AU2008301028A1

AU2008301028A1 - Endoprosthesis component

Info

Publication number: AU2008301028A1
Application number: AU2008301028A
Authority: AU
Inventors: Helmut D. Link; Roger Thull
Original assignee: Waldemar Link GmbH and Co KG
Current assignee: Waldemar Link GmbH and Co KG
Priority date: 2007-09-17
Filing date: 2008-08-07
Publication date: 2009-03-26
Anticipated expiration: 2028-08-07
Also published as: ZA201002205B; DE502008003301D1; EP2036517A1; MX2010002929A; IL204029A; JP5255640B2; EP2190386A1; JP2010538777A; ES2363111T3; TWI457113B; PL2190386T3; AR068525A1; DK2190386T3; AU2008301028B2; BRPI0816831B8; EP2190386B1; TW200920329A; WO2009036846A1; CN101801315B; ATE506032T1

Description

Waldemar Link GmbH & Co. KG LINO960PEP Endoprosthesis component The invention relates to an endoprosthesis component 5 with a body predefining the shape of the endoprosthesis component. On surface portions with which the endoprosthesis component in the implanted state is in contact with human tissue, the body is covered with an outer layer. The outer layer comprises a nitride, an 10 oxynitride or an oxide based on a refractory metal; furthermore, the outer layer contains silver and/or copper. The invention further relates to a method for producing such an endoprosthesis component. 15 Endoprosthesis components used to replace parts of the human skeleton must satisfy a number of requirements. The endoprosthesis component has to be sufficiently stable to ensure that it can take up the forces that occur in the skeleton. In addition, those elements of 20 the endoprosthesis component that are in contact with the tissue, including bone substance, of the human body in the implanted state must have good biocompatibility. It is already known for surface portions of the 25 endoprosthesis component that are designed for contact with human tissue to be covered with a layer composed of a hard material, for example a nitride, an oxynitride or an oxide based on a refractory metal. Hard material coatings of this kind combine good mechanical properties 30 together with good biocompatibility. However, problems occasionally arise concerning the acceptance of such endoprosthesis components by the human body. For example, microorganisms may attach 35 themselves to the surface of the endoprosthesis component and in so doing hinder the acceptance of the endoprosthesis component in the human body. The risk of microorganisms on the surface of endoprosthesis - 2 components is greater, the more invasive the procedure needed to implant the endoprosthesis component into the body, and the greater the surface area across which the endoprosthesis component comes into contact with the 5 tissue of the body. Operations in which an invasive procedure is needed, and in which the endoprosthesis is brought into contact with human body tissue across a large surface area, are, for example, head/shaft prosthesis shafts, or those in which the femur is 10 replaced completely by an endoprosthesis. It is known from WO 03/094774 to oxidize the surface of an implant, made of metal or a metal alloy, and to provide the resulting hard material layer with silver 15 particles in order to obtain an antimicrobial action. Since hard material layers react only very slowly with the surrounding body tissue, the silver particles are released from the hard material layer over a long period of time. A hard material coating of this kind 20 can therefore provide good long-term action. Directly after insertion of the implant, however, a large number of microorganisms may be present in the environment of the implant. The quantity of silver particles released by the hard material layer is too small to be effective 25 against a larger number of microorganisms. The object of the invention is to make available an endoprosthesis component of the type mentioned at the outset and a method for producing such an 30 endoprosthesis component, where there is less chance of the acceptance of the endoprosthesis component in the human body being hindered by microorganisms. The object is achieved by the features of the independent claims. Advantageous embodiments are set forth in the dependent 35 claims. The endoprosthesis component according to the invention is characterized in that an intermediate layer is provided between the outer layer and the body and in that parts of the intermediate layer are accessible from the outside.

