WO2024227247A1

WO2024227247A1 - Intragastric balloon system

Info

Publication number: WO2024227247A1
Application number: PCT/CA2024/050584
Authority: WO
Inventors: Moishe LIBERMAN; Alexandre ABID; Rodin CHERMAT; Saman NAGHIEH; Mark VARTAZARMIAN
Original assignee: Val Chum LP
Current assignee: Val Chum LP
Priority date: 2023-05-01
Filing date: 2024-05-01
Publication date: 2024-11-07
Anticipated expiration: 2025-11-01

Abstract

An intragastric balloon system has a gastric balloon expandable from a retracted condition for delivery inside a stomach lumen to an expanded condition for occupying a part of a volume defined by the stomach lumen. When in the expanded condition, the gastric balloon is adapted to emulate a shape of the stomach lumen and defines a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen, and a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen. A method for making a customized and selectively expandable intragastric balloon for a patient, and a method for installing an intragastric balloon inside a stomach lumen of a patient are described.

Description

INTRAGASTRIC BALLOON SYSTEM

CROSS-REFERENCE

[0001] The present application claims the priority of United States Patent Application No. 63/499,322, filed on May 1 , 2023 and incorporated herein by reference.

TECHNICAL FIELD

[0002] This disclosure generally relates to the field of intragastric devices, and more particularly to the field of intragastric balloons, of the type used to reduce the stomach volume in a weight-loss perspective.

BACKGROUND

[0003] An intragastric balloon is a medical device used to treat patients with various conditions, including for example overweight or obesity conditions. The intragastric balloon, generally of spherical shape, is inserted in the stomach of a patient in a retracted condition, and expanded in the stomach to occupy part of the volume of the stomach. The use of an intragastric balloon may reduce the amount of food the patient can ingest at a time, as the patient may have the feeling of satiety due to the volume occupied by the intragastric balloon and the amount of food. In contrast with some other treatments such as bariatric surgery and sleeve gastrectomy, the use of an intragastric balloon is less invasive and is reversible in that the intragastric balloon can be removed from the stomach of the patient after treatment.

[0004] However, intragastric balloons currently available may be of relatively small size in that they occupy, when in the expanded condition, less than half the volume of the stomach of the patient. In addition, intragastric balloons currently available are of generally spherical shape, and do not conform with the kidney bean-like shape of the stomach. As such, existing intragastric balloons may hamper the digestive function.

[0005] Therefore, improvements are needed.

SUMMARY

[0006] In accordance with one aspect, there is provided a method for making a customized and selectively expandable intragastric balloon for a patient, comprising: generating a model of a stomach lumen of the patient based on a imaging of the stomach lumen; generating a gastric balloon model based on the model of the stomach lumen; and forming an intragastric balloon based on the gastric balloon model.

[0007] Further in accordance with the aspect, for example, a volume of the intragastric balloon, when in an expanded condition, is comprised between 50% and 90% inclusively of a volume of the model of the patient, inclusively.

[0008] Still further in accordance with the aspect, for example, forming the intragastric balloon comprises forming: an internal volume adapted for receiving a fluid therein, and a port for fluidly connecting the internal volume to a fluid source external to the intragastric balloon for selectively configuring the intragastric balloon between a retracted condition and an expanded condition.

[0009] Still further in accordance with the aspect, for example, generating the gastric balloon model further comprises defining the gastric balloon model in an expanded condition for occupying a part of a volume defined by the model of the stomach lumen, the gastric balloon model adapted to emulate at least partly a shape of the stomach lumen and comprising: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and at least one recess defining at least one passage in an outer surface of the gastric balloon model.

[0010] Still further in accordance with the aspect, for example, the lesser curvature portion has a first of the recess defining a first of the passage delimited by the first recess and part of the lesser curvature of the stomach lumen, and wherein the greater curvature portion has a second recess defining a second passage delimited by the second recess and part of the greater curvature of the stomach lumen.

[0011] Still further in accordance with the aspect, for example, generating the gastric balloon model further comprises having the first recess and the second recess meet and coincide in at least one of a proximal portion and a distal portion of the gastric balloon model.

[0012] Still further in accordance with the aspect, for example, generating the gastric balloon model further comprises having the first recess and the second recess define a continuous passage extending over an entire outer perimeter of the gastric balloon model.

