Medical dispensing system with self-closing slit valve

Abstract

The present invention relates to a device for dispensing a medical fluid to a patient, the device comprising: a tube comprising a first medically acceptable material having a Shore A hardness in the range of 75 to 95, where the tube has an inner diameter (ID) and an outer diameter (AD), where 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 configured to retain a fluid in the tube; one or more slits for dispensing fluid from the tube, where the slits each form a channel extending from an inner side of the tube to an outer side of the tube; and wherein the slit is configured to be reversibly opened according to a pressure of a fluid within the tube such that the fluid is dispensed from the slit.

Description

[0001] The present application relates to a device for the temporary, local application of a medical fluid over a period of hours to days. Depending on the anatomy of the implantation site, the length of the device according to the application can be adjusted by simple mechanical shortening without any loss of functionality.

[0002] The local application of a pharmaceutical active ingredient, in particular an antibiotic, is well known and has proven particularly effective in the treatment or alleviation of bone tissue infections. A distinction is 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 under the trademark name GENTAMICIN® since 1977. The known bead chains consist of polymethyl methacrylate beads containing the broad-spectrum antibiotic gentamicin sulfate, which are arranged in chains on a steel wire. This chain-like active ingredient carrier has proven effective in the local antibiotic treatment of osteomyelitis for decades. The advantage here is that gentamicin sulfate is released in large quantities from the active ingredient carrier over a period of several days. Another advantage is that the medical user can easily adapt the chain-like active ingredient carrier to the anatomy of the implantation site by simply cutting off excess beads. The disadvantage is that the active ingredient carrier contains only gentamicin sulfate and the medical user cannot modify the active ingredient carrier by additional antibiotics depending on the sensitivity of the microbacterial bacteria. Successful local treatment of problematic bacterial infections such as MRSA and VRSA is therefore only possible to a limited extent or not at all. The removal of the chain after release of the active ingredient places considerable stress on the patient due to the adhesion to connective tissue.

[0004] Examples of absorbable or biodegradable active ingredient carriers are wool and sponges made of collagen or gelatin. Examples are the patents DE 34 29 038, DE 33 34 595, DE 28 43 963, DE 32 03 957 and DE 33 34 595. These examples contain gentamicin sulfate or a mixture of gentamicin sulfate and a sparingly water-soluble gentamicin salt. In addition, there are a variety of absorbable or biodegradable active ingredient carriers based on tricalcium phosphate, hydroxyapatite, gypsum and mixtures thereof as well as composite materials made of these salts and organic binders.

[0005] ​The listed disadvantages of non-absorbable and absorbable or biodegradable active ingredient carriers are that the antimicrobial active ingredient is determined by the chosen composition and, in addition, after implantation of the active ingredient carrier, the active ingredient cannot be replaced or supplemented by other active ingredients. Furthermore, the release of the active ingredient in all previous local active ingredient release systems is based on the diffusion principle, so that only a large amount of active ingredient is released in the first few hours and days. An exception is the use of sparingly water-soluble active ingredient salts, in which the release of the active ingredient depends on the solubility equilibrium of the active ingredient salt.

[0006] Therefore, an active ingredient carrier is desirable which allows the local application of any pharmaceutical active ingredient and which can be exchanged at any time with other fluid pharmaceutical active ingredients. In addition, it is desirable to be able to directly adjust the active ingredient concentration directly achieved at the implantation site.

[0007] EP3795196B1 discloses a device for the local application of a medical fluid, the device comprising a tube, the tube being flexible and deformable and the tube comprising a tube wall, wherein the tube wall comprises a radially outer outer wall made of a first material and the tube wall comprises a radially inner inner wall made of a second material, the radially inner inner wall delimiting an inner tube line of the tube, wherein the tube comprises a plurality of openings in the tube wall in a distal section of the tube, wherein the plurality of openings connects the inner tube line of the tube to the surrounding environment of the tube, wherein the distal section of the tube is delimited by a distal end of the tube, the device further comprising a closure element with which the tube is liquid-tightly closed or closable at the distal end of the tube, wherein the closure element is manually insertable into the distal end of the tube, wherein a proximal end of the tube is liquid-permeably connected or connectable to a container for the medical fluid, so that the medical fluid is pressable through the proximal end of the tube from the container into the inner tube line of the tube and is pressable through the plurality of openings to the surrounding environment of the tube.

[0008] EP3854437B1 describes a device for the local application of a medical fluid, the device comprising a tube, wherein the tube comprises a plurality of openings in its tube wall, the plurality of openings connecting an inner tube line of the tube with the surrounding environment of the tube, and wherein the tube is closed at a tube distal end of the tube, wherein the device comprises an outer sleeve for liquid-tightly closing a portion of the plurality of openings, wherein the outer sleeve is arranged axially displaceably around the tube, and wherein the outer sleeve is shorter than the tube, so that distal openings not belonging to the closed portion of the plurality of openings are exposed.

[0009] Preferred embodiments

[0010] It is an object of the present invention to solve one or more of the above-mentioned problems of the prior art. It is an object of the present invention to provide a simple, cost-effective device for the release of a topical active ingredient. In some embodiments, a low-cost homogenous tube can be used, thereby avoiding the use of an expensive coaxial tube made of two separate polymers. Such a device can allow for the topical application of a medical fluid, e.g. an antibiotic solution, having any composition. To this end, a part of the device can be placed in the patient’s body after implantation, while another part of the device can be placed outside the patient’s body. The medical fluid can be introduced into the part of the device that is located outside the patient’s body and pass through the device to the implantation site and be released there. The device can be plastically deformable in order to be able to follow the anatomical conditions at the implantation site. The medical fluid can be released from openings arranged longitudinally on the device. The openings can be reversibly closed to prevent ingrowth of connective tissue and / or occlusion of the openings by e.g. coagulated blood. It is desirable that the device does not radially expand during use or only to a minimum extent. Inflamed human tissue is very sensitive to pain under pressure. Therefore, it is preferred to avoid that the device extends significantly radially, which would cause pressure on the patient and in turn pain. A further advantage is that repeated release of the medical liquid by applying pressure does not lead to the openings tearing or any other irreversible enlargement of the openings. Preferably, the opening properties of the device can remain constant in order to ensure uniform release of the drug liquid over the entire length of the device even in case of multiple liquid releases. Furthermore, the device can be designed such that the part of the device that can be positioned in the patient’s body can be adapted to the relevant anatomical situation of the patient by shortening the length of the tube without impairing the functionality of the device.

[0011] These objects are achieved by the methods, devices, kits and medical uses described herein, in particular those in the claims.

[0012] Preferred embodiments of the present invention will be described hereinafter.

[0013] A first embodiment of the present invention is a device for dispensing a medical fluid to a patient, the device comprising:

[0014] a tube comprising a first medically acceptable material having a Shore A hardness in the range of 75 to 95,

[0015] wherein the tube has an inner diameter (ID) and an outer diameter (AD),

[0016] wherein the ratio [ID:AD] is in the range of [1 : 1.8] to [1 : 2.5];

[0017] wherein the tube comprises a first end portion for receiving fluid into the tube;

[0018] wherein the tube comprises a second end portion configured to retain fluid in the tube;

[0019] one or more slits for dispensing fluid from the tube, wherein

[0020] the slits each form a passage extending from the inside of the tube to the outside of the tube;

[0021] and wherein the slits are configured to reversibly open depending on the pressure of the fluid inside the tube,

[0022] so that the fluid is dispensed from the slits.

[0023] A second embodiment relates to the device according to the first embodiment, wherein the device is designed and configured to dispense a medical fluid exclusively via the slits, wherein preferably simultaneous dispensing of the fluid via multiple slits at different positions along the longitudinal axis of the tube takes place.

