Spacer for controlled administration of the active ingredient

Abstract

The present invention provides an embedded spacer for delivering medical fluids to a patient. [Solution] The present invention relates to an implantable spacer 100 for delivering medical fluid to a patient, wherein the spacer has an outer surface 104 and a plurality of delivery valves 110 arranged on the outer surface, each of which is fluidically connected to one another by channels 101 located within the implant, and the delivery valves are designed and configured to open reversibly in response to the pressure of the fluid in the channels in order to deliver fluid from the delivery valves.

Description

Technical Field

[0001] The present invention relates to a spacer for repeated or continuous local release of an active ingredient. Further, a procedure for local release of an active ingredient is described.

[0002] The term "spacer" typically refers to an orthopedic implant that can be implanted into a patient as a temporary placeholder after previous debridement of an infected tissue. The spacer can be modeled to the shape of the hip and knee joints or other joints, or can have the shape of an intramedullary nail for use particularly in infected long bones. Another application of the spacer is to calm infections by local release of an antibacterial active ingredient in previously debrided bone and soft tissue. Conventional spacers are usually made of PMMA bone cement and contain one or more antibiotics embedded within the spacer material. These antibacterial active ingredients are released from the PMMA bone cement after implantation by exposure to aqueous fluids such as wound exudate and blood. The release of the active ingredient occurs through a diffusion process, resulting in an initial release of a large amount of the active ingredient followed by a release of a small amount of the active ingredient. However, it is more desirable to temporarily release a sufficiently high amount of the active ingredient in a constant manner to ensure a consistent local concentration of the active ingredient over a period of several days to several weeks.

[0003] European Patent No. 3763335 (B1) describes a knee joint for drug release that has a supply line for an active ingredient solution and the active ingredient solution can reach a plurality of outlet openings via a channel system. The problem here is that the openings located in the immediate vicinity of the supply line release a larger amount of liquid while the more distant outlet openings can release only a small amount of liquid or no liquid at all. Further, coagulated blood or ingrown connective tissue can clog the outlet openings.

[0004] A similar knee joint spacer system is disclosed in U.S. Patent No. 10864314 (B2).

[0005] International Publication No. 2016 / 205077 describes a spacer with a rinsing function, in which the rinsing liquid is guided along the spacer surface through grooves on the spacer surface.

[0006] European Patent No. 3542759(B1) proposes a similar spacer system having an outlet opening and an opening for discharging rinse fluid.

[0007] Intramedullary nails intended to suppress infections were also disclosed. These intramedullary nails have a perforated wall with an opening. An antibiotic or disinfectant solution can be introduced into the intramedullary nail from outside the patient through a connected tube (U.S. Patent No. 5,681,289(A), Chinese Patent No. 2,857,862(Y), Chinese Patent No. 2013,706,24(Y), International Publication No. 2016 / 205077(A1)). The antibiotic or disinfectant solution exits through an opening in the wall of the intramedullary nail. Problems with these concepts are that the opening can become clogged with clotted blood, and that the opening can be partially or completely closed after several days by internally growing connective tissue. A further problem is that the antibiotic or disinfectant solution tends to leak from the opening of the intramedullary nail located immediately next to the tube connector. Since the solution exits the intramedullary nail via the shortest path behind the introduction tube, only a small amount of antibiotic or disinfectant is released through openings further away from the introduction tube. Therefore, there is no guarantee that a consistent volume of antibiotic or disinfectant solution will be released along the entire length of the intramedullary nail.

[0008] Preferred Embodiment The object of the present invention is to solve one or more of the problems described above and further problems of the prior art.

[0009] The present invention is particularly based on the objective of providing a spacer that enables repeated or continuous release of an active ingredient on the outer surface of the spacer over a period of several days to several weeks. For this purpose, a medical fluid, such as an aqueous solution of the active ingredient, can be introduced into the spacer from the outside, for example, via a supply line, and the fluid can then be released from a plurality of dispensing valves on the outer surface of the spacer. The spacer according to the present invention is preferably designed so that substantially equal volumes of the active ingredient solution can be released simultaneously from all dispensing valves. Furthermore, clogging of the dispensing valves by coagulated blood and infiltrated connective tissue can preferably be avoided. It is also desirable that liquid from the outside cannot penetrate into the interior of the spacer through the dispensing valves. The dispensing valves can be designed so that they do not protrude beyond the outer surface of the spacer, and so that the components of the spacer are not pushed into the surrounding tissue during the delivery of the medical fluid. The spacer can enable the delivery of relatively small volumes of medical fluid, for example, in the range of up to 50 mL per application. The spacer is also suitable for the delivery of medical fluids having high concentrations of active ingredients. The spacer according to the present invention is preferably suitable for the precisely controlled release of the active ingredient, and preferably capable of uniform release at different locations on the spacer. This is an advantage over conventional spacer systems that aim to provide a rinsing function by introducing a larger volume into the spacer to rinse the surrounding tissue. According to the present invention, the spacer described herein preferably does not require any further elements for draining or reabsorbing the rinsing fluid. The spacer may be suitable for temporary implantation in previously infected and debridemented bone cavities.

[0010] These objectives are achieved by the methods, apparatus, kits and medical uses described herein, in particular by the methods, apparatus, kits and medical uses described in the claims.

[0011] Preferred embodiments of the present invention are described below.

[0012] A first embodiment of a first aspect of the present invention relates to an implantable spacer for delivering medical fluid to a patient, the spacer having an outer surface and a plurality of delivery valves disposed on the outer surface, each of which is fluidically connected to one another by channels disposed within the implant, and the delivery valves are designed and configured to reversibly open in response to the pressure of the fluid in the channels in order to deliver fluid from the delivery valves.

[0013] A second embodiment of the present invention relates to a spacer according to the first embodiment, wherein each dispensing valve has a sleeve-shaped housing, the spacer has a plurality of receptacles, and the dispensing valve can be connected to the spacer by positive engagement and / or non-positive engagement of the housing into the receptacles.

[0014] A third embodiment of the present invention relates to a spacer according to any of the prior embodiments, wherein each dispensing valve comprises a first material, the first material being rubber-elastic, and the first material further comprises slits.

[0015] A fourth embodiment of the present invention relates to an embedded spacer according to the third embodiment, wherein the slit is configured to be reversibly opened and closed by the elastic restoring force of the first material.

[0016] A fifth embodiment of the present invention relates to an embedded spacer according to the third or fourth embodiment, wherein the first material has a Shore A hardness of 30 to 80, preferably 40 to 70, and more preferably 50 to 60.

