Duodenal anchor for holding an implant in place within a patient's duodenum, an implant for placement within a patient's duodenum, a connector for connecting a duodenal anchor and a gastric anchor, an implant system for implantation within a patient's gastric tract comprising a gastric anchor, a duodenal anchor and a connector, and a method of treating a patient

Abstract

The present invention relates to an implant system (500) for implantation within a patient's gastric tract. The system includes a gastric anchor (400) adapted for placement within the patient's stomach, 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 attached to the duodenal anchor (100) at the first end (360) and connected to the gastric anchor at the second end (370). The first end (360) and the second end (370) of the connector (300) are connected by the central portion (310) and are adapted to connect the gastric 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 holding an implant in place in the duodenum of a patient, an implant for placement in the duodenum of a patient, a connector for connecting a duodenal anchor and a gastric anchor, an implant system for implantation in the gastric tract of a patient comprising a gastric anchor, a duodenal anchor and a connector, as well as a method for treating a patient, according to the preambles of the independent claims. [Background technology]

[0002] Implants for placement in a patient's gastrointestinal tract, such as the duodenum and / or stomach, are known in the prior art.

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

[0004] EP 4 062 879 discloses an anchor for securing a tube to a patient's pylorus. The anchor may include a gastric bulb that is collapsible for introduction and self-expands to an operative state when required.

[0005] U.S. Patent Application Publication No. 2007 / 250132 discloses a device and method for applying gastrointestinal stimulation, which involves implanting in the gastrointestinal tract a stimulation device including a body having at least one expandable portion, a bridging portion, and at least one stimulation member.

[0006] WO 2011 / 099940 discloses a device that can be placed, retained, and / or anchored within the gastrointestinal tract. The device includes an anchor portion and a chute connectable to the anchor portion. The anchor portion includes a retention unit and is shaped, sized, and / or configured to retain the device in a shape that passes through the pylorus.

[0007] WO 2016 / 067087 discloses a bypass device for passing gastric contents through the pylorus. Summary of the Invention [Problem to be solved by the invention]

[0008] All prior art devices suffer from certain drawbacks, in particular they can be difficult to deploy and / or secure, can result in undesirable mucosal engagement, can be unreliable in securement, and can be unreliable in chyme transfer.

[0009] It is an object of the present invention to overcome the shortcomings of the prior art, and in particular to provide an implant and a duodenal anchor for holding the implant in place within a patient's duodenum that is easier to manufacture, easier to deploy, provides reliable fixation, and reduces negative side effects such as unreliable chyme migration.

[0010] It is a further object of the present invention to provide an implant and procedure for placement within a patient's gastric tract that is easy to manufacture, easy to deploy, provides reliable fixation, and is free of negative side effects, particularly unreliable chyme migration. [Means for solving the problem]

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

[0012] According to the present invention, there is provided a duodenal anchor for holding an implant in place within a patient's duodenum. The duodenal anchor has an outer surface configured to conform to the inner wall of the patient's duodenum. The duodenal anchor includes an inner passageway (preferably central) for carrying chyme. The duodenal anchor further includes a fillable portion disposed at least partially circumferentially relative to the inner passageway. The fillable portion has a circumference greater than the inner circumference of the duodenum when completely filled with fluid.

[0013] The fillable portion may be an inflatable portion, in particular a balloon. The inflatable portion may generally comprise a liquid-tight and / or gas-tight interior volume such that fluid is inserted and prevented from leaving the volume, for example via a valve or closable opening.

[0014] Preferably, the fillable portion may include or be formed by an outer jacket. The outer jacket may have a first end and a second end. The first end may be attached, particularly glued, to the inner passage to form an interior volume that is fillable with fluid. The first end of the outer jacket is attached fluid-tight to the inner passage.

[0015] The outer jacket may at least partially surround the inner passageway. The interior volume defined by the outer jacket and the inner passageway need not be liquid-tight.

[0016] Preferably, the second end of the outer jacket is a free end adapted to move, e.g., slide, at least or preferably only along the surface of the inner passage. In other words, the outer jacket may be attached at one end but not the other end so that fluid stored in the inner volume can escape from the inner volume through a gap formed between the second end and the inner passage. Preferably, the free end is located at the distal end of the duodenal anchor. As a result, the duodenal anchor can move distally away from the proximal portion of the implant system in response to force, while the folding of the outer jacket increases the fixation force of the duodenal anchor.

[0017] The proximal-most surface and / or the first end of the outer jacket may coincide with the proximal end of the inner passageway.

[0018] It will be appreciated that such a configuration can still be filled with fluid even though the fluid is free to exit the interior volume.

[0019] Preferably, at least one connector passes through the fillable portion and is attached to the distal end of the fillable portion. Preferably, three connectors pass through the fillable portion. Particularly preferably, the distal end to which the at least one connector is attached is the second end of the outer jacket. It will be understood that the connectors described herein may be formed by extensions of connectors connecting the duodenal anchor and the gastric anchor.

[0020] At least one connector may 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 jacket. The hole may be fluid-tight sealed and / or adapted to allow the connector to slide through the hole.

[0021] The at least one connector passing through the fillable portion may be the end of a connector as described herein below.

[0022] As a result, the second end may slide in the direction of the force, resulting in a volume reduction when a pulling force is applied to the connector, for example, due to peristaltic movement. The outer jacket may be folded like a bellows. Fluid used to fill the fillable portion may escape from the internal volume due to the volume reduction caused by the folding.

[0023] Although filling with fluid may be necessary for initial fixation, providing an advantageous fit to the inner shape of the patient's duodenum, it has surprisingly been found that fixation of the duodenal anchor is stronger when the outer jacket is collapsed and allowed to escape fluid. Thus, an automatic feedback mechanism can be provided that increases fixation by collapsing the outer jacket when force is applied to the duodenal anchor. As a result, accidental retrieval / movement of the duodenal anchor into the stomach can be avoided.

[0024] The duodenal anchor may also preferably include a tensioning device, which may be attached to the distal end of the outer jacket, and which may interact with the patient's intestine, for example due to peristaltic movement, to move away from the duodenal anchor and pull on the outer jacket.

[0025] In some patients, a gastric anchor attached to a duodenal anchor may permanently exert a certain tension force. Therefore, if the duodenal anchor is configured to fold its outer surface (e.g., outer jacket) under tension, there may be a bias to keep the outer surface permanently folded. While temporary folding is advantageous for the reasons described above, the folded configuration may irritate the duodenum over time. Therefore, it is desirable to unfold the structure when tension is absent and / or when the tension is sufficiently small that the folded structure is not required for adequate fixation. Furthermore, moving the folded structure back and forth to some extent to fit the patient's duodenum can generally reduce irritation. Thus, a tensioning device may reduce irritation by at least partially unfolding the outer jacket in response to a first tensioning force acting on the tensioning device and a second, opposing tensioning force acting on, for example, the gastric anchor.

