WO2009072788A1 - Implant constitué de balles et son procédé de fabrication - Google Patents

Implant constitué de balles et son procédé de fabrication Download PDF

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Publication number
WO2009072788A1
WO2009072788A1 PCT/KR2008/007107 KR2008007107W WO2009072788A1 WO 2009072788 A1 WO2009072788 A1 WO 2009072788A1 KR 2008007107 W KR2008007107 W KR 2008007107W WO 2009072788 A1 WO2009072788 A1 WO 2009072788A1
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WO
WIPO (PCT)
Prior art keywords
balls
implant
ceramic
mold
ceramic balls
Prior art date
Application number
PCT/KR2008/007107
Other languages
English (en)
Inventor
Boo Rak Lee
Original Assignee
Boo Rak Lee
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from KR1020080120408A external-priority patent/KR20090057911A/ko
Application filed by Boo Rak Lee filed Critical Boo Rak Lee
Publication of WO2009072788A1 publication Critical patent/WO2009072788A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
    • 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
    • A61L27/04—Metals or alloys
    • 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
    • A61L27/10—Ceramics or glasses
    • 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
    • A61L27/56—Porous materials, e.g. foams or sponges

Definitions

  • the present invention relates to an inplant having superior biocompatibility and a manufacturing method thereof.
  • an implant made of metal such as titanium is used.
  • the metal implant may be installed as an artificial tooth or as part of a spine, a hip joint, a knee joint, a bone, etc.
  • the metal implant makes it impossible to grow the cells thereon and rejection ensues, undesirably creating aftereffects of the surgical operation.
  • the metal implant is used as a bolt implant for fixing fractured bone or as an implant for an artificial tooth, the bone cells near the surface of the installed metal implant are impaired. Accordingly, 5 to 10 years after the installation of the implant, the hole formed in the bone where the implant (fixture) is installed is enlarged, and thus subsequent installation of the implant is impossible.
  • Korean Utility Model No. 0433571 discloses a zirconia dental implant, which includes a fixture embedded in the alveolar bone at a space where a tooth was lost and an abutment to which an artificial crown is fixed.
  • the fixture has a shape which is tapered downwards, and includes a screw having a threaded portion formed on the outer surface thereof and recessed in a round shape from the ridge of the threaded portion toward the lower end of the fixture, and the fixture is made of a zirconia- alumina composite.
  • the above utility model is disadvantageous because the implant powder composed of zirconia-alumina and an apatite-based compound is pressed and processed into the shape of the implant, and thus the implant has poor strength and is broken upon use.
  • the surface of the implant is smooth and hard but it is difficult for cells to adhere onto the implant. So, with the goal of increasing the cell adhesion, if the surface of the implant is formed to be rough, the implant has poor strength and thus may become broken or fractured upon use after installation.
  • Korean Patent No. 0755950 discloses an implant fixture, which has a fixture body, a part of which is formed with a threaded portion and the other part of which is porously formed through sintering of metal powder, so that the fixture is provided with a screw and a porous portion.
  • This fixture includes a head of a predetermined height, which has an insert hole in the center thereof and is provided with a female threaded portion, and the fixture body under the head.
  • the implant fixture is embedded in the alveolar bone in a manner such that the fixture body is installed in the alveolar bone and an abutment and a dental prosthesis are sequentially fixed thereto through the insert hole.
  • the fixture body includes the threaded portion formed at a part thereof and the porous portion formed through sintering using metal powder at the other part thereof.
  • the fixture body is made of metal and has numerous pores formed through sintering of metal powder between the upper and lower ends thereof at the outer surface thereof.
  • the fixture made of metal has lower cell affinity than ceramics, and thus impairs the cells in the surrounding area, consequently causing problems of enlarging the bored hole in which the implant is installed.
  • the present invention provides an implant composed of an aggregate of spherical balls which are connected to each other through sintering and a manufacturing method thereof.
  • the implant which is used as an artificial bone, in particular, an artificial tooth, is formed to have numerous pores in a body thereof, and thus, upon installation of the implant into the alveolar bone (dentary bone), rejection does not occur, and bone cells are introduced into the pores and thus efficiently live therein, thus increasing ability of the cells to survive and cell affinity and enabling the semipermanent use of the installed implant without it becoming loose.
  • An aspect of the present invention provides an implant composed of an aggregate of spherical balls which are connected to each other.
  • the spherical balls may have a diameter of 0.05-1 mm.
  • the spherical balls may have a size difference of 0.2 or less or a sphericity of 0.05 or less.
