Medical device for implementing ileostomy and / or jejunostomy

Abstract

A medical device (1) for implementing ileostomy and / or jejunostomy, comprising: at least one tubular element (2) comprising at least one passage channel (3) provided with a plurality of excrement inlet openings (4) insertable into the intestine (I) of a patient, and provided with at least one excrement outlet opening (5) positionable outside the intestine (I), wherein the tubular element (2) comprises at least a first section (2a) on which the inlet opening (4) is defined and at least a second section (2b) on which the outlet opening (5) is defined; blocking means (6) of at least one zone (Z) of the intestine (I) associated with the tubular element (2), which blocking means can be inserted into the intestine (I) and can be moved between a constricted configuration and an expanded configuration, respectively, to allow insertion thereof into the intestine (I) and to prevent excreta from passing through the zone (Z), the blocking means (6) being located between the first section (2a) and the second section (2b); at least one sheath member (11) associated with the tubular element (2), the at least one sheath member being arranged to abut against the blocking means (6) and adapted to counteract a relevant sliding between the blocking means (6) and the tubular element (2).

Description

Technical Field

[0001] The present invention relates to a medical device for performing ileostomy and / or jejunostomy. Background Art

[0002] Scientific literature reports that in cases of colorectal resection with ileocolic, colocolic, colorectal, or coloanal anastomosis, a protective ileostomy needs to be performed to reduce complications related to anastomotic dehiscence.

[0003] For example, in cases where surgical resection of the intestine itself is performed due to bowel cancer and anastomosis is subsequently carried out, it is necessary to divert the excretory flow to prevent excreta from reaching the surgical area and infecting it.

[0004] To this end, the common practice is to perform an ileostomy, which is to externalize the small intestine through the abdominal wall to transfer intestinal contents to an external container, thereby preventing them from reaching the anastomosis.

[0005] Specifically, depending on the lesion, the ileostomy can be of a temporary or permanent type.

[0006] As can be easily guessed, a temporary ileostomy is used to suspend the function of a segment of the intestine for a certain period of time and then restore the normal function of the intestine itself after such a temporary suspension.

[0007] On the other hand, a permanent ileostomy is used in cases of specific diseases and provides a permanent intestinal diversion.

[0008] The present disclosure mainly relates to the case of a temporary ileostomy.

[0009] More specifically, currently, a temporary ileostomy is performed by passing a loop of ileum (which is positioned upstream of the area to be protected with respect to the forward direction of intestinal fluid) through an opening (stoma) formed in the abdominal wall.

[0010] When the ileostomy has completed its protective function for the above-mentioned anastomosis, it can be removed through further surgery, and then intestinal continuity can be restored. The ileostomy closure surgery is usually performed about two months after the first surgery.

[0011] The stoma and subsequent closure of a temporary ileostomy have many drawbacks, which are described in detail in the scientific literature.

[0012] The presence of an ileostomy not only causes great physical and mental discomfort to patients who have to undergo various invasive surgeries under general anesthesia, but also results in a long postoperative recovery time.

[0013] In addition, this surgery also incurs high costs for medical institutions in two aspects: the management of ileostomy (outpatient medical examinations for any complications, maintenance, and handling of single-use collection plates and bags), and the additional surgery required for ileostomy closure (high-tech medical devices, use of the operating room, and related personnel).

[0014] In addition, it should be taken into account that the medical staff and equipment mobilized for such surgeries cannot obviously be diverted from other ongoing surgeries, and this fact obviously leads to an extension of the waiting time for other surgeries.

[0015] Therefore, the surgery for implementing the above-mentioned type of temporary ileostomy is also proven to be expensive in terms of medical logistics.

[0016] Medical devices constructed according to the teachings of patent WO2016098064A1 are known to be used to solve at least some of the above-mentioned drawbacks.

[0017] In this document, a device is particularly described, which includes a tubular element in which at least one passage is defined. The passage is provided with a plurality of excrement inlet openings that can be inserted into the patient's intestine, and is provided with at least one excrement outlet opening that can be positioned outside the intestine.

[0018] Specifically, the device includes an occlusion device associated with the tubular element and positioned in the intestinal region between the inlet opening and the outlet opening.

[0019] Specifically, the occlusion device can be inserted into the intestine itself and can move between a constricted configuration and an expanded configuration to respectively enable it to be inserted into the intestine and prevent excrement from passing through the aforementioned region of the intestine itself.

