Medical dispensing system with self-closing slit valves

Abstract

To provide a device for the temporary, local application of medical fluids over a period of hours to several days.SOLUTION: There is provided a device for dispensing a medical fluid to a patient, comprising: a tube 101 comprising a first medically acceptable material with a Shore A hardness in the range of 75 to 95, wherein the tube has an inner diameter (ID) and an outer diameter (AD), wherein the ratio of [ID:AD] is in the range of [1:1.8] to [1:2.5], wherein the tube comprises a first end for receiving a fluid into the tube, wherein the tube comprises a second end 103 configured to retain a fluid in the tube; one or more slits 104 for dispensing a fluid from the tube, wherein the slits each form a passage extending from an inner side of the tube to an outer side of the tube, and wherein the slits are configured to reversibly open depending on the pressure of a fluid within the tube so that the fluid is dispensed from the slits.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present application relates to a device for the temporary local application of medical fluids over a period of several hours to several days. Depending on the anatomical situation at the implantation site, the device according to the invention can be adapted in terms of its length by simple mechanical shortening without loss of function.

[0002] The topical application of pharmaceutical active ingredients, in particular antibiotics, is generally known and has proven to be particularly effective in treating or relieving infections of bone tissue. A distinction can be made between non-absorbable and absorbable or biodegradable active ingredient carriers.

[0003] An example of a non-absorbable active ingredient carrier is the bead chain, known since 1977 under the trade name Septopal®. These consist of polymethyl methacrylate beads containing the broad-spectrum antibiotic gentamicin sulfate, which are arranged in a chain on a steel thread. This chain-like active ingredient carrier has proven effective for decades in the local antibiotic treatment of osteomyelitis. An advantage of this type of carrier is that gentamicin sulfate is released in large quantities from the active ingredient carrier over several days. Another advantage is that the active ingredient carrier in chain form can be easily adapted to the anatomical situation at the implantation site by the medical user simply cutting off excess beads. A disadvantage is that the active ingredient carrier contains only gentamicin sulfate, preventing the medical user from modifying the active ingredient carrier with additional antibiotics depending on the microbial susceptibility. As a result, successful local treatment of infections caused by problematic bacteria such as MRSA and VRSA is only possible to a limited extent, or even completely impossible. Removal of the Septopal® chain after the active ingredient is released is associated with considerable stress for the patient due to its adhesion to connective tissue.

[0004] Examples of absorbable or biodegradable active ingredient carriers include fleeces and sponges made of collagen or gelatin. Examples include patents DE3429038, DE3334595, DE2843963, DE3203957, and DE3334595. These contain gentamicin sulfate or a mixture of gentamicin sulfate and a slightly water-soluble gentamicin salt. Furthermore, there are various absorbable or biodegradable active ingredient carriers based on tricalcium phosphate, hydroxyapatite, gypsum, and mixtures thereof, as well as composite materials made from these salts and organic binders.

[0005] The disadvantages of the listed non-absorbable and absorbable or biodegradable active ingredient carriers are that the antibacterial active ingredient is determined by the selected composition, and furthermore, after implantation of the active ingredient carrier, the active ingredient cannot be replaced or supplemented with other active ingredients. Furthermore, the release of the active ingredient in all conventional local active ingredient delivery systems is based on the principle of diffusion, so a large amount of the active ingredient is only released in the first few hours and days. The exception is the use of an active ingredient salt that is slightly soluble in water, where the release of the active ingredient depends on the solubility equilibrium of the active ingredient salt.

[0006] Therefore, it is desirable to have an active ingredient carrier that allows for the local application of any active pharmaceutical ingredient and allows the active pharmaceutical ingredient to be exchanged at any time with another fluid active pharmaceutical ingredient.Furthermore, it is desirable to be able to directly adjust the active ingredient concentration achieved directly at the implantation site.

[0007] EP 3795196 (B1) discloses a device for the local application of a medical fluid, the medical fluid comprising a flexibly deformable tube having a tube wall, the tube wall including a radially outer outer wall made of a first material and a radially inner inner wall made of a second material, defining an inner line of the tube, the tube having a plurality of openings in the tube wall at a distal section of the tube, the plurality of openings connecting the inner line of the tube to a portion surrounding the tube, the distal section of the tube being defined by a distal end of the tube, the device further comprising a closure element that closes or can close the tube in a liquid-tight manner at the distal end of the tube, the closure element being manually insertable into the distal end of the tube, the proximal end of the tube being connected or can be connected in a liquid-permeable manner to a container for the medical fluid so that the medical fluid can be extruded from the container through the proximal end of the tube into the inner line of the tube and through the plurality of openings into the portion surrounding the tube.

[0008] EP 3854437 (B1) describes a device for the local application of medical fluids comprising a tube, the tube having a plurality of openings in its tube wall connecting an inner line of the tube with a portion surrounding the tube, the tube being closed at a distal tube end of the tube, the device comprising an outer sleeve for fluid-tightly closing some of the plurality of openings, the outer sleeve being axially displaceable around the tube, the outer sleeve being shorter than the tube so that distal openings not belonging to the closed portion of the plurality of openings are exposed.

[0009] Preferred Embodiments The present invention aims to solve one or more of the above-mentioned problems and further problems of the prior art. It is an object of the present invention to provide a simple, cost-effective device for localized active ingredient release. In some embodiments, a low-cost homogenous tube can be used, thus avoiding the use of expensive coaxial tubes made from two separate polymers. Such a device may enable the local application of medical fluids of any composition (e.g., antibiotic solutions). To this end, one portion of the device can be placed inside the patient's body after implantation, and a second portion of the device can be placed outside the patient's body. The medical fluid is introduced into the portion of the device located outside the patient's body, passed through the device to the implantation site, and released there. The device can be plastically deformable to conform to the anatomical conditions at the implantation site. Release of the medical fluid can occur through longitudinally disposed openings on the device. The openings may be reversibly closable to prevent connective tissue ingrowth and / or blockage of the openings, for example, by clotted blood. It is desirable that the device not expand radially during use, or only expand radially to a minimal extent. Inflamed human tissue is highly sensitive to pain under pressure. Therefore, it is preferable to avoid significant radial expansion of the device, which would cause pressure and therefore pain in the patient. Another advantage is that repeated release of medical fluid by applying pressure does not tear or irreversibly dilate the opening. Preferably, the opening characteristics of the opening of the device can be kept constant over the entire length of the device, even in the case of multiple releases, to ensure uniform release of medical fluid. Furthermore, the device can be designed so that the portion of the device that can be positioned within the patient's body can be adapted to the patient's relevant anatomical situation by shortening the length of the tubing without compromising the function of the device.

[0010] These objects are achieved by the methods, devices, kits and medical applications described herein, in particular by the methods, devices, kits and medical applications claimed below.

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

[0012] A first embodiment of the present invention is an apparatus for dispensing medical fluid to a patient, comprising: A tube comprising a medically acceptable first material having a Shore A hardness in the range of 75 to 95, the tube having an inner diameter (ID) and an outer diameter (AD); The ratio of [ID:AD] is within the range of [1:1.8] to [1:2.5], a tube having a first end for receiving a fluid within the tube; a tube having a second end configured to hold a fluid within the tube; one or more slits for dispensing fluid from the tube, each slit forming a passageway extending from the inside of the tube to the outside of the tube; and one or more slits configured to reversibly open in response to pressure of fluid in the tube so that the fluid is dispensed from the slits.

[0013] A second embodiment relates to a device according to the first embodiment, wherein the device is designed and configured to dispense medical fluid only through the slit, and preferably the simultaneous dispensing of fluid is through multiple slits at different positions along the longitudinal axis of the tube.

