Medical product manufacturing method and medical product

Abstract

The present invention relates to a method for manufacturing a medical product, comprising step a), i.e. additively constructing or manufacturing at least one functional element on a surface of a substrate, the at least one functional element being connected to the substrate after step a) has been performed. The present invention further relates to a medical product.

Description

[Technical field]

[0001] The present invention relates to a method for producing a medical product and to a medical product. [Background technology]

[0002] The use of total hip and knee prostheses is one of the most successful surgical treatment options, however many revision surgeries are required each year.

[0003] One possible way to increase the lifespan of hip or knee implants and thus reduce the number of revision surgeries is the provision of patient-specific, i.e. tailored, implants manufactured by additive manufacturing. The disadvantage of implants configured in this way, however, is the long time it takes between the time the surgeon decides to use such an implant and the time it is available for clinical use. To shorten this time, current delivery methods already involve work with 3D printers in the clinical field. However, this form of delivery of implants is not applicable for implants that require finishing, e.g. cutting of interfaces or polishing of sliding surfaces, to achieve the precision and / or surface quality required from a medical point of view. This applies in particular to hip and knee implants, but also to other medical products, e.g. surgical instruments. Summary of the Invention [Problem to be solved by the invention]

[0004] The object of the present invention is to provide a method for producing a medical product and a medical product which partially or completely avoids the drawbacks occurring in the prior art, in particular as mentioned above. [Means for solving the problem]

[0005] This object is achieved by a method having the features according to independent claim 1 and by a medical product according to claim 15. The dependent claims relate to preferred embodiments of the invention. The wording of all claims is hereby expressly incorporated into the content of this description.

[0006] According to a first aspect, the present invention relates to a method for manufacturing a medical product, in particular an implant, preferably a hip or knee implant (hip endoprosthesis or knee endoprosthesis) or a surgical instrument.

[0007] Preferably, the medical product is a prosthesis, in particular a total, semi- or partial prosthesis, which may in particular be selected from the group consisting of hip joint prostheses, knee joint prostheses, shoulder joint prostheses, elbow joint prostheses, ankle joint prostheses and finger joint prostheses.

[0008] Alternatively, the medical product may preferably be a medical instrument, in particular a surgical instrument. The medical instrument may in particular be selected from the group consisting of dilating instruments, gripping instruments, holding and / or clamping instruments, and dissecting and / or separating instruments. The dilating instruments may in particular be selected from the group comprising wound hooks, retractors, spreaders and speculae. The gripping instruments may in particular be selected from the group comprising tweezers, clamps, forceps and needle holders. The holding and clamping instruments may in particular be selected from the group comprising clamps and preparatory clamps, such as temporary clamps for intestines and / or blood vessels. The dissecting and / or separating instruments may in particular be selected from the group comprising blades (scalpels) and scissors.

[0009] The method comprises the following step a) i.e. additive or generative construction or additive or generative manufacture, i.e. additive or generative production, of at least one functional element on the surface of a substrate.

[0010] Here, at least one functional element is in particular indirectly or directly connected to the substrate after step a) has been carried out.

[0011] Preferably, the at least one functional element is connected to the substrate after step a) has been carried out, in particular indirectly or directly, by a substance or material bond.

[0012] In the context of the present invention, the term "functional element" means a part or subpart of a whole, and it is intended that a function is assigned to that part or subsection.

[0013] In the context of the present invention, the term "at least one functional element" is intended to mean a functional element, i.e. only one functional element, or a multiplicity of functional elements, i.e. two or more functional elements.

[0014] In the context of the present invention, the term "substrate" is intended to mean an individual part or individual component, in particular a prefabricated individual part (so-called prefabricated part) or a prefabricated component (so-called prefabricated component), to which a function is generally (also) assigned.

[0015] In the context of the present invention, the term "component" is intended to mean an individual or prefabricated part, in particular an individual or prefabricated part that can be non-destructively separated.

[0016] In the context of the present invention, the term "group of components" is intended to mean an arrangement or a corresponding complex consisting of or made up of two or more components, in particular an arrangement or a corresponding complex produced by an assembly process.

[0017] In the context of the present invention, the term "endoprosthesis" is intended to mean an artificial joint, ie an artificial joint substitute.

[0018] In the context of the present invention, the term "total endoprosthesis" is intended to mean an artificial joint substitute configured to replace the entire natural joint, i.e. the natural joint head and the natural joint socket.

[0019] In the context of the present invention, the term "hemi-endoprosthesis" is intended to mean an artificial joint substitute configured to replace half of a natural joint, e.g. only the natural joint head, or only the natural joint socket.

[0020] In the context of the present invention, the term "partial endoprosthesis" is intended to mean an artificial joint substitute configured to replace only a part of a natural joint.

[0021] By means of the invention, the advantages of conventional, i.e. non-machine or non-generative manufacturing, such as high precision and surface finish, can be realised together with the advantages of additive or generative manufacturing, such as patient-specific or customised adaptation or positioning of a medical product, provision of a medical product "on site" and real-time production, thus manufacturing on demand. By means of the invention, so-called monoblock medical products, i.e. medical products formed in one piece, are preferably provided.

