Duodenal anchor for securing implant in duodenum of patient, implant for placement in duodenum of patient, connector for connecting duodenal anchor and gastric anchor, implant system for implantation in gastric tract of patient comprising gastric anchor, duodenal anchor and connector, and method of treating patient

Abstract

The present invention relates to an implant system (500) for implantation in a gastric tract of a patient. The system includes a stomach anchor (400) adapted to be placed within the stomach of a patient, a duodenal anchor (100), and a connector (300) having a first end (360) and a second end (370) and a central portion (310). The connector (300) is connected to the duodenal anchor (100) at a first end (360) and to the gastric anchor at a second end (370). The first end (360) and the second end (370) of a connector (300) are connected by the central portion (310), the connector being adapted to connect the stomach anchor (400) and the duodenal anchor (100) across the patient's pylorus when the system (500) is implanted.

Description

Technical Field

[0001] The present invention relates to a duodenal anchor for securing an implant in the duodenum of a patient, an implant for placement in the duodenum of a patient, a connector for connecting the duodenal anchor and a gastric anchor, an implant system comprising a gastric anchor, a duodenal anchor and a connector for implantation in the gastric tract of a patient, and a method of treating a patient according to the preambles of the independent claims. Background Art

[0002] Implants for placement into a patient's gastrointestinal tract (eg, the duodenum and / or stomach) are known in the art.

[0003] EP 3 878 415 discloses a device for treating obesity or diabetes, comprising a duodenal tube and a first anchor. The first anchor is adapted to anchor the tube distal to the pylorus, without intervening the mucosa. A second anchor, in the form of a conical, inflatable balloon, is used to anchor the device within the patient's stomach.

[0004] EP 4 062 879 discloses an anchor for anchoring a tube relative to a patient's pylorus. The anchor may comprise a gastric balloon that is collapsible for ease of introduction and optionally self-expandable to a surgical position.

[0005] US 2007 / 250132 discloses a device and method for applying gastrointestinal stimulation, which comprises implanting a stimulation device into the gastrointestinal tract, the stimulation device comprising a body having at least one expandable portion and a bridging portion, and at least one stimulation member.

[0006] WO 2011 / 099940 discloses a device for placement, retention, and / or anchoring within the gastrointestinal tract. The device comprises an anchoring portion and a chute connectable to the anchoring portion. The anchoring portion comprises a retaining element and can be shaped, sized, and / or configured to be retained in a transpyloric configuration.

[0007] WO 2016 / 067087 discloses a bypass device for delivering gastric contents through the pylorus.

[0008] These devices according to the prior art do have some disadvantages. Specifically, they can be difficult to deploy and / or anchor, can have poor contact with the mucosa, can have unreliable anchoring, and can have unreliable chyme transport. Summary of the Invention

[0009] The present invention aims to overcome the deficiencies of the prior art, and in particular to provide an implant and a duodenal anchor for securing an implant in a patient's duodenum that is easier to manufacture, easier to deploy, can provide reliable anchoring, and reduce side effects such as unreliable chyme transfer.

[0010] Another object of the present invention is to provide an implant and a therapeutic device for placement in the gastric tract of a patient that is easy to manufacture, easy to deploy, provides reliable anchoring, and does not cause side effects, particularly due to unreliable transfer of chyme.

[0011] These and other objects are achieved by an apparatus and a method according to the characterizing parts of the independent claims. Further embodiments are provided by the dependent claims.

[0012] According to the present invention, a duodenal anchor for securing an implant within a patient's duodenum is provided. The duodenal anchor has an outer surface configured to conform to the inner wall of the patient's duodenum. The duodenal anchor includes an internal, preferably centrally located, channel for conveying chyme. The duodenal anchor also includes a fillable portion disposed at least partially along the circumference of the internal channel. When the fillable portion is filled with fluid, its circumference is greater than the inner circumference of the duodenum.

[0013] The fillable portion may be an inflatable component, in particular a balloon. The inflatable component may typically comprise a fluid-tight and / or airtight inner volume, such that fluid may be injected through, for example, a valve or a closable opening and prevented from flowing out.

[0014] Preferably, the fillable portion may include or be formed by an outer shell. The outer shell may have a first end and a second end. The first end may be connected (particularly bonded) to the inner passage, thereby forming an inner volume that can be filled with fluid. The outer shell is connected to the inner passage in a fluid-tight manner by the first end.

[0015] The outer shell may at least partially surround the inner passageway.

[0016] The interior volume formed by the outer shell and the interior passageway need not be fluid-tight.

[0017] Preferably, the second end of the outer shell is a free end adapted to move (e.g., slide) at least, or preferably only, along the surface of the internal passage. In other words, the outer shell can be attached at one end and unattached at the other end, such that fluid filling the internal volume can escape through the gap formed between the second end and the internal passage. Preferably, the free end is located distally of the duodenal anchor. Thus, the duodenal anchor can be moved distally relative to the proximal component of the implant system in response to a force, and the folding of the outer shell can increase the anchoring force of the duodenal anchor.

[0018] The proximal-most surface of the outer shell and / or the first end may coincide with the proximal end of the internal passageway.

[0019] It will be appreciated that such a device may still be filled with fluid even though the fluid is free to escape the interior volume.

[0020] Preferably, at least one connector extends through the inflatable portion and is attached to the distal end of the inflatable portion. Preferably, three connectors extend through the inflatable portion. Particularly preferably, the distal end to which the at least one connector is attached is the second end of the outer shell. It should be understood that the connector described herein may be formed by an extension of the connector connecting the duodenal anchor and the gastric anchor.

[0021] At least one connector can be connected to the second end, pass through the interior volume of the fillable portion, and pass through a hole in the proximal portion of the outer shell. The hole can be sealed in a fluid-tight manner and / or adapted to allow the connector to slide through the hole.

[0022] The at least one connector passing through the fillable portion may be an end of a connector as described below.

[0023] Therefore, when a pulling force is applied to the connector (e.g., due to peristaltic motion), the second end can slide in the direction of the force, resulting in a decrease in volume. The outer shell can fold into an accordion shape. Fluid used to fill the fillable portion may escape from the inner volume due to the decrease in volume caused by the folding.

[0024] While the initial anchoring may require filling with fluid to better conform to the internal shape of the patient's duodenum, surprisingly, the anchoring force of the duodenal anchor becomes stronger when the outer layer is folded up and fluid is allowed to flow out. Therefore, an automatic feedback mechanism can be set up to increase the anchoring force by folding the outer layer when the duodenal anchor is subjected to force. This can prevent the duodenal anchor from being accidentally pulled back / migrated into the stomach.

[0025] The duodenal anchor may also preferably include a pulling device. The pulling device may be attached to the distal end of the outer layer. The pulling device may interact with the patient's intestine (e.g., due to peristalsis) to move away from the duodenal anchor and pull the outer layer.

[0026] In some patients, a gastric anchor attached to a duodenal anchor may continuously exert a certain pulling force. Therefore, when the duodenal anchor is configured to fold an outer surface (e.g., an outer jacket) due to said pulling force, there may be a bias to permanently fold the outer surface. While temporary folding is advantageous for the reasons stated above, the folded structure may irritate the duodenum over time. Therefore, it is best to restore the fold when the pulling force is absent and / or the pulling force is sufficiently low that adequate anchoring is achieved without the folded structure. In addition, irritation can generally be reduced when the folded structure is allowed to move back and forth to a certain extent to accommodate the patient's duodenum. Therefore, the traction device can reduce irritation by at least partially unfolding the outer jacket in response to a first pulling force acting on the traction device and a second, opposing pulling force acting on, for example, the gastric anchor.

[0027] The present invention also relates to a pulling device for a duodenal anchor. The pulling device may be attached or connectable to the duodenal anchor, preferably directly, and preferably not attached to a sleeve connected to the duodenal anchor.

