WO2007043149A1

WO2007043149A1 - Implant for bone conjugation and method of producing the same

Info

Publication number: WO2007043149A1
Application number: PCT/JP2005/018476
Authority: WO
Inventors: Chiaki Abe; Akira Shinjo; Kenichi Shimodaira
Original assignee: Homs Engineering Inc.
Priority date: 2005-10-05
Filing date: 2005-10-05
Publication date: 2007-04-19
Also published as: WO2007043149A9; JPWO2007043149A1

Abstract

An implant (10) for bone conjugation having a regulated porosis ability. This implant (10) for bone conjugation, which has an implant base (12) for bone conjugation and a surface layer (14) formed on the implant base (12) for bone conjugation, is characterized in that the content of a metal having a low compatibility with bone in the surface layer (14) is larger than the content thereof in the implant base (12) for bone conjugation. Owing to this characteristic, it is possible in the implant (10) for bone conjugation as described above to regulate the porosis ability on the surface of the implant for bone conjugation at a low level. As a result, the porosis around the implant for bone conjugation can be regulated at a low level during the period from embedding the implant for bone conjugation into the body till the completion of the treatment for bone fracture, which makes it possible to facilitate the procedure of removing the implant for bone conjugation from the body.

Description

Implant for osteosynthesis and method for producing the same

Technical field

[0001] The present invention relates to an osteosynthesis implant and a method for producing the same.

Background art

[0002] In recent years, Ti or Ti alloys (for example, T1-6A1-4 V, ELI alloys) have been widely used as materials for orthopedic implants (see, for example, Patent Document 1). This is because Ti and Ti alloys have excellent corrosion resistance, high strength, and high biocompatibility, but also have high affinity with bone ( (For example, see Patent Document 1.)

[0003] Therefore, by using an orthopedic implant having Ti or Ti alloy force, it is possible to satisfactorily join the orthopedic implant and the bone. Therefore, an orthopedic implant made of Ti or Ti alloy can be preferably used as an orthopedic implant intended for implantation in the body, such as an artificial joint.

Patent Document 1: Japanese Patent Laid-Open No. 7-41889

Disclosure of the invention

Problems to be solved by the invention

[0005] By the way, orthopedic implants for orthopedic implants are used in addition to the above-mentioned orthopedic implants for in-vivo implants, and are removed from the body after fracture treatment for the purpose of fracture treatment. Implants (generally referred to as osteosynthesis implants, henceforth referred to as “osseous implants”).

[0006] However, when an osteosynthesis implant that also has Ti and Ti alloy strength is used as an osteosynthesis implant, Ti or Ti alloy has a high affinity with bone. When a joint implant is implanted in the body and a bone fracture is formed around the bone implant before the fracture treatment is completed, it becomes difficult to remove the bone implant from the body. There is a problem. Especially with high callus formation ability, young patients In some cases, it may be necessary to remove the callus to remove the osteosynthesis implant, or a large force may be applied to the osteosynthesis implant to cause a secondary fracture. There's a problem.

[0007] Therefore, the present invention was made to solve the above-described problems, and is capable of facilitating the work of removing the internal force of the osteosynthesis implant after completion of the fracture treatment. And it aims at providing the manufacturing method.

Means for solving the problem

[0008] (1) The osteosynthesis implant of the present invention is an osteosynthesis implant with suppressed callus formation ability, and is formed on the surface of the osteosynthesis implant substrate and the osteosynthesis implant substrate. The surface layer contains a metal having a low affinity with bone more than the implant base for osteosynthesis.

[0009] Therefore, according to the osteosynthesis implant of the present invention, the surface layer formed on the surface of the osteosynthesis implant base contains more metal than the osteosynthesis implant base with a low affinity for bone. As a result, the ability to form callus on the surface of the osteosynthesis implant can be suppressed to a low level. As a result, it becomes possible to suppress the formation of a callus around the osteosynthesis implant between the time when the osteosynthesis implant is embedded in the body and the end of the force fracture treatment. It is possible to facilitate the work of removing the dental implant from the body. As a result, even in the case of young patients with high callus formation ability, it is necessary to work to scrape the callus to remove the osteosynthesis implant, or to remove the osteosynthesis implant. It is possible to alleviate the problem of causing secondary fractures by force.

[0010] Further, according to the osteosynthesis implant of the present invention, it is possible to select an optimum material for each of the osteosynthesis implant substrate and the surface layer. For this reason, it is possible to select an excellent material such as Ti or Ti alloy, which has been proven in the past, as the material for the bone implant base material, and to select a material having a low affinity for bone as the material for the surface layer. It becomes possible.

[0011] It should be noted that the osteosynthesis implant of the present invention includes a case where a material having low affinity with bone is not included in the osteosynthesis implant substrate. [0012] (2) In the osteosynthesis implant according to (1), the surface layer preferably has a low affinity with the bone and contains 5% by weight or more of a metal.

[0013] Thus, when the surface layer contains 5% by weight or more of a metal having low affinity with bone, it is possible to suppress the osteogenesis ability to a low level.

[0014] In view of this viewpoint power, in the osteosynthesis implant described in (2) above, it is more preferable that the surface layer contains 20% by weight or more of a metal having low affinity for bone. It is more preferable to contain 50% by weight or more of a metal having low affinity with the above. In the osteosynthesis implant described in (2) above, the surface layer is made of a metal having low affinity with bone.

0 weight ^_0/0 contain, even if,.

[0015] In the osteosynthesis implant according to the above (1) or (2), the surface layer contains a metal having a low affinity with the bone and further contains Ti or a Ti alloy. It is preferable to do.

[0016] With this configuration, the surface layer has excellent corrosion resistance, high strength, high biocompatibility, and excellent characteristics. It becomes an implant.

[0017] (3) The osteosynthesis implant of the present invention is an osteosynthesis implant with suppressed callus formation ability, and is formed on the surface of the osteosynthesis implant substrate and the osteosynthesis implant substrate. And a surface layer made of a gradient alloy whose composition gradually changes along the depth direction, and the outermost surface portion of the surface layer is made of a metal having low affinity with bone, It is characterized by containing more than the plant base.

