WO2011101167A1 - Emballage pour un implant - Google Patents

Emballage pour un implant Download PDF

Info

Publication number
WO2011101167A1
WO2011101167A1 PCT/EP2011/000819 EP2011000819W WO2011101167A1 WO 2011101167 A1 WO2011101167 A1 WO 2011101167A1 EP 2011000819 W EP2011000819 W EP 2011000819W WO 2011101167 A1 WO2011101167 A1 WO 2011101167A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
protective material
gels
packaging
polyethylene glycol
Prior art date
Application number
PCT/EP2011/000819
Other languages
German (de)
English (en)
Inventor
Jost Lussi
Original Assignee
Straumann Holding 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 Straumann Holding Ag filed Critical Straumann Holding Ag
Publication of WO2011101167A1 publication Critical patent/WO2011101167A1/fr

Links

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
    • A61C8/0087—Means for sterile storage or manipulation of dental implants
    • 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

Definitions

  • the present invention relates to a method for packaging an implant, in particular a
  • Dental implant and appropriate packaging.
  • Either such instruments or implants are delivered unsterilized, with a sterilization, which is essential before the application of the instrument or the implant to the patient, must be performed by the doctor.
  • a sterilization which is essential before the application of the instrument or the implant to the patient, must be performed by the doctor.
  • Another way to deliver medical instruments or implants is to have the sterilization performed by the manufacturer prior to delivery and to deliver the instrument or implant in a sterile condition for immediate use on the patient.
  • a problem of this method is due to the fact that instruments must often be used in a drive unit, as is the case for example with a drill.
  • Implants must be taken in accordance with most with an auxiliary tool, in order to accomplish this with the insertion of the implant on the patient. This is the case, for example, in the case of a dental implant, which is often screwed into the bone with a ratchet and possibly also with corresponding adapters. It must be ensured that the instrument or implant during Removal from the container and when inserted into the drive unit or the auxiliary tool is not contaminated and / or non-sterile.
  • a container for medical instruments is known for example from DE 101 46 905.
  • an instrument container which has a receiving part for releasably holding at least one working part of the instrument and a detachably attached to this receiving part cap member for receiving at least a portion of the shank of the instrument.
  • This separation of the instrument container into two functional units - the receiving part and the cap part - should enable the instrument to be sterilized by the manufacturer and made available to the doctor ready for use, and that insertion of the instrument into a drive unit or auxiliary tool without contamination is possible ,
  • a further packaging for a product of dental technology, in particular for a dental implant, is disclosed in WO 2004/002357.
  • This package has a lower part of metal foil with a product receiving recess and a product receiving recess closing, upper part, also made of metal foil on. The two parts are welded together. The product receiving well is closed by the upper part such that the product receiving well is substantially free of air, water and moisture.
  • Conventional packaging for dental implants usually have a dimensionally stable housing, which damage the implant, and in particular its surface, during transport or storage should prevent.
  • This housing must also reliably protect the implant from contamination by the external environment.
  • Many such packages additionally have a means for fixing the dental implant inside the housing, for example in the form of a clamping device. Such fixation is intended to prevent the implant from moving back and forth in the housing. As a result, the dental implant is less prone to damage during transport.
  • the implant is sterile.
  • impurities on the implant surface be minimized and, ideally, completely avoided, which would be between the implant and bone or soft tissue during implantation and could impair the connection between implant and bone or tissue.
  • Such deposits on the implant surface can also result from packaging parts, for example by abrasion, when the implant comes into contact therewith.
  • the present invention relates to a method for packaging an implant, in particular a dental implant, in which a protective material is applied directly to at least a part of the surface of the implant.
  • a protective material is applied directly to at least a part of the surface of the implant.
  • the surface of the implant is effectively protected from contamination. Since the protective material is located directly on the implant surface, the implant can not move relative to the protective material and thus also cause no abrasion. At the same time, the protective material surrounds the implant as a protective sheath, so that no contamination from the outside can reach the implant surface.
  • the protective material is applied to at least part of the implant surface.
  • the protective material which is to be inserted into a bone, i. the endosseous area.
  • the protective material is therefore preferably applied at least to the anchoring part.
  • the protective material is applied to the entire implant surface.
  • the term "dental implant”, unless otherwise stated, includes all known forms of implants which are intended to be inserted into the jawbone of a patient. In particular, this means both ceramic implants and those made of metallic materials.
  • the protective material is applied as a coating on at least part of the surface of the implant. It is preferred that the coating is applied to the entire implant surface. Preferably, the protective material is applied at least as onolayer, whereby a partial monolayer is conceivable.
