# US 10,864,314 B2 · Knee spacer system with irrigation device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,864,314 B2 - Document ID: US10864314B2 - Status: Granted - Kind: B2 - Application number: 16/359,471 - Filed: 2019-03-20 - Published: 2019-09-26 - Granted: 2020-12-15 - Earliest claimed: 2018-03-21 - Assignees: Heraeus Medical GmbH - Applicants: Heraeus Medical GmbH - Inventors: Sebastian Vogt; Thomas Kluge - Web page: https://patentgrep.com/patent/US10864314B2 ## CPC - A61F 2/3859: {Femoral components} - A61F 2/389: {Tibial components (A61F2/3868 takes precedence)} - A61F 2/4684: {Trial or dummy prostheses} - A61M 3/0283: {with at least two inner passageways, a first one for irrigating and a second for evacuating (suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92)} - A61M 39/24: Check- or non-return valves - A61F 2/4675: {for cleaning or coating bones, e.g. bone cavities, prior to endoprosthesis implantation or bone cement introduction (for cleaning teeth cavities A61C17/00; irrigators A61M3/02)} - A61F 2002/30672: {temporary} - A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body} - A61F 2002/3068: {the pharmaceutical product being in a reservoir} - A61F 2002/30691: {Drainage means, e.g. for evacuating blood or other fluids} - A61F 2002/30784: {Plurality of holes} - A61F 2002/30878: {with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts} - A61F 2002/4615: {of spacers} - A61F 2002/4631: {the prosthesis being specially adapted for being cemented} - A61M 1/77: {Suction-irrigation systems (aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463)} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 2039/2433: {Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc} - A61M 2039/248: {Ball-valve} - A61M 2205/04: implanted - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Disclosed herein is a temporary knee spacer system for the temporary replacement of a knee joint, which is designed for the interim phase of two-stage septic revisions of knee joint total endoprostheses. The knee spacer system can be used in particular with two-phase septic revisions with which two or more microbial germs are the cause of an infection of the knee joint total endoprosthesis and the surrounding tissue. ## Claims ### Claim 1 A knee spacer system for the temporary replacement of a knee joint, the knee spacer system comprising: a tibia component, wherein the tibia component has a tibia prosthetic body, wherein the tibia prosthetic body has two running surfaces on a proximal side of the tibia component and at least one mounting surface for mounting the tibia component on a tibia on a distal side of the tibia prosthetic body; a first tubular and fluid-permeable connecting means for feeding a medical irrigation fluid into the tibia prosthetic body; a second tubular and fluid-permeable connecting means for draining a medical irrigation fluid from the tibia prosthetic body; an irrigation fluid inlet opening in a surface of the tibia prosthetic body, wherein the first connecting means is connected or connectable in a fluid-permeable manner to the irrigation fluid inlet opening; an irrigation fluid outlet opening in the surface of the tibia prosthetic body, wherein the second connecting means is connected or connectable in a fluid-permeable manner to the irrigation fluid outlet opening; at least one irrigation fluid exit opening in the surface of the tibia prosthetic body, which is connected in the interior of the tibia prosthetic body with the irrigation fluid inlet opening in a fluid-permeable manner; and at least one irrigation fluid entry opening in the surface of the tibia prosthetic body, which is connected in the interior of the tibia prosthetic body with the irrigation fluid outlet opening in a fluid-permeable manner, wherein the at least one irrigation fluid exit opening and the at least one irrigation fluid entry opening are arranged outside the at least one mounting surface, and wherein the at least one irrigation fluid exit opening in the interior of the prosthetic body is not connected in a fluid-permeable manner with the irrigation fluid outlet opening and the at least one irrigation fluid entry opening in the interior of the prosthetic body is not connected with the irrigation fluid inlet opening in a fluid-permeable manner. ### Claim 2 (depends on 1) The knee spacer system of claim 1, wherein the at least one mounting surface is bound by a surrounding ridge that rises from the surface of the tibia prosthetic body, so that the at least one mounting surface is suitable for holding bone cement paste within the ridge. ### Claim 3 (depends on 1) The knee spacer system of claim 1, wherein the tibia component has at least two irrigation fluid exit openings and at least two irrigation fluid entry openings in the surface of the tibia prosthetic body, which are arranged on different sides of the tibia prosthetic body. ### Claim 4 (depends on 3) The knee spacer system of claim 3, wherein an irrigation fluid exit opening and an irrigation fluid entry opening are arranged on the proximal side of the tibia prosthetic body and an irrigation fluid exit opening and an irrigation fluid entry opening are arranged on the distal side of the tibia prosthetic body. ### Claim 5 (depends on 1) The knee spacer system of claim 1, wherein the at least one irrigation fluid exit opening and the at least one irrigation fluid entry opening are spaced apart from each other in pairs, wherein the space