WO1987006842A1

WO1987006842A1 - Composite material for prosthetic purposes, process for its production and use of the composite material or application of the production process for coating of prostheses

Info

Publication number: WO1987006842A1
Application number: PCT/DE1987/000207
Authority: WO
Inventors: Henning Franek; Wolfgang Rosenkranz; Heinz BRÖMER; Klaus-Konrad Deutscher (Verstorben)
Original assignee: Ernst Leitz Wetzlar Gmbh; Deutscher, Anneliese, Heiress Of Deutscher, Klaus-
Priority date: 1986-05-09
Filing date: 1987-05-07
Publication date: 1987-11-19
Also published as: EP0276227A1; JPS63503283A; DE3615732A1

Abstract

The composite material for prosthetic purposes consists of a metallic component (2), for example titanium and of a bioactive material (3), for example bioglass ceramic. The bioactive material (3) has a particle size of between 5 and 1000 mum in the metal phase (2). The composite material is produced in an encapsulated reaction chamber (5) in such a manner that an initial thoroughly-mixed powder or particulate mixture (4) is subjected to an isostatic compression process, possibly with the use of an elevated temperature. The process parameters of pressure, temperature and time can be selected in a freely-variable manner with large limits. The reaction chamber (5) is made of a capsule-type receptacle (6), which is evacuated in advance via a capsule opening (6a) and then hermetically closed. Special requirements have to be imposed on the choice of the glass used for the glass receptacle (6). For specific purposes a metal encapsulation can also be provided. Metal prostheses can be provided in their surface region with recesses in which the composite material (1) as described in the invention is inserted with a precise fit. The prosthesis thus equipped can then be again inserted in a capsule-type receptacle made of metal or glass and subjected to an isostatic compression process. In this way, the inserted bioactive composite material elements are firmly welded. The process is suitable also for the coating of a metal or ceramic implant. For this purpose, the implant is inserted into a capsule which is then enclosed with the initial powder mixture (4) and after that is evacuated. As a result of isostatic compression the composite material adheres as a coating material.

Description

Composite material for prosthetic purposes, process for its production and use of the composite material or application of the production process for coating prostheses

The invention relates to a bioactive composite material for prosthetic purposes, a process for its production and the use of this composite material or the application of this production process for the treatment of metallic and / or ceramic prostheses or prosthesis parts.

Bioactive bone substitute materials essentially consist of inorganic chemical materials, such as bio glasses, bio glass ceramics, tricalcium phosphate ceramics, apatites, etc.

Such materials generally have high compressive strength values, but they all - due to their characteristic "brittleness" - all have the common disadvantage that they can only be subjected to extremely low levels of tension, bending or torsion. The application possibilities of these materials as compact prosthesis materials are subject to considerable restrictions.

In medicine, therefore, hitherto, preference has been given to using high-strength metallic, biologically inert implant materials to a preferred degree, but not for permanent anchoring in the living Organism required property of bioactivity. Examples of such metallic prosthesis materials that meet the extreme mechanical property requirements are titanium, titanium alloy and some other special alloys, for example CoCrMo.

At the interface between the bony tissue and the metallic implant, a soft tissue capsule generally forms - even in the case of what is known as bio-inert material - which prevents a force-locking connection between the bone bed and the implant. In order to achieve a connection between the bone and the implant, the implant surface must be structured. The structuring is provided in the form of recesses, undercuts, grooves, but also in the form of pores or grooves. In spite of the positive connection achieved, the problem of a physiologically correct transfer of force from the bone to the prosthesis and vice versa as a result of the connective tissue layer occurring at the interface is not solved.

In addition to these metallic implant materials, ceramic materials that have better tissue compatibility have also recently been developed. In one group of materials, the bioactive materials, a connective tissue-free bond between bone and implant can be demonstrated. A smooth interface between the bioactive implant material and the bony tissue can be subjected to tension, shear and torsion. A bone / implant composite of this biological-chemical quality is a prerequisite for any biomechanically correct power transmission.