[0020] In this case, the occlusion device basically consists of a balloon pressure probe, which is configured to expand when switching from the constricted configuration to the expanded configuration, and conversely, to contract when switching from the expanded configuration to the constricted configuration.

[0021] Therefore, the probe can expand radially and, in doing so, contact the intestinal wall, thereby blocking the passage of excrement to reach the aforementioned region of the intestine.

[0022] In this regard, it is necessary to emphasize that this medical device allows the problems currently complained about to be solved, and in particular significantly limits the invasive surgeries performed on patients for the application and removal of ileostomy.

[0023] In fact, it is applied during surgeries aimed at treating intestinal lesions, and its removal is completed on an outpatient basis without using any anesthesia.

[0024] In particular, in the case of performing a surgery in a laparoscopic manner, the same ports used for the surgery can also be utilized to apply the relevant device, thereby minimizing the surgery on the patient in this way.

[0025] Compared with the use of the prior art, this fact results in a significantly shortened recovery time because the removal of the ileostomy occurs instantaneously, and the patient not only does not need to undergo further surgery but even does not have to bear the consequences of general anesthesia again.

[0026] Despite achieving the aforementioned benefits, the medical device described in the patent document WO2016098064A1 can still be refined to further improve its effectiveness and convenience of use.

[0027] First of all, it has been found in actual use that high intestinal pressure may cause the probe to shift on the tubular element during the removal of the device, thus hindering the execution of its own removal and damaging the normal function of the device in its subsequent use.

[0028] In addition, it should be emphasized that the probe and the tubular element have quite different thicknesses at the point of transition from the former to the latter; due to this fact, during the insertion of the device into the patient's intestine, the transition from the probe to the tubular element does not occur in a smooth and gradual manner but suddenly and rapidly.

[0029] Therefore, it is easy to understand how the aforementioned insertion may cause considerable physical and psychological discomfort to the patient, thereby directly leading to complications during the surgery and possibly delaying the patient's postoperative recovery. Summary of the Invention

[0030] The main object of the present invention is to design a medical device for implementing ileostomy and / or jejunostomy, which is reliable, practical and easy to remove from the patient's intestine.

[0031] Within the scope of the aforementioned main object, an object of the present invention is to design a medical device for implementing ileostomy and / or jejunostomy, the use of which causes a significant reduction in the physical and psychological discomfort suffered by the patient.

[0032] Another object of the present invention is to design a medical device for implementing ileostomy and / or jejunostomy, which is provided with a rigid and strong structure while maintaining good flexibility of the probe.

[0033] Another object of the present invention is to design a medical device for implementing ileostomy and / or jejunostomy, which allows the aforementioned disadvantages of the prior art to be overcome within the framework of a simple, reasonable, easy-to-use, effective and cost-effective solution.

[0034] The above object is achieved by means of a medical device for performing ileostomy and / or jejunostomy having the features of claim 1. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Other features and advantages of the present invention will become more apparent from the following description of a preferred but non-exclusive embodiment of a medical device for performing ileostomy and / or jejunostomy, which is illustrated by way of indicative and non-limiting example in the list of drawings, in which:

[0036] Figure 1 is an axonometric general view of the device according to the present invention;

[0037] Figure 2 is Figure 1 a partially transparent detailed view of

[0038] Figure 3 is a cross-sectional view of the device according to the present invention;

[0039] Figure 4 is a longitudinal cross-sectional view of the device according to the present invention;

[0040] Figure 5 and Figure 6 show the operation of the device according to the present invention according to a first embodiment;

[0041] Figure 7 show a second embodiment of the device according to the present invention. DETAILED DESCRIPTION

[0042] With particular reference to these drawings, the reference numeral 1 generally denotes a medical device for performing ileostomy and / or jejunostomy.

[0043] The medical device 1 for performing ileostomy and / or jejunostomy first of all comprises at least one tubular element 2, which in turn comprises at least one passageway 3 provided with a plurality of excrement inlet openings 4 which can be inserted into the intestine I of a patient, and at least one excrement outlet opening 5 which can be positioned outside the intestine I.

[0044] The tubular element 2 is made of a radio-opaque material (such as silicone or polyurethane).