[0028] "Fully filled with fluid" can be understood as filling the fillable portion with a maximum amount of fluid and / or gas while maintaining an internal pressure substantially no greater than an external pressure (e.g., atmospheric pressure). Preferably, the fillable portion, when fully inflated and / or filled, can accommodate a maximum of 10 to 60 milliliters of fluid (or gas). More preferably, the fillable portion, when fully inflated and / or filled, can accommodate a maximum of 25 to 45 milliliters of fluid (or gas). In a preferred embodiment, the fillable portion, when fully inflated and / or filled, can maintain a volume of 34 milliliters.

[0029] In particularly preferred embodiments, the fillable portion is filled only with air (and / or other medically acceptable gases) for implantation, and no additional fluid is injected into the fillable portion before, during, or after implantation.

[0030] This allows the inflatable portion to reach the size of the duodenum without having to be fully inflated and / or filled.Thus, the inflatable portion can adapt to the inner surface of the duodenum, in particular its shape.

[0031] The fillable portion can be filled with an incompressible fluid, such as a liquid (e.g., saline) and / or a gas (e.g., air). Filling the fillable portion with air can make its structure particularly flexible when partially inflated.

[0032] The typical inner diameter of the human duodenum is 25 mm and the typical inner circumference is 75 mm. Therefore, when the inflatable portion is fully inflated and / or filled with fluid and / or gas, its circumference may be greater than 75 mm and / or its inner diameter may be greater than 25 mm.

[0033] Preferably, the outer diameter of the fillable portion when fully inflated and / or filled is in the range of 30 mm to 70 mm, more preferably in the range of 35 mm to 55 mm, and most preferably in the range of 35 mm to 45 mm. In a preferred embodiment, the outer diameter of the fillable portion when fully inflated is 40 mm.

[0034] Preferably, the fillable portion is arranged circumferentially relative to the internal passage, while the internal passage may be arranged centrally.

[0035] The outer surface of the duodenal anchor is configured to conform to the inner wall of the patient's duodenum. To this end, the inflatable portion, particularly the outer wall, can be constructed from a mechanically soft material, such as a soft polymer. Additionally or alternatively, the inflatable portion can be sized such that at least one outer wall is mechanically flexible. The mechanical flexibility of the inflatable portion, particularly its outer wall, is sufficient to conform to the inner wall of the patient's duodenum. The inflatable portion, particularly its outer wall, can be made of silicone, such as silicone having a Shore A hardness of 30-60. The tensile strain of the inflatable portion's outer wall material and / or the tube / inner passage material can be 100-300%.

[0036] The diameter of the inner passage is in the range of 10 mm to 25 mm, preferably 15 mm to 21 mm, most preferably 17 mm to 19 mm. In a preferred embodiment, the diameter of the inner passage is 18 mm.

[0037] The duodenal anchor according to the present invention is particularly suitable for delivery to the implantation site and partial inflation there. Thus, the anchor can have a compressed shape that is compact and easy to safely deliver. Particularly preferably, the inflatable portion can be crimped under vacuum conditions for delivery.

[0038] When the anchor is substantially positioned in its final implantation position, partial inflation can be performed, i.e., filling the fillable portion with a quantity of fluid that does not reach a fully filled state. To this end, an inflation port can be provided and fluidically connected to the interior volume of the fillable portion. The fillable portion can be inflated using a static syringe. When the fillable portion is in a vacuum-corrugated state, fluid can penetrate the fillable portion due to a pressure gradient without applying additional pressure to the syringe.

[0039] Because the surrounding mucosa may constrain the inflatable portion before it reaches its nominal shape (i.e., before it is fully inflated), the inflatable portion may reach an underinflated equilibrium state. At this point, the inflation port may close and the inflation tube may be disconnected from the valve. As a result, the inflatable portion will achieve a shape that conforms to the anatomy of the implantation site, meaning that the anchor can be adjusted in situ to the patient's specific shape.

[0040] This patient specificity is made possible by anchors having a circumference greater than the inner circumference of a typical human duodenum, as it allows for secure implantation of underinflated anchors.

[0041] Generally speaking, the terms "distal" and "proximal" refer to directions relative to the gastrointestinal tract. In humans, the stomach is located proximally relative to the intestine. The intestine is located distally relative to the stomach. Therefore, references to the distal and proximal portions of any component herein refer to their respective positions when implanted (i.e., toward the stomach or intestine, as described above).

[0042] In a preferred embodiment, the duodenal anchor is cylindrical over at least part of its length. Preferably, the cylindrical shape extends over more than 40% of its length. The length of the implant is understood to be the extension in a direction substantially parallel to the longitudinal axis of the duodenal anchor.

[0043] The cylindrical shape may in particular allow for easy connection to other implants, such as a duodenal tube.

[0044] In a preferred embodiment, the duodenal anchor comprises a valve mechanism connected or connectable to the inflatable portion for filling the inflatable portion.

[0045] The valve mechanism can be connected to the inflation port. The valve mechanism is adapted to receive an inflation tube, which can open the valve mechanism when the valve mechanism is inserted. The valve mechanism can also be adapted to close after the inflation tube is removed.

[0046] Generally speaking, when the valve mechanism is in an open state, fluid can flow from an external source connected or connectable to the inflation port and / or the valve mechanism into the fillable portion. When the valve mechanism is closed, fluid cannot flow out of the fillable portion through the valve mechanism.

[0047] In a preferred embodiment, the duodenal anchor is attached to a proximal end of a sleeve having a distal end for placement within the small intestine.

[0048] In a preferred embodiment, the inner passageway of the duodenal anchor is substantially tubular.

[0049] The internal passageway of the duodenal anchor may be substantially tubular along at least 60%, more preferably 80%, and most preferably 90% of its length in a direction substantially parallel to the longitudinal axis of the implant body.

[0050] In a preferred embodiment, the inflatable portion of the duodenal anchor comprises a mechanically flexible outer wall.

[0051] When the duodenal anchor with the inflatable portion is placed in the duodenum of a patient, the inflatable portion is only partially inflated. Since it is only partially inflated, the mechanically flexible outer wall of the inflatable portion may take on an amorphous shape.

[0052] A mechanically flexible outer wall offers several advantages. First, in the radial direction, it can yield to the peristaltic motion of the intestine, which attempts to push the outer wall of the fillable portion back and forth. Second, in the axial direction, the mechanically flexible outer wall can assume an amorphous shape due to the partial expansion of the fillable portion. Therefore, only the fluid within the fillable portion, rather than the entire duodenal anchor, is displaced by peristaltic movements of the intestine.

[0053] In a preferred embodiment, the duodenal anchor (preferably the inflatable portion) is crimped together by a release mechanism (preferably a crimping film and a release wire) to reduce the radial size of the duodenal anchor, thereby facilitating delivery. Particularly preferably, the crimping film comprises or is made of silicone.

[0054] To facilitate delivery of the duodenal anchor into the duodenum of a patient, it is advantageous to reduce the size of the duodenal anchor, particularly reducing its radial dimension.

[0055] The inflatable portion can be placed in a vacuum environment and rolled up by a release mechanism. The release mechanism can include a silicone crimping membrane tied together by a release wire. By pulling one end of the release wire, the crimping membrane can release the pressure applied to the duodenal anchor.

[0056] In a preferred embodiment, the duodenal anchor comprises an elongated element having a free distal end extending in a direction generally parallel to the longitudinal axis of the duodenal anchor. Such an elongated element can provide increased mechanical flexibility while preventing the surrounding sleeve from collapsing (eg, by folding).

[0057] When implanted in the patient's duodenum, the distal end of the duodenal anchor may be directed toward the small intestine.

