Kit (kit of parts) or set for medical use

Abstract

The present invention relates to a kit for use in the treatment of, in particular therapeutic treatment of, stone diseases of the human body (e.g. kidney stones, bladder stones, urinary calculus, gallstones, etc.), preferably by removing particles and / or concretions from the lumen of human organs, and / or for preferably therapeutic use when removing particles and / or concretions from the lumen of human organs. The present invention also relates to the production and uses of said kit.

Description

[0001] Kit (kit-of-parts) or set for medical use

[0002] The present invention relates to the medical-technical field of treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removal of particles and / or concretions from the lumen of human organs.

[0003] In particular, the present invention relates to a kit (kit of parts and / or set), (in particular) for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs.

[0004] Furthermore, the present invention also relates to the use of a kit according to the present invention (for the preparation of a medicament and / or pharmaceutical) for the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or (for the preparation of a medicament and / or pharmaceutical) for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs.

[0005] Furthermore, the present invention relates to a method for the treatment, in particular therapeutic treatment, preferably based on a medical treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of an organ, using a kit according to the invention.

[0006] Yet another subject of the present invention is a process for producing a kit, in particular a sterile kit, preferably according to the present invention, or the kit obtainable by the process, in particular for the therapeutic treatment of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs.Furthermore, the present invention relates to the use of a plastic syringe comprising a syringe body, in particular a syringe barrel, and a syringe plunger, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, in a method according to the present invention for producing a kit, in particular a sterile kit, preferably also according to the present invention.

[0007] Finally, the present invention relates to a packaging unit containing at least one package and at least one kit according to the invention.

[0008] Particulate structures such as uroliths, kidney stones (nephrolites), or gallstones (choleliths) are deposits or crystalline precipitation products (concrements) that can form and accumulate in organ lumens. Kidney stones and urinary stones, for example, are formed from urine and occur in the renal pelvis and calyx system or in the urinary tract in varying compositions and sizes. Gallstones are caused by an imbalance of soluble substances in the bile. Complications can arise from these stones or concretions, particularly if they detach from or pass out of the kidneys or gall bladder, blocking the kidney or urinary ducts or bile ducts, causing or potentially resulting in colic. The formation of concretions in organ lumens alone should be taken seriously and therefore constitutes the independent clinical picture of urolithiasis, stone disease, or urolithiasis.

[0009] However, gallstones or kidney stones are often only discovered at an advanced stage, especially when the first (more serious) symptoms appear, especially in the form of pain or the excretion of blood.

[0010] At this stage, the formed concretions are often already too large for minimally invasive removal of the concretions from the body or, in particular, the affected organs and organ ducts to be possible.

[0011] Various methods are available for the treatment and, in particular, removal of kidney or urinary stones, some of which, however, involve significant physical intervention. Percutaneous nephrolitholapaxy, for example, is used for larger kidney stones. This procedure involves inserting an endoscope into the kidney through a small incision. Various techniques (shock waves, laser, ultrasound) are then used to break the stones into fragments, which can then be flushed out. Depending on the size of the fragments, flushing can still be painful and carry the risk of blockage in the urinary tract.

[0012] Ureterorenoscopic stone removal is used for kidney stones as well as ureteral stones. A thin tube with an optical instrument (similar to that used in cystoscopy) is inserted through the urethra into the bladder and then into the affected ureter or kidney. Devices for breaking up and removing the kidney or ureteral stones can be inserted through a working channel in the optical instrument. These can be ultrasound or laser probes or special forceps.

[0013] In addition to these two methods, there are other options for fragmenting kidney or urinary stones, such as extracorporeal shock wave lithotripsy or laser lithotripsy. However, even these methods always carry a certain risk that debris fragments may still be too large to be excreted easily or without complications.

[0014] Therefore, in almost all cases, in addition to the aforementioned measures, a catheter (also called a double-J catheter, stent or ureteral stent) is inserted and left in place for a few days or weeks to dilate and keep the ureter open and to facilitate the natural passage of the stone or debris fragments. To secure it in the ureter, the catheter is rolled up for a few centimeters at the upper end in the renal pelvis or at the lower end in the bladder. Although the ureter is protected by the catheter, as the passing stone fragments are sometimes sharp and could injure the ureteral walls, wearing the catheter for days or weeks is disadvantageous because it is very uncomfortable. Against this background, there is a corresponding need in the state of the art for concepts that specifically facilitate the removal of concretions or stones, and in particular stone fragments, from organ lumina or the ureter.Organ ducts are made safer and more comfortable for the patient, ie in particular less painful.

[0015] At the same time, there is also a need in the state of the art for concepts that make the removal of calculi from organ lumina of affected patients more efficient and reliable, in particular by minimizing the occurrence of risks and complications associated with the excretion of calculi or calculus fragments and / or by simplifying the related therapeutic or surgical procedure with regard to handling and applicability.

[0016] In this regard, US patent US 6,663,594 B2 describes a method for immobilizing an object, for example a kidney stone, in a body. A gel-forming fluid is injected into the body and, upon contact with the object or kidney stone, forms a gel that at least partially captures and immobilizes it. Immobilization serves to prevent fragmentation of the kidney stone during subsequent fragmentation and to enable removal of the object or its fragments from the body using an endoscopic tool. The gel prevents the object or its fragments from slipping and thus from being captured by the tool. After removal of the object or fragments, the gel is dissolved or extracted using an endoscopic tool.A disadvantage of the described method, however, is that the already set gel can be destroyed when crushing the kidney stones. Furthermore, the described procedure is very complex, as the stones or stone fragments must be picked up and removed individually, and it is also to be expected that individual stone fragments will remain in the patient's body.

[0017] A particular problem is the occurrence of medium-sized calculus fragments (< 2 mm in size, also known as "grit"). These fragments, in particular, cannot be grasped or rinsed efficiently. At the same time, such fragments can pass through the mesh of grasping instruments (forceps or baskets), making the extraction of the fragments very time-consuming and practically impossible for larger quantities.

[0018] To date, no technology has been successfully established to completely remove these calculi. However, the retention of these calculus fragments inevitably leads to the formation of new kidney stones, as these fragments essentially serve as "crystallization nuclei."

[0019] Accordingly, it is an object of the present invention to provide an effective concept or a related application form which, on the one hand, allows the aforementioned disadvantages to be overcome, in particular with regard to the removal of concrement fragments from organ lumina, which has so far been hardly possible or only possible with great effort, and, on the other hand, is accompanied by more efficient and improved handling with regard to the application of the concept.

[0020] In this regard, it is specifically an object of the present invention to provide an application concept that is accompanied by a very high degree of application safety and, at the same time, a very high degree of user-friendliness, in particular in order to ensure the successful removal of concretions from organ lumina safely and in the best possible way.

[0021] In a completely surprising manner, the applicant has now found that a very specific application form, in particular a kit (kit-of-part or set), is outstandingly suitable for the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, in particular with regard to ensuring safe, user-friendly, highly effective and largely complete removal of stones or concretions from organ lumina, which is based in particular on the inventive combination of application form and components included.To achieve the above-described object, the present invention thus proposes - according to a first aspect of the present invention - a kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, according to claim 1. Advantageous further developments and embodiments of this aspect of the invention are the subject of the relevant auxiliary or dependent claims.

[0022] A further subject matter of the present invention—according to a second aspect of the present invention—is the use of a kit according to the present invention (for producing a medicament and / or pharmaceutical) for the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or (for producing a medicament and / or pharmaceutical) for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs according to the relevant claim. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaims.

[0023] Yet another subject matter of the present invention—according to a third aspect of the present invention—is a method for producing a kit, in particular a sterile kit, preferably according to the present invention, according to the relevant claim. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaims.

[0024] Yet another subject matter of the present invention - according to a fourth and fifth aspect of the present invention - is a kit (kit of parts and / or set), in particular a sterile kit, preferably according to the present invention, in particular a kit for use or use of a kit in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit is obtained and / or obtainable by a method according to the present invention, according to the claims relating thereto. Advantageous further developments and embodiments of this aspect of the invention are the subject matter of the relevant subclaims.

[0025] Furthermore, a further subject matter of the present invention - according to a sixth aspect of the present invention - is the use of a plastic syringe in a method according to the present invention for producing a kit, in particular a sterile kit, preferably according to the present invention, according to the claim relating thereto.

[0026] Finally, a further subject matter of the present invention - according to a seventh aspect of the present invention - is a packaging unit containing at least one package and at least one kit, preferably several kits, according to the present invention, according to the claim relating thereto.

[0027] It goes without saying that embodiments, forms of embodiment, advantages and the like which are listed below only for one aspect of the invention for the purpose of avoiding repetition, naturally also apply accordingly to the other aspects of the invention without this requiring separate mention.

[0028] Furthermore, it goes without saying that the following specifications of values, numbers, and ranges are not to be understood as limiting; it is self-evident to the person skilled in the art that, depending on the individual case or application, deviations from the specified range or specifications may occur without departing from the scope of the present invention.

[0029] Furthermore, all values ​​or parameter specifications or the like mentioned below can generally be determined using standardized or explicitly stated determination procedures or using determination methods that are familiar to the person skilled in the art. Furthermore, with all relative or percentage, particularly weight-related, quantity specifications mentioned below, it should be noted that these specifications must be selected or combined by the person skilled in the art with regard to the reference system used (e.g., dosage form) in such a way that the total - if necessary including other components or ingredients or additives or constituents, in particular as defined below - always results in 100% or 100% by weight. This is, however, self-evident to the person skilled in the art.

[0030] Furthermore, for the description of the present invention, the features of the present invention cited in connection with the specific configurations, embodiments, advantages, examples, or the like are also deemed to be disclosed in their combination. Thus, higher-level combinations of individual or multiple features cited for respective configurations, embodiments, application examples, or the like are also deemed to be disclosed.

[0031] In particular, for the features characterizing the invention, any combination of these features is also deemed to be disclosed, whereby embodiments of the same preference of the various features in their combination are preferred (e.g. amounts or ranges of amounts of the active ingredients and ingredients in question of the same preference).

[0032] Furthermore, in this context, it is particularly important that, with regard to the quantity specifications listed below relating to the various ingredients, in particular active ingredients, of the dosage form according to the invention, in particular relative quantity specifications or absolute quantity specifications, respective combinations relating to the various ingredients, in particular active ingredients, with the same preference or preference level are also disclosed. Likewise, all other combinations (i.e., combinations based on different preferences or different preference levels) are also disclosed.

[0033] Furthermore, the term "medication" or "drug" (also synonymously "pharmaceutical"), as used in the context of the present invention, is to be understood very broadly and encompasses not only medications, drugs, or pharmaceuticals as such (i.e., in terms of pharmaceutical law), but above all also so-called medical devices. In other words, the kit (kit of parts or set) according to the invention can be in the form of a medication, drug (pharmaceutical) or medical device. This also includes medical devices (e.g., syringes).

[0034] Having said that, the present invention will now be explained in detail below:

[0035] The subject of the present invention - according to a first aspect of the present invention - is thus a kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit comprises: a) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a (first) syringe body, in particular a (first) syringe cylinder, and a (first) syringe piston, wherein at least the syringe body, in particular the syringe cylinder, is made of at least one polyolefin, preferably polypropylene,is formed, wherein the first plastic syringe contains a first component (composition) (A) in the form of a solution and / or dispersion, in particular dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer; b) a second, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a (second) syringe body, in particular a (second) syringe barrel, and a (second) syringe piston, wherein at least the syringe body, in particular the syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe contains a second component (composition) (B) in the form of a solution and / or dispersion, in particular a solution,wherein the second component (B) comprises at least one crosslinking agent, in particular a crosslinking agent that initiates and / or effects ionic crosslinking; in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after contacting and / or interacting the components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed; wherein the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different in color; and / or, preferably and, wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different in color.

[0036] Advantageously, the present invention thus enables the provision of a kit consisting of two components in polyolefin plastic syringes, wherein the components and / or the plastic syringes are designed to be optically and / or visually distinguishable, thus ensuring safe and uncomplicated handling of the kit. Advantageously, components (A) and (B), in particular, can be easily distinguished and assigned from one another even if they are optically and / or visually different, thus minimizing usage errors and facilitating the overall use of the kit.

[0037] Furthermore, it is also advantageously possible to reliably and easily verify during and after use of the kit that the kit has been used correctly, i.e. that a component has not been applied twice or not used at all. For this purpose, the optically and / or visually different design of the first plastic syringe and the second plastic syringe can be advantageously used in particular. Furthermore, the option provided by the present invention of using components (A) and (B) in polyolefin-based plastic syringes is particularly advantageous, something that has not been done in the prior art to date. It is important to emphasize here that the use of polyolefin plastic syringes increases application and / or usage safety, e.g.This can be significantly increased, particularly compared to the use of glass syringes, for example, by reliably eliminating glass breakage or similar events with the present invention. Likewise, the use of polyolefin plastic syringes advantageously ensures that no interactions occur between components (A) and (B) and the plastic syringes used, and in particular, no migration of components or syringe constituents into the other component.

[0038] The present invention thus provides a safe, reliable and uncomplicated application concept in the form of a kit of two components (A) and (B), which can be advantageously used in the context of the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs.

[0039] Stone diseases within the meaning of the present invention refer in particular to the (pathological) predisposition of a person to the formation of stone-like deposits in the form of particles or concretions in the lumen of human organs, in particular in the kidneys, urinary tract, bladder, and gallbladder. In particular, the present invention is directed in this sense to a kit that allows the treatment, in particular therapeutic treatment, of kidney stones, urinary stones, bladder stones, and / or gallstones, preferably by removing corresponding particles and / or concretions from the lumen of the affected organs (kidney, urinary tract, bladder, and / or gallbladder). The present invention is particularly effective in removing comparatively small particles or concretions that, for example, cannot be removed with conventional gripping tools or the like.Furthermore, a dispersion in the context of the present invention is to be understood as meaning at least a two-phase material system, wherein a first phase, namely the dispersed phase, is distributed in a second phase, the continuous phase. In the context of the present invention, a solution means a homogeneous mixture of at least two substances. In the context of the present invention, a sol is understood as meaning a colloidal system consisting of a liquid phase and an at least substantially solid phase, wherein the solid phase is the precursor of a gel obtainable from the sol. The appearance of the sol can approximate that of a solution or of a dispersion, so that an unambiguous classification is not always possible and the transition between solution and dispersion can be fluid. In the context of the present invention, it is accordingly assumed that a sol can have both a dispersion character and a solution character.

[0040] In the context of the present invention, a gel means a disperse system which comprises at least two components - in the present case a crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer in a solution and / or dispersion, ie a solvent and / or dispersant.

[0041] The solid component forms a sponge-like, three-dimensional network. The liquid component is then immobilized within the solid component.

[0042] To initiate gel formation, the invention provides for the use of a crosslinking agent, in particular a crosslinking agent that initiates and / or effects ionic crosslinking. Crosslinking refers to a reaction in which a large number of individual macromolecules are linked or coordinated to form a three-dimensional, relatively rigid network. Within the scope of the present invention, gel formation is thus advantageously effected by ionic interactions between the polymer-containing component (A) and the crosslinking component (B), i.e., rapid or, in particular, instantaneous gel formation can be achieved.

[0043] The concept provided by the present invention is therefore advantageously characterized by a high level of application safety, the reliable guarantee and easy control of a high application quality as well as a safe and immediate effectiveness for the aforementioned indications, so that the present invention provides an efficient and uncomplicated, safely manageable therapy concept for the treatment of stone diseases.

[0044] The present invention therefore relates, as already mentioned at the outset, to a kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit comprises: a) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene,wherein the first plastic syringe contains a first component (A) in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer; b) a second, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) comprises at least one crosslinking agent,in particular a crosslinking agent initiating and / or effecting ionic crosslinking; in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after bringing components (A) and (B) into contact and / or interaction, a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed; wherein the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different in color; and / or, preferably and, wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different in color.

[0045] In the context of the present invention, it has proven useful if the first component (A), in particular before bringing into contact and / or interaction of the components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, in particular at a temperature of 20 °C, has a higher dynamic viscosity compared to the second component (B).

[0046] This advantageously ensures that the flow of component (A), which is preferably applied in the application and brought into contact with component (B) after application, is largely prevented in the application area, thus better enabling local or locally controlled application. This advantageously allows for the efficient removal of calculi or particles from the lumen of human organs.

[0047] Furthermore, it has proven useful if the first component (A), in particular before bringing components (A) and (B) into contact and / or interacting and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at least 1.5 mPas, in particular at least 4 mPas, preferably at least 7 mPas, more preferably at least 10 mPas; and / or if the first component (A), in particular before bringing components (A) and (B) into contact and / or interacting and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at most 100 mPas, in particular at most 60 mPas, preferably at most 40 mPas, more preferably at most 35 mPas.

[0048] According to the invention, it is particularly preferred if the first component (A), in particular before bringing into contact and / or interaction of the components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20 °C, has a dynamic viscosity in the range from 1.5 mPas to 100 mPas, in particular in the range from 4 mPas to 60 mPas, preferably in the range from 7 mPas to 40 mPas, preferably in the range from 10 mPas to 35 mPas.

[0049] The dynamic viscosity can be determined using methods known to those skilled in the art. In particular, the dynamic viscosity can be determined according to the method according to Ph. Eur. [Pharmacopoea Europaea], 9 th Edition (9.0), 2017, 9th English edition, Section 2.2.8. "Viscosity" and Section 2.2.9. "Capillary viscometer method" or based on DIN 51810-1.

[0050] Likewise, it may be advantageous according to the invention if the second component (B), in particular before bringing components (A) and (B) into contact and / or interacting and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at least 0.15 mPas, in particular at least 0.25 mPas, preferably at least 0.5 mPas, preferably at least 0.75 mPas; and / or if the second component (B), in particular before bringing components (A) and (B) into contact and / or interacting and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at most 3 mPas, in particular at most 2.85 mPas, preferably at most 2.65 mPas, preferably at most 2.5 mPas.

[0051] It is particularly advantageous within the scope of the invention if the second component (B), in particular before bringing into contact and / or interaction of the components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20 °C, has a dynamic viscosity in the range from 0.15 mPas to 3 mPas, in particular in the range from 0.25 mPas to 2.85 mPas, preferably in the range from 0.5 mPas to 2.65 mPas, preferably in the range from 0.75 mPas to 2.5 mPas.

[0052] The dynamic viscosity can be determined using methods known to those skilled in the art. In particular, the dynamic viscosity can be determined according to the method according to Ph. Eur. [Pharmacopoea Europaea], 9 th Edition (9.0), 2017, 9th English edition, Section 2.2.8. "Viscosity" and Section 2.2.9. "Capillary viscometer method" or based on DIN 51810-1.

[0053] If, in the context of the present invention, viscosities for components (A) and (B) are set in the above-mentioned range, the advantageous application properties of the kit according to the invention are realized in a particularly pronounced manner.

[0054] The preferably gel-like crosslinking product resulting from components (A) and (B) can in particular have the following properties:

[0055] Thus, within the scope of the present invention, it is preferably provided that the preferably gel-like crosslinking product, especially at a temperature of 20°C, has a higher dynamic viscosity than the first component (A). Accordingly, it goes without saying that the preferably gel-like crosslinking product, especially at a temperature of 20°C, also has a higher dynamic viscosity than the second component (B).

[0056] In particular, it has proven useful if the preferably gel-like crosslinking product has a dynamic viscosity of at least 10,000 mPas, in particular at least 20,000 mPas, preferably at least 30,000 mPas, preferably at least 50,000 mPas, at a temperature of 20°C; and / or if the preferably gel-like crosslinking product has a dynamic viscosity of at most 200,000 mPas, in particular at most 150,000 mPas, preferably at most 100,000 mPas, preferably at most 80,000 mPas, at a temperature of 20°C. According to the invention, it is particularly advantageous if the preferably gel-like crosslinking product has a dynamic viscosity in the range from 10,000 mPas to 200,000 mPas, in particular in the range from 20,000 mPas to 150,000 mPas, preferably in the range from 30,000 mPas to 100,000 mPas, preferably in the range from 50,000 mPas to 80,000 mPas, at a temperature of 20 °C.

[0057] The dynamic viscosity can be determined using methods known to those skilled in the art. In particular, the dynamic viscosity can be determined according to the method according to Ph. Eur. [Pharmacopoea Europaea], 9 th Edition (9.0), 2017, 9th English edition, Section 2.2.8. "Viscosity" and Section 2.2.9. "Capillary viscometer method" or based on DIN 51810-1.

[0058] Viscosities in the aforementioned range allow efficient and safe removal of particles or concretions from the lumen of affected organs, in particular because a sufficiently firm and stable gel structure is achieved that securely encloses particles or concretions and allows them to be removed equally safely and reliably from the lumen of the affected organs, in particular without leaving any residue.

[0059] In this regard, it is further preferably provided for the preferably gel-shaped crosslinking product that the preferably gel-shaped crosslinking product, based on a thread of the preferably gel-shaped crosslinking product with a length of 15 cm and at a temperature of 20 °C, compensates for and / or is able to absorb a tensile force of at least 0.015 N, in particular at least 0.025 N, preferably at least 0.030 N, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining the thread integrity and / or without tearing; and / or that the preferably gel-like crosslinking product, based on a thread of the preferably gel-like crosslinking product with a length of 15 cm and at a temperature of 20 °C, compensates for and / or is capable of absorbing a tensile force of at most 0.20 N, in particular at most 0.15 N, preferably at most 0.10 N, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds,in particular while maintaining thread integrity and / or without tearing. According to the invention, it is preferred if the preferably gel-like crosslinking product, based on a thread of the preferably gel-like crosslinking product with a length of 15 cm and at a temperature of 20°C, compensates for and / or is capable of absorbing a tensile force in the range of 0.015 N to 0.20 N, in particular in the range of 0.025 N to 0.15 N, preferably in the range of 0.030 N to 0.10 N, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining thread integrity and / or without tearing.

