KR101538620B1 - Biodegradable Intervertebral Fusion Cage - Google Patents

Biodegradable Intervertebral Fusion Cage Download PDF

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Publication number
KR101538620B1
KR101538620B1 KR1020150045352A KR20150045352A KR101538620B1 KR 101538620 B1 KR101538620 B1 KR 101538620B1 KR 1020150045352 A KR1020150045352 A KR 1020150045352A KR 20150045352 A KR20150045352 A KR 20150045352A KR 101538620 B1 KR101538620 B1 KR 101538620B1
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KR
South Korea
Prior art keywords
biodegradable
mold part
metal
mold
biodegradable polymer
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Application number
KR1020150045352A
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Korean (ko)
Inventor
이재춘
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(주) 웹스
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Priority to KR1020150045352A priority Critical patent/KR101538620B1/en
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Publication of KR101538620B1 publication Critical patent/KR101538620B1/en
Priority to PCT/KR2016/000037 priority patent/WO2016159493A1/en

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    • 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
    • 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

Abstract

More particularly, the present invention relates to a biodegradable chondroitin sheath component comprising a bioabsorbable metal reinforcement inside a biodegradable polymer.
According to the present invention, there is provided a biodegradable chondroitin fusion splinting material inserted between two vertebrae, wherein the biodegradable chondroitin fusion splinting material comprises: a mold part having a hollow part at the center of the body; A support part inserted into the mold part and supporting the mold part; Wherein the mold part is made of a biodegradable polymer, and the support part is made of at least one of a metal and a metal alloy.

Description

Biodegradable Intervertebral Fusion Cage (Biodegradable Intervertebral Fusion Cage)

More particularly, the present invention relates to a biodegradable chondroitin sheath component comprising a bioabsorbable metal reinforcement inside a biodegradable polymer.

In general, the chi-squared fixed implant is an artificially created spine disc. When the discs constituting the spine of the human body are not functioning, they are removed and inserted or fixed between the vertebrae Replace the function of the disc.

The representative materials of the implant and the implant used for medical treatment are the metal materials with excellent mechanical properties and processability. However, despite the excellent properties of the metal, it has some problems. Such problems include stress shielding, image degradation, and implant migration.

In order to overcome the disadvantages of metallic fixed implants and implants, research and development of biodegradable fixed implants and implants have been proposed. Medical applications of these biodegradable materials have been studied since the mid-1960s mainly on polymers such as polylactic acid (PLA), polyglycolic acid (PGA), and copolymers thereof.

However, the biodegradable polymers have been limited in their applications due to their low mechanical strength, acid generation at the time of decomposition, difficulty in controlling the rate of biodegradation, and the like. Especially, due to the polymer properties having low mechanical strength, It was difficult to apply it to dental implants.

In order to overcome the disadvantages of the biodegradable polymer, a ceramic such as tri-calcium phosphate (TCP) or a biodegradable polymer or a composite material of hydroxyapatite (HA) However, the mechanical properties of these materials are not significantly different from those of the biodegradable polymers, and the weak impact resistance of the ceramic materials is a fatal disadvantage of biomaterials.

Korean Patent No. 10-1202839 (November 13, 2012)

SUMMARY OF THE INVENTION The present invention has been conceived to solve the above problems, and it is an object of the present invention to provide a new type biodegradable interbody fusion splinting material in which a bioabsorbable metal and a biodegradable polymer are combined.

In addition, biodegradation which can compensate for problems such as stress shielding phenomenon of metal, which is a material used mainly for the cholestyramine boehmite, bubble generation and rapid decomposition rate due to hydrogen evolution of bioabsorbable metal, and degradation of mechanical strength of biodegradable polymer The purpose of this study is to provide a simple and easy to assemble beam.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as set forth in the accompanying drawings. It will be possible.

According to the present invention, there is provided a biodegradable chondroitin fusion splinting material inserted between two vertebrae, wherein the biodegradable chondroitin fusion splinting material comprises: a mold part having a hollow part at the center of the body; A support part inserted into the mold part and supporting the mold part; Wherein the mold part is made of a biodegradable polymer, and the support part is made of at least one of a bioabsorbable metal and a bioabsorbable metal alloy.

According to the solution of the above-mentioned problems, the biodegradable chaotic splinting complementary material of the present invention is improved in mechanical strength and impact resistance by providing a splinted splinted bevelling material combining a bioabsorbable metal and a biodegradable polymer, It is possible to provide a biodegradable interbody fusion splinting material having a lower decomposition rate than the shape and implant.

