sternum having two fitting protrusions as shown in FIG. Further, the artificial bone part for artificial sternum was wrapped with a polyglycolic acid fiber mesh fabric (dexon mesh) to obtain a composite material as shown in FIG.

The sternal stalk solitary myeloma site of the living body is excised,
The above composite material is inserted into this excised portion, the protrusion 6 formed on the artificial bone portion 4 as shown in FIG. 5 is fitted to the clavicle, and the steel wire is passed through the wire hole 7. , The artificial bone and the sternum, the first rib, and the second rib are tightly fixed, and the clathrate 5 is attached to the surrounding ribclavicle ligament,
The sternocleidomastoid muscle, the sternothyroid muscle, the sternohyoid muscle were sutured with silk thread.

Despite the complicated movement of the sternal joint after surgery,
The artificial bone part was able to follow the movement well, and was firmly fixed without dislocation. In addition, neither inflammation nor pain was generated, and no major cosmetic defect was generated at the surgical site.

Example 3 An inclusion film made of a titanium metal artificial bone part and a polyglycolic acid fiber woven fabric (dexon mesh) was prepared by using a composite material having a structure as shown in FIGS. 1 and 2. Manufactured by

This composite material was used for femoral replacement surgery. In this case, we performed mass resection of the distal distal femoral osteosarcoma of the body, fixed the knee joint with intramedullary nails and bone cement, and performed femoral reconstruction. This caused a difference in leg length of about 7 cm, which caused bending and bone deformation of the intramedullary nail. For this reason, a femoral extension operation is performed and the intramedullary nail and bone cement are removed,
The above composite material is inserted.

The clathrate was sutured and fixed to the living bone cutting portion and surrounding muscles, tendons, and other soft tissues. The postoperative course was good, and there was no dislocation of the knee joint.
It was able to bend to the angle of degrees, and the stability was extremely good without causing inflammation or pain.

Example 4 An artificial biocomposite material consisting of an artificial knee joint made of ceramics and high-density polyethylene and an encapsulating membrane made of polyglycolic acid fiber cloth (Dexon mesh) covering the artificial knee joint was prepared.

For the living right tibial proximal end osteosarcoma of this living body using this composite material for right knee joint replacement surgery, after cutting this, the composite material is inserted and the artificial joint is joined to the tibia and femur, The clathra was suture anchored to the patella ligament, other accessory ligaments, flexor thigh muscles, tendons, etc. The postoperative course was good, the joint was stable without dislocation, and neither inflammation nor pain occurred.

Example 5 The artificial biocomposite material 11 shown in FIG. 6 was prepared as follows. Plasma spraying of the hydroxyapatite powder (particle size: 88 μm or less) produced by the method described in Example 1 was performed on the surface of the non-porous substrate formed in the desired shape and dimensions by the polycrystalline alumina sintered body. To form a coating layer (thickness: about 200 μm). The artificial bone portion 12 thus obtained was clathrated by the clathrate membrane body 13 made of polyglycolic acid fiber mesh fabric (dexon mesh).

The artificial bone portion 12 comprises a main body portion 14 and a projecting portion 15 extending from one end thereof, and the main body portion 14 has a diameter of 3 mm.
It has a hollow part of mm, and the outer diameter of the central part of the main body 14 is 10
mm. The outer diameter of the protrusion 15 was 5 mm.

This artificial biocomposite material was subjected to femoral bone replacement surgery for animals as shown in FIG. 6 by the same method as described in Example 1. That is, a part of the femur 16 is excised, the artificial bone part 12 of the artificial biocomposite material 11 is inserted into the excised part, and the protrusion 15 thereof is inserted into the remaining part of the femur 16,
In addition, the clathrating membrane body 13 was sutured to the muscle around the excised portion, the patella ligament, and other accessory ligaments.

The postoperative course was good, the joint was stable, without dislocation of the joint, inflammation of the surgical site, or the occurrence of pain.

Example 6 The same operation as in Example 2 was repeated. However, the artificial bone part used here consists of a base body made of alumina sintered body and a coating layer (thickness of about 200 μm) made of plasma hydroxyapatite on the surface of the base body. there were. The postoperative course was good. The biocompatibility of the artificial bone portion was good, and therefore the ability to form new bone was good, and the same effects as in Example 2 were obtained.

Example 7 The same operation as in Example 3 was performed. However, the artificial bone part used here was composed of a titanium metal substrate and a coating layer (thickness: about 200 μm) made of a hydroxyapatite formed on the surface by a plasma spraying method. . The same effect as that described in Example 3 was obtained.

Example 8 The same operation as in Example 4 was performed. However, the artificial bone portion used here was composed of a substrate formed of a high-density polyethylene resin and an alumina coating layer formed on the surface thereof. The same effect as that described in Example 4 was obtained.

[0062]

INDUSTRIAL APPLICABILITY The present invention provides an industrially produced artificial biocomposite material. In this artificial biocomposite material, a specific artificial bone portion is combined with a polyglycolic acid clathrate that encloses the artificial bone portion in the living body, or the stability of fixation of the artificial bone portion filled therein is fixed. In addition, even in joints, replacement without accidents such as dislocation or deviation or filling surgery is possible, and the inclusion membrane can be absorbed into the living body to prevent inflammation. .

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional explanatory view of one embodiment of the artificial biocomposite material of the present invention.

FIG. 2 is a lateral cross-sectional view of the composite material shown in FIG. 1 taken along the line AA.

FIG. 3 is a vertical cross-sectional explanatory view of another embodiment of the artificial biocomposite material of the present invention.

4 is a lateral cross-sectional view of the composite material shown in FIG. 3 taken along the line AA.

FIG. 5 is an explanatory diagram of another embodiment of the artificial biocomposite material of the present invention.

FIG. 6 is an explanatory view showing a usage situation of still another embodiment of the artificial biocomposite material of the present invention.

[Explanation of symbols]

1, 4, 12 ... Artificial bone 2,5,13 ... clathrate membrane 1a ... Hollow disk-shaped core 1b ... Hollow part 1c ... Hollow protrusion 1d ... Base 1e ... coating layer 4 ... Artificial sternum material 6,15 ... Protrusion 7 ... Wire hole 14 ... Main body 16 ... Living bone cutting part

   ─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Takeyuki Kimishima             Sumitomo Cement Co., Ltd. 585 Tomimachi, Funabashi, Chiba Prefecture             Ceremony Company New Business Headquarters

Claims (2)

[Claims] 1. An artificial biomedical tissue material part (hereinafter referred to as an artificial bone part) that has been shaped into a desired shape and size, and this artificial bone part is included and the main constituent is polyglycolic acid. An artificial biocomposite material comprising an inclusion membrane formed as a component. 2. The at least one member selected from a woven fabric, a knitted fabric, a felt, a mesh, and a non-woven web, in which the main structural component of the clathrate film is made of fibers made of polyglycolic acid. The material according to claim 1, wherein