Gastrointestinal device

Abstract

A gastrointestinal device (1) comprises an elongate body (2) having a proximal end (21), a distal end (22), a first anchor (31) at the proximal end., and a support structure (4) extending along a longitudinal axis from the proximal end (21) to the distal end (22), The support structure (4) lias a pre-set curvature prior to insertion in a gastrointestinal tract that mimics a curvature of a section of the gastrointestinal tract. The support structure (4) is configured to return to the pre-set curvature after insertion into the gastrointestinal tract to provide conformational stability for the elongate body (2). The gastrointestinal device (1) further comprises at least one further anchor (32), and the support stmcture (4) maintains a defined distance between the first anchor (31) and the at least one further anchor (32),

Description

[0001] GASTROINTESTINAL DEVICE

[0002] The invention relates to a gastrointestinal device and a method for placing a gastrointestinal device as described in the preamble of the corresponding independent claims.

[0003] Current gastrointestinal endoluminal sleeves are in principle artificial barriers through which partially digested food is distally diverted. Intestinal sleeves prevent the interaction of chyme with intestinal receptors located throughout the bypassed intestinal segments and induce malabsorption thereby inducing weight-loss. A relationship exists between the length of the bypassed intestinal segments and the resultant weight-loss. Weight-loss is shown to improve glycaemic regulation, an outcome that is further improved when also bypassing the duodenum. The duodenum, the first part of the small intestines, encompasses various receptors including those that have a significant role in regulating blood glucose levels. Modulation of these receptors and their related pathways induces considerable benefits in diabetic patients.

[0004] Literature repeatedly discusses the complications arising with such existing gastrointestinal endoluminal sleeves. These include abdominal pain, nausea and vomiting, device migration, gastrointestinal bleeding and hepatic abscess formation.

[0005] CN 109833129 A shows a spiral elastic wire as support for a duodenum-jejunum sleeve. The spiral elastic wire, made of Nitinol shape memory alloy, can comply with intestinal peristalsis, and avoid the collapse of the hose body caused by gastrointestinal peristalsis.

[0006] US 2022 / 0280320 A1 shows a duodenum sleeve in the shape of a helix. The helix can be combined with a covering of porous material.

[0007] US 8425451 B2 shows a gastrointestinal implant device with a flexible sleeve and a collapsible gastrointestinal anchor, coupled to a proximal portion of the sleeve and characterised by a specific spring rate.

[0008] US 11517461 B2, US 2016 / 0228276 A1, EP 4062879 A1, US 2023 / 0107981 A1 show devices anchored to the duodenal bulb or to the pyloric orifice. US11337838B2 also shows such a device, with a sleeve and an elongate resilient member configured to resiliently bias the flexible sleeve toward a predetermined shape.

[0009] US 7931693 B2 shows a series of flow reduction elements arranged in the duodenum and being connected by a curved central shaft having a pre-set curvature.

[0010] US 2018 / 0214292 A1 shows an intragastric sleeve with a double anchor (gastric and duodenal).

[0011] US 2022 / 0133512 A1 shows a method for anchoring an expandable implant between two plications.

[0012] US 2015 / 065939 A1 shows a device comprised of a sleeve, one or more seals, and a resilient wire with a pair of anchor ends, at which it is anchored. The wire lies within the sleeve, and functions to maintain position of the seals and sleeve by pressing them against the wall. There is no fixed relation between the longitudinal position of the wire and sleeve or seals. Their relative position is determined by their placement at surgery time, not defined by the wire. US 2012 / 095384 A1 shows a variety of intragastric implants. Device anchorage is via esophageal, gastric, gastroesophageal and transpyloric structures. In one embodiment (Fig. 3 and 4), struts are arranged to press a cardia flange against the cardia without being anchored to the cardia.

[0013] US 2009 / 093767 A1 shows an endoluminal sleeve with several tube-like lumen sections interdigitated to form a single continuous tube, where lumen sections taper down distally. Each section engages and is interconnected to the subsequent one. The sections are not anchored separately. In another embodiment, attachment points of a sleeve to the gastrointestinal wall are disclosed. It is not disclosed that a sealing effect is implemented by attaching a circumference of a proximal opening of a lumen section to a circumference of an anchor.

[0014] CA 2652419 A1 shows flow reduction elements such as coils, ribs, ribs with nets, closed mesh baskets, baffles, etc., strung along a central tube or member, with an anchoring element in the stomach.

[0015] It is therefore an object of the invention to create a gastrointestinal device and a method for placing a gastrointestinal device of the type mentioned initially, which overcomes the disadvantages mentioned above. Another object is to create a gastrointestinal device that provides new therapeutic options.

[0016] These objects are achieved by a gastrointestinal device and a method for placing a gastrointestinal device according to the corresponding independent claims.

[0017] According to a first aspect, the gastrointestinal device comprises: an elongate body having a proximal end, a distal end, a first anchor at the proximal end, and a support structure extending along a longitudinal axis from the proximal end to the distal end, wherein the support structure has a pre-set curvature prior to insertion in a gastrointestinal tract that mimics a curvature of a section of the gastrointestinal tract, wherein the support structure is configured to return to the pre-set curvature after insertion into the gastrointestinal tract to provide conformational stability for the elongate body. The gastrointestinal device further comprises at least one further anchor, and the support structure maintains a defined distance between the first anchor and the at least one further anchor.

[0018] The fact that the support structure maintains a defined distance between two anchors means that the support structure defines both a minimum distance and a maximum distance between the two anchors. The support structure is configured to resiliently bias the device toward a predetermined shape.

[0019] In embodiments, the pre-set curvature of the support structure mimics a transition from a duodenal bulb to a vertical duodenum and a transition from the vertical duodenum to a horizontal duodenum.

[0020] In embodiments, the pre-set curvature is straight.

[0021] In embodiments, the first anchor and the at least one further anchor are attached to the support structure.

[0022] In embodiments, the support structure comprises at least one elongate member connecting the first anchor and at least one further anchor. In particular the at least one elongate member can be stiff along the longitudinal axis and inhibits rotation of the anchors around axes that are normal to the longitudinal axis.

[0023] The at least one elongate member has a predominantly linear structure similar to a bar or rod. Typically, it realises a shortest connection between neighbouring anchors that follows, after insertion, the shape of the inside of the gastrointestinal tract. In other words, it does not follow a helical path along the inside of the gastrointestinal tract. It can possess a uniform cross-section along its length, which may be circular, rectangular, or another geometric shape. In particular, it can have a tubular structure with a lattice or mesh partem, like, for example, the structure of a medical stent.

[0024] In embodiments, the flexural stiffness of the at least one elongate member is so that it can be elastically bent or curved during insertion of the gastrointestinal device into the gastrointestinal tract without being plastically and / or permanently deformed during insertion. The elongate member can be telescoping or non-telescoping.

[0025] The at least one elongate member can have the function of stabilising its neighbouring anchors, preventing them from rotating and losing contact with the inner wall of the gastrointestinal tract. So, the sipport structure can stabilise the anchors attached to it in the same way.

[0026] In embodiments, the support structure comprises a first elongate member attached to the first anchor and a further elongate member attached to the further anchor. The first and the further elongate member can be designed to ran along the same section of the gastrointestinal tract, in particular of the duodenum. This same section can be located between the two anchors, and / or distal from the further anchor. The distance between the first anchor and the further anchor can be maintained by, for example, plications distal and / or proximal to at least one of the anchors, a sleeve attached to the first anchor and the further anchor, and / or attaching the first elongate member and the further elongate member to one another.

