WO2011069271A1 - Procédé pour fabriquer des implants - Google Patents

Procédé pour fabriquer des implants Download PDF

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Publication number
WO2011069271A1
WO2011069271A1 PCT/CH2010/000307 CH2010000307W WO2011069271A1 WO 2011069271 A1 WO2011069271 A1 WO 2011069271A1 CH 2010000307 W CH2010000307 W CH 2010000307W WO 2011069271 A1 WO2011069271 A1 WO 2011069271A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchoring element
anchoring
mold
core element
core
Prior art date
Application number
PCT/CH2010/000307
Other languages
German (de)
English (en)
Inventor
Peter Schwenter
Peter Perler
Roger Staudenmann
Original Assignee
New Dent Ag
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
Application filed by New Dent Ag filed Critical New Dent Ag
Priority to US13/514,099 priority Critical patent/US9375294B2/en
Priority to EP10787990.0A priority patent/EP2509531B1/fr
Priority to JP2012542326A priority patent/JP5659239B2/ja
Publication of WO2011069271A1 publication Critical patent/WO2011069271A1/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
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/0003—Making bridge-work, inlays, implants or the like
    • 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
    • A61C8/0016—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 polymeric material

Definitions

  • the invention is in the field of medical technology and relates to an implant, in particular a dental implant.
  • it relates to a method for producing a hybrid implant with a, for example, metallic or ceramic core and at least one component forming part of the surface.
  • Implants which have a core and a coating of a biocompatible, in the initial state of polymeric material, are known for example from DE 20 2004 009 060. According to the teaching of this publication, a polymer film is applied by gluing, shrinking, spraying, dip coating, etc., and then carbonized in an oxygen-free atmosphere.
  • WO 97/33017 implants with a hard core and a coating of a polymeric material are known.
  • PMMA in the form of fibers with longitudinally oriented molecular chains is wound around the core, and the resulting mantle is heated so that the fibers contract and bond together. The heating can be done while applying pressure.
  • Implants with surface areas of a thermoplastic material and a core of a material other than this thermoplastic material are known, for example, from US Pat. No. 7,008,226. In such implants mechanical vibrations are coupled in at the intended implantation. The mechanical energy of these vibrations is converted into thermal energy in the thermoplastic material where high stress concentrations occur. The thermoplastic material melts locally and is pressed by a pressure exerted during implantation into cavities and / or other structures of the surrounding tissue. After switching off the mechanical vibrations, the thermoplastic material solidifies, and it forms a positive connection with the structures of the fabric.
  • thermoplastic elements with these structures are often called "energy directors.”
  • energy directors are often in the form of edges, points, and similar geometric structures, and the mechanical workability of such geometric structures is limited, particularly in the art Therefore, the problem arises of how thermoplastic elements with these structures can be attached to a core made of a different material.
  • a method of manufacturing an implant comprises the steps of: providing a core member with a first material; providing a negative mold of the implant;
  • an “elevated temperature” means a temperature which is higher than the room temperature and preferably also higher than the body temperature at which the implant is implanted later, ie in particular higher than 37 ° C.
  • the elevated temperature is, if a glass transition temperature is defined for the second material, preferably above the glass transition temperature. It can be below the liquefaction temperature.
  • a particularly preferred temperature range is a temperature of well above the glass transition temperature - for example, at least a quarter or at least one third of the difference between liquefaction and glass transition temperature - but which is below the liquefaction temperature. It may vary depending on the material composition of the second element may be advantageous if the deformation temperature is closer to the liquefaction temperature than at the glass transition temperature.
  • the deformation temperature does not have to be constant but can have a temperature profile; in this case, the above information on the elevated temperature for the maximum temperature apply.
  • an elevated pressure is also applied during pressurization with the elevated temperature, i. a pressure above atmospheric pressure.