[0060] The tensile strength of the thread of the crosslinking product can advantageously be determined in the context of a so-called thread tension experiment, in particular wherein the above-mentioned values ​​are determined by means of a thread tension experiment and / or by means of a thread tension method, in particular on the gel-like crosslinking product with a predetermined contact surface, in particular in the range of approximately 2 mm 2 up to 10 mm 2 , using a constant pulling speed, in particular in the range of 0.5 cm to 3 cm per second, with, preferably visual, recording of the tear-off force and / or the tear-off behavior, as described in more detail below.

[0061] A gel with the aforementioned properties exhibits advantageous structural stability, which enables the safe and reliable removal of particles or concrements from organ lumina.

[0062] Furthermore, it has proven useful if the preferably gel-shaped crosslinking product, based on a thread of the preferably gel-shaped crosslinking product with a length of 15 cm, carries a mass of at least 1.5 g, in particular at least 2.5 g, preferably at least 3.5 g, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, at a temperature of 20 °C, in particular while maintaining the thread integrity and / or without tearing; and / or if the preferably gel-shaped crosslinking product, based on a thread of the preferably gel-shaped crosslinking product with a length of 15 cm, carries a mass of at most 20 g, in particular at most 15 g, preferably at most 10 g, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, at a temperature of 20 °C, in particular while maintaining the thread integrity and / or without tearing.Good results are obtained within the scope of the invention when the preferably gel-shaped crosslinking product, based on a thread of the preferably gel-shaped crosslinking product with a length of 15 cm, carries a mass in the range of 1.5 g to 20 g, in particular in the range of 2.5 g to 20 g, preferably in the range of 3.5 g to 10 g, at a temperature of 20 °C over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining the thread integrity and / or without tearing.

[0063] A corresponding gel with the aforementioned properties has advantageous structural stability, which enables the safe and reliable removal of particles or concrements from organ lumina.

[0064] The tensile strength of the thread of the crosslinking product can advantageously be determined in the context of a so-called thread tension experiment, in particular wherein the above-mentioned values ​​are determined by means of a thread tension experiment and / or by means of a thread tension method, in particular on the gel-like crosslinking product with a predetermined contact surface, in particular in the range of approximately 2 mm 2 up to 10 mm 2 , using a constant pulling speed, in particular in the range of 0.5 cm to 3 cm per second, with, preferably visual, recording of the tear-off force and / or the tear-off behavior.

[0065] The thread tension experiment, or the control of thread tension, is carried out by bringing component (A) and component (B) into contact or interacting with each other. For this purpose, 5 mL or 1.5 g of component (A) are introduced and brought into contact with component (B) in such a way that interfaces form between the solutions, but no active or extensive mixing of the solutions occurs.

[0066] This essentially corresponds to the application method of the kit in organ lumina (since active mixing is not possible there either, only a sequential injection of components (A) and (B)).

[0067] The gel-like cross-linking product then forms at the interfaces, which resembles a thread and is gripped with a tweezer-like gripping device (contact area approx. 2 mm 2 up to 10 mm 2) and can be lifted or pulled up. The forming gel thread is lifted or pulled up at a constant speed in the range of 0.5 cm to 3 cm per second. The successively forming thread must reach a length within the aforementioned length range and be able to maintain its structural integrity at this length over the aforementioned time periods, i.e., it must not tear or visibly weaken in the gel structure. The aforementioned parameters can then be determined, for example, by weighing the resulting thread.

[0068] According to the invention, it is further preferred if the preferably gel-like crosslinking product has a gel strength of at least 0.6 N, in particular at least 0.8 N, preferably at least 1 N, at a temperature of 20 °C; and / or if the preferably gel-like crosslinking product has a gel strength of at most 4.5 N, in particular at most 3.5 N, preferably at most 2.5 N, at a temperature of 20 °C.

[0069] It can therefore be particularly advantageous if the preferably gel-like crosslinking product has a gel strength in the range from 0.6 N to 4.5 N, in particular in the range from 0.8 N to 3.5 N, preferably in the range from 1.0 N to 2.5 N, at a temperature of 20 °C.

[0070] Furthermore, it has proven advantageous according to the invention if the preferably gel-like crosslinking product has a modulus of elasticity G' of at least 500 Pa, in particular at least 750 Pa, preferably at least 1,000 Pa; and / or if the preferably gel-like crosslinking product has a modulus of elasticity G' of at most 9,000 Pa, in particular at most 5,000 Pa, preferably at most 3,000 Pa.

[0071] It has proven particularly suitable if the preferably gel-shaped crosslinking product has a modulus of elasticity G' in the range from 500 Pa to 9,000 Pa, in particular in the range from 750 Pa to 5,000 Pa, preferably in the range from 1,000 Pa to 3,000 Pa. Finally, with regard to the preferably gel-shaped crosslinking product, it is preferably provided that the preferably gel-shaped crosslinking product has a loss modulus G" of at least 50 Pa, in particular at least 100 Pa, preferably at least 125 Pa; and / or that the preferably gel-shaped crosslinking product has a loss modulus G" of at most 350 Pa, in particular at most 300 Pa, preferably at most 250 Pa.

[0072] Particularly preferably, the preferably gel-like crosslinking product has a loss modulus G" in the range from 50 Pa to 350 Pa, in particular in the range from 100 Pa to 300 Pa, preferably in the range from 250 Pa to 300 Pa.

[0073] All of the aforementioned viscoelastic properties, ie the gel strength, the elastic modulus G' and / or the loss modulus G", can be determined using methods known to the person skilled in the art, in particular based on DIN 51810-1.

[0074] Gel-like crosslinking products obtained from components (A) and (B) having the aforementioned properties are particularly suitable for the use or application of the kit according to the invention preferably provided for according to the invention and in particular allow a safe, reliable and residue-free removal of particles or concretions from organ lumina, in particular those particles or concretions which cannot be removed from organs or can only be removed with difficulty or with great effort using methods known from the prior art.

[0075] As far as component (A) is concerned, it has proven advantageous in this regard if the first component (A) is in the form of an aqueous solution and / or aqueous dispersion, in particular an aqueous dispersion, preferably in the form of a hydrosol, in particular wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a hydrogel, polymer. Particularly good results in terms of particularly advantageous crosslinking and application properties are obtained within the scope of the present invention if the first component (A), in particular the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular a hydrogel, polymer, by means of dispersion of the crosslinkable polymer, in particular in powder form,in at least one dispersant, preferably water, under fluidized bed conditions, in particular using a cyclone mixing device, in particular wherein the dispersion is carried out over a period in the range from 15 min to 120 min, in particular in the range from 40 min to 90 min, preferably in the range from 50 min to 70 min, and at a mixing speed in the range from 30 rpm to 500 rpm (revolutions per minute), in particular in the range from 45 rpm to 250 rpm, preferably in the range from 55 rpm to 125 rpm; and / or in particular wherein the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer is crosslinked by the introduction of shear forces under fluidized bed conditions, in particular in the cyclone mixing device,preferably by means of s / Yu swelling,

[0076] In this context, it is preferably provided that when producing the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer, no separate swelling and / or no separate swelling of the polymer is required and / or carried out.

[0077] A cyclone mixing device suitable according to the invention is described, for example, in EP 0 201 767 A2 and the corresponding US equivalent US 4 729 663 A. The device described there, including the description cited in the aforementioned document, is hereby incorporated in its entirety by reference into the disclosure content of the present application. It has been found that component (A), in particular the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, more preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular a hydrogel, polymer, under the aforementioned conditions advantageously both forms a sol more quickly and also forms a more stable sol. In this way, the production time and the associated expenditure can be significantly minimized. Equally, a sol can be obtained which has more stable orThis results in firmer gels, which is particularly advantageous for the application of the kit and, in particular, for patient-safe handling. The extraction of particles or calculi from organ lumina can be carried out very safely, and the likelihood of structurally weak gels resulting from components (A) and (B), which could, for example, crack or melt, is minimized as much as possible.

[0078] Furthermore, it is preferred according to the invention if the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in amounts of at least 0.25% by weight, in particular at least 0.35% by weight, preferably at least 0.5% by weight, based on the total composition of the first component (A); and / or if the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in amounts of at most 5% by weight, in particular at most 2.5% by weight, preferably at most 1.8% by weight, based on the total composition of the first component (A).

[0079] It can therefore be particularly advantageous if the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in amounts in the range from 0.25 wt.% to 5 wt.%, in particular in the range from 0.35 wt.% to 2.5 wt.%, preferably in the range from 0.5 wt.% to 1.8 wt.%, based on the total composition of the first component (A).

[0080] Likewise, according to the invention, it is preferably provided that the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in concentrations of at least 0.005 mmol / L, in particular at least 0.01 mmol / L, preferably at least 0.03 mmol / L, based on the total composition of the first component (A); and / or that the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in concentrations of at most 1.0 mmol / L, in particular at most 0.5 mmol / L, preferably at most 0.25 mmol / L, based on the total composition of the first component (A).

[0081] It is preferably provided according to the invention that the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in concentrations in the range from 0.005 mmol / L to 1.0 mmol / L, in particular in the range from 0.01 mmol / L to 0.5 mmol / L, preferably in the range from 0.03 mmol / L to 0.25 mmol / L, based on the total composition of the first component (A).

[0082] In the aforementioned ranges, an optimal ratio of crosslinkable polymer and solvent or dispersant is achieved in order to be able to form structurally resilient gels with the addition of component (B).

[0083] Furthermore, particularly good results are achieved within the scope of the present invention if the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer comprises, in particular is and / or consists of alginic acid and / or its salts (alginates) and / or esters, preferably alginates, particularly preferably sodium alginate.

[0084] Alginic acid and its salts (alginates), such as sodium alginate, as well as the esters of alginic acid are polysaccharides composed of the two uronic acids guluronic acid (G) and mannuronic acid (M). In alginic acids or alginates, the proportion of G and the proportion of M in the alginic acid or alginate polymer molecule can vary greatly. The proportion of G determines the proportion of M, i.e. if the G proportion is 75%, the M proportion is 25%. Advantageously, at least 40%, in particular at least 80%, preferably at least 95%, of the alginic acid and / or its salts (alginates) and / or esters in component (A) have a G proportion of at least 20%, in particular at least 40%, preferably at least 50%, or of at most 80%, in particular at most 70%, preferably at most 60%.

[0085] According to the invention, preferably at least 40%, in particular at least 80%, preferably at least 95%, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer, in particular the alginic acid and / or its salts (alginates) and / or esters, in component (A), have a molar mass of at least 50,000 g / mol, in particular at least 100,000 g / mol, preferably at least 150,000 g / mol. Likewise, preferably at least 40%, in particular at least 80%, preferably at least 95%, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer, in particular alginic acid and / or its salts (alginates) and / or esters, in component (A) have a molar mass of at most 500,000 g / mol, in particular at most 300,000 g / mol, preferably at most 250,000 g / mol.

[0086] Likewise preferably according to the invention, the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer, in particular alginic acid and / or its salts (alginates) and / or esters, in component (A) has an average molar mass M n (number-average molar mass) of at least 75,000 g / mol, in particular at least 125,000 g / mol, preferably at least 175,000 g / mol. Likewise, the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular a hydrogel, polymer, in particular alginic acid and / or its salts (alginates) and / or esters, in component (A) has an average molar mass M n(number-average molecular weight) of at most 475,000 g / mol, in particular at most 275,000 g / mol, preferably at most 225,000 g / mol. The aforementioned molecular weight distributions and average molecular weights can be determined, for example, by gel permeation chromatography and dynamic light scattering, and can preferably be determined in accordance with DIN EN ISO 16014.

[0087] For component (A), it has proven further advantageous with regard to its composition if the first component (A) additionally comprises: one or more salts, in particular physiologically acceptable alkali salts, preferably sodium chloride; one or more buffers, in particular neutral buffers, preferably phosphate buffers; in particular wherein salt and buffer are combined in such a way that an isotonic, physiologically acceptable saline solution is formed, preferably in the form of a PBS buffer.

[0088] Good results are obtained according to the invention if the first component (A) comprises salt and buffer in amounts in the range from 0.05 wt.% to 5 wt.%, in particular in the range from 0.15 wt.% to 2.5 wt.%, preferably in the range from 0.3 wt.% to 1.5 wt.%, based on the total composition of the first component (A).

[0089] An appropriate composition advantageously guarantees a stable and storable as well as physiologically compatible design of component (A).

[0090] Furthermore, within the scope of the present invention, it is preferably provided that the first component (A) additionally comprises: a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe, preferably dextran blue.

[0091] It has proven useful here if the first component (A) comprises the dye in amounts in the range from 0.05% by weight to 3% by weight, in particular in the range from 0.10% by weight to 1.5% by weight, preferably in the range from 0.25% by weight to 0.75% by weight, based on the total composition of the first component (A). It has been found that the use of the aforementioned dye, as well as the other constituents of the composition of component (A), is advantageous in that they are migration-stable in plastic syringes which comprise polyolefin or in particular consist thereof, i.e. they do not interact with the syringe material in such a way that constituents of component (A) migrate into the plastic syringe and vice versa.

[0092] This is essential for the preferred use of the kit according to the invention, since interactions and in particular contamination of component (A) by constituents of the syringe material must be reliably excluded for medical-technical applications, which is generally not a given for plastic materials. Accordingly, it is a particular advantage of the present invention that it could be found that a component (A) with the preferred composition described above, in particular with regard to the individual composition constituents, is migration-stable in plastic syringes made of polyolefin and thus does not experience contamination by material constituents of the syringe. In this way, the advantageous properties of plastic syringes for the kit according to the invention, in particular component (A), can be realized in the first place.

[0093] As far as component (B) is concerned, it has proven useful if the second component (B) is in the form of an aqueous solution and / or aqueous dispersion, in particular an aqueous solution, in particular wherein the second component (B) comprises at least one crosslinking agent in the form of a salt, in particular a crosslinking agent initiating and / or effecting ionic crosslinking in the form of a salt.

[0094] By preferably providing for ionic crosslinking using a salt in component (B) according to the invention, very rapid, in particular instantaneous, gel formation with component (A) can advantageously be achieved. Furthermore, with regard to the composition of component (B), it has proven useful if the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent which initiates and / or brings about ionic crosslinking, in particular in the form of a salt, in amounts of at least 0.35% by weight, in particular at least 0.85% by weight, preferably at least 1.25% by weight, based on the total composition of the second component (B); and / or if the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent which initiates and / or brings about ionic crosslinking, in particular in the form of a salt, in amounts of at most 4.5% by weight.-%, in particular at most 3.0 wt.%, preferably at most 2.25 wt.%, based on the total composition of the second component (B).

[0095] Particularly good results are therefore obtained when the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or effecting ionic crosslinking, in particular in the form of a salt, in amounts in the range from 0.35% by weight to 4.5% by weight, in particular in the range from 0.75% by weight to 3.0% by weight, preferably in the range from 1.25% by weight to 2.25% by weight, based on the total composition of the second component (B).

[0096] Equally good results are obtained when the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or bringing about ionic crosslinking, in particular in the form of a salt, in concentrations of at least 0.01 mol / L, in particular at least 0.1 mol / L, preferably at least 0.15 mol / L, based on the total composition of the second component (B); and / or when the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or bringing about ionic crosslinking, in particular in the form of a salt, in concentrations of at most 1.0 mol / L, in particular at most 0.5 mol / L, preferably at most 0.25 mol / L, based on the total composition of the second component (B).It can therefore be particularly advantageous if the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or effecting ionic crosslinking, in particular in the form of a salt, in concentrations in the range from 0.01 mmol / L to 1.0 mol / L, in particular in the range from 0.1 mol / L to 0.5 mol / L, preferably in the range from 0.15 mol / L to 0.25 mol / L, based on the total composition of the second component (B).

[0097] With regard to the crosslinking effect of component (B), in particular in the case where component (A) comprises alginic acid, its salts and / or esters, preferably sodium alginate, optimum results are obtained within the scope of the present invention if the crosslinking agent comprises divalent cations, in particular selected from the group of alkaline earth metals, preferably calcium ions and / or magnesium ions, preferably calcium ions, in particular in the form of a physiologically acceptable salt, in particular halogen salt, preferably calcium chloride.

[0098] Particularly good results are also obtained within the scope of the present invention when the alginic acid or alginate has a comparatively high G content. Advantageously, divalent cations, such as calcium chloride in particular, can interact with alginic acid in such a way that ionic crosslinking is achieved and, as a result, a gel is formed. This process advantageously occurs at physiological pH and, moreover, is kinetically rapid, which is particularly advantageous for the application or use of the kit preferably provided according to the invention. Furthermore, advantageously, no chemical crosslinking reactions in the sense of the formation or re-formation of covalent bonds occur, as this would be considered disadvantageous for physiological applications. The inventive concept accordingly represents a highly efficient and completely physiologically compatible option for removing particles or concretions from organ lumina.Furthermore, it has proven useful according to the invention if the second component (B) additionally comprises: one or more salts, in particular physiologically acceptable alkali salts, preferably sodium chloride; in particular wherein the second component (B) comprises the salt in amounts in the range from 0.05 wt.% to 2.5 wt.%, in particular in the range from 0.10 wt.% to 1.5 wt.%, preferably in the range from 0.25 wt.% to 1.0 wt.%, based on the total composition of the second component (B).

[0099] Furthermore, it is particularly preferred according to the invention if the second component (B) additionally comprises: a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe, preferably riboflavin; in particular wherein the second component (B) comprises the dye in amounts in the range from 0.0005 wt.% to 0.1 wt.%, in particular in the range from 0.001 wt.% to 0.01 wt.%, preferably in the range from 0.0015 wt.% to 0.005 wt.%, based on the total composition of the second component (B).

[0100] For the aforementioned dye, as well as for the dye of component (A), it has been shown to be advantageous, on the one hand, physiologically compatible and harmless, and on the other hand, like the other components of component (B), it is migration-stable with respect to the syringe material, so that advantageously no interactions or contamination of component (B) from the syringe material can occur. Furthermore, the preferred use of a clearly optically and / or visually distinguishable dye for component (B) is advantageously provided, which positively contributes to the handling and application safety of the kit according to the invention.

[0101] In this sense, it is therefore preferably provided within the scope of the present invention that the first component (A) comprises a dye, in particular a physiologically inert dye and / or a dye that is resistant to migration in the plastic syringe, and wherein the second component (B) comprises a dye, in particular a physiologically inert dye and / or a dye that is resistant to migration in the plastic syringe, in particular such that the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different from one another in terms of color, preferably wherein the first component (A) has a blue color and wherein the second component (B) has a yellow color.

[0102] A corresponding design of the kit according to the invention advantageously allows for an uncomplicated and visually easy-to-follow use or application of the kit according to the invention.

[0103] It has also proven useful according to the invention if the preferably gel-like crosslinking product also has a coloration and / or coloring, in particular based on the dye of the first component (A) and / or based on the dye of the second component (B), in particular wherein the preferably gel-like crosslinking product has the coloration of the first component (A) and / or the second component (B), preferably the first component (A), preferably a blue coloration.

[0104] This advantageously facilitates traceability and optical and / or visual control of the kit application.

[0105] As far as the ratios in which component (A) and component (B) are used are concerned, it has proven useful if the first component (A) in the first plastic syringe has a smaller volume than component (B) in the second plastic syringe, in particular wherein the first component (A) and the second component (B) are present in a volume ratio of component (A) to component (B) in the range from 1:1.25 to 1:10, in particular in the range from 1:1.5 to 1:7.5, preferably in the range from 1:1.75 to 1:4.5.

[0106] Likewise, good results are obtained according to the invention when the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably to form a gel, in particular hydrogel, polymer of the first component (A), is present in a lower concentration than the second component (B), in particular the crosslinking agent, in particular the crosslinking agent initiating and / or effecting ionic crosslinking, of the second component (B), in particular wherein the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably to form a gel, in particular hydrogel, polymer of the first component (A), and the second component (B), in particular the crosslinking agent, in particular the crosslinking agent initiating and / or effecting ionic crosslinking, of the second component (B), are present in a concentration ratio in the range from 1:1,000 to 1:5.000, in particular in the range of 1 : 2,500 to 1 : 4,500, preferably in the range of 1 : 3,250 to 1 : 4,000.

[0107] With regard to the combined components (A) and (B), it is accordingly preferably provided that the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably with the formation of a gel, in particular hydrogel, crosslinkable, polymer of the first component

[0108] (A), in comparison to component (B), in particular the crosslinking agent, in particular the crosslinking agent initiating and / or effecting ionic crosslinking, of the second component (B), based on the components (A) brought into contact and / or interacting with one another and

[0109] (B), is present in a molar (total) amount, in particular wherein the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer of the first component (A), and the second component (B), in particular the crosslinking agent, in particular the crosslinking agent initiating and / or effecting ionic crosslinking, of the second component (B), based on the components (A) and (B) brought into contact and / or interacting with one another, are present in a molar (total) amount ratio in the range from 1:2,000 to 1:10,000, in particular in the range from 1:5,000 to 1:9,000, preferably in the range from 1:6,500 to 1:8,000.

[0110] If the above-mentioned conditions are used in the application or use of the kit according to the invention, optimal gel formation can advantageously be achieved.

[0111] In particular, it is preferably provided that the formation of the preferably gel-like crosslinking product, in particular the preferably gel-like crosslinked polymer structure, in particular the gel, from the first component (A) and the second component (B) takes place by means of ionic coordination, in particular ionic crosslinking, of the first component (A) by the second component (B), in particular wherein the crosslinking takes place in a time period of less than 4 min, in particular less than 3.5 min, preferably less than 3 min, more preferably less than 2 min, more preferably less than 1 min.

[0112] In the context of the present invention, it is therefore advantageous to coordinate components (A) and (B) in such a way that rapid gel formation is achieved.

