Medical device and medical kit, in particular for performing vacuum treatment in the body

Abstract

The invention relates to a medical device, in particular for vacuum treatment in vivo, preferably in a lumen and / or in a body cavity inside the body of a patient, comprising a first flexible tube having a proximal end portion and a distal end portion and a second flexible tube having a proximal end portion and a distal end portion, wherein the first flexible tube is adapted to insert an endoscope into a patient's body and the second flexible tube is adapted to insert a fluid drainage device, in particular a fluid drainage device at least partially or sectionally surrounded by a sheath, into the patient's body wherein the fluid drainage device is adapted to expel bodily fluid, and wherein the first flexible tube and the second flexible tube are longitudinally connected or contiguous with each other. Further, the invention relates to a medical kit, in particular for carrying out in vivo, preferably intraluminal and / or intraluminal vacuum treatment, comprising the medical device.

Description

Technical Field

[0001] The present invention relates to a medical device and a medical kit, in particular a medical device and a medical kit for performing in vivo, preferably intraluminal and / or intracavitary vacuum treatment. Background Art

[0002] In vivo vacuum therapy needs to reach the cavity to be treated (for example, in the esophagus or colon) with an endoscope, and deploy an exhaust device at an accurate position to improve the performance of vacuum therapy. Today, with the help of an endoscope, an overtube is placed in the cavity. Afterwards, the endoscope is removed, and the overtube is left in the patient's body, thereby providing a path from the outside to the internal area to be treated. In order to implement vacuum therapy, a fluid drainage device comprising a sponge is pushed through the overtube and will be placed in the patient's cavity, promoting the debridement of the cavity and the formation of granulation tissue. The exhaust device is configured to discharge the body fluid accumulated in the cavity. For this purpose, the fluid drainage device is typically connected to a negative pressure source outside the patient's body. The example of this type of vacuum therapy is known from EP 1572286 B1.

[0003] However, the vacuum therapy procedures described in the prior art face several limitations. First, the fluid drainage device must be implanted according to a vision-free deployment technique, as the presence of the endoscope is incompatible with the introduction of the drainage device. Therefore, a second introduction of the endoscope is required to check the correct placement of the fluid drainage device. Secondly, the semi-rigid nature of the outer cannula limits the movement of the distal part of the endoscope. As a result, difficult-to-access angled cavities cannot be reached, which limits the treatment of such cavities. In addition, the outer cannula may shift when the fluid drainage device is pushed through the outer cannula or when the endoscope is removed from the outer cannula. This situation poses a risk of damaging adjacent tissues or enlarging the orifice into the cavity. Another disadvantage of current delivery systems relates to the high friction generated between the sponge of the fluid drainage device and the inner side of the outer cannula, which leads to the use of large amounts of lubricants.

[0004] In view of the foregoing, addressing the limitations of current approaches represents an unmet need in the field of in vivo vacuum therapy. Summary of the Invention

[0005] The object of the present invention is to provide a medical device and a medical kit that at least partially solve the problems of the prior art and in particular facilitate the performance of intracorporeal vacuum treatments by allowing a more precise and gentle positioning of fluid drainage devices, thereby minimizing the risks for patients undergoing these procedures.

[0006] This object is suitably solved by the medical device and the medical kit defined in the present invention.

[0007] The objects of the invention are further solved by a sheath, a further medical kit and a method for performing vacuum therapy as defined in the description.

[0008] According to a first aspect, the present invention relates to a medical device, in particular for performing intracorporeal, preferably intraluminal and / or intracavitary vacuum therapy, preferably for draining body fluids, preferably for draining body fluids from a body cavity, such as the esophagus, colon, stomach or fistula (e.g. anal fistula).

[0009] A medical device comprises a first flexible tube, in particular a compressible and / or pliable tube, having a proximal portion and a distal portion; and a second flexible tube, in particular a compressible and / or pliable tube, having a proximal portion and a distal portion.

[0010] The first flexible tube is adapted for inserting the endoscope into a patient's body.

[0011] The first flexible tube can be positioned within the patient's body, and the endoscope can be advanced through the first flexible tube. Alternatively, the first flexible tube can be coupled to the endoscope, and then the first flexible tube (coupled to the endoscope) and the endoscope can be advanced into the patient's body. For example, the first flexible tube and the endoscope can be advanced into the patient's body together (e.g., when coupled). In other cases, the endoscope can be advanced into the patient's body (e.g., before the first flexible tube), and then the first flexible tube can be advanced over the endoscope into the patient's body.

[0012] The second flexible tube is adapted for inserting a fluid drainage device into the patient's body, in particular the fluid drainage device is at least partially or sectionally, in particular only partially or sectionally or completely surrounded by a sheath, in particular in the form of a capsule, wherein the fluid drainage device is adapted to drain body fluids.

[0013] Further, the first flexible tube and the second flexible tube are connected or joined together in a longitudinal manner (ie longitudinally or lengthwise), in particular at least partially or sectionally, in particular only partially or sectionally or continuously.

[0014] The term "body fluid" as used according to the present invention refers to body fluids, such as blood, lymph, pus, exudate, pus or intestinal contents. In particular, the term "body fluid" as used according to the present invention may refer to body fluids typically present in abscesses and / or fistulas.

[0015] The term "fistula" as used according to the present invention refers to an abnormal anastomosis, ie an abnormal connection between two hollow spaces (technically, two epithelialized surfaces), such as blood vessels, intestines or other hollow organs, such as the esophagus or colon.

[0016] The term "proximal portion" as used according to the present invention refers to the end portion of the torso facing towards the user, in particular a doctor or medical staff.

[0017] The term "distal portion" as used according to the present invention refers to the end portion facing away from the torso of a user, in particular a doctor or medical staff.

[0018] The term "patient's body" as used according to the present invention preferably refers to the body of a human or other mammal, ie a human mammal or a non-human mammal.

[0019] The term "in vivo" as used in accordance with the present invention preferably refers to an anatomical region located within a patient's body, particularly an anatomical region accessible by endoscopy.

[0020] Preferably, the term "endoscope" as used according to the present invention refers to a flexible, in particular compressible and / or pliable endoscope, in particular a handheld endoscope.

[0021] More specifically, the first flexible tube and the second flexible tube can be connected together in a length direction by material bonding (ie in a material bonding manner). For example, the first flexible tube and the second flexible tube can be glued, welded or sewn together in a longitudinal manner.

[0022] Preferably, the first flexible tube and the second flexible tube are arranged parallel to each other, in particular at least partially or sectionally, preferably only partially or sectionally or continuously, parallel to each other.

[0023] Furthermore, the first flexible tube may have a length of 75 mm to 800 mm, particularly 100 mm to 700 mm, and preferably 150 mm to 600 mm. For example, if the medical device is provided for treating the esophagus, the medical device may have a length of 490 mm. Alternatively, for example, if the medical device is provided for treating another internal body site (e.g., the lower gastrointestinal tract), the medical device may have a length of 200 mm.

[0024] Furthermore, the first flexible tube may have a non-angular, i.e., round, in particular, round, oval, or elliptical cross section. Alternatively, the first flexible tube may have a polygonal cross section, in particular a triangular, rectangular, square, trapezoidal, rhombus, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, or star-shaped cross section.

[0025] Furthermore, the first flexible tube may have an inner diameter of 8 mm to 40 mm, particularly 13 mm to 30 mm, preferably 16 mm to 28 mm. For example, the first flexible tube may have an inner diameter of 20 mm.

[0026] Furthermore, the first flexible tube may have a wall thickness, in particular a film wall thickness, of 50 μm to 500 μm, in particular 60 μm to 350 μm, preferably 70 μm to 250 μm. For example, the first flexible tube may have a wall thickness of 80 μm.

[0027] In some embodiments of the present invention, the first flexible tube can be a relatively rigid tube. For example, the first flexible tube can be in the form of an outer cannula or an introducer, or can be similar to an outer cannula or an introducer. In other embodiments of the present invention, the first flexible tube can include a sleeve or a membrane, or can be in the form of a sleeve or a membrane. The sleeve or membrane can be configured to be mounted on an endoscope, in particular so that, for example, the first flexible tube and the endoscope can be advanced together into the patient's body.

[0028] Furthermore, the first flexible tube may comprise or consist of a polymer, in particular a natural polymer and / or a synthetic polymer and / or a polymer that is degradable or resorbable in vivo, in particular selected from the group consisting of polyolefins, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polyurethanes, polyether block amides, polycarbonates, ethylene vinyl acetate, polyesters, polyacrylates, polyetheretherketones, polyethylene terephthalate, polyethylene terephthalate-glycol, silicone, chitosan, cellulose, silk, gellan gum, polycaprolactone, polylactic acid, polyglycolide, polylactic-co-glycolic acid, polyvinyl alcohol, polyhydroxyalkanoates, poly-3-hydroxybutyrate, polytrimethylene carbonate, copolymers of at least two of the aforementioned polymers, and mixtures of copolymers of at least two of the aforementioned polymers.

[0029] The term "copolymer" as used in the present invention refers to a polymer comprising at least two different monomer units, in particular at least two different repeating monomer units, or a polymer consisting of at least two different monomer units, in particular at least two different repeating monomer units. Thus, the term "copolymer" as used in the present invention may include, for example, dimers, trimers, tetramers, etc.

[0030] Furthermore, the second flexible tube may have a length of 130 mm to 1000 mm, particularly 200 mm to 850 mm, and preferably 250 mm to 700 mm. For example, if the medical device is provided for treating the esophagus, the medical device may have a length of 550 mm. Alternatively, for example, if the medical device is provided for treating another internal body site (e.g., the lower gastrointestinal tract), the medical device may have a length of 300 mm.

[0031] Furthermore, the second flexible tube may have a non-angular, i.e., circular, in particular, circular, oval, or elliptical cross-section. Alternatively, the second flexible tube may have a polygonal cross-section, in particular a triangular, rectangular, square, trapezoidal, rhombus, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, or star-shaped cross-section.

[0032] Furthermore, the second flexible tube may have an inner diameter of 10 mm to 60 mm, particularly 12 mm to 50 mm, and preferably 15 mm to 40 mm. For example, if the medical device is provided for treating the esophagus, the medical device may have an inner diameter of 11 mm. Alternatively, for example, if the medical device is provided for treating another internal body site, the medical device may have an inner diameter of 15 mm.

[0033] Furthermore, the second flexible tube may have a wall thickness, in particular a film wall thickness, of 50 μm to 500 μm, in particular 60 μm to 350 μm, preferably 70 μm to 250 μm. For example, the second flexible tube may have a wall thickness of 80 μm.

[0034] In some embodiments of the present invention, the second flexible tube can be a relatively rigid tube. For example, the second flexible tube can be in the form of an outer sleeve or introducer, or can be similar to an outer sleeve or introducer. In other embodiments of the present invention, the second flexible tube can include a sleeve or a membrane, or can be in the form of a sleeve or a membrane.

[0035] Furthermore, the second flexible tube can (in particular independently of the first flexible tube) comprise or consist of a polymer, in particular a natural polymer and / or a synthetic polymer and / or a polymer that is degradable or resorbable in vivo, in particular selected from the group consisting of polyolefins, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polyurethanes, polyether block amides, polycarbonates, ethylene vinyl acetate, polyesters, polyacrylates, polyetheretherketones, polyethylene terephthalate, polyethylene terephthalate-ethylene glycol, silicones, chitosan, cellulose, silk, gellan gum, polycaprolactone, polylactic acid, polyglycolide, polylactic-co-glycolic acid, polyvinyl alcohol, polyhydroxyalkanoates, poly-3-hydroxybutyrate, polytrimethylene carbonate, copolymers of at least two of the aforementioned polymers, and mixtures of copolymers of at least two of the aforementioned polymers. In principle, the first flexible tube and the second flexible tube can be formed identically or differently, in particular with respect to length, inner diameter, wall thickness, cross section, polymer, or a combination of at least two of the aforementioned properties.

[0036] Preferably, the second flexible tube may have a retractable, in particular foldable, or stretchable (i.e. expandable), in particular unfoldable distal portion, in particular having a length of 15 to 120 mm, in particular 30 to 100 mm, preferably 40 to 90 mm.

[0037] Further, the first flexible tube and / or the second flexible tube may be manufactured independently of each other by die cutting, radio frequency welding, pulse welding, laser welding, ultrasonic welding, thermocompression welding, gluing, sewing, or printing.

