WO2013048000A2

WO2013048000A2 - Porous cage for intervertebral fusion, and method for manufacturing same

Info

Publication number: WO2013048000A2
Application number: PCT/KR2012/006304
Authority: WO
Inventors: 선두훈; 김정성; 김용화; 조유정; 이광훈; 이종서
Original assignee: 주식회사 코렌텍
Priority date: 2011-09-28
Filing date: 2012-08-08
Publication date: 2013-04-04
Also published as: KR101225006B1; WO2013048000A3

Abstract

The present invention relates to a cage to be inserted between adjacent vertebrae and to be used for vertebral fusion, and to a method for manufacturing same, and more particularly, to an intervertebral fusion porous cage and to a method for manufacturing same, wherein the cage includes: a nonporous insert; and a porous structure enclosing the exterior of the insert, wherein the insert includes a connecting portion connected to a surgical instrument used for manipulating the cage, and an extending portion projecting from the top surface of the connecting portion and extending a certain distance in the lengthwise direction of the cage, and the structure is formed so as to contact the top surface of the connecting portion and the outer surface of the extending portion, and is porous and the strength thereof is reinforced.

Description

Porous cage for intervertebral fusion and manufacturing method

The present invention relates to a cage inserted between adjacent vertebral bodies to be used for vertebral fusion and a method of manufacturing the same, and more particularly to a non-porous insert; It includes a porous structure surrounding the outer surface of the insert; The insert is connected to the surgical instrument used for the operation of the cage and an extension extending from the upper surface of the connecting portion extending in a longitudinal direction of the cage It comprises a part, the structure is formed in contact with the upper surface and the outer surface of the extension, the porous cage for intervertebral interbody fusion surgery having a porosity and at the same time reinforced strength and a method of manufacturing the same.

The vertebral body is composed of 32 to 35 vertebrae and intervertebral disks, or discs, that form the trunk, and form the props of the trunk, connecting the upper skull to the lower pelvis. It is a part. The vertebra is composed of seven cervical, 12 thoracic, five lumbar, five sacrum, and three to five coccyx from the stomach. The union is one sacrum, and three to five tailbones are fused to form one tailbone.

When a disc ruptures or weakens due to a disease or accident, pain occurs due to compression of the spinal nerve, in which case a cage is inserted, an artificial compensator that removes the damaged disc and repairs and maintains the spacing of the two vertebral bones between adjacent vertebral bones. Perform fusion between the vertebrae. In the fusion procedure, it is important to increase bone integration between the implanted cage and the vertebral bone. For this purpose, an empty space is designed to grow the bone and autograft to promote bone growth. Attempts have been made to promote bone fusion, such as filling allogeneic bone or synthetic bone in empty spaces. In recent years, the cage is made porous to allow bone ingrowth to occur in the macropore present in the cage when implanted in the body, thereby shortening the time required for fixing the cage and increasing the fixing force.

However, there is a problem that the cost is not very cost-effective when using a cage filled with autologous bone, etc., and when a porous cage is used, it is easy to integrate with surrounding bone tissue, but the strength to support the spinal bone is low, and the cage The conventional method of manufacturing to have a porosity has to use expensive equipment and the manufacturing process is long, the manufacturing cost increases, there is a problem that the toxic pore precursor or binder remains in the cage even after the production of the porous cage.

The present invention has been made to solve the above problems,

It is an object of the present invention to provide a porous cage for intervertebral fusion, which is inserted between adjacent vertebral bodies and used for vertebral fusion.

In addition, an object of the present invention is to provide a porous cage for intervertebral fusion and strengthening the strength by the combination of a porous structure and a non-porous insert and a method of manufacturing the same.

In addition, the present invention includes a recessed groove formed to be recessed to a predetermined depth along the outer surface, increasing the contact area with the extension of the structure to firmly couple the structure to the insert intervertebral fusion It is an object of the present invention to provide a porous cage and a method for manufacturing the same.

In addition, the present invention is harmless to the human body by using no pore precursors or binders at the time of manufacture, and can be produced in a short time at a low temperature using an energization sintering device to reduce the manufacturing cost of interbody fusion porous Its purpose is to provide a cage and a method of manufacturing the same.

The present invention is implemented by the embodiment having the following configuration to achieve the above object.

