Complex surgical device for creating and securing anastomoses

Abstract

To provide a composite surgical device for forming intestinal anastomosis.SOLUTION: A composite surgical device includes: a protector provided with an anchor member composed of (a) a stent (1) and a soft outer sheath (2); and an introducer including (b) at least one deformable first guide tube (12). A downstream end of the outer sheath is connected to the first guide tube (12) or a first connection component. The outer sheath (2) is folded inside the first deformable guide tube (12). The stent is held inside the deformable first guide tube in a compressed state in a radial direction.SELECTED DRAWING: Figure 5B

Description

[Technical Field]

[0001] The present invention relates to a complex surgical device useful for creating and securing intestinal anastomoses. [Background technology]

[0002] Colorectal anastomosis has a nonunion rate of approximately 20%. Nonunion of an anastomotic (fistula) is a serious complication with a mortality rate of approximately 20%. To mitigate the harmful effects of anastomotic fistulas, some patients utilize an outlet (stoma) between the skin and bowel upstream of the anastomosis to divert digestive flow to the external pouch and avoid contact of the anastomosis with feces. The stoma is closed in a second step after the anastomosis has healed. The presence of a stoma and the need for reintervention to remove it represent a significant burden to patients and contribute to high healthcare costs.

[0003] In this regard, an anastomosis protection device has been proposed, as described in FR2941858 and EP2395942, which diverts feces into the intestinal lumen and allows for the avoidance of an ostomy. This device consists of a flexible outer sheath attached to a stent downstream of the stent, which is intended to be fixed upstream of the anastomosis. The stent is a temporary anchor member to the intestinal wall, holding the sheath in place. The sheath diverts feces toward the anal orifice without contacting the intestinal wall at the anastomosis, protecting the anastomosis.

[0004] WO2013 / 014353 further advances this device by adding a means for controlling the fixation or detachment of the stent to or from the intestinal wall. To do this, fixation or detachment of the device is enhanced by a tube opening into a chamber space defined between the inner sheath and the stent wall. This allows the intestinal wall to be pulled towards the stent, creating a suction effect to enhance fixation, or conversely, air or fluid to be injected to release it.

[0005] To achieve this, the essence of the surgical device of WO2013 / 014353 is to utilize the viscoelasticity of the intestine to attract the inner wall of the intestine to the outer wall of the stent. In fact, the intestinal mucosa is flexible and elastic, while the wall of the stent is relatively hard. The intestinal wall can be attracted and adhered to the outer wall of the stent (by suction) by negative pressure at the contact surface between the stent and the mucosa. In this case, the friction force between the intestine and the stent increases rapidly and significantly due to a certain suction effect. As a result, the mobility of the stent is closely related to the suction effect, and its adjustment affects the operation of the stent in the intestine.

[0006] More precisely, patent WO2013 / 014353 describes a surgical anchoring device, said device being able to anchor itself to the mucosa of the inner wall of the intestine, (a) A temporary anchoring element having a controllably modifiable fixation, said temporary anchoring element having at least a stent-type first semi-rigid hollow longitudinal member defining a wall of revolution about a longitudinal axis, referred to as a first wall, said wall being substantially cylindrical with a substantially circular cross section and having a plurality of perforated flow sections, said first hollow longitudinal member being made of a material imparting radially elastic properties such that said first hollow longitudinal member can be radially compressed in a contracted state and can assume said maximum radially expanded state upon release from radial compression, said first wall having a first outer diameter of a first minimum outer diameter of the first wall in the radially contracted state, the first minimum outer diameter being equal to or less than 20 mm, preferably equal to or less than 10 mm; a temporary anchoring member controllably variable between a first maximum outer diameter, preferably between 18 mm and 45 mm, in the maximum radially expanded state of the first wall; (b) a flexible outer sheath attached to the stent and extending from its downstream end; At least a portion, preferably the entire length, of the cylindrical inner surface of the first wall is covered with a separate sealing layer forming an inner sheath, and only opposite longitudinal ends of the inner sheath are sealingly attached to the anchor member by first sealing means, preferably annular seals of bonded fusion or elastomeric adhesive, at each longitudinal end of the inner sheath, thereby defining a chamber between the inner sheath and the first wall, referred to as a vacuum chamber, and the temporary anchor member is connected to a flexible or semi-rigid tube, referred to as an injection-suction tube, extending outside the anchor member, the open end of which opens into the vacuum chamber.

[0007] More specifically, the injection-aspiration tube is preferably reversibly connected at its free longitudinal end to a connecting terminal member, which is reversibly connected or can be reversibly connected to a device such as a syringe for injecting or aspiration of air or liquid, and the connecting terminal is equipped with a shut-off device, preferably a non-return valve, and a vacuum indicator capable of indicating the degree of vacuum in the vacuum chamber, and in particular the vacuum indicator is arranged on the vacuum ampoule.

[0008] When the anchoring member is fixed and stationary against the inner surface of the intestinal wall in its maximally expanded state, the chamber defines a sealed chamber between the sealing film of the inner sheath and the intestinal wall. If the anchoring member is released and / or moves within the intestine, the chamber will lose its sealed state. However, in this case, air can be drawn from outside the patient through the tube at the free end of the tube, thereby attracting the intestinal wall against the outer surface of the first wall over part or all of the outer surface of the first wall defining the chamber, maintaining the vacuum in the chamber and sealing the chamber, thereby stopping the movement of the anchoring member.

[0009] The anchor member can be held in a radially contracted state using an instrument called an "introducer," described below, and radial expansion occurs after the anchor member is released from the introducer.

[0010] WO2013 / 014353 describes that the introducer may be comprised of a semi-rigid guide tube of a known catheter type having a handle at one end and an inner diameter and length capable of accommodating the anchor member and the sheath in a contracted state therein, preferably in a longitudinally expanded state.

[0011] In WO2013 / 014353, for insertion into the anus, the device further comprises an introducer comprising: a tubular outer sheath capable of receiving and holding the anchor member and the infusion-suction tube compressed to the contracted state within a distal end of the outer sheath, the outer sheath being long enough to further receive the sheath and the infusion-suction tube, preferably at least 70 cm, preferably at least 100 cm in length; means for delivering the distal end of the introducer from the anal orifice to the anchoring location in the intestine upstream of the anastomosis; Preferably, means for releasing the anchor member from the outer casing, preferably further comprising a stop tube having a stop at its distal end for optionally contacting a longitudinal end of the anchor member, the sheath downstream of the anchor member surrounding the stop tube inside the outer casing.

[0012] The anastomosis is formed in a known manner using a stapler by inserting a circular section called an "anvil" into the intestine upstream of the location of the anastomosis, then tightening a wire called a "purse string" around the anvil shaft at the free end of the intestine, and then engaging the stapler body downstream of the anastomosis to the anvil shaft, cooperating the circular stapler with the anvil to cut the tissue and place the staples.

[0013] Thus, as in these above-cited earlier patents, when an anastomosis is formed using a stapler, such as in the manner described in FR 2,846,868, an anastomosis protection device is placed in the intestine. The device is introduced by a flexible introducer through the anal orifice, then the anastomosis, and then through the intestine upstream of the anastomosis. After the introducer is removed, the stent radially expands to contact the intestinal wall, while the sheath and suction tube are deployed into the intestinal lumen from a fixed location upstream of the anastomosis, through the anastomosis, and to the anal orifice.

[0014] Although the safety of these procedures has been proven, as described in WO2013 / 014353, some surgeons are reluctant to introduce objects through a newly created anastomosis. Summary of the Invention

[0015] The present invention provides a protection device that can be introduced into the intestine even before the anastomosis is created, which can facilitate the creation of the anastomosis with an anvil and stapler, reducing the number of steps during the surgical procedure and potentially shortening the procedure time.