[0038] Further, both the first flexible tube and the second flexible tube may be provided by cutting a suitable tube material into a pattern and bonding longitudinal sides of the pattern, in particular by welding, for example by means of a sonotrode, to form the flexible tubes.

[0039] Preferably, the second flexible tube is longer than the first flexible tube. For example, the second flexible tube may be 3% to 60% longer than the first flexible tube, particularly 7% to 50%, and preferably 10% to 40% longer. More specifically, the second flexible tube may be 1 cm to 25 cm longer than the first flexible tube, particularly 2 cm to 20 cm, and preferably 3 cm to 18 cm longer.

[0040] In one embodiment of the present invention, the second flexible tube, in particular the distal portion of the second flexible tube, protrudes or exceeds the distal portion of the first flexible tube. This embodiment advantageously allows observing the correct placement of the fluid drainage device in the patient's body.

[0041] In another embodiment of the present invention, the medical device further comprises a first connecting element and a second connecting element.

[0042] Preferably, the first connecting element is adapted to connect, in particular positively connect and / or frictionally connect and / or materially bond, preferably positively connect and / or frictionally connect, a proximal part of the endoscope to the proximal part of the first flexible tube.

[0043] More specifically, the first connecting element can be arranged or positioned at the proximal portion of the first flexible tube. Furthermore, the first connecting element can be arranged or positioned at the proximal portion of the second flexible tube. In particular, the first connecting element, in particular the distal portion of the first connecting element, can be at least partially or segmentally, in particular only partially or segmentally, or completely, inserted or insertable into the proximal portion of the first flexible tube. Furthermore, the first connecting element, in particular the distal portion of the first connecting element, can be at least partially or segmentally, in particular only partially or segmentally, or completely, inserted or insertable into the proximal portion of the second flexible tube.

[0044] More preferably, the first connecting element comprises or is in the form of a double sleeve, preferably wherein one of the two sleeves, in particular the distal end portion of one of the two sleeves, is at least partially or segmentally, in particular only partially or segmentally or completely, inserted or insertable into the proximal end portion of the first flexible tube, and the other of the two sleeves, in particular the distal end portion of the other of the two sleeves, is at least partially or segmentally, in particular only partially or segmentally or completely, inserted or insertable into the proximal end portion of the second flexible tube. Preferably, the double sleeve is in the form of a one-piece structure.

[0045] Furthermore, the first connecting element can be fixed to the proximal end portion of the first flexible tube and optionally the second flexible tube, in particular via a fixing element, such as a thread or wire tied around the proximal end portion of the first flexible tube and optionally the second flexible tube. With regard to further features and advantages of the thread or wire, in particular with regard to useful materials for the thread or wire, reference is made to the materials disclosed below with respect to the pulling element of the second flexible tube, which apply mutatis mutandis.

[0046] Alternatively, the first connecting element may comprise a locking element, in particular a sleeve lock, adapted to secure the first connecting element, in particular the distal end portion of the first connecting element, to the proximal end portions of the first flexible tube and the optional flexible tube, in particular the first flexible tube and the optional second flexible tube. The locking element may be secured to the first connecting element using a screw.

[0047] Preferably, the first connecting element has a hollow cylindrical shape or a hollow conical shape. Further, the first connecting element can have an adjustable inner diameter. The inner diameter can be, for example, 5 mm to 40 mm, in particular 8 mm to 30 mm, preferably 7 mm to 25 mm. In particular, the inner diameter can be adjustable via a locking or fixing member (such as a screw, in particular a turning screw or a knob). Therefore, by narrowing the inner diameter of the first connecting element, the connection between the proximal end portion of the endoscope and the proximal end portion of the first flexible tube and optionally the second flexible tube can be conveniently achieved.

[0048] Further, the first connecting element may be manufactured by injection molding, 3D printing or CNC machining.

[0049] Furthermore, the first connecting element may comprise or consist of a material selected from the group consisting of plastic materials, in particular hard plastic materials, nylon, acrylonitrile butadiene styrene, polyoxymethylene homopolymers, polyoxymethylene copolymers, polyvinyl chloride, polytetrafluoroethylene, polylactide, polycarbonate, polypropylene, polyurethane, polyetheretherketone, polysulfone, metals (e.g. aluminum and / or titanium), alloys (e.g. steel) and mixtures of at least two of the aforementioned materials.

[0050] Preferably, the second connecting element is adapted to connect, in particular form-fittingly and / or frictionally connected and / or materially bond, preferably materially bond (e.g. gluing or welding), the distal part of the endoscope to the distal part of the second flexible tube or a part of the second flexible tube arranged or positioned proximally of the distal part of the second flexible tube.

[0051] More specifically, the second connecting element may be arranged or located at the distal portion of the second flexible tube, or at a portion of the second flexible tube located or arranged proximal to the distal portion of the second flexible tube.

[0052] Preferably, the second connecting element comprises at least one adhesive strip (i.e., only one adhesive strip or multiple adhesive strips) and / or at least one adhesive flap (i.e., only one adhesive flap or multiple adhesive flaps), or is in the form of at least one adhesive strip (i.e., only one adhesive strip or multiple adhesive strips) and / or at least one adhesive flap (i.e., only one adhesive flap or multiple adhesive flaps). For example, the second connecting element may comprise three adhesive strips or be in the form of three adhesive strips, preferably one of the three adhesive strips being arranged, in particular, placed, on a connector for the endoscope, wherein the connector is arranged, in particular, welded, to the second flexible tube, and the remaining two of the three adhesive strips being arranged, in particular, placed, on two flaps of the second flexible tube.

[0053] Furthermore, the at least one adhesive tape may be in the form of at least one strip, in particular at least one square strip, for example having dimensions of 20 mm×20 mm.

[0054] Typically, the first connecting element and / or the second connecting element may be adapted to connect to a proximal portion and a distal portion, respectively, of an endoscope having a size (ie a diameter) of 5 mm to 15 mm.

[0055] In another embodiment of the present invention, the medical device further comprises a manipulation element. Preferably, the manipulation element is connected to the distal end of the second flexible tube. Further preferably, the manipulation element is adapted to retract (particularly fold back or roll up) or extend (particularly unfold or unwind) the distal end of the second flexible tube. This advantageously avoids obstruction of the endoscope's camera.

[0056] Furthermore, a manipulation element may be inserted through the working channel of the endoscope.

[0057] Furthermore, the manipulation element may in particular comprise or consist of a semi-rigid material. With regard to useful semi-rigid materials, reference is made in its entirety to the following description.

[0058] In another embodiment of the present invention, the steering element is in the form of a longitudinal element, in particular in the form of a thread or filament. More specifically, the thread can be in the form of a monofilament, a pseudo-monofilament or a multifilament (in particular a braided or twisted multifilament). Further, the thread can have a diameter of USP 0 (i.e. 0.350 mm to 0.399 mm) or a diameter of USP 3 / 0 (i.e. 0.200 mm to 0.249 mm). Further, the thread can comprise or consist of a polymer, the polymer being in particular selected from the group consisting of: polyester (e.g. polyethylene terephthalate), polyolefins (e.g. polyethylene and / or polypropylene), cotton and a mixture of at least two of the aforementioned polymers. Preferably, the thread comprises or consists of polyester (in particular polyethylene terephthalate). The thread can comprise or consist of a metal or an alloy (in particular steel) and a mixture thereof.

[0059] Preferably, the manipulation element is attached or connected (in particular sewn, sutured or knotted) or temporarily connected to the distal portion of the second flexible tube, in particular along a longitudinal side of the distal portion. Further, the manipulation element is preferably fixed to the distal portion of the second flexible tube, in particular by means of at least one knot, i.e. only one knot or a plurality of knots.

[0060] In another embodiment of the present invention, the distal portion of the manipulator has at least one marker, i.e. only one marker or a plurality of markers. The marker can be in the form of at least two markers, in particular two horizontal markers surrounding the distal portion of the manipulator. The at least one marker is preferably visible through the camera of the endoscope. Advantageously, the at least one marker preferably indicates to the user when the second flexible tube is extended. The at least one marker can be produced by laser printing, ink printing, machining or overmolding technology. Further, the at least one marker can have a width of 0.1 mm to 10 mm, in particular 0.2 mm to 8 mm, preferably 0.3 mm to 5 mm.

[0061] In another embodiment of the present invention, the medical device further comprises a pulling element. Preferably, the pulling element is adapted to fold the distal portion of the second flexible tube, particularly in the direction of or toward the proximal portion of the second flexible tube. This further optimizes avoiding obstruction of the endoscope's camera.

[0062] Preferably, the pulling element is attached or connected (in particular, sewn, sutured or knotted) to the distal portion of the second flexible tube, in particular, in the middle of the distal portion or along a longitudinal side of the distal portion. Further, the pulling element is preferably fixed (in particular, by at least one knot, i.e., only one knot or multiple knots, such as two or more knots) to the distal portion of the second flexible tube, in particular, in the middle of the distal portion or along a longitudinal side of the distal portion.

[0063] Furthermore, the pulling element may be arranged or positioned outside the first and / or second flexible tube. Alternatively, the pulling element may be arranged or positioned at least sectionally, in particular only sectionally, inside the second flexible tube and in particular up to the proximal portion of the second flexible tube.

[0064] Furthermore, the pulling element may be in the form of a wire, in particular a plastic wire or a metal wire. In particular, the pulling element may comprise or consist of a material selected from the group consisting of polyester, polyethylene terephthalate, polyolefins (e.g. polyethylene and / or polypropylene), cotton, alloys, steel, and a combination (in particular a mixture) of at least two of the aforementioned materials.

[0065] In another embodiment of the present invention, the medical device further comprises a sheath adapted to surround or enclose the fluid drainage device at least partially or segmentally, in particular only partially or segmentally or completely, or the sheath at least partially or segmentally, in particular only partially or segmentally or completely surrounds the fluid drainage device.

[0066] In another embodiment of the present invention, the medical device does not contain a sheath adapted to at least partially or segmentally, in particular only partially or segmentally or completely surround or enclose the fluid drainage device, or does not contain a sheath at least partially or segmentally, in particular only partially or segmentally or completely surround the fluid drainage device.

[0067] In another embodiment of the present invention, the medical device further comprises a third connecting element. The third connecting element is preferably arranged or positioned at the distal portion of the second flexible tube. Preferably, the third connecting element is suitable for connecting the distal portion of the operating element, particularly form-fitting connection and / or friction connection and / or material bonding (e.g., gluing or welding) to the distal portion of the second flexible tube, and particularly disconnecting the distal portion of the operating element from the distal portion of the second flexible tube. For example, the third connecting element can be in the form of a screw. Therefore, the distal portion of the second flexible tube can advantageously be retracted, folded or deployed via the operating element. The third connecting element is preferably attached to the distal portion of the second flexible tube, particularly material bonding (e.g., gluing or welding) and / or attached to the distal portion of the second flexible tube via a wire. Regarding other features and advantages of the wire, reference is made to the corresponding features and advantages disclosed for the wire as an embodiment of the operating element, which apply after making necessary modifications.

[0068] In another embodiment of the present invention, the medical device or the second flexible tube further comprises an insertion guide element. The insertion guide element is arranged or positioned at the proximal portion of the second flexible tube. More specifically, the insertion guide element, in particular the distal portion of the insertion guide element, can be at least partially or segmentally, in particular only partially or segmentally or completely inserted into the proximal portion of the second flexible tube. Further, the insertion guide element can be fixed to the proximal portion of the second flexible tube, in particular via a fixing element, such as a thread or wire tied around the proximal portion of the second flexible tube. With regard to further features and advantages with respect to the thread or wire, reference is made to the corresponding features and advantages disclosed for the thread or wire as an embodiment of the manipulating element or pulling element of the medical device, which apply mutatis mutandis.

[0069] Preferably, the insertion guide element is adapted to push and / or insert the fluid drainage device, in particular a fluid drainage device at least partially or sectionally, in particular only partially or sectionally or completely surrounded by the sheath, into and / or through the second flexible tube.

[0070] For example, the insertion guide element may have a hollow cylindrical shape or a hollow conical shape. Further, the insertion guide element may have an inner diameter of 5 mm to 35 mm, particularly 10 mm to 30 mm, preferably 12 mm to 25 mm.

