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    • 专利摘要:
    DENTAL IMPLANT SYSTEM AND PROCESS FOR THE MANUFACTURE OF A DENTAL IMPLANT SYSTEM. The present invention relates to a dental implant system (1, 1 ', 1 ") with a first implant part (2, 2', 2") intended for insertion into a jaw bone, and with a second part implant (4) coordinated with that part, foreseen for the placement of a dental prosthesis piece, in which the implant parts (2, 2 ', 2 ", 4) can be mechanically connected to each other through a pin molded connection (10), which can be inserted in a receiving channel (12) provided in one of the implant parts (2, 2 ', 2 ", 4), in the other implant part (2, 2', 2" , 4) being that, the referred dental implant system must present a particular stability and a long useful life, also in the case of the use of ceramic based materials or comparable in their basic material characteristics for the implant parts (2, 2 ', 2 ", 4). For this purpose, according to the invention, in a contact area for the receiving channel (12) the connecting pin (10) is equipped with a spacer (22) with closure due to the material, made of a softer material in comparison with the material of the connecting pin (10), and for the formation of a closed connection due to the material (...).
    公开号:BR112013011856B1
    申请号:R112013011856-3
    申请日:2011-11-15
    公开日:2020-07-28
    发明作者:Holger Zipprich；Urs Brodbeck；Markus Schlee
    申请人:Holger Zipprich；Urs Brodbeck；Markus SCHLEE；
    IPC主号:
    专利说明:

    [0001] The present invention relates to a dental implant system with a first implant part, intended for insertion into a jaw bone, and with a second implant part, coordinated with that part, intended for the placement of a piece of dental prosthesis, and the implant parts can be mechanically connected to each other through a molded connecting pin, which can be inserted into a receiving channel provided in the other implant part.
    [0002] To compensate for the loss of a tooth, in the context of reconstructive therapy dental implants can be used. In general, they are used in the place of a tooth extracted or fallen on a jaw bone, in order to keep there, after a healing phase of approximately four to twelve weeks, a prosthetic part or a crown that serves as a prosthesis. For this, a dental implant of this type is usually performed as an appropriately shaped metal body, which is inserted into the place provided in the jaw bone by means of screwing. In this case, the dental implant generally has a self-cutting screw thread at the apical end, with which the dental implant is inserted into the correspondingly prepared implant bed.
    [0003] In order to facilitate an easy introduction into the patient's mouth and, in particular, to enable a particularly extensive preparation of the prosthesis itself, during placement on the implant, already in the period of preparation of the patient's treatment, for example, in a dental laboratory, dental implant systems can be implemented in several parts. In this case, in particular, an assembly can basically be envisaged in two parts, and the dental implant system may include a first implant part, intended for introduction into the jaw bone, also known as the implant itself or support part, and in addition to that part, a second implant part, coordinated with that part, also designated as a structural part, in which, in turn, the prosthetic part provided as a prosthesis or similar can be placed. Usually, on its external side, the first implant part or support part is provided with a thread, which can be performed as a self-cutting thread or as a non-self-cutting thread. Usually the support part is anchored in an implant bed correspondingly prepared in the jaw bone. The construction of the thread provided in the external area of the dental implant, in this case, is generally designed for a high primary stability of the disposition and a uniform transmission of the forces that arise during the chewing of the dental implant in the jaw bone.
    [0004] For the mechanical connection of the implant parts to each other, a connection pin molded in one of the implant parts, usually in the structural part, is generally provided. This part can be inserted in a receiving channel provided in the other implant part, usually in the support part. With respect to the choice of geometry and dimensioning, in particular, of the cross sections, in this case, the connecting pin, on the one hand, and the receiving channel, on the other hand, are generally adapted to each other, in such a way that, in the relatively easy assembly, however, a good guide of the components in each other can be obtained and with this, a sufficiently high mechanical stability. The structural part, which is usually in its upper area equipped with a crown, another prosthetic or similar supply, in a very well-known way, in this case, for the mechanical connection with the support part, it can be glued with the support part, through the connecting pin inserted into the receiving channel. But the structural part can also be compressed on the support part, and be fixed only by means of a clamp, or it can also be additionally fixed by means of cementation or gluing.
    [0005] Undoubtedly, in the case of implant systems of this type, during the screwing of the structural part and, in particular, also later during chewing, the dental implant is highly requested, such that an adhesive bond of the type mentioned , with respect to the very long retention period desired in the patient's mouth, possibly no longer has sufficiently high mechanical stability. In order to take this into account, alternatively the structural part can also be screwed with the support part, using an appropriately chosen connecting screw. In this case, during insertion, the thread of the connecting screw is usually screwed into an internal thread coordinated in the support part. The screw head of the connecting screw, in this case, during screwing through a frontal lowering of the structural part presses that part on the dental implant. Multi-part dental implant systems of this type, with a screw connection between the structural part and the support part, are known, for example, from the DE 10 2006 018 726 A1 patent or from the DE 10 2008 054 138 A1 patent.