[0024] A third embodiment relates to the device according to the first or second embodiment, wherein the slits are designed and configured to open at a limit pressure of the fluid inside the tube that is higher than the pressure outside the tube by 1 bar (10^5 Pa), preferably 1.4 bars, and to be fluid-tight closed below the limit pressure.

[0025] A fourth embodiment relates to the device according to one of the preceding embodiments, wherein the slits are configured to reversibly open and close via the elastic restoring force of the first material of the tube.

[0026] A fifth embodiment relates to the device according to one of the preceding embodiments, wherein the slits each have a slit length L, and wherein the ratio [L:ID] of the slit length (L) to the inner diameter (ID) of the tube is in the range of [1 :2.2] to [1 :2.9], and / or the ratio [L:AD] of the slit length L to the outer diameter AD of the tube is in the range of [1 :3.5] to [1 :5.5].

[0027] A sixth embodiment relates to the device according to one of the preceding 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 by 0 to 1 bar (10^5 Pa) above the pressure outside the tube.

[0028] A seventh embodiment relates to the device according to one of the preceding 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 by 0 to 1 bar (10^5 Pa) above the pressure outside the tube.

[0029] The eighth embodiment relates to the device according to one of the preceding embodiments, wherein the tube comprises a plurality of slits, each slit being arranged on the outer side of the tube at a distance (A) from each other and each slit having a slit length (L) along the outer side of the tube, wherein the ratio [A:L] of the distance (A) to the slit length (L) is at least [10:1].

[0030] The ninth embodiment relates to the device according to one of the preceding embodiments, wherein the tube comprises a second material having a higher Shore A hardness than the first material, wherein the second material is preferably arranged as a coaxial surrounding layer or as a strip parallel to the longitudinal axis of the tube, wherein the second material further preferably comprises an elastomer, and wherein it is further preferred that the second material is completely embedded in the first material.

[0031] The tenth embodiment relates to the device according to the ninth embodiment, wherein the second material comprises a radio-opaque agent and / or a dye, wherein the radio-opaque agent preferably comprises barium sulfate or tungsten, and wherein the dye preferably has an absolute emission maximum in the range of 490 nm to 575 nm.

[0032] The eleventh embodiment relates to the device according to one of the preceding embodiments, wherein the slits are arranged parallel to the longitudinal axis of the tube.

[0033] The twelfth embodiment relates to the device according to one of the preceding 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, wherein the first radial position and the second radial position form an angle of approximately 90°.

[0034] The thirteenth embodiment relates to the device according to one of the preceding embodiments, wherein the tube comprises a support structure made of metal, wherein the support structure preferably comprises a metal coating, a metal foil, a metal spiral or a metal wire, and wherein the support structure is preferably embedded in the first material or arranged on the inner side of the tube.

[0035] The fourteenth embodiment relates to the device according to one of the preceding embodiments, wherein the first medically acceptable material comprises a polymer, wherein the polymer preferably comprises a polyether polyurethane or a terpolymer.

[0036] The fifteenth embodiment relates to the device according to one of the preceding embodiments, further comprising a fluid connector arranged, preferably detachably arranged, at the first end of the tube.

[0037] A sixteenth implementation relates to the implementation according to the fifteenth implementation, wherein the fluid connector comprises a luer lock connector and / or a check valve.

[0038] A seventeenth implementation relates to the device according to one of the preceding implementations, wherein the second end portion is preferably closed or closable fluid-tight by welding, melting or by means of a plug or a screw cap.

[0039] An eighteenth implementation relates to the device according to one of the preceding implementations, wherein the slit is producible by severing portions of the tube without removing material from the tube, for example by punching with a blade.

[0040] A nineteenth implementation relates to the device according to one of the preceding implementations, wherein the device is designed and configured to permanently change the length of the tube, for example by removing a tube portion at the second end portion of the tube.

[0041] A twentieth implementation relates to the device according to one of the preceding implementations, wherein the tube is formed as a one-piece and wherein the device does not comprise a second tube.

[0042] A first implementation of another aspect relates to a kit comprising a device according to one of the preceding implementations and a member for introducing a medical fluid, which member is connectable to the first end portion of the tube.

[0043] A second implementation of the kit according to the preceding implementation further comprises a member for closing the second end portion of the tube.

[0044] A third implementation relates to the kit according to the first or second implementation, further comprising a medical fluid comprising an active ingredient, wherein the active ingredient is preferably selected from the group consisting of an antibiotic, an antifungal agent, an antitumoral active ingredient, an osteoinductive active ingredient and an anti-inflammatory active ingredient.

[0045] A fourth implementation relates to the kit according to one of the preceding implementations, further comprising a trocar, wherein the trocar is connectable, preferably detachably connectable, to the first end portion of the tube.

[0046] Another aspect relates to a method of medical treatment, wherein the treatment method comprises administering a medical fluid to a patient using the device according to the preceding implementations or the kit according to one of the preceding implementations.

[0047] Another aspect relates to a medical active ingredient for use in orthopedic surgery, wherein the active ingredient is selected from the group consisting of antibiotics, antifungal agents, antitumor active ingredients, osteoinductive active ingredients and anti-inflammatory active ingredients, wherein the method comprises contacting the device according to the preceding embodiments or the kit according to one of the preceding embodiments with a surgical wound of a patient and using the device or the kit for locally administering the active ingredient as a medical fluid to the surgical wound. BRIEF DESCRIPTION OF DRAWINGS

[0048] Figure 1 A cross-sectional view of a detail of a tube of a device according to the present application is shown.

[0049] Figure 2 An embodiment of a device according to the present application is shown.

[0050] Figure 3 A fluid connector which can be detachably connected to a tube of a device is shown.

[0051] Figure 4 A fluid connector with a check valve is shown.

[0052] Figure 5 A second end of a tube of a device according to the present application is shown, which second end can be closed with a plug.

[0053] Figure 6 A second end of a tube of a device according to the present application is shown, which tube comprises a support structure in the inner lumen of the tube.

[0054] Figure 7 A second end of a tube of a device according to the present application is shown, wherein the second end comprises a tube wall which is fused and thus closed.

[0055] Figure 8 A second end of a tube is shown, wherein a second material is embedded in the tube wall.

[0056] Figure 9 A cross-sectional view of a second end of a tube is shown, wherein a second material is embedded in the tube wall, wherein the second material is arranged in the tube in the form of a strand.

[0057] Figure 10 A cross-sectional view of a second end of a tube is shown, wherein a second material is embedded in the tube wall, wherein the second material is arranged in the tube in a coaxially surrounding manner.

[0058] Figure 11 A longitudinal cross-sectional view of a detail of a tube is shown, wherein two slits are arranged offset from each other.

[0059] Figure 12 A cross-sectional view of a detail of a tube is shown, wherein two slits are arranged offset from each other.

[0060] Figure 13 A longitudinal sectional view showing details of the tube, wherein the slit in the tube is closed.

[0061] Figure 14 A longitudinal sectional view showing details of the tube, wherein the slit in the tube is open.

[0062] Figure 15 A kit comprising a device as described herein, a means for introducing a medical fluid, and a means for closing the second end of the tube. DETAILED DESCRIPTION

[0063] With respect to the embodiments described herein, it is in principle always contemplated that an element "has", "comprises" or "includes" a particular feature (e.g. a material), that further embodiments exist in which the relevant element consists solely of this feature, i.e. does not comprise any other components. The word "comprising" is used herein in the same way as the word "including" in that it is synonymous with "including" or "containing".