Therefore, according to the osteosynthesis implant of the present invention, the outermost surface portion of the surface layer formed on the surface of the osteosynthesis implant substrate is made of a metal having low affinity for bone. Since it is contained in a larger amount than the base, it becomes possible to suppress the osteogenesis ability on the surface of the osteosynthesis implant to a low level. As a result, it becomes possible to suppress the formation of a callus around the osteosynthesis implant to a low level between the implantation of the osteosynthesis implant in the body and the end of the force fracture treatment. It is possible to facilitate the operation of removing the osteosynthesis implant from the body. As a result, even if the callus formation ability is high or young, the osteosynthesis implant is removed even in the case of a patient. Therefore, it is possible to alleviate the problem that the work of scraping the callus is necessary, or that a large force is applied to cause the secondary fracture when the osteosynthesis implant is removed.

[0019] Further, according to the osteosynthesis implant of the present invention, it is possible to select an optimum material for each of the osteosynthesis implant substrate and the surface layer. For this reason, it is possible to select an excellent material such as Ti or Ti alloy, which has been proven in the past, as the material for the bone implant base material, and to select a material having a low affinity for bone as the material for the surface layer. It becomes possible.

[0020] Furthermore, according to the osteosynthesis implant of the present invention, the adhesion between the osteosynthesis implant substrate and the surface layer can be sufficiently enhanced, and a more reliable osteosynthesis implant is provided. It becomes possible to provide.

[0021] (4) In the osteosynthesis implant according to (3), the outermost surface portion of the surface layer has low affinity with the bone and preferably contains 5% by weight or more of a metal. ,.

[0022] Thus, the affinity for the outermost surface partial bone in the surface layer is low, and by containing 5% by weight or more of the metal, the ability to form a callus bone is reduced in the outermost surface portion in the surface layer. It becomes possible to suppress to the level.

[0023] In terms of this viewpoint power, in the osteosynthesis implant described in (4) above, the outermost surface portion of the surface layer has low affinity with bone and may contain 20% by weight or more of metal. It is further preferable to contain 50% by weight or more of a metal having a low affinity with a more preferable bone. In the osteosynthesis implant described in (4) above, the outermost surface portion of the surface layer may have a low affinity with bone and contain 100% by weight of metal.

[0024] In the osteosynthesis implant according to the above (3) or (4), the surface layer contains a metal having a low affinity with the bone, and further contains Ti or a Ti alloy. It is preferable to do.

[0025] With this configuration, the surface layer has excellent corrosion resistance, high strength, high biocompatibility, and excellent characteristics. It becomes an implant.

[0026] (5) The implant for osteosynthesis according to the present invention is for osteosynthesis in which the callus formation ability is partially suppressed. An implant comprising an osteosynthesis implant substrate and a surface layer formed on a part of a surface of the osteosynthesis implant, wherein the surface layer is made of a metal having low affinity with bone. It is characterized by containing more than the implant base for osteosynthesis.

[0027] By the way, in the osteosynthesis implant, the callus formation ability must be suppressed throughout the osteosynthesis implant! /, And not! That is, in the osteosynthesis implant, there are a portion that may have a high callus formation ability and a portion that preferably has a low callus formation ability. According to the osteosynthesis implant of the present invention, it is preferable that the surface of the osteosynthesis implant substrate has a low callus formation ability, and the portion has a low affinity for bone and metal is used for the osteosynthesis implant substrate. Therefore, it is possible to form a surface layer containing a larger amount of the material, so that a portion having a low callus formation ability has a relatively low callus formation ability and a high callus formation ability. However, the portion can have a relatively high callus formation ability.

[0028] Further, with this configuration, it becomes possible to manufacture an osteosynthesis implant based on one osteosynthesis implant substrate. Therefore, an osteosynthesis implant having a high mechanical strength can be produced relatively. It becomes possible to manufacture by an easy method.

[0029] (6) In the osteosynthesis implant according to (5), the surface layer preferably has a low affinity with the bone and contains 5% by weight or more of a metal.

[0030] As described above, when the surface layer contains 5% by weight or more of a metal having low affinity with bone, the surface layer can have low callus formation ability and can be suppressed to a level. It becomes possible.

[0031] In view of this viewpoint power, in the osteosynthesis implant described in (6) above, it is more preferable that the surface layer contains 20% by weight or more of a metal having low affinity with bone. It is more preferable to contain 50% by weight or more of a metal having low affinity with the above. In the osteosynthesis implant according to the above (6), the surface layer may contain 100 wt ^% / _{0 of a} metal having low affinity with bone.

[0032] In the osteosynthesis implant according to the above (5) or (6), the surface layer contains a metal having a low affinity with the bone, and further contains Ti or a Ti alloy. It is preferable to do. [0033] With this configuration, the surface layer has excellent corrosion resistance, high strength, high biocompatibility, and excellent characteristics. It becomes an implant.

[0034] (7) The osteosynthesis implant of the present invention is an osteosynthesis implant in which the ability to form a callus is partially suppressed. The osteosynthesis implant base and the surface of the osteosynthesis implant And a surface layer made of a gradient alloy whose composition gradually changes along the depth direction. The outermost surface portion of the surface layer is made of a metal having low affinity with bone. It contains more than the implant base for osteosynthesis.

[0035] With this configuration as well, as in the case of the osteosynthesis implant described in (5) above, a portion having a low callus forming ability is preferably used in a relatively low temporary bone. In addition to having bone forming ability, it is possible to have relatively high callus forming ability in a portion that may have high callus forming ability.

[0036] With this configuration as well, as in the case of the osteosynthesis implant described in (5) above, an osteosynthesis implant is manufactured based on one osteosynthesis implant substrate. Therefore, it becomes possible to manufacture an osteosynthesis implant having high mechanical strength by a relatively easy method.

[0037] (8) In the osteosynthesis implant described in (7) above, the outermost surface portion of the surface layer preferably has a low affinity with the bone and contains 5% by weight or more of a metal. ,.

[0038] Thus, the affinity for the outermost surface partial bone in the surface layer is low, and by containing 5% by weight or more of the metal, the ability to form a temporary bone is reduced in the outermost surface portion of the surface layer. It becomes possible to suppress to the level.

