JP2008029680A - Anchor member and artificial ligament - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an anchor member capable of intensifying the fixing strength at both ends of a ligament member by the early connection to living bones above and below a knee joint; and an artificial ligament with intensified fixing strength and without a risk of being extended or ruptured even if the tensile force is repeatedly applied. <P>SOLUTION: The anchor member 21 has a porous complex layer 21d made of biodegradable/bioabsorbable polymers including bioceramic power layered and integrated on a part of or the whole of the surface of a dense complex 21c made of biodegradable/bioabsorbable polymers including bioceramic powder. The anchor members 22 and 23 include bioceramic powder and are composed of a porous complex made of biodegradable/bioabsorbable polymers which vary gradually so that the porosity becomes higher from the core toward the outer periphery or from an end to which the ligament member, etc. is attached toward the opposite end. These anchor members 21, 22 and 23 are attached to both ends of the artificial ligament member 1 so that they are not to be detached to form the artificial ligament AL1. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to an anchor member used in the case of reconstructing and fixing a damaged ligament or tendon with a biological or artificial ligament member or tendon member, and an artificial ligament in which the anchor member is attached to both ends. The present invention relates to an anchor member and an artificial ligament that can increase the reliability and strength of natural movement of a ligament member and fixation of both ends thereof with respect to living bones above and below the knee joint (femoral side and tibia side).

As is well known, there are four (two groups) ligaments in the knee joint. One is the medial collateral ligament and the lateral collateral ligament, and the other is the anterior cruciate ligament and the posterior cruciate ligament. In relation to the torsional movement of the knee associated with sports behavior, the most frequent example is an anterior cruciate ligament (Anterior Cruciate Ligament (ACL)) injury. Currently, the treatment includes normal bone-attached ACL ligaments, BTB (Bone Tendon Bone) method using Patella Tendon (PT), and Semitendon method using hamstring tendon without bone. And a method using an artificial ligament has been adopted. And, not only self-organizations (autographs), self-organizations (allografts), and cadaver-derived tendons with bones, ligaments, but also artificial ligaments are fixed with high reliability with natural movement. In order to do this, various ideas have been made. Typical examples of the BTB (Bone Tendon Bone) method for fixing an ACL damaged ligament between bones with these normal ligaments and the method for fixing only a ligament without a bone and a tendon between soft bones include the following: There are three.
1) Fixing by interference screw.
2) Fixing using a cross pin.
3) Fixation using the end button of the hamstring tendon.

  However, these fixing methods generally have a drawback that the fixed portion of the ligament and tendon is loosened with time. In the past, metal screws were mainly used for fixing in 1). However, since various problems occur in extreme knee flexion and extension such as sitting, various absorptive screws have been used in a considerable proportion in recent years. . However, the disadvantage of these screw fixations is that the screw does not directly connect with the bone at the implantation site, which is one of the causes of loosening due to the long-term bending and stretching loads. The same problem is pointed out in 3). In the case of 2), this concern is relatively small. However, if a metal cross pin is present in a joint part with intense movement for a long period of time, the movement of the cross pin and the accompanying stimulus sometimes cause serious problems. The fear of co-occurring is inevitable. Also, it is unreliable in bending strength and deformation due to its relaxation.

Here, the reconstruction using the ligament of the damaged ACL ligament will be described as an example. A method of fixing both ends of a ligament with a metal interference screw is well known. In this case, the ligament with bone passes through the holes in the living bones above and below the knee joint (on the femur side and the tibia side), and the metal part between the bone part and the inner surface of the hole. A bone interference screw is screwed in to fix the bone part at both ends of the ligament. The artificial ligament used for this reconstruction is an artificial ligament made up of a number of filaments that are substantially aligned in a row and stretched, and the end portion is processed into a loop shape and fixed with a screw or the like. What was made into is known (patent document 1).
JP 7-505326 A

  However, in the method of fixing a ligament with bone with a metal interference screw, the interference screw is not directly bonded directly to living bones above and below the bone joint, but physically due to the screw-shaped irregularities of the interference screw itself. Therefore, it was difficult to say that the fixation strength of the bone portions at both ends of the ligament was sufficiently compensated for a long period of time. In particular, when using an artificial ligament like Patent Document 1 and fixing the loop portion at the end thereof with a screw, the loop portion does not directly connect to the living bone above and below the joint, so there is a high possibility of detachment from the living bone. Moreover, when a tensile force is applied repeatedly, there is a possibility that the artificial ligament may be stretched or cut by a screw thread due to stress relaxation of the artificial ligament.

  The present invention has been made under the above circumstances, and is an anchor member (an anchor member corresponding to a ligament with a bone or a tendon bone) attached to an end portion of a ligament member or a tendon member, Faster connection with bones (femur and tibia), leading to earlier fixation of the ends of ligament and tendon members than with conventional metal or resorbable interference screws. An object of the present invention is to provide an anchor member that can be significantly increased and an artificial ligament in which the anchor member is attached to both ends.

  In order to solve the above problems, a first anchor member according to the present invention is an artificial anchor member that is attached so as not to be detached from an end portion of a ligament member or a tendon member, and is a bioabsorbable and bioactive biomaterial. Pore of biodegradable absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive on a part or all of the dense composite of biodegradable absorbable polymer containing ceramic powder It is characterized in that a composite layer is laminated and integrated.

  In this first anchor member, the porosity of the porous composite layer is 50 to 90%, the continuous pores account for 50% or more of the entire pores, and the closer to the surface layer portion from the deep layer portion of the porous composite layer. It is preferable from the standpoint of strength that the porosity is changed sequentially and gradually so as to increase the porosity. And the content rate of the bioceramics powder in the porous composite layer is changed in an inclined manner so that the content increases from the deep part to the surface part of the porous composite layer within the range of 30 to 80% by mass. It is preferable from the viewpoint of osteoconductivity that directly bonds with surrounding bone.

  The second anchor member of the present invention that solves the above-mentioned problems is an artificial anchor member that is attached so as not to be detached from the end of the ligament member or tendon member, and is a bioceramic that is bioabsorbable and bioactive. It consists of a porous complex of biodegradable polymer containing powder, and the porosity is in the range of 0 to 90%, and the larger it is the closer to the outer peripheral part in contact with the bone from the axial core part of the complex It is characterized in that it changes sequentially in an inclined manner.

  In the second anchor member, the content of the bioceramic powder is increased within a range of 30 to 80% by mass from the axial core portion of the porous composite to the outer peripheral portion in contact with the bone. It is preferable that the slope is changed sequentially.

  The third anchor member of the present invention that solves the above problem is an artificial anchor member that is attached so as not to be detached from the end of the ligament member or the tendon member, and is a bioceramic that is bioabsorbable and bioactive. It is composed of a porous composite of biodegradable absorbable polymer containing powder, and the porosity is within a range of 0 to 90%, and the opposite end from the end to which the ligament member or tendon member of the composite is attached It is characterized in that it gradually changes so as to increase as it approaches the part.