[0013] Still further in accordance with the aspect, for example, generating the model of the stomach lumen of the patient includes one of visually examining the stomach lumen through a gastroscope, externally scanning the stomach lumen with X-rays, externally scanning the stomach lumen with three-dimensional computed tomography gastrography, or externally scanning the stomach lumen with ultrasound.

[0014] In accordance with another aspect of the present disclosure, there is provided an intragastric balloon comprising: a gastric balloon expandable from a retracted condition for delivery inside a stomach lumen to an expanded condition for occupying a part of a volume defined by the stomach lumen; an internal volume defined by an inner surface of the gastric balloon; and a port in the gastric balloon configured for fluidly connecting the internal volume to a fluid source external to the intragastric balloon for selectively expanding the gastric balloon between the retracted condition and the expanded condition; when inside the stomach lumen and in the expanded condition, the gastric balloon is adapted to emulate a shape of the stomach lumen and defines: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and at least one recess defining at least one passage in an outer surface of the gastric balloon.

[0015] Further in accordance with the aspect, for example, the lesser curvature portion having a first of the recess defining a first of the passage delimited by the first recess and part of the lesser curvature of the stomach lumen and allowing food transit therein, the greater curvature portion having a second of the recess defining a second of the passage delimited by the second recess and part of the greater curvature of the stomach lumen and allowing food transit therein, and wherein the first passage and the second passage form a continuous passage having ends opposite an esophagus and a duodenum.

[0016] Still further in accordance with the aspect, for example, when inside the stomach lumen and in the expanded condition, the gastric balloon further defines: a proximal portion adapted for facing the esophagus; a distal portion adapted for facing the duodenum; and the first recess and the second recess extend from the proximal portion to the distal portion.

[0017] Still further in accordance with the aspect, for example, the first recess and the second recess meet and coincide in the proximal portion of the gastric balloon.

[0018] Still further in accordance with the aspect, for example, the first recess and the second recess meet and coincide in the distal portion of the gastric balloon. [0019] Still further in accordance with the aspect, for example, the first recess has a first width that is greater in the proximal portion of the gastric balloon than a second width in the distal portion of the gastric balloon.

[0020] Still further in accordance with the aspect, for example, the first recess has a funnel- shaped portion for channeling food transit in the first passage.

[0021] Still further in accordance with the aspect, for example, the funnel-shaped portion is located closer to the proximal portion than the distal portion of the gastric balloon.

[0022] Still further in accordance with the aspect, for example, the continuous passage extends over an entire outer perimeter of a longitudinal cross-section of the gastric balloon.

[0023] Still further in accordance with the aspect, for example, the gastric balloon is made of a polymer material resistant to gastric juices.

[0024] Still further in accordance with the aspect, for example, an anchor may be connected to the gastric balloon for connecting the intragastric balloon to a delivery instrument adapted for positioning the intragastric balloon, when in the retracted condition, inside the stomach lumen.

[0025] Still further in accordance with the aspect, for example, when the intragastric balloon is in the stomach lumen and in the expanded condition, at least one of: the first passage is adapted for continuous food transit between the lesser curvature of the stomach lumen and the first recess; and the second passage is adapted for continuous food transit between the greater curvature of the stomach lumen and the second recess.

[0026] Still further in accordance with the aspect, for example, when inside the stomach lumen and in the expanded condition, the intragastric balloon occupies between 50% and 90% of the volume of the stomach lumen, inclusively.

[0027] Still further in accordance with the aspect, for example, the gastric balloon has a patient specific shape when in the expanded condition, the patient specific shape being as a function of imaging of the stomach lumen.

[0028] In accordance with yet another aspect of the present disclosure, there is provided a method for installing an intragastric balloon inside a stomach lumen of a patient, comprising: obtaining the intragastric balloon in a retracted condition; positioning the intragastric balloon inside the stomach lumen of the patient with a lesser curvature portion adjacent to a lesser curvature of the stomach lumen, and with a greater curvature portion adjacent to a greater curvature of the stomach lumen; and supplying a fluid inside an internal volume defined by an inner surface of the intragastric balloon for configuring the intragastric balloon in an expanded condition where: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and at least one recess defining at least one passage in an outer surface of the gastric balloon.

[0029] Further in accordance with the aspect, for example, positioning the intragastric balloon inside the stomach lumen comprises passing the intragastric balloon in the retracted condition through an esophagus and inside the stomach lumen using a delivery instrument.

