SE517066C2 - Implants showing connection and puncture insertion parts and the procedure for such implants - Google Patents

Abstract

An implant (1) has attachment and hole-insert parts (2, 3) with an outer surface or outer surfaces having external layer arrangements (6, 7). The implant can be provided in a known manner with threads (3a, 3b) on cylindrical and conical portions. The implant is made in principle in two production stages. In a first production stage, the outer surface or outer surfaces (6a) of the implant are given a relatively high roughness value and/or a relatively high degree of porosity. In a second stage, the uneven or porous surface thus obtained is coated with an oxide layer (7) which can be uniform or can have different thicknesses along the longitudinal and/or circumferential directions(s) of the implant. In one embodiment, the oxide layer (7) can be coated with a bone-growth agent or bone-growth-promoting agent and/or calcium phosphate (16), for example by means of chemical deposition, dipping or sputtering.

Description

mi), n other 10 15 20 25 517 066 2. degree of porosity or use untreated or unprocessed surfaces which exert less resistance to screwing. In some cases, it may also be interesting to introduce a barrier to prevent so-called ion release (ion release). In dental contexts, it is interesting to be able to offer porosities of different degrees in some cases in order to expand the surfaces for solid growth. In other cases, it is again essential to reduce the roughness / porosity of the adjacent surfaces. In the event that the porosities are used as depots for bone growth or bone growth maintaining agents, it is important to be able to offer larger or smaller depots or smooth surfaces on which e.g. calcium phosphate must be able to be applied. The purpose of the invention is to solve the problem stated above.

It is important that proposed solutions can follow accepted and well-proven methods for establishing freedom of choice with regard to porosities, smooth surfaces, coatings, etc. The invention also solves this problem.

What can mainly be considered to be characteristic of an implant according to the invention is that one or your arrangements have a machined or treated surface with prominent roughness and / or porosity and with an outer oxide layer applied to this surface.

In one embodiment of the inventive tank, the oxide layer has a thickness in the range of 5 nm to 20 μm. The oxide layer can then have a thickness which varies according to the length and / or circumferential direction (s) of the implant. In one embodiment, a layer of calcium phosphate may be applied to the outside of the oxide layer.

A method according to the invention is characterized in that the implant is processed and / or treated to produce a straightening number or a preferably prominent porosity on the surface or surfaces and that the respective ones are then coated with an oxide layer.

The oxide layer can be provided by means of electrochemical treatment where the actual surface or surfaces of the implant are dipped in an electrolyte, in which an anode and cathode arrangement is arranged. To establish said porosity, a voltage is applied to the anode and cathode arrangement, whereby a current caused by the voltage is passed via the electrolyte and the immersed implant in it. With this method a prominent porosity can be obtained in case the voltage assumes a relatively high value, e.g. a value of 300 volts or more, and a certain type of electrolyte was used. In an optional second step, the oxide layer can be applied in a similar manner, the implant being dipped in the same electrolyte or in another electrolyte, and the stress value is selected at a lower level so that the oxide layer is established with a lower degree of porosity or a porosity which is almost zero. Such a smoother oxide layer can also be produced by heat treatment of the implant in an oxygen-containing atmosphere.

Further developments of the said implants and procedures appear from the following subclaims to the implant and the procedure, respectively.

The method proposed above makes it possible to produce an assortment of implants with different porosities, porosity stretches, treated surfaces, etc. From the assortment, implants can be selected which are optimized for the treatment situation in question.

The bone quality of the bones in question, e.g. jaw or tooth bones, varies greatly in the same individual and between different individuals. In the upper jaw, the bone structure is relatively soft, while in the lower jaw it can vary from a relatively soft structure to a hard structure in the front of the jaw. Implants with greater or lesser porosity can thus be produced and likewise oxide layers with a surface structure can be applied on top of the already fragile surface with a large roughness or porosity. Ion release can thus be limited and also the smoother surface can form a substrate surface for layers with bone growth-freeing or bone growth-maintaining agents. The oxide layer applied to the surface of the uneven or porous surface may consist of a thin or relatively thick oxide layer which can be applied in a known manner with a simple dipping in a beaded electrolyte in a manner known per se. The design and thickness of the oxide layer can then be varied and so can e.g. the oxide layer has a greater thickness at the middle or outer parts of the implant. The oxide layer can coat fl evenly on the porous outer surface in question. Alternatively, the oxide layer can be varied to thickness in the circumferential direction of the implant, etc. A presently proposed embodiment of an implant and a method according to the invention will be described in the following with simultaneous reference to the accompanying drawings, in which Figure 1 shows in vertical section an implant applied in a partial indicated tooth or jawbone, figure 2 in longitudinal section and enlargement shows the outer part of a thread on the implant according to fl guren 1 where it appears that the outer surface of the thread is provided with layers according to the invention, figure 3 in the diagram form shows voltages and currents occurring in an electrode Kenian method in the case of an implant immersed in an electrolyte, and Figure 4 in vertical view and in principle shows the implant according to Figure 1 immersed in an electrolyte and an anode and cathode arrangement arranged therein.