  In this third anchor member, the content of the bioceramic powder is within the range of 30 to 80% by mass, and approaches the opposite end from the end to which the ligament member or tendon member of the porous composite is attached. It is preferable that the slope gradually changes so as to increase.

  Furthermore, in the first anchor member, in the porous composite layer, and in the second and third anchor members, in the porous composite layer, BMP (Bone Morphogenic Protein) which is a biological bone growth factor is used. Impregnated with at least one of TGF-β (Transforming Growth Factor-β), EP4 (Prostanoid Receptor), b-FGF (basic Fibroblast Growth Factor), PRP (platelet-rich plasma) and / or living osteoblasts It is desirable that

  In addition, in the first, second, and third anchor members, it is preferable that a large number of small holes or small protrusions for attaching a ligament member or a tendon member are formed at the ends thereof.

  The artificial ligament of the present invention is characterized in that the above-mentioned anchor member is attached to both ends of the artificial ligament member so as not to be detached. In this artificial ligament, the artificial ligament member is made of a tissue structure in which organic fibers are triaxial or multi-axial three-dimensional woven or knitted structures or composite structures thereof, or an organic fiber braid. It is preferable.

  The first, second, and third anchor members according to the present invention are attached so as not to be detached from both ends of the ligament member, for example, and the ligament is formed in the hole formed in the upper and lower living bones (femur and tibia) of the knee joint When the anchor member at both ends of the member is inserted and the interference screw is screwed between the anchor member and the inner surface of the hole to rebuild and fix the ligament, the anchor attached to the first anchor member is The porous composite layer laminated and integrated on a part or all of the dense composite of the member is quickly hydrolyzed from the surface and inside by the body fluid contacting the surface or the body fluid penetrating the continuous pores. Along with this hydrolysis, bone tissue is induced to the inside of the porous composite layer by the osteoinductive ability of the bioactive bioceramic powder, and the porous composite layer is replaced with living bone at an early stage. , The inner surface of the anchor member and the knee joint of the upper and lower living bone hole formed binds. And in what attached the 2nd, 3rd anchor member, it is in the body fluid which contacts the surface of the porous complex which constitutes an anchor member, the peripheral part with the high porosity of this complex, and the continuous pore of an end. The peripheries and edges are quickly hydrolyzed from the surface and inside by the permeating body fluid, and the bone tissue is accompanied by this hydrolysis, and the outer peripheries have high porosity due to the osteoinductive ability of bioactive ceramic powder. The outer peripheral portion and the end portion are quickly replaced with the living bone, and the anchor member and the inner surface of the hole formed in the living bone above and below the knee joint are combined. As described above, since the first, second, and third anchor members according to the present invention are attached to the end portion of the ligament member, the anchor member is quickly coupled with the living bone (inner surface of the hole), The fixing strength at both ends of the ligament member is significantly improved as compared with the conventional case where the fixing is physically performed only with the interference screw.

  On the other hand, the first anchor member is strong and strong in the dense composite, and the hydrolysis is much slower than the porous composite layer and maintains sufficient strength until the hydrolysis proceeds to some extent. In the end, however, all the body is hydrolyzed and disappears while replacing the living bone formed by conduction with the bioactive bioceramic powder, and the holes formed in the upper and lower living bones of the knee joint become the living bone. It will be filled with. In addition, the second and third anchor members have a low-porosity axial core portion of the porous composite, and an end portion to which the ligament member is attached have strength, and the outer peripheral portion where hydrolysis is highly porous or the opposite. It is much slower than the side edges and maintains sufficient strength for a period of time until hydrolysis proceeds to some extent, but eventually all is hydrolyzed and conductively formed by bioactive bioceramics powder. It disappears while replacing the bone, and the hole in the living bone is filled with the living bone. These first, second, and third anchor members are replaced by bioceramic powders contained in each of the porous composite layer, the dense composite, and the porous composite. The bioceramic powder does not remain and accumulate in the regenerated living bone, and does not leach into soft tissues or blood vessels.

  Further, in the first anchor member, the porosity of the porous composite layer is 50 to 90%, and the continuous pores occupy 50% or more of the entire pores, approaching the surface layer portion from the deep layer portion of the porous composite layer. In order to increase the porosity, the gradient was gradually changed so that body fluid and osteoblasts were more likely to invade the surface of the porous composite layer with high porosity, leading to hydrolysis and bone tissue induction. Since the formation is performed promptly, the anchor member has an advantage of being coupled to the living bone (inner surface of the hole) earlier. Then, the content of the bioceramic powder in the porous composite layer is gradually changed in a range of 30 to 80% by mass so as to increase from the deep part to the surface part of the porous composite layer. Since the bioactivity of the surface layer portion with a high ratio of the bioceramic powder becomes high, the induced formation of osteoblasts and bone tissue on the surface layer portion is particularly active, and the living bone (inner surface of the hole) and This has the advantage that the substitution and bonding of are further promoted.

  In the second anchor member, the bioceramic powder content of the porous composite is within a range of 30 to 80% by mass from the axial core portion of the porous composite to the outer peripheral portion in contact with the bone. In the third anchor member, the content ratio of the bioceramic powder within the range of 30 to 80% by mass or the ligament member of the porous composite or Those that are gradually changed so as to increase from the end where the tendon member is attached to the opposite end also have a high bioactivity at the outer peripheral portion and the opposite end where the content of bioceramics powder is high. Therefore, the induction formation of osteoblasts and bone tissue in the outer peripheral portion and the opposite end portion becomes particularly active, and there is an advantage that replacement and bonding with living bone are further promoted.

  Further, in the first anchor member, at least one of BMP, TGF-β, EP4, b-FGF, and PRP which are biological bone growth factors and / or a bone bud derived from a living body are formed in the porous composite layer. In the cells impregnated or in the second and third anchor members, the continuous porous complex was impregnated with one of the above biological bone growth factors and / or osteoblasts derived from living organisms. Since the proliferation and growth of osteoblasts are greatly promoted, the one has the advantage that the formation of bone tissue is vigorous and the connection and replacement with living bone is performed more promptly.

  And in the case where a large number of small holes or small protrusions for attaching the ligament member or tendon member are formed at the end, the organic fiber of the living body or artificial ligament member or tendon member is passed through the small hole and latched. Or by hooking on the small protrusion, there is an advantage that it can be securely attached so as not to be detached.