[0030] Still further in accordance with the aspect, for example, the delivery instrument is selectively connected to an anchor connected to the intragastric balloon, and positioning the intragastric balloon inside the stomach lumen comprises disconnecting the delivery instrument from the anchor when the intragastric balloon is in the expanded condition, the first recess faces and follows the lesser curvature of the stomach lumen and the second recess faces and follows the greater curvature of the stomach lumen.

[0031] Many further features and combinations thereof concerning the present improvements will appear to those skilled in the art following a reading of the instant disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Fig. 1 is a perspective view taken from a front, top, left side of an intragastric balloon system according to an embodiment, the intragastric balloon being in the expanded condition and positioned inside a stomach lumen depicted in phantom lines;

[0033] Fig. 2 is a perspective view taken from a front, top, left side of the intragastric balloon system of Fig. 1 ;

[0034] Fig. 3 is a left side view of the intragastric balloon system of Fig. 1 ;

[0035] Fig. 4 is a perspective view taken from a front, right side of the intragastric balloon system of Fig. 1 ;

[0036] Fig. 5 is a longitudinal cross-sectional view of the intragastric balloon system of Fig. 1 ; [0037] Fig. 6 is a flowchart showing an exemplary method for making a customized and selectively expandable intragastric balloon system for a patient according to an embodiment; and

[0038] Fig. 7 is a flowchart showing an exemplary method for installing an intragastric balloon system in a stomach lumen of a patient according to an embodiment.

DETAILED DESCRIPTION

[0039] Referring to Fig. 1 , there is shown a stomach lumen 1 of a human patient. The stomach lumen 1 defines a volume 2 that receives and processes food, the food received from an esophagus 3, and digested through an esophageal sphincter 3a (schematically shown in Fig. 1). The stomach lumen 1 contains gastric juices for digesting food. Food exits the volume 2 of the stomach lumen 1 by the duodenum 4 through a pyloric sphincter 4a (schematically shown Fig. 1). The stomach lumen 1 may typically have a lesser curvature 5 on one side, and a greater curvature 6 on the side. The stomach lumen 1 depicted in the figures is exemplary and has a kidney beanlike shape, but could be shaped otherwise, depending on patient specificity.

[0040] Referring to Figs. 1 to 5, an intragastric balloon system 10 is shown positioned inside the stomach lumen 1. The intragastric balloon system 10 may also be referred to as intragastric balloon, gastric balloon, gastroenteric balloon, etc. Generally described, the intragastric balloon system 10 includes a gastric balloon 11 (also known as an intragastric balloon, gastroenteric balloon, etc.) selectively expandable from a retracted condition for delivery inside the stomach lumen 1 to an expanded condition (shown in Figs. 1 to 5) for occupying a part of the volume 2 of the stomach lumen 1. The gastric balloon 11 has a proximal portion 1 1A adapted for facing the esophagus 3, and a distal portion 11 B adapted for facing the duodenum 4. The gastric balloon system 10 has an outer surface 12. Referring to Fig. 5, a longitudinal cross-section of the gastric balloon 11 is shown, and the longitudinal cross-section defines an outer perimeter 12A shown in dashed line in Fig. 5. The gastric balloon 11 may be formed of a biocompatible material that is resistant to gastric juices and peristalsis, so as to ensure that the gastric balloon 1 1 can withstand forces applied to it during its lifetime. The intragastric balloon system 10 has an internal volume 13 defined by an inner surface 14 (Fig. 5) of the gastric balloon 11 . A port 20 in the gastric balloon 1 1 is configured for fluidly connecting the internal volume 13 to a fluid source 21 (schematically shown in Fig. 1) external to the intragastric balloon system 10. The fluid source 21 is used for selectively expanding or collapsing the gastric balloon 11 between the retracted condition and the expanded condition, as will be described in further detail below. In any of the variants herein, the balloon is simply pierced to then be removed. [0041] Still referring to Figs. 1 to 5, when the gastric balloon 11 is positioned inside the stomach lumen 1 and in the expanded condition, the gastric balloon 11 is adapted to emulate a shape of the stomach lumen 1 . Put differently, the gastric balloon 11 generally has a kidney beanlike shape, similar to the shape of the stomach lumen 1 . The gastric balloon 11 is non-spherically shaped, and is better adapted to occupy a larger portion of the volume 2 of the stomach lumen 1 compared to certain gastric balloons. The shape and structure of the gastric balloon 1 1 will now be described in detail. In a variant, the gastric balloon 11 is patient specific, in that its geometry in the expanded condition is based on images or on a model (e.g., three-dimensional model) of the patient stomach. Any appropriate imaging modality may be used to create the stomach model, and the gastric balloon 11 may be fabricated using manufacturing technologies such as 3D printing, additive manufacturing, custom molding/dip molding, etc. Thus, with the exception of clearances and/or passages described below, the geometry of the gastric balloon 11 may be representative of a native stomach. As an alternative, the gastric balloon 11 may come in different sizes and generic shapes that emulate average stomachs, with the different sizes and shapes being selectable as a function of age, height, sex, weight, etc, among other factors. It is also possible to rely on preliminary imaging, i.e., without committing to a complete 3D reconstruction of the stomach. With preliminary imaging, the practitioner could categorize the stomach to a type of shape.