[0045] More particularly, as Figure 2 can be seen, the tubular element 2 comprises at least a first section 2a on which the inlet openings 4 are defined, and at least a second section 2b.

[0046] Specifically, the outlet opening 5 is obtained on the second section 2b ( Figure 1 ).

[0047] The first section 2a can be inserted into the intestine I of the patient through a stoma obtained, for example, on the abdomen A of the patient, in order to perform laparoscopic surgery, such as a surgery for removing an ileal section.

[0048] Advantageously, the inlet opening 4 is defined at the lateral surface of the first section 2a.

[0049] The inlet opening 4 is distributed in such a way as to allow the introduction of the liquid discharged along most of the lateral surface of the first section 2a into the through-channel 3.

[0050] In this regard, at least two of the inlet openings 4 are arranged along the longitudinal extension of the first section 2a.

[0051] Specifically, all the inlet openings 4 are arranged along the longitudinal extension of the first section 2a.

[0052] Specifically, the inlet openings 4 are aligned to define two rows parallel to each other at diametrically opposite positions obtained on the first section 2a.

[0053] Preferably, the inlet opening 4 has a substantially oval configuration.

[0054] More specifically, the major axis of the inlet opening 4 is arranged to be substantially parallel to the longitudinal extension of the first section 2a.

[0055] The inlet opening 4 has a size such as to allow the excretory flow to flow out into the through-channel 3 and, at the same time, prevent the tubular element 2 from being weakened.

[0056] In fact, in the case of equally weakening the first section 2a, the oval shape of the inlet opening 4 allows the maximum possible excretory flow to flow out.

[0057] In this regard, that is, in order to allow a sufficient number of inlet openings 4 having the aforementioned dimensions, the length of the first section 2a is substantially between 8 cm and 10 cm.

[0058] On the other hand, the second section 2b is intended to be arranged outside the intestine I, and the outlet opening 5 arranged at its axial end can be connected to an excretory product collection container not shown in the figure.

[0059] Preferably, the second section 2b has a length substantially equal to 40 cm.

[0060] After having described the two sections 2a and 2b of the tubular element 2, the device 1 comprises an occlusion device 6 of at least one zone Z of the intestine I associated with the tubular element itself.

[0061] Specifically, the blocking device 6 can be inserted into the intestine I and can move between a constricted configuration and an expanded configuration to respectively allow its insertion into the intestine I and prevent excrement from passing through the zone Z.

[0062] As Figure 2 can be seen, the blocking device 6 is positioned between the first section 2a and the second section 2b.

[0063] The blocking device 6 is adapted to isolate the part of the intestine I that is arranged downstream of the zone Z with respect to the direction of excrement advancement.

[0064] In other words, the blocking device 6 allows the intestine I to be divided into two parts, as Figure 5 and Figure 6 shown by way of example, wherein the first part I' and the second part I'' thereof are respectively arranged downstream and upstream of the blocking device with respect to the direction of excrement advancement.

[0065] Thus, the first part I' communicates with the patient's stomach, while the second part I'' including the part to be protected corresponds to the part whose function is to be suspended, for example, the part where an anastomosis has been performed.

[0066] The inlet opening 4 and thus also the first section 2a are intended to be received in the first part I' of the intestine I, that is, always upstream of the blocking device 6 with respect to the direction of excrement advancement, so as to allow the interception of the secretions of the digestive tract.

[0067] In this sense, the blocking device 6 is configured to prevent excrement from passing from the first part I' through the zone Z to reach the second part I'', as expected.

[0068] Preferably, the blocking device 6 includes at least one inflatable balloon pressure probe 6a.

[0069] The probe 6a is arranged outside the tubular element 2 and is substantially contracted in the constricted configuration ( Figure 5 ), and is inflated in the expanded configuration ( Figure 6 ).

[0070] According to the first embodiment visible in the foregoing Figure 5 and Figure 6 , the blocking device 6 includes a single probe 6a.

[0071] According to Figure 7 the second embodiment shown, the blocking device 6 includes two probes 6a arranged at a reference distance D from each other along the device 1.

[0072] Specifically, the reference distance D is between 5 cm and 25 cm, more preferably between 10 cm and 20 cm, and preferably 15 cm.

[0073] It should be noted that, in this regard, compared with the first embodiment, how the special design of providing the additional probe 6a allows for defining an anchoring point within the intestine I of the patient, with the beneficial result of increasing the stability of the device 1 and thus its practicality and ease of use.

