HK1098035A - Multi part non metal implant - Google Patents

Description

Multi-component non-metallic implant

Technical Field

The present invention relates to an implant comprising a first fixation component for insertion into a bone, and at least one abutment component providing a seat for a superstructure.

Background

The dental superstructure may comprise a replacement of individual teeth or a dental prosthesis. For intra-osseous dental implants, a distinction is made between so-called mono-stage and bi-stage systems. Typically, single stage implants are performed in a single surgical step, often for early filling, and double stage implants require two surgical steps, the first being the insertion of the implant component into the bone, which allows healing for a determined time, i.e. mainly tissue coverage, and the second being the reopening of the tissue where it can be performed, securing another implant component, which is used to accomplish the desired functional properties of the implant. The best choice is made for each patient, depending on the need and the corresponding medical concept. In a two-stage system, in the first stage, the first component is inserted into the jaw bone hidden under the gingiva, which allows the implant components to be safely osseointegrated without stress. In the second stage, another part (abutment) carrying the prosthesis or dental prosthesis is applied and mounted to the first part inserted into the jaw. The components anchored in the jaw bone usually have a suitable helicoidal or other macroscopic surface structure in order to obtain a firm initial anchoring in the jaw bone. A variety of metallic materials are known to be suitable for such components, but pure titanium, which is generally commercially approved for use in dentistry, or titanium alloys are more popular in practical use.

Many single-stage, single-part (single) implants made of zirconia ceramics are known in the art. Yttrium stabilized by zirconia ceramics has been demonstrated for many years for its mechanical strength and biocompatibility as a material for making dental crowns. A method for producing a zirconia crown superstructure is described, for example, in WO03/007834A 1. Particularly for those patients who are suffering from allergic reactions to metal dental implants, suitable use for single stage single zirconia dental implants is described in u.volz: ZZI, 2003; pages 19(3), 176 to 180. Typically, the crown or abutment is mounted to the implant by gluing.

Over the last years, different types of dental implants have been used in practice, which usually have a cylindrical shape or a shape somewhat similar to a natural tooth root. The upper end of an alumina ceramic dental implant such as that disclosed in US4,185,383A has a superstructure for anchoring a dental prosthesis. The dental implant comprises a cylindrical or rod-like member which can be implanted in the jaw bone and is repeatedly stepped from the head downwardly toward the root. Such dental implants have proven to be very good in practical use in the past and are known in the art as Tubingen implants. A metal post is glued to the implant.

From WO02/24098 a set of individual implants is known with angled struts for receiving a dental superstructure made of zirconium ceramic.

Generally, dental implants or superstructure elements made of zirconia ceramics are manufactured from powdered raw materials, moulded with suitable pressure to form a green body of a predetermined shape, and then sintered to a final density of the ceramic body. The sintered ceramic body can be treated by generally known machining and grinding, which also has the known disadvantages of scratching it with heavy tools and expensive machining times. However, machining of the internal structure of the sintered ceramic body, like internal threading, is extremely costly and is economically unacceptable for industrial mass production. Zirconium silicate oxide and zirconium aluminum oxide have been suggested as suitable compounds.

DE10159683a1 proposes a single-stage (monolithic) implant for zirconia ceramics, which provides in particular a threaded part with a plasma coating of ceramic or metal, in particular a titanium coating, for insertion into the jaw bone.

WO03/045268a1 states that ceramic implant components for insertion into bone have been found to be unsuitable, and in particular, it seems unlikely to provide zirconia ceramic fixation components as a replacement for known metallic two-stage implant components.

For a two-stage system, the most important thing concerns the mechanical coupling between the first component inserted into the jaw and the connection between the first component and the other component with the dental prosthesis superstructure extending into the mouth. The general requirement for such a connection is to have a damping and transfer function for high chewing forces in extremely small geometrical dimensions, without the connection between the implant parts loosening and being as bacterial-resistant as possible. Such a connection for a metallic two-stage implant is known in the prior art, for example a connection based on a cone is known in the US4,772,204A document corresponding to the WO85/02337 patent document and in the US5,674,072 document corresponding to the EP0707835 document.