[0042] Referring to Figs. 1 to 3, when in the expanded condition and inside the stomach lumen 1 , the gastric balloon 11 defines a lesser curvature portion 15 adapted for facing and following the lesser curvature 5 of the stomach lumen 1. In a variant, the lesser curvature portion 15 is configured to abut against the lesser curvature 5 of the stomach lumen 1. The lesser curvature portion 15 has a recess 15A defining part of a passage 15B. The passage 15B is delimited by the recess 15A and part of the lesser curvature 5 of the stomach lumen 1 . The passage 15B allows for food transit therein, and more particularly from the proximal portion 1 1 A to the distal portion 1 1 B of the gastric balloon 11 . More particularly, the passage 15B is adapted for continuous food transit between the lesser curvature 5 of the stomach lumen 1 and the recess 15A. The recess 15A may have a width 15C in the proximal portion 1 1A that may be greater than a width 15D in the distal portion 11 B of the gastric balloon 11 . As best seen in Fig. 3, the recess 15A may optionally have a funnel-shaped portion 15E, or other larger clearance or empty volume, for channelling food in the passage 15B. If present, the funnel-shaped portion 15E is located closer to the proximal portion 11A than the distal portion 11 B. The funnel-shaped portion 15E may assist in directing food entering the stomach lumen 1 into the passage 15B and assist in the transit thereof toward the duodenum 4 with reduced risks of obstruction. The shape and position of the funnel-shaped portion 15E can vary in other embodiments. The funnel-shaped portion 15E may thus be opposite the esophagus 1 to essentially define a receiving volume, enabling some gastric processing, as food then makes its way into the passage 15B. Again, the funnel-shaped portion 15E is optional, with other possible shapes including a continuous and generally information cross-section for the passage 15B, a flaring in a distal portion of the gastric balloon 11.

[0043] Referring to Fig. 4, when in the expanded condition and inside the stomach lumen 1 , the gastric balloon 11 may define a greater curvature portion 16 adapted for facing and following the greater curvature 6. In a variant, the greater curvature portion 16 is configured to abut against the greater curvature 6 of the stomach lumen 1 . The greater curvature portion 16 may optionally have a recess 16A defining part of a passage 16B. The passage 16B is delimited by the recess 16A and part of the greater curvature 16 of the stomach lumen 1. The passage 16B allows for food transit therein from the proximal portion 11A to the distal portion 1 1 B of the gastric balloon 1 1 . More particularly, the passage 16B is adapted for continuous food transit between the greater curvature 6 of the stomach lumen 1 and the recess 16A. The recess 16A may have a width 16C that may be similar in the proximal portion 11A and in the distal portion 11 B. The recess 16A could be shaped otherwise in other embodiments, and for example feature a width 16C that is varying between the proximal portion 1 1 A and the distal portion 11 B. The gastric balloon 11 , thouh shown as having two passages, i.e., 15B and 16B, may have a single passage, whether it be 15B or 16B.

