Device for treating obesity or diabetes in a patient and method for selecting such a device

Abstract

A device (10) for the treatment of obesity or diabetes includes a duodenal conduit (12) and a first anchor (14) positioned a predetermined distance (D) from a proximal end (15) of the duodenal conduit (12). The first anchor (14) is configured to secure the conduit (12) distal to the pylorus (P) without mucosal involvement. A second anchor (17) in the form of a conical inflatable balloon is used to secure the device (10) within the patient's stomach (S). The duodenal conduit (12) is flexible and positionable in the patient's duodenum (D) and jejunum (J).

Description

[Technical Field]

[0001] The present invention relates to devices for the treatment of obesity or diabetes in a patient, and methods for selecting such devices. [Background technology]

[0002] It is known in the prior art to use implantable devices that bypass a length of the duodenum for the treatment of obesity. Typically, such devices are deliverable in a minimally invasive manner and are fixed in one or more locations.

[0003] U.S. Patent Application Publication No. 2018 / 0214293 discloses anchoring a device to the pylorus using a stent or by using an inflatable balloon. Similar anchoring is disclosed in U.S. Patent No. 9,421,116.

[0004] WO 2014 / 195954 discloses a device having several anchors. First and second anchors comprise stents and are pressed against the wall of a portion of the duodenum. An additional intragastric anchor is disclosed that is placed inside the patient's stomach. WO 2012 / 087669 also discloses an intragastric anchor.

[0005] US Patent Application Publication No. 2005 / 273060 discloses anchoring the device to the pylorus with a balloon which also reduces the volume of the stomach.

[0006] U.S. Patent No. 5,820,584 also discloses fixation of a device on both sides of the pylorus. Fixation of a device for the treatment of obesity and diabetes to the pylorus with an inflatable anchor is also disclosed in U.S. Patent Application Publication No. 2011 / 0004320.

[0007] U.S. Patent Application Publication No. 2017 / 312112 discloses a transpylorus device for receiving chyme from the stomach and directing the chyme through a patient's duodenum in a bypass-like manner, the device being held in place by a balloon segment disposed on a transpylorus guide element.

[0008] All prior art devices suffer from certain drawbacks, in particular they can be difficult to deploy and / or anchor, can result in undesirable mucosal engagement, and can provide unreliable anchoring. Summary of the Invention [Problem to be solved by the invention]

[0009] It is an object of the present invention to provide a device for the treatment of obesity or diabetes that overcomes the drawbacks of the prior art and that is, in particular, easy to manufacture, easy to deploy, provides reliable fixation, and does not have negative side effects due to, among other things, engagement with the mucosa.A further object of the present invention is to provide a method that allows for improved treatment of patients. [Means for solving the problem]

[0010] According to the present invention, these and other objects are solved by the devices and methods set forth in the independent claims.

[0011] According to the present invention, a device for treating obesity or diabetes is provided. Typically, the same principle of the device can be used for both obesity and diabetes, with some minor modifications. The device includes a duodenal tube. The tube is configured to be placed in a patient's duodenum, optionally in the jejunum or ileum. A first anchor is placed a predetermined distance from the proximal end of the duodenal tube. This first anchor is preferably configured to secure the tube distal to the pylorus without substantial mucosal involvement, particularly without penetrating the mucosa. In this context, "without substantial mucosal involvement" means that, even if the first anchor may occasionally or temporarily contact the mucosa, the fixation of the device is not based on, for example, contacting, engaging, or penetrating the mucosa by the anchor. More specifically, the anchor is shaped and / or configured in a manner that does not continuously and strongly contact the mucosa. By providing such an anchor, mucosal irritation can be avoided. Typically, the first anchor is designed to provide a certain weight that results in positioning and fixation due to peristaltic action. Because fixation is not by frictional engagement, the size and shape of the first anchor can be selected to avoid mucosal engagement. Additionally or alternatively, another way to avoid substantial mucosal involvement is to provide a cushioning material, such as a flexible covering, around at least a portion of the anchor. In use, the cushioning material, if used, can separate the anchor from direct contact, engagement, or penetration of the mucosa. The cushioning material can provide a tissue-facing surface that is smoother or more atraumatic than the surface of the anchor alone. The cushioning material can be, for example, a different material from the first anchor. Additionally or alternatively, the cushioning material can be, or include, for example, one or more of polyurethane, silicone, pericardial tissue or other biomaterials, Dacron, polytetrafluoroethylene, etc.

[0012] In a preferred embodiment, the first anchor may comprise or be formed of an expandable structure. Typically, self-expanding structures for providing stents are known in the art. The self-expanding structure may be fabricated from a metal, preferably a shape-memory metal such as Nitinol. Shape-memory plastics may also be used. The self-expanding structure may preferably be braided. Other embodiments are also contemplated, such as those using a self-expanding structure cut from a tube. It is also possible to use a balloon-expandable structure, or a structure that is self-expandable to some extent but requires balloon support for full expansion. Other biocompatible materials, such as other metals, alloys, or biocompatible plastic materials, are also possible. In some embodiments, the expandable structure (e.g., the self-expanding structure) is tubular and / or elongated in the axial direction of the duodenal tract.

[0013] The expandable structure can be covered by one or more layers of covering material, particularly a polymer layer including or made of Dacron, or a biological layer such as pericardial tissue. The layer can be a foil of plastic material or a woven or knitted structure of polymer filaments. The covering material can act as a buffer between the expandable structure and the mucosa to avoid substantial mucosal involvement between the anchor and the tissue, regardless of the shape of the expandable structure.

[0014] The first anchor, particularly the first expandable structure, may be retrievable and repositionable. A retrievable structure can be returned to a narrower, typically initial, configuration, allowing the structure and the entire device to be removed from the patient's body. This allows for easy removal of the device, for example, in the event of an unexpected side effect. Furthermore, the structure, and therefore the device, may be repositionable, i.e., reduced in size to allow displacement of the device at the application site, and then expanded again to anchor at another site.

