Kit for in situ cleaning of intestinal anastomoses

Abstract

The present invention relates to the field of anastomotic care, and in particular to a kit comprising a device for cleansing in situ intestinal anastomoses and a device for protecting the anastomosis, the device for protecting the anastomosis comprising a flexible outer sheath connected to a stent located downstream of the sheath and intended to be fixed upstream of the anastomosis. The device for cleansing comprises a perforated tubular element (3) of annular shape capable of dispensing a cleansing composition upstream of the anastomosis, a supply tube (4) one end (4a) of which opens into the tubular element and one end (4b) of which opens into an injection means (5) intended to introduce the composition into said tubular element, and a means (6) for holding the tubular element upstream of the anastomosis.

Description

[Technical field]

[0001] The present invention relates to the field of anastomotic care, and in particular to a kit for performing in situ enema of an intestinal anastomosis. [Background technology]

[0002] An anastomosis is a connection between two structures, organs, or spaces by means of sutures or staples. For example, an intestinal anastomosis is a junction between two ends of a portion of the intestine that may occur, among other things, after resection of a portion of the intestine. It can refer, among other things, to anastomoses performed in the context of resection of a portion of the colon in cases of colorectal cancer, where a so-called low anastomosis is performed.

[0003] Anastomotic dehiscence (fistula) is a serious complication with a mortality rate of about 20%, especially in the case of intestinal anastomoses, especially colorectal or coloanal anastomoses. An anastomotic fistula is an abnormal communication between two cavities that allows the contents of one cavity to drain into the other.

[0004] Anastomotic fistulas are generally caused by poor healing of the anastomotic sutures and generally occur one week after surgery. Symptoms may include fever, intestinal obstruction, more or less severe intestinal pain, or even septic shock, which may threaten the patient's life. In other cases, the patient may not have any symptoms.

[0005] Depending on the severity of the anastomotic fistula, various treatments may be considered, ranging from antibiotics in less severe cases to endoscopy or a new surgery, which is more risky than the first one, in the most severe cases.

[0006] In particular, in light of the serious outcomes that can be associated with intestinal anastomoses, such as difficult healing or bacterial infection, and even eventual anastomotic rupture, there is a need to treat and / or prevent the therapeutic consequences of performing anastomosis.

[0007] It would be advantageous to provide a technical solution that allows a composition that may contain one or more active compounds to be dispensed directly at the anastomosis and in a minimally invasive manner in order to prevent the occurrence of anastomotic fistulas and, more generally, therapeutic consequences in relation to the performance of anastomoses, and in particular intestinal anastomoses.

[0008] To do so, it may be advantageous to administer repeated enemas at regular intervals to the anastomosis to promote healing of the anastomosis.

[0009] Currently available solutions for intestinal anastomotic enemas are generally performed in a conventional manner by the anal route, requiring the introduction of an enema device for each enema, thus repeatedly passing the anastomosis, or the application of liquid pressure to the area of ​​the anastomosis using an enema bucket, a cannulated bulb, or a simple pair.

[0010] It is also possible to perform the enema percutaneously. For example, it can be by antegrade enema by Maron method, which requires a surgical procedure to create a stoma to receive the enema liquid, or by percutaneous endoscopic enterostomy (PEC), which requires the creation of an enteric fistula between the first part of the colon and the skin for the introduction of the enema fluid. However, these percutaneous enemas are invasive techniques that present medical risks for the patient, such as infection and inflammation. Thus, the various existing solutions for the enema of intestinal anastomoses are invasive because they require the repeated introduction of an enema device, which risks damaging the anastomosis and impairing the healing of the anastomosis, thus encouraging the development of an anastomotic fistula, or they require the creation of an opening in the patient's abdomen to allow liquid access without anal introduction. This is why procedures for repeated intestinal anastomosis enemas are never actually used in the context of treatment and / or prevention of the course of treatment related to the performance of an intestinal anastomosis. Summary of the Invention

[0011] The present invention therefore aims to provide a technical solution that allows the treatment and / or prevention of therapeutic complications related to the performance of intestinal anastomoses, in particular the prevention of anastomotic fistulas, which is minimally invasive, allows the performance of repeated enemas in situ, does not require repeated reintroductions of an enema device into the body, is effective and can be adapted to the situation of use.

[0012] The present invention broadly covers the therapeutic complications associated with performing anastomosis, such as healing difficulties, bacterial infection, pain at the anastomosis site, or anastomotic fistulas, all of which should be treatable and / or preventable in an effective and minimally invasive manner.

[0013] To this end, the invention proposes a kit for in situ enema of an intestinal anastomosis, which allows repeated enemas to be performed, without the need for reintroduction during each enema.

