KIT COMPRISING A DEVICE FOR INTESTINAL ANASTOMOSIS ENEMA AND AN ANASTOMOSIS PROTECTION DEVICE

Abstract

The present invention relates to the field of anastomosis care and concerns, in particular, a kit comprising a device for in situ intestinal anastomosis enema and an anastomosis protection device comprising a flexible outer sheath connected to a stent located downstream of the sheath and designed to be anchored upstream of the anastomosis. The enema device comprises: a perforated tubular element of annular shape (3) that can dispense an enema composition upstream of the anastomosis, a feeding tube (4) one end of which (4a) emerges into the tubular element and one end of which (4b) is open to injection means (5) designed to dispense the composition into said tubular element, retention means (6) for the tubular element upstream of the anastomosis.

Description

KIT COMPRISING A DEVICE FOR INTESTINAL ANASTOMOSIS ENEMA AND AN ANASTOMOSIS PROTECTION DEVICE TECHNICAL FIELD

[001] The present invention relates to the field of anastomosis care and concerns, in particular, a kit for in situ intestinal anastomosis enema. PREVIOUS TECHNIQUE

[002] Anastomoses are the connection between two structures, organs, or spaces by sutures or staples. An intestinal anastomosis, for example, is the union between two ends of a segment of the intestine that can occur especially after the resection of a segment of the intestine. We can refer especially to anastomoses performed in the context of resection of a part of the colon in the case of colorectal cancer, where a so-called low anastomosis is performed.

[003] Anastomotic dehiscence (fistula) is a serious complication with a mortality rate of around 20%, mainly in cases of intestinal anastomosis, especially colorectal or coloanal anastomosis. Anastomotic fistulas are an abnormal communication between two cavities resulting in the discharge of the contents of one cavity into the other.

[004] Anastomotic fistulas are usually caused by poor healing of the anastomosis suture and generally occur one week after the operation. Symptoms may include fever, interruption of bowel movements, more or less intense intestinal pain, or even septic shock, which can be fatal to the patient. In other cases, the patient may not present any symptoms.

[005] Different treatments may be considered depending on the severity of the anastomotic fistula, such as antibiotic therapy for less severe cases or even endoscopy or further surgery with higher risks than Petition 870210115942, dated 12 / 15 / 2021, page 10 / 44 / 29 first for the most serious cases.

[006] Given the serious consequences that can be associated with intestinal anastomoses, in particular, there is a need to treat and / or prevent the therapeutic consequences related to performing an anastomosis, such as difficulty in healing or even bacterial infections and, finally, anastomotic fissures.

[007] To prevent the appearance of anastomotic fistulas and, more generally, the therapeutic consequences related to performing an anastomosis, especially an intestinal one, it would be advantageous to be able to provide a technical solution that would allow the distribution, directly into the anastomosis and in a minimally invasive manner, of a composition that could comprise one or more active compounds.

[008] For this purpose, it might be advantageous to perform regular repeated enemas of the anastomosis to facilitate its healing.

[009] Currently available solutions for intestinal anastomosis enemas are generally implemented in a conventional manner via the anus and require the introduction of an enema device during each enema and therefore repeated passage through the anastomosis or application of liquid pressure to the anastomosis area using an enema bucket, cannulated bulb or simple bulb.

[0010] Enemas can also be performed percutaneously. For example, through anterograde enema according to the Malone method, which requires a surgical procedure to create a stoma to provide access for the enema fluid, or even through percutaneous endoscopic cecostomy (PEC) which requires creating a cecostomy opening 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 to patients, such as infections and inflammation. Various solutions exist for anastomotic enema. Petition 870210115942, dated 12 / 15 / 2021, page 11 / 44 / 29 Intestinal anastomosis procedures are therefore invasive, as they require the repeated introduction of an enema device that risks damaging the anastomosis and hindering its healing, thus promoting the appearance of anastomotic fistulas or creating an opening in the patient's abdomen to allow access to the fluid without anal introduction. This is why intestinal anastomosis enema procedures, especially when performed repeatedly, are practically never used in the context of treatment and / or prevention of therapeutic consequences related to performing an intestinal anastomosis.

[0011] The present invention therefore aims to offer a technical solution that makes it possible to treat and / or prevent therapeutic complications related to performing an intestinal anastomosis and especially to prevent anastomotic fistulas, which are minimally invasive, enabling the performance of repeated in situ enemas that do not require multiple in vivo reintroduction of the enema device, effective and adaptable to the context of use.

[0012] The present invention addresses therapeutic complications related to performing an anastomosis in general, such as difficulty in healing, bacterial infections, pain at the anastomosis site, or even anastomotic fistulas. All these therapeutic complications must be treated and / or prevented in an effective and minimally invasive manner.

[0013] To that end, the present invention proposes a kit for in situ intestinal anastomosis enema, enabling repeated enemas to be performed without the need for reintroduction during each enema. DESCRIPTION OF THE INVENTION

[0014] An object of the invention relates to a kit comprising a device (1) for in situ intestinal anastomosis enema (2) and an anastomosis protection device comprising a flexible outer sheath (9) connected to a stent (7) located downstream of the sheath, said Petition 870210115942, dated 12 / 15 / 2021, page 12 / 44 / 29 stent being designed to be anchored upstream of the anastomosis, the enema device (1) comprising a perforated tubular element of annular shape (3) that can deliver an enema composition, upstream of the anastomosis, a feed tube (4) one end of which (4a) emerges into the tubular element and one end of which (4b) is open for injection means (5) designed to deliver the composition into said tubular element, retention means (6) for the tubular element upstream of the anastomosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 shows the device (1) for intestinal anastomosis enema according to the invention, said device comprising a perforated tubular element of annular shape (3), a feed tube (4) one end of which (4a) emerges into the tubular element and one end of which (4b) is open for injection means (5) designed to distribute the composition into said tubular element and retention means (6) for the tubular element upstream of the anastomosis.