According to one embodiment of the invention, the porous cage for intervertebral fusion according to the invention non-porous inserts; And a porous structure surrounding the outer surface of the insert, wherein the insert is connected to a surgical instrument used for manipulating the cage and protrudes from an upper surface of the connection to extend a predetermined length in the lengthwise direction of the cage. It includes an extension, the structure is formed in contact with the upper surface of the connecting portion and the outer surface of the extension, characterized in that the structure is porous and at the same time reinforced by the insert strength.

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the extension part includes a recessed groove formed by being recessed to a certain depth along the outer surface, the contact with the extension of the structure Increasing the area is characterized in that the structure can be firmly bonded to the insert.

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the structure is characterized in that it has a porosity of 10 to 80%.

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the connection part is formed by being embedded in the lower surface, and includes a coupling groove into which a surgical instrument used for manipulation of the cage is inserted. It is characterized by.

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the length of the structure is characterized in that it has a length of 1 to 70% longer than the length of the extension,

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the length of the structure is characterized in that it has a length of 1 to 20% longer than the length of the extension.

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the structure is filled with the insert and the raw material into a mold, and filled with the mold using an energization sintering device and the outside of the insert. It is characterized by being manufactured by sintering the raw material at a predetermined temperature by applying a predetermined pressure to the raw material located at the same time while energizing the raw material.

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the pressure is 100 to 2000 kgf / cm 2, the temperature is 800 to 1400 ° C., and 500 to energize the raw material. It is characterized by applying a current of 2000A and a voltage of 3-7V.

According to another embodiment of the present invention, in the porous cage for intervertebral fusion according to the present invention, the raw material is metal powder or ceramic powder, and the metal is titanium, titanium alloy, cobalt chromium, cobalt chromium alloy, tantalum, tantalum Alloy, niobium, niobium alloy and titanium nitride, any one or more selected from the group consisting of, the ceramic is characterized in that any one or more selected from the group consisting of tricalcium phosphate, hydroxyapatite, zirconia and alumina.

The present invention can achieve the following effects by the configuration and combination, the use relationship described above in the present embodiment.

The present invention has an effect that can be inserted between adjacent vertebral bodies and used for vertebral fusion.

In addition, the present invention has the effect of having a porous and at the same time reinforced strength by the combination of the porous structure and the non-porous insert.

In addition, the present invention includes a recessed groove formed to be formed to a predetermined depth along the outer surface, there is an effect that can be firmly coupled to the insert by increasing the contact area with the extension of the structure. .

In addition, the present invention is harmless to the human body by using no pore precursor or a binder at the time of manufacture, it can be produced in a short time at a low temperature by using an energization sintering device has the effect of reducing the manufacturing cost.

1 is a perspective view of a porous cage for intervertebral fusion according to an embodiment of the present invention.

Figure 2 is a cross-sectional view of a porous cage for intervertebral fusion according to an embodiment of the present invention.

Figure 3 is a perspective view of the insert used in the porous cage for intervertebral fusion according to an embodiment of the present invention.

Figure 4 is a photograph of a porous cage for intervertebral fusion in accordance with an embodiment of the present invention.

Figure 5 is a SEM picture of the porous cage for intervertebral fusion according to an embodiment of the present invention.

Figure 6 is a schematic view of the energization sintering apparatus used in the method of manufacturing a porous cage for interbody fusion in accordance with an embodiment of the present invention.

Figure 7 is a flow chart showing a method of manufacturing a porous cage for intervertebral fusion according to an embodiment of the present invention.

* Explanation of symbols used in drawings

1: cage 11: insert 12: structure

111: connection part 112: extension part 111a: protrusion part

111b: engaging groove 112a: recessed groove

Hereinafter, a porous cage for intervertebral fusion according to the present invention and a manufacturing method thereof will be described in detail with reference to the accompanying drawings. All terms herein are the same as the general meanings of those terms understood by those of ordinary skill in the art to which the present invention pertains and definitions used herein if they conflict with the meanings of the terms used herein. Follow.

1 is a perspective view of a porous cage for intervertebral fusion according to an embodiment of the present invention, Figure 2 is a cross-sectional view of a porous cage for intervertebral fusion according to an embodiment of the present invention, Figure 3 is an embodiment of the present invention 4 is a perspective view of an insert used in a porous cage for intervertebral fusion according to an embodiment, FIG. 4 is a photograph of a porous cage for intervertebral fusion according to an embodiment of the present invention, and FIG. 5 is a vertebral body according to an embodiment of the present invention SEM picture of porous cage for liver fusion.

