JP2009136652A - Filling material for bone defect part - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a filling material for bone defect part, which is filled in the bone defect part without causing a large space, to be early bonded to the inner face of the bone defect part, and quickly decomposed and absorbed to regenerate bone tissue in a comparatively short time. <P>SOLUTION: The filling material for bone defect part is a porous body 100 of biodegradable absorbent polymer with dispersed bioactive bioceramics powder particles. After the porous body 100 having continuous pores inside and exposing a part of bioceramics powder particles from the surface is cutting-worked as the need arises, the porous body 100 is compressed or deformed under heating and then the form is fixed by cooling to obtain the filling material 1 which restores the original form by re-heating. When the filling material 1 restores the original form by re-heating on the inside of the bone defect part 2, the restored porous body 11 is filled along the inner face of the bone defect part without causing a large space to early bond to the inner face of the bone defect part, and finally the bone tissue is totally replaced and regenerated. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a filling material for a bone defect portion, and more particularly to a filling material that is filled in a bone defect portion without a gap and can regenerate a bone tissue in a relatively short period of time.

  The present applicant, as a new medical material, has bioactive bioceramics particles uniformly dispersed in a biodegradable absorbent polymer, and has continuous pores with a pore size of approximately 100 to 400 μm inside, An organic-inorganic composite porous body in which part of the bioceramic powder particles is exposed on the inner surface of the pore has already been proposed (Patent Document 1).

This organic-inorganic composite porous material is an epoch-making product that is expected to have various medical uses such as scaffolds for regeneration of living bone or cartilage tissue, bioprosthetic materials, bone fillers, cancellous bone substitutes, and drug release carriers. New material.
JP 2003-159321 A

  For example, when the composite porous body of Patent Document 1 is filled in a defect portion of a living bone to regenerate a bone tissue, for example, a substantial gap is not generated between the inner surface of the bone defect portion and the porous body. If there is a large gap, the porous body may drop off from the bone defect portion, or the porous body and the inner surface of the bone defect portion (the bone tissue formed by the porous body). There is a risk of inconveniences such as that the coupling that occurs in the formation of the induction is not performed promptly. However, it is not easy to cut the composite porous body according to the shape of the bone defect part so that a large gap does not occur at the operation site. It is impossible to cut and fill the material to match the shape of the bone defect.

  The present invention has been made under the circumstances described above, and the problem to be solved is that the bone defect portion is filled without a gap, and is quickly coupled to the inner surface of the bone defect portion, and promptly decomposed and absorbed. An object of the present invention is to provide a filling material for a bone defect that can regenerate bone tissue in a relatively short period of time.

  In order to solve the above problems, a filling material for a bone defect according to the present invention is a porous body of biodegradable absorbable polymer in which bioactive bioceramics powder particles are dispersed, and has continuous pores therein. The porous body in which part of the bioceramic powder particles are exposed on the surface and the inner surface of the pores is a filling material formed by compressing or deforming under heating and fixing the shape of the porous body by cooling, The shape of the porous body is restored by reheating. Here, “restoration” is a term of a broad concept including not only “complete restoration” that completely returns to the original shape but also “incomplete restoration” that returns to a shape close to the original shape.

  The filling material of the present invention is divided into two types. One type is a filling material obtained by compressing the porous body under heating and fixing the shape of the porous body by cooling, and the volume expands to 1.2 to 3.5 times by reheating. The other type is a filling material in which the porous body is deformed under heating and the shape of the porous body is fixed by cooling. The shape is intended to be restored to the shape before deformation without changing the volume by heating. Here, “compression” means to reduce the volume by changing the shape of the porous body or by analogy, and “deformation” means changing only the shape of the porous body to substantially reduce the volume. It means not changing.

  In the filling material of the present invention, the porosity of the porous body is preferably 50 to 90%, the continuous pores account for 50 to 100% of the entire pores, and the pore diameter of the continuous pores is preferably 40 to 600 μm. It is preferable that the content rate of the bioceramics particle | grains of a body is 50-90 mass%. Examples of the porous biodegradable polymer include poly-D, L-lactic acid, L-lactic acid and D, L-lactic acid copolymer, lactic acid and glycolic acid copolymer, lactic acid and p-dioxanone. Any one of these copolymers, a copolymer of lactic acid and ethylene glycol, a copolymer of lactic acid and caprolactone, or a mixture of two or more thereof is preferably used.

