Instruments and methods for endoscopic gastric and intestinal anastomosis - Patents.com

Abstract

An apparatus for endoscopically anastomosis of a patient's stomach and intestine to allow food to bypass the duodenum and optionally a portion of the jejunum, the apparatus comprising a tube, a surgical instrument, and at least one operating element. The tube is insertable into the stomach and has a proximal end and a distal end. The surgical instrument is insertable at least partially, preferably completely, through the tube. The operating element for operating the surgical instrument from the proximal end is connected or connectable to the surgical instrument. The surgical instrument is configured to establish an anastomosis between a first region of the stomach and a second region of the intestine.

Description

[Technical field]

[0001] The present invention relates to devices and methods for gastric and intestinal anastomosis, for example for use in treating obesity and / or diabetes in a patient, although some embodiments relate to endoscopic devices and methods, without being limited to such embodiments.

[0002] The use of minimally invasive implantable devices that block nutrient absorption in parts of the intestine, particularly the duodenum, for the treatment of obesity and diabetes is known in the prior art.

[0003] Many minimally invasive implants suffer from the problem that the stomach and intestines, particularly the pylorus, are highly active areas of the digestive tract, and therefore some implants are subject to migration or displacement and / or only provide a short-term solution.

[0004] Minimally invasive and permanent solutions for the treatment of obesity have been proposed. A possible solution is provided by bypassing a portion of the intestine, such as the duodenum, to accommodate nutritional intake.

[0005] Bypassing a portion of the intestine without laparoscopic surgery allows obese patients to recover faster without external and abdominal incisions or wounds and wound infections. However, significant technical challenges remain in performing minimally invasive surgery in a safe and effective manner without risking injury to adjacent tissues or vital organs, without risking tearing of stomach or intestinal tissue, and without risking postoperative gastrointestinal leakage.

[0006] It would be desirable to address one or more of the above problems. Aspects of the invention are defined in the claims.

[0007] In a first aspect, the present invention provides an apparatus for endoscopically anastomosis of a patient's stomach and intestine to allow food to bypass the duodenum and optionally a portion of the jejunum. The apparatus may optionally be configured to facilitate endoscopic procedures through only one (e.g., natural) body orifice.

[0008] The instrument comprises one or more of a tube insertable into the stomach, the tube having a proximal end and a distal end, a surgical instrument deployable at the distal end of the tube and at least partially, preferably completely, insertable through the tube, and / or at least one operating element connected or connectable to the surgical instrument for operating the surgical instrument from the proximal end, The surgical instrument is configured to establish an anastomosis between a first region of the stomach and a second region of the intestine.

[0009] The distal end refers to the insertable end of the instrument where the surgical instruments can be deployed. The proximal end refers to the end opposite the distal end that the surgeon manipulates during the minimally invasive anastomosis procedure.

[0010] The device is preferably insertable through a natural body orifice of the patient, preferably the oral cavity.

[0011] The operating element preferably comprises an inner tube which may be arranged concentrically inside the tube.

[0012] The tube and / or the inner tube preferably comprises an opening in the region of the distal end and an opening in the region of the proximal end connected by a channel or cavity.

[0013] The surgical instrument is preferably partially insertable into the tube or inner tube. Most preferably, the surgical instrument is completely movable through the tube or inner tube.

[0014] The operating element is preferably concentrically surrounded by a tube. At least a portion of the operating element is preferably movable relative to the tube along the longitudinal axis of the tube or rotatable about the longitudinal axis of the tube.

[0015] The surgical instrument is preferably designed to establish intimate contact between a first region of the stomach and a second region of the intestine.

[0016] The instrument preferably comprises at least one imaging element, in particular a radiopaque and / or metallic element, preferably arranged at the distal end of the tube and / or the operating element.

[0017] It is preferred that the tube and / or the inner tube are essentially immobile in the radial direction to prevent bending of the tube and / or the inner tube thereby blocking the cavity.

[0018] The tube and / or inner tube may comprise materials such as stainless steel, titanium, platinum, iridium, barium, tungsten, and / or plastics, particularly thermoplastics such as silicone, polyetheretherketone, polyamide, fluoropolymer, polyvinyl chloride, and / or polyurethane.

[0019] Additionally, the device is preferably hydrophilic due to the coating, which makes insertion into the body passage easier and less traumatic. Additionally, the coating enhances the slidability of the device.

[0020] Additionally or alternatively to any of the above, the surgical instrument may comprise a cutting device for cutting tissue, optionally rotatable in a circumferential direction about the tube, and in particular allowing removal of tissue through the tube, optionally from a first region of the stomach and / or a second region of the intestine.

[0021] Preferably, the cutting devices are arranged or positionable concentrically about the longitudinal axis of the tube.

[0022] The cutting device may be suitable for cutting the edges of the first region and / or the second region. For cutting at different transverse profile sizes several cutting devices can be envisaged.

[0023] The cutting device is preferably capable of cutting only the outer edges of the first and second regions, cutting along the edges allowing the severed tissue to be more easily removed through the tube.

[0024] The operating element preferably comprises a control element for operating the cutting device. The control element and / or the operating element are preferably torsionally rigid.

[0025] Torsionally rigid means that the transmission of torque is preferably substantially 1:1. Thus, the control element is preferably configured such that rotation of the control element at the proximal end through an angle in at least one direction results in substantially the same rotation through that angle at the distal end. Thus, the control element and / or the operating element can be rotated from the proximal end.

[0026] Additionally or alternatively, the manipulating element may be axially movable. The instrument may comprise a mechanism for converting rotational motion into linear motion or vice versa.

[0027] Additionally or alternatively to any of the above, the cutting device may be convertible between (i) a collapsed state for introduction into the first and / or second region, the collapsed state having a first transverse profile about the axis of the tube, and (ii) an unfolded state for effectively cutting tissue, the unfolded state having a second transverse profile about the axis of the tube that is greater than the first transverse profile.

[0028] The second lateral profile can have a predetermined (e.g., fixed) size. The cutting device can be configured to cut tissue when in a deployed state of the predetermined (e.g., fixed) size.

[0029] A cutting device (optionally in a format that is laterally expandable to a larger deployed state) can be attached to a shaft, e.g., a hollow shaft. The cutting device can be configured to cut a closed loop shaped opening in tissue. Optionally, the closed loop shape extends about the axis of the shaft and / or about the axis of the tube.

[0030] The cutting device may have a cutting element and / or cutting surface that faces toward the distal end of the tube when deployed for cutting. Additionally or alternatively, the cutting device may be configured to cut tissue with a cutting direction toward the distal end of the tube when deployed.