1 to 5, the porous cage 1 for intervertebral fusion according to an embodiment of the present invention is a non-porous insert 11; Porous structure 12 surrounding the outer surface of the insert 11; including, while having a porous by the structure 12, characterized in that the strength is reinforced by the insert (11).

The insert 11 is configured to reinforce the strength of the cage (1) and to combine with the surgical instrument for the operation of the cage (1), the outer surface is surrounded by a porous structure (12). Since the insert 11 is configured to reinforce the strength of the cage 1 by being located inside the porous structure 12, it has a non-porous, dense structure. The insert 11 is made of the same or similar material as the conventional nonporous implant, and has strength and porosity comparable to that of the conventional nonporous implant. The insert 11 preferably has a porosity of less than 1%. The insert 11 includes a configuration such as a connection portion 111, an extension portion 112, and the like.

The connecting portion 111 is connected to a surgical instrument used for the operation of the cage 1, and has a certain shape, but preferably has a rectangular shape. A pair of protrusions 111a protruding in parallel are formed at both ends of the lower surface of the connecting portion 111 to maintain the coupling between the cage 1 and the surgical instrument, and near the center of the lower surface of the connecting portion 111. A coupling groove 111b into which a portion of the surgical instrument is inserted is formed to facilitate coupling of the cage 1 and the surgical instrument.

The extension part 112 protrudes from an upper surface of the connection part 111 to extend a predetermined length in the longitudinal direction of the cage 1, and the porous structure 12 is coupled to the outside of the extension part 112. do. Since the structure 12 has a porosity, the strength of the structure 12 is relatively weak, and since the extension part 112 is positioned inside the structure 12, the strength of the cage 1 may be reinforced. The cage 1 has a certain shape, but preferably has a conical shape in which the diameter decreases toward the end. The extension part 112 includes a configuration such as the recessed groove 112a.

The recessed groove 112a is formed to be recessed to a predetermined depth along the outer surface of the extension part 112, and increases the coupling area of the structure 12 and the extension part 112 to the structure 12. To be firmly coupled to the extension 112. Referring to FIG. 3, the recess 112a has a V-shape and is formed over the entire outer surface of the extension 112. This is just an example, and various examples for achieving the purpose of the recess 112a are provided. It may be shaped and formed on a part of the outer surface.

The structure 12 has a structure surrounding the outer surface of the insert 11 and having a porosity, the outer surface of the structure 12 in contact with the spinal bone during the operation of the cage 1 is in the pores of the structure 12 Bone tissue will penetrate. The structure 12 preferably has a porosity of 10 to 80% to have a certain strength to facilitate the penetration of bone tissue therein. The structure 12 is in contact with the outer surface of the extension portion 112 and the upper surface of the connecting portion 111 so that the cage 1 has a strength and reinforced porosity, the length (h2, The distance from the upper surface of the connecting portion 111 to the upper surface of the structure 12 is defined as the length of the structure 12. The length h1 of the extension 112 is perpendicular to the upper surface of the connecting portion 111. The distance to the end of the extension 112 is preferably 1 to 70% longer than the length of the extension 112, and the length h2 of the structure 12 is the extension 112. More preferably, it is 1 to 20% longer than (h1).

1 to 2 are formed such that the structure 12 is not located on the outer surface of the connecting portion 111 and the structure 12 has a form of a rectangular parallelepiped as a whole, but this is only one example and the outside of the connecting portion 111 The structure 12 may be formed on the side surface, and the structure may have various shapes. The structure 12 is made of a metal or ceramic material, and the metal is titanium, titanium alloy, cobalt chromium, cobalt chromium alloy, tantalum, One or more metals selected from the group consisting of tantalum alloy, niobium, niobium alloy and titanium nitride may be used, and the ceramic may be tricalcium phosphate ( Any one or more ceramics selected from the group consisting of Tricalcium phosphate, Hydroxyapatite, Zirconia, and Alumina may be used.

In the present invention, the recess 112a is formed in the extension 112 to increase the coupling area of the structure 12 and the insert 11 so that the structure 12 can be firmly coupled to the insert 11. Since the extension portion 112 having a high strength is positioned inside the structure 12, the cage 1 has a feature of reinforcing strength while having porosity.

Figure 6 is a schematic diagram of the energizing and sintering apparatus used in the method of manufacturing a porous cage according to an embodiment of the present invention, Figure 7 is a flow chart showing a method of manufacturing a porous cage according to an embodiment of the present invention.