  Further, the artificial ligament according to the present invention is such that the anchor member is attached so as not to be detached at both ends of the artificial ligament member, so that the anchor member is connected to the upper and lower bones (the inner surface of the hole) of the knee joint. The fixing strength is greatly improved. The artificial ligament member is an artificial ligament composed of a multi-axial three-dimensional woven or knitted structure having three or more axes of organic fibers, or a composite structure thereof, or an organic fiber braid. Since the ligament member has a tensile strength and flexibility equal to or higher than that of a living body ligament, there is almost no fear of stretching or tearing, and there is an advantage of exhibiting deformation behavior similar to that of a living body ligament.

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

  1 is a perspective view showing an embodiment of an artificial ligament according to the present invention, FIG. 2 is a perspective view showing an embodiment of an anchor member of the present invention used for the artificial ligament, and FIG. A sectional view taken along line A, and FIG. 4 is a sectional view taken along line BB in FIG.

  This artificial ligament AL1 separates the anchor members 21 and 21 made of biodegradable absorbable polymer containing bioceramic powder at both ends of the artificial ligament member 1 made of organic fiber. It is attached so as not to.

  More specifically, the artificial ligament member 1 is composed of a multi-axial three-dimensional or three-dimensional woven or knitted structure or a composite structure of these, or a braid of organic fibers. It has a tensile strength and flexibility equivalent to or higher than that of a living body ligament and exhibits a deformation behavior similar to that of a living body ligament. The above-described tissue structure constituting the artificial ligament member 1 is the same as the tissue structure described in Japanese Patent Application No. 6-254515 (Patent No. 3243679) already filed by the present applicant, When the geometric shape is represented by the number of dimensions and the orientation number of the fiber array is represented by the number of axes, a structure composed of a multiaxial three-dimensional structure having three or more axes as described above is employed.

  The three-axis three-dimensional structure is a three-dimensional structure of fibers in the three directions of length, width, and vertical, and the typical shape of the structure is a thick band shape as shown in FIG. However, it may be cylindrical. This three-axis three-dimensional structure is classified into an orthogonal structure, a non-orthogonal structure, a tangled structure, a cylindrical structure, and the like depending on the difference in structure. In addition, a multi-axis three-dimensional structure with four or more axes improves the strength isotropy of the structure by arranging multi-axis orientations such as 4, 5, 6, 7, 9, and 11 axes. With these options, an artificial ligament member 1 that closely resembles a living body ligament can be produced.

  The internal porosity of the artificial ligament member 1 made of the above tissue structure is preferably in the range of 20 to 90%. When the internal porosity is less than 20%, the ligament member 1 becomes dense and the flexibility and deformability are impaired, so that it becomes unsatisfactory as a substitute for a ligament derived from a living body. On the other hand, when it exceeds 90%, the shape retaining property of the ligament member 1 is lowered and the elongation becomes too large, which is also unsatisfactory as a substitute for a ligament derived from a living body.

  Organic fibers used as the material of the artificial ligament member include bioinert synthetic resin fibers such as polyethylene, polypropylene, polytetrafluoroethylene, and organic core fibers coated with the above-mentioned bioinert resin. For example, coated fibers that are bioinert are preferably used. In particular, a coated fiber having a diameter of about 0.2 to 0.5 mm in which a core fiber of ultra high molecular weight polyethylene is coated with a linear low-density polyethylene film has strength, hardness, elasticity, and ease of weaving and knitting. It is the most suitable fiber in terms of etc.

  The tissue structure of the organic fibers constituting the artificial ligament member 1 is disclosed in detail in the aforementioned Japanese Patent Application No. 6-254515 (Patent No. 3243679), so that further explanation will be omitted. To do.

  In addition to the above-described organic fiber tissue structure and braid, braids and three-dimensional woven fabrics made of bioabsorbable polylactic acid fibers can also be used as the artificial ligament member 1.

  The anchor member 21 attached to both ends of the artificial ligament member 1 is an elliptical columnar member in which a protruding piece 21a is formed from the center of one end surface (end surface on the ligament member 1 side) as shown in FIG. A large number of small holes 21b for attaching the ligament member 1 are formed in the protruding piece 21a. Then, the anchor member 21 is attached to the end portion of the artificial ligament member 1 by suspending the organic fibers of the ligament member 1 through these small holes 21b. The shape of the anchor member 21 is not limited to the elliptical column shape described above, and can be easily inserted into a hole formed in a living bone above and below the knee joint, as will be described later, and the inner surface of the hole and the anchor member Any shape may be used as long as it is stably fixed by an interference screw screwed into the gap.

  As shown in FIGS. 3 and 4, the anchor member 21 is a part of an ellipsoidal column-shaped dense composite 21 c made of a biodegradable absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive. A porous composite layer 21d of a biodegradable and absorbable polymer containing bioabsorbable and bioactive bioceramic powder is laminated and integrated on the surface, that is, the outer peripheral surface in this embodiment, The protruding piece 21a is integrally protruded from one end face of the elliptical columnar dense composite 21c.

  Since the dense composite 21c is required to have high strength as the core material of the anchor member 21, the biodegradable absorbable polymer of the material may be crystalline poly-L-lactic acid or polyglycolic acid. Etc. are preferably used. In particular, the dense complex 21c using poly-L-lactic acid having a viscosity average molecular weight of 150,000 or more, preferably about 200,000 to 600,000 is suitable.

  The bioceramic powder to be contained in the dense composite 21c is bioactive, absorbs in vivo, is completely absorbed by the living body, and completely replaces bone tissue, and has good bone conduction (induction) ability and good. Non-calcined and uncalcined hydroxyapatite, dicalcium phosphate, tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate, calcite, serabital, diopsite, smallpox, etc., which have excellent biocompatibility Is done. Among them, uncalcined and uncalcined hydroxyapatite, tricalcium phosphate, and octacalcium phosphate are optimal because they have extremely high bioactivity, excellent osteoconductivity, low toxicity and are absorbed into the body in a short period of time. It is. These bioceramic powders have a particle size of about 30 μm or less, preferably about 10 μm or less, more preferably about 0.1 to 5 μm in consideration of dispersibility in the biodegradable absorbable polymer and absorbability to the living body. Things are used. The content of bioceramic powder will be described later.

  The dense composite 21c is formed by injection-molding a biodegradable absorbent polymer containing bioceramic powder into an elliptic cylinder having a protruding piece 21a on one end surface, and subjecting the protruding piece 21a to perforation. Alternatively, a molded lump of biodegradable absorbent polymer containing bioceramic powder is cut into an elliptical column having a protruding piece 21a on one end surface, and the protruding piece 21a is punched. Produced by the method. In particular, in the latter method, the compact composite 21c obtained by forming a molded ingot in which polymer molecules and crystals are oriented by means of compression molding or forging molding and cutting this is compressed, and the degree of compactness is high. The polymer molecules and crystals are three-dimensionally oriented and the strength is further increased, which is extremely suitable. In addition, a dense composite obtained by cutting a stretched molded ingot is also used.