Anatomical, biological and aesthetic aspects often require the use of mechanical connections between implant components, thereby eliminating any rotation or movement between the components. Due to the individual condition of the tooth arrangement in the mouth of the patient, not only is it not necessary to use, in the case mentioned, an angled mechanical connection between the component anchored in the bone and the component supporting the dental structure protruding into the mouth, but the aesthetic or functional characteristics even when the axes of the components are aligned with one another also emphasize the need for precise rotational positions of the components with respect to one another. This positional accuracy is generally unaffected by the simple threaded screw fittings described in some prior art documents since 1970. The aforementioned generic device allows in particular an infinite rotational positioning, but this requires a corresponding mechanical positioning function in the patient's mouth. One option is a set of dental implant components with a positive joint, such as a precision hexagonal or octagonal device that allows the two components to be rotationally positioned relative to each other in a predetermined position. Such a definite joint is described in the US5,199,873A1 documents corresponding to EP0438048, US5,125,840 and other patent documents.

Although this connection has the advantage that the adjustment work in the mouth of the patient is much smaller than that of the conical device, it also has the disadvantage that, after the final position of the support to which the dental prosthesis projecting into the mouth is applied has been predetermined in the healing phase, the rotational positioning is defined in stages and rotation of the position is prevented when the component is inserted into the bone and thus firmly anchored in the bone.

Another problem with positive-fit rotational locking is that tolerances must be incorporated in the production of such connecting elements to ensure that the connected parts can fit together properly, and therefore it is difficult, if not impossible, to actually provide a connection that is free of play under cyclic stresses caused by chewing loads applied with great force and at high cyclic rates. This can lead to small gaps occurring in the assembly structure at the beginning becoming larger with increasing functional cycles, leading to small gaps between the components, with the risk of bacteria penetrating the gaps and/or mechanical disintegration of the assembly.

An important problem with respect to dental implants has been described as the mechanical connection between the implant and the jawbone. All dental implants are subject to high occlusal forces which are cyclically applied to the implant over many years. Larger implants offer the advantage that forces can be transmitted to the bone over a larger surface area, and therefore mechanical stresses are reduced, whereas larger implants have the disadvantage that the remaining bone material is reduced and cannot receive the forces transmitted by the implant due to stress overload of the bone material. In addition, the shape of the implant has a great influence on the mechanical reliability of the implant, since the shape of the implant affects the direction of the force transmitted to the bone. Thus, many scientific works and many scientific publications and patent applications have been published over the past years in an attempt to provide a final solution or at least a direction to obtain an optimal solution for an individual patient specific state.

WO99/17675 and US6,280,193B1 disclose a method and apparatus for forming a cavity of an internal thread and a hexagonal part inside an implant component made of titanium oxide ceramic for insertion into the jaw bone of a patient. The internal shape is obtained in an initial moulding step as described above, in which a metal insert is mounted on the moulded upper part, the insert having a negative surface shape compared to the intended implant. The ceramic powder is pressed around the insert during the moulding step, the insert being removed after opening the mould. Both of the above documents describe various ways of removing the insert, including drilling it out. Another proposed method involves cooling the molded body in liquid nitrogen so that the insert can be easily removed.

US6,280,193B1 particularly points out that once the implant component has been molded, it is virtually impossible to properly drill a threaded hole. This publication particularly addresses the problem with non-ceramic implant components secured into non-threaded holes of ceramic implant components. However, the method requires high costs for preparing the molding tool and also requires relatively high production costs due to the many process procedures required.

Disclosure of Invention

It is therefore an object of the present invention to provide an improved dental implant comprising a dental implant component for insertion into a jaw bone of a patient, which implant component provides the dentist with the flexibility to prepare dental non-metallic restorations.

It has been found, quite surprisingly, that the connection arrangement according to the invention provides a better adaptation during the preparation of a dental prosthesis even for incompatible patients who can also tolerate medical metal implants.