[0064] "Operatively connected" or "operably connected" herein means that the two elements in question have a functional relationship with each other. For example, a first element can be configured to control or move a second element by such operative connection. The term "control" also includes here to prevent or enable a certain function, for example to allow or restrict movement or other functions of an element.

[0065] In one embodiment, if an element is denoted by a singular, embodiments in which more than one such element is present are also contemplated. The use of terms for plural elements also in principle includes embodiments in which only a single corresponding element is present.

[0066] Unless indicated otherwise or clearly excluded from the context, it is in principle possible and thus clearly contemplated that features of different embodiments can also be present in other embodiments described herein. Likewise, all features described herein in connection with a method are in principle also considered to apply to products, devices, kits and uses described herein, and vice versa. Not all combinations of all such considerations are explicitly listed in all cases, just to keep the description brief. In principle, the scope of the application is also intended to encompass technical solutions known to be equivalent to the features described herein.

[0067] Technical specifications and standards described herein (e.g. in connection with test procedures) refer to the current version at the priority date of the present application.

[0068] One embodiment of the present application relates to a device for dispensing a medical fluid to a patient, the device comprising:

[0069] a tube, wherein the tube comprises a first end for receiving fluid into the tube;

[0070] wherein the tube comprises a second end portion configured to hold fluid in the tube;

[0071] one or more slits for dispensing fluid from the tube, wherein

[0072] the slits each form a passage extending from an inside of the tube to an outside of the tube;

[0073] and wherein the slits are configured to reversibly open depending on a pressure of the fluid within the tube,

[0074] such that the fluid is dispensed from the slits.

[0075] The device is preferably designed and configured to dispense a medical fluid to a patient. The term "fluid" herein includes aqueous and non-aqueous liquids, gases and mixtures thereof. The term "medical fluid" herein refers to a fluid which is used for medical purposes and has a medicinal effect.

[0076] The term "medical fluid" herein specifically refers to aqueous and non-aqueous liquids which can contain dissolved active ingredients, in particular pharmaceutical active ingredients, or which can have a medicinal effect themselves. The term also includes gases and gas-liquid mixtures which can have a pharmacological effect in the human or animal body. In one embodiment, the medical fluid comprises an active ingredient. In one embodiment, the active ingredient is selected from the group consisting of antibiotics, antifungal agents, antitumor active ingredients, osteoinductive active ingredients and anti-inflammatory active ingredients.

[0077] In one embodiment, the active ingredient is an antibiotic. In one embodiment, the antibiotic is selected from the group consisting of penicillins, 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. Examples of aminoglycosides are clindamycin.

[0078] 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 antineoplastic active ingredient (cytostatic agent). Examples of antineoplastic 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.

[0079] In another 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 factor (FGF) and platelet-derived growth factor (PDGF).

[0080] In another embodiment, the active ingredient is an anti-inflammatory active ingredient. Examples of anti-inflammatory active ingredients include non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, selective COX-2 inhibitors, biologies (e.g., TNF-a inhibitors), and Janus kinase inhibitors. Examples of non-steroidal 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-a inhibitors include infliximab, adalimumab, and etanercept. Examples of Janus kinase inhibitors include tofacitinib and baricitinib.

[0081] In one embodiment, the active ingredient is suitable for the treatment of a bone disease. 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 includes 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 beta-TCP and hydroxyapatite.

[0082] The device comprises a tube, which is fillable with a medical fluid. The tube is preferably designed and configured to receive the medical fluid inside the tube. The hollow interior of the tube is also referred to as "lumen".

[0083] The tube comprises a medically acceptable material. "Medically acceptable" here means the property that the material does not have a deleterious effect on the human body or other biological systems. This means that the material can be safely introduced into the body without causing unnecessary side effects or endangering the health of the patient.

[0084] The tube comprises a first end for receiving a fluid into the tube.

[0085] One embodiment relates to a device for dispensing a medical fluid to a patient, the device comprising:

[0086] a tube comprising a first medically acceptable material having a Shore A hardness in the range of 75 to 95,

[0087] wherein the tube has an inner diameter (ID) and an outer diameter (AD),

[0088] wherein the ratio [ID:AD] is in the range of [1 : 1.8] to [1 : 2.5];

[0089] wherein the tube comprises a first end for receiving a fluid into the tube;

[0090] wherein the tube comprises a second end configured to hold the fluid in the tube;

[0091] one or more slits for dispensing the fluid from the tube, wherein

[0092] the slits each form a passage extending from the inside of the tube to the outside of the tube;

[0093] and wherein the slits are configured to reversibly open depending on the pressure of the fluid within the tube,

[0094] so that the fluid is dispensed from the slits.

[0095] If 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], in particular for tubes made of a material having a Shore A hardness in the range of 75 to 95, this can reduce or prevent an undesired stretching of the tube when the interior of the tube is filled with a fluid having a pressure significantly higher than the ambient pressure.

[0096] This eliminates the need for an additional stabilizing tube layer.

[0097] If 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], it can also be ensured that no excessive force is required when filling the tube with fluid and pressurizing the fluid.

[0098] The tube comprises a first material. 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 (e.g. about 85). The Shore A hardness is determined according to ASTM D2240.

[0099] In one embodiment, the tube comprises at least 50%, preferably at least 60%, 70%, 80% or at least 90% by mass fraction of the first material. The calculation of this mass fraction does not take into account any elements that are detachably connected to the tube, such as fluid connectors or plugs, or contents inside the tube, such as a medical fluid. In one embodiment, the tube consists essentially entirely of the first material. The first material is preferably a polymer, in particular an elastomer. Preferably, the first material comprises or consists of a medically acceptable elastomer. Examples of medically acceptable elastomers include silicone elastomers, thermoplastic elastomers (TPE), polyisoprene, butyl rubber, nitrile rubber, ethylene propylene diene monomer (EPDM), chloroprene rubber, fluoroelastomer, perfluoroelastomer, and polyacrylate elastomer. Examples of silicone elastomers include polydimethylsiloxane (PDMS) and liquid silicone rubber (LSR).

[0100] Examples of thermoplastic elastomers (TPE) include styrene block copolymers (SBC) such as styrene-ethylene-butylene-styrene (SEBS), thermoplastic polyurethane (TPU), and thermoplastic copolyester (TCE). Examples of polyisoprene include natural rubber and synthetic polyisoprene. Examples of butyl rubber include bromobutyl rubber (BIIR) and chlorobutyl rubber (CIIR). A preferred polyurethane is a polyether polyurethane. Polyether polyurethanes can be produced by polyaddition of a polyether polyol with a diisocyanate.

[0101] In one embodiment, the first material has a thermoplastic elastomer. In one embodiment, the first material consists of a thermoplastic elastomer. In one embodiment, the first material has a polyether polyurethane or an ethylene propylene diene rubber. In one embodiment, the first material comprises a polyether polyurethane. In one embodiment, the first material consists of a polyether polyurethane.

[0102] In an embodiment, the first material has only a single elastomer, i.e. no second elastomer is mixed with the first material. In an embodiment, the first material has at least two different materials, e.g. two different elastomers. This allows, for example, to set the hardness of the first material to a desired target value. The first material can comprise a copolymer. The copolymer can be a thermoplastic elastomer. Preferred is a copolymer comprising soft segments and hard segments in its molecular chain. The ratio between the soft segments and the hard segments within the molecular chain of the copolymer can be used to adjust the physical properties of such copolymer (e.g. the Shore A hardness of the copolymer). The hard segments can be connected to the soft segments using a linker (linking agent).

[0103] Furthermore, the first material can comprise additives to adjust the hardness. Examples of such additives are fillers and plasticizers. Examples of fillers include silicon dioxide, titanium dioxide, calcium carbonate, barium sulfate and carbon.