[0027] In embodiments, the support structure and / or the entire gastrointestinal device is made of a metal, in particular a shape memory alloy such as nitinol. Elements of the gastrointestinal device can be welded together and covered in silicone, polymer or otherwise. In embodiments, the elongate members of the support structure do not comprise a lumen or a cavity that is open to their surroundings. In other words, the elongate members are designed to be either solid bodies, or if they are hollow, to be closed to their surroundings. So, the elongate members are not designed to be filled with or transport gastrointestinal fluids.

[0028] In embodiments, tor at least one anchor of the first anchor and the at least one further anchor, at least one of the following is the case:

[0029] • the anchor defines a lumen for gastrointestinal fluids or contents to pass through;

[0030] • the anchor is designed to engage tissue in the gastrointestinal tract and thereby maintain the anchor in a substantially constant position with respect to the gastrointestinal tract;

[0031] • the anchor has the shape of a closed ring or torus, of an open or split ring, of a section of a helix, of a polygon, of a wave, or of a stent;

[0032] • the anchor is designed to be deformed, in particular, expanded, upon insertion into the gastrointestinal tract, thereby adapting a diameter of the anchor to that of the gastrointestinal tract.

[0033] In embodiments, the gastrointestinal device is inserted or introduced with one or more anchors in a collapsed state. When placed at the desired location, at least one of a diameter, an orientation and / or a shape of the one or more anchors is adjusted by known methods so as to give the gastrointestinal device its desired final configuration

[0034] In embodiments, at least one of the following is the case:

[0035] • a length of the elongate body is between five centimetres and thirty centimetres;

[0036] • the first anchor is designed to have, when positioned in the gastrointestinal tract, a diameter between four and seven centimetres; • the least one further anchor is designed to have, when positioned in the gastrointestinal tract, a diameter between three and ten centimetres;

[0037] • for any of the anchors it is the case that its diameter is over three centimetres;

[0038] • a distance between anchors is at least two centimetres, in particular at least three, in particular at least four centimetres;

[0039] • a distance between two consecutive anchors, of which one is to be arranged proximal to and the other one distal to the major duodenal papilla, lies between five and twenty-six centimetres, in particular between six and nine centimetres, more in particular between seven and eight centimetres.

[0040] The diameter of an anchor is understood to be an average outer diameter, not considering radial projections such as barbs or spikes.

[0041] In the context of the gastrointestinal device being placed in the duodenum, and depending on the disease to be addressed, different sleeves and combinations of sleeves can be attached to the elongate body. Sleeves can have one or more of the following properties:

[0042] • A single sleeve that covers at least a portion of the duodenum and can be extended to the jejunum.

[0043] • A single sleeve that starts after the upper part of the duodenum (pars superior, usually abbreviated as “(D1))”, covering the pars descendens (D2).

[0044] • Two or more sleeves in telescopic fashion.

[0045] • Parallel sleeves or multi-lumen sleeves running in parallel to separate chyme from pancreatobiliaryy secretions.

[0046] • A sleeve having its proximal opening oriented to be open in a radial direction.

[0047] For protection of bile acid speciation, parallel or multi lumens sleeves can be implemented: Bile acids are compounds produced by the liver and stored in the gallbladder. They are released into the intestines via the major duodenal papilla (MDP) to help digestion. Bile acids are not only fat emulsifiers, they have active physiologic roles. These roles differ between bile acid species as they have different binding properties and in turn have varying affinities and potencies to different receptors. It is the action of intestinal bacteria on bile acids that changes their chemical structure and creates secondary bile acids. Compared to existing sleeve devices, the proposed parallel or “Multiple Lumens Sleeves” can work to separately divert pancreatobiliary secretions and protect bile acid speciation by reducing the interaction between primary bile acids and intestinal bacteria prior to their release alongside chyme, which in turn can improve the clinical outcome and provide intestinal protection. Multiple Lumens Sleeves can be implemented by concentric sleeves and / or combined sleeves having at least one internal wall separating two lumens.

[0048] In embodiments, the gastrointestinal device 1, comprises at least a first sleeve, the first sleeve comprising a proximal opening and a distal opening,

[0049] • a proximal end of the first sleeve being attached to the first anchor, or

[0050] • the proximal end of the first sleeve being attached to a first one of the one or more further anchors.

[0051] This first sleeve as well as other sleeves mentioned herein are endoluminal sleeves, that is, flexible tubes configured to extend into the gastrointestinal tract and to cany gastrointestinal fluids or contents from the proximal opening at a proximal end of the sleeve to a distal opening at a distal end of the sleeve. They typically are tubes made of a flexible membrane.

[0052] For each of the sleeves described herein, it typically is the case that the anchor to which the proximal end of the sleeve is attached serves to maintain an open lumen of the proximal opening of the sleeve. This allows fluids or other materials to pass into the sleeve unimpeded. In embodiments, a circumference of a proximal opening at the proximal end of the first sleeve is attached to a circumference of the anchor to which the first sleeve is attached.

[0053] It can thus be the case that the lumen of the sleeve covers the entire lumen spanned by the anchor. This has the effect that essentially the entire flow of gastrointestinal fluid flowing through a lumen defined by the anchor passes into the sleeve. Conversely, the anchor with the attached sleeve acts as a seal that prevents fluids passing from a region at the outside of the sleeve into a region proximal to the anchor. Such a sealing function can be implemented for one or more of multiple sleeves arranged at different locations along the gastrointestinal tract.

[0054] In embodiments, a circumference of a proximal opening at the proximal end of the first sleeve is attached only to a section of a circumference and not the entire circumference of the anchor to which the first sleeve is attached, leaving a cross section of a lumen defined by the anchor open for gastrointestinal fluid to flow past the anchor without entering the first sleeve.

[0055] It can thus be the case that the lumen of the sleeve covers only part of the entire lumen spanned by the anchor. This has the effect that a first portion of the flow of gastrointestinal fluid flowing through a lumen defined by the anchor passes into the first sleeve, and a second portion flows past the first sleeve.

[0056] In embodiments, the gastrointestinal device comprises a second sleeve, the second sleeve being attached to an anchor that is located distally from the anchor to which the first sleeve is attached, with the first sleeve extending into the second sleeve.

[0057] This allows to create telescoping sleeves, which in turn allows to separate fluids or contents in the first sleeve from fluids or contents in the second sleeve, and preventing their constituents ftom interacting, along a section of overlap of the two sleeves. In embodiments, the gastrointestinal device comprises a third sleeve, the third sleeve being attached to an anchor distally from the anchor to which the second sleeve is attached, with the second sleeve extending into the third sleeve.

[0058] As for the first sleeve, it can be the case for the second (and / or third) sleeve that a circumference of a proximal openi ng at the proximal end of the second (and / or third) sleeve is attached either to the circumference or only to a section of a circumference of the anchor to which the second (and / or third) sleeve is attached.

[0059] In embodiments, for at least one of the sleeves it is the case that the sleeve is attached to two anchors that are spaced apart along the longitudinal axis, with the proximal opening of the sleeve oriented to be open in a radial direction.

[0060] The radial direction is understood relative to the longitudinal axis along which the gastrointestinal device extends. The radial direction is orthogonal to the longitudinal axis. So, the proximal opening in this case is open for fluids and material to pass into the sleeve in a radial direction relative to the gastrointestinal device. The two anchors to which the proximal end of the sleeve is attached together serve to maintain the open lumen of the proximal opening of the sleeve. This is in contrast to sleeves held open by just one anchor, for fluids and material to pass into them along the longitudinal axis.