[0074] However, the possibility of implementing the device 1 according to additional embodiments in which a greater number (such as three) of probes 6a are provided cannot be excluded.

[0075] In all cases, the device 1 includes activation means 7 for the probe 6a.

[0076] The activation means 7 includes at least one internal cavity 7a through which an air inlet and outlet communicate with the probe 6a via associated conduits associated with the tubular element 2.

[0077] The conduit setting the internal cavity 7a in communication with the probe 6a is separate from the passage 3.

[0078] In the first embodiment, the activation means 7 includes a single internal cavity 7a that communicates with a single probe 6a ( Figure 5 and Figure 6 ).

[0079] Regarding the second embodiment, the activation means 7 includes two internal cavities 7a, each of which communicates with a corresponding probe 6a ( Figure 7 ).

[0080] The activation means 7 further includes a check valve (not shown in detail in the figure), which is adapted to prevent the accidental escape of air contained in the probe 6a, and the user can control the check valve to allow air to flow outwards.

[0081] Advantageously, the blocking means 6 includes a plurality of elastically deformable tensioning elements 8 that are associated with at least the first section 2a to prevent it from bending.

[0082] Specifically, the tensioning elements 8 cover the first section 2a and the blocking means 6 from the outside.

[0083] Specifically, the tensioning elements 8 have a substantially filamentous configuration and are spaced apart from each other to define a plurality of passage gaps 9, which are adapted to allow intestinal contents to pass through to reach the inlet opening 4.

[0084] Advantageously, the tensioning elements 8 are locked together to define a single body member.

[0085] Specifically, the tensioning elements 8 are locked together at the positions where their respective ends are located.

[0086] In this regard, it should be emphasized that the tensioning element 8 just described has: a first end 8a which is associated with the first section 2a near the free end 10 of the tubular element 2 (i.e., in use, the end of the tubular element which is arranged within the patient's intestine I, i.e., the end which is arranged adjacent to the first section 2a and which is located between the free end 10 and the occlusion device 6); and a second end 8b opposite to the first end 8a.

[0087] More specifically, in the constricted configuration, these tensioning elements 8 are in an initial configuration in which they are substantially attached to the tubular element 2 ( Figure 1 , Figure 4 and Figure 5 ).

[0088] Similarly, in the expanded configuration, these tensioning elements 8 are in an active configuration in which they are spaced apart from the profile of the tubular element 2 ( Figure 6 ).

[0089] Specifically, in the active configuration, the tensioning elements 8 exhibit a divergent configuration extending from the free end 10 towards the probe 6a.

[0090] This means that, in the active configuration, the tensioning elements 8 are tensioned by the probe 6a in order to impart rigidity to the first section 2a and to prevent the first section from bending by itself and thus blocking the inlet opening 4.

[0091] For example, the tensioning elements 8 are made of a material suitable for medical use (such as polyurethane or silicone).

[0092] According to the invention, the device 1 comprises at least one sheath member 11 associated with the tubular element 2, which at least one sheath member is arranged to abut against the occlusion device 6 and is adapted to counteract relative sliding between the occlusion device 6 and the tubular element 2.

[0093] In particular, the sheath member 11 is preferably at least partly made of at least one plastic material.

[0094] More specifically, the sheath member 11 is at least partly made of silicone.

[0095] Conveniently, the sheath member 11 is entirely made of silicone.

[0096] In fact, such a material makes it possible to form a sheath member 11 which is completely biocompatible, healthy and hygienic, and thus its use on the human body is absolutely safe.

[0097] As regards its geometry, the sheath member 11 has a substantially tubular shape.

[0098] In particular, the diameter of the sheath member 11 is greater than the diameter of the tubular element 2.

[0099] In particular, the diameter of the sheath member 11 is such that it can be substantially sized to fit onto the tubular element 2.

[0100] Conveniently, the blocking device 6 includes at least one contact portion 12 which, in use, abuts against the sheath member 11.

[0101] As can be seen in the figure, the contact portion 12 has a substantially cylindrical configuration.

[0102] In this regard, it should be emphasized that the contact portion 12 is associated with the tensioning elements 8 just described to define a single body member therewith (see Figure 2 in this regard).

[0103] Specifically, the tensioning elements 8 are associated with the contact portion 12 by means of their second ends 8b.