The above and other objects are obtained by a two-stage implant comprising a fixation part for insertion into a bone, at least a further abutment part for providing a base for a superstructure of a dental prosthesis, and a connecting element for mechanically fixing the abutment to the fixation part, wherein the fixation part comprises an external thread or other protrusion for improved engagement between the fixation part and the bone, wherein the connecting element detachably interconnects the fixation part and the abutment, and wherein the fixation part and the abutment are made of at least a non-metallic material.

Preferably, the fixation component includes a recess or cavity for removably receiving the abutment and/or the connection means of the implant, and the fixation component further includes interlocking means within the recess or cavity for engaging corresponding interlocking means of the abutment and/or the connection means.

In a preferred embodiment of the invention, the non-metal is selected from ceramic materials, plastics or mixtures thereof, preferably the non-metal material is zirconia based on ceramic materials, which may also include yttria, or magnesia or calcia, preferably in an amount of up to about 8% by weight.

In order to easily and cost-effectively manufacture the base-to-individual implant, at least the above-mentioned cavities and interlocking means are manufactured by machining the green ceramic body, in particular if the dimensions of the green ceramic body during machining are a reproduction of the desired enlarged scale of the final product.

In a preferred embodiment of the invention, the ratio is varied in three dimensions, advantageously determined by a three-dimensional transfer function f (x, y, z). The three-dimensional ratio is preferably determined by the three-dimensional distribution of the density in the green body.

In order to increase the healing of the fixation means, it is suitable that the fixation means has at least a rough surface which is mechanically abraded, physically or chemically surface treated, in particular if the surface treatment comprises laser treatment and plasma etching.

Tissue integration is enhanced if at least a portion of the fixation element peripheral surface is provided with a coating comprising one or more of the following: biomolecule components, peptides, polypeptides, amino acids, polyamino acids, growth factors. It may also include a primary amino group, a secondary amino group, a carboxyl group, an amide group, a phosphorus group and/or hydroxyethylamine, or low molecular weight propylenediamine acid.

In a preferred embodiment, the coating comprises a composite having a region of collagen mimicking binding to cells and having enhanced cell binding relative to collagen, in any case the composite being effective to promote cell fixation to the fixation member.

Suitably, the coating comprises a synthetic peptide immobilised on the substrate, the peptide having a region mimicking collagen binding to cells and having enhanced cell binding relative to collagen. It has proved advantageous for promoting osseointegration if the coating comprises synthetic peptides having the sequence glycine-threonine-proline-glycine-proline-glutamine-glycine-isoleucine-alanine-glycine-glutamine-arginine-glycine-valine and/or if the coating comprises synthetic components having all or part of the biological activity compared functionally to P-15.

The preparation and use of such coatings is described in detail in US6,268,348A, the disclosure of which is hereby incorporated in its entirety. These coating compounds are structurally or biologically similar to small regions of collagen, and mimic the morphology recognized by collagen binders. The region referred to for the synthetic peptides of the invention is sometimes referred to as P-15 and includes all or part of the 15 amino acid residue (residue) of the alpha 1(I) chain of collagen, glycine-threonine-proline-glycine-proline-glutamine-glycine-isoleucine-alanine-glycine-glutamine-arginine-glycine-valine, and extends approximately 766-780 the residue of that chain. The P-15 region is not present in the form of a native fragment of collagen, nor is it a product of the breakdown of a native enzyme. However, the coordinates defining the three-dimensional surface or shape, including the presence of-isoleucine-alanine-in a beta bend (beta-bend) configuration, are given below. The surface or shape defined by these coordinates shows a certain biological activity. The dipeptide isoleucine alanine itself showed 60% of the biological activity of P-15. This ensures that the-isoleucine-alanine- β bend in the collagen isoform is critical for biological activity and does solely constitute an important part of the invented peptide.