  The filling material for the bone defect according to the present invention, for example, the compression-type filling material in which the porous body is compressed under heating and the shape is fixed by cooling, is fitted into the bone defect having a slightly larger internal volume. Then, it is reheated to a temperature slightly higher than the glass transition point of the biodegradable absorbent polymer with warm water or warm air. When reheated in this way, the filling material composed of the compressed porous body is restored to its original shape while expanding due to the restoring force of the pore walls, so that a large gap is formed along the inner surface of the bone defect portion. Without filling the bone defect. Therefore, it is possible to fill a bone defect portion having a deep shape that cannot be filled with a porous body before compression without causing a large gap. In addition, the deformation type filling material, for example, a sheet-like porous body bent into a spiral shape and deformed into a spiral cylindrical shape has a small opening diameter and an internal diameter as described later. By sequentially inserting the large bone defect portion and restoring it by reheating, the bone defect portion is filled without generating a large gap.

  As described above, when the filling material composed of the compressed or deformed porous body of the present invention is restored and filled without generating a large gap in the bone defect part, the body fluid is restored from the surface of the restored porous body through the continuous pores. The body rapidly penetrates into the body and hydrolysis of the biodegradable absorbent polymer proceeds almost simultaneously from both the surface and the inside of the porous body. And, along with the hydrolysis, the bone tissue is promptly formed on the surface layer portion of the porous body by the bioceramic powder particles exposed on the surface of the porous body, the porous body is quickly bonded to the inner surface of the bone defect, Furthermore, the bone tissue is induced and formed to the inside of the porous body by the bioceramic powder particles exposed on the inner surface of the pores, and finally is completely replaced with the porous body, thereby regenerating the bone tissue of the bone defect portion. As described above, the filling material of the present invention has an osteoinductive ability, and disappears by completely replacing the induced and regenerated bone tissue.

  It is preferable that the porous body before compression or deformation has a porosity of 50 to 90%, continuous pores account for 50 to 100% of the total pores, and the pore diameter of the continuous pores is 40 to 600 μm. When a porous material is compressed or deformed under heating and its shape is fixed by cooling, when it is reheated and restored inside the bone defect part, the porosity is substantially the same as above, and the ratio of continuous pores In order to return to the original porous body having a pore size, the intrusion of body fluids and osteoblasts into the porous body is good, the hydrolysis and the growth of bone tissue are performed quickly, and the porous material as a filling material It also has the initial physical strength necessary for the body.

  In addition, when the content of the bioceramic powder particles of the porous material before compression or deformation or the filling material composed of the compressed or deformed porous material is 50 to 90% by mass, the bone tissue is bone-induced by the bioceramic powder particles. Or it is guided to the inside of the porous body promptly by the bone conduction ability, so that it is completely replaced with the porous body in a relatively short period of time.

  The expansion ratio of the filling material composed of the compressed porous body can be adjusted depending on the degree of compression of the porous body, but in order to give good restorability, the volume of the compressed porous body is 1.2 to It is preferable to adjust so as to expand 3.5 times. Thus, the filling material whose expansion ratio is adjusted to 1.2 to 3.5 times is restored to its original shape while rapidly expanding by reheating, and a large gap is formed along the inner surface of the bone defect portion. Packed without any problems. And it couple | bonds with the inner wall of a bone defect | deletion part at an early stage, and a bone tissue is completely substituted in a comparatively short period of time.

  Hereinafter, specific embodiments of the present invention will be described in detail with reference to the drawings.

  FIG. 1 is an explanatory view of a manufacturing method example and a usage example of a compression type filling material according to the present invention.