However, the mechanical strength of bioactive materials is not large enough to support high-strength prostheses, e.g. B. Hip prostheses or dental prostheses to be made from such solid material. : The property of bioactivity that is desired at the bone interface with the strength of metallic materials To combine, the coating of prostheses with bioactive substances has been proposed, cf. for example DE-PS 23 26 100. This coating is known in the form of closed layers and in the form of granular granules.

The coating of metallic prostheses with bioactive substances presents difficulties insofar as the adhesive strength of closed bioactive layers on the metal core of the prosthesis is often not sufficient. The use of bio-inert enamels as an adhesion promoter layer between the bioactive granulate and the base metal extends the choice of materials and thus the better possibilities for adhesion; however, the different base alloys each require new adaptable enamel compositions, which leads to considerable development, testing and material expenditure.

It is therefore the object of the present invention, one

Specify composite material that combines the excellent strength properties of the metallic materials with the indispensable biochemical properties of known bioactive prosthetic materials. Another part of the task is to specify a method for producing such a composite material and to demonstrate a prosthesis coating method using the said composite material or using the corresponding production method.

This object is achieved in that the composite material consists of a metallic component in which at least one bioactive material is embedded. The metallic phase can consist of a high-strength biocompatible metal or metal alloy component and the bioactive material can consist of at least one inorganic chemical component. The bioactive material is expediently in particulate form, the particle size being in the range from 5 to 1000 μm, but preferably in the range from 50 to 500 μm. The shape of the particles of the bioactive material is preferably three-dimensional compact. However, it is also possible for these particles to be present in the metallic component in an elongated form, for example in the form of a needle or fiber. The volume ratio of the metallic phase to the bioactive phase can be varied within a wide range; it is between 95: 5 and 5:95% by volume, preferably between 70: 30 and 30: 70% by volume. According to a special embodiment of the present invention, the metallic phase consists of titanium and / or at least one titanium alloy, for example TiAIV or TiAIFe. However, it is also possible for the metallic phase to consist of a cobalt-chromium-molybdenum alloy, for example CoCrMo. The bioactive material consists of at least one of the bio materials listed below: bioglass, bioglass ceramic, apatite, apatite sintered ceramic, tricalcium phosphate, tricalcium phosphate ceramic. It has a density which corresponds to the theoretical density of both starting components in accordance with their respective mixing ratio.

The object is further achieved by a process for the production of the composite material, in which a well-mixed starting mixture consisting of a powdery metallic component and at least one particulate biomaterial in an encapsulated reaction space is an isostatic pressing process, optionally with the additional use of elevated temperature, is subjected. The process parameters pressure, temperature and time can be chosen freely depending on the respective starting substances, the desired material properties and the particular capsule technology used within the following ranges: The pressure can be between 1 and 4000 bar, preferably between 50 and 2000 bar; the

Temperature between 20 and 2000 ° C, preferably between 150 and 900 ° C _/ and the time between 10 minutes and 50 hours, preferably between 30 minutes and 12 hours. at In the process according to the invention, the well-mixed powder or particulate starting mixture is placed in a capsule container, which is hermetically sealed to produce a vacuum of at least 10 mbar and then subjected to an isostatic pressing process. It is possible for the capsule material to be made of glass and for the hermetic sealing of the container to take place by melting the glass capsule opening together. The inner wall of the capsule can advantageously be provided with a contact-inert, thermally stable release agent, for example with a boron nitride powder coating. That for the

Glass used in capsule containers has such a combination of physicochemical properties with regard to its transformation temperature or its softening temperature and its linear thermal expansion coefficient that the latter is already in the plastic deformation range at the process temperature required for the production of the composite material, whereby however the softening temperature has not yet been exceeded. According to an advantageous process variant, the transformation temperature of the capsule container glass is 20 to 200 ° C lower than the process temperature and the softening temperature of the glass is between 20 and 200 ° C higher than the process temperature. The capsule material can also consist of metal or a metal alloy. The capsule container expediently has an ampoule-like, strongly rounded shape. The metal capsule can consist of a thin-walled tube which is closed on one side and which is additionally provided with longitudinal grooves on the tube jacket. A capsule closure designed as a metal stopper with an evacuation tube can be provided, which ensures a vacuum-tight encapsulation by means of an all-round weld seam.