[0014] One object of the invention relates to a kit comprising a device (1) for the enema of an in situ intestinal anastomosis (2) and an anastomosis protection device, the anastomosis protection device comprising a flexible outer sheath (9) connected to a stent (7) located downstream of the sheath, said stent being designed to be fixed upstream of the anastomosis, the enema device (1) comprising a perforated tubular element (3) of tubular shape capable of distributing an enema composition upstream of the anastomosis, a supply tube (4) with one end (4a) emerging inside the tubular element and with one end (4b) opening into an injection means (5) designed to deliver the composition to said tubular element, and a holding means (6) for the tubular element upstream of the anastomosis. [Brief description of the drawings]

[0015] [Figure 1]FIG. 1 shows a device (1) for enema of an intestinal anastomosis according to the invention, comprising a perforated tubular element (3) of annular shape, a supply tube (4) emerging at one end (4a) into the tubular element and opening at one end (4b) into an injection means (5) designed to bring a composition into said tubular element, and a holding means (6) for the tubular element upstream of the anastomosis. [Diagram 2] FIG. 2 shows diagrammatically an enema device (1) according to the invention associated with an anastomosis protection device comprising a fixation element (7) and an outer sheath (9) arranged at the downstream end of the fixation element (7), the tubular element (3) of the enema device being attached to the downstream part of the fixation element by a retaining means (6). [Diagram 3] FIG. 3 shows a schematic diagram of the digestive system in which the rectum (11), anal canal (12), left colon (13), transverse colon (14), right colon (15), small intestine (16), stomach (17) and esophagus (18) can be seen, with an anastomosis (2) connecting the two ends (19a and 19b) of the resected portions of the intestine. [Figure 4] FIG. 4 shows a schematic diagram of an enema device (1) according to the invention coupled to an anastomosis protection device guided by an introducer tube (20) to a position upstream of the anastomosis, with the tubular element (3) and fixation element (7) in their radially contracted state as they leave the introducer, and with the outer sheath (9) and supply tube (4) still housed inside the introducer tube. [Diagram 5] FIG. 5 shows diagrammatically an enema device (1) according to the invention coupled to a device for protecting an anastomosis positioned partially upstream of the anastomosis, in which the tubular element (3) and the fixing element (7) to which the tubular element (3) is attached are held against the intestinal wall in a position of maximum radial expansion. [Figure 6] FIG. 6 shows diagrammatically an enema device (1) according to the invention coupled to an anastomosis protection device, with the supply tube (4) of the enema device and the outer sheath (9) of the anastomosis protection device deployed downstream of the fixation element (7) of the anastomosis protection device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] The applicant of the present application has developed a device for in situ intestinal anastomosis enemas, which is of particular interest in that it allows the repeated and minimally invasive distribution, directly upstream of the anastomosis, of so-called enema compositions which may contain one or more active compounds in order to treat and / or prevent therapeutic complications related to the performance of the anastomosis.

[0017] A first object of the invention relates to a device (1) for the enema of an in situ intestinal anastomosis (2), comprising a perforated tubular element (3) of annular shape capable of distributing an enema composition upstream of the anastomosis, a supply tube (4) emerging at one end (4a) on the tubular element and opening at one end (4b) into an injection means (5) designed to bring the composition into said tubular element, and a holding means (6) for the tubular element upstream of the anastomosis.

[0018] In particular, the device according to the invention relates to a device for in situ enema of an intestinal anastomosis, which device can be maintained in situ for the period during which the anastomosis enema is performed. In the context of the present invention, placement and maintenance of the device in situ also means inside the body, since the object of the present invention is enema of an intestinal anastomosis.

[0019] Thus, by placing and maintaining the device according to the invention in place for the duration of the anastomotic enema, it is advantageously possible to avoid passing the anastomosis for each enema and to eliminate the risk of damage and alteration of the anastomosis, particularly the sutures, thereby allowing anastomotic enemas to be performed in a repeated and minimally invasive manner.

[0020] In fact, this placement does not require multiple passes of the device through the newly performed anastomosis. The device according to the invention can in fact be placed before the performance of the anastomosis, using the resection of the diseased intestinal segment and the opening of the lumen of said segment required for the placement of the device according to the invention. It can also be placed through the anus after the performance of the anastomosis, with only one pass through the newly performed anastomosis. In both cases, the device remains in place throughout the entire period during which the repeated enemas are performed.

[0021] The distribution of the enema composition directly upstream of the anastomosis allows a local improvement of the effectiveness of the enema performed by the device, in particular of the enema composition distributed for the treatment and / or prevention of therapeutic complications related to the performance of the anastomosis. More specifically, the device according to the invention is designed for intestinal anastomotic enemas, i.e. anastomoses performed in the intestine, preferably so-called lower gastrointestinal anastomoses, such as anastomoses in the colon, rectum or anal canal, e.g. colorectal or coloanal anastomoses, corresponding to the connection between the colon and the rectum or between the colon and the anus, respectively.

[0022] In the context of the present invention, an "enema" refers to the dispensing of an enema composition to an anastomosis, particularly upstream of the anastomosis and in the direction of the anastomosis. An enema in the context of the present invention can include various types of enema compositions, depending on the context of use of the device.

[0023] In the context of the present invention, an enema composition means any composition, preferably a liquid, designed to be delivered upstream of the anastomosis and capable of containing one or more active compounds. The enema composition is selected according to the circumstances of use of the device.

[0024] In the sense of the present invention, the "context of use of the device" refers to the purpose of the implementation of the enema device according to the invention, and more specifically to the purpose and indication aimed at by the distribution of an enema composition upstream of the anastomosis during implementation of said device. The context of use of the device, i.e. the purpose of the implementation of the device, may be various, such as cleaning the anastomosis, aiding healing, and more generally treating and / or preventing therapeutic complications related to the implementation of the anastomosis.

[0025] In the sense of the present invention, a "therapeutic complication" refers to a physical and / or physiological condition or disorder that may be associated with or related to the performance of an anastomosis and may be common and normal in occurrence or pathological nature after this procedure. These conditions and disorders include bacterial and / or viral infections, pain at the anastomosis site, difficulty in healing the anastomosis, or even anastomotic fistulas.