[0058] The elongated element may be made of the same or different material as the duodenal anchor. The elongated element preferably comprises or consists of a soft material and is additionally or alternatively dimensioned to be mechanically flexible (i.e., elastically deform under typical forces applied in the implanted state). The elongated element may provide stability, for example, to a cannula placed around the elongated element. It will be appreciated that the functionality of the elongated element is substantially the same as that of the preferred embodiment of the implant according to the present invention. When the elongated element is connected to the duodenal anchor, a particularly simple treatment can be provided, since a separate implant need not be provided.

[0059] Preferably, the elongated element is disposed around the distal end of the inner passage of the duodenal anchor. When extended in a direction parallel to the longitudinal axis of the duodenal anchor, the elongated element preferably forms a tubular structure having straight longitudinal cutouts. Preferably, the width of each cutout is the same as the width of each elongated element.

[0060] In a preferred embodiment, the proximal end of the duodenal anchor is connectable to a connector or stent, preferably by a plurality of connecting elements arranged at circumferential positions relative to the central passage.

[0061] Preferably, the duodenal anchor comprises at least one passage extending through the wall adapted to receive a connector.

[0062] After the duodenal anchor is implanted in the patient's duodenum, its proximal end faces the stomach, and the distal end of the duodenal anchor is opposite to the proximal end.

[0063] When the patient is treated with a gastric anchor in the form of a balloon, the duodenal anchor may also be connected or connectable to the gastric balloon.

[0064] According to another aspect of the present invention, an implant for placement into a patient's duodenum is provided. The implant comprises a generally tubular implant body having a proximal end and a distal end. The proximal end of the implant body can be secured or affixed to a duodenal anchor, preferably a duodenal anchor as described above. The implant body comprises a plurality of elongated elements, the free distal ends of which extend substantially parallel to the longitudinal axis of the implant body. The free ends of the elongated elements form the distal-most portion of the implant body.

[0065] Preferably, the proximal end of the implant body can be fixed or secured to the duodenal anchor, more preferably fixed to the distal end of the duodenal anchor. When implanted in the duodenum of a patient, the distal end of the duodenal anchor can face the small intestine.

[0066] The implant body may be generally tubular for at least 60%, more preferably 80%, and most preferably 90% of its length along a direction substantially parallel to its longitudinal axis.

[0067] The generally tubular implant body together with the elongate elements may be castellated.

[0068] Because the elongated elements bend and kink according to the patient's anatomy, the circumferential space between two adjacent elongated elements can form a chyme channel. Even if the elongated elements bend and / or kink, for example, due to the patient's anatomy, the circumferential space between the elongated elements ensures reliable transport of chyme. Therefore, the chyme channel formed by the tubular structure is less susceptible to clogging due to, for example, kinking.

[0069] Preferably, the width of each circumferential space between the longitudinal elements is equal to the width of each elongated element.

[0070] The circumferential space may be a gap.

[0071] The length of each elongate element may be between 5 mm and 30 mm, preferably between 10 mm and 15 mm.

[0072] Preferably, each elongated element is in the shape of a cuboid. Preferably, the width of the elongated element is greater than its thickness. Preferably, the length of the elongated element is greater than both its width and thickness.

[0073] Preferably, the elongated element comprises or consists of the same material as the implant body. Additionally or alternatively, the elongated element comprises or consists of a material that is more mechanically flexible than the implant body.

[0074] Preferably, the elongated element comprises or consists of a durable thermoplastic material, such as thermoplastic polyurethane (TPU) and / or silicone. The material may have a Shore A hardness of 60.

[0075] Preferably, the elongate elements are arranged around a circumference having the same diameter as the internal passageway, thereby forming an extension of the tubular shape.

[0076] The width of each elongated element may be between 2 and 15 mm, preferably between 4 and 8 mm, particularly preferably between 5 and 6 mm.

[0077] In an advantageous embodiment, the implant further comprises a (preferably intestinal) sleeve arranged around the tubular implant body and attached to the proximal end of the implant body, wherein the distal end of the sleeve is configured for placement within the small intestine. The sleeve may be adapted to transport chyme and to reduce or prevent contact of the chyme with the intestinal wall.

[0078] The sleeve can be placed at a distance of 60 to 100 cm from the proximal intestinal tract, i.e. the sleeve can cover the duodenum and part of the jejunum. The diameter of the sleeve can be between 15 and 30 mm, preferably between 20 and 25 mm.

[0079] In an advantageous embodiment, the implant body comprises 3 to 20 elongated elements, preferably 6 to 12.

[0080] In an advantageous embodiment, the implant body comprises or consists of a soft material, preferably an elastic soft material.

[0081] Preferably, the elongate element and the implant body comprise or consist of the same material.

[0082] Particularly preferably, the elongated element consists of a soft material, preferably an elastic soft material, such as medical grade silicone.

[0083] The material may have a Shore A hardness of less than 55-65.

[0084] In an advantageous embodiment, the outer dimensions of the implant in a direction perpendicular to the longitudinal axis are between 1 and 10 centimeters, preferably between 10 and 30 millimeters.

[0085] In an advantageous embodiment, the elongated element has a closed surface, in particular in a direction perpendicular to the longitudinal axis.

[0086] Closed surfaces may be understood as solid elements, in that they are filled with material, ie for example they have no holes passing through them.

[0087] For example, an elongated element having a rectangular parallelepiped shape, wherein the elongated element is filled with material (ie has no pores), presents four closed surfaces in a direction perpendicular to the longitudinal axis.

[0088] Preferably, the elongated element of the implant presents a closed surface in a direction perpendicular to the longitudinal axis, the closed surface being the largest surface of the elongated element.

[0089] In an advantageous embodiment, the width of at least one circumferential space (preferably all circumferential spaces) between the elongated elements of the implant body corresponds to the width of the elongated elements. When not all elongated elements have the same width, the width of this space can correspond to the width of at least one elongated element.

[0090] In an advantageous embodiment, the elongated element of the implant body is impermeable to liquids and gases.

[0091] Impermeable to liquids and gases means that it does not allow liquids and gases to pass through, or at least reduces the rate at which liquids or gases pass through.

[0092] In advantageous embodiments, the generally tubular implant body has a wall without openings and / or has a substantially continuous surface.

[0093] The elongated element may in particular have a rectilinear shape, without a curve along the longitudinal axis.The elongated element may be made of a soft material and / or the same material as the implant body.

[0094] A solid cuboid can form a wall with no openings.

[0095] According to another aspect of the present invention, a connector for connecting a duodenal anchor and a gastric anchor is provided. Preferably, the duodenal anchor is a duodenal anchor as described above. The connector comprises a central portion and a plurality of first and second ends disposed at opposite ends of the central portion. The central portion has a generally elongated shape along a longitudinal axis. The plurality of first ends are configured to be fixed or securable to the duodenal anchor at their free ends. The plurality of second ends are configured to be fixed or securable to the gastric anchor at their free ends. The plurality of first free ends and the plurality of second free ends extend radially away from the longitudinal axis. Preferably, the plurality of first free ends and the plurality of second free ends each comprise a connection means for connecting to the duodenal anchor and the gastric anchor.

[0096] The connector according to the present invention allows for the connection of two elements, such as a gastric anchor and a duodenal anchor, through the pylorus while still allowing chyme to pass through the pylorus.

[0097] The connector may comprise or be made of medical grade silicone, which is biocompatible and atraumatic.

[0098] The gastric anchor can be a stent or an inflatable gastric anchor, such as a balloon. The inflatable gastric anchor can be fully inflated.

[0099] When the gastric anchor is of the inflatable type, the nominal volume of the inflatable member may be 30 to 80 ml, preferably 50 to 60 ml.

[0100] When the gastric anchor is a stent type, the stent length may be in the range of 15 to 50 mm, preferably 20 to 30 mm. The stent diameter may be in the range of 30 to 80 mm, preferably 50 to 60 mm. The stent may include 9 to 18 stent units, preferably 12 to 15.