[0039] In this viewpoint, in the osteosynthesis implant described in (8) above, the outermost surface portion of the surface layer has low affinity with bone and may contain 20% by weight or more of metal. It is further preferable to contain 50% by weight or more of a metal having a low affinity with a more preferable bone. In the osteosynthesis implant described in (8) above, the outermost surface portion of the surface layer may have a low affinity with bone and contain 100% by weight of metal.

[0040] In the osteosynthesis implant according to the above (7) or (8), the surface layer contains a metal having a low affinity with the bone and further contains Ti or a Ti alloy. Do It is preferable.

[0041] With this configuration, the surface layer has excellent corrosion resistance, high strength, high biocompatibility, and excellent characteristics. It becomes an implant.

[0042] (9) In the osteosynthesis implant according to any one of (1) to (8), the thickness of the surface layer is preferably in the range of lnm to Lmm! / ,.

[0043] That is, the thickness of the surface layer is set to 1 nm or more, and when the thickness of the surface layer is set to less than 1 nm, the affinity with the bone cannot be sufficiently reduced in some cases. Because it occurs. On the other hand, the thickness of the surface layer is set to 1 mm or less. If the thickness of the surface layer exceeds 1 mm, peeling or cracking is likely to occur between the osteosynthesis implant and the surface layer. Power is also. In addition, if the thickness of the surface layer exceeds 1 mm, the time for forming the surface layer becomes longer, and the productivity in producing an osteosynthesis implant decreases.

From these viewpoints, the thickness of the surface layer is 層 ηπ! It is more preferably in the range of ~ 300 μm, more preferably in the range of 10 μm to 100 μm.

[0045] (10) In the osteosynthesis implant according to any one of (1) to (9), it is preferable that the osteosynthesis implant base has Ti or Ti alloy force.

[0046] With such a configuration, the osteosynthesis implant base occupying most of the osteosynthesis implant has excellent characteristics such as excellent corrosion resistance, high strength, and high biocompatibility. Therefore, it becomes an excellent implant for osteosynthesis.

[0047] In the osteosynthesis implant according to any one of the above (5) to (8), in a portion that may have a high callus formation ability, it has excellent corrosion resistance and high strength, The biocompatibility is high and it has excellent characteristics, so it is an excellent implant for osteosynthesis.

[0048] (11) The osteosynthesis implant of the present invention is an osteosynthesis implant in which the ability to form a callus is partially suppressed, and includes a first part having a callus formation ability and the first part. A second portion in which the ability to form callus is suppressed, and the second portion contains more metal than the first portion and has a low affinity for bone, and the first portion and the It must be joined to the second part Is preferred.

[0049] According to this configuration, as in the case of the implant for osteosynthesis described in (5) or (7) above, the portion preferably having a low callus forming ability is Thus, it is possible to have a relatively low callus forming ability and a relatively high callus forming ability in a portion that may have a high callus forming ability.

[0050] (12) In the osteosynthesis implant described in (11) above, the second portion preferably has a low affinity with the bone and contains 5% by weight or more of a metal.

[0051] As described above, the second portion has low affinity with bone and contains 5% by weight or more of metal, whereby the callus forming ability can be suppressed to a low level in the second portion. .

From this point of view, in the osteosynthesis implant described in the above (12), it is more preferable that the second part contains 20% by weight or more of a metal having low affinity with bone. More preferably, it has a low affinity with bone and contains 50% by weight or more of metal.

[0053] (13) In the osteosynthesis implant described in (11) or (12) above, it is preferable that both the first portion and the second portion have a Ti or Ti alloy force.

[0054] By configuring in this way, the first and second parts, which are the constituent parts of the osteosynthesis implant, both have Ti or Ti alloy strength, so that they have excellent corrosion resistance, high strength, and biocompatibility. This is an osteosynthesis implant with high and high characteristics.

[0055] (14) The osteosynthesis implant of the present invention is an osteosynthesis implant with suppressed callus formation ability, and has an affinity for bone at least in the outermost surface portion of the osteosynthesis implant. It is characterized by containing 5% by weight or more of low metal.

[0056] Therefore, according to the osteosynthesis implant of the present invention, at least the outermost surface portion of the osteosynthesis implant contains 5% by weight or more of a metal having low affinity with bone, so that the osteosynthesis implant It is possible to suppress the callus formation ability on the surface of the skin to a low level. As a result, it is possible to suppress the formation of a callus around the osteosynthesis implant to a low level while implanting the osteosynthesis implant in the body and the force until the fracture treatment is completed. The operation of removing the joint implant from the body can be facilitated. As a result, even in the case of young patients with high callus formation ability, it was necessary to scrape the callus to remove the osteosynthesis implant. Therefore, it is possible to alleviate the problem that a large force is applied to cause the secondary fracture when the osteosynthesis implant is removed.

[0057] From this point of view, the osteosynthesis implant according to the above (14) has a low affinity for bone at least on the outermost surface portion of the osteosynthesis implant, and the metal is 20% by weight or more. It is more preferable to contain 50% by weight or more of a metal having a low affinity with bone, which is more preferable.

[0058] It should be noted that in the osteosynthesis implant described in (14) above, at least the outermost surface portion of the osteosynthesis implant has a low affinity for bone and contains 20% by weight or more of metal. Therefore, (a) the bone-implanting implant has a low affinity with the bone, the metal content is uneven, and the bone-implanting implant has an outermost surface portion that is in contact with the bone. Low affinity and contains 5% by weight or more of metal, while other than the outermost part of the osteosynthesis implant, it has low affinity for bone and does not contain 5% by weight or more of metal. In addition, (b) the content of the metal having low affinity with bone in the osteosynthesis implant is uniform, and is present on the outermost surface portion of the osteosynthesis implant. 5 weight of metal that has low affinity with bone, even in parts other than the surface % Is also included.

[0059] (15) In the osteosynthesis implant described in (14) above, it is preferable that the osteosynthesis implant has a Ti alloy force.

[0060] By configuring in this way, excellent osteosynthesis in which the ability to form a callus is suppressed to a low level while maintaining the excellent features of excellent corrosion resistance, high strength, and high biocompatibility. It becomes an implant.

[0061] (16) In the osteosynthesis implant according to any one of (1) to (15), the metal having low affinity with the bone is Zr, Ta, Nb, Si, Au, Pt, Preferred is one or more metals selected from Pd and Rh.