    [0006] The first implant part or support part and, likewise, the second implant part or top part or structural part are generally made up of an appropriately chosen metal and, in fact, in particular titanium or a titanium alloy. Through this choice of material, an acceptable tolerance for the patient and good biocompatibility can be obtained. In addition, implant systems produced on this material base have high long-term stability, with little susceptibility to fracture. Correspondingly, titanium is widely used as a raw material for implant systems, and also enjoys wide scientific acceptance, since the sterilization necessary for use in reconstructive therapy can also be ensured in a relatively simple and reliable way. In addition, material costs are limited, so that, as a general rule, with acceptable expenditure, relatively large part numbers can also be manufactured in implant systems on this basis.
    [0007] On the other hand, however, in such metal-based implant systems, an allergenic potential cannot possibly be excluded. Allergies against metals are usually caused by the formation of metal ions. In addition, there is a danger that, through particles separated from the implant, for example, by flaking off the implant surface or through abrasion in multi-part systems, inflammatory reactions can be caused in the patient's mouth. In addition, the color of the metallic components of the implant can have an interfering aesthetic and / or optical influence, and the electrical conductivity of the metallic components can lead to harmful effects.
    [0008] For these reasons, metal-free execution of implant systems may be desirable. As an alternative to metallic systems, ceramics are considered in particular as the base material for implants, usually on the basis of zirconium oxide (preferably stabilized by yttrium oxide or aluminum oxide), or also alloys containing zirconium, ceramics of zirconium oxide and aluminum oxide, or ceramics that contain either zirconium oxide or aluminum oxide, or which have at least one of the ceramics as the main component. In addition, ceramics can be used, which are mounted on a silicon or silicon oxide base, and which contain, for example, mixtures of nitrogen, hydrogen, carbon or tungsten. Ceramic implant systems have the general advantage of high biocompatibility and, therefore, good tolerance, with the expressed allergenic potential being small. The surface is considerably unfavorable for the growth of bacteria, so that implants of this type, in their entirety, are particularly favorable for long-term applications and long periods of retention in the patient's mouth. In addition, there is almost no gray discoloration in the surrounding fabric, so that aesthetic effects of particularly high quality can be achieved.
    [0009] Dental implants based on ceramics are certainly known today, in essence, only in part. The material properties of the ceramic components (eg, toughness, high, small to no ductility) make it difficult to bond and almost exclude high durability and long-term stability of multi-part implant systems. In particular, due to the small elastic deformation capacity and the lack of plastic deformation capacity of ceramics, precisely in material hardness (according to Vickers) of more than 500, or even more than 1000, a superficial contact of the components between them, therefore, can only be carried out in a very difficult way, such that, just during the transmission of the relatively large masticating forces, point loads may arise in the contact area of the implant parts of multi-part systems. These forces, in turn, can lead to increased local pressure in the connection area and, as a result, to the possible formation of micro cracks or damage to the ceramic structure, which in turn can lead to fractures or breaks in the components . The basic advantages of multiple dental implant systems, therefore, for ceramic-based systems today can only be useful in a very limited way.
    [00010] Therefore, the invention has the task of indicating an implant system - executed, preferably, in two or more parts - of the type mentioned above, which also in the case of the use of ceramic based materials or comparable to those in its basic material properties enable special stability and a long period of use for at least one of the implant parts. In addition, a particularly suitable manufacturing process for the implant system must be indicated.
    [00011] With reference to the implant system, this task is solved with the characteristics of the invention. In this case, the connecting pin is formed of a material with a hardness of at least 500, preferably of at least 750, particularly preferably of at least 1000, and in a contact area for the receiving channel on its surface has a coating, preferably as a spacer, formed of a softer material compared to the material of the connecting pin, in particular, with a hardness of at most 25, preferably a maximum of 20, particularly preferably a maximum of 15. For the formation of a connection with closure due to the material with the coating, in its surface area provided with the coating, in this case, the connection pin is executed porous, preferably with a porosity of at least 0.1. The hardness values mentioned in this case must be understood as hardness values according to Vickers on the basis of a test force of 10 kilograms force according to DIN standard, ie the mentioned hardness value of 500 corresponds to , for example, to a standard indication of 500 HV 10.
    [00012] Advantageous configurations of the invention are indicated in the embodiments.
    [00013] The invention starts from the consideration that, in the case of multi-part implant systems, high stability and longevity can be achieved, then, if the forces that arise precisely during chewing are properly taken into account. Precisely during the transmission of these forces in dental implant systems of several parts, from the structure part to the support part anchored in the jaw bone, a transmission of forces must be ensured, saving the material. This can be achieved, in particular, by the fact that, consequently, superficial contact is produced between the implant parts through considerable avoidance of localized contact points. In contrast to metal-based systems, in which such a surface contact, due to the elastic deformation capacity and the ductility of the material adjusts almost automatically in reaction to the applied forces, the surface contact in ceramic-based systems, due to the lack of ductility of the material, and with respect to existing tolerances and production irregularities, almost necessarily could be only insufficient.
    [00014] In order to properly oppose, from now on an additional element is provided in the assembly of the dental implant system, which in the type of a compensation body must prevent the formation of local, punctual contact points between the implant parts. The spacer provided for this, with respect to your choice of material, must be predetermined in such a way that - due to the appropriate ductility - it produces an appropriate compensation in the intermediate space between the implant parts and, thus, ensures a transmission of force between components. In addition, the material of the spacer must be chosen correspondingly softer and therefore more deformable than the material of the implant parts themselves.