  • the negative mold may have two or more complementary to the negative mold parts which are pressed against each other, either by a suitable mechanism or by an overhead molding is weighted; Also pneumatic, hydrostatic or hydraulic or other means for acting on the mold cavity with a pressure are conceivable.
  • the anchoring element (s) At the deformation temperature and under pressure, the anchoring element (s) will be deformed, thereby permitting the formation of very fine energy directors. At the same time, the at least one anchoring element connects to the core element. It has been found that the resulting compound is particularly intimate and strong. According to one; Aspect of the method, therefore, the liquefiable material is inserted in the form of at least one anchoring element in the negative mold and not formed, for example, in the originally liquid state by encapsulation of the core element. This has massive advantages, because the equipment - injection molding machine, injection mold - which would be needed for such encapsulation, are known to be very complex and expensive.
  • the heating and cooling phases and optionally a holding phase can be driven at will; There is not a predetermined cycle time as in an injection molding process.
  • a deliberately slow procedure also allows no stresses to be frozen in the liquefiable material.
  • the method according to the aspect of the invention also allows the use of an elastic mold. On the one hand, this has the advantage that for a good sealing of the mold, in contrast to an injection molding tool, no very high precision of the dimensions and positions of sealing edges must be present.
  • a shape may then be termed "elastic" if the prevailing forces can cause significant elastic deformation as compared to the characteristic dimensions of structures and the implant surface, in particular elastic deformation may be due at least in part to entropy elasticity and / or the negative mold made of an elastomer or (other) plastic.
  • the core element, anchoring element (s) and female mold are matched to one another such that during the process, ie while the female mold encloses the core element and the anchoring element (s), the female mold is in negative mold in direct contact with the core element surface, for example, so that the common contact surface is under mechanical pressure.
  • Another possible advantage of embodiments of the invention is the material protection. It is generally sufficient pasty state below the liquefaction temperature of the liquefiable material for forming and adhesion. Thus, in many cases discoloration or even decomposition of the material can be avoided.
  • the process is easy to control. It is suitable for single parts and small series as well as for larger series.
  • the mold (negative mold) is held at the deformation temperature during a hold time.
  • cooling may be controlled in a controlled manner.
  • the core element itself is a hybrid of several materials, ie the fact that the core element has a first material does not exclude the presence of other materials.
  • the Core element itself have a metallic Kemstatt and a sheath on ceramic or polymer-based.
  • the second material is, for example, a material based on a thermoplastic polymer. It may be a resorbable or non-absorbable thermoplastic polymer, optionally with additives. Specific examples of suitable materials can be found, for example, in WO 2008/095 327, in particular pages 16-18, whose teaching concerning usable liquefiable materials is incorporated herein by reference; but it is also not mentioned in this document materials (single-phase materials or composites) are conceivable, which are liquefied under the influence of mechanical energy, in particular mechanical vibrations and solidify after discontinuation of energy input again.
  • anchoring elements which remain separate during the deformation and / or adhesion process (i.e., while they are in the negative mold and exposed to elevated temperature) and thereafter, i. do not flow into each other.
  • the anchoring element or the anchoring elements is / are, for example, dimensionally stable and preferably solid, compact elements.
  • the implant - or an enossal area thereof in preferred embodiments, surface areas of the first material and surface areas of the second material, which, for example, both arranged so they are both in contact with bone tissue after implantation.
  • the anchoring elements do not enclose the core like a jacket.
  • the anchoring elements in embodiments are particularly arranged such that surface regions of the first material as well as surface areas are at least one plane perpendicular to the implantation axis along a circumferential line are available from the second material.
  • the core element at least one recess - for example per anchoring element a recess - in which the corresponding anchoring element is inserted and in which the anchoring element is anchored so that it projects beyond an outer contour of the core element.