  • the implant may be composed of two or more kinds of spherical balls having different diameters which are connected to each other.
  • the implat may haver a porosity of 30-70%
  • the spherical balls may be made of ceramic, titanium or polyketone.
  • the implat of the present invention may be an implant for an artificial tooth.
  • Another aspect of the present invention provides a method of manufacturing an implant composed of the ceramic balls, including pre-sintered the ceramic balls at 500 ⁇ 800°C, charging the pre-sintered ceramic balls, sintering the ceramic balls charged in the pre-mold at 1000 ⁇ 1800°C, and processing the ceramic balls sintered in the pre- mold into a shape of the implat.
  • charging the pre-sintered ceramic balls in the pre-mold may be performed by filling the pre-mold with the ceramic balls while the pre-mold is vibrated.
  • water sprayed onto the ceramic balls may contain at least one binder selected from among B 2 O 3 , ceramic powder and glaze.
  • the binder may be used at a concentration of 0.01-10 wt%.
  • a further aspect of the present invention provides a method of manufacturing an implat composed of the titanium balls or the polyketone balls, including charging the titanium balls or the polyketone balls in a pre-mold and connecting the balls to each other, and processing the titanum balls or the polyketone balls connected to each other in the pre-mold into a shape of th implant.
  • the implant according to the present invention may be used as an implant for an artificial tooth or an implant for fixing the bone including a spinal implant and an implant for a knee joint and a hip joint, all of which are installed in the human body.
  • the meaning of the word 'implant' includes a fixture, an abutment, a female screw (bolt) and the like.
  • a material for the spherical balls is not particularly limited as long as it has a predetermined strength and biocompatibility, and examples thereof include ceramic, titanium, and polyketone.
  • ceramic materials particularly useful is zirconia which is metal oxide having excellent biocompatibility.
  • the polyketone is exemlified by polyktheretherketone.
  • spherical balls are used to form the implant is that the pores are naturally formed when the spherical balls are connected to each other in all directions through sintering, and also because, as biotissue grows on the surface of the implant with which it is in contact or in the pores of the implant, the spherical balls remarkably reduce a concern of hurting the biotissue and causing inflammation, compared to materials having sharp or pointed surfaces or lines.
  • the spherical balls have a diameter of 0.05-1 mm, preferably 0.1-0.8 mm, and more preferably 0.2-0.6 mm, When the diameter of the balls is less than the lower limit, the balls are arranged too close to each other, thus making it impossible to obtain a desired porosity. In refast, when the diameter thereof exceeds the upper limit, the number of balls in the implant having the same size is reduced, and thus the number of points of contact between the neighboring ball is decreased, undesirably weakening compressive strength of the implant. Further, because the size of the pores defined by the balls is increased in proportion to the size of the balls, the survival of the calls is reduced.
  • the implant having uniform compressive strength and porosity may be manufactured.
  • spherical balls having uniform sizes for example, two or more kinds of, preferably two to five kids of and preferably two or three kinds of spherical balls having different diameters, may mixed, so that the implant is controlled to have desired compressive strength and porosity.
  • the spherical balls have a sphericity of 0.05 or less, preferably 0.005 or less, more preferably 0.0005 or less, and most prefeably 0.00005 or less,
  • a sphericity of 0.05 or less preferably 0.005 or less, more preferably 0.0005 or less, and most prefeably 0.00005 or less.
  • the ceramic balls having low sphericity and size difference are used, it is possible to manufacture an implat having more uniform compressive strength and porostiy
  • ceramic powder is introduce into a molding machine or a chambe, and the water is sprayed onto the power while the molding machine is roataed at 5-100 rpm and preferaly 10-30 rpm, thus forming and sorting seeds having a spherical shape adequate for the formation of the balls.
  • Such seeds are placed in the molding machine having a cylindrical shape and the manually stirred while water is sprayed theron, and simultaneously, the molding machine is rotated and vibrated, thus spheroidizing the seeds into caramic balls having a prede- terminded size.
  • the ceramic balls thus obtained may be passed through a standard sieve, thus enabling only the ceramic balls having a specific size to be sorted apart from one another.
  • the ceramic balls thus formed are pre- sintered at 500 ⁇ 800°C and preferably 600 ⁇ 700°C, before being placed in a pre-mold.
  • the pre-sintering process is performed in the above temperature range, strength able to maintain the shape of the spherical balls unchanged in a sintering process may be obtained.
  • the pre-sintering temperature is less than the lower limit, a period of time required for performing the pre-sintering and enhancing the strength of the ceramic balls is lengthened. In shoreat, if the pre-sintering temperature exceeds the upper limit, the ceramic balls may be broken of deformed and thus cannot be restored.