  On the other hand, the porous composite layer 21d is a porous body made of a biodegradable absorbent polymer having continuous pores inside and containing bioceramic powder that is bioabsorbable and bioactive. Part of the bioceramic powder is exposed on the surface of the composite layer 21d and the inner surface of the continuous pores. In the anchor member 21 of this embodiment, the porous composite layer 21d is laminated only on the outer peripheral surface of the elliptical columnar dense composite 21c, but the entire surface excluding the protruding piece 21a of the dense composite 21c, That is, the porous composite layer 21d may be laminated and integrated on the outer peripheral surface and both end surfaces of the dense composite 21c.

  The thickness of the porous composite layer 21d is not particularly limited as long as it is thinner than the dense composite 21c. However, in consideration of induced formation of bone tissue and connectivity with living bone, 0.5 to 15 mm. It is preferable that it is a grade. Further, the thickness of the porous composite layer 21d does not necessarily need to be uniform. For example, the thickness may be partially increased or decreased like a porous composite layer that undulates.

  The porous composite layer 21d does not need to be as strong as the dense composite 21c, and needs to be promptly hydrolyzed and bonded to the living bones or replaced completely. Therefore, the biodegradable and absorbable polymer used as the material of the porous composite layer 21d is safe, rapidly decomposed, not so brittle, and is amorphous or a mixture of crystalline and amorphous poly-D, L- Lactic acid, L-lactic acid and D, L-lactic acid copolymer, lactic acid and glycolic acid copolymer, lactic acid and caprolactone copolymer, lactic acid and ethylene glycol copolymer, lactic acid and para-dioxanone copolymer A combination or the like is suitable, and these may be used alone or in admixture of two or more. These biodegradable and absorbable polymers are preferably those having a viscosity average molecular weight of about 50,000 to 600,000 considering the strength required for the porous composite layer 21d and the period of in vivo degradation and absorption. used.

  In addition, considering the physical strength, invasion and stabilization of osteoblasts, the porosity composite layer 21d has a porosity of 50 to 90%, preferably 60 to 80%, and has continuous pores. It is desirable to occupy 50% or more of the total pores, preferably 70 to 90%, and the pore diameter of the continuous pores to be 50 to 600 μm, preferably 100 to 400 μm. When the porosity exceeds 90% and the pore diameter is larger than 600 μm, the physical strength of the porous composite layer 21d is lowered and becomes brittle. On the other hand, when the porosity is less than 50% and the continuous pores are less than 50% of the total pores, and the pore diameter is smaller than 50 μm, it is difficult for the body fluid and osteoblasts to enter, and the porous composite layer 21d is hydrolyzed. In addition, the induction of bone tissue is slowed down, and the time required for connection with the whole bone and total replacement becomes longer. However, it has been found that osteoinductivity is expressed when there are continuous pores as fine as about 1 to 0.1 μm in combination with the above preferable pore diameter.

  The porosity of the porous composite layer 21d may be constant over the entire composite layer, but considering the connectivity with living bones and the formation of conduction / induction, the porosity of the porous composite layer 21d It is preferable that the slope gradually changes so as to increase the porosity as it approaches the surface layer portion from the deep layer portion. As described above, in the porous composite layer 21d having the sloped porosity, the porosity is continuously within the range of 50 to 90%, preferably within the range of 60 to 80%. It is desirable that the pore diameter of the continuous pores increases gradually from the deep layer portion toward the surface layer portion within the range of 50 to 600 μm. Since the porous composite layer 21d is rapidly hydrolyzed on the surface layer side, the invasion of osteoblasts and the induction formation of bone tissue are active, and the bone bone is bonded to the living bone at an early stage. The anchoring strength of the anchor member 21 with respect to can be increased early.

  The bioceramic powder to be contained in the porous composite layer 21d is the same as the bioceramic powder to be contained in the dense composite 21c described above, and in particular, a particle size of about 0.1 to 5 μm. The bioceramics powder having the above has no fear of cutting the fibers formed by means such as spray when the porous composite layer 21d is produced by the method described later, and has good absorbability to living bodies. Because it is, it is preferably used.

  The content of the bioceramic powder in the porous composite layer 21d may be constant over the entire porous composite layer 21d or may vary. In the former case where the content is constant, the content of the bioceramic powder is preferably 60 to 80% by mass. If it exceeds 80% by mass, combined with the high porosity of the porous composite layer 21d, there is a disadvantage in that the physical strength of the porous composite layer 21d is reduced, and if it is below 60% by mass, Since the bioactivity of the porous composite layer 21d is lowered, the inductive formation of the bone tissue is delayed, and there is a disadvantage that it takes too much time to bond with the whole bone or to completely replace it. The more preferable content rate of bioceramics powder is 60-70 mass%.

  On the other hand, in the latter case where the content ratio changes, the content ratio of the bioceramic powder of the porous composite layer 21d is higher than the content ratio of the bioceramic powder of the dense composite body 21c, and 30 to 80 mass. % Of the porous composite layer 21d, it is preferable that the slope gradually changes so as to increase from the deep layer portion toward the surface layer portion. That is, the mass ratio of the bioceramic powder / biodegradable absorbent polymer is larger than the mass ratio of the dense composite 21c as it approaches the surface layer portion from the deep layer portion of the porous composite layer 21d, and 30 It is preferable to change so as to increase gradually in the range of / 70 to 80/20. As described above, the porous composite layer 21d with the inclined content of the bioceramic powder has a high bioactivity on the surface layer side with a high content rate, and the formation of induced osteoblasts and bone tissue on the surface layer side is particularly important. Since the replacement is performed while being coupled with the living bone at an early stage, the anchoring strength of the anchor member 21 to the living bone above and below the knee joint can be increased at an early stage.

  In contrast, the content of the bioceramic powder of the dense composite 21c is lower than the content of the bioceramic powder of the porous composite layer 21d and is in the range of 30 to 60% by mass. Is preferred. If it exceeds 60% by mass, the dense composite 21c required for strength becomes weak and causes insufficient strength. If it is less than 30% by mass, the formation of bone conduction by the bioceramic powder becomes insufficient, and The inconvenience arises that it takes a long time to completely replace. The content of the bioceramic powder is lower than the content in the porous composite layer 21d as described above, and is constant over the entire dense composite 21c within the range of 30 to 60% by mass. Alternatively, it may be changed in an inclined manner so as to increase sequentially from the axial core portion to the outer peripheral portion of the dense composite 21c. In this way, the dense composite body 21c in which the content ratio of the bioceramic powder is inclined has the bone tissue conductively formed in the outer peripheral portion having a high content ratio while the shaft core portion having a low content ratio maintains strength, and eventually the whole Replaced.

  When the content of the bioceramics powder in both the dense composite 21c and the porous composite layer 21d is tilted, the axial core portion of the dense composite 21c extends from the surface portion of the porous composite layer 21d. It is preferable to sequentially incline within the range of 30 to 80% by mass so that the content rate becomes higher as it gets closer.