[0071] Further, the insertion guide element may be manufactured by injection molding, 3D printing, or CNC machining.

[0072] Further, the insertion guide element can include or consist of a material selected from plastic materials, in particular hard plastic materials, nylon, acrylonitrile butadiene styrene, polyoxymethylene homopolymer, polyoxymethylene copolymer, polyvinyl chloride, polytetrafluoroethylene, polylactide, polycarbonate, polypropylene, polyurethane, polyetheretherketone, polysulfone, metals (such as aluminum and / or titanium), alloys (such as steel) and mixtures of at least two of the aforementioned materials.

[0073] In another embodiment of the present invention, the insertion guide element is adapted to be connected, in particular positively connected and / or frictionally connected and / or materially bonded, to the fluid drainage device, or the insertion guide element is connected, in particular positively connected and / or frictionally connected and / or materially bonded, to the fluid drainage device, in particular to the proximal portion of the fluid drainage device, preferably the proximal portion of the fluid communication element of the fluid drainage device. Thus, the stability of the fluid drainage device can advantageously be maintained during insertion, and in particular, it can be held as one element during the insertion operation. With regard to further features and advantages of the fluid communication element, reference is made to the following description in its entirety.

[0074] In another embodiment of the present invention, the handle of the medical device is suitable for being connected, in particular being connected in a form-fitting manner and / or being frictionally connected and / or being materially bonded to the fluid drainage device, or the handle of the medical device is connected, in particular being connected in a form-fitting manner and / or being frictionally connected and / or being materially bonded to the fluid drainage device, in particular the proximal portion of the fluid drainage device, preferably the proximal portion of the fluid communication element of the fluid drainage device. Thus, the stability of the fluid drainage device can advantageously be maintained during insertion, and in particular, it can be maintained as one element during the insertion operation. The handle can be part of the insertion guide element. In particular, the handle and the insertion guide element can be in the form of a one-piece construction. Further, the handle can be attached to the insertion guide element or can be pushed onto the insertion guide element. Alternatively, the handle can be in the form of a separate element of the medical device, in particular independent of the insertion guide element. Further, the handle is preferably arranged or positioned at or on the proximal portion of the insertion guide element. With regard to further features and advantages of the fluid communication element, reference is made to the following description in its entirety.

[0075] In another embodiment of the present invention, the first connecting element and the insertion guide element are formed together as one piece, i.e., are formed together in a one-piece structure. Preferably, the distal end portion of the first connecting element is inserted into or within the proximal end portion of the first flexible tube, and the distal end portion of the insertion guide element is inserted into or within the proximal end portion of the second flexible tube. With respect to further features and advantages, in particular with respect to the first connecting element and the insertion guide element of this embodiment, reference is made in its entirety to the preceding description.

[0076] According to a second aspect, the present invention relates to a medical kit, in particular for performing intracorporeal, preferably intraluminal and / or intracavitary vacuum treatment, preferably for draining pathological body fluids, preferably for draining pathological body fluids from a body cavity, such as the esophagus, colon or fistula.

[0077] The medical kit comprises at least the following components, in particular at least the following components that are spatially separated from each other: a medical device according to the first aspect of the invention; and a fluid drainage device suitable for draining pathological body fluids, and, optionally, a sheath, which is suitable for at least partially or segmentally, in particular only partially or segmentally or completely surrounding or enclosing the fluid drainage device, or optionally, the sheath at least partially or segmentally, in particular only partially or segmentally or completely surrounding or enclosing the fluid drainage device.

[0078] Preferably, the sheath may have a tubular shape, in particular a regular or irregular tubular shape.

[0079] More preferably, the sheath may be in the form of a capsule.

[0080] Preferably, the proximal portion of the sheath is open and the distal portion of the sheath is closed.

[0081] Furthermore, the sheath may have a length of 10 mm to 250 mm, in particular 20 mm to 200 mm, preferably 40 mm to 180 mm. For example, the sheath may have a length of 130 mm.

[0082] Furthermore, the sheath may have an inner diameter of 5 mm to 120 mm, in particular 6 mm to 100 mm, preferably 8 mm to 90 mm. For example, the sheath may have a diameter of 25 mm.

[0083] Furthermore, the sheath may have a wall thickness of 30 μm to 500 μm, in particular 50 μm to 400 μm, preferably 60 μm to 350 μm. For example, the sheath may have a wall thickness of 80 μm.

[0084] Furthermore, the sheath may comprise or consist of a polymer, in particular selected from the group consisting of polymers, in particular natural polymers and / or synthetic polymers and / or in vivo degradable or resorbable polymers, in particular selected from the group consisting of polyolefins, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polyurethanes, polyether block amides, polycarbonates, ethylene vinyl acetate, polyesters, polyacrylates, polyetheretherketones, polyethylene terephthalate, polyethylene terephthalate-ethylene glycol, silicone, chitosan, cellulose, silk, gellan gum, polycaprolactone, polylactic acid, polyglycolide, polylactic-co-glycolic acid, polyvinyl alcohol, polyhydroxyalkanoates, poly-3-hydroxybutyrate, polytrimethylene carbonate, copolymers of at least two of the aforementioned polymers and mixtures of copolymers of at least two of the aforementioned polymers.

[0085] In principle, the sheath can be formed in the same manner as the first flexible tube and / or the second flexible tube of the medical device according to the first aspect of the invention. However, it is preferred that the sheath is formed differently from the first flexible tube and / or the second flexible tube of the medical device according to the first aspect of the invention.

[0086] Alternatively, the medical kit may not include a sheath.

[0087] In another embodiment of the present invention, the fluid drainage device comprises a fluid collecting element and a fluid communicating element. The fluid collecting element is preferably adapted to collect, in particular absorb or soak body fluids (in particular pathological body fluids).

[0088] In principle, the fluid collecting element can have a textile structure or be in the form of a textile structure. For example, the fluid collecting element can have a mesh structure, in particular a rolled mesh structure, or be in the form of a mesh structure, in particular a rolled mesh structure, for example comprising or consisting of a polyolefin, preferably polypropylene.

[0089] Alternatively, the fluid collecting element may have a grid or grid-like structure, or may be in the form of a grid or grid-like structure.

[0090] Furthermore, the fluid collecting element may comprise flocked fibers. In other words, the fluid collecting element may be in the form of a flocked element. With regard to useful materials for the flocked fibers, reference is made to the polymers disclosed below with respect to the fluid collecting element.

[0091] Furthermore, the fluid collecting element may have or be in the form of a ceramic structure.

[0092] Preferably, the fluid collecting element has a foam or sponge structure or is in the form of a foam or sponge.

[0093] Furthermore, the fluid collecting element may preferably have a porous structure.

[0094] More specifically, the fluid collecting element may comprise a linear pore density of 3 pores per cm to 30 pores per cm, in particular 3 pores per cm to 25 pores per cm, preferably 3 pores per cm to 20 pores per cm.

[0095] The term "linear pore density" as used according to the present invention refers to pores arranged one after the other, ie in a row.

[0096] Particularly preferably, the fluid collecting element has an open-cell or open-porous foam structure or an open-cell or open-porous sponge structure or is in the form of an open-cell or open-porous foam or an open-cell or open-porous sponge.

[0097] Further, the fluid collection element may have any shape that allows for placement of the fluid drainage device within a patient's body.

[0098] More specifically, the fluid collecting element may have a polyhedral or non-polyhedral shape. For example, the fluid collecting element may be in the form of a cube, a cuboid, a prism, a cylinder, a pyramid, a cone or a sphere.

[0099] Furthermore, the fluid collecting element may have a non-angular, i.e. circular, in particular circular, oval or elliptical cross section. Alternatively, the fluid collecting element may have a non-circular cross section, in particular a polygonal, such as a triangular, rectangular, square, trapezoidal, rhombus, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal or star-shaped cross section.

[0100] Preferably, the fluid collecting element has a cylindrical shape, or is in the form of a cylinder.

[0101] Further, the fluid collection element may include a tube, in particular an inner tube. Preferably, the tube extends along the fluid collection element (i.e. in the longitudinal direction). The tube may have an inner diameter of 0.5 mm to 15 mm, in particular 1 mm to 5 mm, preferably 1 mm to 4 mm. The tube of the fluid collection element may have a non-angular cross section, i.e. a circular cross section, such as a circular, oval or elliptical cross section. Alternatively, the tube of the fluid collection element may have a non-circular cross section, in particular a polygon, such as a triangle, rectangle, square, trapezoid, rhombus, pentagon, hexagon, heptagon, octagon, nonagon, decagon or star-shaped cross section.

[0102] Further, the fluid collecting element may comprise a longitudinal cut, in particular a longitudinal cut made by means of a punch or a cross-sectioning die. In particular, the longitudinal cut may be in the form of a slot.

[0103] Further, the fluid collecting element may have an outer diameter of 3 mm to 50 mm, in particular 5 mm to 40 mm, preferably 8 mm to 35 mm.

[0104] Furthermore, the fluid collecting element, in particular the tube of the fluid collecting element, may have a length of 10 mm to 250 mm, in particular 50 mm to 200 mm, preferably 80 mm to 150 mm.

[0105] Furthermore, the fluid collecting element may surround or wrap around the fluid communicating element, in particular at least partially or sectionally, preferably only partially or sectionally, preferably only around the distal end portion of the fluid communicating element.

[0106] Furthermore, the fluid collecting element is preferably at least partially or sectionally, preferably only partially or sectionally, connected to the fluid communication element. Particularly preferably, the fluid collecting element is only connected to the distal portion of the fluid communication element.

[0107] Furthermore, the fluid collecting element can be connected to the fluid communicating element in a form-fitting and / or frictional manner. For example, the fluid collecting element can be connected to the fluid communicating element via a connecting element, which is particularly configured to connect the fluid collecting element in a form-fitting and / or frictional manner to the fluid communicating element, in particular to a distal portion of the fluid communicating element. The connecting element can be selected from the group consisting of a thread, a filament or a clamp. Further, the connecting element can pass through the fluid collecting element. Further, the connecting element can be fixed to the fluid collecting element, in particular by at least one knot. Further, the connecting element can preferably at least partially or segmentally retract the fluid collecting element.

[0108] Furthermore, the connecting element can engage with a hole and / or perforation of the fluid communication element, in particular with a hole and / or perforation of the distal portion of the fluid communication element. With regard to other features and advantages of the connecting element, in particular the connecting element in the form of a thread or wire, reference is made to the corresponding features and advantages disclosed for the pulling element of the second flexible tube of the medical device according to the first aspect of the present invention.

[0109] Alternatively or in combination, the fluid collecting element may be connected to the fluid communicating element, in particular to the distal portion of the fluid communicating element, by material bonding. For example, the fluid collecting element may be connected to the fluid communicating element, in particular to the distal portion of the fluid communicating element, by gluing and / or welding (in particular vibration welding or heat welding).

[0110] Furthermore, the fluid collection element may comprise or consist of an in vivo degradable or in vivo resorbable polymer, in particular an in vivo degradable or in vivo resorbable natural polymer and / or an in vivo degradable or in vivo resorbable synthetic polymer.

[0111] The in vivo degradable or in vivo resorbable polymer can be selected from the group consisting of polyvinyl alcohol, polyhydroxyalkanoate, polyglycolide, polylactide, polydioxanone, poly-3-hydroxybutyrate, poly-4-hydroxybutyrate, polytrimethylene carbonate, poly-ε-caprolactone, polyethylene glycol, collagen, hyaluronic acid, polyglutamic acid, gellan gum, gelatin, fibrin, alginate, a copolymer of at least two of the foregoing polymers (e.g., poly(lactide-co-glycolide)), and a mixture of at least two of the foregoing polymers.

[0112] Alternatively, the fluid collection element may comprise or consist of a non-degradable or non-resorbable polymer, in particular a non-degradable or non-resorbable natural polymer and / or a non-degradable or non-resorbable synthetic polymer. The non-degradable or non-resorbable polymer may be selected from the group consisting of polyolefins, polyesters, polyamides, polyurethanes, elastomers (e.g. thermoplastic elastomers), polyetherketones, organic polysulfides, silicones, cellulose, silk, chitosan, copolymers of at least two of the aforementioned polymers, and mixtures of at least two of the aforementioned polymers.