  The compression type filling material 1 of the present invention illustrated in FIG. 1C is a porous body 100 of the material shown in FIG. 1A, that is, a biodegradable absorbent polymer in which bioactive bioceramics particles are dispersed. As shown in (b), by cutting the porous body 100, which has continuous pores inside thereof, and a part of the bioceramic powder particles are exposed on the surface and the inner surface of the pores. A porous body 10 having a downwardly spread shape, that is, a porous body 10 having a three-dimensional shape substantially similar to the bone defect portion 2 having a deep shape shown in (d) and having a slightly larger volume than the bone defect portion 2 is manufactured. The porous body 10 is heated to a temperature slightly higher than the glass transition point of the biodegradable absorbent polymer and compressed from the surroundings, and the shape of the porous body is fixed by cooling, as shown in (c) The diameter is the upper opening diameter of bone defect 2 Even small height is obtained by a porous material having substantially the same cylindrical shape to the depth of the bone defect 2.

  The filling material 1 made of a porous body that is compressed and fixed in shape as described above is filled into the bone defect portion 2 without a gap in the following manner. That is, as shown in FIG. 1 (d), the filling material 1 is fitted into a bone defect 2 having a wide open shape whose upper end opening diameter and internal volume are larger than the diameter and volume of the filling material 1, and hot water W is poured, for example. Thus, the filling material 1 is reheated to a temperature slightly higher than the glass transition point of the biodegradable absorbable polymer, and the filling material 1 made of the compressed porous body is expanded by the restoring force of the pore wall as shown in FIG. As shown in (e), the filling material 1 is restored inside the bone defect portion 2 to form a porous body 11 having a shape that matches the depth of the bone defect portion 2, and between the inner surface of the bone defect portion 2. The bone defect part 2 is filled without causing a large gap. In this way, the filling material 1 is also restored to the bone defect portion 2 having a deep shape that cannot be filled with an uncompressed porous body that is simply shaped to the bone defect portion 2 by cutting. It becomes possible to fill the porous body 11, and by continuing reheating until the inner surface of the bone defect 2 is kept while confirming the restoration state of the filling material 1 with the eye, a large gap is surely not generated. can do.

  As a reheating means, means such as blowing warm air can be adopted, but in the case of blowing warm air, there is a disadvantage that it takes some time to reheat to the inside of the filling material 1. On the other hand, when the hot water W is poured as described above, the hot water W quickly penetrates into the inside through the continuous pores of the compressed filling material 1 made of a compressed porous body, and the entire filling material 1 is evenly distributed in a short time. Since there exists an advantage which can be reheated, it is preferable to use the warm water W as a reheating means.

  As described above, when the filling material 1 made of a compressed porous body is restored and filled into the bone defect part 2 without a gap, the body fluid is quickly restored from the surface of the porous body 11 through the continuous pores to the inside of the porous body. It penetrates and hydrolysis of the biodegradable absorbent polymer proceeds almost simultaneously from both the surface and the inside of the porous body 11. Then, along with the hydrolysis, the bone tissue is promptly formed on the surface layer portion of the porous body 11 by the bioceramic powder particles exposed on the surface of the porous body 11, so that the porous body 11 and the inner surface of the bone defect portion 2 are in an early stage. Furthermore, the bone tissue is guided and formed to the inside of the porous body 11 by the bioceramic powder particles exposed to the inner surface of the pores, and finally is completely replaced with the porous body 11, and the bone tissue of the bone defect portion 2 is regenerated. The

  As described above, the material porous body 100 is a porous body made of a biodegradable absorbable polymer in which bioactive bioceramics particles are dispersed, and has continuous pores therein, and a surface and an inner surface of the pores. A part of the bioceramic powder particles is exposed, and such a porous body 100 can be manufactured by the following method.

First, the biodegradable absorbent polymer is dissolved in a volatile solvent, and bioceramics particles are mixed to prepare a suspension. The suspension is made into a fiber by means of spraying or the like, and a fiber assembly in which fibers are intertwined Form the body. Next, this fiber assembly is immersed in a volatile solvent such as methanol, ethanol, isopropanol, dichloroethane (methane), chloroform, etc. to swell or semi-dissolve, and this is pressurized to form a porous material having a predetermined shape such as a block shape. The fiber fusion aggregate is made of, and the fibers of the fiber fusion aggregate are shrunk and fused, so that the substantially fibrous form disappears to form a matrix, and the voids between the fibers become round pores. The porous body 100 is manufactured by changing the shape of the body and exposing part of the bioceramic powder particles on the inner surface and surface of the pores.
In addition, since the manufacturing method of the porous body 100 of a material is explained in detail in the above-mentioned patent document 1, further detailed explanation is omitted.