[0026] The present invention further relates to a tensioning device for a duodenal anchor. The tensioning device may be attached or attachable, preferably directly to the duodenal anchor, and preferably not attached to a sleeve attached to the duodenal anchor.

[0027] Being fully filled with fluid may be understood as being filled with the maximum amount of fluid and / or gas without substantially increasing the pressure inside the fillable portion above the pressure outside the fillable portion (e.g., atmospheric pressure). Preferably, the fillable portion, in its fully inflated and / or filled state, can accommodate a maximum volume of fluid (or gas) of 10 ml to 60 ml. More preferably, the fillable portion, when fully inflated and / or filled, can accommodate a maximum volume of fluid (or gas) of 25 ml to 45 ml. In a preferred embodiment, the fillable portion can hold a volume of 34 ml when fully inflated and / or filled.

[0028] In particularly preferred embodiments, the fillable portion is filled with only air (and / or another medically acceptable gas) for implantation, and no additional fluid is inserted into the fillable portion before, during, or after implantation.

[0029] This allows the fillable portion to reach the size of the duodenum without being completely inflated and / or filled, and as a result, the fillable portion can conform to the inner surface of the duodenum, and in particular its shape.

[0030] The fillable portion can be filled with an incompressible fluid, such as a liquid (e.g., saline) and / or a gas (e.g., air). The use of air to fill the fillable portion can result in a particularly soft structure when partially inflated.

[0031] A typical internal diameter of the human duodenum is 25 mm and a typical internal circumference of the duodenum is 75 mm. The fillable portion may have a circumference of greater than 75 mm and / or an internal diameter of greater than 25 mm when fully inflated and / or filled with fluid and / or gas.

[0032] Preferably, the outer diameter of the fillable portion when fully expanded and / or filled is in the range of 30 mm to 70 mm, more preferably in the range of 35 mm to 55 mm, most preferably in the range of 35 mm to 45 mm. In a preferred embodiment, the outer diameter of the fillable portion when fully expanded is 40 mm.

[0033] Preferably, the fillable portions are circumferentially disposed relative to the inner passage, which may be centrally disposed.

[0034] The outer surface of the duodenal anchor is configured to conform to the inner wall of the patient's duodenum. To this end, the fillable portion, particularly the outer wall, may comprise a mechanically flexible material, such as a soft polymer. Additionally or alternatively, the fillable portion may be dimensioned such that at least the outer wall is mechanically flexible. The mechanical flexibility of the fillable portion, particularly its outer wall, may be sufficient to conform to the inner wall of the patient's duodenum. The fillable portion, particularly the outer wall of the fillable portion, may be made of silicone, for example, silicone with a Shore A hardness of 30 to 60. The tensile strain of the outer wall material of the fillable portion and / or the tube / inner passage material may be 100 to 300%.

[0035] The diameter of the inner passageway may range from 10 mm to 25 mm, preferably from 15 mm to 21 mm, and most preferably from 17 mm to 19 mm. In a preferred embodiment, the diameter of the inner passageway is 18 mm.

[0036] The duodenal anchor according to the present invention is particularly suitable for delivery to an implantation site and partial expansion at the implantation site. Thus, the anchor can have a compressed shape that is compact and allows for easy and safe delivery. Particularly preferably, the fillable portion can be crimped under vacuum for delivery.

[0037] Then, when the anchor is substantially installed at its final implant site, partial inflation, i.e., filling of the fillable portion with less than a fully filled amount of fluid, can be performed. For this purpose, an inflation port may be present and in fluid communication with the interior volume of the fillable portion. A static syringe may be used to inflate the fillable portion. When the fillable portion is vacuum crimped, fluid may penetrate the fillable portion due to a pressure gradient without applying additional pressure to the syringe.

[0038] Because the surrounding mucosa may constrain the fillable portion before it reaches its nominal shape (i.e., before it is fully filled), the fillable portion may reach equilibrium under-inflated. At this point, the inflation port may be closed and the inflation tube may be disconnected from the valve. As a result, the fillable portion reaches a shape that corresponds to the anatomy of the implant site; i.e., the anchor can be tailored to a patient-specific shape in situ.

[0039] Such patient specificity can be achieved with anchors having a circumference greater than the inner circumference of a typical human duodenum, allowing for reliable implantation of under-expanded anchors.

[0040] Generally, the terms distal and proximal are used in reference to the direction of the gastrointestinal tract. In humans, the stomach is proximal to the intestine. The intestine is distal to the stomach. Thus, the distal and proximal portions of any element herein are meant to refer to their respective positions at the implantation location, i.e., oriented toward the stomach or intestine, as described above.

[0041] In a preferred embodiment, the duodenal anchor has a cylindrical shape over at least a portion of its length. Preferably, the cylindrical shape extends over more than 40% of its length. The length of the implant may be understood as the extension in a direction substantially parallel to the longitudinal axis of the duodenal anchor.

[0042] The cylindrical shape may in particular allow for easy connection to other implants, such as a duodenal tube.

[0043] In a preferred embodiment, the duodenal anchor comprises a valve mechanism connected or connectable to the fillable portion for filling the fillable portion.

[0044] A valve mechanism may be connected to the inflation port. The valve mechanism may be adapted to receive an inflation tube, which may open the valve mechanism when inserted. The valve mechanism may be further adapted to close when such tube is removed.

[0045] Generally, when the valve mechanism is in an open state, fluid may enter the fillable portion from the inflation port and / or an external source connected or connectable to the valve mechanism, and when the valve mechanism is closed, fluid cannot exit the fillable portion through the valve mechanism.

[0046] In a preferred embodiment, the duodenal anchor is attached to the proximal end of the sleeve, and the sleeve has a distal end for placement within the small intestine.

[0047] In a preferred embodiment, the inner passage of the duodenal anchor is substantially tubular in shape. The inner passage of the duodenal anchor may be substantially tubular in shape over at least 60%, more preferably 80%, and most preferably 90% of its length along a direction substantially parallel to the longitudinal axis of the implant body.

[0048] In a preferred embodiment, the fillable portion of the duodenal anchor comprises a mechanically flexible outer wall.

[0049] When a duodenal anchor having a fillable portion is placed in a patient's duodenum, the fillable portion is only partially filled, and as a result, the mechanically flexible outer wall of the fillable portion may have an amorphous shape.

[0050] A mechanically flexible outer wall may offer several advantages. First, in the radial direction, it may yield to the peristaltic movement of the intestine, which tends to push the outer wall of the fillable portion back and forth. Second, in the axial direction, it may allow the mechanically flexible outer wall to have an amorphous shape due to the partial expansion of the fillable portion. As a result, only the fluid within the fillable portion, and not the entire duodenal anchor, may move back and forth as a result of the peristaltic movement of the intestine.

[0051] In a preferred embodiment, the duodenal anchor, preferably the fillable portion, is crimped together by a release mechanism, preferably a crimping membrane and a release wire, to reduce the radial size of the duodenal anchor for delivery. Particularly preferably, the crimping membrane comprises or consists of silicone.