[0017] A sixth embodiment of the present invention relates to an embedded spacer according to any of the preceding embodiments, wherein the channel has an inlet opening for receiving fluid, and the inlet opening is preferably located on the outer surface of the spacer.

[0018] A seventh embodiment of the present invention relates to an embedded spacer according to the second and sixth embodiments, wherein the inlet opening is designed in the same manner as the receptacle, or the inlet opening is designed in a different manner from the receptacle.

[0019] An eighth embodiment of the present invention relates to an implantable spacer according to any of the prior embodiments, wherein the spacer is selected from the group consisting of a knee joint spacer, a hip joint spacer, a vertebral body spacer, and an intramedullary nail spacer.

[0020] A ninth embodiment of the present invention relates to an embedded spacer according to any of the prior embodiments, wherein the spacer is designed and configured to simultaneously deliver substantially the same amount of fluid from each of the discharge valves.

[0021] A tenth embodiment of the present invention relates to an embedded spacer according to any of the preceding embodiments, wherein the spacer is designed and configured to open and / or close all discharge valves simultaneously.

[0022] An eleventh embodiment of the present invention relates to an embedded spacer according to any of the prior embodiments, wherein the discharge valves are arranged so as to be flush with the outer surface of the spacer.

[0023] A twelfth embodiment of the present invention relates to an embedded spacer according to any of the preceding embodiments, wherein the channel has a plurality of branches, and preferably each branch has a discharge valve or inlet opening according to the sixth embodiment.

[0024] A thirteenth embodiment relates to an embedded spacer according to any of the preceding embodiments, wherein the dispensing valve is designed and configured to allow liquid to pass through the dispensing valve in only one direction.

[0025] A second aspect of the present invention relates to a medical fluid for use in medical procedures, wherein the procedure is: The steps include providing an embedded spacer according to one of the prior embodiments, The steps include introducing medical fluid into the channel of the spacer, The procedure includes the steps of opening a discharge valve in a pressure-dependent manner and pressurizing the medical fluid in the channel to deliver the fluid to the patient.

[0026] A further embodiment according to the second aspect of the present invention relates to a fluid for use according to the preceding embodiments, the fluid comprising an active ingredient selected from the group consisting of an antibiotic, an anti-inflammatory agent, an anesthetic and a cytostatic agent.

Brief Description of the Drawings

[0027] [Figure 1] The spacer according to the present invention, designed as a hip joint spacer, is shown. [Figure 2] The spacer according to the present invention, filled with a medical fluid, is shown. [Figure 3] An embodiment of a delivery valve is shown. [Figure 4] A part of the spacer according to the present invention having a modular delivery valve is shown. [Figure 5] The delivery valve in a fully open state is shown. [Figure 6] The delivery valve in a partially open state is shown. [Figure 7] The delivery valve in a closed state is shown. [Figure 8] The spacer according to the present invention, designed as a knee joint spacer, is shown. [Figure 9] The knee joint spacer according to the present invention having a joining element is shown. [Figure 10] The spacer according to the present invention, designed as a vertebral spacer, is shown. [Figure 11] The spacer according to the present invention, designed as an intramedullary nail spacer, is shown.

Mode for Carrying Out the Invention

[0028] With respect to the embodiments described herein, any element that “have,” “contain,” or “comprise” a particular feature (e.g., material) is, in principle, intended to have further embodiments in which the relevant element consists solely of that feature, i.e., does not include other components. The terms “comprise” or “comprising” are used herein to be synonymous with the terms “contain,” “containing,” “have,” or “having.”

[0029] "Operationally connected" or "operationally connectable" means, in this specification, that two related elements have a functional relationship with one another. For example, a first element may be configured to control or move a second element through such an operationally connected connection. The term "control" here also includes blocking or enabling a function, such as allowing or restricting the movement of an element or other functions.

[0030] In one embodiment, where an element is indicated in the singular form, embodiments in which two or more such elements exist are also intended. The use of terminology for plural elements essentially also encompasses embodiments in which only a single corresponding element is included.

[0031] Unless otherwise indicated or explicitly excluded from the context, features of different embodiments may, in principle, also be present in other embodiments described herein, and this possibility is explicitly intended here. Similarly, all features described herein in relation to methods are, in principle, considered applicable to the products, apparatus, kits and uses described herein, and vice versa. For the sake of brevity of explanation, not all such considered combinations are explicitly enumerated in every case. Technical solutions known to be equivalent to the features described herein are also intended to be, in principle, encompassed by the scope of the present invention.

[0032] For example, the technical standards and specifications described herein in relation to test procedures refer to the most recent versions as of the priority date of this application.

[0033] One aspect of the present invention relates to an implantable spacer for delivering medical fluids to a patient, the spacer having an outer surface and a plurality of delivery valves disposed on the outer surface, each of which is fluidically connected to one another by channels disposed within the implant, and the delivery valves are designed and configured to reversibly open in response to the pressure of the fluid in the channels in order to deliver fluid from the delivery valves.

[0034] The term “spacer” as used herein refers to a medical implant designed and configured to be implanted in a patient as a temporary placeholder in place of bone, joint, or part thereof. In one embodiment, the spacer comprises a biocompatible material such as PMMA, stainless steel, or titanium. The spacer may include, or consist of, metal, plastic material, or metal-plastic composite material. Examples of biocompatible metals include 316L steel, cobalt-chromium steel, titanium, and titanium alloys. Examples of biocompatible plastic materials are polymethyl methacrylate, polyamide 12, polyethersulfone, and polyetherketone. In one embodiment, the spacer consists of at least 90% (mass / mass) PMMA.

[0035] In one embodiment, the spacer according to the present invention may be manufactured, or is manufactured, from stainless steel, titanium, or other biocompatible metals or alloys by SLM (selective laser melting) or EBM (electron beam melting). In one embodiment, the spacer according to the present invention may be manufactured, or is manufactured, from a suitable plastic material such as polyamide 12 or polymethyl methacrylate by SLS (selective laser sintering). In one embodiment, the spacer according to the present invention may be manufactured, or is manufactured, from a thermoplastic resin by plastic injection molding. In this case, the spacer may be assembled from a plurality of injection-molded parts, which can be connected to each other, for example, by welding or bonding.

[0036] The spacers described herein are preferably designed and configured to deliver medical fluids. “Medical fluid” as used herein means a fluid intended for medical use and having medicinal properties.