[0061] The proximal opening being open in a radial direction allows, for example, to arrange the proximal opening to cover the major duodenal papilla and thereby to funnel and collect pancreatobiliary secretions. This in turn can serve to isolate and divert pancreatobiliary secretions and block bile reflux to the stomach and the upper gastrointestinal tract.

[0062] In embodiments, a sleeve can be a combined sleeve comprising at least two lumens separated by a separating wall. The two lumens can have proximal openings at different locations along the gastrointestinal device. For example, a proximal opening of a first lumen of the combined sleeve can be oriented to be open in the longitudinal direction, for fluids and material to pass into the first lumen along the longitudinal axis, and a proximal opening of a second lumen of the combined sleeve can be oriented to be open in the radial direction, for fluids and material to pass into the first lumen in the radial direction.

[0063] In embodiments, the gastrointestinal device comprises at least a barrier element, the barrier element comprising a proximal end that is attached to the first anchor or to a first one of the at least one further anchor. In particular at least one of the following is the case:

[0064] • the barrier element is designed to extend along the longitudinal axis and to act as a barrier between regions distal to the proximal end of the barrier element, in particular wherein the barrier element comprises a barrier sheet attached at its proximal end to the first anchor or the first one of the at least one further anchor;

[0065] • the barrier element is designed to operate as a valve element, inhibiting a flow of gastrointestinal fluid in the proximal direction; in particular wherein the barrier element comprises a valve sleeve or one or more sheets attached at their proximal ends to the first anchor or the first one of the at least one further anchor, arranged to implement a valve function.

[0066] In embodiments, the valve sleeve or the one or more sheets implementing the valve element are elastically deformable and arranged to move towards a closed position of the valve element when no external forces are acting on them.

[0067] The first, second and third sheets can be arranged to operate like the leaflets of a heart valve. In embodiments, the barrier element, and thus also the barrier sheet and / or the valve element are attached only at their proximal end by one of the anchors. In other embodiments, they are also attached at a further anchor downstream of said anchor.

[0068] In embodiments, only a single anchor, being the first anchor, is present, and the barrier element is attached to this anchor.

[0069] In embodiments, a length of the barrier sheet in the longitudinal direction is at least five cm. In embodiments, the barrier sheet is attached to the not only at its proximal end, but at one or more locations on the support structure or on one or more anchors.

[0070] When placed with its proximal end proximal to the major duodenal papilla, and oriented accordingly, the barrier sheet can prevent bile reflux by limiting the proximal flow of pancreatobiliary secretions beyond the proximal barrier’s attachment points and by the sealing effects of the anchor, as do the sleeves describe above, albeit with potentially smaller efficacy. This barrier sheet also functions to protect the major duodenal papilla by limiting its interaction with passing chyme, as do the sleeves described above.

[0071] To reduce the risk of distal migration of the device, a surgical procedure called endoscopic intestinal plication can be performed in proximity to the implant location of an anchor. After the device’s deployment location is estimated during endoscopy, this procedure can be performed. Intestinal plication locally folds the intestinal wall, preserving luminal continuity. Such folds restrict the diameter of the bowel to prevent anchor migration. Non-endoscopic approaches may be utilized to achieve a similar outcome.

[0072] Intestinal plication may be performed adjacent to one single anchor or several times adjacent to several anchors or to all anchors. If one plication is distal to an anchor and another plication is proximal to another anchor, then in combination they can prevent the device from moving in the distal as well as in the proximal direction.

[0073] As an example, intestinal plication performed around 0.5 cm distal to the pyloric sphincter would have the effect of enveloping the most proximal anchor between the resulting intestinal fold and the pyloric sphincter.

[0074] According to a second aspect, a method of providing therapy in a gastrointestinal tract comprises the steps of:

[0075] • providing a gastrointestinal device comprising an elongate body having a proximal end, a distal end, a first anchor, and a support structure extending along a longitudinal axis from the proximal end to the distal end, the gastrointestinal device further comprising a further anchor,

[0076] • performing intestinal plication at a first location along the gastrointestinal tract, distal to the pyloric sphincter,

[0077] • positioning the gastrointestinal device with one of the first anchor and the further anchor located proximal to the first location or distal to the first location.

[0078] In embodiments, an additional anchor can be present and, for example, be positioned in the duodenal bulb. Thus, the “first anchor” need not necessarily be located at the proximal end of the gastrointestinal device, or the first when seen along the length of the gastrointestinal device. In other embodiments, the first anchor is located at the proximal end.

[0079] In embodiments, the method comprises the steps of:

[0080] • performing intestinal plication at a second location along the gastrointestinal tract, distal to the first location,

[0081] • in the step of positioning the gastrointestinal device, o positioning the gastrointestinal device with the first anchor located distal to the first location and the further anchor proximal to the first location.

[0082] As a result, the first anchor prevents movement of the gastrointestinal device in the distal or downstream direction, and the further anchor prevents its movement in the proximal or upstream direction.

[0083] In embodiments, the method comprises the steps of:

[0084] • performing intestinal plication at a second location along the gastrointestinal tract, distal to the first location,

[0085] • in the step of positioning the gastrointestinal device, o positioning the gastrointestinal device with the first anchor located proximal to the first location and the further anchor distal to the first location.

[0086] As a result, the first anchor prevents movement of the gastrointestinal device in the proximal or upstream direction, and the further anchor prevents its movement in the distal or downstream direction.

[0087] In both of the above cases, the arrangement of anchors and plications along the gastrointestinal tract stabilises the position of the gastrointestinal device along the gastrointestinal tract.

[0088] In embodiments, the first location is proximal to the major duodenal papilla and the second location is distal to the major duodenal papilla, and preferably the first anchor is proximal to the major duodenal papilla and the second anchor is distal to the major duodenal papilla. In embodiments, the first location is proximal to the duodenum horizontal part and the second location is distal to the duodenum horizontal part, and preferably the first anchor is proximal to the duodenum horizontal part and the second anchor is distal to the duodenum horizontal part.

[0089] According to a third aspect, a gastrointestinal device comprises: a sleeve arrangement configured to be placed in the gastrointestinal tract, in particular into the intestinal tract, the sleeve arrangement, when extended along a longitudinal axis, defining a first lumen and a second lumen, each of the first and second lumen having an associated proximal opening and a distal opening that are distanced from one another along the longitudinal axis, wherein the first and second lumen both are present along at least one section along the longitudinal axis.

[0090] This section along the longitudinal axis can be called overlap section, hi the overlap section, fluids in the two lumens remain separated as they flow, in each lumen, from the respective proximal opening to the respective distal opening.

[0091] In embodiments, the overlap section extends along the longitudinal axis for at least one, in particular at least two, in particular at least five centimetres. In embodiments, a distance along the longitudinal axis between the proximal opening of the first lumen and the proximal opening of the second lumen is at least five, in particular at least six, in particular at least seven centimetres.

[0092] In embodiments, in the gastrointestinal device according to the third aspect, the first and second lumen are defined by separate sleeves, with a first sleeve being arranged concentrically inside a second sleeve in an overlap section along the longitudinal axis, and wherein the first sleeve and second sleeve are attached to one another or to a common support structure. When seen along the longitudinal axis, the proximal opening of the first sleeve precedes the proximal opening of the second sleeve, and the overlap section begins at the proximal opening of the second sleeve.

[0093] In embodiments, in the gastrointestinal device according to the third aspect, the first and second lumen are defined by a combined sleeve, the combined sleeve comprising at least two lumens separated by a separating wall, in particular wherein the proximal opening of one of the first and second lumen is oriented to be open in a radial direction.