    [00015] In principle, the spacer could be executed, in turn, as a network of material wires connected with the connecting pin with closure due to the material, therefore, for example, glued or fused, in such a way that it exists, in particular, in the form of a mesh-like coating. Thus, on the one hand, a reliable adjustment of an appropriate minimum interval is possible, which possibly compensates for surface roughnesses that arise conditioned by the production of the contact surface, while, on the other hand, in the still free intermediate spaces formed by the fabric are formed, volumes suitable for receiving material. These spaces are appropriate, in a special dimension for receiving excess material, for example, adhesive or similar. A spacer made of similar size, similarly seen as inventive, is therefore particularly suitable for bonding the implant parts together.
    [00016] Now, however, the spacer is executed as a coating applied on the surface of the connecting pin. In this case, the coating can be placed partially or in the form of a mesh on the surface of the connecting pin, but advantageously, it is carried out continuously and along the entire surface. This results in a run along the entire surface of the spacer on the connecting pin. In such an execution, the spacer is also suitable for bonding the implant parts together, as well as for producing a connection using screws, since in this case the spacer can also still cause damping during the transmission of force between the implant parts screwed together.
    [00017] For good processing capacity, in this case, the spacer is connected with closure due to the material, therefore, in particular, as a coating or element glued or fused, with the connecting pin. In a similar way, of course, the spacer can also be applied in the type of an inner liner on the inner side of the receiving channel, such that, likewise, after an assembly of the implant parts, it can be positioned between these parts, in the connection area of the implant parts to each other. In addition, a combination of two spacers is also possible, therefore, respectively, one in each of the two implant parts.
    [00018] In order to ensure also during assembly with relatively high compressive forces and in a short assembly time, reliable positioning of the coating that forms the spacer, as well as special long-term stability and reliable adhesion of the cladding, the closing connection due to the material of the spacer with the connecting pin (or, in a similar way, the internal surface of the receiving channel) is made particularly narrow. For this, in the area of its connection with the spacer, or in the area of the coating, the connection pin has a rough and / or porous surface. The porosity of the surface produced, in particular, by the roughness, in this case, is configured in such a way that a porous surface appears precisely in the area of the connection with closure due to the material of the connection pin with the coating, preferably with a porosity with a structure size of at most one micrometer, alternatively or additionally, preferably with a porosity of at least 0.1. Due to a surface of this type, kept porous, it is ensured that, precisely in combination with a choice of material suitable for the coating, its material can penetrate, at least partially, the hollow spaces on the surface conditioned by porosity and, thus, appears a closure due to the particularly narrow material. The porosity indicated with 0.1 was calculated using the following formula:

    [00019] In this case, the letters of the Greek alphabet used here represent: cp = porosity, p = gross density, p0 = pure density.
    [00020] In this case, porosity is a dimensionless dimension. It represents the ratio of volume of hollow space to total volume of a material or mixture of material, and is defined as 1 minus the ratio of gross density of a solid body and pure density.
    [00021] In this case, after manufacturing itself, therefore, in particular, in the context of an additional treatment step, advantageously, the roughness is applied on the surface. Advantageously, in this case, in the area of the connection with closure due to the material with the spacer, the surface of the connection pin has a ra value of a maximum of 10%, preferably of a maximum of 5% of the thickness of cladding or spacer layer. In other words: the average surface roughness is, advantageously, a maximum of 10% of the layer thickness of the coating or spacer. The roughness can be carried out, for example, mechanically (for example, by blasting such as, for example, sandblasting) chemically (for example, by caustic means) or by irradiation with a laser beam, preferably with a femtosecond laser beam. Precisely through irradiation with a laser beam, which has a pulse duration of less than approximately 1 ps, in this case, target structures or models of structure can also be applied on the surface to be coated, and in addition, it can still be applied. deeper damage to the underlying material is avoided, therefore, in particular to the ceramic.
    [00022] In order to provide a reliable mechanical connection between implant parts with high tightness, advantageously, the connection pin has an external contour in the cross section adapted to the coordinated reception channel contour. Viewed in the longitudinal direction of the connecting pin or the receiving channel, both can also be made with a stable cross section, therefore, for example, with a cylindrical base body. Advantageously, however, the cross sections are reduced in the direction of the free end of the connecting pin, in a particularly advantageous configuration, in conical execution, in such a way that, in a particularly simple way, a good closure can be obtained due to the force with high tightness. In another advantageous embodiment, the external contour of the connecting pin - and correspondingly, the receiving channel in its internal contour adapted to it - presents in the cross section, at least part or section, a multiple symmetry. With this, on the one hand, in the type of an indicator, in a simple way, a reliable rotational alignment of the structural part can be obtained during assembly, therefore, during placement in the patient's mouth, and, on the other hand, in the type of a rotational block even during the introduction of high torsional moments in the system, the chosen rotational alignment in the vicinity of the tooth remains reliably maintained.