between each pair of the at least one irrigation fluid exit opening and the at least one irrigation fluid entry opening is at least 5 mm, preferably at least 20 mm and particularly preferably, at least 30 mm. ### Claim 6 (depends on 1) The knee spacer system of claim 1, wherein the first connecting means on the side facing away from the connection with the irrigation fluid inlet opening and the second connecting means on the side facing away from the connection with the irrigation fluid outlet opening each has one adapter, in particular each has a Luer lock adapter. ### Claim 7 (depends on 1) The knee spacer system of claim 1, wherein at the irrigation fluid inlet opening in the interior of the tibia prosthetic body or on the surface of the tibia prosthetic body, a self-sealing coupling is arranged, and at the irrigation fluid outlet opening in the interior of the tibia prosthetic body or on the surface of the tibia prosthetic body, a self-sealing coupling is arranged, wherein the first connecting means is detachably connected or connectable with the irrigation fluid inlet opening and the second connecting means is detachably connected or connectable with the irrigation fluid outlet opening. ### Claim 8 (depends on 1) The knee spacer system of claim 1, wherein the irrigation liquid inlet opening is a first irrigation liquid inlet opening, and the irrigation liquid outlet opening is a first irrigation liquid outlet opening, wherein additionally, a second irrigation liquid inlet opening and a second irrigation liquid outlet opening are provided in the surface of the tibia prosthetic body, wherein at each of the first irrigation liquid inlet opening, the second irrigation liquid inlet opening, the first irrigation liquid outlet opening and the second irrigation liquid outlet opening, one self-sealing coupling is arranged, wherein the first connecting means is connectable in a fluid-tight and detachable manner with the first irrigation liquid inlet opening and with the second irrigation liquid inlet opening, and the second connecting means is connectable in a fluid-tight and detachable manner with the first irrigation liquid outlet opening and with the second irrigation liquid outlet opening, wherein the first irrigation liquid inlet opening and the second irrigation liquid inlet opening are connected in a fluid-permeable manner with each other in the tibia prosthetic body, and the first irrigation liquid outlet opening and the second irrigation liquid outlet opening are connected in a fluid-permeable manner with each other in the tibia prosthetic body. ### Claim 9 (depends on 8) The knee spacer system of claim 8, wherein the first irrigation liquid inlet opening and the first irrigation liquid outlet opening are arranged on a first side of the tibia component in relation to a sagittal plane, and the second irrigation liquid inlet opening and the second irrigation liquid outlet opening is arranged on a second side of the tibia component in relation to the sagittal plane. ### Claim 10 (depends on 9) The knee spacer system of claim 9, wherein the first irrigation liquid inlet opening and the first irrigation liquid outlet opening are arranged in relation to the sagittal plane in a mirror-inverted manner to the second irrigation liquid inlet opening and to the second irrigation liquid outlet opening in the surface of the tibia prosthetic body. ### Claim 11 (depends on 1) The knee spacer system of claim 1, wherein a cross-sectional area of the at least one irrigation liquid entry opening is at least just as large as a cross-sectional area of the irrigation liquid inlet opening. ### Claim 12 (depends on 1) The knee spacer system of claim 1, wherein the total of cross-sectional areas of the at least one irrigation liquid exit opening is at least just as large as a cross-sectional area of the irrigation liquid outlet opening. ### Claim 13 (depends on 1) The knee spacer system of claim 1, wherein the at least one irrigation liquid exit opening and the at least one irrigation liquid entry opening are separated from the at least one mounting surface by a surrounding ridge that rises from the surface of the prosthetic body. ### Claim 14 (depends on 1) The knee spacer system of claim 1, wherein at least one irrigation fluid exit opening of the at least one irrigation fluid exit opening and/or at least one irrigation fluid entry opening of the least one irrigation fluid entry opening is or are arranged between the running surfaces. ### Claim 15 (depends on 1) The knee spacer system of claim 1, wherein the at least one irrigation fluid exit opening and the at least one irrigation fluid entry opening are arranged outside the running surfaces. ### Claim 16 (depends on 1) The knee spacer system of claim 1, wherein one irrigation fluid exit opening of the at least one irrigation fluid exit opening and one irrigation fluid entry opening of the least one irrigation fluid entry opening are arranged adjacent to one of the running surfaces, preferably within 3 mm adjacent to one of the running surfaces. ### Claim 17 (depends on 1) The knee spacer system of claim 1, wherein in the first connecting means or in the irrigation fluid inlet opening, a first valve element is arranged that prevents a return flow of the irrigation fluid into the first connecting means. ### Claim 18 (depends on 1) The knee spacer system of claim 1, wherein in the second connecting means or in the irrigation fluid outlet opening, a second valve