[0026] "In vivo" as used herein means within a living organism, particularly within the intestine, and even more particularly, the portion of the intestine located upstream of the anastomosis.

[0027] In the present invention, "in situ" refers to the location within the body where the device is placed and maintained for the duration of the enema, and more precisely to the portion of the intestine upstream of the anastomosis where the device is placed and maintained for the duration of the enema. Thus, the device according to the present invention is placed and maintained in situ within the body.

[0028] "Anastomotic protection" as used herein means protection of the anastomosis upon resumption of intestinal transit, which occurs on average 3-5 days after the anastomosis is performed. This period is the postoperative paralysis period.

[0029] "Upstream of the anastomosis" refers to a location that is located before the anastomosis site in terms of the direction of intestinal transport, and in particular to a location that is located before the anastomosis and is designed to be installed in accordance with the present invention. The so-called upstream location of the anastomosis is comprised between 1 m and 1 cm upstream of the anastomosis, preferably between 50 cm and 15 cm, and more preferably between 30 cm and 15 cm.

[0030] Holding means (6) for the tubular element in the context of the present invention comprises elements making it possible to attach the tubular element, directly or indirectly, upstream of the anastomosis, more precisely to the inner wall of the intestinal section located upstream of the anastomosis.

[0031] In particular, the retaining means (6) of the device according to the invention is arranged on the tubular element.

[0032] The retention means (6) may be attachment elements such as loops, tabs, or hooks used alone or in combination.

[0033] Preferably, the holding means (6) comprises an indirect attachment means for the annular shaped perforated tubular element of the device according to the invention to the inner wall of the intestinal section located upstream of the anastomosis (2).

[0034] Even more preferably, the retaining means of the device according to the invention is capable of being attached to a temporary attachment element (7) such as a stent.

[0035] In particular, the retaining means (6) of the device according to the invention can be attached to a stent (7).

[0036] Preferably, the stent is included in a protection device for an intestinal anastomosis.

[0037] Even more preferably, the retaining means (6) according to the present invention can be attached to a stent (7) of an intestinal anastomosis protection device designed to be inserted and retained in situ at the inner wall of an anatomical intestinal portion located upstream of the anastomosis (2).

[0038] More specifically, the retaining means (6) of the device according to the invention can be attached to a stent (7) of an intestinal anastomosis protection device which comprises a flexible outer sheath (9) connected to said stent located downstream of the sheath, said stent being designed to be fixed upstream of the anastomosis. Thus, in the context of the present invention, the retaining means (6) can be attached to the tubular element (3) of the enema device on the stent (7) of the anastomosis protection device.

[0039] The device according to the invention is said to be coupled to or paired with an anastomotic protection device when the retaining means (6) of the enema device is mounted on the stent of the anastomotic protection device.

[0040] According to a first embodiment, the retaining means attaches the tubular element of the device according to the invention to the inner part of the stent of the anastomosis protection device.

[0041] According to another embodiment, the retaining means (6) attaches the tubular element of the device according to the invention to the outer part of the stent (7) of the anastomosis protection device.

[0042] According to a preferred embodiment, the retaining means (6) attaches the tubular element (3) of the device according to the invention to the downstream end of the stent (7) of the anastomosis protection device, preferably to the outer part of said stent. Preferably, in this embodiment, the retaining means (6) is arranged close to or around the inner diameter of the tubular element.

[0043] In each of these embodiments, the retaining means (6) attaches the tubular element (3) of the device according to the invention to the outside of the outer sheath (9) of the anastomosis protection device so as to allow the enema composition to be dispensed directly upstream of the anastomosis.

[0044] Anastomosis protection devices to which the retaining means can be attached are anastomosis protection devices as described in the following patent documents: FR 2 941 858, EP 2 395 942, WO 2013 / 014353 or patent application WO 2019 / 077218.

[0045] The intestinal anastomosis protection device to which the retention means (6) can be attached, i.e. to which the device according to the invention is coupled, consists of a flexible outer sheath (9) which is integral with a stent (7) downstream of the outer sheath (9) and which is designed to be fixed upstream of the anastomosis. The stent is an element which is temporarily fixed to the intestinal wall to hold the sheath in place, the sheath serving to guide fecal material towards the anus without contacting the intestinal wall at the anastomosis site, thus protecting the anastomosis.

[0046] More specifically, the anastomosis protection device to which a retaining means (6) can be attached comprises at least one first longitudinal hollow semi-rigid element of the stent type defining a wall of revolution about a longitudinal axis comprising a substantially cylindrical multi-perforated body part of substantially circular cross section, referred to as a first wall, said first hollow longitudinal element being made of a material imparting radial elastic properties such that in a contracted position it is radially compressed and after being released from radial compression it can assume a so-called maximum radially expanded position, thus the first multi-perforated wall has a first outer diameter which can be varied in a controlled manner between a first minimum outer diameter in said contracted radial position of said first wall and a first maximum outer diameter in said maximum radially expanded position of said first wall, and a flexible outer sheath (9) attached to said stent and extending from the downstream end of said stent. These elastic properties of the fixing elements of the anastomosis protection device make it possible to position and hold this device in place upstream of the anastomosis and, consequently, to position and hold the device according to the invention connected thereto, more particularly the perforated tubular element (3) of the device according to the invention, which also has elastic properties.

