WO2018147681A1

WO2018147681A1 - Bone substitute implant

Info

Publication number: WO2018147681A1
Application number: PCT/KR2018/001759
Authority: WO
Inventors: 유현승; 서준혁; 조명래; 권병우; 정의수
Original assignee: 주식회사 바이오알파
Priority date: 2017-02-13
Filing date: 2018-02-09
Publication date: 2018-08-16
Also published as: KR101952597B1; JP2020513198A; KR20180093292A

Abstract

A bone substitute implant is provided. A bone substitute implant according to an embodiment of the present invention comprises: a synostosis member which comprises a body made of a bioactive crystallized glass material, and which contacts the surface of an adjacent bone so as to fuse therewith; an implant body to be retained between adjacent bones; and a buffer member arranged between the synostosis member and the implant body such that the synostosis member and the implant body are spaced from each other.

Description

Bone replacement implant

The present invention relates to a bone replacement implant, and more particularly, to a bone replacement implant that is easy to perform the procedure and can improve the compatibility and mechanical stability with the bone.

In general, bone replacement implants are used to replace bones that have been removed or lost due to lesions, and spinal implants for replacing vertebral bodies or intervertebral bodies are typical.

Conventionally, the bone substitute implant is made of a metal such as titanium (Ti) or a polymer material such as polyetheretherketone (PEEK), and these materials have different compatibility with bone.

Here, the implant material is not highly compatible with bone, and in order to overcome the low compatibility with bone, bone graft material is essentially used separately.

However, in order to apply such a bone graft material, the implant must have a structure that can effectively accommodate the bone graft material, and there is a troublesome problem when the bone graft material is used during the procedure.

In addition, even when using bone grafts, efforts to improve the compatibility between bones and implants have been made because the low compatibility of the implant material in direct contact with the bones is not sufficient to assist the fusion between the implants and the bones. However, there is still no fundamental solution.

In order to solve the problems of the prior art as described above, an embodiment of the present invention is to provide a bone replacement implant that is easy to perform the procedure and improve the union and mechanical stability with the bone.

According to an aspect of the present invention for solving the above problems, including a body made of a bioactive crystallized glass material, the bone union member for contact and fusion in contact with the surface of the adjacent bone; An implant body for fixing between adjacent bones; And a buffer member disposed between the bone union member and the implant body to separate the bone union member and the implant body from each other.

In one embodiment, the implant body is made of titanium (Ti) series, the buffer member may be made of a polyetheretherketone (PEEK) material.

In one embodiment, the bioactive crystallized glass material may include CaSiO ₃ , apatite and Ca ₂ Mg (Si ₂ O ₇ ) in a weight ratio of 1: 0.7 to 1.5: 0.5 to 1.2.

In one embodiment, the body may be manufactured by CAD / CAM or 3D printing based on medical image information of the patient.

In one embodiment, the bone union member is embedded in the space between the adjacent first and second bones, the body has a shape corresponding to the surface shape of each of the first and second bones, the implant body The plate includes a plate fixed to the first vertebra and the second vertebra, is coupled to the shock absorbing member, and a groove portion for coupling the shock absorbing member may be provided on the side of the body.

In one embodiment, the buffer member, a pair of supports for coupling to the body of the bone union member; And a center portion connecting the pair of support portions, wherein the support portion may be inserted into a groove part of the body of the bone union member by fitting.

In one embodiment, the implant body is fixed between the adjacent first and second pole protrusions, the body is formed in a square shape, the side of the body corresponding to the contact surface of each of the first and second pole protrusions A concave portion is provided at a position, and the implant body has a first plate for fixing to one side of the first and second pole protrusions, and a first plate for fixing to the other side of the first and second pole protrusions. It includes two plates, the central portion of the body may be provided with a through hole through which the shaft and the buffer member of the first plate is inserted.

In one embodiment, the buffer member is made of a pair, each of the pair of buffer members, a plate-like spaced apart between the first plate or the second plate and the bone union member, the central portion is A plate-shaped spacer provided with a through hole having a shape corresponding to the shaft of the first plate; And an insertion part extending from the separation part to form a sidewall of the through hole and inserted into the through hole of the bone union member so as to space the shaft and the union member.

In one embodiment, the implant body replaces any one of a plurality of vertebral bodies connected to each other, the bone union member has a shape corresponding to the surface of the vertebral body and includes an upper and lower bone union member spaced apart from each other; The implant body may include a length adjusting part disposed between the upper and lower bone union members and varying the overall length by adjusting a gap between the upper and lower bone union members through a sliding movement during the user's manipulation.

In one embodiment, the implant body is made of a hollow metal material of the upper and lower parts, the first side of the upper side is fixedly coupled to the upper bone union member; And a second case formed of a hollow metal material of which upper and lower portions are opened, and a lower side of which is fixedly coupled to the lower bone union member and slidably coupled to the first case. The buffer member is disposed between the opposing surfaces of the first case and the upper bone union member and between the opposing surfaces of the second case and the lower bone union member, respectively, and protrudes in one direction from the bodies of the upper union member and the lower union member. It may be coupled to the protrusion side.

The bone substitute implant according to the embodiment of the present invention may improve the mechanical stability while improving the compatibility with the bone by using a material having high strength and strength with the bone.

In addition, the present invention is provided with a buffer member between the brittle bone union member and the high-strength implant body can suppress the breakage of the bone union member by external force, thereby further improving the mechanical stability.

In addition, the present invention can increase the area of the union portion to further promote fusion with the bone, it is possible to more securely fix the position between the bone.

In addition, the present invention does not need to provide a separate bone graft material, the procedure can be easily performed without the hassle of applying the bone graft material during the procedure can shorten the procedure time to improve the convenience for patients and medical staff.

1 is a view showing the state of use of the bone replacement implant according to the first embodiment of the present invention,

2 is a view showing a state of use of the bone replacement implant according to a second embodiment of the present invention,

3 is a view showing the state of use of the bone replacement implant according to a third embodiment of the present invention,

4 is a perspective view of the bone replacement implant of FIG. 1, FIG.

5 is an exploded perspective view of FIG. 5;

6 is a perspective view of the bone replacement implant of FIG.

7 is a perspective view of a state in which a part of the second plate is removed from FIG. 6;

8 is a perspective view of the second plate in FIG. 6, FIG.