[0113] As regards the plastic syringes used in the context of the present invention, it has proven advantageous if, in addition, the syringe plunger of the first plastic syringe is also formed from at least one polyolefin, preferably polypropylene; and / or if the syringe body of the first plastic syringe, in particular the syringe barrel, and the syringe plunger are formed from at least one polyolefin, preferably polypropylene.

[0114] Likewise, it is preferably provided that the syringe plunger of the second plastic syringe is also formed from at least one polyolefin, preferably polypropylene; and / or that the syringe body of the second plastic syringe, in particular the syringe barrel, and the syringe plunger are formed from at least one polyolefin, preferably polypropylene.

[0115] In this way, the possibility of contamination of component (A) or component (B) is advantageously further minimized and thus the application safety of the kit according to the invention is increased.

[0116] Within the scope of a particularly preferred embodiment of the present invention, it has also proven useful if the syringe body, in particular the syringe cylinder, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe and / or the syringe body, in particular the syringe cylinder, and / or the syringe plunger, preferably the syringe plunger, of the second plastic syringe, preferably the syringe body, in particular the syringe cylinder, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe, is colored and / or has a coloration, in particular a dye, preferably a physiologically inert dye and / or a dye that is resistant to migration into the first component (A) and / or the second component (B);in particular wherein the coloring and / or coloration, in particular of the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (A) and / or the second component (B), of the syringe body, in particular of the syringe barrel and / or the syringe plunger, preferably of the syringe plunger, of the first plastic syringe and / or the second plastic syringe, preferably of the first plastic syringe, corresponds to the dye color of the dye and / or the coloring of the first component (A) and / or the second component (B), in particular of the first component (A), and / or corresponds thereto, in particular matches it.;

[0117] According to the invention, the optical and / or visual distinguishability of the first plastic syringe and the second plastic syringe is advantageously achieved by the fact that, in particular, the syringe plunger of the plastic syringe is colored or has a coloring. This coloring advantageously corresponds to the color of component (A), which allows for easy tracking of the application and thus increased application safety.

[0118] Within the scope of a preferred embodiment of the present invention, it is therefore provided that the syringe plunger of the first plastic syringe is also formed from at least one polyolefin, preferably polypropylene, and wherein the syringe body, in particular the syringe cylinder, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (A); in particular wherein the coloring and / or coloring, in particular the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (A), of the syringe body, in particular the syringe cylinder, and / or the syringe plunger, preferably the syringe plunger,of the first plastic syringe corresponds to the dye color of the dye and / or coloring of the first component (A) and / or corresponds to this, in particular matches this. Alternatively or additionally, it can preferably also be provided that the syringe plunger of the second plastic syringe is also formed from at least one polyolefin, preferably polypropylene, and wherein the syringe body, in particular syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the second plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (B); in particular wherein the coloring and / or coloring, in particular the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (B), of the syringe body, in particular syringe barrel,and / or the syringe plunger, preferably the syringe plunger, of the second plastic syringe corresponds to the dye color of the dye and / or coloring of the first component (B) and / or corresponds thereto, in particular matches.

[0119] The subject matter of the present invention according to the applicable aspect is therefore in particular a kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, in particular according to the present aspect, wherein the kit comprises: a) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe cylinder, and a syringe piston, wherein the syringe body, in particular a syringe cylinder, and / or the syringe piston are made of at least one polyolefin,preferably polypropylene, and wherein the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (A), and wherein the first plastic syringe contains a first component (A) in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, polymer, preferably crosslinkable to form a gel, in particular a hydrogel, and wherein the first component (A) additionally comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe; b) a second, in particular ready-to-use,Plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein the syringe body, in particular the syringe barrel, and / or the syringe piston are formed from at least one polyolefin, preferably polypropylene, and, optionally, wherein the syringe body, in particular the syringe barrel, and / or the syringe piston, preferably the syringe piston, of the second plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the second component (B), and wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) comprises at least one crosslinking agent,in particular a crosslinking agent initiating and / or effecting ionic crosslinking, and wherein the second component (B) comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe; in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after contacting and / or interacting with components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed, and wherein the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the first component (A) and the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the second component (B) are selected such thatthat the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different in color; and / or, preferably and, wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different in color.,

[0120] The subject matter of the present invention according to the applicable aspect is also in particular a kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, in particular according to the present aspect, wherein the kit comprises: a) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe cylinder, and a syringe piston, wherein the syringe body, in particular a syringe cylinder, and the syringe piston are made of at least one polyolefin,preferably polypropylene, and wherein the syringe body, in particular syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (A), and wherein the first plastic syringe contains a first component (A) in the form of a solution and / or dispersion, in particular dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer, in particular wherein the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer is alginic acid and / or its salts (alginates) and / or esters, preferably alginates,particularly preferably sodium alginate, comprises, in particular is and / or consists of; and wherein the first component (A) additionally comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe; b) a second, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein the syringe body, in particular a syringe barrel, and the syringe piston are formed from at least one polyolefin, preferably polypropylene, and, optionally, wherein the syringe body, in particular a syringe barrel, and / or the syringe piston, preferably the syringe piston, of the second plastic syringe is colored and / or has a coloring, in particular a dye,preferably a physiologically inert and / or migration-resistant dye into the second component (B), and wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) comprises at least one crosslinking agent, in particular a crosslinking agent initiating and / or causing ionic crosslinking, in particular wherein the crosslinking agent comprises divalent cations, in particular from the group of alkaline earth metals, preferably calcium ions and / or magnesium ions, preferably calcium ions, in particular in the form of a physiologically acceptable salt, in particular a halogen salt, preferably calcium chloride, and wherein the second component (B) contains a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe,in particular, wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after contacting and / or interacting the components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed, and wherein the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the first component (A) and the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the second component (B) are selected such that the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different from one another in terms of color; and / or, preferably and,wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different in color, in particular wherein the coloring and / or coloration, in particular the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (A), of the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe corresponds to the dye color of the dye and / or coloration of the first component (A) and / or corresponds thereto, in particular matches, and / or optionally in particular wherein the coloring and / or coloration, in particular the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (B), of the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger,the second plastic syringe corresponds to the dye color of the dye and / or coloring of the first component (B) and / or corresponds to it, in particular matches it.,

[0121] Furthermore, it has proven useful within the scope of the present invention if the syringe body of the first plastic syringe and / or the second plastic syringe, in particular of the first plastic syringe and the second plastic syringe, has an oleophobic and / or hydrophobic coating, in particular a hydrophobic coating, preferably in the form of a siliconization or silicate coating, preferably obtained by means of a silicon-containing, in particular silicone- or silicate-based agent, preferably silicone oil or silicate, in the interior of the syringe body.

[0122] This advantageously enables complete and residue-free dispensing of components (A) and / or (B) from the corresponding plastic syringes. At the same time, interaction or migration of components of the plastic syringe or the components into each other is further hindered or prevented.

[0123] As far as the further design of plastic syringes preferably used according to the invention is concerned, it has proven useful for these if the first plastic syringe and / or the second plastic syringe, in particular the first plastic syringe and the second plastic syringe, preferably their syringe body, has a volume, in particular a receiving volume for the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), in the range from 1 mL to 100 mL, in particular in the range from 2 mL to 50 mL, preferably in the range from 3 mL to 25 mL, preferably in the range from 4 mL to 25 mL, particularly preferably in the range from 6 mL to 20 mL, further preferably in the range from 8 mL to 15 mL, even more preferably in the range from 9 mL to 12 mL, very particularly preferably of about 10 mL;in particular, wherein the first plastic syringe, in particular its syringe body, contains the first component (A) in an amount in the range from 2.5 mL to 15 mL, in particular in the range from 3.5 mL to 10 mL, preferably in the range from 4 mL to 7.5 mL; and / or in particular, wherein the second plastic syringe, in particular its syringe body, contains the second component (B) in an amount in the range from 5 mL to 25 mL, in particular in the range from 7.5 mL to 15 mL, preferably in the range from 9 mL to 12.5 mL.

[0124] Advantageously, plastic syringes which have the same receiving volume are used in the context of the present invention and are preferably filled with different volumes of component (A) and component (B).

[0125] Furthermore, it has proven particularly suitable for plastic syringes within the scope of the present invention if the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringe has an outlet opening, in particular provided at the end and / or front, in particular in an outlet region, in particular for dispensing and / or applying component (A) and / or component (B); and / or if the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringe has a preferably blunt tip having the outlet opening, in particular provided for arranging an application device, in particular a cannula, an endoscope, in particular the (working) channel of an endoscope, or a catheter, preferably a catheter tube; and / or if the syringe body, in particular the syringe barrel,a grip section is arranged on the first plastic syringe and / or the second plastic syringe, in particular designed for finger support, in particular wherein the grip section has laterally projecting, preferably opposite, grip section regions, and / or in particular wherein the grip section is arranged on the end of the syringe body, in particular the syringe barrel, opposite the outlet opening, in particular the front end. Furthermore, it has proven useful if the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringe has a receiving and / or filling opening, in particular for filling the syringe body(s), in particular the syringe barrel,with component (A) and / or component (B) and / or in particular for preferably sealingly receiving the syringe plunger with the plunger stopper and / or in particular wherein the receiving and / or filling opening is closable with the syringe plunger, in particular with the plunger stopper, and / or is designed to be closable and / or is closed, in particular wherein the receiving and / or filling opening is arranged at the end of the syringe body opposite the outlet opening, in particular at the front end.

[0126] It is also proven if a piston stopper is arranged, in particular in a form-fitting and / or friction-fitting manner, on the syringe plunger of the first plastic syringe and / or the second plastic syringe, in particular wherein the piston stopper is arranged on the end of the syringe plunger facing the outlet opening, preferably on the front side, and / or in particular wherein the syringe plunger has a preferably circumferential piston collar for abutment against and / or for arranging the piston stopper.

[0127] Furthermore, it has proven advantageous if the syringe plunger of the first plastic syringe and / or the second plastic syringe has a plunger head at the end opposite the outlet opening, in particular at the front end.

[0128] Likewise, it has proven effective if the preferably blunt tip of the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringe, which tip has the outlet opening, is cylindrical (cylindrical) or conical (truncated cone-shaped), preferably conical (truncated cone-shaped), particularly preferably with a cone angle in the range of 2° to 6°, most preferably as a Luer cone. This enables good compatibility with the arrangement or connection, in particular the coupling, of an application device, in particular a cannula, an endoscope, in particular the (working) channel of an endoscope, or a catheter, preferably a catheter tube.It is particularly preferred within the scope of the present invention that the first plastic syringe and the second plastic syringe are, in particular, at least substantially structurally identical and / or have the same structural features.

[0129] This is particularly advantageous from a production-technical point of view, since in principle the same production equipment can be used, for example, to fill the first plastic syringe with component (A) and the second plastic syringe with component (B), so that a high overall process efficiency can be achieved.

[0130] In this case, it is further preferably provided within the scope of the present invention that the first plastic syringe contains a first volume of component (A) and the second plastic syringe contains a second volume of component (B) and / or is filled with this, in particular wherein the first volume of component (A) and the second volume of component (B) differ from one another, preferably wherein the first volume of component (A) is smaller than the second volume of component (B);and / or preferably wherein the lengths of the syringe plungers of the first plastic syringe and the second plastic syringe protruding from the syringe body, in particular the syringe cylinder, differ from one another in the filled state, in particular complementary to the difference between the first volume of component (A) and the second volume of component (B), preferably wherein the length of the syringe plunger of the first plastic syringe protruding from the syringe body, in particular the syringe cylinder, in the filled state is shorter than the length of the syringe plunger of the second plastic syringe protruding from the syringe body, in particular the syringe cylinder, in the filled state.;

[0131] According to the invention, the first plastic syringe can be filled with a smaller volume of component (A) than the second plastic syringe is filled with component (B), which results in, in particular, the syringe plungers protruding from the syringe bodies to different degrees or lengths in the longitudinal direction. This advantageously corresponds to a straightforward and pragmatic solution when using plastic syringes of the same design and different volumes of components (A) and (B).

[0132] Furthermore, with regard to the design of the first plastic syringe and the second plastic syringe, it has proven advantageous according to the invention if the piston stopper is formed from an elastomeric material, in particular from a rubber material and / or rubber material, preferably rubber material; and / or if the piston stopper is formed from and / or consists of a halogenobutyl rubber, in particular from a chlorobutyl rubber or from a bromobutyl rubber, preferably from a bromobutyl rubber.

[0133] A corresponding piston stopper exhibits high chemical robustness while simultaneously offering advantageous processing and application properties.

[0134] It is further preferably provided that the plunger stopper has at least one, in particular two, preferably three, circumferential collars, in particular wherein a first collar is designed such that the syringe body, in particular the syringe barrel, is secured against the component (A) and / or component (B) escaping from the syringe body, in particular the syringe barrel, and / or that the first collar is designed to seal the component (A) and / or component (B) against the receiving and / or filling opening; and / or in particular wherein at least one second collar, preferably spaced apart from the first collar, forms a further sealing space between the first and second collars; and / or in particular wherein a third collar, preferably spaced apart from the first and / or second collar, is designed to abut against the plunger collar.

[0135] By means of the collars, a sealing function is advantageously achieved in the plastic syringe against the liquid components (A) or (B) running out or escaping from the corresponding syringes. In addition to this, it has also proven useful within the scope of the present invention if the syringe body, preferably the syringe cylinder, has a stop, in particular a circumferential stop, on the inside in the region of the receiving and / or filling opening and / or in the end region of the syringe body, in particular the syringe cylinder, in particular opposite the outlet region, in particular wherein the stop is designed such that the syringe piston and / or the piston stopper is, in particular at least substantially, secured against moving out, in particular being pulled out, from the syringe body, in particular the syringe cylinder, beyond the stop and / or wherein the stop is for, in particular sealing,Stops of the plunger stopper and / or the syringe plunger against the stopper; and / or in particular wherein the stopper is designed in the form of a, in particular, bevelled projection and / or a bevelled step; and / or in particular wherein the stopper is designed as a stop edge for the plunger collar and / or at least one collar of the plunger stopper.

[0136] With the help of the stop, it is advantageous to avoid an excessively easy or force-free pulling or detaching of the syringe plunger from the syringe body, which is positively beneficial to the safety of use as well as the processability of the syringes when filled.

[0137] Furthermore, it is preferably provided according to the invention that the plunger stopper has a displacement means in a front end region of the syringe body, in particular the syringe barrel, facing the outlet region, in particular wherein the displacement means is conical, preferably convex; and / or in particular wherein the first collar of the plunger stopper adjoins the displacement means. It is also further preferred if the outlet region has a tapered section, in particular a conical and / or frustoconical section, for forming the tip; preferably wherein the tapered section is designed to stop the displacement means of the plunger stopper; and / or preferably wherein the tapered section and the displacement means of the plunger stopper are designed to be complementary to one another.

[0138] In this way, it can advantageously be achieved that an efficient, in particular largely complete discharge of component (A) and component (B) from the corresponding plastic syringes is achieved.

[0139] Furthermore, it has proven useful according to the invention if a particularly removable and / or detachable closure element, in particular a closure cap (closure and / or sealing cap), preferably for sealingly closing the outlet opening, is placed and / or plugged onto the outlet opening and / or the tip; preferably wherein the closure element at least substantially completely and / or sealingly encloses and / or covers the outlet opening, in particular at least substantially over the entire outlet opening; and / or preferably wherein the closure element is cap-shaped and / or hat-shaped.

[0140] Furthermore, according to the invention, it is preferably provided that the closure element is formed from an elastomeric material, in particular from a rubber material and / or caoutchouc material; and / or that the closure element is formed from a halobutyl rubber, in particular from a chlorobutyl rubber or from a bromobutyl rubber, preferably from a bromobutyl rubber; and / or that the closure element has a detaching and / or removal device, in particular a pulling device, preferably in the form of a particularly nipple-shaped extension and / or preferably for, in particular, manually detaching, in particular pulling, the closure element from the outlet opening. In this case, it has proven particularly useful if the detaching and / or removal device is arranged on and / or in the region of the closed end and / or at the tip of the closure element and / or in the extension of the longitudinal axis of the closure element;and / or if the closure element has at least one recess, in particular a notch, indentation and / or material taper, on its outer side, in particular wherein the recess is longitudinally and / or linearly and / or rectilinearly formed, and / or in particular wherein the recess is arranged to run at least substantially in the longitudinal direction and / or at least substantially parallel to the longitudinal axis of the closure element; and / or if the closure element has two, three, four, five or more, in particular two, three or four, preferably four, recesses, in particular wherein the recesses are arranged to run at least substantially equidistant from one another and / or at least substantially parallel to one another on the outer side of the closure element.;

[0141] According to a further preferred embodiment of the present invention, it is preferably provided that the first plastic syringe and / or the second plastic syringe, in particular the first plastic syringe and the second plastic syringe, is (are) placed in (each) an outer packaging which is in particular sealed in a water-tight and / or germ-tight manner.has (have) an outer packaging that is in particular sealed in a water-tight and / or germ-tight manner, in particular wherein the outer packaging that is in particular sealed in a water-tight and / or germ-tight manner has a plastic section, preferably deep-drawn and / or format-stamped and / or embossed, and a sealing section that is at least permeable to water vapor, in particular permeable to water vapor and / or gas; and / or in particular wherein the plastic section has a receiving area, in particular open and closed on the underside by the plastic section, for arranging the first plastic syringe filled with component (A) and / or the second plastic syringe filled with component (B).In this case, it has proven useful if the receiving area for arranging the first plastic syringe filled with component (A) and / or the second plastic syringe filled with component (B) is designed such that the first plastic syringe and / or the second plastic syringe is (are) in particular at least substantially completely recessed; and / or if the receiving area is designed at least substantially complementary to the outer shape of the first plastic syringe and / or the second plastic syringe; and / or if the receiving area has a first partial section for at least partially receiving the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringes and a second partial section for receiving the section of the syringe plunger of the first plastic syringe and / or the second plastic syringes that projects relative to the syringe body.

[0142] In this regard, it is further preferred that the second sub-section is also designed to receive the handle section arranged on the syringe body, in particular the syringe barrel; and / or that at least one, preferably two, step(s) for stopping the handle section is (are) provided between the first sub-section and the second sub-section, in particular such that the first sub-section of the receiving area has a smaller, in particular maximum, width than the second sub-section of the receiving area.

[0143] It is further preferably provided that in the first partial section a first stop wall is provided on the end face for stopping the closure element. Preferably, wherein a play is provided between the first stop wall and the closure element in the packaged state, in particular in the range from 0.1 mm to 30 mm, in particular in the range from 1.0 mm to 20 mm, preferably in a range from 1.5 mm to 15 mm. Equally preferably, it can be provided that in the second partial section a second stop wall is provided on the end face for stopping the piston head. Preferably, wherein a play is provided between the second stop wall and the piston head in the packaged state, in particular in the range from 0.1 mm to 30 mm, in particular in the range from 1.0 mm to 20 mm, preferably in a range from 1.5 mm to 15 mm.

[0144] Within the scope of an advantageous further development of the outer packaging, it has proven useful if the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, in particular the preferably deep-drawn and / or format-stamped and / or embossed plastic section, has at least one, preferably two side walls in the second section of the receiving area, preferably for connecting the front ends of the second section.

[0145] In this context, it is further preferred if at least one, preferably both, side wall(s) has / have, at least in some regions, a sliding section for, in particular, at least substantially play-free and / or direct abutment of the handle section, in particular of a handle section region; and / or if the sliding section is provided for the positionally stable arrangement, preferably in exactly one position, of the first plastic syringe and / or the second plastic syringe in the packaged state in the outer packaging; and / or if the sliding section prevents the first plastic syringe and / or the second plastic syringe in the packaged state in the outer packaging from rotating, in particular in the direction of rotation from the top side of the plastic section facing the sealing section to the top side facing away from the sealing section,opposite underside of the plastic section and / or in the direction of rotation from the opposite underside of the plastic section facing away from the sealing section to the top side of the plastic section facing the sealing section; and / or if the sliding section extends at least over the length of the maximum play of the first plastic syringe and / or the second plastic syringe in the packaged state in the outer packaging in the second subsection. For the kit according to the invention, in particular if it comprises an outer packaging, it is therefore advantageous that the plastic syringes are stable in position in the outer packaging and essentially not freely movable, in particular wherein only movement within the scope of the play to the stop walls is possible in the outer packaging, which is particularly beneficial for the storage and transport safety of the kit. This is also advantageous in the case,that a sterilization treatment, which is described in more detail below, is carried out with regard to the packaged, filled plastic syringes, in particular since the positionally stable insertion and fixation in the outer packaging efficiently and effectively suppresses or at least buffers movement impulses due to certain conditions during the sterilization treatment.

[0146] A particularly preferred embodiment of the present invention provides that the plastic section of the outer packaging for the first plastic syringe is designed differently from the plastic section of the outer packaging for the second plastic syringe.

[0147] In this regard, it is then preferably provided that the width of the first plastic section of the outer packaging of the first plastic syringe, which preferably extends transversely, in particular orthogonally, to the longitudinal direction of the first plastic syringe, in particular also with respect to the receiving section of the outer packaging, is at least substantially the same size as the width of the second plastic section of the outer packaging of the second plastic syringe, which preferably extends transversely, in particular orthogonally, to the longitudinal direction of the second plastic syringe, in particular also with respect to the receiving section of the outer packaging;and / or that the, in particular maximum, height of the first plastic section of the outer packaging of the first plastic syringe, in particular also with respect to the receiving section of the outer packaging, is at least substantially equal to the, in particular maximum, height of the second plastic section of the outer packaging of the second plastic syringe, in particular also with respect to the receiving section of the outer packaging; and / or that the sealing section of the outer packaging of the first plastic syringe, in terms of dimensions, is at least substantially equal and / or identical to the sealing section of the outer packaging of the second plastic syringe;and / or that the length of the first plastic section of the outer packaging of the first plastic syringe, which length preferably extends in the longitudinal direction of the first plastic syringe, is at least substantially equal to the length of the second plastic section of the outer packaging of the second plastic syringe, which length preferably extends in the longitudinal direction of the second plastic syringe;

[0148] In this case, it is further preferred that the length of the receiving region of the first plastic section, which preferably extends in the longitudinal direction of the first plastic syringe, is shorter than the length of the second receiving region of the plastic section, which preferably extends in the longitudinal direction of the second plastic syringe.