[0014] A third embodiment relates to a device according to the first or second embodiment, wherein the slit is designed and configured to open when the fluid inside the tube exceeds a threshold pressure of 1 bar (10^5 Pa) higher than the pressure outside the tube, preferably 1.4 bar, and to close fluid-tightly when the pressure falls below this threshold pressure.

[0015] A fourth embodiment relates to a device according to one of the previous embodiments, wherein the slit is configured to reversibly open and close by an elastic restoring force of the first material of the tube.

[0016] A fifth embodiment relates to a device according to one of the previous embodiments, wherein the slits each have a slit length L, and the ratio of the slit length (L) to the inner diameter (ID) of the tube [L:ID] is in the range of [1:2.2] to [1:2.9], and / or the ratio of the slit length L to the outer diameter AD of the tube [L:AD] is in the range of [1:3.5] to [1:5.5].

[0017] A sixth embodiment relates to a device according to one of the previous embodiments, wherein the device is designed and configured to change the outer diameter AD of the tube by less than 10% when the pressure of the fluid inside the tube increases from 0 to 1 bar (10^5 Pa) higher than the pressure outside the tube.

[0018] A seventh embodiment relates to a device according to one of the previous embodiments, wherein the device is designed and configured to change the length of the tube by less than 10%, preferably less than 5%, when the pressure of the fluid inside the tube increases from 0 to 1 bar (10^5 Pa) higher than the pressure outside the tube.

[0019] An eighth embodiment relates to a device according to one of the previous embodiments, wherein the tube comprises a plurality of slits, each slit being arranged at a distance (A) from one another on the outside of the tube, and having a slit length (L) along the outside of the tube, and wherein the ratio [A:L] of the distance (A) to the slit length (L) is at least [10:1].

[0020] A ninth embodiment relates to a device according to one of the previous embodiments, wherein the tube comprises a second material having a higher Shore A hardness than the first material, the second material preferably arranged as a coaxially surrounding layer or as a strip parallel to the longitudinal axis of the tube, and the second material further preferably comprises an elastomer, and further preferably the second material is fully embedded in the first material.

[0021] A tenth embodiment relates to the device according to the ninth embodiment, wherein the second material comprises a radiopaque agent and / or dye, the radiopaque agent preferably comprising barium sulfate or tungsten, and the dye preferably having an absolute emission maximum in the range of 490 nm to 575 nm.

[0022] An eleventh embodiment relates to a device according to one of the previous embodiments, in which the slits are arranged parallel to the longitudinal axis of the tube.

[0023] A twelfth embodiment relates to a device according to one of the previous embodiments, wherein at a first longitudinal position in the direction of the longitudinal axis of the tube, a first slit is arranged at a first radial position, and at a second longitudinal position in the direction of the longitudinal axis of the tube, a second slit is arranged at a second radial position, the first radial position forming an angle of approximately 90° with respect to the second radial position.

[0024] A thirteenth embodiment relates to a device according to one of the previous embodiments, wherein the tube comprises a metallic support structure, which preferably comprises a metal coating, a metal foil, a metal spiral, or a metal thread, and which is preferably embedded in the first material or disposed inside the tube.

[0025] A fourteenth embodiment relates to a device according to one of the previous embodiments, wherein the medically acceptable first material comprises a polymer, which preferably comprises polyether urethane or ethylene propylene diene rubber.

[0026] A fifteenth embodiment relates to a device according to one of the previous embodiments, further comprising a fluid connector arranged, preferably removably arranged, at the first end of the tube.

[0027] A sixteenth embodiment relates to an embodiment according to the fifteenth embodiment, wherein the fluid connector comprises a luer lock connector and / or a check valve.

[0028] A seventeenth embodiment relates to a device according to one of the previous embodiments, wherein the second end is closed or can be closed fluid-tight, preferably by welding, fusion, or with a plug or screw cap.

[0029] An eighteenth embodiment relates to a device according to one of the previous embodiments, in which the slit can be or is made by cutting a portion of the tube without removing material from the tube, for example by perforating it with a blade.

[0030] A nineteenth embodiment relates to a device according to one of the previous embodiments, wherein the device is designed and configured to permanently change the length of the tube, for example by removing a portion of the tube at the second end of the tube.

[0031] A twentieth embodiment relates to a device according to one of the previous embodiments, in which the tube is formed in one piece and the device does not comprise a second tube.

[0032] A first embodiment of a further aspect relates to a kit comprising a device according to one of the previous embodiments and means for introducing a medical fluid that can be connected to the first end of the tube.

[0033] A second embodiment of the kit according to the previous embodiment further comprises means for closing the second end of the tube.

[0034] A third embodiment relates to a kit according to the first or second embodiment, further comprising a medical fluid comprising an active ingredient, the active ingredient preferably being selected from the group consisting of antibiotics, antifungals, antitumor active ingredients, osteoinductive active ingredients, and anti-inflammatory active ingredients.

[0035] A fourth embodiment relates to a kit according to one of the previous embodiments, further comprising a trocar, which is connectable, preferably removably connectable, to the first end of the tube.

[0036] Another aspect relates to a method of medical treatment, the method of treatment comprising administering a medical fluid to a patient using the device of the previous embodiments or the kit of one of the previous embodiments.

[0037] Another aspect relates to a medical active ingredient for use in bone surgery, wherein the active ingredient is selected from the group consisting of an antibiotic, an antifungal, an antitumor active ingredient, an osteoinductive active ingredient, and an anti-inflammatory active ingredient, the method comprising contacting a device of the previous embodiments or a kit of one of the previous embodiments with a surgical wound of a patient, and administering the active ingredient locally as a medical fluid to the surgical wound using the device or kit. [Brief explanation of the drawings]

[0038] [Figure 1] 1 shows a cross-sectional view of a tube detail of a device according to the invention. [Figure 2] 1 shows an embodiment of the device according to the invention. [Figure 3] 1 shows a fluid connector that can be removably connected to the tubing of the device. [Figure 4] 1 shows a fluid connector having a check valve. [Figure 5] 3 shows a second end of the tube of the device according to the invention, which can be closed with a plug. [Figure 6] 10 shows a second end of a tube of a device according to the present invention with a support structure within the lumen of the tube. [Figure 7] 1 shows a second end of the tube of a device according to the invention, the second end having the tube walls welded together thereby closing it off. [Figure 8] 1 shows a second end of the tube having a second material embedded in the tube wall. [Figure 9] 1 illustrates a cross-sectional view of a second end of a tube having a second material embedded in the tube wall, the second material being disposed in strands within the tube. [Figure 10]1 illustrates a cross-sectional view of a second end of a tube having a second material embedded in the tube wall, the second material being disposed coaxially and surroundingly within the tube. [Figure 11] FIG. 1 shows a longitudinal cross section of a detail of a tube with two slits arranged offset from each other. [Figure 12] FIG. 1 shows a cross-sectional view of a detail of a tube with two slits offset from one another. [Figure 13] 1 shows a longitudinal cross section of a detail of a tube with the slits in the tube closed. [Figure 14] 1 shows a longitudinal cross section of a detail of the tube, with the slits in the tube open. [Figure 15] 1 illustrates a kit comprising a device described herein, a means for introducing a medical fluid, and a means for closing the second end of the tube. DETAILED DESCRIPTION OF THE INVENTION

[0039] With respect to the embodiments described herein, elements that "have," "contain," or "comprise" a particular feature (e.g., material) always contemplate further embodiments in which, in principle, the associated element consists solely of that feature, i.e., no other components. The terms "comprise" or "comprising" are used interchangeably herein with the terms "contain," "containing," "have," or "having."

[0040] "Operably connected" or "operably connectable," as used herein, means that the two elements associated therewith have a functional relationship to one another. For example, a first element may be configured to control or move a second element through such an operative connection. The term "control," as used herein, also includes blocking or enabling a function, e.g., allowing or restricting the movement or other function of an element.

