KR20150034316A - Bioabsorbable implant with visible marker and mathod for producing the implant - Google Patents

Bioabsorbable implant with visible marker and mathod for producing the implant Download PDF

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Publication number
KR20150034316A
KR20150034316A KR20130114216A KR20130114216A KR20150034316A KR 20150034316 A KR20150034316 A KR 20150034316A KR 20130114216 A KR20130114216 A KR 20130114216A KR 20130114216 A KR20130114216 A KR 20130114216A KR 20150034316 A KR20150034316 A KR 20150034316A
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KR
South Korea
Prior art keywords
biodegradable
organic polymer
marker
powder
biodegradable organic
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KR20130114216A
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Korean (ko)
Inventor
이민수
이호준
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㈜ 이트리온
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Priority to KR20130114216A priority Critical patent/KR20150034316A/en
Publication of KR20150034316A publication Critical patent/KR20150034316A/en

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    • 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
    • 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
    • A61L27/02—Inorganic materials
    • 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
    • A61L27/14—Macromolecular materials
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Materials For Medical Uses (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)

Abstract

One embodiment of the present invention relates to a body which is inserted into and fixed to a human body at the time of reconstruction of a human body and made of a biodegradable organic polymer material; And a marker, which is provided in the form of a slice containing a biodegradable inorganic substance and is attached to a site of a shape of a part of the main body, the marker including a marker, and a biodegradable organic polymer human body insert.

Description

TECHNICAL FIELD [0001] The present invention relates to a biodegradable organic polymer body insert having a marker and a method for producing the same,

The present invention relates to a human body insert of a biodegradable organic polymer material used for reconstruction of a human tissue, and more particularly, to a human body insert having a marker appearing on an X-ray image and a CT (computed tomograhy) image. The present invention also relates to a method for manufacturing the human body insert.

Due to the development of science and technology, the materials of medical devices used for reconstruction of human tissues are becoming diverse. For example, in the case of a human body insert, which is a medical device used for reconstructing human tissues such as bones, muscles, and ligaments damaged by an accident, the material has been diversified from biocompatible metal to biodegradable organic polymer. Recently, .

Although biocompatible metal and biodegradable organic polymers are mainly used as the material of the human body implant, the new fusion material is limited to the material of some human body inserts.

The most commonly used biocompatible metal inserts in clinical practice have the advantages of excellent physical properties and the advantages of X-ray imaging or computed tomography (CT) images after insertion into the human body. However, the human body insert of the biocompatible metal has to be removed after curing and has a fatal disadvantage of giving a foreign body sensation. Recently, the use of human body inserts made of biodegradable organic polymers has been increasing.

The human implant of a biodegradable organic polymer material has sufficient physical properties for reconstruction of damaged tissue. However, since the biocompatible organic polymer material is decomposed in the human body after a certain period of time, it does not need to be removed through the second procedure, and secondly, it gives little foreign substance. Therefore, the human implant of a biodegradable organic polymer material can overcome the fatal disadvantages of a biocompatible metal implant.

However, since the biodegradable organic polymer does not appear on the X-ray image or CT image, the shape and position of the biocompatible organic polymer material can not be accurately grasped during or after the procedure. Therefore, there is a need for a technique for displaying the shape and position of the biodegradable organic polymeric material implant on X-ray images and CT images.

Accordingly, it is an object of the present invention to provide a human body insert of a biodegradable organic polymer material that can accurately confirm the exact procedure and treatment progress by indicating the shape and position of the X-ray image and the CT image during or after the procedure.

The present invention also provides a method for manufacturing the human body insert.

One embodiment of the present invention relates to a body which is inserted into and fixed to a human body at the time of reconstruction of a human body and made of a biodegradable organic polymer material; And a marker, which is provided in the form of a slice containing a biodegradable inorganic substance and is attached to a site of a shape of a part of the main body, the marker including a marker, and a biodegradable organic polymer human body insert.

Another embodiment of the present invention relates to a body which is inserted into and fixed to a human body at the time of reconstruction of a human body and made of a biodegradable organic polymer material; And a marker provided on the surface of the body, the marker being provided to include a biodegradable inorganic material.

The marker may be a biodegradable organic polymer composed of β-TCP or β-tricalcium phosphate, a biodegradable organic polymer having a β-TCP powder mixed therein, a magnesium biodegradable organic polymer comprising magnesium, .