  • part of the ceramic balls may be broken or deformed, thus making it difficult to obtain an implant having uniform inner cross-sections and compressive strength.
  • the ceramic balls are slowly charged therein layer by layer while water is sprayed onto the ceramic balls so that the entire surface of the balls is covered with water.
  • the reason why water is sprayed onto the entire surface of the pre-sintered ceramic balls is that the connection between the neighboring balls is further enhanced in the sintering process to thus increase the compressive strength of the implant.
  • at lest one binder selected from among B 2 O 3 cermic powder and glaze may be added to the water.
  • the binder may be used at a concentration of 0.001- 10 wt%, preferably 0.005-5 wt%, and more preferably 1-3 wt%.
  • the vibrating of the pre-mold is perferable for the purpose of filling the pre-mold with the ceramic balls without creating void spaces.
  • the pre-mold is placed on a vibrating plate or a vibrating jig and then vibrated at a predetermined rate.
  • the ceramic balls placed in the pre-mold are sintered at 1000-1800 and preferably
  • the titanium balls or the polyketone balls are uniformly placed in a pre-mold without the presence of any void spaces and then fused to each other at 1000-1200 with a high frequency, thus forming a ball aggregate in which the balls are welded to each other.
  • the shape of the pre-mold includes but is not limited to a cylindrical post, a tetragonal post, a hexagonal post, an octagonal post, etc.
  • the cylindrical shape is preferable.
  • the pre-mold may be made of the same material as that of the spherical balls. If so, the mutual connection of the sintered or welded spherical balls may be prevented from being broken due to the difference in the shrinkage rate between the spherical balls and the pre-mold in the sintering process. Further, in order to facilitate the release of the pre-mold, a release agent may be applied on the inner surface of the pre-mold coming into contact with the spherical balls. However, even when the release agent is not applied, the pre-mold may be adequately cut and removed in the course of processing the balls into the implant, thus obviating a need for the separation between the pre-mold and the spherical balls.
  • the implant or the molded body for an implant may have the volume of the pores, namely the porosity of 30-70%, preferably 40-60%, and more preferably 45-50%.
  • the porosity of the implant two or more kinds of, preferably two to five kinds of, and more preferably two or three kinds of the spherical balls having different diameters may be mixed.
  • the implant have as high a compressive strength as possible. However, when the pores necessary for the survival of the cells are increased, the compressive strength may be reduced.
  • the compressive strength of the implant may be set to 40 kgf/ ⁇ mf or more, preferably 60 kgf/mnf, and more preferably 70 kgf/ ⁇ mf or more.
  • FIG. 1 illustrates a state in which a pre-mold is filled with ceramic balls.
  • FIG. 2 is a fragmentary enlarged view of FIG. 1, which shows a contact surface and pores between the neighboring spherical balls which are layered and sintered.
  • FIG. 3 illustrates an outer appearance of an implant after having had its shape processed.
  • FIG. 4 illustrates the implant composed of the spherical balls.
  • the ceramic sample was removed from the molding machine and the degree of spheroidizing thereof was periodically observed, after which only the ceramic balls having a size of about 0.4 mm were stepwisely sorted by use of a sieve.
  • the ceramic balls thus obtained had a diameter of 0.4 mm, a size difference of 0.01, and a sphericity of 0.00005.
  • the pre-sintered ceramic balls were air cooled, and then charged in a pre-mold while water was sprayed thereon.
  • the pre-mold had a cylindrical shape having a diameter of 4.5 mm and a height of 10 mm and was formed from zirconia powder. While the pre-mold was placed on a vibrating plate and vibrated, the ceramic balls were charged in the pre-mold.
  • FIG. 1 shows the state in which the cylindrical pre-mold is filled with the ceramic balls to form a base body of an implant.
  • the ceramic balls charged in the pre-mold were layered through two-step procedures including forming an odd-numbered layer and forming an even-numbered layer, consequently forming a total of 30 layers.
  • the odd-numbered layers of the ceramic balls in the pre-mold were configured in a manner such that a total of 11 ceramic balls having a diameter of 0.4 mm were linearly arranged in a length direction in a circle having a diameter of 4.5 mm on the basis of length and width, and the dimension of the remaining space was divided by 11, thus determining intervals of the balls.
  • the even-numbered layers of the balls were configured in a manner such that the balls were charged between the 11 balls of the odd-numbered layer in the circle having a diameter of 4.5 mm based on the odd- numbered layer.
  • the ceramic balls charged in the mold in this way were layered so that the odd-number layers and the even-numbered layers were partially overlapped, and consequently, the pre-mold was filled with a total of 2295 ceramic balls. [59] After the filling of the pre-mold with the ceramic balls, sintering was performed at
  • FIG. 2 shows the contact surface and the pores between the neighboring ceramic balls which are layered in the pre-mold in the sintering process.