[0016] Figure 2 schematically shows the enema device (1) according to the present invention coupled to an anastomosis protection device comprising an anchoring element (7) and an outer sheath (9) located at the downstream end of the anchoring element (7) wherein the tubular element (3) of the enema device is fixed to the downstream part of the anchoring element by means of retention (6).

[0017] Figure 3 shows a schematic view of the digestive system with an anastomosis (2) connecting the two ends of a segment taken from the intestine (19a and 19b) where the rectum (11), the anal canal (12), the left colon (13), the transverse colon (14), the right colon (15), the small intestine (16), the stomach (17) and the esophagus (18) are located.

[0018] Figure 4 shows a schematic view of an enema device (1) according to the invention coupled to the protection device of Petition 870210115942, dated 12 / 15 / 2021, page 13 / 44 / 29 anastomosis directed to the upstream position of the anastomosis through an introducer tube (20), the tubular element (3) and the anchoring element (7) being in a radially retracted position when leaving the introducer, the outer sheath (9) and the feed tube (4) still housed inside the introducer tube.

[0019] Figure 5 schematically shows an enema device (1) according to the invention coupled to a device to protect the anastomosis partially positioned upstream of the anastomosis, the tubular element (3) and the anchoring element (7) to which it is attached being in the maximum radially expanded position retained against the intestinal wall.

[0020] Figure 6 schematically shows the enema device (1) according to the invention coupled to the anastomosis protection device with the feeding tube (4) of the enema device and outer sheath (9) of the anastomosis protection device implanted downstream of the anchoring element (7) of the anastomosis protection device. DESCRIPTION OF THE MODALITIES

[0021] The Applicants have developed a device for in situ intestinal anastomosis enema. This device is particularly interesting because it is capable of directly, repeatedly and minimally invasively delivering a so-called enema composition upstream of an anastomosis, said composition possibly comprising one or more active compound(s) in order to treat and / or prevent therapeutic complications associated with performing an anastomosis.

[0022] A first object of the invention relates to a device (1) for intestinal anastomosis enema (2) in situ, said device comprising a perforated tubular element of annular shape (3) which can distribute an enema composition upstream of the anastomosis, a feeding tube (4) one end of which (4a) emerges into the tubular element and one end of which (4b) is open for injection means (5) Petition 870210115942, dated 15 / 12 / 2021, p. 14 / 44 / 29 designed to distribute the composition in said tubular element, retention means (6) for the tube element upstream of the anastomosis.

[0023] In particular, the device according to the present invention relates to a device for in situ intestinal anastomosis enema, and said device can be retained in situ during the period in which anastomosis enemas are performed. In the context of the present invention, in situ positioning and maintenance of the device also means in vivo, since the objective of the invention is intestinal anastomosis enema.

[0024] This in situ installation and maintenance of the device according to the present invention during the anastomosis enema period advantageously allows for repeated and minimally invasive anastomosis enemas, since it avoids passing through the anastomosis during each enema, which risks damaging and altering said anastomosis and, in particular, its suture.

[0025] In fact, this installation does not require multiple passes of the device through the newly performed anastomosis. The device according to the present invention can actually be positioned before performing the anastomosis and using the excision of a pathological intestinal segment and the opening of the lumen of said segment necessary for the positioning of the device according to the invention. It can also be positioned after performing the anastomosis via the anus and requires only a single pass through the newly performed anastomosis. In both cases, the device will be kept in situ throughout the period in which repeated enemas are performed.

[0026] The direct distribution of an enema composition upstream of the anastomosis makes it possible to locally improve the effectiveness of the enema implemented by the present device, in particular the enema composition distributed for the treatment and / or prevention of therapeutic complications related to performing an anastomosis. More particularly, the device according to the present invention is designed Petition 870210115942, dated 12 / 15 / 2021, page 15 / 44 / 29 for intestinal anastomosis enema, that is, for an anastomosis performed in the intestines and preferably a so-called low intestinal anastomosis, such as an anastomosis in the colon, rectum or anal canal, for example a colorectal or coloanal anastomosis, corresponding respectively to a connection between the colon and the rectum or between the colon and the anus.

[0027] In the context of the present invention, “enema” means the distribution of an enema composition over the anastomosis and, in particular, upstream of the anastomosis and in the direction of said anastomosis. The enema in the context of the invention may involve various types of enema compositions depending on the context of use of the device.

[0028] In the context of the invention, enema composition means any composition, preferably liquid, designed to be delivered upstream of the anastomosis and capable of comprising one or more active compounds. The enema composition is chosen according to the context of use of the device.

[0029] Within the meaning of the invention, “context of use of the device” means the purpose(s) of implementing the enema device according to the present invention and, more particularly, the purpose(s) and indications sought by dispensing an enema composition upstream of an anastomosis during the implementation of said device. The context of use of the device, i.e., the purposes of implementing the device, may be varied, such as cleaning the anastomosis, assisting in healing and, more generally, treating and / or preventing therapeutic complications related to performing an anastomosis.