[0101] The filaments of the stent can extend within the pylorus and have a length of 5 to 50 mm, preferably 20 to 30 mm. The number of filaments can be 2 to 6, preferably 3 to 4.

[0102] The tensile modulus of elasticity of the filaments can be up to 300%, and the tensile modulus of elasticity of the assembled filaments (usually comprising three filaments, which may also be bonded or tied to the duodenal anchor and / or gastric anchor) is preferably 20% to 100%, particularly preferably 60% to 80%.

[0103] The aspect ratio of the stomach anchor may be 1:5 to 1:1, preferably 1:2 to 1:1, and particularly preferably 8: 11. In some embodiments, the aspect ratio may also be 1:2.

[0104] The duodenal anchor can be an inflatable duodenal anchor or a non-inflatable duodenal anchor. The duodenal anchor can also include an inflatable component and a non-inflatable component.

[0105] Preferably, the central portion is generally elongated in shape and extends in a direction parallel to the longitudinal axis of the connector.

[0106] Preferably, the plurality of first ends are configured to extend into the interior of the duodenal anchor, but they may also be configured within the interior of the duodenal anchor.

[0107] Preferably, the plurality of second ends are configured to extend into the interior of the stomach anchor, but they may also be configured within the interior of the stomach anchor.

[0108] In a particularly preferred embodiment, at least one of the plurality of first ends and the plurality of second ends of the connector is constituted by a rod, preferably by exactly three rods.

[0109] Preferably, the plurality of first end rods extend through the central portion and connect to or form the plurality of second ends.

[0110] Preferably, the plurality of first and / or second ends consists of 2 to 6 rods, more preferably 3 to 4 rods.

[0111] Preferably, the rods of the plurality of first ends and the plurality of second ends have a tensile elasticity of 20% to 100%, more preferably 60% to 80%.

[0112] In a particularly preferred embodiment, at least one of the first plurality of free ends and the second plurality of free ends of the connector are arranged at a substantially constant angular and / or radial distance relative to the longitudinal axis.

[0113] The plurality of first and / or second free ends may all terminate on a virtual circle centered on the longitudinal axis and perpendicular to the longitudinal axis.

[0114] In a particularly preferred embodiment, the length of the central portion of the connector along the longitudinal axis is between 3 and 50 mm, preferably between 20 and 30 mm. Typically, the length of the central portion is at least equal to the length of a typical pyloric sphincter and is preferably less than twice the length of a typical pyloric valve.

[0115] In a particularly preferred embodiment, the length of the plurality of first ends and / or the plurality of second ends of the connector is between 10 and 50 mm, preferably between 20 and 30 mm.

[0116] These lengths allow the connector portion to extend beyond the pyloric valve, thereby reducing or avoiding wear of the anchor on the pylorus.

[0117] In some embodiments, the distance between the first end and the second end along the longitudinal axis is 20 to 30 mm.

[0118] In a particularly preferred embodiment, the plurality of first ends and / or the plurality of second ends and / or the central portion of the connector comprise or consist of a soft material.

[0119] Soft materials are materials with low hardness and high flexibility. For example, silicone and / or polyurethane may be suitable materials. Preferably, the soft material has a tensile strength of 20% to 100%, more preferably 60% to 80%. Preferably, the soft material has a Shore A hardness of 40 to 70, more preferably 55 to 65.

[0120] Particularly preferably, the plurality of first ends and / or the plurality of second ends and / or the central portion of the connector (which may correspond to the soft transpyloric segment) include or consist of an elastic filament that can be elastically stretched to a tensile strain of 500-600% at break. For cyclic loading of such components (cyclic fatigue of the elastic filament), strains of up to 150-200% without failure are conceivable.

[0121] In a particularly preferred embodiment, the central portion of the connector is composed of a plurality of central extensions and a circumferentially arranged tubular element. The central portion may be composed of a plurality of central extensions and a tubular element (350) circumferentially arranged around the central extensions. The length of the tubular element is at least the same as its diameter. The tubular element may be configured to reduce the transverse diameter of the central portion and / or to bring the central extensions into physical contact with each other.

[0122] The length of the tubular element can be measured along a direction parallel to its longitudinal axis and can be the same as the length of the central portion. Preferably, the length of the tubular element is between 3 and 50 mm, more preferably between 5 and 30 mm, particularly preferably between 5 and 15 mm, even more preferably between 6 and 8 mm.

[0123] Preferably, the wall thickness of the tubular element is between 0.2 and 4 mm, more preferably between 0.5 and 2 mm.

[0124] Preferably, the tubular element comprises or consists of the same material as the plurality of first and / or second ends and / or the central portion of the connector.The tubular element may comprise or consist of medical grade silicone.

[0125] The plurality of central extensions may be 2 to 6 rods connected or connectable to the first and second plurality of ends.

[0126] The plurality of central extensions may comprise a smaller number of central extensions than the plurality of first and / or second ends.

[0127] Each central extension of the plurality of central extensions may be connected or connectable to more than one of the plurality of first ends.

[0128] Each central extension of the plurality of central extensions may be connected or connectable to more than one of the plurality of second ends.

[0129] Preferably, the tubular element is configured to surround all elements of the central portion. More preferably, the tubular element is configured to surround a plurality of central extensions.

[0130] According to another aspect of the present invention, an implant system for implantation in a patient's gastric tract is provided. The implant system includes a gastric anchor, preferably a stent or a balloon, adapted for placement within the patient's stomach. The implant system also includes a duodenal anchor, preferably a duodenal anchor as described above. The implant system also includes a connector, preferably a connector as described above. The connector has a first end, a second end, and a central portion. The connector is connected or connectable to the duodenal anchor at the first end and to the gastric anchor at the second end. The first and second ends of the connector are connected by the central portion. When the system is implanted, the connector is adapted to connect the gastric anchor and the duodenal anchor across the patient's pylorus.

[0131] It will be appreciated that in some embodiments, it is contemplated that a non-inflatable duodenal anchor may be used.

[0132] Preferably, the connector is adapted to connect the gastric anchor and the duodenal anchor.The connector may connect the gastric anchor and the duodenal anchor already before implantation of the system, or they may be connected during surgery (eg inside the patient).

[0133] The length of the duodenal anchor can be 20 to 80 mm, preferably 30 to 50 mm or 50 to 60 mm, along the direction of chyme passing through the duodenal anchor / system. This length can include an elongated element as part of the duodenal anchor and / or an implant body with an elongated element connected to the duodenal anchor.

[0134] The gastric anchor, whether in the form of a stent or a balloon, may have a length in the range of 15 to 50 mm, preferably 30 to 50 mm or 20 to 30 mm. The diameter of the gastric anchor may be in the range of 30 to 80 mm, preferably 50 to 60 mm. When the gastric anchor is formed by a balloon, the nominal volume of the gastric anchor may be 40 ml in some embodiments, or typically in the range of 50 to 80 ml, particularly preferably 70 ml.

[0135] The length of the connector (suitable to extend through the pylorus) may be between 5 and 50 mm, preferably 20 and 30 mm.

[0136] In a preferred embodiment, the implant system further comprises an implant, preferably an implant as described above. The implant comprises an implant body. The implant body may be tubular. The implant body may be proximally connected to the duodenal anchor. Preferably, the implant body comprises an elongated element extending in a direction away from the duodenal anchor.

[0137] The system can provide a first channel and a second channel formed by the duodenal anchor and the gastric anchor, separated by a connector. Thus, chyme can pass through the gastric anchor and, since the connector does not substantially impede the passage of chyme, the chyme can pass substantially naturally through the pylorus and then enter the duodenal anchor.

