ANTI-MICROBIAL IMPLANT COATING
20210128782 · 2021-05-06
Assignee
Inventors
Cpc classification
A61L27/306
HUMAN NECESSITIES
A61L2430/38
HUMAN NECESSITIES
A61L2420/06
HUMAN NECESSITIES
A61L2300/404
HUMAN NECESSITIES
C23C14/022
CHEMISTRY; METALLURGY
C23C14/26
CHEMISTRY; METALLURGY
A61L27/047
HUMAN NECESSITIES
A61L27/54
HUMAN NECESSITIES
International classification
A61L27/54
HUMAN NECESSITIES
Abstract
A coating for an implant component, in particular a component of a spinal implant, is provided. The coating is a ceramic titanium nitride coating comprising an at % content of 5 to 30 At % of Ag in addition to an at % content of Ti and an at % content of N.
Claims
1. Coating for an implant component, in particular a component of a spinal implant, wherein said coating is a ceramic titanium nitride coating comprising an at % content of 5 to 30 At % of Ag in addition to an at % content of Ti and an at % content of N.
2. The coating according to claim 1, wherein said coating comprises 5 to 20 at % of Ag, 8 to 15 at % of Ag, 8 to 10 at % of Ag or approximately 10 at % of Ag.
3. The coating according to claim 1 or 2, wherein Ag and titanium nitride are formed adjacent to one another on the coating surface.
4. The coating according to one of the preceding claims, wherein said coating has a thickness of 2.5 to 6 μm, 3.5 to 5.5 μm or approximately 4.5 μm.
5. The coating according to one of the preceding claims, in which the titanium nitride coating is essentially a stoichiometric TiN layer.
6. Implant component, in particular of a spinal implant, which is coated at least in sections with a coating according to one of the preceding claims.
7. The implant component according to claim 6, wherein said implant component is at least one component of a spondylodesis implant or a cage.
8. The implant component according to claim 6 or 7, in which the surface of the coated section comprises titanium nitride with Ag islands embedded therein.
9. The implant component according to one of claims 6 to 8, wherein said implant component to be coated comprises a titanium alloy and consists preferably thereof.
10. Method for applying an implant coating according to one of the preceding claims to an implant component, comprising the steps of: Providing an implant component to be coated, in particular an implant component for a spinal implant, in a coating chamber; Providing at least one target having an at % content of silver and titanium that is predetermined for coating and/or providing at least one Ti target and at least one Ag target; Providing an atmosphere containing at least nitrogen; Evaporating the at least one target; and Simultaneously coating the implant component with the evaporated metal of the at least one target.
11. The method for applying an implant coating according to claim 10, wherein the evaporation of the at least one target is carried out by means of arc evaporation and the voltage applied to the targets is 15 to 30 V or 20 to 25 V, and the applied current is 40 to 70 A.
12. The method according to claim 10 or 11, in which, once the implant to be coated has been provided in the coating chamber, the implant surface to be coated is cleaned by a glow discharge under a hydrogen atmosphere.
13. The method according to one of claims 10 to 12, in which, once the implant to be coated has been introduced into the coating chamber, the implant surface to be coated is cleaned by bombarding the implant surface with ions under an inert atmosphere.
14. Use of the coating according to one of claims 1 to 9 for preventing a biofilm on an implant, in particular a spinal implant.
Description
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0041] In the context of the present invention, a coating is to be understood as a coating applied by a technical process. Examples of such technical processes are chemical vapor deposition (CVD), physical vapor deposition (PVD) or electroplating.
[0042] As described above, a coating according to the invention comprises a mixture of titanium nitride and silver, also referred to herein as a titanium nitride/silver coating. In other words, the coating comprises at least one single layer of a ceramic titanium nitride coating, in which silver is embedded. The silver is present in the form of silver islands, i.e. silver or silver atoms are arranged next to the titanium nitride lattice. Owing to the size of the silver atoms, it is assumed that only a small proportion, if any, of the silver is arranged interstitially in the titanium nitride lattice. It was instead observed that the silver is present in the form of silver agglomerates in the titanium nitride/silver coating. In other words, the silver is present in the titanium nitride lattice but is not integrated therein. These silver agglomerates are preferably present in a range of 1 μm to 50 μm and even more preferably in a range of 5 μm to 30 μm.