[0030] Within the meaning of the present invention, “therapeutic complication(s)” means physical and / or physiological conditions or disorders that may occur after or be related to the performance of an anastomosis and whose occurrence may be common and normal thereafter. Petition 870210115942, dated 12 / 15 / 2021, p. 16 / 44 / 29 procedure or of a pathological nature. These conditions and disorders include bacterial and / or viral infection, pain at the anastomosis site, difficulty in anastomosis healing, or even anastomotic fistulas.

[0031] “In vivo” here means within a living individual, in particular in the intestines and even more particularly in the intestinal segment located upstream of the anastomosis.

[0032] In the present invention, “in situ” refers to the in vivo position in which the device is installed and maintained during the period during which enemas are performed; more precisely, we refer to the intestinal segment located upstream of the anastomosis in which the device is installed and maintained during the period of performing the enemas. The device according to the present invention is therefore installed and maintained in vivo and in situ.

[0033] “Anastomotic protection” here means protecting the anastomosis during the resumption of intestinal transit, which occurs on average 3 to 5 days after the anastomosis is performed. This period is the postoperative paralysis phase.

[0034] “Upstream of the anastomosis” refers to the position located before the anastomosis site considering the direction of intestinal transit, in particular the position located in front of the anastomosis and in which the device according to the invention was designed to be installed. The so-called upstream position of the anastomosis is comprised between 1 and 1 cm, preferably between 50 cm and 15 cm, more preferably between 30 cm and 15 cm upstream of the anastomosis.

[0035] The retention means (6) for the tubular element in the context of the present invention comprise elements that allow direct or indirect mounting of the tubular element, upstream of the anastomosis and more precisely on the inner wall of the intestinal segment located upstream of the anastomosis. Petition 870210115942, dated 12 / 15 / 2021, page 17 / 44 / 29

[0036] In particular, the retention means (6) of the device according to the present invention are positioned in the tubular element.

[0037] The retention means (6) may be mounting elements, such as loops, tabs or hooks, used individually or in combination.

[0038] Preferably, the retention means (6) comprise indirect mounting means for the perforated tubular element of annular shape of the device according to the present invention on the inner wall of the intestinal segment located upstream of the anastomosis (2).

[0039] Even more preferably, the device retention means according to the present invention can be fixed to a temporary mounting element (7), such as a stent.

[0040] In particular, the retention means (6) of the device according to the present invention can be attached to a stent (7).

[0041] Preferably, the stent is included in a protective device for the intestinal anastomosis.

[0042] More preferably still, the retention means (6) according to the present invention are capable of being fixed to the stent (7) of an intestinal anastomosis protection device designed and capable of being inserted and maintained in situ on the inner wall of the anatomical intestinal segment located upstream of the anastomosis (2).

[0043] More particularly, the retention means (6) of the device according to the present invention are capable of being fixed to the stent (7) of an intestinal anastomosis protection device comprising a flexible outer sheath (9) connected to said stent located downstream of the sheath, said stent being designed to be anchored upstream of the anastomosis. In the context of the present invention, the retention means (6) are therefore capable of fixing the tubular element (3) of the enema device to the stent (7) of the anastomosis protection device.

[0044] The device according to the present invention is Petition 870210115942, dated 12 / 15 / 2021, page 18 / 44 / 29 referred to as coupled or paired with the anastomosis protection device when the retention means (6) of the enema device are fixed to the stent of the anastomosis protection device.

[0045] According to a first embodiment, the retention means fix the tubular element of the device according to the present invention to the inner part of the stent of the anastomosis protection device.

[0046] According to another embodiment, the retention means (6) fix the tubular element of the device according to the present invention to the outside of the stent (7) of the anastomosis protection device.

[0047] According to a preferred embodiment, the retention means (6) fix the tubular element (3) of the device according to the present invention at the downstream end of the stent (7) of the anastomosis protection device and preferably on the outside of said stent. Preferably, in this embodiment, the retention means (6) are located near or around the inner diameter of the tubular element.

[0048] In each of these embodiments, the retention means (6) fix the tubular element (3) of the device according to the present invention to the outer part of the outer sheath (9) of the anastomosis protection device in order to allow the enema composition to be directly distributed upstream of the anastomosis.

[0049] The anastomosis protection device to which the retention means can be attached is an anastomosis protection device as described in the following patent documents FR 2 941 858, EP 2395942, WO2013 / 014353 or patent application WO2019 / 077218.

[0050] The intestinal anastomosis protection device to which the retention means (6) can be attached, i.e., to which the device according to the present invention is coupled, comprises a flexible outer sheath (9) of one piece with a stent (7) downstream thereof, said stent being designed to be anchored upstream of the anastomosis. The stent is the Petition 870210115942, dated 12 / 15 / 2021, p. 19 / 44 / 29 temporary fixation element to the intestinal wall, which keeps the sheath in place and the sheath serves to divert fecal matter to the anus without contact with the intestinal wall at the anastomosis site and, therefore, to protect the anastomosis.

[0051] More precisely, the anastomosis protection device to which the retention means (6) can be attached comprises a temporary anchoring element (7), comprising at least one first longitudinal, hollow, semi-rigid stent-type element, defining a wall of revolution around a longitudinal axis comprising a substantially cylindrical multi-perforated main part of substantially circular section called the first wall,the said first hollow longitudinal element being made of a material that confers radial elasticity properties so that it can be radially compressed in the retracted position and adopt a so-called maximum radial expansion position after the release of the radial compression, such that said first multi-perforated wall has a first outer diameter that can be varied in a controlled manner between a minimum first outer diameter in said retracted radial position of said first wall and a maximum first outer diameter in said maximum radial expansion position of said first wall, and a flexible outer sheath (9) attached to said stent and extending from its downstream end. These elasticity properties of the anchoring element of the anastomosis protection device make it possible to install and maintain this device in situ upstream of the anastomosis and, consequently,the device according to the present invention that is connected to it and more particularly the perforated tubular element (3) of the device according to the present invention which also has elastic properties.