[0047] Furthermore, the anastomosis protection device can be lined with an independent watertight layer forming an inner sheath on at least a part, preferably the entire length, of the inner surface of the fixation element, only the longitudinal ends of said inner sheath are attached in a watertight manner to the fixation element using watertight attachment means such as annular seals made of elastomeric adhesive at each longitudinal end of the inner sheath to define a chamber called a vacuum chamber between said inner sheath and the inner surface of the fixation element, the fixation element being coupled to a flexible or semi-rigid injection-aspiration tube extending outside said fixation element, one open end of said injection-aspiration tube opening into the vacuum chamber. The injection-aspiration tube is connected at its longitudinal end, preferably reversibly, to a connecting end piece, which is reversibly connected or reversibly connectable to an air injection or aspiration device such as a syringe or redon, said connecting end piece comprising a closing device, preferably a non-return valve, and a vacuum indicator device capable of indicating the vacuum content in said vacuum chamber. The air suction tube helps to keep the anastomosis protection device in place upstream of the anastomosis by drawing air from the free end from outside the subject, drawing the intestinal wall against the outer surface of the fixation element defining a chamber by suction and establishing a vacuum in said chamber. The combination of the elastic properties of the fixation element of the anastomosis protection device and the air suction tube in the vacuum chamber present in said fixation element ensures a stronger retention of the anastomosis protection device, and thus of the device according to the invention coupled to the anastomosis protection device, in place upstream of the anastomosis.

[0048] The device according to the invention is preferably coupled to the anastomosis protection device prior to placing the anastomosis protection device in situ to facilitate and ensure placement of the device according to the invention.

[0049] A device according to the invention coupled to an anastomosis protection device may be placed in place by an introducer device such as that described in WO 2013 / 014353.

[0050] More precisely, an introducer device useful in the context of the present invention may consist in known manner of a semi-rigid guide tube (20), called an introducer tube, of catheter type, provided with a handle at one end, the inner diameter and length of which make it possible to hold the fixation elements accommodated therein, and thus preferably the stent of the anastomosis protection device in its contracted form, and the sheath in its longitudinally deployed form. Furthermore, the introducer device is capable of keeping the annular shaped perforated tubular element of the device according to the invention accommodated in said guide tube in its contracted form, and of holding the supply tube of the device in its longitudinally deployed form.

[0051] In particular for introduction via the anus after performance of the intestinal anastomosis, the introducer device further comprises an introducer instrument comprising a casing, a tubular outer casing capable of receiving and holding at its distal end the fixation element and the tubular element compressed in a contracted configuration and capable of receiving and holding the outer sheath and the supply tube in a longitudinally deployed configuration, means for guiding the distal end of the introducer from the anus upstream of the anastomosis, and means for detaching the fixation element and the tubular element from the outer casing, the means for detaching the fixation element and the tubular element from the outer casing may consist of a stopper tube comprising at its distal end a stopper which optionally contacts the longitudinal end of the fixation element, the outer sheath of the protection device being positioned downstream of the fixation element and surrounding the stopper tube inside the envelope.

[0052] The means for directing the distal end of the introducer from the anus upstream of the anastomosis may be a pusher extending from a handle connected to the end of the guide tube and comprising a pusher rod and a pusher stopper at the distal end of the pusher rod, which can push a protection device coupled to the enema device according to the invention outside the distal end of the guide tube to allow radial expansion and thus fixation of a fixation element, in particular a stent, against the intestinal wall.

[0053] After the introducer is withdrawn, the fixation element, such as a stent, and the tubular element attached to the fixation element open by radial expansion into contact with the intestinal wall, while the sheath, supply tube, and suction tube are deployed within the intestinal lumen from the fixation site upstream of the anastomosis, by crossing the anastomosis to the anus.

[0054] The device according to the invention comprises a supply tube (4) designed to deliver the enema composition to a perforated tubular element (3) of annular shape, one end (4a) of which emerges within the tubular element and one end (4b) of which opens into an injection means (5) designed to deliver the composition to said tubular element.

[0055] The end (4a) of the supply tube emerging in the tubular element (3) is attached to said element by means of a watertight attachment, preferably an annular seal made of fusion or elastomeric adhesive. The end (4b) opening into an injection means (5) designed to deliver the composition to said tubular element can open directly or indirectly into said injection means. If the end (4b) of the supply tube opens indirectly into the injection means (5), this end is reversibly connected to a connecting piece which is reversibly connected or connectable to an injection means such as a syringe or a pump.

[0056] In particular, the end (4b) of the supply tube (4) opening into the injection means (5) is designed to be located outside the body.

[0057] More precisely, the end (4b) of the supply tube opening into the injection means is located outside the body, ie extracorporeal, when the tubular element (3) is placed upstream of the anastomosis.

[0058] According to a preferred embodiment, the supply tube (4) is a flexible or semi-rigid tube.

[0059] In the context of the present invention, the supply tube (4) has an internal diameter which may be between 1 and 8 mm, preferably between 2 and 5 mm, more preferably the tube has an internal diameter of less than or equal to 5 mm. The tube has an external diameter comprised between 2 and 9 mm, preferably between 3 and 6 mm. A supply tube with an internal diameter of less than or equal to 5 mm advantageously makes it possible to ensure the delivery of the enema composition to the perforated tubular element of annular shape, in particular the delivery of small amounts of said composition.

[0060] The feeding tube (4) according to the invention has an initial length that can be adjusted after the device, in particular the tubular element, is in place, so that the tube has a sufficient length to be able to find the end of the tube outside the body where the composition is inserted. According to a preferred embodiment, the device according to the invention comprises a single feeding tube.