[0052] To facilitate delivery of the duodenal anchor within the patient's duodenum, it is advantageous to reduce the size, particularly the radial size, of the duodenal anchor.

[0053] The fillable portion may be placed under vacuum and crimped together by a release mechanism that may comprise a silicone crimp membrane held together by a release wire adapted to cause pulling on one end of the release wire to cause the crimp membrane to release pressure exerted thereby on the duodenal anchor.

[0054] In a preferred embodiment, the duodenal anchor comprises an elongate element having a free distal end extending in a direction substantially parallel to the longitudinal axis of the duodenal anchor. Such an elongate element may enhance the mechanical flexibility of the surrounding sleeve while preventing collapse, e.g., by folding.

[0055] The distal end of the duodenal anchor may face the small intestine when implanted in the patient's duodenum.

[0056] The elongated element may be made of the same or a different material as the duodenal anchor. The elongated element preferably comprises or consists of a soft material and may additionally or alternatively be 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 sleeve that is placed circumferentially around the elongated element. It will be understood that the elongated element may have substantially the same function as the elongated element according to preferred embodiments of the implant according to the present invention. When the elongated element is attached to the duodenal anchor, this may result in a particularly simple procedure, since a separate implant does not need to be provided.

[0057] Preferably, the elongate elements are disposed around the end of the inner passage at the distal end of the duodenal anchor. When the elongate elements extend along a direction parallel to the longitudinal axis of the duodenal anchor, they preferably form a structure having the shape of a tube with straight longitudinal cuts. Preferably, each cut has the same width as each of the elongate elements.

[0058] In a preferred embodiment, the duodenal anchor is connectable at its proximal end to one of the connector and the stent by a plurality of connecting elements, preferably positioned circumferentially relative to the central passageway.

[0059] Preferably, the duodenal anchor includes at least one channel extending through the wall adapted to receive a connector.

[0060] The proximal end of the duodenal anchor faces the stomach when implanted in the patient's duodenum, and the distal end of the duodenal anchor is opposite the proximal end.

[0061] If the patient is treated with a gastric anchor formed as a balloon, the duodenal anchor may also be connected or connectable to the gastric balloon.

[0062] According to another aspect of the present invention, there is provided an implant for placement within a patient's duodenum. The implant has a generally tubular-shaped implant body having a proximal end and a distal end. The proximal end of the implant body is fixable to or fixed to a duodenal anchor, preferably the aforementioned duodenal anchor. The implant body includes an elongate element having a free distal end extending in a direction substantially parallel to the longitudinal axis of the implant body. The free end of the elongate element forms the distal-most portion of the implant body.

[0063] Preferably, the proximal end of the implant body is securable or securable to a duodenal anchor, more preferably to a distal end of the duodenal anchor, which may face the small intestine when implanted in the patient's duodenum.

[0064] The implant body may be generally tubular in shape over at least 60%, more preferably 80%, and most preferably 90% of its length along a direction substantially parallel to the longitudinal axis of the implant body.

[0065] The generally tubular shaped implant body may have a castle-like shape together with the elongated elements. When the elongate elements bend and twist with the patient's anatomy, the circumferential space between two adjacent elongate elements can form a passageway for chyme. For example, even when the elongate elements are bent and / or twisted due to the patient's anatomy, the circumferential space between the elongate elements can allow reliable transfer of chyme. As a result, the chyme pathway formed by the tubular structure is less susceptible to blockage, for example, due to kinking.

[0066] Preferably, the width of each circumferential space between the longitudinal elements is equal to the width of each of the elongate elements. The circumferential space may be a gap.

[0067] The length of each elongate element may be between 5 mm and 30 mm, preferably between 10 mm and 15 mm. Preferably, each elongate element has the shape of a rectangular cuboid. Preferably, the width of an elongate element is greater than the thickness of the elongate element. Preferably, the length of an elongate element is greater than both the width and thickness of the elongate element.

[0068] Preferably, the elongate element comprises or consists of the same material as the implant body. Additionally or alternatively, the elongate element comprises or consists of a material that is mechanically flexible compared to the implant body.

[0069] Preferably, the elongate elements comprise or consist of a durable thermoplastic material, such as thermoplastic polyurethane (TPU) and / or silicone. The material may have a Shore A hardness of 60.

[0070] Preferably, the elongate elements are arranged around a circle having the same diameter as the inner passageway forming the extension of the tubular shape.

[0071] The width of each of the elongate elements may be 2 to 15 mm, preferably 4 to 8 mm, particularly preferably 5 to 6 mm.

[0072] In an advantageous embodiment, the implant further comprises a preferably intestinal sleeve disposed about the tubular-shaped implant body and attached to the proximal end of the implant body, the distal end of the sleeve being configured to be placed 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.

[0073] The sleeve may be placed over a distance of 60-100 cm of the proximal intestine, i.e., the sleeve may cover the duodenum and part of the jejunum. The diameter of the sleeve may be 15-30 mm, preferably 20-25 mm.

[0074] In an advantageous embodiment, the implant body comprises between 3 and 20, preferably between 6 and 12, elongate elements.

[0075] In an advantageous embodiment, the implant comprises or consists of a soft material, preferably an elastic soft material.

[0076] Preferably, the elongate element and the implant body comprise or consist of the same material.

[0077] Particularly preferably, the elongate element consists of a soft material, preferably a resilient soft material, for example medical grade silicone.

[0078] The material may have a Shore A hardness of 55 to less than 65. In an advantageous embodiment, the external dimensions of the implant are between 1 and 10 cm, preferably between 10 and 30 mm, perpendicular to the longitudinal axis.

[0079] In an advantageous embodiment, the elongate element has a closed surface, in particular in a direction perpendicular to the longitudinal axis.

[0080] A closed surface may be understood to be a solid element in the sense that it is filled with material, ie does not have, for example, through holes.

[0081] For example, the elongate element has the shape of a rectangular cuboid, the elongate element is filled with material (ie has no holes) and presents four closed surfaces in the direction perpendicular to the longitudinal axis.

[0082] Preferably, the elongate elements of the implant present a closed surface in a direction perpendicular to the longitudinal axis, the closed surface being the largest surface of the elongate elements.

[0083] In an advantageous embodiment, at least one circumferential space between the elongate elements of the implant body, and preferably all circumferential spaces, has a width corresponding to the width of the elongate element. If not all elongate elements have the same width, the width of the space may correspond to the width of at least one elongate element.

[0084] In an advantageous embodiment, the elongate elements of the implant body are impermeable to liquids and gases.

[0085] Impermeable to liquids and gases means not allowing the passage of liquids or gases or at least reducing the rate at which liquids or gases can pass.

[0086] In an advantageous embodiment, the generally tubular shaped implant body has a wall without openings and / or has a substantially continuous surface.