In addition, the biodegradable chaotic splinting complementary material of the present invention can provide a biodegradable splinting splinting material that can be applied not only to orthopedic surgeons but also to dentistry, plastic surgery, and the like.

In addition, the biodegradable chaotic splinting complementary material of the present invention has the effect of enabling observation of radiation transmission (X-ray, etc.) by inserting a bioabsorbable metal into the biodegradable polymer.

In addition, the biodegradable chondroitin fusion splint material of the present invention has an effect of minimizing the decrease of pH change in the body by the generation of hydrogen generated in the bioabsorbable metal decomposition process and neutralization of the acid generated from the biodegradable polymer.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view showing a bioabsorbable interbody bone material according to an embodiment of the present invention; FIG.
FIG. 2 is a view showing a biodegradable chi-2 fusion joint according to another embodiment of the present invention.
FIG. 3 is a view showing a biodegradable interbody fusion splinter according to another embodiment of the present invention. FIG.
Fig. 4 is a view showing an application example of the biodegradable hysteroscopic collagenous prosthesis of the present invention.

The above and other objects, features and advantages of the present invention will be more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which: FIG. BRIEF DESCRIPTION OF THE DRAWINGS The advantages and features of the present invention and the manner of achieving them will become apparent by reference to an embodiment which will be described in detail below with reference to the accompanying drawings.

Spinal cage (interverbral body fusion device), which is used for the surgical treatment of spine disease, is used in the spine of patients with damaged discs to improve the mobility of the spine, Of the spinal surgery.

Removal of the degenerative disc causing pain, securing the supply space of the bones for union, reducing the pain by increasing the height of the chest, maintaining the stability of the spine through the fusion, restoring the lordosis of the spine It is also said.

It is mainly used for the treatment of spinal stenosis, which is a degenerative spinal disease caused by degeneration of lumbar and cervical discs. In addition, it is used for the treatment of diseases such as disc herniation and posterior joint hypertrophy.

In general, the conventional trapezoidal shape member is mainly composed of a metal, a bioabsorbable metal, or a biodegradable polymer.

However, each of the metal boom members, the bioabsorbable metal boom members, and the biodegradable polymeric boots have the problems as shown in Table 1 below.

division metal Bioabsorbable metal Biodegradable polymer

problem Stress shielding phenomenon
Secondary removal surgery
Inflammation
Image distortion
Beam shape, implant movement
Hydrogen generation
Stress shielding phenomenon
Fast Disintegration Rate
Weak intensity
Acid generation

Disclosed is a biodegradable chi-square fusion splint member which is formed by inserting a metal stiffener into a biodegradable polymer to solve the above problems.

Hereinafter, the biodegradable interbody fusion splinting material described above will be described in detail with reference to the drawings.

As shown in FIG. 1, the biodegradable chaotic splint complementary prosthesis according to the present invention includes a mold part 10 formed of a biodegradable polymer and having a hollow part formed at the center of the body, a mold part 10 inserted into the mold part 10, And a supporting portion 20 for reinforcing the base 10.

First, the molded part 10 of the biodegradable chaotic splinting complementary member according to the present invention is provided. The mold part 10 is a body of a biodegradable cholesterol splintor, and is inserted between two vertebrae as shown in FIG. 4 to perform a reinforcing role.

The mold part 10 is generally designed in a cylindrical shape, but it can be designed in various shapes such as a triangle and a square depending on the shape and the interval of the vertebrae.

The mold part 10 is made of a biodegradable polymer. The biodegradable polymer includes at least one of poly lactic acid (PLA), polyglycolic acid (PGA), and polylactide-co-glycolide (PLGA).

The polylactide-co-glycolide (PLGA), which is polylactic acid (PLA), polyglycolic acid (PGA) and polylactic acid-glycolic acid copolymer (PLGA), has been approved by the US Food and Drug Administration It is a synthetic polymer which is decomposed in vivo and has excellent biocompatibility and has a relatively good processability.

The mold part (10) is provided with a hollow part (11) at the center of the body. The hollow portion 11 serves to secure a space in which the bone can grow.

Next, as shown in FIG. 2, the biodegradable interbody fusion splinting material according to the present invention is provided with a support portion 20. The support part 20 is inserted into the mold part 10 to reinforce the mold part 10.