    [00023] With regard to its layer thickness, the spacer is advantageously dimensioned in such a way that, on the one hand, too much flexibility and deformation capacity of the whole system is avoided as a result of the layer thickness being too large. and, on the other hand, a reliable compensation of surface roughness and production tolerances is ensured. In this case, preferably, account should also be taken of the circumstance that, precisely in the case of conical connections between the structural part and the support part, the elastic deformation capacity of the support part serves to compensate for the conditioned angle tolerances to production with respect to the cone angle. In the case of traditional, multi-part metallic implant systems, the angle tolerances in this case are usually dimensioned in such a way that the angle of the cone of the mold cavity in the support part is less than the angle of the cone of the pin contact molded on the structural part.
    [00024] In the case of bolted systems, then, when tightening the connecting screw, the wall of the support part deforms in the elastic area, in such a way that a superficial contact of the contact surfaces occurs, one in the other. Since in the case of ceramic materials, due to the lack of deformation capacity and its great hardness (according to Vickers), for example, more than 500 or even more than 1000 ("Vickers hardness", HV ) this is not possible, the covering provided as a spacer must allow for these compensations. For the aforementioned reasons, in the advantageous execution, with reference to the otherwise current design parameters of dental implant systems (total length, diameter of the support part, etc.), a layer thickness of at least 0.001 is envisaged. mm, preferably at least 0.05 mm, particularly preferably at least 0.01 mm and / or at most 0.3 mm, preferably at most 0.2 mm, so particularly preferred of at most 0.1 mm.
    [00025] Regarding the choice of material, the respective components, in particular, the implant parts are chosen appropriately, in an advantageous manner, with respect to a high long-term stability precisely in the intended application medium and also with regard to particularly good tolerance and biocompatibility. For the spacer, in this case, for example, a sufficiently soft metal, preferably gold, can be chosen, in particular, with regard to the choice of material of the implant parts themselves. However, also in order to allow a completely metal-free execution of the implant system, in a particularly advantageous execution, the spacer is made of a synthetic material, preferably a high-load thermoplastic synthetic material from the ketone group. polyester, in particular, polyesteretercetone, also known as PEEK. PEEK generally has a hardness according to Vickers of approximately 12, and thus fulfills the design criteria now foreseen in a particularly satisfactory way.
    [00026] In further improvement or advantageous alternative, the synthetic material that forms the spacer has an elastic modulus of at least 1000 MPa. This makes the spacer hard enough to withstand the forces that arise during chewing, so that plastic deformation and "swelling" of the material are avoided.
    [00027] In order to avoid a swelling of the material after placement in the patient's mouth and, in particular, a crack formation possibly caused by such a swelling in the implant parts, in additional execution or advantageous alternative, the synthetic material that the spacer has a water absorption of at most 1%, preferably at most 0.5%, particularly preferably at most 0.2%.
    [00028] With regard to usual norms and regulations in general, during therapeutic assistance to the patient, the components of the implant system are advantageously designed for a problem-free sterilization capacity. For this purpose, the synthetic material forming the spacer advantageously has a softening temperature of at least 140 ° C, preferably at least 160 ° C, particularly preferably 300 ° C, so so that unrestricted hot steam sterilizations can be carried out (usually at a temperature of 134 ° C), depending on the need once or also several times.
    [00029] The connecting pin is preferably formed of a ceramic, in particular, zirconium oxide, in such a way that, in all, a high stability of the system is ensured. Such a ceramic connecting pin with applied surface coating is particularly advantageous for use in combination with a support part or a receiving channel of titanium or a metallic material, since, in principle, in the case of coupling of ceramic / metal material, in particular ceramic / titanium, due to the clearly greater hardness of the ceramic needs to be calculated with abrasion of the metal and corresponding surface and color changes. Precisely the ceramics mentioned usually have a hardness according to Vickers ("Vickers hardness", HV) of more than 1000. Since the effects mentioned already in ceramics with a Vickers hardness of 500 or more occur in a reinforced way, already for this reason, the spacer provided as an intermediate or damping element is particularly advantageous. The mentioned effects, in particular, surface abrasion, can be effectively avoided, in particular, by means of the surface coating that acts as a spacer between the ceramic, on the one hand, and the metal, in particular, titanium, on the other hand .
    [00030] In particularly advantageous execution, however, for the implant parts as a whole, a ceramic, in particular, zirconium oxide or aluminum oxide, is used, in any case, as the main component, so an exempt base body is prepared of metal. Such materials are characterized by extraordinary biocompatibility, and offer a surface resistant to bacteria. In a particularly advantageous execution, in this case, the connecting pin is made of yttrium oxide and / or aluminum oxide stabilized zirconium oxide, whereas in another advantageous execution, the surface of the connecting pin in the area of the connection with the spacer closed due to the material, it presents a depletion zone with a part of yttrium oxide or aluminum oxide reduced in relation to the internal volume of the connecting pin.
    [00031] For the production of such a depletion zone, preferably, a ceramic body can be treated by means of laser treatment and / or in a liquid and / or gaseous medium, preferably in an acid bath , and the acid bath is treated with ions, which are constituted, respectively, of an element of the main group from V. to VII. of the periodic system of the elements, or comprise such an element as a component. Through this treatment a ceramic body is obtained, in which in a surface area, with respect to a structural parameter, in particular, an alloy component or part of the crystallographic phase, there is a depletion zone, in comparison to the internal volume.