[0052] The anastomosis protection device may also, in at least part, preferably along its entire length, of the surface Petition 870210115942, dated 12 / 15 / 2021, page 20 / 44 / 29 internal part of the anchoring element being lined with an independent watertight layer forming an internal sheath, only the longitudinal ends of said internal sheath being fixed in a watertight manner to the anchoring element using watertight fastening means, such as an annular elastomeric adhesive seal, at each longitudinal end of the internal sheath, in order to delimit a chamber called a vacuum chamber between said internal sheath and the internal surface of the anchoring element, the anchoring element being coupled to a flexible or semi-rigid injection-suction tube that extends outward from said anchoring element, one open end of said injection-suction tube opening into the vacuum chamber.The injection-suction tube is preferably reversibly connected at its free longitudinal end to a connecting terminal piece, which is itself reversibly connected or capable of being reversibly connected to an air injection or suction device, such as a syringe or redon, said connecting terminal piece comprising a closing device, preferably an anti-reflux valve, and a vacuum indicator device capable of indicating the vacuum content in said vacuum chamber. The air suction tube helps to maintain the anastomosis protection device in situ upstream of the anastomosis by air suction from its free end, outside the individual, to pull the intestinal wall by suction against the outer surface of the anchoring element that delimits the chamber and establish the vacuum in said chamber.The combination of the elasticity properties of the anchoring element of the anastomosis protection device and the air suction tube in the vacuum chamber present in said anchoring element ensures a firmer in situ retention upstream of the anastomosis of the anastomosis protection device and, consequently, the device according to the present invention to which it is coupled. Petition 870210115942, dated 12 / 15 / 2021, page 21 / 44 / 29

[0053] The device according to the present invention is preferably coupled to the anastomosis protection device prior to in situ installation of the anastomosis protection device, in order to facilitate and protect the installation of the device according to the present invention.

[0054] The device according to the present invention coupled to the anastomosis protection device can be installed in situ by an introducer device, as described in document WO2013 / 014353.

[0055] More precisely, the introducer device useful in the context of the present invention may consist in a known manner of a semi-rigid guide tube (20) called the introducer tube, of the catheter type, provided at one end with a loop and whose internal diameter and length allow retaining the anchoring element housed therein, therefore preferably the stent of the anastomosis protection device in its retracted form and the sheath in its longitudinally extended form. The introducer device is also capable of being housed in the perforated tubular element of annular shape of the device according to the present invention in the retracted form in said guide tube, and retaining the device's feed tube in its longitudinally extended form.

[0056] For anal introduction, especially after performing an intestinal anastomosis, the introducer device also comprises an introducer instrument comprising: - an outer tubular sheath that may contain and retain the anchoring element and the compressed tubular element in a retracted manner within the distal end of said sheath and the outer sheath and the longitudinally extended feeding tube - means for directing the distal end of said introducer from the anus upstream of the anastomosis and - means for decoupling the anchoring element and the tubular element from the outer sheath, which may consist of a plug tube comprising a plug at its distal end, in contact, where appropriate, with the end Petition 870210115942, dated 12 / 15 / 2021, page 22 / 44 / 29 longitudinal of said anchoring element with the outer sheath of the protection device located downstream of the anchoring element that surrounds the plug tube inside said envelope.

[0057] Means for directing the distal end of the introducer from the anus upstream of the anastomosis may be a pusher extending from the handle connected to the end of the guide tube and comprising a pusher rod and a pusher cap at the distal end of the pusher rod. The pusher cap may push the protective device coupled to the enema device according to the invention on the outside of the distal end of the guide tube to allow its radial extension and anchoring of the anchoring element, especially the stent, against the bowel wall.

[0058] After removing the introducer, the anchoring element, such as the stent and the tubular element attached to it, opens by radial extension and comes into contact with the intestinal walls while the sheath, the feeding tube and the suction tube are extended into the intestinal lumen from the anchoring site upstream of the anastomosis to the anus, crossing the anastomosis.

[0059] The device according to the present invention comprises a feed tube (4) designed to provide the enema composition to the perforated annular tubular element (3). For this purpose, one end (4a) of the feed tube emerges into the tubular element and one end (4b) opens to injection means (5) designed to distribute the composition into said tubular element.

[0060] The end (4a) of the feed tube emerging from the tubular element (3) is fixed to said element by means of watertight fastening, preferably by fusion or by an annular seal of elastomer adhesive. The end (4b) which opens to the injection means (5) designed to distribute the composition in said tubular element may open Petition 870210115942, dated 15 / 12 / 2021, page 23 / 44 / 29 directly or indirectly to said injection means. When the end (4b) of the feed tube opens indirectly to the injection means (5), said end is reversibly connected to a connecting piece, itself connected or capable of being reversibly connected to the injection means, such as a syringe or a pump.

[0061] In particular, the end (4b) of the feed tube (4) that opens to the injection media (5) is designed to be located outside the body.

[0062] More precisely, the end (4b) of the feeding tube that opens to the injection media is located outside the body, i.e., ex vivo, when the tubular element (3) is installed upstream of the anastomosis.

[0063] According to a preferred aspect, the feed tube (4) is a flexible or semi-rigid tube.

