Flexible spacer for applying active substance

Abstract

The present invention relates to an implantable spacer for delivering a medical fluid to a patient wherein the spacer comprises a first sub-element, a second sub-element, an outer surface, a channel, a plurality of delivery valves, and a joint element having a joint body wherein the joint element movably connects the first sub-element to the second sub-element.

Description

[0001] This invention relates to spacers for the repeated or continuous local release of active substances. Furthermore, a method for the local release of active substances is described.

[0002] The term "spacer" generally refers to an orthopedic implant that can be placed in a patient as a temporary placeholder, typically after debridement of infected tissue. Spacers may be modeled according to the shape of the hip, knee, or other joints, or, specifically for use with infected long bones, may have an intramedullary column shape. Another application of spacers is to reduce infection by locally releasing antimicrobial active substances into the previously debrided bone and soft tissue. Conventional spacers are typically made of PMMA bone cement and contain one or more antibiotics embedded in the spacer material. These antimicrobial active substances are released from the PMMA bone cement after implantation through exposure to aqueous bodily fluids such as wound secretions and blood. The release of the active substance occurs through a diffusion process and results in an initial high release of active substance followed by a smaller release. However, a sufficiently high, transient, constant release of active substance is desirable to ensure a consistent local concentration of active substance over a period of several days to several weeks.

[0003] EP3763335B1 describes a knee joint for drug delivery, having a supply line for an active substance solution, wherein the active substance solution can reach multiple outlet openings via a channel system. The problem here is that openings located directly near the supply line release a larger volume of fluid, while more distant outlet openings release only a smaller volume of fluid or no fluid at all. Furthermore, clotted blood or ingrown connective tissue may block the outlet openings.

[0004] A similar knee joint spacer system is disclosed in patent US10864314B2.

[0005] WO2016205077A describes a spacer with a flushing function, wherein flushing fluid is guided on the spacer surface through grooves on the spacer surface.

[0006] EP3542759B1 proposes a similar spacer system having an outlet opening and also an opening for discharging flushing fluid.

[0007] Intramedullary columns designed to reduce infection have also been disclosed. These columns have perforated walls with openings. Antibiotics or antibacterial solutions can be introduced into the intramedullary column from outside the patient through a connected tube (US5681289A, CN2857862Y, CN201370624Y, WO2016205077A1). The antibiotics or antibacterial solution exits through an opening in the wall of the intramedullary column. Problems with these concepts include the possibility that the openings can be blocked by clotted blood, and that the openings may be partially or completely closed by inwardly growing connective tissue after several days. Furthermore, it is problematic that antibiotics or antibacterial solutions tend to leak from an opening on the intramedullary column located directly next to the tube connector. Only a small amount of antibiotics or antibacterial solution is released through an opening further away from the introduction tube, as the solution exits the intramedullary column via the shortest route after the introduction tube. Therefore, it cannot be guaranteed that a constant volume of antibiotics or antibacterial solution will be released along the entire length of the intramedullary column.

[0008] Preferred implementation scheme

[0009] The objective of this invention is to solve one or more of the aforementioned and other problems of the prior art and to provide additional advantages.

[0010] Specifically, the present invention is based on the objective of providing a spacer that enables the repeated or continuous release of an active substance on its outer surface over multiple days to multiple weeks. For this purpose, for example, a medical fluid, such as an aqueous solution of the active substance, can be introduced from the outside into the spacer via a supply line, and the fluid can then be delivered from a plurality of delivery valves on the outer surface of the spacer.

[0011] Specifically, some of the spacers described in this article allow their shape to be adapted to the specific anatomy of the patient to be treated.

[0012] The spacer according to the invention is preferably designed such that approximately equal volumes of active substance solution can be delivered simultaneously from all delivery valves. Furthermore, it is preferable to prevent the delivery valves from being blocked by coagulated blood and ingrown connective tissue. It is also desirable that external fluids cannot penetrate the interior of the spacer through the delivery valves. The delivery valves are designed such that they do not protrude beyond the outer surface of the spacer, and that components of the spacer are not pressed into the surrounding tissue during delivery of the medical fluid. The spacer enables the delivery of relatively small volumes of medical fluid, for example, up to a maximum of 50 ml per single application. The spacer is also suitable for delivering medical fluids with high concentrations of active substance. The spacer according to the invention is preferably suitable for the precise controlled delivery of active substance, wherein uniform delivery can preferably occur at different locations on the spacer. This is an advantage over conventional spacer systems, which are designed to provide flushing functionality by introducing larger volumes into the spacer to flush the surrounding tissue. According to the invention, the spacer described herein preferably does not require any additional elements for draining or reabsorbing the flushing fluid. The spacer is suitable for temporary implantation in previously infected and debrided bone cavities.

[0013] These objectives are achieved through the methods, devices, kits, and medical uses described herein, particularly those described in the claims.

[0014] Preferred embodiments of the present invention will be described below.

[0015] A first embodiment of a first aspect of the invention relates to an implantable spacer for delivering medical fluid to a patient, the spacer including a first sub-element, a second sub-element, an outer surface, a channel, a plurality of delivery valves, and a connector element having a connector body, wherein the connector element movably connects the first sub-element to the second sub-element.

[0016] A second embodiment of the invention relates to a spacer according to the first embodiment, wherein the channel extends from the first sub-element through the connector element into the second sub-element.

[0017] A third embodiment of the invention relates to a spacer according to the foregoing embodiments, wherein the channel defines a connecting axis along its extension direction from the first sub-element through the connector element, and wherein the connector element is designed and configured to allow the second sub-element to move at an angle of at least 20°, preferably at least 30°, or at least 40° relative to the connecting axis.

[0018] A fourth embodiment of the invention relates to an implantable spacer according to any one of the foregoing embodiments, wherein each delivery valve comprises a rubber-elastic first material, and the first material further comprises a slit.

[0019] A fifth embodiment of the invention relates to an implantable spacer according to a fourth embodiment, wherein the slit is configured to open and close by the elastic restoring force of the first material.