    [00032] As has been proven in a totally surprising and unexpected way, precisely this process leads to the formation of surface structures, which guarantee particularly favorable wetting properties, and in the case of using the ceramic body as a support body for the spacer enable particularly good adhesion of the coating provided as a spacer.
    [00033] Through the treatment of the ceramic base body in the caustic type and, in particular, intercrystalline caustic, it forms, because a specific nanostructure on the surface. In this case, a plurality of relatively smaller pores or cavities with an average expansion in the submicrometer area should be found, preferably less than 500 nm and in particular less than 250 nm. Such structures can be proven, for example, with the aid of electron microscopic receptions. The surface is characterized, in particular, by the fact that the depth of the nanostructure, therefore, the depth of the pores that can be made in this case, is greater than the width of the structure, therefore, the lateral expansion characteristic of the structures obtained. Thus, the expected porosity of the surface, therefore, can be prepared with particularly favorable properties for the highly requested desired connection with closure due to the material.
    [00034] The ratio in the nanostructure between the depth of the structure and the width of the structure is more than 1: 1, advantageously, greater than 1.5: 1 and in particular, greater than 2: 1.
    [00035] The depletion zone provided advantageously in the surface area, which ultimately produces the desired structure and the desired properties in connection with the spacer material can be produced, in particular, by selective highlighting or, at least, selectively accelerated from individual components, for example, chemical elements and / or surface oxides, preferably by means of an appropriately chosen caustic process. Favorable structures of this type can be produced, in particular, by the fact that individual elements and / or individual metal oxides found in ceramics (zirconium oxide, aluminum oxide, yttrium oxide, hafnium oxide, etc.) in particular, yttrium oxide and hafnium oxide can be released from the surface. As a result, a zone of depletion of these metal oxides appears above and / or in the area close to the surface limit.
    [00036] In addition, it has been shown during the analysis, with respect to the phase properties that, through one of the treatments described above, on the surface the relationship between the tetragonal and mono-clinical phase has changed in zirconium oxide stabilized. After the sintering process, through such a process, the part of the mono-clinical phase can be increased or reduced on the surface to or around at least 0.1%, advantageously to or around more than 0.5% and, in particular, to or around more than 1.5%. Since the surface is placed under pressure due to the lower density of the monoclinic phase, the formation of initial cracking is inhibited in such a way that an increase in initial strength can be counted on.
    [00037] The production of the expected depletion zone on the surface of the ceramic body can occur, in particular, through a caustic process in an appropriately chosen acid bath. The reaction partners foreseen for the ceramic of the base body, therefore, the ions with components of the main group from V. to VII. of the periodic system of the elements, in this case, they can act as salt formers for the respective metal. In particular, the acid bath can comprise ions, which are made up of the elements nitrogen (N), oxygen (O), fluorine (F), chlorine (Cl), sulfur (S) and / or phosphorus (P), or encompass these elements as components. During the treatment in the acid bath there is a possibility that the acid ions will chemically alter the surface and remain as impurities on the surface.
    [00038] With reference to the process for manufacturing such a dental implant system, the mentioned task is solved by the fact that, before the production of the connection with the spacer with closure due to the material, the connection pin is roughened in its surface, in the area of the intended connection with the spacer.
    [00039] The roughness, in this case, can be carried out in an advantageous way, by means of irradiation with laser beam or by sandblasting. But it is particularly advantageous if, prior to the production of the connection with the spacer with closure due to the material, the connecting pin is made porous on its surface, in the area of the intended connection with the spacer, preferably by means of a caustic process.
    [00040] Advantageously, to apply a coating on the connecting pin provided for the formation of the spacer, a dispersion is applied to this pin, which is then dried. In the dispersion, advantageously, the particles foreseen for the formation of the coating are prepared in solution with a particle size of up to 20 pm. The dispersion can then be sprayed or in another way, it can be applied appropriately, after which, advantageously, a drying step can take place at a drying temperature of, for example, approximately 150 ° C. In this way the components of the solvent are volatized, in such a way that the particles of material are condensed and thereby form the coating. In this case, drying preferably takes place in a vacuum or under low pressure, such that the formation of air inclusions is kept particularly small. In particular, since such air inclusions could block the material from entering the pores of the surface of the support body, therefore, a deep, closed connection due to the material is particularly favorable.
    [00041] In another advantageous embodiment, preferably, after drying, a heat treatment of the connecting pin equipped with the coating is provided at a treatment temperature above the softening temperature of the coating material, preferably at least 350 ° C, particularly preferably at least 400 ° C. This can result in homogenization in the type of a melting of the applied material, and eventually, at the same time, a penetration of the coating material in the surface pores or surface roughness in the connecting pin is favored. Such a treatment is particularly favorable and effective for layer thicknesses up to approximately 0.1 mm. Alternatively, for a layer thickness greater than 0.1 mm, a powder coating could also be provided.