[0062] Zr, Ta, Nb, Si, Au, Pt, Pd, and Rh have low affinity with bone.

By using one or more metals selected from Zr, Ta, Nb, Si, Au, Pt, Pd and Rh, it is possible to suppress the callus formation ability to a low level. Zr, Ta, Nb, Si, Au, Pt, Pd, and Rh have excellent corrosion resistance and relatively high biocompatibility. It can be preferably used as a material used for a bonding implant.

[0063] Among them, it is particularly preferable that the affinity for the bone is low and the metal is Zr.

[0064] In addition to the features that Zr has low affinity with bones, excellent corrosion resistance, and high biocompatibility, Zr is characterized by high strength, familiarity with Ti and Ti alloys, and easy manufacture It also has Therefore, by using Zr as described above, it is possible to suppress the callus formation ability to a low level, and it is easy to manufacture with excellent corrosion resistance, high strength, and high biocompatibility. This is an osteosynthesis implant having excellent characteristics of being.

[0065] (17) A method for manufacturing an osteosynthesis implant according to the present invention is the method for manufacturing an osteosynthesis implant as described in any one of (1) to (4) above. Therefore, the method includes a first step of preparing the osteosynthesis implant base and a second step of forming the surface layer on the surface of the osteosynthesis implant base.

[0066] Therefore, according to the method for producing an osteosynthesis implant of the present invention, the osteosynthesis implant according to any one of (1) to (4) described above, in which the ability to form a callus is suppressed as described above, is easy. Can be manufactured.

[0067] (18) A method for producing an osteosynthesis implant according to any one of the above (5) to (8) is a method for producing an osteosynthesis implant according to any one of (5) to (8). Therefore, the method includes a first step of preparing the osteosynthesis implant base and a second step of forming the surface layer on a part of the surface of the osteosynthesis implant base.

[0068] Therefore, according to the method for producing an osteosynthesis implant of the present invention, the osteosynthesis implant according to any one of (5) to (8) described above, in which the ability to form a callus is suppressed as described above. Can be manufactured.

[0069] (19) In the method for producing an osteosynthesis implant according to (17) or (18), the second step includes vacuum deposition of a metal containing a metal having low affinity with the bone, It is preferable to include a step of sputtering or ion plating.

[0070] By adopting such a method, the osteosynthesis implant according to any one of (1) to (8), in which the callus formation ability is suppressed as described above, can be produced relatively easily. It is possible to do.

[0071] (20) In the method for producing an osteosynthesis implant according to (17) or (18) above, It is preferable that the second step includes a step of metallization by heat-treating a liquid containing a metal having low affinity with the bone, coated with greaves or fats and oils.

[0072] Even with this method, the callus formation ability was suppressed as described above,

It is possible to manufacture the osteosynthesis implant according to any one of (1) to (8) relatively easily.

[0073] Further, when the osteosynthesis implant base has a complicated shape, the surface layer can be formed on the surface of the osteosynthesis implant relatively easily by using such a method. .

[0074] (21) In the method for manufacturing an osteosynthesis implant according to (19) or (20), the second step is to form a gradient alloy between the osteosynthesis implant and the surface layer. It is preferable to further include the heat treatment step.

[0075] By adopting such a method, the callus formation ability is suppressed as described above, (3)

It becomes possible to manufacture the osteosynthesis implant according to (4), (7) or (8) relatively easily.

[0076] (22) In the method for manufacturing an osteosynthesis implant according to (17) or (18), it is preferable that the second step forms the surface layer while changing the composition.

[0077] According to such a method, the callus formation ability is suppressed as described above.

The osteosynthesis implant according to (3), (4), (7) or (8) can be produced relatively easily.

(23) A method for producing an osteosynthesis implant according to the present invention is a method for producing an osteosynthesis implant for producing the osteosynthesis implant according to any one of the above (11) to (13). Accordingly, the method includes a first step of preparing the first portion and the second portion, and a second step of joining the first portion and the second portion.

[0079] Therefore, according to the method for producing an implant for osteosynthesis of the present invention, as described above, the osteosynthesis according to any one of (11) to (13), in which the ability to form a callus is suppressed. This makes it possible to easily manufacture a plant implant.

(24) In the method for manufacturing an osteosynthesis implant according to any one of (17) to (23), the metal having low affinity with bone is Zr, Ta, Nb, Si , Au, Pt, Pd & Rh force It is preferable that it is 1 type, or 2 or more types of metals selected from these.

[0081] Thus, by using one or more metals selected from Zr, Ta, Nb, Si, Au, Pt, Pd, and Rh, the callus formation ability is suppressed to a low level. Therefore, it is possible to produce an osteosynthesis implant that is capable of providing high corrosion resistance and relatively high biocompatibility.

[0082] Among them, it is particularly preferable that the affinity for the bone is low and the metal is Zr.

[0083] By adopting such a method, it is possible to suppress the callus formation ability to a low level, and it is excellent in corrosion resistance, high strength, high biocompatibility, and easy to manufacture.

V, an osteosynthesis implant with excellent characteristics.

Brief Description of Drawings

FIG. 1 is a view for explaining an osteosynthesis implant 10 according to Embodiment 1.

FIG. 2 is a view for explaining an osteosynthesis implant 20 according to a second embodiment.

FIG. 3 is a cross-sectional view of an osteosynthesis implant 30 according to Embodiment 3.

FIG. 4 is a cross-sectional view of an osteosynthesis implant 40 according to Embodiment 4.

FIG. 5 is a cross-sectional view of an osteosynthesis implant 50 according to Embodiment 5.

FIG. 6 is a view for explaining an osteosynthesis implant 60 according to Embodiment 6.

FIG. 7 is a view showing an SEM photograph in the example.

FIG. 8 is a diagram showing an XPS spectrum in an example.

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, an osteosynthesis implant and a manufacturing method thereof according to the present invention will be described based on the embodiments shown in the drawings.

[0086] [Embodiment 1]

FIG. 1 is a view for explaining an osteosynthesis implant 10 according to the first embodiment. Fig. 1 (a) is a perspective view of the osteosynthesis implant 10, Fig. 1 (b) is a cross-sectional view of the osteosynthesis implant 10, and Fig. 1 (c) is an A-A cross section of Fig. 1 (b). FIG.