9 is an exploded perspective view of the union and buffer unit in Figure 5,

10 is a view showing a state before the work tool is fastened in the bone replacement implant of FIG.

11 is an exploded view of FIG. 10;

12 is a cross-sectional view of FIG. 10, and

FIG. 13 is a view illustrating a lock screw fastened in FIG. 12.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art may easily implement the present invention. As those skilled in the art would realize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the present invention. In the drawings, parts irrelevant to the description are omitted in order to clearly describe the present invention, and like reference numerals designate like elements throughout the specification.

Hereinafter, with reference to the drawings will be described in more detail the bone replacement implant according to an embodiment of the present invention.

1 to 3, the

bone replacement implants

100, 200, and 300 according to the embodiment of the present invention include

bone union members

110, 210, 310 to 320,

implant bodies

120, 220 to 230, 330 to 370, and

buffer members

130, 240, and 380.

Here, the bone replacement implant 100 as shown in Figure 1, as a first embodiment of the present invention, to replace the intervertebral body such as liver cartilage may be an intervertebral replacement implant. The bone replacement implant 100 is embedded in the space between the adjacent first bone 11 and the second bone 12.

The bone replacement implant 200 as shown in FIG. 2 is a second embodiment of the present invention, for fixing between adjacent spinous processes, and may be spinous process implants. The bone replacement implant 200 is inserted between the adjacent first pole protrusions 21 and the second pole protrusions 22 and fixed to both sides of the first pole protrusions 21 and the second pole protrusions 22.

The bone replacement implant 300 as shown in FIG. 3 is a third embodiment of the present invention, and serves to replace the one of a plurality of vertebral bodies connected to each other to serve as a replacement vertebral body. Can be. Here, the replaced vertebral body may be a vertebral body in which damage or loss due to a lesion occurs.

The bone union members (110, 210, 310 ~ 320) is to be in contact with the bone in contact with the surface of the adjacent bone, and may include a body made of a bioactive crystallized glass material. The bioactive crystallized glass material may include CaSiO ₃ . In addition, the bioactive crystallized glass material is Ca ₁₀ (PO ₄ ) ₆ A (where A is an oxygen atom) and Ca ₁₀ (PO ₄ ) 6B ₂ (where B is a hydroxyl group, a fluorine atom or a chlorine atom). Apatite and Ca ₂ Mg (Si ₂ O ₇ ) including at least one selected from. Here, the bioactive crystallized glass material may include CaSiO ₃ , apatite and Ca ₂ Mg (Si ₂ O ₇ ) in a weight ratio of 1: 0.7 to 1.5: 0.5 to 1.2.

Since such bioactive crystallized glass material has bone fusion properties and great strength, when implanted in vivo, it can effectively replace the defects of the tissue of the living body or promote fusion with the skeleton.

Therefore, since it is not necessary to provide a separate bone graft material, the procedure can be easily performed without the hassle of applying the bone graft material during the procedure, thereby improving the convenience of the patient and the medical staff.

The body of the bone union member (110, 210, 310 ~ 320) may have a shape corresponding to the surface shape of the bones in contact. In one example, the body of the bone union member (110, 210, 310 ~ 320) may be manufactured by CAD / CAM or 3D printing based on the medical image information of the patient. The body of the bone union member (110, 210, 310 ~ 320) may be formed to be inclined or curved surface in contact with the contact bone.

Through this, the bone union members (110, 210, 310 ~ 320) can be manufactured to be substantially similar or identical to the shape of the patient's vertebrae to minimize the anatomical mismatch between the spine.

Implant body (120,220 ~ 230,330 ~ 370) is for fixing between adjacent bones, it may be made of a variety of structures depending on the application site of the bone replacement implant (100, 200, 300). The implant body (120, 220 ~ 230, 330 ~ 370) may have a structure for replacing the intervertebral body, vertebral body or fixing between spinous processes.

Here, the implant body (120,220 ~ 230,330 ~ 370) may be made of titanium (Ti) series. For example, the

implant bodies

120, 330 to 370 may be made of titanium, and the

implant bodies

220 and 230 may be made of Ti-6Al-4V material.

The

buffer members

130, 240, and 380 are made of polyether ether ketone (PEEK) material, and are disposed between the

bone union members

110, 210, 310 to 320 and the

implant bodies

120, 220 to 230, 330 to 370, and the

bone union members

110, 210, 310 to 320 and the implant body. 120, 220 ~ 230, 330 ~ 370) is spaced apart.

The

buffer members

130, 240, and 380 are for bridging the bone union members (110, 210, 310 to 320) and the implant bodies (120, 220 to 230, 330 to 370) of the metal material having a large brittleness. When 370 directly contacts, it can be prevented from being damaged by an external force applied from the human body or adjacent bones.

4 and 12 will be described in more detail the bone replacement implant (100, 200, 300) according to an embodiment of the present invention.

The bone substitute implant 100 in the first embodiment of the present invention, as shown in Figures 4 and 5, the bone union member 110, the plate 120 and the buffer member 130. Here, the plate 120 corresponds to the implant body.

The bone replacement implant 100 may be coupled to the first vertebral bone 11 by the first screw 140a and coupled to the second vertebrae 12 by the second screw 140b.

At this time, the bone union member 110 is buried between both sides of the first bone 11 and the second bone 12, the plate 120 at one end of the first bone 11 and the second bone 12. Can be fixed.

The bone union member 110 may include a body 110a made of a bioactive crystallized glass material. The body 110a may have a shape corresponding to the surface shape of each of the first and

second bones

11 and 12. In one example, the body 110a may be manufactured by CAD / CAM or 3D printing based on the medical image information of the patient. The body 110a may be formed to have an inclined surface in contact with the first and

second bones

11 and 12.

Here, the body 110a may be provided with

grooves

111a, 111b, and 111c along its side. At this time, the support 131 of the buffer member 130 may be inserted into the groove 111a at both sides of the body 110a.

In addition, the groove portion 111b in front of the body 110a is inserted and coupled to the central portion 132 of the buffer member 130, and the end of the support portion 131 of the buffer member 130 is inserted and coupled to the rear groove portion 111c. Can be. That is, the body 110a may be formed in a shape in which the buffer member 130 is inserted and wrapped in the

grooves

111a, 111b and 111c.

Thereby, the bone union member 110 may be coupled to the plate 120 for fixing to the first vertebrae 11 and the second vertebrae 12 through the buffer member 130.