  • the protective material is applied as a coating, a relatively small amount of protective material is sufficient, which is applied as a thin layer on the implant surface.
  • the protective material itself does not need to form an inherently dimensionally stable body; it adapts to the geometry of the implant.
  • the method according to the invention can be used for implants of any size and shape, as well as for medical instruments.
  • a plug is formed with the protective material around the implant.
  • the entire implant surface comes into contact with the protective material.
  • Such a plug is different from the coating described above mainly in the thickness of the protective material applied to the implant surface.
  • the plug can be used for implants of any size and shape, as well as for medical instruments.
  • the outer geometry of the plug is essentially freely selectable and can deviate from the implant geometry. So the outer shape of the plug can directly on a packaging receptacle are adapted, for example in the form of a cylinder or cuboid, in particular cube.
  • the plug can also absorb mechanical forces and damp against the implant, so that the implant is protected in the packaged state not only from contamination, but also from mechanical damage.
  • a protective material in the form of a coating or a graft may be preferred.
  • the implant is copolymerized.
  • a polymerizable material is used, which is intended to form the protective material in the polymerized state.
  • the implant is preferably immersed in it before and / or during the polymerization of the material intended for the protective material.
  • the material can also be applied to the surface of the implant and brought there for polymerization. In both cases, the application of the protective material to the implant surface is very easy to accomplish and is also completely reliable, which is essential for a good protective effect.
  • the protective material from a solution, for example from an aqueous solution or excreted from the surface of the implant from a suitable organic solvent, such as ethanol.
  • the implant is preferably immersed in the aqueous solution and the protective material, for example by evaporation of the solvent, deposited on the surface.
  • the implant can be introduced in a gel grafting, for example by pushing in or screwing into the finished plug.
  • a liquid, viscous polymer can be applied to the implant surface even after polymerization by application or immersion, the polymer for this purpose must be heated if necessary in advance (in analogy to wax).
  • the implant is sterilized before, during (eg in an autoclave or in aqueous solution) and / or after the application of the protective material.
  • the implant is sterilized prior to implantation. This is done either before the delivery of the implant to the doctor - before, during and / or after the application of the protective material on the implant surface - or is performed directly before implantation by the doctor.
  • the sterilization is preferably carried out as a vapor or gas sterilization or by means of .gamma.-radiation, .gamma.-radiation is particularly advantageous if the sterilization is carried out after the application of the protective material.
  • the implant provided with the protective material is additionally introduced into a packaging housing.
  • This outer packaging part is dimensionally stable and can usually be sealed gas- and liquid-tight.
  • the housing also protects the implant against damage, especially during transport.
  • a marking to such a packaging housing, for example in the form of a sticker, which informs the person skilled in the art about the type of implant, ie, for example, about its size, shape, material, etc.
  • the implant provided with the protective material is preferably fixed in the interior of the housing, for. By means of a clamping device to prevent the implant from moving relative thereto.
  • the protective material used in the method according to the invention assumes this function:
  • the outer shape of the plug is preferably adapted to the packaging housing in such a way that implant and plug can not or hardly move therein. This will prevent mechanical damage as well as the occurrence of abrasion that could contaminate the implant surface.
  • the protective material is at least partially removed from the surface thereof prior to implanting the implant. This can be done purely mechanically, depending on the protective material used, for example by stripping the protective material. Alternatively, it is also possible that the protective material is removed, for example, by immersion in or rinsing with water, with a physiological saline solution (eg Ringer's solution) or with another solvent, which liquids may optionally contain further additives. Alternatively, the Protective material also by means of a chemical reaction, which can be triggered, for example, by a change in pH, salinity or temperature, are removed from the implant surface. In a preferred embodiment, a solid or gel is used as the protective material. A solid or gel is particularly easy to apply to the implant surface, provides reliable protection of the implant and is also very easy to remove from its surface. A solid or gel in graft form can also fix the implant in an outer packaging sleeve, so that no additional support is required.
  • a solid or gel is particularly easy to apply to the implant surface, provides reliable protection of
  • a biocompatible protective material is used.
  • the protective material can be removed purely mechanically, and depending on the material may remain even smaller amounts of protective material on the surface like; An additional cleaning, for example, by rinsing or sterilization, but is no longer necessary. This simplifies the preparation of the implant prior to implantation and thereby also shortens the time during which the implant is exposed unprotected to the environment, which in turn significantly reduces the risk of contamination.