[0037] In this specification, the term “medical fluid” refers in particular to aqueous and non-aqueous liquids that may contain dissolved active ingredients, especially pharmaceutically active ingredients, or that may themselves possess medicinal properties. The term also includes gases and gas-liquid mixtures that may exert pharmacological effects in human or animal organisms. In one embodiment, the medical fluid contains an active ingredient. In one embodiment, the active ingredient is selected from the group consisting of antibiotics, antifungal agents, cell proliferation inhibitors, anesthetics, osteoinducing active ingredients, and anti-inflammatory agents.

[0038] In one embodiment, the active ingredient is an antibiotic. In one embodiment, the antibiotic is selected from the group consisting of penicillin, cephalosporin, carbapenem, quinolone, macrolide, lincosamide, aminoglycoside, and glycopeptide. Examples of penicillin include amoxicillin and benzylpenicillin. Examples of cephalosporin include ceftriaxone and cefuroxime. Examples of carbapenem include meropenem and imipenem. Examples of quinolone include ciprofloxacin and levofloxacin. Examples of macrolides include azithromycin and clarithromycin. Examples of glycopeptides include vancomycin and teicoplanin. Examples of aminoglycosides include gentamicin and tobramycin. An example of an aminoglycoside is clindamycin.

[0039] In one embodiment, the active ingredient is an antifungal agent. Examples of antifungal agents include polyenes (e.g., amphotericin B, nystatin, natamycin), azoles (e.g., fluconazole, voriconazole), echinocandins (e.g., caspofungin, micafungin), and allylamines (e.g., terbinafine).

[0040] In one embodiment, the active ingredient is a cell proliferation inhibitor. Examples of cell proliferation inhibitors include alkylating agents, antimetabolites, natural products, protein kinase inhibitors, and monoclonal antibodies. Examples of alkylating agents include cyclophosphamide, melphalan, and busulfan. Examples of antimetabolites include methotrexate, 5-fluorouracil, and gemcitabine. Examples of natural products include paclitaxel, doxorubicin, and vincristine. Examples of protein kinase inhibitors include imatinib, gefitinib, and sunitinib. Examples of monoclonal antibodies include rituximab, trastuzumab, and bevacizumab.

[0041] In one embodiment, the active ingredient is an anesthetic. Examples of anesthetics include lidocaine, bupivacaine, ropivacaine, propofol, etomidate, ketamine, morphine, fentanyl, and remifentanil.

[0042] In further embodiments, the active ingredient is an osteoinducible active ingredient. Examples of osteoinducible active ingredients include bone morphogenetic proteins (BMPs), parathyroid hormone-related compounds, anti-sclerostin antibodies, and growth factors. Examples of bone morphogenetic proteins include BMP-2 and BMP-7. An example of a parathyroid hormone-related peptide is teriparatide (PTH 1-34). An example of an anti-sclerostin antibody is romosozumab. Examples of growth factors include fibroblast growth factor (FGF) and platelet-derived growth factor (PDGF).

[0043] In further embodiments, the active ingredient is an anti-inflammatory agent. Examples of anti-inflammatory agents include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, selective COX-2 inhibitors, biological agents (e.g., TNF-α inhibitors), and Janus kinase inhibitors. Examples of nonsteroidal anti-inflammatory drugs (NSAIDs) include ibuprofen, diclofenac, and naproxen. Examples of glucocorticoids include prednisone, dexamethasone, and hydrocortisone. Examples of selective COX-2 inhibitors include celecoxib and etoricoxib. Examples of TNF-α inhibitors include infliximab, adalimumab, and etanercept. Examples of Janus kinase inhibitors include tofacitinib and baricitinib.

[0044] In one embodiment, the active ingredient is suitable for treating bone diseases. In one embodiment, the active ingredient is selected from the group consisting of bisphosphonates (e.g., alendronate, zoledronate), calcitonin, selective estrogen receptor modulators (e.g., raloxifene), and strontium ranerate. In one embodiment, the active ingredient comprises hyaluronic acid or a corticosteroid (e.g., betamethasone, triamcinolone). In one embodiment, the active ingredient comprises a calcium salt. Examples of suitable calcium salts include calcium phosphate and calcium sulfate. Examples of calcium phosphate include β-TCP (beta-tricalcium phosphate) and hydroxyapatite.

[0045] In one embodiment, the active ingredient is selected from the group consisting of gentamicin, tobramycin, amikacin, clindamycin, daptomycin, vancomycin, teicoplanin, dalbavancin, fosfomycin, linezolid, eperezolid, colistin, meropenem, fluconazole, micafungin, caspofungin, metronidazole, moxifloxacin, ofloxacin, levofloxacin, ciprofloxacin, rifamycin, and rifampicin.

[0046] In one embodiment, the medical fluid includes an aqueous solution of the active ingredient described herein.

[0047] The spacer has an outer surface. Multiple delivery valves are arranged on this outer surface. The delivery valves are designed and configured to deliver medical fluids. These delivery valves are connected to each other via passages. A channel is located inside the spacer. In some embodiments, the spacer includes an inlet opening. The inlet opening is preferably located on the outer surface of the spacer. The inlet opening is designed and configured to introduce medical fluids into the channel. In one embodiment having an inlet opening and multiple delivery valves, the channel connects the delivery valves to each other and to the inlet opening.

[0048] The discharge valve is preferably designed and configured to reversibly open in response to the pressure of the fluid in the channel in order to deliver fluid from the discharge valve. This allows for controlled delivery of fluid from the spacer.

[0049] In some embodiments, the discharge valves are arranged to be substantially uniformly distributed across the entire outer surface of the spacer so that the fluid can be uniformly delivered around the spacer. In this case, the fluid can be delivered in all spatial directions.

[0050] To ensure uniform delivery of medical fluid around the spacer, it may also be advantageous to provide a sufficient amount of dispensing valves for this purpose on the surface of the spacer. Therefore, in one embodiment, the spacer has an outer surface of 16.0 cm².2 At least one dispensing valve per unit, more preferably with an outer surface of 9.0 cm of spacer 2 Each unit is equipped with at least one dispensing valve.

[0051] The discharge valve can form a unit with the spacer material, i.e., it can be integrated with the spacer. An example of this is the slit valve described herein, in which, for example, the opening on the outer surface of the spacer is coated and covered with a rubber elastic material. Such a rubber elastic material suitable for the manufacture of a slit valve is also referred to herein as the “first material”.

[0052] The dispensing valve can be modular, and as a result, the remaining portion of the spacer can be manufactured separately from the dispensing valve, and then the valve can be joined to the remaining portion of the spacer. This allows for flexible and cost-effective production, for example, by using similar modular dispensing valves with spacers of different shapes.