- 3 A number of terms will first be explained. A body that predefines the shape of the endoprosthesis 5 component differs from the shape of the endoprosthesis component, at least in the area in which the surface of the endoprosthesis component is designed for contact with human tissue, only in terms of coatings that are additionally applied to the surface. 10 It is not generally the entire surface of the endoprosthesis component that is designed to establish a connection to human tissue. Instead, the endoprosthesis component can comprise areas on its 15 surface that are designed to interact, for example, with a further endoprosthesis component, for example in order to form a joint. In the context of the invention, it is not necessary for the entire area of the surface designed for contact with the human tissue to be 20 covered with an outer layer or an intermediate layer. Instead, it can suffice if surface portions of these areas are covered with an outer layer and/or an intermediate layer. 25 The outer layer is understood as a layer that is in direct contact with the environment. An outer layer, therefore, is not covered by a further layer. The outer layer does not have to provide full surface coverage; it can also have interruptions or can be applied only 30 as islands. An intermediate layer is covered at least on parts of its surface with an outer layer. In areas where no outer layer is applied or where the outer layer has 35 interruptions, the intermediate layer itself is in direct contact with the environment. The intermediate layer is therefore partially accessible from the outside. On the surface of the endoprosthesis component, locations where the intermediate layer is - 4 accessible from the outside alternate with locations where the intermediate layer is not accessible from the outside. The intermediate layer is made of a different material than the material from which the 5 endoprosthesis component is made. The term human tissue is to be understood widely. It includes all elements of the human body with which an endoprosthesis can come into contact, for example 10 including bone too. Refractory metals are base metals with high melt points from the fourth, fifth and sixth side groups. These include titanium, zirconium and hafnium from the fourth 15 side group, vanadium, niobium and tantalum from the fifth side group, and chromium, molybdenum and tungsten from the sixth side group. Refractory metals that are especially suitable for the coating of endoprosthesis components are titanium, zirconium, niobium and 20 tantalum. Nitride, oxynitride or oxide based on a refractory metal are understood as compounds that ions of a refractory metal form with oxygen and/or nitrogen as reactive gas. These compounds are distinguished by great hardness; the layer obtained is therefore also 25 referred to as hard material layer. If the outer layer additionally comprises silver and/or copper, the formation of the nitride, oxynitride or oxide involves not only ions of the refractory metal 30 and a reactive gas, but also silver and/or copper ions. The silver and/or copper ions are integrated into the coating obtained. The outer layer has a long-term antimicrobial action through the silver and/or copper contained. The antimicrobial action is combined with 35 good mechanical properties such as hardness and high abrasion resistance. By providing an intermediate layer between the outer layer and the body, which intermediate layer is -5 partially accessible from the outside, it is possible for the surface of the endoprosthesis component not only to have the long-term antimicrobial action of the hard material coating, but also other effects. Thus, 5 for example, the intermediate layer can be designed such that it releases a higher dose of an antimicrobial substance within a short time. The higher dose then acts against infections directly after the operation. 10 The body predefining the shape of the endoprosthesis component can be made of metal or of a metal alloy. Particularly suitable metals are titanium and titanium alloys. The term outer layer also includes a layer that has been created in several application runs. The 15 application of a layer in several application runs will be considered particularly in cases where the layer created in one application run is too thin. The intermediate layer can be a layer of silver, copper 20 and/or gold. The intermediate layer preferably gives full surface coverage. Such an intermediate layer corrodes much more quickly than the hard material of the outer layer when in contact with human tissue. A higher dose of antimicrobial particles is therefore 25 released. In areas where the intermediate layer is accessible from the outside, the outer layer is interrupted. The interruptions can have diameters of just a few pm or 30 can be much larger. In the case of microscopic interruptions with a minimum diameter of just a few pm, this is referred to as a porous outer layer. Macroscopic interruptions with diameters in the mm range, for example, permit access to the intermediate 35 layer from the outside over a larger surface area. In particular, the outer layer can be designed such that the interruptions take up a proportion of at least 20% of the surface, preferably at least 40%, more preferably at least 60%.