[0022] In one embodiment of the present invention, the substrate is produced by a non-additive or non-generative manufacturing method, in particular selected from the group consisting of primary forming, remolding, separation, joining, coating and material property modification methods, as well as a combination of at least two of the aforementioned manufacturing methods. In other words, the substrate is preferably not produced by an additive or generative manufacturing method. In this way, properties such as high precision and surface quality that can only be achieved to a sufficient extent by conventional manufacturing methods can be advantageously realized. Preferably, the substrate is produced by a method selected from the group consisting of casting, forging, rolling, extrusion, deep drawing, bending, sawing, planing, cutting, boring, stamping, cutting, such as shear cutting and / or flame cutting, electric discharge machining, welding, soldering, riveting, screwing, assembly, gluing with adhesives, varnishing, electroplating, powder coating, hot-dip galvanizing, hardening (hardening), annealing, polishing, such as electrolytic polishing, and a combination of at least two of the aforementioned (non-additive or non-generative) manufacturing methods. It is therefore particularly preferred according to the invention that the at least one functional element is manufactured or produced by an additive or productive manufacturing method and the substrate is manufactured by a non-additive or non-productive manufacturing method. In this respect, the medical product in the context of the present invention may also be referred to as a hybrid medical product, in particular a hybrid implant, preferably a hybrid prosthesis, or a medical device, in particular a hybrid surgical device.

[0023] In principle, the same materials, in particular the same substances, may be used for the additive construction or manufacture of the at least one functional element as for the manufacture of the base body. However, according to the invention, it is preferred that different materials, in particular different substances, are used for the additive construction or manufacture of the at least one functional element than for the manufacture of the base body.

[0024] The materials for the additive construction or manufacture of the at least one functional element and the materials for the manufacture of the substrate may be selected independently of one another from the group consisting of metals, alloys, hard metals, ceramics, plastics, and combinations, in particular mixtures, of at least two of the aforementioned materials.

[0025] The metal may in particular be selected from the group consisting of titanium, cobalt, chromium, iron, magnesium, zinc, niobium, tantalum, zirconium, and combinations, in particular alloys, of at least two of the aforementioned metals.

[0026] The alloy may in particular be selected from the group consisting of iron alloys, cobalt alloys, chromium alloys, niobium alloys, zirconium alloys, alloys containing cobalt and chromium, chromium-cobalt-molybdenum alloys, and combinations, in particular mixtures, of at least two of the aforementioned alloys.

[0027] The iron alloy may in particular be a steel, preferably a stainless steel, in particular a corrosion-resistant stainless steel.

[0028] The chromium-cobalt-molybdenum alloy may in particular have a proportion by weight of 62 to 66% cobalt, 27 to 31% chromium and 4 to 5% molybdenum, all expressed in terms of the total weight of the alloy.

[0029] The ceramics may in principle be non-oxide ceramics, oxide ceramics or combinations thereof. The non-oxide ceramics may in particular be selected from the group consisting of chromium nitride (CrN), chromium carbonitride (CrCN), chromium zirconium nitride (CrZrN), zirconium nitride (ZrN) and a combination of at least two of the aforementioned non-oxide ceramics. The oxide ceramics may in particular be selected from the group consisting of aluminum oxide (Al2O3), zirconium dioxide (ZrO2), titanium dioxide (TiO2), chromium(III) oxide (Cr2O3) and a combination of at least two of the aforementioned oxide ceramics. The aforementioned aluminum oxide is preferably aluminum oxide of the corundum type. The aforementioned zirconium dioxide is preferably zirconium dioxide of the baddeleyite type. The aforementioned titanium dioxide is preferably titanium dioxide of the rutile type. The aforementioned chromium(III) oxide is preferably chromium(III) oxide of the corundum type.

[0030] In the context of the present invention, the term "hard metal" is intended to mean a metal-matrix mixture in which hard substances present as particles, in particular small particles, are held together by a metal or alloy matrix. Hard metals are therefore somewhat less hard than pure hard substances, but significantly tougher. On the other hand, they are harder than pure metals, alloys and hardened steels. Preferably, hard metals comprise a metal matrix of cobalt and / or nickel and a hard substance. The hard substance is preferably selected from the group consisting of tungsten carbide (WC), titanium carbide (TiC), titanium nitride (TiN), niobium carbide, tantalum carbide, vanadium carbide and mixtures of at least two of the aforementioned hard substances. In particular, hard metals may have a nickel proportion of 8 wt% to 20 wt% and a metal carbide proportion, in particular a tungsten carbide proportion, of 80 wt% to 92 wt%, expressed by the total weight of the hard metal.

[0031] The plastics may in principle be biodegradable or bioresorbable and / or non-biodegradable or non-bioresorbable plastics.

[0032] The plastics may in particular be selected from the group consisting of polyethylene, polypropylene, polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, polyamides, polyurethanes, polyglycolic acid or polyglycolide, polylactic acid or polylactide, poly-3-hydroxybutyric acid or poly-3-hydroxybutyrates, poly-4-hydroxybutyric acid or poly-4-hydroxybutyrates, polytrimethylene carbonate, polyparadioxanone, poly-ε-caprolactone, and mixtures, i.e. blends, of at least two of the aforementioned plastics.