[0015] Any mechanism for forcing the structure and device into a narrower configuration may be possible, such as an internal engagement member that allows engagement with an internal tool for crimping from the inside. When the structure is expanded against a radial force, e.g., elastic deformation, the expanded structure can collapse by defeating a supporting structure, such as an inflated balloon. It is also contemplated that thermal or chemical mechanisms may be used to return the structure to a narrower configuration.

[0016] Additionally or alternatively, the duodenal tract may be secured by a patch that can be attached to the mucosa and connected to the duodenal tract by a connector, such as a thread, fiber, or wire. The patch preferably comprises a biocompatible adhesive. Alternatively or additionally, it may be configured to promote cellular biocolonization. Furthermore, the patch may be biodegradable. Such a patch can help further secure the device without having any traumatic effect on the mucosa.

[0017] The layers and / or patches may be configured to avoid endothelialization. According to a particularly preferred embodiment of the present invention, the duodenal tract can include a second anchor disposed at the proximal end, the second anchor configured to be disposed proximal to the pylorus to secure the device within the stomach. Optionally, the size and / or shape and / or configuration of this second anchor can be selected to avoid mucosal engagement.

[0018] The second anchor may be formed as or comprise a balloon (e.g., an inflatable balloon) configured to be placed within the patient's stomach to reduce the working volume of the stomach. The balloon may be shaped and / or sized and / or configured to avoid intimate contact with the inner wall of the stomach when properly inflated.

[0019] As used herein, the term "balloon" is intended to encompass any flexible sac or pouch capable of leak-tightly containing a volume of fluid, such as a gas (e.g., air or nitrogen) or a liquid (e.g., saline). Terms such as "inflatable" refer to a balloon that can be at least partially filled with a fluid to at least partially inflate the balloon, whether the balloon is completely filled to capacity or only partially filled. In some embodiments, only partially filling (or partially inflating) the balloon can be a way of configuring the balloon to avoid substantial mucosal involvement. A partially filled balloon is more flexible and can better conform to the stomach wall when subjected to gastric muscle contractions than a balloon that is fully inflated by being filled (or inflated) to capacity.

[0020] In the first variant, the balloon can have an annular shape that surrounds the duodenal tract, which allows for uniform fixation. Furthermore, a regular annular shape that completely surrounds the duodenal tract can result in a regular closure pattern of the passage into the duodenum.

[0021] In a first variant, the balloon can have a crown shape when inflated. In a particularly preferred variant, the balloon may have the shape of a toroid.

[0022] According to another variant, the balloon, in its inflated state, can have a specific shape and size in the region adjacent to the connection to the duodenal tract, and the inflated balloon can have, for example, a conical outer diameter or a concave outer profile in a cross section through a plane passing through the axis of the device. The balloon can also have a tulip shape. These shapes combine secure fixation with avoidance of distal migration of the device, but do not require continuous engagement of the anchor with the tissue, in particular with the mucosa.

[0023] According to another variation, the second anchor can include one or more balloons defining multiple chambers or bodies. The bodies 60 can be independently inflatable or interconnected to communicate with each other. The bodies can optionally be defined by multiple individual balloons and / or by at least a first balloon being divided into multiple bodies or compartments. The bodies can have one or more shapes selected from spherical, teardrop, and / or any other desired shape. For example, the bodies can be tulip-shaped, but nestled together to cooperatively define a large bulb with a grooved or lobed profile that reduces the tissue-contacting end compared to a single, smooth, bulbous body. Additionally, the space between and around adjacent bodies helps maintain an open natural passageway to allow chyme to enter the duodenal tract and avoid chyme trapping outside the duodenal tract in the cavity.

[0024] By using a conical, concave, or tulip shape, and / or one or more balloons defining multiple bodies, the device can be positioned closer to the pylorus without risk of contacting tissue.

[0025] Typically, the balloon and / or the entire body, if used, may be configured to inflate to a volume of between 200ml and 800ml, more preferably between 300ml and 450ml.

[0026] It will be appreciated that such types of second anchors are particularly preferred in combination with devices having first anchors as described hereinabove, although those skilled in the art will appreciate that such second anchors may be used without such first anchors or in conjunction with first anchors of other configurations.

[0027] Additionally or alternatively, the second anchor may comprise a second expandable structure, particularly a self-expanding structure. Such a device may be particularly suitable for treating diabetes, particularly by reducing sugar and lipid absorption.

[0028] The second anchor can have at least a partial hourglass shape, preferably in cooperation with the first anchor, such that there is an hourglass shape for fixation on either side of the pylorus. The hourglass shape can be symmetrical or asymmetrical, for example, with respect to the shape on either side of the pylorus and / or with respect to the shape about the longitudinal axis of the tube.

[0029] This expandable structure can also be made of metal, preferably a shape-memory metal such as Nitinol. The second expandable structure can also be braided or laser cut from a metal tube. The second expandable structure can also include one or more layers, particularly Dacron, or can be covered by a polymer layer made of Dacron or a biological layer such as pericardial tissue. The layer can be a foil of a plastic material or a woven or knitted structure of polymer filaments. The layer can act as a buffer to prevent substantial mucosal involvement between the expandable structure and the stomach tissue.

[0030] The self-expanding structure of the second anchor can include at least a tubular portion. In some embodiments, the self-expanding structure flares outward in a direction away from the distal end of the duodenal tract. The flared shape can be, for example, conical or at least partially curved (e.g., curved). The flared shape can resemble, for example, a tulip, an umbrella, a saucer, or the mouth of a trumpet. The flared portion can include, for example, multiple arms or ribs extending from a hub. Alternatively, the flared shape can include a lattice structure or braid.