[0104] Examples of plasticizers include adipate esters, trimellitate esters, citrate-based plasticizers and polyol esters.

[0105] For example, TOTM (trimellitic acid tri(2-ethylhexyl) ester), DINCH (diisononyl cyclohexane-1,2-dicarboxylate), ATBC (acetyl tributyl citrate) or DEHA (di(2-ethylhexyl) adipate) can be used as plasticizer.

[0106] In an embodiment, the first material is free of plasticizers. In an embodiment, the first material is free of fillers. In an embodiment, the first material is free of endocrine disruptors, such as phthalates or bisphenols.

[0107] In an embodiment, the first material can further comprise a lubricant. Preferably, the lubricant is medically acceptable. Preferably, the lubricant is free of polyhalogenated substances and silicones. In an embodiment, the lubricant has a natural product, e.g. a lipid, a triglyceride or a biopolymer.

[0108] The first material can have a Young's modulus of 1.2 x 10^7 Pa to 2.1 x 10^7 Pa, e.g. 1.3 x 10^7 Pa to 2.0 x 10^7 Pa, 1.4 x 10^7 Pa to 1.9 x 10^7 Pa, 1.5 x 10^7 Pa to 1.8 x 10^7 Pa, or 1.5 x 10^7 Pa to 1.7 x 10^7 Pa. In an embodiment, the first material can have a Young's modulus of elasticity of about 1.6 x 10^7 Pa. In an embodiment, the first material can have a Young's modulus of elasticity of 2000 psi to 2500 psi. The latter approximately corresponds to 1.4 x 10^7 to 1.7 x 10^7 Pa.

[0109] The Young's modulus of elasticity can be determined according to ASTM D412.

[0110] The first material is preferably sterilisable using common sterilisation processes, i.e. resistant to UV radiation, gamma radiation and ethylene oxide treatment within the range of these processes.

[0111] The first material is preferably mouldable using standard extrusion and / or injection moulding processes.

[0112] The tube has an inner diameter (ID) and an outer diameter (AD).

[0113] In the present context, the term "inner diameter" refers to a measurement of the straight-line distance between two opposing inner surfaces of the tube. The measurement is determined along the central longitudinal axis of the tube. The inner diameter is determined when the tube is at rest, i.e. when no external forces, such as tension, pressure or torsion, act on the tube to change its original shape. The measurement only takes into account the net width of the tube.

[0114] Similarly, the term "outer diameter" refers to a measurement of the straight-line distance between two opposing outer surfaces of the tube. The measurement is determined perpendicular to the central longitudinal axis of the tube. The outer diameter is measured when the tube is at rest.

[0115] Preferably, the ratio of the inner diameter to the outer diameter has a value in the range of [1 : 1.8] to [1 : 2.5], i.e. the outer diameter has a value of 1.8 to 2.5 times the inner diameter. In some embodiments, the ratio of the inner diameter to the outer diameter has a value in 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].

[0116] The tube comprises a first end for receiving fluid into the tube. This means that fluid can be introduced into the tube at the first end of the tube. To this end, the first end of the tube can comprise a fluid connector. The fluid connector can be used to connect a container or a fluid-conducting connection for receiving 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 connected to the tube. The fluid connector can be operatively connected to the tube. To this end, the fluid connector can comprise a substantially cylindrical nozzle with a thickening in order to form a frictional engagement connection with the tube.

[0117] In one embodiment, the fluid connector can comprise a check valve. The check valve is preferably designed to prevent fluid from escaping from the tube through the fluid connector. Thus, fluid can be introduced into the tube through the fluid connector, while fluid cannot flow back through the fluid connector.

[0118] The tube comprises a second end portion. The second end portion is designed to retain the fluid in the tube. This means that the inner cavity of the tube is fluid-tight or can be closed liquid-tight in the region of the second end portion. For example, the tube can be closed at the second end portion by a plug or by a fused or glued tube wall.

[0119] The presence of the slits in the tube wall is still not affected, i.e. the slits can also be provided in the region of the second end portion, as described herein.

[0120] This ensures that the fluid can only exit the tube through the slits in the tube wall and the dispensing of the fluid can be controlled depending on the pressure.

[0121] The tube comprises one or more slits for dispensing the fluid from the tube. The slits each form a passage extending from the inside of the tube to the outside of the tube. This means that the slits represent penetrations in the tube wall. The slits are configured to be reversibly opened depending on the pressure of the fluid within the tube, so that the fluid is dispensed from the slits. This allows the slits to be used as valves which can be opened and closed depending on the pressure.

[0122] The slits are preferably designed such that they comprise slit walls which come into contact with one another when closed and preferably comprise a common contact surface over the entire area of the slit walls when closed.

[0123] This prevents the slits from being blocked, since the slits only open when fluid is simultaneously flowing out of the tube through the slits. In this way, inward growth of cells and penetration of tissue components can also be prevented. Due to the advantageous design of the device according to the application, additional coatings, complex geometrical designs and / or the addition of lubricants or anticoagulants (e.g. heparin) can be dispensed with, which can be necessary in designs not according to the application. Furthermore, a step of flushing the device in the implanted state can be dispensed with.

[0124] By suitable selection of the tube materials and / or the geometrical design described herein, in particular with regard to the wall thickness of the tube and the length, depth and / or arrangement of the slits, on the one hand the pressure-dependent opening properties of the slits can be achieved or improved, while on the other hand the stability of the device is ensured. In particular, irreversible deformation or tearing of the tube in the region of the slits can be effectively prevented. Furthermore, the embodiments described herein can achieve a dispensing amount of fluid which is easy to handle for the medical user. Furthermore, the design of the tube according to the application can allow opening properties of the slits which allow the slits to open at a limit pressure which can be easily established manually using a commercially available plastic syringe. This is the case, for example, at an overpressure of approximately 1 bar.

[0125] In one embodiment, the slit is arranged within the first material. In one embodiment, the slit is arranged in the tube such that the opening behavior of the slit relative to the limit pressure at which the slit opens results from the material properties of the first material. In one embodiment, the tube comprises a first material and a second material, wherein the opening behavior of the slit is independent of the second material.

[0126] In one embodiment, the tube comprises a first tube region at a first end of the tube comprising a uniform closed wall without slits. In one embodiment, the tube further comprises a second tube region at a second end of the tube comprising a plurality of slits. In one embodiment, the tube comprises no slits in the first tube region and a plurality of slits in the second tube region.

[0127] In one embodiment, the device according to the present application is designed and configured to dispense the medical fluid exclusively via the slits. Preferably, the device is designed and configured to dispense the fluid via a plurality of slits at different positions along the longitudinal axis of the tube. In one embodiment, the device is designed and configured to dispense the medical fluid exclusively in a pressure-dependent manner via the slits. Further preferably, the device is designed and configured to dispense the same volumetric flow of fluid through the plurality of slits simultaneously. The term "volumetric flow" refers to the volume of fluid dispensed from the tube to the outside through the respective slit per unit of time.

[0128] In one embodiment, the slit is designed and configured to open at a limit pressure of the fluid inside the tube that is higher than the pressure outside the tube by 1 bar (10^5 Pa) and to close fluid-tightly below this limit pressure. This means that the slit closes when the overpressure of the fluid in the tube is less than 1 bar and opens when the overpressure of the fluid in the tube is 1 bar or more. "Overpressure" here refers to the difference between the atmospheric pressure and the fluid pressure in the tube.

[0129] In one embodiment, this limit pressure is about 1 bar, about 1.2 bar, about 1.3 bar, about 1.4 bar, or more than 1.4 bar.