    [00042] The advantages obtained with the invention consist, in particular, in the fact that, through the spacer provided in the connection area between the connecting pin and the receiving channel, inaccuracies and production tolerances in the components can be compensated, in such a way so that even in the case of using ceramic materials for the connecting pin, or also for the implant parts in total, a superficial contact between these parts can be produced. In this way, even with regard to the high masticating forces that arise, reliable transmission of forces is possible, in such a way that the use of ceramic materials in themselves desirable is also possible in multi-part dental implant systems.
    [00043] Also in other areas of application of ceramic materials, in particular, on the basis of zirconium oxide, a predicted porosity, at least in the surface area of at least 0.1, is particularly advantageous in order to be able apply an adhesive coating of a synthetic material, in particular PEEK. The advantages of a synthetic-based coating over a ceramic-based body are, in particular, in changing chemical properties and, in particular, resistance to acids. With reference to changes in mechanical properties, mention should be made in particular of the introduction of optimized force / force transmission. But also changing the friction value p by means of an adherent coating provides clear advantages in applicability, in particular, compared to other metallic materials.
    [00044] An example of carrying out the invention will be clarified in detail, with the aid of a drawing. It shows: In FIG. 1 to 3, respectively, a dental implant system as an explosion design, In FIG. 4, the dental implant system according to FIG. 3 in the longitudinal section, In FIG. 5, a structural part of the dental implant system according to FIG. 1 to 3, in cross section, In FIG. 6, a support part of the dental implant system according to FIG. 1 to 3, in cross section, In FIG. 7, 8, a structural part of the dental implant system according to FIG. 1 to 3, in side view, In FIG. 9, 10, respectively, an alternative embodiment of a dental implant system and In FIG. 11, in the cutout, the connection area of the components of the dental implant system.
    [00045] The same reference numbers are shown in all figures.
    [00046] The dental implant system 1.1 ’, 1” according to FIG. from 1 to 4 is intended, respectively, for use in the jaw bone, in the place of an extracted or fallen tooth, in order to keep there a prosthetic part or a crown that serves as a prosthesis. The dental implant system 1, 1 ', 1 ”for this is executed respectively, in several parts and comprises a first implant part 2, 2', 2”, executed as the so-called support part, and a second implant part 4, coordinated with this part, provided for the placement of a piece of dental prosthesis also designated as a structural part. The first implant part 2, 2 ’, 2” or support part, in this case, on the external side is equipped with an external thread 6, which is designed, in particular, at the apical end 8 as a self-cutting screw thread. With this, the first implant part 2, 2 ', 2 ”or support part can be inserted by screwing it into the jaw bone at the predicted location.
    [00047] In order, after proper placement of the dental prosthesis piece or prosthesis in the structural part or in the second implant part 4, to make possible a placement in the support part or first implant part 2, 2 ', 2 ” with high mechanical stability, in the second implant part 4, a connecting pin 10 is molded, which can be inserted in a coordinated receiving channel 12, provided for in the first implant part 2, 2 ', 2 ”. Due to the insertion of the connecting pin 10 in the receiving channel 12, a mechanical connection of the implant parts 2, 4 between them appears. In this case, for a high mechanical stability, the connecting pin 10 is adapted in its external contour to the internal contour of the receiving channel 12, and, seen in the longitudinal direction, the two can be conical (example of execution according to Figure 2). Furthermore, as is provided, in particular, in the example of execution according to FIG. 1, the external contour of the connecting pin 10 -and, correspondingly adapted, the internal contour of the receiving channel 12 -can be executed, in the cross section, with multiple symmetry (in the example of six-fold execution), in such a way that, during the joining of the mentioned components, a rotating lock appears and, with this, a reliable rotating alignment of the structural part in relation to the support part can be adjusted. In the example of execution according to FIG. 3, 4, for that purpose an indexing or for the formation of a rotary lock on the end side on the connecting pin 10 an indexing element 14 is arranged with a cross section, in turn, with multiple symmetry, which in the assembled state meshes in a piece of the final channel 16 in the receiving channel 12.
    [00048] Dental implant systems 1, 1 ', 1 "in the execution examples according to Figures 1 to 4 are performed, respectively, for a screw connection of the implant parts 2, 4 to each other. this is provided, respectively, with a connecting screw 18, which engages in a screw thread 20 provided respectively within the first implant part 2, 2 ', 2 ".
    [00049] Regarding your choice of material, the implant parts 2, 4 are adapted appropriately for the purpose of use and, in principle, are made of ceramic material such as, for example, zirconium oxide or aluminum oxide. In particular, yttrium-stabilized zirconium oxide is chosen as the material for connection pin 10. This oxide has a relatively high hardness of 1500 + -100 according to Vickers ("Vickers hardness", HV). However, due to the low elastic deformation capacity and the lack of plastic deformation capacity of a hard material of this type, it is assumed that there is no surface contact between the implant parts 2, 4, precisely in the area of the connection 10. In this case, it is precisely in the transmission of the relatively large masticating forces that punctual loads can occur in the contact area of the implant parts 2, 4. In turn, these loads can result in high local pressure in the area of implantation. bonding and, as a result, result in the possible formation of microcracks or damage to the ceramic structure which, in turn, can lead to fractures or ruptures in the components. Furthermore - just in a combination of a ceramic connecting pin 10 with a metal support part 4 - due to the great difference in hardness between the components, metal abrasion in the support part could occur, which could lead to dirt and / or undesirable discolorations or similar.