The coating also contains synthetic components having biological activity that function like all or some portion of P-15. "functionally similar" refers to shape, size, and adaptation of a compound such that the biological activity of the compound is similar to the P-15 region, or a portion thereof. The biological activities possessed by the peptides include inhibition of collagen synthesis, inhibition of collagen binding, inhibition of cell migration. Of particular interest for the present invention are properties that increase cell binding. Useful compounds should be selected on the basis of having similar steric and electronic properties compared to P-15 or a portion thereof. These compounds are typically small amino acids of 100 or less molecules, or these compounds have a molecular weight range of up to about 5,000 daltons, more typically up to 2,500 daltons. The inventive compounds are described in terms of synthetic peptides, but non-peptides that mimic the necessary structure for identifying and shortening collagen-binding species are also contemplated within the scope of the invention. For example, a cyclic peptide on another compound, wherein the essential structure is non-peptide stabilized (e.g., a thioester) is also a way to practice the invention. The preparation and use of such coatings is described in greater detail at US5,958,428A, the disclosure of which is hereby incorporated by reference.

In a preferred application of the invention, the dental prosthesis is provided comprising at least one dental implant as described above.

The above and other objects are also achieved by a method of manufacturing a fixation component for an implant as described above, comprising the steps of: determining the desired dimensions of the final implant component, pre-sintering the green body to an average density that is lower than the average density of the final product to form a shaped green body, determining a three-dimensional density distribution within the green body, calculating a three-dimensional proportion function from the density distribution, machining the green body at the calculated three-dimensional proportion, and sintering the machined green body to the final density.

The present invention can very effectively treat human and animal bodies by using the implant and/or the fixing member as described above.

Drawings

The present invention will be more easily and clearly understood from the following description of the embodiments of the present invention.

Fig. 1 schematically shows a cross-sectional view of an implant according to the invention comprising an inventive implant component;

FIG. 2 is a side view of another embodiment of a dental implant of the present invention partially sectioned along an axial plane;

FIG. 3 is a view corresponding to FIG. 2, but with the attachment device inserted;

fig. 4 is a side view of a third embodiment of an implant component according to the present invention.

Detailed Description

Fig. 1 to 4 show various embodiments of dental implants as examples of the invention. Although each embodiment has its own advantages in use, common features of each embodiment are not described in detail. Therefore, similar features in different embodiments will be denoted by the same reference numerals. All descriptions of these embodiments are for purposes of illustration and are merely exemplary in nature. No description of parts or aspects in this regard should be construed as limitations on the claims.

In fig. 1, a two-stage, two-part dental implant is shown, which can be positioned step-less in its direction of rotation, comprising a first implant fixture part 1, which fixture part 1 has a central cavity opening 2, which fixture part 1 can be inserted into the jaw bone, and a second implant abutment part 3, which abutment part 3 can support a dental prosthetic superstructure (not shown) like a crown or a bridge. The second component 3 comprises a conical base element 4 for a dental prosthesis and a portion 5 cooperating with a central cavity 6 of the first implant component 1. The central cavity 6 in the first implant component 1 is conically shaped and the part 5 of the second implant component 3 that fits into the central cavity 6 in the first implant component 1 is a matching cone that fits into the opening 2 in the top surface 7 of the first component 1.

The second implant component 3 has a central bore 8 through the second implant component 3. A tapered cylindrical shaft of a tensioning screw 9 of reduced diameter is provided in the central bore 8. The screw 9 has a widened end with an external fastening thread 10, which fastening thread 10 cooperates with an internal thread 11 of a blind hole 12. The central seating opening 2 of the first implant component 1 includes a blind bore 12, the blind bore 12 being an elongate region beyond its required depth to accommodate the tapered cone 5 of the second implant component 3, which region also accommodates the tip of the screw 9.

Each of the two implant components 1, 3 defines a longitudinal axis 13, 14, respectively. The axes of the two conical portions 4, 5 of the second implant component 3 are generally aligned with each other, but these axes may form an angle under certain implantation conditions.

It has proven to be advantageous if the angle of the conical cavity 6 of the first implant component 1 and the angle of the portion 5 of the second implant component 3 fitting within this conical cavity 6 are selected to produce a self-locking cone connection. The angles are thus virtually equal.