In addition, a plurality of protrusions 112 may be provided in one direction on the upper and lower surfaces of the body 110a, that is, the surfaces contacting each of the first and

second bones

11 and 12. Each of the protrusions 112 may be provided at a predetermined thickness and length from the surface of the body 110a and may be provided at regular intervals from each other.

Through this, it is possible to further promote the fusion with the bone by increasing the union area is joined to the first and

second bones

11 and 12, and fused with the first and

second bones

11 and 12. By the protrusion 112 to be more stable position of the body (110a) between the bones.

In addition, the protrusion 112, the first vertebrae 11 and the second vertebrae 12 may improve the fixing force of the body (110a) by frictional coupling with each other.

The plate 120 includes a body 121 made of titanium (Ti), and is fixed to the first vertebrae 11 and the second vertebrae 12 by the first screw 140a and the second screw 140b. .

The plate 120 may be provided on both sides of the body 121, the first receiving hole 122a for receiving the first screw 140a and the second receiving hole 122b for receiving the second screw 140b. have. The first accommodation hole 122a and the second accommodation hole 122b may be inclined at different angles from each other. That is, since the first screw 140a and the second screw 140b are coupled to the first vertebrae 11 and the second vertebrae 12 at different angles, the first screw 140a and the second screw 140b. The first accommodating hole 122a and the second accommodating hole 122b may be inclined so that the 140b may be different from each other at an angle inserted into the plate 120.

In addition, the first accommodating hole 122a and the second accommodating hole 122b may be optionally provided with threads for fastening the first screw 140a and the second screw 140b therein.

In addition, the plate 120 accommodates the locking screw 129 for locking the first screw 140a and the second screw 140b at the center between the first accommodation hole 122a and the second accommodation hole 122b. A pair of receiving grooves 124 may be provided.

Here, the pair of accommodating grooves 124 are separated from each other by a partition wall and provided independently, and a communication portion 125 communicating with the first accommodating hole 122a and the second accommodating hole 122b is provided at one side thereof. Can be. That is, the pair of accommodating grooves 124, the first accommodating hole 122a, and the second accommodating hole 122b are provided to overlap each other so that a part thereof communicates with each other.

Through this, the head portion of the locking screw 129 in the communication portion 125 blocks a part of the first accommodation hole 122a and the second accommodation hole 122b, whereby the first screw 140a and the second screw ( Locking may be performed to prevent 140b) from escaping to the outside.

In this case, the locking screw 129 may include a first portion 129a which is partially recessed inward on one side. Here, the first portion 129a may be formed in a shape corresponding to the communicating portion 125. That is, when the lock screw 129 is integrally provided in the plate 120, the first portion 129a is rotated to be positioned in the communication portion 125, thereby the first accommodation hole 122a and the second accommodation hole ( Since 122b) is completely open without a blockage by the locking screw 129, the first screw 140a and the second screw 140b can be inserted into the first accommodation hole 122a and the second accommodation hole 122b. have.

In addition, the plate 120 may be provided with at least one wedge portion 123 on the surface in contact with the first vertebrae 11 and the surface in contact with the second vertebrae 12. That is, as shown in FIG. 5, the plate 120 has at least one wedge portion 123 at a position symmetrical with each other on the lower surface of the first accommodation hole 122a and the upper surface of the second accommodation hole 122b. ) May be provided.

Here, the wedge 123 may be provided at a position opposite to the fastening direction of the first screw 140a and the second screw 140b. That is, as shown in Figure 4, when the first screw 140a is coupled to the upper side of the bone union member 110, the wedge 123 is disposed below the first receiving hole 122a, the second screw When the 140b is coupled to the lower side of the bone union member 110, the wedge 123 may be disposed above the second accommodation hole 122b.

However, the formation position of the wedge portion 123 may be modified according to the fastening direction of the first screw 140a and the second screw 140b.

When the wedge 123 is provided in plural numbers, the wedges 123 may be spaced apart from each other at regular intervals, and one end thereof may be sharply formed to be fixed to the first vertebrae 11 or the second vertebrae 12.

Through this, it is possible to suppress or minimize the twist of the bone replacement implant 100 that can occur in accordance with the movement of the patient to further improve the structural stability, thus extending the service life of the bone replacement implant (100). .

In addition, the plate 120 may be provided with a fastening protrusion 127 corresponding to the fastening groove 135 of the buffer member 130 on both sides. The fastening protrusion 127 may be formed toward the rear side of the plate 120, that is, toward the buffer member 130. Here, the fastening protrusion 127 may be provided in a form in which one end thereof is bent inwardly of the body 121. That is, the fastening protrusion 127 may be formed in the "b" shape on the back of the body 121.

Through this, the plate 120 may be coupled to the buffer member 130 by a simple structure. For this reason, the plate 120 may be formed to have a thin thickness, thereby minimizing the volume of the plate 120 so that the volume of the bone union member 110 may be increased, thus increasing the union area with the bone. have.

The buffer member 130 may be made of polyether ether ketone (PEEK) material, and may be disposed between the bone union member 110 and the plate 120 to couple the bone union member 110 and the plate 120. Here, the shock absorbing member 130 may include a pair of support parts 131 and a central part 132.

The pair of support parts 131 are for coupling to the body 110a of the bone union member 110 and may be inserted and coupled to the groove 111a of the body 110a. At this time, one end of the support 131 may include a bent portion 133 bent inward. Here, the bent portion 133 may be inserted and coupled to both sides of the groove portion 111c of the body 110a of the bone union member 110.

The central portion 132 connects between the pair of support portions 131, and may be inserted into the groove 111b of the body 110a of the bone union member 110.

Through this, the buffer member 130 is inserted into and coupled to the

grooves

111a, 111b, and 111c of the bone union member 110, respectively, the support portion 131 and the central portion 132, in this case can be inserted and coupled.

Here, a pair of guide grooves 134 on both sides of the central portion 132 such that the first screw 140a and the second screw 140b are coupled to the first and

second bones

11 and 12 at a predetermined angle. It may be provided. That is, since the first screw 140a and the second screw 140b are obliquely coupled to the first vertebrae 11 and the second vertebrae 12 as shown in FIG. 1, the rear side of the plate 120. It may interfere with the central portion 132 of the buffer member 130 disposed in the.