[0020] A sixth embodiment of the invention relates to an implantable spacer according to any one of the preceding embodiments, wherein the spacer is designed and configured to deliver substantially the same amount of fluid from each of the delivery valves simultaneously.

[0021] The seventh embodiment of the present invention relates to an implantable spacer according to any one of the foregoing embodiments, wherein the connector body comprises, or is preferably composed of, the rubber-elastic second material.

[0022] The eighth embodiment of the invention relates to an implantable spacer according to the seventh embodiment, wherein the second material of the rubber elasticity has a Shore A hardness in the range of 15 to 80, preferably in the range of 20 to 70, or in the range of 30 to 60.

[0023] The ninth embodiment of the present invention relates to an implantable spacer according to the seventh or eighth embodiment, wherein the rubber-elastic second material has a closed porosity.

[0024] The tenth embodiment of the invention relates to an implantable spacer according to any one of the preceding embodiments, wherein the outer diameter of the connector body is 0.25 to 0.75 times the outer diameter of the surrounding first or second sub-element.

[0025] The eleventh embodiment of the present invention relates to an implantable spacer according to any one of the preceding embodiments, wherein the diameter of the channel has a ratio to the outer diameter of the connector body, the ratio being in the range of 1:1 to 1:6.

[0026] The twelfth embodiment of the present invention relates to an implantable spacer according to the eleventh embodiment, the implantable spacer further comprising an anchor that connects the connector body to, preferably directly to, the first sub-element and / or the second sub-element.

[0027] The thirteenth embodiment relates to an implantable spacer according to any one of the foregoing embodiments, wherein the channel extends through the anchor.

[0028] The fourteenth embodiment relates to an implantable spacer according to any one of the foregoing embodiments, wherein the delivery valves are each fluidly connected to each other through the channel.

[0029] The fifteenth embodiment relates to an implantable spacer according to any one of the preceding embodiments, wherein the delivery valve is designed and configured to reversibly open according to the pressure of the fluid within the channel in order to deliver the fluid from the delivery valve. Attached Figure Description

[0030] Figure 1 A spacer according to the invention is shown, which is designed as an intramedullary column spacer.

[0031] Figure 2 A spacer according to the invention is shown, which is designed as a hip joint spacer.

[0032] Figure 3 A spacer according to the invention is shown, which has sub-elements that move relative to each other by means of a connector element.

[0033] Figure 4 A spacer with internal branch channels according to the present invention is shown.

[0034] Figure 5 A modular delivery valve is shown.

[0035] Figure 6 Details of a spacer with a modular delivery valve according to the present invention are shown.

[0036] Figure 7 The delivery valve is shown in the fully open position.

[0037] Figure 8 The delivery valve is shown in a partially open state.

[0038] Figure 9 The delivery valve is shown in the closed state. Detailed Implementation

[0039] Regarding the embodiments described herein, where an element "has," "comprises," or "includes" a specific feature (e.g., a material), it is always anticipated in principle that there are other embodiments in which the relevant element consists solely of that feature, i.e., excluding any other components. The word "comprises" is used synonymously with the words "comprising" or "having" herein.

[0040] "Operationally connected" or "operably connected" in this document refers to a functional relationship between two related elements. For example, a first element may be configured to control or move a second element via such an operational connection. The term "control" here also includes preventing or enabling a function, such as allowing or restricting the movement of an element or other functions.

[0041] In one implementation, if an element is represented by a singular number, it is also expected that there are implementations containing more than one such element. The use of the terminology for plural elements also, in principle, includes implementations containing only a single corresponding element.

[0042] Unless otherwise indicated or clearly excluded from the context, it is in principle possible, and thus clearly anticipated, for features of different embodiments to also exist in other embodiments described herein. Similarly, all features described herein in conjunction with the methods are also considered in principle to apply to the products, apparatuses, kits, and uses described herein, and vice versa. Not all combinations of such considerations are explicitly listed in all cases, merely for the sake of brevity. In principle, the scope of the invention is also intended to cover technical solutions known to be equivalent to the features described herein.

[0043] The technical specifications and standards mentioned herein (e.g., in conjunction with test procedures) refer to the current versions as of the priority date of this application.

[0044] One aspect of the invention relates to an implantable spacer for delivering medical fluid to a patient, the spacer including a first sub-element, a second sub-element, an outer surface, a channel, a plurality of delivery valves, and a connector element having a connector body, wherein the connector element movably connects the first sub-element to the second sub-element.

[0045] The term "spacer" as used herein refers to a medical implant designed and configured to be implanted in a patient as a temporary placeholder to replace bone or a joint or a portion thereof. In one embodiment, the spacer comprises a biocompatible material such as PMMA, stainless steel, or titanium. The spacer may comprise or be composed of metal, plastic, or metal-plastic composites. Examples of biocompatible metals include 316L steel, cobalt-chromium steel, titanium, and titanium alloys. Examples of biocompatible plastics are polymethyl methacrylate, polyamide 12, polyethersulfone, and polyetherketone. In one embodiment, the spacer is composed of at least 90% (by weight) PMMA.

[0046] In one embodiment, the spacer according to the invention may be produced by SLM (Selective Laser Melting) or EBM (Electron Beam Melting) from stainless steel or titanium or other biocompatible metals or alloys. In one embodiment, the spacer according to the invention may be produced by SLS (Selective Laser Sintering) from a suitable plastic (such as polyamide 12 or polymethyl methacrylate). In one embodiment, the spacer according to the invention may be produced by injection molding from a thermoplastic plastic. The spacer may be assembled from multiple injection-molded parts, wherein these parts may be joined together, for example, by welding or gluing.

[0047] The spacers described herein are preferably designed and configured for delivering medical fluids. "Medical fluid" herein refers to fluids intended for medical use and having pharmaceutical effects.

[0048] The term "medical fluid" as used herein specifically refers to aqueous and non-aqueous liquids that may contain dissolved active ingredients (particularly pharmaceutical active ingredients) or may themselves have medicinal effects. The term also includes gases and gas-liquid mixtures that can exert pharmacological effects in the human or animal body. In one embodiment, the medical fluid contains an active ingredient. In one embodiment, the active substance is selected from the group consisting of antibiotics, antifungals, cell growth inhibitors, anesthetics, bone-inducing active substances, and anti-inflammatory agents.