  The biodegradable and absorbable polymer is safe, is relatively fast to decompose, is not brittle even when it becomes a porous material, and is amorphous or a mixture of crystalline and amorphous poly-D, L-lactic acid, L-lactic acid, D, L-lactic acid copolymer, lactic acid and glycolic acid copolymer, lactic acid and p-dioxanone copolymer, lactic acid and ethylene glycol copolymer, lactic acid and caprolactone copolymer are suitable. These are used alone or in admixture of two or more. As these polymers, those having a viscosity average molecular weight of about 50,000 to 1,000,000 are preferably used in consideration of the ease of forming a non-woven fiber aggregate by fiberization and the period of degradation and absorption in vivo. .

  Bioceramics powder is bioactive, bioresorbable, completely replaced with bone tissue, and has good bone induction or osteoconductivity and good biocompatibility. Hydroxyapatite, dicalcium phosphate, tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate, calcite, serabital, diopsite, smallpox and the like are preferably used. Among them, uncalcined and uncalcined hydroxyapatite, tricalcium phosphate, and octacalcium phosphate have extremely high bioactivity, excellent bone induction or osteoconductivity, low toxicity, and absorption in the living body in a short period of time. Are very preferably used.

  The bioceramic powder particles have a particle size of about 30 μm or less, preferably about 10 μm or less, more preferably about 0.1 to 5 μm, considering dispersibility in the biodegradable absorbent polymer and absorbability to the living body. Things are used. In particular, bioceramic powder particles having a particle size of about 0.1 to 5 μm are formed when the porous body 100 is produced by the spray method described above in addition to good absorbability to the living body. It is preferably used because there is no fear of cutting the fiber short.

  The content of the bioceramic powder particles in the porous body 100 is preferably 50 to 90% by mass, and the filling material 1 obtained by compressing the porous body having the content is restored by reheating inside the bone defect 2. When filled, as described above, the bone tissue is promptly formed to the inside of the restored porous body 11 by the bone induction or osteoconductivity of the bioceramics particles, and the whole is replaced with the porous body in a relatively short period of time. To come. If the content of the bioceramic powder particles is less than 50% by mass, the period required for the restored porous body 11 to completely replace the bone tissue becomes longer, and if it exceeds 90% by mass, When producing the porous body 100, the biodegradable absorbent polymer fibers containing the bioceramic powder particles are disadvantageous in that they can be cut short.

  It is preferable that the porous body 100 of the material has a porosity of 50 to 90%, the continuous pores account for 50 to 100% of the entire pores, and the pore diameter of the continuous pores is 40 to 600 μm. Further, in addition to continuous pores having a large pore diameter of 40 to 600 μm, a porous body having small pores having a pore diameter of 1 μm or less in the pore walls of the continuous pores, and a part of the continuous pores and a part of the small pores are continuous. 100 is also preferably used. The filling material 1 obtained by cutting the porous body 100 and compressing the porous body 10 having a three-dimensional shape substantially similar to the bone defect 2 under heating and fixing the shape of the porous body by cooling is as follows. When this is restored by reheating inside the bone defect portion 2, the porous body 11 has substantially the same porosity, the ratio of continuous pores, and the pore diameter as described above. The body fluids and osteoblasts penetrate well, and hydrolysis and bone tissue growth occur promptly. They are not brittle and have sufficient initial physical strength necessary for the porous material as a filling material. Yes. In particular, the filling material 1 obtained by compressing the porous body 100 in which a part of small pores having a pore diameter of 1 μm or less and a part of continuous pores is continuous is restored to the porous body 11 inside the bone defect 2 by reheating. Then, hydrolysis proceeds rapidly from both the inner surface of the large continuous pores and the inner surface of the small pores due to the invading body fluid, and the osteoblasts that have entered through the continuous pores are fixed to the small pores and actively proliferate and differentiate. Therefore, the bone tissue is regenerated more quickly. The preferable pore diameter range of the small pores is 0.05 to 1 μm, and the more preferable pore diameter range is 0.1 to 1 μm.

