WO2021177828A1

WO2021177828A1 - Device for protecting a gastro-intestinal anastomosis

Info

Publication number: WO2021177828A1
Application number: PCT/NL2021/050148
Authority: WO
Inventors: Johan Frederik LANGE; Gert Jan KLEINRENSINK; Pim Pavel EDOMSKIS; Robrecht Hendrik DEN OUDEN; Arie Huibrecht Den Ouden
Original assignee: Erasmus University Medical Center Rotterdam
Priority date: 2020-03-04
Filing date: 2021-03-04
Publication date: 2021-09-10
Also published as: NL2025051B1

Abstract

A device for protecting a gastro-intestinal anastomosis, in particular a colorectal anastomosis or an esophageal anastomosis, is provided. The device comprises a support structure providing a passage for allowing passage of gastro-intestinal content such as faecal matter and/saliva from a first end to a second end of the support structure, a first expandable compartment, connected to the support structure and circumferentially surrounding the support structure at or near the first end, wherein an outer diameter of the first expandable compartment is larger than an outer diameter of the support structure the first expandable compartment is in an expanded state.

Description

Title: Device for protecting a gastro-intestinal anastomosis

FIELD OF THE INVENTION The invention relates to a device for protecting a gastro-intestinal anastomosis, including an esophageal anastomosis, in particular a colorectal anastomosis.

BACKGROUND When a section of for example a colon is removed, an anastomosis can be made by a surgeon to reconnected the colon parts between which the section has been removed. Faecal matter passing the anastomosis may leak out of the colon if the anastomosis does not provide a fluid and gas tight seal. US20140243950A1 discloses a stent for repairing post anastomosis surgery leaks. The stent includes an elongated tube having a flared proximal end and a flared distal end, and an intermediate region disposed between those two ends. An inflatable balloon is disposed about the intermediate region. The inflatable balloon is provided in the middle of the stent between the flared ends, and is used to prevent distal/proximal displacement and/or migration of the stent, once the stent is positioned and expanded.

SUMMARY It is preferred to provide an intraluminal device for protecting a gastro-intestinal anastomosis, in particular a colorectal anastomosis or a esophageal anastomosis, which inter alia may prevent or at least minimise anastomotic leakage, may be less prone to migrate within the colon, and may be more convenient to implant. A first aspect provides a device for protecting a gastro-intestinal anastomosis, in particular a colorectal anastomosis, comprising a support structure providing a passage for allowing passage of gastro-intestinal content such as faecal matter or any other gastro-intestinal content such as saliva in esophageal anastomosis from a first end to a second end of the support structure, a first expandable compartment, connected to the support structure and circumferentially surrounding the support structure at or near the first end, wherein an outer diameter of the first expandable compartment is larger than an outer diameter of the support structure the first expandable compartment is in an expanded state.

In general, the device may be arranged for protecting any gastro intestinal anastomoses, for example in the oesophagus, gastric tube, small bowel, colon, rectum, or any other bodily conduit of a human or animal. The device according to the first aspect may be preop eratively inserted. As such, a time lag before inserting may be prevented compared to a device which is inserted postoperative.

In embodiments, the device may further comprise a second expandable compartment, connected to the support structure and circumferentially surrounding the support structure at or near the second end, wherein an outer diameter of the second expandable compartment is larger that an outer diameter of the support structure between the first and second expandable compartments when the first and second expandable compartments are in an expanded state.

The support structure is arranged to provide a passage for faecal matter or any other gastro-intestinal content like saliva through the device. The support structure may further be arranged to transfer forces and/or torques between the first expandable compartment and the second expandable compartment. The support structure may in embodiments act as a spring and/or damper between the first expandable compartment and the second expandable compartment for one or more degrees of freedom between the first expandable compartment and the second expandable compartment. The geometry and/or materials of the support structure may provided the desired stiffness and/or damping in the one or more degrees of freedom.

In embodiments, the support structure comprises a tube-shaped body with a hollow passage for faecal matter or any other gastro-intestinal content like sahva there through. Alternatively, in embodiments, the support structure comprises two rings which provide the first end and the second end of the support structure. In such embodiments, the support structure further comprises one or more connecting elements connecting the two rings such that forces and/or torques may be transferred between the rings. In particular, tension and/or compression forces may be transferred.

F aecal matter may comprise solid or semisolid remains of food which passes through the colon. Faecal matter may also comprise gasses and/or fluids. Typically, faecal matter passes through the colon from an upstream side at the stomach to a downstream side at the anus. However, some retrograde passing of faecal matter from the downstream side to the upstream side may also occur.

In a non-expanded state, outer diameters of the first expandable compartment and optional second expandable compartment may be smaller than an inner diameter of a body lumen in which they are to be inserted.

In expanded state, the outer diameters of the first expandable compartment and optional second expandable compartment may engage an inner wall of a body lumen, such as a colon. Preferably, the tension on the inner wall can be controlled by adding a particular volume of fluid, gas, for example inert air or CO₂, or a mixture thereof under a particular pressure into the expandable compartments. This allows a surgeon to control the tension on the inner wall of the colon.

In general, in the context of the present description, a fluid is defined as a liquid, a gas, any other matter which can flow through a conduit when a proper force is applied to it, or any mixture thereof. Hence, a fluid chamber may be arranged to hold a liquid, a gas, or a mixture thereof. A fluid inlet and a fluid outlet are arranged to transport a liquid, a gas, or a mixture thereof through. Furthermore, a fluid connection may thus be arranged to transport a liquid, a gas, or a mixture thereof through. A fluid- tight seal may prevent passage of a liquid, a gas, or a mixture thereof through said seal.