[0033] The polyethylene may be, in particular, a high density polyethylene (HDPE), a low density polyethylene (LDPE), a high molecular weight polyethylene (HMWPE), an ultra-high molecular weight polyethylene (UHMWPE), a copolymer of at least two of the aforementioned types of polyethylene, or a mixture, i.e., a blend, of at least two of the aforementioned types of polyethylene.

[0034] In the context of the present invention, the term "additive manufacturing" or "generative manufacturing" is intended to mean a manufacturing method in which materials or substances, in particular metals, hard metals, alloys, ceramics, plastics or a combination of at least two of the aforementioned materials or substances, are applied layer by layer, thus generating a three-dimensional object. Preferably, the layer-by-layer building is carried out under computer control from one or more liquid or solid materials or substances according to predetermined dimensions and shapes (CAD and / or CAM). During the building, physical and / or chemical hardening or melting processes generally take place. Typical materials or substances are metals, alloys, plastics, synthetic resins, ceramics.

[0035] In a further embodiment of the invention, step a) is performed by deposition welding, in particular laser deposition welding, preferably laser powder deposition welding or laser wire deposition welding.

[0036] In laser deposition welding, a surface deposition is carried out on a workpiece or component by melting and simultaneous application of a material. The material can be in the form of a powder, for example a metal powder (laser powder deposition welding) or in the form of a welding wire or tape (laser wire deposition welding). A laser, in particular a high-power laser, is used as the heat source. The laser is in particular a diode laser, a fiber laser, a CO2 laser or a Nd:YAG laser. In the context of the present invention, the term "diode laser" means a laser diode, i.e. a laser that generates light with a semiconductor material. Diode lasers can generate optical powers of up to 60 kW and more. In the context of the present invention, the term "fiber laser" means a solid-state laser in which the active medium is formed by a doped core of a glass fiber. A fiber laser is therefore a glass laser with optical waveguiding properties. The laser radiation guided by the laser-active fiber is highly amplified due to its long length. A fiber laser comprises one or more dot laser diodes, input coupling optics (discrete or fiber-coupled diode lasers bonded to a cladding material) and a resonator. The fiber usually consists of several layers. The main part is usually quartz glass, for example 0.25 mm thick, surrounded by a thin plastic layer. The active core is thinner, for example 10 μm, and consists mainly of doped quartz glass, for example with a low percentage of aluminum and a few rare earths per thousand. The electro-optical efficiency of fiber lasers is up to 30% or more. In the context of the present invention, the term "carbon dioxide laser" or "CO2 laser" is intended to mean a laser whose laser medium comprises or consists of a CO2-N2-He (helium) gas mixture. The N2 molecules are excited in the resonator by a DC or RF glow discharge. CO2 lasers can achieve powers up to 80 kW and pulse energies up to 100 kJ. CO2 lasers generate infrared light beams with wavelengths of 9.4 μm and 10.6 μm. The efficiency is about 15% to 20%. An "Nd:YAG laser" is a solid-state laser (neodymium-doped yttrium aluminum garnet laser) that uses neodymium-doped YAG crystal as the active medium, and typically emits infrared radiation with a wavelength of 1064 nm.Additionally, there are transitions at 946 nm, 1320 nm, and 1444 nm.

[0037] Laser deposition welding can be used to produce both layers and free-formed 2.5D structures. In the latter case, it is classified as a 3D printing method. In laser deposition welding with powder, the laser heats the workpiece or component, usually in a defocused manner, and melts it locally. At the same time, an inert gas mixed with fine metal powder is supplied. The supply of the metal / gas mixture to the active area is preferably carried out by a nozzle, for example a trailing nozzle or a coaxial nozzle. At the heated location, the metal powder melts and bonds with the material of the workpiece or component, in particular the metal. Besides metal powders, ceramic powder substances, in particular hard substances, may also be used. Laser deposition welding with wire or tape works similarly to the method with powder, but with wire or tape as the filler material.

[0038] In a further embodiment of the invention, step a) is carried out by beam sintering, in particular laser sintering, preferably selective laser sintering. Laser sintering is a generative layer-building method, in which the workpiece or component is built up layer by layer. Due to the effect of the laser beam, any three-dimensional shape can be generated, in particular shapes with undercuts. In this way, it is possible to produce workpieces or components that cannot be produced by traditional mechanical or casting techniques. Usually, a CO2 laser, a Nd:YAG laser or a fiber laser is employed as the laser. The substance used to produce the workpiece or component is preferably in powder form. In particular, plastic powders, plastic-coated foundry sand, metal or alloy powders, ceramic powders can be used. Preferably, the powder is applied using a blade or roller, spread on the surface of the workpiece or component, in particular with a thickness of 1 μm to 200 μm. The layer is then sintered or melted stepwise on the surface of the workpiece or component by driving the laser beam according to the contour of the layer of the workpiece or component. Afterwards, the workpiece or component is slightly lowered and a new layer is applied. The process is carried out step by step in the vertical direction. This also makes it possible to generate the contour of the undercut. The energy delivered by the laser is absorbed by the material, which is preferably in powder form, resulting in localized limited sintering of the particles with a concomitant reduction in overall surface area.