[0104] Thus, due to the tensioning elements 8 changing from an initial configuration to an active configuration or vice versa, or due to the blocking device 6 changing from a constricted configuration to an expanded configuration or vice versa, the contact portion 12 slides along the tubular element 2.

[0105] In this case, as Figure 4 clearly visible in, the contact portion 12 and the sheath member 11 have substantially consistent lateral dimensions at the location of their contact area to define a seamless outer engagement surface 13.

[0106] Stating this means that the configurations of the contact portion 12 and the sheath member 11 are such that a straight line tangent to their outer surfaces does not encounter any kind of geometric discontinuity in the transition between the two.

[0107] In fact, the contact portion 12 and the sheath member 11 engage with each other to jointly define a substantially uninterrupted peripheral surface.

[0108] It should be emphasized that what has been described so far for the sheath member 11 allows, in the context of a technically feasible solution with low implementation costs, to overcome the drawbacks of the prior art that have been complained about previously.

[0109] First of all, the fact that the sheath member 11 abuts against the blocking device 6 and thus prevents their relative sliding with respect to the tubular element 2 avoids the risk that the probe 6a slips out of the tubular element itself when removing the device 1.

[0110] Therefore, this fact allows the operation of the removal device 1 to be greatly facilitated and ensures the normal functioning of the device in its subsequent use.

[0111] In addition, the unique configuration of the sheath member 11 (and in particular the substantially uninterrupted external engagement surface 13 between this member and the blocking device 6) allows the device 1 to be smoothly and progressively inserted into the intestine I of the patient.

[0112] For this reason, it is easy to understand how the device 1 can be advantageously used to perform ileostomy and / or jejunostomy without causing any physical and psychological discomfort to the patient, thus directly leading to a simplification of the procedure and therefore to a simplification of the postoperative recovery.

[0113] After having described these advantages, it is also to be added that, advantageously, the tubular element 2 includes a discharge device 14 ( Figure 2 and Figure 4 clearly visible in), which is adapted to facilitate the discharge of the fluid present in the passageway 3 to the outside of this passageway.

[0114] In this sense, the discharge device 14 operates in conjunction with the inlet opening 4 to allow the fluid present in the passageway 3 to be even more effectively conveyed to the outside of this passageway.

[0115] In this regard, it is worth noting that the use of the discharge device 14, which is available for any type of fluid, is particularly convenient for the following operation: discharging any lubricating fluid introduced into the passageway 3 to facilitate the insertion and / or removal of the device 1 from the intestine I of the patient from this passageway.

[0116] More specifically, the discharge device 14 includes at least one discharge hole 14 through which the fluid to be discharged can pass, and the at least one discharge hole is obtained on at least one of the first section 2a or the free end 10.

[0117] Preferably, the discharge hole 14 is obtained on the first section 2a.

[0118] Specifically, the discharge hole 14 is located on the first section 2a between the free end 10 and the inlet opening 4 ( Figure 2 ).

[0119] The position of the discharge hole 14 is particularly convenient because it allows reducing the risk of its being blocked by the excrement introduced through the inlet opening 4.

[0120] As Figure 2 and Figure 4 clearly visible in, the discharge hole 14 has a substantially elliptical configuration.

[0121] In this sense, the size of the discharge hole 14 is determined to be substantially similar to the inlet opening 4.

[0122] It should be noted that, conveniently, the discharging device 14 includes two discharging holes 14, which are obtained at diametrically opposite positions on the first section 2a.

[0123] Specifically, the two discharging holes 14 are placed at equal distances from the free end 10 of the tubular element 2, and thus form a through hole that extends transversely to the first section on the first section 2a.

[0124] As Figure 3 visible in the cross-section of the tubular element 2 shown, the device 1 includes a strengthening device 15, which is adapted to counteract the bending of the tubular element itself.

[0125] Specifically, the strengthening device 15 includes:

[0126] - at least one receiving channel 15a, which is longitudinally opened through the tubular element 2; and

[0127] - at least one strengthening element 15b, which is inserted into the receiving channel 15a.

[0128] Therefore, the strengthening device 15 enables the device 1 to be obtained, which has a sufficiently rigid and strong structure while maintaining the good flexibility of the probe 6a, and this structure imparts high reliability and effectiveness to it during use.