[0149] This is preferably the case when the first volume of component (A) and the second volume of component (B) differ from one another, in particular when the first volume of component (A) is smaller than the second volume of component (B); and / or preferably when the lengths of the syringe plungers of the first plastic syringe and the second plastic syringe protruding from the syringe body, in particular the syringe barrel, differ from one another in the filled state; in particular when the length of the syringe plunger of the first plastic syringe protruding from the syringe body, in particular the syringe barrel, in the filled state is shorter than the length of the syringe plunger of the second plastic syringe protruding from the syringe body, in particular the syringe barrel, in the filled state.

[0150] If this is the case, it is preferably provided that the first plastic section of the outer packaging of the first plastic syringe in this case has an extension section which protrudes and / or stands out from the second section of the receiving area; and / or that the second section of the receiving area and the extension section are separated from one another by the second stop wall; and / or that the extension section forms a recess in the first plastic section, wherein the height, in particular the maximum height, of the extension section is preferably less than the height, in particular the maximum height, of the second section. From a production technology perspective, this is particularly advantageous since it can be efficiently and flexibly adapted to the contours orthe external shape of the plastic syringes of the set according to the invention can be provided with outer packaging which has as far as possible comparable dimensions and at the same time realizes an efficient compensation of different shape features of the plastic syringes.

[0151] Furthermore, it has proven useful within the scope of the present invention if the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, is tear-resistant and / or waterproof and / or temperature-resistant, in particular up to 140°C; and / or if the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, preferably the deep-drawn and / or format-stamped and / or embossed plastic section, comprises a polyolefin, in particular polypropylene, in particular consists thereof; and / or if the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, preferably the at least water vapor-permeable, in particular water vapor- and / or gas-permeable, sealing section, comprises a paper, in particular an uncoated medical paper, in particular consists thereof;and / or in particular wherein the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, preferably the at least water vapor-permeable, in particular water vapor- and / or gas-permeable, sealing section, has an indicator, in particular a sterile indicator;

[0152] A particularly preferred development of the present invention further provides that the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B), in particular the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B), is (are) heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized. In this case, it has proven useful if the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B),and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B), in particular the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B), is (are) heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized, with an F0 value in the range from 6 min to 45 min, in particular in the range from 8 min to 40 min, preferably in the range from 10 min to 38 min, more preferably in the range from 11 min to 35 min, particularly preferably in the range from 15 min to 32 min, most preferably in the range from 19 min to 30 min; and / or if the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B),and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B), in particular the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B), is (are) heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized, under atmospheric conditions and / or at about 121°C and / or for a period of at least 6 minutes, preferably of about 6 minutes, or of at least 20 minutes, preferably of about 20 minutes; and / or if the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B),in particular, the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B) are heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized, according to Pharmacopoea Europaea (Ph. Eur.), Chapter 5.1.1 (07 / 2017:50101), in particular under over / / / conditions and / or at about 121°C and / or for a period of at least 15 minutes, in particular of at least 20 minutes, preferably of about 20 minutes. For this embodiment of the present invention, it has proven useful if the heat sterilization, in particular steam sterilization, preferably steam-sterilization, preferably terminal (heat, steam, steam-)sterilization, is carried out under temperature application (heating); and / or if heat sterilization, in particular steam sterilization, preferably steam sterilization,preferably terminal (heat, steam, water vapor) sterilization is carried out at temperatures of at least 105 °C, in particular at least 110 °C, preferably at least 115 °C, preferably at least 120 °C; and / or if the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization is carried out at temperatures of at most 160 °C, in particular at most 150 °C, preferably at most 140 °C, preferably at most 130 °C; and / or if the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization is carried out at temperatures in the range from 105 °C to 160 °C, in particular in the range from 110 °C to 150 °C, preferably in the range from 115 °C to 140 °C, preferably in the range of 120 °C to 130 °C, particularly preferably at about 121 °C.,

[0153] Furthermore, good results are obtained according to the invention if the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out for a (total) period of at least 1 minute, in particular of at least 2 minutes, preferably of at least 3 minutes, preferably of at least 4 minutes, particularly preferably of at least 5 minutes, very particularly preferably of at least 6 minutes; and / or if the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out for a (total) period of at most 600 minutes, in particular of at most 500 minutes, preferably of at most 400 minutes, preferably of at most 350 minutes, particularly preferably of at most 300 minutes, very particularly preferably of at most 250 minutes;and / or if the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out for a (total) period in the range from 1 min to 600 min, in particular in the range from 2 min to 500 min, preferably in the range from 3 min to 400 min, preferably in the range from 4 min to 350 min, particularly preferably in the range from 5 min to 300 min, very particularly preferably in the range from 6 min to 240 min;

[0154] It is also preferred that the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out under pressure.

[0155] In this case, particularly good results are obtained when the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out at a relative pressure in the range from 0.1 bar to 10 bar, in particular in the range from 0.5 bar to 5 bar, preferably in the range from 1 bar to 3.5 bar, preferably in the range from 1.1 bar to 3 bar; and / or when the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out at an absolute pressure in the range from 1.1 bar to 10 bar, in particular in the range from 1.5 bar to 6 bar, preferably in the range from 2 bar to 4.5 bar.

[0156] In addition, it has proven useful if the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization, is carried out in the presence of an atmosphere containing, in particular, pure water vapor and / or as a saturated steam process; or wherein the steam sterilization is carried out in the presence of a water vapor / gas mixture, in particular a mixture of water vapor with inert gas, in particular nitrogen, and / or oxygen, preferably a water vapor / air mixture.Correspondingly good results are obtained within the scope of the present invention when the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization, is carried out in a preferably closed sterilization device, in particular in a gas-tight pressure vessel, preferably in an autoclaving device (autoclave); in particular wherein the sterilization atmosphere is generated by injecting water vapor and / or water vapor / compressed air mixtures, preferably water vapor / compressed air mixtures, into the sterilization device; and / or in particular wherein the sterilization atmosphere is generated by injecting already premixed water vapor / compressed air mixtures and / or by separate injections of water vapor and compressed air into the sterilization device.

[0157] In addition, it is advantageous that during heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, the steam is generated from distilled and / or demineralized water; and / or that during heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, the compressed air is generated from sterile air, in particular wherein the air is cleaned and / or sterilized by flowing through filters.

[0158] In particular, it has proven advantageous for the present invention if the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out under over-temperature conditions and / or at about 121°C and / or for a period of at least 6 minutes, preferably of about 6 minutes, or of at least 20 minutes, preferably of about 20 minutes; and / or if the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out in accordance with Pharmacopoea Europaea (Ph. Eur.), Chapter 5.1.1 (07 / 2017:50101), in particular under over-temperature conditions and / or at about 121°C and / or for a period of at least 15 minutes, in particular of at least 20 minutes, preferably of about 20 minutes.Equally good results are obtained if the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out in multiple cycles, in particular wherein at least the final and / or terminal cycle is carried out under at least one of the conditions defined in the preceding claims and / or in particular wherein at least the final and / or terminal cycle is carried out under over / / / conditions and / or at about 121 °C and / or for a period of at least 6 min, preferably of about 6 min, or of at least 20 min, preferably of about 20 min.

[0159] A particularly preferred embodiment of the present invention provides that the first plastic syringe and / or the second plastic syringe, in particular the first plastic syringe and the second plastic syringe, has been introduced into the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, before carrying out the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization, in particular wherein the outer packaging is sterilized in the same way when carrying out the steam sterilization.

[0160] Within the scope of a further preferred embodiment of the present invention, it has also proven useful if the first plastic syringe and / or second plastic syringe introduced into the outer packaging and sterilized in the outer packaging is dried and / or allowed to dry after steam sterilization has been carried out, in particular in the preferably closed sterilization device, in particular in the gas-tight pressure container, preferably in the autoclaving device (autoclave), preferably using a defined and predetermined drying process, preferably using a respective drying program.

[0161] In other words, it is preferably provided that the packaged first plastic syringe and / or the packaged second plastic syringe is / are steam-sterilized, preferably steam-sterilized, preferably terminally (heat, steam, water vapor)-sterilized, in particular in the preferably closed sterilization device, in particular in the gas-tight pressure vessel, preferably the autoclaving device (autoclave), and is then dried or allowed to dry, in particular in the preferably closed sterilization device, in particular in the gas-tight pressure vessel, preferably the autoclaving device (autoclave), preferably using a defined and predetermined drying process, preferably using a respective drying program.

[0162] This preferred embodiment of the kit according to the invention or of the related manufacturing method has the significant advantage that the sealing section of the outer packaging, which is still permeable to air and moisture when moist, dries in a sterile environment, reliably precluding recontamination of the outer packaging and the syringes. Consequently, the relevant method feature is also directly reflected in the resulting product, i.e., the first plastic syringe and / or second plastic syringe placed in the outer packaging and sterilized therein. After drying, however, the sealing section is no longer permeable to air or water vapor and consequently can no longer be easily contaminated. In this way, the likelihood of contamination of the plastic syringes in the outer packaging is significantly reduced or at least essentially eliminated.

[0163] In this context, it is particularly also possible for a plurality of first plastic syringes filled with the first component (A) and / or second plastic syringes filled with the second component (B) to be sterilized simultaneously, in particular wherein preferably during the steam sterilization several plastic syringes are brought together on one (syringe) carrier.

[0164] Preferably, within the scope of the present invention, with regard to the sterilization product obtained, it is provided that the sterile first component (A) obtained and / or the sterile second component (B) obtained, in particular the sterile first component (A) obtained and the sterile second component (B), and / or the sterile first plastic syringe containing the first component (A) and obtained after completion of heat sterilization and / or the sterile second plastic syringe containing the second component (B) and obtained after completion of heat sterilization, in particular the sterile first plastic syringe containing the first component (A) and obtained after completion of heat sterilization and the sterile second plastic syringe containing the second component (B) and obtained after completion of heat sterilization, have an SAL value (Sterility Assurance Level) of at least 10" 5 , in particular at least 10"6 , preferably at least 10" 7 , has.

[0165] Furthermore, it is preferably provided that the first component (A) in the first plastic syringe and / or the second component (B) in the second plastic syringe is sterile, in particular wherein the first component (A) in the first plastic syringe and / or the second component (B) in the second plastic syringe is heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized, with an F0 value in the range from 6 min to 45 min, in particular in the range from 8 min to 40 min, preferably in the range from 10 min to 38 min, preferably in the range from 11 min to 35 min, particularly preferably in the range from 15 min to 32 min, very particularly preferably in the range from 19 min to 30 min, and / or has an SAL value (Sterility Assurance Level) of at least 10" 5 , in particular at least 10"6 , preferably at least 10" 7 , has.

[0166] It is equally preferred if the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) is sterile, in particular wherein the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) has a SAL value (Sterility Assurance Level) of at least 10" 5 , in particular at least 10" 6 , preferably at least 10" 7 , has.

[0167] It has also proven useful according to the invention if the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) in an outer packaging is sterile, in particular the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) in an outer packaging has a SAL value (Sterility Assurance Level) of at least 10 5 , in particular at least 10" 6 , preferably at least 10" 7, has been found to be particularly advantageous within the scope of the present invention if the kit as a whole, preferably including any outer packaging that may be present, is sterile, in particular where the kit as a whole, preferably including any outer packaging that may be present, has a SAL value (Sterility Assurance Level) of at least 10" 5 , in particular at least 10" 6 , preferably at least 10" 7 , has.

[0168] The present invention thus advantageously comprises a highly effective possibility of providing the kit according to the invention in packaged form, completely sterilized in the sense of having a double sterile barrier, in that both the outer packaging and the plastic syringes as primary packaging can advantageously be sterilized according to the invention, which guarantees particularly safe application. In particular, this advantageously largely eliminates the possibility of recontamination of components (A) or (B). The inventive embodiment of the kit according to the invention, which in particular also provides for sterilization of the outer packaging, advantageously minimizes such a risk.

[0169] The subject of the present invention - according to the applicable aspect of the present invention - is also a kit (kit of parts and / or set) for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, in particular a kit according to the present invention, wherein the kit comprises: a) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is made of at least one polyolefin,preferably polypropylene, wherein the first plastic syringe contains a first component (A) in the form of a solution and / or dispersion, in particular dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer; b) a second, in particular ready-to-use, plastic syringe, in particular disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a syringe body, in particular syringe barrel, and a syringe piston, wherein at least the syringe body, in particular syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular solution, wherein the second component (B) comprises at least one crosslinking agent,in particular a crosslinking agent initiating and / or effecting ionic crosslinking; in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after contacting and / or interacting the components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed; wherein the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different in color; and / or, preferably and wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different in color.

[0170] According to the invention, it has proven particularly useful in this regard if a patient having and / or suffering from a stone disease, in particular a patient having and / or suffering from particles and / or concretions in a lumen of the affected organ of the patient, is administered an amount of the first components (A) and the second component (B) which is effective for removing the particles and / or concretions, in particular a therapeutically effective amount, and / or is applied in each case into the lumen of the organ in question;and / or if the kit is employed and / or used for use in the treatment, in particular therapeutic treatment, of kidney, bladder, urinary and / or gallstones of the human body, preferably by removing particles and / or concretions from the lumen of the human organs in question, and / or for preferably therapeutic use in the removal of kidney, bladder, urinary and / or gallstones from the lumen of the human organs in question;

[0171] A further subject matter of the present invention - according to a second aspect of the present invention - is also the use of a kit according to the present invention (for producing a medicament and / or pharmaceutical) for the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or (for producing a medicament and / or pharmaceutical) for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs.

[0172] In this context, it has proven advantageous within the scope of the present invention if a patient having and / or suffering from a stone disease, in particular a patient having and / or suffering from particles and / or concretions in a lumen of his affected organ, is administered an amount of the first components (A) and the second component (B) which is effective for removing the particles and / or concretions, in particular a therapeutically effective amount, and / or is applied in each case into the lumen of the organ in question;and / or if the kit is employed and / or used in the treatment, in particular therapeutic treatment, of kidney, bladder, urinary and / or gallstones in the human body, preferably by removing particles and / or concretions from the lumen of the human organs in question, and / or for preferably therapeutic use in the removal of kidney, bladder, urinary and / or gallstones from the lumen of the human organs in question. Very specifically, within the scope of the present invention, it is preferred if the kit according to the present invention is employed and / or used in the treatment, in particular therapeutic treatment, of kidney and urinary stones in the human body, preferably by ureterorenoscopic removal and / or by removal by means of percutaneous nephrolitholapaxy of particles and / or concretions from the lumen of the kidney and / or ureter.

[0173] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0174] Also described is a method for the treatment, in particular therapeutic treatment, preferably based on medical treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of an organ, using a kit according to the present invention, wherein a patient having a stone disease and / or suffering therefrom, in particular a patient having particles and / or concretions in a lumen of his affected organ and / or suffering therefrom, is administered an amount of the first components (A) and the second component (B) which is in each case effective for removing the particles and / or concretions, in particular a therapeutically effective amount, and / or is applied in each case into the lumen of the organ in question.

[0175] For further details on this aspect, in particular also on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention. Both with regard to the kit according to the invention, the use according to the invention and the aforementioned method, each according to the preceding aspects, it has proven useful within the scope of the present invention if, in the lumen of the organ containing the particles and / or concretions, the first component (A) and the second component (B) are brought into contact and / or interaction in such a way that a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed in the lumen of the organ.in particular, wherein the particles and / or concretions are at least substantially completely enclosed by the preferably gel-like cross-linking product and / or are at least substantially completely absorbed by the preferably gel-like cross-linking product, preferably such that the preferably gel-like cross-linking product is removed from the lumen of the organ together with the particles and / or concretions at least substantially completely enclosed and / or absorbed thereby.

[0176] Likewise, with regard to the kit according to the invention, the use according to the invention and the aforementioned method, in each case according to the preceding aspects, it has proven useful within the scope of the present invention if the preferably gel-like crosslinking product is removed from the lumen of the organ together with the particles and / or concretions at least substantially completely enclosed and / or absorbed thereby by means of pulling and / or by means of negative pressure, preferably by means of pulling.

[0177] Furthermore, a further subject matter of the present invention - according to a third aspect of the present invention - is a method for producing a kit, in particular a sterile kit, preferably according to one of the relevant preceding claims, comprising the following steps: i) Providing a first plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the first plastic syringe is filled with a first component (A) in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable,preferably crosslinkable polymer to form a gel; in particular, wherein the first plastic syringe filled with the first component (A) is introduced into a first outer packaging, in particular, wherein the first outer packaging has a preferably deep-drawn and / or format-stamped and / or embossed plastic section, in particular for receiving the first plastic syringe, as well as a sealing section that is particularly permeable to water vapor, in particular, wherein the first plastic syringe filled with the first component (A) is first introduced and / or inserted into the deep-drawn and / or format-stamped and / or embossed plastic section and then the deep-drawn and / or format-stamped and / or embossed plastic section provided with the first plastic syringe is closed with the sealing section that is particularly permeable to water vapor; ii) providing a second plastic syringe,in particular a plastic disposable syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe is filled with a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) has at least one crosslinking agent, in particular a crosslinking agent initiating and / or effecting ionic crosslinking; in particular wherein the second plastic syringe filled with the first component (B) is introduced into a second outer packaging, in particular wherein the second outer packaging has a preferably deep-drawn and / or format-stamped and / or embossed plastic section,in particular for receiving the second plastic syringe, and a sealing section, in particular one that is permeable to water vapor, in particular wherein firstly the second plastic syringe filled with the second component (B) is introduced and / or inserted into the deep-drawn and / or format-stamped and / or embossed plastic section and then the deep-drawn and / or format-stamped and / or embossed plastic section provided with the second plastic syringe is sealed with the sealing section, in particular one that is permeable to water vapor, and subsequently iii) heat sterilization, in particular steam sterilization, of the first component (A) in the first plastic syringe, in particular in the packaged first plastic syringe, and / or the first plastic syringe filled with the first component (A), in particular packaged; and / or iv) heat sterilization of the second component (B) in the second plastic syringe,in particular in the packaged second plastic syringe, and / or the second plastic syringe filled, in particular packaged, with the second component (B).

[0178] In this case, it can preferably be provided for the method according to the invention that the method steps i) and ii) are carried out spatially and / or temporally independently of one another; and / or that the method steps iii) and iv) are carried out spatially and / or temporally independently of one another; and / or that the method steps i) and iii) are carried out spatially and / or temporally dependent on one another, in particular sequentially; and / or that the method steps ii) and iv) are carried out spatially and / or temporally dependent on one another, in particular sequentially;and / or that the method steps i) and iii) are carried out spatially and / or temporally independently of the method steps ii) and iv), in particular wherein the method steps i) and iii) are carried out spatially and / or temporally dependent on one another, in particular sequentially, and in particular wherein the method steps ii) and iv) are carried out spatially and / or temporally dependent on one another, in particular sequentially;

[0179] The method according to the invention is therefore advantageously characterized by flexible executability and efficient or lean process control. For process steps iii) and iv) within the scope of the present invention, it is preferably provided that the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out under over / / / conditions and / or at about 121 °C and / or for a period of at least 6 minutes, preferably of about 6 minutes, or of at least 20 minutes, preferably of about 20 minutes; and / or that the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, according to Pharmacopoea Europaea (Ph. Eur.), Chapter 5.1.1 (07 / 2017:50101 ), in particular under over / / / conditions and / or at about 121 °C and / or for a period of at least 15 minutes, in particular of at least 20 minutes, preferably of about 20 minutes; and / or that the heat sterilization is carried out as described in connection with the first aspect of the present invention.

[0180] In this way, reliably sterilized, especially pre-packaged, kits are obtained that are safely protected against recontamination, preferably due to the double sterile barrier that preferably results for the kit, which also reliably ensures the safe applicability of the kit.

[0181] With regard to the preparation of components (A), it has further proven advantageous if the first component (A), in particular the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular a hydrogel, polymer, is produced by dispersing the crosslinkable polymer, in particular in powder form, in at least one dispersing agent, preferably water, under fluidizing conditions, in particular using a cyclone mixing device. Particularly good results are obtained if the dispersion is carried out over a period in the range of 15 minutes to 120 minutes, in particular in the range of 40 minutes to 90 minutes, preferably in the range of 50 minutes to 70 minutes, and at a mixing speed in the range of 30 rpm to 500 rpm (revolutions per minute).in particular in the range from 45 rpm to 250 rpm, preferably in the range from 55 rpm to 125 rpm; and / or when the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer is produced by the introduction of shear forces under vortex conditions, in particular in the cyclone mixing device, preferably by means of in s / t swelling; preferably wherein no separate swelling and / or swelling of the polymer is required and / or carried out in the production of the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel.

[0182] In this way, within the scope of the present invention, the production time for component (A) can be advantageously shortened, while at the same time more stable dispersions or sols of component (A) are obtained, which moreover also have better gel formation properties with regard to achievable strengths and / or the mechanical strength of the crosslinking product obtained from components (A) and (B).

[0183] For further details on this aspect of the invention, in particular also on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention. Furthermore, a further subject of the present invention—according to a fourth aspect of the present invention—is a kit (kit of parts and / or set), in particular a sterile kit, preferably according to the present invention, wherein the kit is obtained and / or obtainable by a method according to the present invention.