In another embodiment of the present invention, there is provided a method of manufacturing a biodegradable organic polymer, comprising the steps of: (A) forming a body to be inserted into and fixed to a human body, (B) forming a segmented marker comprising biodegradable minerals; And (C) fusing the marker to the body. The present invention also provides a method for producing a biodegradable organic polymer human body insert having a marker.

Wherein the step (B) comprises: (B-1) forming the biodegradable inorganic material into a powder; And (B-2) forming the marker by melting the biodegradable inorganic powder or incorporating the biodegradable inorganic powder into the biodegradable organic polymer melt, and then forming the marker with the biodegradable organic polymer melted .

In another embodiment of the present invention, there is provided a method of manufacturing a biodegradable organic polymer, comprising the steps of: (A) forming a body to be inserted into and fixed to a human body, And (B) coating a surface of the body with a powder containing a biodegradable inorganic substance. The present invention also provides a method for producing a biodegradable organic polymer human body insert having a marker.

The step (B) may include: (B-1) forming the biodegradable inorganic material as a powder; (B-2) placing the biodegradable inorganic powder on the surface of the body; And (B-3) fusing the biodegradable inorganic powder to the surface of the body.

The step (B) may further comprise: (B-1) forming the biodegradable inorganic material into a powder; (B-2) mixing the biodegradable inorganic powder into the molten biodegradable organic polymer and curing the biodegradable organic polymer; (B-3) forming the cured biodegradable organic polymer into a powder; (B-4) placing the biodegradable organic polymer powder on the surface of the body; And (B-5) fusing the biodegradable organic polymer powder to the surface of the body.

The step (B) may further comprise: (B-1) forming the biodegradable inorganic material as a powder; (B-2) mixing the biodegradable inorganic powder into a molten biodegradable organic polymer; And (B-3) spraying the molten biodegradable organic polymer onto the surface of the body.

The biodegradable inorganic material is betacyimine or magnesium.

According to the present invention, the human body insert can exhibit its approximate or perfect shape and position on the X-ray image and the CT image, and all of the body insert is disassembled without being left in the human body after a certain time.

Further, according to the present invention, a human body insert having the above-described effects can be easily manufactured.

1 is a plan view showing a biodegradable organic polymer human body insert having a marker according to a first embodiment of the present invention.
2 is a sectional view taken along line A-A 'in Fig.
3 is a block diagram showing a method of manufacturing the human body insert shown in FIG.
4 is a plan view showing a biodegradable organic polymer human body insert having a marker according to a second embodiment of the present invention.
5 is a cross-sectional view taken along line B-B 'of FIG.
6 is a block diagram showing a method of manufacturing the human body insert shown in FIG.

Hereinafter, preferred embodiments of a biodegradable organic polymer human body insert having a marker according to the present invention and a method for producing 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 an ordinary sense or a dictionary, and that the inventor can 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 body insert according to the present invention may be of any kind provided that it has a body of a biodegradable organic polymer material. For example, the human body implant according to the present invention may be used for bone reconstruction of a fractured bone, a screw for fixing the bone fixation plate to the bone, a suture anchor for securing the broken muscle or ligament to the bone, reconstruction of the fractured orbital wall An orbital wall plate to be used at the time of use, and the like.

The human body insert according to the present invention may be in any form. For example, when the human body insert according to the present invention is the bone fixation plate, the human body insert may have various shapes such as a straight shape, an X shape, a Y shape, a rectangular shape, and the like.

As such, the human body insert according to the present invention is not limited to any type or form as long as the body of the biodegradable organic polymer material is provided. Therefore, the rectangular bone plate described in the following embodiments is merely an example of the human body insert according to the present invention, and is not intended to limit the present invention.

≪ Embodiment 1 >

The human body insert 100 according to the first embodiment of the present invention includes a main body 110 and a marker 120 as shown in FIGS.

The body 110 is made of a biodegradable organic polymer, which is inserted into and fixed to a human body during reconstruction of a damaged body tissue (bone, muscle, ligament, etc.). Examples of the biodegradable organic polymer include polylactic acid (PLA), polylactic acid (PLLA), polylactic acid (PLDLA), polyglycolide (PGA) poly (lactic-co-glycolic acid), PLC (poly (camprolactone)), and copolymers containing at least one of these.

The marker 120 has a slice shape and is made of a biodegradable organic polymer or a biodegradable organic polymer in which a biodegradable inorganic powder is mixed. Biodegradable minerals are materials that are displayed on X-ray images and CT images. Therefore, when the marker 120 is made of the above material, it appears on the X-ray image and the CT image. The biodegradable inorganic and biodegradable organic polymers decompose in the body after a certain period of time. Therefore, the marker 120 of the above material is not left in the human body. Examples of the biodegradable inorganic material include β-TCP, β-tricalcium phosphate, magnesium, and the like.

