EP3975904A1 - Handgelenksendoprothese - Google Patents
HandgelenksendoprotheseInfo
- Publication number
- EP3975904A1 EP3975904A1 EP20728731.9A EP20728731A EP3975904A1 EP 3975904 A1 EP3975904 A1 EP 3975904A1 EP 20728731 A EP20728731 A EP 20728731A EP 3975904 A1 EP3975904 A1 EP 3975904A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- carpal
- wrist
- endoprosthesis
- component
- radius
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F2/4261—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for wrists
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30721—Accessories
- A61F2/30734—Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
-
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
-
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B22—CASTING; POWDER METALLURGY
- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
- B22F10/10—Formation of a green body
- B22F10/18—Formation of a green body by mixing binder with metal in filament form, e.g. fused filament fabrication [FFF]
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
-
- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
-
- A—HUMAN NECESSITIES
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- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
- A61B2034/101—Computer-aided simulation of surgical operations
- A61B2034/102—Modelling of surgical devices, implants or prosthesis
-
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- A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
-
- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30028—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30285—Three-dimensional shapes rugby-ball-shaped
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30322—The prosthesis having different structural features at different locations within the same prosthesis differing in surface structures
-
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- the invention relates to a wrist endoprosthesis having a radius component, with a shaft for anchoring in the radius, a head, and a first joint surface which is formed on a distal head side, and a carpal component with a proximal carpal side, a distal carpal side and a second joint surface which is formed on the proximal carpal side and interacts with the first joint surface of the radius component.
- the invention also relates to a method for producing a wrist endoprosthesis of the type mentioned at the outset and a computer program product.
- Total wrist endoprostheses are used to treat various diseases, such as rheumatoid arthritis, or traumatic injuries to the wrist.
- the product Remotion from the manufacturer Stryker Corporation or WO 2008/024853 A2 are known as disclosed wrist endoprostheses.
- These are total wrist endoprostheses with a radius component, which is anchored with a shaft in the radius of a patient, and a carpal component. Both the radius component and the carpal component each have a joint surface which interacts with the joint surface of the other component and the joint function of the natural wrist of the Patient takes over.
- What both wrist endoprostheses have in common is that the carpal components are anchored inside the patient's carpal bones with the help of screws and pins.
- the bones of the first carpal row are completely or partially removed and the bone marrow spaces in the area of the anchoring pins and screws are largely opened.
- the resulting serious invasive trauma complicates the subsequent treatment and is the cause of a lengthy healing process.
- Wrist endoprosthetics are still a relatively unexplored area, especially in comparison to hip and knee arthroplasty.
- the complexity of the movements in the wrist makes it much more difficult to imitate the physiological movements with an endoprosthesis, and the attachment of the carpal component is difficult due to the small size of the carpal bones.
- wrist endoprostheses are known from WO 2018/086765 A1 and WO 2018/053431 A1.
- the known wrist endoprostheses are partial prostheses that are not suitable for the treatment of serious injuries and / or diseases of the entire human wrist apparatus.
- US 2017/0360578 A1 discloses a manufacturing method for prostheses
- US 2002/0082705 A1 discloses a finger prosthesis. The present invention is therefore based on the object of providing a wrist endoprosthesis with an extended service life.
- the stated object is achieved in the case of a wrist endoprosthesis of the type mentioned at the outset in that the carpal component is essentially trough-shaped for at least partially enclosing the carpal bones.
- the invention is based on the knowledge that a trough-shaped carpal component enables a particularly simple and secure fixation of the carpal component on the carpal bones of a patient.
- bone resections can be minimized or ideally avoided entirely when using a trough-shaped carpal component.
- the carpal component is that component of a wrist endoprosthesis according to the invention which is designed for attachment to the carpal bones of a patient.
- a trough shape allows the carpal component to be at least partially pushed over one or more carpal bones of a patient to be treated, so that the carpal bones are at least partially arranged in the interior of the carpal component.
- the one or more carpal bones are arranged inside the carpal component, they are enclosed on at least three sides by the carpal component.
- the carpal bones are preferably enclosed on a palmar, dorsal and proximal carpal side by the trough-shaped carpal component.
- a wrist endoprosthesis designed in this way can achieve a longer service life compared to the prior art.
- a proximal carpal side is that side of the carpal component which, when used according to the invention, points in the direction of the center of the patient's body.
- the second articular surface is formed on this proximal carpal side.
- a palmar carpal side is that side of the carpal component which, when used according to the invention, points in the direction of the palm of a patient.
- the palmar carpal side is essentially perpendicular to the proximal carpal side.
- the dorsal carpal side is opposite the palmar carpal side.
- the distal side of the carpal bones is the side that is further away from the center of the body.
- one of the proximal Carpal side opposite side of the carpal component referred to as the distal carpal side.
- a trough-shaped carpal component enclosing the one or more carpal bones allows the carpal bones to be poured into the carpal component or the carpal bones to be glued to the carpal component. This enables secure and reversible fastening of the carpal component to the carpal bones of a patient.
- the carpal bones are preferably surrounded by bone cement or some other medical potting agent, with loosening of the carpal component being avoided. There is no need to fasten the carpal component with the aid of screws and pins which extend into the carpal bones from a proximal side in the direction of a distal side. Bone resections can also be avoided or minimized.
- the carpal component can preferably have screws or pins which extend from the palmar carpal side to the opposite dorsal carpal side and are provided for further fixing the carpal component in the area of the carpal bones.
- screws or pins are preferred which extend from the dorsal carpal side to the palmar carpal side of the carpal component.
- the trough-shaped carpal component is preferably elongated, an extension in a first direction, measured between the palmar carpal side and the dorsal carpal side, being less than an extension in a second direction perpendicular to this first direction.
- a thickness of the head of the radius component, measured between the first joint surface and a connecting section to the shaft, on a radius side of the head is greater than a corresponding thickness of the head on an ulnar side of the head.
- the first joint surface is preferably embodied essentially concave in a sagittal plane and / or a frontal plane.
- the frontal plane corresponds to a plane that is essentially parallel to the palmar and dorsal carpal sides.
- the tub has a carpal cavity which is open to the distal carpal side and forms the tub shape.
- This carpal cavity is used to accommodate the one or more carpal bones of a patient.
- the carpal component particularly preferably has an inner surface which is formed by the carpal cavity. It is also preferred that the inner surface has a surface structure which is designed for improved adhesion of bone cement. For this purpose, the surface structure particularly preferably has an increased roughness and / or small elevations exercises on. In a further preferred embodiment, the inner surface is formed essentially continuously. A steadily developed inner surface that is free from edges and / or projections can avoid unpleasant or harmful loads on the patient's bone structure. This can extend the service life.
- the carpal cavity is essentially U-shaped in a sagittal plane.
- the at least one carpal bone can be enclosed by the carpal cavity both on the palmar side and on a dorsal side.
- the sagittal plane is arranged essentially perpendicular to the palmar and the proximal carpal side and is preferably a sectional plane of the carpal component.
- a contact area between the carpal cavity and the at least one carpal bone is enlarged. If the carpal component is fixed by means of a potting agent, for example bone cement, the strength of the fixation can thus be improved.
- the U-shaped carpal cavity makes it possible to avoid impairments and punctual loads on the at least one carpal bone and to improve the fit of the carpal cavity. Furthermore, the U-shaped structure ensures increased mechanical stability of the carpal component and even load distribution. In addition, the U-shaped structure of the carpal cavity enables improved filling with potting agent. For example, bone cement can slowly penetrate into the spaces between the bones and / or the formation of cavities can be avoided.
- the carpal cavity preferably has a maximum internal width, measured in the sagittal plane, a corresponding internal width of the carpal cavity at a distal end of the carpal component being smaller than the maximum internal width.
- the distal end of the carpal component is located on the distal carpal side and, when used according to the invention, points in the direction of the fingertips of a patient.
- the inner cavity therefore preferably has an undercut in the sagittal plane and / or is designed to taper in the direction of the distal end. With such a shape of the inner cavity, it can be achieved that after the at least one carpal bone has been poured inside the cavity, a form-fitting and / or material connection of the carpal component with the one or more carpal bones of the patient is achieved.