[0044] Referring to Figs. 2 to 5, the passages 15B, 16B, if both present, form a continuous passage 17 having an esophagus end 17A and a duodenum end 17B (Fig. 5). More particularly, the continuous passage 17 is defined by the recesses 15A, 16A that meet and coincide in the proximal portion 1 1A and in the distal portion 1 1 B of the gastric balloon 1 1. Having the recesses 15A, 16A defined by the outer surface 12 and facing and following the lesser curvature 5 and the greater curvature 6 respectively may reduce the risks of obstruction of the food transit by the intragastric balloon system 10, even in a situation where the gastric balloon 1 1 is displaced or improperly positioned inside the stomach lumen 1 , for instance when the gastric balloon 11 is flipped such that the lesser curvature portion 15 faces the greater curvature 6 and the greater curvature portion 16 faces the lesser curvature 5. Indeed, the continuous passage 17 forms two paths between the proximal portion 1 1A and the distal portion 1 1 B of the gastric balloon 11. Referring to Fig. 5, the continuous passage 17 extends over the entire outer perimeter 12A defined by a longitudinal cross-section of the gastric balloon 11. In other embodiments, the recesses 15A, 16A may extend differently than what is shown in the Figs. For example, the recesses 15A, 16A could meet and coincide in the proximal portion 11 A, but not in the distal portion 1 1 B.

[0045] As best seen in Figs. 1 to 4, when the intragastric balloon system 10 is inside the stomach lumen 1 and in the expanded condition, the intragastric balloon system 10 occupies between 50% and 90% of the volume 2 of the stomach lumen 1 , inclusively. In an alternative embodiment, the intragastric balloon system 10 occupies between 70% and 80% of the volume 2 of the stomach lumen 1 , inclusively. The intragastric balloon system 10 occupies a greater portion of the volume 2 of the stomach lumen 1 compared to certain gastric balloons, notably gastric balloons of spherical shape. Since the volume occupied by the intragastric balloon system 10 is greater compared to other gastric balloons, the patient may have a more important sensation of satiety that may limit their food intake, and further accelerate weight loss. The comfort for the patient should not be compromised despite the larger volume. Due to the shape, the balloon system 10 may not be exerting excessive punctual pressure on the gastric walls, but would instead be dispersed around the gastric wall.

[0046] Referring back to Fig. 1 , the intragastric balloon system 10 further has an anchor 30 (schematically shown) connected to the outer surface 12 of the gastric balloon 1 1 . The anchor 30 is adapted for connecting the gastric balloon 11 to a delivery instrument 31 . The delivery instrument 31 is adapted for positioning the intragastric balloon system 10, when in the retracted condition, inside the stomach lumen 1. The delivery instrument 31 can be a gastroscope, an orogastric tube or a nasogastric tube. In a variant, the anchor 30 may be removable and reattachable, for instance by way of a port, a connector, a valve, etc. A threaded engagement is a possibility. Other delivery instruments are contemplated. The installation of the intragastric balloon system 10 using the delivery instrument 31 will be described below.

[0047] Turning now to Fig. 6, a method 40 for making a customized intragastric balloon system 10 for a patient is shown. Generally described, the method 40 may be used to make a gastric balloon of an intragastric balloon system, such as that of Figs. 1 to 5, adapted to better suit the shape of the patient’s stomach, thus increasing the patient’s comfort, and to occupy a portion of the volume 2 of the stomach lumen 1 , when in the expanded condition, adapted for the treatment of the patient. The method 40 is described with reference to features of the intragastric balloon system 10 described above. [0048] At step 41 , a stomach model is generated based on a three-dimensional representation of the stomach lumen 1. The three-dimensional representation of the stomach lumen 1 can be obtained using one or a combination of techniques, such as visually examining the stomach lumen 1 through a gastroscope, externally scanning the stomach lumen 1 with X- rays (e.g., using radiopaque substances), externally scanning the stomach lumen 1 with three- dimensional computed tomography gastrography, and externally scanning the stomach lumen 1 with ultrasound, among other imaging modalities. In a variant, a 3D reconstruction software may be used to convert the imaging (e.g., CT scan image) to usable data such as the model. With a 3D reconstruction method, a method of inflating the stomach during the scan may be usable to obtain proper images of the stomach. For example, the patient may be required to ingest an effervescent pill or a liquid with good contrast that will bloat the stomach, for the imaging.