The first implant component 1 has a substantially cylindrical outer configuration with a rounded end 15 along the spherical shape and a specially modified geometric thread 16 (e.g. with a varying flank depth), as described at US5,674,072A, the contents of which are thus also incorporated herein. The outer surface of the implant member 1, except for its top region 17, may be roughened by abrasive machining, physical or chemical surface treatment, such as laser treatment and plasma etching. The roughness of the surface increases the osseointegration of the implant component 1. The outer circumferential surface of the implant member 1 may also be treated by etching in a suitable acidic composition. The fixation member 1 may also be provided with a porous or micro-rough coating, such as a hydroxyapatite coating.

However, the top 17 of the fixation component 1, and in particular the top surface 7 of the first implant component 1, may be micro-roughened, preferably with an arithmetic average RA of the roughness of about 0.7 μm to about 1.1 μm.

The surface of the fixing element 1 can be provided with a coating, either directly or by means of a porous or micro-rough coating as interlayer coating, wherein at least a part of the circumferential surface of the fixing element 1 is provided with a coating. The coating may include one or more of the following: biomolecule components, peptides, polypeptides, amino acids, polyamino acids, growth factors.

The optimal coating comprises a compound having a region of collagen mimicking binding to cells and having enhanced cell binding relative to collagen, which compound, in general, is effective to promote cell attachment to the fixation member. Preferably, the coating comprises a synthetic peptide immobilized on the substrate, the peptide having a region that mimics collagen binding to cells and having enhanced cell binding relative to collagen. More preferably, the coating comprises synthetic peptides having the sequence: glycine-threonine-proline-glycine-proline-glutamine-glycine-isoleucine-alanine-glycine-glutamine-arginine-glycine-valine.

The coating comprises a suitable synthetic component having a biological activity functionally comparable to all or part of P-15.

Since the taper angle is matched to the friction ratio of the taper connection and to the central tensioning screw 9 aligned with the axis 14 of the taper 5, the taper connection enables the implant parts 1, 3 to be joined together firmly in a play-free, rotationally stable connection, the rotational position of the two implant parts 1, 3 being freely and steplessly selectable during assembly.

The first and second implant parts 1, 3 are made of a non-metallic material, preferably selected from ceramic materials, plastics, mixtures thereof or compounds thereof.

Preferred non-metallic materials are ceramic materials of zirconia which may include yttria, preferably not more than 8% by weight thereof, or magnesia or calcia. Zirconia may be included as a main component, or may be a mixture of zirconia and alumina.

The fixation component 1 is preferably obtained by determining the desired dimensions of the final implant component 1, pressing and pre-sintering a green blank of powder composition as described above to an average density lower than the average final product density to form a shaped green blank, wherein the pre-sintered green blank is able to withstand the machining forces without loss, then determining the three-dimensional density distribution in the green blank, calculating a three-dimensional scaling function from the density distribution in the green blank, machining the inner cavity 6 of the green blank in particular according to the calculated three-dimensional scaling, sintering the machined green blank to a final density to obtain the fixation component 1, optionally roughening and/or coating at least a part of the surface of the sintered fixation component 1 as described above.

During machining, the dimensions of the pre-sintered green body are a reproduction of the desired enlarged scale of the end product, wherein the scale is varied in three dimensions, preferably determined by a three-dimensional transfer function f (x, y, z) determined by the three-dimensional density distribution within the pre-sintered green body.

The first implant component 1 can be anchored first in the bone by means of an external thread 16, which during the healing phase is surrounded and stably supported by the bone structure, the geometry of the flanks of this external thread 16 varying over the length of the implant 1. The particular shape of the external thread 16 is such that the chewing forces are distributed in a direction perpendicular to the surface of the threaded flanks and directed to the depth of the bone in conformity with the shape of these flanks, which varies over the length of the implant 1. This positive fit is supported by the lower recess and the microstructure over the entire surface, which is in contact with the cancellous bone. The internal thread 11 cooperates with the thread of the central tensioning screw 9.

The second implant component 3 has two cylindrical truncated cones 4, 5 mounted one on the other by their bottoms, the truncated cones 4, 5 having axes 14 aligned or forming an angle with each other, one of the two truncated cones 5 fitting into the central cavity 6 of the first implant component 1 anchored in the bone, while the other truncated cone 4 supports the dental prosthesis.