- the carpal component has one or two lateral openings which are formed in a side parallel to the sagittal plane.
- the side of the carpal component parallel to the sagittal plane is preferably an ulnar side or radial side of the carpal component.
- the ulnar side is essentially perpendicular to the proximal, distal, dorsal and palmar carpal side of the carpal component and, when used according to the invention, points in the direction of the ulna of a patient.
- the one or two lateral openings can facilitate fastening of the carpal component and reduce its weight.
- the lateral openings can extend entirely or partially over the ulnar side and / or radial side.
- the one or two lateral openings are particularly preferably designed as essentially U-shaped slots that are open towards the distal side. The slots opened in the direction of the distal carpal side enable the carpal component to partially enclose one or more carpal bones in a direction between the distal and proximal carpal side.
- the scaphoid, lunar bone, triangular bone and small polygonal bone of a patient can be arranged completely in the carpal cavity, while the large polygonal bone, the head bone and / or the hooked bone are only partially arranged within the carpal cavity and extend partially or completely through the slots.
- the head leg and the hook leg can extend through the slots, while the large polygonal leg lies entirely outside the cavity.
- the edges of the openings are preferably rounded. It is also preferred that edges of the carpal cavity, which form a transition between the carpal cavity and one or more outer surfaces of the carpal components, are rounded.
- the carpal cavity has a concave bulge which is formed in the direction of the proximal carpal side.
- the bulge increases the volume of the carpal cavity and forms a concave floor of the carpal cavity.
- the carpal cavity has a maximum depth, measured in an axial direction between the distal and proximal carpal sides. The maximum depth is greater than the corresponding depths of the carpal cavity on the ulnar side and the radial side.
- a depth of the lateral openings, measured in the axial direction, is particularly preferably less than the maximum depth of the carpal cavity.
- the concave bulge preferably corresponds essentially to a negative shape of the proximal side of one or more carpal bones of a human wrist.
- the concave bulge for example, the scaphoid and / or lunar bone of a patient can be accommodated in the carpal cavity and the occurrence of punctual loads on the carpal bones can be avoided.
- the carpal component is preferably designed to taper parallel to the frontal plane in the direction of the distal carpal side.
- a first width of the carpal component measured between the ulnar side and the radial side, is therefore preferably less on the distal carpal side than a corresponding second width of the carpal component in a central area which is arranged between the proximal carpal side and the distal carpal side.
- the carpal component is preferably designed to taper in an essentially trapezoidal shape parallel to the frontal plane in the direction of the distal carpal side, particularly preferably to taper essentially in an isosceles trapezoidal shape.
- a proximal end of the carpal component is designed as a thickening.
- the preferred thickening can increase the mechanical stability of the carpal component at the proximal end.
- pressure forces that act on the second joint surface can be introduced evenly into the carpal bones.
- a first wall thickness at the distal end of the carpal component is preferably less than a second wall thickness at the proximal end.
- the proximal end is preferably configured to be essentially convex in the frontal plane and / or in the sagittal plane.
- the second joint surface is particularly preferably arranged at least partially on the thickening.
- the carpal component is particularly preferably designed to be essentially mirror-symmetrical with respect to a frontal plane.
- the carpal component is designed mirror-symmetrically to a sagittal plane.
- a mirror-symmetrical design of the carpal component can facilitate production both by means of machining processes and by means of additive manufacturing processes. For example, a model creation, production of the carpal components by means of 3D printing and / or post-processing of the carpal component can be improved. Since twisting or incorrect insertion of the carpal component is prevented by the symmetrical shape, the reliability of the implantation can also be increased. Furthermore, a symmetrical shape ensures that the joint surfaces slide smoothly.
- the object mentioned at the beginning is achieved in that the wrist endoprosthesis has a protection against dislocation.
- the occurrence of complete or incomplete loss of contact between the carpal component and the radial component can be reduced by the anti-luxation protection, whereby damage to the prosthesis or the surrounding tissue can be avoided.
- the dislocation protection is preferably designed as a mechanical component which restricts a freedom of movement of the carpal component relative to the radius component. Movements that do not change a distance between the joint surfaces, as is the case, for example, for rotational and pivoting movements, are particularly preferably not restricted. It is also preferred that the dislocation protection connects the carpal component and the radius component.
- the protection against dislocation has a band which connects the carpal component and the radius component.
- the band is preferably formed from a plastic, a fiber material and / or a metallic material.
- a protection against dislocation is also preferred, which has several ligaments connecting the carpal component and the radius components.
- a tension force is applied by the band, which brings the first and second joint surfaces into contact and / or counteracts a lifting of the carpal component from the radius component.
- the clamping force can preferably be individually adapted to the patient before and / or during the implantation.
- the radius component preferably has a tunnel which extends from a dorsal side of the radius component to a palmar side of the radius component, the band running through the tunnel.
- the tunnel runs between two sides of the head.
- the tunnel runs from a first side of the head, which corresponds to the dorsal side of the radius components, to a second side of the head, which corresponds to the palmar side of the radius component.
- the tunnel inside the radius component can also extend into the shaft.
- the head of the radius component is provided to protrude from a distal end of the radius after implantation of the radius component in the radius of a patient, while the shaft is anchored in the radius.
- the palmar side of the radius component and the palmar carpal side are arranged on the same side of the wrist endoprosthesis.
- the dorsal side of the radius component is an opposite side from the palmar side.
- a second tunnel extends from the ulnar side to a radius side of the radius component and a second band of the anti-luxation protection extends through the second tunnel.
- embodiments are preferred with a plurality of tunnels which extend from the ulnar side to a radius side of the radius component, with further ligaments of the anti-luxation protection running through the tunnels.
- a width of the belt essentially corresponds to a width of the tunnel so that twisting of the belt is avoided.
- the tunnel is curved in the direction of a proximal end of the shaft.
- the proximal end of the shaft lies opposite the distal side of the head and, when used according to the invention, is the section of the wrist endoprosthesis which is closest to the center of the patient's body.
- the tunnel is particularly preferably curved in the direction of the shaft in such a way that a maximum distance of the tunnel from the first joint surface lies on a central axis of the radius component which runs from the proximal end of the shaft to the distal head side. Curving the tunnel can minimize friction on the belt. For this reason, openings in the tunnel are preferably rounded.
- the band particularly preferably has a first end connected to a palmar carpal side and a second end connected to a dorsal carpal side.
- a first length of the first end and a second length of the second end are preferably variable as a result of the relative movement of the belt through the tunnel.
- the connection of the first end to the palmar side and / or the connection of the second end to the dorsal side is preferably cohesive, frictional and / or form-fitting.
- a connection of the first and / or second end on a shoulder of the carpal component, which forms a transition area to the thickening, is preferred.
- a first material forming the wrist endoprosthesis is an isoelastic material, preferably a thermoplastic, particularly preferably polyetheretherketone (PEEK).
- An isoelastic material has one or more mechanical properties that essentially correspond to the mechanical properties of a human bone in the area of the wrist.
- a modulus of elasticity of the first material essentially corresponds to the modulus of elasticity of a human radius.
- Sections of the wrist endoprosthesis formed from an isoelastic material show a reaction to acting forces that essentially corresponds to the reaction of a real bone. Compared to rigid implants that absorb the forces acting on them, remodeling processes in the bone structure surrounding the prosthesis and the resulting loosening can be avoided.
- PEEK has such isoelastic properties and is also biocompatible.
- the use of other supplementary materials such as titanium is also preferred. These can be used, for example, to increase mechanical stability or bone affinity.
- the further material is particularly preferably added to the isoelastic material and / or the isoelastic material is completely or partially coated with the further material.
- the invention solves the problem mentioned at the beginning with a wrist endoprosthesis for partial functional replacement of the human wrist, comprising: a carpal component with a proximal carpal side, a distal carpal side and a second joint surface, which are arranged on the proximal carpal side and interact with of a distal joint surface of a human radius, characterized in that the carpal component is substantially trough-shaped, for at least partially enclosing the carpal bones. If a bony structure of the radius is still largely present on the wrist to be treated, the carpal component can also interact directly with the articular surface of the human radius that is still present.