[0049] At step 42, a gastric balloon model is generated based on the stomach model and/or on the imaging of step 41 . In some embodiments, step 42 involves defining a model of the gastric balloon 11 in the expanded condition for occupying a part of a volume defined by the stomach model. The model of the gastric balloon 11 may be designed to occupy between 50% and 90% inclusively of the volume of the stomach model of the patient, though it could be more or less. In some embodiments, the volume of the stomach model and the volume 2 of the stomach lumen 1 substantially correspond. For example, the volume of the stomach model may be within 5% of the volume 2 of the stomach lumen 1 . The model of the gastric balloon is also adapted to emulate a shape of the stomach model. More particularly, the model of the gastric balloon has a lesser curvature portion 15 adapted for facing and following a lesser curvature 5 of the stomach model. Once the model has adopted the shape of the stomach model, parts thereof may be removed to define food transiting recesses and/or clearances. The lesser curvature portion 15 may have a recess 15A defining a passage 15B delimited by the recess 15A and part of the lesser curvature 5 of the stomach model. The model of the gastric balloon may further have a greater curvature portion 16 adapted for facing and following a greater curvature 6 of the stomach model. The greater curvature portion 16 may have a recess 16A defining a passage 16B delimited by the recess 16A and part of the greater curvature 6 of the stomach model. In some embodiments, when generating the gastric balloon model, the recesses 15A, 16A are shaped and configured to meet and coincide in the proximal portion 11A and/orthe distal portion H B of the gastric balloon model. In some embodiments, when generating the gastric balloon model, the recesses 15A, 16A are shaped and configured to define a continuous passage 17 extending over an entire outer perimeter 12A of the gastric balloon model. [0050] At step 43, the intragastric balloon system 10 is formed based on the gastric balloon model. In some embodiments, the internal volume 13 is formed within the intragastric balloon system 10 for receiving a fluid therein, and the port 20 is formed for fluidly connecting the internal volume 13 to the fluid source 21 external to the intragastric balloon system 10. The fluid source 21 is used for selectively configuring the intragastric balloon system 10 between the retracted condition and the expanded condition. The port 20 may include a valve system enabling the inflating of the gastric balloon 11 and the preserving of the shape of the gastric balloon 1 1 once inflated. The valve system may include a check valve that prevents the fluid media from escaping the gastric balloon 1 1 . The valve system and the port 20 may also be configured to fluidly connect to an inflating tube fluidly connected to the fluid source 21 for selectively inflating or deflating the gastric balloon 11. However, the port 20 may also be accessible remotely for the gastric balloon 1 1 to be deflated. The material of the gastric balloon 1 1 is for example a polymer or like rubberized and/or deformable material, that can collapse in a deflated condition, but that can inflate when at a given pressure range, and adopt a desired and predetermined shape when inflated.

[0051] Turning now to Fig. 7, a method 50 for installing the intragastric balloon system 10 inside the stomach lumen 1 of a patient is shown. The method 50 is also described with reference to features of the intragastric balloon system 10 described above.

[0052] At step 51 , the intragastric balloon system 10 is obtained in the retracted condition, also referred to as a deflated condition (i.e., when the volume of fluid inside the balloon 1 1 is substantially below the volume required for the balloon 1 1 to have its desired design shape when inflated).

[0053] At step 52, the intragastric balloon system 10 is positioned inside the stomach lumen 1 of the patient with the lesser curvature portion 15 adjacent to the lesser curvature 5, and with the greater curvature portion 16 adjacent to the greater curvature 6. In some embodiments, the intragastric balloon system 10 is in the retracted condition and is passed through the esophagus 3 of the patient and inside the stomach lumen 1 using the delivery instrument 31 connected to the anchor 30.

[0054] At step 53, when the intragastric balloon system 10 is inside the stomach lumen 1 and positioned as described above, the fluid source 21 supplies an inflation media through the port 20 to at least partially fill the internal volume 13 of the intragastric balloon system 10 until the intragastric balloon system 10 is in the expanded condition. The inflation media can include a liquid (such as a saline solution) and/or a gas for providing incompressible and/or compressible fluid inside the intragastric balloon system 10. When adequately positioned, the lesser curvature portion 15 faces and follows the lesser curvature 5, and the recess 15A and the lesser curvature 5 delimit the passage 15B for allowing food transit therein. This may be facilitated by the complementary shapes of the gastric balloon 11 and of the stomach lumen 1 , with the gastric balloon 1 1 having a tendency to position and orient itself in the adequate way. Similarly, the greater curvature portion 16 faces and follows the greater curvature 6, and the recess 16A (if present) and the greater curvature 6 delimit the passage 16B for allowing food transit therein. When the intragastric balloon system 10 is in the expanded condition and positioned as described above, the delivery instrument 31 , which may include an inflating tube, is disconnected from the anchor 30 and withdrawn from the patient’s body. In a variant, the delivery instrument 31 is the inflating tube, and the inflating tube establishes a fluid communication between the fluid source 21 and the internal volume 13 of the gastric balloon 11 . In a variant, the inflating tube is configured to cooperate with the valve system of the port to allow fluid flow of the inflation media only when the inflating tube is adequately connected to the port 20.