[0041] In one embodiment, where an element is referred to in the singular, embodiments where there are two or more such elements are also contemplated. The use of a term for plural elements essentially encompasses embodiments where only a single corresponding element is included.

[0042] Unless otherwise indicated or clearly excluded from the context, it is possible in principle that features of different embodiments may also be present in other embodiments described herein, and this possibility is expressly contemplated herein. Similarly, all features described herein in the context of methods are also considered to be applicable in principle to the products, devices, kits, and uses described herein, and vice versa. Merely for the sake of brevity, all such possible combinations have not been explicitly listed in all cases. Technical solutions known to be equivalent to features described herein are also intended to be encompassed in principle by the scope of the present invention.

[0043] For example, technical standards and specifications set forth herein relating to testing procedures refer to the latest edition as of the priority date of this application.

[0044] One embodiment of the present invention is an apparatus for dispensing medical fluid to a patient, comprising: a tube having a first end for receiving a fluid within the tube; a tube having a second end configured to hold a fluid within the tube; one or more slits for dispensing fluid from the tube, each slit forming a passageway extending from the inside of the tube to the outside of the tube; and one or more slits configured to reversibly open in response to pressure of fluid in the tube so that the fluid is dispensed from the slits.

[0045] The device is preferably designed and configured to dispense medical fluids to a patient. As used herein, the term "fluid" includes aqueous and non-aqueous liquids, gases, and mixtures thereof. "Medical fluid" as used herein refers to a fluid intended for medical use and having medicinal properties.

[0046] The term "medical fluid" as used herein refers in particular to aqueous and non-aqueous liquids that may contain dissolved active ingredients, in particular pharmaceutical active ingredients, or that may themselves have medicinal properties. The term also includes gases and gas-liquid mixtures that may exert a pharmacological effect in the human or animal organism. In one embodiment, the medical fluid comprises an active ingredient. In one embodiment, the active ingredient is selected from the group consisting of antibiotics, antifungals, antitumor active ingredients, osteoinductive active ingredients, and anti-inflammatory active ingredients.

[0047] 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 penicillins include amoxicillin and benzylpenicillin. Examples of cephalosporins include ceftriaxone and cefuroxime. Examples of carbapenems include meropenem and imipenem. Examples of quinolones 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.

[0048] 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). In one embodiment, the active ingredient is an antitumor active ingredient (cytostatic agent). Examples of antitumor active ingredients (cytostatic agents) 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.

[0049] In a further embodiment, the active ingredient is an osteoinductive active ingredient. Examples of osteoinductive active ingredients include bone morphogenetic proteins (BMPs), parathyroid hormone-related peptides, 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 factors (FGFs) and platelet-derived growth factors (PDGFs).

[0050] In a further embodiment, the active ingredient is an anti-inflammatory active ingredient. Examples of anti-inflammatory active ingredients include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, selective COX-2 inhibitors, biologics (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.

[0051] 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 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 (beta tricalcium phosphate) and hydroxyapatite.

[0052] The device includes a tube that can be filled with a medical fluid. The tube is preferably designed and configured to receive the medical fluid within the tube. The hollow interior of the tube is also referred to as the "lumen."

[0053] The tube comprises a medically acceptable material. "Medically acceptable," as used herein, refers to the property of a material that does not adversely affect the human body or other biological systems. This means that the material can be introduced into the body safely and without undesirable side effects, without endangering the patient's health.

[0054] The tube has a first end for receiving a fluid within the tube.

[0055] One embodiment is an apparatus for dispensing medical fluid to a patient, comprising: A tube comprising a medically acceptable first material having a Shore A hardness in the range of 75 to 95, the tube having an inner diameter (ID) and an outer diameter (AD); The ratio of [ID:AD] is within the range of [1:1.8] to [1:2.5], a tube having a first end for receiving a fluid within the tube; a tube having a second end configured to hold a fluid within the tube; one or more slits for dispensing fluid from the tube, each slit forming a passageway extending from the inside of the tube to the outside of the tube; and one or more slits configured to reversibly open in response to pressure of fluid in the tube so that the fluid is dispensed from the slits.

[0056] When the ratio of the inner diameter to the outer diameter of the tube [ID:AD] is in the range of [1:1.8] to [1:2.5], this can reduce or prevent undesired stretching of the tube when the inside of the tube is filled with a fluid whose pressure is significantly higher than the ambient pressure, especially for tubes made of materials with a Shore A hardness in the range of 75 to 95.

[0057] This eliminates the need for an additional stabilizing tubing layer.

[0058] If the ratio of the inner diameter to the outer diameter of the tube [ID:AD] is within the range of [1:1.8] to [1:2.5], it is also possible to avoid the need for excessive force when filling and pressurizing the tube with fluid.

[0059] The tube comprises a first material. The first material comprises: The first material has a Shore A hardness in the range of 75 to 95. In one embodiment, the first material has a Shore A hardness of 80 to 90, for example about 85. Shore A hardness is determined according to ASTM D2240.

[0060] In one embodiment, the tubing comprises a mass fraction of at least 50%, preferably at least 60%, 70%, 80%, or at least 90% of the first material. This mass fraction is calculated without considering any elements removably connected to the tubing, such as fluid connectors or plugs, or contents inside the tubing, such as medical fluids. In one embodiment, the tubing is substantially entirely made of the first material. The first material is preferably a polymer, particularly an elastomer. Preferably, the first material comprises 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).

[0061] 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 polyetherurethane. Polyetherurethanes can be produced by the polyaddition reaction of polyether polyols with diisocyanates.

[0062] In one embodiment, the first material comprises a thermoplastic elastomer. In one embodiment, the first material consists of a thermoplastic elastomer. In one embodiment, the first material comprises a polyetherurethane or an ethylene propylene diene rubber. In one embodiment, the first material comprises a polyetherurethane. In one embodiment, the first material consists of a polyetherurethane.

[0063] In one embodiment, the first material contains only a single elastomer, i.e., the second elastomer is not mixed with the first material. In one embodiment, the first material contains at least two different materials, e.g., 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. Copolymers containing soft and hard segments in the molecular chain are preferred. The ratio between the soft and hard segments in the molecular chain of the copolymer can be used to adjust the physical properties of such copolymers, such as the Shore A hardness of the copolymer. The hard segments can be connected to the soft segments using connectors (linkers).

[0064] Furthermore, the first material may contain additives to adjust hardness. Examples of such additives include fillers and plasticizers. Examples of fillers include silica, titanium dioxide, calcium carbonate, barium sulfate, and carbon.

[0065] Examples of plasticizers include adipate, trimellitate, citrate-based plasticizers, and esters of polyhydric alcohols.

[0066] 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.

[0067] 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 disruptors such as phthalates or bisphenols.

[0068] In one embodiment, the first material may further comprise a lubricant. Preferably, the lubricant is medically acceptable. Preferably, the lubricant is free of polyhalogenated substances and silicones. In one embodiment, the lubricant comprises a natural product, such as a lipid, triglyceride, or biopolymer.

[0069] The first material may have a Young's modulus of elasticity between 1.2x10^7 Pa and 2.1x10^7 Pa, e.g., between 1.3x10^7 Pa and 2.0x10^7 Pa, between 1.4x10^7 Pa and 1.9x10^7 Pa, between 1.5x10^7 Pa and 1.8x10^7 Pa, or between 1.5x10^7 Pa and 1.7x10^7 Pa. In one embodiment, the first material may have a Young's modulus of elasticity between about 1.6x10^7 Pa. In one embodiment, the first material may have a Young's modulus of elasticity between 2000 and 2500 psi, the latter corresponding to between about 1.4x10^7 Pa and 1.7x10^7 Pa.

[0070] The Young's modulus of elasticity can be determined according to ASTM D412.