- the wrist endoprosthesis can then also be designed without a radius component and / or only have a carpal component.
- a carpal component When the wrist endoprosthesis is implanted, fewer steps are necessary and the patient can be spared. Owing in particular to the tub shape of the carpal component, bone resections, that is to say the removal of bone material, can also be completely omitted.
- the carpal component encloses the carpal bones and interacts with the second joint surface with the distal joint surface of the human radius.
- the wrist endoprosthesis then partially takes over the function of the human wrist.
- the wrist endoprosthesis can preferably have a protection against dislocation, which is designed to be fixed to a human radius component.
- the proximal carpal side has a thickening that is designed as a convex elevation.
- a convex elevation is particularly adapted to the anatomy of the distal joint surface of a human radius.
- the thickening also allows a dimensionally stable structure. Irritation and / or wear and tear of the patient's radius interacting with the carpal component are thus effectively prevented.
- the object described at the outset is achieved by a method for producing a wrist endoprosthesis, preferably according to one of the preferred embodiments of a wrist endoprosthesis described above, the method comprising the steps of: providing or producing a non-individualized 3D model a wrist endoprosthesis; Acquisition of data material, in particular x-ray images, magnetic resonance tomography data, ultrasound images and / or computer tomography data, of a patient's wrist to be treated; Ascertaining one or more parameters from the data material for approximating an approximated geology of the patient from the data material; Individualizing the non-individualized 3D model based on the derived parameters to obtain an individualized 3D model; and manufacturing the wrist endoprosthesis by means of an additive manufacturing process based on the individualized 3D model.
- wrist endoprostheses can be produced which are individually adapted to the geometry of the patient's wrist to be treated and made to measure.
- an improved implant fit or integration into the joint chain lower postoperative pain, improved postoperative function and / or lower operative blood loss can be achieved.
- protrusions and the resulting soft tissue injuries can be avoided.
- Manufacturing by means of an additive manufacturing process such as a 3D printing process in particular, enables production costs, material consumption and / or the production time to be reduced.
- very complex geometric shapes can be produced.
- the 3-D printing process Fused Deposition Modeling (FDM) is particularly preferred.
- a filament preferably a plastic filament, particularly preferably PEEK
- a mechanism for melting and applying using a mechanism, with the object to be created being built up in layers.
- the production and individualization of the 3D model can be based on CAD applications.
- One or more of the steps mentioned are preferably carried out in an automated manner.
- only partial components of the wrist endoprosthesis can also be manufactured by means of an additive manufacturing process.
- the wrist endoprosthesis and / or partial components of the Wrist endoprosthesis based on the individualized 3D model can also be manufactured by means of a machining process.
- the parameter represents at least one geometric shape or shape, preferably full shape, of a ligamentary connection between adjacent carpal bones of the proximal carpal row of the wrist to be treated
- the individualized 3D model has a side facing the anatomy to deepen the corresponding survey.
- the side facing the anatomy is a side of the 3D model or of the wrist endoprosthesis to be produced, which is facing the anatomy, in particular the bony structure, of the wrist to be treated.
- the wrist endoprosthesis has a trough-shaped carpal component according to the first aspect of the invention, the anatomy-facing side is defined by the carpal cavity.
- the ligamentous or ligamentous connections between the carpal bones are characterized by depressions which, in a healthy wrist, are filled with soft tissue.
- An elevation corresponding to at least one of these depressions on the anatomy-facing side of the wrist endoprosthesis can be placed on this depression and prevents the prosthesis from slipping after implantation. Furthermore, the risk of incorrect positioning is reduced.
- the side facing the anatomy is preferably a section-wise geometric negative of the bony structure of the wrist to be treated.
- the method preferably further comprises: providing a surface structuring on at least one surface section of the anatomy-facing side of the individualized 3D model, the manufacture of the wrist endoprosthesis taking place based on the individualized 3D model with surface structuring.
- the surface section of the anatomy-facing side is preferably smooth.
- the surface structuring is preferably provided on the entire anatomy-facing side.
- the surface structuring is also present on the anatomy-facing side of the manufactured wrist endoprosthesis, since it is manufactured based on the 3D model with surface structuring.
- the surface structuring then brings about a better and / or more secure fit of the wrist endoprosthesis, since the total surface area of the side facing the anatomy is enlarged.
- the surface structuring is preferably generated randomly.
- a second parameter represents a shape and position of a cartilage-covered joint surface of the wrist to be treated and a third parameter represents a shape and position of a cartilage-free surface of the wrist to be treated, the individualized 3D model on the anatomy-facing side facing the cartilage-covered Having a first connection surface corresponding to the joint surface and a second connection surface corresponding to the cartilage-free surface.
- Cartilage-covered articular surfaces typically move relative to other bones as the wrist moves and are covered with cartilage to protect against wear.
- proximal sections of the proximal carpal row are covered at least in sections with cartilage. Distal sections of the proximal carpal row are usually not or not completely covered with cartilage and are therefore free of cartilage.
- the wrist endoprosthesis can advantageously be adapted to different properties of the cartilage-covered joint surface and the cartilage-free surface of the wrist to be treated.
- the position of the connecting surfaces corresponds to the respective surfaces of the wrist. If the finished wrist endoprosthesis is inserted into the wrist to be treated, the first connection surface rests against the cartilage-covered joint surface or is arranged adjacent to it.
- the second connection area is then assigned to the cartilage-free area.
- the surface structuring preferably has first structural elements on the first connecting surface at least in sections and second structural elements on the second connecting surface at least in sections, which are different from the first structural elements.
- the first structural elements are structural elements protruding from the first connecting surface.
- the first structural elements then protrude in the direction of the anatomical structure.
- the protruding structural elements reduce a direct contact area between the first connection area and the human tissue.
- the contact is then no longer flat, but only in the area of the contact elements.
- a manufacturing accuracy for the wrist endoprosthesis can be reduced in comparison to a flat contact. This is particularly desirable because often only limited accuracies can be achieved when recording data material. In this way, individual contact elements can be reworked more easily in the context of an implantation than a large-area direct contact area and handling is made easier.
- the protruding structural elements nevertheless increase the total surface of the first connecting surface. This increases the strength of a connection between the wrist endoprosthesis and the patient's bony structure that is produced by potting agents. Furthermore, distribution of the casting agent, in particular bone cement, is also promoted.
- the first structural elements are preferably rhombuses, rectangles, triangles, circular structures, ellipses, polygons and / or ribs in cross section.
- the second structural elements are preferably pores in the second connecting surface. Pores enable bone tissue to grow in and thus ensure a particularly secure hold of the wrist joint prosthesis.
- the wrist endoprosthesis preferably allows independent and / or externally controlled unfolding.
- the wrist endoprosthesis can be designed with joint sections for unfolding.
- the wrist endoprosthesis can preferably be produced from a reversibly deformable material.
- the size of wrist endoprostheses that allow unfolding can be reduced during implantation, as a result of which such wrist endoprostheses can be implanted in a particularly patient-friendly manner.
- the wrist endoprosthesis is inserted into the wrist to be treated, it returns to its original shape by unfolding. This can take place independently or automatically, i.e. when deformation forces are withdrawn, or externally controlled with the aid of instruments provided for this purpose.
- the wrist endoprosthesis according to the first aspect of the invention can also have a surface structuring on an anatomy-facing side, in particular on an anatomy-facing side of the carpal component. This can preferably be provided partially or completely on an inner surface of the carpal cavity.
- the wrist endoprosthesis according to the first aspect of the invention can also preferably allow an independent or automatic and / or externally controlled unfolding.
- the step of acquiring data material, in particular x-ray images, ultrasound images, magnetic resonance tomography data and / or computed tomography data, of a patient's wrist to be treated is not possible, at least one of the following steps is carried out: Acquiring data material , in particular x-ray images and / or computed tomography data, of the second wrist of a patient; and / or providing data from a statistical comparison group. It is not possible to record data material if the recorded data material is not suitable for further use in the process. However, it may be technically possible to collect data that is not suitable for further use in the preferred method for producing a wrist endoprosthesis.