[0039] In a further embodiment of the invention, step a) is carried out by beam melting, in particular laser melting, preferably selective laser melting. In laser melting, the material to be processed is applied in the form of a powder as a thin layer onto the workpiece or component. The powdered material is melted locally by all laser radiation and forms a solid material layer after solidification. The workpiece or component is then lowered by one layer thickness and powder is applied again. This cycle is repeated until all layers are melted. Excess powder is cleaned off the finished workpiece or component and processed as required or used directly. Typical layer thicknesses of the workpiece or component are preferably 15 μm to 500 μm for all materials. Data for guiding the laser beam are generated by the software from a 3D CAD body. In a first calculation step, the workpiece or component is subdivided into individual layers. In a second calculation step, the path (vector) to be followed by the laser beam is generated for each layer. To avoid contamination of the material with oxygen, this process may be advantageously carried out in a protective gas atmosphere, for example argon and / or nitrogen.

[0040] Alternatively, step a) may be carried out by other additive or generative manufacturing methods, such as, for example, electron beam melting, in particular selective electron beam melting (electron beam sintering). In this case, the powdered substance, preferably metal powder, is melted in a controlled manner using an electron beam as an energy source, so that in particular compact components with almost any shape can be produced directly from the design data. Based on a digital 3D model, for this purpose, layers of powder, in particular metal powder, are applied alternately over the surface on the component with a blade, first preheated over a large area by the electron beam and then melted locally. After cooling, the melt solidifies and forms a solid layer, in particular a metal layer, with a structural density of about 100%. The component is then lowered by a layer and the next powder layer, in particular a metal powder layer, is applied on top of the previous layer. These steps are repeated many times. Preferably, after the manufacturing step, the powder is removed from the component with compressed air. In this way, the desired component is produced layer by layer. To prevent the powdered substance from changing its material properties by reacting with the surrounding gas, this step is preferably carried out under reduced pressure or in vacuum.

[0041] In a further embodiment of the invention, the at least one functional element is configured differently from the substrate when performing step a), in particular step a) may be performed such that the at least one functional element is distinguishable from the substrate with respect to at least one characteristic, which is preferably selected from the group consisting of shape, material, hardness, flexibility, dimensions, in particular height and / or depth and / or length and / or diameter, as well as a combination of at least two of the aforementioned characteristics.

[0042] Preferably, a component, section of a component or group of components of a medical product is used as the substrate.

[0043] Preferably, the medical product components, sections of components or groups of components are additively constructed or manufactured as functional elements when performing step a).

[0044] In a further embodiment of the invention, an implant, preferably a component, a section of a component or a group of components of a prosthesis, in particular a total, hemi- or partial prosthesis, is used as substrate.

[0045] In a further embodiment of the invention, when carrying out step a), a component, a section of a component or a group of components of an implant, preferably a prosthesis, in particular a full, semi- or partial prosthesis, is additively constructed or manufactured on the surface of the substrate as at least one functional element.

[0046] In a further embodiment of the invention, the prosthesis is selected from the group consisting of hip joint prostheses, knee joint prostheses, shoulder joint prostheses, elbow joint prostheses, ankle joint prostheses and finger joint prostheses. The knee joint prosthesis may in particular be a unicondylar or bicondylar knee joint prosthesis.

[0047] Preferably, the prosthesis is a hip joint prosthesis, in particular a total, hemi or partial hip joint prosthesis, or a knee joint prosthesis, in particular a total, hemi or partial knee joint prosthesis.

[0048] Preferably, the implant component or components are selected from the group consisting of an artificial joint socket, an artificial joint socket insert, an artificial joint head insert, an artificial joint head, an articulation shaft, a cylinder or cone for an articulation shaft, and a group of components consisting of at least two of the aforementioned components.

[0049] In a further embodiment of the invention, the implant component or components are selected from the group consisting of an artificial acetabulum, an artificial acetabulum insert, an artificial femoral head insert, an artificial femoral head, a hip joint shaft, a cylinder or cone for a hip joint shaft, and a group of components consisting of at least two of the aforementioned components.

[0050] In a further embodiment of the invention, the component or components of the implant are selected from the group consisting of an upper thigh prosthesis (so-called femoral component), a shaft for an upper thigh prosthesis, a lower thigh prosthesis (so-called tibial component), a shaft for a lower thigh prosthesis and a component group consisting of at least two of the aforementioned components.

[0051] In a further embodiment of the invention, a component which is at least cylindrical or conical in cross section, in particular a component which is only cylindrical or conical in cross section, in particular a prefabricated part, or a component which is continuously cylindrical or conical (in the longitudinal direction) is used as base body, and when carrying out step a), a shaft, in particular a joint shaft, preferably a hip joint shaft, is additionally constructed or manufactured as at least one functional element on the surface of the component which is at least cylindrical or conical in cross section, in particular a prefabricated part.

[0052] In a further embodiment of the invention, an upper leg prosthesis (femoral component) or a lower leg prosthesis (tibial component) is used as a base, and when performing step a), a shaft, in particular an upper leg shaft or a lower leg shaft, is additionally constructed or manufactured as at least one functional element on the surface of the upper leg prosthesis or the lower leg prosthesis.

