# US 11,998,451 B2 · Device and method for producing spacers > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,451 B2 - Document ID: US11998451B2 - Status: Granted - Kind: B2 - Application number: 17/205,221 - Filed: 2021-03-18 - Published: 2021-09-23 - Granted: 2024-06-04 - Earliest claimed: 2020-03-20 - Assignees: Heraeus Medical GmbH - Applicants: Heraeus Medical GmbH - Inventors: Sebastian Vogt; Thomas Kluge - Web page: https://patentgrep.com/patent/US11998451B2 ## CPC - A61F 2/3094: {Designing or manufacturing processes} - A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques} - A61F 2/30724: {Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity} - A61F 2/32: for the hip - A61F 2/36: Femoral heads {; Femoral endoprostheses} - A61F 2/3609: {Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts (A61F2/3601 takes precedence)} - A61F 2/3662: {Femoral shafts} - A61F 2/40: for shoulders - A61F 2/4014: {Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts} - A61F 2/4059: {Humeral shafts} - B29C 45/34: having venting means - A61F 2002/30672: {temporary} - A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body} - A61F 2002/30957: {using a positive or a negative model, e.g. moulds} - A61F 2310/00353: Bone cement, e.g. polymethylmethacrylate or PMMA - B29C 45/0001: {characterised by the choice of material} - B29K 2033/12: {Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate} - 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 (dental prosthetics A61C) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS ## Abstract The invention relates to a device for producing a spacer having a casting mold with at least one filling opening, a valve seat, which is connected to the casting mold, wherein the valve seat has an regionally closed head side with at least one first feed-through, a valve body which is mounted so as to be rotatable relative to the valve seat and which has a sealing face, wherein at least one second feed-through is arranged in the sealing face, wherein the valve seat and the valve body together form a valve, wherein the valve is reversibly transferable into an open position and a closed position by rotation of the valve body relative to the valve seat, wherein, in the open position of the valve, the at least one first feed-through of the valve seat and the at least one second feed-through of the valve body are located above one another at least in places and provide a permeable connection through the valve into the casting mold, wherein, in the closed position of the valve, the at least one first feed-through of the valve seat is covered by the sealing face of the valve body, wherein, in the closed position of the valve, the at least one filling opening of the casting mold is covered and wherein the valve is connected on the side remote from the casting mold to a port for liquid-tight connection of a bone cement cartridge or the valve has such a port. The invention also relates to a method for producing spacers using such a device. ## Claims ### Claim 1 A device for producing a spacer by curing bone cement paste, wherein the spacer is provided in the medical field for replacing a joint or part of a joint comprising an articulating surface of the joint, or for replacing a hip joint or a shoulder joint, the device having a casting mold for molding the spacer from bone cement paste, the casting mold having at least one filling opening for introducing the bone cement paste; a valve seat, the valve seat being connected to the casting mold in the region of the at least one filling opening, wherein the valve seat has, at least in places, a closed head side with at least one first feed-through, wherein the at least one first feed-through opens into the at least one filling opening; a valve body mounted so as to be rotatable relative to the valve seat and which has a sealing face, wherein the sealing face is oriented in the direction of the closed head side of the valve seat, wherein at least one second feed-through is arranged in the sealing face; wherein the valve seat and the valve body together form a valve, wherein the valve is reversibly transferable into an open position and into a closed position by rotation of the valve body relative to the valve seat, wherein, in the open position of the valve, the at least one first feed-through of the valve seat and the at least one second feed-through of the valve body are located above one another at least in places and provide a connection permeable to bone cement through the valve into the casting mold, wherein, in the closed position of the valve, the at least one first feed-through of the valve seat is covered by the sealing face of the valve body, wherein, in the closed position of the valve, the at least one filling opening of the casting mold is covered and closed for bone cement paste and wherein the valve is connected on the side remote from the casting mold to a port for liquid-tight connection of a bone cement cartridge or the valve has the port, and wherein at least one vent opening is provided in the casting mold, through which air or gas can escape from the interior of the casting mold. ### Claim 2 (depends on 1) The device according to claim 1, characterized in that the valve seat is connected to the casting mold so as not to be rotatable relative to the casting mold, and is rigidly connected to the casting mold. ### Claim 3 (depends on 1) The device according to claim 1, characterized in that the valve is manually operable from outside the device, wherein the valve body is manually rotatable relative to the valve seat and the valve is transferable by rotation from the closed position into the open position and from the open position into the closed position. ### Claim 4 (depends on 1) The device according to claim 1, characterized in that, in the closed position of the valve, the at least one first feed-through of the valve seat is covered by the sealing face of the valve body, wherein the closed head side of the