- Determining parameters from data material of the wrist is useful if the data material has information and / or references to one or more features of the natural structure of the patient's wrist in an especially healthy state. By customizing the wrist endoprosthesis, a natural structure of the patient's healthy wrist is approximated and / or simulated. Determining parameters from the data does not make sense if the data does not allow any conclusions to be drawn about the patient's healthy wrist.
- the joint structures can already be changed so much due to rheumatoid arthritis that it does not make sense to determine parameters from data material for this wrist, since the data material does not contain any information and / or references to the healthy structure of the wrist.
- the wrist has a healthy structure if a bony geometry is intact and this allows a symptom-free use of the wrist.
- the data material of the statistical comparison group preferably contains data from comparison persons of the same age, same sex, with the same body size and / or with the same body type.
- the step of providing data material for a statistical comparison group is preferably carried out as an alternative or in addition, if the acquisition of data material, in particular x-ray images and / or computed tomography data, of the second wrist of a patient is not possible or not sufficiently possible. Acquiring data material of the second wrist of a patient is not sufficiently possible, for example, if the data material only allows limited conclusions to be drawn about a natural structure of the patient's wrist in a particularly healthy state due to various clinical pictures or injury patterns.
- the method preferably has: providing or creating a 3D instrument model of one or more surgical instruments based on the individualized 3D model of the wrist endoprosthesis and / or the data material; and manufacturing the surgical instrument based on the 3D instrument model.
- At least one of the surgical instruments is preferably a cutting template which specifies an intraoperative cutting course.
- cutting templates for a joint surface of the radius templates for orienting and guiding the drilling channel in the radius and / or rasps or files that are used to process the bones of a patient can represent such preferred surgical instruments.
- the surgical instrument is preferably an instrument for supporting and / or converting a folding of the wrist endoprosthesis.
- the data material contains at least data relate to one of the following parameters: ulnar variance, thickness of the cortex, plane shape of the inner cavity of the radius, radius of the proximal carpal row in a sagittal plane and / or frontal plane, radius of the distal carpal row in a sagittal plane and / or frontal plane, radius of one or more carpal bones in a sagittal plane and / or frontal plane, joint surface angle in a sagittal plane and / or frontal plane, course of the mechanical forearm axis, location points and / or orientation of anatomical axes of the carpal, location points and / or ori Entation of the anatomical axes of individual carpal bones, width and / or length of one or more carpal bones, measured in a sagittal plane and / or a frontal plane, width of the proximal carpal row in a frontal plane and / or the sagittal plane, width of the
- the ulnar variance represents a distal length difference between the radius and ulna of a patient.
- An extension from a proximal end of the carpal or carpal bone to a distal end of the carpal or carpal bone is involved referred to as length.
- the width of the carpal or carpal bone is an extension perpendicular to the length.
- a joint line preferably bisects a distance between the proximal carpal row and the joint surface of the radius and / or the joint surface of the ulna.
- the step of individualizing the 3D model further preferably comprises at least one of the following steps: adapting an angle of a first joint surface to the derived joint surface angle in a sagittal plane; Adapting an angle of a second articular surface to the derived articular surface angle in a sagittal plane; Adapting an angle of a first articular surface to the derived articular surface angle in a frontal plane; Adapting an angle of a second articular surface to the derived articular surface angle in a frontal plane; Adapting a radius of a convex elevation of a carpal component to the derived radius of the proximal carpal row in a sagittal plane and / or frontal plane; Adapting a size of a distal part of a radius component such that protruding of the distal part beyond a radius of a patient is avoided or adapted; Adapting a diameter and / or a shape of a shaft of a radius component as a function of
- a first material used to manufacture the wrist endoprosthesis is an isoelastic material, preferably a plastic, particularly preferably PEEK.
- the first material can also preferably pass through a second material, preferably titanium, can be added.
- a surface formed by the first material is preferably completely or partially coated with the second material.
- the invention achieves the object mentioned at the beginning with a method for producing a wrist endoprosthesis, in particular a wrist prosthesis according to one of the above-described embodiments according to the first aspect of the invention, the method having the steps: providing or producing a non- customized 3D model of a wrist endoprosthesis; Acquisition of data material, in particular x-ray images, magnetic resonance tomography data, ultrasound images and / or computer tomography data, of a patient's wrist to be treated; Creating a patient-specific 3D model of at least one anatomy section of the wrist to be treated using the data material; Deriving a negative shape of the anatomy section of the wrist to be treated; Adapting an anatomy-facing side of the non-individualized 3D model to the derived negative shape of the anatomy section of the wrist to be treated in order to obtain an individualized 3D model; and manufacturing the wrist endoprosthesis by means of an additive manufacturing process based on the individualized 3D model.
- the side facing the anatomy preferably reproduces the negative shape
- the invention achieves the aforementioned object by a computer program product having code means which, when executed on a computer, are designed to carry out one of the steps of the previously defined method according to the fourth and / or fifth aspect of the invention.
- a computer program product having code means which, when executed on a computer, are designed to carry out one of the steps of the previously defined method according to the fourth and / or fifth aspect of the invention.
- Fig. 1 is an isometric view of the wrist endoprosthesis with attached
- FIG. 7 shows a section of the wrist endoprosthesis along the sagittal plane; 8 is a flow diagram illustrating the method for producing a wrist endoprosthesis;
- Figure 9 is a dorsal view of the human bones of the right forearm.
- 10 shows a view of the human radial bone in the sagittal plane; 11 shows an anterior-posterior view of the bone structure of a human wrist;
- FIG. 12 is a view of the bone structure of a human wrist in a
- 13a-13c are schematic views showing an individualized 3D model of a
- a wrist endoprosthesis 2 has a radius component 4, a carpal component 6 and a dislocation protection 8 as main elements.
- the radius component 4 is formed here by a shaft 10 and a head 12.
- a first joint surface 16 is arranged on a distal head side 14.
- the carpal component 6 is trough-shaped and preferably has a carpal cavity 18. In this embodiment, the trough shape of the carpal component 6 is formed by the carpal cavity 18.
- the carpal cavity 18 is open to a distal carpal side 20.
- a second joint surface 24 is arranged on a proximal carpal side 22, which lies opposite the distal carpal side 20. In this exemplary embodiment, there is contact between the first joint surface 16 and the second joint surface 24.
- wrist endoprostheses 2 with a distance between the first joint surface 16 and the second joint surface 24 are also preferred.
- the carpal component 6 On a radius side 26, the carpal component 6 has a first lateral opening 28.
- the carpal component 6 On an ulnar side 30 opposite the radius side 26, the carpal component 6 has a second lateral opening 32.
- the wrist endoprosthesis 2 has a dislocation protection 8, which is formed by a band 34 which connects the radius component 4 and the carpal component 6.
- the band 34 runs through a tunnel 36 formed in the radius component.
- the carpal component 6 is preferably in the direction of the central Ralachse ZA arranged on the distal head side 14.
- the central axis ZA runs from a proximal shaft end 38 to the distal head side 14.
- a second central axis ZA2 of the carpal component 6 is congruent to the central axis ZA in this embodiment. It should be understood that the central axis ZA and the second central axis ZA2 are at a distance and / or can include an angle with one another.
- a first maximum width B1 of the radius component, measured parallel to the frontal plane E1, is preferably greater than or equal to a corresponding second maximum width B2 of the carpal component 6.
- the second maximum width B2 preferably has a range from 70% to 100%, preferably 85% to 100% %, particularly preferably 90% to 95% of the first maximum width B1.
- the anti-luxation protection 8 applies a restoring force F which causes contact between the first joint surface 16 and the second joint surface 24.
- a dislocation protection 8 is also preferred which does not apply any restoring force in a rest position.
- the band 34 of the luxation protection 8 could be designed as a rigid band that counteracts longitudinal expansion.
- the shaft 10 of the radius component 4 is designed to be implanted in a radius of a patient.
- the head 12 protrudes from a distal end of the radius. In the preferred embodiment, the head 12 extends in the direction of the central axis ZA from the shaft 10 to the first joint surface 16.
- the head 12 is connected to the shaft 10 at a connecting section 40.