[0071] The first material is preferably sterilizable using common sterilization processes, ie, resistant to UV radiation, gamma radiation, and treatment with ethylene oxide, among other processes.

[0072] The first material is preferably moldable using standard extrusion and / or injection molding processes.

[0073] The tube has an inside diameter (ID) and an outside diameter (AD).

[0074] As used herein, the term "inner diameter" refers to the measurement of the linear distance between two opposing interior surfaces of a tube. This measurement is determined along the central longitudinal axis of the tube. The inner diameter is determined when the tube is relaxed, i.e., when no external forces such as tension, pressure, or torsion are acting on the tube that would alter its original shape. The measurement considers only the inside width of the tube.

[0075] Similarly, the term "outer diameter" refers to the measurement of the linear distance between two opposing outer surfaces of a tube. This measurement is determined perpendicular to the central longitudinal axis of the tube. The outer diameter is measured when the tube is in a relaxed state.

[0076] Preferably, the ratio of the inner diameter to the outer diameter is within the range of [1:1.8] to [1:2.5], i.e., the outer diameter is 1.8 to 2.5 times the inner diameter. In some embodiments, the ratio of the inner diameter to the outer diameter is within the range of [1:1.8] to [1:2.5], [1:1.9] to [1:2.4], [1:2.0] to [1:2.3], or [1:2.1] to [1:2.2].

[0077] The tube has a first end for receiving a fluid therein. This means that a fluid can be introduced into the tube at the first end of the tube. For this purpose, the first end of the tube can be equipped with a fluid connector. The fluid connector can be used to connect a container or a fluid-conducting connection to receive a liquid into the tube. One example of a fluid connector is a Luer lock connector. Using such a connector, a commercially available Luer lock syringe can be connected to the first end of the tube in a liquid-tight and fluid-conducting manner. The fluid connector can be detachably connectable to the tube. The fluid connector can be operably connectable to the tube. For this purpose, the fluid connector can have a substantially cylindrical nozzle having a thickened portion for forming a friction-engagement connection with the tube.

[0078] In one embodiment, the fluid connector may include a check valve, which is preferably designed to prevent fluid from exiting the tubing through the fluid connector, so that fluid can be introduced through the fluid connector into the tubing without backflowing through the fluid connector.

[0079] The tube includes a second end. The second end is designed to retain a fluid within the tube. This means that the lumen of the tube in the region of the second end is fluid-tight or can be closed fluid-tight. For example, the tube can be closed at the second end by a plug or by a fused or glued tube wall.

[0080] The presence of slits in the tube wall remains unaffected, ie slits may also be provided in the region of the second end as described herein.

[0081] This ensures that fluid can only exit the tube through slits in the tube wall, allowing fluid distribution to be controlled as a function of pressure.

[0082] The tube includes one or more slits for dispensing fluid from the tube. Each slit forms a passageway extending from the inside of the tube to the outside of the tube. This means that the slits represent a penetration in the tube wall. The slits are configured to reversibly open in response to fluid pressure within the tube so that fluid can be dispensed from the slit. This allows the slits to function as valves that can open and close in response to pressure.

[0083] The slits preferably include slit walls that contact each other when closed, and are preferably designed to include a common contact surface over the entire area of ​​the slit walls when closed.

[0084] This prevents the slit from becoming blocked, as it only opens when fluid simultaneously exits the tube through the slit. In this way, cellular ingrowth and penetration of tissue components can also be prevented. Therefore, the advantageous design of the device according to the present invention can eliminate additional coatings, complex geometric designs, and / or the addition of lubricants or anticoagulants (e.g., heparin), which may be necessary in designs other than those according to the present invention. Furthermore, cleaning of the device in the implanted state can be eliminated.

[0085] By appropriately selecting the tube material and / or geometric design, particularly with respect to the tube wall thickness and the length, depth, and / or placement of the slits, pressure-dependent opening characteristics of the slits can be achieved or improved while simultaneously ensuring device stability. In particular, irreversible deformation or rupture of the tube in the region of the slits can be effectively prevented. Furthermore, the embodiments described herein can achieve fluid dispensing volumes that are easy for medical users to handle. Additionally, the tube design according to the present invention can enable slit opening characteristics that allow the slits to open at a limit pressure that can be easily increased manually using a commercially available plastic syringe. This is the case, for example, for an overpressure of approximately 1 bar.

[0086] In one embodiment, the slit is disposed in a first material. In one embodiment, the slit is disposed in a tube such that the opening characteristics of the slit relative to a threshold pressure at which the slit opens result from the material properties of the first material. In one embodiment, the tube includes a first material and a second material, and the opening characteristics of the slit are independent of the second material.

[0087] In one embodiment, the tube includes a first tube region at a first end of the tube, the first tube region including a uniform, closed wall without slits. In one embodiment, the tube further includes a second tube region at a second end of the tube, the second tube region including multiple slits. In one embodiment, the tube includes no slits in the first tube region and multiple slits in the second tube region.

[0088] In one embodiment, the device according to the present invention is designed and configured to dispense medical fluid only through the slit. Preferably, the device is designed and configured to dispense fluid through multiple slits at different locations along the longitudinal axis of the tube. In one embodiment, the device is designed and configured to dispense medical fluid only through the slits in a pressure-dependent manner. More preferably, the device is designed and configured to dispense the same volumetric flow rate of fluid through multiple slits simultaneously. The term "volumetric flow rate" refers to the volume of fluid dispensed per unit time out of the tube through corresponding slits.

[0089] In one embodiment, the slit is designed and configured to open above a threshold pressure of the fluid inside the tube, which is about 1 bar (10^5 Pa) above the pressure outside the tube, and to close fluid-tight below this threshold pressure. This means that the slit is closed when the overpressure of the fluid in the tube is less than 1 bar, and open when the overpressure of the fluid in the tube is 1 bar or greater. "Overpressure" as used herein refers to the difference between atmospheric pressure and the pressure of the fluid in the tube.

[0090] In one embodiment, the threshold pressure is about 1 bar, about 1.2 bar, about 1.3 bar, about 1.4 bar, or greater than 1.4 bar.

[0091] In one embodiment, the slit is configured to reversibly open and close due to the elastic restoring force of the first material of the tube, and the slit can be opened by overpressure of a fluid within the tube as the material of the tube, particularly the first material of the tube, is forced apart by the fluid.

[0092] The stability of the slit and the threshold pressure at which it opens may depend on the dimensions of the tube and the slit.

[0093] The slit has a slit length L. In one embodiment, the ratio of the slit length L to the inner diameter ID of the tube [L:ID] is within the range of [1:2.2] to [1:2.9]. This means that the inner diameter of the tube is 2.2 to 2.9 times the slit length. The ratio of the slit length L to the inner diameter ID of the tube [L:ID] can be within the range of, for example, [1:2.3] to [1:2.8], [1:2.4] to [1:2.7], or [1:2.5] to [1:2.6]. In one embodiment, the ratio of the slit length L to the inner diameter ID of the tube [L:ID] is approximately [1:2.5].

[0094] In one embodiment, the ratio of the slit length L to the outer diameter AD of the tube [L:AD] is within the range of [1:3.5] to [1:5.5]. This means that the outer diameter of the tube is 3.5 to 5.5 times the slit length. For example, the ratio of the slit length L to the outer diameter AD of the tube [L:AD] is within the range of [1:3.6] to [1:5.4], [1:3.7] to [1:5.3], [1:3.8] to [1:5.2], [1:3.9] to [1:5.1], [1:4.0] to [1:5.0], [1:4.1] to [1:4.9], [1:4.2] to [1:4.8], [1:4.3] to [1:4.7], or [1:4.4] to [1:4.6]. In one embodiment, the ratio of the slit length L to the outer diameter AD of the tube is approximately 4.5.

