IMPLANT WITH INTRINSIC ANTIMICROBIAL EFFICACY, AND METHOD FOR THE PRODUCTION THEREOF

20220168473 · 2022-06-02

    Inventors

    Cpc classification

    International classification

    Abstract

    The invention relates to an implant (1) with antimicrobial activity, comprising an implant mixture (IM) which has a base granular material (2) formed from a raw material mixture of biocompatible polymers and/or a ceramic granular material, the implant mixture (IM) also comprising at least one type of metal (3) in particle form which is suitable for releasing ions, the metal particles (3) being present in the form of silver particles and/or copper particles. The metal particles (3) are distributed in the volume of the implant (1). The invention also relates to a method for producing an implant (1) of said type.

    Claims

    1. An implant with antimicrobial activity comprising an implant mixture having a base granular material made of a raw material mixture of biocompatible polymers and/or a ceramic granular material, wherein the implant mixture further comprises at least one kind of particulate metal suitable for releasing ions, wherein the metal particles are provided in the form of silver particles and/or copper particles, wherein the metal particles are distributed in the volume of the implant so that the metal is interspersed with further metal particles in the form of magnesium particles and/or iron particles, which are highly pure and elemental as well as biodegradable metals.

    2. The implant according claim 1, wherein the distribution, density, quantity and/or concentration of the metal particles in the implant mixture is such that the antimicrobial activity of the implant is forced to occur in its direct environment.

    3. The implant according to claim 1, wherein the silver particles have a grain size in the range of 1-200 μm, the copper particles have a grain size in the range of 1-100 μm, and the magnesium particles and iron particles have a grain size in the range of 1-200 μm.

    4. The implant according to claim 1, wherein the implant is porous in such a way that the antimicrobial activity of the porous implant is forced to occur on the pore surface.

    5. The implant according to claim 1, wherein the implant is designed to be solid in such a way that the antimicrobial activity of the solid implant is forced to occur on the implant surface.

    6. The implant according to claim 1, wherein the implant is produced with patient-specific shape and material properties.

    7. The implant according to claim 1, wherein the implant is manufactured by compression molding, milling, laser sintering, or injection molding.

    8. A method for producing an implant according to claim 1, characterized by the steps: a) mixing of the raw materials for producing the base granular material; b) mixing or blasting of the base granular material with the metal particles in a defined ratio, by which the implant mixture is formed, and c) pressing the implant mixture for producing a material block which is crushed into chunks, and wherein these chunks are subsequently formed into the final implant shape.

    Description

    [0039] The following describes in detail an embodiment of the implant according to the invention and the method of producing the implant with reference to the accompanying drawings.

    [0040] The following is shown:

    [0041] FIG. 1 shows a schematic cross-sectional view of an implant;

    [0042] FIG. 2 shows a flowchart illustrating the steps involved in the production of the implant.

    [0043] FIG. 3A shows conceivable particle shapes of the biogranule;

    [0044] FIG. 3B shows a scanning electron microscope image of the implant 1 with round granular material particles;

    [0045] FIG. 3C shows a scanning electron microscope image of the implant 1 with potato-shaped granular material particles;

    [0046] FIG. 4A shows a longitudinal sectional view of the implant 1 using a scanning electron microscope;

    [0047] FIG. 4B shows the section IV from FIG. 4B.

    [0048] FIG. 5A shows a schematic representation of the implant 1 in the μm range with hexagonal granular material particles and a type of metal particles; and

    [0049] FIG. 5B shows a schematic representation of the implant 1 in the μm range with pentagonal granular material particles and two types of metal particles.

    [0050] The figures are only schematic in nature and serve only for the purpose of understanding the invention. The configuration example is purely exemplary.

    [0051] FIG. 1 shows the implant 1, which comprises the base granular material 2 as well as the metal particles 3. It can be seen that both the base granular material 2 and the metal particles 3 are mixed together and are present in the implant 1 over the entire volume of the implant 1.