[0053] In some embodiments, each dispensing valve has a sleeve-shaped housing. In some embodiments, the spacer has a plurality of receptacles that allow such dispensing valves to be coupled to the spacer. In some embodiments, the dispensing valves are connectable to or connected to the spacer by positive engagement and / or non-positive engagement of the housing into the receptacles.

[0054] The dispensing valve is preferably a pressure relief valve, i.e., a valve that opens when a specified pressure is exceeded. This pressure is referred to herein as the “limit pressure.” Preferably, all dispensing valves of the spacer have the same limit pressure. Furthermore, it is preferable that the valve is “non-contact” with respect to the surrounding spacer, i.e., designed so that there is no part that moves toward the surrounding tissue when the valve is opened. This can prevent irritation of sensitive patient tissue, especially in the presence of inflammation. An example of such a dispensing valve has a rubber elastic membrane with a slit-shaped opening, as described below.

[0055] In one embodiment, the discharge valve is designed and configured to open when the fluid pressure inside the channel exceeds a limit pressure, which is 1 bar (10^5 Pa) higher than the pressure outside the spacer, and to close fluid-tight when it falls below this limit pressure. This means that the discharge valve is closed when the overpressure of the fluid in the channel is less than 1 bar, and the discharge valve is open when the overpressure of the fluid in the channel is 1 bar or greater. "Overpressure" as used herein refers to the difference between atmospheric pressure and the pressure of the fluid in the channel of the spacer.

[0056] In one embodiment, each discharge valve comprises a first material, the first material being rubber-elastic. The rubber-elastic material is characterized in particular by its ability to automatically return to its original shape after mechanical deformation. According to the present invention, this property gives slits placed in the elastic material the ability to open and close in response to pressure, as will be further described below.

[0057] The discharge valve may include a first material, for example, in the form of a coating on the outer surface of a spacer. The channel of the spacer may open to an opening on the outer surface of the spacer, and such an opening may be provided with the coating. In this case, the coating can form a sealing boundary for such an opening.

[0058] In one embodiment, each dispensing valve has a housing into which such a first material is introduced. For example, the housing may have a substantially cup shape with an opening. In such an embodiment, the first material can liquid-tightly seal the opening of the housing of the dispensing valve. The first material may be disc-shaped or cup-shaped.

[0059] The dispensing valve may be connectable to a spacer positively, negatively, and / or integrally. For example, the dispensing valve may be connectable to a spacer by pressing and / or bonding and / or welding and / or screwing. In particular, such a connection may exist between the housing of the dispensing valve and the receptacle of the spacer described herein.

[0060] In one embodiment, the first material has a Shore A hardness in the range of 30 to 80. In another embodiment, the first material has a Shore A hardness in the range of 40 to 70, or 50 to 60, for example, about 55. The Shore A hardness is determined according to ASTM D2240. Elastomers with Shore A hardness in this range have very good resilience and are very suitable for the manufacture of rubber elastic discs or rubber elastic coatings, such as those described herein as part of a dispensing valve. Slits in such elastomers close automatically and quickly when the pressure acting on them decreases. In another embodiment, the first material has a Shore A hardness in the range of 75 to 95.

[0061] The first material is preferably a polymer, particularly an elastomer. Preferably, the first material includes or consists of a medically acceptable elastomer. Examples of medically acceptable elastomers include silicone elastomers, thermoplastic elastomers (TPEs), polyisoprene, butyl rubber, nitrile rubber, ethylene propylene diene monomer (EPDM), chloroprene rubber, fluoroelastomers, perfluoroelastomers, and polyacrylate elastomers. Examples of silicone elastomers include polydimethylsiloxane (PDMS) and liquid silicone rubber (LSR).

[0062] Examples of thermoplastic elastomers (TPEs) include styrene block copolymers (SBCs) such as styrene-ethylene-butylene-styrene (SEBS), thermoplastic polyurethanes (TPUs), and thermoplastic copolyesters (TCEs). Examples of polyisoprenes include natural rubber and synthetic polyisoprenes. Examples of butyl rubbers include bromobutyl rubber (BIIR) and chlorobutyl rubber (CIIR). A preferred polyurethane is polyether urethane. Polyether urethane can be produced by a polyaddition reaction between a polyether polyol and a diisocyanate.

[0063] In one embodiment, the first material has a thermoplastic elastomer. In one embodiment, the first material consists of a thermoplastic elastomer. In one embodiment, the first material has a polyether urethane or ethylene propylene diene rubber. In one embodiment, the first material includes a polyether urethane. In one embodiment, the first material consists of a polyether urethane.

[0064] In one embodiment, the first material has only a single elastomer, i.e., the second elastomer is not mixed with the first material. In one embodiment, the first material has at least two different materials, for example, two different elastomers. This allows, for example, the hardness of the first material to be set to a desired target value. The first material may include a copolymer. The copolymer may be a thermoplastic elastomer. A copolymer containing soft segments and hard segments in its molecular chain is preferred. The ratio between soft segments and hard segments in the molecular chain of the copolymer can be used to adjust the physical properties of such copolymer, for example, the Shore A hardness of the copolymer. The hard segments can be connected to the soft segments using connectors (linkers).

[0065] Furthermore, the first material may contain additives to adjust its hardness. Examples of such additives are fillers and plasticizers. Examples of fillers include silica, titanium dioxide, calcium carbonate, barium sulfate, and carbon.

[0066] Examples of plasticizers include adipates, trimellitates, citrate-based plasticizers, and esters of polyhydric alcohols.

[0067] For example, TOTM (tris(2-ethylhexyl) trimellitate), DINCH (diisononylcyclohexane-1,2-dicarboxylate), ATBC (acetyl tributyl citrate), or DEHA (di(2-ethylhexyl) adipate) can be used as plasticizers.

[0068] In one embodiment, the first material does not contain plasticizers. In one embodiment, the first material does not contain fillers. In one embodiment, the first material does not contain endocrine disruptors such as phthalates or bisphenols.

[0069] In one embodiment, the first material may further contain a lubricant. Preferably, the lubricant is medically acceptable. Preferably, the lubricant does not contain polyhalogens or silicones. In one embodiment, the lubricant is a natural product, such as a lipid, triglyceride, or biopolymer.