[0053] In a further embodiment of the invention, components, sections of components or groups of components of a medical instrument, in particular a surgical instrument, are used as substrate.

[0054] In a further embodiment of the invention, when carrying out step a), components, sections of components or groups of components of a medical instrument, in particular a surgical instrument, are constructed or manufactured as at least one functional element on the surface of the substrate.

[0055] In a further embodiment of the invention, the medical instruments, in particular the surgical instruments, are selected from the group consisting of dilating instruments, gripping instruments, holding and / or clamping instruments, and dissection and / or separation instruments (cutting and / or separating instruments). The dilating instruments may in particular be selected from the group consisting of wound hooks, retractors, spreaders and specula. The gripping instruments may in particular be selected from the group consisting of tweezers, clamps, forceps and needle holders. The holding and clamping instruments may in particular be selected from the group consisting of clamps and preparatory clamps, such as clamps for temporary clamping for intestines and / or blood vessels. The dissection and / or separation instruments may in particular be selected from the group consisting of blades (scalpels) and scissors.

[0056] In a further embodiment of the invention, the component, section of a component or group of components of a medical instrument, in particular a surgical instrument, is selected from the group consisting of a branch or branch section (arm or arm section), a grip or grip section, a link or link section, a mouth or mouth section, a grip or holding jaw or grip or holding jaw section, a holding and / or clamping jaw or holding and / or clamping jaw section, a cutting and / or separating jaw or cutting and / or separating jaw section, and a group of components consisting of at least two of the above mentioned components.

[0057] In a further embodiment of the invention, components of a medical instrument, in particular a surgical instrument, are used as substrate, said components comprising branches or branch sections which are attached to one another for rotational or pivotal, in particular shear, movement by means of joints or connections, in particular links, each branch or branch section comprising a grip section at its proximal end, and when performing step a), a functional section, in particular a functional section selected from the group consisting of gripping or holding jaws or gripping or holding jaw sections, holding and / or clamping jaws or holding and / or clamping jaw sections, and cutting and / or separating jaws or cutting and / or separating jaw sections, respectively, is additionally constructed or manufactured as at least one functional element at the distal end of the branch or branch section.

[0058] The term "link" is intended in the context of the present invention to mean a connection, especially in the form of a joint, by which two branches of a medical instrument, in particular a surgical instrument, are attached to one another in a rotatable or pivotal, in particular shearable, manner.

[0059] In a further embodiment of the invention, a component group of a medical instrument, in particular a surgical instrument, is used as a substrate, said component group comprising two branches or branch sections attached to each other by a joint or connection, in particular a link, for rotational or pivotal, in particular shear, movement, each branch or branch section comprising a grip or grip section at its proximal end and a functional section at its distal end, in particular selected from the group consisting of grip or holding jaws or grip or holding jaw sections, holding and / or clamping jaws or holding and / or clamping jaw sections and cutting and / or separating jaws or cutting and / or separating jaw sections, each functional section having a recess, in particular an elongated recess, for receiving an insert, in particular an elongated recess, in which, when carrying out step a), an insert, in particular a recess shape-complementary insert, i.e. a recess having a shape complementary to the shape of the respective recess, is additionally constructed or manufactured in each recess as at least one functional element. The insert is preferably a metal insert, i.e. an insert comprising or consisting of a metal, in particular a hard metal insert, i.e. an insert comprising or consisting of a hard metal. With regard to suitable metals, in particular hard metals, reference is made to the above description.

[0060] Preferably, chronologically following step a), the method further comprises a step b) of thermal post-treatment, in particular annealing. Preferably, step b) is carried out by means of a laser beam. The thermal post-treatment step can particularly advantageously eliminate or at least reduce distortions or stresses that may occur in the substrate and / or at least one functional element when carrying out step a).

[0061] According to a second aspect, the present invention relates to a medical product, in particular an implant, preferably a prosthesis, in particular a hip or knee prosthesis, or a medical instrument, in particular a surgical instrument.

[0062] The medical product comprises at least one functional element manufactured by additive or generative manufacturing processes and a substrate.

[0063] The substrate is preferably not manufactured by additive or productive manufacturing processes, in other words, the substrate is preferably manufactured by non-additive or non-productive manufacturing processes.

[0064] The at least one functional element is in particular indirectly or directly connected to the substrate, preferably the at least one functional element is connected to the substrate by a substance or material bond.

[0065] Alternatively or in combination, the medical product is produced or producible by a method according to the first aspect of the invention.

[0066] For further features and advantages of the medical product, please refer in full to the comments made in the scope of the first aspect of the invention. The features and advantages described therein in relation to the method and the medical product apply correspondingly to the medical product according to the second aspect of the invention.