[0031] Regardless of how the cutting device is implemented, the control element may comprise means for converting the cutting device to the deployed and retracted states, and separate means for operating the cutting device once deployed.

[0032] The cutting device is preferably reversibly convertible from a folded state to a deployed state.

[0033] A selectively convertible cutting device may be housed within the tube and / or inner tube, preferably in a collapsed state.

[0034] The area enclosed by the lateral profile of the cutting device in the deployed state is optionally at least twice, optionally at least three times, optionally at least four times the area enclosed by the lateral profile in the collapsed state.

[0035] The lateral profile of the cutting device preferably extends radially from the longitudinal axis of the tube in the deployed state and collapses radially in the collapsed state.

[0036] The deployable cutting device can allow for a cutting area with a transverse profile larger than the transverse profile of the tube, which must be small enough to be inserted through the esophagus.

[0037] The cutting device can preferably extend radially in the shape of a closed loop, particularly preferably in the shape of a circle or an ellipse.

[0038] The cutting device may optionally comprise a reversibly rollable blade element convertible between an unfolded state and a rolled state. The blade element may have a predetermined size and / or shape, preferably a circular shape, outside the tube in the unfolded state and may be positionable in a cross section of the tube in the folded state. In the folded state, the blade element may have a helical transverse profile. The cutting device may be formed from only one blade element.

[0039] The rollable blade element is preferably convertible from a folded state to an unfolded state and vice versa by a control element.

[0040] It is also contemplated that the cutting device may be constructed of at least two segments that are functional only when the cutting device is transformed into an unfolded state. For example, the cutting device may include segments that fold into an overlapping, space-saving state and deploy side-by-side into a larger configuration.

[0041] Cutting devices are contemplated that can only be transformed to a second transverse profile by rotational movement about the longitudinal axis of the tube, for example, the cutting device may be collapsible by rolling it into a helix shape and unfoldable by unrolling the helix.

[0042] It is contemplated that the cutting device will move only radially relative to the tube when transformed from the folded to the deployed state and vice versa.

[0043] As an alternative to the cutting device, a dilating element, in particular for stomach dilatation, is also conceivable. The cutting device may include at least one retention device that may limit and / or guide the radial expansion of the cutting device to a predetermined size when transitioning to the deployed state and / or may guide the cutting device as it collapses to the collapsed state.

[0044] The retaining device may include a removable and / or releasable latch that preferably locks when the cutting device expands to a predetermined size.

[0045] The latch is preferably releasable by rotation and / or translation by a control element.

[0046] However, regardless of how the cutting element is implemented, the cutting device can be configured to cut tissue from a first side, and the instrument further comprises a counter element deployable on an opposite second side of the tissue. Optionally, the counter element can function and / or be configured to (i) protect surrounding tissue from the cutting device on the second side, and / or (ii) provide a cutting plate for the cutting device, and / or (iii) cooperate with the cutting device to capture the cut tissue for removal through the tube.

[0047] Protection of adjacent tissue can provide significant safety benefits to the patient: when cutting tissue, the active portion of the cutting element can be covered or enveloped by the counter element, reducing the risk of injury.

[0048] By clamping the tissue on both sides, the dissection is less dependent on the surgeon's skill and the surrounding tissue is protected.

[0049] In some embodiments, the cutting device is located distal to the opposing element, at least in the deployed state of the cutting device.

[0050] The lateral profile of the tube can be greater than the lateral profile of the cut by the cutting device. The tube can preferably be designed to protectively cover the incision by the cutting device in the first region. Leakage of fluids from and into the stomach can preferably be prevented.

[0051] The tissue to be cut is preferably clamped by the surgical instrument such that only the cutting movement by the cutting device contacts the tissue to be cut. The transmission of forces to the surrounding tissue is preferably optimized by applying pressure to the tissue.

[0052] The opposing element may be convertible between (i) a folded state for introduction into the first region and / or the second region, the folded state having a first lateral profile centered about the axis of the tube, and (ii) an unfolded state having a second lateral profile centered about the axis of the tube that is greater than the first lateral profile.

[0053] In some embodiments, this allows the opposing elements to be passed through a small opening to the opposite side of the tissue and deployed on the opposite side without fear of tearing the tissue.

[0054] The counter element may be and / or can be arranged concentrically with respect to the tube, preferably at the distal end of the tube. The counter element in the deployed state preferably surrounds at least the same area as the second lateral profile of the cutting device.

[0055] The counter element is or may be connectable to a cutting device. The counter element is or can be connectable to a distal end of the tube and / or the manipulation element.

[0056] The counter element can preferably be transformed from the folded state to the unfolded state and vice versa by an operating element.

[0057] The transformation can be performed by a translation along the longitudinal axis of the operating element and / or a rotation along the circumference or profile of the operating element. The counter elements in the deployed state can be opened and / or unfolded, and the counter elements in the folded state can be folded and / or retracted.

[0058] The counter elements in the folded state can preferably be inserted and exercised through the tube and / or the inner tube.

[0059] The cutting device may comprise a knife element and / or a piercing element and / or an electrical or optical ablation element. The cutting element may be movable in a rotational motion that follows a curve and / or may be movable axially when cutting.

[0060] Rotation of the control element optionally enables rotation of the cutting device, which can particularly preferably cause a helical rotation of the cutting device along the longitudinal axis of the instrument.

[0061] Cutting devices which cut point by point are also conceivable. In particular, ablation devices using electrical ablation, such as radiofrequency ablation, are contemplated.Ablation devices using radiofrequency or microwave ablation would preferably allow for a less traumatic procedure.

[0062] The point-by-point cutting device is preferably rotatable around the longitudinal axis of the control element in a closed loop, particularly preferably in a circular or elliptical manner.

[0063] The instrument may include a cutting device for cutting the first region and a cutting device for cutting the second region.

[0064] The perimeter or lateral profile of the cutting device for the first region of the stomach is preferably smaller than the perimeter or lateral profile of the cutting device for the anastomosis between the first and second regions.

[0065] Additionally or alternatively to any of the above, the device can include at least one insertable element insertable through a tissue wall of the first region and / or the second region, the insertable element having a collapsed state for introduction through the tissue wall and expandable to an unfolded state at least partially overlapping tissue of the tissue wall.

[0066] The surgical instrument may include an insertable element. The expanded and collapsed states of the insertable element are reversibly convertible into each other by means of the operating element.

[0067] An insertable element in an unfolded state can be rotated, opened, and / or unfolded. An insertable element in a folded state can be reverse rotated, folded, and / or collapsed. Insertable elements that are at least partially inflatable and deflatable are also contemplated.

[0068] The cross-section of the insertable element in the deployed state preferably encloses at least the same area as the second lateral profile of the cutting device.