[0094] According to a fourth aspect, a method of providing therapy in a gastrointestinal tract comprises the steps of:

[0095] • providing a sleeve arrangement designed to function as a gastrointestinal sleeve, the sleeve arrangement, when extended along a longitudinal axis, defining a first lumen having an associated proximal opening and a distal opening that are distanced from one another along the longitudinal axis;

[0096] • positioning the sleeve arrangement in the intestinal tract in a target configuration in which the proximal opening covers the major duodenal papilla; and

[0097] • anchoring the sleeve arrangement in the target configuration.

[0098] In embodiments of the method of the fourth aspect, the sleeve arrangement, when extended along a longitudinal axis, defines the first lumen and a second lumen, each of the first and second lumen having an associated proximal opening and a distal opening that are distanced from one another along the longitudinal axis, wherein the first and second lumen both are present along at least one section along the longitudinal axis. This allows for the first lumen to divert pancreatobiliary secretions and the second lumen to divert chyme while keeping them separated along the section, to be called overlap section.

[0099] In embodiments, the method of the fourth aspect, that is, for providing therapy in a gastrointestinal tract, is implemented by anchoring a barrier element as described herein in place of the sleeve arrangement. In this case, the method of providing therapy in a gastrointestinal tract comprises the steps of:

[0100] • providing a barrier element comprising a proximal end that is attached to an anchor or to a first one of one or more further anchors of an elongate body;

[0101] • positioning the barrier element in the gastrointestinal tract in a target configuration; and

[0102] • anchoring the barrier element in the target configuration.

[0103] In embodiments, the barrier element is a barrier sheet, and in the target configuration the barrier sheet extends in the longitudinal direction at least in a region of the major duodenal papilla, with a proximal end of the barrier sheet being arranged to form a seal against the intestinal wall. Longitudinal edges of the barrier sheet can be in contact with the intestinal wall and thereby form a longitudinal seal between the barrier sheet and the intestinal wall.

[0104] In embodiments, the anchor is part of an elongate body with two or more anchors. The proximal end of the barrier element can be attached to a first anchor or to a first one of at least one further anchor.

[0105] In embodiments of the method of the fourth aspect, the step of anchoring the sleeve arrangement comprises at least one of: • suturing at least a section of the sleeve arrangement to the intestinal wall, in particular suturing a rim of the proximal opening of the first lumen to the intestinal wall;

[0106] • anchoring in the duodenum a support structure to which the sleeve arrangement is attached.

[0107] According to a fifth aspect, which can be implemented in combination with the other aspects, or independently, a method of providing therapy in a gastrointestinal tract comprises the steps of:

[0108] • providing a gastrointestinal device as described herein;

[0109] • positioning the gastrointestinal device in the gastrointestinal tract in a target configuration; and

[0110] • anchoring the gastrointestinal device in the target configuration.

[0111] In embodiments of the fifth aspect, the gastrointestinal device is attached to, for example, one or more lines, inflation lines, tubes, catheters, balloon catheters, wires or drawstrings. Attachment can be temporary or permanent.

[0112] In embodiments of the fifth aspect, the target configuration is located in the esophagus. The gastrointestinal device can comprise a sleeve arrangement that serves as a barrier or valve to prevent flow in the proximal direction, in particular when a feeding tube is placed within the esophagus. The gastrointestinal device or sleeve arrangement can be attached to the feeding tube.

[0113] In embodiments of the fifth aspect, the target configuration is located in the colorectum.

[0114] Further embodiments ate evident from the dependent patent claims. Features of the method claims may be combined with features of the device claims and vice versa. In particular, the method of the second aspect can be implemented with devices according to the first and third aspect. The method of the fourth and fifth aspect can be implemented with devices according to the third aspect and with suitably configured devices of the first aspect. Furthermore, devices according to the first aspect can incorporate features of devices of the third aspect. The method according to the fourth aspect can be implemented using the anchoring method according to the second aspect. On the other hand, each of the five aspects can be implemented independent of the others.

[0115] Whereas the embodiments herein mainly describe the placement of the gastrointestinal device, sleeves and barrier elements in the duodenum, it is understood that they can be placed at other locations in the gastrointestinal tract, with analogous functions depending on the location.

[0116] In embodiments, the device is located and / or anchored exclusively in the intestines, that is, in a non-gastric section of the gastrointestinal tract.

[0117] The subject matter of the invention will be explained in more detail in the following text with reference to exemplary embodiments which are illustrated in the attached drawings, which schematically show:

[0118] Figure 1 a gastrointestinal device arranged in a gastrointestinal tract;

[0119] Figure 2-8 different configurations and embodiments of anchors in combination with elongate members;

[0120] Figure 9-15 cross sections of different configurations of sleeves;

[0121] Figure 16-19 relative arrangements of plications and anchors;

[0122] Figure 20-21 different barrier elements.

[0123] In principle, identical or functionally identical parts are provided with the same reference symbols in the figures. Figure 1 shows a gastrointestinal device 1 arranged in a gastrointestinal tract. The gastrointestinal device 1 comprises an elongate body 2 which in turn comprises a support structure 4, which can also be called backbone, along which a number of anchors 31, 32 are arranged. The support structure 4 can be a single part, or a sequence of elongate members. The gastrointestinal device 1 can also comprise endoluminal sleeves attached to the anchors 31, 32. The gastrointestinal device 1 is placed in the gastrointestinal tract, in this Figure in the duodenum. Parts of the gastrointestinal tract shown are the pyloric sphincter 91, the duodenal bulb 92, the duodenum superior part 93, the duodenum descending part 94, the duodenum horizontal part 95, the duodenum ascending part 96, the jejunum 97 and the major duodenal papilla 98. The shape of the gastrointestinal device 1 is such that it conforms to or mimics the shape of the section of the gastrointestinal tract in which it is arranged. This can be a C- shape. This helps to stabilise the position of the gastrointestinal device 1 in relation to the gastrointestinal tract. In particular, this is done by the support structure 4 having a pre-set curvature prior to insertion in the gastrointestinal tract that mimics a curvature of the section of the gastrointestinal tract into which it is to be placed.

[0124] The anchors shown are a first anchor 31, a further anchor 32, a third, fourth and fifth anchor 33, 34, 35. They can serve to further stabilise the position of the gastrointestinal device 1 along the length of the gastrointestinal tract. This pre-set curvature works to improve fixation of the gastroi ntestinal device 1 and prevent migration into regions of the gastrointestinal tract with different curvatures. In embodiments, not all of the anchors are present.

[0125] The anchors can be sized differently, so that the diameter of each anchor corresponds to a diameter of the gastrointestinal tract at a location at which the anchor is placed. In particular, the first anchor 31 can have a diameter that is adapted to the diameter of the duodenal bulb, and thus is larger than the diameters of the remaining anchors. Figure 1 shows the first anchor 31 placed in the duodenal bulb. This anchors the gastrointestinal device 1 in the duodenal bulb and functions to prevent both proximal and distal device migration.

[0126] Figure 1 shows the gastrointestinal (GI) device 1 implanted in the duodenum of a human subject. This can allow it to be used in the management of different diseases including obesity, type 2 diabetes mellitus (T2DM), and in the prevention of various upper gastrointestinal cancers, for example esophageal cancer. The duodenum is the first portion of the small intestine, located at the distal end of the stomach. Its natural anatomy forms a C-shape. Between the outlet of the stomach and the duodenum is a restriction called pyloric sphincter. Chyme is propelled along the duodenum, as the rest of the digestive tract, through peristalsis, a simultaneous contraction of a portion, approx. 5 cm in length, of the longitudinal and circular layer of the intestinal muscles. This movement controlled by the autonomous nervous system normally propels chyme distally. Normally, only one single wave at a time occurs in the duodenum.

