• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    implant with antimicrobial coating”. The invention refers to an implant with a coating (23) that releases silver ions into the human body and as a result has antimicrobial action. according to the invention, a first coating surface component (23) is formed of an anode material (25). a second coating surface component (23) is formed of a cathode material (26). the cathode material is higher in the electrochemical voltage series than the anode material (25). the cathode material (26) and the anode material (25) are connected to each other in an electrically conductive manner. together with the body electrolyte in the implant environment, the anode material (25) and the cathode material (26) form a plurality of local galvanic elements. the antimicrobial action of the coating (23) is enhanced as a result.
    公开号:BR112012026448B1
    申请号:R112012026448-6
    申请日:2011-04-13
    公开日:2021-09-08
    发明作者:Thull Roger
    申请人:Waldemar Link Gmbh & Co. Kg；
    IPC主号:
    专利说明:

    The invention relates to an implant with a coating that releases silver ions into the human body and as a result has an antimicrobial effect.
    When implants are introduced into the human body, there is a risk of infection. Infection triggers can be microorganisms that are introduced into the human body with the implant or that are arranged on the surface of the implant. It is known that the risk of infection can be reduced by providing the implant with a coating that releases silver ions into its surrounding area. As is known, silver ions have an antimicrobial effect. Additionally, these have the advantage (if they do not encounter a microorganism and exert an effect on that microorganism) of combining with the chloride in the body's electrolyte to form AgCl and can be excreted from the body in this form. In contrast to other substances with an antimicrobial effect, therefore, silver ions do not accumulate in the body.
    Known silver coatings only release silver ions to a certain extent. The released silver ions still move randomly close to the implant. Thus, there is a likelihood that silver ions combine in the body's electrolyte to form AgCl and as a result lose their antimicrobial effectiveness before encountering a microorganism.
    The objective that forms the basis of the invention is to provide an implant, the coating of which has an antimicrobial efficacy. Adopting the above-mentioned prior art as a starting point, the objective is solved by the features of claim 1. Advantageous modalities can be found in the sub-claims.
    According to the invention, a first surface portion of the coating is formed of an anode material containing silver, which is provided to release silver ions. A cathode material is provided for a second surface portion. The cathode material is situated higher in the electrochemical voltage series than the 2711 anode material. The cathode material and anode material are connected to each other in an electrically conductive manner.
    First, some expressions will be explained. The expression implant includes all types of objects that must be inserted into the body. These are, for example, endoprostheses for bones or joints, as well as implants that are inserted into other types of body tissue, such as, for example, stents in the cardiovascular system. Also included are implants that are only partially inserted into the human body and partly protrude from that, such as dental implants or external fixators that constitute an indirect external stabilization orthosynthesis that sometimes occurs with a device of tensioning.
    The expressions first surface portion and second surface portion express that the cathode material in the coating is spatially separate from the anode material. It does not, therefore, mean a coating in which a plurality of materials are uniformly mixed with one another. It is possible, although not absolutely necessary, for the second surface portion to be extensively covered with the cathode material.
    In the electrochemical voltage series, substances are classified in order of their standard electrode potential. The higher the position of a substance in the electrochemical voltage series, the lower its solution pressure, that is, its tendency 20 to release ions into the water located in the surrounding area. A metal that is higher in the electrochemical voltage series is called a precious metal; a metal that is lower in the electrochemical voltage series is called the base metal. The position in the electrochemical voltage series is known to most substances, and the respective value can be taken from the relevant tables. If the position of a substance in the electrochemical voltage series is not known, this can be determined by forming a galvanic element with a known substance and by measuring the resulting potential difference. The position in the voltage series can be determined based on the potential difference. The terms anode material and cathode material serve to demonstrate the relative position of the materials used relative to one another in the electrochemical voltage series. Anode material and cathode material are electrically conductive materials.
    When the implant is inserted into the body, the anode material and cathode material of the coating form a local galvanic element with the body's electrolyte located close to the implant. The tendency of the anode material to release silver ions into the surrounding area is thereby increased. Electrons that remain in the anode material after the release of silver ions can move to the cathode material as a result of the electrical connection. In relation to the potential difference, silver ions are pulled towards the cathode material.