[0070] In one embodiment, the first material may have a Young's modulus of elasticity of 1.2 × 10^7 Pa to 2.1 × 10^7 Pa, for example, 1.3 × 10^7 Pa to 2.0 × 10^7, 1.4 × 10^7 Pa to 1.9 × 10^7 Pa, 1.5 × 10^7 Pa to 1.8 × 10^7 Pa, or 1.5 × 10^7 Pa to 1.7 × 10^7 Pa. In one embodiment, the first material may have a Young's modulus of elasticity of about 1.6 × 10^7 Pa. In one embodiment, the first material may have a Young's modulus of elasticity of 2000 to 2500 psi. The latter corresponds to about 1.4 × 10^7 Pa to 1.7 × 10^7 Pa.

[0071] The Young's modulus of elasticity can be determined according to ASTM D412.

[0072] The first material is preferably sterilizable using common sterilization processes, i.e., resistant to UV radiation, gamma radiation, and ethylene oxide treatment within the scope of these processes.

[0073] The first material is preferably moldable using a standard extrusion and / or injection molding process.

[0074] The first material may include slits. In one embodiment, the slits have a straight, curved, star-shaped, cross-shaped, or horseshoe-shaped form. In one embodiment, each slit has an overall length in the range of 0.4 mm to 3.0 mm, for example, in the range of 0.8 mm to 2.5 mm, or in the range of 1.0 mm to 2.0 mm.

[0075] In one embodiment, each of the dispensing valves comprises a first material having a slit. In one embodiment, each of the dispensing valves has exactly one, i.e., one or fewer slits within the first material.

[0076] In one embodiment, all slits in the discharge valve are substantially the same length. In one embodiment, all slits are of a length that deviates by no more than 25% above or below a certain value, for example, a length of 1.00 mm ± 25%, i.e., a length of 0.75 mm to 1.25 mm.

[0077] In one embodiment, the slit is configured to be reversibly opened and closed by the elastic restoring force of the first material. In this case, the slit can be opened by overpressure of the fluid in the channel, in that the first material is pushed away by the fluid when the fluid exceeds a predetermined limit pressure of the fluid.

[0078] In one embodiment, the slit can be manufactured, or has been manufactured, by partially separating the first material without removing a portion of the first material in the process. In this case, the slit can be formed, for example, by punching with a blade. Such a slit is completely closed unless there is a pressure difference on both sides of the first material. This prevents tissue or liquid from penetrating into the spacer from the outside.

[0079] In one embodiment, the slit has walls which are in contact with each other when the dispensing valve is closed and move away from each other when the dispensing valve is opened.

[0080] In further embodiments, the channel has an inlet opening for receiving fluid, and the inlet opening is preferably located on the outer surface of the spacer.

[0081] Furthermore, the spacer may have a fluid connector. The fluid connector may be used to connect a container or fluid conduction connection to receive liquid into the spacer. An example of a fluid connector is a syringe connector, such as a Luer-Lock connector. Using such a connector, a commercially available Luer-Lock syringe can be connected to the inlet opening of the spacer in a liquid-tight and fluid conduction manner. The fluid connector may be removablely connectable to the inlet opening. The fluid connector may be operably connectable to the spacer.

[0082] The spacer may further comprise a supply line, which is connectable to or connected to the inlet opening. Preferably, the supply line may be operably connectable to or connected to the inlet opening. In one embodiment, the spacer has a fluid connector, which is connectable to or connected to the inlet opening via the supply line. The supply line may have a tube made of, for example, a medically acceptable material.

[0083] In one embodiment, the spacer may be equipped with a check valve. The check valve is preferably designed to prevent fluid from flowing out of the spacer through the inlet opening. The check valve may or may be operably connected to the inlet opening. The check valve may be located directly in the inlet opening or in a supply line or fluid connector. Thus, fluid can be introduced into the spacer through the inlet opening without backflow through the inlet opening.

[0084] To ensure secure connection of the supply line to the inlet opening, the spacer may further comprise a locking mechanism, preferably located at the inlet opening. In one embodiment, the locking mechanism comprises, for example, one or more movable locking elements, which are designed and configured to move radially inward when the supply line is inserted into the inlet opening and to engage with corresponding grooves or recesses in the inlet opening. The locking mechanism may preferably be spring-biased to enable engagement of the locking elements at the inlet opening.

[0085] The locking mechanism may have release means designed and configured to remove the locking element.

[0086] In further embodiments, the spacer further includes a trocar. The trocar has a pointed end that allows it to penetrate tissue. Furthermore, the trocar includes a shaft along which the trocar can be guided. The shaft may have a cylindrical cavity, similar to that of a cannula.

[0087] The trocar is preferably connectable to the supply line described herein. Preferably, the trocar may be detachably connected to the distal end of the supply line. Using the trocar, a medical user can insert the supply line into the patient's tissue, thereby positioning and securing the supply line at a desired location. The trocar can enable gentle and precise penetration of the target tissue. In this case, a channel can be created to the desired administration site, and accordingly, a spacer for administering the medical fluid can be positioned. In this case, the supply line can be introduced into the patient's tissue through the channel created with the help of the trocar. Preferably, the trocar is removable so that the medical fluid can be received through the supply line after the delivery valve has been positioned using the trocar. In this case, the trocar may be removed from the supply line, for example, and replaced with a fluid connector such as a Luer lock connector. The medical fluid can then be added to the supply line, for example, using a Luer lock syringe, in order to deliver the medical fluid to a target location on the patient's tissue using the device.

[0088] In one embodiment, the inlet opening described herein may be configured in the same manner as the receptacle described herein. In one embodiment, the inlet opening is configured differently from the receptacle described herein.

[0089] The spacer can be adapted to different positions. In one embodiment, the spacer is selected from the group consisting of a knee joint spacer, a hip joint spacer, a vertebral body spacer, and an intramedullary nail spacer.

[0090] A knee joint spacer may be a one-piece or multi-piece knee joint spacer. A hip joint spacer may be a one-piece or multi-piece hip joint spacer. A vertebral body spacer may be a one-piece or two-piece vertebral body spacer. In a multi-piece spacer, the delivery system described herein may be present in only one of the two parts or in both parts.

[0091] The spacers described herein, for example, a hip joint spacer or a knee joint spacer, may each have a first sub-element and a second sub-element. The first sub-element and / or the second sub-element may be intended to be introduced into the patient's bone. In this case, fixation may be performed with bone cement.

[0092] In one embodiment, both the first sub-element and the second sub-element are equipped with a discharge valve.

[0093] In one embodiment, the spacer further comprises an inlet opening, a delivery valve, or a cement region without an inlet opening. This cement region is preferably designed and configured to be fixed within the bone of the patient being treated using bone cement. In this way, the spacer can be held in place at a desired target location after implantation.