[0087] The elongate elements may in particular have a straight shape with no curves along the longitudinal axis.The elongate elements may be made of a soft material and / or of the same material as the implant body.

[0088] A solid rectangular cuboid may form a wall without openings. According to another aspect of the present invention, there is provided a connector for connecting a duodenal anchor and a gastric anchor. Preferably, the duodenal anchor is the duodenal anchor described above. The connector has a central portion and first and second limbs disposed at opposite ends of the central portion. The central portion has a generally elongated shape along a longitudinal axis. The first limbs are configured to be secured or securable to the duodenal anchor at a free end of the first limb. The second limbs are configured to be secured or securable to the gastric anchor at a free end of the second limb. The first and second limbs extend radially away from the longitudinal axis. Preferably, the first and second limbs have connecting means for connecting to the duodenal anchor and the gastric anchor, respectively.

[0089] A 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 allowing the passage of chyme.

[0090] The connector may include or consist of medical grade silicone, which provides biocompatibility and is atraumatic.

[0091] The gastric anchor may be a stent or an expandable gastric anchor such as a balloon. The expandable gastric anchor may be fully expanded.

[0092] If the gastric anchor is expandable, the nominal volume of the expandable portion may be 30-80 ml, preferably 50-60 ml.

[0093] When the gastric anchor is a stent, the length of the stent may be in the range of 15 to 50 mm, preferably 20 to 30 mm. The diameter of the stent may be in the range of 30 to 80 mm, preferably 50 to 60 mm. The stent may include 9 to 18, preferably 12 to 15, stent cells.

[0094] The wires of the stent may extend to the pylorus with a length of 5 to 50 mm, preferably 20 to 30 mm. The number of wires may be 2 to 6, preferably 3 or 4.

[0095] The tensile modulus of the wire may be up to 300%, and the tensile modulus of the assembly wire (which may typically include three wires, which may also be adhered or tied to the duodenal and / or gastric anchors) is preferably in the range of 20 to 100%, particularly preferably 60 to 80%.

[0096] The length to diameter ratio of the gastric anchor may be 1:5 to 1:1, preferably 1:2 to 1:1, and particularly preferably 8: 11. In some embodiments, the length to diameter ratio may be 1:2.

[0097] The duodenal anchor may be an expandable or non-expandable duodenal anchor. The duodenal anchor may also include an expandable portion and a non-expandable portion.

[0098] Preferably, the central portion has a generally elongated shape and extends in a direction parallel to the longitudinal axis of the connector.

[0099] Preferably, the first plurality of limbs are configured to extend inside the duodenal anchor and may be cast into the duodenal anchor.

[0100] Preferably, the second plurality of limbs are configured to extend inside the gastric anchor and may be cast into the gastric anchor.

[0101] In a particularly preferred embodiment, at least one of the first and second pluralities of limbs of the connector is formed by rods, preferably exactly three rods.

[0102] Preferably, the rods of the first plurality of limbs extend through the central portion and connect to or form the second plurality of limbs.

[0103] Preferably, the first and / or second plurality of limbs are formed by 2 to 6 rods, more preferably 3 to 4 rods.

[0104] Preferably, the rods of the first and second pluralities of limbs have a tensile modulus of elasticity between 20% and 100%, more preferably between 60% and 80%.

[0105] In particularly preferred embodiments, at least one of the first plurality of free ends and the second plurality of free ends of the connector are disposed at a substantially constant angle and / or radial distance relative to the longitudinal axis.

[0106] The first and / or second pluralities of free ends may all terminate on an imaginary circle centered on and perpendicular to the longitudinal axis.

[0107] In particularly preferred embodiments, the connector central portion extends along the longitudinal axis over a length of 3 to 50 mm, preferably 20 to 30 mm. Generally, the length of the central portion will be at least the length of a typical pyloric sphincter, and preferably less than twice the length of a typical pyloric valve.

[0108] In a particularly preferred embodiment, the length of the first and / or second plurality of limbs of the connector is 10 to 50 mm, preferably 20 to 30 mm.

[0109] These lengths allow the connector to extend partially beyond the pyloric valve, thus reducing or avoiding abrasion of the anchor shaft against the pylorus.

[0110] In some embodiments, the distance between the first and second limbs in the direction along the longitudinal axis is set to 20 to 30 mm.

[0111] In particularly preferred embodiments, the first plurality of limbs and / or the second plurality of limbs and / or the central portion of the connector comprise or consist of a soft material.

[0112] A soft material is a material with low hardness and high flexibility. For example, silicone and / or polyurethane may be suitable materials. Preferably, the soft material has a tensile modulus of elasticity 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.

[0113] Particularly preferably, the first plurality of limbs and / or the second plurality of limbs and / or the central portion (which may mean the transpyloric soft portion) of the connector comprise or consist of an elastic wire that can be elastically stretched up to a tensile strain of 500-600% at break.

[0114] Due to cyclic loading on such assemblies (cyclic fatigue of the elastic wire), strains of up to 150-200% without failure are conceivable.

[0115] In a particularly preferred embodiment, the central portion of the connector is formed by a plurality of central extensions and circumferentially arranged tubular elements. The central portion may be formed by a plurality of central extensions and tubular elements (350) circumferentially arranged around the central extensions. The length of the tubular elements may be at least as long as their diameters. The tubular elements 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.

[0116] The length of the tubular element may be measured along a direction parallel to the longitudinal axis of the tubular element and may be the same length as the central portion. Preferably, the length of the tubular element is 3 to 50 mm, more preferably 5 to 30 mm, particularly preferably 5 to 15 mm, and even more preferably 6 to 8 mm.

[0117] Preferably, the wall thickness of the tubular element is between 0.2 and 4 mm, more preferably between 0.5 and 2 mm. Preferably, the tubing element comprises or consists of the same material as the first and / or second plurality of limbs and / or central portion of the connector. The tubing element may comprise or consist of medical grade silicone.

[0118] The plurality of central extensions may be 2 to 6 rods connected or connectable to the first and second plurality of limbs.

[0119] The plurality of central extensions may include a fewer number of central extensions than the first and / or second plurality of limbs comprising the limbs.

[0120] Each central extension of the plurality of central extensions may be connected or connectable to two or more limbs of the first plurality of limbs.

[0121] Each central extension of the plurality of central extensions may be connected or connectable to two or more limbs of the second plurality of limbs.

[0122] 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.

[0123] According to yet another aspect of the present invention, there is provided an implant system for implantation within a patient's gastric tract. The implant system includes a gastric anchor, preferably one of a stent and a balloon, adapted to be placed within the patient's stomach. The implant system further includes a duodenal anchor, preferably the aforementioned duodenal anchor. The implant system further includes a connector, preferably the aforementioned connector. The connector has first and second ends and a central portion. The connector is connected or connectable to the duodenal anchor at the first end and connected or connectable to the gastric anchor at the second end. The first and second ends of the connector are connected by the central portion. The connector is adapted to connect the gastric anchor and the duodenal anchor across the patient's pylorus when the system is implanted.