    The effect of the coating according to the invention is therefore doubled. First, relative to the local galvanic element, the anode material has an increased tendency to release silver ions into the electrolyte from the surrounding body. Compared to a coating consisting simply of the respective anode material, a greater number of silver ions are thereby released, as a result of which the antimicrobial effectiveness is increased. Additionally, the movement of the released silver ions no longer occurs in random directions; preferably, the silver ions are moved in the direction of the potential difference between the two substances, that is, in the direction of the cathode material. The probability is increased as the silver ions will actually exert an effect on microorganisms disposed on the implant surface rather than combining the body's electrolyte to form AgCl and thereby losing antimicrobial efficacy. The effect of the coating according to the invention is therefore concentrated on the surface of the implant. The coating is particularly well suited to combating the dangerous biofilm that can form on the surface of implants.
    The coating can cover the entire surface of the implant. This would be suitable for many implants that are introduced into the body in its entirety. This can also be provided, in particular, in the case of joint stent grafts, where only part of the surface is coated. The coating can be applied to that part of the surface with which the prosthesis comes into contact with the bodily tissue in the implanted state, while another part of the surface, which is intended, for example, to act together with another prosthesis component or which, as in the case of a fastener, is disposed outside the body, is exempt from the coating.
    Anode material can be pure silver. With a standard electrode potential of approximately +0.8 V, silver is a relatively precious metal that belongs to the upper range of the electrochemical voltage series. The normal hydrogen electrode is the reference parameter for the voltage values of the standard electrode potential.
    The cathode material acting in conjunction with pure silver must have a standard electrode potential of more than +0.8V. If the cathode material is a metal, this is therefore more precious than silver. A cathode material that is suitable for acting together with pure silver is, for example, gold, which has a standard electrode potential in the magnitude of +1.5V. Even if pure silver is not used as the anode material, but preferably a silver alloy and another substance, the standard electrode potential of the cathode material should be greater than +0.8V. The standard electrode potential of the cathode material is preferably at least 0, 3V, more preferably at least 0.5V, more preferably at least 0.7V higher than the standard electrode potential of the anode material.
    The greater the difference between the standard electrode potential of the anode material and the standard electrode potential of the cathode material, the stronger the effect of the local galvanic element. In an advantageous modality, a material containing silver is therefore used as the anode material, the standard electrode potential of this being less than +0.8V. The anode material then also contains other components in addition to the components of silver that are supposedly dissolved out of the anode. The standard electrode potential specified for the anode material refers to the solution pressure for silver ions. Preferably, a material that does not release substances other than silver ions into the body's electrolyte is selected as the anode. If substances other than silver ions are released, there is a risk that the other substances would have undesirable effects on the body. Additionally, a material that is biocompatible must be selected for both the anode and the cathode.
    The antimicrobial effect of the coating according to the invention depends on the silver ions that are released from the cathode material. The greater the portion of the coating surface occupied by the anode material, the higher the number of silver ions released. The portion of the coating surface which is occupied by the anode material is therefore preferably greater than 50%, more preferably greater than 70%, most preferably greater than 80%. In comparison, the surface portion occupied by the cathode material is less important. However, the portion of the cathode material may not be so small if good effectiveness of the galvanic elements is to be achieved. The portion of the cathode material on the surface of the coating is preferably greater than 0.1%, more preferably greater than 1%, more preferably greater than 5%.
    It is desirable that silver ions, once they leave the anode material, be able to travel a certain distance before finding the cathode material. During this movement, silver ions can exert an antimicrobial effect. The surface portions of the coating which are occupied by the anode material and the cathode material must therefore be separated from one another in such a way that the silver ions do not necessarily immediately encounter the cathode material. The coating therefore preferably has a plurality of circular surface areas that have a diameter greater than 1 µm, more preferably greater than 5 µm, more preferably greater than 15 µm, more preferably greater than 50 µm, which are simply formed of anode material and are free of cathode material. On the other hand, this is also not beneficial to the effectiveness of the coating if the free path along which the silver ions travel is too long. The diameter of the circular surface areas should therefore be less than 5 mm, preferably less than 1 mm, more preferably less than 0.5 mm. Preferably more than 30%, more preferably more than 50% of the surface of the coating is occupied by such surface portions.
    Silver ions exiting at the center of such an area must travel a certain distance before finding the cathode material. While traveling this distance, they can exert an antimicrobial effect. The free path that the silver ions must travel can be guided by the diameter of the bacteria that are also in the µm range.