[0055] In an embodiment, the present disclosure therefore pertains to a method for making a customized and selectively expandable intragastric balloon for a patient, that may include: generating a model of a stomach lumen of the patient based on a imaging of the stomach lumen; generating a gastric balloon model based on the model of the stomach lumen; and forming an intragastric balloon based on the gastric balloon model.

[0056] In another embodiment, the present disclosure therefore pertains to an intragastric balloon that may have: a gastric balloon expandable from a retracted condition for delivery inside a stomach lumen to an expanded condition for occupying a part of a volume defined by the stomach lumen; an internal volume defined by an inner surface of the gastric balloon; and a port in the gastric balloon configured for fluidly connecting the internal volume to a fluid source external to the intragastric balloon for selectively expanding the gastric balloon between the retracted condition and the expanded condition; when inside the stomach lumen and in the expanded condition, the gastric balloon is adapted to emulate a shape of the stomach lumen and defines: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and at least one recess defining at least one passage in an outer surface of the gastric balloon. [0057] In accordance with another embodiment, the present disclosure also pertains to a method for installing an intragastric balloon inside a stomach lumen of a patient, that may include: obtaining the intragastric balloon in a retracted condition; positioning the intragastric balloon inside the stomach lumen of the patient with a lesser curvature portion adjacent to a lesser curvature of the stomach lumen, and with a greater curvature portion adjacent to a greater curvature of the stomach lumen; and/or supplying a fluid inside an internal volume defined by an inner surface of the intragastric balloon for configuring the intragastric balloon in an expanded condition where: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and/or at least one recess defining at least one passage in an outer surface of the gastric balloon.

[0058] As can be seen therefore, the examples described above and illustrated are intended to be exemplary only. The scope is indicated by the appended claims.

Claims

WHAT IS CLAIMED IS:

1 . A method for making a customized and selectively expandable intragastric balloon for a patient, comprising: generating a model of a stomach lumen of the patient based on a imaging of the stomach lumen; generating a gastric balloon model based on the model of the stomach lumen; and forming an intragastric balloon based on the gastric balloon model.

2. The method of claim 1 , wherein a volume of the intragastric balloon, when in an expanded condition, is comprised between 50% and 90% inclusively of a volume of the model of the patient, inclusively.

3. The method of claim 1 or claim 2, wherein forming the intragastric balloon comprises forming: an internal volume adapted for receiving a fluid therein, and a port for fluidly connecting the internal volume to a fluid source external to the intragastric balloon for selectively configuring the intragastric balloon between a retracted condition and an expanded condition.

4. The method of any one of claims 1 to 3, wherein generating the gastric balloon model further comprises defining the gastric balloon model in an expanded condition for occupying a part of a volume defined by the model of the stomach lumen, the gastric balloon model adapted to emulate at least partly a shape of the stomach lumen and comprising: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and at least one recess defining at least one passage in an outer surface of the gastric balloon model.

5. The method of claim 4, wherein the lesser curvature portion has a first of the recess defining a first of the passage delimited by the first recess and part of the lesser curvature of the stomach lumen, and wherein the greater curvature portion has a second recess defining a second passage delimited by the second recess and part of the greater curvature of the stomach lumen

6. The method of claim 5, wherein generating the gastric balloon model further comprises having the first recess and the second recess meet and coincide in at least one of a proximal portion and a distal portion of the gastric balloon model.

7. The method of claim 5, wherein generating the gastric balloon model further comprises having the first recess and the second recess define a continuous passage extending over an entire outer perimeter of the gastric balloon model.

8. The method of any one of claims 1 to 7, wherein generating the model of the stomach lumen of the patient includes one of visually examining the stomach lumen through a gastroscope, externally scanning the stomach lumen with X-rays, externally scanning the stomach lumen with three-dimensional computed tomography gastrography, or externally scanning the stomach lumen with ultrasound.