In order to solve this, a pair of guide grooves 134 may be formed in communication with the first accommodation hole 122a and the second accommodation hole 122b. In this case, the pair of guide grooves 134 may be disposed at positions symmetrical with each other on both sides of the central portion 132.

That is, the guide groove 134 corresponding to the first accommodation hole 122a is disposed at the upper side in the center portion 132, and the guide groove 134 corresponding to the second accommodation hole 122b is disposed at the lower side in the center portion 132. Can be placed in.

Here, the guide groove 134 may be provided at the same position as the fastening direction of the first screw 140a and the second screw 140b. That is, as shown in Figure 4, when the first screw 140a is coupled to the upper side of the bone union member 110, the guide groove 134 corresponding to the first receiving hole (122a) is the upper side in the center portion 132 When the second screw 140b is coupled to the lower side of the bone union member 110, the guide groove 134 corresponding to the second accommodation hole 122b may be disposed below the central portion 132.

However, the shape of the first accommodating hole 122a, the second accommodating hole 122b, and the pair of guide grooves 134 may be modified depending on the fastening direction or the fastening method of the first screw 140a and the second screw 140b. Of course it can be.

The guide groove 134 may be provided in an open form upward or downward from the central portion 132. For example, the guide groove 134 may be provided in a hemispherical shape.

Through this, the variable coupling angle of the first screw 140a and the second screw 140b coupled to the first vertebrae 11 and the second vertebrae 12 can be easily secured.

In addition, the buffer member 130 may be provided with a fastening groove 135 for coupling the plate 120 on both sides of the central portion (132). The fastening groove 135 may be provided in a shape corresponding to the fastening protrusion 127 of the plate 120.

For example, as shown in FIG. 5, the fastening groove 135 may be formed inward from one side of the support part 131 on both sides of the central part 132. Here, the lower end 135a of the fastening groove 135 may extend from the support part 131 so that the bottom surface of the fastening protrusion 127 of the plate 120 is supported.

As a result, the plate 120 is coupled to the front surface of the buffer member 130 and the bone union member 110 is coupled to the rear surface of the buffer member 130, so that the plate 120 and the bone union member 110 are spaced at a predetermined interval. Can be combined stably.

The bone substitute implant 200 in the second embodiment of the present invention, as shown in Figure 6 to 9, the bone union member 210, the first plate 220, the second plate 230 and the buffer member 240 ). Here, the first plate 220 and the second plate 230 corresponds to the implant body.

The bone replacement implant 200 adjusts the length with the second plate 230 through the thread 226 provided on the shaft 224 of the first plate 220, thereby, the first plate 220 and the second plate 230 may press and fix both side surfaces of the first and

second pole protrusions

21 and 22.

In this case, the bone union member 210 may be buried in the space between the first pole protrusion 21 and the second pole protrusion 22 to be in close contact with the opposite sides of the first pole protrusion 21 and the second pole protrusion 22. .

The bone union member 210 may include a body 211 made of a bioactive crystallized glass material. The body 211 may have a shape corresponding to the shape of each of the first and

second pole protrusions

21 and 22. In one example, the body 211 may be manufactured by CAD / CAM or 3D printing based on the medical image information of the patient.

Here, the body 211 is formed in a rectangular shape, as shown in Figure 9, the side of the body 211 is concave at a position corresponding to the contact surface of each of the first and

second pole projections

21 and 22. The unit 212 may be provided. That is, the concave portion 212 may be provided on the side surface of the body 211 such that side surfaces of the first and

second pole protrusions

21 and 22 which are opposed to each other may easily contact each other.

The concave portion 212 may be provided with a thread portion 212a having a thread structure. That is, the recess 212 may be provided with a plurality of grooves or protrusions continuously at predetermined intervals to form a thread structure.

As a result, the fusion with the bone can be further promoted by increasing the union area that is joined to the first and

second pole protrusions

21 and 22, and the first and

second pole protrusions

21 and 22 and the thread are formed. By the part 212a, the position of the body 211 can be more stably fixed between the bones.

In addition, the sides of the threaded portion 212a, the first pole protrusions 21, and the second pole protrusions 22 may further improve the fixing force of the body 211 by frictional coupling with each other.

In addition, as illustrated in FIG. 8, a through hole 213 into which the shaft 224 of the first plate 220 is inserted may be provided at the center portion of the body 211. A buffer member 240 may be inserted into the through hole 213 to space the first plate 220 and the second plate 230 from the bone union member 210.

The through hole 213 may lead to a shape corresponding to the shape of the buffer member 240 and may have a substantially circular shape. That is, the pair of shock absorbing members 240 may be inserted into the through holes 213 first, and then the shaft 224 of the first plate 220 may be inserted into the through holes 243 in the shock absorbing members 240.

As a result, the bone union member 210 may be coupled to the first plate 220 and the second plate 230 with the buffer member 240 interposed therebetween.

The first plate 220 includes a body 221 made of titanium (Ti), and is fixed to one side surfaces of the first and

second pole protrusions

21 and 22. Here, the body 221 may be made of a Ti-6Al-4V material.

The first plate 220 may be formed in a pair, as shown in FIG. That is, the first plate 220 may be adjusted differently from the second plate 230 according to the shape of the first pole protrusion 21 and the second pole protrusion 22.

In this case, each of the pair of first plates 220 may be integrally provided with a shaft 224 inserted into the through hole 213 of the bone union member 210. Here, the shaft 224 may be provided at the center side of the pair of first plates 220. That is, the pair of first plates 220 may be provided with a shaft 224 on the side facing each other.

In addition, since the first plate 220 is formed in a pair, the shapes may be different from each other depending on the part of the patient to be treated. For example, when the bone replacement implant 200 is inserted into the pelvic region, the first plate 220 disposed below is provided in a form suitable for the bonding surface of the pelvic bone, the first plate 220 disposed on the upper portion The spinous process may be provided in a form suitable for the bonding surface.

Here, the thread 226 may be provided at one end of the shaft 224 in the sun region. The thread 226 may have a sawtooth shape. In this case, as shown in FIG. 7, the thread 226 is engaged with the thread of the gap adjusting member 236 of the second plate 230 so as to linearly move, thereby causing the gap between the first plate 220 and the second plate 230. Can be adjusted.

Here, one end 225 of the shaft 224 may be formed in a pointed shape. That is, the shaft 224 may be formed in a pointed shape through the chamfer on one end of the opposite side of the body 221, as shown in FIG.