    It can be assumed that silver ions move along an arc-shaped path and that the greatest distance to the surface that silver ions have in their path is of a similar order of magnitude to the distance traveled parallel to the surface. . Thus, if the free path to be traversed approximately corresponds to the diameter of the bacteria, it is possible for the silver ions to exert an effect on 10 bacteria disposed on the surface along their entire path.
    The coating can be designed such that the cathode material is embedded in the anode material in an island-shaped manner or is applied to the anode material in an island-shaped manner. The cathode material can further be applied in the form of connected surface areas which have a diameter, for example, of a few µm. It is not inconceivable that the cathode material is applied to the second surface area in the form of individual particles, without the anode material being extensively coated in that area.
    In many cases, the implant surface is supposed to be smooth. This can be achieved if the anode material and cathode material are level with each other. In an alternative embodiment, the cathode material may protrude relative to the anode material. The silver ions then move a small distance in relation to the coating surface and in this way a good effect on microorganisms in the immediate vicinity of the coating is achieved. It is suitable for this purpose to first of all apply anode material with a uniform layer thickness and then apply cathode material to the coating in selected regions. The layer thickness of anode material can be between 100 nm and 10,000 nm. preferably between 200 nm and 400 nm. This range particularly applies if the anode material is pure silver. The layer thickness of the cathode material applied to the anode material can also be between 100 nm and 10,000 nm, preferably between 200 nm and 400 nm.
    It is also possible to first extensively apply a layer of the cathode material. A layer of anode material can be applied to the cathode material, which comprises openings so that the cathode material can be accessed from outside through the anode material. If the anode material is applied using a plasma coating method, openings can be generated by targeting larger fragments that have a diameter, for example, 20 μm on the surface by applying the layer, which fragments to remove a part of the layer that is formed, see WO 2009/036846. When using this method, the thickness of the layers is also preferably between 100 nm and 10,000 nm, more preferably between 200 nm and 400 nm.
    The invention will be described below, by way of example, by means of advantageous embodiments and with reference to the drawings covered:
    Figure 1 shows a first embodiment of an implant according to the invention;
    Figure 2 shows a component of the implant of Figure 1;
    Figure 3 shows a second embodiment of an implant according to the invention;
    Figure 4 shows a section of the body of an implant according to the invention which has a coating;
    Figure 5 shows the coating of Figure 4 in a top view;
    Figure 6 shows the view of Figure 4 in another embodiment of the invention;
    Figure 7 shows the view of Figure 5 in the embodiment according to Figure 6;
    Figure 8 shows the view of Figure 4 in a further embodiment of the invention; and
    Figure 9 shows the view of Figure 5 in a further embodiment of the invention.
    An implant shown in Figure 1 is intended to replace a portion of the human skeleton that extends from the hip to below the knee. A ball-shaped joint head 10 forms a joint surface that is designed to interact with an acetabulum. The joint head 10 is connected to a head piece 11 of the implant by means of a threaded connection. The part of the implant that replaces the central axis of the femur comprises three implant components 12, 13 and 14. The implant components 12, 13 and 14 are connected to each other and to the head piece 11 also by means of threaded connections. A knee piece 15 forms a hinged connection with an axis 16 that is intended to connect the implant to the tibia.
    Implant components 12, 13 and 14 are available in different lengths so that the implant can be adapted to femurs of different lengths. Figure 2 shows an enlarged view of an implant component 17 corresponding to implant components 12, 13 and 14. The implant component 17 comprises a threaded screw 18 as well as a threaded hole 19 which is indicated by dashed lines. By means of the threaded screw 18 and the threaded hole 19, the implant component 17 can be connected at both ends to additional implant components. The screw thread 18, the thread hole 19 and the mating end faces 20 and 21, therefore, are not seated in the patient's bodily tissue in the implanted state of the implant component 17, but are preferably seated in others. implant components. The outer surface 22 of the implant component 17 is, on the other hand, designed to come into contact with human tissue in the implanted state. The outer surface 22 is provided with an antimicrobial coating 23 which is indicated by dots. The remaining surface of the implant component is free from coating 23.