Generally, the biodegradable polymer constituting the mold part 10 is severely shrunk in strength, so that a durability problem arises in a case of a shape-retaining material which must receive a load of 80% of the maximum weight. By inserting the support portion 20 into the mold portion 10, the mold portion 10, which is a body, is reinforced to improve durability and mechanical strength.

The number and shape of the support portions 20 can be variously changed according to the area of the mold portion 10 and the support portion 20, the position of the spine, and the like, as shown in FIGS.

More specifically, the support part 20 includes a first support part 21 provided in a vertical direction with respect to the mold part 10, a second support part 21 formed in a horizontal direction with respect to the mold part 10, (22).

As shown in FIG. 3, the first support part 21 is provided in a direction perpendicular to the mold part 10 and reinforced by supporting both ends of the mold part 10.

The first support portion 21 can be variously modified if it can perform a reinforcing role in a vertical direction such as a rod shape or a cylindrical shape including a hollow portion.

3, the second support portion 22 is provided in a horizontal direction with respect to the mold portion 10 to widen the contact surface with the mold portion 10 so that the mold portion 10 and the support portion 20 ) Can be smoothly performed.

3 (c), the second support part 22 is attached to the upper and lower surfaces of the mold part 10, and when the support part 20 is exposed due to the decomposition action of the mold part 10, By widening the contact surface with the abutting bone, the stress applied to the bone can be dispersed.

The second support portion 22 may be designed in various shapes as long as it is plate-shaped and horizontally provided to reduce stress concentration.

The support portion 20 is formed of at least one of a metal and a metal alloy. The support portion 20 is made of a metal or a metal alloy to improve the mechanical strength of the shape-retaining member.

In particular, when the support 20 is made of a bioabsorbable metal, it can be decomposed in vivo, and secondary effects such as secondary removal surgery, inflammation reaction, and the like occurring after the progress of osseointegration can be prevented.

The bioabsorbable metal used for the support portion 20 includes at least one metal or metal alloy of magnesium, calcium, manganese, iron, zinc, silicon, yttrium, zirconium and gadolinium.

For example, it is most preferable that the bioabsorbable cholesteric plasticity material of the present invention uses magnesium or a magnesium alloy as the bioabsorbable metal.

The magnesium is an inorganic component that constitutes the human body and does not exhibit toxicity in vivo, has high strength and biodegradability, and is light and has excellent processability.

In addition, the modulus of elasticity of magnesium is significantly lower than that of other medical metal materials, which is an advantage of preventing stress shielding, which is one of the failing factors of metallic base material and implant.

When the support 20 is made of a metal or a metal alloy, not only the mechanical strength is improved but also the metal is inserted into the mold 10, thereby enabling the observation of the radiation.

Generally, implants made only of biodegradable polymers can not be observed after surgery by radiation (x-ray, etc.). The support part (20), which is a metal, is inserted into the mold part (10) to serve as a marker to enable observation of radiation.

The support portion 20 is inserted into the mold portion 10 as described above. This structure has the effect of slowing down the decomposition rate of the metal with a high decomposition rate.

In general, the metal has a very rapid corrosion and decomposition rate, so that when exposed to the outside, the metal decomposes faster than the mold part 10, and it is difficult to perform the function of reinforcing the mold part 10. The mold part 10 made of the biodegradable polymer encapsulates the support part 20 and protects the support part 20 from the outside, thereby slowing the decomposition rate of the metal.

In addition, the generation of hydrogen generated in the decomposition process of the metal of the support part 10 and the acid generated from the biodegradable polymer of the mold part 10 are combined and neutralized.

Metal causes various problems such as generation of large amount of hydrogen due to decomposition reaction, inflammation due to pH increase, and necrosis of surrounding tissues. On the other hand, a biodegradable polymer may generate a large amount of acid in the decomposition reaction, which may cause harmful action to the human body. By combining the biodegradable polymer and the metal, it is possible to enhance the safety of the body through neutralization.

Next, the biodegradable chaotic splint complementary material according to the present invention may further include a hole 30 on a side surface of the mold part 10.

The hole 30 is formed on a side surface of the mold part 10 so that the medical device can be inserted into the beam member.

The position, size, shape and the like of the hole 30 can be changed according to the position of the used spine and the use of the prosthesis.

Hereinafter, with reference to FIG. 4, the operation of the biodegradable chi-2 fusion splint according to the present invention will be described in detail.

First, as shown in FIG. 4 (a), the mold part 10 is inserted between two vertebrae. At this time, the mold part 10 becomes a body between the vertebrae, and the support part 20 reinforces the mold part 10 to enhance the durability of the shape-retaining material.