[0094] Furthermore, the inventions described herein can be designed as implants intended to remain permanently in a patient's body. For example, a bone fixation plate as described herein may be provided with the channels and delivery valves described herein. Thus, in one embodiment, the present invention also provides an implant for delivering medical fluids to a patient, the implant having an outer surface and a plurality of delivery valves disposed on the outer surface, each delivery valve being fluidically connected to one another by channels disposed within the implant, and the delivery valves are designed and configured to reversibly open in response to the pressure of the fluid in the channels in order to deliver fluid from the delivery valves. The implant may be designed as a fixation implant, for example, as a hip joint implant, a shoulder joint implant, or a knee joint implant.

[0095] In further embodiments, the spacers or implants described herein are designed and configured to deliver substantially identical amounts of fluid simultaneously from each of the dispensing valves. For example, substantially identical amounts may be amounts having a statistical standard deviation of less than 10% of the arithmetic mean.

[0096] In further embodiments, the spacers or implants described herein are designed and configured to open and / or close all dispensing valves simultaneously. Depending on the pressure of the fluid in the channel, each dispensing valve is either open or closed, as described herein.

[0097] In one embodiment, each delivery valve is positioned flush with the outer surface of the spacer. Such a design prevents the delivery valve from forming protrusions relative to the spacer, which could result in damage or irritation to the patient's tissue.

[0098] In one embodiment of the present invention, the channel has a plurality of branches. In this case, each branch preferably has a discharge valve or inlet opening according to the embodiments described herein. This means, in particular, that in the case of branches, the discharge valve or inlet opening is located on each side arm of the channel, in this case the discharge valve or inlet opening is preferably located on the outer surface of the spacer.

[0099] In one embodiment, the discharge valve is designed and configured to allow liquid to pass through the discharge valve in only one direction. This means that the discharge valve in this case is designed as a one-way valve. According to the present invention, this means that liquid cannot enter the channel from the outside through the discharge valve as long as the pressure of the fluid in the channel is greater than or equal to the ambient pressure outside the spacer.

[0100] In one embodiment, the spacer or implant has a connecting element. The connecting element may have a joint. The connecting element can movably connect a first sub-element to a second sub-element. A channel may extend from the first sub-element through the connecting element into the second sub-element. In this case, the channel may be positioned along the central axis of the connecting element.

[0101] In one embodiment, the channel defines a connecting axis along its extension from the first sub-element through the connecting element. This axis is defined when no external force is acting on the spacer. The connecting element may be designed and configured to allow movement of the second sub-element at an angle of at least 20° with respect to this connecting axis. In one embodiment, this angle is at least 30° or at least 40°. For example, the second sub-element may be laterally bent by at least 20°, at least 30°, or at least 40° relative to the first sub-element. To enable such movement, the joint may include a rubber-elastic second material. In one embodiment, the joint consists of the second material. The second material may be identical to the first material described herein, or the second material may be different from the first material described herein. The second material may have a Shore A hardness in the range of 15 to 80. In one embodiment, the second material has a Shore A hardness in the range of 20 to 70, or in the range of 30 to 60. The second material may have closed porosity.

[0102] The joint may have an outer diameter of 0.25 to 0.75 times the outer diameter of the surrounding first or second sub-element. Preferably, these two outer diameters are defined in directions perpendicular to the aforementioned connecting axis. Preferably, these two outer diameters are defined along the same line.

[0103] In one embodiment, the channel has a diameter that has a ratio to the outer diameter of the joint, within the range of [1:1] to [1:6]. In this case, the diameter of the channel is defined as the inner width of the channel.

[0104] In one embodiment, the spacer has a fastener that connects the joint to a first sub-element and / or a second sub-element. In one embodiment, the fastener directly connects the joint to the first sub-element or the second sub-element. In one embodiment, the fastener connects the joint to the first sub-element. In one embodiment, the fastener connects the joint to the second sub-element. In one embodiment, the first fastener connects the first joint to the first sub-element, and the second fastener connects the second joint to the second sub-element.

[0105] In one embodiment, the channel extends through a fastener. In one embodiment, the channel extends through a joint. In one embodiment, the channel extends through the fastener and through the joint. In one embodiment, the fastener has a substantially cylindrical shape. The fastener may be designed, for example, as a screw or bolt. Thus, the fastener may include threads. The fastener may also include peripheral grooves, projections, or other locking means. The fastener may include cavities for forming a portion of the channel as described herein.

[0106] The fastener may be connected to the second material positively, negatively, and / or integrally. The fastener may be connected to the first sub-element positively, negatively, and / or integrally. The fastener may be connected to the second sub-element positively, negatively, and / or integrally.

[0107] In one embodiment, a joint element, preferably a joint of joint elements, may have a discharge valve as described herein. In this case, the discharge valve may be located within a second material. The second material may include a slit. In one embodiment, the slit is configured to be reversibly opened and closed by the elastic restoring force of the second material.

[0108] In one embodiment, the spacer comprises a plurality of connecting elements. The connecting elements may be connected to each other directly or indirectly. For example, a plurality of connecting members may be directly connected to each other. For this purpose, the connecting members may have locking elements such as threads or recesses and / or protrusions. The connecting members may be connected to each other by intermediate fasteners as described herein.

[0109] In addition to the first and second sub-elements, the spacer may comprise further such sub-elements, each connected to one another by the connecting elements described herein. This allows for greater mobility of the spacer. For example, in such embodiments, the spacer may bend simultaneously in different directions in a manner similar to how the vertebral joints of the spine enable it.

[0110] Further aspects of the present invention relate to a kit for manufacturing a spacer as described herein, comprising a plurality of sub-elements and one or more connecting elements as described herein. In one embodiment, the kit includes a plurality of interchangeable sub-elements. These sub-elements may be of different sizes and / or shapes, for example, different lengths and / or thicknesses. This allows a medical user to individually fit the spacer to the patient being treated.

[0111] In one embodiment, the kit is designed and configured to manufacture an implantable spacer for delivering medical fluid to a patient, the spacer having an outer surface and a plurality of delivery valves positioned on the outer surface, each of which is fluidically connected to one another by channels positioned within the implant, and the delivery valves are designed and configured to reversibly open in response to the pressure of the fluid in the channels in order to deliver fluid from the delivery valves.

[0112] A second aspect of the present invention relates to a medical fluid for use in medical procedures, wherein the procedure is: The steps of providing the spacer described herein, The steps include introducing medical fluid into the channel of the spacer, The procedure includes the steps of opening a discharge valve in a pressure-dependent manner and pressurizing the medical fluid in the channel to deliver the fluid to the patient.