The composite material according to the invention can be used as a solid material for the production of prostheses or prosthesis parts. It is also possible to use it as a full-surface coating to use processing material and to use the manufacturing method according to the invention as a one-step coating method of metallic and / or ceramic prostheses or prosthesis parts. In the coating method mentioned, a void-free metallic and / or ceramic prosthesis or such a prosthesis part can be introduced into or held in a glass capsule in such a way that there is essentially one between the prosthesis to be coated and the inner wall of the glass capsule The distance is the same on all sides, so that the remaining space in the capsule is then filled with the mixed powdered starting mixture, the capsule is then hermetically sealed and placed under vacuum and finally subjected to the isostatic pressing process.

In addition, the composite material can be used as a solid material for the production of compact molded storage bodies for insertion into geometrically analogous recesses which are provided or introduced in the near-surface areas of prostheses or prosthesis parts in such a way that the the prosthesis fitted in this way is then subjected to an isostatic pressing process for anchoring the fitted molded articles in or with their corresponding recesses. In this case, the shaped inserts in plan view can have surface geometries with linear and / or non-linear contours that correspond to the respective geometries of the recesses in the surface areas of the prostheses to be fitted. They can be simple geometric shapes such as circles, rectangles, triangles, rhombuses, trapezoids, parallelograms, etc. The shaped inserts can have a wide variety of external contours in cross section; For example, they can have a lenticular, cusp, trough, truncated pyramid and / or truncated cone-shaped or a multiple-groove outer contour, in their respective anchoring area either with a positive fit or with a defined allowance for thermal shrinking can be provided.

The isostatic pressing method according to the invention can also be used to fill in notches, grooves, grooves, rings and other surface defects on the prosthesis. It is also possible to carry out the coating process in such a way that a metallic and / or ceramic prosthesis or. a corresponding prosthesis part, for example a tubular or sleeve-shaped prosthesis part, is externally and / or internally coated in such a way that a tube prefabricated from the composite material is pushed onto the sleeve in accordance with the wall thickness and diameter dimension with the outer coating or with the inner coating is inserted into the sleeve with a precise fit, that this covered prosthesis part sleeve is then brought into a double-shell capsule shape, so that an isostatic pressure effect is achieved in the inner and outer wall region of the sleeve surface in such a way that the double-shell, consisting of inner and outer tubes The capsule is then closed and placed under vacuum and that the actual isostatic pressing process finally leads to all-round, permanently solid welding of the composite material linings to the actual prosthesis sleeve. It is possible, for example, to use the composite material to produce a grooved plate of a straight or oblique ossicular prosthesis, the stem itself being made of biocompatible metal or ceramic material.

The invention is explained in more detail below with reference to the figures. In a schematic representation:

1: the mixed starting mixture for the composite material according to the invention located in a sealed glass capsule container; 2 shows a greatly enlarged illustration of the composite material produced by the method according to the invention; 3: an ampoule-like, closed glass container with a metallic or ceramic prosthesis part, which is completely enveloped by the powdery starting mixture; Fig. 4: a metallic hip joint endoprosthesis in one

Glass capsule container, which is essentially adapted to the shape of the prosthesis and is dimensioned such that the prosthesis shaft is encased on all sides by a bed of the powdery starting mixture; Ffg. 5: a metal sleeve provided with longitudinal grooves as a capsule

Container, which has, among other things, a metal stopper that contains an evacuation tube to create a vacuum. A prosthesis or a prosthesis part with alternately larger or smaller diameter ranges is located in the metal sleeve in a central-axial holder; 6: an endoprosthesis with circular or rectangular recesses, in which there are correspondingly fitted molded inserts. The prosthesis equipped in this way is located in an encapsulated reaction chamber which is under vacuum in order to carry out the isostatic pressing process; Ffg. 7a: a section of the surface area of a

Prosthesis or a prosthesis part with various recesses; 7b: different compact geometrical embedding