[0127] The main challenge of an intestinal anchoring system is to prevent device migration while avoiding complications such as injury or perforation of the intestinal wall.

[0128] The gastrointestinal device 1 comprises several anchors, here in the shape of tori, connected by a stiff, C-shaped rod that conforms to the anatomical shape of a specific section of the gastrointestinal tract, in this case the duodenum. The gastrointestinal device 1 preferably is at least 5cm long. When used in the duodenum, it should not be any longer than 30cm, corresponding to the approximate upper range length limit of a normal duodenum. A standard configuration can include three to five tori. Preferably, the gastrointestinal device 1 has at least a first anchor 31 located at the proximal end. The anchor closest to the pyloric sphincter is located within the duodenal bulb, at the proximal end of the device.

[0129] An outer diameter of anchors in general, and of the first anchor 31 in particular, in embodiments is between three and seven centimetres, in particular between four and six centimetres, more in particular approximately 4.5 centimetres. This is larger than the expansion diameter of the pyloric orifice, preventing proximal migration of the device. The diameter refers to an anchor being in its expanded state, after placement in the gastrointestinal tract, and excluding radial projections that may be present in order to improve fixation of the anchor.

[0130] In an ideal anatomical configuration, the anchors are spaced at a minimum of two centimetres, in particular of three, more particular of five centimetres apart to distribute the force of peristalsis and prevent distal migration. A distance between the second anchor 32 and third anchor 33 can be wider due to variations in the location of the

[0131] MDP (major duodenal papilla 98) and the anchor's function as a sleeve attachment point. A spacing of 7 to 8 centimetres between these two anchors would cover over 90% of the population When a contraction occurs at the location of one anchor, the resulting force is shared by the others until the peristaltic wave passes this anchor.

[0132] Throughout this document, when the major duodenal papilla 98 or its location are referenced, this is understood to include the minor duodenal papilla, if present.

[0133] A total length of the gastrointestinal device preferably is less than thirty centimetres, in particular less than twenty-five centimetres. The total length can be between five and thirty, centimetres, in particular between seven and twenty-five centimetres, in particular between ten and twenty centimetres.

[0134] An angle between the second anchor 32 and third anchor 33 can be between zero degrees and 150 degrees, preferably between 20 and 120 degrees, preferably between 30 and 110 degrees. In the configuration shown in Figure 1, the angle is roughly ninety degrees. The same can be the case for ranges of the angle between the first anchor 31 and the second anchor 32. In embodiments, the anchors have a toroidal shape, or at least an approximation to a toms shape. The roundness of the surface would ensure a good fit with the tubular wall of the gastrointestinal tract. For the insertion of the device, the anchors can be expandable. They can be inserted in a compressed or folded state, and expanded after they have been placed at the target location along the gastrointestinal tract, thereby anchoring the device. Means for placing and expanding such anchors are generally known.

[0135] Figures 2 to 8 show different configurations and embodiments of anchors 31, 32, 33, 34 in combination with elongate members 41, 42, 43.

[0136] The anchors, the elongate members and the entire support structure 4 can be made of metal wires and can be coated with a synthetic material, such as silicone or a polymer- based coating, or otherwise. The metal can be a material such as nitinol. Sleeves can be made of commonly known materials for gastrointestinal sleeves, such as soft polymers. These materials can be provided with an antibacterial coating, to act against bacterial growth along the sleeve walls.

[0137] Such wires, and in particular the anchors 31, 32, 33, 34 and / or elongate members 41, 42, 43 can be provided with barbs or spikes. These can be arranged as radial projections. They serve to improve fixation relative to the gastrointestinal lumen. However, such projections can be omitted for anchors that define an opening to a sleeve, with such anchors having a sealing function, preventing gastrointestinal fluids from flowing past the opening. The projections can be used to anchor the gastrointestinal device 1 alone or in combination with other anchoring or attachment elements.

[0138] The embodiments comprise anchors 31, 32 being shaped as closed rings or tori (Figure 2), as open or spit rings (Figure 3), as sections of a helix (Figure 4), as polygonal, in particular hexagonal (Figure 5), as a wave (Figure 6), or as a stent (Figure 7). In each case, a first anchor 31 and a further anchor 32 are joined by a first elongate member 41. The first elongate member 41 can be a section of the support structure 4, or a separate part that is joined to a second elongate member 42. The second elongate member 42 joins the further anchor 32 to a third anchor 33, not illustrated in these figures.

[0139] Figure 7 shows a configuration in which an elongate member 41 is formed with a structure like that of a medical stent. Figure 8 shows a configuration in which elongate members 41, 42, 43 ate joined to the anchors 32, 33 at different positions along the circumference of the anchors.

[0140] Figures 9 to 15 show cross sections of gastrointestinal devices 1 with different configurations of sleeves 51, 52, 53 attached to the elongate body 2. The Figures show the gastrointestinal device 1 extended with its longitudinal axis along a straight line, with the purpose of showing the structure and topology. In reality, the gastrointestinal device 1 has a pre-set curvature corresponding to that of the gastrointestinal tract, as explained in the context of Figure 1. As already noted, in embodiments not all of the anchors are present.

[0141] Figure 9 shows a first sleeve 51 with a proximal opening 61 of the first sleeve 51 attached to the first anchor 31. The first anchor 31 maintains an open lumen of the proximal opening of the first sleeve 51. This can be done by the rim of the proximal opening 61 of the first sleeve 51 being attached to the circumference of the first anchor 31. This allows fluids or other materials to pass into the first sleeve 51 along the longitudinal axis, in the direction of the block arrow. A distal end of the sleeve, with a distal opening, can be located at the distal end of the support structure 4. In this case, at the last anchor 35. In the embodiment shown, the distal end of the sleeve extends beyond the end of the support structure 4. With the gastrointestinal device 1 according to this configuration placed in the duodenum, the following can be the case: One single sleeve covers at least a portion of the duodenum and can be extended to the jejunum is attached to the most proximal anchor. Located within the duodenum are receptors that activate the release of diabetogenic signals. A short sleeve that bypasses only the duodenum is thus sufficient to improve glucose control and can be used in T2DM management. In the management of obesity, a longer sleeve is more advantageous as malabsorption is induced along a larger section of the intestines.

[0142] This device can thereby be used in the management of T2DM and obesity. This represents a relatively simple sleeve system, and the clinical outcome of such a sleeve system has been studied and proven.

[0143] Figure 10 shows the first sleeve 51 with its proximal opening 61 attached to a further, in particular the second anchor 32, instead of the first anchor 31. The first part of the duodenum has the highest concentrations of Brunner’s glands and bicarbonate secreting epithelium Deploying the gastrointestinal device 1 within the duodenum as in Figure 10 allows for the diversion of higher pH (less acidic) chyme within the sleeve

[0144] With the gastrointestinal device 1 according to this configuration placed in the duodenum, the following can be the case: One single sleeve is attached to the second most proximal anchor, shielding the duodenum from the duodenum descending part 94 (D2, pars descendens) on and the first part of the jejunum. A1ternatively, the sleeve could be shortened to shield a portion of the duodenum only. This sleeve configuration enables the interaction of chyme and the first portion of the duodenum, leading to a more neutral chyme exiting the sleeve.

[0145] This device can thereby be used in the management of T2DM and obesity. This represents a relatively simple sleeve system. Increasing the pH of chyme prior to its release from the sleeve’s distal end works to reduce the risk of abdominal pain and intestinal inflammation, and potentially reduce patient reliance on medication used to reduce gastric acidity during device deployment.