Through this, the operation of inserting the first plate 220 into the space between the first pole protrusion 21 and the second pole protrusion 22 may be easily performed.

In addition, as shown in FIGS. 6 and 7, the body 221 may include a receiving hole 223 for accommodating bone morphogenetic protein (BMP). The receiving hole 223 is formed through both sides of the body 221, thereby providing a passage through which the bone morphogenic protein (BMP) or the fluid can move.

Through this, it is possible to improve the fusion between the bone replacement implant 200 and the bone between the first spinous process 21 and the second spinous process 22.

In addition, the body 221 may be provided with a plurality of protrusions 222 on the surface in contact with the first and

second pole protrusions

21 and 22, that is, the inner surface provided with the shaft 224. Here, as shown in Figure 6, the first plate 220 may be provided with a plurality of protrusions 222 on the outer side from the inner side. That is, the protrusion 222 may be provided on the opposite side where the shaft 224 is provided in the body 221.

The protrusion 222 may have a sharp tip so as to be fixed to the first and

second pole protrusions

21 and 22. In this case, the shape of the protrusion 222 may be provided in different sizes depending on the portion fixed to the first pole protrusion 21 and the second pole protrusion 22.

Through this, it is possible to suppress or minimize the twist of the bone replacement implant 200 that can occur according to the movement of the patient to further improve the structural stability, thus extending the service life of the bone replacement implant 200. .

The second plate 230 includes a body 230a made of titanium (Ti) series, and is fixed to the other side surfaces of the first and

second pole protrusions

21 and 22. Here, the body 230a may be made of Ti-6Al-4V material.

The body 230a may be provided with a receiving hole 233 in which the second plate 230 is integrally formed, and the shaft 224 of the first plate 220 is inserted in the central portion thereof.

Here, the space portion 235 is formed in communication with the accommodation hole 233 on the upper side of the receiving hole 233, and the space adjusting member 236 is inserted in the space portion 235, as shown in FIG. Can be. In this case, the gap adjusting member 236 may be provided with a screw thread having a shape corresponding to the screw thread 226 provided on the shaft 224 of the first plate 220.

A locking screw 237 for fixing the gap adjusting member 236 is provided on the upper side of the gap adjusting member 236, and a fixing pin 239 and a fixing pin for fixing the locking screw on one side of the locking screw 237. Lock pin 238 for fixing the 239 may be provided.

Accordingly, after adjusting the length in the state in which the shaft 224 of the first plate 220 is inserted into the receiving hole 233 of the second plate 230, the gap adjusting member 236 of the shaft 224 By rotating the locking screw 237 to be fixed to the thread 226 at the corresponding position, the locking pin 238 may be inserted to fix the distance between the first plate 220 and the second plate 230. .

In addition, the body 230a may be provided with an extension guide 234 for guiding the receiving hole 233 to extend to the right side. The expansion guide 234 may protrude outward from the body 230a, that is, outward from the opposite side of the first plate 220.

Through this, it is possible to accommodate the momentum (momentum) in the shaft 224 of the first plate 220 is inserted into the receiving hole 233 to protrude out of the second plate 230 to further improve the mechanical stability Can be.

In addition, as shown in FIG. 8, the second plate 230 may include a receiving hole 232 for accommodating bone morphogenetic protein (BMP). The receiving hole 232 is formed through both sides of the body 230a, thereby providing a passage through which the bone morphogenic protein (BMP) or the fluid can move.

In addition, the body 230a may be provided with a plurality of protrusions 231 on a surface in contact with the first and

second pole protrusions

21 and 22, that is, on an inner side surface facing the first plate 220. . Here, as shown in Figure 8, the second plate 230 may be provided with a plurality of protrusions 231 on the outer side from the inner side. That is, the protrusion 231 may be provided at both sides of the receiving hole 233 in the body 2310a.

The protrusion 231 may be sharply formed with a tip so as to be fixed to the first pole protrusion 21 and the second pole protrusion 22. In this case, the shapes of the protrusions 231 may be provided in different sizes depending on the portions fixed to the first and

second pole protrusions

21 and 22.

Through this, it is possible to suppress or minimize the twist of the bone replacement implant 200 that can occur in accordance with the movement of the patient can further improve the structural stability, thus extending the service life of the bone replacement implant 200. .

As such, since the first plate 220 and the second plate 230 may be detachably coupled to each other, the bone replacement implant 200 may be removed without removing the ligaments of the first and

second pole protrusions

21 and 22. The procedure can be performed and the patient's recovery time can be shortened.

The buffer member 240 is made of polyether ether ketone (PEEK) material, and is disposed between the bone union member 210, the first plate 220, and the second plate 230, and the union member 210 and the first plate. 220 and the second plate 230 may be spaced apart. Here, the buffer member 240 may include a spacer 241 and the insertion portion 242.

The spacer 241 may be formed in a plate shape with a predetermined thickness so as to space between the first plate 220 or the second plate 230 and the bone union member 210. That is, the spacer 241 may be formed in a plate shape such that both side surfaces of the buffer member 240 are spaced apart from the first plate 220 and the second plate 230, as shown in FIG. 9.

At this time, the buffer member 240 is spaced apart between the first plate 220 and the second plate 230 and the bone union member 210 and at the same time the shaft 224 of the first plate 220 is inserted therein It may be made in a shape. Here, the outer diameter of the buffer member 240 may be smaller than the width of the bone union member 210, the inner diameter may be larger than the through hole 213 of the bone union member 210.

In addition, the buffer member 240 is to be spaced apart from the shaft 224 of the first plate 220 in the through hole 213 of the buffer member 240, as shown in FIG. That is, the buffer member 240 should be inserted into the through hole 213 of the bone union member 210. At this time, since the spacer 241 is larger than the inner diameter of the through hole 213 of the bone union member 210, the buffer member 240 is formed in a pair to be inserted into the through hole 213 of the bone union member 210. Can be. In this case, each of the pair of buffer members 240 may be inserted at both sides of the bone union member 210, as shown in FIG.

In addition, a through hole 243 may be provided at a central portion of the spacer 241. The through hole 243 may have a shape corresponding to the shape of the shaft 224 of the first plate 220. For example, the through hole 243 may have a square shape corresponding to the square shaft 224.