  When the porosity of the porous material 100 is less than 50%, the continuous pores are less than 50% of the total pores, and the pore diameter of the continuous pores is smaller than 40 μm, the porosity restored from the filling material 1 inside the bone defect 2 Since the invasion of body fluids and osteoblasts into the body 11 decreases, the hydrolysis of the porous body 11 and the growth of the bone tissue are slowed, and the porous body completely replaces the bone tissue to regenerate the bone defect 2. Since the required period becomes long, it is not preferable. On the other hand, when the porosity of the porous body 100 exceeds 90% and the pore diameter is larger than 600 μm, the physical strength of the porous body 11 restored from the filling material 1 inside the bone defect portion 2 is reduced and becomes brittle. It is unsuitable as a filling. The more preferable pore diameter of the continuous pores is 100 to 400 μm.

  In addition, adjustment of the porosity of the porous body 100, the ratio occupied by the continuous pores, the pore diameter, and the like is performed when the porous body 100 is manufactured by the above-described spraying method, the fiber density of the fiber assembly, the thickness of the fiber, and the fiber assembly. Can be performed by controlling the pressure and the like when forming a porous fiber fusion aggregate.

  As long as the porous body 10 cut from the porous body 100 is slightly larger than the bone defect portion 2, the shape may be slightly different from the shape of the bone defect portion 2, but the shape is different. Since the filling material 1 obtained by compressing the porous body does not expand and recover substantially uniformly by reheating inside the bone defect portion 2, there is a possibility that a partial stress strain or a partial gap may occur. On the other hand, when the porous body 10 has a three-dimensional shape that is substantially similar to the bone defect portion 2 as described above, the filling material 1 that compresses the porous body 10 expands and restores substantially uniformly within the bone defect portion 2. Then, it comes along the inner surface of the bone defect portion 2 and is preferable because it does not cause a partial stress distortion or a partial gap.

  Further, depending on the shape of the bone defect part 2, the porosity of the porous body 100 of the material, and the pore diameter of the continuous pores, the porous body 100 of the material is compressed as it is without producing the porous body 10 of FIG. Even if the filling material 1 is used, the bone defect portion 2 may be filled without generating a large gap. That is, when the filling material 1 is flexible with a sufficient expansion rate, and the difference between the upper end opening diameter and the lower end diameter is not so large in the bone-shaped defect portion 2 having a deepened shape, the porous body 10 is not manufactured. However, the bone defect 2 can be filled using the filling material 1 obtained by compressing the porous body 100. In this case, when the filling material 1 expands and is filled without generating a large gap along the inner surface of the bone defect portion 2, as a result, the lower end of the filling material 1 (the back end side of the bone defect portion 2) is obtained. ) And the upper end of the filling material 1 (the portion corresponding to the upper end opening side of the bone defect portion 2) have different restoration ratios (expansion ratios), but still the pores at the upper end of the filling material 1 If the rate is 40 μm or more, preferably 100 μm or more, osteoblasts can invade and finally replacement with bone tissue is performed. In addition, it is good to remove suitably the upper end protrusion part of the porous body 11 which protruded from the upper end opening of the bone defect part 2 by cutting etc. by expansion | swelling of the filling material 1, and a decompression | restoration.

  In addition, when the shape of the bone defect portion 2 is a simple shape such as a round hole shape, a square hole shape, or a round hole shape spreading in the back of this embodiment, It is possible to delete the cutting process by forming a cylindrical shape corresponding to the shape of the bone defect portion 2, a prismatic shape, or a downwardly expanding cylindrical shape.

  The expansion ratio of the filling material 1 due to reheating can be adjusted by the degree of compression of the cut porous body 10, and the porosity of the porous body 10 is adjusted to 50 to 90% as described above. If the shape is compressed and fixed until the rate becomes considerably small, it can be restored by being expanded at a high magnification of 5 times or more. However, if the body is compressed too much, the porous body 10 is destroyed and it becomes difficult to restore. Therefore, in order to give good restoration, the volume of the filling material 1 is adjusted to 1.2 to 3 by adjusting the degree of compression. It is preferable to adjust so that it expands 5 times. Even if the porous bodies 100 and 10 are compressed so as to have an expansion ratio of this level, the porous bodies 100 and 10 are made of the above-mentioned non-brittle amorphous or biodegradable absorbent polymer in which a crystal and an amorphous are mixed. There is no worry about it becoming difficult. Thus, the filling material 1 adjusted so that the expansion ratio becomes 1.2 to 3.5 times is restored to the porous body 11 having the original shape while rapidly expanding by reheating, so that the bone defect portion is restored. 2 is filled without generating a large gap, and is quickly joined to the inner surface of the bone defect 2 to be completely replaced with bone tissue in a relatively short period of time.