[0146] Figure 11 shows the first sleeve 51 attached to the first anchor 31 and a second sleeve 52 attached to the further anchor 32. The first sleeve 51 extends into the proximal opening 62 of the second sleeve 52 and along the second sleeve 52 for a certain distance, in particular at least up to the location of the subsequent anchor. Fluids or other materials pass into the second sleeve 52 from a section of the intestine that lies between the first anchor 31 and the further anchor 32, in the direction of the block arrows.

[0147] With the gastrointestinal device 1 according to this configuration placed in the duodenum, the following is the case: This can be called a two telescopic sleeves configuration. One sleeve is attached to the most proximal anchor and runs into a second sleeve attached to the second most proximal anchor. This sleeve configuration allows the secretions released from the proximal part of the duodenum to enter the second sleeve whilst still shielding the bypassed duodenal section from any interaction with chyme. This sleeve configuration enables bypassing the proximal duodenum whilst still allowing for distal diversion of higher pH chyme. The second sleeve shields at least part of the duodenum and may extend to the first part of the jejunum, thereby providing the same advantages and effects as the single sleeve configuration. This device can thereby be used in the management of T2DM and obesity. This represents a relatively simple sleeve system and the clinical outcome of intestinal diversion as discussed here has been studied and proven. Increasing the pH of chyme prior to its release from the sleeve’s distal end works to reduce the risk of abdominal pain and intestinal inflammation, and potentially reduce patient reliance on medication used to reduce gastric acidity during device deployment.

[0148] Figure 12 shows the configuration of Figure 11 with a third sleeve 53, attached to the third anchor 33. The second sleeve 52 extends into the third sleeve 53 through its proximal opening 63 and for a certain distance, in particular at least up to the location of the subsequent anchor. Fluids or other materials pass into the third sleeve 53 from a section of the intestine that lies between the further anchor 32 and the third anchor

[0149] 33, in the direction of the block arrows.

[0150] With the gastrointestinal device 1 according to this configuration placed in the duodenum, the following is the case: In this configuration, the sleeves split the tract into two lumens. They create a multi-lumen sleeve with concentric lumens, with the second sleeve 52 being inside the third sleeve 53. The physiological effects are essentially as described for the embodiment of Figure 13a and 13b.

[0151] Figure 13a and 13b show a configuration similar to that of Figure 12. Figure 13b shows a schematic 3D view of only a section of the gastrointestinal device 1 of Figure 13a, that is, the part between the further anchor 32 and third anchor 33. In Figure 12 the second sleeve 52 and third sleeve 53 are concentric - in the sense that they are separate but with the second sleeve 52 running inside the third sleeve 53. In Figure 13a and 13b, the second sleeve 52 and third sleeve 53 form a combined sleeve with two lumens separated by a separating wall 59 (for clarity, in Fig. 13b borders of the peripheral proximal opening into the third sleeve 53 are not drawn immediately adjacent to the anchors, in contrast to Fig. 13a). Fluids or other materials pass into the third sleeve 53 from a section of the intestine that lies between the further anchor 32 and the third anchor 33, in the direction of the block arrow. This direction is substantially in a radial direction. The corresponding proximal opening 63 of the third sleeve 53 is oriented to one side of the circumference of the gastrointestinal device 1. That is, it is oriented to be open in the radial direction. The proximal opening 63 of the third sleeve is attached to and held open by two separate anchors, in this case the further anchor 32 and third anchor 33.

[0152] With the gastrointestinal device 1 according to this configuration placed in the duodenum, the following can be the case: A sleeve splits the tract into two lumens. They create a multi-lumen sleeve with a dividing wall This sleeve configuration enables distal diversion of less acidic chyme as well as the separate distal diversion of pancreatobiliary secretions. Here, chyme enters the first sleeve 51 then flows into the second sleeve 52 where it interacts with the secretions released from the intestinal section around the first sleeve 51 that works to neutralize the pH of the diverted chyme. Pancreatobiliary secretions released from the major duodenal papilla are diverted distally into the third sleeve 53 through the proximal opening 63 of the third sleeve. The dividing wall here works to ensure minimal interaction between the sleeve walls and the MDP thus reducing the risk of MDP obstruction. The sealing function of both the further anchor 32 and the third anchor 33 work to ensure collection and diversion of secretions released from the intestinal section located between these anchors. By isolating, collecting and separately diverting pancreatobiliary secretions, bile diversion is achieved whilst protecting bile acid speciation to improve metabolic outcomes. This method of bile diversion also functions to prevent bile reflux, a significant risk factor in the development and progression of various upper gastrointestinal cancers and precancerous conditions. This device can thereby be used in the management of T2DM and obesity.

[0153] Figure 14a and 14b show just a single sleeve - in this case labelled as first sleeve 51 - with its proximal opening 61 being attached to and held open by two separate anchors, in this case the further anchor 32 and third anchor 33. Attachment locations at which corners of the proximal opening 61 can be attached to the anchors are schematically represented by black circles. Fluids or other materials pass through the proximal opening 61, which is open in the radial direction, into the first sleeve 51 in a section of the intestine that lies between the further anchor 32 and the third anchor 33.

[0154] This flow is in the radial direction, in the direction of the block arrow. What is stated for the third sl eeve 53 of Figure 13 applies to the first sleeve 51 of Figure 14 as well. For both figures it can be the case that the proximal opening 61, 63 that is held open in the radial direction is arranged between and held open by two or more other anchors. Figure 15a and 15b show a variation of the embodiment of Figure 14a and 14b with, in addition to the first sleeve 51 of Figure 14a and 14b, a second sleeve 52 arranged between the further anchor 32 and the third anchor 33. In embodiments not illustrated, the second sleeve 52 extends further along the distal direction. The further anchor 32, to which the second sleeve 52 is attached, forms a seal between the volume surrounding the second sleeve 52 and a proximal section of the duodenum. Sleeve 52 works to divert secretions around the proximal opening 61 of the first sleeve 51 in the case that the proximal opening 61 does not establish a reliable seal against the walls of the intestines. This sleeve formation functions to isolate, collect and separately divert pancreatobiliary secretions, with the second sleeve 52 and the sealing effects of the anchors working in tandem towards complete diversion of pancreatobiliary secretions and prevention of bile reflux. As with Figure 14a and 14b, this device can thereby be used in the management of precancerous upper gastrointestinal conditions in patients with established bile reflux. As with Figure 14a and 14b, Sleeve 51 works to limit interactions with the MDP thus reducing the risk of MDP obstruction. Partial bypass of the duodenum here and, as with Figure 14a and 14b, metabolic benefits due to both bile diversion and the protection of bile acid speciation achieved by this device may also allow the use of this device in the management of T2DM and obesity.

[0155] In a variation (not illustrated) of Figure 15a and 15b, a sleeve is attached to the first anchor 31 (as in Figures 11 to 13a, 13b) and extends beyond the further anchor 32 and into the second sleeve 52. This can further ensure complete distal diversion of pancreatobiliary secretions.

[0156] With the gastrointestinal device 1 according to any one of the configurations of Figures 12, 13a, 13b, 14a, 14b and 15a, 15b placed in the duodenum, the following can be the case: A sleeve splits the tract into two lumens. The two lumens can be either concentric or with any other type of dividing wall. The aim of this sleeve configuration is to block bile reflux to the stomach and the upper gastrointestinal tract. Refluxed bile causes damage to intestinal tissue that manifests in a range of symptoms. Importantly, bile reflux is a significant risk factor to the development of various upper gastrointestinal cancers.