[0031] In some embodiments, the second anchor can include both a self-expanding structure and at least one balloon. The self-expanding structure can optionally be attached to the balloon. The self-expanding structure can be disposed on the outside of the balloon, within a fluid chamber of the balloon, within an open space around which the balloon is disposed, or within the wall of the balloon. The self-expanding structure can extend circumferentially around a portion of the duodenal tract adjacent to or located at the proximal end of the duodenal tract.

[0032] The self-expanding structure can help to keep the passageway within the duodenal tract and / or balloon open for gastric emptying and resist the tendency of the tract or passageway to permanently collapse or narrow under the inflation pressure exerted by the surrounding balloon. Furthermore, the self-expanding structure can temporarily deform in response to the contractile forces of the stomach, but return to its expanded state when the gastric contractions relax. Additionally or alternatively, the self-expanding structure can function to bias the balloon toward a predetermined expanded shape before and / or after inflation of the balloon.

[0033] The self-expanding structure and the balloon can generally be coextensive in at least one axial direction relative to the axis of the duodenal tract, and optionally in both axial directions. Additionally or alternatively, one of the self-expanding structure and the balloon can extend proximally of the other or extend proximally beyond the other. For example, the balloon can extend proximally beyond the end of the self-expanding structure and / or extend proximally beyond the proximal end of the duodenal tract.

[0034] Optionally, only one of the two anchors includes both a self-expanding structure and a balloon, which can reduce the amount of material that needs to be folded and / or folded into a compressed state for deployment. The other anchor can optionally include only an expandable structure (e.g., a self-expanding structure) or only a balloon.

[0035] For example, in some embodiments, only the second anchor comprises a combination of a self-expanding structure and a balloon. There is more space for such anchors in the stomach than in the duodenum. Furthermore, the need for fluid inflation would make the delivery system more complex, for example, with fluid inflation conduits and removable connections, so including these features only on the stomach side avoids overly complicating the delivery system, especially in the duodenal region where space is scarce. It also simplifies the procedure for introducing and placing a duodenal tube into a patient.

[0036] In a manner similar to that described in the context of the first anchor, the second anchor may also be retrievable and / or repositionable.

[0037] The second anchor may also comprise a patch similar to the patch described above in the context of the first anchor.

[0038] According to a preferred embodiment of the present invention, the device may include at least one element on the duodenal tract in addition to the anchor. Such an element may have several purposes. If it is made of a metal or other radiopaque material, it may be used for imaging, for example, to provide higher contrast in X-ray imaging or CT scans. If it is made of a metal or other material with a high specific gravity, it may also be used to further secure the device due to its weight.

[0039] In one embodiment, at least one element can be made of metal and configured as a ring attached to the surface of the duodenal tract. Typically, the ring can be attached to the distal end of the duodenal tract. Additionally or alternatively, the ring can be attached to a region of the duodenal tract away from the distal end. Typically, the ring can be positioned 8 to 12 cm from the distal end of the duodenal tract.

[0040] Additionally or alternatively, the duodenal tube can include reinforcement in at least one localized region to resist the tendency of the duodenal tube to kink. Twisting of the tube can narrow the tube and, in severe cases, cause kinks that could completely block the tube from passing any stomach contents through the twisted region. In one variation, reinforcement of the duodenal tube can be provided between the first and second anchors. The reinforcement can include, for example, intraluminal or epiluminal structures, struts, or filaments that optionally extend from one or both anchors. Additionally or alternatively, reinforcement can be provided in a portion of the tube distal to the first anchor. The reinforcement can also optionally include intraluminal or epiluminal structures, struts, or filaments that extend helically along the axis of the tube. In either case, some of the structures, struts, or filaments can extend in an at least partially axial direction to support the tube against kinking. The structures, struts, or filaments may be made of metal, for example, nitinol or stainless steel, or may be made of plastic, such as PET or polyurethane or polytetrafluoroethylene.

[0041] According to yet another embodiment of the present invention, the duodenal tube may be configured to be shortened to accommodate at least one patient characteristic. For this purpose, the tube may be provided with markings indicating a specific length and / or a weakened zone to facilitate shortening. Depending on the specific characteristics of the patient to be treated, a shorter or longer tube may be selected for implantation. The characteristic may typically be abdominal fat panicle thickness, peri-abdominal fat mass, visceral fat mass, or fat inside and / or outside the abdominal cavity. Computed tomography may be used for non-invasive, objective, and easily repeatable assessment. Other characteristics may be body surface area, body mass index, or abdominal circumference. Providing such adaptations allows for optimal treatment. In particular, the magnitude of the bypass effect may be individually selected.

[0042] According to another preferred embodiment of the present invention, the device may be activatable in response to contact with stomach and / or intestinal contents. To this end, at least one of the duodenal tract, the first anchor, and the second anchor may be activated, e.g., expanded, when contacted with body fluids or nutrients. In particular, the duodenal tract may expand in response to contact with stomach or intestinal contents. Thus, in particular, the device may expand only when necessary, i.e., when the stomach or intestines are full.

[0043] Typically, the first anchor has an axial length of 1 to 10 cm, optionally 1 to 3 cm. Typically, the second anchor has an axial length of 2 to 10 cm.

[0044] The duodenal tube can have a length in the range of 300 to 800 mm, preferably 400 to 700 mm, and a diameter in the range of 20 to 35 mm. In a particularly preferred embodiment, the tube has a length of about 600 mm and a diameter of about 28 mm.

