KR20160016372A - Spinal implant cage and manufacturing method thereof - Google Patents

Spinal implant cage and manufacturing method thereof Download PDF

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Publication number
KR20160016372A
KR20160016372A KR1020140100397A KR20140100397A KR20160016372A KR 20160016372 A KR20160016372 A KR 20160016372A KR 1020140100397 A KR1020140100397 A KR 1020140100397A KR 20140100397 A KR20140100397 A KR 20140100397A KR 20160016372 A KR20160016372 A KR 20160016372A
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KR
South Korea
Prior art keywords
cage
spinal implant
powder
biodegradable
inorganic
Prior art date
Application number
KR1020140100397A
Other languages
Korean (ko)
Inventor
이민수
이호준
Original Assignee
㈜ 이트리온
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Publication date
Application filed by ㈜ 이트리온 filed Critical ㈜ 이트리온
Priority to KR1020140100397A priority Critical patent/KR20160016372A/en
Publication of KR20160016372A publication Critical patent/KR20160016372A/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645—Connective tissue
    • A61L27/3654—Cartilage, e.g. meniscus
    • A61L27/3658—Intervertebral discs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body

Abstract

The present invention provides a cage for a spinal implant to be inserted into a place where a damaged disc is removed. Here, the cage for vertebral implant is made of a biodegradable organic polymer containing biodegradable inorganic powder or biocompatible inorganic powder. Alternatively, the cage for spinal implant may be formed of a laminate in which a first layer made of a biodegradable organic polymer and a second layer made of a biodegradable or biocompatible inorganic material are alternately stacked.

Description

TECHNICAL FIELD [0001] The present invention relates to a cage for a spinal implant and a method for manufacturing the same,

The present invention relates to a cage for a spinal implant used in a spinal fusion and a method of manufacturing the same.

The human spine includes several vertebrae that form the trunk and intervertebral discs that lie between each vertebrae. These vertebrae can cause various diseases. If there is insufficient damage to the intervertebral disc, medication is performed, but severe spinal fusion is performed.

Vertebral fusion is a procedure that removes the damaged discs and then fills the bones (the bones of the patient's own bone or other bones or artificial bone fragments) into the vertebrae of the upper and lower vertebrae. There are two main methods of performing the spinal fusion. Firstly, the bone material is filled in the place where the disc is removed, and then the upper and lower vertebrae are fixed with the metal plate and screw. The second is the cage cage) in the place where the disc was removed.

The cage for vertebral implant is prepared in various shapes according to the position of the procedure, but most of the cages have hollows for containing bone materials. In addition, the cage for the spinal implant has irregularities on the upper and lower surfaces so as not to be separated from between the upper and lower vertebrae. The cage for a spinal implant further includes a fastening hole for fastening the setting tools and a plurality of inflow holes for introducing the bone producing material into the hollow.

Metals such as titanium or titanium alloys are known as materials for such spinal implant cages. However, titanium or titanium alloy remains in the body after the procedure and has greater stiffness than the vertebrae. And, due to the habit or age of the recipient, the cervical vertebrae of the cage are deformed over a long period of time, and the cervical vertebrae are slightly broken by the cage. Therefore, cages for metal spinal implant implants are not good for athletes from a long-term perspective.

Biodegradable organic polymers (PLLA, PLGA, PGA, PCL, etc.) are also known as cage materials for vertebral implants. Since the biodegradable organic polymer is decomposed in the body after a predetermined time, it does not cause the problem of the metal-made cage for spinal implant. However, once the cage is disassembled, the site becomes empty and the bone-forming material contained in the hollow of the cage must withstand the load. If this situation persists for a long time, it may cause problems due to lack of strength of the bone-producing material.

Korean Patent No. 10-0464829 (spinal fusion cage)

As described above, the cage for metal spinal implant implies a problem of damaging the upper and lower vertebrae although it has excellent strength. On the other hand, a biodegradable organic polymer material cage for a spinal implant does not damage the upper and lower vertebrae but causes a lack of strength.

Accordingly, the present invention provides a cage for a spinal implant capable of solving both a vertebral body injury problem and a lack of strength. The present invention also provides a method for manufacturing the above-described spinal implant cage.

The present invention provides a cage for a spinal implant to be inserted into a place where a damaged disc is removed. Here, the cage for vertebral implant is made of a biodegradable organic polymer containing biodegradable inorganic powder or biocompatible inorganic powder. Alternatively, the cage for spinal implant may be formed of a laminate in which a first layer made of a biodegradable organic polymer and a second layer made of a biodegradable or biocompatible inorganic material are alternately stacked.