[0124] It will be appreciated that in some embodiments, it is contemplated that a non-expandable duodenal anchor may be used.

[0125] Preferably, the connector is adapted to connect the gastric anchor and the duodenal anchor. The connector may already connect the gastric anchor and the duodenal anchor before the system is implanted, or the connector may be connected during the surgical procedure, e.g., while in the patient.

[0126] The length of the duodenal anchor, along the direction of chyme passage through the duodenal anchor / system, can be 20-80 mm, preferably 30-50 mm, or 50-60 mm. The length can include an elongated element as part of the duodenal anchor and / or an implant body having an elongated element connected to the duodenal anchor.

[0127] The length of the gastric anchor, whether formed as a stent or a balloon, can range from 15 to 50 mm, preferably 30 to 50 mm, or 20 to 30 mm. The diameter of the gastric anchor can range from 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 can be 40 ml in some embodiments, or generally anywhere within the range of 50 to 80 ml, with 70 ml being particularly preferred.

[0128] The length of the connector adapted to extend across the pylorus may be 5 to 50 mm, preferably 20 to 30 mm.

[0129] 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 in shape. The implant body may be attached at its proximal end to the duodenal anchor. Preferably, the implant body comprises an elongate element extending away from the duodenal anchor.

[0130] The system can provide first and second passageways formed by the duodenal anchor and the gastric anchor separated by a connector, such that the connector does not substantially obstruct the passage of chyme, allowing chyme to pass through the gastric anchor, pass through the pylorus in a substantially natural manner, and enter the duodenal anchor.

[0131] In a preferred embodiment, the implant system further comprises a sleeve disposed about the tubular-shaped implant body, the sleeve attached to the proximal end of the implant body, the distal end of the sleeve configured to be placed within the small intestine.

[0132] According to yet another aspect of the present invention, there is provided a method of treating a patient comprising implanting the implant system disclosed above.

[0133] The method of treating a patient may include any one of the following: -Place a guidewire into the proximal duodenum through the endoscope working channel.

[0134] - A concentric delivery system loaded with the implant system disclosed above and terminating in an atraumatic ball at the distal tip of the delivery system is inserted over the indwelling guidewire.

[0135] - Push the delivery system with the portion having the loaded docking station through the patient's pharynx and esophagus until it reaches the stomach, so that the ball and a portion of the sleeve may be distal to the pylorus.

[0136] -Insertion of an endoscope into the stomach for imaging purposes. -Under the visual guidance of the endoscope, the docking station is advanced forward until the duodenal member passes through the pylorus.

[0137] -Push the sleeve distally through the inner catheter at the rear end of the delivery system until the sleeve is fully deployed within the small intestine.

[0138] -Release the distal atraumatic ball. - The catheter is withdrawn while pressurized fluid is injected through the sleeve via the inner catheter. The sleeve is fully patent, which may be confirmed by x-ray imaging.

[0139] -Release the crimp sleeve of the duodenal anchor and allow it to partially expand to the desired volume. - Unsheathing the gastric stent in the antrum (distal stomach) if the system includes a gastric anchor formed by a stent, or inflating the gastric anchor to its nominal volume if the gastric anchor is formed by a balloon.

[0140] -Anchor position and deployment are visually confirmed through the endoscope, and the balloon is then detached. -Retrieve the endoscope.

[0141] - Retrieve the delivery system. According to yet another aspect of the present invention, a method of treating a patient is disclosed. The method of treating a patient includes placing a duodenal anchor having a fillable portion, preferably the duodenal anchor described above, in the patient's duodenum. The method of treating a patient further includes 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 expanded. When fully expanded, the fillable portion can accommodate a volume of 10 ml to 60 ml, preferably 25 ml to 45 ml, and particularly preferably 34 ml.

[0142] In a preferred embodiment, the predetermined amount of fluid for the method of treating a patient is 5 to 10 ml. However, it will be understood that, depending on the size of the duodenal anchor used, any amount of fluid less than 50 ml, preferably less than 20 ml, and particularly preferably less than 10 ml, may be appropriate and may result in only partial distension. In some embodiments, 1 to 5 ml is used.

[0143] The duodenal anchor may be retrievable from the patient's duodenum after implantation. The retrievability of the duodenal anchor allows for the duodenal anchor to be removed from the patient's duodenum, for example, after successful treatment of the patient.

[0144] The duodenal anchor and / or gastric anchor may 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 placing a duodenal anchor, such as a duodenal anchor described herein, and / or an expandable gastric anchor in the patient's duodenum and / or gastric tract, respectively, wherein at least one of the duodenal anchor and gastric anchor comprises an expandable portion. The method further comprises inflating or deflating the expandable portion.

[0145] The implant system according to the present invention and / or any element thereof (e.g., gastric anchor, duodenal anchor, sleeve, connector) may be installed by an autonomous robot. To this end, the present invention further relates to a method of treating a patient, comprising installing an implant system, e.g., an implant system described herein, preferably a duodenal anchor, e.g., a duodenal anchor described herein, and / or a gastric anchor, in the patient's duodenum and / or gastric tract, respectively. The method comprises positioning the duodenal anchor and / or gastric anchor in the patient's duodenum by a robot, preferably the robot is at least partially autonomous. The robot may be adapted to inflate and / or deflate the gastric anchor and / or duodenal anchor. The robot may also install a sleeve attached to the duodenal anchor.

[0146] The implant system may include at least one sensor, particularly a biosensor, adapted to collect information, for example, about the content of nutrients (such as glucose and / or lipids) in the chyme passing through the implant system. Additionally or alternatively, the sensor may be adapted to sense the shape and / or size of any part of the implant system, for example, the duodenal anchor or gastric anchor, and, for example, to determine whether the implant system is correctly positioned at any time after implantation. Such information may be used within the duodenal anchor in closed-loop feedback and / or transmitted externally, for example, via wireless communication, for subsequent use by a caregiver. In particular, it may be possible to selectively change the size and shape of the duodenal anchor depending on the amount of nutrients measured in the stomach and / or intestine.