[0129] In this sense, the strengthening device 15 operates in combination with the sheath member 11 to counteract the relative displacement between the blocking device 6 and the tubular element 2 with additional strength, thereby further increasing the advantages regarding the sheath member itself just mentioned.

[0130] In this regard, it should be emphasized that, preferably, the receiving channel 15a and the strengthening element 15b have longitudinal extensions that are substantially consistent with the longitudinal extension of the tubular element 2.

[0131] In other words, the receiving channel 15a extends substantially along the entire longitudinal portion of the tubular element 2 and has a length that is substantially consistent with the length of the strengthening element 15b.

[0132] The fact that the strengthening element 15b is completely inserted into the tubular element along the entire length of the tubular element 2 enables the bending stiffness of the tubular element itself to be increased, and thus significantly strengthens the structure of the tubular element.

[0133] In a preferred embodiment, the strengthening element 15b has a filamentous configuration and is at least partially made of a metallic material.

[0134] In this regard, the strengthening element 15b has a thickness of less than 1 mm.

[0135] Specifically, the reinforcing element 15b has a thickness between 0.3 mm and 0.9 mm, more preferably between 0.4 mm and 0.8 mm, and preferably between 0.5 mm and 0.7 mm.

[0136] In this sense, the receiving channel 15a has a transverse dimension similar to that of the reinforcing element 15b just provided, so as to allow the reinforcing element to be sized to fit in the receiving channel.

[0137] Conveniently, the device 1 includes a holding device 16 which is associated with the sheath member 11 at a pre-defined distance from the blocking device 6 and is intended to be placed in abutment against the patient's body in use.

[0138] In this case, the holding device 16 is configured to cooperate with the patient's abdomen A to hold the position of the blocking device 6 relative to the patient's body (see in this regard Figure 6 ).

[0139] More specifically, the holding device 16 includes at least one holding element 16 which is drilled and slidably fitted on the sheath member 11.

[0140] Specifically, the holding element 16 defines a contact surface 16a which is intended to rest against the patient's body.

[0141] More specifically, the shape of the contact surface 16a is substantially flat.

[0142] In the embodiment shown in the drawings, the holding element 16 is of the type of a disc provided with a central through-hole, through which the tubular element 2 and the sheath member 11 fitted on the tubular element pass.

[0143] In fact, the central hole has a diameter substantially consistent with the cross-sectional dimension of the sheath member 11.

[0144] Preferably, the holding element 16 is made of a material with a high coefficient of friction (e.g., silicone), so that it is difficult to slide relative to the tubular element 2.

[0145] Therefore, in use, the holding element 16 is slid on the sheath member 11 until its contact surface 16a rests against the patient's abdomen A (compare Figure 5 and Figure 6 ).

[0146] However, different embodiments of the holding element 16 not depicted in the drawings cannot be excluded and are provided with guiding means for the sheath member 11, for example.

[0147] Such a guiding device consists, for example, of a receiving seat of a part of the sheath member 11, which extends in a direction substantially inclined with respect to the axis of the through-hole.

[0148] More particularly, the receiving seat extends in a direction substantially parallel to the contact surface 16a of the holding element 16.

[0149] In another embodiment, the holding element 16 may further include fixing means, which consists, for example, of one or more through-holes capable of being associated with the patient's body (e.g., using sutures).

[0150] Regardless of which embodiment is chosen, the presence of the holding device 16 clearly allows the position of the blocking device 6 to be precisely and simply blocked into a specific region Z of the intestine I, thus greatly facilitating the performance of the operation on the patient and thus promoting the patient's psychological and physical health.

[0151] The operation of the present invention is as follows.

[0152] It is assumed that a stoma has been performed on the patient's abdomen A, for example, in order to perform a laparoscopic operation on the patient's intestine, or more specifically, to perform an ileostomy and / or a jejunostomy.

[0153] At the end of the surgical operation involving the intestine, the tubular element 2 is passed through the aforementioned stoma, such that its first section 2a is inserted inside the intestine I, where there is this region Z located upstream of the surgical site with respect to the direction of the advancement of the excrement.

[0154] The tubular element 2 is pushed inside the intestine I, such that the inlet opening 4 is guided towards the patient's stomach.

[0155] Finally, if a lubricating fluid is to be inserted into the through-channel 3 to facilitate the insertion of the device 1, the lubricating fluid can be effectively discharged from the device itself by transporting the lubricating fluid through the inlet opening 4 and the discharge hole 14.