  The filling material 1 in which the porous body 10 is greatly compressed and fixed in shape so that the expansion ratio is larger than 3.5 times has a restoration rate (the volume of the restored porous body 11 relative to the volume of the porous body 10 before compression). Since the number of cases where the ratio) decreases increases, it is not preferable. When the restoration rate is lowered, the porosity and pore diameter of the porous body 11 after restoration are considerably smaller than the porosity and pore diameter of the porous body 10 before compression, so that body fluid and osteoblasts invade accordingly. This makes it difficult to hydrolyze the porous body and replace bone tissue. In addition, the porous body 10 may be slightly compressed so that the expansion ratio of the filling material 1 is smaller than 1.2 times. In that case, even if the filling material 1 is restored by reheating, The body 11 may become difficult to follow along the entire inner surface of the bone defect portion 2 and a large gap may be generated.

  The compression of the porous body 10 is to change the shape of the porous body 10 or reduce the volume thereof so that the filling material 1 obtained by the compression can be fitted into the bone defect 2. For example, at least one axial dimension may be reduced without increasing the dimension in any of the three directions of the three-dimensional, and the volume may be reduced, or one or two axial directions may be used. The volume may be reduced by reducing the size of the remaining and increasing the size in the remaining axial direction. The filling material 1 of the above embodiment does not increase the dimensions in any of the three axes of the porous body 10, reduces the dimensions in the two axial directions in the horizontal plane, and does not change the dimensions in the vertical axis direction. The volume is reduced by changing the shape of the porous body 10 to a cylindrical shape.

  As the heating means for compressing the porous body 10, it is preferable to employ hot water or hot air, and the heating temperature is preferably set to a temperature slightly higher than the glass transition point of the biodegradable absorbent polymer. Since the glass transition point of the biodegradable absorbable polymer is around 55 ° C., specifically, the heating temperature is preferably set to about 55 to 70 ° C.

  The porous body compressed under heating as described above is cooled or rapidly cooled to a room temperature or a temperature lower than that while maintaining the shape, and the shape is fixed, and the target filling material 1 is obtained.

  Such a filling material 1 is fitted into a bone defect part of a human body or a companion animal, for example, a bone defect part from which an abnormal part such as cancer has been removed, and as described above, the original porous body 10 is expanded while being expanded by reheating. It is restored to the porous body 11 having a shape close to, and packed into the bone defect portion without causing a large gap. And it couple | bonds with the inner surface of a bone defect part at an early stage, and finally replaces with a bone tissue, and a bone tissue is reproduced | regenerated in a bone defect part.

  FIG. 2 is an explanatory view of a manufacturing method example and a usage example of a deformation type filling material according to the present invention.

  A deformable filling material 1A illustrated in FIG. 2B is a biodegradable absorbable material in which a sheet-like (band-like) porous body 100A shown in FIG. 2A, that is, bioactive bioceramic powder particles are dispersed. A sheet-like porous body 100A which is a porous body made of a polymer and has continuous pores therein, and a part of the bioceramic powder particles are exposed on the surface and the inner surface of the pores, is made of biodegradable absorbent polymer. It is heated to a temperature slightly higher than the glass transition point, bent into a spiral shape as shown in (b), and a spiral cylinder (cylinder) shape having a smaller diameter than the small opening 21A of the bone defect portion 2A shown in (c). And the shape of the porous body is fixed by cooling. The height dimension of the spiral cylindrical (cylindrical) filling material 1A is substantially the same as the depth dimension of the bone defect portion 2A. Since the porous body 100A itself is the same as the porous body 100 described above, description thereof is omitted.