[0016] For this purpose, the subject of the invention is, in principle: A means for placing an anastomotic protection device in the intestinal lumen upstream of an anastomosis, which does not require instruments introduced through the anal orifice and the newly formed anastomosis, but rather uses the resection of pathological bowel required for placement of a stapler anvil and opening of the upstream intestinal lumen for prior placement of the anastomotic protection device. Means for deploying the fixation device, the outer sheath, and, if applicable, the suction tube through the anastomosis only after the anastomosis has been formed, wherein deployment of the sheath and suction tube occurs with and in conjunction with removal of the stapler, i.e., after the steps of: Closing the upper bowel on the anvil shaft using a purse string; - introducing a stapler body into the intestine downstream from the anal orifice; Fixing the anvil to the stapler body; Stapling and Remove the anvil and stapler from the anal orifice.

[0017] To this end, the present invention relates to a composite surgical device, more precisely a composite surgical device having ready-to-use components for creating an anastomosis in the intestine by means of an anvil and a circular stapler and for securing said anastomosis in the intestine, comprising: (a) a protection device including an anchoring member having at least one stent and a flexible outer sheath that can be temporarily secured to the inner wall of the intestine upstream of the anastomosis, wherein at least an upstream end of the sheath is secured to the stent, and in particular, the outer sheath can extend downstream of the anchoring member and downstream of the anastomosis to allow the anastomosis to be protected after the anvil and stapler are removed; (b) at least one first tube, called a first guide tube, inside which the stent is held in a radially compressed state, preferably at the distal end of the first guide tube, the first tube being part of a guide tube of an introducer or adapted to be reversibly attached to an introducer, the first tube being capable of changing the shape of its bend relative to its longitudinal axis (XX'); The flexible sheath is housed, preferably folded, inside the first guide tube and possibly partially or completely inside the stent, the downstream end of the sheath being connected to the first guide tube or to a first connecting part independent of the first guide tube, and the flexible sheath withdraws the proximal end of the first guide tube or to the respective first connecting part to which the sheath is fixed. The present invention provides a hybrid surgical device that can be deployed downstream of the stent by

[0018] More specifically, the proximal end of the first guide tube or the first connecting part is provided with a reversible fixing means by which the proximal end can be reversibly fixed to the anvil, and the flexible sheath can be deployed downstream of the stent by withdrawing the anvil, which is reversibly fixed to the proximal end of the first guide tube or to the first connecting part.

[0019] More specifically, the proximal end of the first guide tube or the first connecting piece comprises means for reversibly attaching to the front face of the anvil by gluing, screwing, clamping or magnetic connection, and removal of the anvil is understood to include prior detachment of the anvil from the proximal end of the first guide tube or the first connecting piece.

[0020] In a known manner, the introducer comprises at least (i) the first deformable guide tube, (ii) a second rigid guide tube, the proximal end of the first deformable guide tube being attached or attachable to the distal end of the second rigid guide tube, (iii) a handle connected to the proximal end of the second rigid guide tube, and (iv) a pusher extending from the handle within the second rigid guide tube and the first deformable guide tube, the pusher comprising a pusher rod and a pusher stop at the distal end of the pusher rod.

[0021] In a known manner, the introducer can allow placement of a protection device upstream of the anastomosis location, the pusher stop can push the protection device outward from the distal end of the first deformable guide tube to allow radial expansion and fixation of the stent against the intestinal wall, and the proximal end of the pusher rod can cooperate with the handle by manually controlling the relative translation of the pusher rod with respect to the first deformable guide tube.

[0022] In the prior art, this type of introducer is used to introduce a stent only after the anastomosis has been created, and the first deformable guide tube is longer than in accordance with the present invention because the first deformable guide tube of the prior art must extend from the anal orifice to upstream of the anastomosis, which in practice is at least 45 cm.

[0023] According to the present invention, since an introducer is used to introduce a stent before the anastomosis is formed, the length of the first deformable guide tube for placing a stent upstream of the anastomosis location is, for example, 30 cm or less.

[0024] Thus, removal of the introducer after fixation of the protection device upstream of the anastomosis allows partial deployment of the sheath in the intestine downstream of the anastomosis, with full deployment of the outer sheath occurring during removal of the stapler through the anal orifice. After removal of introducer parts other than the first connecting piece or first tube of the introducer attached to the outer sheath, the first connecting piece or first tube may be reversibly attached, directly or indirectly, to a stapler anvil to form the anastomosis, as described below.

[0025] Even more specifically, when the downstream end of the sheath is attached to the first connecting piece, the first connecting piece is positioned immediately downstream of the stent, and the means for reversibly attaching the first connecting piece can successively serve the following functions: 1) At the initial stage of introduction, the stent is attached to the stopper of the pusher of the introducer, and at the end of the initial stage of introduction, the stent is released upstream of the first guide tube under the influence of the thrust of the pusher, so that the stent is found in the upstream intestine at a certain distance upstream from the location of the anastomosis, preferably 10 cm to 20 cm upstream from the location of the anastomosis. 2) After removal and withdrawal of the pusher and introducer parts, they are secured to the anvil, allowing the anastomosis to be created using a stapler. Optionally, the creation of the anastomosis occurs after partial deployment of the sheath downstream of the stent by withdrawing the pusher to the location of the anastomosis and before removal of the pusher. Complete deployment of the sheath downstream of the anastomosis occurs after the anastomosis has been created by withdrawal of the first connecting part, the anvil, and parts integral with the stapler.

[0026] Even more specifically, when the downstream end of the sheath is connected to the first tube, the first tube can be reversibly attached to an introducer, and the reversible attachment means at the proximal end of the first guide tube successively serves the following functions: 1) At the initial stage of introduction, the handle and the pusher are fixed to the end of the second guide tube of the introducer. 2) After removal of the remainder of the introducer, including removal of the pusher, the first guide tube is secured to the anvil, allowing the anvil and stapler to be used to create the anastomosis. Optionally, creation of the anastomosis is achieved by returning the sheath downstream of the stent from the first tube to the anastomotic location after partial deployment of the sheath downstream of the stent. Full deployment of the sheath downstream of the anastomosis occurs by complete removal of the first guide tube, the integral anvil, and the integral stapler components after the anastomosis is created.

[0027] The invention is particularly advantageous when the protection device comprises at least one flexible tube called a suction tube, preferably two suction tubes, which can extend outside the stent downstream thereof, in particular after forming the anastomosis and removing the anvil and the stapler, and whose open ends open inside the stent into a vacuum chamber formed between the inner wall of the stent and an inner film covering the inner wall of the stent, which film preferably constitutes an extension of the sheath, and wherein the suction tube is housed, preferably folded and more preferably spirally wound, inside the first guide tube, optionally partially or completely inside the stent, and whose downstream ends are connected to the first guide tube or to the first connecting piece, and wherein the suction tube can be deployed downstream of the stent by removing the anvil, which is reversibly attached to the proximal end of the first guide tube or to the first connecting piece.

[0028] The open end of the suction tube preferably has the distal portion of the tube within said chamber pierced with a plurality of holes.

[0029] The use of two suction tubes provides increased fixation and protects against failure of the first suction tube, for example, if the first suction tube becomes clogged.