The marker 120 is fastened to a portion of the main body 110 that can measure the shape of the main body 110. For example, if the main body 110 is rectangular as shown, the markers 120 can be fastened to the four corners of the main body 110. Also, although not shown, if the main body is for the screw or suture anchor, the marker 120 can be fastened to both ends of the main body.

The human body insert 100 as described above can display its position or shape on the X-ray image and the CT image. In the meantime, the human body 100 is disassembled without being left in the human body after a predetermined time.

Hereinafter, a method of manufacturing the human body insert 100 will be described with reference to FIG.

The method of manufacturing the human body insert 100 includes a first step S110 to a third step S130.

The first step (S110) is a step of forming the main body 110 using the biodegradable organic polymer. This step (S110) may be performed by melting the biodegradable organic polymer and then injecting the melted biodegradable organic polymer.

The second step S120 is a step of forming the segmented marker 120 and includes a 2-1st step S121 and a 2-2st step S122. In step 2-1 (S121), the biodegradable inorganic material is ground into a powder form. In the step 2-2 (S122), the biodegradable inorganic powder is melted and then the molten inorganic powder is injected to form the segmented marker 120, or the biodegradable inorganic powder is mixed with the biodegradable organic polymer previously melted The mixture is mixed with a mixer, and the melted biodegradable organic polymer is injected to form the segmented marker 120.

The third step S 130 is a step of coupling the marker 120 to the main body 110. This step S130 may be performed by fusing the marker 120 made in the second step S120 to the surface of the main body 110 made in the first step S110. The surface of the main body 110 is slightly melted and integrated with the marker 120 at the time of fusion. As the fusion bonding method, thermal fusion bonding, ultrasonic fusion bonding, or the like can be used.

≪ Embodiment 2 >

The human body insert 200 according to the second embodiment of the present invention includes a main body 210 and a marker 220 as shown in FIGS. The main body 210 is the same as the main body 110 of the first embodiment and the material of the marker 220 is the same as the material of the marker 120 of the first embodiment. .

Unlike in the first embodiment, in this embodiment, the marker 220 has a shape coated on the surface of the body 210. For example, if the main body 210 is rectangular as shown in FIG. 4, the marker 220 has a shape coated on one surface (upper surface or lower surface) of the main body 210 as shown in FIG. Also, although not shown, if the main body is for a screw or a suture anchor, the marker 220 has a shape coated on the entire surface of the main body.

The human body insert 200 according to the present embodiment can express its complete shape in an X-ray image and a CT image. In addition, the human body insert 200 is disassembled without being left in the human body after a predetermined period of time.

Hereinafter, a method of manufacturing the human body insert 200 will be described with reference to FIG.

The method of manufacturing the human body insert 200 includes a first step S210 and a second step S220.

The first step S210 is a step of forming the main body 210 using the biodegradable organic polymer and is the same as the first step S110 of the first embodiment.

The second step S220 is a step of forming the marker 220 in the form of a coating layer, and may be performed in various ways as follows.

When the marker 220 is made of a biodegradable inorganic material, the second step S220 is performed through three processes. In the first step (S221), the biodegradable inorganic material is ground into a powder form. In the second process (S222a), the biodegradable inorganic powder is placed thinly and evenly on the surface of the main body 210. In the third step (S223a), the biodegradable inorganic powder is fused to the surface of the main body 210. During the third process 223a, the surface of the main body 210 is slightly melted and the biodegradable inorganic powder is integrated with the surface of the main body 210. The biodegradable inorganic powder layer integrated with the surface of the main body 210 becomes the marker 210. As the fusion bonding method, thermal fusion bonding, ultrasonic fusion bonding, or the like can be used.

If the marker 220 is a biodegradable organic polymer having a biodegradable inorganic powder mixed therein, the second step S220 may be performed in two ways.

The first method is performed through five processes, and the first process (S221) is as described above. In the second step (S222b), the biodegradable inorganic powder is mixed with the biodegradable organic polymer previously melted and then the biodegradable organic polymer is cured. In the third step (S223b), the cured biodegradable organic polymer is shaped into a powder form. In the fourth step (S224b), the biodegradable organic polymer powder is placed on the surface of the main body 210 in a thin and uniform manner. In the fifth step (S225b), the biodegradable organic polymer powder is fused to the surface of the main body 210. During the fifth process 225b, the surface of the main body 210 and the biodegradable organic polymer powders are slightly melted and integrated with each other. The biodegradable organic polymer powder layer integrated with the surface of the main body 210 becomes the marker 210. As the fusion bonding method, thermal fusion bonding, ultrasonic fusion bonding, or the like can be used.