[0045] Preferably, the duodenal tube is made of a material that prevents contact between nutrients traveling through the tube and the duodenal wall. Typically, the duodenal tube can be made of polyurethane. Any other material with a suitable anti-migration effect for nutrients can be used. Furthermore, it is possible to select a duodenal tube material that is reactive to the contents of the stomach or intestine, and in particular, the duodenal tube material can have a permeability to certain nutrients that may be lower the higher the nutrient content. It is also possible to select a material that selectively reduces the retention or absorption of certain components in the duodenum. For example, the material can be selectively permeable to fat, protein, or sugar, depending on the desired treatment.

[0046] According to another preferred embodiment, the duodenal tract can include sensors and / or actors (e.g., actuators) for actively changing the structure and / or shape and / or size of the duodenal tract in response to changing conditions. In particular, there can be actors on the device that change the shape of the tract in response to the amount or type of body fluid measured by the sensors. To this end, the device can include electronics for processing the signals provided by the sensors and controlling actuators, e.g., voltages that affect the structure of the material of the duodenal tract, or drive members for changing the shape or size, such as piezoelectric elements.

[0047] Another aspect of the present invention provides a device (e.g., a duodenal tract optionally having any of the features described above) for placement in a patient's gastrointestinal tract for the treatment of obesity or diabetes, the device having one or more sensors, e.g., one or more biosensors, that provide information regarding, for example, nutrient content, or the state, shape, or size of the device. Such information may be used within the device in closed-loop feedback and / or transmitted externally, e.g., via wireless communication, for later use by a caregiver. In particular, it is contemplated that the size and shape of the device may be selectively altered in response to the amount of nutrient measured in the stomach and / or intestine. In particular, the volume occupied by the device and / or the surface of the stomach and / or intestine covered by the device may be increased when the amount of nutrient is high.

[0048] In some embodiments, the sensor may be a pressure sensor for measuring inflation pressure within the balloon. The balloon may be, for example, a balloon of one or both of the anchors of the duodenal tract as described above. Additionally or alternatively, the balloon may be a balloon placed within the stomach. The measured pressure may be transmitted externally to an external monitor or display (e.g., a wrist-worn or handheld portable electronic device).

[0049] Transmission of data between the device and an external monitor can be via any wired or wireless communication path, such as near-field wireless communication technology that also allows power to be transmitted to the sensor via inductive or radio frequency communication coupling.

[0050] It will be understood that certain adaptive or selective materials or features or sensors for a device, particularly a duodenal tract, are particularly advantageous in the context of a device having an anchor as described hereinabove, although it will be understood that such materials or features can be used in the context of any other implantable device for the treatment of obesity or diabetes that can be placed in the gastrointestinal tract. The device may optionally be configured to be placed in the stomach and / or can have a duodenal tract configured to be placed in the duodenum, and optionally the jejunum or ileum, of a patient.

[0051] Another aspect of the invention relates to a method for selecting a device for the treatment of obesity or diabetes in a patient, in particular the method being used to select a device as described herein above.

[0052] In a first step, at least one characteristic of the patient is determined. This characteristic may be the thickness of the abdominal fat panicle, the amount of fat around the abdominal cavity, the amount of visceral fat, or the amount of fat inside and / or outside the abdominal cavity. The characteristic may be the body surface area, the body mass index, or the abdominal circumference measured at the navel with the patient in an upright position. Furthermore, the characteristic may be the gastric elasticity, the gastric elasticity index, or a test to assess the absorption of nutrients, thereby taking into account, for example, the patient's specific absorption of fat. Of course, it is also possible to use several of these characteristics in combination with each other.

[0053] An appropriate length of the duodenal tract is then determined based on the selected one or more characteristics.

[0054] In a final step, a device is provided with a duodenal tube having a predetermined length. This can be done by shortening the duodenal tube to the predetermined length or by selecting a device having a duodenal tube with the predetermined length. Such selection can be done by selecting a device from a set of devices with different lengths or by individually manufacturing a device with the selected length.

[0055] Alternatively, or in addition to determining the length of the duodenal tract, the fill volume of the intragastric anchoring balloon can be determined based on one or more of the determined characteristics.

[0056] According to a preferred embodiment of the present invention, the fat inside and / or outside the abdominal cavity can be determined by computer cross-sectional densitometry.

[0057] This method provides an individualized and optimized device for specific treatment for each individual patient.

[0058] Additionally or alternatively to any of the above, one aspect of the present invention provides a device for treating obesity or diabetes. The device includes a duodenal tube. The tube is configured to be placed in a patient's duodenum, optionally in the jejunum or ileum. A first anchor is placed on the duodenal tube, optionally a predetermined distance from the proximal end of the duodenal tube. The first anchor is configured to secure the tube distal to the pylorus (e.g., without substantial mucosal involvement). A second anchor is placed at and / or coupled to the proximal end of the tube (e.g., without substantial mucosal involvement). Each of the first and second anchors can include a self-expanding structure, e.g., made of a shape-memory material, optionally a shape-memory metal, optionally Nitinol. One of the first and second anchors, optionally only the second anchor, further includes a balloon, e.g., an inflatable balloon.