  • a protective material is used that is physiologically compatible.
  • the protective material is also at least partially degradable under physiological conditions.
  • the protective material is preferably degraded in the body after implantation and / or transported away. The degradation of the protective material in the body is preferably carried out relatively quickly and can be triggered, for example, by the body temperature, which is increased in comparison to the outside temperature, by the prevailing pH in the oral cavity or by the salt concentration present.
  • the protective material used it may also be advantageous or even necessary to activate it before implantation, for example by treatment with a (cooking) saline solution, by means of enzymes or by heating, so that it can be degraded faster in the body.
  • the protective material used is also water-soluble.
  • a protective material selected from the group consisting of monosaccharides, polysaccharides, salts, proteins, peptides, amino acids, lipids, phospholipids, hydrocolloids, hydrogels and mixtures thereof is used. These materials are particularly suitable for use as a protective material in the process according to the invention. They are very easy to apply to the implant surface, are stable in the air, biocompatible and easily degradable under body conditions, and also ensure reliable protection of the implant surface.
  • Particularly suitable for a coating are in particular proteins, monosaccharides, polysaccharides, salts, lipids and colloids (from polymers or proteins).
  • proteins monosaccharides, polysaccharides, salts, lipids and colloids (from polymers or proteins).
  • gelatin, hydrogels and salts are particularly suitable for grafting.
  • a protective material selected from the group consisting of glucose, fructose, endogenous salts (ie, salts that are physiologically present in the blood or other body fluids), albumin, gelatin, polyethylene glycol hydrogels, and mixtures thereof is used.
  • the degradation products are unproblematic for the body in a limited amount, ie these substances are biocompatible.
  • a protective material comprising glucose, fructose, endogenous salts, albumin or mixtures thereof is applied as a coating to the implant surface, for example by precipitation from an aqueous or alcoholic solution.
  • a protective material comprising gelatin and / or a polyethylene glycol hydrogel preferably forms a plug around the implant, the implant being preferably polymerized in or surrounded with an already polymerized layer.
  • a gel is preferably used.
  • the gel is selected from the group consisting of polyethylene glycol hydrogels, gels of polyethylene glycol derivatives, fibrin gels, protein gels, oligomer gels, hydrocolloid gels, gelatin, and mixtures thereof.
  • gels are used which contain polyethylene glycol, polyethylene glycol derivatives, fibrin, proteins, oligomers, hydrocolloids and / or gelatin.
  • these gels are biocompatible and can be optimally adapted to the shape of the implant or instrument to be packaged.
  • these gels additionally contain active ingredients, such as growth factors or anti-inflammatories. As a result, the healing of the implant in the bone or soft tissue can be further improved.
  • the plug may also be formed from a gel-like material which is non-wetting and has no leaching of low molecular weight substances (ie leaves no residue)
  • silicones can be used.
  • Another aspect of the present invention relates to the use of monosaccharides, polysaccharides, salts, proteins, peptides, amino acids, lipids, phospholipids, hydrocolloids and / or hydrogels in the process according to the invention for packaging an implant, in particular a dental implant.
  • these materials are particularly well suited as a protective material for the implant surface.
  • glucose, fructose, endogenous salts, albumin and / or of a polyethylene glycol hydrogel is particularly preferred.
  • Gels especially polyethylene glycol hydrogels, gels of polyethylene glycol derivatives, fibrin gels, protein gels, oligomer gels, hydrocolloid gels, gelatin and mixtures thereof are preferably used for the preparation of grafting.
  • gels are thus used, the polyethylene glycol, polyethylene glycol derivatives, fibrin, Proteins, oligomers, hydrocolloids and / or gelatin.
  • the present invention relates to a packaging for an implant, in particular for a dental implant, comprising a protective material, characterized in that the protective material is intended to cover at least a portion of the surface of the implant in the packaged state.
  • the inventive packaging allows reliable protection of the implant and in particular its surface from damage and contamination.
  • the protective material forms a plug surrounding the implant.
  • the packaging according to the invention additionally comprises a
  • Packaging housing intended to receive the implant covered by the protective material.
  • the packaging housing provides additional protection against contamination and damage.
  • the packaging housing also has a means for fixing the implant in its interior, so that the implant covered with the protective material can not move relative to the housing.
  • a protective material in the form of a plug eg, a salt block or a gel plug
  • the protective material it is also possible for the protective material to fix the implant in the housing.
  • the housing may preferably be hermetically sealed and preferably comprises at least two parts which may be releasably connected together to form a package for the implant.
  • Another aspect of the present invention relates to a set comprising an implant, in particular a dental implant, and a packaging according to the invention.