- the connecting section 40 is preferably designed as an edge 42. It should be understood that rounded and / or continuous connecting sections 40 are also preferred.
- the connecting section 40 is essentially circular in a plane perpendicular to the central axis ZA. Substantially oval or egg-shaped connecting sections 40 are likewise preferred.
- a thickness D1 on a radius side 44 of the radius component 4, measured in the direction of the central axis, is greater than a thickness D2 on an ulnar side 46.
- the first joint surface 16 on the ulnar side 46 merges directly into the shaft 10 and the thickness D2 disappears.
- thicknesses D2 of the head 12 in the area of the ulnar side 46 which are greater than zero are also preferred.
- a tangent TG1 to the first joint surface 16 encloses an angle ⁇ with a plane perpendicular to the central axis ZA.
- the angle a has a range from 0 ° to 60 °, preferably 0 ° to 45 °, particularly preferably 15 ° to 20 °. Be likewise negative angles ⁇ are also preferred, so that the thickness D2 is greater than the thickness D1.
- the first joint surface 16 can preferably also have flat sections. In the embodiment shown, the first joint surface 16 is essentially oval, so that the width B1 is greater than a third width B3 of the joint surface 16 perpendicular to the first width B1.
- the tunnel 36 has a first access 50 on the head 12 of the radius component 4.
- the first access 50 is arranged on the dorsal side 64 of the radius component 4.
- a second access 51 is preferably arranged on the palmar side 66 of the radius component 4.
- the second access 51 is preferably mirror-symmetrical to the first access 50 in the frontal plane.
- the first access 50 has an elongated cross-section.
- the narrow sides 52,54 of the first entrance 50 are closed by semicircles 56,58.
- the long sides 60,62 of the first access 50 are parallel and larger than the narrow sides 52,54.
- a width B4 of the band 34 is less than a length of the long sides 60, 62 and / or a thickness D3, measured perpendicular to the width B4, of the band 34 is less than a length of the narrow sides 52, 54.
- Round, oval and / or rectangular cross-sections of the first access 50 and / or second access 51 are also preferred.
- the accesses 50, 51 can be rounded.
- the first access 50 and the second access 51 are preferably arranged completely on the head 12 of the radius component 4. In the embodiment shown, the first access 50 directly adjoins the connection section 40 in the direction of the distal head side 14.
- first access 50 is designed at a distance from the connection section 40 in the direction of the central axis ZA.
- the first access 50 particularly preferably has a smaller distance from the connecting section 40 in the direction of the central axis ZA than from the first joint surface 16.
- the shaft 10 tapers steadily in the direction of the central axis ZA towards the proximal shaft end 38.
- a shaft 10 alternately tapering and expanding in the direction of the proximal shaft end are also preferred.
- the proximal shaft end 38 is shown flattened. Pointed and / or rounded proximal shaft ends 38 are also preferred.
- a lateral surface 70 of the shaft 10 is formed continuously.
- the shaft 10 can preferably be designed to be rotationally symmetrical to the central axis ZA.
- the shaft 10 preferably has a length L1, measured along the central axis ZA between the connecting section 40 and the proximal shaft end 38, in a range from 10 mm to 150 mm, particularly preferably 50 mm to 100 mm.
- a thickness D4 of the head 12 adjoining the length L1 along the central axis ZA has a range from 0 mm to 100 mm, preferably 10 mm to 40 mm, particularly preferably 20 mm to 30 mm.
- FIG. 3 shows a section through the radius component 4 along the frontal plane E1.
- the first joint surface 16 is alternately concave and convex in the frontal plane E1. Purely concave or purely convex courses of the first joint surface 16 are likewise preferred.
- the tunnel 36 preferably has a constant cross section 72 which corresponds to the cross section of the first access 50.
- the cross section 72 is preferably designed mirror-symmetrically to the central axis ZA.
- the maximum width B1 measured perpendicular to the central axis ZA, is arranged in the transition area 40 in the exemplary embodiment. It should be understood that embodiments with maximum widths B1 are also preferred along the central axis ZA in the direction of the first joint surface 16 from the transition region 40.
- FIG. 4 shows a section through the radius component 4 along a sagittal plane E2.
- an upper transition area 74 between the first joint surface 16 and a side surface 76 of the head 12 is designed as an edge. Furthermore, completely or partially rounded transition areas 74 are also preferred.
- first joint surface 16 is designed in the sagittal plane E2 as a concave recess 78 which runs along the central axis ZA in the direction of the proximal shaft end 38.
- first joint surfaces 16 are also preferred, which are designed as convex elevations.
- the tunnel 36 runs in the area of the head 12 from the dorsal side 64 of the radius component 4 to the palmar side 66 and is arched in the direction of the proximal shaft end 38.
- a proximal point 84 of the tunnel 36 measured in the direction of the central axis ZA, is preferably arranged on the central axis ZA.
- the proximal point 84 is that point of the tunnel 36 which, measured in the direction of the central axis ZA, has the smallest distance from the proximal shaft end 38.
- Distal transition regions 86, 88 of the tunnel 36 to the dorsal side 64 and palmar side 66 are preferably rounded. Fully rounded first and second accesses 50, 51 are also preferred.
- the material of the head 12 between the joint surface 16 and the tunnel 36 has a minimum thickness D5 in a range of 20% to 200%, preferably 30% to 150%, particularly preferably 40% to 110%, of the length of the narrow side 52,54 of the Tunnel 8.
- the minimum thickness is also preferred D5 has a range from 10% to 60%, preferably 50% to 60% of the thickness D4.
- the thickness D5 is preferably greater near the transition areas 86, 88 than in the area of the central axis ZA.
- the radius component 4 is designed mirror-symmetrically to the frontal plane E1. It should be understood that non-symmetrical or component-wise symmetrical embodiments of the radius component 4 are preferred.
- an angle ⁇ between the tangent TG2 and a plane perpendicular to the central axis ZA is 90 °. It should be understood that angles ⁇ are preferred which have a range from 30 ° to 150 °, particularly preferably 80 ° to 120 °.
- the first joint surface 16 is designed to be concave in the sagittal plane E2.
- first joint surfaces 16 which are concave in the frontal plane E1 are preferred.
- the side surface 76 of the head 12 is formed on the dorsal side 64 of the radius component 4 and the palmar side 66 essentially parallel to the central axis ZA, so that the width of the head 12 is constant in the sagittal plane E2 and the width B3 of the first joint surface 16 corresponds.
- Embodiments are also preferred in which the head 12 widens and / or tapers in the direction of the first joint surface 16 so that a maximum width B5 differs from the width of the joint surface B3.
- the width B3 has a range from 10% to 150%, preferably 50% to 100%, particularly preferably 70% to 90%, of the width B1 in the frontal plane E1.
- an angle ⁇ measured between the central axis ZA and a tangent TG1 at a first end point 81 on the dorsal side 64 and a second end point 83 on the palmar side 66, is 90 °; other angles are also in a range of 0 ° to 180 ° preferred.
- FIG. 6 shows a section through the carpal component 6 in the sagittal plane E2.
- the carpal component 6 has a distal section 90 and a proximal section 92.
- the carpal cavity 18 is open to a distal carpal side 20.
- a second joint surface 24 is formed on a proximal carpal side 22 opposite the distal carpal side 20.
- a maximum width B2 of the carpal component 6 parallel to the frontal plane E1 is greater than one to it vertical maximum width B6 of the carpal component 6 in the sagittal plane E2 (see FIG. 6).
- the carpal component 6 is elongated parallel to the frontal plane E1.
- the first lateral opening 28 arranged on the radius side 26 is designed as a first slot 94.
- the second lateral opening 32 arranged on the ulnar side 30 is designed as a second slot 96.
- the slots 94, 96 are open in the direction of the distal carpal side 20.
- the first slot 94 and the second slot 96 are formed mirror-symmetrically to the sagittal plane E2.
- a depth T1 of the slots 94, 96 measured starting from the distal carpal side 20 in the direction of the proximal carpal side 22, extends into the proximal section 92.
- the slots 94, 96 can only be arranged in the distal section 90 of the carpal component 6.