[0130] In one embodiment, the slit is configured to open and close reversibly by the elastic restoring force of the first material of the tube. The slit can be opened by the overpressure of the fluid in the tube when the material of the tube, in particular the first material of the tube, is pushed apart by the fluid.

[0131] The stability of the slit and the limit pressure at which the slit opens can depend on the dimensions of the tube and the slit.

[0132] The slit has a slit length L. In an embodiment, 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]. 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 for example be in the range of [1 :2.3] to [1 :2.8], [1 :2.4] to [1 :2.7] or [1 :2.5] to [1 :2.6]. In an embodiment, the ratio of the slit length L to the inner diameter ID of the tube [L:ID] is about [1 :2.5].

[0133] In an embodiment, 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]. This means that the outer diameter of the tube is 3.5 to 5.5 times the slit length. For example, the ratio between the slit length L and the outer diameter AD of the tube [L:AD] is in 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 an embodiment, the ratio of the slit length L to the outer diameter AD of the tube is about 4.5.

[0134] In an embodiment, the device is designed and configured to change the outer diameter AD 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 is increased by 0 to 1 bar (10^5 Pa) above the pressure outside the tube. This can prevent the tube from expanding when the fluid in the tube reaches the limit pressure at which the slit opens. The dimensional stability of the tube can prevent irritation of sensitive tissue even at increased fluid pressure. In some embodiments, the outer diameter of the tube changes by less than 9%, 8%, 7%, 6% or 5% when the overpressure of the fluid is increased from 0 to 1 bar.

[0135] In an 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 is increased by 0 to 1 bar (10^5 Pa) above the pressure outside the tube.

[0136] In an embodiment, the tube comprises a plurality of slits, each slit being arranged at a distance A from each other on the outside of the tube and each slit having a slit length L along the outside of the tube, wherein the ratio of the distance (A) to the slit length (L) [A:L] is at least [10:1]. This means that the shortest distance between two slits is at least ten times the slit length.

[0137] The distance between two slits is determined starting from the adjacent ends of the slits. The distance between two adjacent slits is determined using a measurement method that does not determine the center distance between the centers of the slits, but determines the minimum distance between the outermost boundaries of the slits. This determination means that the focus of the measurement is the shortest physical existing distance between the closely spaced interfaces of the slits, independent of the shape, orientation and position of the slit centers relative to each other. Thus, the minimum distance is determined exactly at the position where the closest points of the 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].

[0138] This can prevent the slits from tearing in the longitudinal direction and excessive radial expansion of the tube.

[0139] In one embodiment, the tube comprises a second material having a higher Shore A hardness than the first material. For example, the Shore A hardness of the second material can have a value that is at least 1.1 times, 1.2 times, 1.3 times, 1.4 times, 1.5 times or 2 times the Shore A hardness of the first material. The second material can comprise an elastomer. An elastomer is a plastic material that has rubber-like elastic properties. The Shore A hardness of the second material can be adjusted by plasticizers and / or fillers, as described above in connection with the first material. Thus, the first material and the second material can differ only in the content of such plasticizers and / or fillers. Thus, the first material and the second material can comprise the same or different elastomers. In one embodiment, the first material comprises a first elastomer and the second material comprises a second elastomer. In one embodiment, the second material does not comprise any elastomer that is comprised in the first material. In one embodiment, the first material and the second material comprise the same elastomer.

[0140] The second material can comprise a thermoplastic elastomer. The second material can comprise a copolymer. The copolymer can be a thermoplastic elastomer. Preferred is a copolymer comprising soft segments and hard segments in its molecular chain. The ratio between the soft segments and the hard segments within the molecular chain of the copolymer can be used to adjust the physical properties of such copolymer. The hard segments can be connected to the soft segments using a linker (linker).

[0141] Furthermore, the first material can comprise additives to adjust the hardness, as described herein.

[0142] 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 disrupting substances, such as phthalates or bisphenols.

[0143] In this embodiment, neither the first material nor the second material contains plasticizers, fillers, and endocrine disrupting substances. Other product groups described herein, such as radiopaque agents, polymers, or dyes, are not to be understood as “fillers”. Fillers are herein only understood to refer to those substances whose main function is to adjust the stiffness of the first material or the second material and which do not belong to one of the other product groups described herein.

[0144] In one embodiment, the second material further comprises a lubricant. Preferably, the lubricant is medically acceptable. Preferably, the lubricant does not contain polyhalogenated substances and silicones.

[0145] In one embodiment, the first material comprises a polyether polyurethane and the second material comprises a polyether block amide.

[0146] The second material can be arranged in the tube as a coaxial surrounding layer or on the surface of the tube. The second material can be arranged as a strip parallel to the longitudinal axis of the tube. The second material can be located on the inside of the tube or on the outside of the tube. The second material can be embedded in the first material, for example completely therein. In one embodiment, the second material is arranged in the tube in such a way that it does not affect the opening and closing properties of the slits, in particular with regard to the limit pressure of the fluid when the slits are open. The second material can be designed to stabilize the overall structure of the tube, in particular the longitudinal or radial expansion of the tube when the pressure of the fluid received in the tube changes.

[0147] 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, in particular when the tube is in the area of a surgical wound. Dyes with a significant light emission in the range of 490 nm to 575 nm can provide a particularly good contrast to the pale red body tissue for the human eye.

[0148] In one embodiment, the second material comprises both an elastomer and a radiopaque agent. The radiopaque agent can be embedded in the elastomer.

[0149] In one embodiment, the slits are arranged parallel to the longitudinal axis of the tube. This 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 arranged parallel to the longitudinal axis of the tube.

[0150] The slits can be arranged circumferentially in different directions to distribute fluid from the tube in different directions. This can allow for a more spatially uniform distribution of fluid. For example, in one embodiment, 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. In one embodiment, the first radial position forms an angle of approximately 90° with the second radial position. This corresponds to an arrangement in which, in a cross-sectional view of the tube, the first slit is arranged at e.g. the “12 o’clock position” and the second slit is arranged at the “9 o’clock position” or the “3 o’clock position”. In one embodiment, the above statements relate to a first slit and a second slit in mutually adjacent longitudinal positions.

[0151] In one embodiment, the tube comprises multiple pairs of slits, each pair of slits being located at the same longitudinal position in the direction of the longitudinal axis of the tube, but forming an angle of 180° with each other in their radial position. This corresponds to an arrangement in which, in a cross-sectional view of the tube, a first slit of this pair of arrangement is arranged at e.g. the “12 o’clock position” and a second slit of this pair of arrangement is arranged at the “6 o’clock position”.

[0152] In one embodiment, both of the above arrangements are realized, i.e. a first pair of slits forms an angle of approximately 90° with a second pair of slits with respect to the radial position, while within the first pair of slits and within the second pair of slits, the two slits each form an angle of 180° with respect to each other.

[0153] In one embodiment, the tube comprises a support structure made of metal. In one embodiment, the support structure comprises a metal coating, a metal foil, a metal spiral or a metal wire. In one embodiment, the support structure is embedded in the first material. In one embodiment, the support structure is arranged on the inside of the tube. Similar support structures can alternatively or additionally be formed of the second material described herein.

[0154] In order to achieve a uniform distribution of fluid from the tube, it is advantageous to close the second end of the tube. This means that the tube in particular does not comprise an opening at the second end which is larger than the largest cross-section of the open slits.

[0155] Thus, in one embodiment of the application, the second end of the tube is sealed against the passage of liquid. For this purpose, the tube can be welded or fused, for example at the second end, so that the interior of the tube comprises a fluid-conducting connection to the outside only via the first end and the slits.