[0030] More specifically, the combined ready-to-use device according to the present invention can be implemented in a surgical procedure using the combined surgical device according to the present invention in which the following sequential steps are performed: S1) The surgical device is introduced into the intestine by an abdominal route in a portion of the intestine upstream of the location of the anastomosis using an introducer, the introducer comprising or attached to a first guide tube, and the anchor member is released upstream of the location of the anastomosis by actuating a pusher within the first guide tube. S2) A plurality of parts of the introducer other than the first guide tube or a plurality of parts other than the first connecting part, each of which has the sheath and the suction tube attached, or a plurality of parts of which one has the sheath attached and the other has the suction tube attached, are removed from the intestine. S3) A stapler anvil reversibly fixed to the proximal end of the first guide tube or to the first connecting part is inserted. S4) Incision of the intestinal tissue in the anastomosis area and creation of the anastomosis is performed by stapling with a stapler in cooperation with an anvil. S5) The stapler attached to the anvil, which itself is attached to the first tube or the first connecting piece, is removed, thereby deploying the sheath and the suction tube. S6) After passing through the anal orifice, the downstream end of the outer sheath and the downstream end of the suction tube are detached from the first guide tube or the first connecting piece outside the anal orifice, preferably using scissors. S7) The downstream end of the suction tube is connected to a device external to the patient that is capable of maintaining a vacuum in the vacuum chamber and therefore preventing migration of the anchor member.

[0031] This method is particularly useful for temporarily protecting an anastomosis of the large intestine or colon, rectum or anal canal to prevent or reduce the risk of anastomotic fistula, preferably with a distance between the fixation point upstream of the anastomosis and the anastomosis of at least 10 cm, more particularly with a distance of at most 20 cm between the anastomosis and the fixation point.

[0032] As will be explained below, the device according to the invention allows for the implementation of stents and sheaths that are on the one hand smaller in size and therefore placed a shorter distance upstream of the location of the anastomosis, in particular only 10 to 20 cm, compared to what was required in previous designs such as WO 2013 / 014355, since the device can be placed before the anastomosis is created.

[0033] The term "anastomotic protection" as used herein refers to protection of the anastomosis when intestinal transit is resumed.

[0034] "Downstream" and "upstream" herein refer to the direction of travel from upstream to downstream in the intestinal passage and the location of the associated device when it is deployed and functional within the intestine. The "downstream end" of the sheath is understood to be the end intended to be deployed within the stent after the stapler is removed and the sheath is deployed after the anastomosis is completed, even if this downstream end is initially closer to the upstream end due to being fixed to the inner wall of the first guide tube.

[0035] The terms "proximal" and "distal" herein refer to the location of an associated member in or relative to the location of initial introduction into the patient's body, and indeed also herein relative to the introducer handle relative to the introducer member. The proximal and upstream ends correspond to the downstream and upstream ends, respectively, for introduction through the anal orifice or a portion of the intestine downstream of the anastomosis.

[0036] In this case according to the invention, only the first deformable guide tube and a portion of the second rigid guide tube of the introducer are introduced into the lumen of a portion of the intestine upstream of the anastomosis, while the remaining portion of the second rigid guide tube and the handle remain outside the intestine.

[0037] The term "first deformable guide tube" of the introducer actually refers to a semi-flexible tube made of an elastomer or PU material that is thicker than the sheath and that can be deformed by bending it about its longitudinal axis until it forms an apparent 90° bend. This first deformable guide tube is marked with graduations to allow confirmation of its placement before it is released.

[0038] More specifically, in a known manner, the sheath is hermetically secured at each longitudinal end of the inner sheath to the anchoring member by a sealing fastening means, preferably by a fusion or annular bond of an elastomeric adhesive, and the temporary anchoring member is connected to the flexible or semi-rigid tube called a suction tube, which extends outside the anchoring member and whose open end opens into the vacuum chamber, so as to define a vacuum chamber between the inner sheath and the first wall.

[0039] In a first embodiment, the downstream end of the sheath and the downstream end of the suction tube are connected to the distal end of the first guide tube, and the proximal end (or downstream end) of the first guide tube is fixed or reversibly fixable to the distal end (or upstream end) of a second rigid guide tube of an introducer to introduce the protection device upstream of the anastomosis location, and is then provided with a second connecting part that can be reversibly fixed to the anvil to form the anastomosis.

[0040] A second connecting piece is fixed or reversibly fixable to the first guide tube at the distal end of the second rigid guide tube of the introducer for connecting the first guide tube and the second rigid guide tube to introduce a protection device upstream of the anastomosis location, and then disconnecting the first guide tube and the second rigid guide tube to remove the introducer and use an anvil and stapler.

[0041] In this first embodiment, the first guide tube, which has a second connecting piece at its proximal end, remains inserted into the intestine during the formation of the anastomosis and is pulled out of the intestine when the stapler is removed after the formation of the anastomosis by connecting it to the anvil, thereby allowing full unfolding and deployment of the sheath and suction tube downstream of the stent by their connection with the first tube.

[0042] More specifically, in this first embodiment, the downstream end of the sheath and the downstream end of the suction tube are connected to the distal end (or upstream end) of the first guide tube by gluing or screwing.

[0043] In this first embodiment, more specifically, the sheath and the suction tube are entirely disposed within the stent, specifically folded or rolled, except for their downstream portions, which are separated from the stent at the downstream end of the stent and joined to the upstream end of the first guide tube upstream of the stent, and these external portions of the sheath and the suction tube are inserted between the stent and the inner wall of the first guide tube.

[0044] More specifically, in this first embodiment, said second connecting part is fixed or reversibly securable to the adapter, which itself is reversibly securable to the stapler anvil.

[0045] More specifically, in this first embodiment, the second connecting part is fixed or reversibly fixable to the adapter by threading, gluing, clamping, or magnetic connection, and the adapter is itself reversibly fixable to the stapler anvil by gluing, clamping, or magnetic connection.

[0046] More specifically, in this first embodiment, the second connecting part comprises: a first complementary threaded portion disposed on the distal end of the second rigid guide tube; and then a second complementary threaded portion disposed on the distal end of the adapter; It has threaded portions that can cooperate by being screwed together.

[0047] It is understood that: the second connecting piece is reversibly attached to the distal end of the second rigid guide tube during introduction and release of the protection device by the pusher to allow introduction and subsequent fixation of the stent in the intestine upstream of the location of the anastomosis before the anastomosis is created; The second connecting piece is reversibly attached to the anvil or the adapter after removing the pusher to reversibly attach an anvil so that the anastomosis can be formed using the stapler after the stent has been fixed in the intestine upstream of the location of the anastomosis.

[0048] More specifically, the flat proximal portion of the adapter is adapted for adhesive attachment to the flat front surface of the anvil.

[0049] In a second embodiment, the downstream end of the sheath and preferably the downstream end of the suction tube are connected to the first connecting part, and at least one proximal end of the first connecting part is positioned outside the downstream end of the stent.

[0050] More specifically, in this second embodiment, the downstream end of the sheath and preferably the downstream end of the suction tube are connected to a distal portion of the first connecting piece independent of the first guide tube, preferably a tubular distal portion positioned or adapted to be positioned inside the downstream end of the stent, and the proximal portion of the first connecting piece is positioned outside and at the downstream end of the stent, the stent preferably having a flat proximal surface with a larger diameter than the tubular distal portion.

[0051] Thus, during the initial and introduction phase, the first connecting piece is located inside the first guide tube.

[0052] More specifically, in this second embodiment, the sheath and suction tube are all stored inside the stent except for its swallowing portion, which exits the stent at its swallowing end and is joined to a first connecting piece pressed against the swallowing end of the stent.

[0053] In this second embodiment, the entire protection device and said first connecting piece are independent from the first guide tube and the introducer.

[0054] More specifically, the downstream end of the sheath and the downstream end of the suction tube are connected to the first connecting part by adhesive or wire.

[0055] More specifically, in this second embodiment, the first connecting part is adapted to be reversibly fixed, preferably by gluing, screwing, clamping or magnetic coupling, to a stop of the pusher rod in the first guide tube when the protection device is introduced upstream of the location of the anastomosis.

[0056] More particularly, in this second embodiment, said first connecting part is suitable to be reversibly attached directly to said anvil by gluing, screwing, clamping or magnetic coupling, preferably by gluing.