In Figure 1, 1 shows an implant of the type indicated above, i.e. an implant that can be included in the prior art and i.a. is described in the above references.

The implant has a connecting part 2, for example for a spacer, and a retaining part 3. The outer surface 2a of the connecting part can be smooth or unprocessed (eg machined) or have a smaller or larger porosity. The hole insertion part 3 may have a cylindrical portion at the top with an outer thread 3a and a conical portion with an outer thread 3b at the free / lower end of the implant. The implant is of so-called self-tapping type and is screwable into a hollow socket 4 in a leg, e.g. a tooth or jaw bone. In the present case, the surface layer of the threaded portions has a relatively high roughness / porosity created, for example, by etching or blasting known per se. In accordance with the invention, an oxide layer is applied outside the said relatively raw and porous layers in accordance with the following. w- nous.

: Icon u ~ nu »u-v 10 15 20 25 30 517 066 5 In Figure 2, the layer with a large raw number is indicated by 6 and the outer oxide layer by 7.

The layer 6 can, as already mentioned, be created by etching or blasting the implant part in question. The layer 6 can have a surface roughness of between 0.4 and 5 μm. The thickness t of the outer oxide layer 7 assumes values preferably in the range 4-5 nm to about 20 μm.

The layer can be prominently porous with 1 x 107 - 1 x 101 ° pores / cm 2. In a preferred embodiment, the porosity is significantly lower in the outer oxide layer 7.

In the application of the said layer 7, methods known per se can be used. In the present case, the electrochemical method used in the above-mentioned Swedish patent applications 9901971-3 and 9901974-7 is preferably used. A voltage / current ratio in accordance with the fi gure occurs in such an electrochemical method. As this method is known per se per se, it should not be described here, but reference is made to related Swedish patent applications. As can be seen from the clock 3, a voltage increase occurs according to the curve 9 and a current 10 initially has a substantially constant value in order to fall after a time according to the curve part 10a. The formation of titanium oxide layers and their final properties and structures are affected by a number of parameters in the said indicated process. Thus, the composition and temperature of the electrolyte, applied voltage and current, electrode geometry, treatment time, etc., have an effect on thickness, degree of porosity, etc. in the titanium oxide layer to be created.

Oxide thicknesses and porosities can thus be varied by means of said parameters. At e.g. a prominent thickness of the layer 7 according to fi guren 2 shall be used i.a. a relatively high voltage, e.g. a voltage of 300 volts. A constant current (cf. curve part 10) is of the order of 0.2 amperes. It has been found that with voltage increases upwards of the above-mentioned order of magnitude, a certain spark formation occurs at the surface of the electrolyte and between the electrolyte and the outer surface part in question. This sparking can be used to eliminate burrs that have occurred during machining of the inner surface 8 of the implant. Such degree separations are symbolized in Figure 2 by 11.

Figure 4 shows the immersion of the parts of the implant to be provided with the oxide layer 7 in an electrolyte 12 in accordance with the known electrochemical method mentioned above. 10 15 20 25 517 066 6 methods. In this case, the implant basically functions as an anode in a combined anode and cathode arrangement where the cathode part is symbolized by 13. An energy source is indicated by 14 and the negative potential 14a of the energy source is connected to the cathode 13 and plus potential 14b is connected to the anode / implant. The connection can be effected by means of a connection means 15, by means of which the positive potential 14 is connected to the anode / implant.

Regarding the application of the layer 7, reference is also made to the Swedish application XXXX submitted on the same day, which relates to the formation of implants with elongated zones, in which the porosity decreases continuously within the respective zone. In making the underlying surface layer 6, the implant is provided, e.g. of titanium, with an outer surface 6a of a preferably prominent roughness number established by means of blasting, etching, plasma spraying, etc. In the electrochemical method, the layer 7 is then produced with the appropriate setting of said parameters.