[0069] In the collapsed state, the insertable element can be inserted through a smaller opening in tissue, thus allowing for a smaller entrance opening and the instrument can allow for a less traumatic and / or invasive surgical procedure with less risk of tearing tissue.

[0070] The insertable element is preferably convertible from the deployed state to the folded state by rotational and / or translational movement of a manipulation element from the proximal end of the instrument.

[0071] The insertable element in the deployed state preferably has an increased radial or lateral dimension. Particularly preferably, the insertable element may have a larger cross-sectional area in the deployed state.

[0072] The insertable element is preferably capable of protectively covering the punctured tissue in the deployed state to prevent leakage.

[0073] The operating element may comprise an extension element attached to the insertable element. It is contemplated that the extension element may transform the insertable element from an unfolded state to a folded state and vice versa.

[0074] In one possible embodiment, the extension element can be retracted to force the insertable element against an opposing element or an operating element such that the insertable element is in a folded position.

[0075] Stretching the extender element can transform the insertable element into an expanded state. The insertable element may include stainless steel, titanium, nickel titanium, tungsten, a fluoropolymer layer, a thermoplastic, particularly polyetheretherketone.

[0076] The opposing element may preferably be located proximally of the insertable element. The cross-sectional profile area of ​​the opposing element in the deployed state is preferably at least equal to that of the cross-sectional profile area of ​​the insertable element in the deployed state.

[0077] The insertable element may be movable relative to the tube from a distal end of the tube, preferably in the longitudinal direction of the tube. The insertable element is preferably movable by rotational or translational movement of the manipulation element.

[0078] The insertable element is preferably movable relative to the remainder of the instrument by means of a manipulation element.

[0079] Furthermore, the inner tube or the entire operating element is preferably relatively movable in the longitudinal direction of the tube.

[0080] The operating element can be inserted through a first region of the stomach. The insertable element is preferably capable of being converted to the deployed state after introduction through a tissue wall.

[0081] The insertable element is preferably capable of being pulled or retracted in the deployed state so that the second region can be pulled towards the first region to establish a tight seal.

[0082] The insertable element can be folded radially outward from the longitudinal axis of the tube, preferably in an umbrella shape, from the folded state to the unfolded state, and particularly preferably around a fixed point in the distal region of the insertable element.

[0083] The insertable element in its collapsed state can be thought of as having an increasing lateral profile width from its distal end to its proximal end.

[0084] A distal region of the insertable element in the collapsed state may include a second cutting device for piercing and / or cutting tissue.

[0085] The area of ​​tissue cut by puncturing with the second cutting device is preferably smaller than the area of ​​tissue cut by the cutting device.

[0086] The second cutting device can be used for piercing and / or cutting, preferably by translational motion in a direction parallel to the longitudinal axis of the instrument.

[0087] The insertable element may be movable relative to the tube to allow the second cutting device to puncture gastric and / or intestinal tissue when the insertable element is in a collapsed state.

[0088] It is further conceivable that the insertable element may be provided with a cutting device at its proximal end. It is conceivable that cutting by the insertable element can be mechanically operable, preferably by means of an operating element, by pulling and / or rotating the insertable element.

[0089] The combination of at least two of the inserted element in the deployed state, the opposing element in the deployed state, and the cutting element is adapted to form an interface surrounding tissue, for example, the inserted element and the opposing element can have a lateral profile that is greater than a lateral profile of the cutting device.

[0090] By surrounding the tissue with the opposing element and the insertable element, the tissue can be cut, preferably in a portion of the first region and / or the second region.

[0091] The cutting device can be located between the opposing element and the insertable element. Further, the cutting device can be located at a distal end of the opposing element and / or at a proximal end of the insertable element.

[0092] The transverse profile of the cutting device in the deployed state can essentially correspond to the diameter of the resulting anastomosis, which is preferably large enough to replace the function of the pylorus. Thus, the diameter of the preferably circular cutting device for establishing the anastomosis is preferably between 1 cm and 6 cm.

[0093] The pylorus can be closed, preferably by suturing or stapling, after the procedure so that food can be expelled exclusively through the anastomosis. The anastomosis preferably has a larger lateral area than the pylorus to account for muscles such as the pyloric sphincter that are lost in the anastomosis.

[0094] The insertable element, counter element, and / or cutting device can be designed to hold the removed tissue and remove it through the tube.

[0095] The insertable element is preferably capable of covering the cut in a proximal direction when in the deployed state. To this end, the insertable element is preferably bendable radially outwardly from the longitudinal axis of the tube. The insertable element is preferably capable of preventing fluid from passing through an entry point of the insertable element.

[0096] The insertable element may preferably have a concave curvature in the deployed state. The insertable element may preferably cover an entrance opening in tissue with a concave curvature on tissue.

[0097] The operating element may comprise a folding device. The insertable element is preferably foldable about a fixed point in a distal region of the insertable element by a folding device, such as a hinge.

[0098] A folding device, preferably operable from the proximal end of the instrument, can convert the insertable element from the deployed state to the folded state.

[0099] The insertable element in the folded state can preferably be arranged inside the operating element or the inner tube.

[0100] The device can include an implantable stent with a check mechanism convertible between an open and a closed state. The closed state can prevent the passage of fluid and the open state can allow the traverse of fluid. The implantable stent can include a check valve that can allow the passage of fluid in only one direction.

[0101] In areas of the digestive tract where a lot of movement and expansion is necessary for nutrient absorption and digestion, a non-return mechanism is advantageous because sensitive enzyme and acid balances cannot be adversely affected by the movement of fluid from the intestine to the stomach and vice versa.

[0102] The stent may be preferably positioned near the anastomotic opening. The stent may be positioned at least partially inside the anastomotic opening. The stent is preferably positioned inside the anastomotic opening and protrudes into the stomach and / or intestine.

[0103] In an embodiment for preventing leakage between the stomach and the intestine, the stent may include a balloon that can be filled with fluid to close the anastomotic opening and emptied to open the anastomotic opening. Fluid for the balloon is preferably provided by a fluid reservoir that can be reversibly emptied and filled. The fluid reservoir is preferably located within the stomach or intestine.

[0104] The balloon is preferably capable of being selectively filled and emptied with fluid, preferably under the control of an external device.

[0105] The check valve may comprise at least one sealing element, preferably a flap. The sealing element of the check valve may preferably be forced into the sealing seat by the pressure of fluid flow from the intestine to the stomach.In an alternative embodiment, the check valve comprises a tubular polymer.