  • the depression can form a defined, for example, flat support for the anchoring element at its bottom. It may take the form of a slot, a rectangular pocket, a circular pocket, a polygon pocket, an elliptical pocket, a pocket approximating one of these shapes, or any other shape.
  • the recesses may also have undercuts to additionally connect the anchoring element with the core element by a geometrical positive connection.
  • the contact surface between the core element and the anchoring element or the anchoring elements - that is, for example, the bottom of the depression - can be treated to improve the adhesion in advance to the deformation and / or adhesion process. This can be done, for example, with sandblasting, shot peening, etching, lasers or other surface-modifying, erosive and / or performing procedures.
  • the anchoring element and / or depending on the composition also the core element can / can be activated for adhesion improvement by plasma and / or by a primer.
  • the negative mold used has at least two molded parts, which can be positioned relative to one another in such a way that an internal cavity of the desired implant shape results.
  • Positioning aids can be present on the molded parts, which engage in one another during the merging of the molded parts in such a way that the relative position is defined.
  • a pressure can be exerted in particular in embodiments with positioning aid in the form of a directed force - the moldings are pressed against each other.
  • An example of such a directed force is the weight.
  • the negative mold is preferably elastic at least in the region of the interface between moldings and can for example consist entirely of an elastic material.
  • the negative mold can be comparatively soft in comparison with an injection mold, with a hardness of, for example, between 20 Shore OO and 100 Shore D, in particular between 10 Shore A and 80 Shore D, between 10 and 100 Shore A, or between 10 and 60 Shore A, particularly preferably between 15 and 40 Shore A.
  • Suitable materials for the negative form include, but are not limited to, silicones, but also other elastic materials which readily withstand the deformation temperature, for example polyurethane, nitrile rubber, etc.
  • FIG. 2 a representation of an anchoring element before the deformation and / or adhesion process
  • Figure 3 is an exploded view of the core element, two anchoring elements and a negative mold for performing the method before the deformation and / or adhesion process;
  • Figure 4 shows the negative mold in the closed state and under pressure
  • FIG. 5 shows the implant after the process.
  • the core element 1 according to FIG. 1 for forming a dental implant has, in a manner known per se, an anchoring part 2, which is anchored in the implanted state in the bone and an integral body 3 for fixing a crown or another element.
  • a widening 4 is formed, which, for example, can form a shoulder that is supported on the gum and sealed after implantation.
  • the core element is made, for example, from a titanium material or a ceramic material, for example based on zirconium oxide.
  • the residual endosteal surface area i.e., the surface area of the anchoring portion surrounded by bone tissue in the implanted state
  • the average surface roughness in this remaining surface area is, for example, between 1 ⁇ m and 10 ⁇ m, the maximum surface roughness, for example, between 3 ⁇ m and 15 ⁇ m
  • the anchoring element 1 1 according to Figure 2 has in the illustrated original state adapted to the shape of the elongated hole 6 shape with a thickness which is greater than the depth of the slot. Specific structures such as energy directors or similar need not be present.
  • the anchoring element 1 1 is made for example of a resorbable or non-absorbable (optionally with additives) thermoplastic polymer, such as a polylactide (PLA) or polymethyl methacrylate (PMMA).
  • a resorbable or non-absorbable optionally with additives
  • thermoplastic polymer such as a polylactide (PLA) or polymethyl methacrylate (PMMA).
  • FIG 3 can be seen in addition to the core element 1 and two anchoring elements 1 1 of the type described above, the two-part negative mold.
  • the two mold parts 21, 22 form, separated along a parting plane, together the negative form.
  • the negative mold is made of an elastic material, for example a silicone material.
  • the mold parts 21, 22 may also have Formzentrierstoff (positioning aids), by their relative position is precisely defined.
  • the positioning aids here have the form of conical positioning pins 25 of the first molded part, which engage in corresponding recesses (not shown) of the second molded part during assembly.