[0138] In a preferred embodiment, the implant system further comprises a sleeve arranged around the tubular implant body, the sleeve being connected to the proximal end of the implant body, and the distal end of the sleeve being configured to be placed in the small intestine.

[0139] According to another aspect of the present invention, there is provided a method of treating a patient, comprising implanting an implant system as provided above.

[0140] The method of treating a patient may include any of the following steps:

[0141] - Place a guidewire through the working channel of the endoscope into the proximal duodenum;

[0142] - Inserting a concentric delivery system loaded with the aforementioned implant over the placed guidewire, with the distal end of the delivery system equipped with an atraumatic bulb;

[0143] - advancing the delivery system down the patient's throat and esophagus until it reaches the stomach, with the portion of the delivery system loaded with the docking station positioned so that the ball and part of the cannula are distal to the pylorus;

[0144] - Inserting an endoscope into the stomach for imaging;

[0145] - Under visual guidance of the endoscope, advance the docking station forward to allow the duodenal member to pass through the pylorus;

[0146] - Advance the sheath distally through the internal catheter at the rear end of the delivery system until the sheath is completely placed in the small intestine;

[0147] - Release the distal atraumatic ball;

[0148] - While retracting the catheter, pressurized fluid is injected into the cannula through the inner catheter. Complete patency of the cannula is achieved, which can be confirmed by X-ray imaging;

[0149] - Release the duodenal anchor coil sleeve and partially inflate to the desired volume;

[0150] - If the system includes a gastric anchor formed by a stent, remove the gastric stent sheath at the antrum (distal stomach); if the gastric anchor is formed by a balloon, inflate the gastric anchor to its nominal volume;

[0151] - Once anchor position and deployment are visually confirmed through the endoscope, disconnect the balloon;

[0152] - Remove the endoscope;

[0153] - Remove the delivery system.

[0154] According to another aspect of the present invention, a method for treating a patient is disclosed. The method comprises placing a duodenal anchor comprising a fillable portion (preferably the duodenal anchor described above) into the duodenum of the patient. The method further comprises filling the fillable portion with a predetermined amount of fluid. The predetermined amount of fluid is 10% to 80% of the volume of the fillable portion when fully inflated. The fillable portion can accommodate a volume of 10 ml to 60 ml, preferably 25 ml to 45 ml, and particularly preferably 34 ml when fully inflated.

[0155] In a preferred embodiment, the predetermined amount of fluid used in the method of treating a patient is between 5 and 10 ml. However, it should be understood that any amount of liquid less than 50 ml (preferably less than 20 ml, and particularly preferably less than 10 ml) may be suitable, depending on the size of the duodenal anchor used, and may only result in partial inflation. In some embodiments, 1 to 5 ml is used.

[0156] The duodenal anchor can be removed from the patient's duodenum after implantation. The removability of the duodenal anchor allows it to be removed from the patient's duodenum, for example, after the patient has been successfully treated.

[0157] The duodenal anchor and / or gastric anchor can be adapted to be filled, unfilled, inflated, or deflated after implantation. To this end, the present invention further relates to a method of treating a patient, comprising the steps of: placing a duodenal anchor (e.g., a duodenal anchor described herein) and / or an inflatable gastric anchor in the patient's duodenum and / or gastric tract, respectively, wherein at least one of the duodenal anchor and the gastric anchor comprises an inflatable member. The method further comprises the step of inflating or deflating the inflatable member.

[0158] The implant system according to the present invention and / or any element of the implant system (e.g., gastric anchor, duodenal anchor, cannula, connector) can be placed by an autonomous robot. To this end, the present invention also relates to a method for treating a patient, comprising the steps of placing an implant system (e.g., an implant system as described herein, preferably a duodenal anchor, such as the duodenal anchor described herein) and / or a gastric anchor in the duodenum and / or gastric tract of the patient, respectively. The method comprises the steps of positioning the duodenal anchor and / or gastric anchor in the duodenum of the patient by a robot, preferably at least partially autonomous. The robot can be adapted to inflate and / or deflate the gastric anchor and / or duodenal anchor. The robot can also place a cannula connected to the duodenal anchor.

[0159] The implant system may include at least one sensor, in particular a biosensor, adapted to collect information, such as information related to the content of nutrients (e.g., glucose and / or lipids) in chyme flowing through the implant system. Additionally or alternatively, the sensor may sense the shape and / or size of any portion of the implant system (e.g., the duodenal anchor or the gastric anchor), for example, to determine whether the implant system is correctly positioned at any point in time after implantation. Such information may be used within the duodenal anchor in a closed-loop feedback loop and / or may be transmitted externally, such as by wireless communication, for subsequent use by a caregiver. Specifically, the size and shape of the duodenal anchor may be selectively altered based on the measured nutrient content in the stomach and / or intestine. BRIEF DESCRIPTION OF THE DRAWINGS

[0160] The present invention will now be described with reference to the embodiments and accompanying drawings, which are as follows:

[0161] Figure 1: Schematic diagram of a first embodiment of a duodenal anchor.

[0162] FIG2 : Schematic diagram of a second embodiment of a duodenal anchor.

[0163] FIG3 : Schematic diagram of a first embodiment of a duodenal anchor connected to an implant.

[0164] Figure 4: Schematic diagram of an embodiment of an implant.

[0165] Figure 5: Schematic diagram of an embodiment of a connector.

[0166] FIG6 : Schematic diagram of an embodiment of a connector connected to a duodenal anchor.

[0167] Figure 7: Schematic diagram of an embodiment of an implant system.

[0168] FIG8 : Schematic diagram of another embodiment of an implant system.

[0169] FIG. 9 : Schematic diagram of another embodiment of an implant system.

[0170] FIG. 10 : Schematic diagram of an embodiment of a duodenal anchor wrinkled by a release mechanism.

[0171] FIG. 11 : Schematic diagram of an embodiment of a duodenal anchor in a deflated state.

[0172] 12a-12c are schematic diagrams of a third embodiment of an implant with a duodenal anchor from different perspectives.

[0173] Figure 13: Schematic cross-section of the duodenal anchor shown in Figure 12a.

[0174] 14a-14b are schematic diagrams showing the working mechanism of the duodenal anchor described in FIG13 .

[0175] Figure 15: Perspective view of the implant system with a retraction device.

[0176] 16a-16b: Schematic diagram of the working mechanism of the pulling device described in FIG15. DETAILED DESCRIPTION

[0177] FIG1 illustrates a first embodiment of a duodenal anchor 100. Duodenal anchor 100 includes an internal passage 20, indicated by two dashed lines, for conveying chyme. Internal passage 20 is tubular and centered about a longitudinal axis L of duodenal anchor 100. An inflatable member 30 is disposed around internal passage 20. Inflatable member 30 has a mechanically flexible outer wall 31 configured to conform to the inner wall of a patient's duodenum. Inflatable member 30 is connected to a valve mechanism 41. A proximal end 101 of duodenal anchor 100 carries a connecting element 82, which is adapted to connect to, for example, a connector and / or a gastric anchor (not shown). The duodenal anchor shown here is made of silicone.

[0178] FIG2 illustrates another embodiment of a duodenal anchor 100. Duodenal anchor 100 is similar to the embodiment shown in FIG1 . For the sake of clarity, identical features are not individually described here. Here, duodenal anchor 100 is made of polyurethane and further includes an elongated member 70 having a plurality of free ends 72 separated by gaps 71. Alternatively, duodenal anchor 100 can be made of silicone. Duodenal anchor 100 has a mechanically flexible outer wall 10 configured to conform to the inner wall of a patient's duodenum.