[0061] The perforated tubular element (3) of the annular shape of the device is capable of distributing the enema composition upstream of the anastomosis, said element being therefore positioned and placed upstream of the anastomosis. By placing the perforated tubular device upstream of the anastomosis, the composition can be made to flow in the direction of the anastomosis until it reaches the anastomosis. Preferably, the device according to the invention comprises a single perforated tubular element (3) of annular shape.

[0062] According to a particularly preferred embodiment, the tubular element (3) of the device according to the invention is made of a material that provides radial elastic properties so that it can be radially compressed in the contracted position and can assume a maximum radially expanded position after the release of the radial compression. These properties can advantageously allow the tubular element, in particular when accommodated in the guide tube of the introducer device, to adapt to variations in the diameter of the fixing element of the protection device to which it is attached. In other words, the radial elastic properties of the perforated tubular element allow it to be retained in a contracted configuration so that it can be accommodated in the guide tube of the introducer device and return to its outer diameter at rest after installation in situ.

[0063] The annular shaped perforated tubular element (3) of the device according to the invention has at least one, and preferably several, perforations (10) arranged on the circumference of the element and facing the anastomosis. The arrangement of the perforations (10) facing the anastomosis allows the enema composition to easily flow in the direction of the anastomosis.

[0064] The tubular element of the device according to the invention preferably comprises between 5 and 50, more preferably between 5 and 20 perforations.

[0065] The perforations (10) contained in the tubular element may have a diameter comprised between 0.1 and 5 mm, preferably between 0.1 and 2 mm, more preferably between 0.5 and 1 mm. The number and / or diameter of the perforations present in the tubular element varies depending on the number or diameter of the perforations or depending on the desired dispensing flow rate of the enema composition.

[0066] Preferably, the tubular element (3) according to the invention comprises between 5 and 10 perforations (10) having a diameter that may range from 0.1 to 1 mm.

[0067] According to a particular embodiment, the tubular element (3) of the device according to the invention comprises a plurality of perforations (10) arranged at regular intervals around the circumference of the tubular element, this configuration allowing a uniform distribution of the enema composition upstream of and in the direction of the anastomosis.

[0068] The outer diameter of the tubular element (3) before installation in situ, also called the outer diameter at rest, may be comprised between 10 and 70 mm, preferably between 20 and 50 mm, more preferably between 20 and 40 mm, and the inner diameter of the tubular element before installation in situ, also called the inner diameter at rest, may be comprised between 15 and 65 mm, preferably between 25 and 45 mm, more preferably between 35 and 40 mm.

[0069] The outer diameter of the tubular element (3) corresponds to the maximum diameter formed by the wall of said element, and the inner diameter corresponds to the minimum diameter formed by the wall of said element.

[0070] Preferably, the tubular element (3) has an outer diameter at rest comprised between 20 and 50 mm and an inner diameter at rest comprised between 15 and 40 mm.

[0071] When the tubular element (3) of the device is attached to the outer portion of the fixation element (7) of the anastomosis protection device, the inner rest diameter of the tubular element is similar to the outer rest diameter of the fixation element of the anastomosis protection device. Preferably, the inner rest diameter of the tubular element and the outer rest diameter of the fixation element of the anastomosis protection device are adapted to the diameter of the intestinal section of the subject into which they are to be inserted.

[0072] The outer and inner diameters of the tubular element (3) after being placed in place are substantially smaller than their resting outer and inner diameters due to the pressure of the inner wall of the intestinal section in which it is placed and the elastic properties of the material that makes up the element.

[0073] In particular, the device according to the invention is made of biocompatible materials.

[0074] More precisely, the perforated tubular element (3), the supply tube (4) and the holding means (6) of the device according to the invention consist of biocompatible materials.

[0075] "Biocompatible material" or "biomaterial" refers to a material that has the ability to directly or indirectly, for short or long periods of time, come into contact with tissues and fluids inside the human or animal body without disturbing or degrading the biological environment in which it is used. Examples of biocompatible materials that can be used in the context of the present invention include, but are not limited to, metals and metal alloys such as titanium, platinum, and nickel, polymers of natural origin such as collagen, agarose, chitosan, carrageenan, cellulose and its derivatives, xanthan, and alginate, or polymers of synthetic origin such as polyesters, polyolefins, polyanhydrides, vinyl polymers, polyurethanes, polyamides, and polyetheramides, preferably thermosensitive polymers such as thermosensitive polyurethanes (TSPs) or thermosensitive polyetheramides (TSP-A).

[0076] Preferably, biocompatible materials useful in the context of the present invention are selected from one or more materials including the nickel-titanium metal alloy known as Nitinol, heat sensitive polyurethane (TSP), and heat sensitive polyetheramide (TSP-A).

[0077] More preferably, the biocompatible material constituting the tubular element is selected from among a nickel-titanium metal alloy or a thermosensitive polyetheramide (TSP-A), more preferably a thermosensitive polyetheramide (TSP-A).

[0078] More preferably, the biocompatible material comprising the feeding tube is a heat sensitive polyurethane (TSP).

[0079] More preferably, the biocompatible material constituting the retaining means of the tubular element is selected from among a nickel-titanium metal alloy or a heat sensitive polyetheramide (TSP-A), more preferably a heat sensitive polyetheramide (TSP-A).