[0184] A further subject matter of the present aspect according to this aspect is also a kit (kit of parts and / or set), in particular a sterile kit, preferably according to the present invention, for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit is obtained and / or obtainable by a method according to the present invention.

[0185] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0186] Yet another subject matter of the present invention - according to a fifth aspect of the present invention - is the use of a kit according to the present invention (for producing a medicament and / or pharmaceutical) for the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or (for producing a medicament and / or pharmaceutical) for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit is obtained and / or obtainable by a method according to the present invention. For further details on this aspect of the invention, in particular also on the associated advantages and special technical effects or.Effects, reference can be made to the statements on the further aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0187] Yet another subject matter of the present invention - according to a sixth aspect of the present invention - is the use of a plastic syringe comprising a syringe body, in particular a syringe barrel, and a syringe plunger, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, in a method according to the present invention for producing a kit, in particular a sterile kit, preferably according to the present invention.

[0188] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0189] Finally, a further subject matter of the present invention - according to a seventh aspect of the present invention - is a packaging unit containing at least one package and at least one kit, preferably a plurality of kits, according to the present invention, wherein the kit, preferably the kits, is (are) introduced into the packaging unit and / or is (are) present in the packaging unit.

[0190] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention. The present invention, both according to the first aspect of the invention and according to all other aspects of the invention, is associated with a multitude of advantages and special features that make the inventive application concept unique and highly efficient.

[0191] The following invention is explained in more detail with reference to preferred embodiments and drawings or figures illustrating preferred embodiments. In connection with the explanation of these preferred embodiments or embodiments of the present invention, which are in no way limiting with respect to the present invention, further advantages, properties, aspects, and features of the present invention are also presented.

[0192] In the figure representations shows:

[0193] Fig. 1 is a schematic exploded view of a kit according to the invention according to a preferred embodiment;

[0194] Fig. 2A is a partial cross-sectional view of a first plastic syringe used according to the invention containing component (A) according to a preferred embodiment;

[0195] Fig. 2B is a partial cross-sectional view of a second plastic syringe used according to the invention containing component (B) according to a preferred embodiment;

[0196] Fig. 3A is a plan view of an outer packaging of the first plastic syringe according to a preferred embodiment;

[0197] Fig. 3B is a plan view of an outer packaging of the second plastic syringe according to a preferred embodiment.

[0198] Figures 1 to 3B each illustrate preferred embodiments of the kit according to the invention, including a corresponding outer packaging.

[0199] Fig. 1 thus shows a preferred embodiment of a kit according to the invention, namely a kit 1, in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs.

[0200] The kit 1 comprises: a) a first, in particular ready-to-use, plastic syringe 2, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe 2 has a syringe body 6, in particular a syringe barrel, and a syringe piston 8, wherein at least the syringe body 6, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the first plastic syringe contains a first component (A) 4 in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol, wherein the first component (A) 4 has at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer;b) a second, in particular ready-to-use, plastic syringe 3, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe 3 has a syringe body 7, in particular a syringe barrel, and a syringe piston 9, wherein at least the syringe body 7, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe contains a second component (B) 5 in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) has at least one crosslinking agent, in particular a crosslinking agent initiating and / or causing ionic crosslinking;

[0201] In particular, the first component (A) 4 and the second component (B) 5 can be selected and / or designed such that during and / or after contacting and / or interacting of the components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed.

[0202] The first component (A) 4 and the second component (B) 5 are optically and / or visually different from one another, in particular different in color. The first plastic syringe 2 and the second plastic syringe 3 are preferably also optically and / or visually different from one another, in particular different in color.

[0203] The kit 1 is further designed such that the first plastic syringe 2 and / or the second plastic syringe 3, in particular the first plastic syringe 2 and the second plastic syringe 2, are introduced into (each) an outer packaging 10, 11 which is in particular sealed in a water-tight and / or germ-tight manner or have an outer packaging 10, 11 which is in particular sealed in a water-tight and / or germ-tight manner.

[0204] Fig. 2A and Fig. 2B show preferred embodiments of a first plastic syringe 2 and a second plastic syringe 3 suitable according to the invention.

[0205] The first plastic syringe 2 and the second plastic syringe 3 are designed such that the syringe bodies 6, 7, in particular syringe cylinders, of the first plastic syringe 2 and the second plastic syringe 3 have an outlet opening 15, provided in particular at the end and / or front side, in particular in an outlet region, in particular for dispensing and / or applying the component (A) 4 and the component (B) 5.

[0206] It is further provided that the syringe bodies 6, 7, in particular syringe cylinders, of the first plastic syringe 2 and the second plastic syringe 3 have a preferably blunt tip having the outlet opening 15, in particular intended for the arrangement of an application device, in particular a cannula, an endoscope, in particular the (working) channel of an endoscope, or a catheter, preferably a catheter tube.

[0207] It is also provided that the syringe bodies 6, 7, in particular the syringe cylinders, of the first plastic syringe 2 and the second plastic syringe 3 have a receiving and / or filling opening 16, in particular for filling the syringe bodies 6, 7, in particular the syringe cylinder, with the component (A) 4 and / or the component (B) 5 and / or in particular for preferably sealingly receiving the syringe plungers 8, 9 with the plunger stopper 13. The receiving and / or filling opening 16 is designed to be closable and / or closed with the syringe plungers 8, 9, in particular with the plunger stopper 13. In general, according to the preferred embodiment of the kit 1 according to the invention shown in Fig. 2, the first plastic syringe 2 and the second plastic syringe 3 are, in particular, at least substantially structurally identical and / or have the same structural features.

[0208] Furthermore, the first plastic syringe 2 contains and / or is filled with a first volume of component (A) 4 and the second plastic syringe 3 contains and / or is filled with a second volume of component (B) 5, wherein the first volume of component (A) 4 and the second volume of component (B) 5 differ from one another and the first volume of component (A) 4 is smaller than the second volume of component (B) 5.

[0209] Accordingly, it follows that the lengths of the syringe plungers 8, 9 of the first plastic syringe 2 and the second plastic syringe 3, which protrude relative to the syringe bodies 6, 7, in particular syringe cylinders, differ from one another in the filled state, in particular complementary to the difference between the first volume of component (A) 4 and the second volume of component (B) 5, wherein the length of the syringe plunger 8 of the first plastic syringe 2, which protrudes relative to the syringe body 6, in particular syringe cylinder, in the filled state is shorter than the length of the syringe plunger 9 of the second plastic syringe 3, which protrudes relative to the syringe body 7, in particular syringe cylinder, in the filled state.

[0210] It is further provided that the syringe bodies 6, 7, preferably syringe cylinders, have a stop 14, in particular a circumferential stop, on the inside, in the region of the receiving and / or filling opening 16 and / or in the end region of the syringe bodies 6, 7, in particular syringe cylinders, in particular opposite the outlet region 15. The stop 14 is designed such that the syringe piston 8, 9 and / or the piston stopper 13 is (are) secured, in particular at least substantially, against moving out, in particular being pulled out, from the syringe body 6, 7, in particular syringe cylinder, beyond the stop 14 and / or the stop 14 is (are) designed for the stop, in particular sealing, of the piston stopper 13 and / or the syringe piston 8, 9 against the stop. The stop 14 is designed in the form of a particularly bevelled projection and / or a bevelled step.In particular, this prevents the syringe piston 8, 9 and / or the piston plug 13 from being moved undesirably (in particular due to heat expansion of the filling volume) out of the syringe body 6, 7, in particular the syringe cylinder, beyond the stop 14 during heat sterilization.

[0211] Furthermore, the plastic syringes 2, 3 are designed such that a particularly removable and / or detachable closure element 12, in particular a closure cap (closure and / or sealing cap), preferably for sealingly closing the outlet opening, is placed and / or plugged onto the outlet opening 15 and / or the tip.

[0212] 3A and 3B each show a preferred embodiment of an outer packaging suitable according to the invention. As shown there for these preferred outer packagings, the outer packaging 10, 11, which is in particular sealed in a water-tight and / or germ-tight manner, has a preferably deep-drawn and / or format-stamped and / or embossed plastic section 17, 20 and a sealing section that is at least permeable to water vapor, in particular permeable to water vapor and / or gas. The plastic section 17, 20 has a receiving area 18, which is in particular open and closed on the underside by the plastic section, for arranging the first plastic syringe 2 filled with component (A) and / or the second plastic syringe 3 filled with component (B).

[0213] Furthermore, it is provided for the kit 1 that the plastic section 18 of the outer packaging for the first plastic syringe 2 is designed differently from the plastic section 18 of the outer packaging of the second plastic syringe 3.

[0214] In this case, the length of the receiving area 18 of the first plastic section 17, which preferably extends in the longitudinal direction of the first plastic syringe 2, is shorter than the length of the second receiving area 18 of the plastic section 20, which preferably extends in the longitudinal direction of the second plastic syringe 3, since the first volume of the component (A) 4 and the second volume of the component (B) 5 differ from one another, in particular wherein the first volume of the component (A) 4 is smaller than the volume of the components (B) 5, so that it follows accordingly that the lengths of the syringe pistons 8, 9 of the first plastic syringe 2 and the second plastic syringe 3, which protrude relative to the syringe bodies 6, 7, in particular syringe cylinders, differ from one another in the filled state;in particular such that the length of the syringe plunger 8 of the first plastic syringe 2, which protrudes relative to the syringe body 6, in particular the syringe cylinder, in the filled state is shorter than the length of the syringe plunger 9 of the second plastic syringe 4, which protrudes relative to the syringe body 7, in particular the syringe cylinder, in the filled state.;

[0215] In order to comply with this, it is provided that the first plastic section 18 of the outer packaging 10 of the first plastic syringe 2 has an extension section 19 which protrudes and / or projects relative to the second section of the receiving area 18, wherein the second section of the receiving area 18 and the extension section 19 are separated from one another by the stop wall 21 and wherein the extension section 19 forms a recess in the first plastic section, wherein the, in particular maximum, height of the extension section 19 is less than the, in particular maximum, height of the second section of the receiving area 18. In this way, it is advantageously ensured that the syringe piston 8 of the first plastic syringe 2 is demobilized against moving out or being pulled out of the syringe body 6, in particular the syringe cylinder, in particular during heat sterilization.

[0216] Finally, Fig. 4 shows a preferred embodiment of a method according to the invention.

[0217] Within the scope of this preferred embodiment of a method according to the invention for producing a kit, in particular a sterile kit, the following steps are included: i) Providing a first plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene (step A(1)), wherein the first plastic syringe is filled with a first component (A) in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol (step A(2)), wherein the first component (A) has at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer; in particular wherein the first,a plastic syringe filled with the first component (A) is introduced into a first outer packaging (step A(3)), in particular wherein the first outer packaging has a preferably deep-drawn and / or format-stamped and / or embossed plastic section, in particular for receiving the first plastic syringe, as well as a sealing section, in particular one that is permeable to water vapor, in particular wherein firstly the first plastic syringe filled with the first component (A) is introduced and / or inserted into the deep-drawn and / or format-stamped and / or embossed plastic section and then the deep-drawn and / or format-stamped and / or embossed plastic section provided with the first plastic syringe is closed with the sealing section, in particular one that is permeable to water vapor; ii) providing a second plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe,wherein the second plastic syringe has a syringe body, in particular a syringe barrel, and a syringe plunger, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene (step B(1)), wherein the second plastic syringe is filled with a second component (B) in the form of a solution and / or dispersion, in particular a solution (step B(2)), wherein the second component (B) has at least one crosslinking agent, in particular a crosslinking agent initiating and / or effecting ionic crosslinking; in particular wherein the second plastic syringe filled with the first component (B) is introduced into a second outer packaging (step B(3)), in particular wherein the second outer packaging has a preferably deep-drawn and / or format-stamped and / or embossed plastic section, in particular for receiving the second plastic syringe,and a sealing section, in particular one that is permeable to water vapor, in particular wherein firstly the second plastic syringe filled with the second component (B) is introduced and / or inserted into the deep-drawn and / or format-stamped and / or embossed plastic section and then the deep-drawn and / or format-stamped and / or embossed plastic section provided with the second plastic syringe is sealed with the sealing section, in particular one that is permeable to water vapor, and subsequently iii) heat sterilization, in particular steam sterilization, of the first component (A) in the first plastic syringe, in particular in the repackaged first plastic syringe, and / or the first plastic syringe filled with the first component (A), in particular repackaged (step A(4)); and iv) heat sterilization of the second component (B) in the second plastic syringe,in particular in the repackaged second plastic syringe, and / or the second plastic syringe filled with the second component (B), in particular repackaged (step B(4)).

[0218] The method is carried out to obtain a kit, in particular as described above (step K). Finally, the resulting kit can be placed into a packaging unit in step V.

[0219] For further embodiments, modifications, variations, and advantages of the above-described products and the described method, reference is made to the relevant sections of the description. Further embodiments, modifications, variations, and advantages of the present invention will be readily apparent and achievable to those skilled in the art upon reading the description, without departing from the scope of the present invention.

[0220] The following exemplary embodiments serve merely to illustrate the present invention, but do not limit the present invention thereto. EXEMPLARY EMBODIMENTS:

[0221] A preferred embodiment of the manufacturing process according to the invention for the kit according to the invention and of the kit according to the invention itself is shown below.

[0222] A. Production of the kit according to the invention in an outer packaging with a double sterile barrier

[0223] 1. Bulk production of component (A):

[0224] To prepare a pre-solution of component (A), 167.184 kg of purified water are metered into a pre-dissolution container. 0.118 kg of disodium hydrogen phosphate and 0.023 kg of potassium dihydrogen phosphate are added. The pre-solution is stirred at 69 ± 1 rpm for 600 seconds (10 minutes) until a clear solution is obtained.

[0225] A quantity of 0.668 kg of sodium chloride is then added to the pre-solution. The resulting pre-solution is stirred at 69 ± 1 rpm for 300 seconds (5 minutes).

[0226] A bottom valve on the pre-dissolving tank connects the tank to a Ytron® XC cyclone mixer (see EP 0 201 767 A2 and US 4 729 663 A) via a hose. The mixer is connected to a preparation tank via a second hose.

[0227] A quantity of 1.505 kg of sodium alginate is slowly added to the hopper of the cyclone mixer. The pre-solution is introduced into the cyclone mixer via the hose. After the pre-solution and sodium alginate have been completely added to the mixing container, the solids valve of the cyclone mixer is closed, and the resulting mixture is stirred at 69 ± 1 rpm for 3,600 seconds (60 minutes).

[0228] By using the cyclone mixing device, the powdered sodium alginate is advantageously introduced in high concentrations into a pre-solution and spontaneously dispersed within it. This allows for the highest concentrations of dispersed sodium alginate in a single pass. The first stage in the cyclone mixing device creates a strong vacuum and draws in the powdered sodium alginate. Immediately after contact with the pre-solution, the powder is thrown against baffle plates located in the device and is dissolved, deagglomerated, and dispersed by high-frequency impacts.

[0229] In the second stage of the mixing process, a homogeneous, wetted product in the form of an alginate sol is discharged. Advantageously, the introduction of the alginate into the pre-solution using a cyclone mixer enables direct processing of the dispersion obtained in the form of a sol, without the need for it to stand and swell overnight, for example, at 2°C to 8°C. Compared to conventional manufacturing processes, a shorter processing time and faster sol formation can be achieved. The shorter processing time is advantageous with regard to the sterility of the product, as it reduces the likelihood of contamination. At the same time, the method of manufacturing the alginate sol preferred according to the invention has a beneficial effect on the strength of the crosslinked product, in particular the gel obtained from components (A) and (B).

[0230] For this purpose, a weighed amount of 0.502 kg of dextran blue is slowly added to the pre-solution. The resulting dispersion is stirred at 69 ± 1 rpm for 900 seconds (15 minutes).

[0231] At the same time, a sample of the dispersion is taken and stirred at the same speed for 900 seconds (15 minutes) at 69 ± 1 rpm. The sample is visually inspected to determine whether a clear, blue solution is present. If this is not the case, the entire solution and sample are stirred for another 900 seconds (15 minutes) at 69 ± 1 rpm. After a maximum of 60 minutes, a clear, blue solution is obtained.

[0232] During the process, the thread tension (so-called thread tension test) and the visual appearance of the dispersion to be produced are checked. For this purpose, samples are taken from the mixing device using an autoclaved sampling lance. The color of the solution is checked using a color chart. The test is considered "passed" if the determined color of the produced component (A) matches the sample and the solution is clear and transparent.

[0233] The in-process control of the thread tension is carried out by contacting or interacting the dispersion with an aqueous CaCl2 stock solution. To control the thread tension, 5 mL or 1.5 g of the dextran blue-stained sample are introduced and brought into contact with the aqueous CaCl2 solution in such a way that interfaces form between the solutions, but no active or extensive mixing of the solutions occurs.

[0234] At the interfaces, a gel-like crosslinking product forms, resembling a thread. It can be grasped and lifted or pulled with a tweezer-like gripper. The gel thread is lifted or pulled at a constant speed in the range of 0.5 cm to 3 cm. The successively forming thread must reach a length of 15 cm and be able to maintain its structural integrity over a period of 30 seconds, i.e., it must not tear or visibly weaken the gel structure.

[0235] Once these quality control measures have been positively assessed and completed, the produced dispersion is initially stored in a closed stainless steel mixing container supplied with sterile, filtered compressed air. The temperature in the production area is maintained at a constant 18 °C to 24 °C. The storage time of the produced dispersion of component (A) in the container and syringes is limited to a maximum of 72 hours from the start of production until the end of the final steam sterilization.

[0236] 2. Bulk production of component (B):

[0237] 391.052 kg of purified water are metered into a pre-dissolution container. The weighed amounts of 1.756 kg of sodium chloride and 7.184 kg of calcium chloride dihydrate are added to the pre-dissolution container. The resulting solution is stirred at 69 ± 1 rpm for 300 seconds (5 minutes) until a clear solution is obtained.

[0238] A quantity of 0.009 kg of riboflavin is added. The resulting solution is stirred at 69 ± IU / min for 1800 seconds (30 minutes).

[0239] A total sample of approximately 200 ml is taken. This sample is visually inspected to determine whether a clear, yellow solution is obtained. If this is not the case, the total solution is stirred for another 900 seconds (15 minutes) at 69 ± 1 rpm. After a maximum of 60 minutes, a clear, yellow solution is obtained.

[0240] Once the bulk solution is clear and yellow, the thread tension is checked again during the process (thread tension test), in this case using a sodium alginate stock solution. The procedure and criteria are the same as for component (A). Furthermore, a visual inspection of the appearance of the resulting component (B) is performed. The color of the sample taken from the prepared solution is checked using a color chart.

[0241] The test is considered "passed" if the determined color of the syringe contents is within the "OK range" of the template or the solution is clear and transparent.

[0242] The resulting solution of component (B) is then initially stored in a closed stainless steel mixing vessel pressurized with sterile, filtered compressed air. The temperature in the production area is maintained at a constant 18 °C to 24 °C.

[0243] After filling, the bulk product is stored in prefilled syringes. The temperature in the production area is maintained at a constant 18-24 °C. The storage time of the bulk product in the container and syringes is limited to a maximum of 72 hours, from the start of production until the end of the final steam sterilization.

[0244] 3. Fill the first plastic syringe with component (A) and the second plastic syringe with component (B):

[0245] The filling and packaging of disposable syringes takes place as part of an automated, batch-based process.

[0246] The plastic syringes for components (A) and (B) are first printed, filled with the solutions for component (A) and for component (B), then assembled, packed in blisters, packed in folding boxes (100 syringes per box) and loaded onto sterilization pallets.

[0247] The plastic syringes used consist of a transparent polypropylene syringe barrel, a rubber cap on the tip of the syringe barrel, and a polypropylene syringe plunger with a rubber plunger at the other end of the barrel, which is screwed into the syringe plunger. Syringes of the same or identical design are preferably used. Visually, the syringes are advantageously distinguished by a coloring of the plastic syringe, preferably the syringe plunger, preferably the plastic syringe for component (A), with the syringe plunger being particularly preferred. The areas of the production line in which components (A) and (B), the syringes or their outer packaging, and / or the surfaces in direct contact with the product are open or exposed are protected by laminar flow (GMP cleanroom class C).

[0248] The syringe barrels are first siliconized using spray nozzles. Excess silicone oil is sucked off using a vacuum pump. The resulting sliding behavior is checked before filling begins. The barrels are fitted with syringe plungers and transported to a filling machine via a conveyor belt. The syringes are filled with components (A) and (B) under a filling station. The filling volume is controlled by weighing. Preferably, the syringes are filled with different volumes of component (A) and component (B). In particular, it is intended that the first plastic syringe is filled with a volume of 5 mL of component (A), while the second plastic syringe is filled with a volume of 10 mL of component (B).

[0249] The caps are placed on the syringes, and the assembled syringes are transported via a conveyor belt to the blister packaging machine, where they are repackaged, i.e., blistered, and then collectively packaged. The outer packaging, in the form of a blister, consists of a transparent polypropylene film, which is covered with a pre-printed sterile paper of 60 g / m². 2 Covered with sterilization paper. The paper is advantageously permeable to water vapor and air when moist, ensuring that the interior of the outer packaging can be sterilized. When dry, the paper is impermeable to water vapor and air.

[0250] The film of the plastic section of the outer packaging, i.e., the blister pockets, is heated and formed into deep-drawn plastic sections in the shape of blister pockets using a format stamp or by thermoforming. The prefilled syringes are automatically placed into the blister pockets.

[0251] The blister pockets are then sealed with sterile paper along the edges of the outer packaging, especially the plastic section, under a heating plate. The individual outer packagings are then punched out.