The osteosynthesis implant 10 according to Embodiment 1 is an osteosynthesis implant with suppressed callus formation ability, and as shown in FIG. 1, the osteosynthesis implant substrate 12 and the osteosynthesis implant And a surface layer 14 formed on the surface of the implant substrate 12. And the surface layer 14 Is characterized by containing a metal having a low affinity with bone more than the implant base 12 for osteosynthesis. The osteosynthesis implant 10 according to Embodiment 1 is an osteosynthesis screw.

[0088] In the osteosynthesis implant 10 according to Embodiment 1, the surface layer 14 contains 5% by weight or more of a metal having low affinity with bone. In the osteosynthesis implant 10 according to the first embodiment, Zr, Ta, Nb, Si, Au, Pt, Pd, and Rh force are selected as one or two kinds of metals having low affinity with bone. Use these metals.

[0089] In the osteosynthesis implant 10 according to Embodiment 1, the surface layer 14 contains 5% by weight or more of a metal having low affinity with bone, and the remainder is made of metal Ti or a Ti alloy. .

[0090] In the osteosynthesis implant 10 according to Embodiment 1, the content of the metal having low affinity for bone in the osteosynthesis implant substrate 12 is 5% by weight or less, and the balance is the rest. Metal Ti or Ti alloy.

[0091] In the osteosynthesis implant 10 according to the first embodiment, the thickness of the surface layer 14 is set to a value within the range of lnm to lmm.

[0092] Since the osteosynthesis implant 10 according to Embodiment 1 is configured as described above, it has the following effects.

That is, according to the osteosynthesis implant 10 of the first embodiment, the surface layer 14 formed on the surface of the osteosynthesis implant base 12 uses a metal having low affinity with bone for the osteosynthesis implant. Since it contains more than the base | substrate 12, it becomes possible to suppress the callus formation ability in the surface of the implant 10 for osteosynthesis to a low level. As a result, it is possible to suppress the formation of a callus around the osteosynthesis implant 10 between the implantation of the osteosynthesis implant 10 in the body and the completion of the fracture treatment to a low level. Therefore, the operation of removing the osteosynthesis implant 10 from the body can be facilitated. As a result, even in a young patient with high callus formation ability, it is necessary to scrape the callus to remove the osteosynthesis implant, or a large force is required to remove the osteosynthesis implant. It is possible to alleviate the problem of causing secondary fractures. Further, according to the osteosynthesis implant 10 according to the first embodiment, it is possible to select an optimal material for each of the osteosynthesis implant base 12 and the surface layer 14. For this reason, an excellent material such as Ti or Ti alloy, which has been proven in the past, is selected as the implant base 12 for osteosynthesis, and a material having low affinity with bone is selected as the surface layer 14. It becomes possible.

[0095] Furthermore, according to the osteosynthesis implant 10 according to Embodiment 1, the surface layer 14 has low affinity with bone! By containing 5% by weight or more of metal, it is possible to suppress the callus formation ability to a low level.

The osteosynthesis implant 10 according to Embodiment 1 can be manufactured by a method for manufacturing an osteosynthesis implant including the following steps.

[0097] (1) First step

Prepare an implant base 12 for osteosynthesis with Ti alloy strength.

[0098] (2) Second step

A surface layer 14 is formed on the surface of the implant base 12 for osteosynthesis. The formation of the surface layer 14

, Zr, Ta, Nb, Si, Au, Pt, Pd and Rh.

[0099] By performing the above steps, the osteosynthesis implant 10 according to Embodiment 1 can be easily manufactured.

[0100] The second step is not performed by sputtering a metal containing a metal having a low affinity with bone, but a metal containing a metal having a low affinity with bone is vacuum-deposited or ion-plated. This is what you do from Kotoko.

[0101] Further, the second step has low affinity with bone, and includes metals (metal ions and metal complex ions).

This is done by heat treating and metallizing a liquid containing), rosin or oil.

[0102] [Embodiment 2]

FIG. 2 is a view for explaining the osteosynthesis implant 20 according to the second embodiment.

. FIG. 2 (a) is a sectional view of the osteosynthesis implant 20, and FIG. 2 (b) is an enlarged view of the main part of FIG. 2 (a). The surface layer 24 in Fig. 2 (b) contains a lot of metals with low affinity for bone. The area is shown as darker and grayer.

[0103] The osteosynthesis implant 20 according to the second embodiment basically has a similar structure to the osteosynthesis implant 10 according to the first embodiment, but the osteosynthesis implant 10 according to the first embodiment. The structure of the surface layer is different from Implant 10. That is, as shown in FIG. 2 (b), the osteosynthesis implant 20 according to Embodiment 2 has a surface layer 24 that also has a gradient alloying force whose composition gradually changes along the depth direction. . The outermost surface portion of the surface layer 24 is characterized by containing more metal having a low affinity with bone than the implant base material 22 for osteosynthesis. The osteosynthesis implant 20 according to Embodiment 2 is an osteosynthesis screw.

As described above, the osteosynthesis implant 20 according to the second embodiment is different from the osteosynthesis implant 10 according to the first embodiment in the configuration of the surface layer, but the outermost surface portion in the surface layer 24 is different. Since the metal having a low affinity for bone is contained in a larger amount than the osteosynthesis implant substrate 22, the callus forming ability on the surface of the osteosynthesis implant 20 can be suppressed to a low level. As a result, as in the case of the osteosynthesis implant 10 according to the first embodiment, a callus is formed around the osteosynthesis implant 20 between the implantation of the osteosynthesis implant 20 in the body and the end of the force fracture treatment. Therefore, the operation of removing the osteosynthesis implant 20 from the body can be facilitated. As a result, even in the case of young patients with high callus formation ability, it is necessary to scrape the callus to remove the osteosynthesis implant, or a large force is required to remove the osteosynthesis implant. This can alleviate the problem of causing secondary fractures.

In addition, according to the osteosynthesis implant 20 according to the second embodiment, it is possible to select an optimal material for each of the osteosynthesis implant base 22 and the surface layer 24. Therefore, as in the case of the implant 10 for osteosynthesis according to the first embodiment, an excellent material such as Ti or Ti alloy that has been proven in the past is selected as the material for the implant base 22 for osteosynthesis. As a material for the surface layer 24, it is possible to select a material having a low affinity with bone.