[0080] The biocompatible materials constituting the tubular elements and the supply tubes of the device according to the invention may be the same or different.

[0081] According to a particular embodiment, the injection means (5) of the device according to the invention comprise a syringe or a pump.

[0082] The injection means (5) included in the device according to the invention is capable of capturing, puncturing, withdrawing and aspirating the enema composition of the device according to the invention into the container or vessel in which it is located.

[0083] The enema composition is designed to be inserted into the end (4b) of the supply tube (4) opening into the injection means (5) so as to be delivered to the tubular element (3) and distributed upstream of the anastomosis (2). The composition is selected depending on the situation of use of the device, i.e. the purpose of the anastomosis enema.

[0084] An enema composition in the context of the present invention is a dermatological composition designed and suitable for application to the intestinal mucosa.

[0085] In the context of the present invention, enema compositions may be aqueous, alcoholic, or hydroalcoholic solutions, or emulsions, which may contain one or more active compounds and pharma- ceutically acceptable excipients.

[0086] For example, the enema composition may be an emulsion obtained by dispersion of a fatty phase in an aqueous phase, or vice versa.

[0087] The composition can be prepared according to any method known to those skilled in the art.

[0088] In particular, enema compositions for devices according to the invention are aqueous, alcoholic, or hydroalcoholic compositions which may contain one or more active compounds and pharma- ceutically acceptable excipients.

[0089] According to a first embodiment, the enema composition for the device according to the invention is an aqueous, alcoholic or hydroalcoholic composition which may contain one or more active compounds and pharma- ceutically acceptable excipients.Preferably, the enema composition is an aqueous composition.

[0090] The enema composition may contain several different enema compounds or the same enema compound.

[0091] In the context of the present invention, an "active compound" refers to any compound capable of having pharmacological activity and / or a physiological effect in a subject patient to whom a composition containing it is administered.

[0092] The active compound included in the enema composition may be selected from an antiseptic, an antibacterial agent, an antibiotic, an antiviral agent, an antiparasitic agent, an antifungal agent, an antiallergic agent, an immunosuppressant, an analgesic agent, an anesthetic agent, an angiogenesis inhibitor, an antiproliferative agent, an anti-inflammatory agent, a wound healing agent, a probiotic agent, or mixtures thereof.

[0093] More specifically, enema compositions according to the present invention contain one or more active compounds selected from antiseptics, antibacterial agents, anti-inflammatory agents, analgesics, and healing agents.

[0094] More particularly, the active compound may be selected from the group consisting of preservatives such as chlorhexidine, hexamidine, benzalkonium, benzyl alcohol, triclosan, iodine, and the like; antibacterial agents such as butyrate, demeclocycline, chlortetracycline, oxytetracycline, tetracycline, chloramphenicol, fusidic acid, mupirocin, neomycin, and the like; corticosteroids such as butyrate, hydrocortisone prednisolone, and the like; anti-inflammatory agents such as clobetasol, desonide, triamcinolone, ketoprofen, diclofenac, benzydamine, ibuprofen, and the like; The analgesic may be selected from an analgesic such as squalene, hyaluronic acid butyrate, sodium butyrate, dexpanthenol, trolamine, retinol or vitamin A, wound healing agents such as cadexomer, dextranomer, clinomer, enoxolone, calcium pantothenate, non-opioid analgesics such as diclofenac, ibuprofen, paracetamol or ketoprofen, phase II opioid analgesics such as tramadol or codeine, or phase III opioid analgesics such as fentanyl, morphine, oxycodone or sufentanil.

[0095] This list of active compounds is merely exemplary and a person skilled in the art would know how to determine which active compounds can be used in the context of the present invention.

[0096] The enema composition may contain between 0.001 and 10% by weight, preferably between 0.01 and 8% by weight, preferentially between 0.1 and 5% by weight, more preferentially between 0.1 and 3% by weight, preferably between 0.1 and 2% by weight, more preferably 2% by weight of active compound relative to the total weight of the composition.

[0097] According to a preferred embodiment, the enema composition according to the invention comprises 5% by weight of active compound relative to the total weight of the composition.

[0098] According to a second embodiment, the enema composition for the device according to the invention is an aqueous, alcoholic or hydroalcoholic composition free of active compounds, preferably the enema composition is an aqueous composition such as saline, particularly suitable when the purpose of the enema is the irrigation of the anastomosis.

[0099] The compositions according to the invention may contain inert or pharmacodynamically active additives, such as solvents, wetting agents, stabilizers, surfactants, preservatives, pH adjusters, vitamins, emulsifiers, humectants, moisturizers, soothing agents, penetrating agents, antioxidants, cosmetically active substances, electrolytes, conventional acids or bases, or mixtures, alone or in combination.

[0100] Those skilled in the art will take care to select the active compounds, additives, and pharmaceutical excipients according to the purpose of the enema and the desired form of the composition.

[0101] In the context of the present invention, a pharma- ceutically acceptable excipient is any compound, other than the active compound, that is compatible with any other compounds present in the composition, that is compatible with the elements of the device with which it comes into contact, and that is compatible with the skin and mucous membranes, in particular the intestinal mucous membranes.

[0102] By "subject" or "patient" in the sense of the present invention is meant any mammal, and in particular humans, men, women and children.

[0103] The enema composition of the device according to the invention is designed to be contained in a container suitable for said composition, from which it may be collected by injection means.