[0156] In one embodiment, the second end of the tube is closable. For example, the tube can be designed to be closed with a plug or a screw cap at the second end. Such a closure can be included in the device.

[0157] In one embodiment, the tube is closed or closable at the second end in such a way that the second end is closed against the passage of liquid even at a pressure of at least 1 bar, preferably at least 2 bar. The pressure-dependent opening of the slit remains unaffected.

[0158] According to the 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. This functionality can be achieved economically and efficiently by severing portions of the tube. Preferably, no material is removed from the tube, so that the tube can comprise a smooth and uniform surface in the configuration in which the slit is closed. One embodiment of the invention therefore relates to a device as described herein, wherein the slit is produced by severing portions of the tube without removing material from the tube or the slit is produced by severing portions of the tube without removing material from the tube. This can be achieved, for example, by cutting or punching with a blade. As a result, the slit can be formed as a cut into the tube wall. This can result in better lubrication, less damage to tissue and prevention of clogging or adhesion of body tissue to the opening.

[0159] It can be advantageous to design the device such that the medical user can shorten the length of the tube before bringing the device into contact with the patient. In one embodiment, the device is therefore designed and configured to permanently change the length of the tube. This can be done, for example, by removing a tube portion at the second end of the tube, i.e. the tube can be severed at the second end without affecting the functionality of the device.

[0160] Subsequently, it can be advantageous to close the second end of the tube, as previously described, for example with a plug.

[0161] As described above, similar devices are known from the prior art which necessarily comprise several tubes or several tube layers which can be moved relative to one another in order to ensure the stability of the device, to prevent the entire tube from swelling due to the pressurized fluid contained therein and / or to adjust the fluid distribution area. On the other hand, the present invention allows a functional device to be achieved even with a one-piece design of the tube, without the need for a further tube or a further separate tube layer. A further embodiment therefore relates to a device as described herein, wherein the tube is formed in one piece. In one embodiment, the device does not comprise a second tube. In one embodiment, the device neither comprises a second tube nor two tube layers which can be displaced relative to one another. In one embodiment, the first material and the second material together form a monolithic unit.

[0162] Another aspect of the present application relates to a kit comprising the device described herein and a means for introducing a medical fluid. The means for introducing a medical fluid is preferably connectable, preferably operably connectable, to the first end of the tube. The means for introducing a medical fluid can for example comprise a syringe. Other standard devices can also be used to introduce a 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, as well as spacers allowing proper connection of a medicament container. Examples of infusion pumps include peristaltic pumps, syringe pumps, balloon pumps, piston pumps and other pumps commonly used in a medical environment. 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 can comprise matching elements of a luer lock connection.

[0163] The kit can also comprise a means for closing the second end of the tube. For example, the kit can contain a plug, with which the second end of the tube can be closed. In one embodiment, the kit contains a tool configured to close the second end of the tube. Such a tool can for example crimp, melt, clamp or plug the tube to close it at the second end.

[0164] The kit can also comprise a medical fluid intended for administration by the means of the device. The fluid preferably contains an active ingredient. In one embodiment, the active ingredient is preferably selected from the group consisting of antibiotics, antifungal agents, antitumor active ingredients, osteoinductive active ingredients and anti-inflammatory active ingredients. The active ingredient can contain all active ingredients described herein as well as other active ingredients that can be administered in liquid form.

[0165] In another embodiment, the kit also comprises a trocar. The trocar comprises a tip allowing it to penetrate tissue. Furthermore, the trocar comprises a shaft along which the trocar can be guided. The shaft can comprise a cylindrical cavity, which is similar to the cannula.

[0166] The trocar can preferably be connected to the first end of the tube. Preferably, the trocar can be detachably connected to the first end of the tube. Using the trocar, the medical user can insert the tube of the device into the tissue of the patient, thereby positioning and fixing the tube at the desired location. The trocar can allow for a gentle and precise penetration of the target tissue. In this case, a passage to the desired administration site can be formed, thereby allowing for positioning the device for administering the medical fluid accordingly. The tube of the device can be inserted into the tissue of the patient through the passage formed by means of the trocar. Preferably, the trocar is removable to allow for receiving the medical fluid through the first end of the tube after positioning the device using the trocar. For example, the trocar can be removed from the first end of the tube and replaced by a fluid connector, such as a luer lock connector. The medical fluid can then be added into the tube using, for example, a luer lock syringe, and the medical fluid can then be distributed to the target location on the patient tissue using the device.

[0167] Another aspect of the present invention relates to a method of medical treatment, wherein the treatment method comprises administering a medical fluid to a patient using the device described herein or the kit described herein.

[0168] The treatment method can in particular comprise one, several or all of the following steps:

[0169] • shortening the tube at the second end of the tube, if necessary

[0170] • closing the second end of the tube, if necessary

[0171] • connecting a trocar to the first end of the device

[0172] • penetrating the tissue of the patient using the trocar to form a passage to a target location of the patient tissue

[0173] • inserting the tube through the passage formed by the trocar

[0174] • bringing the tube into contact with the target location of the patient tissue

[0175] • removing the trocar from the first end of the tube

[0176] • connecting a fluid connector to the first end of the tube

[0177] • introducing a medical fluid into the tube, preferably via the fluid connector at the first end of the tube

[0178] • pressurizing the medical fluid within the tube to open the slit and distribute the medical fluid through the slit to the patient tissue.

[0179] In one embodiment, the method of treatment specifically includes pressurizing the medical fluid within the tube to open the slit and dispense the medical fluid through the slit to the tissue of the patient. This means that the pressure of the medical fluid inside the tube is increased to a value at which the slit opens due to the rubber-elastic properties of the first material.

[0180] Another aspect relates to a medical active ingredient for use in bone surgery, wherein the active ingredient is selected from the group consisting of antibiotics, antifungal agents, antitumor active ingredients, osteoinductive active ingredients, and anti-inflammatory active ingredients, wherein the method comprises contacting the device described herein or the kit described herein with the surgical wound of the patient and using the device or the kit to locally administer the active ingredient as a medical fluid to the surgical wound. Examples of such active ingredients are described herein.

[0181] For the purposes of this patent application, "bone surgery" means any surgical procedure involving the treatment of bone tissue of the human or animal body. This includes, but is not limited to, interventions on 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, implant surgery, arthroscopic surgery, spinal surgery, and microsurgical procedures.

[0182] Trauma surgery involves the treatment of various bone fractures, dislocations, bone injuries, the restoration of bone integrity and function after acute and chronic injuries.

[0183] Corrective and reconstructive surgery includes procedures to correct bone misalignments, deformities, and defects, which can be caused by genetics, trauma, or disease. This also includes the reconstruction of bone defects after tumor resection and treatment of infections.

[0184] Orthopedic surgery involves the diagnosis, treatment, rehabilitation, and prevention of diseases, disorders, and injuries of the musculoskeletal system.

[0185] Implant surgery includes the insertion of orthopedic implants, prostheses, artificial joints, fixation elements such as screws, plates, pins, wires, and anchoring systems to support or replace bone structures.

[0186] Arthroscopic surgery includes minimally invasive procedures on joints to treat injuries or conditions such as arthritis, meniscus tears, or cruciate ligament injuries.

[0187] Spinal surgery includes, for example, the correction of spinal deformities, the treatment of herniated discs, spinal fusion, and the stabilization of spinal fractures.

[0188] Microsurgical procedures include processes that require the use of a microscope for precise treatment of smaller bone structures, including nerve repair and vascular anastomosis.

[0189] In the context of the present application, bone surgery comprises a surgical intervention, for example in the region of a joint, in particular the hip joint, the knee joint or the shoulder joint.