[0064] In the context of the present invention, the feed tube (4) has an internal diameter that can be between 1 and 8 mm, preferably between 2 and 5 mm, and more preferably the tube has an internal diameter less than or equal to 5 mm. The tube has an external diameter between 2 and 9 mm, preferably between 3 and 6 mm. A feed tube with an internal diameter less than or equal to 5 mm advantageously ensures the distribution of the enema composition to the perforated annular tubular element, especially small quantities of said composition.

[0065] The feed tube (4) according to the present invention has an initial length that can be adjusted after installation of the device and, in particular, of the tubular element in situ, so that the tube is long enough for the end of the tube through which the composition is inserted to be found outside the body. According to a preferred aspect, the device according to the invention comprises a single feed tube.

[0066] Perforated, the annular shaped tubular element (3) of Petition 870210115942, dated 12 / 15 / 2021, page 24 / 44 / 29 The device is capable of dispensing an enema composition upstream of the anastomosis, such that said element is positioned, installed, upstream of the anastomosis. Positioning the perforated tubular device upstream of the anastomosis allows the composition to flow towards the anastomosis until it reaches it. Preferably, the device according to the present invention comprises a single perforated tubular element of annular shape (3).

[0067] According to a particularly preferred aspect, the tubular element (3) of the device according to the present invention is made of a material that imparts radial elasticity properties to it, so that it can be radially compressed in the retracted position and adopt a maximum radial expansion position after the radial compression is released. These properties advantageously allow the tubular element to adapt to variations in the diameter of the anchoring element of the protective device to which it is attached, especially when housed within the guide tube of the introducer device. In other words, the radial elasticity properties of the perforated tubular element make it possible to retain this element in the retracted form so that it can be kept housed in the guide tube of the introducer device and return to its resting outer diameter after in situ installation.

[0068] The perforated tubular element of annular shape (3) of the device according to the invention has at least one, preferably several perforations (10), said perforations being positioned on the circumference of said element and facing said anastomosis. Positioning the perforations (10) facing the anastomosis allows the enema composition to flow easily in the direction of the anastomosis.

[0069] The tubular element of the device according to the present invention preferably comprises between 5 and 50, more preferably between 5 and 20 perforations. Petition 870210115942, dated 12 / 15 / 2021, page 25 / 44 / 29

[0070] The perforations (10) included in the tubular element may have a diameter 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 vary according to the number or diameter of the perforations, or according to the desired enema composition distribution flow rate.

[0071] Preferably, the tubular element (3) according to the present invention comprises between 5 and 10 perforations (10) having a diameter that can vary from 0.1 to 1 mm.

[0072] According to a particular aspect, the tubular element (3) of the device according to the present invention comprises multiple perforations (10) regularly spaced on the circumference of the tubular element. This configuration allows a homogeneous distribution of the enema composition upstream of the anastomosis and in the direction of the anastomosis.

[0073] The external diameter of the tubular element (3) before in situ installation, also called the external diameter at rest, may be between 10 and 70 mm, preferably between 20 and 50 mm, more preferably between 20 and 40 mm and the internal diameter of the tubular element before in situ installation, also called the internal diameter at rest, may be between 15 and 65 mm, preferably between 25 and 45 mm, preferably between 35 and 40 mm.

[0074] The outer diameter of the tubular element (3) corresponds to the larger diameter formed by the walls of said element and the inner diameter corresponds to the smaller diameter formed by the walls of said element.

[0075] Preferably, the tubular element (3) has an outer diameter at rest between 20 and 50 mm and an inner diameter at rest between 15 and 40 mm.

[0076] When the tubular element (3) of the device is fixed to the outside of the anchoring element (7) of the protective device of Petition 870210115942, dated 12 / 15 / 2021, page 26 / 44 / 29 anastomosis, the resting internal diameter of the tubular element is similar to the resting external diameter of the anchoring element for the anastomosis protection device. Preferably, the resting internal diameter of the tubular element and the resting external diameter of the anchoring element of the anastomosis protection device are adapted according to the diameter of the intestinal segment of the individual in which they are to be inserted.

[0077] The outer diameter and inner diameter of the tubular element (3) after in situ installation are substantially smaller than the outer and inner diameter at rest due to the pressure of the inner wall of the intestinal segment in which the element is installed and the elasticity properties of the materials that compose it.

[0078] In particular, the device according to the present invention is made of biocompatible material.

[0079] More precisely, the perforated tubular element of annular shape (3), the feed tube (4) and the retention means (6) of the device according to the present invention are made of biocompatible material.

[0080] “Biocompatible material” or “biomaterial” refers to a material with the ability not to interfere with or degrade the biological environment in which it is used, in direct or indirect, brief or prolonged contact with the tissues and internal fluids of the body of a human being or an animal. 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, nickel, polymers of natural origin such as collagen, agarose, chitosan, carrageenan, cellulose and its derivatives, xanthan and alginate or of synthetic origin, such as polyesters, polyolefins, polyanhydrides, vinyl polymers, polyurethanes, polyamides, polyether amides, preferably thermosensitive polymers, such as thermosensitive polyurethane (TSP) or thermosensitive polyether amide (TSP-A). Petition 870210115942, dated 12 / 15 / 2021, p. 27 / 44 / 29

[0081] Preferably, the biocompatible material useful in the context of the present invention is chosen from one or more materials, including nickel-titanium metal alloy known as nitinol, thermosensitive polyurethane (TSP) and thermosensitive polyether amide (TSP-A).

[0082] More preferably, the biocompatible material that makes up the tubular element is chosen from nickel-titanium alloy or thermosensitive polyether amide (TSP-A), more preferably thermosensitive polyether amide (TSP-A).