[0106] Furthermore, according to the osteosynthesis implant 20 according to the second embodiment, it is possible to sufficiently improve the adhesion between the osteosynthesis implant substrate 22 and the surface layer 24, and the reliability is further improved. An osteosynthesis implant can be provided.

[0107] Since the osteosynthesis implant 20 according to the second embodiment has the same configuration as the osteosynthesis implant 10 according to the first embodiment except for the above, the osteosynthesis implant according to the first embodiment is used. It has a corresponding effect among the effects that 10 has.

[0108] The osteosynthesis implant 20 according to the second embodiment is similar to the osteosynthesis implant 20 according to the first embodiment, in the first step of preparing the osteosynthesis implant substrate 22, and the osteosynthesis implant substrate. And a second step of forming the surface layer 24 on the surface of 22.

[0109] In the second step, the surface layer 24 is formed by vacuum deposition, sputtering or ion plating of a metal containing metal having low affinity with bone, and then the osteosynthesis implant substrate 22 and the surface layer 24 are formed. Is performed by performing a heat treatment for forming a gradient alloy.

[0110] Further, in the second step, the surface layer 24 is formed by heat-treating a liquid containing a metal having a low affinity with bone, coated with greaves or oils, to form a surface layer 24, and then an implant for osteosynthesis. It can also be carried out by performing a heat treatment for forming a gradient alloy between the substrate 22 and the surface layer 24. When the osteosynthesis implant has a complicated shape, the surface layer can be relatively easily formed on the surface of the osteosynthesis implant substrate by such a method.

[0111] In addition, the second step is performed by forming a surface layer by vacuum deposition, sputtering or ion plating of a metal containing a metal having low affinity with bone while changing the composition. .

[0112] Furthermore, in the second step, a surface layer is formed by heat-treating a liquid, greaves or oil-and-fat coated metal containing a metal having low affinity with bone while changing the composition to form a surface layer. It ’s better to do it.

[0113] [Embodiment 3]

FIG. 3 is a cross-sectional view of the osteosynthesis implant 30 according to the third embodiment.

The osteosynthesis implant 30 according to Embodiment 3 is an osteosynthesis implant in which the callus formation ability is partially suppressed. And, as shown in FIG. 3, it has an osteosynthesis implant substrate 32 and a surface layer 34 formed on a part of the surface of the osteosynthesis implant substrate 32. The face layer 34 is characterized by containing more metal having a low affinity with bone than the implant base 32 for osteosynthesis. The osteosynthesis implant 30 according to Embodiment 3 is an osteosynthesis screw.

[0114] As described above, in an osteosynthesis implant, the callus formation ability must be suppressed throughout the osteosynthesis implant! /, And not necessarily! /. In other words, in the osteosynthesis implant, there are a portion that may have a high callus formation ability and a portion that preferably has a low callus formation ability. For example, in an osteosynthesis screw, the space where the callus is originally formed is small around the screw part that will enter the bone, so the part that may have high callus formation ability (screw Part 36). On the other hand, since there is a large space for forming a callus around the head that will be exposed outside the bone, it is preferable to have a low callus formation ability (head 38). It becomes.

[0115] According to the osteosynthesis implant 30 according to Embodiment 3, the portion (head 38) preferably having a low callus formation ability of the osteosynthesis implant 30 has low affinity with bone. Since the surface layer 34 containing more metal than the osteosynthesis implant base 32 is formed, a portion having a low callus formation ability (head 38) has a relatively low callus shape. It is possible to provide a relatively high callus forming ability to the part (screw portion 36) that may have a high callus forming ability and have a high callus forming ability.

[0116] Furthermore, according to the osteosynthesis implant 30 according to the third embodiment, it becomes possible to manufacture an osteosynthesis implant based on the single osteosynthesis implant base 32, so that high mechanical strength is achieved. It becomes possible to manufacture an osteosynthesis implant having a relatively easy method.

[0117] The osteosynthesis implant 30 according to Embodiment 3 includes a first step of preparing an osteosynthesis implant base 32 and a second step of forming a surface layer 34 on a part of the surface of the osteosynthesis implant base 32. It can manufacture by performing.

The formation of the surface layer 34 can be performed in the same manner as in the case of the osteosynthesis implant 10 according to the first embodiment and the case of the osteosynthesis implant 20 according to the second embodiment.

[Embodiment 4]

FIG. 4 is a cross-sectional view of the osteosynthesis implant 40 according to the fourth embodiment. The osteosynthesis implant 40 according to the fourth embodiment is an osteosynthesis implant in which the ability to form a callus is partially suppressed as in the case of the osteosynthesis implant 30 according to the third embodiment. Then, as shown in FIG. 4, it has an osteosynthesis implant base 42 and a surface layer 44 formed on a part of the surface of the osteosynthesis implant base 42. It has a low affinity and is characterized by containing more metal than the implant base material 42 for osteosynthesis. The osteosynthesis implant 40 according to Embodiment 4 is an osteosynthesis screw.

[0120] As described above, in an osteosynthesis implant, the callus formation ability must be suppressed throughout the osteosynthesis implant! /, And not necessarily! /. In other words, in the osteosynthesis implant, there are a portion that may have a high callus formation ability and a portion that preferably has a low callus formation ability. For example, in the case of an osteosynthesis screw, there is a working space for removing a callus around the head that will be exposed to the outside of the bone, and the environment is relatively easy to remove the callus. It is also considered to be a part (head 48) that may have callus formation ability. In addition, it is difficult to remove the callus around the screw that will enter the bone, and it is relatively difficult to remove the callus. It is preferable to have a function, and it is not considered when it becomes a part (screw part 46).

[0121] According to the osteosynthesis implant 40 according to Embodiment 4, the portion (screw portion 46) preferably having a low callus formation ability of the osteosynthesis implant 40 has low affinity with bone. Since it becomes possible to form the surface layer 44 containing more metal than the osteosynthesis implant base 42, the portion (screw portion 46) that preferably has a low callus formation ability is relatively low. While having the ability of forming a callus callus and having a high callus callus formation ability, the portion (head 48) can have a relatively high callus formation ability.