[0106] The tubular polymer is preferably insertable in the direction of the digestive tract. The tubular polymer may comprise a plurality of sealing elements. The sealing elements of the tubular polymer may preferably be located along the inner lateral profile of the tubular polymer. The sealing elements are preferably circular and / or helical in shape.

[0107] The tubular polymer preferably allows fluid to pass through it in only one direction. The tubular polymer is preferably designed to allow the passageway to be widened by the fluid as it passes from the stomach to the intestine. Otherwise, the passageway is preferably closed.

[0108] The passage of the tubular polymer from the intestine to the stomach can be closed, preferably by radial constriction of the tubular polymer, which is preferably optimized by selection of material, thickness, length, and / or placement in the digestive pathway. The tubular polymer can preferably be crumpled to prevent the passage of fluid from the intestine to the stomach.

[0109] The tubular polymer may include silicone, polyurethane, polyester polyethylene terephthalate, fluoropolymer, and / or polyamide.

[0110] The instrument may include a pressure device for selectively applying negative pressure to at least one region within the tube and / or a retention element in the region of the distal end of the instrument for holding the distal end of the instrument against tissue.

[0111] The pressure device can apply negative pressure to create suction at the distal end of the tube and / or the operating element.

[0112] In particular, the pressure device is preferably capable of exerting pressure in the cavity of the operating element, particularly preferably at the opening of the inner tube.

[0113] The distal end of the instrument may be removably attachable to target tissue in the first region and / or the second region via a pressure device.

[0114] By attaching the instrument, the cut can be made more precise and the risk of injury is minimized.

[0115] The tube and / or the inner tube are preferably radially rigid so as not to be deformed by the pressure device.

[0116] The retention element is preferably capable of adhering to the gastric mucosa and / or the intestine. In some embodiments, the tube may have a length of 30 cm to 100 cm, particularly 45 cm to 60 cm, and a diameter of 4 mm to 20 mm, particularly 6 mm to 14 mm.

[0117] The diameter and / or length of the instrument is preferably at least large enough to extend from the patient's oral cavity to a second region of the intestine for a minimally invasive procedure.

[0118] Additionally or alternatively, the instrument may comprise a fastening device, such as a suturing device and / or a stapling device, which may be designed to suture and / or staple the outer edges of the first and second regions, preferably in a predetermined fashion, particularly preferably in a circular fashion.

[0119] Sutured and / or stapled anastomoses may prevent leakage more reliably than stents because they can better accommodate movement in the digestive tract without the risk of dislodging. Fixation devices may be designed to be used on either side of the tissue to be cut, adjacent to the tissue surface, in the first and / or second regions.

[0120] The fixation device can be preferably positioned proximally behind the tissue entrance opening or distally in front of the entrance opening. The fixation device can be connectable or connectably positionable to the insertable element, the cutting device, and / or the opposing element.

[0121] The fixation device is preferably capable of allowing for suturing and / or stapling while tissue is clamped by the opposing element and the insertable element.

[0122] The fixation device may be concentrically positionable around the tube. The fixation device is preferably designed to connect both the stomach wall in a first region and the intestinal wall in a second region with sutures or staples by puncturing both regions.

[0123] The fixation device is preferably insertable and removable through the tube and / or the inner tube.

[0124] It is contemplated that the fixation device may be circumferentially rotatable relative to the surgical instrument. It can be considered that the fixation device can be convertible between a collapsed state and a deployed state, and the fixation device can have a second lateral profile that is larger about the longitudinal axis of the tube in the deployed state compared to a first lateral profile in the collapsed state.

[0125] The anastomosis and / or cutting shape and / or fastening (eg, suture or staple) pattern can have a closed loop shape, which can be circular, or elliptical, or any other closed loop shape, whether symmetrical or asymmetrical.

[0126] In some embodiments, the fixation device may comprise a fusion means, which may be designed to cause fusion of tissue of a first region of the stomach and a second region of the intestine by applying pressure and heat, preferably radio frequency heating, to at least the edges of the first and second regions.

[0127] The fusion means may be designed to apply and / or maintain a radial force to keep the communication between the stomach and the intestine open. The radial force may be applied by an expandable element such as a balloon and / or a mechanical element such as a spike. Furthermore, the fusion means preferably comprises means for applying pressure to the tissue walls from both sides of the enclosed tissue.

[0128] The fusion means is preferably capable of preventing leakage at the fused tissue interface. Additionally or alternatively to any of the above, the device can include a second tube, the distal end of which can be guided from the stomach through the duodenum and connectable with the distal end of the tube across the stomach wall at the first region and the intestinal wall at the second region.

[0129] The device can include a guidewire, and the tube and / or the second tube can be advanced over the guidewire to surround the first region and / or the second region.

[0130] The tube and / or the second tube may be advanced over the guidewire, preferably by being positioned concentrically around the guidewire.

[0131] An alternative embodiment contemplates a guidewire that can be threaded through the first and second regions in a less invasive manner, the guidewire preferably having a diameter of less than 1 mm.

[0132] Furthermore, the problem is solved by a method for endoscopic anastomosis of the stomach and intestine of a patient as already described, allowing food to bypass the duodenum and optionally part of the jejunum.

[0133] In a related aspect, the invention provides a method of using an apparatus, optionally having any one or more of the above-mentioned features, comprising: - inserting the device into the stomach, preferably through the esophagus, and attaching it to the stomach wall at a first region, preferably by applying negative pressure; - puncturing and / or cutting the stomach wall and deploying the insertable element outside the stomach, preferably by opening and / or spreading the insertable element; - advancing a counter element, preferably having a cutting device connected thereto, into a first region within the stomach; - clamping the stomach wall in a first region between the insertable element and an opposing element and cutting a hole in a portion of the first region with a cutting device; - removing the cut stomach tissue, preferably between the opposing element and the insertable element; - advancing an instrument through the hole to locate a target location that constitutes a second area for anastomosis; - attaching to the outside of the intestinal wall in a second region, preferably by applying a negative pressure; - puncturing and / or cutting the intestinal wall to deploy the insertable element inside the intestine, preferably opening and / or spreading the insertable element in the second region; - pulling the insertable element to bring the first region into contact with the second region; - advancing a counter element comprising a fixing device to clamp the first region and the second region between the counter element and the insertable element; - cutting a hole in a portion of the second region with a cutting device and fastening (optionally stapling and / or suturing) the edges of the first and second regions together with a fastening device; - removing the preferably severed stomach and / or intestinal tissue through a tube. Includes.

[0134] Following this procedure, the counter elements, fixation devices, and / or insertable elements can be withdrawn and the anastomosis can be inspected for size, shape, and / or leaks.

[0135] In a preferred method, the pylorus can be closed, for example by suturing and / or stapling, so that food can no longer pass through it. All ingested food must pass through the digestive tract, preferably through the anastomotic opening.