    An enlarged view of the coating 23 is shown in Figures 4 and 5. The coating 23 consists mostly of pure silver, which extensively covers the outer surface. As shown in Figure 5, the gold material is introduced into the silver layer in the form of a plurality of rectangular islands. The gold material is embedded in the silver layer in such a way that the two materials lie flat against each other and a smooth surface is formed. A smooth surface is desired, since imitation of the surrounding bodily tissue concerning rubbing must be minimized. The coating 23 has a first surface portion 28, which is formed from the silver material, and a second surface portion 29, which is formed from the gold material. The surface portion 28, which is formed of the silver material, occupies more than 80% of the surface of the cladding 23. As indicated in Figure 5 by means of a dashed line, the circular surface areas 27 remain between the islands, at that the surface of the coating 23 consists entirely of silver material and is not interrupted by the gold material. The surface area 27 has a diameter of more than 0.1 mm.
    Silver and gold are connected together in an electrically conductive manner in coating 23. Silver is a less precious metal than gold and is situated lower in the electrochemical voltage series than gold. Within the meaning of the function of the coating according to the invention, silver is therefore a 25-anode material and gold is a 26-cathode material.
    After implantation, the coating 23 is surrounded by body electrolyte. Silver material has a tendency to release positively charged silver ions into the body's electrolyte. This trend is called solution pressure. When silver ions are released from the coating, excess electrons remain in the coating and an excess of negatively charged vehicles forms in the coating. Since the silver material and the gold material are connected to each other in an electrically conductive manner, excess electrons can move freely towards the gold material. The gold material is also subjected to certain solution pressure to release ions into the body's electrolyte. Since gold is a more precious metal than silver and is situated higher in the electrochemical voltage series, the solution pressure is, however, lower than the solution pressure of silver. Silver ions that are released at a higher concentration move towards the gold material. In this way, the body's electrolyte, together with silver as the 25-anode material and gold as the 26-cathode material, form local galvanic elements. The silver ions leave the anode material 25 and move parallel to the coating 23 towards the cathode material 26. In this way, the silver ions can exert an antimicrobial effect on microorganisms that are disposed on the surface of the coating 23 .
    The dental implant shown in Figure 3 is an alternative embodiment of the invention. An implant body 30 is screwed into the jaw bone 31 at its lower end. The upper end of the implant body 30 projects upward from the jaw bone 31 and the gingiva 32 surrounding the jaw bone 31. A mounting rod 34 which is covered with an artificial dental crown 33 is screwed onto the free end. of the implant body 30. The dental implant replaces a natural tooth in this way. The implant body 30 is, in turn, provided with a coating 23 which is indicated by means of dots.
    Coating 23 is shown in an enlarged view in Figures 6 and 7. A silver coating is first of all applied to the implant surface 30, and has a uniform thickness of approximately 400 nm. The gold material is applied to the surface of the silver coating in a grid-like arrangement and also has a layer thickness of approximately 400 nm. The regions involved in the grid, in which the surface of the coating 23 is formed from the silver material, form, in its entirety, the first surface portion 28 of the coating 23. The grid-like arrangement of the gold material forms the second portion of surface 29 of the coating. The grid shape of the gold material is dimensioned in such a way that the circular surface areas 27 having a diameter of more than 50 µm remain free from the gold material.
    In the coating shown in Figure 8, the implant component 17 is first of all extensively covered with a layer of gold as the cathode material 26. A layer of silver applied thereto as the anode material 25 comprises a plurality of apertures. The openings in their entirety form the second surface portion 29, wherein the anode material 25 can be accessed from the outside through the cathode material 26.
    In the embodiment according to Figure 9, anode material 26 is not extensively applied to the second surface portion 29, but is preferably applied as a plurality of individual particles. This does not change anything about the effect of the coating according to the invention.
    As already explained above, silver is an anode material 25 within the meaning of the invention and gold is a cathode material 26. Along with the body electrolyte close to the implant body 30, the coating 23 forms a plurality of galvanic elements locations. Since gold as the cathode material 26 projects relative to the anode material 25, the silver ions can also move a small distance relative to the silver layer towards the cathode material 26.
    In the case of dental implants, the antimicrobial coating 23 has a particular function of exerting an effect on microorganisms in the transition between the implant body 30 and the gingiva 32 and/or the jaw bone 31. It is well known that there are numerous microbes. -organisms in the mouth environment and that the risk of an infection in the area surrounding the implant body 30 is high. If the antimicrobial coating 23 can prevent the penetration of microorganisms between the implant body 30 and the gingiva 32, infections unpleasant to the patient can be avoided.