[0083] More preferably, the biocompatible material that makes up the feeding tube is heat-sensitive polyurethane (TSP).

[0084] More preferably, the biocompatible material comprising the retention media for the tubular element is chosen from nickel-titanium alloy or thermosensitive polyether amide (TSP-A), more preferably thermosensitive polyether amide (TSP-A).

[0085] The biocompatible material that makes up the tubular element and the feeding tube of the device according to the present invention may be identical or different.

[0086] According to a particular aspect, the injection means (5) of the device according to the present invention comprise a syringe or a pump.

[0087] The injection means (5) comprised in the device according to the present invention are capable of capturing, piercing, retrieving and aspirating the enema composition from the device according to the invention into the container or receptacle in which they are located.

[0088] The enema composition is designed to be inserted into the end (4b) of the feed tube (4) which opens to the injection media (5) to be delivered to the tubular element (3) and distributed upstream of the anastomosis (2). The composition is chosen according to the context of use of the device, i.e. the purpose(s) of the anastomosis enema. Petition 870210115942, dated 12 / 15 / 2021, page 28 / 44 / 29

[0089] The enema composition in the context of the present invention is a dermatological composition designed and suitable for application to the intestinal mucosa.

[0090] In the context of the present invention, the enema composition may be an aqueous, alcoholic or hydroalcoholic solution or an emulsion which may comprise one or more active compounds and a pharmaceutically acceptable excipient.

[0091] For example, the composition of an enema may be an emulsion obtained by dispersing a fatty phase in an aqueous phase or vice versa.

[0092] This composition can be prepared according to all methods well known to a skilled person.

[0093] In particular, the enema composition for the device according to the present invention is an aqueous, alcoholic or hydroalcoholic composition that may comprise one or more active compound(s) and a pharmaceutically acceptable excipient.

[0094] According to a first embodiment, the enema composition for the device according to the present invention is an aqueous, alcoholic or hydroalcoholic composition that may comprise one or more active compound(s) and a pharmaceutically acceptable excipient. Preferably, the enema composition is an aqueous composition.

[0095] The composition of an enema may comprise several different or identical enema compounds.

[0096] In the context of the present invention, “active compound” refers to any compound that may have a pharmacological activity and / or a physiological effect on the individual to whom the composition comprising it is administered.

[0097] The active compound(s) included in the enema composition may be chosen from an antiseptic agent, an antibacterial agent, an antibiotic, an antiviral agent, an antiparasitic agent, Petition 870210115942, dated 12 / 15 / 2021, page 29 / 44 / 29 an antifungal agent, an antiallergic agent, an immunosuppressant agent, an analgesic agent, an anesthetic agent, an antiangiogenic agent, an antiproliferative agent, an anti-inflammatory agent, a wound healing agent, a probiotic agent or a mixture of these compounds.

[0098] More particularly, the enema composition according to the invention comprises one or more active compounds selected from an antiseptic agent, an antibacterial agent, an anti-inflammatory agent, an analgesic agent and a healing agent.

[0099] More specifically still, the active compound(s) may be chosen from an antiseptic agent, such as chlorhexidine, hexamidine, benzalkonium, benzyl alcohol, triclosan, iodine; an antibacterial agent, such as butyrate, demeclocycline, chlortetracycline, oxytetracycline, tetracycline, chloramphenicol, fusidic acid, mupirocin, neomycin; an anti-inflammatory agent, such as butyrate, corticosteroids, such as hydrocortisone, prednisolone, clobetasol, desonide, triamcinolone, ketoprofen, diclofenac, benzydamine, ibuprofen; a wound-healing agent, such as butyrate, hyaluronic acid, hyaluronic acid butyrate, dexpanthenol, trolamine, retinol or vitamin A, cadexomer, dextranomer, crilanomer, enoxolone, pantothenate calcium, an analgesic agent, such as non-opioid analgesics like diclofenac, ibuprofen, paracetamol or ketoprofen, stage II opioid analgesics like tramadol or codeine, or stage III opioid analgesics like fentanyl, morphine,oxycodone or sufentanil.

[00100] This list of active compounds is given by way of example; those skilled in the art will know how to determine the active compounds that can be used in the context of the present invention.

[00101] The enema composition may comprise between 0.001 and 10% of active compound(s), preferably between 0.01 and 8%, preferably between 0.1 and 5%, more preferably between 0.1 and 3%, preferably between 0.1 and 2%, and most preferably 2% by weight relative to the total weight of the Petition 870210115942, dated 12 / 15 / 2021, page 30 / 44 / 29 composition.

[00102] According to a preferred aspect, the enema composition according to the present invention comprises 5% by weight of active compound(s) relative to the total weight of the composition.

[00103] According to a second embodiment, the enema composition for the device according to the present invention is an aqueous, alcoholic or hydroalcoholic composition that does not comprise an active compound, preferably the enema composition is an aqueous composition, such as physiological saline, particularly suitable when the purpose of the enema is to cleanse the anastomosis.

[00104] The composition according to the present invention may also comprise inert or pharmacodynamically active additives, individually or in combination, such as solvents, humectants, stabilizing agents, surfactants, preservatives, pH regulators, vitamins, emulsifying agents, humectants, moisturizers, soothing agents, penetrating agents, antioxidants, cosmetically active agents, electrolytes, conventional acids or bases or mixtures.

[00105] The expert will take care to choose the active compound(s), additives and pharmaceutical excipient according to the purpose(s) of the enema and the desired form of the composition.

[00106] In the context of the present invention, a pharmaceutically acceptable excipient is any compound other than the active compound and compatible with any other compounds present in the composition, compatible with the elements of the device with which it is in contact, and compatible with the skin and mucous membranes, in particular the intestinal mucosa.