-6 The antimicrobial action can be strengthened if the outer layer has a microstructure or nanostructure with distinct peaks. A distinct peak in a surface structure 5 is understood as a formation in which the surface, starting from one extreme, falls off in all directions at an angle of more than 45 degrees relative to the direction of the surface. Electrically conductive peaks, compared to smooth surfaces, generate a strong 10 electric field in their environment, which field has a negative effect on microorganisms. The invention further relates to a method for producing such an endoprosthesis component. To produce the 15 endoprosthesis component, a body is first made ready that predefines the shape of the endoprosthesis component. Surface portions of the body that are intended for a connection to human tissue are provided with a coating which, although at this time not yet 20 covered with an outer layer, will, however, be referred to as intermediate layer for the sake of simplicity. No particular requirements are placed on the surface structure of the intermediate layer. The surface can therefore be smooth, macrostructured, micro-structured 25 or nanostructured. Moreover, targets are made ready from which the material later to form the coating can be released. It is possible to make available a single target, which 30 comprises both the -refractory metal and also the silver and/or copper. It is also possible, however, to make available several targets, in which case a first target comprises a refractory metal, and a second target comprises silver and/or copper. 35 Ions of the refractory metal and ions of silver and/or copper are released from the one or more targets. In order to release the ions, for example, an electric arc can be generated between an electrode and the target, -7 which electric arc delivers so much energy to the target that ions are released. Another possible way of delivering sufficient energy locally to the target can be to direct a laser beam at the target. One 5 alternative, albeit an expensive one, is for the energy to be delivered by an electron beam. The free ions are conducted, together with a reactive gas, onto surface portions of the body covered with the 10 intermediate layer in such a way that an outer layer forms through which the intermediate layer is accessible. To do so, a voltage can be applied between the target and the body so as to accelerate the ions in the direction of the body. The reaction vessel with 15 target and body contains a reactive gas, for example oxygen or nitrogen, or a mixture of oxygen and nitrogen. The ions of the refractory metal and the ions of silver and/or copper react with the reactive gas, and molecules are formed which contain all three 20 constituents. In one embodiment, TiAgN molecules are formed. The outer layer according to the invention occurs as a result of the reaction taking place on the surface of the body. The reaction can take place under vacuum, preferably under high vacuum. Methods of this 25 kind are referred to as plasma coating methods. An improved hold of an applied layer can be achieved if the surface of the body is treated beforehand by sand blasting. 30 There are several options by means of which it can be ensured that the outer layer forms such that the intermediate layer remains accessible. For example, a porous outer layer having microscopic interruptions can be generated by delivering so much energy to the single 35 target or the several targets that not only ions are released from the targets, but also fragments with a maximum diameter of over 20 pm. The fragments move randomly in all directions and impinge on that surface of the body on which the outer layer forms. At the - 8 locations where the fragments impinge, a piece of the forming outer layer is struck out. A porous outer layer forms through which the intermediate layer is accessible. 5 Another possible way of ensuring accessibility to the intermediate layer is to use a mask made of temperature-stable material to cover the surface portion of the body that is to be coated. The mask 10 covers parts of the surface and leaves other parts of the surface free. The mask can, for example, have a mesh-like or lattice-like form. The outer layer then only forms as islands at the places that are left free by the mask. After the temperature-stable material has 15 been removed, the intermediate layer is accessible in accordance with the mask. A material is referred to as being temperature-stable when it is resistant to the conditions that arise in plasma coating methods. The temperature-stable material can, in particular, be a 20 metal. If the parameters of the plasma coating method are suitably chosen, an outer layer is obtained that has a microstructure or nanostructure with distinct peaks. 25 If the intermediate layer is made of silver, copper and/or gold, it can likewise be applied by means of a plasma coating method. Alternatively, it is possible to apply the intermediate layer to the body by means of 30 electrochemical deposition. The invention is described by way of example below on the basis of an advantageous embodiment and with reference to the attached drawings, in which: 35 Fig. 1 shows an endoprosthesis comprising several endoprosthesis components; - 9 Fig. 2 shows an endoprosthesis component according to the inventi*-on; Fig. 3 shows an enlarged detail from a cross section 5 through Fig. 2; Fig. 4 shows the view from Fig. 3 in the case of another embodiment of the invention; 10 Fig. 5 shows the view from Fig. 3, in the case of a further embodiment of the invention; and Fig. 6 shows an enlarged detail of the surface of the endoprosthesis component according to Fig. 2, in the 15 case of one embodiment of the invention. An endoprosthesis shown in Fig. 1 is designed to replace a part of the human skeleton reaching from the hip to below the knee. A spherical joint head 10 forms 20 an articulation surface that is designed to interact with an acetabulum. The joint head 10 is connected to a head piece 11 of the endoprosthesis by a screwed connection. The part of the endoprosthesis replacing the shaft of the femur comprises three endoprosthesis 25 components 12, 13, 14. The endoprosthesis components 12, 13, 14 are connected to one another and also to the head piece 11 by screwed connections. A knee piece 15 forms an articular connection to a shaft 16, which is designed to connect the endoprosthesis to a tibia. 30 The endoprosthesis components 12, 13, 14 are available in different lengths, such that the endoprosthesis can be adapted to different lengths of femurs. Fig. 2 shows an endoprosthesis component 17, corresponding to the 35 endoprosthesis components 12, 14, 14, in an enlarged view. The endoprosthesis component 17 comprises a screw pin 18, and a screw hole 19 indicated by broken lines. By way of the screw pin 18 and the screw hole 19, the endoprosthesis component 17 can be connected at its two - 10 ends to similar endoprosthesis components, for example the endoprosthesis components 12, 13, 14. The screw pin 18, the screw hole 19 and the adjacent end faces 20 and 21 thus form areas of the surface of the endoprosthesis 5 component 17 that are designed to interact with other endoprosthesis components. By contrast, the lateral surface 22 of the endoprosthesis component 17 is designed to make contact with human tissue in the implanted state. 10 In the area of the lateral surface 22, the body 23 predefinincr the shape of the endoprosthesis component 17 is covered with an intermediate layer 24 and an outer layer 25. The intermediate layer 24, composed of 15 silver, completely covers the body 23 in the area of the lateral surface 22. The outer layer 25 covering the intermediate layer 24 is a hard material coating which was created by means of a plasma coating method from titanium, nitrogen and silver. 20 In the illustrative embodiment shown in Fig. 4, the outer layer 25 is porous. The intermediate layer 24 can exert an antimicrobial action on the surrounding tissue through microscopic interruptions in the outer layer 25 25. Fig. 6 shows a plan view of the lateral surface 22 of the endoprosthesis component 17 in an enlarged representation. The intermediate layer 24 is covered by 30 the outer layer 25 only in individual islands. The outer layer 25 thus has macroscopic interruptions through which the surrounding tissue can come into direct contact with the intermediate layer 24. In the areas in which the outer layer 25 is applied to the 35 intermediate layer 24, the intermediate layer 24 can be dense as shown in Fig. 3 so that no direct contact exists between the surrounding tissue and the intermediate layer 24.