The insertion part 242 may extend from the spacer part 241 to form a sidewall of the through hole 243. Here, the insertion portion 242 may be configured in length according to the thickness of the bone union member 210. That is, the length of the insertion part 242 may be a length inserted into the through hole 213 of the bone union member 210. At this time, when the buffer member 240 is a pair having the same shape, the length of the insertion portion 242 may be the same, but may be configured differently from each other.

As a result, the buffer member 240 ensures a space between the first plate 220 and the second plate 230 in both sides and the through hole 213 of the bone union member 210 by external force. Can be damaged.

At this time, the body 221 of the pair of first plate 220 and the body 230a of the second plate 230 may be formed at the same inclination of approximately 45 degrees so that both sides do not interfere with each other when arranged in succession. have.

Such spinous process implant 200 may be used in successive spinous process. That is, the first and

second protrusions

21 and 22 may be disposed in succession between the second and second protrusions 22 and 3, respectively.

Through this, a plurality of spinous process implants 200 can be easily performed according to the extent and extent of damage to the spine.

On the other hand, the spinous process implant 200 according to the second embodiment of the present invention may be provided in a form different from one side and the other side according to the portion of the patient to be treated each of the first plate 220 and the second plate 230. have. That is, the spinous process implant 200 may change the body of one side of the integrated second plate 230 and the body of one side of the pair of first plates 220 into a wing shape to maximize the area in contact with the pelvic bone. have.

For example, the spinous process implant 200 may be bent on one side of both the first plate 220 and the second plate 230 in the form of "b" or inverted "b".

That is, one plate of the pair of first plates 220 is made of a body 221 as described above, the other plate is a "b" or inverse "b" shaped body (not shown) It may be made of.

The "b" shaped body (not shown) of one side of the first plate 220 configured as described above and the "b" shaped body (not shown) of one side of the second plate 230 may be disposed in contact with the pelvic bone and then screwed (not shown). It is fixed to the pelvic bone through the), it is possible to fix the other body 221 of the first plate 220 and the other body 230a of the second plate 230 to the joint surface with the spinous process (21, 22). .

Through this process, the spinous process implant 200 can be easily fixed to the spinous process adjacent to the pelvic bone and can be suitably used for spinal diseases of the pelvic area.

The bone substitute implant 300 in the third embodiment of the present invention, as shown in Figures 10 to 13, the bone union member (310,320), the length adjusting portion (330, 340, 350), the case (360,370) and the buffer member (380) Include. Here, the length adjusting unit (330, 340, 350) and the case (360,370) corresponds to the implant body.

The

bone union members

310 and 320 are for directly connecting the surfaces of the vertebral bodies with one surface thereof disconnected to interconnect the two

vertebral bodies

32 and 34 which are disconnected from each other. That is, the

bone union members

310 and 320 may be provided in two, and may be contacted with two

vertebral bodies

32 and 34 which are disconnected from each other by being spaced apart from each other by the length adjusting unit.

To this end, the bone union member (310,320) is located on the lower side of the upper bone union member 310 and the two vertebral body in which one surface is in contact with the surface of the vertebral body 32 located on the upper side of the two vertebral bodies (32, 34) disconnected from each other It may be composed of a lower bone union member 320 is in contact with the surface 34 and the surface of the vertebral body.

The

bone union members

310 and 320 may have a shape in which one surface contacting the vertebral body corresponds to the surface shape of the vertebral body. For example, one surface of the

bone union members

310 and 320 may be manufactured by CAD / CAM or 3D printing based on medical image information of the patient. Here, one surface of the

bone union members

310 and 320 in contact with the vertebral body may have a horizontal plane or may be inclined.

For example, the

union member

310, 320 may be composed of a body (312, 322) having a contact surface of the shape corresponding to one surface of the vertebral body and protrusions (314, 324) extending to a predetermined length on the opposite surface of the contact surface, protrusions (314, 324) The side may be fastened to the buffer member 380 to be described later.

Here, the bone union member (310, 320) of the upper bone union member 310 may be coupled to the power transmission member 350 of the length adjustment unit to be described later, the lower bone union member 320 is a movable member 340 of the length adjustment unit to be described later Can be combined.

In this case, the plurality of

protrusions

311 and 321 may protrude in one direction on the contact surface side. The

protrusions

311 and 321 may be formed in a predetermined pattern having a predetermined height from the surface of the contact surface.

In this way, it is possible to further promote the fusion between the

vertebral bodies

32 and 34 and the

bone union members

310 and 320 by increasing the union area that is joined to the respective

vertebral bodies

32 and 34, and the protrusions to be fused to the

vertebral bodies

32 and 34. It is possible to more stably fix the position of the bone union member (310,320) between the vertebral body (32,34) disconnected from each other through (311,321).

In addition, the

bone union member

310, 320 may be formed with at least one wedge portion 390 protruding to a predetermined length on the contact surface in contact with the vertebral body (32, 34). Such wedge 390 is when the bone replacement implant 300 according to the third embodiment of the present invention is disposed between the two

vertebral bodies

32, 34 to replace any one of the plurality of vertebral bodies that are continuously arranged The coupling force may be increased by being embedded in one surface of the

vertebral bodies

32 and 34 in contact with each other. In this way, the risk of separation of the respective

vertebral bodies

32 and 34 and the

bone union members

310 and 320 from each other through the wedge 390 is minimized, so that the bone replacement implant 300 according to the third embodiment of the present invention is different from each other. Two disconnected

vertebral bodies

32 and 34 can be supported more stably.

Here, the wedge 390 may be formed integrally with the body (312,322), but may be coupled in a manner that is inserted into the seating grooves (313,323) formed in a predetermined depth inward from the contact surface of the body (312,322). In addition, the wedge 390 may have a shape in which the cross-sectional area gradually decreases toward the outside from the contact surfaces of the

bodies

312 and 322 so as to increase the engagement and fastening with the

vertebral bodies

32 and 34. In one example, the wedge 390 may be conical. In addition, the wedge 390 may be made of the same material as the bone union member (310,320), but may be made of a polyether ether ketone (PEEK) material.

The length adjusting part is for varying the total length of the bone replacement implant 300 by adjusting the distance between the two union members (310,320). In this case, when the bone replacement implant 300 according to the third embodiment of the present invention connects two

vertebral bodies

32 and 34 which are disconnected from each other by replacing any one of the plurality of vertebral bodies which are continuously arranged with each other, the upper side and the lower side Each of the

vertebral bodies

32 and 34 and the upper bone union member 310 and the lower bone union member 320 positioned in the state can be disposed in close contact with each other to ensure stable support.