  When the porous composite layer 21d as described above is present on the surface of the dense composite 21c, it is possible to impregnate bone growth factors and various drugs, which is also useful in this respect. That is, the porous composite layer 21d has biological bone growth factors such as BMP (Bone Morphogenic Protein), TGF-β (Transforming Growth Factor-b), EP4 (Prostanoid Receptor), b-FGF (basic Fibroblast). It is desirable to impregnate at least one kind of growth factor), PRP (platelet-rich plasma) and / or osteoblasts derived from a living body, and impregnating these biological bone growth factors and osteoblasts, Proliferation and growth of osteoblasts are greatly promoted, and bone tissue is formed in the surface layer portion of the porous composite layer 21d in a very short period (about 1 week), and is immediately combined with living bones. The entire composite layer 21d is replaced with living bone. Among the above factors, BMP and EP4 are particularly effective for the growth of bones. Therefore, the porous structure of the anchor member 21 to be embedded and fixed in the holes formed in the bones such as the femur and the tibia above and below the knee joint. The layer 21d is particularly preferably impregnated with BMP and EP4s among the above factors. PRP is plasma rich in platelets, and the addition of this promotes the formation of new bone. In some cases, other growth factors such as IL-1, TNF-α, TNF-β, and IFN-γ may be impregnated.

  Further, the surface of the porous composite layer 21d may be subjected to oxidation treatment such as corona discharge, plasma treatment, hydrogen peroxide treatment, etc. When such oxidation treatment is carried out, the porous composite layer 21d. The surface wettability is improved, and osteoblasts more effectively invade and grow into the continuous pores of the composite layer 21d, so that the binding and replacement with living bone is further promoted, and the earlier The fixing strength of the anchor member 21 is improved. Of course, such an oxidation treatment may be performed on the exposed surface of the dense composite 21c.

  The above-mentioned porous composite layer 21d is produced by the following method, for example. First, a biodegradable polymer is dissolved in a volatile solvent, and a bioceramic powder is mixed to prepare a suspension. The suspension is made into a fiber by means of spraying or the like, and the fibers are intertwined. Form an aggregate. Then, this fiber assembly is immersed in a volatile solvent such as methanol, ethanol, isopropanol, dichloroethane (methane), chloroform, etc. to be in a swollen or semi-molten state, and this is pressed to apply elliptical cylindrical porous fiber fusion. An elliptical cylindrical shape in which the fibers are made into a matrix by substantially eliminating the fibrous form while shrinking and fusing the fibers of the fiber fusion aggregate, and forming a matrix with rounded pores between the fibers. It is produced by changing the shape of the porous composite layer. In that case, a semi-elliptical cylindrical porous composite layer may be prepared and used by combining two of them.

  When producing a porous composite layer whose porosity increases as it approaches the surface layer portion from the deep layer portion by this method, the fiber assembly is immersed in the volatile solvent to be in a swollen or semi-molten state, and this is pressurized. Thus, when the porous fiber fusion aggregate having an elliptic cylinder shape or a semi-elliptical cylinder shape is used, the amount of the fiber aggregate may be reduced as the depth layer portion approaches the surface layer portion. In addition, when creating a porous composite layer in which the content of bioceramic powder increases from the deep layer to the surface layer, several types of suspensions with different mixing amounts of bioceramic powder are prepared, Several types of fiber aggregates with different ceramic powder contents may be formed, and these fiber aggregates may be stacked in order from the one with the lowest content of bioceramic powder and pressed as a swollen or semi-molten state. .

  The anchor member 21 shown in FIGS. 2 to 4 is configured such that the ellipsoidal cylindrical dense composite 21c is fitted inside the elliptic cylindrical porous composite layer 21d or the semi-elliptical cylindrical shape described above. The two porous composite layers are combined and superposed on the outer peripheral surface of the elliptic columnar dense composite 21c, and are laminated and integrated by means such as heat welding. The means for laminating and integrating the dense composite 21c and the porous composite layer 21d is not limited to heat welding. For example, the dense composite 21c and the porous composite layer 21d can be integrated by adhesion or the dense composite 21c and the porous composite layer 21d. Alternatively, a dovetail groove may be formed on either one of the contact surfaces, and an ant may be formed on the other, and the ants may be integrated into the dovetail.

  FIG. 13 is an explanatory diagram of one usage example of the artificial ligament AL1 as described above.

  This use example illustrates the case where the artificial ligament AL1 is transplanted and reconstructed into the knee joint between the femur 3 and the tibia 4, and according to this, first, the femur 3 and the tibia 4 are respectively perforated. 3a and 4a are opened, the artificial ligament AL1 is passed through the knee joint through the hole, and the anchor members 21 and 21 at both ends of the artificial ligament member 1 are inserted into the holes 3a and 4a. Then, the interference screw 5 is screwed into the gap between the inner surface of the hole 3 a of the femur 3 and one anchor member 21, and the one anchor member 21 is press-fixed to the inner surface of the hole 3 a opposite to the screw 5. The interference lance screw 5 is screwed into the gap between the inner surface of the hole 4a of the tibia 4 and the other anchor member 21 while taking an appropriate slack in the artificial ligament member 1, and the other anchor member 21 is placed on the side opposite to the screw 5 The artificial ligament AL1 is transplanted and fixed to the knee joint by pressing and fixing to the inner surface of the hole 4a.

When the artificial ligament AL1 is transplanted in this way, the porous composite layer 21d of the anchor member 21 is rapidly hydrolyzed from the surface and inside by the body fluid contacting the surface and the body fluid penetrating the continuous pores. Along with the decomposition, the bone tissues on the inner surfaces of the holes 3a, 4a are guided and formed to the inside of the porous composite layer 21d by the osteoinductive ability of the bioactive bioceramic powder, and the porous composite layer 21a is rapidly formed into the bone. By replacing the tissue, the anchor member 21 is coupled with the bone tissue on the inner surfaces of the holes 3a and 4a of the femur 3 and the tibia 4. Therefore, the fixing strength of the anchor members 21 at both ends of the artificial ligament is greatly improved as compared with the conventional case where both ends of the ligament are fixed only by the interference screw. On the other hand, the dense composite 21c of the anchor member 21 is hard and strong, the hydrolysis is much slower than the porous composite layer 21d, and maintains sufficient strength until the hydrolysis proceeds to some extent. Finally, all of the holes are hydrolyzed and replaced with the living bone formed by conduction with the bioactive bioceramic powder, so that the bones are removed, so that the holes 3a and 4a in the femur 3 and tibia 4 of the knee joint are opened. Almost everything is buried with living bones. In addition, since the bioceramic powder contained in the porous composite layer 21d and the dense composite 21c of the anchor member 21 is in vivo absorbable, the bioceramic powder remains on the deposited and regenerated biological bone and is deposited. Without leaching into soft tissue or blood vessels.