[0067] Further features and advantages of the invention can be found in the following description of preferred embodiments of the invention, which are illustrated by the claims and the figures and the associated figure description. The individual features of the invention can be implemented in this case independently of each other or in combination with one another. The exemplary embodiments described merely serve for further illustration of the invention, without the latter being limited thereto. [Brief description of the drawings]

[0068] [Figure 1] 1 shows an implementation of the laser deposition welding method according to the invention; [Diagram 2] 1 illustrates one embodiment of a medical product according to the present invention. [Diagram 3] 4 shows a further embodiment of a medical product according to the present invention. [Figure 4]4 shows a further embodiment of a medical product according to the present invention. [Diagram 5] 4 shows a further embodiment of a medical product according to the present invention. [Figure 6] 4 shows a further embodiment of a medical product according to the present invention. [Figure 7] 4 shows a further embodiment of a medical product according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0069] FIG. 1 shows a schematic representation of one embodiment of the method according to the invention.

[0070] For the additive construction or production of the functional element 20, the powdered material 15 is applied to the surface 11 of the substrate 10 by laser powder deposition welding. For this purpose, the material 15 is heated with the aid of a laser beam 16, in particular in a defocused manner, and melted on the surface 11 of the substrate 10. The application of the powdered material 15 on the surface 11 of the substrate 10 is preferably carried out by means of a nozzle 17. The nozzle 17 may be configured, for example, as a coaxial nozzle, a multi-jet nozzle or a wide-jet nozzle. Preferably, the powdered material 15 is applied continuously to the surface 11 of the substrate 10. The powdered material 15 is heated in the laser beam and then melted in the construction and joining areas on the surface 11 of the substrate 10. As the powdered material 15, for example, metals, alloys or ceramics may be used.

[0071] Laser powder deposition welding advantageously allows high precision of material application, in particular deposition welding of multiple layers. Metallurgical fusion of the applied layers takes place and thus connection to the substrate 10 by a substance or material bond. Due to the low energy input compared to conventional welding methods, both the additively constructed or manufactured functional element 20 and the substrate 10 are less distorted and in particular without structural damage.

[0072] Fig. 2 shows diagrammatically an embodiment of a medical product 1 according to the invention in the form of a hip joint implant 1. The hip joint implant 1 comprises a conically configured base body 10 and a functional element 20 in the form of a shaft. The functional element 20 is connected to the base body 10, preferably by a substance or material bond. To manufacture the hip joint implant 1, the base body 10 is preferably used as a pre-manufactured, in particular ground and / or polished, component and the functional element 20 is additively constructed or manufactured, preferably on one of its end faces, by means of laser deposition welding, selective laser melting or selective laser sintering. The base body 10 is preferably manufactured by a non-additive manufacturing method.

[0073] For suitable materials for the substrate 10 and the functional element 20, reference is made to the materials disclosed in the general description or above regarding the substrate and the at least one functional element.

[0074] In the context of the present invention, the hip implant shown in FIG. 2 may also be referred to as a hybrid implant.

[0075] FIG. 3 shows diagrammatically a further embodiment of a medical product 1 according to the invention in the form of a partial knee prosthesis 1 .

[0076] The partial knee prosthesis 1 comprises a base body in the form of a femoral component 10 and a functional element 20 connected to the femoral component 10, in particular by a substance or material bond. The functional element 20 is preferably configured in the form of a shaft.

[0077] To manufacture the partial knee prosthesis 1, the femoral component 10 is preferably used as a pre-manufactured component, i.e. in particular as a ground and / or polished prefabricated part, and the functional element 20 is additively constructed or manufactured on the surface of the femoral component 10. The additive construction or manufacturing of the functional element 20 is preferably performed by laser deposition welding, selective laser melting or selective laser sintering.

[0078] For suitable materials for the base or femoral component 10 and the functional element 20, reference is made to the materials disclosed in the general description or previous description of the base and at least one functional element.

[0079] The partial knee prosthesis 1 shown in FIG. 3 may be referred to as a hybrid prosthesis in the context of the present invention.

[0080] FIG. 4 shows diagrammatically a further embodiment of a medical product 1 according to the invention in the form of a partial knee prosthesis 1 .

[0081] The partial knee prosthesis 1 comprises a base body in the form of a tibial component 10 and a functional element 20 connected to the tibial component 10, in particular by a substance or material bond. The functional element 20 is preferably (also) configured in the form of a shaft.

[0082] To manufacture the partial knee prosthesis 1, the tibial component 10 is preferably used as a prefabricated component, i.e. in particular as a ground and / or polished prefabricated part, and the functional element 20 is additively constructed or manufactured on the surface of the tibial component 10. The additive construction or manufacturing of the functional element 20 is preferably performed by laser deposition welding, selective laser melting or selective laser sintering.

[0083] For suitable materials for the base or tibial component 10 and the functional element 20, please refer to the general description of the base and at least one functional element or the materials disclosed in the previous description.

[0084] The partial knee prosthesis 1 shown in FIG. 4 may be referred to as a hybrid prosthesis in the context of the present invention.

[0085] FIG. 5 shows diagrammatically a further embodiment of a medical product 1 according to the invention in the form of a total knee prosthesis.

[0086] The total knee prosthesis 1 comprises a base body 10 and two functional elements 20a and 20b. Preferably, the two functional elements 20a and 20b are configured in the form of a shaft.

[0087] The base 10 includes a femoral component 10a, a tibial component 10c, and a sliding component or sliding surface component 10b disposed therebetween.

[0088] The functional element 20a is connected to the femoral component 10a, preferably by a material connection, and the functional element 20b is connected to the tibial component 10c, preferably (also) by a material connection.