[0095] In one embodiment, the device is designed and configured to change the outer diameter of the tube AD by less than 10% when the fluid pressure inside the tube increases from 0 bar to 1 bar (10^5 Pa) above the pressure outside the tube. This prevents the tube from expanding when the fluid in the tube reaches a critical pressure at which the slit opens. The dimensional stability of the tube as the fluid pressure increases can prevent irritation of sensitive tissue. In some embodiments, the outer diameter of the tube therefore changes by less than 9%, 8%, 7%, 6%, or 5% when the fluid overpressure increases from 0 bar to 1 bar.

[0096] In one embodiment, the device is designed and configured to change the length of the tube by less than 10%, preferably less than 9%, 8%, 7%, 6%, or 5% when the pressure of the fluid inside the tube increases from 0 to 1 bar (10^5 Pa) higher than the pressure outside the tube.

[0097] In one embodiment, the tube comprises a plurality of slits, each slit being spaced a distance A from each other on the outside of the tube, and having a slit length L along the outside of the tube, and the ratio [A:L] of the distance (A) to the slit length (L) is at least [10:1], meaning that the shortest distance between two slits is at least 10 times the slit length.

[0098] The distance between two slits is determined starting from the adjacent ends of the slits. The distance measurement between two adjacent slits is determined using a measurement method that determines the minimum distance between the outermost boundaries of the slits, rather than the center-to-center distance between the slits. This determination refers to a measurement that focuses on the shortest physically existing distance between closely spaced boundary surfaces of the slits, regardless of the shape, orientation, and position of the slit centers relative to each other. Therefore, the minimum distance is determined precisely at the position where the closest points of two adjacent slits have the smallest possible spatial distance from each other. In some embodiments, the ratio [A:L] of the distance (A) to the slit length (L) is at least [15:1], [20:1], or [30:1].

[0099] This allows the slits to tear open longitudinally and prevent excessive radial expansion of the tube.

[0100] In one embodiment, the tube includes a second material having a higher Shore A hardness than the first material. For example, the Shore A hardness of the second material may be at least 1.1, 1.2, 1.3, 1.4, 1.5, or 2 times that of the first material. The second material may include an elastomer. An elastomer is a plastic material having rubber-elastic properties. The Shore A hardness of the second material can be adjusted using plasticizers and / or fillers, as described above with respect to the first material. Thus, the first and second materials can differ only in the content of such plasticizers and / or fillers. Thus, the first and second materials can include the same or different elastomers. In one embodiment, the first material includes a first elastomer, and the second material includes a second elastomer. In one embodiment, the second material does not include the elastomer contained in the first material. In one embodiment, the first material and the second material comprise the same elastomer.

[0101] The second material may comprise a thermoplastic elastomer. The second material may comprise a copolymer. The copolymer may be a thermoplastic elastomer. A copolymer comprising soft and hard segments in the molecular chain is preferred. The ratio between the soft and hard segments in the molecular chain of the copolymer can be used to adjust the physical properties of such a copolymer. The hard segments can be connected to the soft segments using connectors (linkers).

[0102] Additionally, the first material may include additives to adjust hardness, as described herein.

[0103] In one embodiment, the second material is free of plasticizers. In one embodiment, the second material is free of fillers. In one embodiment, the second material is free of endocrine disruptors such as phthalates or bisphenols.

[0104] In this embodiment, both the first material and the second material are free of plasticizers, fillers, and endocrine disruptors. Other product groups described herein (e.g., radiopaque agents, polymers, or dyes) should not be understood as "fillers." Fillers, as used herein, are understood to mean only substances whose main function is to adjust the hardness of the first or second material and that do not belong to other product groups described herein.

[0105] In one embodiment, the second material may further comprise a lubricant. Preferably, the lubricant is medically acceptable. Preferably, the lubricant is free of polyhalogenated materials and silicones.

[0106] In one embodiment, the first material comprises a polyether urethane and the second material comprises a polyether block amide.

[0107] The second material can be disposed as a coaxially surrounding layer within or on the surface of the tube. The second material can be disposed as a strip parallel to the longitudinal axis of the tube. The second material can be located inside the tube or on the outside of the tube. The second material can be embedded in, for example completely embedded within, the first material. In one embodiment, the second material is disposed within the tube so as not to affect the opening and closing characteristics of the slit, particularly with respect to the critical pressure of the fluid at which the slit opens. The second material can be designed to stabilize the overall structure of the tube, particularly to stabilize the longitudinal or radial expansion of the tube when the pressure of the fluid received within the tube changes.

[0108] In one embodiment, the second material comprises a radiopaque agent. Examples of suitable radiopaque agents include barium sulfate and tungsten. In one embodiment, the second material comprises a dye. The dye can have an absolute emission maximum in the range of 490 nm to 575 nm. The dye can improve the visibility of the tube, especially when the tube is in the surgical wound area. A dye with significant emission in the range of 490 nm to 575 nm can provide particularly good contrast to the human eye against reddish-colored body tissue.

[0109] In one embodiment, the second material includes both an elastomer and a radiopaque agent, which may be embedded in the elastomer.

[0110] In one embodiment, the slits are aligned parallel to the longitudinal axis of the tube, which can improve the stability of the slits and the tube. In one embodiment, at least 40%, at least 50%, or at least 90% of all slits are aligned parallel to the longitudinal axis of the tube.

[0111] The slits may be circumferentially positioned facing different directions to distribute fluid in different directions from the tube. This can allow for a more spatially uniform distribution of fluid. For example, in one embodiment, a first slit is positioned at a first radial position at a first longitudinal position along the longitudinal axis of the tube, and a second slit is positioned at a second radial position at a second longitudinal position along the longitudinal axis of the tube. In one embodiment, the first radial position forms an angle of approximately 90° with respect to the second radial position. This corresponds to a cross-sectional view of the tube in which the first slit is positioned, for example, at the "12 o'clock position" and the second slit is positioned at the "9 o'clock position" or "3 o'clock position." In one embodiment, the above description refers to the first and second slits being positioned at adjacent longitudinal positions.

[0112] In one embodiment, the tube comprises pairs of slits that are located at the same longitudinal position in the direction of the longitudinal axis of the tube, but that form a 180° angle with respect to each other in their radial positions, such that in a cross-sectional view of the tube, the first slit of the pair is located at, for example, the "12 o'clock position" and the second slit of the pair is located at the "6 o'clock position."

[0113] In one embodiment, the two arrangements described above are implemented simultaneously, i.e., the first pair of slits forms an angle of approximately 90° relative to the radial position with respect to the second pair of slits, and within the first pair of slits and within the second pair of slits, each of the two slits forms an angle of 180° relative to each other.

[0114] In one embodiment, the tube comprises a metallic support structure. In one embodiment, the support structure comprises a metal coating, a metal foil, a metal spiral, or a metal thread. In one embodiment, the support structure is embedded in the first material. In one embodiment, the support structure is disposed inside the tube. An equivalent support structure may alternatively or additionally be formed from a second material as described herein.

[0115] To achieve uniform distribution of the fluid from the tube, it is advantageous to close the second end of the tube, which means that the tube does not contain any opening at the second end that is larger than the maximum cross section of the open slit.

[0116] Therefore, in one embodiment of the present invention, the second end of the tube is sealed fluid-tight, for example, the tube may be welded or fused at the second end so that the interior of the tube contains a fluid-conducting connection to the outside only through the first end and the slit.

[0117] In one embodiment, the second end of the tube can be closed. For example, the tube can be designed to be closed at the second end by a plug or screw cap. Such a closure means can be included in the device.

[0118] In one embodiment, the tube is closed or closable at the second end such that the second end is closed fluid-tight even at pressures of at least 1 bar, preferably at least 2 bar, while the pressure-dependent opening of the slit remains unaffected.