9. An intragastric balloon comprising: a gastric balloon expandable from a retracted condition for delivery inside a stomach lumen to an expanded condition for occupying a part of a volume defined by the stomach lumen; an internal volume defined by an inner surface of the gastric balloon; and a port in the gastric balloon configured for fluidly connecting the internal volume to a fluid source external to the intragastric balloon for selectively expanding the gastric balloon between the retracted condition and the expanded condition; when inside the stomach lumen and in the expanded condition, the gastric balloon is adapted to emulate a shape of the stomach lumen and defines: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and at least one recess defining at least one passage in an outer surface of the gastric balloon.

10. The intragastric balloon of claim 9, wherein the lesser curvature portion having a first of the recess defining a first of the passage delimited by the first recess and part of the lesser curvature of the stomach lumen and allowing food transit therein, the greater curvature portion having a second of the recess defining a second of the passage delimited by the second recess and part of the greater curvature of the stomach lumen and allowing food transit therein, and wherein the first passage and the second passage form a continuous passage having ends opposite an esophagus and a duodenum.

11. The intragastric balloon of claim 10, wherein, when inside the stomach lumen and in the expanded condition, the gastric balloon further defines: a proximal portion adapted for facing the esophagus; a distal portion adapted for facing the duodenum; and the first recess and the second recess extend from the proximal portion to the distal portion.

12. The intragastric balloon of claim 10 or claim 11 , wherein the first recess and the second recess meet and coincide in the proximal portion of the gastric balloon.

13. The intragastric balloon of any one of claims 10 to 12, wherein the first recess and the second recess meet and coincide in the distal portion of the gastric balloon.

14. The intragastric balloon of any one of claims 10 to 13, wherein the first recess has a first width that is greater in the proximal portion of the gastric balloon than a second width in the distal portion of the gastric balloon.

15. The intragastric balloon of any one of claims 10 to 14, wherein the first recess has a funnel- shaped portion for channeling food transit in the first passage.

16. The intragastric balloon of claim 15, wherein the funnel-shaped portion is located closer to the proximal portion than the distal portion of the gastric balloon.

17. The intragastric balloon of claim 9, wherein the continuous passage extends over an entire outer perimeter of a longitudinal cross-section of the gastric balloon.

18. The intragastric balloon of any one of claims 9 to 17, wherein the gastric balloon is made of a polymer material resistant to gastric juices.

19. The intragastric balloon of any one of claims 9 to 18, further comprising an anchor connected to the gastric balloon for connecting the intragastric balloon to a delivery instrument adapted for positioning the intragastric balloon, when in the retracted condition, inside the stomach lumen.

20. The intragastric balloon of claim 9, wherein, when the intragastric balloon is in the stomach lumen and in the expanded condition, at least one of: the first passage is adapted for continuous food transit between the lesser curvature of the stomach lumen and the first recess; and the second passage is adapted for continuous food transit between the greater curvature of the stomach lumen and the second recess.

21 . The intragastric balloon of any one of claims 9 to 20, wherein, when inside the stomach lumen and in the expanded condition, the intragastric balloon occupies between 50% and 90% of the volume of the stomach lumen, inclusively.

22. The intragastric balloon of any one of claims 9 to 21 , wherein the gastric balloon has a patient specific shape when in the expanded condition, the patient specific shape being as a function of imaging of the stomach lumen.

22. A method for installing an intragastric balloon inside a stomach lumen of a patient, comprising: obtaining the intragastric balloon in a retracted condition; positioning the intragastric balloon inside the stomach lumen of the patient with a lesser curvature portion adjacent to a lesser curvature of the stomach lumen, and with a greater curvature portion adjacent to a greater curvature of the stomach lumen; and supplying a fluid inside an internal volume defined by an inner surface of the intragastric balloon for configuring the intragastric balloon in an expanded condition where: a lesser curvature portion adapted for facing and following a lesser curvature of the stomach lumen; a greater curvature portion adapted for facing and following a greater curvature of the stomach lumen; and at least one recess defining at least one passage in an outer surface of the gastric balloon.

23. The method of claim 22, wherein positioning the intragastric balloon inside the stomach lumen comprises passing the intragastric balloon in the retracted condition through an esophagus and inside the stomach lumen using a delivery instrument.

24. The method of claim 23, wherein the delivery instrument is selectively connected to an anchor connected to the intragastric balloon, and positioning the intragastric balloon inside the stomach lumen comprises disconnecting the delivery instrument from the anchor when the intragastric balloon is in the expanded condition, the first recess faces and follows the lesser curvature of the stomach lumen and the second recess faces and follows the greater curvature of the stomach lumen.