    [00050] In order to properly oppose as an additional element, in the assembly of the dental implant system 1, 1 ', 1 ", in the type of a compensation body or spacer 22, the connecting pin 10, in an area of contact in the receiving channel 12, on its surface 24, is equipped with a coating 26 as shown in the cross-sectional drawing according to Fig. 5. In this case, as a design criterion for the coating 26, it is provided , it must be made of a material considerably softer than the material of the connecting pin 10, with a hardness (according to Vickers) of a maximum of 25. With this, - due to the appropriate ductility - the coating 26 establishes an appropriate compensation in the intermediate space between the implant parts 2, 4, in such a way that a transmission of superficial forces between the components is guaranteed.In the embodiment example, the coating 26 is made of synthetic material, that is, of a synthetic material d and high-load thermoplastic polyetheretherketone, also known as PEEK. PEEK normally has a hardness according to Vickers of around 12, and thus meets the design criteria now foreseen, in a particularly satisfactory way.
    [00051] Of course, with the same effect, in an alternative or additional way, the coating 26 can also be arranged on the inner surface 28 of the receiving channel 12 in the support part 2, or in the second implant part 4 as shown in the drawing of the cross section in FIG. 6.
    [00052] Preferably, the coating 26 provided for forming the spacer 22 is continuous, in the type of a coating over the entire surface. Alternatively, however, in the type of a net, mesh or similar, involving the connecting pin 10, it can also comprise a plurality of partial elements or partial coatings 30 which, by forming intermediate spaces 32 as structures in the form of mesh (FIG. 7), or also independent of each other (FIG. 8), are respectively connected with closure due to the material with the connecting pin 10 -or, in the case of laying on the inner side, with the inner surface of the receiving channel 12. In this way, on the one hand, through the partial elements or the partial coatings 30, it is possible to reliably adjust a minimum, appropriate interval, which compensates for the surface roughness, which arise possibly conditioned to the production, of the contact surfaces, between the contact areas, and, on the other hand, in the intermediate spaces 32, appropriate volumes are still formed for receiving material. In particular, these volumes are suitable for receiving excess material, for example, adhesive material or the like. Such a connection system carried out in this way is therefore particularly suitable for adhesive bonding of the implant parts 2, 4 to each other. This formation of receiving chambers for surplus adhesive can be further favored by the fact that, on the other side, respectively, shown in FIG. 9 for the receiving channel 12, and shown in FIG. 10 for the connecting pin 10 - other receiving chambers 34 are mechanically provided, in the embodiment according to FIG. 9, 10 in the form of continuous grooves 36 additionally made.
    [00053] In the two preferred variants, therefore, in an execution as a continuous coating 26 over the entire surface, as well as, in the case of an execution with intermediate spaces 32, a close connection with closure due to the material between the pin connection 10 and the inner surface 28 of the receiving channel 12, on the one hand, and the liner 26 that forms the spacer 22, on the other hand. In order to favor, particularly this, in this case, the surface of the connecting pin 10 is roughened and / or made porous in the area of the coating. As shown schematically in an enlarged cutout in FIG. 11, the roughness or porosity acts on the surface area, in particular, of the respective ceramic component, in such a way that a multiplicity of small chambers of material 38 is formed, into which the relatively soft material that forms the coating can penetrate. 26. This results in the desired narrowness of the connection with closure due to the material, in such a way that the coating 26 adheres particularly firmly to the surface that supports it. In this case, the aforementioned porosity or roughness of the surface can be produced by means of a particularly appropriate process, for example, by caustic means - occasionally specific to the material - through the objective adjustment of a depletion zone of a material parameter or a crystallographic or similar parameter.
    [00054] In the enlarged cutout representation in FIG. 11, the connection of the liner 26 with closure due to the material, obtained in this way, is shown schematically with the component that supports it, in the figure, the connecting pin 10. Through the roughness of the surface of the connecting pin, possibly connected with a depletion zone in the vicinity of the surface, which can be produced, for example, through intentional dissolution or caustic of individual substances or material components, a connection zone 40 appears, in which the material of the coating 26 penetrates into the pores, holes in the surface or the like on the surface of the correspondingly prepared connecting pin 10. Therefore, in this connection zone 40, the materials of the connecting pin 10 and, on the other hand, of the coating 26 are available together, in such a way that they form an intimate indentation. In addition, a concept of this type for the application of a coating on a surface, preferably ceramic, is seen, moreover, as a stand-alone inventive concept also for independent application areas of dental implants. Reference list 1, 1 ', 1 ”dental implant system 2, 2', 2” first implant part 4 second implant part 6 external thread 8 apical end 10 connecting pin 12 receiving channel 14 indexing element 16 piece end channel 18 connecting screw 20 screw thread 22 spacer 24 surface 26 coating 28 inner surface 30 partial coating 32 intermediate space 34 receiving chamber 36 groove 38 material chamber 40 connection zone
    权利要求:
    Claims (14)
    [0001]
    1. Dental implant system (1, 1 ', 1 ”) with a first implant part (2, 2', 2”) intended for insertion into a jaw bone, and with a second implant part (4) , coordinated with that part, provided for the placement of a dental prosthesis piece, characterized by the fact that the implant parts (2, 2 ', 2 ", 4) can be mechanically connected to each other through a connecting pin ( 10) molded in one of the implant parts (2, 2 ', 2 ”, 4), which can be inserted in a receiving channel (12) provided in the other implant part (2, 2', 2”, 4) , and the connecting pin (10) is formed of a material with a hardness (according to Vickers) of at least 500, and in a contact area for the receiving channel (12) on its surface it presents a coating (26) formed from a softer material compared to the material of the connecting pin (10), with a layer thickness of a maximum of 0.3 mm, and for the formation of a closed connection due to the material with the coating (26), in its surface area provided with the coating (26), the connecting pin (10) has a porous surface, and, in the area of the connection with the coating (26), with closure due to material, the surface of the connecting pin (10) has an RA value of at most 10% of the layer thickness.