    [0052] FIG. 2 shows a flow chart illustrating the steps of the method according to the invention. First, in the first step S1, a first raw material RM1, which is for example a biocompatible polymer (LDPE), and as a second raw material RM2 a ceramic granular material (for example calcium carbonate) are mixed together. By mixing these two raw materials, the base granular material 2 is obtained. In a second step S2, a first type of metal particles MP1, for example silver particles, and a second type of metal particles MP2, for example copper particles, are added to this base granular material 2 or are brought together with the base granular material 2 by blasting. After step S2, the implant mixture IM is obtained. In the third step S3 of the method, this implant mixture IM is pressed. This results in a material block which is crushed into chunks, for example by machining or grinding, which in turn are subsequently shaped into the final implant form. Thus, after step S3, the finished implant 1 is obtained, which can be placed/inserted into a patient body.

    [0053] FIG. 3A shows, by way of example and without being limited thereto, nine different types/shapes/versions in which the particles of the biogranules 2 may be formed. Here, an implant 1 is assumed which has calcium carbonate as biogranules 2 and has, for example, silver particles, magnesium particles, etc. as metal particles 3. The particle types/particle shapes of the particles in the biogranules are continuously characterized by the symbols ‘V1’ to ‘V9’. The basic shape of the particles is round according to V1, potato-shaped according to V2, oval according to V3, square according to V4, octagon-shaped according to V5, parallelogon-shaped according to V6, semicircular according to V7, pentagon-shaped according to V8, and hexagon-shaped according to V9.

    [0054] FIG. 3B shows a scanning electron microscope image of implant 1, which has round (V1) granular material particles in its biogranules 2. Here, UHMW-PE granular material is selected as biogranules 2 as an example. The metal particles 3 adhering to the entire surface of each individual granular material particle/biogranules 2 are silver particles here.

    [0055] FIG. 3C shows, similarly to FIG. 3B, a scanning electron microscope image of the implant 1, which here has potato-shaped (V2) granular material particles. The implant 1 in FIG. 3C is composed of the same materials as the implant shown in FIG. 3B and differs from the latter only in the shape of its granular material particles 2.

    [0056] FIG. 4A shows a longitudinal sectional view of the implant 1 using a scanning electron microscope. This is an example of a UHMW-PE implant with calcium carbonate particles mixed with magnesium particles, silver particles, etc. The implant 1 is porous in this case. Each particle of the granular material 2 has a layer of metal particles 3 distributed over its entire surface, which here stand out brightly against the granular material 2. Thus, the pore spaces (spaces between the individual particles of the granular material) are at least partially filled with metal particles 3.

    [0057] FIG. 4B shows the section IV from FIG. 4A and thus the implant 1 from FIG. 4A on an enlarged scale.

    [0058] FIG. 5A is a schematic representation of the implant 1 in the μm range, which here shows exemplary hexagonal/six-sided particles of biogranules 2, wherein UHMW-PE is chosen as biogranules 2 as an example. The dot-like/circle-like elements symbolize the metal particles 3 (of a metal type, for example MP1), which here may be silver, copper or zinc. The arrows A1 point in the direction of the porous surface of the implant 1. The ‘*’ symbol marks the areas between the granular material particles 2, i.e. the areas in the pores (pore spaces), which are characterized in particular by their intrinsically antimicrobially active pore structure.

    [0059] Like FIG. 5A, FIG. 5B also shows a schematic representation of the implant 1 in the pm range. The two illustrations (FIG. 5A and FIG. 5B) of the implant 1 differ in that the granular material particles 2 in FIG. 5B are pentagonal/five-sided in shape and here, in addition to the metal particles 3 of type MP1, other particles MP2 with antimicrobial activity also adhere to these granular material particles 2, for example ceramic components, which are shown here as a polygon (regular decagon).

    LIST OF REFERENCE SIGNS

    [0060] 1 implant

    [0061] 2 base granular material

    [0062] 3 metal particles

    [0063] IM implant mixture

    [0064] RM1 raw material 1

    [0065] RM2 raw material 2

    [0066] MP1 metal particles 1

    [0067] MP2 metal particles 2

    [0068] S1 first step

    [0069] S2 second step

    [0070] S3 third step

    [0071] V1 to V9 (nine different) variants of granular material shapes