Shaped body for insertion into the recesses according to FIG. 7a; 8: a cross section through another surface area of a prosthesis or a prosthesis part with recesses and different designs

Storage moldings; Fig. 9: a two-shell metal capsule container with a

Inner tube (inner jacket) and an outer tube (outer jacket), the two tubes being welded together in the lower and upper area. In the container there is a tubular prosthesis part which is surrounded by an outer sleeve made of composite material;

9a: a sleeve-shaped prosthesis section made of metal or ceramic; FIG. 9b: a tube consisting of the composite material as a slip-on sleeve for the prosthesis part shown in FIG. 9a;

10: a metallic hip joint endoprosthesis with differently dimensioned geometric recesses in the surface area;

Fig. 11: a hip joint endoprosthesis with differently dimensioned shaped inserts;

12: a skewed ossicular prosthesis with a head plate made of the composite material according to the invention and a shaft made of bio-inert metal

(or ceramics);

Fig. 13: a cross section through a block of bioinert

Metal or ceramic that has a thick surface coating made of the composite material according to the invention. The illustration shows a possibility of separating dimensioned special prostheses or prosthesis parts from such a coated metal block.

1 shows the well-mixed powdery or particulate starting mixture 4 in an already closed glass capsule container 6. The glass capsule opening 6a is melted after generating a certain negative pressure - hereinafter referred to as "vacuum" - for example by means of a burner flame. This starting mixture, consisting of the powdered metallic material and the particulate bioactive material, together with the capsule, are subjected to the process parameters pressure, temperature and time. In order to facilitate the detachment of the glass jacket after the isostatic pressing process, the inside of the container can be provided with a contact-inert and thermally stable release agent, for example powdered boron nitride. It must be ensured that the capsule container still has a negative pressure even after it has melted. The process conditions can be freely selected within wide limits. They depend, inter alia, on the batch chosen, the respective proportions, the composition of the starting batch. The dimensioning of the glass container depends primarily on the dimensions of the isostatic process chamber. The height of the capsule container can e.g. B. with a cylindrical cross section between 10 and 25 cm. It should be noted that corners and

Edges of the container are strongly rounded to avoid breakage of the container as a result of thermal stresses occurring during the heating phase in the process chamber. The glass material used for the encapsulation must be selected with regard to its physical-thermal material data so that it already lies in the plastic deformation range at the process temperature required for the production of the composite material, but the softening temperature has not yet been exceeded.

A section through the composite material 1 produced is shown in a greatly enlarged illustration in FIG. 2. The bioactive material 3 is embedded in particulate form in the metal or alloy phase 2.

3 shows an ampoule-like glass container 6 in which a rod-shaped prosthesis part 10a made of metal or ceramic is axially centered. For this purpose, 6 centering receptacles are inserted in the upper and lower part of the capsule container. sets, which can remain temporarily on the then coated prosthesis parts even after the pressing process has ended and the glass container has been removed. These two mounting brackets can be made of ceramic or metallic material; they then serve as a centering fixture or as a clamping holder for any mechanical mechanical reworking of the coated prosthesis part. The capsule container 6 contains the starting batch 4 in the space between the prosthesis part 10a and the inner wall of the capsule. The closed glass container 6, which was evacuated via the glass capsule opening 6a, can then be subjected to the isostatic pressing process.

In Fig. 4, a metallic hip joint endoprosthesis is surrounded by a similarly contoured glass container 6. The space between the prosthesis socket and the inner wall of the capsule container 6 is again completely filled with the starting mixture 4. The glass container was evacuated through the opening 6a. It should be pointed out that the encapsulation technique shown in FIGS. 3 and 4 can only be used for prosthesis base bodies which are made of solid material and therefore have no cavities. It is furthermore essential in this process that the bulk thicknesses of the powdery starting mixture 4 are kept as small and as uniform as possible in order to avoid a purely mechanical deformation of the encapsulated base of the prosthesis during the isostatic pressing process. The extent of a possible deformation essentially depends on the geometric dimension of the base body and on the process parameters used.