[00107] Within the meaning of the present invention, "individual" or "patient" means any mammal and especially human beings, males, females and children.

[00108] The enema composition of the device according to the Petition 870210115942, dated 12 / 15 / 2021, page 31 / 44 / 29 The present invention is designed to be contained in a receptacle suitable for said composition and from which the injection means can collect it.

[00109] The objective(s) of an enema all have as a direct or indirect consequence the treatment and / or prevention of therapeutic complications related to the performance of an anastomosis and especially the prevention of anatomical fistulas.

[00110] In the context of the present invention, “treat” or “treatment” means an improvement or reversal of a specified disease or disorder or at least a discernible or indiscernible symptom. The term “treat” may also mean the reduction or slowing of the progression of the disease or disorder, or the onset of symptoms of this disease or disorder. For example, in the context of the present invention, the term “treat” may correspond to the reduction or slowing of a therapeutic complication associated with performing an anastomosis, such as a bacterial infection of the anastomosis, pain at the anastomosis site, impaired healing, and / or reduction or slowing of the appearance of anastomotic fistulas.

[00111] In the context of the present invention, “prevent” or “prevention” means a reduction in the risk of acquiring a specific disease or disorder or a reduction or slowing of the onset of symptoms of this disease. For example, in the context of the present invention, the term “prevent” may correspond to reducing the risk of a complication associated with performing an anastomosis, such as a bacterial infection of the anastomosis, pain at the anastomosis site, impaired healing, and / or a reduction or slowing of the onset of anastomotic fistulas.

[00112] The present invention also relates to the use of the device according to the first object or a method for treating or preventing one or more therapeutic complications related to performing an anastomosis in an individual. Petition 870210115942, dated 12 / 15 / 2021, pp. 32 / 44 / 29

[00113] More particularly, the present invention relates to the use of the device according to the first object or a method for treating and / or preventing one or more therapeutic complications related to performing an anastomosis in an individual, in whom the device, in particular the tubular element of said device, is installed in situ upstream of said anastomosis, and the enema composition is inserted by means of injection into the end of the feeding tube of the device opening so that said means of injection are distributed upstream of the anastomosis by means of said tubular element. The composition of the enema and the quantity of said composition are determined according to the desired therapeutic complication(s).

[00114] The present invention also relates to a device according to the first object for its use in the treatment or prevention of one or more therapeutic complications related to performing an anastomosis in an individual.

[00115] More particularly, the present invention relates to a device according to the first object for its use in the treatment or prevention of one or more therapeutic complications related to performing an anastomosis in an individual, in whom the device, in particular the tubular element of said device, is installed in situ upstream of said anastomosis and the enema composition is inserted by means of injection at the end of the feeding tube of the device opening so that said means of injection are distributed upstream of the anastomosis by means of said tubular element. The composition of the enema and the quantity of said composition are determined according to the therapeutic complication(s) sought.

[00116] In the case of the uses and methods mentioned above, the device retention means according to the invention are fixed to the anchoring element, especially the stent, of a protective device. Petition 870210115942, dated 12 / 15 / 2021, page 33 / 44 / 29 anastomosis before its in situ installation. In other words, the device according to the present invention is coupled to the anastomosis protection device before its in situ installation.

[00117] Preferably, the device according to the present invention is installed upstream of the anastomosis after it has been performed through the anus by an introducer device as described in relation to the first object of the present invention. More precisely, the introducer device may consist of a semi-rigid guide tube, of the catheter type, provided at one end with a loop and whose inner diameter and length allow the anchoring element of the anastomosis protection device to be housed, therefore, preferably, the stent and the tubular element of the device according to the present invention, in its retracted form, and the sheath of the anastomosis protection device and the feeding tube of the device according to the present invention implanted longitudinally.

[00118] Preferably, the device according to the present invention is installed upstream of the anastomosis immediately after the anastomosis is performed, that is, at the end of the surgical procedure.

[00119] In the context of the uses and methods mentioned above, the device according to the present invention can be used alone or combined with the simultaneous or sequential administration of other medicinal compounds, such as antibacterial agents, analgesic agents or wound healing agents, said compounds being administered enterally, such as orally or anally, or parenterally, such as intravenously or otherwise.

[00120] In the context of the uses or methods mentioned above, the device and, in particular, the tubular element of said device is installed upstream of said anastomosis at a distance of between 20 and 5 cm, preferably between 15 and 10 cm from the area where the anastomosis is to be performed. Petition 870210115942, dated 12 / 15 / 2021, pages 34 / 44 / 29 completed.

[00121] In the context of the uses or methods mentioned above, the enema composition is repeatedly distributed upstream of the anastomosis one or more times a day, preferably at least once a day, for a period suitable for the purpose of the enema.

[00122] The appropriate enema period may be between 1 day and 3 weeks, preferably 1 day and 15 days, more preferably 9 days. Preferably, in the context of the uses and methods mentioned above, the enema composition is distributed upstream of the anastomosis once a day for 9 days, starting from the second day after the anastomosis is performed.

[00123] In the context of the uses or methods mentioned above, different enema compositions may be administered upstream of the anastomosis, simultaneously or at different times with a delay between each administration.

[00124] The expert will know how to determine the treatment and / or prevention parameters to be implemented, such as the amount of enema composition to be inserted, the frequency of administration, the active compound(s) present in the composition, the dosage of each active compound, and the form of the composition.