    [0002]
    2. Dental implant system (1, 1 ', 1 ”) according to claim 1, characterized by the fact that the connecting pin (10) is made as a ceramic body, in which the porous surface is produced by a caustic process, and has a nanostructure with a plurality of pores or cavities with an average expansion less than 500 nm.
    [0003]
    3. Dental implant system (1, 1 ', 1 ”) according to claim 1 or 2, characterized by the fact that, in its surface area provided with the coating (26), the connecting pin (10) has a bonding zone (40) below the liner (26), in which liner material (26) penetrates the pores and surface holes of the porous surface of the bonding pin (10) and, on the one hand, the pin materials connection points (10) and, on the other hand, the covering (26), exist together within the connection zone (40), such that they form an intimate indentation.
    [0004]
    4. Dental implant system (1, 1 ', 1 ”) according to any one of claims 1 to 3, characterized in that the porous surface of the connecting pin (10) has a porosity of at least 0 ,1.
    [0005]
    5. Dental implant system (1, 1 ', 1 ”) according to any one of claims 1 to 4, characterized in that its coating (26) consists of a number of partial coatings (30) connected with the connecting pin (10) for closing due to the material.
    [0006]
    6. Dental implant system (1, 1 ', 1 ") according to any one of claims 1 to 5, characterized in that its coating (26) has a layer thickness of at least 0.001 mm, from preferably at least 0.05 mm, particularly preferably at least 0.01 mm and / or at most 0.2 mm, particularly preferably at most 0.1 mm.
    [0007]
    7. Dental implant system (1, 1 ', 1 ") according to any one of claims 1 to 6, characterized in that the coating (26) is produced from a synthetic material with an elasticity module of at least least 1000 MPa.
    [0008]
    8. Dental implant system (1, 1 ', 1 ”) according to claim 7, characterized by the fact that the synthetic material that forms the coating (26) has a water absorption of at most 1%, preferably, at most 0.5%, particularly preferably at most 0.2%.
    [0009]
    9. Dental implant system (1, 1 ', 1 ") according to claim 7 or 8, characterized by the fact that the synthetic material that forms the coating (26) has a softening temperature of at least 140 ° C, preferably at least 180 ° C.
    [0010]
    10. Dental implant system (1, 1 ', 1 ") according to any one of claims 1 to 9, characterized by the fact that the surface of the connecting pin (10) has an RA value of at most 5 %, of the layer thickness, in the area of the connection with the coating (26) with closure due to the material.
    [0011]
    11. Dental implant system (1, 1 ', 1 ”) according to any of claims 1 to 10, characterized in that its connecting pin (10) is made of zirconium oxide stabilized by yttrium oxide and / or aluminum oxide, and the surface of the connecting pin (10), in the area of the connection with the coating (26) with closure due to the material, presents a depletion zone with a part of yttrium oxide or oxide of reduced aluminum in relation to the internal volume of the connecting pin (10).
    [0012]
    12. Process for the manufacture of a dental implant system (1, 1 ', 1 ”), as defined in any one of claims 1 to 11, characterized by the fact that before the production of the bond with the coating (26) with closing due to the material, the connecting pin (10) is roughened on its surface in the area of the intended connection with the coating (26).
    [0013]
    Process according to claim 12, characterized in that the connecting pin (10) is exposed to a caustic process.
    [0014]
    Process according to claim 12 or 13, characterized in that for the application of the coating (26) on the connecting pin (10) a dispersion is applied, which is then dried
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    ES2573681T3|2016-06-09|
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    US9770311B2|2017-09-26|
    BR112013011856A2|2016-08-16|
    CN103327928B|2016-10-19|
    EP2640306A1|2013-09-25|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-08-20| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-05-26| B09A| Decision: intention to grant|
    2020-07-28| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/11/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DE102010051176.5|2010-11-15|
    DE102010051176A|DE102010051176A1|2010-11-15|2010-11-15|Dental implant system and method for producing a dental implant system|
    PCT/EP2011/005748|WO2012065718A1|2010-11-15|2011-11-15|Dental implant system and method for producing a dental implant system|
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