In general, controlling the tension allows the surgeon to prevent or at least reduce lessened perfusion and/or blood supply to the body lumen section in which the device is implanted. Furthermore, damage and/or necrosis at the level of the body lumen section may be reduced or prevented, and/or angiogenesis, angioneogenesis and/or anastomotic healing may be activated and/or stimulated by being able to control the amount of tension exerted by the one or more expandable compartments on the inner wall of the body lumen, for example on the inner wall of the colon, and/or the duration of the application of the tension

The first expandable compartment may comprise one or more ridges or other protruding structures, such as dots, 360° or less circumferentially surrounding the expandable compartment. The protruding structures may protrude in a direction away from the support structure. The device may thus be arranged such that the ridges are the only part of the device to engage an inner wall of a body lumen in which the device is inserted.

When an expandable compartment comprises one or more ridges or other protruding structures, one or more of these structures may be slanted towards a middle of the device, in particular towards a centre of the support structure. When the support structure is a substantially elongated support structure, the centre may be defined with respect to the elongation direction, which elongation direction may correspond to a passage direction for faecal matter or any other gastro-intestinal content like saliva through the device. When an expandable compartment comprises one or more slanted ridges or other protruding structures, one or more of the slanted ridges or other protruding structures may be slanted under an angle between 45 and 85 degrees, relative to a passage direction for faecal matter or any other gastro-intestinal content like saliva through the device. In further embodiments, the one or more of the slanted ridges or other protruding structures may be slanted under a different angle, for example between 50 degrees and 75 degrees, or even between 60 and 70 degrees.

In embodiments, the device may comprise a first cover, and the first expandable compartment may be formed by at least a first part of the support structure and the first cover covering the first part of the support structure. When the device comprises a plurality of expandable compartments, the device may comprise a plurality of covers.

The device may further comprise an expandable structure, provided at least partially inside the first expandable compartment, wherein the expandable structure in an expanded state at least substantially determines the outer diameter of the first expandable compartment, and wherein an outer diameter of the expandable structure in the expanded state is larger than the outer diameter of the expandable structure in a non- expanded state. In general, any expandable compartment comprised by the device may be provided with such an expandable structure.

As an example, an expandable structure may comprise a Bourdon tube, comprising a fluid or gas chamber and a fluid or gas inlet for providing a fluid or gas to the fluid or gas chamber, wherein an outer diameter of the Bourdon tube can be increased by increasing a fluid or gas pressure in the fluid or gas chamber for expanding the expandable structure.

When the device comprises a plurality of expandable compartments, for example the first expandable compartment and the second expandable compartment, any of the expandable compartments may each be provided with an inlet port for filling the expandable compartments separately.

The support structure may comprise a flange protruding from an outer wall of the support structure, wherein the flange forms part of the first expandable compartment, and the flange comprises a through hole as the inlet port for filling the first expandable compartment.

In embodiments, the support structure may comprise an outer wall, an inner wall defining the passage for faecal matter or any other gastro-intestinal content like saliva and a side wall connecting the outer wall and the inner wall, part of the first expandable compartment may circumferentially surround the outer wall of the support structure, and part of the first expandable compartment circumferentially may surround at least part of the inner wall.

In further embodiments, the support structure may comprise an outer wall, an inner wall defining the passage for faecal matter or any other gastro-intestinal content like saliva and a side wall connecting the outer wall and the inner wall, part of the first expandable compartment may circumferentially surround the outer wall of the support structure, and part of the first expandable compartment may circumferentially surround at least part of the side wall.

At least one of the expandable compartments may be at least partially filled with a contrast fluid, which contrast fluid may be used more easily detectable by a medical imaging device, such as a CT or MRI scanner or any other type of x-ray imaging device.

The support structure may comprise or consist of a substantially non-translucent or echogenic material or compound comprising such material. As such, the support structure may be more visible when using a medical imaging device.

A second aspect provides a method for installing a device for protecting a gastro-intestinal anastomosis for example in a colon of a human or animal patient, comprising the steps of inserting a first end of a device for protecting an anastomosis, in particular according to the first aspect, into a lumen of a first section of a colon or any other gastro-intestinal segment including the esophagus, at least partially expanding a first expandable compartment of the device to abut against an inner wall of the first section of the colon, forming part of an anastomosis between the first section of the colon or any other gastro-intestinal segment including the esophagus and a second section of the colon or any other gastro-intestinal segment including the esophagus, inserting a second end of the device into a lumen of the second section of the colon or any other gastro-intestinal segment including the esophagus, and completing the anastomosis between the first section of the colon or any other gastro-intestinal segment including the esophagus and the second section of the colon or any other gastro-intestinal segment including the esophagus.

When the device comprises a second expandable compartment, the method according to the second aspect may further comprise expanding a second expandable compartment of the device to abut against an inner wall of the second section of the colon or other segment of the gastro intestinal tract including the esophagus.

The method according to the second aspect allows a surgeon to at least partially fixate a first end of the device prior to forming a first part of the anastomosis, and to fully fixate the device prior to completing the anastomosis.