[0147] The present invention will now be described with reference to embodiments and drawings. [Brief explanation of the drawings]

[0148] [Figure 1]1 is a schematic diagram of a first embodiment of a duodenal anchor. [Figure 2] FIG. 1 is a schematic diagram of a second embodiment of a duodenal anchor. [Figure 3] FIG. 1 is a schematic diagram of one embodiment of the first embodiment of the duodenal anchor connected to an implant. [Figure 4] 1 is a schematic diagram of one embodiment of an implant. [Figure 5] FIG. 1 is a schematic diagram of one embodiment of a connector. [Figure 6] FIG. 10 is a schematic diagram of one embodiment of a connector connected to a duodenal anchor. [Figure 7] FIG. 1 is a schematic diagram of one embodiment of an implant system. [Figure 8] 10A-10C are views of another embodiment of an implant system. [Figure 9] FIG. 10 is a schematic diagram of another embodiment of an implant system. [Figure 10] FIG. 10 illustrates one embodiment of a duodenal anchor crimped with a release mechanism. [Figure 11] FIG. 1 illustrates an embodiment of a duodenal anchor in a contracted state. [Figure 12a] 10A-10C show different views of a third embodiment of an implant having a duodenal anchor. [Figure 12b] 10A-10C show different views of a third embodiment of an implant having a duodenal anchor. [Figure 12c] 10A-10C show different views of a third embodiment of an implant having a duodenal anchor. [Figure 13] FIG. 12b is a schematic cross-sectional view of the duodenal anchor of FIG. 12a. [Figure 14a] FIG. 14 is a schematic diagram of the actuation mechanism of the duodenal anchor of FIG. 13. [Figure 14b] FIG. 14 is a schematic diagram of the actuation mechanism of the duodenal anchor of FIG. 13. [Figure 15] FIG. 1 is a perspective view of an implant system having a pulling device. [Figure 16a] FIG. 16 is a schematic diagram of the actuation mechanism of the pulling device of FIG. 15. [Figure 16b] FIG. 16 is a schematic diagram of the actuation mechanism of the pulling device of FIG. 15. DETAILED DESCRIPTION OF THE INVENTION

[0149] FIG. 1 illustrates a first embodiment of a duodenal anchor 100. The duodenal anchor 100 includes an inner passage 20, indicated by two dotted lines, for transporting chyme. The inner passage 20 has a tubular shape and is centered on the longitudinal axis L of the duodenal anchor 100. An expandable portion 30 is disposed around the inner passage 20. The expandable portion 30 has a mechanically flexible outer wall 31 configured to conform to the inner wall of the patient's duodenum. The expandable portion 30 is connected to a valve mechanism 41. The duodenal anchor 100 has a proximal end 101 having a connecting element 82 adapted to connect to, for example, a connector and / or a gastric anchor (not shown). The duodenal anchor shown here is made of silicone.

[0150] FIG. 2 shows a further embodiment of duodenal anchor 100. Duodenal anchor 100 is similar to the embodiment shown in FIG. 1. For clarity, identical features will not be separately described here. Here, duodenal anchor 100 is made of polyurethane and further comprises elongated elements 70 having free ends 72 separated by gaps 71 between the free ends. Alternatively, duodenal anchor 100 may 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.

[0151] FIG. 3 shows a schematic diagram of an implant 200 connected to the duodenal anchor 100 shown in FIG. 1 . The implant 200 has a tubular-shaped implant body 210 having a proximal end 211 and a distal end 212. The proximal end 211 is attached to the duodenal anchor 100. A plurality of elongated elements 270 having free distal ends 272 extend in a direction substantially 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 is defined between the elongated elements 270 in a direction following 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 a patient's duodenum.

[0152] FIG. 4 schematically illustrates an implant 200 according to the present invention, substantially formed by an implant body 210. At the proximal end 211, the implant body is substantially formed as a tube with closed sides. From the proximal end 211, extending generally distally along the longitudinal axis L (from left to right as shown in FIG. 4), elongated elements 270 are formed, each having a free distal end 272 and separated by a gap 271 therebetween. The elongated elements 270 substantially form 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 outer dimension D of 5 cm in a direction perpendicular to the longitudinal axis L. Here, the elongated elements 270 have a closed surface and no holes or discontinuities. The elongated elements are substantially solid, integrally formed extensions.

[0153] It will be appreciated that the implant of FIG. 4 combined with the duodenal anchor of FIG. 1 may result in a device functionally similar to the integrally formed embodiment of FIG.

[0154] FIG. 5 shows a schematic diagram of one embodiment of a connector 300. The connector 300 has a central portion 310, a first plurality of limbs 320, and a second plurality of limbs 330. Preferably, the first plurality of limbs 320 and the second plurality of limbs 330 are formed by rods. The first and second plurality of limbs 320, 330 terminate in first and second free ends 321, 331, respectively. The first plurality of limbs 320 and the second plurality of limbs 330 are connected by a plurality of central extensions 340, which in this example are integrally formed and extend throughout the central portion 310. Tubular elements 350 are circumferentially disposed around the central extensions 340 within the central portion 310. The tubular elements 350 extend the entire length of the central portion 310, and this length is considered in a direction along the longitudinal axis L of the connector 300. Multiple central extensions 340 may additionally or alternatively be glued together at their centers.

[0155] 6 shows a schematic diagram of one embodiment of a connector 300 connected to a duodenal anchor 100. A view along the longitudinal axis of the connector is shown (see FIG. 5). A first plurality of limbs 320 of connector 300 extend from a central portion (not shown) surrounded by a tubular element 350. First limb free ends 321 are connected to duodenal anchor 100 at a circumferential position of inner passageway 20 at the proximal end of duodenal anchor 100. First plurality of limbs 320 are disposed at a substantially constant angle and radial distance relative to the longitudinal axis of the connector.

[0156] FIG. 7 shows a schematic diagram of one embodiment of an implant system 500. The implant system 500 includes a gastric anchor 400, a duodenal anchor 100 having an expandable portion 30 similar to that shown in FIG. 1, a connector 300 similar to that shown in FIG. 5, and an implant 200 similar to the implant shown in FIG. 4. The implant 200 includes an elongated element 70 having a free distal end 72. The elongated element 70 has a closed surface 73, i.e., the elongated element 70 is filled with a material. The implant 200 is connected to the distal end of the duodenal anchor 100. The distal end of the duodenal anchor is opposite the proximal end 101 of the duodenal anchor 100. The duodenal anchor 100 has an outer surface 10 configured to conform to the inner wall of the patient's duodenum. At the proximal end 101 of the duodenal anchor 100, a first plurality of limbs 320 of a connector 300 are connected to the duodenal anchor 100. From the proximal end 101 toward the central portion 310 of the duodenal anchor 100, the first plurality of limbs 320 are pulled together by a tubular element 350. The portion covered by the tubular element 350 has a length of 7 mm. A second plurality of limbs 330 of the connector 300 are connected to a gastric anchor 400. The gastric anchor 400 shown here is an inflatable balloon, but in some embodiments may be replaced by a stent.

[0157] Figure 8 shows a diagram of another embodiment of an implant system 500. A duodenal anchor 100 is connected via a connector 300 to a gastric anchor 400 formed by a stent. The rest of the system substantially corresponds to the embodiment shown in Figure 7, and for the sake of clarity, identical parts will not be described again.

[0158] FIG. 9 shows a schematic diagram of another embodiment of an implant system 500. The gastric anchor 400 is formed as a balloon and is connected via a connector 300 to a duodenal anchor 100 comprising an elongated element 70. The elongated element is disposed inside a sleeve 50. The gastric balloon 400 comprises a valve mechanism 40 for inflation. The duodenal anchor is inflatable by a separate valve mechanism (not shown, see FIGS. 2 and 3). Additionally or alternatively, the valve mechanism 40 may also be connected to an expandable portion of the duodenal anchor for expanding the expandable portion. 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 inside the sleeve 50 at the proximal end 51 of the sleeve 50.