[0113] The polyolefin may be selected from the group consisting of polyethylene, low density polyethylene, high density polyethylene, high molecular weight polyethylene, ultra high molecular weight polyethylene, polypropylene, polytetrafluoroethylene, polyvinylidene fluoride, polyvinylidene chloride, polytetrafluoropropylene, polyhexafluoropropylene, copolymers of at least two of the above polyolefins, and mixtures of at least two of the above polyolefins.

[0114] The polyester may be selected from the group consisting of polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, a copolymer of at least two of the foregoing polyesters, and a mixture of at least two of the foregoing polyesters.

[0115] The polyamide can be selected from the group consisting of polyamide 6 (a polymer of ε-caprolactam or ω-aminocaproic acid units), polyamide 66 (a polymer of hexamethylenediamine units and adipic acid units), polyamide 69 (a polymer of hexamethylenediamine units and azelaic acid units), polyamide 612 (a polymer of hexamethylenediamine units and dodecanedioic acid units), polyamide 11 (a polymer of 11-aminoundecanoic acid units), polyamide 12 (a polymer of laurolactam units and ω-aminododecanoic acid units), polyamide 46 (a polymer of tetramethylenediamine units and adipic acid units), polyamide 1212 (a polymer of dodecanedioic acid units and dodecanedioic acid units), polyamide 6 / 12 (a polymer of caprolactam units and laurolactam units), polyamide 66 / 610 (a polymer of hexamethylenediamine units, adipic acid units and sebacic acid units), copolymers of at least two of the above polyamides, and mixtures of at least two of the above polyamides.

[0116] The polyurethane may be selected from the group consisting of aliphatic polycarbonate urethanes, silicone polycarbonate urethanes, polyether urethanes, silicone polyether urethanes, polyurethane ethers, copolymers of at least two of the foregoing polyurethanes, and mixtures of at least two of the foregoing polyurethanes.

[0117] The thermoplastic elastomer may be selected from the group consisting of thermoplastic copolyamides, thermoplastic polyester elastomers, thermoplastic copolyesters, olefin-based thermoplastic elastomers, styrene block copolymers, urethane-based thermoplastic elastomers, olefin-based cross-linked thermoplastic elastomers, copolymers of at least two of the above elastomers, and mixtures of at least two of the above elastomers.

[0118] The polyetherketone may be selected from the group consisting of polyetherketoneketone, polyetheretheretherketone, polyetheretherketoneketone, polyetherketoneetherketoneketone, a copolymer of at least two of the above polyetherketones, and a mixture of at least two of the above polyetherketones.

[0119] The fluid communication element may have a tubular shape, ie may be in the form of a tube, in particular a plastic tube, preferably a flexible plastic tube. More preferably, the fluid communication element is in the form of a drain tube, in particular a redon drain tube.

[0120] Furthermore, the fluid communication element may have a flat (ie round) cross section, in particular a round, oval or elliptical cross section.

[0121] Alternatively, the fluid communication element may have a non-circular, in particular polygonal, cross section. For example, the fluid communication element may have a triangular, rectangular, square, trapezoidal, rhombus, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal or star-shaped cross section.

[0122] Further, the fluid communication element may have a length of 200 mm to 1500 mm, in particular 300 mm to 1300 mm, preferably 350 mm to 1000 mm.

[0123] Furthermore, the fluid communication element may have an outer diameter of 0.5 mm to 15 mm, in particular 1 mm to 8 mm, preferably 1 mm to 5 mm.

[0124] Furthermore, the fluid communication element may have an inner diameter of 0.1 mm to 13 mm, in particular 0.2 mm to 4 mm, preferably 0.5 mm to 2 mm.

[0125] Furthermore, the fluid communication element may comprise or consist of a polymer, in particular a natural polymer and / or a synthetic polymer and / or a polymer that is degradable or resorbable in vivo, in particular selected from the group consisting of polyolefins, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polyurethanes, polyether block amides, polycarbonates, ethylene vinyl acetate, polyesters, polyacrylates, polyetheretherketones, polyethylene terephthalate, polyethylene terephthalate-ethylene glycol, silicone, chitosan, cellulose, silk, gellan gum, polycaprolactone, polylactic acid, polyglycolide, polylactic acid-co-glycolic acid, polyvinyl alcohol, polyhydroxyalkanoates, poly-3-hydroxybutyrate, polytrimethylene carbonate, copolymers of at least two of the above polymers and mixtures of copolymers of at least two of the above polymers.

[0126] Further, the fluid communication element can be arranged or positioned inside the fluid collection element, preferably inside the inner tube of the fluid collection element, in particular at least partially or segmentally, preferably only partially or segmentally, arranged or positioned inside the fluid collection element, preferably inside the inner tube of the fluid collection element.

[0127] More preferably, the distal portion of the fluid communication element, in particular only the distal portion, is arranged inside the fluid collecting element, preferably inside the inner tube of the fluid collecting element, in particular at least partially or segmentally, preferably only partially or segmentally or completely arranged inside the fluid collecting element, preferably inside the inner tube of the fluid collecting element. In other words, more preferably, the distal portion of the fluid communication element, in particular only the distal portion, is surrounded or wrapped around by the fluid collecting element, in particular at least partially or segmentally, preferably only partially or segmentally or completely surrounded or wrapped around by the fluid collecting element. For example, the distal portion of the fluid communication element surrounded or wrapped around by the fluid collecting element can have a length of 10 mm to 250 mm, in particular 40 mm to 200 mm, preferably 40 mm to 150 mm.

[0128] Further, the fluid communicating element, in particular the distal portion of the fluid communicating element, may comprise holes and / or perforations. Advantageously, the holes and / or perforations may be configured in the form of breakthroughs, i.e. holes and / or perforations configured to break through the wall of the fluid communicating element. The holes and / or perforations are advantageously suitable for transferring pathological body fluids that have been absorbed by the fluid collecting element into the fluid communicating element. Preferably, the holes and / or perforations are arranged along the fluid communicating element (i.e. in the longitudinal direction), in particular along the distal portion of the fluid communicating element. The holes and / or perforations may have a mutual distance of, for example, 1 mm to 20 mm, in particular 2 mm to 10 mm, preferably 3 mm to 8 mm. Further, the holes and / or perforations may have a non-angular, i.e. circular, in particular round, oval or elliptical cross section. Alternatively or in combination, the holes and / or perforations may have a non-circular cross section, in particular a polygonal cross section, such as a triangle, square, rectangle, trapezoid, rhombus, pentagon, hexagon, heptagon, octagon, nonagon, decagon or star-shaped cross section. Furthermore, the holes and / or perforations may have a diameter of 0.1 mm to 5 mm, in particular 0.3 mm to 4 mm, preferably 0.5 mm to 3 mm.

[0129] Furthermore, the fluid communication element may include a connector, in particular a Luer lock connector, preferably a male Luer lock connector. Preferably, the connector is in the form of a negative pressure or vacuum connector, i.e., the connector is adapted to connect the proximal portion of the fluid communication element to an extension tube and / or to a negative pressure or vacuum source, in particular a digital negative pressure or vacuum source. The negative pressure source and the vacuum source may, for example, be in the form of a negative pressure pump and a vacuum pump, respectively. More preferably, the connector is arranged at the proximal portion of the fluid communication element, in particular attached to the proximal portion of the fluid communication element.

[0130] The term "extension tube" as used according to the present invention refers to a tube adapted to connect a fluid communication element to a negative pressure or vacuum source, in particular to a digital negative pressure or vacuum source.

[0131] Preferably, the sheath is adapted to surround or enclose the fluid collecting element of the fluid drainage device, in particular only the fluid collecting element of the fluid drainage device, or the sheath surrounds or encloses the fluid collecting element of the fluid drainage device, in particular only the fluid collecting element of the fluid drainage device.

[0132] Furthermore, the sheath is preferably in the form of a flexible sheath, in particular a compressible or pliable sheath.

[0133] Furthermore, the sheath may have a removable rigid or semi-rigid interface, particularly adapted to facilitate insertion of a fluid drainage device or a fluid collecting element of a fluid drainage device into the sheath.

[0134] Preferably, the inner diameter of the sheath (in particular in the stretched state, preferably in the unfolded or uncoiled state) is smaller than the outer diameter, in particular the largest outer diameter, of the fluid drainage device or the fluid collecting element of the fluid drainage device. Thus, the sheath is preferably adapted to compress the fluid drainage device or the fluid collecting element of the fluid drainage device when inserted into the sheath.

[0135] In another embodiment of the present invention, the sheath has a release element adapted to release the fluid drainage device or the fluid collecting element of the fluid drainage device from the sheath. The release element may comprise an openable closure element, or in particular be in the form of an openable closure element, preferably in the form of a zipper mechanism. Advantageously, the release element is located at the distal end portion of the sheath.

[0136] Preferably, the release element extends axially, in particular along at least one longitudinal side, preferably two oppositely arranged longitudinal sides, of the sheath, in particular along the distal portion of the sheath.

[0137] Preferably, the release element comprises, in particular additionally comprises, or is in the form of a longitudinal element, in particular in the form of a thread or a wire, which is connected (in particular sewn, i.e., sutured) to the distal end portion of the sheath. Thus, the fluid drainage device or the fluid collecting element of the fluid drainage device can advantageously be released from the sheath by pulling the longitudinal element and thereby releasing the connection (in particular sewing, suturing, or clamping) of the longitudinal element to the sheath. With regard to further features and advantages of the thread or wire, reference is made to the corresponding features and advantages disclosed for the thread or wire as an embodiment of the pulling element of the second flexible tube of the medical device according to the first aspect of the invention.

[0138] Alternatively or in combination, the release element may comprise or be in the form of a number of material weakenings of the sheath.For example, the release element may comprise or be in the form of a perforation or material thinning.

[0139] Furthermore, the release element may extend linearly or nonlinearly, in particular in a zigzag or wavy manner, along at least one longitudinal side (preferably two oppositely arranged longitudinal sides) of the sheath (in particular the distal portion of the sheath). For example, the release element may extend over a length of 10 mm to 100 mm, in particular 20 mm to 90 mm, preferably 30 mm to 80 mm, along at least one longitudinal side, in particular two oppositely arranged longitudinal sides, of the sheath (in particular along the distal portion of the sheath). If the medical device is provided for vacuum treatment of the esophagus, the release element may, for example, extend over a length of 50 mm along at least one longitudinal side, in particular two oppositely arranged longitudinal sides of the sheath (in particular the distal portion of the sheath). Alternatively, if the medical device is provided for use in another internal body site, the release element may, for example, extend over a length of 70 mm along at least one longitudinal side, in particular two oppositely arranged longitudinal sides of the sheath (in particular the distal portion of the sheath).

[0140] In another embodiment of the present invention, a tail, in particular a longitudinal tail, is formed at the proximal portion of the sheath. Preferably, the tail is suitable for removing the sheath from the interior of the patient's body after releasing the fluid drainage device or the fluid collecting element of the fluid drainage device from the sheath. The tail can be in the form of a strip, for example. Further, the tail can have a length of 50mm to 1500mm, in particular 150mm to 1200mm, preferably 250mm to 1000mm. For example, if the medical kit is provided for treating esophageal wounds, the tail can have a length of 650mm. Alternatively, for example, if the medical device is provided for treating a wound at another internal part of the body, the tail can have a length of 310mm. Further, the tail can have a width of 1mm to 50mm, in particular 5mm to 40mm, preferably 10mm to 30mm. For example, the tail can have a width of 20mm. Furthermore, the tail can comprise or consist of a polymer, in particular a natural and / or synthetic polymer and / or a polymer that is degradable or resorbable in vivo, in particular selected from the group consisting of polyolefins, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polyurethanes, polyether block amides, polycarbonates, ethylene vinyl acetate, polyesters, polyacrylates, polyetheretherketones, polyethylene terephthalate, polyethylene terephthalate-ethylene glycol, silicones, chitosan, cellulose, silk, gellan gum, polycaprolactone, polylactic acid, polyglycolide, polylactic-co-glycolic acid, polyvinyl alcohol, polyhydroxyalkanoates, poly-3-hydroxybutyrate, polytrimethylene carbonate, copolymers of at least two of the aforementioned polymers, and mixtures of copolymers of at least two of the aforementioned polymers. In principle, the tail and the sheath can be formed identically or differently with respect to the polymer.