[0136] Finally, the device may be removed from the patient's opening, preferably the esophagus. In any of the above aspects, the instrument may be configured or the method may be performed to create the anastomosis by inserting the instrument into the body through a single opening. The single opening may be a natural body opening, such as the oral cavity. By performing the procedure solely endoscopically and avoiding the need for additional openings, the procedure may be less invasive compared to the multiple openings used in laparoscopic surgery. In other embodiments, the instrument may be used in combination with other laparoscopic tools.

[0137] Non-limiting embodiments of the present invention will now be described, by way of example only, with reference to the accompanying schematic drawings, in which: FIG. [Brief description of the drawings]

[0138] [Figure 1] 1 shows a diagram of gastric and intestinal anastomosis. [Figure 2a] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2b] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2c] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2d] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2e] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2f] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2g] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2h] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2i] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2j] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2k] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2l] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2m] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2n] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2o] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 2p] 1 illustrates endoscopic anastomosis of an instrument having an insertable element. [Figure 3a] 1 shows a schematic diagram of pylorus closure. [Figure 3b] 1 shows a schematic diagram of pylorus closure. [Figure 4a] 1 shows the cutting device in a folded state. [Figure 4b] 1 shows the cutting device in a deployed state. [Figure 4c] 1 shows the cutting device in a folded state. [Figure 4d] 1 shows the cutting device in a deployed state. [Figure 4e] 1 shows the cutting device in a deployed state. [Figure 4f] 1 shows the cutting device in a deployed state. [Figure 5a] 13 illustrates the use of an instrument having an insertable element in a collapsed state to cut tissue with an opposing element. [Figure 5b] 13 illustrates the use of an instrument having an insertable element in a collapsed state to cut tissue with an opposing element. [Figure 5c] 13 illustrates the use of an instrument having an insertable element in a deployed state to cut tissue together with an opposing element. [Figure 5d] 13 illustrates the use of an instrument having an insertable element in a deployed state to cut tissue together with an opposing element. [Figure 5e] 13 illustrates the use of an instrument having an insertable element in a deployed state to cut tissue together with an opposing element. [Figure 5f]13 illustrates the use of an instrument having an insertable element in a deployed state to cut tissue together with an opposing element. [Figure 5g] 13 illustrates the use of an instrument having an insertable element in a deployed state to cut tissue together with an opposing element. [Figure 5h] 13 illustrates the use of an instrument having an insertable element in a collapsed state to cut tissue with an opposing element. [Figure 6a] 13 shows an alternative embodiment of an instrument having an insertable element in a collapsed state that cuts tissue with an opposing element. [Figure 6b] 13 shows an alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue with an opposing element. [Figure 6c] 13 shows an alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue with an opposing element. [Figure 6d] 13 shows an alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue with an opposing element. [Figure 6e] 13 shows an alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue with an opposing element. [Figure 6f] 13 shows an alternative embodiment of an instrument having an insertable element in a collapsed state that cuts tissue with an opposing element. [Figure 6g] 13 shows an alternative embodiment of an instrument having an insertable element in a collapsed state that cuts tissue with an opposing element. [Figure 7a] 13 shows another alternative embodiment of an instrument having an insertable element in a collapsed state that cuts tissue with an opposing element. [Figure 7b] 13 shows another alternative embodiment of an instrument having an insertable element in a collapsed state that cuts tissue with an opposing element. [Figure 7c] 13 shows another alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue together with an opposing element. [Figure 7d]13 shows another alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue together with an opposing element. [Figure 7e] 13 shows another alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue together with an opposing element. [Figure 7f] 13 shows another alternative embodiment of an instrument having an insertable element in a deployed state that cuts tissue together with an opposing element. [Figure 7g] 13 shows another alternative embodiment of an instrument having an insertable element in a collapsed state that cuts tissue with an opposing element. [Figure 8a] 1 illustrates the surgical anastomosis of the device using a guidewire. [Figure 8b] 1 illustrates the surgical anastomosis of the device using a guidewire. [Figure 8c] 1 illustrates the surgical anastomosis of the device using a guidewire. [Figure 8d] 1 illustrates the surgical anastomosis of the device using a guidewire. [Figure 8e] 1 illustrates the surgical anastomosis of the device using a guidewire. [Figure 8f] 1 illustrates the surgical anastomosis of the device using a guidewire. [Figure 8g] 1 illustrates the surgical anastomosis of the device using a guidewire. [Figure 9a] 1 shows a fusing means that can be advanced over a guidewire to fuse tissue by heat and pressure. [Figure 9b] 1 shows a fusing means that can be advanced over a guidewire to fuse tissue by heat and pressure. [Figure 10] 1 is a schematic, partial cross-sectional view illustrating a technique for reducing stomach volume. [Figure 11] FIG. 11 is a schematic diagram showing an enlarged detail of FIG. 10; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0139] Referring to the drawings, Figure 1 shows a schematic anastomosis 301 between the stomach 201 and the intestine 202. The anastomosis 301 allows food to bypass the duodenum, thus reducing nutrient uptake. The anastomosis diameter can range from 1 cm to 6 cm.

[0140] 2a shows the insertion of the device 101 into the stomach via the patient's oral cavity and esophagus. After insertion, a pressure device (not shown) can apply negative pressure to the tube 1, causing the device 101 at the distal end 3 of the tube 1 to attach to the mucosa of the stomach 201 in a first region.

[0141] FIG. 2b shows the puncture of the stomach wall by the puncture element 11. The puncture element 11 can puncture a hole in the stomach wall with a lateral profile sufficient for inserting the surgical instrument 4 in the form of the insertable element 12 in the folded state 13 into the puncture opening, as can be seen in FIG. 2c. The insertable element 12 can be transformed into the deployed state 14 by spreading radially outwards. The insertable element 12 spreads laterally outwards by bending radially outwards around a fixed point in the distal region of the umbrella-shaped insertable element 12. In this way, the lateral profile of the insertable element 12 overlaps with the lateral profile of the cut in the tissue where the insertable element 12 was introduced. The insertable element 12 can be spread outwards of the stomach wall to cover the cut made to introduce the insertable element 12, as can be seen in FIG. 2d.

[0142] Fig. 2e shows that the cutting device 6 can be advanced to the distal end 17 of the operating element 5 in the first region. The cutting device 6 can be operated by rotation of the operating element 5, although translational movements are also conceivable.