[0057] In this embodiment, after introducing the protection device upstream of the location of the anastomosis before the anastomosis is formed, the introducer can be completely removed from the intestine, with only the first connecting part remaining introduced into the intestine being fixed to the anvil for the purpose of forming the anastomosis, and when the stapler is removed after the anastomosis is formed by connecting the stapler to the anvil, the first connecting part is pulled out of the intestine, thereby allowing full deployment of the sheath and the suction tube downstream of the stent by their connection with the first connecting part.

[0058] It is understood that: the first connecting piece is reversibly attached to the pusher stop during introduction and release of the protection device by the pusher to allow introduction and fixation of the stent in the intestine upstream of the location of the anastomosis before the anastomosis is created; After the introducer is completely removed, the first connecting piece is reversibly attached to the stapler or the adapter so that the anastomosis can be formed using a stapler after the stent has been fixed in the intestine upstream of the location of the anastomosis.

[0059] Even more specifically, in both embodiments, the distal end of the first guide tube is closed by a flexible retaining portion, which is capable of retaining the protection device inside the first guide tube in the absence of a thrust by a pusher rod stop, and which is capable of elastically deforming so that the protection device can slip out under the influence of the thrust by the pusher rod stop.

[0060] Even more specifically, the composite surgical device according to the invention comprises the protection device and an introducer capable of allowing the protection device to be placed upstream of the location of the anastomosis, the introducer comprising a handle that can be fixed and / or cooperate with the following two parts of the introducer: (b1) a first deformable guide tube, the stent being held in radial compression within the first deformable guide tube near a distal end of the first deformable guide tube, the proximal end of the first deformable guide tube being secured to a second rigid guide tube integral with the handle; (b2) A pusher comprising a pusher rod capable of changing the shape of its bend relative to a longitudinal axis of the pusher, and a pusher stop at a distal end of the pusher rod, the pusher extending from the handle within a second rigid guide tube and the first deformable guide tube, and a proximal end of the pusher rod adapted to cooperate with the handle by manually controlling the relative translation of the pusher rod with respect to the first deformable guide tube.

[0061] More specifically, the pusher rod is a helical rod made of steel wire, wound in a spiral shape along an imaginary longitudinal axis XX' and having a plurality of coaxial, tangential turns of the same diameter, the diameter of which makes the rod deformable in such a way that it can change the shape of its bending relative to the longitudinal axis and achieve a bending that forms a 90° bend.

[0062] Even more specifically, the stent comprises at least one withdrawal loop at one of its longitudinal ends, and preferably two loops at each of its opposite longitudinal ends.

[0063] Advantageous and novel features of the method for anchoring the stent and creating the anastomosis, which result from the novel structural features of the combined surgical device according to the present invention, include: Fixing the protection device upstream of the anastomosis location and forming the anastomosis with a surgical stapler, then deploying the sheath and suction tube in a single motion and removing the stapler; The introducer does not pass through the newly formed anastomosis, -Shortening surgery time.

[0064] More specifically, the suction tube is a semi-rigid tube, in particular made of PE or PP, having a length that enables it to extend through the intestine from the patient's anal orifice to the anchor member without changing shape, the length of the injection-suction tube preferably being at least 20 cm, more particularly between 50 cm and 150 cm, and the free end of the suction tube outside the patient being connected to a device for suction or injection of gaseous or liquid fluids, in particular air or cold liquids, as will be described below.

[0065] More specifically, the length of the outer sheath protects the anastomosis and protrudes from the anal orifice when the anchoring member is in a secured position and deployed downstream thereof.

[0066] The outer sheath is made of an elastomer, and thus has radial and longitudinal elastic properties similar to those of the intestinal wall, which are the properties of the elastomeric material from which the sheath is formed. These radial and longitudinal elastic properties of the sheath are similar to those of the colon wall.

[0067] In a preferred embodiment, the extension of the first wall extends from the upstream longitudinal end of the first wall to a profiled downstream end portion having a diameter smaller than the diameter of the cylindrical extension, the outer diameter of the downstream end of the first wall at its maximum radial expansion being between 20 mm and 40 mm, the length of the profiled downstream end of the first wall being between 10 mm and 30 mm, preferably between 15 mm and 25 mm, and preferably the diameter of the end portion gradually decreasing between the extension and the downstream end of the first wall.

[0068] More specifically, the temporary anchoring member is an intestinal prosthesis, the first wall of which is formed by a mesh of spiral wires, preferably metal wires, and then, as is known, by changing the crossing angle of the metal wires, the width of the diamonds or tetragons of the mesh of the spiral wires can be changed, resulting in radial expansion.

[0069] Preferably, the anchoring element is made of a material that elastically expands in the radial direction only at a temperature at least equal to the ambient temperature of 20° C., in particular at the temperature of the human body, and the anchoring element is in the radially contracted state at temperatures below the ambient temperature, preferably below 5° C. It is understood that the tubular material automatically changes diameter depending on the ambient temperature.

[0070] More specifically, the anchor member is an intestinal prosthesis, and the first wall of the anchor member is formed of a mesh of helical threads, preferably nitinol threads. Nitinol is an alloy that exhibits the property of gradually expanding radially in response to temperature above ambient temperature (25°C). This allows the prosthesis to maintain a contracted shape at lower temperatures, specifically at 4°C during storage. Once contracted at low temperatures, the prosthesis remains contracted long enough to be housed within an introducer tube and introduced into the intestine by the introducer. Once released into the intestine, the prosthesis gradually expands radially under the effect of higher ambient temperatures, i.e., the temperature of the human body. In fact, a nitinol stent can change its shape and stiffness depending on the ambient temperature due to the shape memory of this alloy. Specifically, nitinol becomes flexible and soft when the ambient temperature is below 15°C. Therefore, the stent can be softened by injecting a cold liquid between 0°C and 15°C into a vacuum chamber, making it easier to move, for example, when passing through an anastomosis or a stricture.

[0071] Preferably, the sheath is made of a biocompatible synthetic material with a wall thickness of 0.01 mm to 1 mm, preferably an elastomeric material of silicone or polyurethane type with a thickness of 0.05 mm to 1 mm, preferably having radial and longitudinal elastic properties, at least the outer sheath having shape memory and non-adhesive properties.

[0072] By being made of an elastomer, the outer sheath exhibits radial and longitudinal elasticity, similar to that of the intestinal wall, which is a property of the elastomeric material forming the outer sheath, and the sheath exhibits radial and longitudinal elasticity properties that are similar to those of the colon wall, allowing for proper intestinal transit within the outer sheath over the migration period of the anchor member, i.e., a period of at least 6 to 10 days.

[0073] The longitudinal elasticity of the elastomeric outer sheath can be made greater than that of the intestine without difficulty, and even has the advantage that the portion of the outer sheath that has passed through the anus can be pulled to remove the sheath and retract it back into the rectum. Its radial elasticity ensures that the longitudinal ends of the outer sheath remain fixed to the ends of the anchoring members regardless of the degree of radial expansion.

[0074] On the other hand, the thickness characteristics of the outer sheath, combined with its elasticity, provide it with shape memory properties. The term "shape memory properties" as used herein means that the elastomeric material that makes up the outer sheath naturally returns to its original shape after being folded and deformed. Because the outer sheath is long, these shape memory properties are important so that when the outer sheath is folded, the material naturally returns to its original elongated shape without creating an obstacle to movement. This may actually occur during movement after release of the anchoring member.

[0075] The term "non-adhesive properties" means that the elastomer material constituting the outer sheath has an adhesion coefficient such that, even when bent, the two opposing surfaces of the inner wall of the outer sheath do not adhere to each other and do not create resistance to gases or substances passing through.