[0049] In one embodiment, the active ingredient is an antibiotic. In one embodiment, the antibiotic is selected from the group consisting of penicillin, cephalosporins, carbapenems, quinolones, macrolides, lincosamides, aminoglycosides, and glycopeptides. Examples of penicillins are amoxicillin and benzylpenicillin. Examples of cephalosporins are ceftriaxone and cefuroxime. Examples of carbapenems are meropenem and imipenem. Examples of quinolones are ciprofloxacin and levofloxacin. Examples of macrolides are azithromycin and clarithromycin. Examples of glycopeptides are vancomycin and teicoplanin. Examples of aminoglycosides are gentamicin and tobramycin. An example of an aminoglycoside is clindamycin.

[0050] 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).

[0051] In one embodiment, the active substance is a cell growth inhibitor. Examples of cell growth inhibitors include alkylating agents, antimetabolites, natural products, protein kinase inhibitors, and monoclonal antibodies. Examples of alkylating agents include cyclophosphamide, phenylalanine mustard, 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.

[0052] In one implementation, the active substance is an anesthetic. Examples of anesthetics include lidocaine, bupivacaine, ropivacaine, propofol, etomidate, ketamine, morphine, fentanyl, and remifentanil.

[0053] In another embodiment, the active ingredient is a bone-inducing active ingredient. Examples of bone-inducing active ingredients include bone morphogenetic protein (BMP), parathyroid hormone-related peptide, anti-sclerosing antibody, and growth factors. Examples of bone morphogenetic proteins include BMP-2 and BMP-7. Examples of parathyroid hormone-related peptide are teriparatide (PTH 1-34). Examples of anti-sclerosing antibody are romozolomide. Examples of growth factors include fibroblast growth factor (FGF) and platelet-derived growth factor (PDGF).

[0054] In another embodiment, the active substance is an anti-inflammatory agent. Examples of anti-inflammatory agents include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, selective COX-2 inhibitors, biologics (e.g., TNF-α inhibitors), and Janus kinase inhibitors. Examples of NSAIDs include ibuprofen, diclofenac, and naproxen. Examples of glucocorticoids include prednisone, dexamethasone, and hydrocortisone. Examples of selective COX-2 inhibitors include celecoxib and etorcoxib. Examples of TNF-α inhibitors include infliximab, adalimumab, and etanercept. Examples of Janus kinase inhibitors include tofacitinib and baricitinib.

[0055] 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, zoledronic acid), calcitonin, selective estrogen receptor modulators (e.g., raloxifene), and strontium ranelate. 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 and hydroxyapatite.

[0056] In one embodiment, the active substance is selected from the group consisting of gentamicin, tobramycin, amikacin, clindamycin, daptomycin, vancomycin, teicoplanin, dabavancin, fosfomycin, linezolid, epazonamide, colistin, meropenem, fluconazole, micafungin, caspofungin, metronidazole, moxifloxacin, ofloxacin, levofloxacin, ciprofloxacin, rifampicin, and rifampin.

[0057] In one embodiment, the medical fluid comprises an aqueous solution of the active substance described herein.

[0058] 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. The delivery valves are interconnected via channels. The channels are arranged inside the spacer. In some embodiments, the spacer includes an inlet opening. The inlet opening is preferably arranged on the outer surface of the spacer. The inlet opening is designed and configured to introduce medical fluid into the channels. In one embodiment having inlet openings and multiple delivery valves, the channels connect the delivery valves to each other and are connected to the inlet opening.

[0059] In some implementations, the delivery valve is designed and configured to open reversibly according to the pressure of the fluid within the passage in order to deliver fluid from the delivery valve. This enables controlled delivery of fluid from the spacer.

[0060] In some implementations, the delivery valves are arranged to be substantially uniformly distributed above the entire outer surface of the spacer, so that fluid can be uniformly delivered to the entire environment of the spacer. Fluid can be delivered in all spatial directions.

[0061] To ensure uniform delivery of medical fluids to the spacer environment, it may also be advantageous to provide a sufficient number of delivery valves relative to the surface area of ​​the spacer. In one embodiment, the spacer thus provides a sufficient number of delivery valves for every 16.0 cm of the outer surface of the spacer. 2 Includes at least one delivery valve, more preferably for every 9.0 cm of the outer surface of the spacer. 2 Includes at least one delivery valve.

[0062] The delivery valve can be integrated into the spacer material as a unit. An example of this is the slit valve described herein, where, 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 production of slit valves is also referred to herein as the "first material".

[0063] The delivery valve can be modular, allowing the remainder of the spacer to be manufactured separately from the delivery valve, and then the valve can be integrated into the remainder of the spacer. This allows for flexible and cost-effective production, as the same modular delivery valve can be used, for example, for spacers of different shapes.

[0064] In some embodiments, each delivery valve has a sleeve-shaped housing. In some embodiments, the spacer has multiple receiving portions that allow such delivery valves to be coupled to the spacer. In some embodiments, the delivery valve can be coupled to the spacer, or is coupled to the spacer in this way, through a form-fit and / or non-form-fit engagement of the housing to the receiving portions.

[0065] The delivery valve is preferably a pressure-reducing valve, i.e., a valve that opens at a pressure above a predetermined level. This pressure is referred to herein as the "threshold pressure." Preferably, all delivery valves of the spacer have the same threshold pressure. Furthermore, valves that are "non-contact" relative to the spacer environment are preferred, i.e., they are designed in such a way that no part moves toward the surrounding tissue when they open. This prevents irritation to the patient's sensitive tissues, especially in the presence of inflammation. Examples of such delivery valves have a rubber-elastic diaphragm with slit-shaped openings disposed therein, as described below.

[0066] In one embodiment, the delivery valve is designed and configured to open when the pressure is above a threshold pressure of the fluid inside the passage, and to close in a fluid-impermeable manner when the pressure is below this threshold pressure, which is 1 bar (10^5 Pa) higher than the pressure outside the spacer. This means that the delivery valve closes when the overpressure of the fluid in the passage is less than 1 bar, and opens when the overpressure of the fluid in the passage is 1 bar or higher. "Overpressure" here refers to the difference between atmospheric pressure and the pressure of the fluid in the passage of the spacer.