[0141] In another embodiment of the invention, the sheath has a marking element adapted to indicate the proximal start or origin of the release element.The marking may be in the form of a colored, in particular red, marking, for example.

[0142] In another embodiment of the present invention, the medical kit comprises at least one additional kit component, wherein the at least one additional kit component is selected from the group consisting of: a feeding element, a manipulation element, a pulling element, at least one pushing element, a clamp, an endoscope, a syringe, a dilator extensor tube, a tube connector (such as a Luer lock connector and / or a Y-shaped connector), a connector suitable for arrangement between the fluid communication element and / or the dilator extensor tube, a lubricant, a wipe, a scissors, instructions for use, and a combination of at least two of the aforementioned additional kit components.

[0143] The feed element can, in particular, be in the form of a two-piece assembly, i.e., an assembly comprising or consisting of two parts. More specifically, the feed element can include a first part that has, at least partially or in sections, a cylindrical and / or conical shape. Furthermore, the first part can have an external thread, in particular between the proximal and distal ends of the first part. Advantageously, the feed element can additionally include a second part, in particular in the form of a cap nut or union nut, having an internal thread that is complementary to the external thread of the first part.

[0144] The feed element is adapted to insert the fluid drainage device or the fluid collecting element of the fluid drainage device into the sheath. Preferably, the inner diameter of the feed element is smaller than the outer diameter, in particular the maximum outer diameter, of the fluid drainage device or the fluid collecting element of the fluid drainage device. Thus, the fluid drainage device or the fluid collecting element can be compressed and pushed through the feed element until the fluid drainage device or the fluid collecting element is completely positioned within the sheath.

[0145] Furthermore, the feed element, in particular the above-mentioned first and second piece of the feed element, can be manufactured (in particular independently of one another) by injection molding, 3D printing or CNC machining.

[0146] Furthermore, the distal end of the feed element (in particular the distal end of the first part of the feed element mentioned above) is preferably adapted to be inserted into the sheath. The sheath can be fixed to the feed element, in particular via a form-fitting or form-locking connection and / or a friction connection and / or a material connection. For example, the sheath can be fixed to the feed element by means of a screw or a screwing mechanism.

[0147] Furthermore, the feed element, in particular the above-mentioned first and second part of the feed element, can (in particular independently of one another) comprise or consist of a material selected from the group consisting of: rigid plastic material, nylon, acrylonitrile butadiene styrene, polyoxymethylene homopolymer, polyoxymethylene copolymer, polyvinyl chloride, polytetrafluoroethylene, polycarbonate, polypropylene, polyurethane, polyetheretherketone, polysulfone, metal (for example aluminum and / or titanium), alloy (for example steel) and a mixture of at least two of the aforementioned materials.

[0148] Furthermore, the feed element, in particular the above-mentioned first and second pieces, may be in the form of a rigid assembly.

[0149] Further, the sheath may be manufactured by die cutting, radio frequency welding, laser welding, pulse welding, ultrasonic welding, heat pressure welding, gluing, sewing or printing.

[0150] Furthermore, the manipulation element can be adapted to pass through a working channel of the endoscope. Preferably, the manipulation element is connected to the distal portion of the second flexible tube. The connection can be achieved, for example, by a screw or a clamping element. The manipulation element advantageously functions to retract (particularly deploy) the distal portion of the second flexible tube. The manipulation element can be, for example, in the form of a wire, such as plastic or metal.

[0151] Furthermore, the manipulator element may have one or more markings, particularly at its distal end. The markings may be in the form of at least two markers, particularly two horizontal markings surrounding the manipulator element, particularly around the distal end of the manipulator element. The markings are preferably visible through an endoscopic camera and indicate to the user when the second flexible tube is extended. The markings may be produced by laser printing, ink printing, machining or overmolding techniques. Further, the markings may have a width of 0.1 mm to 10 mm, particularly 0.2 mm to 8 mm, preferably 0.3 mm to 5 mm.

[0152] With regard to further features and advantages of the operating element, reference is made in its entirety to the corresponding features and advantages disclosed in accordance with the first aspect of the invention, which apply mutatis mutandis.

[0153] With regard to further features and advantages of the pulling element, reference is made in its entirety to the corresponding features and advantages disclosed according to the first aspect of the invention, which apply mutatis mutandis.

[0154] At least one pushing element can be suitable for pushing the fluid drainage device or the fluid collecting element of the fluid drainage device (particularly within the sheath) through the second flexible tube of the medical device according to the first aspect of the present invention. In particular, the at least one pushing element can be in the form of at least one flexible hollow tube. This advantageously allows the fluid communicating element of the fluid drainage device to pass through the inner cavity of the at least one pushing element. Advantageously, the length of the at least one pushing element can be greater than the length of the second flexible tube of the medical device according to the first aspect of the present invention. Further, the at least one pushing element can have a marking, particularly close to the proximal portion of the at least one pushing element. Therefore, if the marking reaches the insertion guide element of the second flexible tube of the medical device according to the first aspect of the present invention, the user knows that the distal portion of the pushing element has reached the distal portion of the second flexible tube, and therefore the fluid drainage device or the fluid collecting element of the fluid drainage device (particularly within the sheath) has left the second flexible tube. Further, the at least one pushing element can have a handle, or may not have a handle.

[0155] Furthermore, at least one pushing element may be in the form of a first pushing element and a second pushing element. With regard to the features and advantages of the first pushing element and the second pushing element, reference is made in its entirety to the aforementioned paragraphs relating to the at least one pushing element, however, preferably with the prerequisite that the second pushing element is shorter than the first pushing element. Preferably, the first pushing element is suitable for pushing the fluid drainage device or the fluid collecting element of the fluid drainage device (particularly within the sheath) through the second flexible tube of the medical device according to the first aspect of the present invention. The second pushing element is preferably suitable for pushing the fluid drainage device or the fluid collecting element of the fluid drainage device through the feed element until the fluid drainage device or the fluid collecting element of the fluid drainage device reaches the sheath.

[0156] Furthermore, at least one pushing element, in particular the first pushing element and the second pushing element can be produced (in particular independently of one another) by extrusion, cutting to length or printing.

[0157] Further, at least one pushing element, in particular the first pushing element and the second pushing element can (in particular independently of each other) include a material selected from the following group: plastic material, polyphenylsulfone, polyamide, polyurethane, polyolefin, polyethylene, polytetrafluoroethylene, polypropylene, polyvinyl chloride, polycarbonate and a mixture of at least two of the aforementioned materials, or consist of a material selected from the above group.

[0158] Further, the clamp may be in the form of a plastic clamp, in particular adapted to retain the fluid communication element when the fluid collecting element (and in particular the sheath) of the fluid drainage device is fitted inside the at least one pushing element.

[0159] With regard to further features and advantages of the kit, in particular as far as the medical device according to the first aspect of the invention is concerned, reference is made in its entirety to the embodiments disclosed according to the first aspect of the invention, which apply mutatis mutandis.

[0160] According to a third aspect, the present invention relates to a sheath. The sheath is adapted to surround or enclose a fluid drainage device at least partially or sectionally, in particular only partially or sectionally or completely.

[0161] With regard to further features and advantages of the sheath, reference is made in its entirety to the above description, in particular to the corresponding embodiments disclosed according to the second aspect of the invention, which apply mutatis mutandis.

[0162] According to a fourth aspect, the present invention relates to a further medical kit, in particular for performing intracorporeal, preferably intraluminal and / or intracavitary vacuum treatment, preferably for draining body fluids, preferably for draining body fluids from a body cavity, such as in the esophagus, stomach or colon or for example a fistula (such as an anal fistula).

[0163] Another medical kit comprises at least the following components, in particular at least the following components that are spatially separated from one another: - a fluid drainage device suitable for draining body fluids, and A sheath adapted to surround or enclose the fluid drainage device at least partially or sectionally, in particular only partially or sectionally or completely, or the sheath at least partially or sectionally, in particular only partially or sectionally or completely surrounds or encloses the fluid drainage device.

[0164] The further medical kit may additionally comprise at least one further kit component selected from the group consisting of: a medical device according to the first aspect of the invention, a feeding element, a manipulation element, a pulling element, at least one pushing element, a clamp, an endoscope, a syringe, a dilator extensor tube, a tube connector, such as a Luer lock connector and / or a Y-connector, the connector being suitable for being arranged between the fluid communication element and / or the dilator extensor tube, a lubricant, a wipe, a scissors, instructions for use and a combination of at least two of the aforementioned further kit components.

[0165] With regard to further features and advantages of the further medical kit, reference is made in its entirety to the above description, in particular to the corresponding embodiments disclosed according to the first and second aspects of the invention, which apply mutatis mutandis.

[0166] According to a fifth aspect, the present invention relates to a method for treating an internal body cavity of a human or non-human mammal, preferably by means of vacuum therapy, more preferably by means of endoscope-assisted surgery.

[0167] The internal body cavity may, for example, be selected from the group consisting of: the esophagus, the stomach, the colon, the blood, a fistula (such as an anal fistula), and a vessel (such as a blood vessel and / or a lymphatic vessel).

[0168] Preferably, the method comprises the following steps, in particular the following steps in chronological order or in any other suitable order (in particular which can be performed sequentially or in other cases in combination): a) inserting and positioning an endoscope into an internal body cavity of a human or non-human mammal by passing the endoscope through a first flexible tube of a medical device according to the first aspect of the invention, in particular wherein the first flexible tube of the medical device according to the first aspect of the invention is already inserted into the internal body cavity of a human or non-human mammal, or connecting the first flexible tube of the medical device according to the first aspect of the present invention to an endoscope, and then inserting the first flexible tube of the medical device according to the first aspect of the present invention (coupled to the endoscope) and the endoscope into an internal body cavity of a human or non-human mammal, b) extending or inserting the distal end portion of the second flexible tube of the medical device according to the first aspect of the invention into an internal body cavity of a human or non-human mammal, in particular while visualizing the internal body cavity through an endoscope, in particular by advancing a guide wire inwardly and using a marking or marker of the guide wire as a reference, or loading a fluid drainage device or a fluid collecting element of a fluid drainage device or a sheath at least partially or sectionally surrounding or enclosing the fluid drainage device or the fluid collecting element of a fluid drainage device into the second flexible tube of the medical device according to the first aspect of the invention, c) inserting the fluid drainage device or the fluid collecting element of the fluid drainage device or the sheath at least partially or sectionally surrounding or enclosing the fluid drainage device or the fluid collecting element of the fluid drainage device into the second flexible tube of the medical device according to the first aspect of the invention, in particular the distal end portion of which has been extended or inserted into an internal body cavity of a human or non-human mammal, or extending or inserting the distal end portion of the second flexible tube of the medical device according to the first aspect of the invention, loaded with the fluid drainage device or the fluid collecting element of the fluid drainage device or the sheath at least partially or sectionally surrounding or enclosing the fluid drainage device or the fluid collecting element of the fluid drainage device, into an internal body cavity of a human or non-human mammal, in particular while visualizing the internal body cavity through an endoscope, in particular by pushing a guide wire inwardly and using a marking or a marker of the guide wire as a reference, d) pushing the sheath (together with the fluid drainage device or fluid collecting element of the fluid drainage device surrounded or enclosed by the sheath) through the second flexible tube of the medical device according to the first aspect of the invention to the internal body cavity viewed endoscopically. e) releasing the fluid drainage device or the fluid collecting element of the fluid drainage device from the sheath after the sheath has been deployed from the second flexible tube of the medical device according to the first aspect of the invention (i.e. the sheath has been placed into the internal body cavity), f) retracting the medical device according to the first aspect of the invention and the (opened) sheath from the body of a human or non-human mammal while keeping the fluid drainage device in place, and g) Connecting the fluid drainage device, in particular the fluid communication element of the fluid drainage device, to a source of negative pressure or vacuum.