Through the above proposed, different types of implants based on the same technology can be manufactured. The structures and thicknesses of layers 6 and 7 can be determined according to the respective dental situation and the purpose of the implants is to achieve optimal results.

The outer layers 6 or 7 can extend evenly around the respective outer surface the entire circumference.

Alternatively, they may extend along only parts of the circumference. In further alternatives, the layer 6 may extend along all or parts of the circumference and be covered by the outer layer only partially. This also applies to the extensions in the longitudinal or vertical direction. According to fi guren 2, the outer oxide layer on its outer surface 7a can be provided with a coating of calcium phosphate 16 which is sputtered or otherwise applied to said outer surface 7a after the outer layer 7 has been applied.

The invention is not limited to the embodiment shown above as an example, but can be subjected to modifications within the scope of the appended claims and the inventive concept.

Claims (14)

10 15 20 25 30 517 066 7 nu .nu PATENTKRAV Titanium implants (1) having spacer connection and hole insertion parts (2, 3) with outer surface (s) (2a, 3a, 3b) with outer layer arrangement (6, 7), characterized therefrom, one or more arrangements has a machined or treated inner surface (6a) with prominent roughness and / or porosity with an outer titanium oxide layer (7) applied to the outer surface. An implant according to claim 1, characterized in that the outer titanium oxide layer (7) has a thickness in the range 5 nm to 2 μm and / or a lower roughness number than the roughness number of the inner surface. Implant according to claim 1, characterized in that the outer titanium oxide layer (7) has a thickness varying along the length and / or circumference of the implant (s). An implant according to claim 1, 2 or 3, characterized in that the arrangement comprises a layer of calcium phosphate (16) applied to the outside of the titanium oxide layer (7). An implant according to any one of the preceding claims, characterized in that it comprises one or more outer threads (3a, 3b) on said perforation part (s) (3). Method for producing outer layer arrangements (6, 7 and optionally 16) on outer surface (s) (2a, 3a, 3b) included on titanium implants with spacer connection and hole insertion parts, characterized in that the implant (1) processed and / or treated to produce a pronounced roughness number and / or porosity on the outer surface (6a or 8) and the outer surfaces, respectively, and that it is processed and / or treated and / or with 10 15 20 25 30 517 066 ° 'v I n. . . 'f' »O -n-.". f. '.nu nu o.' '- u: man,' "'~: = ::': - ~ -. ° .. :: ': l a .__, 'Ü I 8 n I' '' '' "" 'porosite surface (6a or 8) or the surface parts where fi er is coated with a titanium oxide layer (' /). 7. A method according to claim 5, characterized in that the outer layer arrangement structure is provided by electrochemical treatment where current surface or surfaces of the implant are provided by electrolyte and an anode and cathode arrangement (13, 14, 14a, 14b) to which the implant (1) is arranged, and that the anode and cathode assemblies are connected in voltage so that a current (J) passes through the implant. Method according to claim 6, characterized in that the implant (1) is immersed in an electrolyte (12) and that the current (J) is conducted via electrolyte-coated parts (3a, 3b) of the implant (1). 9. A method according to claim 6 or 7, characterized in that for establishing the porosity the voltage is selected to be prominently high, e.g. 300 volts or more, and that the resulting current causes spark activation (9a) in connection with the transition between the electrolyte and the implant and that in said spark formation a degree-limiting (1 1) effect is obtained on the outer surface of the implant. 10. A method according to claim 7, 8 or 9, characterized in that degree elimination function is obtained at the thread or threads of the implant (3a, 3b). 11. ll. A method according to any one of claims 6-10, characterized in that a fully or partially porous outer surface of the implant is immersed in said electrolyte (12) or another electrolyte, and that a voltage of a relatively low value is applied to an anode. and cathode arrangements, and that the titanium oxide layer is thereby established by a dipping in preferably disposable dipping, in electrolyte and voltage application. 12. A method according to any one of claims 6-1, characterized in that the surface or surfaces (3a, 3b) supporting said titanium oxide layer (7) are machined with prominent roughness numbers, e.g. by blasting. 517 066 sgïj 3 "; -s =" ¿¿:: __- 'j == §j, j- - o 1 r I o u. F? A method according to any one of the preceding claims, characterized in that fi äühïdâ íiïâiïüxiåâkikï (7) is assigned an ijuukick of 5: nu 'to 2 pm and / or tzíí lower roughness number than the inner surface roughness number. A method according to any one of claims 6-13, characterized in that the calcium phosphate layer (16) is applied to the outside of the titanium oxide layer (7) by means of sputtering.