A second possibility for encapsulation is to manufacture capsule containers from metallic material. This is shown in FIG. 5. A thin-walled cylindrical metal tube 7, which is expediently soft on its outer circumference with longitudinal grooves 8 is provided to ensure a uniform deformation during the isostatic pressing process is closed with Metall¬ stopper 9 by all-round welds. The stopper 9 carries the evacuation tube 9a required to produce a vacuum. Before the container is hermetically sealed, the powdery and well-mixed starting mixture 4 is placed in the container in which the prosthesis 10 or a special prosthesis part 10a is already held centrally. A certain amount of pre-compression takes place mechanically and then under vacuum and after hermetic sealing and production of the

Vacuum the isostatic pressing process already described. Here, too, the inner wall of the metallic container 7 can also be provided with a release agent. The dimensions of the container 7 essentially depend on the dimensions of the isostatic process chamber; but additionally in this case also according to the elastic properties of the jacket material and its structural design. The metal capsule technique described here according to the one-stage isostatic pressing process is essentially limited to simple, rotationally symmetrical prosthesis base body geometries.

6 shows a hip joint endoprosthesis which has recesses 12 in its shaft area, into which corresponding molded insert bodies 11 made of the composite material 1 according to the invention have been fitted. A metallic prosthesis equipped in this way is placed in a glass capsule container 6, which is then evacuated via the opening 6a in a known manner. The isostatic pressing process already described then takes place, which leads to the composite material present in the form of the molded insert body 11 being firmly connected to the recesses in the surface areas of the prosthesis. After removing the glass container 6, processing of the entire prosthesis, e.g. B. polishing, blank etching, etc., are carried out. As already stated, the criteria for the required process parameters can be freely selected within wide limits; In principle, they are in the range between 1 and 4000 bar with regard to the pressure to be used, with regard to the temperature range between room temperature and 2000 ° C and with regard to the process time between a few minutes and a few days. The process parameters depend on the material properties of the starting mixture 4, on the transformation temperature (T, -) of the bioactive component, on the structural transformation temperature of the metallic phase, on the structural transformation temperature of the base body (in the case of a prosthesis coating) and on the particular capsule technology chosen (Glass capsule container 6 or metal capsule container 7).

7a shows a detail from a surface area of a prosthesis or. of a prosthesis part made of metal or ceramic. Compact geometric recesses in the form of a rectangle 12a, a circle 12b or a triangle 12c are shown. The recesses shown in Fig. 7b insulated molded articles 11a, 11b and 11c, which have been produced from the composite material 1 according to the invention. The recesses 12 can be produced by methods known per se, for example by milling, turning or grinding. In principle, all geometries that can be produced economically using mechanical methods are possible. The molded insert bodies 11 can be produced in a similar manner from the solid material of the composite material 1 by mechanical processing methods known per se. They have to fit geometrically exactly into the recesses 12, which can also be shrunk thermally with a correspondingly small allowance. This is done, for example, by heating the component to be coated or by cooling the molded bodies 11 to be inserted before insertion. In FIG. 8, which shows a section through the area of a prosthesis 10 or a prosthesis part 10a near the surface, recesses 12 are again shown, into which differently contoured shaped inserts 11d-11h can be fitted. Of course, the forms shown do not represent a final list; rather, other forms of training are possible.

9 shows a variant of a metallic capsule container 7. It consists of a "2-tube system", the two capsule tubes being welded to one another in such a way that the isostatic pressing pressure also acts on the inner tube, so that there is no one-sided pressure on the hollow prosthesis part to be coated . In this capsule container 7, a prosthesis sleeve 13 can be used, for example, before welding the upper end cover, which is to be provided with an outer jacket coating made of the composite material 1. This sleeve 10b is shown in Fig. 9a. FIG. 9b shows a correspondingly dimensioned outer tube 13, consisting of the composite material 1 according to the invention, which can be put over the sleeve 10b and then bears against the sleeve-shaped prosthesis part 10b without play. Such a sleeve combination can then be subjected to a pressure acting on all sides in the container shown in FIG. 9. Of course, it is also possible to carry out an inner coating instead of an outer coating of the sleeve 10b. All that is necessary for this is to provide an appropriately dimensioned inner tube made of the composite material 1, to fit it and then to insert it into the capsule container 7 and finally to subject it to the known ispstatic pressing process.