[0119] According to the present invention, the tube is designed to open the slit in a fluid-conducting manner or to close the slit in a fluid-tight manner depending on the pressure of the fluid received therein. Such a function can be cost-effectively achieved by cutting a portion of the tube. Preferably, no material is removed from the tube, so that the tube comprises a smooth, uniform surface in the closed slit configuration. Accordingly, one embodiment of the present invention relates to a device described herein in which the slit can be or is produced by cutting a portion of the tube without removing material from the tube. This can be done, for example, by cutting with a blade or punching. As a result, the slit can be formed as an incision in the wall of the tube. This can result in better lubrication, less damage to tissue, and prevention of clogging or sticking of the opening by body tissue.

[0120] It may be advantageous to design the device so that the medical user can shorten the length of the tubing before contacting the device with a patient. Thus, in one embodiment, the device is designed and configured to permanently change the length of the tubing. This can be done, for example, by removing a portion of the tubing at the second end of the tubing, i.e., the tubing can be cut at the second end without affecting the function of the device.

[0121] It may then be advantageous to close the second end of the tube, for example with a plug, as previously described.

[0122] As explained above, comparable devices are known in the prior art that necessarily comprise several tubes or several tube layers that can be moved relative to one another to ensure the stability of the device, prevent the entire tube from expanding due to the pressurized fluid contained therein, and / or adjust the area of ​​fluid distribution. On the other hand, the present invention allows for a functional device even with a one-piece design of the tube, without the need for additional tubes or additional separate tube layers. Accordingly, further embodiments relate to devices described herein in which the tube is formed in one piece. In one embodiment, the device does not comprise a second tube. In one embodiment, the device does not comprise a second tube or two mutually displaceable tube layers. In one embodiment, the first material and the second material together form a monolithic unit.

[0123] Another aspect of the present invention relates to a kit comprising a device described herein and a means for introducing a medical fluid. The means for introducing a medical fluid is preferably connectable, and preferably operably connectable, to a first end of a tube. The means for introducing a medical fluid may include, for example, a syringe. Other standard devices may also be used to introduce the medical fluid into the tube. Other examples of means for introducing a medical fluid include fluid adapters, infusion pumps, and gravity infusion systems. Examples of fluid adapters are port systems and similar access and spacers that allow for proper connection of a drug container. Examples of infusion pumps include peristaltic pumps, syringe pumps, balloon pumps, piston pumps, and other pumps commonly used in medical environments. The means for introducing a medical fluid is preferably designed to establish a fluid-tight connection with the first end of the tube. For example, the means for introducing a medical fluid and the first end of the tube may include a matching element for a Luer lock connection.

[0124] The kit may further comprise means for closing the second end of the tubing. For example, the kit may include a plug capable of closing the second end of the tubing. In one embodiment, the kit includes a tool configured to close the second end of the tubing. Such a tool may, for example, crimp, weld, clamp, or plug the tubing to close the tubing at the second end.

[0125] The kit may further comprise a medical fluid intended for administration using the device. The fluid preferably comprises an active ingredient. In one embodiment, the active ingredient is preferably selected from the group consisting of antibiotics, antifungals, antitumor active ingredients, osteoinductive active ingredients, and anti-inflammatory active ingredients. It may include all of the active ingredients described herein, as well as other active ingredients that can be administered in liquid form.

[0126] In a further embodiment, the kit further includes a trocar. The trocar has a pointed end that allows it to penetrate tissue. The trocar further includes a shaft along which the trocar can be guided. The shaft may have a cylindrical cavity, similar to a cannula.

[0127] A trocar can preferably be connected to the first end of the tube. Preferably, the trocar can be removably connected to the first end of the tube. Using the trocar, a medical user can insert the device's tube into a patient's tissue, thereby positioning and securing it at a desired location. The trocar can enable gentle and precise penetration of the target tissue. In this case, a channel can be created at the desired administration site, allowing the device to be positioned accordingly for administering the medical fluid. The device's tube can be inserted into the patient's tissue through the channel created with the aid of the trocar. Preferably, the trocar is removable so that medical fluid can be received through the first end of the tube after positioning the device with the trocar. For example, the trocar can be removed from the first end of the tube and replaced with a fluid connector, such as a Luer lock connector. The medical fluid can then be added to the tube, for example, using a Luer lock syringe, and then dispensed to the target location on the patient's tissue using the device.

[0128] Another aspect of the invention relates to a method of medical treatment, the method of medical treatment comprising administering a medical fluid to a patient using a device described herein or a kit described herein.

[0129] The method of treatment may include, inter alia, one, some or all of the steps described below. If necessary, shorten the tube at the second end of the tube. If necessary, close the second end of the tube. Connecting the trocar to the first end of the device • Penetrating a patient's tissue using a trocar to create access to a target location in the patient's tissue. Inserting a tube through the access created using a trocar - Contacting the tube with the target location in the patient's tissue Removing the trocar from the first end of the tube Connecting the fluid connector to the first end of the tube Introducing a medical fluid into the tubing, preferably via a fluid connector at the first end of the tubing. Pressurizing the medical fluid in the tube to open the slit and distribute the medical fluid through the slit to the patient's tissues

[0130] In one embodiment, the method of treatment includes, among other things, pressurizing the medical fluid within the tube to open the slit and dispensing the medical fluid through the slit to the patient's tissue, which means that the pressure of the medical fluid inside the tube increases to a value that causes the slit to open due to the elastomeric properties of the first material.

[0131] Another aspect relates to a medical active ingredient for use in bone surgery, wherein the active ingredient is selected from the group consisting of an antibiotic, an antifungal, an antitumor active ingredient, an osteoinductive active ingredient, and an anti-inflammatory active ingredient, the method comprising contacting a device described herein or a kit described herein with a surgical wound of a patient, and locally administering the active ingredient as a medical fluid to the surgical wound using the device or kit. Examples of such active ingredients are described herein.

[0132] For purposes of this patent application, "bone surgery" means any surgical procedure involving the treatment of bone tissue in the human or animal body. This includes, but is not limited to, intervention in the bone itself, adjacent soft tissue, joints, and associated structures such as cartilage, tendons, ligaments, skeletal muscle, and blood vessels. The term "bone surgery" includes, for example, trauma surgery, corrective and reconstructive surgery, orthopedic surgery, transplant surgery, arthroscopic surgery, spinal surgery, and microsurgical procedures.

[0133] Trauma surgery deals with the treatment of all types of fractures, dislocations, bone injuries, and the restoration of bone integrity and function after acute and chronic injuries.

[0134] Corrective and reconstructive surgery includes procedures to correct bone misalignments, deformities, and defects that may be of genetic, traumatic, or disease-related origin. It also includes the reconstruction of bone defects after tumor resection and the treatment of infection.

[0135] Orthopaedic surgery deals with the diagnosis, treatment, rehabilitation and prevention of diseases, disorders and injuries of the musculoskeletal system.

[0136] Implantation procedures include the insertion of orthopedic implants, prostheses, artificial joints, fixation elements such as screws, plates, nails, wires, and fixation systems to support or replace bone structures.

[0137] Arthroscopic surgery involves minimally invasive procedures in joints to treat injuries or conditions such as arthritis, meniscal tears or cruciate ligament disease.

[0138] Spinal surgery includes, for example, correction of spinal deformities, treatment of herniated discs, spinal fusion, and stabilization of spinal fractures.

[0139] Microsurgical procedures include procedures that require the use of a microscope for precise treatment of smaller bone structures, including nerve repair and vascular anastomosis.

[0140] In the context of the present invention, bone surgery includes, for example, surgical interventions in the area of ​​the joints, in particular the hip, knee or shoulder joints.