[0252] The blisters are packaged in pre-printed folding boxes. The folding boxes are printed with variable data such as batch number and expiration date and weighed. The folding boxes are then manually sealed and placed on sterilization trays. The resulting prefilled and packaged syringes (in outer packaging and packaging units such as folding boxes) are stored in the production area (GMP Class D cleanroom) until final steam sterilization. The temperature in the production area is maintained at a constant 18°C ​​to 24°C.

[0253] 4. Sterilization of the first plastic syringe filled with component (A) and the second plastic syringe filled with component (B):

[0254] The prefilled and packaged syringes obtained according to step 3 are stored in the production area (GMP Class D cleanroom) for a maximum of 72 hours until final sterilization. The temperature in the production area is maintained at a constant 18°C ​​to 24°C.

[0255] Since the plastic syringes for the components (A) and (B) are preferably filled with different volumes of the components and further preferably are structurally the same or identical, it is preferably provided that the outer packaging of the component (A), which is preferably present in a smaller volume, has a special design which fixes the plastic syringe with the component (A), in particular during sterilization, in particular in an autoclave, and in particular demobilizes or secures the piston stopper of the plastic syringe against moving out of the syringe cylinder.

[0256] For this purpose, the outer packaging of the first plastic syringe, specifically the deep-drawn plastic section or the blister pocket, preferably has a flattened portion in the area of ​​the blister pocket that accommodates the plunger stopper. The flattened portion is designed such that it adjoins the plunger stopper at least substantially directly, so that the plunger stopper cannot be moved out of the plastic syringe beyond the blister pocket due to the flattened portion. Preferably, the blister pocket nevertheless allows for a slight amount of play of the plastic syringe within the blister pocket.

[0257] The terminal sterilization of the product is carried out using a steam-air mixture process and represents an overkill process with > 121 °C for > 20 minutes, which ensures a higher SAL than the EP 5.1.1 reference cycle at > 121 °C for > 15 minutes. The use of a steam-air mixture process is due to the fact that sterile-filtered compressed air must be supplied to the autoclave or sterilization chamber to prevent boiling or expansion of components (A) and / or (B) in the plastic syringes (counterbalance) and thus ensure that components (A) and / or (B) are not damaged by internal or external pressure during the process.

[0258] The pressure in the autoclave or sterilization chamber during the sterilization phase is > 1.3 bar. The folding boxes with repackaged, prefilled plastic syringes are loaded onto pallets manually on a non-sterile loading side of the sterilization device or autoclave.

[0259] After sterilization, the autoclave chambers are cooled and then heated again to 125°C for 35 minutes, 120°C for 50 minutes, and 40°C for 15 minutes to dry the syringes. The resulting kit advantageously features a so-called double sterile barrier, as the outer packaging and plastic syringe are sterilized, which is significantly advantageous for medical applications.

[0260] Finally, the ready-to-use kit according to the invention is obtained, which can be further transferred into appropriate packaging units.

[0261] B. Analysis of the manufactured components (A) and (B) or the manufactured kit

[0262] 1. No color interaction of components (A) or (B) with the plastic syringes used

[0263] The interaction of the components with the polypropylene material of the syringe barrel and the bromobutyl rubber of the plunger and tip cap was tested using FT infrared spectroscopy on samples of a terminally sterilized batch of components stored for 6 months at 40 °C and 75% rH (accelerated storage conditions, worst case).

[0264] Three packaged syringes are sampled after one, three, and six months of storage. The filling is removed, and the inner surface of the barrel and the rubber parts are rinsed with purified water. Three siliconized and terminally sterilized empty syringe barrels, three plunger materials, and three caps are used as negative controls. The purity of the polypropylene material and the bromobutyl rubber material of the three empty syringe barrels, plungers, and tip caps (without product contact) and the three discharged syringe barrels, plungers, and tip caps (with product contact under accelerated conditions, worst case) at all three time points (after one, three, and six months) is tested using FT infrared spectroscopy.

[0265] The acceptance criteria are: No interaction of the components with the primary packaging material, i.e., the plastic syringes used, was detected, as the spectra of sampled syringe components and the corresponding control parts are comparable (90% agreement factor). 2. Analysis of component (A) and component (B)

[0266] Components (A) and (B) are analyzed separately with respect to the following criteria:

[0267] The parameters pH, sterility, and microbiological packaging control are measured according to EP standards. Functional testing using the thread-pulling method is performed as previously described in Section A.1. Using tweezers, for example, the gel formed at the interface between component (A) and component (B) is controlled and pulled upwards evenly. The gel body must be pulled to a length of at least 15 cm for the test to be evaluated. To pass the test, the gel must remain stable in its extended length for 30 seconds. This corresponds to a tensile force of 0.03 N or more that must be compensated.

[0268] Furthermore, the viscosity is measured using a viscometer. The measurement setup is a cone-and-plate geometry based on DIN 51810-1 or according to the method according to Ph. Eur. [Pharmacopoea Europaea], 9 thEdition (9.0), 2017, 9th English edition, Section 2.2.8. "Viscosity" and Section 2.2.9. "Capillary viscometer method" were used, using a CPA-41Z cone. 2 mL of component (A) and component (B) were used, respectively, and measured at 25 °C for 60 seconds. A sample chamber with an integrated temperature sensor was used, and the temperature was kept constant using a TC-550 circulating thermostat bath.

[0269] The results of the viscometric measurement are as follows:

[0270] Component (A): 23.5 mPa*s (+ / - 0.5 mPa*s)

[0271] Component (B): 1.7 mPa*s (+ / - 0.7 mPa*s).

[0272] List of reference symbols:

[0273] 1 kit

[0274] 2 first plastic syringe

[0275] 3 second plastic syringe

[0276] 4 Component (A)

[0277] 5 Component (B)

[0278] 6 Syringe body of the first plastic syringe

[0279] 7 Syringe body of the second plastic syringe

[0280] 8 syringe plungers of the first plastic syringe

[0281] 9 Syringe plunger of the second plastic syringe

[0282] 10 Outer packaging of the first plastic syringe

[0283] 11 Outer packaging of the second plastic syringe

[0284] 12 locking element

[0285] 13 piston plugs

[0286] 14 Stop edge of the syringe body

[0287] 15 Outlet opening

[0288] 16 Filling opening

[0289] 17 Plastic section of the outer packaging of the first plastic syringe

[0290] 18 Receiving area for plastic syringe

[0291] 19 Extension section

[0292] 20 Plastic section of the outer packaging of the second plastic syringe

[0293] 21 Stop edge of the outer packaging

[0294] A(1 ) Process step A(1 )

[0295] A(2) Process step A(2) A(3) Process step A(3) A(4) Process step A(4) B(1 ) Process step B(1) B(2) Process step B(2) B(3) Process step B(3) B(4) Process step B(4) K Process step K

[0296] V Process step V

Claims

Patent claims:

1. Kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit comprises: a) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the first plastic syringe comprises a first component (A) in the form of a solution and / or dispersion, in particular a dispersion,preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer; b) a second, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic plunger syringe, wherein the second plastic syringe comprises a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) comprises at least one crosslinking agent, in particular a crosslinking agent initiating and / or effecting ionic crosslinking; in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after bringing into contact and / or interaction of the components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed; wherein the first component (A) and the second component (B) are designed to be optically and / or visually different from one another, in particular different from one another in terms of color; and / or, preferably and, wherein the first plastic syringe and the second plastic syringe are designed to be optically and / or visually different from one another, in particular different from one another in terms of color.

2. Kit according to claim 1, wherein the first component (A), in particular before bringing into contact and / or interaction of the components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, in particular at a temperature of 20 °C, has a lower dynamic viscosity compared to the second component (B).

3. Kit according to claim 1 or 2, wherein the first component (A), in particular before bringing into contact and / or interaction of components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at least 1.5 mPas, in particular at least 4 mPas, preferably at least 7 mPas, preferably at least 10 mPas; and / or wherein the first component (A), in particular before bringing into contact and / or interaction of components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at most 100 mPas, in particular at most 60 mPas, preferably at most 40 mPas, preferably at most 35 mPas; and / or wherein the first component (A), in particular before bringing into contact and / or interaction of components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20 °C, has a dynamic viscosity in the range from 1.5 mPas to 100 mPas, in particular in the range from 4 mPas to 60 mPas, preferably in the range from 7 mPas to 40 mPas, preferably in the range from 10 mPas to 35 mPas; in particular wherein the determination of the dynamic viscosity is carried out using methods known to the person skilled in the art, in particular according to the method according to Ph. Eur. [Pharmacopoea Europaea], 9 th Edition (9.0), 2017, 9th edition English, Section 2.2.

8. "Viscosity" and Section 2.2.

9. "Capillary viscometer method" and / or based on DIN 51810-1.

4. Kit according to one of the preceding claims, wherein the second component (B), in particular before bringing components (A) and (B) into contact and / or interacting and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at least 0.15 mPas, in particular at least 0.25 mPas, preferably at least 0.5 mPas, preferably at least 0.75 mPas; and / or wherein the second component (B), in particular before bringing components (A) and (B) into contact and / or interacting and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20°C, has a dynamic viscosity of at most 3 mPas, in particular at most 2.85 mPas, preferably at most 2.65 mPas, preferably at most 2.5 mPas;and / or wherein the second component (B), in particular before bringing into contact and / or interaction of the components (A) and (B) and / or in the first, in particular ready-to-use, plastic syringe state, at a temperature of 20 °C, has a dynamic viscosity in the range from 0.15 mPas to 3 mPas, in particular in the range from 0.25 mPas to 2.85 mPas, preferably in the range from 0.5 mPas to 2.65 mPas, preferably in the range from 0.75 mPas to 2.5 mPas; in particular, the determination of the dynamic viscosity is carried out using methods known to the person skilled in the art, in particular according to the method according to Ph. Eur. [Pharmacopoea Europaea], 9 th Edition (9.0), 2017, 9th edition English, Section 2.2.

8. "Viscosity" and Section 2.2.

9. "Capillary viscometer method" and / or based on DIN 51810-1.

5. Kit according to one of the preceding claims, wherein the preferably gel-like crosslinking product, in particular at a temperature of 20 °C, has a greater dynamic viscosity than the first component (A).

6. Kit according to one of the preceding claims, wherein the preferably gel-like crosslinking product has a dynamic viscosity of at least 10,000 mPas, in particular at least 20,000 mPas, preferably at least 30,000 mPas, preferably at least 50,000 mPas, at a temperature of 20°C; and / or wherein the preferably gel-like crosslinking product has a dynamic viscosity of at most 200,000 mPas, in particular at most 150,000 mPas, preferably at most 100,000 mPas, preferably at most 80,000 mPas, at a temperature of 20°C; and / or wherein the preferably gel-like crosslinking product has, at a temperature of 20°C, a dynamic viscosity in the range from 10,000 mPas to 200,000 mPas, in particular in the range from 20,000 mPas to 150,000 mPas, preferably in the range from 30,000 mPas to 100,000 mPas, preferably in the range from 50,000 mPas to 80.000 mPas; in particular, the determination of the dynamic viscosity is carried out using methods known to the person skilled in the art, in particular according to the method according to Ph. Eur. [Pharmacopoea Europaea], 9. th Edition (9.0), 2017, 9th edition English, Section 2.2.

8. "Viscosity" and Section 2.2.

9. "Capillary viscometer method" and / or based on DIN 51810-1.

7. Kit according to one of the preceding claims, wherein the preferably gel-shaped crosslinking product, based on a thread of the preferably gel-shaped crosslinking product with a length of 15 cm and at a temperature of 20 °C, compensates for and / or is capable of absorbing a tensile force of at least 0.015 N, in particular at least 0.025 N, preferably at least 0.030 N, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining the thread integrity and / or without tearing;and / or wherein the preferably gel-like crosslinking product, based on a thread of the preferably gel-like crosslinking product with a length of 15 cm and at a temperature of 20 °C, is capable of compensating and / or absorbing a tensile force of at most 0.20 N, in particular at most 0.15 N, preferably at most 0.10 N, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining the thread integrity and / or without tearing;and / or wherein the preferably gel-like crosslinking product, based on a thread of the preferably gel-like crosslinking product with a length of 15 cm and at a temperature of 20°C, compensates for and / or is capable of absorbing a tensile force in the range of 0.015 N to 0.20 N, in particular in the range of 0.025 N to 0.15 N, preferably in the range of 0.030 N to 0.10 N, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining the thread integrity and / or without tearing; in particular wherein the aforementioned values are determined by means of a thread tension experiment and / or by means of a thread tension method, in particular on the gel-like crosslinking product with a predetermined contact area, in particular in the range of approximately 2 mm; 2 up to 10 mm 2, using a constant pulling speed, in particular in the range of 0.5 cm to 3 cm per second, with, preferably visual, recording of the tear-off force and / or the tear-off behavior.

8. Kit according to one of the preceding claims, wherein the preferably gel-shaped crosslinking product, based on a thread of the preferably gel-shaped crosslinking product with a length of 15 cm, at a temperature of 20 °C, carries a mass of at least 1.5 g, in particular at least 2.5 g, preferably at least 3.5 g, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining the thread integrity and / or without tearing; and / or wherein the preferably gel-shaped crosslinking product, based on a thread of the preferably gel-shaped crosslinking product with a length of 15 cm, at a temperature of 20 °C, carries a mass of at most 20 g, in particular at most 15 g, preferably at most 10 g, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, in particular while maintaining the thread integrity and / or without tearing;and / or wherein the preferably gel-like crosslinking product carries a mass in the range of 1.5 g to 20 g, in particular in the range of 2.5 g to 20 g, preferably in the range of 3.5 g to 10 g, over a period of 20 seconds, in particular 25 seconds, preferably 30 seconds, on a thread of the preferably gel-like crosslinking product with a length of 15 cm, at a temperature of 20 °C, in particular while maintaining the thread integrity and / or without tearing; in particular wherein the aforementioned values are determined by means of a thread tension experiment and / or by means of the thread tension method, in particular on the gel-like crosslinking product with a predetermined contact area, in particular in the range of approximately 2 mm; 2 up to 10 mm 2 , using a constant pulling speed, in particular in the range of 0.5 cm to 3 cm per second, with, preferably visual, recording of the tear-off force and / or the tear-off behavior.

9. Kit according to one of the preceding claims, wherein the preferably gel-like crosslinking product has a gel strength of at least 0.6 N, in particular at least 0.8 N, preferably at least 1 N, at a temperature of 20 °C; and / or wherein the preferably gel-like crosslinking product has a gel strength of at most 4.5 N, in particular at most 3.5 N, preferably at most 2.5 N, at a temperature of 20 °C; and / or wherein the preferably gel-like crosslinking product has a gel strength in the range from 0.6 N to 4.5 N, in particular in the range from 0.8 N to 3.5 N, preferably in the range from 1.0 N to 2.5 N, at a temperature of 20 °C, in particular wherein the gel strength is determined using methods known to those skilled in the art, in particular based on DIN 51810-1.

10. Kit according to one of the preceding claims, wherein the preferably gel-shaped crosslinking product has a modulus of elasticity G' of at least 500 Pa, in particular at least 750 Pa, preferably at least 1,000 Pa; and / or wherein the preferably gel-shaped crosslinking product has a modulus of elasticity G' of at most 9,000 Pa, in particular at most 5,000 Pa, preferably at most 3,000 Pa; and / or wherein the preferably gel-shaped crosslinking product has a modulus of elasticity G' in the range from 500 Pa to 9,000 Pa, in particular in the range from 750 Pa to 5,000 Pa, preferably in the range from 1,000 Pa to 3,000 Pa, in particular wherein the determination of the modulus of elasticity G' is carried out using methods known to the person skilled in the art, in particular based on DIN 51810-1.

11. Kit according to one of the preceding claims, wherein the preferably gel-shaped crosslinking product has a loss modulus G" of at least 50 Pa, in particular at least 100 Pa, preferably at least 125 Pa; and / or wherein the preferably gel-shaped crosslinking product has a loss modulus G" of at most 350 Pa, in particular at most 300 Pa, preferably at most 250 Pa; and / or wherein the preferably gel-shaped crosslinking product has a loss modulus G" in the range from 50 Pa to 350 Pa, in particular in the range from 100 Pa to 300 Pa, preferably in the range from 250 Pa to 300 Pa, in particular, the loss modulus G" is determined using methods known to those skilled in the art, in particular based on DIN 51810-1.

12. Kit according to one of the preceding claims, wherein the first component (A) is in the form of an aqueous solution and / or aqueous dispersion, in particular aqueous dispersion, preferably in the form of a hydrosol, in particular wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a hydrogel, polymer.

13. Kit according to one of the preceding claims, wherein the first component (A), in particular the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer, is produced by dispersing the crosslinkable polymer, in particular in powder form, in at least one dispersing agent, preferably water, under fluidizing conditions, in particular using a cyclone mixing device, in particular wherein the dispersion is carried out over a period of time in the range from 15 min to 120 min, in particular in the range from 40 min to 90 min, preferably in the range from 50 min to 70 min and at a mixing speed in the range from 30 rpm to 500 rpm (revolutions per minute), in particular in the range from 45 rpm to 250 rpm, preferably in the range from 55 rpm to 125 rpm,is carried out; and / or in particular wherein the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer is produced by the introduction of shear forces under vortex conditions, in particular in the cyclone mixing device, preferably by means of s / Yu swelling;, preferably wherein in the production of the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer, no separate swelling and / or no separate swelling of the polymer is required and / or carried out.

14. Kit according to one of the preceding claims, wherein the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in amounts of at least 0.25 wt.%, in particular at least 0.35 wt.%, preferably at least 0.5 wt.%, based on the total composition of the first component (A); and / or wherein the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably to form a gel, in particular hydrogel, polymer in amounts of at most 5 wt.%, in particular at most 2.5 wt.%, preferably at most 1.8 wt.%, based on the total composition of the first component (A); and / or wherein the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably to form a gel, in particular hydrogel, polymer in amounts in the range from 0.25 wt.% to 5 wt.-%, in particular in the range from 0.35 wt.% to 2.5 wt.%, preferably in the range from 0.5 wt.% to 1.8 wt.%, based on the total composition of the first component (A).

15. Kit according to one of the preceding claims, wherein the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in concentrations of at least 0.005 mmol / L, in particular at least 0.01 mmol / L, preferably at least 0.03 mmol / L, based on the total composition of the first component (A); and / or wherein the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in concentrations of at most 1.0 mmol / L, in particular at most 0.5 mmol / L, preferably at most 0.25 mmol / L, based on the total composition of the first component (A); and / or wherein the first component (A) comprises the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer in concentrations in the range from 0.005 mmol / L to 1.0 mmol / L, in particular in the range from 0.01 mmol / L to 0.5 mmol / L, preferably in the range from 0.03 mmol / L to 0.25 mmol / L, based on the total composition of the first component (A).

16. Kit according to one of the preceding claims, wherein the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer comprises, in particular is and / or consists of alginic acid and / or its salts (alginates) and / or esters, preferably alginates, particularly preferably sodium alginate.

17. Kit according to one of the preceding claims, wherein the first component (A) additionally comprises: one or more salts, in particular physiologically acceptable alkali salts, preferably sodium chloride; one or more buffers, in particular neutral buffers, preferably phosphate buffers; in particular wherein the salt and buffer are combined to form an isotonic, physiologically acceptable saline solution, preferably in the form of a PBS buffer; in particular wherein the first component (A) comprises salt and buffer in amounts in the range of 0.05 wt% to 5 wt%, in particular in the range of 0.15 wt% to 2.5 wt%, preferably in the range of 0.3 wt% to 1.5 wt%, based on the total composition of the first component (A).

18. Kit according to one of the preceding claims, wherein the first component (A) additionally comprises: a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe, preferably dextran blue; in particular wherein the first component (A) comprises the dye in amounts in the range from 0.05 wt% to 3 wt%, in particular in the range from 0.10 wt% to 1.5 wt%, preferably in the range from 0.25 wt% to 0.75 wt%, based on the total composition of the first component (A).

19. Kit according to one of the preceding claims, wherein the second component (B) is in the form of an aqueous solution and / or aqueous dispersion, in particular an aqueous solution, in particular wherein the second component (B) comprises at least one crosslinking agent in the form of a salt, in particular a crosslinking agent initiating and / or effecting ionic crosslinking in the form of a salt.

20. Kit according to one of the preceding claims, wherein the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or effecting ionic crosslinking, in particular in the form of a salt, in amounts of at least 0.35 wt.%, in particular at least 0.85 wt.%, preferably at least 1.25 wt.%, based on the total composition of the second component (B); and / or wherein the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or causing ionic crosslinking, in particular in the form of a salt, in amounts of at most 4.5 wt.%, in particular at most 3.0 wt.%, preferably at most 2.25 wt.%, based on the total composition of the second component (B); and / or wherein the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or causing ionic crosslinking, in particular in the form of a salt, in amounts in the range from 0.35 wt.% to 4.5 wt.%, in particular in the range from 0.75 wt.% to 3.0 wt.%, preferably in the range from 1.25 wt.% to 2.25 wt.%, based on the total composition of the second component (B).

21. Kit according to one of the preceding claims, wherein the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or causing ionic crosslinking, in particular in the form of a salt, in concentrations of at least 0.01 mol / L, in particular at least 0.1 mol / L, preferably at least 0.15 mol / L, based on the total composition of the second component (B); and / or wherein the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or causing ionic crosslinking, in particular in the form of a salt, in concentrations of at most 1.0 mol / L, in particular at most 0.5 mol / L, preferably at most 0.25 mol / L, based on the total composition of the second component (B);and / or wherein the second component (B) comprises the crosslinking agent, in particular in the form of a salt, in particular a crosslinking agent initiating and / or causing ionic crosslinking, in particular in the form of a salt, in concentrations in the range from 0.01 mmol / L to 1.0 mol / L, in particular in the range from 0.1 mol / L to 0.5 mol / L, preferably in the range from 0.15 mol / L to 0.25 mol / L, based on the total composition of the second component (B); 22. Kit according to one of the preceding claims, wherein the crosslinking agent comprises divalent cations, in particular selected from the group of alkaline earth metals, preferably calcium ions and / or magnesium ions, preferably calcium ions, in particular in the form of a physiologically acceptable salt, in particular a halogen salt, preferably calcium chloride.