Such a length adjusting unit may be applied to all known methods as long as the distance between the two

union members

310 and 320 may be changed through a sliding method when the user operates.

For example, the length adjusting unit applied to the third embodiment of the present invention may be provided with a driving force through a known bevel gear system when the user operates, thereby adjusting the distance between the two

union members

310 and 320.

Specifically, the length adjusting part provides a driving force for moving the movable member 330 and the movable member 330 when the movable member 330 is rotated by the gear coupling with the work tool 30 when the user operates. The movable member 340 and the movable member 330 may include a power transmission member 350 for transmitting the driving force generated by the relative movement of the movable member 340 to the upper bone union member 310 side.

Movable member 330 may be provided in a hollow cylindrical shape having a predetermined length, a plurality of gear grooves along the circumferential direction at the upper end to be geared in a bevel gear method when contacting the work tool 30 331 may be formed. Here, the movable member 330 may serve as a driven gear by engaging with the drive gear formed in the work tool 30 through the gear groove 331 (see FIG. 10).

Accordingly, when the user rotates the work tool 30 in one direction, the movable member 330 may be rotated in a clockwise or counterclockwise direction by providing driving force through a gear coupling.

In addition, the movable member 330 may be formed with a first screw portion 332 in the longitudinal direction on the outer peripheral surface, the movable member 340 is a second screw portion 342 corresponding to the first screw portion 332 along the inner peripheral surface. ) May be formed. Accordingly, the movable member 330 may be screwed through a relative movement with the driven member 340 during rotation by the gear coupling.

Here, the movable member 340 may be provided in a hollow cylindrical shape having a predetermined length to accommodate the movable member 330 and the second screw portion 342 formed on the inner circumferential surface thereof, and the lower side of the lower union It may be fixed to the member 320.

Thus, when the movable member 330 is rotated while the movable member 340 is fixed, the movable member 330 is moved by the first screw portion 332 is screwed along the second screw portion 342. It may be raised or lowered along the longitudinal direction of 340.

On the other hand, the power transmission member 350 may have a predetermined length and the upper end may be fixed to the upper bone union member 310 and the lower end may be disposed to contact the upper side of the movable member 330. For example, the movable member 330 may be supported by the stepped portion 333 because the lower edge side of the power transmission member 350 is formed by the stepped portion 333 formed on the upper side where the gear groove 331 is formed.

Accordingly, the power transmission member 350 supported by the stepped portion 333 of the movable member 330 when the movable member 330 is rotated through the user's operation and the screw is moved through the relative movement with the driven member 340. ) May move upward or downward with the upper union member 310. As a result, the two

union members

310 and 320 may be spaced apart from each other or narrowed so that the total length of the bone replacement implant 300 may be adjusted (see FIGS. 12 and 13).

Here, an insertion groove 352 is formed at one side of the power transmission member 350 so that the end side of the work tool 30 can be inserted and supported, thereby allowing the user to operate the work tool 30. The work tool 30 can be smoothly rotated about the insertion groove 352 in a state where the gear groove 331 formed on the driving gear (not shown) and the movable member 330 are engaged with each other.

On the other hand, the bone replacement implant 300 according to the third embodiment of the present invention may include a pair of cases (360,370) coupled to the sliding movable is provided in the hollow upper and lower parts, a

pair Cases

360 and 370 may be fixed to any one of the upper union member 310 and the lower union member 320, respectively.

For example, the first case 360 of the pair of

cases

360 and 370 may have an upper side fixedly coupled to the upper bone union member 310, and the second case 370 may have a lower side bone union member 320. It may be combined with, and may be disposed so that the first case 360 is located inside the second case 370.

Accordingly, when the movable member 330 is screwed along the longitudinal direction of the driven member 340, the first case 360 is connected to the upper bone union member 310 by the driving force transmitted through the power transmission member 350. By moving the same with the second case 370 can be moved slidingly.

At this time, the pair of cases (360,370) is a bone replacement implant 300 according to the third embodiment of the present invention is placed between the two disconnected

vertebral body

32, 34 the vertebral body 32, 34) If the torsion occurs between the may be made in the shape of a polygonal cross-section so as to support the torsional load, it may be made of a metal material to prevent breakage by the load. For example, the pair of

cases

360 and 370 may have a hollow rectangular pipe shape in which upper and lower portions are open, and may be made of titanium (Ti).

In addition, the pair of

cases

360 and 370 may be arranged to surround the outside of the length adjusting part to accommodate the bone morphogenetic protein therein. Accordingly, the bone replacement implant 300 according to the third embodiment of the present invention may further promote the compatibility with the

vertebral bodies

32 and 34 through the bone morphogenetic proteins disposed inside the

cases

360 and 370.

Meanwhile, the pair of

cases

360 and 370 may have a plurality of through-

holes

362 and 372 formed therethrough, and the first case 360 is positioned in an overlapped position in a state in which the first case 360 is slid with respect to the second case 370. The first through hole 362 and the second through hole 372 may be formed to always communicate.

For example, the first through holes 362 and the second through holes 372 may be formed at positions corresponding to each other, and the first through holes 362 may be formed as long holes along the height direction of the first case 360. have. Accordingly, although the first case 360 is slidably moved so that the relative positions of the first through holes 362 and the second through holes 372 change, the first case 360 and the second case 370 overlap with each other. The formed second through hole 372 may always maintain a state in communication with the first through hole 362. As a result, the inside and outside of the first case 360 and the second case 370 remain connected to each other through the first through holes 362 and the second through holes 372 so that the movement of the body fluid existing in the living body is prevented. It can be made smoothly. Through this, problems such as bacterial propagation or necrosis, which may occur when body fluids are stagnated inside the

cases

360 and 370, may be prevented.

In addition, the pair of

cases

360 and 370 may have openings 363 and 373 having a predetermined area so that the end side of the work tool 30 can easily enter and be engaged with the gear groove 331 of the movable member 330. Each of the openings 373 formed in the second case 370 may prevent the middle of the length of the opening 363 formed in the first case 360 from being blocked when the first case 360 slides. One side may be open so as to be open.

On the other hand, the bone replacement implant 300 according to the third embodiment of the present invention is a cushioning member to prevent direct contact between the case 360,370 made of a metal material and the bone union member 310,320 made of a bioactive crystallized glass material 380 may be disposed. The buffer member 380 may be formed of a polyether ether ketone (PEEK) material, and may be coupled to the

protrusions

314 and 324 of the

bone union members

310 and 320 as described above.