Various other applications are of course conceivable, for example a rod made of solid metallic or ceramic material can be encased with the described sleeve technique and thus made bioactive. Another idea is that to drill out such coated sheath from voile material. In this way, coated tubes for special prosthetic parts can be manufactured. It is also possible to reverse the process described for the external coating of prosthesis rods or the subsequent production of tubes by means of boring in such a way that the rod consists of composite material 1 and this with an outer sleeve or. is provided with a coating of another material. In the latter case, an internally coated tube can be represented as a prosthesis part by subsequently drilling out the component obtained.

Further geometry examples for prosthesis parts that can be provided with an inner and / or outer coating with composite material 1 are dome-shaped constructions, spherical shells, skull caps, etc. Also sandwich arrangements (composite material / bioinert material / composite material / bioinert material / etc .) possible.

10 shows further recesses 12 in the surface area of the shaft of a hip joint endoprosthesis. For example, in addition to the already known annular recesses 12b, large-area recesses 12f and elongated grooves 12d or circumferential rings 12e are shown.

In FIG. 11, the recesses 12 are already provided with corresponding shaped insert bodies 11. In detail, an elongated plate 11 i, a large-area plate 11 k, a plurality of differently shaped, shaped, shaped insert bodies 11b and a large-area all-round coating 111 are shown.

FIG. 12 shows an oblique shaft-ossicular prosthesis 15 which consists of a plate 10d and a shaft 10c attached to its underside, the plate consisting of the composite material 1 and the shaft 10c made of a bio-inert metal or ceramic material. The plate 10d has in a known manner Have a groove for receiving a portion of an ossicle in situ.

In the Fig. 13 shows schematically how such a special prosthesis can be "cut out" from a bio-inert solid material (ceramic or metal), which has an adequate coating with the composite material 1, by machining production processes.

The composite material according to the invention can be prepared by methods known in powder metallurgy and in technology for special ceramics, such as, for example, B. Pressure sintering, isostatic pressing (hot isostatic pressing, cold isostatic pressing), hot pressing, solid body welding, soldering, reaction sintering, pressure welding, reaction welding and the like can be produced. However, the "hot isostatic pressing method" (HIP method) is preferred, which is characterized in that pressure, temperature and time profiles can be set independently of one another; and secondly, that a special capsule technique can be used. Any geometries for specific implant shapes can then be made from the compressed bioactive composite material by conventional processing methods, such as, for example, B. sawing, drilling, grinding and polishing.

Reference number list

1 - composite material

2 - metallic component

3 - bioactive material

4 - initial batch of (1)

5 - encapsulated reaction space

6 - (Glass) capsule container 6a - glass capsule opening

7 - (metal) capsule container

7a - (double-shell metal) capsule container - longitudinal grooves - metal plug a - evacuation pipe

10 - prosthesis (made of metal or ceramic)

10a - prosthesis part (made of metal or ceramic)

10b - (sleeve-shaped) prosthesis part (made of metal or

Ceramic) 10c - shaft of an ossicular prosthesis 10d - plate of an ossicular prosthesis 1 - molded insert

11a - 11h (compact-geometric) embedding molded body 11i (elongated) plate 11k - (large area) plate 111- (large area) all-round coating 2 - recesses in (10)

12a - 12c (compact geometric) recesses

12d - grooves, grooves

12e - ring (half ring)

12f- (large-area) recess 3 - tube from (1) 4 - straight shaft-ossicle prosthesis 5 - oblique-shaft ossicle prosthesis 6. biocompatible solid metal or ceramic material

17 - groove

Claims

Expectations

1. Composite material for prosthetic purposes, so that it consists of a metallic component (2) in which at least one bioactive material (3) is embedded.

2. Composite material according to claim 1, so that the metallic phase (2) consists of a high-strength biocompatible metal or metal alloy component.

3. Composite material according to claim 1, so that the bioactive material (3) consists of at least one inorganic-chemical component.