[0157] The sleeves can be made of a flexible material that is deformed according to the flow of the fluids and other materials passing through it. In embodiments, especially for combined sleeves, the material is so thick and stiff that one of the lumens is kept open despite pressure in a neighbouring lumen. In the embodiments in which an opening of a sleeve is oriented in a radial direction, the rim of the opening can comprise stiffening elements. The stiffening elements stabilise the shape of the opening so that it conforms to the shape of the intestinal wall and provides a seal against the intestinal wall. Such stiffening elements can be implemented, for example, by having thicker sections of the material of the sleeves, and / or by incorporating wires.

[0158] In all embodiments it can be the case that sleeves are attached to and held by not only anchors but also the support structure 4 and / or other sleeves.

[0159] The sealing effect of anchors and the effects of such sleeve systems in isolating and separately diverting pancreatobiliary secretions and preventing MDP obstruction also works to prevent duodenal biliary reflux and potentially limit bacterial colonization and infections in select patient populations e.g. following biliary stent inplantation.

[0160] Figures 9 through 15b represent gastrointestinal devices 1 with five anchors, to be placed as in Figure 1. This number of anchors allows for a stable anchoring. In embodiments, only one of the fourth anchor 34 and fifth anchor 35 is present. Assuming that the first anchor 31 is to be placed in the duodenal bulb 92, then the distance between the further anchor 32 (to be placed proximal to the major duodenal papilla 98) and third anchor 33 (distal to the major duodenal papilla 98) can be between five and ten centimetres. This distance, as well as the distance between the first anchor 31 and the further anchor 32, can be adapted in order to be compatible with an expected location of the major duodenal papilla 98 in a particular patient population, or on the actual location in a particular patient. In embodiments in which the first anchor 31 is not present, and the gastrointestinal device 1 is anchored using plications (see below) or by other means, the same distances can be implemented, taking into account that the labels for “further" and “third” anchor apply to anchors in the same location as in Figure 1, regardless of the fact that there is no “first” anchor.

[0161] In embodiments not shown, only three or four anchors are present, to be placed at locations corresponding to the location of the first anchor 31, the fiirther anchor 32 and somewhere between that of the third anchor 33 and fifth anchor 35 shown in Figure 1. In this case, the distance between the anchor to be placed proximal to and the anchor to be placed distal to the major duodenal papilla 98 can be between five and twenty or up to twenty-six centimetres. Such a configuration can be a bit less stable than a configuration with more anchors, but the larger distance allows to cover a larger population of patients, including those in which the major duodenal papilla 98 is located fiirther distally within the 3rd part of the duodenum. In embodiments in which the first anchor 31 is not present, and the gastrointestinal device 1 is anchored using plications (see below) or other means, the same distances can be implemented, again taking into account the above remark regarding labelling.

[0162] Figure 16 shows a section of the duodenum and the location for a pair of plications, with a first location 81 of a first plication and a second location 82 of a second plication indicated by crosses. The first anchor 31 is present, stabilising the location of the support structure 4 and thereby the gastrointestinal device 1 with regard to movement in the proximal direction. The first and second location 81, 82 are distal each to a respective one of the anchors. Thereby, they stabilise the location of the gastrointestinal device 1 with regard to movement in the distal direction. In Figure 16, the first location is distal to the third anchor 33 and the second location 82 is distal to the fourth anchor 34. In embodiments not shown, the second location 82 is distal to the fifth anchor 34, and / or only a single plication or more than two plications are present. Figure 17 shows a section of the duodenum and the location for a pair of plications, wherein the first anchor 31 is not present (but the labelling of the other anchors is kept the same as in the preceding embodiments, for the sake of consistency). One anchor - in this case the further anchor 32 - is located distal to the first location 81, and another anchor - in this case the third anchor 33 - is located proximal to the second location 82. Movement of the further anchor 32 is constrained in the proxi mal direction by the first plication, and movement of the third anchor 33 is constrained in the distal direction by the second plication. Consequently, the position of the entire support structure 4 and the gastrointestinal device 1 is stabilised in the longitudinal direction along the duodenum.

[0163] Figure 18 shows an inverse configuration. One anchor - in this case the further anchor 32 - is located proximal to the first location 81, and another anchor - in this case the third anchor 33 - is located distal to the second location 82. Movement of the further anchor 32 is constrained in the distal direction by the first plication, and movement of the third anchor 33 is constrained in the proximal direction by the second plication.

[0164] Figure 19 shows a further configuration, in which the first anchor 31, further anchor 32 and the section of the support structure 4 joining them to the third anchor 33 need not be present. A first location 81 is proximal to the third anchor 33 and a second location is distal to the fourth anchor. This stabilises the position of the support structure 4 and the gastrointestinal device 1 as in the configuration of Figure 17. In an inverse configuration, the locations are arranged in analogy to Figure 18.

[0165] While the invention has been described in present embodiments, it is distinctly understood that the invention is not limited thereto, but may be otherwise variously embodied and practised within the scope of the claims. Figure 20a and 20b show a barrier element 7 in the form of a barrier sheet 74 attached at its proximal end to one of the anchors, in this case, the further anchor 32. The proximal end is attached along a section of the circumference of the further anchor 32. Endpoints of the attachment section are indicated by black dots. In embodiments, the barrier sheet 74 can be attached, distally to the further anchor 32, to the third anchor 33, indicated by dotted circles.

[0166] As with Figure 14a. 14b, 15a and 15b, this device can be used in the management of precancerous upper gastrointestinal conditions inpatients with established bile reflux. The barrier element 7 in the form of the barrier sheet 74 works to limit interactions with the MDP thus reducing the risk of MDP obstruction. It is simpler than the previously described configurations.

[0167] Figure 21a and 21b through 21d show a barrier element 7 in the fonn of a valve element 75 in different variations. The valve element 75 is attached at its proximal end to one of the anchors, in this case, the further anchor 32. The proximal end is attached along the circumference of the further anchor 32. The valve element 75 comprises one or more sleeves or sheets of material arranged to act as a valve, inhibiting flow in the proximal direction. The material can be elastic so as to open when fluids flow in the distal direction and to close the valve otherwise. Figures 21b through 21d schematically show different embodiments of a valve element 75 viewed along the longitudinal direction, each in a slightly opened configuration. AD of these embodiments essentially have a cross section as in in Figure 21a. Figure 21b shows a valve sleeve 76 that tapers from the attached end to a flattened shape, acting as a duckbill valve. Figure 21c shows a bicuspid leaflet valve with a cooperating first sheet 71 and second sheet 72. Figure 21d shows a tricuspid leaflet valve with a cooperating first sheet 71, second sheet 72 and third sheet 73.

[0168] While the above embodiments show the proximal end of the respective barrier elements 7 attached to the further anchor 32, in other embodiments they can be attached to another one of the anchors present. Also, the elongate body 2 can have only two, or more anchors. In embodiments, only one anchor is present.

Claims

PATENT CLAIM S1. A gastrointestinal device (1) comprising: an elongate body (2) having a proximal end (21), a distal end (22), a first anchor (31) at the proximal end, and a support structure (4) extending along a longitudinal axis from the proximal end (21) to the distal end (22), wherein the support structure (4) has a pre-set curvature prior to insertion in a gastrointestinal tract that mimics a curvature of a section of the gastrointestinal tract, wherein the support structure (4) is configured to return to the pre-set curvature after insertion into the gastrointestinal tract to provide conformational stability for the elongate body (2), characterized in that the gastrointestinal device (1 ) further comprises at least one further anchor (32), and the support structure (4) maintains a defined distance between the first anchor (31) and the at least one further anchor (32).

2. The gastrointestinal device (1) of claim 1, wherein the first anchor (31) and the at least one further anchor (32) are attached to the support structure (4).