(A) mixing a biodegradable organic polymer powder with a biodegradable inorganic powder, or mixing the biodegradable organic polymer powder and a biocompatible inorganic powder to prepare a mixed powder; (B) applying heat to the mixed powder at a forming temperature of the biodegradable organic polymer powder to form a powder-containing paste; And (C) preparing a cage for a spinal implant with the powder-containing paste.

In the step (A), heat may be applied to the biodegradable organic polymer powder to form a paste. In this case, in the step (B), a biodegradable inorganic powder or a biocompatible inorganic powder is mixed with the paste to form a powder-containing paste.

The step (C) includes the steps of: (C-1) injecting the powder-containing paste into a mold to prepare a workpiece; And (C-2) cutting the to-be-cut body to form the cage for the spinal implant. Alternatively, in the step (C), the powder-containing paste may be injection-molded to directly form the cage for spinal implant.

The present invention provides a laminate comprising (A) an organic plate laminated alternately and bonded together, and an inorganic plate, wherein the organic plate is made of a biodegradable organic polymer and the inorganic plate is made of a biodegradable or biocompatible inorganic material ; And (B) cutting the laminate to form a cage for the spinal implant.

At this time, in the step (A), the organic substance plate and the inorganic substance plate previously prepared are alternately laminated and then heat and pressure are applied to make the laminate, or the previously prepared inorganic plate is laminated, and the organic substance plate The biodegradable organic polymer paste is applied and cured alternately, and then heat and pressure are applied to produce the laminate.

According to the present invention, firstly, the strength of the connecting portion between the upper and lower vertebrae is improved compared with the case of using a conventional cage for vertebral implant having biodegradable organic polymer material, and second, the upper and lower vertebrae are scratched by the cage And the third effect is that the cage for the spinal implant is easily manufactured and the bone-producing material is unnecessary.

According to the present invention, since the cage for spinal implant includes a biodegradable organic polymer that complements the large brittleness of the biodegradable inorganic material or the biocompatible inorganic material, the overall brittleness of the cage for spinal implant becomes low.

Further, according to the present invention, a cage for a spinal implant having the above-described effects can be easily manufactured.

Fig. 1 shows a cage for a spinal implant. Fig.
2 is a photograph showing various forms of a cage for a spinal implant.
3 is a perspective view showing an example of a cage for a spinal implant according to the present invention.
4 is a cross-sectional view taken along line A-A 'in Fig.

Hereinafter, preferred embodiments of a cage for a spinal implant according to the present invention and a method of manufacturing the same will be described in detail with reference to the drawings. It is to be understood that the terminology or words used herein are not to be construed in a limiting sense and that the inventor may properly define the concept of a term to describe its invention in the best possible way And should be construed in accordance with the meaning and concept consistent with the technical idea of the present invention.

The human vertebrae include intervertebral discs 12 positioned between vertebrae 10 and vertebrae 10 as shown in Fig. When severe damage to the vertebral disc 12 occurs, the damaged disc 12 is removed, and then the bone-producing material (the bone marrow of the subject's own bone or other person's bone or the artificial bone fragment) (10) is performed as a vertebral bone.

Spinal fusion can be performed in a variety of ways, one of which is insertion of a cage 30 for a spinal implant at the site from which the intervertebral disc 12 has been removed. The cage 30 for the spinal implant has a cavity in which the bone producing material 20, which connects the upper and lower vertebrae 10 together to form a single bone, is filled. The spinal implant cage 30 is provided in various forms as shown in FIG.

The present invention relates to a cage for a spinal implant as described above, and is characterized by its material. Therefore, the form of the spinal implant cage according to the present invention is not specifically limited. Hereinafter, a cage for a spinal implant according to the present invention will be described with reference to FIG. 3 and FIG. 4, but will be divided into two embodiments.

≪ Embodiment 1 >

The cage 100 for vertebra implant according to the first embodiment of the present invention may be made of a biodegradable organic polymer 120 in which a biodegradable inorganic powder 110 is embedded as shown in FIG. The biodegradable organic polymer 120 in which the biocompatible inorganic powder 110 is embedded is made of a material.

As the biodegradable inorganic material, TCP (tricalcium phosphate) may be used, and as the biocompatible inorganic material, hydroxyapatite (HA) may be used. Examples of the biodegradable organic polymer include polylactic acid (PLA), polylactic acid (PLLA), polylactic acid (PLDLA), poly (glycolide) glycolic acid), PLGA (poly (lactic-co-glycolic acid)), PLC (poly (camprolactone)) or a mixture of two or more thereof.