By means of a standardized, equally dimensioned conical connection, parts 1 anchored in the jaw bone and having different geometries, for example with different diameters and lengths, are possible to freely engage with the part 3 projecting into the mouth, so that the individual condition of the patient to be treated can be adjusted to a high degree with a relatively small number of parts.

The invention will be described in more detail with reference to a further embodiment shown in the accompanying drawings, in which:

fig. 2 shows a half in front view in the form of a rod or column, half as a part 1 of a dental implant fixture component, sectioned along the longitudinal axis, wherein the implant component 1 can be anchored in the jaw bone and receives in its cavity 6 a head, which is part of the connecting means 3, which is coupled to the column 1. The head may be a two-piece structure, a bonding tool 9 and a crown support 3, which may also be integral with each other.

The second part 3 with the crown support 18 has an outer surface tapering towards the post 1. The bottom surface of the part 3 is thus smaller than it would be in a cylindrical configuration having the same outer diameter as the column 1. Due to this "shrinking" of the bottom surface, it is easier to handle, in particular to grind or flatten the surface in the machining step of the manufacturing method described in the first embodiment.

The implant member or post 1 is preferably made of a non-metallic material as described in the first embodiment of the invention. The column 1 has a stepped profile with successive steps decreasing in diameter towards the root end 15 of the column 1. The top portion 17 adjacent the top end 19 has a cylindrical outer surface and the three different steps 20, 21, 22 are self-tapping for rotation and insertion into the jaw bone. The three threaded steps 20, 21, 22 each have substantially the same length.

In the embodiment shown in fig. 2 and 3, each of the thread steps 20, 21, 22 is provided with at least about three thread pitches (thread flight) so that only three turns are required to tighten it. Since the post 1 is simply inserted into the stepped hole 23 in the jaw bone leaving only one step length exposed and then screwed in with only one step length by three turns, the operation time is reduced and there is no fear that the cortex will be damaged with the screw thread.

The recess or cavity 6 provided inside the implant member or post 1 comprises a hexagonal shaped portion 24 with a flat surface. This portion 24 is intended to receive an inserted tool, such as the "Inbus" key of a hexagonal screwdriver, so as to apply torque about the longitudinal axis 13 in order to implant the column 1. Of course, the portion 24 can also be shaped to receive a tool with other configurations in order to insert the post 1 into the mandible and screw it down to a depth corresponding to the length of one step and then into the drilled hole 23.

Furthermore, the portion 24 may be tapered along the axis 14, as described in the first embodiment of the invention, to provide a combination of hexagonal or octagonal coupling surfaces as the seat of the conical coupling loosens.

Towards the root end 15, the cavity 6 contains an internal thread 11, which internal thread 11 has a smaller diameter than the portion 24. The internal thread 11 is longitudinally spaced from the portion 24. Damage to the internal thread 11 by tools designed for the portion 24 is thus reliably prevented.

Although the shape of the threads 20, 21, 22 on the outer surface coaxial with the longitudinal axis 13 as described above has proven practical, it is within the scope of the present invention to use a structure in which the gap is present on the outer surface, corresponding to US patent 4,185,383. The second implant component 3 or the attachment means is securely coupled to the post 1 by means of a screw 9, the root end 10 of the screw 9 engaging with an internal thread 11 of the post 1. The cavity 6 is advantageously plugged by a temporary screw or the like (not shown) as soon as the post 1 is implanted. After the post 1 has been placed in the jaw bone, much of the gingival tissue that has grown over the top surface 7 is incised, the temporary screws are again removed, whereupon the connecting device 3 is introduced into the cavity 6 and fixed by means of the screws 9 in the manner shown.