element is arranged that prevents a return flow of the irrigation fluid into the second connecting means. ### Claim 19 (depends on 18) The knee spacer system of claim 18, wherein the first and second valve element are selected from a non-return valve, a ball valve with spring, a lip valve, a Bunsen valve or a plate valve. ### Claim 20 (depends on 1) The knee spacer system of claim 1, wherein in a first line within the tibia prosthetic body, which connects the at least one irrigation fluid entry opening with the irrigation fluid outlet opening in a fluid-permeable manner, a first valve is arranged which can only be opened by applying negative pressure to the irrigation fluid outlet opening, and which prevents a return flow of the irrigation fluid into the first line. ### Claim 21 (depends on 1) The knee spacer system of claim 1, wherein in a second line within the tibia prosthetic body, which connects the at least one irrigation fluid exit opening with the irrigation fluid inlet opening in a fluid-permeable manner, a second valve is arranged which can only be opened by applying negative pressure to the irrigation fluid inlet opening, and which prevents a return flow of the irrigation fluid into the second line. ### Claim 22 (depends on 1) The knee spacer system of claim 1, wherein in the tibia prosthetic body, the irrigation fluid inlet opening, the irrigation fluid outlet opening, the at least one irrigation fluid exit opening and the at least one irrigation fluid entry opening and the fluid-permeable connections are formed. ### Claim 23 (depends on 1) The knee spacer system of claim 1, wherein the tibia prosthetic body is preferably made of plastic, metal, ceramic, glass ceramic, bone cement or a combination of these. ### Claim 24 (depends on 1) The knee spacer system of claim 1, wherein the irrigation fluid inlet opening and the irrigation fluid outlet opening are arranged in a side surface of the tibia prosthetic body or on a lateral side surface of the tibia prosthetic body. ### Claim 25 (depends on 1) The knee spacer system of claim 1, wherein at least one first irrigation fluid exit opening of the at least one irrigation fluid exit opening is arranged on the proximal side in the surface of the tibia prosthetic body, and at least one second irrigation fluid exit opening of the at least one irrigation fluid exit opening is arranged on the distal side in the surface of the tibia prosthetic body, and at least one first irrigation fluid entry opening of the at least one irrigation fluid entry opening is arranged on the proximal side in the surface of the tibia prosthetic body, and at least one second irrigation fluid entry opening of the at least one irrigation fluid entry opening is arranged on the distal side in the surface of the tibia prosthetic body. ### Claim 26 (depends on 1) The knee spacer system of claim 1, wherein the knee spacer system has a femur component, wherein the femur component has two condyles on one distal side. ### Claim 27 (depends on 26) The knee spacer system of claim 26, wherein the femur component has a femur prosthetic body, wherein the femur prosthetic body has at least one mounting surface for mounting the femur component with a bone cement to a femur on one proximal side of the femur prosthetic body, the femur component further comprising: a third tubular and fluid-permeable connecting means for feeding a medical irrigation fluid into the femur prosthetic body; a fourth tubular and fluid-permeable connecting means for draining a medical irrigation fluid from the femur prosthetic body; an irrigation fluid inlet opening in a surface of the femur prosthetic body, wherein the third connecting means is connected or connectable in a fluid-permeable manner to the irrigation fluid inlet opening of the femur prosthetic body; an irrigation fluid outlet opening in a surface of the femur prosthetic body, wherein the fourth connecting means is connected or connectable in a fluid-permeable manner to the irrigation fluid outlet opening of the femur prosthetic body; at least one irrigation fluid exit opening in the surface of the femur prosthetic body, which is connected in the interior of the femur prosthetic body with the irrigation fluid inlet opening of the femur prosthetic body in a fluid-permeable manner; and at least one irrigation fluid entry opening in the surface of the femur prosthetic body, which is connected in the interior of the femur prosthetic body with the irrigation fluid outlet opening of the femur prosthetic body in a fluid-permeable manner, wherein the at least one irrigation fluid exit opening of the femur prosthetic body and the at least one irrigation fluid entry opening of the femur prosthetic body are arranged outside the at least one mounting surface of the femur prosthetic body. ### Claim 28 (depends on 27) The knee spacer system of claim 27, wherein the at least one irrigation fluid exit opening of the femur prosthetic body and the at least one irrigation fluid entry opening of the femur prosthetic body are arranged outside the condyles of the femur prosthetic body. ### Claim 29 (depends on 1) The knee spacer system of claim 1, wherein at least one irrigation fluid exit opening of the at least one irrigation fluid exit opening or at least one irrigation fluid entry opening of the least one irrigation fluid entry opening is arranged on a distal side of a protrusion extending in the distal direction between two mounting surfaces of the tibia component.