In the method, the first section of the colon or another part of the gastro-intestinal tract may be a proximal section. The second section of the colon or another part of the gastro-intestinal tract may be a distal section. The proximal section may be upstream of the distal section. As a further option, the step of forming part of the anastomosis may be performed prior to expanding the first expandable compartment in the proximal section as the first section. BRIEF DESCRIPTION OF THE FIGURES

The various aspects and embodiments thereof will now be discussed in further detail in conjunction with figures. In the figures,

Fig. 1A shows a schematic longitudinal section view of an embodiment of a device for protecting an anastomosis;

Fig. IB shows a schematic section view of the embodiment of the device of Fig. 1A;

Fig. 2A shows a schematic longitudinal cross-sectional view of a further embodiment of a device for protecting an anastomosis;

Fig. 2B shows a schematic longitudinal cross-sectional view of yet another embodiment of a device for protecting an anastomosis;

Fig. 3A shows a schematic longitudinal cross-sectional view of a further embodiment of a device for protecting an anastomosis;

Fig. 3B shows the device of Fig. 3Ain expanded state;

Fig. 4A shows a schematic longitudinal cross-sectional view of a partially inserted embodiment of a device for protecting an anastomosis;

Fig. 4B shows a schematic longitudinal cross-sectional view of yet another embodiment of a device for protecting an anastomosis;

Fig. 5 shows a schematic longitudinal cross-sectional view of yet further embodiment of a device for protecting an anastomosis; and

Fig. 6 shows a schematic longitudinal cross-sectional view of again another embodiment of a device for protecting an anastomosis.

DETAILED DESCRIPTION OF THE FIGURES

Fig. 1A shows a schematic longitudinal section view of an embodiment of a colorectal anastomosis protector 100 as an example of a device for protecting any gastro-intestinal anastomosis. In this particular example, the protector 100 is provided in a colon with a colon wall 101 as an example of a colon lumen. The colorectal anastomosis protector 100 comprises a tube-shaped body 102 as a support structure. The tube-shaped body 102 may comprise a rigid material or compound comprising such material or characteristic, providing a substantially rigid support structure. Rigid is to be understood as substantially maintaining its original shape under application of a force. Alternatively or additionally, the tube-shaped body 102 may comprise an elastic or resilient material or compound comprising such material or characteristic, in the sense that it changes shape under influence of a force apphed and after removal of the force, substantially returns to its original shape. Such applied force would be a force sustained during normal use of the anastomosis protector 100. Substantially is to be understood as a maximum deviation of 10%, preferably 5% and more preferably 2%.

Alternatively or additionally, the tube-shaped body 102 may comprise a flexible material or compound comprising such material or characteristic, which is a material that changes shape in a non-destructive way under minimal force applied and maintains that shaped if no forces are apphed. As will be discussed below, some parts of the tube-shaped body 102 may be predominantly rigid, some parts may be elastic or resilient and some may be flexible.

Provided through the tube-shaped body 102 is a passage 104 for faecal matter as an example of gastro-intestinal content to pass through the tube-shaped body 102 from an upstream end 106 as a first end to a downstream end 108 as a second end. Faecal matter may pass through the passage 104 from the upstream end 106 to the downstream end 108, and may pass through the passage 104 from the downstream end 108 to the upstream end 106.

The tube-shaped body 102 may be closed or substantially closed, apart from an opening at the upstream end 106 allowing faecal matter to enter the passage 104, and an opening at the downstream end 108 allowing faecal matter to exit the protector 100. As such, faecal matter may not be able to exit the passage 104 anywhere other than through one of the described openings.

Provided at the upstream end 106 is a first balloon 110 as an example of a first expandable compartment, and provided at the downstream end 108 is an optional second balloon 112 as an example of a second expandable compartment. In Fig. 1A, the first balloon 110 and the second balloon 112 are shown in an expanded state. The first balloon 110 confines a first expandable volume 191, and the second balloon 112 confines a second expandable volume 192. In particular, the first balloon 110 and the second balloon 112 are examples of an inflatable compartment as an example of an expandable compartment.

In general, any of the embodiments described herein and depicted in the figures may comprise one, two, or even more expandable compartments. Any features disclosed in conjunction with a first balloon 110 may be used in conjunction with a second balloon 112, or an even further balloon, and vice-versa.

The outer diameters of the first balloon 110 and the second balloon 112 are larger than an outer diameter of the tube 102 at a centre position 114 of the tube-shaped body 102, which centre position 114 is situate between the first balloon 110 and the second balloon 112. In embodiments, the first balloon 110 and the second balloon 112 may be shaped substantially equally. In other embodiments, the first balloon 110 and the second balloon 112 may be shaped differently, for example taking into account their positioning respectively upstream and downstream the typical flow direction for faecal matter through the colon wall as an example of a gastro-intestinal wall.

The outer diameters of the first balloon 110 and the second balloon 112 may in expanded state correspond to a typical inner diameter of the gastro-intestinal wall 101 or be larger than the typical inner diameter of the gastro-intestinal wall 101, which gastro-intestinal wall in this particular embodiment is a colon wall 101. The outer diameter of the tube-shaped body 102 may thus be smaller than the inner diameter of the gastro-intestinal wall 101, and it may thus be prevented that the gastro-intestinal wall 101 comes into contact with the tube-shaped body 102.