That is, the shock absorbing member 380 may secure physical stability by serving as a spacer for separating the

brittle union members

310 and 320 and the

metal cases

360 and 370 that are highly brittle. If the

bone union members

310 and 320 are in direct contact with the

cases

360 and 370, the brittle

bone union members

310 and 320 may be damaged by the

cases

360 and 370 due to external force applied from the human body or the

vertebral bodies

32 and 34. Because.

Here, a stepped structure corresponding to each other is formed on the surface of the

protrusions

314 and 324 and the inner surface of the buffer member 380 to prevent the buffer member 380 from being easily separated from the

protrusions

314 and 324, and the buffer member 380. ) May be fixed through a separate fixing member such as a bolt member in a state in which it is arranged to surround the

protrusions

314 and 324, and both methods may be applied.

Meanwhile, the bone replacement implant 300 according to the third embodiment of the present invention has a locking screw 392 to prevent the movable member 330 from being rotated by an external force applied from the human body or the

vertebral bodies

32 and 34. Rotation of the movable member 330 can be constrained.

That is, the bone replacement implant 300 according to the third embodiment of the present invention is disposed so as to be located between the

vertebral bodies

32 and 34 disconnected from each other, and then each of the

bone union members

310 and 320 correspond to each other through a user's manipulation. 32 and 34, the locking screw 392 may be fastened to the length adjusting part in a state of being completely in contact with the surfaces of the 32 and 34 to restrain the rotation of the movable member 330.

To this end, the movable member 340 may have at least one fastening hole 344 formed therein, and the second passing hole 374 at a position corresponding to the fastening hole 344 on the side of the second case 370. ) May be penetrated. Here, the first case 360 is the second case 370 by forming the first through hole 364 of the long hole in the longitudinal direction at the position corresponding to the second through hole 374 on the side of the first case 360. Even when sliding relative to the first through hole 364 and the second through hole 374 to maintain the communication state.

Accordingly, in the state in which the overall length adjustment of the bone replacement implant 300 is completed through the user's operation, the user locks the screw 392 through the first through hole 364 and the second through hole 374. 344), the rotation of the movable member 330 may be constrained by pressing the side of the movable member 330 by the end side of the locking screw 392.

Here, the locking screw 392 is the middle of the length or the head 392a is located in the first through hole 364, the rotation is constrained by the first case 360, as a result of the movable member by the locking screw 392 Rotation of 330 may be constrained.

At this time, the fastening hole 344 may be a threaded portion formed on the inner surface so that the lock screw 392 can be screwed, the second through hole 374 is the head 392a of the lock screw 392 is the second It may be formed to have the same or relatively larger area than the head portion 392a of the lock screw 392 so as not to protrude out of the case 370.

Although one embodiment of the present invention has been described above, the spirit of the present invention is not limited to the embodiments set forth herein, and those skilled in the art who understand the spirit of the present invention, within the scope of the same idea, the addition of components Other embodiments may be easily proposed by changing, deleting, adding, and the like, but this will also fall within the spirit of the present invention.

Claims

A bone union member including a body made of a bioactive crystallized glass material and being in contact with the surface of an adjacent bone;

An implant body for fixing between adjacent bones; And

A buffer member disposed between the bone union member and the implant body to space the bone union member from the implant body;

Bone replacement implant comprising a.
The method of claim 1,

The implant body is made of titanium (Ti) series,

The buffer member is a bone substitute implant made of a polyetheretherketone (PEEK) material.
The method of claim 1,

The bioactive crystallized glass material is a bone substitute implant containing CaSiO 3 , apatite and Ca 2 Mg (Si 2 O 7 ) in a weight ratio of 1: 0.7 to 1.5: 0.5 to 1.2.
The method of claim 1,

The body is a bone substitute implant produced by CAD / CAM or 3D printing based on the medical image information of the patient.
The method of claim 1,

The bone union member is embedded in the space between the adjacent first and second bones,

The body has a shape corresponding to the surface shape of each of the first and second bones,

The implant body includes a plate fixed to the first vertebra and the second vertebra, and is coupled to the buffer member,

A bone replacement implant is provided on the side of the body for engaging the buffer member.
The method of claim 5,

The buffer member,

A pair of supports for coupling to the body of the bone union member; And

A central portion connecting the pair of supports,

The support portion bone replacement implant is inserted into the groove portion of the body of the bone union member.
The method of claim 1,

The implant body is fixed between the adjacent first and second pole projections,

The body is made of a square shape,

The side of the body is provided with a recess at a position corresponding to the contact surface of each of the first and second pole protrusions,

The implant body includes a first plate for fixing to one side of the first and second pole protrusions, and a second plate for fixing to the other side of the first and second pole protrusions,

A bone replacement implant having a through hole into which the shaft and the buffer member of the first plate are inserted in the central portion of the body.
The method of claim 7, wherein

The buffer member is composed of a pair, each of the pair of buffer members,

A plate-shaped separation part formed in a plate shape so as to be spaced apart from the first plate or the second plate and the bone union member, and having a through hole having a shape corresponding to a shaft of the first plate at a central part thereof; And

And an insertion portion extending from the spaced portion to form a sidewall of the through hole and inserted into the through hole of the bone union member so as to space the shaft and the bone union member.
The method of claim 1,

The implant body replaces any one of a plurality of vertebral bodies connected to each other,

The bone union member has a shape corresponding to the surface of the vertebral body and includes an upper and lower bone union member spaced apart from each other,

The implant body is disposed between the upper and lower bone union member and the bone replacement implant including a length adjusting unit for varying the overall length by adjusting the distance between the upper and lower bone union member through a sliding movement during the user's operation.
The method of claim 9,

The implant body is made of a hollow metal material of the upper and lower portions, the first case is the upper side is fixedly coupled to the upper bone union member; And

And a second case formed of a hollow metal material having an upper and a lower part open, the lower side of which is fixedly coupled to the lower bone union member and slidably coupled to the first case.

The buffer member is disposed between the opposite surface of the first case and the upper bone union member and between the opposite surface of the second case and the lower bone union member,

The bone replacement implant coupled to the side of the protrusion protruding in one direction from the body of the upper bone union member and the lower bone union member.