[0043] It is furthermore assumed that the effectiveness of the silver is due in particular to the fact that in the implanted state of the implant, the silver transforms via local element formation into the ionic state upon contact with body fluid and thus develops its antimicrobial effect. That this local element formation can take place is made possible by an arrangement of these islands on the surface of the coating. This arrangement is achieved by an at least partially simultaneous coating of the implant with titanium nitride and silver.
[0044] Owing to its antimicrobial properties, the coating has an infection-inhibiting effect, which particularly applies to Staphylococcus epidermidis. It is presumed that the silver content of the coating present in the titanium nitride matrix disrupts the formation of a biofilm that these bacteria develop. As a result of this disruption, the protective mechanism of the bacteria against antibiotics that is generated by this biofilm at least no longer functions adequately.
[0045] It was furthermore observed that the silver can dissolve out of the coating in ion form. It is assumed that these silver particles ionised on the surface of the coating form an effect zone (inhibition zone) in the immediate vicinity of the implant, in which they display an antimicrobial effect. Consequently, not only an infection spreading directly from the surface of the implant can be prevented by the coating.
[0046] A titanium nitride/silver coating with a silver content of 5 to 30 At-% displays an antimicrobial effect. It is particularly effective against Staphylococcus epidermidis. As described above, this pathogen is usually found on the skin of humans and, presumably for this reason, is in many cases the cause of post-implantation infection. Studies indicate that, in particular in the spinal region, there is an increased risk of this pathogen causing an infection after implantation. This is possibly aided by the fact that Staphylococcus epidermidis has a comparatively low virulence among staphylococci. This leads to the signs of infection appearing later and thus possibly being overlooked at first. Since the coating is effective against precisely this pathogen, in particular an infection that is often detected very late for the aforementioned reason can be prevented.
[0047] The at % content of silver is preferably lower than the at % content of titanium. In other words, it is not necessary for there to be a stoichiometric distribution. The distribution may be hyperstoichiometric or substoichiometric. In total, the coating comprises a content of at least 70 at-% titanium nitride.
[0048] A maximum silver content of 30 at % ensures that the titanium nitride comprises deposits of silver or silver islands and not vice versa. This has the advantage that the titanium nitride provides an essentially continuous coating, in which the silver is embedded. A dissolving out of silver therefore generally has no negative influence on the functionality of the coating. As already described above, this even tends to extend the antimicrobial range of protection.
[0049] Other preferred silver contents for the present coating, such as a silver content of 5 to 20 at %, 8 to 15 at %, 8 to 10 at % or approximately 10 at %, also have this advantage. This structure of the coating inter alia leads to at least part of the silver content being present on the coating surface in addition to the titanium nitride content.
[0050] In addition to the aforementioned anti-microbial effect, the silver content, together with the ceramic titanium nitride content as a titanium nitride/silver coating, also leads to a change in the mechanical properties as compared to a pure titanium nitride coating. This structure in particular makes the coating softer.
[0051] It is presumed that owing to the ductility associated therewith, its mechanical resistance or strength is still sufficient to withstand the mechanical influences that occur during implantation of the implant. Such mechanical influences occur, for example, when creating a press fit of an implant in the bone tissue, through contact of an implant component with a fastening element, such as, for instance, when screwing in bone screws to fix a plate, or during assembly with another implant component, such as in a spondylodesis structure.
[0052] For this reason, the present coating is suitable in particular for implants which support the skeleton of a patient after implantation or replace parts of this skeleton. In the case of such implants, mechanical stress on the coating generally occurs during implantation and assembly of an implant. After implantation tensions and extensions occur in the coating in particular owing to the everyday stress on the implant in a patient's body. The present coating is advantageous here too.