[0104] The purpose of all enemas is, as a direct or indirect consequence, to treat and / or prevent therapeutic complications associated with the performance of anastomoses, in particular the prevention of anatomical fistulas.

[0105] In the context of the present invention, "treat" or "treatment" refers to the amelioration or reversal of a particular disease or disorder or at least a discernible or indiscernible symptom. Furthermore, the term "treat" can refer to reducing or delaying the progression of a disease or disorder or the occurrence of a symptom of this disease or disorder. For example, in the context of the present invention, the term "treat" can correspond to reducing or delaying therapeutic complications associated with the performance of anastomosis, such as bacterial infection of the anastomosis, pain at the anastomosis site, difficulty in healing, and / or reducing or delaying the occurrence of anastomotic fistulas.

[0106] In the context of the present invention, "prevent" or "prevention" means reducing the risk of a particular disease or disorder, or reducing or delaying the onset of symptoms of the disease. For example, in the context of the present invention, the term "prevent" may correspond to reducing the risk of the onset of complications associated with the performance of anastomoses, such as bacterial infection of the anastomosis, pain at the anastomosis site, difficulty in healing, and / or reducing or delaying the onset of anastomotic fistulas.

[0107] Furthermore, the present invention relates to a method for treating or preventing one or more therapeutic complications associated with the use of the device according to the first object, or with the performance of an anastomosis in a subject.

[0108] More specifically, the present invention relates to a method for treating and / or preventing one or more therapeutic complications associated with the use of a device according to the first purpose or with the performance of an anastomosis in a subject, in which the device, in particular the tubular element of said device, is placed in situ upstream of said anastomosis, and an enema composition is inserted by an injection means into the end of the supply tube of the device opening into said injection means and distributed upstream of the anastomosis by said tubular element. The enema composition and the amount of said composition are determined depending on the therapeutic complication to be targeted.

[0109] Furthermore, the present invention relates to a device according to the first objective that is used to treat or prevent one or more therapeutic complications associated with the performance of an anastomosis in a subject.

[0110] More specifically, the present invention relates to a device according to a first objective used to treat and / or prevent one or more therapeutic complications associated with the performance of an anastomosis in a subject, in which the device, in particular the tubular element of said device, is placed in situ upstream of said anastomosis, and an enema composition is inserted by means of an injection means into the end of the supply tube of the device opening into said injection means and distributed upstream of the anastomosis by said tubular element. The enema composition and the amount of this composition are determined depending on the therapeutic complication to be targeted.

[0111] For the above mentioned uses and methods, the retaining means of the device according to the invention are attached to a fixing element of the anastomosis protection device, in particular a stent, prior to being placed in situ, in other words the device according to the invention is coupled to the anastomosis protection device prior to being placed in situ.

[0112] Preferably, the device according to the invention is placed upstream of the anastomosis via the anus by an introducer device as described in relation to the first object of the invention, after the performance of the anastomosis. More precisely, the introducer device may consist of a catheter-type semi-rigid guide tube provided with a handle at one end, the inner diameter and length of which make it possible to accommodate and hold in the contracted configuration the fixation elements of the anastomosis protection device, thus preferably the stent, and the tubular elements of the device according to the invention, as well as the sheath of the longitudinally deployed anastomosis protection device and the supply tube of the device according to the invention.

[0113] Preferably, the device according to the invention is placed upstream of the anastomosis immediately after performance of the anastomosis, ie, at the end of the surgical procedure.

[0114] In the context of the above uses and methods, the device according to the invention can be used alone or in combination with the simultaneous or sequential administration of other medicinal compounds, such as antibacterial, analgesic or healing agents, which can be administered enterally, such as orally or anally, parenterally, such as by intravenous injection, or otherwise.

[0115] In the context of the above-mentioned uses or methods, the device, in particular the tubular element of this device, is placed upstream of said anastomosis at a distance between 20 and 5 cm, preferably between 15 and 10 cm, of the area where the anastomosis has to be performed.

[0116] In the context of the above uses or methods, the enema composition is repeatedly dispensed upstream of the anastomosis, one or more times per day, preferably at least once per day, for a period of time appropriate for enema purposes.

[0117] A suitable enema period may be comprised between 1 day and 3 weeks, preferably between 1 day and 15 days, more preferably 9 days. Preferably, in the context of the above uses and methods, the enema composition is delivered upstream of the anastomosis once a day for 9 days, counting from the second day after the anastomosis is performed.

[0118] In the context of the above uses or methods, different enema compositions may be dispensed upstream of the anastomosis either simultaneously or at different times with a delay between each administration.

[0119] A person skilled in the art would know to determine the treatment and / or prophylaxis parameters to be performed, such as the amount of enema composition to be inserted, the frequency of administration, the active compounds present in the composition, the dose of each active compound, and the form of the composition.

[0120] The present invention further provides a method for placement upstream of an anastomosis, comprising: - coupling the enema device (1) according to the first object to an anastomosis protection device, in particular attaching the tubular element (3) of the device according to the invention to the fixing element (7) of the anastomosis protection device, - accommodating, in a contracted form, the tubular element (3) of the device according to the invention and the fixing element (7) of the anastomosis protection device in the distal end of an introducer device consisting of a semi-rigid guide tube (20) provided at one end with a handle, introducing the distal end of the guide tube of the introducer device via the anus upstream of the anastomosis by any suitable means; Releasing the fixation element and the tubular element from the guide tube by suitable means It concerns the method.