- the depth T1 measured between the distal carpal side 20 and the proximal carpal side 22, has a range from 20% to 80%, preferably 30% to 70%, before particularly preferably 40% to 60%, of the length L2 of the carpal component 6 . It should be understood that asymmetrically designed slots 94, 96 are also preferred.
- the first slot 94 can preferably have a third depth T3, which is different from the depth T1. It is also preferred that the carpal cavity 18 has a bulge 112 in the direction of the proximal carpal side 22. A depth T2 of the bulge, measured from the distal carpal side 20 in the direction of the proximal carpal side 22, is preferably greater than the depth T1 and / or the depth T3. In the embodiment shown, the transition regions 102 between an inner surface 98 of the carpal cavity and an outer surface 100 of the carpal component 6 are formed with edges 103. Rounded transition areas 102 are also preferred.
- the transition 104 between the distal section 90 and the proximal section 92 is designed as a shoulder 105.
- the distal section 90 of the carpal component 6 is parallel to the frontal plane E1, tapering in the direction of the distal carpal side 20, so that it has a trapezoidal shape in this exemplary embodiment.
- outer corners 1 13, 1 14, 1 16, 1 18 are pointed.
- Rounded corners 1 13, 1 14, 1 16, 1 18 are also preferred.
- a width B7 parallel to the frontal plane at the distal end 106 of the carpal component 6 is less than a maximum width B2.
- the proximal end 108 of the carpal component 6 is arranged on the proximal side 22.
- the proximal end 108 is preferably designed as a thickening 110.
- the second joint surface 24 is arranged on the thickening 110.
- the thickening 110 is designed here as a convex elevation.
- the thickening can be designed as a concave depression, so that the second joint surface 24 is concave in the frontal plane E1.
- the thickening 110 extends over the entire proximal section 92 of the carpal component 6.
- embodiments with a thickening 110 that only partially extends over the proximal section 92 are also preferred.
- a thickness D7 of the carpal component 6, measured between the inner surface 98 and the outer surface 100 in the region of the distal end 106, is here less than a corresponding thickness D8 in the region of the proximal end 108.
- a ratio of the wall thicknesses D8: D7 preferably has a range of 8: 1 to 1: 1, more preferably 6: 1 to 1: 1, particularly preferably 6: 1 to 3: 1.
- the carpal cavity 18 has a substantially U-shaped cross section. According to this exemplary embodiment, a clear width W1 of the carpal cavity 18 at the distal end 106 is smaller than a maximum clear width W2 inside the carpal cavity 18.
- the carpal cavity 18 preferably tapers in the direction of the distal carpal side 20. Likewise, carpal cavities 18 that extend into Widen towards the distal carpal side 20.
- the transition regions 102 at the distal end of the carpal component 6 are designed as flat surfaces 117, 119. A rounded transition between inner surface 98 and outer surface 100 is also preferred.
- the second joint surface 24 is convex in the sagittal plane E2.
- concave or concavo-convex second articulation surfaces are also preferred.
- a first transition 120 between shoulder 105 and proximal section 92 is rounded, while a second transition 122 between shoulder 105 and distal section 90 is angled, especially right-angled.
- Two rounded or angular transitions 120, 122, as well as a continuous transition without a shoulder 105 between the distal section 90 and the proximal section 92 are also preferred.
- the proximal end 108 of the carpal component 6 preferably has a continuous and / or rounded outer surface.
- the band 34 of the anti-luxation protection 8 has a first end 124 which is attached to the dorsal carpal side 126. Furthermore, a second end 128 of the band 34 is attached to a palmar carpal side 130.
- the dorsal carpal side 126 is preferably essentially perpendicular to the distal carpal side 20 and to the radius side 26. In this exemplary embodiment, the first end 124 and the second end 128 are fastened on the shoulder 105.
- first end 124 and / or the second end 128 are attached to the distal end 106 of the carpal part 6, to the distal section 90, to the proximal section 92, to the proximal end 108 and / or to the inner surface 98 of the carpal cavity 18 .
- the fastening can preferably take place in a form-fitting, frictional and / or cohesive manner.
- the band 34 runs between the first end 124 and the second end 128 through the tunnel 36.
- the carpal component 6 and the radius component 4 of the wrist endoprosthesis 2 are thereby connected.
- the band 34 is only connected to the radius component 4 in a form-fitting manner by a loop formed between the first end 124 and the second end 128.
- the belt 34 can preferably slide relative to the tunnel 36. Rotational and tilting movements of the carpal component 6 relative to the radius component 4 are possible. For this purpose, the frictional forces between belt 34 and tunnel 36 and between the first joint surface 16 and the second joint surface 24 have to be overcome. Synovial fluid can act as a lubricant. Furthermore, embodiments with a fixed connection of the band 34 to the radius component 4 are preferred.
- the band is preferably formed from a fiber material and / or a plastic.
- the band 34 is preferably pretensioned in such a way that it applies a pretensioning force F which brings about a contact between the first joint surface 16 and the second joint surface 24. A lifting of the carpal component 6 from the radius component 4 can be avoided by the pretensioning force.
- the pretensioning force has a range from 0 N to 1000 N, preferably 5 N to 200 N, particularly preferably 100 N to 150 N.
- Embodiments that have a rigid band 34 are also preferred.
- a rigid band 34 has a high resistance to longitudinal expansion and thus counteracts its longitudinal expansion. The pretensioning force can be reduced or omitted, as a result of which frictional forces occurring between the first joint surface 16 and the second joint surface 24 are reduced. A slight gap between the first joint surface 16 and the second joint surface 24 is possible.
- embodiments of the invention with a second band running through a second tunnel are preferred (not shown).
- the second tunnel preferably runs perpendicular to the first tunnel 36, a first end of the second band being attached to a radius side 26 of the carpal component 6 and a second end of the second band being attached to an ulnar side 28 of the carpal component 6.
- the luxation protection 8 with two straps, the carpal component 6 can be prevented from slipping off the first joint surface 16.
- embodiments are preferred in which the head 12 does not have a tunnel (not shown). In such configurations, a first end 124 of the band 34 can be connected to the carpal part 6 and a second end 128 of the band 34 can be connected to the radius part 36.
- the further embodiments can have the same or similar features as the embodiment according to the example described, for which reason reference is made in full to the above description.
- the flow diagram shown in FIG. 8 illustrates a method for producing a wrist endoprosthesis 2.
- a non-individualized 3D model of a wrist endoprosthesis 2 is provided or produced.
- the non-individualized 3D model is preferably produced using computer-aided image processing programs and / or 3D CAD programs.
- Providing the non-individualized 3-D model can preferably have the following steps: selecting a suitable non-individualized 3-D model from a database and loading the selected non-individualized 3-D model into an image processing program and / or 3-D CAD program .
- a second step S2 data material, in particular x-ray images, ultrasound images, magnetic resonance tomography data, and / or computed tomography data, of a patient's wrist to be treated is recorded.
- the data material is preferably acquired at least in a first view parallel to the frontal plane E1 and in a second view parallel to the sagittal plane E2. Further views at an angle to the first and second view are preferably recorded.
- a 3D model of the wrist to be treated is preferably created from the magnetic resonance tomography data and / or computed tomography data.
- step S2a is preferably carried out: Acquisition of data material, in particular X-ray images, ultrasound images, magnetic resonance tomography data and / or computer tomography data, of the second wrist of a patient. Data material is preferably recorded that matches the data material from step S2, which is why reference is made in full to the above description. If information on both wrists of the treating patient is no longer available, step S2b is preferably carried out: providing data material for a statistical comparison group. The data material of the statistical comparison group can contain information equivalent to that of the data material recorded in steps S2 or S2a.
- the comparison group can include people of the same sex, same age, same height, same arm length, have the same hand size and / or the same anthropometric data. It should be understood that steps S2, S2a and S2b can also be carried out in combination.
- a first joint surface of the radius can be determined from x-ray images of the wrist to be treated and an angle of a second joint surface can be determined from data from a statistical comparison group.
- Alternative or supplementary data material can preferably be provided which is based on individual empirical values, simulation data, literature data, statistical models, anthropometric comparison data, anthropometric ratio calculations, geometric relationships, previous examinations of the patient and / or mathematically determined optima.