3. The gastrointestinal device (1) of one of the preceding claims, wherein the support structure (4) comprises at least one elongate member (41, 42) connecting the first anchor (31) and at least one further anchor (32), in particular wherein the at least one elongate member (41, 42) is stiff along the longitudinal axis and inhibits rotation of the anchors around axes that are normal to the longitudinal axis.

4. The gastrointestinal device (1) of one of the preceding claims, wherein, for at least one anchor of the first anchor (31) and the at least one further anchor (32), at least one of the following is the case:• the anchor (31, 32) defines a lumen for gastrointestinal fluids to pass through;• the anchor (31, 32) is designed to engage tissue in the gastrointestinal tract and thereby maintain the anchor (31, 32) in a substantially constant position with respect to the gastrointestinal tract;• the anchor (31, 32) has the shape of a closed ring or torus, of an open or split ring, of a section of a helix, of a polygon, of a wave, or of a stent;• the anchor (31, 32) is designed to be deformed, in particular, expanded, upon insertion into the gastrointestinal tract, thereby adapting a diameter of the anchor (31, 32) to that of the gastrointestinal tract.

5. The gastrointestinal device (1) of one of the preceding claims, wherein at least one of the following is the case:• a length of the elongate body (2) is between five centimetres and thirty centimetres;• the first anchor (31) is designed to have, when positioned in the gastrointestinal tract, a diameter between four and seven centimetres;• the least one further anchor (32) is designed to have, when positioned in the gastrointestinal tract, a diameter between three and ten centimetres;• for any of the anchors it is the case that its diameter is over three centimeties;• a distance between anchors is at least two centimetres, in particular at least three, in particular at least four centimetres;• a distance between two consecutive anchors, of which one is to be arranged proximal to and the other one distal to the major duodenal papilla, lies between five and twenty-six centimetres, in particular between six and nine centimetres, more in particular between seven and eight centimetres.

6. The gastrointestinal device (1) of one of the preceding claims, comprising at least a first sleeve (51 ), the first sleeve (51) comprising a proximal opening and a distal opening,• a proximal end of the first sleeve (51) being attached to the first anchor (31), or• the proximal end of the first sleeve (51) being attached to a first one of the one or more further anchors (32).

7. The gastrointestinal device (1) of claim 6, wherein a circumference of a proximal opening at the proximal end of the first sleeve (51) is attached to a circumference of the anchor to which the first sleeve (51) is attached.

8. The gastrointestinal device (1) of claim 6, wherein a circumference of a proximal opening at the proximal end of the first sleeve (51 ) is attached only to a section of a circumference and not the entire circumference of the anchor to which the first sleeve (51) is attached, leaving a cross section of a lumen defined by the anchor open for gastrointestinal fluid to flow past the anchor without entering the first sleeve (51 ).

9. The gastrointestinal device (1) of one of claims 6 to 8, comprising a second sleeve (52), the second sleeve (52) being attached to an anchor that is located distally from the anchor to which the first sleeve (51) is attached, with the first sleeve (51) extending into the second sleeve (52).

10. The gastrointestinal device (1) of claim 9, comprising a third sleeve (53), the third sleeve (53) being attached to an anchor distally from the anchor to which the second sleeve (52) is attached, with the second sleeve (52) extending into the third sleeve (53).

11. The gastrointestinal device (1) of one of claims 6 to 10, wherein for at least one of the sleeves it is the case that the sleeve is attached to two anchors that are spaced apart along the longitudinal axis, with the proximal opening of the sleeve oriented to be open in a radial direction.

12. The gastrointestinal device (1) of one of claims 1 to 5, comprising at least a barrier element (7), the barrier element (7) comprising a proximal end that is attached to the first anchor (31) or to a first one of the at least one further anchor (32), in particular wherein at least one of the following is the case:• the barrier element (7) is designed to extend along the longitudinal axis and to act as a barrier between regions distal to the proximal end of the barrier element (7), in particular wherein the barrier element (7) comprises a barrier sheet 74 attached at its proximal end to the first anchor or the first one of the at least one further anchor;• the barrier element (7) is designed to operate as a valve element (75), inhibiting a flow of gastrointestinal fluid in the proximal direction; in particular wherein the barrier element (7) comprises a valve sleeve (76) or one or more sheets (71, 72, 73) attached at their proximal ends to the first anchor or the first one of the at least one further anchor, arranged to implement a valve function.

13. A method of providing therapy in a gastrointestinal tract comprising the steps of:• providing a gastrointestinal device (1) comprising an elongate body (2) having a proximal end (21), a distal end (22), a first anchor (31), and a support structure (4) extending along a longitudinal axis from the proximal end (21) to the distal end (22), the gastrointestinal device (1) further comprising a further anchor (32),• performing intestinal plication at a first location along the gastrointestinal tract, in particular distal to a narrowing in the gastrointestinal tract, more in particular distal to the pyloric sphincter,• positioning the gastrointestinal device (1) with one of the first anchor (31) and the further anchor (32) located proximal to the first location or distal to the first location.

14. The method of claim 13, comprising the steps of:• performing intestinal plication at a second location along the gastrointestinal tract, distal to the first location,• in the last step of claim 13, o positioning the gastrointestinal device ( 1 ) with the first anchor (31) located distal to the first location and the further anchor (32) proximal to the first location15. The method of claim 13, comprising the steps of:• performing intestinal plication at a second location along the gastrointestinal tract, distal to the first location,• in the last step of claim 13, o positioning the gastrointestinal device (1) with the first anchor (31) located proximal to the first location and the further anchor (32) distal to the first location.

16. A gastrointestinal device (1) comprising: a sleeve arrangement configured to be placed in the gastrointestinal tract, in particular into the intestinal tract, the sleeve arrangement, when extended along a longitudinal axis, defining a first lumen and a second lumen, each of the first and second lumen having an associated proximal opening and a distal opening that are distanced from one another along the longitudinal axis, wherein the first and second lumen both are present along at least one section along the longitudinal axis.

17. The gastrointestinal device (1) of claim 16, wherein the first and second lumen are defined by separate sleeves, with a first sleeve (51) being arranged concentrically inside a second sleeve (52) in an overlap section along the longitudinal axis, and wherein the first sleeve (51) and second sleeve (52) are attached to one another or to a common support structure (4).

18. The gastrointestinal device (1) of claim 16, wherein the first and second lumen are defined by a combined sleeve, the combined sleeve comprising at least two lumens separated by a separating wall, in particular wherein the proximal opening of one of the first and second lumen is oriented to be open in a radial direction.

19. A method of providing therapy in a gastrointestinal tract, comprising the steps of:• providing a sleeve arrangement designed to function as a gastrointestinal sleeve, the sleeve arrangement, when extended along a longitudinal axis, defining a first lumen having an associated proximal opening and a distal opening that are distanced from one another along the longitudinal axis;• positioning the sleeve arrangement in the intestinal tract in a target configuration in which the proximal opening covers the major duodenal papilla; and• anchoring the sleeve arrangement in the target configuration.

20. The method of claim 19, wherein the sleeve arrangement, when extended along a longitudinal axis, defines the first lumen and a second lumen, each of the first and second lumen having an associated proximal opening and a distal opening that are distanced from one another along the longitudinal axis, wherein the first and second lumen both are present along at least one section along the longitudinal axis.

21. The method of claim 19 or 20, wherein the step of anchoring the sleeve arrangement comprises at least one of:• suturing at least a section of the sleeve arrangement to the intestinal wall, in particular suturing a rim of the proximal opening of the first lumen to the intestinal wall;• anchoring in the duodenum a support structure (4) to which the sleeve arrangement is attached.

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