[0179] FIG3 shows a schematic diagram of the implant 200 shown in FIG1 connected to the duodenal anchor 100. The implant 200 has a tubular implant body 210 with a proximal end 211 and a distal end 212. The proximal end 211 is connected to the duodenal anchor 100. A plurality of elongated elements 270 have free distal ends 272 that extend generally parallel to the longitudinal axis L. The plurality of elongated elements 270 form a distal-most portion 213 of the implant body 210. A circumferential space 271 exists between the elongated elements 270 along the circumference of the implant body 210. The duodenal anchor 100 has a mechanically flexible outer wall 10 configured to conform to the inner wall of the patient's duodenum.

[0180] Fig. 4 schematically shows an implant 200 according to the present invention, which is mainly composed of an implant body 210. At the proximal end 211, the implant body is basically formed into a tubular shape with a closed side. From the proximal end 211, along the longitudinal axis L, roughly to the distal direction (as shown in Figure 4 from left to right), a plurality of elongated elements 270 with a free distal end 272 are formed, and these elongated elements 270 are separated by gaps 271. These elongated elements 270 basically constitute the distal end 212 of the implant body 210. The implant is made of medical grade silicone. The implant body 210 shown here has an external dimension D of 5 cm in a direction perpendicular to the longitudinal axis L. Here, the elongated elements 270 have a closed surface and do not have any holes or discontinuities. The elongated elements are basically solid and integrally formed extensions.

[0181] It will be appreciated that the implant of FIG. 4 combined with the duodenal anchor of FIG. 1 can produce an integrally formed device that functions similarly to the embodiment of FIG. 2 .

[0182] FIG5 shows a schematic diagram of an embodiment of a connector 300 . The connector 300 comprises a central portion 310 , a plurality of first ends 320 , and a plurality of second ends 330 . Preferably, the plurality of first ends 320 and the plurality of second ends 330 are formed from rods. The plurality of first ends 320 and the plurality of second ends 330 terminate at first free ends 321 and second free ends 331 , respectively. The plurality of first ends 320 and the plurality of second ends 330 are connected by a plurality of central extensions 340 , which, in this example, are integrally formed and extend throughout the central portion 310 . A tubular element 350 is circumferentially arranged around the central extensions 340 in the central portion 310 . The tubular element 350 extends across the entire length of the central portion 310 , with its length being considered along the longitudinal axis L of the connector 300 . Additionally or alternatively, the plurality of central extensions 340 may be bonded together within the central portion.

[0183] FIG6 illustrates a schematic diagram of an embodiment of a connector 300 connected to a duodenal anchor 100. The diagram shows a view along the longitudinal axis of the connector (see FIG5 ). A plurality of first ends 320 of the connector 300 extend from a central portion (not shown) surrounded by a tubular member 350. Free ends 321 of the first ends are connected to the duodenal anchor 100 at circumferential locations within the interior passageway 20 at the proximal end of the duodenal anchor 100. The plurality of first ends 320 are arranged at substantially constant angles and radial distances relative to the longitudinal axis of the connector.

[0184] FIG7 shows a schematic diagram of an embodiment of an implant system 500. Implant system 500 includes a gastric anchor 400, a duodenal anchor 100 (similar to that shown in FIG1 ) having an inflatable member 30, a connector 300 similar to that shown in FIG5 , and an implant 200 similar to that shown in FIG4 . Implant 200 includes an elongated member 70 with a free distal end 72. Elongated member 70 has a closed surface 73, i.e., elongated member 70 is covered with material. Implant 200 is connected to the distal end of duodenal anchor 100. The distal end of the duodenal anchor is located opposite the proximal end 101 of duodenal anchor 100. Duodenal anchor 100 has an outer surface 10 configured to conform to the inner wall of a patient's duodenum. At the proximal end 101 of duodenal anchor 100, a plurality of first ends 320 of connector 300 are connected to duodenal anchor 100. From the proximal end 101 to the central portion 310 of the duodenal anchor 100, the plurality of first ends 320 are pulled together by the tubular member 350. The tubular member 350 covers a length of 7 mm. The plurality of second ends 330 of the connector 300 are connected to the gastric anchor 400. The gastric anchor 400 shown here is an inflatable balloon, but in some embodiments, a stent can be used instead.

[0185] Figure 8 shows another embodiment of an implant system 500. The duodenal anchor 100 is connected to a gastric anchor 400 formed of a stent via a connector 300. The other components of the system are substantially the same as those of the embodiment shown in Figure 7, and for the sake of clarity, the same components are not described again.

[0186] FIG9 shows a schematic diagram of another embodiment of an implant system 500. A gastric anchor 400 is formed in a balloon shape and is connected to a duodenal anchor 100 comprising an elongated element 70 via a connector 300. The elongated element is disposed within a sleeve 50. The gastric balloon 400 includes a valve mechanism 40 for inflation. The duodenal anchor can be inflated via a separate valve mechanism (not shown; see FIGS. 2 and 3 ). Additionally or alternatively, the valve mechanism 40 can be connected to the inflatable member of the duodenal anchor for inflating the inflatable member. The sleeve 50 has a distal end 52 and a proximal end 51. The proximal end 51 of the sleeve 50 is connected to the duodenal anchor 100 such that the elongated element 70 is located within the sleeve 50 at the proximal end 51.

[0187] FIG10 illustrates the crimped state of the duodenal anchor 100 according to the present invention. The duodenal anchor 100 is crimped by a release mechanism 60, which includes a silicone crimping membrane 61 and a release wire 62. The silicone crimping membrane 61 of the release mechanism 60 is placed around the duodenal anchor 100 and tightened, exerting a concentric force on the anchor 100. This state is maintained by the release wire 62. The release wire can be selectively released by the operator without inflation, for example, to expand the duodenal anchor 100.

[0188] FIG11 illustrates the duodenal anchor 100 of FIG10 after the release wire has been released and the silicone sheath has been removed (both not shown, see FIG10 ). The inflatable member 30 of the duodenal anchor 100 is in a deflated state, i.e., there is no or very little liquid and / or gas in the inflatable member 30 of the duodenal anchor 100.

[0189] FIG12a shows an implant system 500 having a gastric anchor 400, a duodenal anchor 100, and a cannula 50. A connector (see FIG12c) connects the gastric anchor and the duodenal anchor 100. The cannula 50 and its connection to the duodenal anchor 100 are substantially the same as those shown in FIG7 and FIG9 and will not be described again for clarity. Here, the duodenal anchor 100 comprises an interior passage 20 having a wall 21 and an outer shell 110 disposed around the interior passage 20. The arrangement of the outer shell 110 relative to the interior passage 20 will be described in more detail in FIG12C and FIG13. As shown here, an extension 130 of the connector extends through the interior volume 120 formed between the outer shell 110 and the inner wall 21. When implanted, the gastric anchor 400 resides in the patient's stomach in the substantially illustrated configuration and allows passage of chyme. The duodenal anchor 100 is positioned within the patient's duodenum and receives chyme that passes through the gastric anchor 400 and the patient's pylorus and then exits the implant assembly 500 through the cannula 50. The chyme generally passes through the implant assembly 500 along the longitudinal axis L. Here, the distal end of the outer shell 110 is not connected to the wall 21, thereby forming a gap 102 that allows the outer shell 110 to slide along the outer wall 21. Two radiopaque markers 55 are arranged at the distal end of the cannula 50 to facilitate placement of the implant and / or to check the position of the implant.

[0190] FIG12 b shows a perspective view of duodenal anchor 100 taken along a direction parallel to longitudinal axis L (see FIG12 a ), from distal to proximal (i.e., opposite the direction of chyme transport when implanted and used as intended). Distal end 132 of connector extension 130 is located on the outer surface of sheath 110 and is connected because its diameter is larger than the hole through which connector extension 130 passes. Extension 130 is a flexible wire made of silicone.