[0076] It is also understood that: the diameter of the outer sheath in a resting state is at least substantially equal to the reduced outer diameter of the hollow anchoring member in its radially contracted state and is smaller than the diameter of the intestine in a resting state, preferably the resting diameter of the outer sheath is substantially equal to the diameter of the intestinal wall in a resting state; and The outer sheath extends downstream from the end of the anchoring member at which it is fixed, over a length corresponding to the distance between the fixing point upstream of the anastomosis and a downstream position preferably reaching the anal orifice.

[0077] As is known, by varying the crossing angle of the metal wires, the width of the diamonds or equilaterals of the mesh of the helical wire mesh can be varied, with radial expansion being the result.

[0078] Preferably, and as is known, the design and shape of the helical wire mesh of the stent is such that it changes minimally in length as the diameter of the stent changes, preferably so that it does not change substantially in length when radially compressed.

[0079] Other features and advantages of the present invention will become more apparent from the following description, taken in conjunction with the accompanying drawings, in which: The following description is illustrative and not exhaustive. [Brief explanation of the drawings]

[0080] 1A, 1B, and 1C show schematic diagrams of a protection device 5 according to the present invention, including a side view (FIG. 1A) of the sheath 2 and suction tube 3 deployed downstream of the stent 1, a front view (FIG. 1B) of the upstream or distal end of the stent 1 with the lasso loop 6b, and a longitudinal cross-section of the protection device 5 showing the respective arrangement of the stent 1, sheath 2, and suction tube 3, with the suction tube 3 opening into a vacuum chamber 4 between the stent wall and the interior 2a of the sheath 2. FIG. 2 shows the various parts of introducer 10 disassembled. FIG. 2A shows an introducer 10 with a first guide tube 12 inserted into an upstream portion 100a of the intestine. FIG. 2B shows the release of the stent from the first guide tube 12 by the thrust of a pusher rod 15 (not visible in FIG. 2B). 3A and 3B show details of a deformable pusher rod 15b having a helical shape in a side view (FIG. 3A) and a front view (FIG. 3B) of one of the ends of the pusher rod 15b. 4A-4C illustrate various steps in positioning an anvil 8 and stapling an anastomosis 101 between an upstream portion 100a and a downstream portion 100b of the intestine using a stapler 9 cooperating with the anvil 8. FIG. 5A, 5B, 6 and 7A to 7D relate to the embodiment of Example 1. Figures 5A and 5B show two variants of schematic cross-sectional views of the protective device 5 (partially disassembled in Figure 5A) in which the stent is compressed at the distal end of the first tube 12, the sheath 2 and the suction tube 3 are folded inside the stent within the first tube 12, the downstream ends of the sheath 2 and the suction tube 3 are attached to the distal end of the first tube, and the protective device 5 is ready to be pushed out of the first guide tube 12 by the stop 15b of the pusher 15. Figure 6 shows a schematic representation of the stent 1 released to the outside, with the first guide tube 12 to which the sheath 2 and suction tube 3 are attached being removed, releasing the stent and deploying the sheath 2 and suction tube 3 downstream of the stent 1, after which the first guide tube 12 has been separated from the rest of the introducer and the push rod has been retracted. 7A-7C illustrate various steps for placing an anvil at the proximal end of first guide tube 12 before the anastomosis is created. FIG. 7D shows that the sheath 2 can be deployed by removing the stapler attached to the first tube 12 after the anastomosis is formed. 8A, 8B, 9A, 9B, 10A to 10C, 11A, and 11B show an embodiment of Example 2. 8A and 8B show two variants for attaching the suction tube 3 and the sheath 2 to a first connecting piece 11 downstream of the stent 1 and independent of the first guide tube. 9A and 9b show the protection device 5 with the stent 1 at the distal end of the first guide tube 12, the sheath 2 and the suction tube 3 attached to the adapter 11, which itself is reversibly attached to the stop 15b of the pusher 15. Figures 10A, 10B and 10C show various steps in which the introducer 10 including the first guide tube 12 is removed after the stent 1 has been released and the sheath 2 and suction tube 3 connected to the first connecting piece 11 have been partially deployed. Figure 10B shows the anvil 8 approaching the first connecting piece 11. Figure 10C shows the anvil 8 being fixed at the upstream portion 10a of the intestine before the anastomosis is formed with the stapler 9. 11A and 11B show the stapler 9 with the anvil 8 attached to the downstream end of the sheath 2 and the downstream end of the tube 3 as the anastomosis 101 is formed (FIG. 11A), and after the stapler has been removed and separated from the first connecting piece 11 after the anastomosis 101 has been formed (FIG. 11B). DETAILED DESCRIPTION OF THE INVENTION

[0081] In two embodiments, Examples 1 and 2 below, an anastomosis protection device 5 of Figures 1A to 1C of the type described in WO2013 / 014353, packaged as part of an introducer as described below with reference to Figures 2, 2A, 2B, 3A and 3B, is used to create the anastomosis described with reference to Figures 4A to 4C.

[0082] The anastomosis protection device 5 comprises an anchor member having a stent 1, the inner wall of which is covered by a flexible inner sheath 2a, which defines an annular chamber 4 between annular seals 4a and 4b, which seal between the inner sheath 2a and the perforated stent wall. The inner sheath 2a comprises a sealing film forming a flexible tubular wall and is extended by a flexible outer sheath 2, which extends outside the anchor member in the longitudinal direction of the stent. Thus, the entire length of the cylindrical inner surface of the inner wall of the stent is doubled by the separate sealing layer forming the inner sheath 2a, and only the longitudinal ends of the inner sheath 2a are sealed and attached to the anchor member 1 by elastomeric annular seals obtained by fusing the inner sheath at each of the longitudinal ends.

[0083] As is well known, as shown in patent WO2013 / 014353, the stent 1 preferably includes flared flanges at its upstream and downstream ends.

[0084] Since the inner sheath 2a is not overstretched to prevent the stent from becoming taut, the distance between said inner sheath 2a and the maximum outer diameter of the stent is preferably 0.2 mm to 10 mm, more preferably 1 mm to 5 mm, and it is understood that the space between said inner sheath 2a and the stent wall defines a chamber called vacuum chamber 4.

[0085] The protection device 5 according to the invention further comprises a flexible or semi-rigid tube called the suction tube 3, which extends downstream outside the stent and opens into a vacuum chamber 4 between the inner sheath 2a and the wall of the stent 1, the upstream part of which comprises a plurality of holes and which extends over substantially the entire length of the chamber 4 in the longitudinal direction XX of the device. The suction tube 3 opens into the vacuum chamber by passing sealed through an elastomeric annular seal at the downstream end of the inner sheath 2a when the tube 3 is introduced through the anal orifice. The suction tube 3 and the outer sheath 2 extend from the same downstream end of the stent to the outside of the stent.

[0086] The suction tube 3 is used to inject or suction air into the chamber 4, drawing the intestinal wall 100a outwards from the stent 1 and more generally altering the fixation properties of the stent 1 relative to the intestinal wall 100a.

[0087] The portion 3 a of the suction tube 3 that is within the chamber 4 can be attached to the inside of the stent 1 or to the outside of the outer sheath 2 .

[0088] Alternatively, the outer sheath 2 may be attached at its upstream end to the same elastomeric fusion joints 4a and 4b, or may be attached to the outer surface at the downstream longitudinal end of the stent by overlapping a short portion of its length (not shown).

[0089] The stent is of a type formed of a mesh of helical nitinol metal wires that imparts radial elastic properties so that the stent can be compressed to a radially contracted state and can assume a fully radially expanded state when released from radial compression, and the first outer diameter of the first wall having a plurality of holes is: - a minimum outer diameter of 16 mm in the radially contracted state of the first wall, and - a maximum outer diameter of 37 mm in the maximally radially expanded state of the first wall.