Hereinafter, referring to FIG. 6, first, the current sintering device 2 used to manufacture the cage 1 according to an embodiment of the present invention will be described, and then the cage 1 using the current sintering device 2. It will be described how to prepare.

The energizing and sintering device 2 is a device for applying a pressure to the raw material (3) made of the powder inserted therein and directly through electricity to sinter the raw material (3) at a predetermined temperature to make a product, the casing (21) , A mold 22, a punch 23, a pressurizing means 24, a power supply unit 25, a control unit (not shown), and the like.

The casing 21 forms an outer shape of the energizing and sintering device 2 and accommodates the mold 22 and the punch 23 therein, and the inside of the casing 21 is maintained in a vacuum state when manufacturing the product.

The mold 22 is configured to accommodate a raw material 3 such as metal powder or ceramic powder, which is a raw material of a product, and is inserted into the casing 21. The mold 22 includes a hollow 221 penetrating up and down, and the punch 23 is installed at the upper and lower ends of the hollow 221 so that the punch 23 can be moved up and down. The raw material (3) is located in the space (S) formed by the hollow 221 and the punch 23, the product is manufactured, by deforming the shape of the hollow 221 and punch 23 Products of various shapes can be produced. The mold 22 is formed of an electrically heat-resistant material such as graphite, tungsten oxide or tungsten.

The punch 23 is installed in the upper and lower ends of the hollow 221 of the mold 22 so as to be movable, respectively, the end of the punch 23 is coupled to the pressing means 24 to be described later. The punch 23 is formed of an electrically heat-resistant material such as graphite, tungsten oxide or tungsten.

The pressing means 24 is connected to the punch 23, and provides a driving force for allowing the punch 23 to move up and down in the hollow 221 of the mold 22.

The power supply unit 25 is configured to generate electricity so that electricity can flow to the raw material 3 in the mold 22, the power supply unit 25 is the pressing means 24, punch 23, the mold 22 Is electrically connected). When the power source unit 25 is operated to allow electricity to be supplied to the raw material 3 in the mold 22, heat is generated and the raw material 3 is sintered.

The control unit (not shown) is configured to control the overall operation of the energization and sintering apparatus 2, by operating the pressing means 24 to press the raw material 3 or to operate the power supply unit 24 to the raw material 3 It plays a role in making electricity flow.

1 to 7, a method of manufacturing a porous cage according to an embodiment of the present invention includes an insert preparation step (S1) of manufacturing an insert 11, which serves to reinforce the strength of the cage 1; A filling step (S2) of filling the insert 11 and the raw material 3 into a mold; It includes a sintering step (S3) for producing a structure 12 having a porosity and surrounds the outer surface of the insert (11).

The insert preparation step S1 is a step of manufacturing the insert 11 which serves to reinforce the strength of the cage 1, and prepares the insert 11 as shown in FIG. 3. Since the manufacturing method of the insert 11 is manufactured according to the conventional manufacturing method of the implant, detailed description thereof will be omitted.

In the filling step S2, the mold 22 and the punch 23 forming a space in which the raw material 3 and the insert 11 are inserted are prepared to have a specific shape, and the raw material 3 is formed in the mold 22. ) And insert 11, and the punch 23 is coupled to the upper and lower ends of the mold 22 so as to be movable.

The raw material 3 and the insert 11 are located in the space S formed by the mold 22 and the punch 23 to manufacture a product, thereby deforming the shape of the mold 22 and the punch 23. To fabricate various shapes 12 desired. As a raw material, metal powder and / or ceramic powder having a size of 10 to 2000 μm may be used, and the raw material may have a spherical or irregular shape. The metal powder is titanium, titanium alloy, cobalt chromium, cobalt chromium alloy, tantalum, tantalum alloy, niobium, Any one or more metal powder selected from the group consisting of niobium alloy and titanium nitride may be used. The ceramic powder may be any one or more ceramic powders selected from the group consisting of tricalcium phosphate, hydroxyapatite, zirconia, and alumina.

The sintering step (S3) is a step of manufacturing a structure 12 that pressurizes and energizes the raw material 3 positioned outside the insert 11 to sinter at a predetermined temperature to have porosity and surround the outer surface of the insert 11. . The sintering step S3 includes a mold inserting step S31, a vacuum forming step S32, a pressurizing and energizing step S33.

In the mold inserting step S31, in the filling step S2, the raw material 3 and the insert 11 are inserted into the mold 22 to which the punch 23 is coupled. ) And connecting the punch 23 to the pressing unit 24.