23. Kit according to one of the preceding claims, wherein the second component (B) additionally comprises: one or more salts, in particular physiologically acceptable alkali salts, preferably sodium chloride; in particular wherein the second component (B) comprises the salt in amounts in the range from 0.05 wt% to 2.5 wt%, in particular in the range from 0.10 wt% to 1.5 wt%, preferably in the range from 0.25 wt% to 1.0 wt%, based on the total composition of the second component (B).

24. Kit according to one of the preceding claims, wherein the second component (B) additionally comprises: a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe, preferably riboflavin; in particular wherein the second component (B) comprises the dye in amounts in the range from 0.0005 wt.% to 0.1 wt.%, in particular in the range from 0.001 wt.% to 0.01 wt.%, preferably in the range from 0.0015 wt.% to 0.005 wt.%, based on the total composition of the second component (B).

25. Kit according to one of the preceding claims, wherein the first component (A) comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe, and wherein the second component (B) comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe, in particular such that the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different in color, preferably wherein the first component (A) has a blue color and wherein the second component (B) has a yellow color.

26. Kit according to one of the preceding claims, wherein the preferably gel-shaped crosslinking product also has a coloration and / or coloring, in particular based on the dye of the first component (A) and / or based on the dye of the second component (B), in particular wherein the preferably gel-shaped crosslinking product has the coloration of the first component (A) and / or the second component (B), preferably the first component (A), preferably a blue coloration.

27. Kit according to one of the preceding claims, wherein the first component (A) in the first plastic syringe has a smaller volume compared to component (B) in the second plastic syringe, in particular wherein the first component (A) and the second component (B) are present in a volume ratio of component (A) to component (B) in the range from 1:1.25 to 1:10, in particular in the range from 1:1.5 to 1:7.5, preferably in the range from 1:1.75 to 1:4.

5.

28. Kit according to one of the preceding claims, wherein the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer of the first component (A), is present in a lower concentration than the second component (B), in particular the crosslinking agent, in particular the crosslinking agent initiating and / or effecting ionic crosslinking, of the second component (B), in particular wherein the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer of the first component (A), and the second component (B), in particular the crosslinking agent, in particular the crosslinking agent initiating and / or effecting ionic crosslinking, of the second component (B), are present in a concentration ratio in the range from 1:1,000 to 1:5,000, in particular in the range from 1:2,500 to 1:4,500, preferably in the range from 1:3,250 to 1:4,000.

29. Kit according to one of the preceding claims, wherein the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer of the first component (A), is present in a smaller molar (total) amount compared to component (B), in particular the crosslinking agent, in particular the crosslinking agent initiating and / or effecting ionic crosslinking, of the second component (B), based on the components (A) and (B) brought into contact and / or interacting with one another, preferably mixed, in particular wherein the first component (A), in particular the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer of the first component (A), and the second component (B), in particular the crosslinking agent,in particular the crosslinking agent initiating and / or causing ionic crosslinking of the second component (B), based on the components (A) and (B) brought into contact and / or interacting with one another, preferably mixed, is present in a molar (total J) ratio in the range from 1:2,000 to 1:10,000, in particular in the range from 1:5,000 to 1:9,000, preferably in the range from 1:6,500 to 1:8,000.

30. Kit according to one of the preceding claims, wherein the formation of the preferably gel-like crosslinking product, in particular the preferably gel-like crosslinked polymer structure, in particular the gel, from the first component (A) and the second component (B) by means of ionic coordination, in particular ionic Crosslinking of the first component (A) by the second component (B), in particular wherein the crosslinking takes place in a period of less than 4 minutes, in particular less than 3.5 minutes, preferably less than 3 minutes, more preferably less than 2 minutes, more preferably less than 1 minute.

31. Kit according to one of the preceding claims, wherein the syringe plunger of the first plastic syringe is also formed from at least one polyolefin, preferably polypropylene; and / or wherein the syringe body of the first plastic syringe, in particular the syringe barrel, and the syringe plunger are formed from at least one polyolefin, preferably polypropylene.

32. Kit according to one of the preceding claims, wherein the syringe plunger of the second plastic syringe is also formed from at least one polyolefin, preferably polypropylene; and / or wherein the syringe body of the second plastic syringe, in particular the syringe barrel, and the syringe plunger are formed from at least one polyolefin, preferably polypropylene.

33. Kit according to one of the preceding claims, wherein the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe and / or the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the second plastic syringe, preferably the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe, is colored and / or has a coloration, in particular a dye, preferably a physiologically inert dye and / or a dye that is resistant to migration into the first component (A) and / or the second component (B); in particular wherein the coloring and / or coloration, in particular the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (A) and / or the second component (B), of the syringe body, in particular the syringe barrel and / or the syringe plunger, preferably the syringe plunger, the first plastic syringe and / or the second plastic syringe, preferably the first plastic syringe, corresponds to the dye color of the dye and / or the coloring of the first component (A) and / or the second component (B), in particular the first component (A), and / or corresponds thereto, in particular matches it.

34. Kit according to one of the preceding claims, wherein the syringe plunger of the first plastic syringe is also formed from at least one polyolefin, preferably polypropylene, and wherein the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (A);in particular wherein the coloring and / or coloration, in particular of the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (A), of the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe corresponds to the dye color of the dye and / or coloring of the first component (A) and / or corresponds thereto, in particular matches it.; 35. Kit according to one of the preceding claims, wherein the syringe plunger of the second plastic syringe is also formed from at least one polyolefin, preferably polypropylene, and wherein the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the second plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (B); in particular wherein the coloring and / or coloration, in particular of the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (B), of the syringe body, in particular syringe cylinder, and / or syringe plunger, preferably syringe plunger, of the second plastic syringe corresponds to the dye color of the dye and / or coloring of the first component (B) and / or corresponds thereto, in particular matches it.

36. Kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, in particular according to one of the preceding claims, wherein the kit comprises: b) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe cylinder, and a syringe piston, wherein the syringe body, in particular a syringe cylinder, and / or the syringe piston are formed from at least one polyolefin, preferably polypropylene, and wherein the syringe body,in particular syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (A), and wherein the first plastic syringe contains a first component (A) in the form of a solution and / or dispersion, in particular dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, polymer, preferably crosslinkable to form a gel, in particular hydrogel, and wherein the first component (A) additionally comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe; b) a second, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic plunger syringe, wherein the second plastic syringe comprises a syringe body, in particular a syringe barrel, and a syringe plunger, wherein the syringe body, in particular the syringe barrel, and / or the syringe plunger are formed from at least one polyolefin, preferably polypropylene, and, optionally, wherein the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger,the second plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the second component (B), and wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) has at least one crosslinking agent, in particular a crosslinking agent initiating and / or effecting ionic crosslinking, and wherein the second component (B) has a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe; in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after contacting and / or interacting the components (A) and (B), a preferably gel-like crosslinking product,in particular a preferably gel-like cross-linked polymer structure, in particular a gel, is formed, and, wherein the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the first component (A) and the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the second component (B) are selected such that the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different from one another in terms of color; and / or, preferably and, wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different from one another in terms of color.

37. Kit (kit of parts and / or set), in particular for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, in particular according to one of the preceding claims, wherein the kit comprises: b) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein the syringe body, in particular a syringe barrel, and the syringe piston are formed from at least one polyolefin, preferably polypropylene, and wherein the syringe body, in particular a syringe barrel,and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the first component (A), and, wherein the first plastic syringe contains a first component (A) in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, polymer that can be crosslinked preferably to form a gel, in particular a hydrogel, in particular wherein the crosslinkable, in particular ionically crosslinkable, polymer that can be crosslinked preferably to form a gel, in particular a hydrogel, comprises, in particular is and / or consists of alginic acid and / or its salts (alginates) and / or esters, preferably alginates, particularly preferably sodium alginate; and wherein the first component (A) additionally comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe; b) a second, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe,preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a syringe body, in particular a syringe cylinder, and a syringe piston, wherein the syringe body, in particular a syringe cylinder, and the syringe piston are formed from at least one polyolefin, preferably polypropylene, and, optionally, wherein the syringe body, in particular a syringe cylinder, and / or the syringe piston, preferably the syringe piston, of the second plastic syringe is colored and / or has a coloring, in particular a dye, preferably a physiologically inert and / or migration-resistant dye into the second component (B), and wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) contains at least one crosslinking agent, in particular a crosslinking agent initiating and / or causing ionic crosslinking,has, in particular wherein the crosslinking agent comprises divalent cations, in particular from the group of alkaline earth metals, preferably calcium ions and / or magnesium ions, preferably calcium ions, in particular in the form of a physiologically acceptable salt, in particular halogen salt, preferably calcium chloride, and wherein the second component (B) comprises a dye, in particular a physiologically inert and / or migration-resistant dye in the plastic syringe;in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after bringing into contact and / or interaction of the components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed, and wherein the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the first component (A) and the dye, in particular the physiologically inert and / or migration-resistant dye in the plastic syringe, of the second component (B) are selected such that the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different from one another in terms of color;and / or, preferably and, wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different in color, in particular wherein the coloring and / or coloring, in particular the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (A), of the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the first plastic syringe corresponds to the dye color of the dye and / or coloring of the first component (A) and / or corresponds thereto, in particular matches it, and / or; optionally in particular wherein the coloring and / or coloration, in particular the dye, preferably the physiologically inert and / or migration-resistant dye into the first component (B), of the syringe body, in particular the syringe barrel, and / or the syringe plunger, preferably the syringe plunger, of the second plastic syringe corresponds to the dye color of the dye and / or coloring of the first component (B) and / or corresponds thereto, in particular matches it.

38. Kit according to one of the preceding claims, wherein the syringe body of the first plastic syringe and / or the second plastic syringe, in particular of the first plastic syringe and the second plastic syringe, has an oleophobic and / or hydrophobic coating, in particular a hydrophobic coating, preferably in the form of a siliconization or silicate coating, preferably obtained by means of a silicon-containing, in particular silicone- or silicate-based agent, preferably silicone oil or silicate, inside the syringe body.

39. Kit according to one of the preceding claims, wherein the first plastic syringe and / or the second plastic syringe, in particular the first plastic syringe and the second plastic syringe, preferably their syringe body, has a volume, in particular a receiving volume for the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), in the range from 1 mL to 100 mL, in particular in the range from 2 mL to 50 mL, preferably in the range from 3 mL to 25 mL, preferably in the range from 4 mL to 25 mL, particularly preferably in the range from 6 mL to 20 mL, further preferably in the range from 8 mL to 15 mL, even more preferably in the range from 9 mL to 12 mL, most preferably of about 10 mL;in particular wherein the first plastic syringe, in particular its syringe body, contains the first component (A) in an amount in the range from 2.5 mL to 15 mL, in particular in the range from 3.5 mL to 10 mL, preferably in the range from 4 mL to 7.5 mL; and / or; in particular wherein the second plastic syringe, in particular its syringe body, contains the second component (B) in an amount in the range from 5 mL to 25 mL, in particular in the range from 7.5 mL to 15 mL, preferably in the range from 9 mL to 12.5 mL; and / or wherein the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringe has an outlet opening, in particular provided at the end and / or front, in particular in an outlet region, in particular for dispensing and / or applying component (A) and / or component (B);and / or wherein the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringe has a preferably blunt tip having the outlet opening, in particular intended for the arrangement of an application device, in particular a cannula, an endoscope, in particular the (working) channel of an endoscope, or a catheter, preferably a catheter tube; and / or wherein a handle section, in particular designed for finger support, is arranged on the syringe body, in particular on the syringe barrel, of the first plastic syringe and / or the second plastic syringe, in particular wherein the handle section has in particular laterally projecting, preferably opposite, handle section regions, and / or in particular wherein the handle section is arranged on the end of the syringe body, in particular the syringe barrel, opposite the outlet opening, in particular on the front end;and / or wherein the syringe body, in particular the syringe cylinder, of the first plastic syringe and / or the second plastic syringe has a receiving and / or filling opening, in particular for filling the syringe body(s), in particular the syringe cylinder, with the component (A) and / or the component (B) and / or in particular for preferably sealingly receiving the syringe piston with the piston stopper and / or in particular wherein the receiving and / or filling opening is closable with the syringe piston, in particular with the piston stopper, and / or is designed to be closable and / or is closed; in particular wherein the receiving and / or filling opening is arranged at the end of the syringe body opposite the outlet opening, in particular at the front end; and / or wherein a piston stopper is arranged, in particular in a form-fitting and / or friction-fitting manner, on the syringe plunger of the first plastic syringe and / or the second plastic syringe, in particular wherein the piston stopper is arranged at the end of the syringe plunger facing the outlet opening, preferably at the front end, and / or in particular wherein the syringe plunger has a, preferably circumferential, piston collar for abutting against and / or arranging the piston stopper; and / or wherein the syringe plunger of the first plastic syringe and / or the second plastic syringe has a piston head at the end opposite the outlet opening, in particular at the front end.

40. Kit according to one of the preceding claims, wherein the first plastic syringe and the second plastic syringe are in particular at least substantially structurally identical and / or have the same structural features.

41. Kit according to one of the preceding claims, wherein the first plastic syringe contains and / or is filled with a first volume of component (A) and the second plastic syringe contains and / or is filled with a second volume of component (B), in particular wherein the first volume of component (A) and the second volume of component (B) differ from one another, preferably wherein the first volume of component (A) is smaller than the second volume of component (B); and / or preferably wherein the lengths of the syringe plungers of the first plastic syringe and the second plastic syringe protruding from the syringe body, in particular the syringe barrel, differ from one another in the filled state, in particular complementary to the difference between the first volume of component (A) and the second volume of component (B). Preferably, the length of the syringe plunger of the first plastic syringe projecting relative to the syringe body, in particular the syringe cylinder, in the filled state is shorter than the length of the syringe plunger of the second plastic syringe projecting relative to the syringe body, in particular the syringe cylinder, in the filled state.

42. Kit according to one of the preceding claims, wherein the plunger plug is formed from an elastomeric material, in particular from a rubber material and / or rubber material, preferably rubber material; and / or wherein the plunger plug is formed from and / or consists of a halobutyl rubber, in particular from a chlorobutyl rubber or from a bromobutyl rubber, preferably from a bromobutyl rubber.

43. Kit according to one of the preceding claims, wherein the plunger stopper has at least one, in particular two, preferably three, circumferential collars, in particular wherein a first collar is designed such that the syringe body, in particular the syringe barrel, is secured against the component (A) and / or component (B) escaping from the syringe body, in particular the syringe barrel, and / or that the first collar is designed to seal the component (A) and / or component (B) against the receiving and / or filling opening; and / or in particular wherein at least one second collar, preferably spaced from the first collar, forms a further sealing space between the first and second collars; and / or in particular wherein a third collar, preferably spaced from the first and / or second collar, is designed to abut against the plunger collar.

44. Kit according to one of the preceding claims, wherein the syringe body, preferably the syringe cylinder, has a stop, in particular a circumferential stop, on the inside in the region of the receiving and / or filling opening and / or in the end region of the syringe body, in particular the syringe cylinder, in particular opposite the outlet region, in particular wherein the stop is designed such that the syringe piston and / or the piston stopper is, in particular at least substantially, secured against moving out, in particular being pulled out, from the syringe body, in particular the syringe cylinder, beyond the stop, and / or wherein the stop is designed for, in particular sealing, abutment of the piston stopper and / or the syringe piston against the stop; and / or in particular wherein the stop is designed in the form of a, in particular bevelled projection and / or a bevelled step;and / or in particular wherein the stop is designed as a stop edge for the piston collar and / or at least one collar of the piston plug; 45. Kit according to one of the preceding claims, wherein the plunger stopper has a displacement means in a front end region of the syringe body, in particular the syringe barrel, facing the outlet region, in particular wherein the displacement means is conical, preferably convex; and / or in particular wherein the first collar of the plunger stopper adjoins the displacement means.

46. Kit according to one of the preceding claims, wherein the outlet region has a tapered section, in particular a conical and / or truncated cone, for forming the tip; preferably wherein the tapered section is designed to abut the displacement means of the piston plug; and / or Preferably, the tapered portion and the displacement means of the piston plug are designed to be complementary to one another.

47. Kit according to one of the preceding claims, wherein a particularly removable and / or detachable closure element, in particular a closure cap (closure and / or sealing cap), preferably for sealingly closing the outlet opening, is placed and / or plugged onto the outlet opening and / or the tip; preferably wherein the closure element at least substantially completely and / or sealingly encloses and / or covers the outlet opening, in particular at least substantially over the entire outlet opening; and / or preferably wherein the closure element is cap-shaped and / or hat-shaped; and / or preferably wherein the closure element is formed from an elastomeric material, in particular from a rubber material and / or caoutchouc material;and / or preferably wherein the closure element is formed from a halobutyl rubber, in particular from a chlorobutyl rubber or from a bromobutyl rubber, preferably from a bromobutyl rubber; and / or preferably wherein the closure element has a detaching and / or removal device, in particular a pulling device, preferably in the form of a particularly nipple-shaped extension and / or preferably for in particular manually detaching, in particular pulling, the closure element from the outlet opening; preferably wherein the detaching and / or removal device is arranged on and / or in the region of the closed end and / or at the tip of the closure element and / or in the extension of the longitudinal axis of the closure element; and / or; Preferably, the closure element has at least one recess, in particular a notch, indentation and / or material taper, on its outer side, in particular the recess is designed to be longitudinal and / or linear and / or straight, and / or in particular the recess is arranged to run at least substantially in the longitudinal direction and / or at least substantially parallel to the longitudinal axis of the closure element; and / or Preferably, the closure element has two, three, four, five or more, in particular two, three or four, preferably four, recesses, in particular the recesses are arranged to run at least substantially equidistant from one another and / or at least substantially parallel to one another on the outer side of the closure element.

48. Kit according to one of the preceding claims, wherein the first plastic syringe and / or the second plastic syringe, in particular the first plastic syringe and the second plastic syringe, is (are) introduced into (each) an outer packaging which is in particular sealed in a water-tight and / or germ-tight manner and / or has (have) an outer packaging which is in particular sealed in a water-tight and / or germ-tight manner, in particular wherein the outer packaging which is in particular sealed in a water-tight and / or germ-tight manner has a plastic section, preferably deep-drawn and / or format-stamped and / or embossed, and a sealing section which is at least permeable to water vapor, in particular permeable to water vapor and / or gas;and / or in particular wherein the plastic section has a receiving area, in particular open and closed on the underside by the plastic section, for arranging the first plastic syringe filled with the component (A) and / or the second plastic syringe filled with the component (B); 49. Kit according to one of the preceding claims, wherein the receiving area for arranging the first plastic syringe filled with the component (A) and / or the second plastic syringe filled with the component (B) is designed such that the first plastic plastic syringe and / or the second plastic syringe is (are) in particular at least substantially completely recessed; and / or wherein the receiving area is designed to be at least substantially complementary to the outer shape of the first plastic syringe and / or the second plastic syringe; and / or wherein the receiving area has a first partial section for at least partially receiving the syringe body, in particular the syringe barrel, of the first plastic syringe and / or the second plastic syringes and a second partial section for receiving the section of the syringe plunger of the first plastic syringe and / or the second plastic syringes that protrudes from the syringe body, in particular wherein the second partial section is also designed to receive the handle section arranged on the syringe body, in particular the syringe barrel;and / or in particular wherein at least one, preferably two, step(s) is / are provided between the first sub-section and the second sub-section for stopping the handle section, in particular so that the first sub-section of the receiving area has a smaller, in particular maximum, width than the second sub-section of the receiving area; and / or in particular wherein a first stop wall is provided on the front side of the first sub-section for stopping the closure element, preferably wherein a play is provided between the first stop wall and the closure element in the packaged state, in particular in the range from 0.1 mm to 30 mm, in particular in the range from 1.0 mm to 20 mm, preferably in a range from 1.5 mm to 15 mm;and / or in particular wherein a second stop wall is provided on the end face of the second partial section for stopping the piston head, preferably wherein a play is provided between the second stop wall and the piston head in the packaged state, in particular in the range from 0.1 mm to 30 mm, in particular in the range from 1.0 mm to 20 mm, preferably in a range from 1.5 mm to 15 mm; 50. Kit according to one of the preceding claims, wherein the outer packaging, in particular the outer packaging which is sealed in a water-tight and / or germ-tight manner, in particular the preferably deep-drawn and / or format-stamped and / or embossed plastic section, has at least one, preferably two side walls in the second partial section of the receiving area, preferably for connecting the front ends of the second partial section, in particular wherein at least one, preferably both, side wall(s) has / have at least in some regions a sliding section for, in particular, at least substantially play-free and / or direct abutment of the handle section, in particular of a handle section area; and / or in particular wherein the sliding section is provided for the positionally stable arrangement, preferably in exactly one position, of the first plastic syringe and / or the second plastic syringe in the packaged state in the outer packaging;and / or in particular wherein the sliding section secures the first plastic syringe and / or the second plastic syringe in the packaged state in the outer packaging against rotation, in particular in the direction of rotation from the top side of the plastic section facing the sealing section to the opposite bottom side of the plastic section facing away from the sealing section and / or in the direction of rotation from the opposite bottom side of the plastic section facing away from the sealing section to the top side of the plastic section facing the sealing section; and / or in particular wherein the sliding section extends at least over the length of the maximum play of the first plastic syringe and / or the second plastic syringe in the packaged state in the outer packaging in the second subsection.; 51. Kit according to one of the preceding claims, wherein the plastic portion of the outer packaging for the first plastic syringe is designed differently from the plastic portion of the outer packaging for the second plastic syringe, in particular wherein the width of the first plastic section of the outer packaging of the first plastic syringe, which preferably extends transversely, in particular orthogonally, to the longitudinal direction of the first plastic syringe, in particular also with respect to the receiving section of the outer packaging, is at least substantially equal to the width of the second plastic section of the outer packaging of the second plastic syringe, which preferably extends transversely, in particular orthogonally, to the longitudinal direction of the second plastic syringe, in particular also with respect to the receiving section of the outer packaging;and / or in particular wherein the, in particular maximum, height of the first plastic section of the outer packaging of the first plastic syringe, in particular also with respect to the receiving section of the outer packaging, is at least substantially equal to the, in particular maximum, height of the second plastic section of the outer packaging of the second plastic syringe, in particular also with respect to the receiving section of the outer packaging; and / or in particular wherein the sealing section of the outer packaging of the first plastic syringe, with respect to its dimensions, is at least substantially equal and / or identical to the sealing section of the outer packaging of the second plastic syringe;and / or in particular wherein the length of the first plastic section of the outer packaging of the first plastic syringe, which length preferably extends in the longitudinal direction of the first plastic syringe, is at least substantially the same size as the length of the second plastic section of the outer packaging of the second plastic syringe, which length preferably extends in the longitudinal direction of the second plastic syringe, preferably wherein the length of the receiving region of the first plastic section, which length preferably extends in the longitudinal direction of the first plastic syringe, is shorter than the length of the second receiving region of the plastic section, which length preferably extends in the longitudinal direction of the second plastic syringe, preferably in the event that the first volume of component (A) and the second volume of component (B) differ from one another, in particular that the first volume of component (A) is smaller than the second volume of component (B);and / or preferably in the event that; the lengths of the syringe plungers of the first plastic syringe and the second plastic syringe protruding from the syringe body, in particular the syringe cylinder, differ from one another in the filled state; in particular, the length of the syringe plunger of the first plastic syringe protruding from the syringe body, in particular the syringe cylinder, in the filled state is shorter than the length of the syringe plunger of the second plastic syringe protruding from the syringe body, in particular the syringe cylinder, in the filled state; further preferably, the first plastic section of the outer packaging of the first plastic syringe in this case has an extension section protruding and / or projecting from the second subsection of the receiving area; and / or further preferably, the second subsection of the receiving area and the extension section are separated from one another by the second stop wall;and / or further preferably wherein the extension section forms a recess in the first plastic section, wherein preferably the, in particular maximum, height of the extension section is less than the, in particular maximum, height of the second partial section; 52. Kit according to one of the preceding claims, wherein the outer packaging, in particular sealed in a water-tight and / or germ-tight manner, is tear-resistant and / or waterproof and / or temperature-resistant, in particular up to 140°C; and / or wherein the outer packaging, in particular sealed in a water-tight and / or germ-tight manner, preferably the deep-drawn and / or format-stamped and / or embossed plastic section, comprises, in particular consists of, a polyolefin, in particular polypropylene; and / or wherein the outer packaging, in particular sealed in a water-tight and / or germ-tight manner, preferably the at least water vapor-permeable, in particular water vapor- and / or gas-permeable, sealing section, comprises, in particular consists of, a paper, in particular an uncoated medical paper; and / or in particular wherein the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, preferably the at least water vapor-permeable, in particular water vapor and / or gas-permeable, sealing section, has an indicator, in particular a sterile indicator.