- step S3 is carried out in the method: determination of one or more parameters from the data material for approximating an approximated body structure of the patient from the data material.
- the parameters can be determined from the data material manually, partially or fully automatically, preferably based on image material or 3D models.
- the parameter determined from the data material can be at least one of the parameters from the following group of parameters: ulnar variance UV, thickness of the cortex, plane shape of the inner cavity of the radius, radius of the proximal carpal row in a sagittal plane and / or frontal plane, joint surface angle in one Sagittal plane and / or frontal plane, course of the mechanical forearm axis, curve course of the proximal and / or distal carpal row in a sagittal plane and / or frontal plane.
- the ulnar variance UV describes a length difference between the section of the distal end 136 of the radius 134 pointing towards the ulna 132 and the section of the distal end 138 of the ulna 132 of the arm to be treated pointing towards the radius 134. It is also possible to derive the course of the proximal and / or distal carpal row as an exact curve or to approximate this curve course as a radius or a curve course composed of several radii.
- the plane shape of the joint surfaces of the radial bone 134, the ulna 132 and / or the proximal carpal row can be derived exactly or approximately from the data material. The exact plane shape is preferably approximated by circular and / or elliptical fittings.
- the joint surfaces can be approximated by multi-axis convex, multi-axis concave or multi-axis convex-concave planes.
- an angle ⁇ is preferably determined between a straight line tangent to the distal end of the radius in the frontal plane and a straight line of the radius which is perpendicular to the longitudinal axis and lies in the frontal plane.
- an angle e between a straight line tangent to the distal end of the radius in the sagittal plane and a straight line to the longitudinal axis is also preferred of the radius perpendicular straight lines which lie in the sagittal plane.
- the parameters of the data material such as plane shapes and surface designs are preferably approximated.
- the approximation preferably includes at least the step: Rounding the determined variables to variables that can be processed in the method. It is further preferred to carry out step S1 following one of steps S2, S2a, S2b or S3.
- the non-individualized 3D model is individualized based on the derived parameters in order to obtain an individualized 3D model.
- Geometric properties of the non-individualized 3D model are preferably adapted to the approximated parameters.
- the angle o of the first joint surface is adjusted or approximated to the determined or approximated angle ⁇ .
- the angle ⁇ is preferably adjusted or approximated to the determined or approximated angle e.
- the length L1 and the taper of the shaft 10 are preferably adapted taking into account at least one of the determined or approximated sizes, thickness of the cortex, diameter of the radius of a patient, diameter ratio of the radius.
- first joint surface is preferably individualized in such a way that it corresponds to the exact or approximated distal surface of the radius of the patient to be treated.
- second joint surface is individualized in such a way that it corresponds to the approximated and / or exact curve shape of the proximal carpal row of the patient in the sagittal plane and / or frontal plane.
- step S5 Manufacture of the wrist endoprosthesis 2 by means of an additive manufacturing method based on the individualized 3D model.
- the additive manufacturing process is preferably one of the processes: Fused Deposition Modeling, Selective Laser Sintering, Selective Laser Melting, Electron Beam Melting, Laser Deposition Welding, Multi-Jet Modeling, Stereolithography, Laminated Object Modeling.
- Step S5 preferably comprises at least one of the steps: loading the individualized 3D model, generating the layer information of the individual layers based on the individualized 3D model, generating the layer information of the individual layers to be manufactured taking into account support structures, preparing the manufacturing machine and / or the Materials, layered construction of the wrist endoprosthesis 2, removal of the support structures, reworking of the upper and / or active surfaces, checking for damage and / or compliance with the individualized 3D model, completely or partially coating the wrist endoprosthesis with a coating material, preferably titanium.
- Part is particularly preferred of the shaft 10, which is arranged in the epiphysis 142 and / or the metaphysis 144 of the radius 134 as part of the implantation of the wrist endoprosthesis 2.
- the wrist endoprosthesis 2 is preferably made of a metal, fiber composite material and / or plastic, particularly preferably polyetheretherketone, cobalt-chromium alloys and / or titanium.
- Steps S3 and S4 of a preferred development of the method for producing a wrist endoprosthesis 2 will now be described with reference to FIG. 11 and FIG.
- the anterior-posterior view of the bone structure of a human wrist shown in FIG. 11 and the view of the bone structure of a human wrist in a sagittal plane shown in FIG. 12 were previously acquired in step S2.
- parameters P1 to P16 are determined, which preferably form a basis for an individualization of the shaft 10 of the radius component 4 carried out in step S4.
- the parameters P1 to P4 represent frontal radius diameters of the radius 134, which are parallel to one another and are determined perpendicular to a central axis of the radius 134 in the frontal plane E1.
- the frontal radius diameter P1 is preferably determined at the level of the distal end 138 of the ulna 132.
- a second frontal radius diameter P2 is preferably determined at a first transition 140 between an epiphysis 142 and a metaphysis 144 of the radius 134 and / or a third frontal radius diameter P3 is determined at a second transition 146 between the metaphysis 144 and a diaphysis 148 of the radius 134.
- a position of the fourth frontal radius diameter P4 is determined individually for each patient, based on the patient's bone structure. Further frontal radius diameters can preferably also be determined from the data material.
- the thickness of the cortex of the radius 134 is used as parameter P5 bis P8 determined.
- Sagittal radius diameters P9 to P12 of radius 134 and sagittal thicknesses of cortex P13 to P16 are preferably determined in an analogous manner from the bone structure in the sagittal plane (FIG. 12).
- the sagittal radius diameters P9 to P12 are preferably determined perpendicular to the frontal radius diameters P1 to P4. It is also preferred that the sagittal thicknesses of the cortex P13 to P16 are determined perpendicular to the frontal thicknesses of the cortex P5 to P8.
- the ulnar variance UV is determined as parameter P17 (not shown in FIG. 11).
- a width P18 of the proximal carpal row 150 in the frontal plane E1 and / or a width P19 of the proximal carpal row 150 in the sagittal plane E2 are preferably determined as parameters.
- the width P18 is preferably measured in a lateral-medial direction R1 from a most lateral end 152 of the proximal carpal row 150 to a most medial end 154 of the proximal carpal row 150.
- the width P19 is preferably measured in an anterior-posterior direction R2 from a most anterior end 156 of the proximal carpal row 150 to a most posterior end 158 of the proximal carpal row 150.
- a height P20 of the proximal carpal row, measured between a most distal end 160 of the proximal carpal row and a most proximal end 162 of the proximal carpal row is preferably a further parameter.
- a height of the carpal P21 is preferably determined between the most proximal end 162 and a most distal end 164 of a distal carpal row 166.
- a frontal joint line P24 preferably bisects a distance between the proximal carpal row 150 and the joint surfaces 168, 170 of the radius 134 and the ulna 132.
- a sagittal joint line P25 bisects a distance between the proximal carpal row 150 and the joint surface 168 of the radius 134 the frontal joint line P24 and / or the sagittal joint line P25 processed by an elliptical fitting and / or circular fitting.
- a real course of the joint line is approximated by one or more circles and / or one or more ellipses.
- the position of a longitudinal axis of the radius 134 in extension through a third metacarpal bone 172 is determined as the final parameter P26.
- the non-individualized 3D model of a wrist endoprosthesis 2 provided in step S1 is then individualized in step S4 based on the parameters P1 to P24.
- a diameter of the shaft 10 of the radius component 4 in the area of the connecting section 40 is individualized here based on the parameters P1, P5, P9 and P12.
- a diameter of the shaft 10 at the connecting section is preferred 40 individualized in the frontal plane in such a way that it corresponds to the difference between the frontal radius diameter P1 and the thickness of the cortex P5.
- a jamming allowance which is determined individually for each patient, is preferably added.
- the jamming allowance preferably has a range from 0% to 25%, particularly preferably 5% to 10%, of the frontal radius diameter P1.
- the jamming allowance is calculated based on the cavity. In the case of a single radius, an increase in the radius, in the case of an elliptical shape, correspondingly along the axes of the ellipse. Similarly, P13 is subtracted from P9 and a deadlock surcharge is added. The addition factor is preferably added symmetrically.