In examples, depending for example on the size of the human or the animal for which the device is designed, the outer diameter of any expandable compartment in expanded state or in non-expanded state may lie between 20 mm and 100 mm, between 30 mm and 80 mm, 40 mm and 70 mm, or between 50 mm and 60 mm. A person skilled in the art will appreciate that the exact outer diameter of the expandable compartment or expandable compartments in expanded and non-expanded state may be varied depending on circumstances, such as the type of patient, for example human or animal, the size and/or age of the patient, where the device is to be implanted, for example in which type of gastro-intestinal wall, any other parameter on which the outer diameter of an expandable compartment may depend, or any combination thereof.

In embodiments, the difference between the outer diameter of an expandable compartment, such as the first balloon 110 and the second balloon 112, in expanded state and in non-expanded state may be more than 2%, more than 5%, more than 10%, even more than 15%, or in particular embodiments even more than 20%, more than 30%, more than 50% or even more than 60%.

At or near the axial position of the centre position 114, an anastomosis 103 may be present in the gastro-intestinal wall 101 in which the protector 100 is placed. By virtue of the smaller outer diameter of the tube-shaped body 102, preferably there is no contact between the anastomosis 103 and the tube-shaped body 102.

As an option, the embodiment of the protector 100 as shown in Fig. 1A comprises a plurality of ridges as an example of a plurality of protruding structures, of which a first ridge as an example of a first protruding structure is indicated with reference sign 116. The ridge 116 protrudes in a general direction away from the tube-shaped body 102. In this particular embodiment, the outer diameter of the first balloon 110 is determined by the outer diameter of the ridge 116. As such, in use, the protector 100 may contact and/or engage the colon wall 101 only with the ridges.

In general, embodiments are envisioned in which one or both of the first expandable compartment and the second expandable compartment comprise one or more protruding structures, for example two protruding structures, three protruding structures, four protruding structures , or five or more protruding structures . Protruding structures may be similarly shaped, or alternatively protruding structures with different shapes may be used for a particular expandable compartment. Furthermore, embodiments of the protector 100 are envisioned without protruding structures. Preferably, the protruding structures circumferentially surround the protector 100. However, embodiments are also envisioned wherein one or more of the protruding structures only partially circumferentially surround the protector 100, for example only over a circumference part of 45 degrees or less, 50 degrees of more, 90 degrees or more, 180 degrees or more, or even 270 degrees or more.

As an option, embodiments of one or more protruding structures such as ridges comprised by the protector 100 may have a substantially constant outer diameter around the entire circumference. As a further option, the outer diameter of one or more protruding structures may be non-constant, and may thus comprise one or more radially extending sections. In general, the outer dimensions of one or more protruding structures may expand with the expansion of a expandable compartment to which the protruding structures s are connected or by which the protruding structures are comprised. As an option, the ridge 116 as depicted in Fig. 1A is a slanted ridge 116, slanted towards the centre of the protector 100. Being slanted towards the centre implies for a ridge comprised by the first balloon 110 that the ridge is slanted away from the upstream end 106, and implies for a ridge comprised by the second balloon 110 that the ridge is slanted away from the downstream end 108.

The ridge 116 is, as an option, slanted at an angle a relative to a centre axis 120 of the tube-shaped body 102, which in embodiments corresponds to a centre axis of the first balloon 110. In embodiments, the angle a may be between 10 degrees and 85 degrees, preferably between 30 and 80 degrees, between 50 and 75 degrees, and even more preferably between 60 and 70 degrees relative to the centre axis 120, or the angle a may have any other value. The centre axis 120 preferably corresponds to a passage direction for faecal matter or any other gastro-intestinal content through the passage 104 of the protector 100.

In a particular embodiment of the protector 100 comprising a plurality of ridges, different ridges may be slanted at different angles relative to the centre axis 120. In general, a ridge may be slanted at any angle between 5 and 175 degrees relative to the centre axis 120. In particular embodiments, a ridge may be slanted at any angle between 15 and 160 degrees, between 30 and 145 degrees, or between 45 and 130 degrees relative to the centre axis 120.

The ridge 116 as depicted in Fig. 1A comprises two slanted walls facing away from each other, which are slanted at substantially the same angle and are as such substantially parallel. Alternatively, the two slanted walls may be slanted at different angles, and may as such be substantially non parallel. For example, one of the walls of a ridge may protrude substantially perpendicular from an expandable compartment, which in use may be a direction substantially perpendicular to the colon wall 101 as an example of a gastro-intestinal wall. Although the ridges 116 are shown in the figures as having a substantially constant angle the relative to the centre axis 120, embodiments are envisioned wherein this angle varies over the length of the ridges 116. One or more of the ridges 116 may as such be at least partially curved, may be at least partially hook-shaped, or have any other shape of form.

When a pulling force is exerted on the upstream part of the colon wall 101 in a direction away from the protector 100, and when the ridge 116 engages the colon wall 101, the ridge 116 is also pulled in an upstream direction. By virtue of the ridge 116 being slanted, the slanting angle a may increase with the pulling, and with the increasing angle the outer diameter of the ridge 116 increases. This increased outer diameter of the ridge 116 may increase the radial force exerted by the ridge 116 on the colon wall 101 and may thus increase the friction force which holds the protector 100 in place.

Hence, with the ridge 116, a mechanism is provided which may decrease the risk of the protector 100 migrating through the colon or any other gastro-intestinal segment including the esophagus. Furthermore, transmission of tension forces to the anastomosis 103 may be decreased, prevented or substantially prevented, which may protect the anastomosis from these undesired tension forces. Even further, for example, if a ridge or any other protruding structure during inserting of the protector 100 into the colon or any other gastro-intestinal segment including the esophagus contacts the gastro-intestinal wall 101, the ridge or any other protruding structure may hinge towards the tube-shaped body 102, preventing the ridge or any other protruding structure from hampering the insertion.