    权利要求:
    Claims (11)
    [0001]
    1. Implant for bone or a joint comprising a coating (23) which releases silver ions into the human body and as a result has an antimicrobial effect, CHARACTERIZED by the fact that a first surface portion (28) of the coating (23) is formed by a silver-containing anode material (25), a cathode material (26) is provided on a second surface portion (29) that is spatially separate from the first surface portion (28), wherein the cathode material (26) is situated higher in the electrochemical voltage sequence with respect to the anode material (25), and that the cathode material (26) and the anode material (25) are coupled together in an electrically conductive manner, where the implant is an endoprosthesis.
    [0002]
    2. Implant, according to claim 1, CHARACTERIZED by the fact that the anode material (25) is pure silver.
    [0003]
    3. Implant, according to claim 1, CHARACTERIZED by the fact that the standard electrode potential for releasing silver ions from the anode material (25) is less than +0.8 V.
    [0004]
    4. Implant, according to any one of claims 1 to 3, CHARACTERIZED by the fact that the standard electrode potential of the cathode material (26) is greater than +0.8V.
    [0005]
    5. Implant, according to claim 4, CHARACTERIZED by the fact that the cathode material (26) is gold.
    [0006]
    6. Implant, according to any one of claims 1 to 5, CHARACTERIZED by the fact that the standard electrode potential of the cathode material (26) is greater than the standard electrode potential of the anode material (25) at least 0.3V, preferably 0.5V, more preferably 0.7V.
    [0007]
    7. Implant, according to any one of claims 1 to 6, CHARACTERIZED by the fact that the cathode material (26) is embedded in the anode material (25) in an island-shaped manner.
    [0008]
    8. Implant, according to any one of claims 1 to 7, CHARACTERIZED by the fact that the first surface portion (28) which is formed by the anode material (25) occupies more than 50%, preferably more than 70%, or more preferably, more than 80% of the coating surface (23).
    [0009]
    9. Implant, according to any one of claims 1 to 8, CHARACTERIZED by the fact that the coating (23) comprises circular surface areas (27) having a diameter of more than 0.1 mm, preferably more than 0.5 mm, more preferably more than 1 mm, said surface areas are free from cathode material (26).
    [0010]
    10. Implant, according to any one of claims 1 to 9, CHARACTERIZED by the fact that the anode material (25) and the cathode material (26) are level with each other.
    [0011]
    11. Implant, according to any one of claims 1 to 10, CHARACTERIZED by the fact that the cathode material (26) projects in relation to the anode material (25).
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    法律状态:
    2021-05-04| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-05-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2021-06-15| B25C| Requirement related to requested transfer of rights|Owner name: DERU GMBH ENTWICKLUNG VON MEDIZINISCHEN PRODUKTEN (DE) Free format text: A FIM DE ATENDER A TRANSFERENCIA, REQUERIDA ATRAVES DA PETICAO NO 870160013598 DE 12/04/2016, E NECESSARIO ESCLARECER A DIVERGENCIA ENTRE O NOME DA EMPRESA TITULAR DO PEDIDO E O NOME DA EMPRESA CEDENTE. ALEM DISSO, E PRECISO APRESENTAR A GUIA DE CUMPRIMENTO DE EXIGENCIA. |
    2021-07-27| B25L| Entry of change of name and/or headquarter and transfer of application, patent and certificate of addition of invention: publication cancelled|Owner name: DERU GMBH (DE) Free format text: ANULADA A PUBLICACAO CODIGO 25.3 NA RPI NO 2632 DE 15/06/2021 POR TER SIDO INDEVIDA. |
    2021-08-10| B25A| Requested transfer of rights approved|Owner name: WALDEMAR LINK GMBH AND CO. KG (DE) |
    2021-08-10| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-09-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/04/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |
    优先权:
    申请号 | 申请日 | 专利标题
    EP10004140A|EP2382960A1|2010-04-19|2010-04-19|Implant with antimicrobial coating|
    EP10004140.9|2010-04-19|
    PCT/EP2011/055808|WO2011131536A1|2010-04-19|2011-04-13|Implant with antimicrobial coating|
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