[0090] The above diameter dimension data correspond to dimensions suitable for anchoring the device to the mucosa 10 of the intestinal wall at various locations throughout the body, including the rectum. The stent is made of a mesh of 0.32 mm wire nitinol woven at a 30° angle, has a diameter of 34 mm at the open end, a diameter of 37 mm at the flared ends, and is 100 mm long.

[0091] The proximal and distal portions of the stent, and flanges (not shown), if applicable, are equipped with lasso wires 6a and 6b, respectively, to reduce the diameter of the stent under tension, which can be grasped using specialized clamps or hooks inserted through the endoscope.

[0092] The outwardly extending sheath 2 has a length that covers the distance between the anastomosis and the upstream anchoring point, ie a length of at least 10 cm.

[0093] The sheath 2 is made of a radiopaque, biocompatible synthetic material, specifically 18% BaSO4 It is made of TPU90AE containing 100 μm thick, has a resting length of 400 mm (excluding the inner part of the stent) and an outer diameter of 37 mm.

[0094] The suction tube 3, made of Pebax® elastomer material (ARKEMA, France), is attached to the stent at both ends by the same fusion joints 4a and 4b as the inner sheath 2a, and has a length that covers at least the distance between the anastomosis and the upstream fixation point, i.e., at least 10 cm. Its characteristics are: length 500 mm ± 2 mm; thickness 0.5 mm; inner diameter 2 mm; and outer diameter 3 mm.

[0095] The outer longitudinal free end of the suction tube 3 is reversibly connected to a connecting part having a shut-off device, which has a non-return valve with a device for indicating the degree of vacuum in the chamber 4.

[0096] The stent 1, outer sheath 2, and infusion-aspiration tube 3 are encased in a deformable semi-rigid plastic tube 11 made of an elastomeric material, which will be referred to hereinafter as a deformable first guide tube 12. This first guide tube 12 is part of an introducer 10, which will be described below.

[0097] The stent is introduced in a contracted state (radially compressed) into the upstream distal end of the deformable first guide tube 12, and the outer sheath 2 and the suction tube 3 are folded in several overlapping layers, partly within the stent and partly within the first guide tube 12 of the introducer 10.

[0098] The fixation of the outer sheath 2 and the downstream end of the suction tube 3 differs between the two embodiments, Example 1 and Example 2, and the first guide tube 11 has different characteristic implementations between the two embodiments, as described below. The stent is held inside the first guide tube 12 by a device called a tulip 12a made of a cutout tab. The tulip 12a blocks the passage at the upstream or distal end of the first guide tube 12 and prevents the stent from being dislodged in the absence of a thrust from a pusher stop, which will be described later. The tab is elastically deformable under the influence of the thrust, which allows the stent to be expelled from the first guide tube 12.

[0099] The introducer 10 comprises a handle 14 attached to a second rigid tube 13, also referred to as the second guide tube, the distal end of which terminates in a junction 13a with the first guide tube 12. This junction 13a is convexly curved outward and has a larger diameter than the first deformable guide tube 12 and the second rigid guide tube 13, acting as a stop.

[0100] Actuation by a pressure or push button 14a on the handle 14 controls the longitudinal translation of a pusher rod 15a, which terminates in a pusher stop 15b of the pusher 15. The pusher rod 15a and pusher stop 12b are coaxially disposed within the second rigid tube 13. The proximal end of the pusher rod 15a cooperates with the push button 14a on the handle 14. The distal end of the pusher rod and the pusher stop interact relative to one another within the first deformable guide tube 12, and actuation of the pusher rod and pusher stop allows the stent to be pushed out of the upstream (distal) end of the first deformable guide tube 12.

[0101] Pusher stop 15b is initially positioned within first deformable guide tube 12 just downstream of the stent.

[0102] In the following two embodiments, Example 1 and Example 2, the first deformable guide tube 12 of the introducer, which houses the protection device 5 radially compressed as described above, is introduced into the upstream portion 100a of the segmented intestine at the position 101 where the anastomosis is to be formed in the abdomen. In this case, the placement position is 10 cm to 20 cm upstream of the anastomosis.

[0103] At this stage, the stent and the outer sheath 2 and the aspiration tube 3 are housed stationarily inside the stent and at least partly housed stationarily inside the first deformable guide tube 12. In its initial configuration, the stent 1 is housed closed in the introducer and has a diameter reduced to the diameter of the deformable guide tube 11, i.e., specifically, to 10 mm.

[0104] The stent gradually returns to its final diameter once released into the lumen of the upstream intestine 100a outside the first deformable guide tube 12. The surgeon can temporarily hold the stent in place by manually pinching the stent through the intestinal wall. At least a portion of the introducer is then removed without the outer sheath 2 and suction tube 3 unfolding or deploying downstream of the stent. However, these components are allowed to partially deploy to the anastomosis area (the stent is released between 10 and 20 cm beyond this area). This allows the anastomosis to form, after which the outer sheath and suction tube unfold and deploy more fully downstream of the stent. At this stage, the stent, gradually returning to its final diameter, is released into the intestinal lumen outside the first deformable guide tube 12, ideally followed by the formation of the anastomosis.

[0105] The first deformable guide tube 12 has an inner diameter of 10 mm, an outer diameter of 17 mm, and is at least 70 cm long, preferably at least 100 cm long, with graduations every 5 cm. The first deformable guide tube 12 is made of Pebax (R mark) material to limit friction during insertion and removal.

[0106] The second rigid tube 13 is 176 mm long and includes a convexly curved connecting portion 13a with a 53 mm diameter protrusion, forming a 46 mm long stopper. The second rigid tube 13 has a central guide groove 13b, which controls the translation of the internal pusher rod.

[0107] The shaft 15a of the pusher 15 is made of stainless steel and has a length of 487 mm in front of the stop 15b. The rod 15a is made of a wire with a diameter of 1.4 mm, which is spirally wound along an imaginary longitudinal axis XX' and has a plurality of tangent turns, forming a deformable rod with an outer diameter of 7 mm. Such a rod 15a can change its bending shape and bend up to 90°.

[0108] 4A-4D illustrate various steps involved in creating an anastomosis using an anvil 8 and a circular stapler 9. The anvil 8 is inserted into the upstream section 100a of the intestine just upstream of the location 101 of the anastomosis at the free end of the upstream section 100a. Ligation of this free end of the intestine is then performed with a purse string 8' around the shaft 8b behind the circular cross-sectional portion 8a of the anvil 8. The stapler 9 is then introduced into the downstream section 100b of the intestine, the stapler 9 having a hollow body 9b of circular cross-section to cover the annular section 8a of the anvil and including axial fingers 9a that can cooperate with an axial hollow (not shown) within the shaft 8b, thereby allowing the stapler 9 to cooperate with the anvil 8 to staple the anastomosis 101 between the upstream section 100a of the intestine and the downstream section 100b of the intestine, before the anvil 8 and stapler 9 components are removed from the intestine, as shown in FIG. 4D. 4B to 4D, the stapler 9 is shown in a schematic view downstream of the distal part of the intestine, with the understanding that it is first actually introduced via the rectum. In particular, an EEA (R mark) stapler from the company COVIDIEN (France) is used, which comprises a handle 9d and a deformable duct 9c that can follow the curvature of the intestine to connect the handle 9d to a stapler part 9b that cooperates with an anvil 8 for controlling the staples.