  Further, the artificial ligament member 1 made of a tissue structure of a biologically inert organic fiber has a strength and flexibility equal to or higher than that of a living body ligament and exhibits a deformation behavior similar to that of a living body ligament. Even if a tensile force is repeatedly applied due to bending and stretching of the joint, there is no fear that the artificial ligament member 1 is torn, and there is no sense of incongruity when bending and stretching.

  In addition, when the screw made from the biodegradable absorbable polymer containing the bioceramic powder similar to the dense complex 21c of the anchor member 21 is used as the interference screw 5, this screw is also hydrolyzed to replace the living bone. However, there is an advantage that the holes 3a and 4a are completely filled with living bones.

  FIG. 5 is a perspective view showing an anchor member according to another embodiment of the present invention.

  This anchor member 21 is provided with a large number of small protrusions 21e instead of the small holes 21b on the upper, lower, left and right surfaces of the protruding piece 21a protruding from the end surface on the ligament member 1 side, and the organic material of the artificial ligament member 1 By anchoring the fiber to the small protrusion 21e, the anchor member 21 can be attached to both ends of the artificial ligament member 1 so as not to be detached. The small protrusion 21e may have a uniform thickness from the base to the tip as shown in the figure, but the tip of the small protrusion 21e is inflated or bent so that the organic fiber that is hooked does not come off. It is preferable to do. Since the other structure of this anchor member 21 is the same as that of the anchor member shown in above-mentioned FIGS. 2-4, description is abbreviate | omitted.

  The anchor member 21 is also attached so as not to be detached from the ligament member 1 by locking the organic fiber of the artificial ligament member 1 to the small protrusion 21e, used for transplantation reconstruction, and the artificial ligament AL1 described above. Needless to say, the same effect as the ligament anchor member 21 can be obtained.

  FIG. 6 is a longitudinal sectional view showing an anchor member according to still another embodiment of the present invention.

  The anchor member 21 is formed with an annular protrusion 21f having a sawtooth cross-sectional shape on the outer peripheral surface of the dense composite 21c, and the porous composite layer 21d described above is formed between the annular protrusion 21f and the annular protrusion 21f. In this state, the concave portions are filled and integrated on the outer peripheral surface of the dense composite 21c. Since the other structure of this anchor member 21 is the same as the anchor member 21 of the above-mentioned artificial ligament AL1, description is abbreviate | omitted.

  In addition to the above-described effects of the anchor member 21 of the artificial ligament AL1 as described above, the anchor member 21 is inserted into the holes of the femur 3 and the tibia 4 of the knee joint with the interference screw 5 as shown in FIG. When press-fixed to 3a and 4a, the tip of the serrated annular projection 21f of the dense composite 21c of the anchor member 21 slightly bites into the inner surfaces of the holes 3a and 4a, so that the porous composite layer 21d of the anchor member 21 is Even when the tensile force accompanying the bending and stretching of the knee joint acts on the artificial ligament and the anchor member 21 is applied with the force F in the direction of the arrow in FIG. There is an effect that 21 does not have to worry about coming out of the holes 3a and 4a.

  FIG. 7 is a cross-sectional view showing an anchor member according to still another embodiment of the present invention.

  This anchor member 21 is formed with a convex section 21g having a triangular cross-sectional shape on the outer peripheral surface of an ellipsoidal columnar dense composite body 21c, and the above-mentioned porous composite layer 21d is made up of the convex strip 21g and the convex strip 21g. In this state, the concave portions are filled and integrated on the outer peripheral surface of the dense composite 21c. Since the other structure is the same as the anchor member 21 of the artificial ligament AL1 described above, the description thereof is omitted.

  Even when such an anchor member 21 is attached to both ends of the artificial ligament member, the distal end of the ridge 21g slightly bites into the inner surface of the hole of the living bone above and below the knee joint. There is an effect that it is possible to improve the fixing strength of the anchor member 21 until the layer 21d is combined with the bone tissue on the inner surface of the hole of the living bone.

  FIG. 8 is a cross-sectional view showing an anchor member according to still another embodiment of the present invention.

  The anchor member 21 is provided on one side of the outer peripheral surface of the above-described elliptic cylinder-like dense composite 21c, that is, on one side outer peripheral surface pressed against the inner surface of the hole 3a (4a) formed in both living bones of the bone joint. The aforementioned porous composite layer 21d is laminated and integrated. Since the other structure is the same as that of the anchor member 21 of the artificial ligament AL1, description thereof will be omitted.

  In this way, the artificial ligament in which the anchor member 21 in which the porous composite layer 21d is laminated and integrated only on one outer peripheral surface of the dense composite 21c is attached to both ends of the artificial ligament member 1 is also formed in the hole 3a (4a). Since the porous composite layer 21d pressed against the inner surface is quickly hydrolyzed and replaced with bone tissue and bonded to the inner surface of the hole 3a (4a), the bond strength of the anchor member 21 can be improved early. . However, the opposite outer peripheral surface of the dense composite 1 where the porous composite layer is not laminated is slow in hydrolysis and formation of conduction in bone tissue, so that most of the holes 3a (4a) are filled with living bone. Will take quite a while.

  FIG. 9 is a longitudinal sectional view showing an anchor member according to still another embodiment of the present invention.

  The anchor member 21 has a three-layer structure in which the porous composite layers 21d and 21d are laminated and integrated on the upper and lower surfaces of the core layer made of the dense composite 21c. The anchor member 21 is formed in an elliptic column shape as a whole. Is. And the protrusion piece (not shown) which formed the said small hole and protrusion which latches the organic fiber of the artificial ligament member 1 is protrudingly provided from the end surface of the core layer which consists of the dense complex 21c.

  Also in the artificial ligament in which such an anchor member 21 is attached to both ends of the artificial ligament member 1, the porous composite layer 21d on one side of the anchor member 21 has an inner surface of the hole 3a (4a) of the living bone of the bone joint. Since the bone tissue is replaced and replaced with the bone tissue while being hydrolyzed promptly, the bond strength of the anchor member 21 can be improved at an early stage. The opposite side porous composite layer 21d is also hydrolyzed early, and osteoblasts are induced into the continuous pores by the bioceramic powder to form a bone tissue, so that it is more than the anchor member 21 shown in FIG. The period required for most of the holes 3a (4a) to be filled with living bone can be shortened.

  FIG. 10 is a longitudinal sectional view showing an anchor member according to still another embodiment of the present invention, and FIG. 11 is a transverse sectional view of the anchor member.

  The anchor member 22 is an elliptical columnar member made of a porous composite 22c of a biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive, and is the artificial ligament member 1 described above. It is attached so that it may not detach | leave at the both ends. The same biodegradable absorbent polymer and bioceramic powder as the material of the porous composite 22c are the same as those of the porous composite layer 21d of the anchor member 21 described above.