When the pulling force is removed, the ridge or any other protruding structure 116 may resiliently hinge back into its original position with the corresponding angle a when the ridge or any other protruding structure 116 is in a non-loaded state. Fig. IB shows a schematic section view of the embodiment of the protector 100 of Fig. 1A, perpendicular to the centre axis 120. In Fig. IB, with different types of cross-hatches for legibility of the figure, from the centre outwards, the passage 104 for faecal matter or any other gastro intestinal content such as sahva, the tube-shaped body 102, the first balloon 110, the optional ridge 116, and the colon wall 101 are shown. Note that Fig. IB is only a schematic representation. The ratio between diameters of the different components of the protector 100 may differ in different embodiments.

As visible in Fig. IB, the first balloon 110 and the ridge 116 fully circumferentially surround the tube-shaped body 102. As a result of the circumferential surrounding, when the ridge 116 engages the colon wall 101, no flow path or passage is provided for faecal matter between the ridge 116 and the colon wall 101, and no or substantially no faecal matter can pass the protector 100 towards the anastomosis 103. Hence, the anastomosis 103 may be protected from coming into contact with faecal matter as an example of gastro-intestinal content.

For filling the first balloon 110 and the second balloon 112, as an option also apphcable in other embodiments of the protector 100, one or both of the first balloon 110 and the second balloon 112 may comprise a valve allowing input of a fluid, gas, or combination thereof into the one or both of the first balloon 110 and the second balloon 112. In embodiments, a fluid connection may be provided between the first balloon 110 and the second balloon 112, and as such only one of the first balloon 110 and the second balloon 112 has to comprise a valve or other fluid input. In other embodiments, no fluid connection is provided between the first balloon 110 and the second balloon 112.

Fig. 2A shows a schematic longitudinal cross-sectional view of a further embodiment of a colorectal anastomosis protector 100, placed in a colon and engaged to the colon wall 101. Whereas in the embodiment of Fig. 1A the first and second expandable compartments were formed respectively by the first balloon 110 and the second balloon 112, in this particular embodiment, as an option, the protector 100 comprises a first membrane 210 as a first cover and a second membrane 212 as a second cover. Preferably, the first membrane 210 and the second membrane 212 are flexible membranes.

In this particular embodiment, the first expandable compartment is formed by an outer wall of a first tube part 201 of the tube-shaped body 102 and the first membrane 210 which circumferentially surrounds the first tube part 201. Similarly, the second expandable compartment is formed by an outer wall of a second tube part 202 of the tube-shaped body 102 and the second membrane 212 which circumferentially surrounds the second tube part 201.

As such, the first membrane 210 and the outer wall of the first tube part 201 confine the first expandable volume 191. The second membrane 212 and the outer wall of the second tube part 202 confine the second expandable volume 192.

In the particular embodiment as shown in Fig. 2A, as an option also applicable to other embodiments of the device, the tube-shaped body 102 as the support structure comprises a first flange 208 protruding from the outer wall of the tube-shaped body 102, in particular from the first tube part 201. The first flange 208 comprises through hole 122 as an inlet port for providing a fluid and/or gas to the first expandable volume 191 for expanding the first expandable compartment.

As depicted in Fig. 2 A, as an option also applicable to other embodiments of the device, the second tube part 202 comprises a through hole 122’ as an inlet port for providing a fluid and/or gas to the second expandable volume 192 for expanding the second expandable compartment. The through hole 122’ extends between an inner wall of the tube-shaped body 102 and the outer wall of the tube-shaped body. To create an at least substantially fluid-tight expandable compartment, a first circumferential seal 204 and a second circumferential seal 206 are provided, which connect the first membrane 210 to the first tube part 201. In examples, the first circumferential seal 204 and the second circumferential seal 206 are created using ultrasonic welding, laser welding, gluing, soldering, heat sealing, by using a snap-fit connection, by using a press-fit connection, by any other method of sealing two parts together, or a combination thereof.

One or both of the first membrane 210 and the second membrane 212 may be provided with one or more ridges 116. In the embodiment depicted in Fig. 2A, as an option, the ridges 116 are provided outside the expandable compartments. In other embodiments, for example the embodiment depicted in Fig. 1A, the ridges or other protruding structures 116 are part of the expandable compartments. Hence, in the latter case, a volume inside the ridges or other protruding structures 116 is in fluid connection with the expandable volume and the volume of the ridges or other protruding structures 116 in expanded state may be larger than the volume of the ridges or other protruding structures 116 in non-expanded state.

In Fig. 2B, a schematic cross-sectional view of yet a further embodiment of a colorectal anastomosis protector 100 is shown. In this particular embodiment, as an option which also may be implemented in other embodiments, a tube-shaped body 102 is provided as the support structure. The tube-shaped body 102 comprises an outer wall 220, an inner wall 222, and a side wall 224 connecting the outer wall 220 and the inner wall 222. In particular embodiments, the side wall 224 and one or both of the inner wall 222 and the outer wall 220 may gradually blend into one another, for example using a radius.

As an option, the side wall 224 is not perpendicular to the outer wall 220 nor to the inner wall 222. Instead, the side wall 224 may be shaped tapered towards the middle of the tube-shaped body 102. By virtue of this tapered shape faecal matter or any other gastro-intestinal content including saliva may enter the passage 104 more easily.