  • the ceramic balls having a diameter of 0.4 mm were aggregated while the contact surface between the neighboring balls had a size of 0.12 mm.
  • the horizontal interval between the centers of the neighboring aggregated balls was 0.33 mm, and the vertical height interval therebetween was 0.38-0.39 mm.
  • numerous pores 24 were defined by the neighboring ceramic balls.
  • FIG. 3 the implant 20 indicates a fixture, and a groove 23 is formed in the top of the implant as in a typical implant and processed so that an abutment is fixed thereto.
  • a threaded portion 22 formed on the outer surface of the implant (fixture) is screwed into the alveolar bone (jaw bone).
  • the etching portion 21 ensures that the alveolar bone is coupled with the implant without breakage.
  • FIG. 4 illustrates the implant composed of the ceramic balls, in which the ceramic balls are aggregated by sintering the ceramic balls 10 in a state of being densely layered in all directions.
  • the implant according to the present invention includes the aggregate of the ceramic balls. Hence, when this implant is fixed to the bone, the cells are introduced into numerous pores 24 between the neighboring ceramic balls and survive, thereby increasing the adhesion between the implant (fixture) and the alveolar bone.
  • An implant was manufactured in the same manner as in Example 1, with the exception that, upon filling of the pre-mold with the ceramic balls, water containing 1 wt% sintering glaze (barium, lime) diluted therein was sprayed onto the ceramic balls.
  • sintering glaze barium, lime
  • Example 4 An implant was manufactured in the same manner as in Example 1, with the exception that water containing 1 wt% B 2 O 3 diluted therein was used as the spraying solution upon filling of the pre-mold with the ceramic balls. [70] Example 4
  • Example 1 Thereafter, the titanium balls which were aggregated were heated at
  • the zirconia powder was directly pre-sintered at 600, charged in the pre-mold of Example 1, and then sintered at 1200, thus producing a cylindrical sintered body for an implant having a diameter of 4.5 mm and a height of 10 mm.
  • a cylindrical sample for an implant having a diameter of 4.5 mm and a height of 10 mm, was produced from polyetheretherketone (PEEK-OPTIMA LTl, available from
  • a cylindrical sample for an implant having a diameter of 4.5 mm and a height of 10 mm was produced from titanium.
  • Example 3 As the concentration of the B 2 O 3 in the spraying solution was higher, the maximum load and the compressive strength were increased, thus increasing the connective force between the neighboring ceramic balls.
  • Example 6 using the ceramic slurry instead of glaze or B 2 O 3 , similar results were obtained.
  • Example 1 composed of the ceramic ball aggregate exhibited the greatest cell survival rate.
  • the sample of Example 7 composed of the titanium ball aggregate exhibited a comparatively higher cell survival rate in relation to the comparative examples. Thereby, it could be seen that the inner pores of the sample increased initial adsorption and growth of the cells. Even when the same balls were formed, the ceramic material which has an affinity for the cells of the human body manifested the higher cell survival rate, compared to the metal material.
  • the bioceramic is used, thus increasing the cell affinity and the ability of cells to survive.
  • the base body of the implant is produced from the aggregate of balls, thus forming many pores.
  • the artificial tooth can be used for a long period of time without it becoming loose, and problems in which the hole in the alveolar bone where the implant (fixture) is installed is enlarged can be solved.
  • the present invention provides an implant composed of an aggregate of spherical balls which are connected to each other through sintering.
  • the implant having numerous pores When the implant having numerous pores is installed into the portion of the human body, the cells of the human body are introduced into the pores and survive, thus increasing the cell survival area to thereby result in increased ability of the cells to survive.
  • the bioceramic balls are used, thus increasing affinity for the bone cells, thereby preventing the aftereffects of a surgical operation and enabling the use of an implant without it becoming loose as did the original bone or tooth.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Ceramic Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dentistry (AREA)
  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un implant composé d'un agrégat de balles sphériques qui sont reliées entre elles par frittage; et un procédé de fabrication d'un tel implant. Lors de l'utilisation de l'implant qui présente de nombreux ports définis par des balles en céramique sphériques agrégées, il est possible d'accroître l'affinité cellulaire et le potentiel de survie des cellules. Cet implant peut être utilisé pendant longtemps, sans prendre de jeu, et peut éviter l'élargissement du trou situé dans l'os alvéolaire dans lequel l'implant est fixé.
PCT/KR2008/007107 2007-12-03 2008-12-02 Implant constitué de balles et son procédé de fabrication WO2009072788A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
KR10-2007-0124489 2007-12-03
KR20070124489 2007-12-03
KR1020080120408A KR20090057911A (ko) 2007-12-03 2008-12-01 세라믹 볼을 이용한 임플란트 제조방법 및 임플란트
KR10-2008-0120408 2008-12-01
KR1020080120409A KR20090057912A (ko) 2007-12-03 2008-12-01 볼로 이루어진 임플란트
KR10-2008-0120409 2008-12-01