[0156] The blocking device 6 is also introduced inside the intestine I, and together with this blocking device, the contact part 12 and a part of the sheath member 11 are also introduced.

[0157] As described above, the presence of the external engagement surface 13 between the contact part 12 and the sheath member 11 allows for a smooth transition from the second to the first during the insertion of the device 1 into the stoma, thus reducing the risk of physical and mental discomfort for the patient.

[0158] Obviously, during the insertion of the tubular element 2 inside the intestine I, the probe 6a is in a constricted configuration in order to facilitate its passage through the stoma.

[0159] Therefore, during this stage, it follows that the tensioning element 8 is also in its initial configuration.

[0160] The tubular element 2 is then inserted in the manner just described and the above-mentioned surgical operation is completed, isolating the surgically affected intestinal portion by performing an ileostomy and / or a jejunostomy.

[0161] More particularly, the probe 6a is placed in the expanded configuration by blowing air through the lumen 7a.

[0162] In this way, the probe 6a bulges and, as it expands, gradually occupies the entire section of the zone Z into which it is inserted, thus occluding the zone.

[0163] The probe 6a is deformable and thus, when in the expanded configuration, it conforms to the inner wall of the intestine I.

[0164] After the probe 6a has inflated, the tensioning element 8 also moves from its initial configuration to the active configuration, in which, due to the expansion of the probe itself, the tensioning element is tightened in order to impart rigidity to the first section 2a.

[0165] The reinforcement device 15 contributes to this fact, operating in synergy with the tensioning element 8 so as to keep the first section 2a substantially extended.

[0166] As anticipated above, in use, the first section 2a is arranged upstream of the occluding device 6, i.e. along the first part I' of the intestine I.

[0167] Conveniently, the probe 6a is moved towards the stoma by applying a traction force to the second section 2b which remains outside the intestine I and protrudes from the patient's body.

[0168] At this point, the holding device 16 is brought closer to the patient's body by sliding the holding device 16 along the second section 2b and by making the contact surface 16a rest against the patient's skin.

[0169] In this way, since the holding device 16 and the probe 6a are arranged on opposite sides of the stoma, the tubular element 2 is blocked with respect to the patient's body.

[0170] The secretions coming from the patient's stomach and passing through the first part I' of the intestine I are then intercepted by the probe 6a, which prevents the secretions from advancing into the second part I'', and thus the secretions enter the passageway 3 through the inlet opening 4 defined along the first section 2a and arranged so as to substantially cover its entire side wall.

[0171] The excrement then passes through the passageway 3 until it reaches the outlet opening 5 through which the excrement is conveyed to a suitable collection container.

[0172] To remove the ileostomy and / or jejunostomy, simply operate the valve placed near the lumen 7a to contract the probe 6a and pull out the tubular element 2 through the stoma.

[0173] Similarly to the above, if it is planned to insert a lubricant through the channel 3 to facilitate the removal of the device 1, the lubricant can be effectively discharged through the inlet opening 4 and the discharge device 14.

[0174] Once the tubular element 2 has been removed, the intestine I is once again unobstructed and can thus resume its normal function. Thus, the secretions discharged from the stomach pass through the now unobstructed region Z and travel through the second part I" of the intestine itself.

[0175] Then, the stoma obtained on the patient's abdomen A is appropriately medicated and protected until it heals completely.

[0176] In fact, it has been shown that the described invention achieves the intended goal.

[0177] In particular, it should be emphasized that the special design of the sheath member provided to abut against the blocking device allows the probe to be firmly held in place on the tubular element during the use of the device, and especially during the removal of the device from the patient's intestine.

[0178] This fact enables the implementation of the aforementioned removal operation to be greatly simplified compared to the prior art described above, and significantly increases the reliability of using the device.

[0179] Finally, it should be noted that providing a sheath member that defines a seamless outer engagement surface together with the blocking device allows for a smooth and gentle transition from the blocking device itself to the tubular element during the insertion of the device into the patient's body, thereby reducing the patient's physical pain and psychological stress and promoting the patient's postoperative recovery.