The second method is performed through three steps, and the first step (S221) is as described above. In the second step (S222c), the biodegradable inorganic powder is mixed with the biodegradable organic polymer previously melted by a mixer. In the third step (S223c), the molten biodegradable organic polymer is injected onto the surface of the main body 210 using the injection nozzle. During the third process (S223c), the melted biodegradable organic polymer is integrated with the surface of the main body 210 while slightly cooling the surface of the main body 210 in a normal temperature environment and rapidly cooling the same. The biodegradable organic polymer powder layer integrated with the surface of the main body 210 becomes the marker 210. As the fusion bonding method, thermal fusion bonding, ultrasonic fusion bonding, or the like can be used.

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.

100, 200: human body insert (bone fixing plate) 110, 210:
120, 220: Marker

Claims (11)

A body inserted and fixed in a human body at the time of reconstitution of a human tissue and made of a biodegradable organic polymer; And
And a marker provided in the form of a slice containing a biodegradable inorganic material and attached to a region of the body where the shape of the body can be determined. A body inserted and fixed in a human body at the time of reconstitution of a human tissue and made of a biodegradable organic polymer; And
And a marker provided on the surface of the body, the marker being provided to include a biodegradable inorganic material. 3. The method according to claim 1 or 2,
Wherein the marker is made of betacythin, or has a marker made of a biodegradable organic polymer into which a beta -cype powder is incorporated. 3. The method according to claim 1 or 2,
Wherein the marker is made of magnesium or has a marker made of a biodegradable organic polymer having magnesium powder incorporated therein. (A) forming a body to be inserted into and fixed to a human body with a biodegradable organic polymer when the human tissue is reconstructed;
(B) forming a segmented marker comprising biodegradable minerals; And
(C) fusing the marker to the main body. The method of manufacturing a biodegradable organic polymer body insert according to claim 1, 6. The method of claim 5,
The step (B)
(B-1) forming the biodegradable inorganic material into a powder; And
(B-2) forming the marker by melting the biodegradable inorganic powder, mixing the biodegradable inorganic powder into the biodegradable organic polymer, and forming the marker with the biodegradable organic polymer melted; Wherein the biodegradable organic polymer body insert has a marker. (A) forming a body to be inserted into and fixed to a human body with a biodegradable organic polymer when the human tissue is reconstructed; And
(B) coating a surface of the body with a powder containing a biodegradable inorganic substance. 8. The method of claim 7,
The step (B)
(B-1) forming the biodegradable inorganic material into a powder;
(B-2) placing the biodegradable inorganic powder on the surface of the body; And
(B-3) fusing the biodegradable inorganic powder to the surface of the body. The method of manufacturing a biodegradable organic polymer body insert according to claim 1, 8. The method of claim 7,
The step (B)
(B-1) forming the biodegradable inorganic material into a powder;
(B-2) mixing the biodegradable inorganic powder into the molten biodegradable organic polymer and curing the biodegradable organic polymer;
(B-3) forming the cured biodegradable organic polymer into a powder;
(B-4) placing the biodegradable organic polymer powder on the surface of the body; And
(B-5) fusing the biodegradable organic polymer powder to the surface of the body. The method of manufacturing a biodegradable organic polymer body insert according to claim 1, 8. The method of claim 7,
The step (B)
(B-1) forming the biodegradable inorganic material into a powder;
(B-2) mixing the biodegradable inorganic powder into a molten biodegradable organic polymer; And
(B-3) spraying the melted biodegradable organic polymer onto the surface of the main body. 11. The method according to any one of claims 5 to 10,
Wherein the biodegradable inorganic material is a beta-citrate or a magnesium-based marker.

KR20130114216A 2013-09-26 2013-09-26 Bioabsorbable implant with visible marker and mathod for producing the implant KR20150034316A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180059085A (en) * 2016-11-25 2018-06-04 (주)오스테오닉 Biodegradable plate being capable of monitoring quantitative level of biodegradation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180059085A (en) * 2016-11-25 2018-06-04 (주)오스테오닉 Biodegradable plate being capable of monitoring quantitative level of biodegradation

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