[0053] In other words, the coating is particularly suitable for implants in which abrasion primarily occurs during implantation and/or assembly of the implant. In other words, the coating essentially does not suffer any function-related abrasion in the implanted state. It was found that a thickness of the coating of less than 10 μm, in particular of 2.5 to 6 μm, preferably 3.5 to 5.5 μm and even more preferably approximately 4.5 μm, is sufficient herefor. However, it is also conceivable to use such a coating with a higher layer thickness. This can, for example, be advantageous when using this coating on the joint surfaces of a joint implant.
[0054] Furthermore, in the present coating, the difference in material properties, in particular the elasticity, as compared to the underlying base material of the implant can sometimes be lower owing to the silver content. This also ensures sufficient mechanical resistance and adhesion of the coating. For inter alia this reason, the coating can also be applied to a wide variety of different implant materials.
[0055] In summary, the titanium nitride/silver layer of the coating thus exhibits both advantageous anti-microbial and mechanical properties that are useful for an implant coated with this coating at least in sections.
[0056] Such a coating is preferably produced using the physical vapour deposition (PVD) process mentioned above. Before being inserted into the coating chamber, the implant to be provided with the coating is cleaned with water.
[0057] The implant is then inserted into the coating chamber, which is then evacuated. For the subsequent processes, the implant is preferably heated to 400 to 600° C. in order to improve the mobility of ions on the surface of the implant and to achieve better adhesion of the coating on the implant.
[0058] Further cleaning of the implant surface is preferably carried out inside the coating chamber and before the coating is applied. For example, cleaning can be carried out by means of a glow discharge in a hydrogen atmosphere in order to remove any organic residues on the uncoated implant surface.
[0059] It is furthermore possible to carry out cleaning of the implant surface by means of ion etching. The implant is hereby bombarded with ions (for example titanium ions, argon ions) under an inert atmosphere, in particular an argon atmosphere, in order to remove an oxide layer that may be present on the surface of the uncoated implant material. This also results in a better adhesion of the coating to the surface of the implant.
[0060] The cited cleaning steps preferably take place in a vacuum atmosphere of 10.sup.−1 to 10.sup.−4 mbar.
[0061] After this optional cleaning, the coating is applied to the implant under a nitrogen atmosphere.
[0062] As already described above, this coating can be realised according to its desired composition with at least one silver target and at least one titanium target. It is also possible to use one or more targets that comprise the at % contents of silver and titanium intended for the coating. The composition of the coating is hereby consequently determined by the composition of the at least one target.
[0063] In order to keep a scattering of the evaporated target material on gas particles in the coating chamber and thus the loss of target material as low as possible, the coating is carried out under a vacuum in a range of 10.sup.−2 to 10.sup.−3 mbar.
[0064] Once the desired atmosphere has been set, the evaporation process of the at least one target begins. An arc is particularly preferred for this purpose, which removes material from the targets by means of electrical discharge using a strong current and transfers it to the gas phase. During this discharge, voltages in a range of 15 to 30 V and preferably in a range of 20 to 25 V, and currents in a range of 40 to 70 A are in particular used. However, the person skilled in the art understands that other methods can also be used for evaporating the targets, such as thermal evaporation, electron beam evaporation or laser evaporation.
[0065] At least during part of the coating process, coating with the silver target and the titanium target occurs simultaneously when using targets with different materials in order to produce the titanium nitride/silver coating structure described above.
[0066] Depending on the base material of the implant to be coated, a negative voltage of 100 V to 1500 V can also be applied thereto in order to improve adhesion and layer homogeneity. In order to achieve the most uniform coating possible, the targets and the implant can also be moved relative to one another during the coating process.
[0067] Following coating and a cooling phase, the coating chamber is ventilated again and the coated implant or implants can be removed. Cooling is preferably carried out with the support of a gas atmosphere (for example nitrogen or an inert gas) for improved heat dissipation such that the cooling process is accelerated.