Unlike the case where the biodegradable organic polymer 120 is decomposed in the human body after a predetermined time, the biodegradable inorganic material and the biocompatible inorganic material are ossified after a predetermined time in the human body. Therefore, when the spinal implant cage 100 includes the biodegradable inorganic powder 110 or the biocompatible inorganic powder 110 as in the present embodiment, the cage 100 for the spinal implant gradually develops ossification So that it is integrated with the bone-producing material 20 and the upper and lower vertebrae 10.

Conventional vertebral implant cages having only the biodegradable organic polymer material 120 are completely disintegrated in the human body after a predetermined period of time. Therefore, when a conventional cage for spinal implant is used, only the bone-producing material 20 remains in between the upper and lower vertebrae 10 to bear the load. However, in this embodiment, both the bone-producing material 20 and the ossified cage 100 for the spinal implant between the inferior and inferior vertebrae 10 bear the residual load. Therefore, according to the present embodiment, the strength of the connecting portion between the upper and lower vertebrae 10 is improved as compared with the prior art.

According to the present embodiment, since the cage 100 for a spinal implant is integrated with the bone biomaterial 20 and the upper and lower vertebrae 10, the problem of a conventional spinal implant cage made of a metal material, The problem that the vertebra 10 is scratched and damaged by the cage does not occur.

In addition, according to the present embodiment, the manufacture of the cage 100 for a spinal implant becomes easy, and the effect that the bone-producing material 20 becomes unnecessary occurs. That is, according to the present embodiment, since the spinal implant cage 100 itself is ossified, it is not necessary to form the hollow 130 for holding the bone-producing material 20 in the spinal implant cage.

The advantage of this embodiment is that the biodegradable inorganic material or the biocompatible inorganic material is used as the material of the cage 100 for the spinal implant. However, biodegradable minerals and biocompatible minerals are brittle and easily break even with weak external forces. Therefore, a cage for a spinal implant having only a biodegradable inorganic or biocompatible inorganic material is not only difficult to be processed, but also has a high possibility of being broken during or after the procedure. Therefore, in this embodiment, a biodegradable organic polymer is adopted as a material in order to compensate for a large brittleness of the biodegradable inorganic material or the biocompatible inorganic material.

The cage 100 for a spinal implant according to the present embodiment as described above can be manufactured through the following first to third steps.

In the first step, the biodegradable organic polymer powder and the biodegradable inorganic powder 110 are physically mixed to form a mixed powder, or the biodegradable organic polymer powder and the biocompatible inorganic powder 110 are physically mixed to produce a mixed powder .

In the second step, heat is applied to the mixed powder, and the heat at this time has a forming temperature of the biodegradable organic polymer powder. When the second step is performed, the biodegradable inorganic powder 110 or the biocompatible inorganic powder 110 is embedded in the paste-like biodegradable organic polymer, that is, the powder-containing paste is produced.

In the third step, the cage 100 for spinal implant is made of the powder-containing paste. In this third step, injection molding can be used. In this case, the powder-containing paste is injected into the injection mold to directly produce the cage 100 for the spinal implant. Alternatively, injection molding and cutting may be used in the third step. In this case, a powder-containing paste is injected into the injection mold to form a cutter of a predetermined shape, and then the cutter is cut to form a cage 100 for a spinal implant.

Meanwhile, in the first step, the biodegradable organic polymer powder may be subjected to heat at a molding temperature to form a paste. In this case, in the second step, the biodegradable inorganic powder 110 or the biocompatible inorganic powder 110 is mixed with the paste in the atmosphere of the molding temperature to form the powder-containing paste.

≪ Embodiment 2 >

4 (b), the cage 100 for a spinal implant according to the second embodiment of the present invention includes a first layer 210 made of a biodegradable organic polymer and a biodegradable or biocompatible inorganic material And a second layer (220) made of a material are alternately laminated. In this case, as in the first embodiment, the cage 100 for the spinal implant becomes osseous over time and becomes integral with the bone-producing material 20 and the upper and lower vertebrae 10.

Therefore, the effects of the first embodiment, that is, the strength of the connecting portion between the upper and lower vertebrae 10 is improved compared with the conventional one, and the problem that the upper and lower vertebrae 10 are scratched and damaged by the cage The cage 100 for a spinal implant is easily manufactured, and the bone-producing material 20 is unnecessary. On the other hand, the provision of the first layer 210 between the second layers 220 is intended to compensate for the large brittleness of the second layer 220 made of biodegradable inorganic or biocompatible inorganic materials.

The cage 100 for a spinal implant according to the present embodiment can be manufactured through the following first and second steps.