As described above, the osteosynthesis implant 40 according to Embodiment 4 is different from the osteosynthesis implant 30 according to Embodiment 3 in that it preferably has a low callus-forming ability and a high callus. However, as in the case of the implant for osteosynthesis 30 according to the third embodiment, the low callus formation of the osteosynthesis implant is low. Since the surface layer 44 containing more metal than the bone graft implant base 42 is formed in the part that preferably has the ability (screw part 46), it has a low callus formation. The portion (screw portion 46) that preferably has the ability to have the ability to have a relatively low callus formation ability and the portion (head portion 48) that may have a high callus formation ability to the relative ability. High callus formation ability.

[0123] It should be noted that the osteosynthesis implant 40 according to the fourth embodiment has the same configuration as the osteosynthesis implant 30 according to the third embodiment in other points, and thus the osteosynthesis implant 30 according to the third embodiment. Has the corresponding effect among the effects of

The osteosynthesis implant 40 according to Embodiment 4 includes a first step of preparing an osteosynthesis implant base 42 and a second step of forming a surface layer 44 on a part of the surface of the osteosynthesis implant base 42. It can manufacture by performing.

The formation of the surface layer 44 is the same as in the case of the osteosynthesis implant 10 according to the first embodiment, in the case of the osteosynthesis implant 20 according to the second embodiment, and in the case of the osteosynthesis implant 30 according to the third embodiment. It can be done by the method.

[Embodiment 5]

FIG. 5 is a cross-sectional view of an osteosynthesis implant 50 according to the fifth embodiment.

The osteosynthesis implant 50 according to Embodiment 5 is an osteosynthesis implant in which the callus formation ability is partially suppressed. Then, as shown in FIG. 5, it has a first part 56 having a callus forming ability, and a second part 58 in which the callus forming ability is suppressed more than the first part 56. Is characterized in that it contains a metal having a lower affinity for bone than the first portion 56, and the first portion 56 and the second portion 58 are joined. The osteosynthesis implant 50 according to Embodiment 5 is an osteosynthesis screw.

[0127] This configuration also has a low callus formation ability as in the case of the osteosynthesis implant 30 according to Embodiment 3 and the osteosynthesis implant 40 according to Embodiment 4. The preferred portion (second portion 58) has a relatively low callus formation ability, and the portion that may have a high callus formation ability (first portion 56) is relatively high. It is possible to have callus formation ability.

[0128] The osteosynthesis implant 50 according to Embodiment 5 includes a first step of preparing the first portion 56 and the second portion 58, and a second step of joining the first portion 56 and the second portion 58. Can be manufactured by performing the above. [Embodiment 6]

FIG. 6 is a view for explaining an osteosynthesis implant 60 according to the sixth embodiment. FIG. 6 (a) is a view showing a state in which the osteosynthesis implant 60 is implanted in the body, and FIG. 6 (b) is an enlarged view of a main part of FIG. 6 (a).

[0130] As shown in FIG. 6, the osteosynthesis implant 60 according to Embodiment 6 is an osteosynthesis plate. In the osteosynthesis implant 60 according to Embodiment 6, the back surface of the osteosynthesis plate corresponds to the first portion 66, and the front and side surfaces of the osteosynthesis plate correspond to the second portion 68. In the osteosynthesis implant 60 according to Embodiment 6, the outermost surface portion of the second portion 68 contains more metal having a low affinity for bone than the outermost surface portion of the first portion 66. It is said. As a result, the portions that preferably have low callus formation ability (surface and side surfaces of the osteosynthesis plate) have relatively low callus formation ability and high callus formation ability. The part that may be present (the back surface of the osteosynthesis plate) can have a relatively high callus formation ability.

[0131] As described above, the osteosynthesis implant 60 according to Embodiment 6 is different from the osteosynthesis implants 30 to 50 according to Embodiments 3 to 5 in that the type of osteosynthesis implant is different. As in the case of the osteosynthesis implants 30 to 50 according to 3 to 5, a relatively low V bone callus is present in the part (surface and side surface of the osteosynthesis plate) that preferably has low callus formation ability. It is possible to have a high callus formation ability while having a high callus formation ability as well as a formation ability and a relatively high callus formation ability in the portion (the back surface of the osteosynthesis plate).

[0132] In the sixth embodiment, as shown in FIG. 6, the osteosynthesis implant 30 according to the third embodiment is used as an osteosynthesis screw for fixing the osteosynthesis implant 60 to the bone. .

Example

[0133] Hereinafter, the effect of suppressing the formation of callus in the osteosynthesis implant of the present invention will be described with reference to examples.

[Example 1]

A Zr thin film having a thickness of 35 μm was formed on a pure titanium substrate having a diameter of 10 mm and a thickness of 3 mm by sputtering, and this was used as a sample according to Example 1. [0135] [Comparative Example 1]

A pure titanium substrate having a diameter of 10 mm and a thickness of 3 mm in Example 1 was directly used as a sample according to Comparative Example 1.

[0136] Next, each of the sample according to Example 1 and the sample according to Comparative Example 1 was immersed in a Hanks solution (3 10K) for 14 days. After that, each of the sample according to Example 1 and the sample according to Comparative Example 1 was taken out from the Hanks solution, and (1) SEM photograph observation with a scanning electron microscope function in an electron probe microanalyzer (JEOL Ltd .: 8-8621MX) And (2) XPS spectra were observed with a photoelectron spectrometer (SSI SSX-100), and the presence of calcium phosphate was observed to evaluate the ability of callus formation.

FIG. 7 is a view showing an SEM photograph in the example. FIG. 7 (a) is a diagram showing an SEM photograph of the sample according to Example 1, and FIG. 7 (b) is a diagram showing an SEM photograph of the sample according to Comparative Example 1.

As is clear from FIG. 7, in the sample according to Comparative Example 1, precipitates of calcium phosphate were observed (see symbol A in FIG. 7 (b)), whereas in the sample according to Example 1, No precipitate of calcium phosphate was observed.

FIG. 8 is a diagram showing an XPS spectrum in the example. FIG. 8 (a) is a diagram showing an XPS spectrum in the sample according to Example 1, and FIG. 8 (b) is a diagram showing an XPS spectrum in the sample according to Comparative Example 1. The XPS spectrum in Fig. 8 was obtained by measuring with a spot diameter of about lmm.