[0191] FIG12c shows a cross-sectional view of the implant assembly 500 of FIG12a along plane A in FIG12b. The gastric anchor 400 is an inflatable anchor that can be inflated with gas and / or fluid via a valve mechanism 40 embedded in the shaft of the gastric anchor 400. The extension 131 of the connector 300 extends through the gastric anchor 400 at the inner wall of the gastric anchor. The connector 300 is substantially identical to the connector shown in FIG7 and FIG8 , and comprises extensions 131, 130 that extend through the gastric anchor 400 and the duodenal anchor 100 and are connected to form a single strand at the midsection. The sleeve 50 connected to the duodenal anchor 100 generally corresponds to the configuration shown, for example, in FIG9 . To this end, the duodenal anchor 100 comprises a so-called castellated structure having elongated portions 70 formed in the wall 21 of the internal passage 20 and gaps 71 therebetween. The duodenal anchor also includes an outer shell 110 bonded to the wall 21 at a proximal anchor point 101, which is generally located on the proximal side 111 of the duodenal anchor 100 and forms a fluid-tight seal. The outer shell 110 has a thickness of 0.6 mm. An extension 130 of the connector extends through the outer shell 110 and through a passage hole located near the anchor point 101 and generally on the proximal side of the duodenal anchor. The extension 130 is slidably disposed within the passage hole 104 and forms a substantially fluid-tight seal therein, although it will be appreciated that fluid passage through this passage is acceptable. On the distal side 112 of the duodenal anchor 100, the extension 130 extends through a second distal passage hole in the outer shell 110 and is secured by a distal bulb 132 of the extension 130. Additionally or alternatively, an adhesive may be employed to secure the extension 130 to the outer shell 110. The outer shell 110 is not fixed to the wall 21 on the distal side 112, thereby forming a gap 102 that extends around the circumference of the wall 21 and allows the outer shell 110 to slide along the wall 21. Therefore, as will be shown in more detail in Figure 14b, the outer shell 110 can move proximally and reduce the internal volume 120.

[0192] FIG13 schematically illustrates the configuration of the outer shell 110 and internal channel 20 of the duodenal anchor 100 of FIG12 a-12 c. The connector 300 and internal channel 20 correspond to the previously described embodiments and are not further described for clarity. Here, the outer shell 110 forms an internal volume 120 with the wall 21 of the internal channel 20 and is proximally attached to the wall 21 by a first adhesive layer 101. It will be appreciated that the adhesive layer 101 (here shown in cross-section) extends around the entire circumference of the wall 21 and forms a fluid-tight seal at the proximal end of the duodenal anchor 100. An extension 130 of the anchor 300 extends through the internal volume 120. It will be appreciated that, while two extensions 130 are visible here according to plane A of FIG12 b, in this embodiment, there are three extensions 130, equiangularly distributed about the longitudinal axis of the duodenal anchor 100. The extensions 130 proximally extend through the aperture 104 of the outer shell 110 and are slidably disposed therein. At the distal end of duodenal anchor 100, extension 130 extends through outer shell 110, with bulb 132 secured to the outer surface of outer shell 110 by second adhesive layer 103. At the distal end of outer shell 110, and generally within the region of connection between extension 130 and outer shell 110, outer shell 110 is not connected to wall 21 of internal passageway 20, forming a gap 102. Because gap 102 extends around the circumference of internal passageway 20, outer shell 110 can slide in the proximal direction when traction is applied to the extension. Due to connector 101, the proximal end of outer shell 110 is secured to internal passageway 20, and when extension 130 is pulled back and the distal end of outer shell 110 moves proximally, the proximal end of outer shell 110 does not move relative to wall 21.

[0193] FIG14a schematically illustrates a duodenal anchor 100 similar to the one in FIG13 , in its expanded configuration. Here, extension 130 is attached to outer shell 110 solely via bulb 132, but without the need for additional adhesive on the distal end (see FIG13 ). The proximal end is attached to wall 21 via adhesive layer 101. Gap 102 allows outer shell 110 to slide over wall 21 of tube 20. Extension 130 extends through opening 104 on the proximal side of outer shell 110.

[0194] FIG14 b shows a schematic diagram of duodenal anchor 100 of FIG14 b with extension 130 retracted. As described above, gap 102 allows for sliding movement, allowing the distal end of outer shell 110 to move along wall 21 while adhesive layer 101 secures the proximal end to wall 21. Thus, when extension 130 is retracted through opening 104 in outer shell 110, outer shell 110 is pulled back and forms a folded, accordion-like structure. Filling fluid (not shown) can escape through gap 102. Due to the accordion-like structure, anchoring force in the duodenum can be enhanced.

[0195] FIG15 illustrates an embodiment of an implant system 500 similar to the previous embodiments. The gastric anchor 400, duodenal anchor, connector 300, and sleeve 50 are substantially identical to the embodiment of FIG12c , but it will be appreciated that any of these components may be identical to any of the previously described configurations. Specifically, the duodenal anchor 100 need not include a gap and thus corresponds to, for example, the embodiment of FIG9 . Here, the ring 170 is connected to the outer shell 110 via three rods 160. Rods 160 can be made of the same material and thickness as the extensions 130 of the connector 300. The rods are connected to the outer shell 110 via holes with bulbs 161 disposed on the inner surface of the outer shell 110 between the ends of the extensions 130 connected to the outer shell 110. It will be appreciated that the rods 160 can be attached by any means known in the art and are typically attached anywhere at the distal end of the outer shell 110. It is also conceivable to configure the extension 130 to extend beyond the end of the outer shell 110 so as to be integrally formed with the stem 160 and connected to the ring 170 .

[0196] 16a and 16b schematically illustrate the function of the ring 170.

[0197] FIG. 16 a shows the implant system 500 of FIG. 15 , when implanted, in an expanded configuration corresponding to the configuration of FIG. 14 a .

[0198] FIG16b shows the implant system 500 of FIG15 , in a folded configuration corresponding to the configuration of FIG14b , upon implantation. The natural peristaltic motion of the intestine I, symbolically indicated by arrows PM, interacts with and exerts traction on the ring 170. The ring 170 is typically larger than the cannula 50 so as to encircle it. Consequently, the ring 170 is pulled back against the outer shell 110 via the shaft 160 with the bulb 161. Thus, the ring 170 and the shaft 160 act as a traction device. While traction on the duodenal anchor is generally desirable in some situations, providing this type of traction device is particularly advantageous when the outer shell 110 is not connected to the distal end and thus folds when traction is applied to the extension 130, as described above. The traction device can then act as a counterforce, reopening and / or inhibiting the folding of the outer shell 110, thereby allowing the duodenal anchor 100 to better conform to the patient's intestine. The shaft 160 is made of a non-elastic wire core coated with medical-grade silicone. Thus, rod 160 is atraumatic and biocompatible while being suitable for transmitting traction forces. Furthermore, the increased rigidity provided by the inelastic core prevents loop 170 from bending, rotating, and / or flipping. The length of rod 160 is adjusted so that loop 170 remains at the distal end of duodenal anchor 100 even when sheath 110 is fully collapsed.

Claims

1. A duodenal anchor (100) for securing an implant in position within a patient's duodenum, the anchor having an outer surface (10, 31) configured to conform to the inner wall of the patient's duodenum, the anchor comprising: - an internal channel (20), preferably centrally located, for transporting chyme; as well as - a fillable portion (30) arranged at least partially circumferentially with respect to the inner channel (20), The invention is characterized in that when the fillable portion (30) is filled with fluid, its circumference is greater than the inner circumference of the duodenum.

2. The duodenal anchor (100) according to claim 1, wherein: The fillable portion is formed by an outer shell (110) having a first end (111) and a second end (112), wherein the first end (111) is attached, preferably bonded, to the interior passage (20) to form an interior volume (120).

3. The duodenal anchor (100) according to claim 2, wherein: The second end (112) is a free end adapted to move at least, and preferably only, along the surface of the internal passage (20).