The tapered shape may however provided a sharp corner 226, which may damage the gastro-intestinal wall 101 when the protector 100 is inserted into the colon or any other gastro-intestinal segment including the esophagus. In embodiments, the corner 226 may be rounded of to decrease the sharpness. Additionally or alternatively, as shown in Fig. 2B, the first membrane 210 may surround the corner 226. In such embodiments, the first circumferential seal 204 may be used to connect the first membrane 210 to the side wall 224, to the inner wall 222, on an intersection between the side wall 224 and the inner wall 222, or to any combination thereof.

One or both of the first membrane 210 and the second membrane 212 may be flexible and/or resilient for allowing the expanding.

Alternatively or additionally, one or both of the first membrane 210 and the second membrane 212 may comprise one or more bellowed or folded sections for allowing the expanding.

Fig. 3A depicts a schematic longitudinal cross-section of yet another embodiment of a colorectal anastomosis protector 100 as an example of a device for protecting a gastro-intestinal anastomosis. In this particular embodiment, as an option also applicable in other embodiments, the device comprises a Bourdon tube 302 as an example of an expandable structure.

The Bourdon tube 302 comprises a fluid chamber 304 with a fluid inlet, which fluid inlet may be in fluid connection with a through hole 122, 122’ such that a fluid may be provided to the fluid chamber 304. In the embodiment depicted in Fig. 3A, the Bourdon tube 302 is spiralled, and comprises a single winding which may substantially circumferentially surround the tube shaped body 102, for example over more than 300 degrees, more than 340 degrees, or even more than 350 degrees. Embodiments of the Bourdon tube 302 are also envisioned comprising a plurality of windings, for example two, three, four or five windings.

As an option, the Bourdon tube 302 is substantially aligned with the ridges 116, and as such, when the Bourdon tube 302 is expanded, the ridges 116 are abutted by the Bourdon tube 302. The Bourdon tube 302 may be expanded, i.e. its outer diameter is increased, by increasing a fluid pressure inside the fluid chamber 304.

In particular embodiments, the Bourdon tube 302 may comprises multiple windings around the tube-shaped body 102, for example the bourdon tube 302 may encircle the tube-shaped body 102 more than 360 degrees. For example, two windings would be 720 degrees, and two-and-a- halve winding would correspond to 900 degrees. Additionally or alternatively, the Bourdon tube 302 may comprise one or more ridges at an outer surface, which function similarly to ridges 116 which may be present around the outer surface of an expandable compartment.

Fig. 3B depicts the colorectal anastomosis protector 100 of Fig.

3A, wherein the Bourdon tube 302 as the expandable structure is in an expanded state. Whereas in Fig. 3A the outer diameter of the first and second expandable compartments were to small to abut the colon wall 101, now with the Bourdon tubes 302 in the expanded state, the outer diameter of the first and second expandable compartments have sufficiently expanded to abut the colon wall 101 to form a substantially fluid and gas tight seal to prevent faecal matter as an example of gastro-intestinal content from passing the protector 100 towards the anastomosis 103.

As an option which may also be applied in other embodiments of the protector 100, the protection 100 as depicted in Fig. 3B comprises a weakened section 306, preferably extending between the upstream end 106 and the downstream end 108. The weakened section 306 may be used to remove the protector 100 from the colon 101 without opening up the anastomosis 103. The weakened section 306 may be severed for example using a cutting or dissecting instrument such as a scalpel or scissors or a grasping element such as a pair of forceps. When the weakened section 306 is severed, the tube-shaped body 102 may collapse inwards, decreasing the outer diameter of the expandable sections to a diameter smaller than the diameter of the inner wall 101 of the colon. The protector 100 may then be removed from the colon more easily, for example via the anus.

Other embodiments of expandable structures may comprise one or more springs, resilient elements, actuators, folding mechanisms, any other expandable structure, or any combination thereof. For expanding an expandable structure, a fluid, gas, pressurised fluid, pressurised gas, chemical reaction, electrical energy, mechanical energy, or any combination thereof may be used.

Fig. 4A depicts a schematic cross-sectional view of yet another embodiment of the colorectal anastomosis protector 100. In the particular view shown in Fig. 4A, the anastomosis 103 is not fully completed. Hence, a gap 403 is still present between the two colon section between which the anastomosis 103 is to be completed. The first expandable compartment has already been expanded, and as such the ridges 116 as the outer diameter of the first expandable compartment engage the colon wall 101. The second expandable compartment is not expanded yet.

As an option also applicable to other embodiments of the protector 100, the protector 100 as depicted in Fig. 4A comprises a piece of tubing 402 as a fluid conduit. The tubing 402 is connected to the through hole 122 as the inlet port for providing a fluid to the first expandable volume 191 for expanding the first expandable compartment. By virtue of the tubing 402, the inlet port may be moved outside the colon 101, allowing easier access for the surgeon. After using the tubing 402 for expanding the first expandable compartment, the tubing 402 may be at least partially removed, or may be stored in a volume 404 between the first expandable compartment, the second expandable compartment, and the colon. In particular embodiments, tubing may be provided for both expandable compartments, or just for one of the expandable compartments.

At an end of the tubing, an optional connector 405 is provided which allows a surgeon to connect a tool such as a syringe to inject a fluid into the expandable compartment. The connector 405 may for example be a Luer Lock or Luer Slip connector.