[0059] The present invention will now be described with reference to specific embodiments and the accompanying drawings. [Brief explanation of the drawings]

[0060] [Figure 1] 1 shows a schematic diagram of a first embodiment of the present invention; [Figure 2] 2 shows a schematic diagram of a second embodiment of the present invention; [Figure 3] 1 shows a diagram of a third embodiment of the present invention. [Figure 4] 4 shows the device according to FIG. 3 deployed within a patient's body. [Figure 5] 1 shows a schematic diagram of a fourth embodiment of the present invention. [Figure 6] 6 shows the device of FIG. 5 deployed in a patient. [Figure 7] 1 shows a flow chart illustrating the steps of a method according to the invention; [Figure 8] 10 shows a schematic diagram of a fifth embodiment of the present invention. [Figure 9] CT images for the evaluation of abdominal fat are shown. [Figure 10] 10 shows a schematic diagram of a sixth embodiment of the present invention, mainly showing the anchor in situ. [Figure 11] 10 shows a schematic diagram of a seventh embodiment of the present invention, mainly showing the anchor in situ. [Figure 12] 13 shows a schematic view of an eighth embodiment of the present invention in situ. [Figure 13] FIG. 13 shows a schematic view of a ninth embodiment of the present invention in situ. [Figure 14] 13 shows a schematic view of a tenth embodiment of the present invention in situ. [Figure 15] 15 shows a schematic perspective view of the device of FIG. 14 in isolation. [Figure 16A] 1 shows a schematic diagram of a technique for deploying a device in the gastrointestinal tract of a patient. [Figure 16B] 1 shows a schematic diagram of a technique for deploying a device in the gastrointestinal tract of a patient. [Figure 16C]1 shows a schematic diagram of a technique for deploying a device in the gastrointestinal tract of a patient. [Figure 16D] 1 shows a schematic diagram of a technique for deploying a device in the gastrointestinal tract of a patient. [Figure 16E] 1 shows a schematic diagram of a technique for deploying a device in the gastrointestinal tract of a patient. [Figure 16F] 1 shows a schematic diagram of a technique for deploying a device in the gastrointestinal tract of a patient. [Figure 16G] 1 shows a schematic diagram of a technique for deploying a device in the gastrointestinal tract of a patient. [Figure 17] FIG. 16 shows a schematic diagram of an eleventh embodiment of the present invention. [Figure 18] 1 shows a schematic diagram of an electronic system for monitoring the state of the device. DETAILED DESCRIPTION OF THE INVENTION

[0061] In the following description, when the same reference numerals are used, they refer to similar or corresponding features, whether or not explicitly described. Thus, the disclosure of one embodiment should be understood in conjunction with another embodiment. Also, where helpful in the description, different reference numerals may be used to refer to similar or corresponding features.

[0062] FIG. 1 discloses a first embodiment of a device 10 used to treat a patient suffering from obesity. The device 10 is primarily formed by a duodenal conduit 12 having a second anchor 17 attached to its proximal end 15. A first anchor 14 is positioned a distance d from the proximal end 15. The first anchor 14 is formed as a mass that tends to move the duodenal conduit 12 distally within the duodenum. This movement can occur through peristalsis and / or gravity. The second anchor 17 prevents excessive distal movement of the device 10.

[0063] Second anchor 17 is formed in the shape of a ring and surrounds duodenal conduit 12 adjacent proximal end 15. An entrance opening 18 is disposed in second anchor 18, which is a ring. Nutrients can enter the interior of duodenal conduit 12 from the stomach through opening 18, as shown by the arrow in FIG. 1 . The nutrients then leave duodenal conduit 12 at distal end 20, also shown by the arrow. This bypasses a distance of the duodenum, preventing nutrients from contacting the duodenal wall.

[0064] In this embodiment, the duodenal tract has a length of 600 mm and a diameter of 28 mm, and is integrally formed with a balloon-like second anchor 17, which is made of polyurethane. The mass 14 is preferably made of a self-expanding braided structure of wires made of a shape-memory material. The second anchor 17 has an inlet opening (not shown) that can be connected to an inflation device that allows the balloon to be inflated to an appropriate volume and size, typically to a volume of 350 ml.

[0065] Figure 2 shows an alternative embodiment of second anchor 17. In contrast to the embodiment of Figure 2, second anchor 17 is not formed as a toroid, but rather has a tulip shape, i.e., a shape that is slightly convex in cross section through a plane passing through the axis of the device.

[0066] In the embodiment shown in Figure 2, the first anchor 14 is designed as a self-expanding structure made of braided nitinol wire. An additional support structure 22 is disclosed that helps stabilize and / or anchor the device.

[0067] FIG. 3 illustrates a more specific embodiment of a device 10 for treating obesity in patients. The device is partially similar to the device of FIG. 1, with the following differences: the first anchor 14 is formed as a self-expanding structure made of braided nitinol. The embodiment of FIG. 3 is formed with a duodenal conduit 12 made of polyurethane and an inflatable second anchor 17. The second anchor 17 is attached to the duodenal conduit 2 by adhesive bonding and is made of silicone. The second anchor 17 can have a toroidal, conical, or tulip shape. The second anchor 17 has an axial length l1 of approximately 50 mm, an inner diameter d1 of the opening 18 of approximately 28 mm, and an outer diameter d2 of approximately 50 mm. The lip of the second anchor 17 can typically have a radial length r of 10 to 25 mm. By appropriately selecting the size, thickness, and / or material of the duodenal tube 12, it can be ensured that the tube is sufficiently flexible to conform to the shape of, for example, the duodenum D and optionally the jejunum J.

[0068] The device 10 deployed within a patient is shown in Figure 4. The device is anchored proximally to the pylorus P by a second anchor 17 and distally to the pylorus P by a first anchor 14. The second anchor 17 has a cone- or tulip-shaped configuration to avoid contact with the mucosal wall of the stomach S. The second anchor 17 has a dual function: on the one hand, it reduces stomach volume to reduce the patient's hunger sensation. It also prevents distal migration of the device. However, due to its cone- or tulip-shaped configuration, persistent contact with the mucosal wall is avoided. The second anchor 17 is free-floating in the stomach. The first anchor 14 is also sized and shaped to avoid contact with the mucosa. It is made sufficiently short, typically 10 mm to 25 mm long, and is covered by a layer of cushioning material, not shown in detail in Figures 3 and 4, made of a biocompatible material such as Dacron and having a thickness of 0.7 mm to 2 mm.