  • the core element and the anchoring elements in the intended position and orientation - as shown in Figure 3 - placed in the negative mold and this is exposed to an elevated deformation temperature, for example in a furnace with adjustable temperature addition is advantageous applied a pressure with which the slightly elastic molded parts are pressed against each other. In the embodiment shown in FIG. 4, this is done by means of a weight 31.
  • a pressure is applied, for example.
  • the, negative mold in the still assembled state and preferably still slowly cooled under pressure.
  • This can be done by controlling the furnace temperature in a controlled manner, or by removing the mold from the furnace and at ambient temperature, eg. Room temperature - slow to cool.
  • the resorbable polylactide LR706 from Boehringer Ingelheim is pre-pressed into plates.
  • the Resomer LR706 is a mixture of L-lactide and R-polymer.
  • the glass transition temperature is 50 ° -60 °
  • the liquefaction temperature is between 170 ° C and 210 ° C.
  • a positive-mold mold is modeled using a Computer Aided Design (CAD) system, which is then built up layer by layer by stereolithography.
  • CAD Computer Aided Design
  • the resulting positive mold is poured with the two-component silicone Dublosil by Simed (often used in dentistry as Dubliermasse).
  • two silicone blocks are obtained with the respective negative mold, which also have the negative or positive mold centering means (positioning aids).
  • the Shore hardness of the two moldings is between 24 and 26 shore A.
  • the emelement is made of grade 4 titanium with sandblasted surface with diameter 4 mm and an endosseous length of 10 mm.
  • the implant body is provided with two oblong holes of 1 .5 mm width, 5 mm length and a depth of 0.5 mm (see Fig. 1).
  • the first anchoring element is placed on the implant body (i.e., the core element) and placed therewith in the intended mold half.
  • the second strip is then placed on top of the core element and closed with the second mold half.
  • the weight used is a 500 gram steel cylinder.
  • the whole package is heated in a convection oven for 30 minutes at 1 30 degrees and then cooled outside the oven but still with the weight for 20 min in the air.
  • the result is an implant with the desired energy directors and an excellent, intimate connection between the core element and the anchoring elements.
  • the anchoring elements are made of acrylic glass XT (PMMA, glass transition temperature about 1 I 5 ° C).
  • the negative mold is made of silicone Elite double 32 by Zhermack with a hardness of 32 Shore A. The anchoring elements are placed together with the core element in the intended negative mold and this is closed.
  • the weight used is a 500 gram steel cylinder.
  • the whole package is heated in a convection oven for 20 minutes at 140 degrees and then cooled outside the oven but still with the weight for 20 minutes in the air.
  • a zirconia core element (containing less than 10% yttria) is used. Specifically, an yttrium-stabilized, tetragonal, partially crystalline zirconium dioxide is used.
  • the zirconia ceramic used fulfills the ISO 13356: 2008 standard for "Implants for Surgery - Ceramic Materials based on yttria-stabilized tetragonal zirconia (Y-TZP)".
  • connection between the core element and the anchoring elements is also good. Due to the elasticity of the mold, the risk of mechanical damage to the core element in the process is low.
  • a negative form may have a plurality of side-by-side or array-like or otherwise arranged regularly or irregularly . Inner cavities for each core element with the associated number of anchoring elements be present.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ceramic Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne, selon un aspect, un procédé pour fabriquer un implant qui comporte les étapes suivantes: préparation d'un élément noyau (1) avec un premier matériau; - préparation d'un moule négatif (21, 22) de l'implant; introduction de l'élément noyau (1) et d'au moins un élément d'ancrage (11) en un deuxième matériau dans le moule négatif, le deuxième matériau étant thermoplastique, fermeture du moule négatif (21, 22) et application d'une température de déformation plus élevée, le deuxième matériau étant plastiquement déformable, visqueux ou liquide, et le premier matériau étant solide à la température de déformation, refroidissement du moule négatif avec l'élément noyau et l'élément d'ancrage, et - retrait de l'implant résultant composé de l'élément noyau et de l'élément d'ancrage du moule négatif.
PCT/CH2010/000307 2009-12-11 2010-12-07 Procédé pour fabriquer des implants WO2011069271A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US13/514,099 US9375294B2 (en) 2009-12-11 2010-12-07 Method for producing implants
EP10787990.0A EP2509531B1 (fr) 2009-12-11 2010-12-07 Procédé pour fabriquer des implants
JP2012542326A JP5659239B2 (ja) 2009-12-11 2010-12-07 インプラントの製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH1906/09 2009-12-11
CH01906/09A CH702349A1 (de) 2009-12-11 2009-12-11 Verfahren zum Herstellen von Implantaten.