4. Composite material according to at least one of the preceding claims, characterized in that the bioactive material (3) is in particulate form in the size range from 5 to 1000 microns, preferably from 50 to 500 microns, in the metallic phase (2).

5. Composite material according to claim 4, so that the bioactive material (3) is in the form of compact three-dimensional particles.

6. Composite material according to claim 4, that the bioactive material (3) is in the form of one-dimensional - for example needle-like or fibrous - particles.

7. Composite material according to at least one of the preceding claims, characterized in that the volume ratio of the metallic phase (2) to the bioactive phase (3) between 95: 5 and 5:95 vol .-%, preferably between 70:30 and 30:70 vol .-%.

8. Composite material according to at least one of the preceding claims, that the metallic phase (2) consists of titanium and / or at least one titanium alloy.

9. Composite material according to at least one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the titanium alloy is TiAIV or TiAIFe.

10. Composite material according to at least one of claims 1 to 7, d a d u r c h g e k e n z e i c h n e t that the metallic phase consists of a Co-Cr-Mo alloy, for example CoCrMo.

11. Composite material according to at least one of the preceding claims, that the bioactive material (3) consists of at least one of the biomaterials listed below:

Biogias, bioglass ceramics, apatite, apatite sintered ceramics, tricalcium phosphate, tricalcium phosphate ceramics.

12. Composite material according to at least one of the preceding claims, that it has a density that corresponds to the theoretical density of both starting components in accordance with their respective mixing ratio.

13. A method for producing a composite material according to at least one of the preceding claims, characterized in that a well-mixed starting mixture (4) consisting of a powdery metallic component and at least one particulate biomaterial ι material in an encapsulated reaction chamber (5) isostatic Preß¬ process, optionally with additional use of elevated temperature, is subjected.

14. The method according to claim 13, d a d u r c h g e - k e n n z e i c h n e t that the process parameters pressure

The temperature and time depending on the respective starting substances, the desired material properties and the capsule technology used in each case are freely variable within the following ranges: pressure: 1 to 4000 bar, preferably 50 to 2000 bar;

Temperature: 20 to 2000 ° C, preferably 150 to 900 ° C; Time: from 10 minutes to 50 hours, preferably

30 minutes to 12 hours.

15. The method according to at least one of claims 13 and 14, characterized in that the well-mixed powder or particulate starting mixture (4) is placed in a capsule container (6; 7) which is hermetically sealed to produce a vacuum of at least 10 mbar and then the isostatic. Pressing is subjected.

16. The method according to any one of claims 13 and 15, so that the capsule material consists of glass and the container (6) is hermetically sealed by melting the glass capsule opening (6a).

17. The method according to at least one of claims 13 to 16, so that the inner wall of the capsule is provided with a contact-inert, thermally stable release agent, preferably with a boron nitride powder coating.

18. The method according to at least one of claims 13 to 17, characterized in that the glass used for the capsule container (6) has such a combination of physicochemical properties with regard to its transformation temperature ( _c ) or its softening temperature (T _E ) and its linear thermal expansion coefficient shows that the latter is already in the plastic deformation range at the process temperature (T _p ) required for the production of the composite material (1), but the softening temperature (TV) has not yet been exceeded.

19. The method according to claim 18, characterized in that the transformation temperature (T _c ) between 20 and 200 ° C lower than the process temperature (T ") and the softening temperature ( _£ ) between 20 and 200 ° C greater than the process temperature (T _p ) is, so that: T _G <(20 to 200 ° C) as T _Rroz

T _E > (20 to 200 ° C) as T _prQZ .

20. The method according to any one of claims 18 and 19, characterized in that the following applies to the property parameters of the glass for its capsule container (6) at a process temperature (T _p ) of, for example, 680 ° C:

5 ^T G ^{<(U80 to 660} ° ^C -

T _£ > (700 to 880 ° C).

21. The method according to claim 15, d a d u r c h g e ¬ k e n n z e i c h n e t that the capsule material consists of metal (7).