[0169] Furthermore, step b) and / or step c) may specifically include loading the fluid drainage device or the fluid collecting element of the fluid drainage device or a sheath that at least partially or segmentally surrounds or encapsulates the fluid drainage device or the fluid collecting element of the fluid drainage device into the second flexible tube, and advancing the endoscope, the first flexible tube, and the second flexible tube (e.g., loaded with the fluid drainage device or the fluid collecting element of the fluid drainage device or the sheath that at least partially or segmentally surrounds or encapsulates the fluid drainage device or the fluid collecting element of the fluid drainage device) into the internal body cavity of a human or non-human mammal (e.g., simultaneously advancing the endoscope, the first flexible tube, and the second flexible tube (e.g., loaded with the fluid drainage device or the fluid collecting element of the fluid drainage device or the sheath that at least partially or segmentally surrounds or encapsulates the fluid drainage device or the fluid collecting element of the fluid drainage device) into the internal body cavity of a human or non-human mammal). Preferably, step c) is performed by using a feeding element suitable for inserting the fluid drainage device or the fluid collecting element of the fluid drainage device into the sheath.

[0170] Further, the fluid drainage device or the fluid communication element of the fluid drainage device may be inserted into the pushing element and in particular locked to a recess present in the handle of the pushing element.

[0171] Further, the fluid drainage device or the fluid communicating element of the fluid drainage device can be inserted into the feeding element and pushed via the pushing element until the entire fluid drainage device or the fluid collecting element of the fluid drainage device passes a marking indicating the proximal starting point of a release element suitable for releasing the fluid drainage device or the fluid collecting element of the fluid drainage device from the sheath.

[0172] Furthermore, the pushing element can be removed and the feed element can be unlocked (in particular unscrewed) to release the sheath at least partially or sectionally surrounding or enclosing the fluid drainage device or the fluid collecting element of the fluid drainage device from the feed element.

[0173] Furthermore, the fluid communication element of the fluid drainage device can be inserted into a further pushing element different from, in particular longer than, the above-mentioned pushing element until the further pushing element contacts the fluid collecting element, in particular the base of the fluid collecting element.

[0174] Preferably, the fluid communication element is longer than the further push element and thus protrudes through the proximal portion of the further push element. Advantageously, a holder (particularly in the form of a clamp) is used to secure the fluid communication element, particularly at the base of the further push element. This advantageously prevents the fluid collection element from falling during handling.

[0175] Furthermore, the endoscope is preferably passed through the first flexible tube of the medical device until the leading end portion of the endoscope is exposed. Preferably, the second flexible tube, and thus the medical device, can be secured to the endoscope, particularly below the distal end portion of the endoscope, using an adhesive tape or adhesive tab placed at the distal end portion of the second flexible tube.

[0176] Further, the first connecting element of the first flexible tube may be tightened to secure the medical device to the endoscope, in particular to the proximal portion of the endoscope.

[0177] Further, the guide wire can be passed through the working channel of the endoscope until the guide wire exits the distal end portion of the endoscope. Further, the guide wire can be connected to a connecting element located at the distal end portion of the second flexible tube. The connecting element can be in the form of a screw or a clamping mechanism, for example.

[0178] Furthermore, a steering element of the second flexible tube and / or the guidewire, in particular a steering element in the form of a wire, may be pulled to retract the distal end portion of the second flexible tube and thereby advantageously clear a blockage of the endoscope's camera.

[0179] Further, the distal portion of the second flexible tube is preferably deployed within the internal body lumen by pushing a guidewire and using the guidewire's markings or markers as a reference to know when the second flexible tube is fully extended, particularly until the entire fluid drainage device or fluid collection element of the fluid drainage device is released from the sheath.

[0180] Further, the endoscope can be retrieved outside the internal body cavity, in particular in such a way that the endoscope is preferably outside the internal body cavity and the medical device according to the first aspect of the invention is inside the internal body cavity.

[0181] Further, the sheath can be pushed through the second flexible tube of the medical device by means of a pushing element until the sheath reaches the internal body cavity. Advantageously, the path of the sheath through the second flexible tube can be screened via an endoscope.

[0182] Once the aforementioned markings of the additional push element reach the insertion guide element of the second flexible tube, the sheath is external to the second flexible tube and, therefore, external to the medical device. The pull element of the second flexible tube can then be pulled to open the sheath, thereby releasing the fluid drainage device or the fluid collecting element of the fluid drainage device from the sheath. Furthermore, the clamp can be removed by pulling on the tail of the sheath, and the additional push element and sheath can be removed from the patient. Furthermore, the guidewire can be pulled to retract the medical device. Furthermore, the fluid drainage device or the fluid collecting element of the fluid drainage device can be inspected with an endoscope, and the endoscope can be removed.

[0183] Further, the fluid drainage device or the fluid collecting element of the fluid drainage device may be connected, in particular via an extension tube, to a negative pressure or vacuum source, in particular to a negative pressure or vacuum pump or a vacuum bottle.

[0184] Further, negative pressure or vacuum may be applied, for example 20 mmHg to 700 mmHg, particularly 30 mmHg to 300 mmHg, preferably 50 mmHg to 250 mmHg.

[0185] Further, the negative pressure or vacuum may be applied for 1 day to 31 days, particularly 1 day to 7 days, preferably 1 day to 5 days.

[0186] With regard to further features and advantages of the method, reference is made to the previous description in its entirety. The features and advantages disclosed therein apply mutatis mutandis. BRIEF DESCRIPTION OF THE DRAWINGS

[0187] Further features and advantages of the present invention are provided in the following description of preferred embodiments in the form of drawings and drawings. These may relate to individual embodiments of each feature or to embodiments combining several features. The described embodiments are intended only to illustrate the present invention and the present invention is in no way limited to the described embodiments.

[0188] The accompanying drawings schematically illustrate the following:

[0189] Figure 1 ad: an embodiment of the medical device according to the present invention,

[0190] Figure 2 ae: According to an embodiment of the medical kit of the present invention,

[0191] Figure 3-5 : According to an embodiment of the sheath of the present invention,

[0192] Figure 6 : According to an embodiment of the medical kit of the present invention,

[0193] Figure 7 ae: Another embodiment of the medical kit according to the present invention, DETAILED DESCRIPTION

[0194] Figure 1 Ad schematically illustrate embodiments of the medical device 100 .

[0195] A medical device 100 comprises a first flexible tube 10, in particular a compressible and / or pliable tube 10, having a proximal portion 12 and a distal portion 18; and a second flexible tube 20, in particular a compressible and / or pliable tube 20, having a proximal portion 22 and a distal portion 28.

[0196] The first flexible tube 10 is suitable for inserting the endoscope 30 into the body of a patient.

[0197] The first flexible tube 10 can be positioned within the patient's body, and the endoscope 30 can be advanced through the first flexible tube 10. For example, the first flexible tube 10 can be advanced into the patient's body (e.g., in front of the endoscope 30). After the first flexible tube 10 is properly positioned, the endoscope 30 can be advanced through the first flexible tube 10 into the patient's body. Alternatively, the first flexible tube 10 can be coupled to the endoscope 30, and the first flexible tube 10 (coupled to the endoscope) and the endoscope can be advanced into the patient's body. For example, the first flexible tube 10 and the endoscope 30 can be advanced into the patient's body together (e.g., when coupled). In still other cases, the endoscope 30 can be advanced into the patient's body (e.g., in front of the first flexible tube 10), and then the first flexible tube 10 can be advanced over (along the endoscope) the endoscope 30 into the patient's body.

[0198] The second flexible tube 20 is adapted for inserting a fluid drainage device into a patient's body, in particular the fluid drainage device is at least partially or sectionally, in particular only partially or sectionally or completely surrounded by a sheath, wherein the fluid drainage device is adapted to drain body fluids.

[0199] Preferably, the second flexible tube 20 , in particular the distal end portion 28 of the second flexible tube 20 , protrudes beyond the distal end portion 18 of the first flexible tube 10 .

[0200] Furthermore, the first flexible tube 10 and the second flexible tube 20 are connected or joined together longitudinally (ie longitudinally or lengthwise), in particular at least partially or sectionally, in particular only partially or sectionally or continuously.

[0201] Furthermore, the medical device 100 may have a first connecting element 14 and a second connecting element 16. The first connecting element 14 may be located at the proximal portion 12 of the first flexible tube 10 and is adapted to connect (particularly form-fittingly and / or frictionally connect) the proximal portion of the endoscope to the proximal portion 12 of the first flexible tube 10. For example, the first connecting element 14 may have a hollow form, such as a hollow cylindrical form or a hollow conical form. More preferably, the hollow form may have an adjustable inner diameter, wherein the inner diameter of the hollow form is preferably adjustable via a fixing element (such as a knob or a screw).

[0202] The second connecting element 16 can be located at the distal portion 28 of the second flexible tube 20 or at a portion of the second flexible tube 20 located proximal to the distal portion 28 of the second flexible tube 20, and is suitable for connecting (particularly materially bonding) the distal portion 38 of the endoscope 30 to the distal portion 28 of the second flexible tube 20 or at a portion of the second flexible tube 20 located proximal to the distal portion 28 of the flexible tube 20.

[0203] Preferably, the second connection element 16 is in the form of at least one adhesive strip or at least one adhesive flap.

[0204] Furthermore, the medical device 100 may include a manipulation element 40. Preferably, the manipulation element 40 is connected to the distal portion 28 of the second flexible tube 20. Preferably, the manipulation element 40 is adapted to retract (particularly fold back or roll up) or extend (particularly unfold or unroll) the distal portion 28 of the second flexible tube 20. Thus, blocking of the camera of the endoscope 30 can be advantageously avoided.

[0205] Preferably, the manipulation element 40 can be in the form of a longitudinal element, in particular in the form of a thread or a wire.

[0206] Furthermore, the medical device 100 preferably has a third connecting element 26 located at the distal end portion 28 of the second flexible tube 20. Preferably, the connecting element 26 is adapted to connect and disconnect the distal end portion 48 of the manipulation element 40 to the distal end portion 28 of the second flexible tube 20. The connecting element 26 may be, for example, in the form of a screw that is fixed, in particular materially bonded (e.g., welded), to the distal end portion 28 of the second flexible tube 20. Thus, depending on the movement of the manipulation element 40, the distal end portion 28 of the second flexible tube 20 can be retracted (in particular, folded or compressed) or extended (in particular, unfolded or expanded). This allows for a non-invasive observation of the body lumen to be treated via the endoscope 30.

[0207] Furthermore, the medical device 100 preferably comprises a pulling element 80. Preferably, the pulling element 80 is adapted to fold the distal portion 28 of the second flexible tube 20, in particular in the direction of or towards the proximal portion 22 of the second flexible tube 20. Thus, avoiding obstruction of the camera of the endoscope 30 can be further optimized.

[0208] Preferably, the pulling element 80 is attached or connected (in particular sewn, stitched or knotted) to the distal portion 28 of the second flexible tube 20, in particular in the middle of the distal portion 28 or along a longitudinal side of the distal portion 28, in particular by at least one knot, i.e. only one knot or multiple knots, such as two or more knots.

[0209] Furthermore, the pulling element 80 may be arranged or positioned at least sectionally, in particular only sectionally, inside the second flexible tube 20 and in particular up to the proximal end portion 22 of the second flexible tube 20 .

[0210] Furthermore, the pulling element 80 may be in the form of a wire, in particular a plastic wire or a metal wire.

[0211] Figure 2 ae schematically shows an embodiment of a medical kit 1 according to the invention.

[0212] The medical kit 1 is particularly intended for treating a body lumen (eg the colon or the esophagus) of a human or non-human mammal and / or for performing an in vivo (preferably intraluminal and / or intracavitary) vacuum treatment.

[0213] The medical kit 1 comprises at least the following components, in particular at least the following components that are spatially separated from one another: - a medical device 100, and - a fluid drainage device 50 adapted to drain body fluids, and - Optionally, a sheath 200 adapted to surround or enclose the fluid drainage device at least partially or segmentally, in particular only partially or segmentally or completely, or the sheath at least partially or segmentally, in particular only partially or segmentally or completely surrounds or encloses the fluid drainage device.

[0214] A medical device 100, comprising: a first flexible tube 10 , in particular a compressible and / or pliable tube 10 , having a proximal portion 12 and a distal portion 18 , and A second flexible tube 10 , in particular a compressible and / or pliable tube 20 , having a proximal portion 22 and a distal portion 28 .

[0215] The first flexible tube 10 is suitable for inserting the endoscope 30 into the body of a patient.