[00125] The present invention also relates to a method for upstream installation of an anastomosis in which: - the enema device (1) according to the first object is coupled to the anastomosis protection device, in particular the tubular element (3) of the device according to the invention is fixed to the anchoring element (7) of the anastomosis protection device.

[00126] - the tubular element (3) of the device according to the present invention and the anchoring element (7) of the anastomosis protection device are housed in a retracted form within the distal end of the semi-rigid guide tube (20) of an introducer device consisting of said Petition 870210115942, dated 12 / 15 / 2021, page 35 / 44 / 29 tube provided with a handle at one of its ends.

[00127] - the distal end of the guide tube of the introducer device is introduced from the anus upstream of the anastomosis by appropriate means.

[00128] - the anchoring element and the tubular element are released from the guide tube by appropriate means.

[00129] The means for directing the anchoring element and the tubular element from the anus upstream of the anastomosis may be a pusher extending from the loop connected to the end of the guide tube and comprising a pusher rod and a pusher plug at the distal end of the pusher rod. Since the pusher plug can release the anchoring element and the tubular element by pushing them out of the distal end of the guide tube to allow their radial extension and anchoring of the anchoring element, especially the stent, against the bowel wall.

[00130] Preferably, the installation method is implemented immediately after the anastomosis is performed, that is, at the end of the surgical procedure.

[00131] The enema device according to the present invention is removed at the end of the chosen enema period by an endoscopic technique using an endoscopic forceps. More precisely, the anchoring element, i.e., the stent (7) of the anastomosis protection device to which the tubular element (3) of the device according to the invention is coupled, is separated from the intestinal wall by the upstream end of the stent in a first step and then is removed by the downstream end of the stent from the individual's body through the anus.

[00132] The present invention also relates to a kit comprising device (1) according to the first object of the invention, which comprises injection means (5) and a protection device. Petition 870210115942, dated 12 / 15 / 2021, page 36 / 44 / 29 anastomosis comprising a flexible outer sheath (9) connected to a stent (7) located downstream of the sheath, said stent being designed to be anchored upstream of the anastomosis. Preferably, the kit also comprises an enema composition.

[00133] Preferably, the kit according to the invention comprises the device according to the first object of the invention comprising a perforated tubular element of annular shape capable of dispensing an enema composition upstream of the anastomosis, a feed tube one end of which emerges into the tubular element and the other end opens to injection means designed to dispense the composition into said tubular element, retention means for the tubular element upstream of the anastomosis, injection means for an enema composition and a device for protecting the anastomosis comprising an outer sheath connected to a stent located downstream of the sheath, said stent being designed to be anchored upstream of the anastomosis.

[00134] The injection means (5) may be a syringe or a pump, preferably a syringe.

[00135] In particular, the kit according to the present invention also comprises a receptacle comprising an enema composition ready to be inserted through the free end of the tube of the device according to the first object.

[00136] According to a preferred aspect, the kit according to the present invention comprises the device according to the first object of the invention coupled to the anastomosis protection device, that is, wherein the tubular element (3) of the device according to the present invention is fixed by means of retention (5) to the anchoring element (7) of the anastomosis protection device.

[00137] Preferably, the kit according to the present invention also comprises an introducer device capable of inserting the device Petition 870210115942, dated 12 / 15 / 2021, p. 37 / 44 / 29 according to the present invention coupled to the anastomosis protection device upstream of the anastomosis. The introducer device may consist of a semi-rigid guide tube (20), of the catheter type, provided at one end with a loop and whose inner diameter and length allow the anchoring element of the anastomosis protection device to be housed, therefore preferably the stent and the tubular element of the device according to the present invention, in its retracted form, and the sheath of the anastomosis protection device and the feeding tube of the device according to the present invention implanted longitudinally.

[00138] The kit according to the present invention comprises the tubular element (3) of the device according to the present invention and the anchoring element (7) of the anastomosis protection device in the retracted form within the guide tube (20) of the introducer device.

[00139] The invention will be further illustrated by the following figures. However, these figures should in no way be interpreted as limiting the scope of the invention.

Claims

1. Kit comprising a device (1) for intestinal anastomosis enema (2) in situ and an 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 anchored upstream of the anastomosis, characterized in that the enema device (1) comprises a perforated tubular element of annular shape (3) that can deliver an enema composition upstream of the anastomosis, a feeding tube (4) one end of which (4a) emerges into the tubular element and one end of which (4b) is open for injection means (5) designed to deliver the composition into said tubular element, retention means (6) for the tubular element upstream of the anastomosis.

2. Kit according to claim 1, characterized in that the retention means (6) of the enema device (1) are positioned in the tubular element.

3. Kit according to claim 1 or 2, characterized in that the retention means (6) of the enema device (1) are fixed to the stent (7) of the anastomosis protection device.

4. Kit according to any of the preceding claims, characterized in that the feed tube (4) of the enema device (1) has an internal diameter between 1 and 8 mm.

5. Kit according to any of the preceding claims, characterized in that the tubular element (3) of the enema device (1) comprises multiple perforations (10) regularly spaced in the circumference of the tubular element.

6. Kit according to any of the preceding claims, characterized in that the enema device (1) is made of biocompatible material. Petition 870210115942, dated 12 / 15 / 2021, page 39 / 44 2 / 2 7. Kit according to any of the preceding claims, characterized in that the injection means (5) of the enema device (1) comprise a syringe or a pump.

8. Kit according to any of the preceding claims, characterized in that it comprises an enema composition.

9. Kit according to any of the preceding claims, characterized in that the tubular element (3) of the enema device (1) is fixed by retention means (6) in the stent (7).

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