[0143] FIG. 2f shows that the stomach wall in the first region is clamped by the deployed insertable element 12 and the counter element 9. A hole can be cut in the first region by operating the cutting device 6 with the control element. It is conceivable that the cutting device 6 is attached or attachable to the insertable element 12 or the counter element 9. It is also conceivable that the cutting device 6 is deployable independently from the insertable element 12 or the counter element 9. In this embodiment, the cutting device 6 is placed on the inner surface of the stomach 201. After the hole is cut in FIG. 2g, the cut tissue 26 is clamped between the insertable element 12 and the cutting device 6, as seen in FIG. 2h. The cut tissue 26 can be removed through the tube 1 by the insertable device in the collapsed state 13.

[0144] As shown in Figure 2i, the manipulating element 5 can be advanced through the cut tissue to locate a target location in a second region of the intestine 202, as shown in Figure 2j. To this end, the instrument 101 may optionally be equipped with a camera.

[0145] The operating element 5 is movable relative to the distal end 3 of the tube 1 from at least a first region of the stomach 201 to a second region of the intestine 202 .

[0146] Once the second area is located, the operating element 5 can apply negative pressure to attach the instrument 101 to the second area and pierce it with the piercing element 11 .

[0147] In Fig. 2l, the insertable element 12 is introduced into the intestine through the puncture cut in a folded state 13. It is also conceivable that the insertable element 12 comprises a piercing element 11 at its distal end for insertion simultaneously with puncturing the tissue.

[0148] In FIG. 2m, the insertable element 12 is transformed into the unfolded state 14. The operating element 5 and the insertable element 12 in the deployed state 14 can be pulled or retracted to bring the first and second regions into close contact. The insertable element 12 in the deployed state 14 can function to protect the surrounding tissue that it is surrounded by and prevent leakage.

[0149] The cutting device 6 can be used to cut the clamped tissue between the insertable element 12 and the counter element 9. Figures 2n and 2o show that the fixation device 15 can be advanced to secure the intestinal and stomach walls to create an anastomosis 301, for example by staples or sutures. In this embodiment, the fixation device 15 is concentric with the manipulation element 5 and connected to the cutting device 6. However, it is also conceivable that the fixation device 15 is connected or connectable to its counter element 9, the insertable element 12, and / or the manipulation element 5.

[0150] As can be seen in Fig. 2o, the fixation device 15, the insertable element 12 and the cutting device 6 can be retrieved through the tube 1. The cut tissue can be removed through the tube 1 with the insertable element in the collapsed state 13.

[0151] The anastomosis 301 can be inspected for size, shape and leaks, so that the instrument 101 can be removed, as seen in FIG. 2p.

[0152] Figure 3a shows the pylorus 27 that can be closed after successful creation of a permanent anastomosis 301 between the stomach 201 and the jejunum of the intestine 202. Closure of the pylorus can be performed by attaching an instrument 101 to the proximal opening of the pylorus 27 and deploying a fixation device (not shown). As shown in Figure 3b, the pylorus 27 is closed by a number of sutures and / or staples 37. It is also contemplated that the pylorus 27 can be closed by an implantable stent.

[0153] Figures 4a and 4c show an embodiment of the cutting device 6 in the folded state 7. Figures 4b and 4d show the cutting device 6 in the deployed state 8. The cutting device 6 comprises a reversibly rollable or spirally rollable blade element 10 which is convertible between the folded state 7 and the deployed state 8. The conversion of the blade element 10 can be performed by rotation of the control element 28. However, conversion of the cutting device 6 by relative movement of the control element 28 is also conceivable. The blade element 10 in the deployed state 8 has a circular lateral profile as shown in Figure 4b. The blade element 10 can be rotated from the proximal end of the tube 1 (not shown in Figures 4a to 4d) by the control element 28, which is preferably torsionally rigid. The blade element 10 in this embodiment consists of only a single segment. The control element 28 is connected to a lateral distal region 39 of the blade element 10 so that a reversible conversion between the deployed state 8 and the folded state 7 can be performed using the control element 28.

[0154] Figures 4e and 4f show the rollable blade element 10 in a fully unfolded state. As shown in Figures 4e and 4f, the cutting device 6 includes a retaining device 29 in the form of one or more releasable latches 30 for locking the blade element 10 in the deployed state (8). The latches 30 lock into latch openings 41 when the cutting device 6 reaches a predetermined size by radial expansion.

[0155] Fig. 5a shows a schematic diagram of one embodiment of the insertable element 12 in the folded state 13 introduced by the operating element 5 through the tissue wall 25. As indicated by the arrow in Fig. 5b, the insertable element 12 can be transformed into an unfolded state 14 having a larger lateral profile. The lateral profile is larger than the lateral profile of the inlet opening 31. In Fig. 5c, the insertable element 12 is in the unfolded state 14 and can form a protective covering of tissue from the other side of the tissue wall 25. The tissue wall 25 can be grasped by the insertable element 12 and the counter element 9 forming an enveloping interface 40 and cut by a cutting device (not shown) in a process as shown diagrammatically in Fig. 5e.

[0156] By grasping the tissue wall 25 prior to engaging in the cutting process, the cut can be made atraumatically with respect to the surrounding tissue.

[0157] The cutting device 6 can be positioned proximal to the insertable element 12 in the deployed state 14 or distal to the opposing element 9 in the deployed state (not shown in Figures 5a to 5h).

[0158] In this embodiment, a fixation (e.g., suturing and / or stapling) device 15 is disposed on the insertable element 12, allowing suturing of the tissue wall 25 in the deployed state 14. It is also conceivable that the fixation device 15 is disposed at the distal end of the counter element 9. As shown in Fig. 5f, the insertable element 12 and the counter element 9 may be rotatable about the entrance opening 31 to cut and fix (e.g., suture and / or staple) the anastomosis 301. It is also conceivable that only the fixation device 15 is rotatable about the cut tissue wall 25.

[0159] Figures 5g and 5h show that after cutting and fixation are completed, the insertable element 12 can be transformed into the folded state 13. In a final step, the insertable element 12 can be removed in the folded state 13 through the tube 1 together with the cut tissue (not shown in Figure 5h).

[0160] Figures 6a-6g show another embodiment of the insertable element 12 in the folded state 13 and the unfolded state 14, cutting the tissue together with the counter element 9. Figure 6a shows the insertable element 12 in the folded state 13 with a lateral profile corresponding to the entrance opening 31 of the tissue. Figure 6b shows that the lateral profile of the insertable element 12 is increased by mechanically folding radially outwards. However, an inflatable and / or rotating insert element 12 is also conceivable. Figures 6c and 6d show that an enclosed tissue interface 40 is formed between the counter element 9 on the proximal side of the tissue and the insertable element 12 in the unfolded state 14 on the distal side of the tissue. The cut tissue can be gripped at the interface 40 and removed through a tube (not shown in Figures 6d-6g). The insertable element 12 and the counter element 9 may be rotatable around the entrance opening 31. A portion of the tissue wall 25 can be cut and the edges of the interface 40 can be secured (e.g., sutured and / or stapled) by the securing device 15. Figures 6e-6g show that the insertable element 12 in the folded state 13 can be subsequently removed. Although not explicitly shown in Figures 5a-5g and 6a-6g, the tissue wall 25 can in fact include tissue walls of a first region of the stomach 201 and a second region of the intestine 202. After formation of the anastomosis 301, the insertable element 12 in the folded state 13 can be removed by pulling back the operating element 5.