[0069] 3, the duodenal conduit 12 is further provided with a ring 19 of radiopaque material, in particular metal, which is positioned in a region 21 of the duodenal conduit 12 remote from the proximal end 20 of the duodenal conduit 12. This aids in positioning the device under x-ray control.

[0070] Figure 5 shows an embodiment of the invention suitable for treating diabetic patients. The device 30 according to Figure 5 also comprises a duodenal conduit 32. The duodenal conduit 32 is provided with a first anchor 34 and a second anchor 37. The first anchor 34 is positioned a distance d from the proximal end 35, while the second anchor 37 is positioned adjacent to the proximal end 35 of the duodenal conduit 32. The first anchor 34 and the second anchor 37 are formed of expandable structures 36, 38, respectively, both made of braided nitinol wire.

[0071] The duodenal tube 32 comprises two rings on its outer surface, with a first ring 39a located at the distal end 40 and a second ring 39b located in a region 41 away from the distal end 40. As with the embodiment of FIG. 3, the duodenal tube 32 of FIG. 5 is made of polyurethane. The anchors 34, 37 and the rings 39a, 39b are attached to the duodenal tube by adhesive bonding. However, it is also conceivable to integrate the rings 39a, 39b, in particular, between layers of the duodenal tube.

[0072] In the embodiment shown in FIG. 5, the second ring 39 is typically positioned 10 cm from the distal end 40 .

[0073] Figure 6 shows the device 30 of Figure 5 deployed within a patient. First and second anchors 34, 37 are positioned on either side of the pylorus to prevent distal or proximal migration of the device while still avoiding direct contact with the tissue of the relevant stomach S or duodenum D. Anchors 37 are substantially smaller than anchors 17 of the embodiment of Figures 3 and 4, and therefore device 30 of Figures 5 and 6 is less suitable for treating obesity but is more suitable for treating diabetes.

[0074] FIG. 7 shows a schematic diagram of the various steps for selecting a suitable device for an individual patient. In the first step, "Imaging," the patient is examined using a diagnostic imaging method known to those skilled in the art. Based on this examination or imaging step, the patient's specific characteristics are then determined in the step "Characterization." Based on a CT scan, abdominal fat panicle thickness, peri-abdominal fat mass, and visceral fat mass are determined. Furthermore, body surface area, body mass index, and abdominal circumference are clinically determined. Furthermore, the fat inside and / or outside the abdominal cavity can also be determined by CT scan. Based on these six or seven objective criteria, the length of the duodenal tract is determined in the step "Length Determination." The length is typically 450-600 mm. As a general rule, for example, the more severe the obesity, the longer the tract is selected.

[0075] The first three criteria are based on a cross-section along the third lumbar vertebra and can be easily determined manually based on the images shown on the CT scanner display. Of course, these criteria can also be fully or partially evaluated automatically using artificial intelligence software.

[0076] In the final step, "Tract Shortening," the tract is shortened to a defined length. The shortening can be performed by cutting. For this purpose, markings can be made on the outer surface of the duodenal tract (not specifically shown in FIG. 3). A ruler can be combined with the device.

[0077] Instead of shortening the tube, a tube of the appropriate length may be selected from a set of standard sizes or may be individually manufactured.

[0078] In addition to or instead of determining the length, the inflation volume of a balloon, such as second anchor 17, can also be determined based on the characteristics. By inflating the balloon to various volumes, further adaptation to individual patients is possible. The extent to which the stomach should be occupied, and therefore the size of the second anchor, can be determined.

[0079] Figure 8 shows another embodiment of a device 10 similar to that shown in Figure 1. In the embodiment of Figure 8, the first and second anchors are formed by inflatable balloons 14,17.

[0080] Two CT images are shown in Figure 9. Abdominal fat is assessed using CT images and grayscale variation.

[0081] Figures 10-17 illustrate further embodiments of a device 10 similar to the previous embodiments. The embodiments of Figures 10-17 are similar to each other in that the device 10 includes a first anchor 14 attached to the duodenal tract 12. The first anchor includes a self-expanding structure, which may optionally be in the form of a stent-like structure made of braided wire. The first anchor 14 may be made of a shape-memory material, such as nitinol. The first anchor 14 may be covered with a cushioning material 50, such as polyurethane. The configuration of the first anchor 14 and / or the provision of the cushioning material may avoid substantial mucosal involvement between the first anchor 14 and the duodenal mucosa.

[0082] For example, as seen in FIG. 10 , the first anchor 14 is sized to extend beyond the duodenal bulb DB without substantial mucosal involvement. The first anchor 14 can have a length of approximately 50 mm to 100 mm, e.g., approximately 80 mm. The first anchor 14 can have a diameter (e.g., approximately 20 mm to 40 mm, e.g., approximately 25 mm or 30 mm) such that the first anchor 14 resists the tendency of the duodenal tract to move proximally through the pylorus toward the stomach S. The first anchor 14 may include a distal shoulder (e.g., approximately 40 mm in diameter) to provide an additional stop.

[0083] The embodiments of Figures 10-17 differ from one another in the implementation of the second anchor 17. In the embodiment of Figure 10, the second anchor 17 comprises a self-expanding structure 52 similar to that of Figure 6. However, in Figure 10, the self-expanding structure has a horn-like shape, with a proximal end forming a flange 54. The self-expanding structure 52 can have a braided or lattice structure made of a shape-memory material, such as Nitinol. The self-expanding structure is covered with a cushioning material 50, such as silicone or polyurethane.

[0084] 10, second anchor 17 closes gastric antrum A. Proximal flange 54 engages the stomach wall and defines a closed space behind the flange, thereby reducing the stomach volume available to receive food.

[0085] 11, second anchor 17 includes a flared shape defined by a plurality of diverging ribs or fingers 56. Fingers 56 diverge away from the distal end of tube 12 and extend from a collar 58 at the proximal end of tube 12. As described above with reference to FIG. 10, second anchor 17 may be covered by a cushioning material 50.