[0109] More precisely, the following sequence of steps is carried out: 1) The diseased bowel is resected using a linear stapler to form an occlusion 100d and section the bowel downstream 100b of the diseased section of bowel. 2) Place the purse bag 8' on the intestine located upstream of the affected area and cut it. 3) The anvil 8 of the circular stapler is inserted into the proximal portion 100a of the intestine, and the purse string 8' is tightened and knotted around its central axis 8b. 4) The body 9b of the circular stapler is inserted into the downstream portion 100b of the intestine (through the anal orifice) up to its closed end 100d. 5) The central shaft 9a of the circular stapler is forced through the wall of the downstream intestine by penetration. 6) The central shaft 9a of the circular stapler is connected to the central shaft 8b of the anvil. 7) The two joined pins 8a and 9a are inserted into the stapler body, thereby attaching the anvil portion to the stapler body portion. 8) The walls of the two intestinal sections 100a and 100b joined together at 101 are stapled and cut into a circular cross section. The pusher distal stop 15b is made of Pebax (R mark) material and has a diameter and thickness in the longitudinal direction of the rod of 10 mm.

[0110] In the two embodiments of Example 1 and Example 2, the outer sheath 2 and suction tube 3 are expanded and extended downstream of the stent by removing the anvil after stapling has been performed.

[0111] Ideally, the protective device should be removed after the anastomosis has healed, which typically takes 14 days.

[0112] Withdrawals can be made in two ways. a) Removal by inversion during an endoscopic procedure. In this case, the lasso loop 6b at the distal (or upstream) end of the stent is grasped with forceps. This has the effect of reducing the diameter of the stent. Once the stent has been sufficiently radially contracted, it can be inverted by pulling on the lasso wire. This inverts or turns the stent inside out and gently pulls it from the tissue. b) The second method of extraction involves the use of an extraction tube. In this case, the outer sheath and suction tube are inserted into the extraction tube. The lasso loop 6a at the proximal (or swallowing) end of the stent is grasped with forceps (guided by the use of an endoscope). This has the effect of reducing the diameter of the stent (by radial contraction). Once the stent has sufficiently contracted, it can be slid into the removal tube. Advancement of the shrink tube loosens the tissue, allowing the stent to be retrieved intact. The extraction tube containing the stent is then removed via the anal passage.

[0113] In the two embodiments of Example 1 and Example 2, the connection configurations of some introducer components differ between each other or between the protection devices 1, in particular the downstream longitudinal ends of the outer sheath 3 and of the suction-infusion tube 4 are connected to different introducer components. The downstream ends of the outer sheath 2 and of the suction tube 3 are attached to the distal end of the first guide tube 12 in the embodiment of Example 1 and to the first connecting piece 11, which can be reversibly attached to the pusher stop 15b in the embodiment of Example 2. [Example]

[0114] Example 1 5A, 5B, 6, 7A and 7B show a first embodiment of a combined device according to the present invention, in which the downstream ends of the sheath 2 and suction tube 3 are fixed to 2b-3b near the upstream or proximal end of the first deformable tube 12.

[0115] 5A, the sheath 2 and suction tube 3 are folded inside the stent 1 and protrude beyond the seal 4b downstream of the stent, joining the upstream end of the first guide tube 12 from the outside with the ends of the sheath 2 and the suction tube 3. The suction tube 3 is then glued to the inner wall of the first guide tube 12 at 2b-3b near the upstream or proximal end of the first guide tube 12.

[0116] 5B shows a schematic representation of an embodiment in which there are several folds of the sheath 2 and suction tube 3 inside the stent 1, and the sheath 2 and suction tube 3 are inserted between the outer wall of the stent 1 and the inner wall of the first guide tube 12, thereby joining the inner wall of the first deformable tube 12. In FIG. 5B, the arrangement of the stent 1 inside the first guide tube 12 is shown schematically by exaggerating the space between the stent 1 and the inner wall of the first guide tube 12 to show the arrangement of the sheath 2 and suction tube 3 outside the stent 1. However, in reality, the stent 1 is in a radially compressed state pressing against the inner wall of the first guide tube 12, with the sheath 2 inserted and compressed between them at this initial stage.

[0117] In this embodiment, the stop 15b of the pusher 15 has a cross-sectional diameter slightly larger than the diameter of the stent, and therefore, under the influence of the translational thrust of the pusher 15 actuated by the handle 14 of the introducer 10, the stent can be expelled towards the outlet of the proximal end 12a of the first deformable guide tube 12.

[0118] Figure 6 shows that after completion of the anastomosis, as described below in connection with Figures 7A-7D, the sheath 2 downstream of the stent 1 and the suction tube 3 are fully deployed when the first tube 12 is removed from the intestine, as shown in Figure 7D. In practice, this removal occurs until the stapler exits the anal orifice. At this point, as shown in Figure 7D, the sheath 2 and the suction tube 3 are cut with scissors 16 to separate them from the composite part of the first tube 12, which is attached to the stapler 9 by the second connecting part 12b.

[0119] In this embodiment, as shown in Figures 7A to 7C, the proximal end of the first deformable guide tube 12 actually comprises a part called the second connecting part 12b, which has an internal thread that can be threaded into a complementary threaded portion 7a of a part called the adapter 7. The adapter 7 can be fixed, for example, by reversible coupling with the front face 8c of the anvil 8.

[0120] In this embodiment, the second connecting piece 12b serves to receive the introducer 10 by first threading the complementary threaded portion 13b onto the distal end of the second rigid guide tube 13, as shown in FIG. 2, to reach the configuration shown in FIGS. 2A and 5A. In FIGS. 2A and 5A, the stop 15b is located near the downstream end of the stent 1 inside the first guide tube 12. At this point, the pusher rod 15a is actuated by translation of the second rigid guide tube 13 relative to the handle 14 via a recess 13c along the second rigid guide tube 13. This translation is controlled by actuation of the pusher rod 14a to push the stent 1 out of the first guide tube 12, as shown in FIG. 2B. At this point, the second connecting piece 12b is located approximately at the free end of the upstream intestinal portion 100a and is therefore in a position to receive the anvil 8 via the interposition of the adapter 7, as shown in FIGS. 7A-7C. The anastomosis is then created using stapler 9 as described with reference to Figures 4A-4C. The first guide tube 12-anvil 8-stapler 9 are then removed from outside the patient at the anal orifice to the configuration shown in Figures 6 and 7D, where stapler 9 is shown in schematic form downstream of the downstream portion 100b of the intestine with the understanding that it has actually been removed from the intestine via the rectum.

[0121] In this embodiment, the sheath 2 and suction tube 3 are preferably not directly attached to the ends of the deformable tube 12 at 2b and 3b, but rather via ties such as sutures (not shown).

[0122] Example 2 8A, 8B, 9A, 9B, 10A, 10B, 10C, 11A and 11B show the salient features of a second embodiment of a composite device according to the present invention.

[0123] In this second embodiment, the downstream end of the sheath 2 and the downstream end of the suction tube 3 are attached to a first connecting piece 11 located just outside the downstream end of the stent 1 .

[0124] 8A and 8B show two variants of the arrangement of the sheath 2 and the suction tube 3 inside the stent 1. In both cases, the sheath 2 and the suction tube 3 are initially positioned inside the stent. In the first preferred variant of FIG. 8A, the suction tube 3 and the sheath 2 are simply attached to the tubular part 11a at the distal end of the first connecting part 11 and are folded inside the stent 1; the suction tube 3 is not wound onto the tubular part 11a as in the second variant of FIG. 8B. The various stages of the implementation of the combined device according to the invention in this second embodiment are shown with respect to this second variant of FIG. 8B, but can be transposed to the variant of FIG. 8A. The tubular portion 11a of the connecting part 11 initially fits inside the stent 1 at its downstream end, and the larger diameter part 11b serves as a support for the pusher rod stop 15b for the insertion stage and then serves to reversibly fix the connecting part 11 against the front face 8c of the anvil 8 for the stapling and anastomosis forming stage.