The dashed lines indicate a stepped bore 23 in the jaw bone, the upper edge 25 of the stepped bore 23 likewise being indicated by dashed lines. The bar 1 shows a position in which the jaw bone has been inserted and only one step length is exposed to the outside. As can be seen, the bore 23 has four steps, each of which has a diameter at least equal to the outside or crest diameter of the thread of the steps 20, 21, 22 of the column 1, the column 1 being screwed into the next following step of the bore 23. The post 1 has been inserted three quarters of the full length of the stepped bore 23 so that precise alignment with the longitudinal axis 26 of the bore 23 is established. The column 1 can then be reliably threaded into more than one step length without particular difficulty and without special methods for guiding the column 1.

In fig. 3, the second part 3, which is part of the connecting device, is inserted into a blind hole 12 in the column 1. The longitudinal hole 8 for coupling the screw 9 to the column 1 can be easily seen here. The longitudinal bore 8 has an annular shoulder 27 for engagement with the head of a connecting screw 9, which connecting screw 9 together with its external thread 10 is screwed into the internal thread 11 of the column 1. The upper edge 25 of the jaw bone is shown in dashed lines. The upper end 19 of the column 1 extends upwardly a distance beyond the upper edge 25 of the bore 23. The top surface 7 of the post 1 and the attachment means 3 are thus positioned in the gingival area.

The second part 3 of the connecting device is inserted into the cavity 6 and the cooperation of the outer surface of the cavity 6 with the side of the hexagonal portion 24 ensures the counter-locking of the connecting device with respect to the post 1.

The implant parts as shown in fig. 2 and 3 have a stepped top surface provided with an inner, upwardly directed first top surface 28 and an outer, second top surface 7, respectively. The top portion 17 of the first implant member 1, and particularly the outer portion 7 of the first implant member 1, and preferably also the inner top surface 28, may be micro-roughened, preferably with a roughness RA of about 0.7 μm to about 1.1 μm, and preferably 0.7 μm to about 0.9 μm. This roughness is preferably obtained by the processing described in connection with the first embodiment of the invention.

Alternatively or additionally, the surface of the fixation part 1 may be provided with one or more coatings as described above in connection with the first embodiment of the invention.

The first top surface 28 of the implant member 1 surrounding the opening 2 of the cavity 6 is generally disposed perpendicular to the longitudinal axis 13 of the implant member 1, and depending on the size of the implant member 1, the top surface 28 is preferably at least 0.2mm wide.

Fig. 4 shows another embodiment of the implant fixture unit 1 according to the present invention. This type of implant is specially designed to form part of a platform-like system, while allowing to provide a single-sized fixation part 1 inserted into the jaw bone in combination with a plurality of sizes of abutment parts 3, the abutment parts 3 forming connecting means to support the dental prosthesis superstructure. In this regard, it is preferred that the outer diameter of the abutment 3 interacting with the top surface 7 of the first implant component 1 does not exceed the diameter of the top surface 7 of the implant component 1 inserted into the jaw bone. In contrast, it has been found desirable to use a smaller diameter connection device instead. The individual condition of the patient to be treated can then be adjusted to a high degree with a relatively small number of components, so that correspondingly large implant components 1 which reduce the mechanical stresses in the bone can also be used to accommodate only small dental prosthesis parts in the mechanical conditions required for the jaw bone.

Also the top surface of this type of implant, depending on its size, may be a stepped arrangement with an inner upward first top surface 28 and an outer second top surface 7. The top portion 17 of the first implant component 1, and in particular the outer portion 7 of the first implant component 1, and preferably also the inner top surface 28, may be micro-roughened as described in other embodiments of the invention.

Alternatively, or in addition, the surface of the fixation part 1 may be at least partly provided with one or more coatings as described in other embodiments of the invention.

The inner edge of the upper first top surface 28, which is intended to form the outer diameter of the opening 2 of the cavity 6 accommodating the connecting means 3, has a diameter of approximately 1.6 mm. The overall outer diameter of the top surfaces 7, 28 ranges from 2.7 to 8mm depending on the size of the implant component.

The invention may be implemented more effectively by treating the human or animal body with an implant and/or a fixation member as described above.