The vacuum composition step S32 is a step of making a vacuum atmosphere inside the casing 21 after the mold insertion step S31.

The pressurizing and energizing step S33 is a step of pressing and energizing the raw material 3 positioned outside the insert 11 in the mold 22 and sintering at a predetermined temperature, and controlled by the controller. The pressurizing and energizing step (S33) is generated by the control unit by operating the pressing unit 24 to push the punch 23 to press the raw material 3 in the mold 22 at the same time to generate electricity from the power supply unit 25 Electricity flows through the pressurizing portion 24, the punch 23, and the mold 22 to energize the raw material 3. In the pressurizing and energizing step S33, the raw material 3 is pressurized and at the same time electricity is flowed into the punch 23, the mold 22, and the raw material 3 to generate Joule heat, and thus the raw material 3 is locally dissolved. To be combined. That is, the porous structure 12 is bonded to the outside of the insert 11 and a plurality of pores are formed. In the pressurizing and energizing step (S33), it is preferable to apply a pressure of 100 to 2000kgf / cm 2, sinter at a temperature of 800 to 1400 ° C., and generate electricity of a current of 500 to 2000A and a voltage of 3 to 7V. .

Figure 4 is an example of a porous cage (1) manufactured by the method of manufacturing the porous cage, as shown in the SEM photograph of Figure 5, the outer surface of the porous cage (1) shown in Figure 4, a number of pores It can be seen that it is formed. The porous cage 1 may have various shapes by changing the shape of the mold 22 and the punch 23, as well as the pores by adjusting the particle size of the raw material, the pressure applied in the sintering step in the manufacturing method The size and porosity of the can be easily adjusted.

In the above, the Applicant has described various embodiments of the present invention, but these embodiments are merely one embodiment for implementing the technical idea of the present invention, and any changes or modifications may be made to the present invention as long as the technical idea of the present invention is implemented. It should be interpreted as falling within the scope of.

Claims

In a cage inserted between adjacent vertebral bodies and used for vertebral fusion,

The cage includes a nonporous insert; Includes; porous structure surrounding the outer surface of the insert;

The insert includes a connecting portion connected to a surgical instrument used for the operation of the cage, and an extension portion protruding from the upper surface of the connecting portion to extend a predetermined length in the longitudinal direction of the cage,

The structure is formed in contact with the upper surface and the outer surface of the extension, the porous cage for intervertebral fusion, characterized in that the porous structure by the structure and the strength is reinforced by the insert.
The method of claim 1, wherein the extension portion

For intervertebral fusion surgery, including a recessed groove formed to be formed to a predetermined depth along the outer surface, by increasing the contact area with the extension of the structure can be firmly coupled to the insert Porous cage.
The method of claim 1, wherein the structure

Porous cage for intervertebral fusion, characterized in that having a porosity of 10 to 80%.
The method of claim 1, wherein the connection portion

It is formed in the lower surface, the porous cage for intervertebral fusion, characterized in that it comprises a coupling groove into which the surgical instrument used for the operation of the cage is inserted.
The method of claim 1,

The length of the structure is a porous cage for intervertebral fusion, characterized in that 1 to 70% longer than the length of the extension.
The method of claim 1,

The length of the structure is a porous cage for intervertebral fusion, characterized in that 1 to 20% longer than the length of the extension.
The method of claim 1, wherein the structure

The insert and the raw material is filled into the mold, and the filling is applied to the mold by using an energization and sintering device is applied by applying a constant pressure to the raw material located outside the insert and at the same time by energizing the raw material is produced by sintering the raw material at a predetermined temperature Porous cage for intervertebral fusion surgery, characterized in that.
The method of claim 7, wherein

The pressure is 100-2000 kgf / cm 2,

The temperature is 800 to 1400 ℃,

Porous cage for intervertebral fusion, characterized in that to apply a current of 500 to 2000A and a voltage of 3 to 7V to energize the raw material.
The method of claim 7, wherein the raw material

Metal powder or ceramic powder,

The metal is any one or more selected from the group consisting of titanium, titanium alloys, cobalt chromium, cobalt chromium alloys, tantalum, tantalum alloys, niobium, niobium alloys and titanium nitride,

The ceramic is a porous cage for intervertebral fusion, characterized in that any one or more selected from the group consisting of tricalcium phosphate, hydroxyapatite, zirconia and alumina.