[0067] In some embodiments, each delivery valve comprises a first material. The first material is rubber-elastic. A characteristic of rubber-elastic materials is, in particular, that they automatically return to their original shape after mechanical deformation. In some embodiments, as further explained below, this property provides a slit arranged in the elastic material, the slit having the ability to open or close depending on pressure.

[0068] The delivery valve may, for example, include a first material disposed as a coating on the outer surface of the spacer. A passage in the spacer leads to an opening on the outer surface of the spacer, which may be coated with this material. The coating may form the boundary of such an opening, thereby sealing it.

[0069] In one embodiment, each delivery valve has a housing into which such a first material is introduced. For example, the housing may have a generally cup-shaped geometry with an opening. In such embodiments, the first material can seal the opening in the housing of the delivery valve in a fluid-impermeable manner. The first material may be disc-shaped or cup-shaped.

[0070] The delivery valve can be connected to the spacer via a form-fit connection, a non-form-fit connection, and / or a material bonding connection. For example, the delivery valve can be connected to the spacer by pressing and / or gluing and / or welding and / or threading, or in this way. Specifically, such a connection can exist between the housing of the delivery valve and the receiving portion of the spacer described herein.

[0071] In one embodiment, the first material has a Shore A hardness of 30 to 80. In another embodiment, the first material has a Shore A hardness of 40 to 70 or 50 to 60 (e.g., about 55). Shore A hardness is determined according to ASTM D2240. Elastomers within this Shore A hardness range have very good restoring power and are well-suited for producing rubber-elastic discs or rubber-elastic coatings as described herein as part of a delivery valve. When the pressure acting on the elastomer decreases, the slit in such an elastomer closes automatically and rapidly. In one embodiment, the first material has a Shore A hardness in the range of 75 to 95.

[0072] The first material is preferably a polymer, particularly an elastomer. Preferably, the first material comprises or is composed 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, fluorinated elastomers, perfluorinated elastomers, and polyacrylate elastomers. Examples of silicone elastomers include polydimethylsiloxane (PDMS) and liquid silicone rubber (LSR).

[0073] Examples of thermoplastic elastomers (TPEs) include styrene block copolymers (SBCs), such as styrene-ethylene-butene-styrene (SEBS), thermoplastic polyurethanes (TPUs), and thermoplastic copolyesters (TCEs). Examples of polyisoprene include natural rubber and synthetic polyisoprene. Examples of butyl rubber include bromobutyl rubber (BIIR) and chlorobutyl rubber (CIIR). Preferred polyurethanes are polyether polyurethanes. Polyether polyurethanes can be produced by the addition polymerization of polyether polyols with diisocyanates.

[0074] In one embodiment, the first material is a thermoplastic elastomer. In one embodiment, the first material is composed of a thermoplastic elastomer. In one embodiment, the first material is polyether polyurethane or EPDM rubber. In one embodiment, the first material comprises polyether polyurethane. In one embodiment, the first material is composed of polyether polyurethane.

[0075] In one embodiment, the first material has only a single elastomer, i.e., no second elastomer is mixed with the first material. In another embodiment, the first material has at least two different materials, such as two different elastomers. For example, this allows 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. Preferably, it is a copolymer whose molecular chain contains both soft and hard segments. The physical properties of such a copolymer (e.g., the Shore A hardness of the copolymer) can be adjusted using the ratio between the soft and hard segments within the copolymer's molecular chain. The hard segments can be connected to the soft segments using connectors (linkers).

[0076] In addition, 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.

[0077] Examples of plasticizers include adipates, trimellitates, citrate-based plasticizers, and polyol esters.

[0078] For example, TOTM (tris(2-ethylhexyl) trimellitate), DINCH (diisononyl cyclohexane-1,2-dicarboxylic acid), ATBC (acetyl tributyl citrate), or DEHA (di(2-ethylhexyl) adipate) can be used as plasticizers.

[0079] In one embodiment, the first material is free of plasticizers. In one embodiment, the first material is free of fillers. In one embodiment, the first material is free of endocrine disrupting substances such as phthalates or bisphenol.

[0080] In one embodiment, the first material may further include a lubricant. Preferably, the lubricant is medically acceptable. Preferably, the lubricant is free of polyhalogenated substances and silicones. In one embodiment, the lubricant has a natural product, such as a lipid, triglyceride, or biopolymer.

[0081] In one embodiment, the first material may have a Young's modulus of 1.2 × 10^7 Pa to 2.1 × 10^7 Pa, for example, 1.3 × 10^7 Pa to 2.0 × 10^7 Pa, 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 about 1.6 × 10^7 Pa. In one embodiment, the first material may have a Young's modulus of 2000 psi to 2500 psi. The latter approximately corresponds to 1.4 × 10^7 Pa to 1.7 × 10^7 Pa.

[0082] Young's modulus can be determined according to ASTM D412.

[0083] The first material is preferably sterilized using common sterilization processes, i.e., resistant to UV radiation, γ radiation, and ethylene oxide treatment within these process ranges.

[0084] The first material is preferably molded using standard extrusion and / or injection molding processes.

[0085] 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 a total length in the range of 0.4 mm to 3.0 mm (e.g., in the range of 0.8 mm to 2.5 mm, or in the range of 1.0 mm to 2.0 mm).

[0086] In one embodiment, each of the delivery valves includes a first material having a slit. In another embodiment, each of the delivery valves has exactly one (i.e., no more than one) slit in the first material.

[0087] In one embodiment, all slits of the delivery valve have substantially the same length. In another embodiment, the length of all slits deviates from a certain value by no more than 25% up or down, for example, 1.00 mm + / - 25% of the length, i.e., 0.75 mm to 1.25 mm.

[0088] In one embodiment, the slit is configured to open and close reversibly by the elastic restoring force of a first material. The slit can be opened by overpressure of the fluid in the channel due to the fact that the first material is pushed away by the fluid when a predetermined threshold pressure is exceeded.