[0190] Another aspect relates to a medical active ingredient for the treatment or prevention of a bone disease, wherein the active ingredient is selected from the group consisting of an antibiotic, an antifungal agent, an antitumor active ingredient, an osteoinductive active ingredient and an anti-inflammatory active ingredient, wherein the method comprises the local application of the active ingredient as a medical fluid to the target tissue of the patient using the device or kit described herein.

[0191] The bone disease can comprise an infection, an injury, a degeneration or an inflammatory disease of the bone. Examples of bone diseases include rheumatism, arthritis, cancer, bone or cartilage injury, joint infection and osteomyelitis.

[0192] Examples

[0193] The application is further illustrated below using examples, however, these examples should not be understood as limiting. It will be apparent to the person skilled in the art that other equivalent devices can be used analogously instead of the features described here.

[0194] The following tubes were produced by extrusion from commercially available medical polyether urethanes with a Shore A hardness of 75, 85 and 95:

[0195]

[0196]

[0197] Three trapezoidal knife blades with a blade length (length of the cutting edge parallel to the tube surface) of 0.5 mm, 0.7 mm and 1.0 mm were manufactured from tool steel. Using these knife blades, the tube sample was cut open at one point on the tube from both opposite sides at different distances. Preliminary tests using a 5 ml syringe with distilled water showed that a uniform release of the liquid was possible with a blade length of 0.7 mm and 1.0 mm.

[0198] With a blade length of 0.5 mm, the amount of fluid released per slit was very small and the force required to operate the syringe was unacceptably high. Therefore, no further tests were carried out on the corresponding samples.

[0199] Further, it was found that the force of the hand required to open the slits in the samples of embodiments 1, 6 and 11 was uncomfortably high when operating the syringe. Further tests were performed on the remaining samples using a caliper to measure the expansion of the tube samples with slit lengths of 0.7 mm and 1.0 mm. The results showed that at a pressure of 1.0 bar or higher, the slits opened and liquid escaped from the slits. During liquid dispensing, the pressure is between 1.4 and 2.0 bar and this pressure is established manually with the syringe. In further tests, it was observed that with slit lengths of 0.7 mm and distances between the slits of less than 7 mm, especially between 2 and 3 mm, the slits temporarily expanded radially and sometimes enlarged when the pressure was applied multiple times. Similarly, a similar effect occurred with slit lengths of 1.0 mm and distances between the slits of less than 10 mm.

[0200] Therefore, the following tests were performed with a slit distance of 7 mm for 0.7 mm slits and a slit distance of 10 mm for 1.0 mm slits. The expansion from the opening of the slit was determined using a caliper. An expansion of the outer diameter of more than 10% was chosen as a limit value. A radial expansion of less than 10% was rated as “+” and an expansion of more than 10% was rated as “-”.

[0201]

[0202] Figure

[0203] Figure 1 A cross-sectional view showing details of a tube 101 of a device 100 according to the present application. The tube 101 comprises a first end 102 (not shown in this figure) and a second end 103. In the wall of the tube 101 there are slits 104, each slit extending from the inside 105 of the tube to the outside 106 of the tube. The slits 104 thus form a fluid-conducting connection between the inside 105 and the outside 106 of the tube, through which fluid 200 from the inside of the tube 101 can be dispensed to the outside. The tube has an inner diameter ID, which corresponds to the net width of the tube. The tube still has an outer diameter AD, which is a measure of the straight-line distance between the 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 such that fluid 200 can only escape through the slits 104.

[0204] Figure 2 An embodiment of a device 100 according to the present application is shown. The device comprises a first end 102 designed to receive fluid into the tube 101. The tube comprises a first tube region 112 comprising a uniform closed wall without slits. The tube further comprises a second tube region 113 comprising a plurality of slits 104. The first end 102 adjoins the first tube region 112, while the second end 103 adjoins the second tube region 113.

[0205] Figure 3 A fluid connector 212 is shown which can be detachably connected to the tube 101 of the device. The fluid connector can be connected to the first end portion 102 of the tube to allow receiving fluid into the tube 101.

[0206] Figure 4 A fluid connector 212 is shown which has a luer lock connector 220, a tube connector 230 and a check valve 240. The luer lock connector 220 allows for example detachable connection of the device to a syringe for introducing medical fluid into the device. At the same time, the syringe can be used to pressurize the fluid within the tube to open the slits. The tube connector 230 allows for detachable, fluid conducting and liquid tight connection to the first end portion 102 of the tube 101. To this end, the tube connector 230 can be inserted into the tube 101. The tube connector comprises a cylindrical nozzle with a thickened portion to form a liquid tight connection with frictional engagement to the tube.

[0207] Figure 5 A second end portion 103 of the tube of the device according to the invention is shown which can be closed with a plug 120. The plug 120 is here provided with a thread to form a frictional engagement connection to the tube such that the tube at the second end portion 103 can be liquid tight sealed. The plug can similarly be provided with a circumferential protrusion which can be engaged in the flexible first material 141 of the tube to liquid tight seal the tube.

[0208] Figure 6 A second end portion 103 of the tube of the device according to the invention is shown which comprises a support structure 130 in the inner lumen of the tube. The support structure is here designed as a helically wound wire which is arranged on the inner side 105 of the tube. The support structure 130 can increase the bending strength of the tube such that for example kinks in the tube can be avoided.

[0209] Figure 7 A second end portion of the tube 103 of the device according to the invention is shown in which the second end portion 103 comprises a tube wall which is fused and thus closed. In particular, the first material 141 can form a fused tube end portion.

[0210] Figure 8 A second end portion 103 of the tube is shown in which a second material 142 is embedded in the tube wall. The second material 142 has a higher hardness than the surrounding first material 141 and extends in the form of a strand parallel to the central longitudinal axis of the tube towards the second end portion 103 of the tube. This stabilizes the geometry of the tube. In particular, expansion of the tube due to pressurized liquid inside the tube can be reduced or avoided.

[0211] Figure 9A cross-sectional view of the second end of the tube 103 is shown, in which the second material 142 is embedded in the tube wall, wherein the second material 142 is arranged in strand form in the tube. The second material 142 is here arranged in strand form within the first material 141 and comprises a circular closed cross-section. The second material 142 is completely surrounded by the first material 141.

[0212] Figure 10 A cross-sectional view of the second end of the tube 103 is shown, in which the second material 142 is embedded in the tube wall, wherein the second material 142 is arranged such that it extends coaxially in a surrounding manner in the tube. The second material 142 here comprises a circular open cross-section. The second material 142 here forms a complete radially surrounding layer, which is completely embedded in the first material 141. The first material 141 and the second material 142 together form a monolithic unit, so that the first material 141 and the second material 142 cannot move relative to one another.

[0213] Figure 11 A longitudinal sectional view of a detail of the tube 101 is shown, in which two slits 104, 104' are arranged offset from one another. The first slit 104 is located at a first longitudinal position 301 and a first radial position 401 of the tube. The second slit 104' is located 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 in the longitudinal direction of the tube, i.e. parallel to the longitudinal axis LA of the tube, and point in different radial directions in order to distribute the medical fluid to spatially separated target regions.

[0214] Figure 12 A cross-sectional view of a detail of the tube is shown, in which two slits 104, 104' are arranged offset from one another. The first slit 104 is located at a first longitudinal position 301 and a first radial position 401 of the tube. The second slit 104' is located at a second longitudinal position 302 and a second radial position 402 of the tube. Here, the first radial position 401 forms an angle of approximately 90° with the second radial position 402, wherein the legs of the angle intersect on the longitudinal axis of the tube.