[0159] 10 shows a duodenal anchor 100 according to the present invention in a crimped state. Duodenal anchor 100 is crimped by a release mechanism 60 comprising a silicone crimp membrane 61 and a release wire 62. Silicone crimp membrane 61 of release mechanism 60 is placed around duodenal anchor 100 and pulled together to apply a concentric force to duodenal anchor 100, and is held in this configuration by release wire 62. The release wire can be selectively released by the operator independent of inflation, such as to expand duodenal anchor 100.

[0160] Figure 11 shows the duodenal anchor 100 of Figure 10 after the release wire has been released and the silicone jacket has been removed (both not shown, see Figure 10). The expandable portion 30 of the duodenal anchor 100 is in a deflated state, i.e., there is little or no liquid and / or gas inside the expandable portion 30 of the duodenal anchor 100.

[0161] FIG. 12a shows an implant system 500 having a gastric anchor 400, a duodenal anchor 100, and a sleeve 50. A connector (see FIG. 12c) connects the gastric anchor and the duodenal anchor 100. The sleeve 50 and its connection to the duodenal anchor 100 are substantially as shown in FIGS. 7 and 9 and will not be described again for clarity. Here, the duodenal anchor 100 is formed by an inner passageway 20 having a wall 21 and an outer jacket 110 circumferentially disposed about the inner passageway 20. The positioning of the outer jacket 110 relative to the inner passageway 20 is described in more detail in FIGS. 12c and 13. As shown there, the extension 130 of the connector extends through an interior volume 120 formed between the outer jacket 110 and the inner wall 21. When implanted, the gastric anchor 400, substantially in the configuration shown, is positioned within a patient's stomach and allows passage of chyme. Duodenal anchor 100 may be positioned within the patient's duodenum and receive chyme, which passes through gastric anchor 400 and the patient's pylorus and then exits implant assembly 500 via sleeve 50. Chyme generally passes through implant assembly 500 along longitudinal axis L. Here, outer jacket 110 is not connected to wall 21 at its distal end, thus forming gap 102 and allowing jacket 110 to slide along outer wall 21. Two radiopaque markers 55 are disposed on the distal end of sleeve 50 to facilitate placement and / or confirmation of implant positioning.

[0162] Figure 12b shows a perspective view of duodenal anchor 100 in a direction parallel to longitudinal axis L (see Figure 12a) and 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 disposed on the outer surface of jacket 110, providing attachment with a larger diameter than the hole through which connector extension 130 passes. Extension 130 is a resilient wire made of silicone.

[0163] FIG. 12c shows a cross-sectional view of the implant assembly 500 of FIG. 12a along plane A of FIG. 12b. The gastric anchor 400 is an inflatable anchor that can be filled 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 and into the inner wall of the gastric anchor. The connector 300 is substantially identical, for example, as shown in FIGS. 7 and 8, and is formed by extensions 131, 130 that extend through the gastric anchor 400 and the duodenal anchor 100 and are joined in a single strand at their midsections. The sleeve 50 attached to the duodenal anchor 100 substantially corresponds to the configuration shown in FIG. 9, for example. To this end, the duodenal anchor 100 comprises a so-called castle-like structure having elongated portions 70 formed in the wall 21 of the inner tube 20 and a gap 71 between them. The duodenal anchor further comprises an outer jacket 110, which is generally adhered to the wall 21 at a proximal anchor point 101 located on the proximal side 111 of the duodenal anchor 100 to form a fluid-tight seal. The outer jacket 110 has a thickness of 0.6 mm. A connector extension 130 passes through the outer jacket 110 through a pass-through hole near the anchor point 101, generally on the proximal side of the duodenal anchor. The extension 130 is slidably disposed within the pass-through hole 104, where it is substantially fluid-tight, although it will be understood that passage of fluid through the passage may be acceptable. At the distal side 112 of the duodenal anchor 100, the extension 130 passes through a second distal pass-through hole in the outer jacket 110 and is retained by a distal bulb 132 of the extension 130. Additionally or alternatively, an adhesive may be used to secure the extension 130 to the outer jacket 110. Outer jacket 110 is not fixed to wall 21 at distal side 112, thus forming gap 102, which extends around wall 21 and allows outer jacket 110 to slide along wall 21. As a result, outer jacket 110 can move proximally, reducing interior volume 120, as shown in more detail in FIG. 14b.

[0164] FIG. 13 schematically illustrates the configuration of the outer jacket 110 and inner tube 20 of the duodenal anchor 100 of FIGS. 12a-12c. The connector 300 and inner tube 20 correspond to the previous embodiment and will not be described again for clarity. Here, the outer jacket 110, which forms the interior volume 120 with the wall 21 of the inner tube 20, is attached to the wall 21 at a proximal location via a first adhesive layer 101. It will be understood that adhesive layer 101, seen here 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. The extensions 130 of the anchor 300 extend through the interior volume 120. Here, two extensions 130 are visible according to plane A in FIG. 12b, but it will be understood that in this embodiment there are three extensions 130, equally angularly spaced about the longitudinal axis of the duodenal anchor 100. Extension 130 passes through hole 104 in outer jacket 110 proximally and is slidably disposed therein. Extension 130 passes through outer jacket 110 distal to duodenal anchor 100, where bulb 132 is attached to the outer surface of outer jacket 110 via second adhesive layer 103. At the distal end of outer jacket 110, generally in the region of extension 130's attachment to outer jacket 110, outer jacket 110 is not attached to wall 21 of inner tube 20, forming gap 102. Gap 102, which extends around inner tube 20, allows outer jacket 110 to slide proximally when a pulling force is applied to the extension. Due to attachment 101, the proximal end of outer jacket 110 is fixed to inner tube 20 and does not move relative to wall 21 when extension 130 is pulled back and the distal end of jacket 110 is moved proximally.

[0165] Figure 14a shows a schematic diagram of a duodenal anchor 100 in an expanded configuration, similar to the duodenal anchor of Figure 13. Here, extension 130 is attached to outer jacket 110 only via bulb 132, with no additional adhesive on the distal side (see Figure 13). The proximal end is attached to wall 21 via adhesive layer 101. Gap 102 allows outer jacket 110 to slide over wall 21 of tube 20. Extension 130 extends through opening 104 on the proximal side of outer jacket 110.

[0166] FIG. 14b shows the duodenal anchor 100 of FIG. 14b when the extension 130 is retracted. As described above, the gap 102 allows the distal end of the outer jacket 110 to slide to move along the wall 21 while the adhesive layer 101 secures the proximal end on the wall 21. Thus, the outer jacket 110 is retracted, forming a folded, bellows-like structure as the extension 130 is retracted through the opening 104 in the outer jacket 110. The filler liquid (not shown) may escape through the gap 102. Due to the bellows-like structure, increased fixation in the duodenum may be achieved.