[0089] In one embodiment, the slit can be created by partially cutting through the first material, or it can be created without removing a portion of the first material. For example, the slit can be formed by punching with a blade. Such a slit will close completely unless there is a pressure difference across two opposite sides of the first material. This prevents tissue or fluid from penetrating the spacer from the outside.

[0090] In one embodiment, the slit has walls that are in contact with each other when the delivery valve is closed, and that move away from each other when the delivery valve is open.

[0091] In another embodiment, the channel has an inlet opening for receiving fluid, wherein the inlet opening is preferably arranged on the outer surface of the spacer.

[0092] In addition, the spacer may have a fluid connector. The fluid connector can be used to connect a container or fluid-conducting connector to receive liquid into the spacer. An example of a fluid connector is a syringe connector (e.g., 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 fluid-impermeable and fluid-conducting manner. The fluid connector can be detachably connected to the inlet opening. The fluid connector can be operatively connected to the spacer.

[0093] The spacer may also include a supply line that can be connected to or attached to an inlet opening. The supply line may preferably be operatively connected to or attached to an inlet opening. In one embodiment, the spacer has a fluid connector that can be connected to or attached to an inlet opening via the supply line. The supply line may, for example, have tubing made of a medically compatible material.

[0094] In one embodiment, the spacer may include a check valve. The check valve is preferably designed to prevent fluid from escaping from the spacer through the inlet opening. The check valve may be operatively connected to the inlet opening or connected in such a way that it is located directly in the inlet opening, or it may be located in the supply line or fluid connector. Thus, fluid can be introduced into the spacer through the inlet opening without backflow through it.

[0095] To securely connect the supply line to the inlet opening, the spacer may also include a latching mechanism, preferably disposed at the inlet opening. In one embodiment, the latching mechanism includes, for example, one or more movable latching elements designed and configured to move radially inward and engage in corresponding grooves or recesses on the inlet opening when the supply line is inserted into the inlet opening. The latching mechanism may preferably be spring-loaded so that the latching elements can engage at the inlet opening.

[0096] The latching mechanism may have a release element that is designed and configured to release the latching element.

[0097] Preferably, the supply line can be connected to the inlet opening in a manner that ensures fluid conduction at a pressure of at least 1 bar, or in a manner that ensures fluid conduction at the inlet opening.

[0098] In another embodiment, the spacer also includes a cannula. The cannula includes a tip that allows it to penetrate tissue. Furthermore, the cannula includes a shaft along which it can be guided. The shaft may include a cylindrical cavity that resembles a cannula.

[0099] The cannula is preferably connectable to the supply line described herein. Preferably, the cannula is detachably connected to the distal end of the supply line. Using the cannula, a medical user can insert the supply line into the patient's tissue and thus position and hold it at the desired location. The cannula allows for gentle and precise penetration of the target tissue. In this case, a channel can be formed to the desired administration site, thereby allowing for the corresponding positioning of a spacer for administering the medical fluid. The supply line can be inserted into the patient's tissue through the channel formed by the cannula. Preferably, the cannula is removable to then allow the medical fluid to be received via the supply line after positioning using the cannula. For example, the cannula can be removed from the supply line and replaced with a fluid connector (e.g., a Luer lock connector). The medical fluid can then be added to the supply line using, for example, a Luer lock syringe, so that the medical fluid can be delivered to the target location on the patient's tissue using the device.

[0100] In one embodiment, the inlet opening described herein may be configured identically to the receiving portion described herein. In another embodiment, the inlet opening may be configured differently from the receiving portion described herein.

[0101] The spacer can be adapted to different application sites. In one embodiment, the spacer is selected from the group consisting of knee joint spacers, hip joint spacers, vertebral body spacers, and intramedullary column spacers.

[0102] The knee joint spacer can be a single-piece or multi-piece knee joint spacer. The hip joint spacer can be a single-piece or multi-piece hip joint spacer. The vertebral body spacer can be a single-piece or two-piece vertebral body spacer. The delivery system described herein can be present in only one of the two parts of a multi-part spacer or in both parts.

[0103] The spacers described herein (e.g., hip or knee spacers) may each have a first sub-element and a second sub-element. The first and / or second sub-element may be designed for insertion into the bone of a patient. Anchoring may be achieved via bone cement.

[0104] In one implementation, both the first sub-element and the second sub-element include a delivery valve.

[0105] In one embodiment, the spacer also includes a cementation region that does not have a delivery valve or inlet opening. This cementation region is preferably designed and configured to be fixed to the bone of the treated patient using bone cement. In this way, the spacer can remain in place at the desired target location after implantation.

[0106] Furthermore, the invention described herein can be designed as an implant intended to be permanently retained in a patient's body. For example, a bone plate as described herein may be provided with the channels and delivery valves described herein. Therefore, in one aspect, the invention also provides an implant for delivering medical fluids to a patient, wherein the implant has an outer surface and a plurality of delivery valves disposed on the outer surface, wherein each delivery valve is fluidly connected to each other via a channel disposed within the implant, and wherein the delivery valve is designed and configured to reversibly open according to the pressure of the fluid within the channel to deliver the fluid from the delivery valve. The implant may be designed as a joint implant, such as a hip implant, shoulder implant, or knee implant.

[0107] In another embodiment, the spacer or implant described herein is designed and configured to simultaneously deliver substantially the same amount of fluid from each of the delivery valves. For example, substantially the same amount could be an amount having a statistical standard deviation of less than 10% of the arithmetic mean.

[0108] In another embodiment, the spacer or implant described herein is designed and configured to simultaneously open and / or close all delivery valves. Depending on the pressure of the fluid in the channel, the delivery valves are opened or closed accordingly, as described herein.

[0109] In one embodiment, the delivery valves are each arranged such that they are flush with the outer surface of the spacer. This design prevents the delivery valves from forming protrusions relative to the spacer, which could potentially cause damage or irritation to the patient's tissues.