[0089] In principle, the femoral component 10a and the tibial component 10c may be made of the same material or of different materials.

[0090] For suitable materials for the femoral component 10a and the tibial component 10c, please refer to the general description of the base or the materials disclosed in the previous description.

[0091] Furthermore, in principle, the functional elements 20a and 20b may be made of the same material or of different materials.

[0092] For suitable materials for the functional elements 20a and 20b, reference is made to the materials disclosed in the general description or preceding description of at least one of the functional elements.

[0093] The sliding component or sliding surface component 10b may for example be made from polyethylene, in particular ultra-high molecular weight polyethylene.

[0094] To manufacture the total knee prosthesis 1, the base body 10 is preferably used as a prefabricated component group comprising or consisting of the femoral component 10a, the sliding or sliding surface component 10b and the tibial component 10c, the functional element 20a being additively constructed or manufactured on the surface of the femoral component 10a which faces the femur in the implanted state, and the functional element 20b being additively constructed or manufactured on the surface of the tibial component 10c which faces the tibia in the implanted state. The additive construction or manufacturing of the functional elements 20a, 20b is preferably performed by laser deposition welding, selective laser melting or selective laser sintering.

[0095] FIG. 6 shows diagrammatically a further embodiment of a medical product 1 according to the invention in the form of a medical instrument, in particular a surgical instrument.

[0096] The medical instrument 1 comprises two branches 2a, 2b which are rotatably or pivotally mounted or rotatably or pivotally connected to one another at a link 5. In this way, the branches 2a, 2b are movable relative to one another in rotation or pivoting, in particular in shear. At their proximal ends, the branches 2a, 2b are provided with grip sections 3a, 3b, respectively.

[0097] The link 5 may be configured as a bearing link or as a plug link or a box link.

[0098] In the context of the present invention, the term "bearing link" means a connection in which two branches of a medical instrument, in particular a surgical instrument, are guided through one another, the branches being respectively flat on opposite sides in the intersection area and a connecting element, for example in the form of a screw or a rivet, is intended to pass through the two branches and be fastened or fixed to the other branch. In a bearing link, one branch is therefore above the other branch.

[0099] In the context of the present invention, the term "plug or box link" is intended to mean a connection in the crossing area of ​​two branches of a medical instrument, in particular a surgical instrument, where one branch is flat on both sides and the other branch has a through hole. The flattened branch, also called the male branch, is guided through the branch with a through hole, also called the female branch. In order to define the center of rotation or articulation, in this design a connecting element, for example in the form of a screw or a rivet, may also be guided through the two branches. Alternatively, for example, the male branch may comprise one or more, for example two, pins, which are received in one or more, for example two complementary shaped pin sockets, of the female branch.

[0100] The medical device 1 further comprises two locking arms 7, 8. The locking arm 7 projects from the branch 2a in the direction of the branch 2b. The locking arm 8 projects from the branch 2b in the direction of the branch 2a, and a locking, in particular a locking, of the two locking arms 7, 8 and thus of the medical device 1 is made possible by a locking hook 9 attached to the locking arm 8 and a locking hook (not shown) attached to the locking arm 8. The locking hook 9 of the locking arm 7 and the locking hook of the locking arm 8 are configured in such a way that a form-fit lock is achieved when the gripping sections 3a, 3b are pressed against one another. The locking hooks can be configured, for example, in the shape of a shark's tooth.

[0101] Each of the branches 2a, 2b comprises a functional section 4a, 4b at its distal end. The functional section 4a, 4b is connected to the branch 2a, 2b, respectively, preferably by a material bond. The functional section 4a, 4b may be configured, for example, as a gripping or holding jaw, a holding and / or clamping jaw, or a cutting and / or separating jaw. Correspondingly, the medical instrument may be configured, for example, as a surgical gripping or holding instrument, a surgical holding and / or clamping instrument, or a surgical cutting and / or separating instrument, in particular a surgical forceps, a surgical tweezers, a surgical needle holder, or a surgical scissors.

[0102] To manufacture the medical instrument 1, the branches 2a, 2b together with the link 5 and the grip sections 3a, 3b are preferably used as a prefabricated component group, and the functional sections 4a, 4b are additively constructed or manufactured at the distal ends of the branches 2a, 2b. The additive construction or manufacturing of the functional sections 4a, 4b is preferably performed by laser deposition welding, selective laser melting or selective laser sintering.

[0103] FIG. 7 shows diagrammatically a further embodiment of a medical product 1 according to the invention in the form of a medical instrument, in particular a surgical instrument.

[0104] The medical device 1 corresponds substantially in its structure to the medical device represented in FIG. 6, although the functional sections 4a, 4b are each provided with an insert, in particular a metal insert, preferably a hard metal insert 6a, 6b.

[0105] To manufacture the medical device 1, the branches 2a, 2b together with the links 5, the grip sections 3a, 3b and the functional sections 4a, 4b are preferably used as a prefabricated component group and the inserts 6a, 6b are additively constructed or manufactured in recesses in the functional sections 4a, 4b. The additive construction or manufacturing of the inserts 6a, 6b is preferably performed by laser deposition welding, selective laser melting or selective laser sintering.