Claims

1. A medical device (1) for implementing an ileostomy and / or a jejunostomy, the medical device comprising: - at least one tubular element (2), the at least one tubular element including at least one passageway (3), the at least one passageway being provided with a plurality of excrement inlet openings (4) capable of being inserted into the patient's intestine (I), and being provided with at least one excrement outlet opening (5) capable of being positioned outside the intestine (I), wherein the tubular element (2) includes at least a first section (2a) on which the inlet opening (4) is defined and at least a second section (2b) on which the outlet opening (5) is defined; - an occlusion device (6) for at least one region (Z) of the intestine (I) associated with the tubular element (2), the occlusion device being capable of being inserted into the intestine (I) and being movable between a constricted configuration and an expanded configuration to respectively allow its insertion into the intestine (I) and prevent excrement from passing through the region (Z), the occlusion device (6) being located between the first section (2a) and the second section (2b); characterized by the fact that it includes at least one sheath member (11) associated with the tubular element (2), the at least one sheath member being arranged to abut against the occlusion device (6) and being adapted to counteract the relative sliding between the occlusion device (6) and the tubular element (2).

2. The device (1) according to claim 1, characterized in that The fact that the occlusion device (6) includes at least one contact portion (12) that abuts against the sheath member (11) in use, the contact portion (12) and the sheath member (11) having substantially consistent lateral dimensions at the location of their contact area to define a seamless outer engagement surface (13).

3. The device (1) according to one or more of the preceding claims, characterized in that The fact that the sheath member (11) is at least partially made of at least one plastic material.

4. The device (1) according to claim 3, characterized in that The fact that the sheath member (11) is at least partially made of silicone.

5. The device (1) according to one or more of the preceding claims, characterized in that The fact that the tubular element (2) includes a discharge device (14), the discharge device being adapted to facilitate the discharge of the fluid present in the passageway (3) to outside the passageway.

6. The device (1) according to claim 5, characterized in that The fact that: - the tubular element (2) has a free end (10), the free end being arranged in the patient's intestine (I) in use, the first section (2a) being located between the occlusion device (6) and the free end (10); and in the fact that: - the discharge device (14) includes at least one discharge hole (14), the fluid to be discharged being capable of passing through the at least one discharge hole, and the at least one discharge hole being formed in at least one of the first section (2a) or the free end (10).

7. The device (1) according to claim 6, characterized in that The fact that the discharge hole (14) is formed in the first section (2a).

8. The device (1) according to claim 7, characterized in that The fact that the discharge hole (14) is located between the free end (10) and the inlet opening (4).

9. The device (1) according to one or more of the preceding claims, characterized in that The fact that it includes a strengthening device (15), the strengthening device being adapted to counteract the bending of the tubular element (2).

10. The device (1) according to claim 9, characterized in that The following facts: the reinforcing device (15) comprises: - at least one receiving channel (15a) which is provided to pass longitudinally through the tubular element (2); and - at least one reinforcing element (15b) which is inserted into the receiving channel (15a).

11. The device (1) according to claim 10, characterized in that The following fact: the receiving channel (15a) and the reinforcing element (15b) have a longitudinal extension which is substantially consistent with the longitudinal extension of the tubular element (2).

12. The device (1) according to claim 10 or 11, characterized in that The following fact: the reinforcing element (15b) has a filamentary configuration and is at least partially made of a metallic material.

13. The device (1) according to claim 12, characterized in that The following fact: the reinforcing element (15b) has a thickness of less than 1 mm.

14. The device (1) according to one or more of the preceding claims, characterized in that The following fact: it comprises a holding device (16) which is associated with the sheath member (11) at a pre-defined distance from the blocking device (6) and which is intended to be placed in use in abutment against the patient's body.

15. The device (1) according to one or more of the preceding claims, characterized in that The following fact: the blocking device (6) comprises a plurality of elastically deformable tensioning elements (8) which are associated with the at least first section (2a) to prevent it from folding and which are locked together at the positions where their respective ends are located.

16. The device (1) according to claim 15, characterized in that The following fact: the tensioning elements (8) have a substantially filamentary configuration and are spaced apart from each other to define a plurality of through-gaps (9).

17. The device (1) according to claim 16, characterized in that The following fact: the tensioning elements (8) have a first end (8a) which is associated with the first section (2a) near the free end (10), and a second end (8b) which is associated with the contact portion (12).

18. The device (1) according to claim 17, characterized in that The following fact: the tensioning elements (8) and the contact portion (12) define a single body member.

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