[0141] Another aspect relates to a medical active ingredient for the treatment or prevention of bone disease, wherein the active ingredient is selected from the group consisting of an antibiotic, an antifungal, an antitumor active ingredient, an osteoinductive active ingredient, and an anti-inflammatory active ingredient, and the method comprises locally administering the active ingredient as a medical fluid to a target tissue of a patient using a device or kit described herein.

[0142] Bone diseases may include infectious, damaging, degenerative, or inflammatory diseases of the bone. Examples of bone diseases include rheumatism, arthritis, cancer, bone or cartilage damage, joint infections, and osteomyelitis. [Example]

[0143] The present invention is further explained below using examples which should not be understood as limiting, as it will be clear to those skilled in the art that other equivalent means can be used in place of the features described herein.

[0144] The following tubing was manufactured by extrusion from commercially available medical grade polyether urethane having a Shore A hardness of 75, 85 and 95. [Table 1]

[0145] Three trapezoidal grinding blades with blade lengths (length of the blade edge parallel to the tube surface) of 0.5 mm, 0.7 mm, and 1.0 mm were manufactured from tool steel. These were used to slit tube samples at a single point on the tube at different distances from two opposite sides. Preliminary tests with distilled water using a 5 ml syringe showed that uniform release of liquid could be achieved with blade lengths of 0.7 mm and 1.0 mm.

[0146] At a blade length of 0.5 mm, the amount of fluid released per slit was very low and the force required to operate the syringe was unacceptably high, so no further testing was performed on the corresponding samples.

[0147] Furthermore, the manual force required to open the slits in the samples of Examples 1, 6, and 11 was found to be uncomfortably high when manipulating a syringe. Further testing was performed on the remaining samples using a vernier caliper to measure the expansion of tubing samples with slit lengths of 0.7 mm and 1.0 mm. Pressures above 1.0 bar were shown to open the slits and allow liquid to escape through them. During liquid dispensing, the pressure was increased to 1.4 bar to 2.0 bar, and this pressure was manually increased using a syringe. Further testing revealed that with a slit length of 0.7 mm and a slit spacing of less than 7 mm, particularly a distance of 2 to 3 mm, temporary radial expansion and sometimes widening of the slits occurred when pressure was applied several times. Similarly, a similar effect occurred with a slit length of 1.0 mm and a slit spacing of less than 10 mm.

[0148] Therefore, the following tests were performed with a 7 mm slit spacing for the 0.7 mm slits and a 10 mm slit spacing for the 1.0 mm slits. The expansion from the slit opening was measured using a vernier caliper. An expansion of more than 10% of the outer diameter was chosen as the limit value. Radial expansion of less than 10% was rated "+", and expansion of more than 10% was rated "-". [Table 2]

[0149] drawing FIG. 1 shows a cross-sectional view of a detail of a tube 101 of a device 100 according to the present invention. The tube 101 has a first end 102 (not shown in this view) and a second end 103. The wall of the tube 101 has slits 104, each of which extends from the inside 105 of the tube to the outside 106 of the tube. The slits thus form a fluid-conducting connection 104 between the inside 105 and the outside 106 of the tube, through which a fluid 200 from the interior of the tube 101 can be distributed to the outside. The tube has an inner diameter ID, which corresponds to the inside width of the tube. The tube still has an outer diameter AD, which is a measure of the linear distance between two opposing outer surfaces of the tube 101. The slits each have a slit length L. At the second end 103, the tube 101 is closed so that the fluid 200 can exit only through the slits 104.

[0150] 2 shows one embodiment of a device 100 according to the present invention. The device comprises a first end 102 designed to receive a fluid within a tube 101. The tube comprises a first tube region 112 comprising a uniformly closed wall without slits. The tube also comprises a second tube region 113 comprising a number of slits 104. The first end 102 is adjacent to the first tube region 112, and the second end 103 is adjacent to the second tube region 113.

[0151] 3 shows a fluid connector 212 that can be removably connected to the tubing 101 of the device. The fluid connector is connectable to the first end 102 of the tubing to allow fluid to be received within the tubing 101.

[0152] FIG. 4 shows a fluid connector 212 having a luer lock connector 220, a tubing connector 230, and a check valve 240. The luer lock connector 220 allows the device to be removably connected to a syringe, for example, to introduce medical fluid into the device. At the same time, the syringe can be used to pressurize the fluid inside the tubing and open the slit. The tubing connector 230 allows for a removably fluid-conductive and liquid-tight connection with the first end 102 of the tubing 101. For this purpose, the tubing connector 230 can be inserted into the tubing 101. The tubing connector includes a cylindrical nozzle with a thickened portion for forming a frictionally engaged, liquid-tight connection with the tubing.

[0153] 5 shows the second end 103 of the tube of a device according to the invention, which can be closed with a plug 120. The plug 120 is here provided with threads for creating a friction-engagement connection with the tube, thereby liquid-tight sealing the tube at the second end 103. The plug can also include a circumferential ridge that can engage the flexible first material 141 of the tube to liquid-tight seal the tube.

[0154] 6 shows the second end 103 of the tube of the device according to the invention, which comprises a support structure 130 in the lumen of the tube. The support structure is here designed as a helically wound metal wire and is arranged on the inside 105 of the tube. The support structure 130 can increase the bending strength of the tube, so that, for example, the formation of kinks in the tube can be avoided.

[0155] 7 shows the second end 103 of the tube of the device according to the invention, the second end 103 comprising a fused and therefore closed tube wall. In particular, the first material 141 can form the fused tube end.

[0156] 8 shows the second end 103 of the tube with a second material 142 embedded in the tube wall. The second material 142 has a higher hardness than the surrounding first material 141 and extends in strands parallel to the central longitudinal axis of the tube toward the second end 103 of the tube. This stabilizes the tube geometry. In particular, it reduces or prevents expansion of the tube due to pressurized liquid inside the tube.

[0157] 9 shows a cross-sectional view of the second end 103 of the tube with a second material 142 embedded in the tube wall, the second material 142 being disposed in strands within the tube. The second material 142 is here disposed in strands within the first material 141 and has a circular closed cross-section. The second material 142 is completely surrounded by the first material 141.

[0158] 10 shows a cross-sectional view of the second end 103 of the tube having a second material 142 embedded in the tube wall, the second material 142 disposed so as to extend coaxially around the tube. Here, the second material 142 comprises a circular open cross-section. Here, the second material 142 forms a completely radially surrounding layer and is completely embedded in the first material 141. The first material 141 and the second material 142 together form a monolithic unit, such that the first material 141 and the second material 142 cannot move relative to each other.

[0159] 11 shows a longitudinal cross-sectional view of a detail of a tube 101, showing two slits 104, 104' offset from one another. The first slit 104 is at a first longitudinal position 301 and a first radial position 401 of the tube. The second slit 104' is at a second longitudinal position 302 and a second radial position 402 of the tube. In this case, the first longitudinal position is different from the second longitudinal position, and the first radial position is different from the second radial position. The two slits 104, 104' are offset from one another and point in different radial directions along the length of the tube, i.e., parallel to the longitudinal axis LA of the tube, to distribute medical fluid to spatially separated target areas.

[0160] 12 shows a cross-sectional view of a detail of the tube, with two slits 104, 104' offset from one another. The first slit 104 is at a first longitudinal position 301 and a first radial position 401 of the tube. The second slit 104' is at a second longitudinal position 302 and a second radial position 402 of the tube, where the first radial position 401 forms an angle of approximately 90° with the second radial position 402, with the sides of the angle intersecting at the longitudinal axis of the tube.

[0161] 13 shows a longitudinal cross-section of a detail of tube 101, with slit 104 in the tube closed. Slit 104 extends from inside 105 of the tube to outside 106 of the tube. The restoring force of first material 141 compresses slit 104, so it remains liquid-tight unless a force is applied to the tube.