[0113] Medical treatment preferably includes the treatment of inflammation, mechanical injury (trauma), infection, or neoplastic disease. This treatment preferably includes the treatment of the affected bone or joint. Infections may be, for example, osteomyelitis or osteitis. Furthermore, this treatment may include the treatment of pain.

[0114] In one embodiment, the medical procedure includes treating joint infections, such as hip joint infections, knee joint infections, shoulder joint infections, or spondylodiscitis. In one embodiment, the treated joint infection is surgically induced, for example, as a result of a surgical procedure to implant an artificial joint. In some embodiments, the joint infection is treated using a medical fluid containing antibiotics and / or antifungal agents.

[0115] A further embodiment according to a second aspect of the present invention relates to a medical fluid for use in the medical procedures described above, wherein the fluid contains an active ingredient. In principle, all of the active ingredients described herein can be used. In one embodiment, the fluid contains an active ingredient selected from the group consisting of antibiotics, anti-inflammatory agents, anesthetics, and cell proliferation inhibitors.

[0116] In one embodiment, the active ingredient is selected from the group consisting of gentamicin, tobramycin, amikacin, clindamycin, daptomycin, vancomycin, teicoplanin, dalbavancin, fosfomycin, linezolid, eperezolid, colistin, meropenem, fluconazole, micafungin, caspofungin, metronidazole, moxifloxacin, ofloxacin, levofloxacin, ciprofloxacin, rifamycin, and rifampicin.

[0117] In one embodiment, the medical fluid is an aqueous solution of the active ingredient described herein.

[0118] In one embodiment, the medical procedure includes implanting a spacer within the patient's tissue, preferably within the area of ​​a joint or within the tissue of a fracture site. In one embodiment, the medical procedure includes using a trocar to penetrate the patient's tissue and deliver a supply line of the spacer from the inside of the patient's body through the skin to the outside.

[0119] In one embodiment, the medical fluid is introduced into the spacer channel using a pump, for example, a syringe pump. In one embodiment, the medical fluid is delivered to the patient continuously over a period of several minutes, several hours, or several days. In one embodiment, the medical fluid is delivered to the patient repeatedly. For example, the medical fluid may be delivered to the patient once a day, or several times a day, for example, two, three, or four or more times a day. In one embodiment, the medical fluid is delivered according to the patient's health parameters. Health parameters may be, for example, diagnostic measurements or the patient's pain level.

[0120] In one embodiment, the medical fluid is administered using manual or automatic control.

[0121] A further aspect of the present invention relates to a medical procedure, wherein the procedure is: The steps of providing a spacer, implant, or kit as described herein, The steps include introducing medical fluid into the channel of a spacer or implant, The procedure includes the steps of opening a discharge valve in a pressure-dependent manner and pressurizing the medical fluid in the channel to deliver the fluid to the patient.

[0122] The above embodiments relating to medical fluids for use in medical procedures are applied accordingly.

[0123] figure Figure 1 is a cross-section of a first embodiment of a spacer 100 according to the present invention. A fluid conduction channel 101 is disposed within the spacer. The channel 101 has branches 106. The spacer has an outer surface 104 on which a receptacle 102 is disposed. A delivery valve 110 is introduced within the receptacle 102. In the example shown in this figure, one of the receptacles 102 is designed as an inlet opening 103 to provide a fluid conduction connection to a supply line 201. In this case, the proximal end of the supply line 201 engages positively or non-positively within the inlet opening 103. The supply line 201 has a distal end that is fluidically connected to a fluid connector 202. The fluid connector 202 is designed as a Luer lock connector in this figure. The delivery valve 110 is positioned at different locations on the outer surface 104 of the spacer to allow for the delivery of medical fluid into the periphery of the spacer as uniformly as possible. Channel 101 connects the inlet opening 103 to the discharge valve 110 so that fluid received through the inlet opening 103 can reach the discharge valve 110 via channel 101. The spacer also has a cemented area 105 that does not have an inlet opening, a discharge valve, or an inlet opening. This cemented area 105 is designed and configured to be fixed in the bone of the patient being treated using bone cement. In this way, the spacer can be held in place at the desired target location after implantation.

[0124] Figure 2 shows a cross-section of the spacer according to Figure 1, filled with medical fluid 200. The spacer design shown in this figure allows for filling the channel 101 with medical fluid using a syringe via the fluid connector 202, supply line 201, and inlet opening 103. Pressurization of the fluid 200 in the channel 101 causes the delivery valve 110 to open to remove the fluid from the spacer 100 to the patient's target tissue. The delivery valve 110 is designed and configured to open at a pressure exceeding a predetermined pressure of the fluid 200 in the channel 101. This makes it possible to achieve temporally and quantitatively uniform delivery of the fluid 200 through all delivery valves 110.

[0125] Figure 3 is a cross-sectional view of an embodiment of the discharge valve 110. This embodiment of the discharge valve 110 is constructed in a modular design so that it can be manufactured separately and introduced into a spacer 100 according to the present invention. The discharge valve 110 has a housing 111, the housing 111 having a projection 114 designed for a firm connection with the spacer's receptacle. Inside the discharge valve is a first rubber-elastic material 112 having a slit 113. The slit 113 is designed and configured to open or close in a pressure-dependent manner, as shown in more detail in Figures 5 to 7 below. The slit 113 is shown here in a partially open state.

[0126] Figure 4 shows a partial embodiment of the spacer 100 according to the present invention, in which a modular delivery valve 110 is non-positively engaged within the spacer's receptacle 102. In this case, the delivery valve 110 is positioned such that its housing 111 is flush with the outer surface 104 of the spacer. This prevents the delivery valve 110 from being positioned within the receptacle 102 in a way that would form a protrusion that could pose a risk of injury to the patient. The delivery valve 110 is shown here in a partially open state.

[0127] Figure 5 shows an embodiment of the discharge valve 110 in a fully open state. As the pressure of the fluid 200 flowing into the discharge valve 110 from the spacer channel increases, slits 113 located in the rubber-elastic first material 112 open. The slits 113 have slit walls that separate from each other as the pressure of the fluid 200 increases, resulting in the slits 113 opening and allowing the fluid 200 to be delivered from the discharge valve 110.

[0128] Figure 6 shows an embodiment of the discharge valve 110 in a partially open state. In this figure, the pressure of the fluid 200 is only slightly above the limiting pressure at which the slit 113 opens. The two slit walls 115 are positioned close to each other, allowing only a relatively small amount and rate of fluid 200 to be delivered from the discharge valve 110 compared to the state shown in Figure 5.