[0216] The first flexible tube 10 can be positioned within the patient's body, and the endoscope 30 can be advanced through the first flexible tube 10. For example, the first flexible tube 10 can be advanced into the patient's body (e.g., in front of the endoscope 30). After the first flexible tube 10 is appropriately positioned, the endoscope 30 can be advanced into the patient's body through the first flexible tube 10. Alternatively, the first flexible tube 10 can be coupled to the endoscope 30, and the first flexible tube 10 (coupled with the endoscope) and the endoscope can be advanced into the patient's body. For example, the first flexible tube 10 and the endoscope 30 can be advanced into the patient's body together (e.g., when coupled). In still other cases, the endoscope 30 can be advanced into the patient's body (e.g., in front of the first flexible tube 10), and then the first flexible tube 10 can be advanced over the endoscope 30 into the patient's body.

[0217] The second flexible tube 20 is adapted to insert a fluid drainage device 50 into the patient's body, in particular said fluid drainage device 50 being at least partially or sectionally, in particular only partially or sectionally or completely surrounded by the sheath 200 .

[0218] Preferably, the second flexible tube 20 , in particular the distal end portion 28 of the second flexible tube 20 , protrudes beyond the distal end portion 18 of the first flexible tube 10 .

[0219] Furthermore, the first flexible tube 10 and the second flexible tube 20 are connected or joined together longitudinally (ie longitudinally or lengthwise), in particular at least partially or sectionally, in particular only partially or sectionally or continuously.

[0220] Fluid drainage device 50 includes a fluid collection element 53 and a fluid communication element 55. Preferably, fluid collection element 53 has a foam or sponge-like structure. More preferably, fluid collection element 53 is in the form of a foam or sponge structure, particularly an open-cell foam or sponge structure, for example, comprising or consisting of polyurethane. Fluid communication element 55 is preferably in the form of a drain tube. Preferably, the distal end portion of fluid communication element 55 is surrounded or encapsulated by fluid collection element 53.

[0221] The distal portion of the fluid communication element 55 preferably has holes or perforations through the wall of the fluid communication element 55. Thus, a fluid connection is achieved between the fluid collection element 53 and the fluid communication element 55. The fluid collection element 53 is adapted to collect, in particular absorb or adsorb body fluids (in particular pathological body fluids).

[0222] Furthermore, the inner diameter of the second flexible tube 20 can be smaller than the maximum diameter of the fluid collecting element 53 (particularly surrounded or encapsulated by the sheath 200). Therefore, when inserted into and pulled through the second flexible tube 20, the fluid collecting element 53 (particularly the fluid collecting element 53 surrounded or encapsulated by the sheath 200) can be compressed.

[0223] Furthermore, the medical device 100 may have a first connecting element 14 and a second connecting element 16. The first connecting element 14 may be located at the proximal portion 12 of the first flexible tube 10 and is adapted to connect (particularly form-fittingly and / or frictionally connect) the proximal portion of the endoscope to the proximal portion 12 of the first flexible tube 10. For example, the first connecting element 14 may have a hollow form, such as a hollow cylindrical form or a hollow conical form. More preferably, the hollow form may have an adjustable inner diameter, wherein the inner diameter of the hollow form is preferably adjustable via a fixing element (such as a knob or a screw).

[0224] The second connecting element 16 can be located at the distal portion 28 of the second flexible tube 20 or at a portion of the second flexible tube 20 located proximal to the distal portion 28 of the second flexible tube 20, and is suitable for connecting (particularly materially bonding) the distal portion 38 of the endoscope 30 to the distal portion 28 of the second flexible tube 20 or at a portion of the second flexible tube 20 located proximal to the distal portion 28 of the flexible tube 20.

[0225] Preferably, the second connection element 16 is in the form of at least one adhesive strip or at least one adhesive flap.

[0226] Furthermore, the medical device 100 may include a manipulation element 40. Preferably, the manipulation element 40 is connected to the distal portion 28 of the second flexible tube 20. Preferably, the manipulation element 40 is adapted to retract (particularly fold back or roll up) or extend (particularly unfold or unroll) the distal portion 28 of the second flexible tube 20. Thus, blocking of the camera of the endoscope 30 can be advantageously avoided.

[0227] Preferably, the manipulation element 40 can be in the form of a longitudinal element, in particular in the form of a thread or a wire.

[0228] Furthermore, the medical device 100 preferably has a third connecting element 26 located at the distal end 28 of the second flexible tube 20. Preferably, the connecting element 26 is adapted to connect and disconnect the distal end 48 of the manipulation element 40 to the distal end 28 of the second flexible tube 20. The connecting element 26 may be, for example, in the form of a screw that is fixed, in particular materially bonded (e.g., welded), to the distal end 28 of the second flexible tube 20. Thus, depending on the movement of the manipulation element 40, the distal end 28 of the second flexible tube 20 can be retracted (in particular, collapsed or compressed) or stretched (in particular, unfolded or extended). This allows for a non-invasive observation of the body lumen to be treated via the endoscope 30.

[0229] Furthermore, the medical kit 1 may include an insertion guide element 60. The insertion guide element 60 is adapted to push the fluid drainage device 50 (particularly the fluid collection element 53 surrounded or encapsulated by the sheath 200) through the second flexible tube 20. To prevent uncontrolled movement of the fluid drainage device 50, particularly the fluid collection element 53, during treatment, the medical kit may further include a locking mechanism, particularly a clamp 70. Thus, the fluid communication element 55 can be secured, particularly near the proximal portion 62 of the insertion guide element 60. Thus, the stability of the fluid drainage device 50 can be advantageously maintained during insertion.

[0230] If the sheath 200 with the fluid collecting element 53 inside the sheath 200 has reached the body cavity to be treated, the fluid collecting element 53 is preferably released from the sheath 200. To this end, the sheath 200 has a release element 210, in particular in the form of an openable closure element, preferably in the form of a zipper mechanism. More preferably, the release element 210 comprises a longitudinal element 214, in particular in the form of a thread or wire, which is sewn to the sheath 200.

[0231] After releasing the fluid collecting element 53 from the sheath 200, the locking mechanism 70 and the insertion guide element 60 are preferably removed.

[0232] Furthermore, the sheath 200 preferably has a tail portion. Therefore, after releasing the fluid collecting element 53, the sheath 200 can be conveniently removed from the patient's body. Furthermore, after releasing the fluid collecting element 53, the guide wire 40 is preferably pulled to retract the second flexible tube 20, particularly the distal end portion of the second flexible tube 20.

[0233] Further, the fluid collecting element 53 may be inspected with the endoscope 30 and the endoscope 30 may then be removed.

[0234] Finally, the fluid communication element 55 can be connected, in particular via an extension tube, to a negative pressure or vacuum source, in particular to a negative pressure or vacuum pump.

[0235] Figure 3 One embodiment of a sheath 200 according to the invention is schematically shown.

[0236] The sheath 200 is adapted to surround or enclose the fluid drainage device at least partially or sectionally, in particular only partially or sectionally or completely.

[0237] Preferably, the sheath 200 has a tubular form at least partially or sectionally, in particular only partially or sectionally or continuously.

[0238] More preferably, the sheath 200 may be in the form of a balloon or have the form of a balloon. Further preferably, the sheath 200 is flexible, in particular compressible or pliable.

[0239] Further, the sheath 200 preferably has a release element 210 adapted to release the fluid discharge device from the sheath 200 .

[0240] More specifically, the release element 210 may be in the form of an openable closure element, preferably in the form of a zipper mechanism.

[0241] Furthermore, the release element 210 preferably extends along at least one longitudinal side of the sheath 200 , in particular along two oppositely arranged longitudinal sides.

[0242] More specifically, the release element 210 may comprise a perforation or a material thinning portion, or may be in the form of a perforation or a material thinning portion. Alternatively or in combination, the release element 210 may comprise a longitudinal element (particularly a thread or a wire) that is connected, particularly sewn (i.e., sutured), to the sheath 200, particularly to the distal end portion of the sheath 200. Thus, the fluid collecting element 53 of the fluid drainage device 50 may advantageously be released from the sheath 200 by pulling the longitudinal element and thereby releasing the sewing or suturing of the longitudinal element from the sheath 200.

[0243] Further, the sheath 200 may comprise a tail, in particular a longitudinal tail 220. Preferably, the tail 220 is arranged at the proximal portion 202 of the sheath 200. The tail 220 is adapted to retract the sheath 200 after the fluid drainage device is released therefrom.

[0244] Figure 4 Another embodiment of a sheath 200 according to the present invention is shown.

[0245] The sheath 200 is adapted to surround or enclose the fluid drainage device at least partially or sectionally, in particular only partially or sectionally or completely.

[0246] The sheath 200 has a release element 210 adapted to release the fluid drainage device from the sheath 200. The release element 210 comprises a perforation 212 and a longitudinal element 214 (particularly in the form of a thread or wire), which is connected, particularly sewn (i.e., sutured), to the sheath 200. Thus, the fluid drainage device can advantageously be released from the sheath 200 by pulling the longitudinal element 214 and thereby releasing the sewing or suturing of the longitudinal element 214 to the sheath 200 and simultaneously tearing the perforation 212.

[0247] Further, the sheath 200 may comprise a tail, in particular a longitudinal tail 220. Preferably, the tail 220 is arranged at the proximal portion 202 of the sheath 200. The tail 220 is adapted to retract the sheath 200 after the fluid drainage device is released therefrom.

[0248] Figure 5 Another embodiment of a sheath 200 according to the present invention is shown.

[0249] The sheath 200 is adapted to surround or enclose the fluid drainage device at least partially or sectionally, in particular only partially or sectionally or completely.

[0250] The sheath 200 has a release element 210 adapted to release the fluid drainage device from the sheath 200. The release element 210 comprises a material thinning 213 and a longitudinal element 214 (particularly in the form of a thread or wire), the longitudinal element 214 being attached, particularly sewn (i.e., sutured), to the sheath 200. Thus, the fluid drainage device can advantageously be released from the sheath 200 by pulling the longitudinal element 214 and thereby releasing the sewing or suturing of the longitudinal element 214 to the sheath 200 and simultaneously tearing the material thinning 213.

[0251] Further, the sheath 200 may comprise a tail, in particular a longitudinal tail 220. Preferably, the tail 220 is arranged at the proximal portion 202 of the sheath 200. The tail 220 is adapted to retract the sheath 200 after the fluid drainage device is released therefrom.

[0252] Figure 6 An embodiment of a further medical kit 1 ′ according to the invention is shown schematically.

[0253] The medical kit 1 ′ includes a fluid drainage device 50 and a sheath 200 .

[0254] The fluid-guiding device 50 and the sheath 200 may be spatially separated from one another, or the fluid-guiding device 50 may be surrounded or enclosed at least partially or sectionally, in particular only partially or sectionally, by the sheath 200 .

[0255] The fluid drainage device 50 preferably comprises a fluid collection element 53 and a fluid communication element 55. The fluid collection element 53 is advantageously adapted to collect, in particular absorb or adsorb body fluids (in particular pathological body fluids). More preferably, the fluid collection element 53 may have a foam or sponge structure, or may be in the form of a foam or sponge, in particular an open-pore foam or sponge. The fluid communication element 55 is preferably in the form of a fluid discharge tube. Advantageously, the fluid communication element 55 is attached to the fluid collection element 53. More particularly, the distal portion of the fluid communication element 55 is preferably surrounded or enclosed by the fluid collection element 53.

[0256] Preferably, the sheath 200 has a tubular shape, in particular at least partially or sectionally.More preferably, the sheath 200 is in the form of a capsule, wherein the proximal portion 202 of the sheath 200 is open and the distal portion 208 of the sheath 200 is closed.

[0257] Preferably, the sheath 200 is in the form of a flexible sheath, in particular a compressible or pliable sheath.

[0258] Furthermore, the inner diameter of the sheath 200, in particular in the extended or unfolded state, is smaller than the outer diameter, in particular the maximum outer diameter, of the fluid collecting element 53. Thus, the fluid collecting element 53 can be compressed during its insertion in the sheath 200.

[0259] Furthermore, the cover 200 has a release element 210, in particular in the form of an openable closure element, preferably in the form of a zipper mechanism. Furthermore, the release element 210 preferably extends along at least one longitudinal side of the cover 200, in particular along two oppositely arranged longitudinal sides. For example, the release element 210 can be in the form of a perforation or a material thinning. Alternatively or in combination, the release element 210 can include a pulling element, in particular in the form of a thread or wire, which is sewn or sutured to the cover 200 and also extends along at least one longitudinal side of the cover 200, in particular along two oppositely arranged longitudinal sides.