- a cross section of the shaft 10 in the area of the connecting section 40 is circular if a difference between P1 and P5 and P13 and P9 coincide, and elliptical if the differences between P1 and P5 and P13 and P9 differ.
- a diameter of the shaft 10 of the radius component 4 at the first transition 140, at the second transition 146 and in the region of the proximal shaft end 38 are preferably determined analogously from the parameters P2 to P4, P6 to P8, P10 to P12 and P14 to P16.
- the lateral surface 70 of the shaft 10 between the connecting section 40 and the first transition 140 to the metaphysis 144 preferably has a porous surface structure. Growing in of the shaft 10 into the radius 134 can be improved by a porous surface structure. Between the first transition 140 and the proximal shaft end 38, the lateral surface 70 of the shaft 10 is preferably smooth and / or polished. As a result, the insertion of the shaft 10 into the radius 134 can be facilitated in the course of treating a patient.
- the first joint surface 16 of the shaft 10 of the wrist endoprosthesis 2 is preferably aligned based on the parameters P22 and P23.
- the thickness D1 of the head 12 on the radius side 44 and the thickness D2 of the head 12 on the ulnar side 46 are particularly preferably adapted such that an ulnar variance UV disappears after an implantation of the radius component 4. It is also preferred that the ulnar variance UV of a natural wrist and the ulnar variance UV of a wrist fitted with a wrist endoprosthesis coincide.
- a shape of the first joint surface 16 is preferably adapted based on the frontal joint line P24 and / or sagittal joint line P25.
- the second maximum width B2 of the carpal component 6 is individualized based on the width P18 of the proximal carpal row 150.
- the clear width W1 at the distal end 106 of the carpal cavity 18 and the maximum Clear width W2 are individualized based on the width P19 of the proximal carpal row 150 in the sagittal plane E2.
- the length L2 of the carpal component 6 is preferably individualized in step S4 based on the height of the wrist P21.
- a height P20 of the proximal carpal row 150 can serve as a supplementary and / or stand-alone basis for the individualization of the length L2.
- the height P20 of the proximal carpal row 150 can preferably be used as a basis for customizing the depth T1 of the carpal component 6, the depth T2 of the bulge 112 and / or the thickness D8 at the proximal end 108 of the carpal component 6.
- a surcharge for individual adjustment in a range of 0% to 25%, particularly preferably 5% to 10%, of the height P20 and / or the height of the carpal P21 (carpal height) is preferably added.
- the second joint surface 24 is adapted based on the frontal joint line P24 and the sagittal joint line P25.
- the radius component 4 and the carpal component 6 are then aligned with one another, the radius component 4 and / or the carpal component 6 preferably being arranged perpendicular to the determined position P26 of the longitudinal axis through the radius 134 and the third metacarpal bone 172.
- the wrist endoprosthesis 2 is then produced in the fifth step S5.
- FIG. 13 a to c illustrate an individualized 3D model 174 of a carpal component 6 or an adapted anatomy-facing side 176 of the individualized 3D model 174 of a carpal component 6 of a wrist endoprosthesis 2.
- An outer side 178 of the 3D model 174 is in a view from FIG distal to proximal (FIG. 13a) oval. In this way, irritation of the tissue surrounding the later wrist endoprosthesis 2 can be prevented.
- the anatomy-facing side 176 of the individualized 3D model 174 which here is the inner surface 98 of the carpal component 6, has been adapted to the patient-specific anatomy.
- the anatomy-facing side 176 has several elevations 178a, 178b, 178c which correspond to depressions of ligamentous connections of the wrist to be treated (not shown).
- a first elevation 178a here corresponds to a ligamentous connection between the triangular bone and the lunar bone.
- a second elevation 178b corresponds to a ligamentous connection between the lunar bone and the navicular bone.
- a third elevation corresponds to a ligamentous connection between the navicular bone and the small polygonal bone.
- Figure 13b illustrates a view of the individualized 3D model 174 in the radial-ulnar direction.
- the outside 178 is substantially U-shaped in this view.
- Section lines of the anatomy-facing side 176 which are also illustrated by means of lines 180a, 180b, are essentially U-shaped.
- a height of the elevation 178a is greater than a height of the elevation 178b, so that a depth of the u-shape formed by line 180a is less than a depth of the u-shape formed by line 180b.
- the entire anatomy-facing side 174 represents a negative shape 182 of the anatomy, in particular of the bony structure, of the wrist to be treated.
- the remaining inner surface 98 is also adapted to the anatomy of the wrist to be treated (cf. FIGS. 13a, 13b).
- the elevations 178a, 178b, 178c can engage in corresponding depressions between the carpal bones and prevent the implanted wrist endoprosthesis 2 from slipping.
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Abstract
Description
Claims
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Application Number | Priority Date | Filing Date | Title |
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DE102019114314.4A DE102019114314A1 (de) | 2019-05-28 | 2019-05-28 | Handgelenksendoprothese |
PCT/EP2020/064595 WO2020239777A1 (de) | 2019-05-28 | 2020-05-26 | Handgelenksendoprothese |
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EP3975904A1 true EP3975904A1 (de) | 2022-04-06 |
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EP20728731.9A Pending EP3975904A1 (de) | 2019-05-28 | 2020-05-26 | Handgelenksendoprothese |
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US (1) | US20220233325A1 (de) |
EP (1) | EP3975904A1 (de) |
DE (1) | DE102019114314A1 (de) |
WO (1) | WO2020239777A1 (de) |
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Publication number | Priority date | Publication date | Assignee | Title |
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US8480754B2 (en) * | 2001-05-25 | 2013-07-09 | Conformis, Inc. | Patient-adapted and improved articular implants, designs and related guide tools |
US6383223B1 (en) * | 1997-06-18 | 2002-05-07 | BAEHLER ANDRé | Endoprosthesis for a joint, especially a finger, toe or wrist joint |
EP1195150A1 (de) * | 2000-09-22 | 2002-04-10 | Ceramtec AG Innovative Ceramic Engineering | Fingergrundgelenksimplantat |
US8052756B2 (en) * | 2002-10-24 | 2011-11-08 | Biomet Manufacturing Corp. | Method and apparatus for wrist arthroplasty |
US8105388B2 (en) * | 2002-10-24 | 2012-01-31 | Biomet Manufacturing Corp. | Method and apparatus for wrist arthroplasty |
DK2059194T3 (da) * | 2006-08-22 | 2014-11-03 | New York Soc Ruptured & Crippled Maintaining Hospital For Special Surgery | Håndledsimplantater |
EP2976045B1 (de) * | 2013-03-21 | 2021-06-23 | ConforMIS, Inc. | Herstellungsverfahren und vorrichtungen in verbindung mit patientenadaptierten hüftgelenkimplantaten |
WO2016090093A1 (en) * | 2014-12-04 | 2016-06-09 | Shin James | System and method for producing clinical models and prostheses |
EP3170477B1 (de) * | 2015-11-22 | 2020-02-19 | Medartis Holding AG | Kahnbeinprothese |
WO2017120645A1 (en) * | 2016-01-15 | 2017-07-20 | Field Orthopaedics Pty Ltd | A joint stabilisation method and apparatus |
US20190201207A1 (en) * | 2016-09-19 | 2019-07-04 | Guilherme Giusti | Proximal carpal row implant |
US10918488B2 (en) * | 2017-05-14 | 2021-02-16 | Orthopedix, Inc. | Intercarpal surgical implant |
US11166822B2 (en) * | 2017-09-08 | 2021-11-09 | Orthopedix, Inc. | Implant for total wrist replacement |
-
2019
- 2019-05-28 DE DE102019114314.4A patent/DE102019114314A1/de active Pending
-
2020
- 2020-05-26 EP EP20728731.9A patent/EP3975904A1/de active Pending
- 2020-05-26 WO PCT/EP2020/064595 patent/WO2020239777A1/de unknown
- 2020-05-26 US US17/614,448 patent/US20220233325A1/en active Pending
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DE102019114314A1 (de) | 2020-12-03 |
WO2020239777A1 (de) | 2020-12-03 |
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