[0086] In the embodiment of FIGS. 12-17, the second anchor 17 comprises a self-expanding structure 52 and a balloon 60, such as an inflatable balloon. Various implementations are contemplated. When the self-expanding structure 52 and the balloon 60 are used together, as in the illustrated embodiment of the second anchor 17, this is optionally the case, but preferably only for one of the anchors. The combination of both structures increases the amount of material used in the anchor, which may have some effect on the size to which the anchor can be folded or compressed for delivery. Using a combination of structures for one anchor can help reduce the impact on size compared to using such a combination for both anchors. The use of a combination of structures, particularly for the second anchor 17, is believed to be more appropriate for the anatomy of the body due to the greater amount of space available in the stomach than in the duodenum. Furthermore, because the natural flow of chyme and the majority of muscle movement are from the stomach side, there is likely a greater need for fixation from the stomach side (to resist displacement toward the intestine) than from the duodenum side (to resist displacement toward the stomach).

[0087] 12, self-expanding structure 52 has a flared shape that widens outward in a direction away from the distal end of tube 12. Self-expanding structure 52 may comprise a braid or lattice of a shape-memory material such as Nitinol. Self-expanding structure 52 biases anchor 17 toward an expanded state. Inflation of balloon 60 provides additional bulk to occupy volume within the stomach, thus reducing functional stomach volume and providing an atraumatic lip around the entrance to tube 12.

[0088] 13, the self-expanding structure 52 includes a plurality of ribs or fingers 56 that bias the anchor toward the expanded state. Subsequent inflation of the balloon completes or fills the tulip-shaped formation around the central drainage channel, reducing the functional stomach volume while keeping the central drainage channel open for chimes to enter the duodenal tract 12.

[0089] 14 and 15, the self-expanding structure 52 disposed radially inward of the balloon 60 supports the tube 12 against the inflation pressure of the balloon 60. This reinforces the tube 12 and prevents it from being crushed or collapsed by the inflation pressure of the surrounding balloon 60, avoiding the risk of blockage. However, the combination of the self-expanding structure 52 and the balloon 60 allows stomach contractions to be transmitted to the tube 12 for advancing the chime into and along the tube 12 and emptying it into the duodenum. The balloon 62 can be partially inflated, e.g., less than its full capacity, to facilitate the transmission of stomach contractions to the self-expanding structure 52 and to provide flexibility and compliance to the balloon 60.

[0090] The self-expanding structure 52 can be generally coextensive with the balloon 60, at least toward the proximal end of the device. The self-expanding structure 52 can comprise a tubular, stent-like structure, such as a braided or lattice structure made of a shape-memory metal such as Nitinol. In some configurations, the axial length of the self-expanding structure can be about 50 mm to 100 mm, e.g., about 80 mm. The diameter of the self-expanding structure 52 can be about 30 mm along the majority of its length and can optionally have a flared port at the proximal end.

[0091] Figures 16a-16g illustrate a technique for introducing and deploying the device of Figures 14 and 15. Referring to Figure 16a, device 10 is compressed to a small size and loaded into a delivery system 70 having a sheath 72 for holding device 10 in a radially compressed state. Delivery system 70 is introduced through the patient's mouth and into the stomach over a guidewire 74 positioned along the digestive tract. An imaging sensor 76 can optionally provide guidance to the medical practitioner.

[0092] Referring to Figure 16b, delivery system 70 is advanced through the pylorus into the duodenum until radiopaque marker 78 (either on tube 12 or on delivery system 70) is aligned with the location of the pylorus.

[0093] Referring to Figures 16c and 16d, by retracting the sheath 72, the duodenal conduit 12 is gradually deployed from the distal end, allowing the self-expanding structures of the first anchor 14 and the second anchor 17 to unfold on either side of the pylorus. Referring to Figure 16e, by fully retracting the sheath 72, the initially uninflated balloon 60 is revealed. Referring to Figure 16f, the balloon 60 is inflated to a working size by an inflation line 79 of the delivery system 70 connected to an inflation port 80 of the balloon 60. Referring to Figure 16g, after inflation, the inflation line 78 is disconnected from the port 80, and the delivery system 70 is then removed, leaving the device 10 in place.

[0094] FIG. 17 illustrates a further embodiment in which the second anchor 17 comprises one or more balloons defining multiple expandable bodies 60. In the illustrated embodiment, the bodies 60 are formed by separate balloons, but in other embodiments, the bodies 60 may be realized as individual chambers of the same balloon structure. The bodies 60 may be independently expandable, or the bodies 60 may be interconnected. The bodies 60 may have one or more shapes selected from elongated and / or spherical and / or teardrop-shaped and / or any other desired shape. The bodies 60 may be, for example, tulip-shaped, but nestled together to cooperatively define a large bulb with a grooved or lobed profile that reduces the tissue-contacting end compared to a smooth, bulbous, single body. Additionally, the space between and around adjacent bodies helps maintain an open natural pathway to allow chyme to enter the duodenal tract and prevent chyme from becoming trapped outside the duodenal tract and body.

[0095] Optionally, second anchor 17 further comprises a self-expanding structure 52. Self-expanding structure 52 may at least partially overlap body 60, or the self-expanding structure may be shorter so that there is little, if any, overlap.