As is clear from FIG. 8, in the sample according to Comparative Example 1, a signal attributed to calcium was observed in the vicinity of 350 eV (see symbol B in FIG. 8 (b)). In the sample according to 1, no such signal was observed.

[0141] As can be seen from the above results, the sample according to Example 1 was different from the sample according to Comparative Example 1 in spite of being immersed in Hanks solution (310 ° K) for 14 days. Z

The precipitation of calcium phosphate was not observed. From this, it was confirmed that the callus forming ability was suppressed for the sample according to Example 1.

[0142] As described above, the osteosynthesis implant and the manufacturing method thereof according to the present invention are based on the above embodiments. Although the present invention has been described above, the present invention is not limited to the above-described embodiments, and can be carried out in various modes without departing from the gist thereof.

Explanation of symbols

10, 20, 30, 40, 50, 60 ... Osteoplast for osteosynthesis K 12, 22, 32, 42, 52, 62 ... Insole base for osteosynthesis, 14, 24, 34, 44, 54, 64 ... Surface layer, 36, 46 ... Screw part, 38, 48 ... Head, 56, 66 ... First part, 58, 68 ... Second part, 第 ... Precipitation of calcium phosphate , Β—Ca signal

Claims

The scope of the claims

[1] An osteosynthesis implant with suppressed callus formation ability,

An implant base for osteosynthesis, and a surface layer formed on the surface of the implant base for osteosynthesis,

The osteosynthesis implant according to claim 1, wherein the surface layer contains more metal having a low affinity with bone than the osteosynthesis implant substrate.

[2] The osteosynthesis implant according to claim 1, wherein

The osteosynthesis implant according to claim 1, wherein the surface layer has a low affinity with the bone and contains 5% by weight or more of a metal.

[3] An osteosynthesis implant with reduced callus formation ability,

An osteosynthesis implant base and a surface layer formed of a gradient alloy formed on the surface of the osteosynthesis implant base and gradually changing in composition along the depth direction;

The osteosynthesis implant characterized in that the outermost surface portion of the surface layer contains more metal having a low affinity for bone than the osteosynthesis implant substrate.

[4] In the osteosynthesis implant according to claim 3,

An implant for osteosynthesis, wherein the outermost surface portion of the surface layer has a low affinity with the bone and contains 5% by weight or more of a metal.

[5] An osteosynthesis implant with partially suppressed callus formation ability,

An osteosynthesis implant base and a surface layer formed on a part of the surface of the osteosynthesis implant;

[6] In the osteosynthesis implant according to claim 5,

[7] An osteosynthesis implant with partially reduced callus formation ability,

An osteosynthesis implant base, and a surface layer formed of a gradient alloy formed on a part of the surface of the osteosynthesis implant and gradually changing in composition along the depth direction; The osteosynthesis implant characterized in that the outermost surface portion of the surface layer contains more metal having a low affinity for bone than the osteosynthesis implant substrate.

[8] The osteosynthesis implant according to claim 7,

[9] The osteosynthesis implant according to any one of claims 1 to 8,

The osteosynthesis implant is characterized in that the thickness of the surface layer is in the range of lnm to Lmm.

[10] The osteosynthesis implant according to any one of claims 1 to 9,

The bone implant according to claim 1, wherein the bone implant base is Ti or Ti alloy.

[11] An osteosynthesis implant with partially suppressed callus formation ability,

A first portion having a callus formation ability and a second portion in which the callus formation ability is suppressed as compared to the first portion;

The second part contains a metal having a low affinity for bone more than the first part, and the first part and the second part are joined together. And

[12] The osteosynthesis implant according to claim 11, wherein

The osteosynthesis implant characterized in that the second part has a low affinity with the bone and contains 5% by weight or more of a metal.

[13] The osteosynthesis implant according to claim 11 or 12,

Both the first part and the second part are made of Ti or a Ti alloy cover.

[14] An osteosynthesis implant with reduced callus formation ability,

An osteosynthesis implant characterized in that at least the outermost surface portion of the osteosynthesis implant contains 5% by weight or more of a metal having low affinity for bone.

[15] The osteosynthesis implant according to claim 14,

The implant for osteosynthesis is characterized by having Ti alloy force.

[16] The osteosynthesis implant according to any one of claims 1 to 15, wherein the metal having low affinity with bone is selected from Zr, Ta, Nb, Si, Au, Pt, Pd, and Rh. An implant for osteosynthesis, characterized by being one or more metals.

[17] A method for producing an osteosynthesis implant for producing the osteosynthesis implant according to any one of claims 1 to 4,

A first step of preparing the osteosynthesis implant substrate;

And a second step of forming the surface layer on the surface of the osteosynthesis implant substrate.

[18] A method for producing an osteosynthesis implant for producing the osteosynthesis implant according to any one of claims 5 to 8,

A first step of preparing the osteosynthesis implant substrate;

And a second step of forming the surface layer on a part of the surface of the osteosynthesis implant substrate.

[19] In the method for producing an osteosynthesis implant according to claim 17 or 18,

The method for producing an osteosynthesis implant, wherein the second step includes a step of vacuum deposition, sputtering or ion plating of a metal containing a metal having low affinity with the bone.

[20] In the method for producing an osteosynthesis implant according to claim 17 or 18,

The second step includes a step of heat-treating a metal-coated liquid, greaves, or oil / fat containing a metal having a low affinity with the bone, to produce a bone graft implant, Method.

[21] In the method for producing an osteosynthesis implant according to claim 19 or 20,

The method for manufacturing an osteosynthesis implant, wherein the second process further includes a heat treatment process for forming a gradient alloy between the osteosynthesis implant substrate and the surface layer.

[22] In the method for producing an osteosynthesis implant according to claim 17 or 18,

In the second step, the surface layer is formed while changing the composition.

[23] A method for producing an osteosynthesis implant for producing an osteosynthesis implant according to any one of claims 11 to 13,

A first step of preparing the first part and the second part;

A method for producing an osteosynthesis implant, comprising: a second step of joining the first part and the second part.

[24] The method for producing an osteosynthesis implant according to any one of claims 17 to 23, wherein the metal having low affinity with bone is made of Zr, Ta, Nb, Si, Au, Pt, Pd and Rh. A method for producing an osteosynthesis implant, which is one or more selected metals.