[0167] FIG. 15 illustrates an embodiment of an implant system 500 similar to the previously illustrated embodiments. The gastric anchor 400, duodenal anchor, connector 300, and sleeve 50 are substantially identical to the embodiment of FIG. 12c, although it will be understood that any of these elements may be identical to any of the previously described configurations. Notably, the duodenal anchor 100 need not have any gaps and thus corresponds, for example, to the embodiment of FIG. 9. Here, the ring 170 is attached to the outer jacket 110 via three rods 160. The rods 160 may be made of the same material and thickness as the extensions 130 of the connector 300. The rods are attached to the outer jacket 110 via holes fitted with balls 161 located on the inner surface of the outer jacket 110 between the ends of the extensions 130. It will be understood that the rods 160 may be attached by any means known in the art, generally at any location distal to the outer jacket 110. It is also contemplated that the extension 130 may extend beyond the end of the outer jacket 110 such that the rod 160 is integrally formed and connected to the ring 170 .

[0168] 16a and 16b show the function of the ring 170 in a schematic manner. FIG. 16a shows the implant system 500 of FIG. 15 when implanted in an expanded configuration corresponding to the configuration of FIG. 14a.

[0169] FIG. 16b shows the implant system 500 of FIG. 15 when implanted in a collapsed configuration corresponding to the configuration of FIG. 14b. The intestine I undergoes natural peristaltic movements, symbolically indicated by arrow PM, which interact with and apply a tensile force to the ring 170. The ring 170 is generally larger than the sleeve 50 so that it surrounds the sleeve 50. As a result, the ring 170 pulls back on the outer jacket 110 via the rod 160 having the bulb 161. The ring 170 and the rod 160 thus function as a tensioning device. While a tensioning force acting on the duodenal anchor may generally be desirable in certain circumstances, as discussed above, providing this type of tensioning device is particularly advantageous when the outer jacket 110 is not attached to its distal end and therefore collapses when a tensile force is applied to the extension 130. The tensioning device can act as a counterforce that reopens and / or dampens the collapse of the outer jacket 110, thereby providing a better fit of the duodenal anchor 100 to the patient's intestine. Rod 160 is formed by an inelastic wire core surrounded by medical-grade silicone. Thus, rod 160 is atraumatic and biocompatible while adapting to transmit tensile forces. Additionally, the increased rigidity provided by the inelastic core wire may prevent bending, rotation, and / or inversion of ring 170. Rod 160 has a length adapted to allow ring 170 to be positioned distal to duodenal anchor 100 even when jacket 110 is fully collapsed.

Claims

1. 1. A duodenal anchor (100) for holding an implant in place within a patient's duodenum, the duodenal anchor having an outer surface (10, 31) configured to conform to the inner wall of the patient's duodenum, the duodenal anchor (100) comprising: an inner, preferably central, passage (20) for conveying the chyme; a fillable portion (30) arranged at least partially circumferentially relative to said inner passage (20), A duodenal anchor characterized in that the fillable portion (30) has a circumference greater than the inner circumference of the duodenum when completely filled with fluid.

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

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

4. 10. The duodenal anchor (100) of any one 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 the second end (112) of the outer jacket (110).

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

6. 10. The duodenal anchor (100) of claim 1, wherein the duodenal anchor (100) has a cylindrical shape over at least a portion of its length, preferably over more than 40% of its length, in a direction substantially 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. 10. The duodenal anchor (100) of any one of the preceding claims, wherein the duodenal anchor (100) is attached to a proximal end (51) of a sleeve (50), the sleeve having a distal end (52) for placement in the small intestine.

9. 10. The duodenal anchor (100) of any one of the preceding claims, wherein the inner passage (20) is substantially tubular in shape.

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

11. 10. The duodenal anchor (100) of 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 membrane (61) and a release wire (62), particularly preferably a silicone crimping membrane, to reduce the radial size of the duodenal anchor (100) for delivery.

12. 10. The duodenal anchor (100) of claim 1, wherein the duodenal anchor (100) comprises an elongate element (70, 270) having a free distal end (72, 272) extending in a direction substantially parallel to the longitudinal axis (L) of the duodenal anchor (100).

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

14. 1. An implant (200) for placement in a patient's duodenum, the implant (200) having a generally tubular-shaped implant body (210) having a proximal end (211) and a distal end (212), the proximal end (211) being fixable to or fixed to a duodenal anchor, preferably the duodenal anchor (100) of any one of the preceding claims, the implant body (210) comprising a plurality of elongated elements (220) having free distal ends (272) extending in a direction substantially parallel to a longitudinal axis (L) of the implant body (210), the free ends (72, 272) of the elongated elements (70, 270) forming the distal-most portion of the implant body (210).

15. 15. The implant (200) of claim 14, further comprising a sleeve (50) disposed around the tubular implant body (210) and attached to the proximal end (211) of the implant body (210), the distal end (52) of the sleeve (50) being configured to be placed in the small intestine.

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

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

18. An implant (200) according to any one of claims 14 to 17, wherein the implant (200) has an outer dimension (D) perpendicular to the longitudinal axis (L) of 1 to 10 cm.

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

20. An implant (200) according to any one of claims 14 to 19, wherein at least one circumferential space (271) between said elongate elements (70, 270) has a width corresponding to a width of said elongate elements (70, 270).

21. An implant (200) according to any one of claims 14 to 20, wherein said elongate element (70, 270) is impermeable to liquids and gases.

22. An implant (200) according to any one of claims 14 to 21, wherein the generally tubular shaped implant body (210) has a wall without any openings.

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

24. 24. The connector (300) of claim 23, wherein at least one of the first and second pluralities of limbs (320, 330) is formed by rods, preferably exactly three rods.

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

26. A connector (300) according to any one of claims 23 to 25, wherein the central portion (310) extends over a length in the direction along the longitudinal axis (L) of 3 to 50 mm, preferably 20 to 30 mm.

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

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

29. 29. The connector (300) of 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) preferably arranged circumferentially around the central extensions so as to bring the central extensions (340) into physical contact with one another.

30. An implant system (500) for implantation within a patient's gastric canal, comprising: a gastric anchor (400), preferably one of a stent and a balloon, adapted for placement within 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), a second end (370) and a central portion (310); the connector (300) is attached at a first end (360) to the duodenal anchor (100) and connected at a second end (370) to the gastric anchor; Further, the first end (360) and the second end (370) of the connector (300) are connected by a central portion (310) adapted to be placed across the patient's pylorus to connect the gastric anchor (400) and the duodenal anchor (100) when the system (500) is implanted.

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

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

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

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

35. 35. The method of treating a patient according to claim 34, wherein said predetermined volume is between 5 and 10 ml.

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