53. Kit according to one of the preceding claims, wherein the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B), in particular the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B), is (are) heat-sterilised, in particular steam-sterilised, preferably steam-sterilised, preferably terminally (heat-, steam-, steam-)sterilised;and / or wherein the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B), in particular the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B), is (are) heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized, with an F0 value in the range from 6 min to 45 min, in particular in the range from 8 min to 40 min, preferably in the range from 10 min to 38 min, more preferably in the range from 11 min to 35 min, particularly preferably in the range from 15 min to 32 min, very particularly preferably in the range from 19 min to 30 min;and / or wherein the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B), in particular the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B), under over / / / conditions and / or at about 121 °C and / or for a period of at least 6 min, preferably of about 6 min, or of at least; 20 min, preferably of about 20 min, heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized; and / or wherein the first component (A) and / or the second component (B), in particular the first component (A) and the second component (B), and / or the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B), in particular the first plastic syringe containing the first component (A) and the second plastic syringe containing the second component (B), according to Pharmacopoea Europaea (Ph. Eur.), Chapter 5.1.1 (07 / 2017:50101), in particular under over / / / conditions and / or at about 121 °C and / or for a period of at least 15 min, in particular of at least 20 min, preferably of about 20 min, heat sterilized, in particular steam sterilized, preferably steam sterilized, preferably terminally (heat, steam, steam) sterilized.

54. Kit according to claim 53, wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out under temperature exposure (heating); and / or wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out at temperatures of at least 105°C, in particular at least 110°C, preferably at least 115°C, preferably at least 120°C; and / or wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out at temperatures of at most 160°C, in particular at most 150°C, preferably at most 140°C, preferably at most 130°C;and / or wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, at temperatures in the range from 105 °C to 160 °C, in particular in the range from 110 °C to 150 °C, preferably in the range of; 115 °C to 140 °C, preferably in the range of 120 °C to 130 °C, particularly preferably at about 121 °C.

55. Kit according to claim 53 or 54, wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out for a (total) period of at least 1 minute, in particular of at least 2 minutes, preferably of at least 3 minutes, preferably of at least 4 minutes, particularly preferably of at least 5 minutes, very particularly preferably of at least 6 minutes; and / or wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out for a (total) period of at most 600 minutes, in particular of at most 500 minutes, preferably of at most 400 minutes, preferably of at most 350 minutes, particularly preferably of at most 300 minutes, very particularly preferably of at most 250 minutes;and / or wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out for a (total) period in the range from 1 min to 600 min, in particular in the range from 2 min to 500 min, preferably in the range from 3 min to 400 min, preferably in the range from 4 min to 350 min, particularly preferably in the range from 5 min to 300 min, very particularly preferably in the range from 6 min to 240 min; 56. Kit according to one of claims 53 to 55, wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out under pressure.

57. Kit according to one of claims 53 to 56, wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, at a relative pressure in the range of 0.1 bar to 10 bar, in particular in the range of 0.5 bar to 5 bar, preferably in the range of 1 bar to 3.5 bar, preferably in the range from 1.1 bar to 3 bar; and / or wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out at an absolute pressure in the range from 1.1 bar to 10 bar, in particular in the range from 1.5 bar to 6 bar, preferably in the range from 2 bar to 4.5 bar.

58. Kit according to one of claims 53 to 57, wherein the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization, is carried out in the presence of an atmosphere containing, in particular, pure water vapor and / or as a saturated steam process; or wherein the steam sterilization is carried out in the presence of a water vapor / gas mixture, in particular a mixture of water vapor with inert gas, in particular nitrogen, and / or oxygen, preferably a water vapor / air mixture.

59. Kit according to one of claims 53 to 58, wherein the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization, is carried out in a preferably closed sterilization device, in particular in a gas-tight pressure vessel, preferably in an autoclaving device (autoclave); in particular wherein the sterilization atmosphere is generated by injecting water vapor and / or water vapor / compressed air mixtures, preferably water vapor / compressed air mixtures, into the sterilization device; and / or in particular wherein the sterilization atmosphere is generated by injecting already premixed water vapor / compressed air mixtures and / or by separate injections of water vapor and compressed air into the sterilization device.

60. Kit according to one of claims 53 to 59, wherein during heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, the steam is generated from distilled and / or demineralized water; and / or wherein during heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, the compressed air is generated from sterile air, in particular wherein the air is cleaned and / or sterilized by flowing through filters.

61. Kit according to one of claims 53 to 60, wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out under over / / / conditions and / or at about 121 °C and / or for a period of at least 6 min, preferably of about 6 min, or of at least 20 min, preferably of about 20 min; and / or wherein the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization, is carried out according to Pharmacopoea Europaea (Ph. Eur.), Chapter 5.1.1 (07 / 2017:50101), in particular under over / / / conditions and / or at about 121 °C and / or for a period of at least 15 min, in particular of at least 20 min, preferably of about 20 min.

62. Kit according to one of claims 53 to 61, wherein the heat sterilization, in particular steam sterilization, preferably water vapor sterilization, preferably terminal (heat, steam, water vapor) sterilization, is carried out in multiple cycles, in particular wherein at least the final and / or terminal cycle is carried out under at least one of the conditions defined in the preceding claims and / or in particular wherein at least the final and / or terminal cycle is carried out under over / / / conditions and / or at about 121 °C and / or for a period of at least 6 min, preferably of about 6 min, or of at least 20 min, preferably of about 20 min.

63. Kit according to one of claims 53 to 62, wherein the first plastic syringe and / or the second plastic syringe, in particular the first plastic syringe and the second plastic syringe, has been introduced into the outer packaging, which is in particular sealed in a water-tight and / or germ-tight manner, before carrying out the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, in particular wherein the outer packaging is sterilized in the same way when carrying out the steam sterilization.

64. Kit according to claim 63, wherein the first plastic syringe and / or second plastic syringe introduced into the outer packaging and sterilized in the outer packaging is dried and / or allowed to dry after carrying out the steam sterilization, in particular in the preferably closed sterilization device, in particular in the gas-tight pressure container, preferably in the autoclaving device (autoclave), preferably using a defined and predetermined drying process.

65. Kit according to one of claims 53 to 64, wherein a plurality of first plastic syringes filled with the first component (A) and / or second plastic syringes filled with the second component (B) are sterilized simultaneously, in particular wherein preferably during the steam sterilization several plastic syringes are brought together on a (syringe) carrier.

66. Kit according to one of claims 53 to 65, wherein the obtained sterile first component (A) and / or the obtained sterile second component (B), in particular the obtained sterile first component (A) and the obtained sterile second component (B), and / or the sterile first plastic syringe containing the first component (A) and obtained after completion of heat sterilization and / or the sterile second plastic syringe containing the second component (B) and obtained after completion of heat sterilization, in particular the sterile first plastic syringe containing the first component (A) and obtained after completion of heat sterilization and the sterile second plastic syringe containing the second component (B) obtained after completion of heat sterilization has a SAL value (Sterility Assurance Level) of at least 10" after completion of heat sterilization 5 , in particular at least 10" 6 , preferably at least 10" 7 , has.

67. Kit according to one of the preceding claims, wherein the first component (A) in the first plastic syringe and / or the second component (B) in the second plastic syringe is sterile, in particular wherein the first component (A) in the first plastic syringe and / or the second component (B) in the second plastic syringe is heat-sterilized, in particular steam-sterilized, preferably steam-sterilized, preferably terminally (heat-, steam-, steam-)sterilized, with an F0 value in the range of 6 min to 45 min, in particular in the range of 8 min to 40 min, preferably in the range of 10 min to 38 min, preferably in the range of 11 min to 35 min, particularly preferably in the range of 15 min to 32 min, very particularly preferably in the range of 19 min to 30 min, and / or has an SAL value (Sterility Assurance Level) of at least 10" 5 , in particular at least 10" 6 , preferably at least 10" 7, and / or wherein the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) is sterile, in particular wherein the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) has a SAL value (Sterility Assurance Level) of at least 10" 5 , in particular at least 10" 6 , preferably at least 10" 7, and / or wherein the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) present in an outer packaging is sterile, in particular wherein the first plastic syringe containing the first component (A) and / or the second plastic syringe containing the second component (B) present in an outer packaging has a SAL value (Sterility Assurance Level) of at least 10" 5 , in particular at least 10" 6 , preferably at least 10" 7 , has; in particular wherein the kit as a whole, preferably including any outer packaging, is sterile, in particular wherein the kit as a whole, preferably including any outer packaging, has a SAL value (Sterility Assurance Level) of at least 10" 5, in particular at least 10" 6 , preferably at least 10" 7 , has.

68. Kit (kit of parts and / or set) for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, in particular a kit according to one of the preceding claims, wherein the kit comprises: a) a first, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene,wherein the first plastic syringe contains a first component (A) in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol, wherein the first component (A) comprises at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer; b) a second, in particular ready-to-use, plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic plunger syringe, wherein the second plastic syringe comprises a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe contains a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) has at least one crosslinking agent, in particular a crosslinking agent that initiates and / or effects ionic crosslinking; in particular wherein the first component (A) and the second component (B) are selected and / or designed such that upon and / or after bringing into contact and / or interaction of the components (A) and (B), a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed; wherein the first component (A) and the second component (B) are optically and / or visually different from one another, in particular different from one another in terms of color;and / or, preferably and wherein the first plastic syringe and the second plastic syringe are optically and / or visually different from one another, in particular different in color; 69. Kit for use according to claim 68, wherein a patient having and / or suffering from a stone disease, in particular a patient having and / or suffering from particles and / or concretions in a lumen of the affected organ thereof, is administered an amount of the first components (A) and the second component (B) which is in each case effective for removing the particles and / or concretions, in particular a therapeutically effective amount, and / or is applied in each case into the lumen of the organ in question;and / or wherein the kit is employed and / or used for use in the treatment, in particular therapeutic treatment, of kidney, bladder, urinary and / or gallstones of the human body, preferably by removing particles and / or concretions from the lumen of the human organs in question, and / or for preferably therapeutic use in the removal of kidney, bladder, urinary and / or gallstones from the lumen of the human organs in question.; 70. Use of a kit according to any one of the preceding claims (for the manufacture of a medicament and / or pharmaceutical) for the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or (for the manufacture of a medicament and / or pharmaceutical) for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs.

71. Use according to claim 70, wherein a patient having and / or suffering from a stone disease, in particular a patient having and / or suffering from particles and / or concretions in a lumen of his affected organ, is administered an amount of the first components (A) and the second component (B) which is respectively effective for removing the particles and / or concretions, in particular a therapeutically effective amount, and / or is respectively applied into the lumen of the organ in question, and / or wherein the kit is used in the treatment, in particular therapeutic treatment, of kidney, bladder, urinary and / or gallstones of the human body, preferably by removing particles and / or concretions from the lumen of the human organs in question, and / or for preferably therapeutic use in the removal of kidney, bladder,urinary and / or gallstones from the lumen of the human organs concerned.

72. Kit for use according to claim 68 and 69 or use according to claim 70 and 71, wherein in the lumen of the organ containing the particles and / or concretions, the first component (A) and the second component (B) are brought into contact and / or interaction in such a way that a preferably gel-like crosslinking product, in particular a preferably gel-like crosslinked polymer structure, in particular a gel, is formed in the lumen of the organ, in particular wherein the particles and / or concretions are at least substantially completely enclosed by the preferably gel-like crosslinking product and / or by the preferably gel-like Crosslinking product is at least substantially completely absorbed, preferably so that the preferably gel-like crosslinking product is removed from the lumen of the organ together with the particles and / or concretions at least substantially completely enclosed and / or absorbed thereby.

73. Kit for use according to claim 68 and 69 or use according to claim 70 and 71, each according to claim 73, wherein the preferably gel-like crosslinking product together with the particles and / or concretions at least substantially completely enclosed thereby and / or taken up thereby is removed from the lumen of the organ by means of pulling and / or by means of depression, preferably by means of pulling.

74. A method for producing a kit, in particular a sterile kit, preferably according to one of the preceding claims, comprising the following steps: i) providing a first plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the first plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the first plastic syringe is filled with a first component (A) in the form of a solution and / or dispersion, in particular a dispersion, preferably in the form of a sol, wherein the first component (A) has at least one crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, polymer;in particular wherein the first plastic syringe filled with the first component (A) is introduced into a first outer packaging, in particular wherein the first outer packaging has a preferably deep-drawn and / or format-stamped plastic section and / or embossed, in particular for receiving the first plastic syringe, as well as a sealing section which is in particular permeable to water vapor, in particular wherein first the first, with the first; Component (A) filled, plastic syringe is introduced and / or inserted into the deep-drawn and / or format-stamped and / or embossed plastic section and then the deep-drawn and / or format-stamped and / or embossed plastic section provided with the first plastic syringe is sealed with the sealing section, in particular one which is permeable to water vapor;ii) Providing a second plastic syringe, in particular a disposable plastic syringe, preferably in the form of a plastic piston syringe, wherein the second plastic syringe has a syringe body, in particular a syringe barrel, and a syringe piston, wherein at least the syringe body, in particular the syringe barrel, is formed from at least one polyolefin, preferably polypropylene, wherein the second plastic syringe is filled with a second component (B) in the form of a solution and / or dispersion, in particular a solution, wherein the second component (B) has at least one crosslinking agent, in particular a crosslinking agent initiating and / or causing ionic crosslinking;in particular wherein the second plastic syringe filled with the first component (B) is introduced into a second outer packaging, in particular wherein the second outer packaging has a preferably deep-drawn and / or format-stamped and / or embossed plastic section, in particular for receiving the second plastic syringe, and a sealing section that is in particular permeable to water vapor, in particular wherein firstly the second plastic syringe filled with the second component (B) is introduced and / or inserted into the deep-drawn and / or format-stamped and / or embossed plastic section and then the deep-drawn and / or format-stamped and / or embossed plastic section provided with the second plastic syringe is closed with the sealing section that is in particular permeable to water vapor, and subsequently; iii) heat sterilization, in particular steam sterilization, of the first component (A) in the first plastic syringe, in particular in the repackaged first plastic syringe, and / or the first plastic syringe filled with the first component (A), in particular repackaged; and / or iv) heat sterilization of the second component (B) in the second plastic syringe, in particular in the repackaged second plastic syringe, and / or the second plastic syringe filled with the second component (B), in particular repackaged.

75. Method according to the preceding claim, wherein method steps i) and ii) are carried out spatially and / or temporally independently of one another; and / or wherein method steps iii) and iv) are carried out spatially and / or temporally independently of one another; and / or wherein method steps i) and iii) are carried out spatially and / or temporally dependent on one another, in particular sequentially; and / or wherein method steps ii) and iv) are carried out spatially and / or temporally dependent on one another, in particular sequentially;and / or wherein the method steps i) and iii) are carried out spatially and / or temporally independently of the method steps ii) and iv), in particular wherein the method steps i) and iii) are carried out spatially and / or temporally dependent on one another, in particular sequentially, and in particular wherein the method steps ii) and iv) are carried out spatially and / or temporally dependent on one another, in particular sequentially.; 76. Method according to one of the preceding claims, wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out under over / / / conditions and / or at about 121 °C and / or for a period of at least 6 min, preferably of about 6 min, or of at least 20 min, preferably of about 20 min; and / or wherein the heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal (heat, steam, steam) sterilization, is carried out according to Pharmacopoea Europaea (Ph. Eur.), Chapter 5.1.1 (07 / 2017:50101), in particular under over / / / conditions and / or at about 121 °C and / or for a period of at least 15 min, in particular of at least 20 min, preferably of about 20 min; and / or wherein the heat sterilization is carried out according to any one of claims 55 to 67.

77. Process according to one of the preceding claims, wherein the first component (A), in particular the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably crosslinkable to form a gel, in particular hydrogel, polymer is produced by dispersing the crosslinkable polymer, in particular in powder form, in at least one dispersing agent, preferably water, under fluidizing conditions, in particular using a cyclone mixing device, in particular wherein the dispersion is carried out over a period in the range from 15 min to 120 min, in particular in the range from 40 min to 90 min, preferably in the range from 50 min to 70 min and at a mixing speed in the range from 30 rpm to 500 rpm (revolutions per minute), in particular in the range from 45 rpm to 250 rpm, preferably in the range from 55 rpm to 125 rpm,is carried out; and / or in particular wherein the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably to form a gel, in particular hydrogel, polymer is produced by the introduction of shear forces under vortex conditions, in particular in the cyclone mixing device, preferably by means of s / Yu swelling; preferably wherein in the production of the aqueous solution and / or dispersion, in particular dispersion, preferably in the form of a sol, preferably a hydrosol, of the crosslinkable, in particular ionically crosslinkable, preferably to form a gel, in particular, Hydrogel, crosslinkable, polymer no separate swelling and / or no separate swelling of the polymer is required and / or carried out.

78. Kit (kit of parts and / or set), in particular sterile kit, preferably according to one of the relevant preceding claims, obtained and / or obtainable by a method according to one of claims 74 to 77.

79. Kit according to the preceding claim, characterized by one of the features of the kit according to any one of claims 1 to 69.

80. Kit (kit of parts and / or set), in particular a sterile kit, preferably according to one of the relevant preceding claims, for use in the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or in particular for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit is obtained and / or obtainable by a method according to one of claims 74 to 77.

81. Kit according to the preceding claim, characterized by one of the features of the kit according to any one of claims 1 to 69.

82. Use of a kit according to any one of the preceding claims (for the manufacture of a medicament and / or pharmaceutical) for the treatment, in particular therapeutic treatment, of stone diseases of the human body, preferably by removing particles and / or concretions from the lumen of human organs, and / or (for the manufacture of a medicament and / or pharmaceutical) for preferably therapeutic use in the removal of particles and / or concretions from the lumen of human organs, wherein the kit is obtained and / or obtainable by a method according to any one of claims 74 to 77.

83. Use according to the preceding claim, characterized by one of the features of the kit according to any one of claims 1 to 69.

84. Use of a plastic syringe comprising a syringe body, in particular a syringe barrel, and a syringe plunger, wherein at least the syringe body, in particular a syringe barrel, is formed from at least one polyolefin, preferably polypropylene, in a method according to one of claims 74 to 77 for producing a kit, in particular a sterile kit, preferably according to one of the relevant preceding claims.

85. Packaging unit containing at least one package and at least one kit, preferably a plurality of kits, according to one of the relevant preceding claims, wherein the kit, preferably the kits, is (are) introduced into the packaging unit and / or is (are) present in the packaging unit.

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