[0129] Figure 7 shows an embodiment of the discharge valve 110 in a closed state. In the figure shown, the pressure of the fluid 200 is below the limit pressure at which the slit 113 opens. The two slit walls 115 are in contact with each other and are in complete contact with each other, and as a result, the slit 113 is closed and does not allow any flow of fluid 200.

[0130] Figure 8 shows an embodiment of the spacer according to the present invention, which in this example is designed as a knee joint spacer. The spacer has a first sub-element 120 and a second sub-element 130, both of which are equipped with a delivery valve 110 designed and configured to deliver and discharge a medical fluid. The spacer also has a supply line 201 having a fluid connector 202 for introducing the medical fluid, as previously described herein.

[0131] Figure 9 shows a cross-sectional view of a further embodiment of the spacer according to the present invention, designed as a knee joint spacer. This embodiment has a plurality of outlet valves 110 connected to each other and connected to an inlet opening 103 via channels 101. Furthermore, in the embodiment shown in this figure, the spacer comprises a connecting element 107 made of a rubber elastic material. The connecting element 107 is positively connected to a second sub-element 130 of the spacer. Furthermore, the connecting element 107 is positively and / or non-positively connected to a first sub-element 120 of the spacer via a fixture 108. The channels 101 extend into the spacer through the first sub-element 120, the fixture 108, the connecting element 107, and the second sub-element 130. The connecting element 107 allows for lateral rotation of the second sub-element 130 relative to the first sub-element 120. The embodiment shown in this figure has two similar second sub-elements 130, each of which is connected to the same first sub-element 120 via a fastener 108 and a connecting element 107, as described above.

[0132] Figure 10 shows a further embodiment of the spacer according to the present invention, designed as a vertebral spacer. The spacer 100 has a plurality of delivery valves 110, a supply line 201, and a fluid connector 202. The supply line 201 is fluidly connected to the delivery valves 110 via a channel 101 (not shown in this figure) as described herein.

[0133] Figure 11 shows a further embodiment of the spacer according to the present invention, designed as an intramedullary nail spacer. The spacer 100 has a first sub-element 120 and a second sub-element 130, the first sub-element 120 being connected to the second sub-element 130 via a connecting element 107. The connecting element 107 can be connected to the first sub-element 120 and the second sub-element 130 using a fastener 108, as in Figure 9. The first sub-element 120 has an inlet opening 103 together with a supply line 201 and a fluid connector 202, the inlet opening 103 being fluidically connected to a plurality of delivery valves 110 via a channel 101, the delivery valves 110 being located in both the first sub-element 120 and the second sub-element 130. The discharge valve 110 is distributed uniformly across the outer surface of the spacer, i.e., across the outer surfaces of the first sub-element 120 and the second sub-element 130, to ensure the most uniform possible delivery of the medical fluid around the spacer 100. [Explanation of Symbols]

[0134] 100 Spacer 101 channels 102 Receptacle 103 Inlet opening 104 Exterior 105 Cement Area 106 Branches 107 Joint elements 108 Fixtures 110 Discharge valve 111 Housing 112 First material 113 Slits 114 Protrusion 115 Slit wall 120 First sub-element 130 Second sub-element 200 fluid 201 Supply Line 202 Fluid Connector

Claims

1. An implantable spacer (100) for delivering medical fluid to a patient, wherein the spacer has an outer surface (104) and a plurality of delivery valves (110) disposed on the outer surface (104), each of the delivery valves (110) being fluidically connected to one another by channels (101) disposed within the implant, and the delivery valves (110) are designed and configured to reversibly open in response to the pressure of the fluid (200) in the channels (101) in order to deliver fluid (200) from the delivery valves (110).

2. The embedded spacer according to claim 1, wherein each of the discharge valves (110) has a sleeve-shaped housing (111), the spacer has a plurality of receptacles (102), and the discharge valves (110) can be connected to the spacer by positive engagement and / or non-positive engagement of the housing (111) into the receptacles (102).

3. The embedded spacer according to claim 1, wherein each of the discharge valves (110) comprises a first material (112), the first material being rubber-elastic, and the first material further comprises a slit (113) in each case.

4. The embedded spacer according to claim 3, wherein the slit (113) is designed to be reversibly opened and closed by the elastic restoring force of the first material (112) of the discharge valve.

5. The embedded spacer according to claim 3, wherein the first material (112) has a Shore A hardness of 30 to 80, preferably 40 to 70, and more preferably 50 to 60.

6. The embedded spacer according to claim 1, wherein the channel (101) has an inlet opening (103) for receiving fluid, and the inlet opening (103) is preferably located on the outer surface (104) of the spacer.

7. The embedded spacer according to claim 2, wherein the channel (101) has an inlet opening (103) for receiving fluid, and the inlet opening (103) is designed in the same manner as the receptacle (102) or the inlet opening (103) is designed in a different manner from the receptacle (102).

8. The implantable spacer according to claim 1, wherein the spacer is selected from the group consisting of a knee joint spacer, a hip joint spacer, a vertebral body spacer, and an intramedullary nail spacer.

9. The embedded spacer according to claim 1, wherein the spacer is designed and configured to deliver substantially the same amount of fluid simultaneously from each of the discharge valves (110).

10. The embedded spacer according to claim 1, wherein the spacer is designed and configured to open and / or close all of the discharge valves (110) simultaneously.

11. The embedded spacer according to claim 1, wherein each of the discharge valves (110) is arranged to be flush with the outer surface (104) of the spacer.

12. The embedded spacer according to claim 1, wherein the channel (101) has a plurality of branches (106), and preferably each branch has a discharge valve (110) or an inlet opening (103).

13. The embedded spacer according to claim 1, wherein the discharge valve (110) is designed and configured to allow liquid to pass through the discharge valve (110) in only one direction.

14. A medical fluid for use in medical procedures, wherein the procedure is The steps of providing the embedded spacer (100) described in claim 1, The steps include introducing a medical fluid into the channel (101) of the spacer, The steps include opening the discharge valve (110) in a pressure-dependent manner and pressurizing the medical fluid in the channel (101) in order to deliver the fluid to the patient, Medical fluids, including [specific component].

15. The medical fluid for use according to claim 14, wherein the fluid comprises an active ingredient selected from the group consisting of antibiotics, anti-inflammatory agents, anesthetics, and cell proliferation inhibitors.

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