[0161] Figures 7a-7g show another embodiment of the instrument with an insertable element 12 in a folded state 13 and an unfolded state 14 for cutting tissue together with a counter element 9. Figures 7a-7g are generally similar to Figures 5a-5h and / or 6a-6g, and the same explanations apply, respectively. As shown in Figure 7a, the counter element 9 can be arranged concentrically with respect to the operating element 5. Figure 7b shows that the distal region of the insertable element 12 in the folded state 13 comprises a piercing element 11 insertable into the entrance opening 31. The operating element 5 comprises a connection means 33 to the insertable element 12, which allows the insertable element 12 to be rotated to the unfolded state 14. In the unfolded state 14, the lateral profile of the insertable element 12 is increased with respect to the folded state 13. The insertable element 12 can be freely rotated to adapt to the surface conditions of the tissue surface, although fixed angle rotations are also conceivable.

[0162] 7c-7f show that the connecting means 33 can be moved relative to the counter element 9 in order to enclose the tissue wall 25 between the insertable element 12 in the deployed state 14 and the counter element 9.

[0163] The opposing element 9 and the insertable element 12 are designed to surround the tissue concentrically around the entrance opening 31 .

[0164] The cutting device can cut a portion of the tissue wall 25 in the enclosed first region and / or second region (not shown).

[0165] The severed tissue 26 can be grasped between the insertable element 12 and the manipulation element 5 and removed through the tube.

[0166] 8a-8g show a surgical anastomosis 301 of the device 101 using guidewires 24. The device 101 includes two guidewires 24 that can be inserted into the stomach 201. FIG. 8b shows that one guidewire 24 can be inserted into a first region of the stomach 201. The other guidewire 24 can be inserted through the pylorus 27 and duodenum into a second region inside the intestine 202. FIG. 8c shows that the distal ends of the two guidewires 24 can be connected across the tissue walls of the stomach 201 and the intestine 202. FIGS. 8d and 8e show that the tube 1 and the second tube 21 can be advanced along the guidewires 24.

[0167] Figure 8e further illustrates that the distal end 22 of the second tube and the distal end 3 of the tube 1 can be connected across the first and second regions and across the tissue walls of the stomach 201 and intestine 202. Figure 8f illustrates that the instrument 101 can be removed after successfully forming the anastomosis 301.

[0168] FIG. 8g shows that the fusing means 20 shown in FIGS. 9a and 9b can be advanced along the guidewire 24. The fusing means 20 is designed to establish apposition between the first and second regions. To establish apposition, the fusing means 20 can be equipped with an expandable balloon 34. However, fusing means 20 with expandable flanges 35 (shown in FIGS. 9a and 9b) are also conceivable. The fusing means 20 can be positioned between the cut region of the first region and the second region by guiding the tube 1 or the second tube 21 along the guidewire 24.

[0169] The fusion means 20 is designed to cause tissue fusion by the application of compressive force and heat.

[0170] FIG. 9a shows the fusion means 20 with the flanges 35 closed, and FIG. 9b shows the fusion means 20 with the flanges 35 open. In the embodiment of FIG. 9a and FIG. 9b, the tissue can be clamped by the flanges 35 and heated by radio frequency heating. However, other heating means can be envisaged. The distal end 38 of the fusion means 20 is conical so that it can be more easily inserted into the area of ​​the first and second regions to form the anastomosis 301 by fusing the tissue edges. The transverse profile of the anastomosis 301 is determined by the transverse width 36 of the fusion means 20 in the area between the flanges 35. The anastomosis 301 using the fusion means 20 can establish a permanent communication between the stomach 201 and the intestine 202. After the procedure, the fusion means 20 can be retrieved and no permanent implants, sutures and / or staples are required.

[0171] 10 and 11 show an optional technique for complementing the formed anastomosis (not explicitly shown in FIG. 10). This technique involves applying at least one tissue penetrating fastener 80 to reduce the natural volume of the stomach by creating one or more pleats 82 (or artificial folds) in the stomach wall. In the illustrated example, the fastener 80 is a staple with T-shaped limb ends, optionally with a U-shaped profile. The fastener can be placed, for example, by endoscopic or laparoscopic techniques. Optionally, the fastener can be placed using the same instrument used to create the anastomosis, or a different instrument can be used.

[0172] The one or more pleats 82 may extend generally (i) from the upper to the lower part of the stomach, and / or (ii) from the esophagus to the pylorus. Such pleats 82 may form a generally sleeve-shaped cavity or passageway within the stomach.

[0173] It will be understood that the above description is merely a non-limiting description of exemplary embodiments of the invention and is not intended to limit the scope of protection. Protection is claimed for all novel features and / or ideas described in this specification and / or shown in the drawings, regardless of whether emphasis is placed on them.

Claims

1. 1. An instrument (101) for endoscopically anastomosis (301) between a patient's stomach (201) and intestine (202) to allow food to bypass the duodenum and, optionally, a portion of the jejunum, comprising: a tube (1) insertable into the stomach (201) and having a proximal end (2) and a distal end (3); a surgical instrument (4) deployable at the distal end (3) of the tube (1) and insertable at least partially, preferably completely, through the tube (1); at least one operating element (5) connected or connectable to the surgical instrument (4) for operating the surgical instrument (4) from the proximal end (2); Equipped with The surgical instrument (4) is configured to establish an anastomosis (301) between a first region of the stomach (201) and a second region of the intestine (202).

2. 2. The instrument according to claim 1, characterized in that the surgical instrument (4) comprises a cutting device (6) for cutting tissue.

3. 3. The instrument of claim 2, wherein the cutting device (6) is rotatable in a circumferential direction about the tube (1), and optionally the cutting device enables removal of tissue from the first region of the stomach (201) and / or the second region of the intestine (202) through the tube (1).

4. 4. The instrument according to claim 2 or 3, wherein the cutting device (6) is convertible between: (i) a folded state (7) for introduction into the first area and / or the second area, the folded state (7) having a first transverse profile about the axis of the tube (1), and (ii) an unfolded state (8) for effective cutting of tissue, the unfolded state (8) having a second transverse profile about the axis of the tube (1) that is greater than the first transverse profile.