  The porous composite 22c constituting the anchor member 22 has a porosity in the range of 0 to 90%, preferably in the range of 15 to 80%, from the axial core portion 22d of the composite 22c to the outer peripheral portion. It gradually changes so as to increase as it approaches 22e. In the porous composite 22c, it is preferable that the continuous pores account for 50 or more of the total pores, especially 70 to 90%, and the pore diameter of the continuous pores is in the range of 50 to 600 μm, preferably in the range of 100 to 400 μm. It is preferable that the hole diameter becomes larger as it approaches the outer peripheral portion 22e having a higher porosity.

  When the porosity and the pore diameter are changed in this way, the outer peripheral portion 22e of the porous composite body 22c (hereinafter referred to as a high porosity outer peripheral portion) having a large pore diameter and a high porosity can easily penetrate body fluid. Combined with the rapid hydrolysis and the invasion of osteoblasts and the high content of bioactive bioceramic powder as described later, bone tissue is induced and formed at an early stage. Replaced and combined with Therefore, when the anchor member 22 made of the porous composite 22c is inserted into the hole 3a (4a) formed in the living bone above and below the knee joint and fixed with the interference screw, the high porosity of the anchor member 22 is quickly achieved. The outer peripheral portion 22e is combined with the living bone on the inner surface of the hole 3a (4a), and the fixing strength is improved as compared with the case where the outer peripheral portion 22e is fixed only by the interference screw. If the porosity of the high-porosity outer peripheral portion 22e exceeds 90% and the pore diameter is larger than 600 μm, the physical strength of the high-porosity outer peripheral portion 22e is lowered and becomes brittle. In addition, if the continuous pores are less than 50% of the total pores and the pore diameter is smaller than 50 μm, it is difficult for the body fluid and osteoblasts to enter, and hydrolysis and bone tissue induction formation are slowed down. This is not preferable because the time required for substitution and bonding with is increased.

  On the other hand, the shaft core portion 22d having a low porosity of the porous composite 22 (hereinafter referred to as a low porosity shaft core portion) has strength, and the strength of the low porosity shaft core portion 22d is improved as the porosity is lowered. Will do. Therefore, when high strength is required for the anchor member of the artificial ligament, the porosity of the low-porosity axial core portion 22d needs to be 0% as described above, but it is not always required when high strength is not required. It is not necessary to make it 0%. Therefore, the lower limit of the porosity of the low-porosity axial core portion 22d is preferably set to 15% as described above, and it provides strength suitable for the ligament anchor member and is required for hydrolysis and total replacement with living bone. It is good to shorten the time. Then, a projecting piece 22a is integrally projected from one end face of the strong low-porosity axial core portion 22d, and the small hole 22b formed in the projecting piece 22a is hooked through the organic fiber of the artificial ligament member 1. Thus, the anchor member 22 is attached to the end portion of the ligament member 1 so as not to be detached. Of course, the organic fibers at the end of the artificial ligament member 1 may be embedded and fixed so as not to come out of the strong low-porosity axial core portion 22d of the anchor member 22.

  The content of the bioceramics powder of the porous composite 22e constituting the anchor member 22 may be constant over the entire composite 22e, but within the range of 30 to 80% by mass, the low porosity It is preferable that the slope gradually changes so as to increase as it approaches the high porosity outer peripheral portion 22e from the rate axis portion 22d. That is, as the low porosity axial core portion 22d approaches the high porosity outer peripheral portion 22e, the mass ratio of bioceramic powder / biodegradable absorbent polymer is successively and continuously within a range of 30/70 to 80/20. It is preferable to change so that it may become large. When the content of the bioceramic powder is inclined as described above, the bioactivity of the high-porosity outer peripheral portion 22e is large, and the induction formation of osteoblasts and bone tissue becomes particularly active. There is an advantage that the bonding is further promoted. When the content of the bioceramic powder in the high porosity outer peripheral portion 22e exceeds 80% by mass, there is a disadvantage in that the physical strength of the high porosity outer peripheral portion 22e is lowered, and the content in the low porosity axial core portion 22d is caused. If the rate is less than 30% by mass, guided formation of the bone tissue by the bioceramic powder of the low-porosity axial core portion 22d becomes inactive, which causes inconvenience that it takes too much time to completely replace the living bone. The upper limit of the more preferable content rate of bioceramics powder is 70 mass%.

  Further, the porous composite 22c constituting the anchor member 22 is impregnated with the above-described biological bone growth factor or living osteoblasts, thereby greatly promoting the proliferation and growth of osteoblasts, In a very short period (about one week), a bone tissue is formed on the high porosity outer peripheral portion 22e of the porous composite 22c to further accelerate the bonding with the inner surface of the hole 3a (4a), and the porous composite 22c. It is preferable to shorten the period required for most of the holes 3a (4a) to be filled with living bone by the total replacement. Further, by subjecting the surface of the porous composite 22c to oxidation treatment such as corona discharge, plasma treatment, and hydrogen peroxide treatment, the wettability of the surface of the porous composite 2 is improved, and osteoblast invasion, Growth may be further promoted.

  The anchor member 22 made of the above porous composite 22c is manufactured, for example, by the following method. First, a biodegradable polymer is dissolved in a volatile solvent, and a bioceramic powder is mixed to prepare a suspension. The suspension is made into a fiber by means of spraying or the like, and the fibers are intertwined. Form an aggregate. Then, this fiber assembly is filled in the elliptic cylinder so that the amount of fibers decreases from the center to the periphery, and further immersed in a volatile solvent to be in a swollen or semi-molten state, which is the axis of the elliptic cylinder Pressing in the direction to form an elliptical columnar porous fiber fusion aggregate, while the fibers of this fiber fusion aggregate are contracted and fused, the fibrous form disappears substantially into a matrix, and the inter-fiber voids When the shape is changed to a porous composite having rounded continuous pores, and one end of this elliptical columnar porous composite is cut to form protruding pieces and small holes, the anchor member 22 is manufactured. . In the case of producing a porous composite 22c in which the content of the bioceramic powder increases from the low-porosity axial core portion 22d toward the high-porosity outer peripheral portion 22e, several types of mixed bioceramic powders are different. The suspension is prepared to form several types of fiber aggregates with different bioceramic powder content, and the fiber aggregate with the lowest content is placed at the center, and the content increases as it approaches the periphery. As long as the fiber aggregates are arranged, these fiber aggregates are filled in an elliptical cylinder, and are swelled or semi-molten with a volatile solvent and pressed.

  FIG. 12 is a longitudinal sectional view of an anchor member according to still another embodiment of the present invention.