[0121] The means for delivering the fixation element and the tubular element from the anus upstream of the anastomosis may be a pusher extending from a handle connected to the end of the guide tube and comprising a pusher rod and a pusher stopper at the distal end of the pusher rod that can be released by pushing the fixation element and the tubular element out of the distal end of the guide tube, thus allowing radial expansion of the fixation element, particularly the stent, and fixation against the intestinal wall.

[0122] Preferably, this installation method is performed immediately after performance of the anastomosis, i.e., at the end of the surgical procedure.

[0123] The enema device according to the invention is removed at the end of the selected enema period by endoscopic techniques using endoscopic forceps. More precisely, the fixing element of the anastomosis protection device, i.e. the stent (7), to which the tubular element (3) of the device according to the invention is coupled, is in a first step detached from the intestinal wall by the upstream end of the stent and then removed from the subject's body via the anus by the downstream end of the stent.

[0124] Furthermore, the present invention relates to a kit comprising the device (1) according to the first object of the present invention, comprising an injection means (5) and an anastomosis protection device comprising a flexible outer sheath (9) connected to a stent (7) located downstream of said sheath, said stent being designed to be fixed upstream of the anastomosis. Preferably, the kit further comprises an enema composition.

[0125] Preferably, the kit according to the invention comprises a device according to the first object of the invention, comprising a perforated tubular element of tubular shape capable of distributing an enema composition upstream of the anastomosis, a supply tube, one end of which emerges within the tubular element and the other end of which opens into an injection means designed to deliver the composition to said tubular element, a holding means for the tubular element upstream of the anastomosis, an injection means for the enema composition and a device for protecting the anastomosis, the device for protecting the anastomosis comprising an outer sheath, the sheath being connected to a stent located downstream of the sheath, the stent being designed to be fixed upstream of the anastomosis.

[0126] The injection means (5) may be a syringe or a pump, preferably a syringe.

[0127] In particular, the kit according to the invention further comprises a container containing an enema composition ready for insertion into the free end of the tube of the device according to the first object.

[0128] According to a preferred embodiment, the kit according to the invention comprises a device according to the first object of the invention combined with an anastomosis protection device, i.e. the tubular element (3) of the device according to the invention is attached to the fixing element (7) of the anastomosis protection device by means of a retaining means (5).

[0129] Preferably, the kit according to the invention further comprises an introducer device with which the device according to the invention coupled to the anastomosis protection device can be inserted upstream of the anastomosis. The introducer device may consist of a catheter-type semi-rigid guide tube (20) provided with a handle at one end, the inner diameter and length of which make it possible to accommodate and hold in the contracted configuration the fixation elements of the anastomosis protection device, thus preferably the stent, and the tubular elements of the device according to the invention, as well as the sheath of the longitudinally deployed anastomosis protection device and the supply tube of the device according to the invention.

[0130] The kit according to the invention comprises the tubular element (3) of the device according to the invention and the fixing element (7) of the anastomosis protection device, in the contracted form, in the guide tube (20) of the introducer device.

[0131] The present invention is further illustrated by the following figures, which should not, however, be interpreted in any way as limiting the scope of the invention.

Claims

1. 1. A kit comprising a device (1) for enema of an in situ intestinal anastomosis (2) and an anastomosis protection device, the anastomosis protection device comprising a flexible outer sheath (9), the outer sheath being connected to the downstream end of a stent (7), the stent being designed to be fixed upstream of the anastomosis, the enema device (1) comprising a perforated tubular element (3) of annular shape capable of distributing an enema composition upstream of the anastomosis, a supply tube (4) having one end (4a) emerging within the tubular element and opening at one end (4b) into an injection means (5) designed to deliver the composition to the tubular element, and a holding means (6) for the tubular element upstream of the anastomosis, the tubular element (3) of the enema device (1) comprising a number of perforations (10) arranged in the circumferential direction of the tubular element and pointing in the downstream direction towards the anastomosis.

2. 2. The kit according to claim 1, wherein the holding means (6) of the enema device (1) is located on the tubular element.

3. 3. The kit according to claim 1 or 2, wherein the retaining means (6) of the enema device (1) is attached to the stent (7) of the anastomosis protection device.

4. A kit according to any one of claims 1 to 3, wherein the supply tube (4) of the enema device (1) has an internal diameter comprised between 1 and 8 mm.

5. A kit described in any one of claims 1 to 4, wherein the plurality of perforations (10) are arranged at regular intervals around the circumference of the tubular element.

6. The kit according to any one of claims 1 to 5, wherein the enema device (1) is made of a biocompatible material.

7. The kit according to any one of claims 1 to 6, wherein the injection means (5) of the enema device (1) comprises a syringe or a pump.

8. A kit according to any one of claims 1 to 7, comprising an enema composition.

9. A kit according to any one of the preceding claims, wherein the tubular element (3) of the enema device (1) is mounted on the stent (7) by means of a retaining means (6).

10. An inner sheath covering the inner surface of the stent (7), each longitudinal end of the inner sheath being fixed to the stent (7) in a watertight manner and defining a vacuum chamber between the inner sheath and the inner surface of the stent; a suction tube having an open end opening into the vacuum chamber and a free end connected to a suction device; 10. The kit of claim 1, wherein the suction tube is configured to draw air from the free end to draw the intestinal wall against the outer surface of the stent by suction, establishing a vacuum in the vacuum chamber and maintaining the stent upstream of the anastomosis.

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