[0125] In this embodiment, the combined device according to the invention comprises components of a protection device 5 and a first connecting piece 11, which is independent of the first guide tube 12. The first guide tube 12 can therefore be irreversibly fixed to the distal end of the second rigid guide tube 13 of the introducer 10 at connection 13a, as shown in Figure 9A.

[0126] 9A and 9B show that initially, the stop 15b at the distal end of the pusher rod 15a rests against the flat proximal surface 11b of the first connecting part 11, and translation of the pusher rod 15 pushes the stent 1 out of the first guide tube 12. Next, as shown in FIG. 10A, the introducer 10 is removed from the upstream portion 100a of the intestine, leaving the first connecting part 11 at the anastomosis position 101. As shown in FIG. 10B, it is advantageous to reversibly bond the stop 15a to the first connecting part 11, allowing the sheath 2 and suction tube 3 to be partially deployed during preliminary partial removal of the introducer 10 until the part 11 reaches the anastomosis position. At this point, the anvil 8 is reversibly fixed to the first connecting part 11, for example, by a reversible bond. The anastomosis is then formed as in Example 1 and as shown in FIGS. 4A to 4C, until the state shown in FIGS. 11A and 11B is reached. 11A and 11B, the components attached to the first connecting part 11-anvil 8-stapler 9 are removed and the sheath 2 and cube 3 are fully deployed downstream of the stent 1 and downstream of the anastomosis 101 up to the anal orifice, where the sheath 2 and suction tube 3 are detached from the first connecting part 11 using scissors 16. Although FIGS. 11A and 11B show the stapler 9 diagrammatically downstream of the downstream portion 100b of the intestine, the stapler 9 is actually inserted and removed from the intestine through the rectum using the handle 9d, which remains outside the rectum.

[0127] In a simplified variant (not shown), the flexible sheath 2 and the two suction tubes 2 are initially arranged within the first tube 12, but completely outside the stent, downstream of which the stent is radially compressed within the first guide tube. The two suction tubes 2 are arranged so that they can extend radially opposite the stent and outside the sheath.

Claims

1. 1. A composite surgical device for protecting an anastomosis (101) in the intestine, said composite surgical device comprising: a protection device (5) comprising an anchoring member and a flexible sheath (2), the anchoring member being temporarily fixable to the inner wall of the intestine upstream (100a) of the anastomosis, at least an upstream end of the flexible sheath (2) being fixed to the anchoring member, the flexible sheath being extendable downstream of the anchoring member and downstream of the anastomosis to allow the anastomosis to be protected; an introducer (10) comprising a first guide tube (12), a second guide tube (13) proximal to the first guide tube (12), a handle (14), and a connection portion (13a) between an end of the first guide tube (12) and the second guide tube (13), the connection portion (13a) having a larger diameter than the first guide tube (12) and the second guide tube (13), the anchor member being configured to be held in a radially compressed state inside the first guide tube (12); The flexible sheath (2) is configured to be stored inside the first guide tube (12), and the flexible sheath (2) can be deployed downstream of the anchor member by pulling the first guide tube (12) downstream of the anchor member; The protective device (5) comprises at least one suction tube (3), which can extend outside the anchor member downstream of the suction tube, and the open end of the suction tube opens into a vacuum chamber (4) formed between the anchor member and the flexible sheath, inside the anchor member.

2. 2. The composite surgical device of claim 1, wherein the downstream end (2) of the flexible sheath (2) and the downstream end of the suction tube (3) are configured to be disposed within the first guide tube.

3. A complex surgical device for protecting an anastomosis (101) in the intestine, the complex surgical device comprising: a protection device (5) comprising an anchoring member and a flexible sheath (2), the anchoring member being temporarily fixable to the inner wall of the intestine upstream (100a) of the anastomosis, at least an upstream end of the flexible sheath (2) being fixed to the anchoring member, the flexible sheath being extendable downstream of the anchoring member and downstream of the anastomosis to allow the anastomosis to be protected; an introducer (10) comprising a first guide tube (12), a second guide tube (13) proximal to the first guide tube (12), a handle (14), and a connection portion (13a) between an end of the first guide tube (12) and the second guide tube (13), the connection portion (13a) having a larger diameter than the first guide tube (12) and the second guide tube (13), the anchor member being configured to be held in a radially compressed state inside the first guide tube (12); The flexible sheath (2) is configured to be stored inside the first guide tube (12), and the flexible sheath (2) can be deployed downstream of the anchor member by pulling the first guide tube (12) downstream of the anchor member; A composite surgical device, wherein the distal end of the first guide tube (12) is closed by a flexible retaining portion (12a), which is capable of retaining the protection device (5) inside the first guide tube in the absence of a thrust force inside the first guide tube by a pusher rod stop portion (15a), and the retaining portion is capable of elastically deforming and allowing the protection device (5) to slip out under the influence of the thrust force by the pusher rod stop portion.

4. A complex surgical device for protecting an anastomosis (101) in the intestine, the complex surgical device comprising: a protection device (5) comprising an anchoring member and a flexible sheath (2), the anchoring member being temporarily fixable to the inner wall of the intestine upstream (100a) of the anastomosis, at least an upstream end of the flexible sheath (2) being fixed to the anchoring member, the flexible sheath being extendable downstream of the anchoring member and downstream of the anastomosis to allow the anastomosis to be protected; an introducer (10) comprising a first guide tube (12), a second guide tube (13) proximal to the first guide tube (12), a handle (14), and a connection portion (13a) between an end of the first guide tube (12) and the second guide tube (13), the connection portion (13a) having a larger diameter than the first guide tube (12) and the second guide tube (13), the anchor member being configured to be held in a radially compressed state inside the first guide tube (12); The flexible sheath (2) is configured to be stored inside the first guide tube (12), and the flexible sheath (2) can be deployed downstream of the anchor member by pulling the first guide tube (12) downstream of the anchor member; A composite surgical device, wherein a distal end of the first guide tube comprises a cutout tab, the cutout tab configured to block the distal end of the first guide tube.

5. 5. The hybrid surgical device of claim 4, wherein the cutout tab is resiliently deformable such that the protector device can be deployed through the cutout tab.

6. 6. The hybrid surgical device of claim 1, wherein the introducer comprises a pusher (15) comprising a pusher rod (15a) and a pusher stop (15b) at a distal end of the pusher rod, the pusher extending from the handle within the second guide tube (13) and the first guide tube (12), and a proximal end of the pusher rod (15a) adapted to cooperate with the handle by manually controlling the relative translation of the pusher rod with respect to the first guide tube.

7. 6. The multifunctional surgical device of claim 1, further comprising a pusher located within the first guide tube, the pusher configured to cause release of the protective device from the distal end of the first guide tube when a distance between the first guide tube and the handle is reduced.

8. 8. The hybrid surgical device of claim 1, wherein the distance between the first guide tube and the handle is reduced to release the protection device from the distal end of the first guide tube at a location upstream of the anastomosis to deploy the protection device to protect the anastomosis.

9. 9. The hybrid surgical device of claim 8, wherein the second guide tube is configured to be moved toward the handle when the distance between the first guide tube and the handle is reduced.

10. 10. The multifunctional surgical device of claim 8, wherein the distance between the first guide tube and the handle is configured to be reduced until the connection is located at or near the handle.

11. 11. The multifunctional surgical device of claim 1, wherein the second guide tube includes a guide groove, the guide groove configured to control translation.

12. 12. The hybrid surgical device of any one of claims 1-11, wherein the introducer comprises a pusher rod, the handle comprises an actuator, the pusher rod having a longitudinal direction, and the actuator configured to control movement of the pusher rod in the longitudinal direction.

13. The multifaceted surgical device of claim 12 , wherein the actuator comprises a button on the handle.

Images