Although the tubing 402 is in Fig. 4A shown connected at the flange 208, in embodiments, tubing may connected to an inlet or outlet positioned anywhere else on the device 100, for example at the fluid inlet 122’ provided in the passage 104.

Fig. 4B shows two further options for positions for a fluid inlet, which may be applied in conjunction with any expandable compartment in any of the envisioned embodiments. In the particular embodiments as shown in Fig. 4B, for the first expandable volume 191, the fluid inlet 122” is provided in a wall of the first membrane 210 as an example of the first cover. For the second expandable volume 192, the fluid inlet 122’” is provided through an outer flange 209 comprised by the tube-shaped body 102. This fluid inlet 122”’ may for example be used by a fluid injection tool inserted at the downstream end of the colon, or other lumen in which the protector 100 may be inserted.

From the figures and the description, the person skilled in the art will thus understand that a fluid inlet and/or a fluid outlet may be positioned anywhere between the inside of a expandable compartment and its surroundings, for example through the tube-shaped body 102, a cover, and/or any other components of the protector 100.

Fig. 5 shows a particular embodiment of a protector 100 as a device for protecting an anastomosis, for example a colorectal anastomosis. The protector 100 comprises a tube-shaped body 102 as a support structure. Provided through the tube-shaped body 102 is a passage 104 for faecal matter to pass through the tube-shaped body 102 from an upstream end 106 as a first end to a downstream end 108 as a second end. Faecal matter may pass through the passage 104 from the upstream end 106 to the downstream end 108, and may pass through the passage 104 from the downstream end 108 to the upstream end 106. Provided at the upstream end 106 is a first balloon 110 as an example of a first expandable compartment.

As shown in Fig. 5, the tube-shaped body 102 may extend away from the first balloon 110 in the downstream direction, the tube-shaped may extend away from the first balloon 110 in the upstream direction, or in a combination thereof. In examples, the tube-shaped body 102 may extend further away from the first balloon 110 in the downstream direction than in the upstream direction.

Fig. 6 shows a particular embodiment of a protector 100 as a device for protecting an anastomosis, for example a colorectal anastomosis. The protector 100 comprises a tube-shaped body 102 as a support structure. The tube shaped body 102 comprises a middle section 136, a first end section 132 and a second end section 134. The first end section 132 provides support to the first balloon 110, which may be connected to the first end section 132. The second end section 134 provides support to the second balloon 112, which may be connected to the second end section 134.

The middle section 136 comprises in this embodiment predominantly a substantially flexible compound, having a flexibility larger than that of the end sections. The end sections comprise a compound that has predominantly rigid or elastic characteristics and is less flexible than the material or compound of the middle section 136. In another embodiment, the middle section 136 may have a particular elastic character, requiring a low non-negligible force to keep the middle section 136 in a particular shape different from the original shape. In such embodiment, the end sections may still have an elastic characteristic, but with a more rigid character than the middle section 136.

It is noted that the middle section 136 may have a flexible as well as elastic character. In particular if the middle section 136 comprises an elastomer, hke natural or synthetic rubber, the middle section 136 may be changed in shape - straight, curved, with an angle - with minimal force. For changing the circumferential diameter of the middle section 136, force would have to be apphed in such case.

The first end section 132 and the second end section 134 are end extremities of the protector 100 shaped in the same way as in Figure 1. In other embodiments, the end sections may be shaped as shown by Figure 2 A, Figure 2 B, Figure 3 A, Figure 3 B, Figure 4 A or figure 4 B. Also in the embodiment as shown by Figure 5, the first balloon 110 may be provided around the first end section 132, with no second end section provided on the protector 100.

The end sections may be connected to the middle sections by means of welding, gluing or equivalent way. In another embodiment, the end sections comprise one or more protrusions at the endsconnected to the middle section 136, protruding radially outwardly, hke one or more parallel flanges. With the middle section 136 provided in an elastic material, the middle section may be provided over the protrusions in a force-fit fashion by virtue of the elastic and resilient nature of the material or compound predominantly comprised by the middle section 136.

In embodiments, an expandable compartment, in particular when the expandable compartment is arranged as an inflatable compartment, may be provided with one or more inlets and/or outlets for changing the volume of fluid, which may comprise on or more of a gas and a liquid, inside the compartments.

For example, an inlet or outlet may be provided with a membrane, a one-way valve such as a duckbill valve or an umbrella valve, a controllable valve for selectively opening and closing an inlet or outlet, or any combination thereof. Using a valve may allow for selectively filling and/or draining of an expandable compartment and/or components provided inside an expandable compartment such as a Bourdon tube 302. Using a valve may also allow pressure regulation, and may for example prevent the exceeding of a particular pressure inside the expandable compartment.

In general, in the figures, when the protector comprises a first expandable compartment and the optional second expandable compartment, the protector is symmetrical around two perpendicular axes: the centre axis 120 and an imaginary axis perpendicular to the centre axis 120 in the middle of the protector. Not every component is given a reference sign for clarity and legibility of the figures. The person skilled in the art will appreciate that embodiments are envisioned with a first expandable compartment as described in conjunction with a first embodiment of the protector, and a second expandable compartment as described in conjunction with a second, different, embodiment.

It is emphasised that although many of the embodiments of the protector have been discussed in conjunction with a colon and a colorectal anastomosis, the aspects and embodiments thereof may be applied in conjunction with other gastro-intestinal anastomoses as well. For example, the protector may be used for esophageal anastomosis, wherein the gastro intestinal content may comprise saliva and the protector is arranged to engage an espohageal wall.