[0110] In one embodiment of the invention, the channel has multiple branches. In this case, each branch preferably has a delivery valve or inlet opening according to the embodiment described herein. This specifically means that, in the case of branches, a delivery valve or inlet opening is present on each side arm of the channel, wherein each delivery valve or inlet opening is preferably arranged on the outer surface of the spacer.

[0111] In one embodiment, the delivery valve is designed and configured to allow liquid to pass through the delivery valve in only one direction. This means that, in this case, the delivery valve is designed as a non-return valve. According to the invention, this means that as long as the pressure of the fluid in the channel is equal to or higher than the ambient pressure outside the spacer, no liquid can enter the channel from the outside through such a delivery valve.

[0112] In one embodiment, the spacer or implant has a connector element. The connector element may have a connector body. The connector element movably connects a first sub-element to a second sub-element. A channel may extend from the first sub-element through the connector element into the second sub-element. The channel may be arranged along the central axis of the connector element.

[0113] In one embodiment, the channel defines a connecting axis along its extension direction from the first sub-element through the joint element. This axis is defined in the absence of external forces acting on the spacer. The joint element may be designed and configured to allow the second sub-element to move at an angle of at least 20° relative to the connecting axis. In one embodiment, this angle is at least 30° or at least 40°. For example, the second sub-element may bend laterally relative to the first sub-element by at least 20°, at least 30°, or at least 40°. The spacer may be designed and configured to allow such bending without closing the channel. To allow this movement, the joint body may comprise a rubber-resilient second material. In one embodiment, the joint body is composed of a second material. The second material may be the same as or 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.

[0114] The channel may have deformable (e.g., flexible) regions.

[0115] The outer diameter of the connector body can be 0.25 to 0.75 times the outer diameter of the surrounding first or second sub-element. These two outer diameters are preferably defined in directions orthogonal to the aforementioned connection axis. Preferably, these two outer diameters are defined along the same line.

[0116] In one embodiment, the ratio of the channel diameter to the outer diameter of the connector body is in the range of [1:1] to [1:6]. The channel diameter is defined as the net width of the channel.

[0117] In one embodiment, the spacer has anchors that connect the connector body to a first sub-element and / or a second sub-element. In one embodiment, the anchors directly connect the connector body to the first or second sub-element. In one embodiment, the anchors connect the connector body to the first sub-element. In one embodiment, the anchors connect the connector body to the second sub-element. In one embodiment, a first anchor connects a first connector body to the first sub-element, and a second anchor connects a second connector body to the second sub-element.

[0118] In one embodiment, the channel extends through the anchor. In one embodiment, the channel extends through the joint body. In one embodiment, the channel extends through the anchor and through the joint body. In one embodiment, the anchor has a substantially cylindrical shape. For example, the anchor may be designed as a screw or bolt. Therefore, the anchor may include threads. The anchor may also include circumferential grooves, protrusions, or other latching devices. The anchor may include cavities to form part of the channel as described herein.

[0119] Anchors can be connected to the second material via form-fit connections, non-form-fit connections, and / or adhesive connections. Anchors can be connected to the first sub-element via form-fit connections, non-form-fit connections, and / or adhesive connections. Anchors can be connected to the second sub-element via form-fit connections, non-form-fit connections, and / or adhesive connections.

[0120] In one embodiment, the anchor is surrounded by a joint body and a first sub-element. In another embodiment, the anchor is surrounded by a joint body and a second sub-element.

[0121] In one embodiment, the spacer is designed and configured to maintain the channel in a fluid conduction state when the first sub-element moves relative to the second sub-element.

[0122] In one embodiment, the anchor has a higher Shore A hardness than the joint body. In one embodiment, the anchor's Shore A hardness is at least 10%, 20%, 30%, 40%, or 50% higher than the joint body's Shore A hardness. This prevents the channel from closing due to movement of the joint elements, such as through... Figure 3 to illustrate.

[0123] In one embodiment, the connector element (preferably the connector body of the connector element) may have a delivery valve as described herein. The delivery valve may be disposed in a second material. The second material may include a slit. In one embodiment, the slit is configured to open and close reversibly by the elastic restoring force of the second material.

[0124] In one embodiment, the spacer includes multiple connector elements. These connector elements can be directly or indirectly connected to each other. For example, multiple connector bodies can be directly connected to each other. For this purpose, the connector bodies may have threaded or latching elements (such as recesses and / or protrusions). The connector bodies can be connected to each other via insert anchors as described herein.

[0125] In addition to the first and second sub-elements, the spacer may also include additional such sub-elements, each of which is connected to each other via a connector element described herein. This allows for greater mobility of the spacer. For example, in such embodiments, the spacer can bend simultaneously in different directions in a manner similar to how vertebral joints in the spine allow bending.

[0126] Another aspect of the invention relates to a kit for producing the spacer described herein, the spacer having a plurality of sub-elements and one or more connector elements described herein. In one embodiment, the kit includes a plurality of interchangeable sub-elements. These sub-elements may have different sizes and / or geometries, such as different lengths and / or thicknesses. This allows medical users to individually adapt the spacer to a patient to be treated.

[0127] In one embodiment, the kit is designed and configured to produce an implantable spacer for delivering medical fluid to a patient, wherein the spacer includes an outer surface and a plurality of delivery valves disposed on the outer surface, wherein each delivery valve is fluidly connected to the others via a channel disposed within the implant, and wherein the delivery valve is preferably designed and configured to reversibly open according to the pressure of the fluid within the channel in order to deliver the fluid from the delivery valve.

[0128] A second aspect of the invention relates to a medical fluid for a medical method, wherein the method includes the following steps:

[0129] Provide the spacer described in this article;

[0130] Medical fluid is introduced into the channel of the spacer;

[0131] And to deliver the fluid from the device to the patient.

[0132] Medical methods may also include pressurizing the medical fluid in the channel to open the delivery valve of the device according to the pressure, and delivering the fluid to the patient.

[0133] The medical approach preferably includes treating inflammation, mechanical injury (trauma), infection, or cancer. The approach preferably includes treating diseased bone or joint. For example, an infection could be osteomyelitis or osteoarthritis. Furthermore, the approach may include pain treatment.