  The anchor member 23 is also an elliptical columnar member made of a biocomposite-absorbable polymer porous composite containing bioceramic powder, and the porous composite 23c constituting the anchor member 23 has a pore structure. When the rate is in the range of 0 to 90%, preferably in the range of 15 to 80%, the one end of the composite 23c, that is, the end 23d to which the ligament member 1 is attached approaches the opposite end 23e. The content of the bioceramics powder is gradually changed so as to increase, and the content of the bioceramic powder is increased within a range of 30 to 80% by mass from the one end 23d to the opposite end 23e. It changes gradually in an inclined manner. A large number of small holes 23b are formed in the projecting piece 23a projecting from one end having a low porosity or 0%, and the organic fibers of the artificial ligament member 1 are inserted into the small holes 23b. By doing so, the ligament member 1 is attached so as not to be detached. Since the other structure of this anchor member 23 is the same as that of the anchor member 22, the description thereof is omitted.

  When the anchor member 23 of an artificial ligament in which such an anchor member 23 is attached to both ends of the ligament member 1 is inserted into the hole 3a (4a) formed in the living bone above and below the knee joint and fixed with an interference screw, The upper surface and the outer peripheral surface of the opposite end portion 23e with high porosity and the outer peripheral surface of the portion with a relatively high porosity below the opposite end portion 23e with high porosity are rapidly hydrolyzed, so that Since it is bonded to the inner surface of the hole 3a (4a) while replacing the living bone, the fixing strength of the anchor member 23 is improved early. The one end portion 23d having a low porosity or 0% is slowly hydrolyzed and maintains strength for a certain period of time, but eventually disappears by being replaced with living bone, and most of the holes 3a (4a). Will be buried with the replaced bone.

  The anchor members 22 and 23 are both formed in an elliptical column shape, but are not limited to the elliptical column shape, and can be easily inserted into the holes 3a (4a) formed in the living bones above and below the knee joint. Any shape can be used as long as it is stably fixed by the interference screw.

  Further, any of the anchor members 21, 22, and 23 can be attached and used so as not to be detached from an end portion of a living body-derived ligament member, a tendon member, or an artificial tendon member.

It is a perspective view of the artificial ligament which concerns on one Embodiment of this invention. It is a perspective view which shows one Embodiment of the anchor member of this invention used for the artificial ligament. It is the sectional view on the AA line of FIG. FIG. 3 is a sectional view taken along line B-B in FIG. 2. It is a perspective view of an anchor member concerning other embodiments of the present invention. It is a longitudinal cross-sectional view of the anchor member which concerns on other embodiment of this invention. It is a cross-sectional view of an anchor member according to still another embodiment of the present invention. It is a cross-sectional view of an anchor member according to still another embodiment of the present invention. It is a cross-sectional view of an anchor member according to still another embodiment of the present invention. It is a longitudinal cross-sectional view of the anchor member which concerns on other embodiment of this invention. It is a cross-sectional view of the anchor member. It is a longitudinal cross-sectional view of the anchor member which concerns on other embodiment of this invention. It is explanatory drawing of the example of 1 use of the artificial ligament which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Artificial ligament member 21, 22, 23 Anchor member 21a, 22a, 23a Protruding piece 21b, 22b, 23b Small hole 21c Dense complex 21d Porous complex layer 21e Small projection 22c, 23c Porous complex 22d Porous Axial core portion 22e Peripheral portion 23d of porous composite body End 23d End portion to which ligament member or tendon member of porous composite body is attached 23e Opposite end portion of porous composite body AL1 Artificial ligament

Claims (12)

  An artificial anchor member that is attached to an end of a ligament member or tendon member so as not to be detached, and is a dense composite of biodegradable and absorbable polymer containing bioceramic powder that is bioabsorbable and bioactive. An anchor member comprising a biodegradable / absorbable polymer porous composite layer containing a bioceramic powder that is bioabsorbable and bioactive on a partial surface or the entire surface. .   The porosity of the porous composite layer is 50 to 90%, continuous pores account for 50% or more of the total pores, and the slope gradually increases so that the porosity increases from the deep layer portion to the surface layer portion of the porous composite layer The anchor member according to claim 1, wherein   The content of the bioceramics powder in the porous composite layer is gradually changed so as to increase from the deep layer portion to the surface layer portion of the porous composite layer within the range of 30 to 80% by mass. The anchor member according to claim 1 or 2, wherein the anchor member is provided.   BMP (Bone Morphogenic Protein), TGF-β (Transforming Growth Factor-β), EP4 (Prostanoid Receptor), b-FGF (basic Fibroblast Growth Factor), PRP, which are biological bone growth factors, are formed on the porous composite layer. The anchor member according to any one of claims 1 to 3, wherein the anchor member is impregnated with at least one kind of (platelet-rich plasma) and / or osteoblasts derived from a living body.   An artificial anchor member that is attached so as not to be detached from an end portion of a ligament member or a tendon member, and is composed of a biocomposite and bioactive bioceramic powder containing a biodegradable and absorbable polymer porous composite. The anchor is characterized in that the porosity is gradually changed so as to increase as it approaches the outer peripheral portion in contact with the bone from the axial portion of the composite in the range of 0 to 90%. Element.   The content ratio of the bioceramics powder is gradually changed so as to increase from the axial core part of the porous composite to the outer peripheral part in contact with the bone within the range of 30 to 80% by mass. The anchor member according to claim 5.   An artificial anchor member that is attached so as not to be detached from an end portion of a ligament member or a tendon member, and is composed of a biocomposite and bioactive bioceramic powder containing a biodegradable and absorbable polymer porous composite. And within a range of 0 to 90%, the slope of the composite gradually changes so as to increase from the end to which the ligament member or tendon member is attached toward the opposite end. An anchor member characterized by the above.   In order to increase the content of the bioceramic powder within a range of 30 to 80% by mass from the end where the ligament member or tendon member of the porous composite is attached to the opposite end, The anchor member according to claim 7, wherein the anchor member is changed.   BMP (Bone Morphogenic Protein), TGF-β (Transforming Growth Factor-β), EP4 (Prostanoid Receptor), b-FGF (basic Fibroblast Growth Factor), PRP (BRP) are biological bone growth factors. The anchor member according to any one of claims 5 to 8, wherein the anchor member is impregnated with at least one of platelet-rich plasma) and / or osteoblasts derived from a living body.   The anchor member according to any one of claims 1 to 9, wherein a plurality of small holes or small projections for attaching a ligament member or a tendon member are formed at an end portion.   An artificial ligament, wherein the anchor member according to any one of claims 1 to 10 is attached to both ends of the artificial ligament member so as not to be detached.   The artificial ligament member is composed of an organic fiber made of a multi-axial three-dimensional multi-dimensional three-dimensional woven or knitted structure or a composite structure thereof, or an organic fiber braid. The described artificial ligament.

Images