22. The method according to at least one of claims 13 to 21, that the capsule container (6; 7) has an ampoule-like, strongly rounded shape.

23. The method according to any one of claims 21 and 22,

T5 d a d u r c h g e k e n n z e i c h n e t that the capsule

(7) consists of a thin-walled tube which is closed on one side, which is additionally provided with longitudinal grooves (8) on the tube jacket, and that a metal stopper (9) with evacuation tube (9a) is provided as the capsule closure, which is sealed by means of all-round welding a vacuum-tight encapsulation is guaranteed.

24. Use of the composite material according to one of the preceding claims as a solid material (1) for the production of prostheses (10; 14; 15) or prosthesis parts (10a-10d; 11,11a-11l).

25. Use of the composite material according to at least one of the preceding 5 claims as a full-surface coating material (11k, 11l; 13) and the manufacturing method as a one-step coating method for metallic and / or ceramic prostheses (10; 14; 15) or prosthesis parts (10a- 10d; 11,11a-11l).

26. Coating method according to claim 25, characterized in that a hollow-free metallic and / or ceramic prosthesis (10; 14; 15) or such a prosthesis part (10a-10d; 11,11a-11l) ^ in a glass - Kapsei (6) is introduced and held in such a way that between the prosthesis (10; 14; 15) to be coated and the inner wall of the glass capsule (6) there is an essentially equally large distance on all sides that the The capsule (6) remaining space is then filled with the mixed powdered starting mixture (4), the capsule (6) then hermetically sealed and placed under vacuum and finally subjected to the isostatic pressing process.

27. Use of the composite material according to at least one of the preceding claims as a solid material for the production of compact molded insert bodies (11; 11a-11l) for insertion into geometrically analogous recesses (12; 12a-12f) which are in the regions of prostheses (10; 14; 15) or prosthesis parts (10a-10d; 11,11a-11l) are provided or introduced, as well as the isostatic pressing process for anchoring the fitted molded articles (11; 11a-11l) in or with their corresponding recesses (12; 12a-12f).

28. Use according to claim 27, d a d u r c h g e k e n n z e i c h n e t that the storage molded body

(11; 11a-11I) in plan view have surface geometries with linear and / or non-linear contours which correspond to the respective geometries of the recesses (12; 12a-12f) in the surface areas of the prostheses (10; 10a-10d; 14; 15) correspond.

29. Use according to claim 28, characterized in that the surface geometries correspond to simple geometric shapes, such as circles (11b), rectangles (11a), triangles (11c), rhombuses, etc.

30. Use according to at least one of claims 27 to 29, characterized in that the shaped insert body (11; 11a-11h) in cross section a lens, double hump, trough, truncated pyramid and / or truncated cone-shaped or a multiple grooves - Have outer contour, in which they are either positively in their respective anchoring areas or are provided with a defined allowance for the purpose of thermal shrinking.

31. Use of the isostatic pressing method according to at least one of claims 13 to 23 for filling in on the prosthesis

(10; 10a) notches, grooves, grooves (12d), rings (I2e) and other surface defects.

32. Coating method according to claim 25, characterized in that a cavity having a metallic and / or ceramic prosthesis or a corresponding prosthesis part, for example a tubular or sleeve-shaped prosthesis part (10b), is externally and / or internally coated in such a way that a tube (13) prefabricated from the composite material (1) corresponding to the wall thickness and diameter dimensioning with outer coating is pushed onto the sleeve (10b) or with the inner coating is pushed into the sleeve (10b) with a precise fit that this covered prosthesis sleeve (10b ) is then brought into a double-shell capsule shape (7a), so that an isostatic pressure effect is achieved in the inner and outer wall area of the sleeve surface, so that the double-shell capsule (7a) consisting of inner and outer tubes is then closed and placed under vacuum and that, finally, the actual isostatic pressing process into one i¬ term, permanently firm welding of the composite material linings (13) with the actual prosthesis sleeve (10b).

33. Use of the composite material as a plate (10d), provided with a groove (17), of a straight or oblique ossicular prosthesis (14 or 15), the shaft (10c) made of bio-compatible metal or ceramic material (16) consists.