4. The duodenal anchor (100) according to any of the preceding claims, wherein at least one connector (130), preferably three connectors (130), pass through the fillable portion (30) and are attached to the distal end (112) of the fillable portion (30), preferably to the second end (112) of the outer shell (110).

5. The duodenal anchor (100) according to any one of the preceding claims, further comprising a pulling device (160, 170) attached to the distal end (112) of the outer shell (110).

6. The duodenal anchor (100) according to any one of the preceding claims, wherein: The duodenal anchor (100) is cylindrical along at least a portion of its length, preferably more than 40% of its length, in a direction generally parallel to the longitudinal axis (L) of the duodenal anchor (100).

7. The duodenal anchor (100) according to any one of claims 1 to 3, wherein: The duodenal anchor (100) comprises a valve mechanism (40, 41) connected or connectable to the fillable portion (30) for filling the fillable portion (30).

8. The duodenal anchor (100) according to any one of the preceding claims, wherein: The duodenal anchor (100) is attached to a proximal end (51) of a sleeve (50) having a distal end (52) for placement within the small intestine.

9. The duodenal anchor (100) of any one of the preceding claims, wherein the interior passageway (20) is generally tubular.

10. The duodenal anchor (100) according to any one of the preceding claims, wherein The fillable portion (30) includes a mechanically flexible outer wall (31).

11. The duodenal anchor (100) according to any one of the preceding claims, wherein: The duodenal anchor (100), preferably the fillable portion (30), is crimped together by a release mechanism (60), preferably a crimping film (61) and a release wire (62), particularly preferably a silicone crimping film, to reduce the radial size of the duodenal anchor (100) for easy delivery.

12. The duodenal anchor (100) according to any one of the preceding claims, wherein The duodenal anchor (100) includes an elongated member (70, 270) having a free distal end (72, 272) extending in a direction generally parallel to a longitudinal axis (L) of the duodenal anchor (100).

13. The duodenal anchor (100) according to any one of the preceding claims, wherein: The duodenal anchor (100) is connectable at a proximal end (101) to one of a connector (300) and a stent (400), preferably via a plurality of connecting elements (82) arranged at circumferential positions relative to the central passage (20).

14. An implant (200) for placement in the duodenum of a patient, having a generally tubular implant body (210) with a proximal end (211) and a distal end (212), wherein: The proximal end (211) is fixable to or secured to a duodenal anchor, preferably a duodenal anchor (100) according to any one of the preceding claims, and wherein the implant body (210) comprises a plurality of elongated elements (220), the free distal ends (272) of the elongated elements extending in a direction generally parallel to the longitudinal axis (L) of the implant body (210), such that the free ends (72, 272) of the elongated elements (70, 270) form the distal-most portion of the implant body (210).

15. The implant (200) according to claim 14, wherein The implant (200) further includes a sleeve (50) disposed about the tubular implant body (210) and attached to a proximal end (211) of the implant body (210), wherein a distal end (52) of the sleeve (50) is configured to be placed within the small intestine.

16. The implant (200) according to claim 14 or 15, wherein the implant body (210) comprises 3 to 20, preferably 6 to 12, elongated elements (70, 270).

17. The implant (200) according to claims 14 to 16, wherein The implant (200) comprises or consists of a soft material, which is preferably an elastic soft material.

18. The implant (200) according to claims 14 to 17, wherein The implant (200) has an outer dimension (D) between 1 and 10 centimeters along a direction perpendicular to the longitudinal axis (L).

19. Implant (200) according to claims 14 to 18, wherein the elongated element (70, 270) has a closed surface (73), in particular in a direction perpendicular to the longitudinal axis (L).

20. The implant (200) according to claims 14 to 19, wherein At least one circumferential space (271) between two elongated elements (70, 270) has a width corresponding to the width of the elongated elements (70, 270).

21. The implant (200) according to claims 14 to 20, wherein the elongated element (70, 270) is impermeable to liquids and gases.

22. The implant (200) according to claims 14 to 21, wherein The generally tubular implant body (210) has a wall without openings.

23. A connector (300) for connecting a duodenal anchor (100) and a gastric anchor (400), preferably wherein the duodenal anchor (100) is the duodenal anchor (100) according to any one of claims 1 to 13, The connector has a central portion (310) and a plurality of first ends (320) and a plurality of second ends (330) arranged at opposite ends of the central portion (310), wherein the central portion (310) has a generally elongated shape along a longitudinal axis (L). in, The plurality of first ends (320) are configured to be fixed or fixable to the duodenal anchor (100) at free ends (321) of the first ends, wherein the plurality of second ends (330) are configured to be fixed or fixable to the gastric anchor (400) at free ends (331) of the second ends, Therein, the plurality of first free ends (321) and the plurality of second free ends (331) extend radially away from the longitudinal axis (L) and preferably have connection means for connection to the duodenal anchor (100) and the gastric anchor (400), respectively.

24. The connector (300) according to claim 23, wherein At least one of the plurality of first ends (320) and the plurality of second ends (330) is formed by a rod, preferably by exactly three rods.

25. The connector (300) according to claim 23 or 24, wherein At least one of the plurality of first free ends (321) and the plurality of second free ends (331) is arranged at a substantially constant angle and / or radial distance relative to the longitudinal axis (L).

26. The connector (300) according to claims 23 to 25, wherein The length of the central portion (310) extending in the direction of the longitudinal axis (L) is between 3 and 50 mm, preferably between 20 and 30 mm.

27. The connector (300) according to claims 23 to 26, wherein The length of the plurality of first ends (320) and / or the plurality of second ends (330) is between 10 and 50 mm, preferably between 20 and 30 mm.

28. The connector (300) according to claim 23 or 27, wherein The plurality of first ends (320) and / or the plurality of second ends (330) and / or the central portion (310) include or consist of a soft material.

29. The connector (300) according to any one of claims 23 to 28, wherein The central portion (310) is formed by a plurality of central extensions (340) and tubular elements (350) arranged circumferentially around the central extensions, preferably such that the central extensions (340) are in physical contact with each other.

30. An implant system (500) for implantation into the gastric tract of a patient, comprising a gastric anchor (400), preferably a stent or a balloon, adapted to be placed in the patient's stomach; A duodenal anchor (100), preferably a duodenal anchor (100) according to any one of claims 1 to 13; A connector (300), preferably a connector (300) according to any one of claims 23 to 29, having a first end (360) and a second end (370) and a central portion (310); in, The connector (300) is connected to the duodenal anchor (100) at a first end (360) and to the gastric anchor at a second end (370); Furthermore, the first end (360) and the second end (370) of the connector (300) are connected by a central portion (310) and are adapted to be placed through the patient's pylorus to connect the gastric anchor (400) and the duodenal anchor (100) when the system (500) is implanted.

31. The system (500) according to claim 30, further comprising an implant (200), preferably an implant (200) according to claims 10 to 18, having an implant body (210), wherein The implant body (210) is attached to the duodenal anchor (100) at a proximal end (101), and preferably wherein the implant body (210) includes an elongated element (70) extending in a direction away from the duodenal anchor (100).

32. The system (500) of claim 30 or 31, further comprising a sleeve (50) disposed around the tubular implant body (210) and attached to the proximal end (211) of the implant body, wherein The distal end of the sleeve (50) is configured to be placed in the small intestine.

33. A method of treating a patient comprising implanting a system (500) according to claims 30 to 32.

34. A method of treating a patient, comprising the steps of placing a duodenal anchor (100) comprising a fillable portion (30), preferably a duodenal anchor (100) according to claims 1 to 9, in the duodenum of the patient, and further comprising the step of filling the fillable portion (30) with a predetermined amount of fluid, wherein: The predetermined amount is 10% to 80% of the volume of the fillable portion when fully inflated.

35. The method of treating a patient according to claim 34, wherein the predetermined amount is between 5 and 10 milliliters.

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