  The spiral cylindrical (cylindrical) filling material 1A is filled in the bone defect portion 2A without any gap in the following manner. That is, as shown in FIG. 2 (c), a filling material 1 having a spiral cylindrical (cylinder) shape is inserted into the bone defect portion 2a through a small opening 21a of the bone defect portion 2A, and hot water W is poured into the filling material. 1 is reheated to a temperature slightly higher than the glass transition point of the biodegradable absorbent polymer, and the diameter of the filling material 1A in the shape of a spiral cylinder (cylinder) is expanded using the restoring force to restore the sheet shape. As shown in (d), they are filled in a single or multiple manner along the inner peripheral surface of the bone defect portion 2A. Next, as shown in FIG. 2 (e), a second spiral cylindrical (cylinder) -shaped filling material 1A is inserted from the opening 21A and reheated with hot water W in the same manner. While expanding the diameter of the first filling material 1A, the inside of the first filling material 1 is filled in a single or multiple manner. Then, by repeating this work several times, as shown in FIG. 2 (f), a plurality of filling materials 1 are filled so that no hollow portion remains in the bone defect 2A, and finally, the opening 21A is filled. A matching porous body 12 (same porous body as described above) is packed in the opening 21A. In this way, it is possible to regenerate the bone tissue by reliably filling the filling material 1A so that a large gap does not occur in the bone defect 2A in which the diameter of the opening 21A is small and the inner diameter is much larger.

  In addition, without using the porous body 12 described above, the height of the last spiral cylinder (cylinder) -shaped filling material 1A inserted into the central portion of the bone defect 2A is increased by the opening 21A. The opening 21a may be closed with the material 1A.

  The deformation type filling material of the present invention is a material in which the shape of the porous body is changed by heating without substantially changing the volume of the porous body, and the shape of the porous body is fixed by cooling. Is obtained by bending a porous body like the above-mentioned filling material 1A, but in addition, without changing the volume of the porous body, one or two axial dimensions of the three axes of the porous body. Without changing the size of one of the three axes of the porous body, such as those that have been increased and the remaining axial dimensions are reduced to change the shape (for example, extended, elongated) This includes one in which the remaining dimension in the axial direction is increased and the other dimension in the other axial direction is decreased to change the shape (for example, the thickness is kept constant and the length is reduced).

It is explanatory drawing of the example of a manufacturing method and usage example of the filling material which concerns on one Embodiment of this invention. It is explanatory drawing of the example of a manufacturing method and usage example of the filling material which concerns on other embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1,1A Filling material 2,2A Bone defect | deletion part 10 The cut porous body 11 The restored porous body 100,100A The raw material porous body W Warm water

Claims (6)

  It is a porous body of biodegradable absorbent polymer in which bioactive bioceramics particles are dispersed, and has continuous pores inside, and part of the bioceramics particles are exposed on the surface and the inner surface of the pores. To a bone defect where a porous body is compressed or deformed under heating and the shape of the porous body is fixed by cooling, and the shape of the porous body is restored by reheating. Filling material.   A filling material obtained by compressing a porous body under heating and fixing the shape of the porous body by cooling, wherein the volume expands by 1.2 to 3.5 times by reheating to restore the shape. The filling material for the bone defect part according to 1.   The bone defect according to claim 1, wherein the porous material is a filling material obtained by deforming the porous body under heating and fixing the shape of the porous body by cooling, and the shape is restored by reheating without changing the volume. Filling material.   The porosity of the porous body is 50 to 90%, the continuous pores occupy 50 to 100% of the entire pores, and the pore diameter of the continuous pores is 40 to 600 µm. Filling material for bone defect.   The material for filling a bone defect according to any one of claims 1 to 4, wherein the content of the bioceramic powder particles of the porous body is 50 to 90 mass%.   Porous biodegradable polymer is poly-D, L-lactic acid, L-lactic acid and D, L-lactic acid copolymer, lactic acid and glycolic acid copolymer, lactic acid and p-dioxanone copolymer The filling into a bone defect part according to any one of claims 1 to 5, which is any one of a copolymer of lactic acid and ethylene glycol, a copolymer of lactic acid and caprolactone, or a mixture of two or more thereof. material.

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