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

Abstract

La présente invention concerne un procédé d'emballage d'un implant, en particulier d'un implant dentaire, selon lequel un matériau de protection est appliqué directement sur la surface de l'implant. Le matériau de protection forme un tampon autour de l'implant. Les hydrogels de polyéthylène glycol, les gels à base de dérivés de polyéthylène glycol, les gels de fibrine, les gels de protéines, les gels oligomères, les gels hydrocolloïdes, la gélatine et leurs mélanges sont particulièrement appropriés en tant que matériau de protection.
PCT/EP2011/000819 2010-02-22 2011-02-21 Emballage pour un implant WO2011101167A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP10001755.7 2010-02-22
EP10001755 2010-02-22

Publications (1)

Publication Number Publication Date
WO2011101167A1 true WO2011101167A1 (fr) 2011-08-25

Family

ID=42308352

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2011/000819 WO2011101167A1 (fr) 2010-02-22 2011-02-21 Emballage pour un implant

Country Status (1)

Country Link
WO (1) WO2011101167A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014113852A1 (fr) 2013-01-23 2014-07-31 Jjgc Indústria Comércio De Materiais Dentários S.A. Système d'emballage pour le stockage, la capture et le transport d'implants dentaires

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001045585A1 (fr) * 1999-12-21 2001-06-28 Consiglio Nazionale Delle Ricerche Prothese dentaire equipee de moyens servant a liberer des substances actives
US20030033016A1 (en) * 2001-08-07 2003-02-13 Gyrus Group Plc Implant sheath
DE10146905A1 (de) 2001-09-24 2003-07-31 Brasseler Gmbh & Co Kg Geb Instrumentenbehälter
WO2004002357A1 (fr) 2002-07-01 2004-01-08 Nobel Biocare Ab (Publ) Systeme et procede de conservation de l'effet de nouvelle ossification de substances de stimulation de la croissance d'un produit d'implant
WO2005007012A2 (fr) * 2003-07-11 2005-01-27 Leimbruckner, Bernhard Implant dentaire
WO2005120366A2 (fr) * 2004-06-07 2005-12-22 Ophir Fromovich Distraction periostioque
WO2006089380A1 (fr) * 2005-02-24 2006-08-31 Roland Dricot Implant osseux
US20070202144A1 (en) * 2004-03-10 2007-08-30 Scil Technology Gmbh Coated Implants, Their Manufcturing And Use Thereof
EP1847278A1 (fr) * 2006-04-13 2007-10-24 Camlog Biotechnologies AG Revêtements bio-dissolubles des implants pour la protection contre des impuretés organiques

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001045585A1 (fr) * 1999-12-21 2001-06-28 Consiglio Nazionale Delle Ricerche Prothese dentaire equipee de moyens servant a liberer des substances actives
US20030033016A1 (en) * 2001-08-07 2003-02-13 Gyrus Group Plc Implant sheath
DE10146905A1 (de) 2001-09-24 2003-07-31 Brasseler Gmbh & Co Kg Geb Instrumentenbehälter
WO2004002357A1 (fr) 2002-07-01 2004-01-08 Nobel Biocare Ab (Publ) Systeme et procede de conservation de l'effet de nouvelle ossification de substances de stimulation de la croissance d'un produit d'implant
WO2005007012A2 (fr) * 2003-07-11 2005-01-27 Leimbruckner, Bernhard Implant dentaire
US20070202144A1 (en) * 2004-03-10 2007-08-30 Scil Technology Gmbh Coated Implants, Their Manufcturing And Use Thereof
WO2005120366A2 (fr) * 2004-06-07 2005-12-22 Ophir Fromovich Distraction periostioque
WO2006089380A1 (fr) * 2005-02-24 2006-08-31 Roland Dricot Implant osseux
EP1847278A1 (fr) * 2006-04-13 2007-10-24 Camlog Biotechnologies AG Revêtements bio-dissolubles des implants pour la protection contre des impuretés organiques

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014113852A1 (fr) 2013-01-23 2014-07-31 Jjgc Indústria Comércio De Materiais Dentários S.A. Système d'emballage pour le stockage, la capture et le transport d'implants dentaires
US9220582B2 (en) 2013-01-23 2015-12-29 Jjgc Indústria E Comércio De Materiais Dentários S.A. Packaging system for storing, capturing and transporting dental implants

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