In the first step, a laminate composed of an organic plate and an inorganic plate alternately stacked and bonded together is made. Here, the organic plate is a plate made of a biodegradable organic polymer and constitutes a first layer 210 of a cage for a spinal implant. The inorganic plate is a plate made of a biodegradable inorganic material or a biocompatible inorganic material and constitutes the second layer 220 of the cage for spinal implant.

The laminate may be prepared by alternately laminating an organic plate and an inorganic plate previously prepared, and then applying a predetermined pressure and heat having a forming temperature of the organic plate. The inorganic plate is prepared by applying heat and pressure to a biodegradable or biocompatible inorganic powder. At this time, an inorganic plate is manufactured such that a gap is formed between the inorganic powder particles (the volume occupied by the gap is the size of the inorganic powder particles, The temperature and pressure of the heat applied to the powder are appropriately selected and adjusted). Thus, during the application of the heat and the pressure, a part of the organic plate is impregnated into the gaps of the inorganic plate, whereby the organic plate and the inorganic plate are bonded to each other.

Alternatively, the laminate may be manufactured by alternately performing a process of laminating a previously prepared inorganic plate and a process of applying and curing the biodegradable organic polymer paste constituting the organic plate, followed by applying heat and pressure thereto.

Meanwhile, in the second step, the laminate is cut to form a cage 100 for a spinal implant.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. It is to be understood that various changes and modifications may be made without departing from the scope of the appended claims.

10: vertebrae 12: disc
20: bone-producing material 100: cage for spinal implant
110: Biodegradable or biocompatible inorganic powder
120: biodegradable organic polymer 130: hollow
210: first layer 220: second layer

Claims (9)

A cage for a spinal implant to be inserted in a place where a damaged intervertebral disc is removed,
A biodegradable organic polymer containing biodegradable inorganic powder or biocompatible inorganic powder is used as a material for a spinal implant cage. A cage for a spinal implant to be inserted in a place where a damaged intervertebral disc is removed,
A cage for a spinal implant comprising a laminate in which a first layer made of a biodegradable organic polymer and a second layer made of a biodegradable or biocompatible inorganic material are alternately laminated. A manufacturing method for manufacturing a cage for a spinal implant to be inserted in a place where a damaged intervertebral disc is removed,
(A) mixing a biodegradable organic polymer powder and a biodegradable inorganic powder or mixing the biodegradable organic polymer powder and a biocompatible inorganic powder to prepare a mixed powder;
(B) applying heat to the mixed powder at a forming temperature of the biodegradable organic polymer powder to form a powder-containing paste; And
(C) making a cage for a spinal implant with the powder-containing paste. A manufacturing method for manufacturing a cage for a spinal implant to be inserted in a place where a damaged intervertebral disc is removed,
(A) preparing a paste by applying heat to a biodegradable organic polymer powder;
(B) mixing a biodegradable inorganic powder or a biocompatible inorganic powder with the paste to form a powder-containing paste;
(C) making a cage for a spinal implant with the powder-containing paste. The method according to claim 3 or 4,
The step (C)
(C-1) preparing a workpiece by injecting the powder-containing paste into a mold; And
(C-2) cutting the to-be-cut body to form the cage for the spinal implant. The method according to claim 3 or 4,
Wherein the step (C) comprises injection molding the powder-containing paste to form the cage for the spinal implant. A manufacturing method for manufacturing a cage for a spinal implant to be inserted in a place where a damaged intervertebral disc is removed,
(A) are alternately stacked and bonded together to form a laminate composed of an organic plate and an inorganic plate, wherein the organic plate is made of a biodegradable organic polymer and the inorganic plate is made of a biodegradable or biocompatible inorganic material; And
(B) cutting the laminate to form a cage for the spinal implant. 8. The method of claim 7,
In the step (A), the laminate is prepared by alternately laminating the organic and inorganic plates previously prepared and applying heat and pressure to the laminate. 8. The method of claim 7,
In the step (A), the process of laminating the inorganic plate previously prepared and the process of applying and curing the biodegradable organic polymer paste constituting the organic plate are alternately performed, and then heat and pressure are applied to form the laminate, For manufacturing a cage.
KR1020140100397A 2014-08-05 2014-08-05 Spinal implant cage and manufacturing method thereof KR20160016372A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110025409A (en) * 2019-04-17 2019-07-19 东南大学 A kind of elastic Invasive lumbar fusion device and preparation method thereof of magnesium powder function enhancing high molecular material porous structure

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110025409A (en) * 2019-04-17 2019-07-19 东南大学 A kind of elastic Invasive lumbar fusion device and preparation method thereof of magnesium powder function enhancing high molecular material porous structure

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