Publications (1)

Publication Number Publication Date
WO2011069271A1 true WO2011069271A1 (fr) 2011-06-16

Family

ID=42045379

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH2010/000307 WO2011069271A1 (fr) 2009-12-11 2010-12-07 Procédé pour fabriquer des implants

Country Status (5)

Country Link
US (1) US9375294B2 (fr)
EP (1) EP2509531B1 (fr)
JP (1) JP5659239B2 (fr)
CH (1) CH702349A1 (fr)
WO (1) WO2011069271A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997033017A1 (fr) 1994-03-30 1997-09-12 Northwestern University Procede de fabrication de thermoplastiques a renforcement integre
WO2004017857A1 (fr) * 2002-08-23 2004-03-04 Woodwelding Ag Implant a implanter dans un tissu osseux ou dans un tissu osseux comble par un materiau de substitution osseuse
DE202004009060U1 (de) 2003-05-16 2004-08-12 Blue Membranes Gmbh Biokompatibel beschichtete medizinische Implantate
WO2008036034A1 (fr) * 2006-09-19 2008-03-27 Centri Ab Produit prothétique comprenant une paroi en matériau composite et son procédé de fabrication
WO2008095327A1 (fr) 2007-02-08 2008-08-14 Woodwelding Ag Implant, procédé de préparation d'un implant, procédé d'implantation et trousse de pièces

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02209148A (ja) 1989-02-08 1990-08-20 Mitsubishi Mining & Cement Co Ltd 人工骨、人工歯及び骨固定用ねじ
JP2740071B2 (ja) 1992-03-31 1998-04-15 日新製鋼株式会社 インプラント用金属焼結体の製造方法
JPH08131460A (ja) 1994-11-10 1996-05-28 Takeshi Masumoto 歯科用人工歯根とその製造方法
JP3417230B2 (ja) * 1996-09-25 2003-06-16 信越化学工業株式会社 型取り母型用光硬化性液状シリコーンゴム組成物
JP3401552B2 (ja) 1998-08-27 2003-04-28 独立行政法人産業技術総合研究所 塑性セラミックス及びその製造方法
JP4732368B2 (ja) 2004-02-20 2011-07-27 ウッドウェルディング・アクチェンゲゼルシャフト 骨組織に移植されるインプラント、その生産方法および移植方法
US7867426B2 (en) * 2006-03-23 2011-01-11 Ziran Bruce H Method of forming a temporary implant
JP5253251B2 (ja) 2008-03-19 2013-07-31 株式会社トクヤマデンタル 歯科インプラント用保護材

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997033017A1 (fr) 1994-03-30 1997-09-12 Northwestern University Procede de fabrication de thermoplastiques a renforcement integre
WO2004017857A1 (fr) * 2002-08-23 2004-03-04 Woodwelding Ag Implant a implanter dans un tissu osseux ou dans un tissu osseux comble par un materiau de substitution osseuse
US7008226B2 (en) 2002-08-23 2006-03-07 Woodwelding Ag Implant, in particular a dental implant
DE202004009060U1 (de) 2003-05-16 2004-08-12 Blue Membranes Gmbh Biokompatibel beschichtete medizinische Implantate
WO2008036034A1 (fr) * 2006-09-19 2008-03-27 Centri Ab Produit prothétique comprenant une paroi en matériau composite et son procédé de fabrication
WO2008095327A1 (fr) 2007-02-08 2008-08-14 Woodwelding Ag Implant, procédé de préparation d'un implant, procédé d'implantation et trousse de pièces

Also Published As

Publication number Publication date
JP5659239B2 (ja) 2015-01-28
JP2013513402A (ja) 2013-04-22
EP2509531A1 (fr) 2012-10-17
US20120292815A1 (en) 2012-11-22
CH702349A1 (de) 2011-06-15
US9375294B2 (en) 2016-06-28
EP2509531B1 (fr) 2014-06-18

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