valve seat and the sealing face of the valve body are spaced apart from one another by a maximum of 2 mm. ### Claim 5 (depends on 1) The device according to claim 1, characterized in that the valve body is mounted so as to be rotatable about an axis of rotation relative to the valve seat, wherein the axis of rotation extends perpendicular to the sealing face of the valve body or wherein the axis of rotation extends along an axis of rotational symmetry of the sealing face of the valve body. ### Claim 6 (depends on 1) The device according to claim 1, characterized in that the valve body has the port for liquid-tight connection of a bone cement cartridge or is firmly connected to such a port. ### Claim 7 (depends on 1) The device according to claim 1, characterized in that the device has an adapter element which is connected or connectable to the bone cement cartridge, wherein the adapter element is detachably and interlockingly connected or connectable to the port, such that an interior of the bone cement cartridge is connected or connectable permeably for bone cement paste via the adapter element to the at least one second feed-through in the valve body. ### Claim 8 (depends on 1) The device according to claim 1, characterized in that the device comprises the bone cement cartridge for mixing bone cement starting components and for delivering mixed bone cement paste from the bone cement cartridge or comprises the bone cement cartridge for mixing polymethyl methacrylate bone cement starting components and for delivering mixed polymethyl methacrylate bone cement paste from the bone cement cartridge, wherein the bone cement cartridge contains the bone cement starting components for producing the bone cement in mutually separate regions. ### Claim 9 (depends on 1) The device according to claim 1, characterized in that the casting mold consists of a plastics film or the casting mold is constructed from two or more plastics films, which are welded or adhesively bonded together, and wherein the casting mold is fabricated from PETG film and/or polyamide film and/or PE film. ### Claim 10 (depends on 1) The device according to claim 1, characterized in that a sum of all the openings of the at least one first feed-through in the closed head side is at most as large as the closed surface of the head side and a sum of all the openings of the at least one second feed-through in the sealing face is at most as large as the closed surface of the sealing face. ### Claim 11 (depends on 1) The device according to claim 1, characterized in that the valve seat has an inner thread on an inside and the valve body has a matching outer thread on an outside, such that the valve body is able to be screwed into the valve seat. ### Claim 12 (depends on 11) The device according to claim 11, characterized in that the inner thread in the valve body or the outer thread on the valve body is a right-hand thread and the valve is transferable from the closed to the open position by equidirectional rightward rotation of the valve body and the valve is transferable from the open to the closed position by contradirectional leftward rotation of the valve body or the inner thread in the valve body or the outer thread on the valve body is a left-hand thread and the valve is transferable from the closed to the open position by equidirectional leftward rotation of the valve body and the valve is transferable from the open to the closed position by contradirectional rightward rotation of the valve body or the inner thread of the valve seat and the inner thread and the outer thread of the valve body are all left-hand threads or all right-hand threads, wherein an outer thread of an adapter element also has the same direction of rotation for liquid-tight connection of the bone cement cartridge to the port. ### Claim 13 (depends on 1) The device according to claim 1, characterized in that the port comprises, for liquid-tight connection of the bone cement cartridge, an inner thread in the valve body or an outer thread on the valve body, wherein an adapter element of the bone cement cartridge or on the bone cement cartridge has a mating thread matching the inner thread or the outer thread. ### Claim 14 (depends on 1) The device according to claim 1, characterized in that the at least one first feed-through in the closed head side has the same size and shape as the at least one second feed-through in the sealing face and/or the at least one first feed-through in the closed head side is two first feed-throughs and the at least one second feed-through in the sealing face is two second feed-throughs. ### Claim 15 (depends on 1) The device according to claim 1, characterized in that a collar is arranged on the sealing face of the valve body, and the collar rests on an edge of the valve seat or the collar is arranged on the closed head side of the valve seat and rests on an edge of the valve body. ### Claim 16 (depends on 1) The device according to claim 1, characterized in that a lever is arranged on the valve body, wherein the lever has a radial extent with regard to an axis of rotation of the valve body, wherein the lever projects through an orifice in the casting mold or in the valve seat, wherein the orifice in the casting mold is optionally arranged in the region of the connection to the valve seat, wherein the orifice is dimensioned such that the valve may be transferred from the open position into the closed position and vice versa by rotation of the valve body in the valve seat by means of the lever, and wherein the orifice is dimensioned such that the valve body may be rotated by a maximum of 90° relative to the valve seat. ### Claim 17 (depends on 1) The device according to claim 1, characterized in that the valve body and the valve seat are fabricated of plastic, or of a thermoplastic, wherein the valve seat is adhesively bonded or welded to a wall of the casting mold. ### Claim 18 (depends on 1) The device according to claim 1, characterized in that the