[0215] Figure 13 A longitudinal sectional view of a detail of the tube 101 is shown, in which the slit 104 in the tube is closed. The slit 104 extends from the inside 105 of the tube to the outside 106 of the tube. Due to the restoring force of the first material 141, the slit 104 is compressed and thus remains liquid-tight as long as no force acts on the tube.

[0216] Figure 14A longitudinal sectional view showing details of the tube 101, wherein the slits 104 in the tube are open. Pressurized medical fluid 200 received in the tube presses here against the inner side 105 of the tube, so that the slits 104 are pushed open and open. This allows the medical fluid 200 to be dispensed from the inner lumen of the tube through the slits 104 to the outside. Here, the open state of the slits 104 can be controlled by the pressure of the medical fluid.

[0217] Figure 15 A kit comprising the device 100 described herein, a means 500 for introducing a medical fluid, which is designed here as a syringe, and a means 120 for closing the second end of the device, which is designed here as a plug. Using the syringe 500, a medical fluid can be introduced into the device 100, in particular by connecting the syringe 500 with the first end of the tube of the device 100. The plug 120 can be used to liquid-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.

[0218] List of Figures

[0219] 100 device

[0220] 101 tube

[0221] 102 first end

[0222] 103 second end

[0223] 104 slit

[0224] 105 inner side of the tube

[0225] 106 outer side of the tube

[0226] 112 first tube region

[0227] 113 second tube region

[0228] 120 means for closing the second end

[0229] 130 support structure

[0230] 141 first material

[0231] 142 second material

[0232] 200 fluid

[0233] 212 fluid connector

[0234] 220 luer lock connector

[0235] 230 tube connector

[0236] 240 check valve

[0237] 301 first longitudinal position

[0238] 302 second longitudinal position

[0239] 401 first radial position

[0240] 402 second radial position

[0241] 500 means for introducing a medical fluid

[0242] A distance between two slits on the outer side of the tube

[0243] AD outer diameter of the tube

[0244] L slit length

[0245] LA longitudinal axis of the tube

[0246] ID inner diameter of the tube

Claims

1. A device (100) for dispensing medical fluid to a patient, the device comprising: Tube (101), said tube comprising a first medically acceptable 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 in the range of [1:1.8] to [1:2.5]. The tube (101) includes a first end (102) for receiving fluid (200) into the tube (101); The tube (101) includes a second end (103) configured to hold fluid (200) in the tube (101); One or more slits (104) for dispensing fluid (200) from the tube (101), wherein each of the slits (104) forms a channel extending from the inside (105) of the tube (101) to the outside (106) of the tube; And the slit (104) is configured to open reversibly according to the pressure of the fluid (200) in the tube (101), so that the fluid (200) is dispensed from the slit (104).

2. The device of claim 1, wherein the device is designed and configured to dispense medical fluid only via the slits, wherein the fluid is preferably dispensed simultaneously via a plurality of slits at different locations along the longitudinal axis (LA) of the tube.

3. The device according to any one of the preceding claims, wherein the slit is designed and configured to open at a pressure higher than the ultimate pressure of the fluid inside the tube and to close impermeably at a pressure lower than the ultimate pressure, the ultimate pressure being 1 bar (10^5 Pa) higher than the pressure outside the tube, preferably 1.4 bar.

4. The apparatus according to any one of the preceding claims, wherein the slit is configured to open and close reversibly via the elastic restoring force of a first material of the tube.

5. The apparatus according to any one of the preceding claims, wherein each of the slits has a slit length (L), and wherein 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].

6. The apparatus according to any one of the preceding claims, wherein the apparatus 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 to 0 to 1 bar (10^5 Pa) higher than the pressure outside the tube.

7. The apparatus according to any one of the preceding claims, wherein the apparatus 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 to 0 to 1 bar (10^5 Pa) higher than the pressure outside the tube.

8. The apparatus according to any one of the preceding claims, wherein the tube comprises a plurality of slits, each slit being arranged on the outer side of the tube at a distance (A) from each other, and each slit having a slit length (L) along the outer side of the tube, wherein the ratio [A:L] of the distance (A) to the slit length (L) is at least [10:1].

9. The device according to any one of the preceding claims, wherein the tube comprises a second material (142) having a higher Shore A hardness than the first material (141), wherein the second material is preferably arranged as a coaxial wrapping layer or as a strip arranged parallel to the longitudinal axis (LA) of the tube, wherein the second material further preferably comprises an elastomer, and wherein more preferably the second material is completely embedded in the first material.

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

11. The apparatus according to any one of the preceding claims, wherein the slit is arranged parallel to the longitudinal axis (LA) of the tube.

12. The apparatus according to any one of the preceding claims, wherein at a first longitudinal position (301) in the direction of the longitudinal axis (LA) of the tube, the 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, the second slit (104') is arranged at a second radial position (402), wherein the first radial position (401) and the second radial position (402) form an angle of approximately 90°.

13. The device according to any one of the preceding claims, wherein the tube includes a support structure (130) made of metal, wherein the support structure (130) preferably includes a metal coating, metal foil, metal spiral or metal wire, and wherein the support structure is preferably embedded in the first material (141) or disposed on the inner side (105) of the tube.

14. The device according to any one of the preceding claims, wherein the first medically acceptable material (141) comprises a polymer, wherein the polymer preferably comprises polyether polyurethane or ethylene propylene diene monomer (EPDM) rubber.

15. The apparatus according to any one of the preceding claims, further comprising a fluid connector (212) disposed, preferably detachably disposed, at the first end (102) of the tube (101).

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

17. The device according to any one of the preceding claims, wherein the second end (103) is preferably closed or can be closed by welding, melting or by means of a plug or nut without fluid flow.

18. The apparatus according to any one of the preceding claims, wherein the slit (104) is capable of being created by cutting off portions of the tube without removing material from the tube.

19. The device according to any one of the preceding claims, wherein the device 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 according to any one of the preceding claims, wherein the tube is formed as a single piece, and wherein the device does not include a second tube.

21. A kit comprising the means according to any one of the preceding claims and a component (500) for introducing medical fluid, the component being connectable to the first end (102) of the tube.

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

23. The kit according to claim 21 or 22, further comprising a medical fluid containing an active ingredient, wherein the active ingredient is preferably selected from the group consisting of antibiotics, antifungal agents, antitumor active ingredients, bone-inducing active ingredients, and anti-inflammatory active ingredients.

24. The kit according to any one of claims 21 to 23, the kit further comprising a cannula needle, wherein the cannula needle is connectable to, and preferably detachably connectable to, the first end (102) of the tube.

25. A medical treatment method, wherein the treatment method comprises administering a medical fluid to a patient using the device according to any one of claims 1 to 20 or the kit according to any one of claims 21 to 24.

26. A medically active ingredient for bone surgery, wherein the active ingredient is selected from the group consisting of antibiotics, antifungal agents, antitumor active ingredients, bone-inducing active ingredients, and anti-inflammatory active ingredients, wherein the method comprises contacting a device according to any one of claims 1 to 20 or a kit according to any one of claims 21 to 24 with a patient's surgical wound and applying the active ingredient locally as a medical fluid to the surgical wound using the device or kit.

27. A medically active ingredient for treating or preventing bone diseases, wherein the active ingredient is selected from the group consisting of antibiotics, antifungal agents, antitumor active ingredients, bone-inducing active ingredients, and anti-inflammatory active ingredients, wherein the method comprises applying the active ingredient as a medical fluid topically to a patient's target tissue using the apparatus described herein according to any one of claims 1 to 20 or the kit according to any one of claims 21 to 24.

Images