[0260] Further, the sheath 200 may have a tail 220. The tail 220 is advantageously adapted to retract or remove the sheath 200 from the patient's body after the fluid collecting element 53 is released from the sheath 200.

[0261] Figure 7 ae schematically shows a further embodiment of the medical kit 1 according to the invention,

[0262] The medical kit 1 is particularly intended for treating a body lumen (eg the colon or the esophagus) of a human or non-human mammal and / or for performing an in vivo (preferably intraluminal and / or intracavitary) vacuum treatment.

[0263] The medical kit 1 comprises at least the following components, in particular at least the following components that are spatially separated from one another: - a medical device 100, and - A fluid drainage device 50 adapted to drain body fluids.

[0264] A medical device 100, comprising: a first flexible tube 10 , in particular a compressible and / or pliable tube 10 , having a proximal portion 12 and a distal portion 18 , and a second flexible tube 20 , in particular a compressible and / or pliable tube 20 , having a proximal portion 22 and a distal portion 28 .

[0265] The first flexible tube 10 is suitable for inserting the endoscope 30 into the body of a patient.

[0266] The first flexible tube 10 can be positioned within the patient's body, and the endoscope 30 can be advanced through the first flexible tube 10. For example, the first flexible tube 10 can be advanced into the patient's body (e.g., in front of the endoscope 30). After the first flexible tube 10 is appropriately positioned, the endoscope 30 can be advanced through the first flexible tube 10 into the patient's body. Alternatively, the first flexible tube 10 can be coupled to the endoscope 30, and the first flexible tube 10 (coupled to the endoscope) and the endoscope can be advanced into the patient's body. For example, the first flexible tube 10 and the endoscope 30 can be advanced into the patient's body together (e.g., when coupled). In still other cases, the endoscope 30 can be advanced into the patient's body (e.g., in front of the first flexible tube 10), and then the first flexible tube 10 can be advanced over the endoscope 30 into the patient's body.

[0267] The second flexible tube 20 is suitable for inserting the fluid drainage device 50 into the patient's body.

[0268] Preferably, the second flexible tube 20 , in particular the distal end portion 28 of the second flexible tube 20 , protrudes beyond the distal end portion 18 of the first flexible tube 10 .

[0269] Furthermore, the first flexible tube 10 and the second flexible tube 20 are connected or joined together longitudinally (ie longitudinally or lengthwise), in particular at least partially or sectionally, in particular only partially or sectionally or continuously.

[0270] Fluid drainage device 50 includes a fluid collection element 53 and a fluid communication element 55. Preferably, fluid collection element 53 has a foam or sponge-like structure. More preferably, fluid collection element 53 is in the form of a foam or sponge structure, particularly an open-pore foam or sponge structure, for example, comprising or consisting of polyurethane. Fluid communication element 55 is preferably in the form of a drain tube. Preferably, the distal end portion of fluid communication element 55 is surrounded or encapsulated by fluid collection element 53.

[0271] The distal portion of the fluid communication element 55 preferably has holes or perforations through the wall of the fluid communication element 55. Thus, a fluid connection is achieved between the fluid collection element 53 and the fluid communication element 55. The fluid collection element 53 is adapted to collect, in particular absorb or soak up body fluids (in particular pathological body fluids).

[0272] Further, the inner diameter of the second flexible tube 20 may be smaller than the maximum diameter of the fluid collecting element 53. Therefore, when inserted into and pulled through the second flexible tube 20, the fluid collecting element 53 may be compressed.

[0273] Furthermore, the medical device 100 may have a first connecting element 14 and a second connecting element 16. The first connecting element 14 may be located at the proximal portion 12 of the first flexible tube 10 and is adapted to connect (particularly form-fitting and / or frictionally connect) the proximal portion of the endoscope to the proximal portion 12 of the first flexible tube 10. For example, the first connecting element 14 may have a hollow form, such as a hollow cylindrical form or a hollow conical form. More preferably, the hollow form may have an adjustable inner diameter, wherein the inner diameter of the hollow form is preferably adjustable via a fixing element (such as a knob or a screw).

[0274] The second connecting element 16 can be located at the distal portion 28 of the second flexible tube 20 or at a portion of the second flexible tube 20 located proximal to the distal portion 28 of the second flexible tube 20, and is suitable for connecting (particularly materially bonding) the distal portion 38 of the endoscope 30 to the distal portion 28 of the second flexible tube 20 or at a portion of the second flexible tube 20 located proximal to the distal portion 28 of the flexible tube 20.

[0275] Preferably, the second connection element 16 is in the form of at least one adhesive strip or at least one adhesive flap.

[0276] Furthermore, the medical device 100 may include a manipulation element 40. Preferably, the manipulation element 40 is connected to the distal portion 28 of the second flexible tube 20. Preferably, the manipulation element 40 is adapted to retract (particularly fold back or roll up) or stretch (particularly unfold or unwind) the distal portion 28 of the second flexible tube 20. Thus, blocking of the camera of the endoscope 30 can be advantageously avoided.

[0277] Preferably, the manipulation element 40 can be in the form of a longitudinal element, in particular in the form of a thread or a wire.

[0278] Furthermore, the medical device 100 preferably has a third connecting element 26 located at the distal end 28 of the second flexible tube 20. Preferably, the connecting element 26 is adapted to connect the distal end 48 of the manipulation element 40 to the distal end 28 of the second flexible tube 20 and to disconnect the distal end 48 of the manipulation element 40 from the distal end 28 of the second flexible tube 20. The connecting element 26 may be, for example, in the form of a screw that is fixed, in particular materially bonded (e.g., welded), to the distal end 28 of the second flexible tube 20. Thus, depending on the movement of the manipulation element 40, the distal end 28 of the second flexible tube 20 can be retracted (in particular, collapsed or compressed) or stretched (in particular, unfolded or extended). This allows for a non-invasive observation of the body lumen to be treated through the endoscope 30.

[0279] Further, the medical kit 1 may comprise an insertion guide element 60. The insertion guide element 60 is adapted to push or insert the fluid drainage device 50 into and / or through the second flexible tube 20.

[0280] During insertion, the proximal portion 52 of the fluid drainage device 50, preferably the proximal portion 52 of the fluid communication element 55 of the fluid drainage device 50, is preferably connected to the handle 90 of the medical device 100, specifically by a form-fitting connection, a frictional connection, and / or a material bond. For example, the proximal portion 52 of the fluid drainage device 50 may snap into a groove or recess in the handle 90. This advantageously maintains the stability of the fluid drainage device 50 during insertion. The handle 90 may be part of the insertion guide element 60. Specifically, the handle 90 and the insertion guide element 60 may be integrally formed. Furthermore, the handle 90 may be attached to the insertion guide element 60 or may be sleeved onto the insertion guide element 60. Alternatively, the handle 90 may be a separate component of the medical device 100, particularly separate from the insertion guide element 60. Furthermore, the handle 90 may be disposed at or on the proximal portion of the insertion guide element 60.

[0281] After the fluid collection element 53 is deployed into the body lumen to be treated, the handle 90 and the insertion introducer element 60 are preferably removed.

[0282] Further, the fluid collecting element 53 may be inspected with the endoscope 30 and the endoscope 30 may then be removed.

[0283] Finally, the fluid-passing element 55 can be connected, in particular via an extension tube, to a negative pressure or vacuum source, in particular to a negative pressure or vacuum pump.

[0284] With respect to further features and advantages of the embodiments shown in the accompanying drawings, reference is made to the general description thereof as a whole.

Claims

1. A medical device, in particular a medical device for performing intracorporeal, preferably intraluminal and / or intracavitary vacuum therapy, comprising: - a first flexible tube having a proximal portion and a distal portion, and - a second flexible tube having a proximal portion and a distal portion, The first flexible tube is suitable for inserting an endoscope into a patient's body, and the second flexible tube is suitable for inserting a fluid drainage device, in particular a fluid drainage device at least partially or sectionally surrounded by a sheath, into a patient's body, wherein the fluid drainage device is suitable for draining body fluids, and wherein the first flexible tube and the second flexible tube are connected to each other along the length direction.

2. The medical device according to claim 1, wherein The second flexible tube, in particular the distal end portion of the second flexible tube, protrudes beyond the distal end portion of the first flexible tube.

3. The medical device according to claim 1 or 2, characterized in that The medical device further comprises a first connecting element and a second connecting element, wherein the first connecting element is adapted to connect, in particular form-fittingly and / or frictionally connect, the proximal portion of the endoscope to the proximal portion of the first flexible tube, and the second connecting element is adapted to connect, in particular materially bond, the distal portion of the endoscope to the distal portion of the second flexible tube or a portion of the second flexible tube located proximal to the distal portion of the second flexible tube.

4. The medical device according to any one of the preceding claims, characterized in that The medical device further includes a manipulation element adapted to retract or extend the distal portion of the second flexible tube.

5. The medical device according to claim 4, characterized in that The manipulation element is in the form of a longitudinal element, in particular a semi-rigid longitudinal element, in particular a thread or a wire, which is attached, in particular sewn or knotted or temporarily connected to the distal portion of the second flexible tube.

6. The medical device according to claim 4 or 5, characterized in that The distal portion of the manipulation element has at least one marker.

7. The medical device according to any one of claims 4 to 6, characterized in that The medical device further comprises a third connecting element adapted to connect the distal portion of the manipulation element to the distal portion of the second flexible tube and to disconnect the distal portion of the manipulation element from the distal portion of the second flexible tube.

8. The medical device according to any one of the preceding claims, characterized in that The medical device further comprises a pulling element, in particular in the form of a wire, adapted to fold the distal portion of the second flexible tube in the direction of the proximal portion of the second flexible tube.

9. The medical device according to any one of the preceding claims, characterized in that The medical device further comprises: a sheath adapted to at least partially or segmentally surround or enclose the fluid drainage device, or at least partially or segmentally surround the fluid drainage device; or the medical device does not comprise a sheath adapted to at least partially or segmentally surround or enclose the fluid drainage device, or at least partially or segmentally surround the fluid drainage device.

10. The medical device according to any one of the preceding claims, characterized in that The medical device further comprises an insertion guide element, which is located at the proximal portion of the second flexible tube and is adapted to push the fluid drainage device into the second flexible tube, in particular to push the fluid drainage device at least partially or sectionally surrounded by a sheath into the second flexible tube.

11. The medical device according to any one of the preceding claims, characterized in that The handle of the medical device or the insertion guide element is connected or adapted to be connected to the fluid drainage device, in particular to the proximal portion of the fluid drainage device.

12. The medical device according to any one of claims 3 to 11, characterized in that The first connecting element and the insertion guide element are formed together as a single piece, wherein preferably the distal portion of the first connecting element is inserted into / inside the proximal portion of the first flexible tube and the distal portion of the insertion guide element is inserted into / inside the proximal portion of the second flexible tube.

13. A medical kit, in particular for performing intracorporeal, preferably intraluminal and / or intracavitary vacuum therapy, comprising: - A medical device according to any one of the preceding claims, - a fluid drainage device suitable for draining body fluids, and - Optionally, a sheath adapted to at least partially or sectionally surround or enclose said fluid drainage device, or at least partially or sectionally surround said fluid drainage device.

14. The medical kit according to claim 13, wherein: The fluid drainage device comprises a fluid collecting element and a fluid communicating element. The fluid collecting element particularly has a foam or sponge-like structure.

15. The medical kit according to claim 13 or 14, characterized in that The sheath has a release element adapted to release the fluid drainage device or the fluid collecting element from the sheath.

16. The medical kit according to any one of claims 13 to 15, characterized in that A longitudinal tail is formed at a proximal portion of the sheath, and / or the sheath has markings indicating a proximal origin of the release element.

17. The medical kit according to any one of claims 13 to 16, characterized in that The medical kit comprises at least one additional kit component selected from the group consisting of a feeding element, a manipulation element, a pulling element, at least one pushing element, a clamp, an endoscope, a syringe, a dilator extensor tube, a tube connector such as a Luer lock connector and / or a Y-shaped connector, a connector suitable for being positioned between the fluid communication element and the dilator extension tube, a lubricant, a wipe, a scissors, instructions for use, and a combination of at least two of the above other kit components.

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