[0134] In one implementation, the medical approach involves a joint infection, such as a hip infection, knee infection, shoulder infection, or intervertebral discitis. In one implementation, the treated joint infection is caused by surgery, such as due to a surgical procedure for implanting an artificial joint. In some implementations, a medical fluid comprising antibiotics and / or antifungal agents is used to treat the joint infection.

[0135] Another embodiment of the invention, according to a second aspect, relates to a medical fluid for use in a medical method as described above, wherein the fluid comprises an active substance. In principle, all active substances described herein may be used. In one embodiment, the fluid comprises an active substance selected from the group consisting of antibiotics, anti-inflammatory agents, anesthetics, and cell growth inhibitors.

[0136] In one embodiment, the active substance is selected from the group consisting of gentamicin, tobramycin, amikacin, clindamycin, daptomycin, vancomycin, teicoplanin, dabavancin, fosfomycin, linezolid, epazonamide, colistin, meropenem, fluconazole, micafungin, caspofungin, metronidazole, moxifloxacin, ofloxacin, levofloxacin, ciprofloxacin, rifampicin, and rifampin.

[0137] In one embodiment, the medical fluid is an aqueous solution of the active substance described herein.

[0138] In one embodiment, the medical method includes implanting a spacer into a patient's tissue, preferably in a joint region or at a fracture site. In another embodiment, the medical procedure includes using a cannula to penetrate the patient's tissue to guide a supply line for the spacer from inside the patient through the skin to the outside.

[0139] In one embodiment, a pump (e.g., an infusion pump) is used to introduce medical fluid into the channels of the spacer. In one embodiment, the medical fluid is delivered continuously to the patient over time periods of minutes, hours, or days. In one embodiment, the medical fluid is delivered repeatedly to the patient. For example, the medical fluid may be delivered to the patient once a day or multiple times a day (e.g., twice, three, or more than three times a day). In one embodiment, the medical fluid is delivered based on the patient's health parameters. Health parameters may be, for example, diagnostic measurements or the patient's pain level.

[0140] In one implementation, a manual or automatic controller is used to meter the medical fluid.

[0141] Another aspect of the present invention relates to a medical treatment method comprising the following steps:

[0142] Provide the spacers, implants, or kits described in this article;

[0143] Introduce medical fluid into the channel of the spacer or implant;

[0144] The medical fluid in the channel is pressurized and then delivered to the patient.

[0145] The method may also include pressurizing the medical fluid in the channel to open the delivery valve of the device according to the pressure, and delivering the fluid to the patient.

[0146] Therefore, the above statements regarding medical fluids used in medical methods apply here.

[0147] Attached Figure

[0148] Figure 1A cross-section of a first embodiment of a spacer 100 according to the invention is shown, which is designed as an intramedullary column spacer. The spacer 100 has a first sub-element 120 and a second sub-element 130, wherein the first sub-element 120 is connected to the second sub-element 130 via a connector element 107. In each case, the connector element 107 is connected to the first sub-element 120 and the second sub-element 130 by means of an anchor 108. The first sub-element 120 has an inlet opening 103 with a supply line 201 and a fluid connector 202, wherein the inlet opening 103 is fluidly connected via a channel 101 to a plurality of delivery valves 110, wherein the delivery valves 110 are arranged on the first sub-element 120 and the second sub-element 130. The delivery valves 110 are uniformly distributed above the outer surface 104 of the spacer, i.e., above the outer surfaces of the first sub-element 120 and the second sub-element 130, so as to deliver medical fluids most uniformly throughout the environment of the spacer 100.

[0149] Channel 101 has a branch 106. The spacer has an outer surface 104 on which a receiving portion 102 is arranged. The receiving portion 102 has a delivery valve 110 inserted therein. In the example shown here, one of the receiving portions 102 is configured as an inlet opening 103 to establish a fluid conduction connection with the supply line 201. The proximal end of the supply line 201 is form-fitted or non-form-fitted into the inlet opening 103. The supply line 201 has a distal end that is fluidly connected to a fluid connector 202. In this case, the fluid connector 202 is designed as a Luer lock connector. The delivery valves 110 are arranged at different locations on the outer surface 104 of the spacer to enable the most uniform distribution of medical fluid into the spacer environment. Channel 101 connects the inlet opening 103 to the delivery valve 110, such that fluid received through the inlet opening 103 can flow through channel 101 to the delivery valve 110.

[0150] Figure 2A cross-sectional view of another embodiment of the spacer according to the invention is shown, designed as a knee joint spacer. This embodiment has a plurality of delivery valves 110 connected to each other via a channel 101 and connected to an inlet opening 103. Furthermore, in the embodiment shown here, the spacer includes a connector element 107 made of a rubber-elastic material. The connector element 107 is connected to a second sub-element 130 of the spacer via a form-fit connection. Additionally, the connector element 107 is connected to a first sub-element 120 of the spacer via a form-fit and / or non-form-fit connection via an anchor 108. The channel 101 extends within the spacer through the first sub-element 120, the anchor 108, the connector element 107, and the second sub-element 130. The connector element 107 allows for lateral rotational movement of the second sub-element 130 relative to the first sub-element 120. The channel 101 remains open in any position, allowing fluid to be directed through the connector element 107. The embodiment shown here has two identical second sub-elements 130, which, as described above, are each connected to the same first sub-elements 120 via anchors 108 and connectors 107.

[0151] Figure 3 The cross-sectional view shows the results according to Figure 2 According to an embodiment of the spacer 100 of the invention, the second sub-element 130 is laterally movable relative to the first sub-element 120 by means of a connector element 107, wherein the connector element 107 enables the second sub-element 130 to be laterally rotatably moved. This allows the spacer shown herein to be implanted into the patient with greater precision than that achievable with conventional rigid spacers, without compromising the fluid conductivity properties of the spacer.

[0152] Figure 4 A cross-section of a spacer filled with medical fluid 200 is shown. The spacer shown here is designed to allow medical fluid to be injected into channel 101 via a syringe through fluid connector 202, supply line 201, and inlet opening 103. Due to the pressurization of the fluid 200 within channel 101, delivery valve 110 opens to deliver fluid from spacer 100 to the patient's target tissue. Delivery valve 110 is designed and configured to open at a predetermined pressure above the fluid 200 in channel 101. This allows for uniform delivery of fluid 200 in both time and quantity via all delivery valves 110.