- 11 In Fig. 5, the outer layer 25 has a nanostructure with pronounced peaks 26. With electrically conductive peaks 26, an electric field forms around the peaks 26 and strengthens the antimicrobial action of the outer layer 5 25. The in--ermediate layer is not shown in Fig. 5.

Claims

1. An endoprosthesis component which comprises a body 5 (23) predefining the shape of the endoprosthesis component (17) and in which, on surface portions (22) with which the endoprosthesis component in the implanted state is in contact with human tissue, the body (23) is covered with an outer 10 layer (25) which comprises a nitride, an oxynitride or an oxide based on a refractory metal, the outer layer (25) containing silver and/or copper wherein an intermediate layer (24) is arranged between the outer layer (25) and the 15 body (23) and wherein parts of the intermediate layer (24) are accessible from the outside.

2. The endoprosthesis component as claimed in claim 1, wherein the intermediate layer (24) is composed 20 of silver, copper and/or gold.

3. The endoprosthesis component as claimed in 1 or 2, wherein the outer layer (25) is interrupted, and wherein the interruptions occupy a proportion of 25 the surface area of at least 20%, preferably of at least 40%, more preferably of at least 60%.

4. The endoprosthesis component as claimed in one of claims 1 through 3, wherein the outer layer (25) 30 is porous.

5. The endoprosthesis component as claimed in one of claims 1 through 4, wherein the outer layer (25) has a microstructure or nanostructure with 35 distinct peaks (26).

6. A method for producing an endoprosthesis component (17), with the following steps: - 13 a. Making available a body (23) that predefines the shape of the endoprosthesis component, surface portions (22) of the body (23), which are intended for a connection with human tissue, being provided 5 with an intermediate layer (24); b. Making available a refractory metal and also silver and/or copper in the form of one or more targets; c. Releasing ions of the refractory metal and also 10 ions of the silver and/or copper from the one or more targets; d. Conducting the ions, together with a reactive gas, onto surface portions (22) of the body (23) covered with the intermediate layer (24), so that 15 an outer layer (25) forms through which the intermediate layer (24) is accessible.

7. The method as claimed in claim 6, wherein the ions are released from the one or more targets by means 20 of an electric arc.

8. The method as claimed in claim 6, wherein the ions are released from the one or more targets by means of laser. 25

9. The method as claimed in claim 6, wherein the ions are released from the one or more targets by means of an electron beam. 30

10. The method as claimed in one of claims 6 through 8, wherein, in step a), a body (23) is made available in which the intermediate layer (24) consists of silver, gold and/or copper. 35

11. The method as claimed in one of claims 6 through 9, wherein, in step c), fragments with a diameter of more than 20 gm are additionally released from the target, and wherein, in step d), the fragments are conducted onto the body (23). - 14

12. The method as claimed in one of claims 6 through 10, wherein, before step d), the surface portion of the body to be coated is covered with a mask 5 made of a temperature-stable material.