Publications (1)

Publication Number Publication Date
WO2009072788A1 true WO2009072788A1 (fr) 2009-06-11

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2008/007107 WO2009072788A1 (fr) 2007-12-03 2008-12-02 Implant constitué de balles et son procédé de fabrication

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WO (1) WO2009072788A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4737411A (en) * 1986-11-25 1988-04-12 University Of Dayton Controlled pore size ceramics particularly for orthopaedic and dental applications
US5344457A (en) * 1986-05-19 1994-09-06 The University Of Toronto Innovations Foundation Porous surfaced implant
US7090494B2 (en) * 2001-07-12 2006-08-15 Innova Corp. Implant for use in aesthetic regions of the mouth with colored contoured edge portion
US20070110823A1 (en) * 2004-10-11 2007-05-17 Kong Young M Sintered bioactive ceramic composite implant and preparation thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5344457A (en) * 1986-05-19 1994-09-06 The University Of Toronto Innovations Foundation Porous surfaced implant
US4737411A (en) * 1986-11-25 1988-04-12 University Of Dayton Controlled pore size ceramics particularly for orthopaedic and dental applications
US7090494B2 (en) * 2001-07-12 2006-08-15 Innova Corp. Implant for use in aesthetic regions of the mouth with colored contoured edge portion
US20070110823A1 (en) * 2004-10-11 2007-05-17 Kong Young M Sintered bioactive ceramic composite implant and preparation thereof

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