The foregoing description and illustrated examples are merely illustrative of the present invention and are not to be construed as limiting thereof. Since modifications of the described embodiments incorporating the spirit and substance of the invention may be effected by persons skilled in the art, the scope of the invention should include all variations falling within the scope of the appended claims or the like. In addition, modifications and variations of the foregoing will be apparent to those of ordinary skill in the art and, thus, such modifications and variations are intended to be covered by the appended claims.

Claims (19)

1. Implant comprising a fixation part (1) for insertion into a bone, at least one abutment part (3) providing a base for a prosthetic superstructure, and a connecting element (9) for mechanically fixing the abutment (3) to the fixation part (1), characterized in that the fixation part (1) comprises an external thread (16), or other protrusions for improving the engagement between the fixation part (1) and the bone, wherein the connecting element (9) is detachably interconnected with the fixation part (1) and the abutment (3), wherein at least the fixation part (1) and the abutment (3) are made of a non-metallic material.

2. Implant according to claim 1, characterised in that the fixture (1) comprises a recess or cavity (6) for detachably receiving the abutment (3) and/or the attachment means (9) of the implant, the fixture (1) further comprising interlocking means (11) in the cavity (6) or recess for engaging with the interlocking means (10) of the abutment (3) and/or the attachment means (9).

3. Implant according to claim 1 or 2, characterised in that the non-metallic material is selected from ceramic materials, plastics or mixtures thereof, or compounds thereof.

4. Implant according to claim 3, characterised in that the non-metallic material is a zirconia ceramic material, which may contain yttria or magnesia or calcia, preferably in an amount of at most 8% by weight.

5. Implant according to one of the preceding claims, characterized in that at least the cavity (6) of the fixation part (1) and the interlocking means (11) are manufactured by machining a pre-sintered green body.

6. The implant of claim 5, wherein the size of the pre-sintered green body during machining is a reproduction of a desired end product on a larger scale.

7. The implant of claim 6, wherein the ratio is variable in all three dimensions.

8. Implant according to claim 6, characterised in that the ratio is determined by a three-dimensional transfer function f (x, y, z).

9. The implant of claim 8, wherein the three-dimensional scale is determined by a three-dimensional distribution of density within the pre-sintered green body.

10. Implant according to one of the preceding claims, characterized in that at least the fixture (1) has a surface which is roughened by means of a grinding mechanical, physical or chemical surface treatment.

11. The implant of claim 10, wherein the surface treatment comprises laser treatment and plasma etching.

12. Implant according to one of the preceding claims, characterized in that at least a part of the circumferential surface of the fixation part (1) is provided with a coating comprising one or more of the following: biomolecule components, peptides, polypeptides, amino acids, polyamino acids, growth factors.

13. An implant as claimed in claim 12, characterised in that the coating comprises a compound having a region mimicking collagen binding to cells and having enhanced cell binding relative to collagen, in an amount effective to promote cell attachment to the anchoring member.

14. An implant as claimed in claim 12 or 13, characterised in that the coating comprises synthetic peptides immobilised to the matrix, the peptides having a region mimicking collagen binding to cells and having enhanced cell binding relative to collagen.

15. An implant as claimed in any one of claims 12 to 14, characterized in that the coating comprises synthetic peptides in the following order: glycine-threonine-proline-glycine-proline-glutamine-glycine-isoleucine-alanine-glycine-glutamine-arginine-glycine-valine.

16. An implant as claimed in any one of claims 12 to 14, characterised in that the coating comprises a synthetic compound having a biological activity functionally comparable to all or some of P-15.

17. A dental prosthesis arrangement comprising at least one dental implant according to any of the preceding claims.

18. Method for manufacturing a fixation component (1) for an implant according to any of claims 1-16, comprising the steps of:

the desired dimensions of the final implant component are determined,

pre-sintering the green body to an average density lower than that of the final product to form a shaped green body,

determining the three-dimensional density distribution in the green body,

a three-dimensional scale function is calculated from the density distribution,

machining the green body according to the calculated three-dimensional proportion,

sintering the machined green body to a final density, optionally roughening and/or coating at least a portion of the surface of the sintered fastening component.

19. A method of treatment of the human or animal body with an implant and/or a fixation component according to any preceding claim.