[0096] In all of the embodiments described herein, whether or not shown in the drawings, the duodenal conduit 12 can optionally include a reinforcement 82 (e.g., FIGS. 10 and 17 ) to resist the tendency of the duodenal conduit to kink in at least one or more localized regions. Twisting of the conduit can narrow the conduit and, in extreme cases, cause kinks that could completely block the conduit from all passage of stomach contents through the kink region. In one variation, the reinforcement 82 of the duodenal conduit 12 can be provided between the first anchor 14 and the second anchor 17. The reinforcement 82 can, for example, include intraluminal or epiluminal structures, struts, or filaments optionally extending from one or both anchors 14 and 17. Additionally or alternatively, a reinforcement can be provided in the portion of the conduit 12 distal to the first anchor 14, as shown in FIG. 17 . The reinforcement 82 may also optionally comprise structures, struts, or filaments in or on the tube 12 that extend helically along the axis of the tube 12. In either case, some of the structures, struts, or filaments may extend in a direction that is at least partially axial to support the tube against twisting. The structures, struts, or filaments may be made of metal, such as nitinol or stainless steel, or may be made of plastic, such as PET or polyurethane or polytetrafluoroethylene.

[0097] A further aspect of the embodiments described herein is the provision of at least one sensor 90 for sensing characteristics useful for monitoring the condition, shape, or size of device 10, or information regarding nutrients passing through (e.g., transiting) device 10. In one form, sensor 90 can optionally monitor the condition, shape, or size of one or both of anchors 14 and 17. With reference to FIGS. 16 and 17, one such sensor 90 may be a pressure sensor for measuring the inflation pressure of balloon or body 60 and / or pressure changes transmitted through the balloon due to stomach contractions. Additionally or alternatively, sensor 90 (FIG. 17) may be a sensor for sensing a parameter of chyme passing through tube 12, such as flow rate.

[0098] 18 , a communication interface (not shown) enables the communication of the sensed information to an external receiver and / or monitor 92, e.g., a portable device such as a wrist-worn or handheld electronic device. By way of example, the external device may be a smartwatch or a dedicated wrist-worn electronic bracelet 92. Data transmission between the device 10 and the external monitor 92 can be via any wired or wireless communication path, such as near-field communication technology, which also enables power transmission to the sensor 90 via inductive or radio frequency communication coupling when the external device 92 is brought into proximity with the device 10 or its sensor 90. The communication interface may optionally be incorporated into the sensor 90 as an integrated module. The wrist-worn device 92 may further include a skin-contact sensor for measuring one or more of blood pressure, pulse, blood glucose level, and / or blood oxygen saturation.

[0099] Optionally, the monitoring device 92, or a partner device such as the patient's smartphone 92a, can include a software application that stores information received from the sensor 90 over time and enables it to communicate the information via wired or wireless communication to a healthcare practitioner's system (e.g., the healthcare practitioner's smartphone 92b) for monitoring the performance of the device 10 after placement in the patient. In the case of a device 10 intended for weight loss, the smart device can also receive information from a weighing scale 94 that allows the patient to periodically monitor their weight and, optionally, their body mass index. In the case of a device 10 intended for the treatment of diabetes, the smart device 92 / 92a / 92b can also receive information from a glucose monitor, such as a skin-worn device (e.g., 92) or an electronic patch.

Claims

1. A device (10; 30) for the treatment of obesity or diabetes in a patient, comprising: a duodenal tube (12; 32) configured to be placed in the patient's duodenum (D) and optionally the jejunum (J) or ileum; a first anchor (14; 34) positioned a predetermined distance (d) from the proximal end (15; 35) of said duodenal tract (12; 32) and configured to anchor said tract (12; 32) distal to the pylorus (P) without substantial mucosal involvement; The device (10; 30) is configured such that the first anchor does not make continuous strong contact with the mucosa, and the duodenal tract further comprises a second anchor provided at the proximal end (15; 35), the second anchor being configured to be positioned proximal to the pylorus (P) to anchor the device, and comprising a balloon configured to reduce the functional volume of the stomach.

2. The device of claim 1 , wherein the first anchor (34) comprises an expandable structure (36).

3. 3. The device of claim 2, wherein the expandable structure (36) is made of metal.

4. 4. The device of claim 2 or 3, wherein the expandable structure (36) is covered by at least one layer of material.

5. The device of any one of claims 1 to 4, wherein the first anchor is retrievable and / or repositionable.

6. The device of any one of claims 1 to 5, wherein the size and / or shape and / or configuration of the first anchor avoids mucosal engagement.

7. 7. The device of any one of claims 1 to 6, wherein the second anchor (17) is formed as an inflatable balloon (18) and is shaped to avoid close contact with the inner wall of the stomach.

8. The device of any one of claims 1 to 7, wherein the size and / or shape and / or configuration of the second anchor avoids mucosal engagement.

9. The device according to any one of the preceding claims, wherein the second anchor comprises at least one balloon (17; 60).

10. 10. The device according to any one of claims 1 to 9, wherein the balloon (17; 60), optionally in an inflated state, has a conical outer diameter or a concave outer shape in a cross section through a plane passing through the axis of the device in the region adjacent to the connection to the duodenal tract (12).

11. The device of any one of claims 1 to 10, wherein the second anchor has an at least partial hourglass shape.

12. 12. A computer implemented method for selecting a device for the treatment of obesity or diabetes in a patient according to any one of claims 1 to 11, comprising: - acquiring by a computer an image of at least one characteristic of the patient selected from the group consisting of abdominal fat panicle thickness, periabdominis fat mass, visceral fat mass, inner and / or outer abdominal fat, body surface area, body mass index and abdominal circumference, gastric elasticity, gastric elasticity index, umbilical absorption index of nutrients measured with the patient in an upright position; - automatic determination by artificial intelligence software of the length of the duodenal tract (12; 32) based on said acquired images; A method comprising:

13. A further step in which artificial intelligence software automatically determines the filling volume of the intragastric fixation balloon based on the acquired image.

13. The method of claim 12, comprising:

14. 14. The method of claim 12 or 13, wherein the fat inside and / or outside the abdominal cavity is determined by computer cross-sectional densitometry.

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