Claims

1. Device for protecting a gastro-intestinal anastomosis, in particular a colorectal anastomosis, comprising: a support structure providing a passage for allowing passage of gastro intestinal matter from a first end to a second end of the support structure; a first expandable compartment, connected to the support structure and circumferentially surrounding the support structure at or near the first end; wherein an outer diameter of the first expandable compartment is larger than an outer diameter of the support structure if the first expandable compartment is in an expanded state.

2. Device according to claim 1, further comprising a second expandable compartment, connected to the support structure and circumferentially surrounding the support structure at or near the second end, wherein an outer diameter of the second expandable compartment is larger than an outer diameter of the support structure between the first and second expandable compartments when the first and second expandable compartments are is in an expanded state.

3. Device according to claim 1 or 2, wherein the first expandable compartment comprises a protruding structure, at least partially circumferentially surrounding the expandable compartment and protruding in a direction away from the support structure.

4. Device according to claim 3, wherein the protruding structure is slanted towards a middle of the device.

5. Device according to claim 4, wherein the protruding structure is slanted under an angle between 45 and 85 degrees relative to a passage direction for gastro-intestinal content through the device.

6. Device according to any of the preceding claims, wherein the device comprises a first cover, and the first expandable compartment is formed by at least a first part of the support structure and the first cover covering the first part of the support structure.

7. Device according to claim 6, wherein the device further comprises an expandable structure, provided at least partially inside the first expandable compartment, wherein the expandable structure in an expanded state at least substantially determines the outer diameter of the first expandable compartment, and wherein an outer diameter of the expandable structure in the expanded state is larger than the outer diameter of the expandable structure in a non-expanded state.

8. Device according to claim 7, wherein the expandable structure comprises a Bourdon tube, comprising a fluid chamber and a fluid inlet for providing a fluid to the fluid chamber, wherein an outer diameter of the Bourdon tube can be increased by increasing a fluid pressure in the fluid chamber for expanding the expandable structure.

9. Device according to any of claims 2-8, wherein the first expandable compartment and the second expandable compartment are each provided with an inlet port for filhng the expandable compartments separately.

10. Device according to any of the preceding claims, the support structure comprising a first support section and a second support section having a greater flexibility than the first support section, wherein: the first support section is connected to the second support section at a first end of the second support section; and the first expandable compartment is connected to the first support section.

11. Device according to claim 10 to the extent dependent on claim 2, the support structure further comprising a third support section connected to the second support section at a second end of the second support section, the second end being opposite to the first end, the second expandable compartment being connected to the third support section.

12. Device according to claim 10 or claim 11, wherein the first support section is substantially rigid.

13. Device according to claim 10 or claim 11, wherein the first support section is substantially resilient.

14. Device according to any one of claim 10-13, wherein the second support section is substantially flexible.

15. Device according to any one of claim 10-13, wherein the second support section is substantially resilient.

16. Device according to claim 15, wherein the first support section comprises at least one protruding member at or near an end of the first support section and the second support section it force fit over the protruding member, the protruding member protruding outwardly radially relative to the passage.

17. Device according to claim 16, wherein the protruding member is a substantially continuous flange, substantially concentrically provided relative to the passage.

18. Device according to any of the preceding claims, wherein the support structure comprises a flange protruding from an outer wall of the support structure, wherein the flange forms part of the first expandable compartment, and the flange comprises a through hole as the inlet port for filhng the first expandable compartment.

19. Device according to any of the preceding claims, wherein: the support structure comprises an outer wall, an inner wall defining the passage for gastro-intestinal content and a side wall connecting the outer wall and the inner wall; part of the first expandable compartment circumferentially surrounds the outer wall of the support structure; and part of the first expandable compartment circumferentially surrounds at least part of the inner wall.

20. Device according to any one of the preceding claims wherein: the support structure comprises an outer wall, an inner wall defining the passage for gastro-intestinal content and a side wall connecting the outer wall and the inner wall; part of the first expandable compartment circumferentially surrounds the outer wall of the support structure; and part of the first expandable compartment circumferentially surrounds at least part of the side wall.

Device according to any of the preceding claims, wherein at least one of the expandable compartments is at least partially filled with a contrast fluid.

Device according to any of the preceding claims, wherein the support structure comprises a substantially non-translucent material.

Method for installing a device for protecting a gastro-intestinal anastomosis of a human or animal patient, comprising: inserting a first end of a device according to any of the preceding claims into a lumen of a first section of a gastro-intestinal segment; at least partially expanding a first expandable compartment of the device to abut against an inner wall of the first section of the gastro intestinal segment; forming part of an anastomosis between the first section of the gastro intestinal segment and a second section of the gastro-intestinal segment; inserting a second end of the device into a lumen of the second section of the gastro-intestinal segment; and completing the anastomosis between the first section of the gastro-intestinal segment and the second section of the gastro-intestinal segment.

24. Method according to claim 23, wherein the device is according to any of the claims 2-18, and the method further comprises, prior to completing the anastomosis, expanding a second expandable compartment of the device to abut against an inner wall of the second section of the gastro-intestinal segment.

25. Method according to any of the claims 23-24, wherein the first section of the gastro-intestinal segment is upstream of the second section of the gastro-intestinal segment.

26. Method according to any of the claims 23-25, wherein the step of forming part of the anastomosis is performed prior to expanding the first expandable compartment.