As time passes, new bones grow inside the hollow part 11 formed through the mold part 10 as shown in (b) and (c) of FIG. 4 to fill the inside. At this time, the mold part 10 composed of the biodegradable polymer is decomposed at a slow speed, and the support part 20 is inserted into the mold part 10 and is not exposed to the outside, so that a decomposition (absorption) reaction occurs Do not.

As the decomposition of the mold part 10 which is a biodegradable polymer continues, exposure of the support part 10 inserted into the mold part 10 occurs as shown in FIG. 4 (d).

When the support portion 20 is exposed, the support portion 20, which is a metal, is decomposed (absorbed) at the same time as the mold portion 10 is disassembled as shown in FIG. At this time, a new bone is grown at the position where the mold part 10 and the support part 20 are disassembled.

As the mold part 10 and the support part 20 are completely disassembled, no foreign matter remains between the two vertebrae where the prosthesis is inserted as shown in FIG. 5 (b), and new bone is grown and completely filled .

As described above, it is to be understood that the technical structure of the present invention can be embodied in other specific forms without departing from the spirit and essential characteristics of the present invention.

Therefore, it should be understood that the above-described embodiments are to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than the foregoing description, All changes or modifications that come within the scope of the equivalent concept are to be construed as being included within the scope of the present invention.

10. Mold part
11. Hollow part
20. Support
30. Hall

Claims (5)

In a biodegradable interbody fusion splinting material inserted between two vertebrae,
The biodegradable hysteroscopic uniwine-
A mold part having a hollow part at the center of the body;
A support part inserted into the mold part and supporting the mold part; And,
The mold part is composed of a biodegradable polymer,
Characterized in that the support portion is composed of at least one of a bioabsorbable metal and a bioabsorbable metal alloy. The method according to claim 1,
Wherein the biodegradable polymer is at least one of poly lactic acid (PLA), polyglycolic acid (PGA), and polylactide-co-glycolide (PLGA) Biodegradable interbody fusion The method according to claim 1,
The support portion
A first support portion provided perpendicularly to the mold portion;
A second support portion provided to the mold portion in a horizontal direction; And the biodegradable interbody fusion splinting material The method according to claim 1,
Wherein the bioabsorbable metal comprises at least one of magnesium, calcium, and zinc. The method according to claim 1,
In the mold part,
And a hole formed in a side surface of the mold part.
KR1020150045352A 2015-03-31 2015-03-31 Biodegradable Intervertebral Fusion Cage KR101538620B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
KR1020150045352A KR101538620B1 (en) 2015-03-31 2015-03-31 Biodegradable Intervertebral Fusion Cage
PCT/KR2016/000037 WO2016159493A1 (en) 2015-03-31 2016-01-05 Biodegradable implant structure

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020150045352A KR101538620B1 (en) 2015-03-31 2015-03-31 Biodegradable Intervertebral Fusion Cage

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190076538A (en) * 2017-12-22 2019-07-02 가톨릭대학교 산학협력단 Biomechanical stress adaptive hybrid scaffold for bone reconstruction

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004305262A (en) * 2003-04-02 2004-11-04 Olympus Corp Biological tissue connector
KR20090112284A (en) * 2008-04-24 2009-10-28 주식회사 지에스메디칼 A cage for cervical vertebral
KR20100116566A (en) * 2009-04-22 2010-11-01 유앤아이 주식회사 A biodegradable implants and a manufacture method thereof
KR20130032575A (en) * 2011-09-23 2013-04-02 주식회사 제노스 Spinal implant

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004305262A (en) * 2003-04-02 2004-11-04 Olympus Corp Biological tissue connector
KR20090112284A (en) * 2008-04-24 2009-10-28 주식회사 지에스메디칼 A cage for cervical vertebral
KR20100116566A (en) * 2009-04-22 2010-11-01 유앤아이 주식회사 A biodegradable implants and a manufacture method thereof
KR20130032575A (en) * 2011-09-23 2013-04-02 주식회사 제노스 Spinal implant

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190076538A (en) * 2017-12-22 2019-07-02 가톨릭대학교 산학협력단 Biomechanical stress adaptive hybrid scaffold for bone reconstruction
KR102423076B1 (en) * 2017-12-22 2022-07-26 가톨릭대학교 산학협력단 Biomechanical stress adaptive hybrid scaffold for bone reconstruction

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