[0106] For further features and advantages of the device 1 shown in Fig. 7, reference is made to the corresponding comments given in relation to the corresponding Fig. 6. In particular, the reference numerals in Fig. 7 (except for reference numerals 6a, 6b, which have no counterpart in Fig. 6) have the same meaning as the corresponding reference numerals in Fig. 6.

Claims

1. 1. A method for manufacturing a medical product, comprising: Step a), i.e. additively constructing or manufacturing at least one functional element on the surface of the substrate, the at least one functional element is connected to the substrate after step a) has been performed; The substrate is manufactured by a non-additive manufacturing method. method.

2. 2. The method according to claim 1, characterized in that step a) is performed by deposition welding, in particular laser deposition welding, preferably laser powder deposition welding or laser wire deposition welding.

3. 3. The method according to claim 1 or 2, characterized in that step a) is performed by a beam sintering method, in particular selective laser sintering, or a beam melting method, in particular selective laser melting.

4. 2. The method of claim 1, wherein the at least one functional element is configured differently than the substrate when performing step a).

5. An implant, preferably a component, a section of a component or a group of components of a prosthesis, in particular a total, semi- or partial prosthesis, is used as said substrate, characterised in that, when carrying out step a), a component, a section of a component or a group of components of an implant, preferably a prosthesis, in particular a full, semi- or partial prosthesis, is additionally constructed or manufactured on the surface of the substrate as at least one functional element, The method of claim 1.

6. 6. The method of claim 5, wherein the prosthesis is selected from the group consisting of a hip joint prosthesis, a knee joint prosthesis, a shoulder joint prosthesis, an elbow joint prosthesis, an ankle joint prosthesis and a finger joint prosthesis.

7. 7. The method according to claim 5 or 6, characterized in that the component or group of components is selected from the group consisting of an artificial acetabulum, an artificial acetabulum insert, an artificial femoral head insert, an artificial femoral head, a hip joint shaft, a cylinder or cone for a hip joint shaft, an upper thigh prosthesis, a shaft for an upper thigh prosthesis, a transtibial prosthesis, a shaft for a transtibial prosthesis, and a group of components consisting of at least two of the above-mentioned components.

8. At least one component having a cylindrical or conical cross section is used as the substrate, characterised in that, when carrying out step a), a joint shaft, preferably a hip joint shaft, is additionally constructed or manufactured as at least one functional element on a surface of said component having a cylindrical or conical shape at least in cross section, The method of claim 1.

9. An upper leg prosthesis or a lower leg prosthesis is used as the base, When performing step a), a shaft is additionally constructed or manufactured as at least one functional element on the surface of the upper leg prosthesis or the lower leg prosthesis. The method of claim 1.

10. A component, a section of a component or a group of components of a medical device, in particular a surgical device, is used as said substrate, characterised in that, when carrying out step a), components, sections of components or groups of components of a medical device, in particular a surgical device, are additively constructed or manufactured as at least one functional element on the surface of the substrate, The method of claim 1.

11. 11. The method of claim 10, wherein the medical instruments are selected from the group consisting of dilating instruments, gripping instruments, holding and / or clamping instruments, and dissecting and / or separating instruments.

12. 12. The method according to claim 10 or 11, characterized in that the component, section of the component or group of components is selected from the group consisting of branches or branch sections, grips or gripping sections, links or link sections, mouths or mouth sections, grips or holding jaws or grip or holding jaw sections, holding and / or clamping jaws or holding and / or clamping jaw sections, cutting and / or separating jaws or cutting and / or separating jaw sections, and group of components consisting of at least two of the above mentioned components.

13. A group of components of a medical device are used as the substrate, said group of components comprising two branches or branch sections rotatably or pivotally attached to one another by a link; each branch or branch section includes a grip or grip section at a proximal end; When carrying out step a), a functional section, in particular a functional section selected from the group consisting of gripping or holding jaws or gripping or holding jaw sections, holding and / or clamping jaws or holding and / or clamping jaw sections and cutting and / or separating jaws or cutting and / or separating jaw sections, respectively, is additionally constructed or manufactured at the distal end of said branch or said branch section as at least one functional element, or Components of a medical device are used as the substrate; said group of components comprising two branches or branch sections rotatably or pivotally attached to one another by a link; each branch or branch section includes a grip or grip section at a proximal end and a functional section at a distal end; said functional sections are in particular selected from the group consisting of gripping or holding jaws or gripping or holding jaw sections, holding and / or clamping jaws or holding and / or clamping jaw sections, and cutting and / or separating jaws or cutting and / or separating jaw sections, characterised in that each said functional section has a recess for receiving an insert, in particular a metal insert, and when carrying out step a), an insert, in particular a metal insert, having a shape complementary to the shape of the recess is respectively additionally constructed or manufactured in said recess as at least one functional element.

12. The method of any one of claims 1 and 11.

14. A medical product comprising: At least one functional element manufactured by additive or generative manufacturing methods; a substrate connected to the at least one functional element; Equipped with The substrate is not manufactured by additive manufacturing and / or is manufactured or producible by the method of claim 1. Medical products.