casting mold has at least three cavities, starting from an inner chamber of the casting mold, for receiving retaining pins, wherein the casting mold comprises two parts and the cavities are arranged in edges or flanges of at least one part of the two-part casting mold; or the casting mold has four cavities, starting from an inner chamber of the casting mold, for receiving retaining pins, wherein the casting mold comprises two parts and the cavities are arranged in edges or flanges of at least one part of the two-part casting mold. ### Claim 19 (depends on 1) The device according to claim 1, characterized in that the device has a metal core for arrangement in the casting mold, wherein the metal core has bores for receiving retaining pins, wherein the bores are not arranged in a region of the casting mold for molding a sliding surface of the spacer, the bores being arranged in a region of the casting mold for molding a stem of the spacer. ### Claim 20 (depends on 1) The device according to claim 1, characterized in that at least one of the at least one vent opening is arranged in a region of the casting mold which forms a sliding surface or a joint head of the spacer. ### Claim 21 (depends on 1) The device according to claim 1, characterized in that the at least one first feed-through in the in areas closed head side is two first feed-throughs and the at least one second feed-through in the sealing face is two second feed-throughs, wherein the two first feed-throughs are arranged in the valve seat in quadrants arranged opposingly with regard to the axis of rotation of the valve body and the two second feed-throughs are arranged in the sealing face in quadrants arranged opposingly with regard to an axis of rotation of the valve body. ### Claim 22 (depends on 1) A method for producing a spacer for replacing a joint or part of a joint, in particular a hip joint or a shoulder joint, comprising an articulating surface of the joint, wherein the method is carried out with the device according to claim 1, the method having the following chronological steps: A) connecting a bone cement cartridge to the port of the device in liquid-tight manner; B) injecting bone cement paste from the bone cement cartridge through the valve in the open position into the casting mold; C) rotating the valve body relative to the valve seat and so transferring the valve into the closed position and shearing off the bone cement paste at the at least one first feed-through in the closed head side of the valve seat by rotating the valve body relative to the valve seat; D) detaching the bone cement cartridge from the port; E) curing the bone cement paste in the casting mold; and F) removing the resultant molded and cured spacer from the casting mold. ### Claim 23 (depends on 22) The method according to claim 22, characterized in that the following intermediate steps proceed after step D) and before step E): D2) connecting a new bone cement cartridge to the port of the device in liquid-tight manner, wherein bone cement paste or starting components for producing the bone cement paste is/are present in the new bone cement cartridge; D3) rotating the valve body relative to the valve seat and so transferring the valve into the open position; D4) injecting the bone cement paste from the new bone cement cartridge through the valve in the open position into the casting mold; D5) rotating the valve body relative to the valve seat and so transferring the valve into the closed position and shearing off the bone cement paste at the at least one first feed-through in the closed head side of the valve seat by rotating the valve body relative to the valve seat; and D6) detaching the new bone cement cartridge from the port. ### Claim 24 (depends on 22) The method according to claim 22, characterized in that the bone cement paste is mixed before step B), in the bone cement cartridge from a monomer liquid and a cement powder, wherein, optionally before step D3) and before step D2), the bone cement paste is mixed in the new bone cement cartridge from a monomer liquid and a cement powder. ### Claim 25 (depends on 22) The method according to claim 22, characterized in that the bone cement cartridge and/or the new bone cement cartridge is screwed into the port for liquid-tight connection of the bone cement cartridge and/or the new bone cement cartridge to the port and, for detaching the bone cement cartridge and/or the new bone cement cartridge from the port, the bone cement cartridge or the new bone cement cartridge is unscrewed from the port. ### Claim 26 (depends on 22) The method according to claim 22, characterized in that the valve body is rotated relative to the valve seat by screwing the valve body in the valve seat or by manually rotating the valve body relative to the valve seat, wherein manual rotation proceeds by operation of a lever extending radially away from the valve body and extending through an orifice in the casting mold or in the valve seat. ### Claim 27 (depends on 22) The method according to claim 22, characterized in that injection of the bone cement paste from the bone cement cartridge or the new bone cement cartridge proceeds by pushing a piston into an interior of the bone cement cartridge. ### Claim 28 (depends on 22) The method according to claim 22, characterized in that a metal core is arranged within the casting mold before step B), wherein the metal core is spaced from an internal wall of the casting mold via a plurality of retaining pins, wherein the plurality of retaining pins are fastened in bores in the metal core and in cavities for receiving retaining pins in the internal wall of the casting mold. ### Claim 29 (depends on 23) The method according to claim 23, characterized in that steps D2) to D6) are repeated once or multiple times with in each case new bone cement cartridges which contain bone cement paste or the starting components thereof until the casting mold is filled completely or as required with bone cement paste.