[0153] Figure 5A cross-sectional view of an embodiment of the delivery valve 110 is shown. This embodiment of the delivery valve 110 is configured with a modular design, allowing it to be manufactured separately and incorporated into the spacer 100 according to the invention. The delivery valve 110 has a housing 111, wherein the housing 111 has a protrusion 114 designed for a fixed connection with a receiving portion of the spacer. A rubber-resilient first material 112 with a slit 113 is arranged inside the delivery valve. The slit 113 is designed and configured to open or close according to pressure, such as... Figures 7 to 9 As shown in more detail below. Slit 113 is shown here as partially open.

[0154] Figure 6 Details of an embodiment of the spacer 100 according to the invention are shown, wherein a modular delivery valve 110 is non-form-fitted into the receiving portion 102 of the spacer. In this case, the delivery valve 110 is arranged such that the housing 111 of the delivery valve 110 is ultimately flush with the outer surface 104 of the spacer. This prevents the delivery valve 110 from being arranged in the receiving portion 102 in a manner that forms a protrusion that could pose a risk of injury to the patient. The slit 113 is shown here as being in a partially open state.

[0155] Figure 7 An embodiment of the delivery valve 110 in the fully open state is shown. Due to the increased pressure of the fluid 200 flowing into the delivery valve 110 from the passage of the spacer, a slit 113 arranged in a rubber-elastic first material 112 opens. The slit 113 has slit walls that separate and move away from each other due to the increased pressure of the fluid 200, thereby opening the slit 113 and enabling the delivery of fluid 200 from the delivery valve 110.

[0156] Figure 8 An embodiment of the delivery valve 110 in a partially open state is shown. In the figure shown here, the pressure of the fluid 200 is only slightly higher than the threshold pressure for opening the slit 113. The two slit walls 115 are positioned close to each other and... Figure 5 Compared to the state shown, only a relatively small amount and low delivery speed of fluid 200 from delivery valve 110 are allowed.

[0157] Figure 9 An embodiment of the delivery valve 110 in a closed state is shown. In the figure shown here, the pressure of the fluid 200 is below the threshold pressure at which the slit 113 will open. The two slit walls 115 are in contact with each other and fully abut against each other, such that the slit 113 is closed and the flow of fluid 200 is not permitted.

[0158] List of icon numbers

[0159] 100 spacers

[0160] Channel 101

[0161] 102 Reception Department

[0162] 103 Entrance opening

[0163] 104 Outer Surface

[0164] 105 Bonded Area

[0165] 106 branches

[0166] 107 Connector Components

[0167] 108 Anchors

[0168] 110 Delivery Valve

[0169] 111 Shell

[0170] 112 First Material

[0171] 113 Slit

[0172] 114 Protrusion

[0173] 115 Slit Wall

[0174] 120 First Sub-element

[0175] 130 Second Sub-element

[0176] 200 fluid

[0177] 201 Supply Pipeline

[0178] 202 Fluid Connector

Claims

1. An implantable spacer (100) for delivering medical fluid to a patient, the implantable spacer comprising a first sub-element (120), a second sub-element (130), an outer surface (104), a channel (101), a plurality of delivery valves (110), and a connector element (107) having a connector body (109), wherein the connector element (107) movably connects the first sub-element (120) to the second sub-element (130).

2. The implantable spacer according to claim 1, wherein the channel (101) extends from the first sub-element (120) through the connector element (107) into the second sub-element (130).

3. The implantable spacer of claim 2, wherein the channel (101) defines a connecting axis (310) of the connector element (107) from the first sub-element (120) along its extension direction, and wherein the connector element (107) is designed and configured to allow the second sub-element (130) to move at an angle of at least 20°, preferably at least 30°, or at least 40° with respect to the connecting axis (310).

4. The implantable spacer according to any one of the preceding claims, wherein each of the delivery valves (110) comprises a rubber-elastic first material (112), and the first material further comprises a slit (113).

5. The implantable spacer according to claim 4, wherein the slit (113) is configured to reversibly open and close by the elastic restoring force of the first material (112).

6. An implantable spacer according to any one of the preceding claims, wherein the spacer is designed and configured to deliver substantially the same amount of fluid from each of the delivery valves (110) simultaneously.

7. The implantable spacer according to any one of the preceding claims, wherein the connector body (109) comprises a rubber-elastic second material (116), or preferably is composed of the rubber-elastic second material.

8. The implantable spacer according to claim 7, wherein the second rubber-elastic material (116) has a Shore A hardness in the range of 15 to 80, preferably in the range of 20 to 70, or in the range of 30 to 60.

9. The implantable spacer according to claim 7 or 8, wherein the rubber-elastic second material (116) has a closed porosity.

10. The implantable spacer according to any of the preceding claims, wherein the outer diameter (320) of the connector body (109) is 0.25 to 0.75 times the outer diameter of the surrounding first sub-element (120) or second sub-element (130).

11. The implantable spacer according to any one of the preceding claims, wherein the diameter (330) of the channel (101) has a ratio to the outer diameter (320) of the connector body (109), the ratio being in the range of 1:1 to 1:

6.

12. The implantable spacer according to any one of the preceding claims, the implantable spacer further comprising an anchor (108) that connects the connector body (109) to, preferably directly to, the first sub-element (120) and / or the second sub-element (130), wherein the channel (101) further preferably extends through the anchor (108).

13. The implantable spacer according to any one of the preceding claims, wherein each of the delivery valves (110) is fluidly connected to each other through the channel (101).

14. The implantable spacer according to any one of the preceding claims, wherein the delivery valve (110) is designed and configured to reversibly open according to the pressure of the fluid (200) within the channel (101) to deliver the fluid (200) from the delivery valve (110).

15. The implantable spacer according to any one of the preceding claims, the implantable spacer further comprising an inlet opening (103) for receiving fluid, wherein the inlet opening (103) is preferably disposed on the outer surface (104) of the spacer.

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