5. The instrument of claim 4 , wherein the second lateral profile has a predetermined size and the cutting device is configured to cut tissue when in the deployed state.

6. The instrument of any one of claims 2 to 5, wherein the cutting device is mounted on a shaft, the cutting device configured to cut a closed loop shaped aperture in tissue, the closed loop shape extending around an axis of the shaft.

7. The instrument of any of claims 2 to 6, wherein the cutting device has a cutting element and / or cutting surface that faces towards the distal end of the tube when deployed for cutting.

8. The instrument of any of claims 2 to 7, wherein the cutting device, when deployed, is configured to cut tissue in a cutting direction toward the distal end of the tube.

9. The instrument according to any of claims 2 to 8, wherein the cutting device (6) is configured to cut tissue from a first side, and the instrument (101) further comprises a counter element (9) deployable on a second, opposite side of the tissue.

10. The instrument of claim 9 , wherein the cutting device is located distal to the opposing element, at least in the deployed state of the cutting device.

11. 10. The instrument according to claim 8 or 9, wherein the counter element (9) is configured to (i) protect surrounding tissue from the cutting device (6) on the second side, and / or (ii) provide a cutting plate for the cutting device (6), and / or (iii) cooperate with the cutting device (6) to capture cut tissue for removal through the tube (1).

12. 12. The device according to claim 9, 10 or 11, wherein the opposing element (9) is convertible between (i) a folded state for introduction into the first area and / or the second area, the folded state having a first transverse profile centered on the axis of the tube (1), and (ii) an unfolded state having a second transverse profile centered on the axis of the tube (1) that is greater than the first transverse profile.

13. The device according to any of claims 2 to 12, wherein the cutting device (6) comprises at least one selected from a blade element (10), a piercing element (11), an electrical or optical ablation element.

14. Tool according to any of claims 2 to 13, wherein the cutting device (6) is movable in a rotational movement following a curve and / or is axially movable during cutting.

15. 15. The device (101) of any of claims 9 to 14, comprising at least one insertable element (12) insertable through a tissue wall of the first region and / or the second region, the insertable element (12) having a folded state (13) for introduction through the tissue wall and expandable to an unfolded state (14) in at least partial overlap with tissue of the tissue wall.

16. 16. The device according to claim 15, wherein the insertable element (12) is movable relative to the tube (1) optionally (i) in the longitudinal direction of the tube (1) and / or (ii) by rotational or translational movement of the operating element (5) up to 20 cm, preferably up to 15 cm from the distal end (3) of the tube (1).

17. 17. The instrument according to claim 15 or 16, characterized in that a distal region of the insertable element (12) in the folded state (13) comprises a second cutting device for piercing and / or cutting tissue.

18. 18. The device according to any one of claims 15 to 17, characterized in that at least two of the insertable element (12) in the deployed state (8), the counter element (9) in the deployed state (19), or the cutting device (6) are adapted to form an interface (40) for surrounding tissue, in particular for surrounding the first region and / or the second region.

19. The device according to any one of claims 15 to 18, characterized in that the insertable element (12) is foldable from the folded state (13) to the unfolded state (14) radially outwardly from the longitudinal axis of the tube (1), preferably in the shape of an umbrella, particularly preferably folded around a fixing point in the distal region of the insertable element (12).

20. 20. The device (101) of any one of claims 1 to 19, comprising an implantable stent with a check mechanism convertible between an open state and a closed state, the closed state preventing the passage of fluid and the open state allowing the traverse of fluid, or a check valve allowing only one-way passage of fluid.

21. 21. An instrument according to any one of claims 1 to 20, characterized in that it comprises a pressure device for selectively applying negative pressure to at least one region within the tube (1) and / or a retaining element in the region of the distal end of the instrument for retaining the distal end of the instrument against tissue.

22. 22. The instrument (101) according to any one of claims 1 to 21, characterized in that it comprises a fastening device (15) designed to suture and / or staple the outer edges of the first and second areas, preferably in a predefined manner, particularly preferably in a circular manner.

23. 23. The device according to any of the preceding claims, characterized in that the fixation device (15) comprises fusing means (20) designed to cause fusion of tissues of the first region of the stomach (201) and the second region of the intestine (202) by applying pressure and heat, preferably radiofrequency heating, at least to the edges of the first and second regions.

24. 24. The device according to any one of claims 1 to 23, characterized in that the device comprises a second tube (21) whose distal end (22) can be guided from the stomach (201) through the duodenum and can be connected with the distal end (3) of the tube (1) across the stomach wall in the first region and the intestinal wall in the second region.

25. 25. The device (101) according to claim 24, further comprising a guidewire (24) along which the tube (1) and / or the second tube (21) can be guided to surround the first region and / or the second region.

26. 26. The device of claim 1 , wherein the device is configured to create the anastomosis by inserting the device into the body through a single opening, the opening being a natural body orifice.

27. A method for performing an endoscopic anastomosis (301) between the stomach (201) and the intestine (202) of a patient to allow food to bypass the duodenum and optionally a part of the jejunum, optionally using an instrument according to the instrument (101) of claims 1 to 25, - inserting the device (101) into said stomach (201), preferably through the esophagus, and attaching it to the stomach wall in a first region, optionally by applying negative pressure; - puncturing and / or cutting the stomach wall and deploying the insertable element (12) outside the stomach, preferably by spreading the insertable element (12); - advancing a counter element (9), preferably having a cutting device (6) connected thereto, inside the stomach (201) towards the first region; - clamping the stomach wall in the first region between the insertable element (12) and the counter element (9) and cutting a hole in a portion of the first region with the cutting device (6); - optionally removing said cut stomach (201) tissue through said tube (1); - advancing said instrument (101) through said hole to locate a target location constituting a second area for said anastomosis (301); - attachment to the outside of the intestinal wall in said second region, preferably by applying a negative pressure; - puncturing and / or cutting the intestinal wall to deploy the insertable element (12) inside the intestine (202), preferably opening and / or spreading the insertable element (12) in the second region; - pulling said insertable element (12) to bring said first area into close contact with said second area; - advancing said counter element (9) equipped with a fixing device (15) and clamping said first and second regions between said counter element (9) and said insertable element (12); - cutting a hole in a portion of said second area with said cutting device (6) and stapling and / or suturing said edges of said first area and said second area together with said fastening device (15); - removing said cut tissue preferably through said tube (1).

28. 28. The method of claim 27, performed endoscopically through a single opening into the body, optionally a single natural body orifice.

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