[0162] 14 shows a longitudinal cross-sectional view of a detail of the tube 101, in which the slit 104 is open. The pressurized medical fluid 200 received in the tube presses against the inside 105 of the tube, forcing the slit 104 open. This allows the medical fluid 200 from the lumen of the tube to be distributed to the outside through the slit 104. The open state of the slit 104 can be controlled by the pressure of the medical fluid.

[0163] 15 shows a kit comprising the device 100 described herein, a means 500 for introducing a medical fluid, herein designated as a syringe, and a means 120 for closing the second end of the device, herein designated as a plug. The syringe 500 can be used to introduce a medical fluid into the device 100, in particular by connecting the syringe 500 to a first end of a tube of the device 100. The plug 120 can be used to fluid-tightly seal the second end of the tube of the device 100. If necessary, the user can shorten the length of the tube before connecting it to the plug 120 at the second end of the tube of the device. [Explanation of symbols]

[0164] 100 devices 101 Tube 102 first end 103 Second end 104 Slit 105 Inside the tube 106 Outside of the tube 112 First Tube Region 113 Second Tube Region 120 means for closing the second end 130 Support structure 141 First Ingredient 142 Second Ingredient 200 fluid 212 Fluid Connector 220 Luer Lock Connector 230 Tube Connector 240 Check valve 301 first longitudinal position 302 second longitudinal position 401 first radial position 402 second radial position 500 Means for introducing medical fluids A is the distance between two slits on the outside of the tube AD Tube outer diameter L slit length LA Longitudinal axis of the tube ID Tube Inner Diameter

Claims

1. 1. An apparatus (100) for dispensing medical fluids to a patient, comprising: A tube (101) comprising a medically acceptable first material (141) having a Shore A hardness in the range of 75 to 95, the tube (101) has an inner diameter (ID) and an outer diameter (AD); The ratio of [ID:AD] is within the range of [1:1.8] to [1:2.5], the tube (101) having a first end (102) for receiving a fluid (200) within the tube (101); a tube (101) having a second end (103) configured to hold a fluid (200) within the tube (101); one or more slits (104) for dispensing fluid (200) from said tube (101), each said slit (104) forming a passageway extending from an inside (105) of said tube (101) to an outside (106) of said tube; one or more slits (104) configured to reversibly open in response to pressure of the fluid (200) within the tube (101) such that the fluid (200) is dispensed from the slits (104); 1. An apparatus (100) for dispensing medical fluids to a patient, comprising:

2. 10. The device of claim 1, wherein the device is designed and configured to dispense medical fluid only through the slit, and preferably the simultaneous dispensing of fluid occurs through multiple slits at different locations along the longitudinal axis (LA) of the tube.

3. 2. The device of claim 1, wherein the slit is designed and configured to open when the fluid inside the tube exceeds a threshold pressure of 1 bar (10^5 Pa), preferably 1.4 bar, higher than the pressure outside the tube, and to close fluid-tightly when the pressure falls below this threshold pressure.

4. The device of claim 1 , wherein the slit is configured to reversibly open and close due to an elastic restoring force of the first material of the tube.

5. 2. The device of claim 1, wherein the slits each have a slit length (L), and the ratio of the slit length (L) to the inner diameter (ID) of the tube [L:ID] is within the range of [1:2.2] to [1:2.9], and / or the ratio of the slit length L to the outer diameter (AD) of the tube [L:AD] is within the range of [1:3.5] to [1:5.5].

6. 2. The device of claim 1, designed and configured to change the outer diameter (AD) of the tube by less than 10% when the pressure of the fluid inside the tube increases from 0 to 1 bar (10^5 Pa) higher than the pressure outside the tube.

7. 2. The device of claim 1, designed and configured to change the length of the tube by less than 10%, preferably less than 5%, when the pressure of the fluid inside the tube increases from 0 to 1 bar (10^5 Pa) higher than the pressure outside the tube.

8. 2. The apparatus of claim 1, wherein the tube comprises a plurality of slits, each slit spaced a distance (A) from one another on the outside of the tube, each slit having a slit length (L) along the outside of the tube, and wherein the ratio [A:L] of the distance (A) to the slit length (L) is at least [10:1].

9. 2. The device of claim 1, wherein the tube comprises a second material (142) having a Shore A hardness higher than that of the first material (141), the second material being preferably arranged as a coaxially surrounding layer or as a strip parallel to the longitudinal axis (LA) of the tube, the second material further preferably comprising an elastomer, and further preferably the second material being completely embedded in the first material.

10. 10. The device of claim 9, wherein the second material comprises a radiopaque agent and / or dye, the radiopaque agent preferably comprising barium sulfate or tungsten, and the dye preferably having an absolute emission maximum in the range of 490 nm to 575 nm.

11. The device of claim 1 , wherein the slit is disposed parallel to the longitudinal axis (LA) of the tube.

12. 2. The device of claim 1, wherein at a first longitudinal position (301) in the direction of the longitudinal axis (LA) of the tube, a first slit (104) is arranged at a first radial position (401), and at a second longitudinal position (302) in the direction of the longitudinal axis of the tube, a second slit (104') is arranged at a second radial position (402), the first radial position (401) forming an angle of approximately 90° with respect to the second radial position (402).

13. 2. The device of claim 1, wherein the tube comprises a metallic support structure (130), preferably comprising a metal coating, foil, spiral, or thread, the support structure preferably being embedded in the first material (141) or disposed inside the tube (105).

14. 2. The device of claim 1, wherein the medically acceptable first material (141) comprises a polymer, preferably comprising polyether urethane or ethylene propylene diene rubber.

15. 2. The device of claim 1, further comprising a fluid connector (212) disposed, preferably removably disposed, at the first end (102) of the tube (101).

16. 16. The device of claim 15, wherein the fluid connector comprises a luer lock connector (220) and / or a check valve (240).

17. 2. The device according to claim 1, wherein the second end (103) is closed or can be closed fluid-tight, preferably by welding, fusion or with a plug or screw cap.

18. 10. The apparatus of claim 1, wherein the slit (104) can be or is made by cutting a portion of the tube without removing material from the tube.

19. 2. The apparatus of claim 1, wherein the apparatus is designed and configured to permanently change the length of the tube (101), for example, by removing a portion of the tube at the second end (103) of the tube.

20. The device of claim 1 , wherein the tube is formed in one piece and the device does not include a second tube.

21. A kit comprising the device of claim 1 and a means (500) for introducing a medical fluid connectable to the first end (102) of the tube.

22. 22. The kit of claim 21, further comprising means (120) for closing the second end (103) of the tube.

23. 22. The kit of claim 21, further comprising a medical fluid containing an active ingredient, said active ingredient preferably being selected from the group consisting of antibiotics, antifungals, antitumor active ingredients, osteoinductive active ingredients, and anti-inflammatory active ingredients.

24. 22. The kit of claim 21, further comprising a trocar, said trocar connectable, preferably removably connectable, to said first end (102) of said tube.

25. 22. A method of medical treatment comprising administering a medical fluid to a patient using the device of claim 1 or the kit of claim 21.

26. 22. An active medical ingredient for use in bone surgery, wherein the active ingredient is selected from the group consisting of an antibiotic, an antifungal, an antitumor active ingredient, an osteoinductive active ingredient, and an anti-inflammatory active ingredient, the method comprising contacting a device according to claim 1 or a kit according to claim 21 with a surgical wound of a patient, and locally administering the active ingredient as a medical fluid to the surgical wound using the device or kit.

27. 22. A medical active ingredient for the treatment or prevention of bone disease, wherein the active ingredient is selected from the group consisting of an antibiotic, an antifungal, an antitumor active ingredient, an osteoinductive active ingredient, and an anti-inflammatory active ingredient, the method comprising locally administering the active ingredient as a medical fluid to a target tissue of a patient using the device described herein in claim 1 or the kit described in claim 21.

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