JP6285067B2 - Intragastric device - Google Patents

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is hereby incorporated by reference in its entirety, and is hereby incorporated by reference into US Application No. 13/011 filed January 21, 2011. , 842, part continuation application.

  Devices and methods for treating obesity are provided. More specifically, an intragastric device is provided, as well as methods for manufacturing, deploying, inflating, monitoring and removing it.

  Obesity is a serious health problem in developed countries. Obesity exposes you to a higher risk of developing hypertension, diabetes and many other serious health problems. In the United States, the troublesome problem of overweight or overweight is estimated to affect nearly 1 in 3 adults in the United States, with annual medical costs exceeding $ 80 billion and indirect costs such as lost wages Total annual economic costs exceed 120 billion dollars. Except in rare pathological conditions, weight gain is directly correlated with overeating.

  Non-invasive methods for weight loss include increasing metabolic activity and / or caloric intake, either by modifying lifestyle or using pharmacological interventions that reduce appetite Including reducing. Other methods include surgery that reduces stomach volume, banding that limits the size of the fistula, and intragastric devices that reduce appetite by occupying space in the stomach.

  The intragastric volume occupancy device gives the patient a feeling of fullness after eating a very small amount of food. Therefore, the calorie intake is reduced while the person is satisfied with the fullness. Currently available volume occupancy devices have a number of drawbacks. For example, complicated intragastric procedures are required to insert several devices.

  U.S. Pat. No. 4,133,315, the entire contents of which are incorporated herein by reference, discloses an apparatus for reducing obesity comprising an inflatable elastic bag and tube combination. The bag can be inserted into the patient's stomach by swallowing. The end of the attached tube distal to the bag remains in the patient's mouth. A second tube snakes through the nasal cavity and into the patient's mouth. The tube ends located in the patient's mouth are connected together to form a continuous tube for fluid communication with the bag through the patient's nose. Alternatively, the bag can be implanted by an intragastric procedure. The bag is inflated through the tube to the desired degree before the patient eats so that the desire for food is reduced. After the patient eats, the bag is deflated. The tube extends from the patient's nose or abdominal cavity throughout the course of treatment.

  US Pat. No. 5,259,399, US Pat. No. 5,234,454, and US Pat. No. 6,454,785, the entire contents of which are incorporated herein by reference, are surgically implanted. Disclosed is an intragastric volume occupancy device for weight management.

  U.S. Pat. No. 4,416,267, U.S. Pat. No. 4,485,805, U.S. Pat. No. 4,607,618, U.S. Pat. No. 4,694, the entire contents of which are incorporated herein by reference. No. 827, U.S. Pat. No. 4,723,547, U.S. Pat. No. 4,739,758, and U.S. Pat. No. 4,899,747, and European Patent No. 246,999 are inserted with an endoscope. It relates to an intragastric volume occupancy device for weight management. Of these, U.S. Pat. No. 4,416,267, U.S. Pat. No. 4,694,827, U.S. Pat. No. 4,739,758, and U.S. Patents, the entire contents of which are incorporated herein by reference. No. 4,899,747 relates to a balloon whose surface is undulated in some way to achieve the desired purpose. In U.S. Pat. No. 4,416,267 and U.S. Pat. No. 4,694,827, the entire contents of which are incorporated herein by reference, the balloon is torus-shaped and the flared central opening is solid. It facilitates the passage of objects and fluids through the stomach cavity. The balloon of US Pat. No. 4,694,827, the entire contents of which are incorporated herein by reference, has a plurality of convex protrusions with smooth surfaces. These protrusions reduce the amount of surface area in contact with the stomach wall, thereby reducing the deleterious effects that result from excessive contact with the gastric mucosa. These protrusions also define a flow path between the balloon and the stomach wall through which solids and liquids can pass. The balloon of US Pat. No. 4,739,758, the entire contents of which are incorporated herein by reference, has a bulge on its outer periphery that prevents it from abutting against the cardia and pylorus.

  The balloons of U.S. Pat. No. 4,899,747 and U.S. Pat. No. 4,694,827, the entire contents of which are incorporated herein by reference, are tubing that is releasably attached to a deflated balloon. And is pushed by pushing it under the gastric tube. U.S. Pat. No. 4,723,547, the entire contents of which are incorporated herein by reference, discloses a specially adapted insertion catheter for positioning a balloon. In US Pat. No. 4,739,758, the entire contents of which are hereby incorporated by reference, filler tubes cause balloon insertion. In U.S. Pat. No. 4,485,805, the entire contents of which are incorporated herein by reference, the balloon is threadedly attached to the end of a conventional gastric tube that is inserted down the patient's throat. Inserted into the cot. The balloon of EP 246,999 is inserted using a gastroscope with integrated forceps.

  U.S. Pat. No. 4,416,267, U.S. Pat. No. 4,485,805, U.S. Pat. No. 4,694,827, U.S. Pat. No. 4,739, the entire contents of which are incorporated herein by reference. No. 758, and US Pat. No. 4,899,747, and European Patent No. 246,999, the balloon is inflated with fluid from a tube that extends down from the patient's mouth. In these patents, balloons are also self-sealing holes (US Pat. No. 4,694,827, the entire contents of which are incorporated herein by reference), injection sites (the entire contents of which are hereby incorporated by reference). U.S. Pat. No. 4,416,267 and U.S. Pat. No. 4,899,747), self-sealing filling valve (U.S. Pat. 485,805), a self-closing valve (European Patent No. 246,999, the entire contents of which are hereby incorporated by reference), or a duckbill valve (the United States of which is hereby incorporated by reference in its entirety). Patent No. 4,739,758). In U.S. Pat. No. 4,723,547, the entire contents of which are incorporated herein by reference, an elongated and thick plug is used and the balloon is threaded through the plug by inserting a needle attached to an air source. Filled by.

  U.S. Pat. No. 4,607,618, the entire contents of which are incorporated herein by reference, relates to a collapsible instrument formed from semi-rigid skeleton members that are connected to form a collapsible hollow structure. Explains. This device is not inflatable. This is inserted endoscopically into the stomach using a specially modified bougie with an ejector rod to release the folded instrument. After being released, the instrument returns to its larger relaxed size and shape.

  In US Pat. No. 5,129,915, the entire contents of which are hereby incorporated by reference, the contents of which are incorporated herein by reference, but are intended to be swallowed and the effect of temperature Related to intragastric balloons that automatically expand underneath. Three ways in which the intragastric balloon can be inflated by changes in temperature are described. Compositions comprising solid acids and non-toxic carbonates or bicarbonates are separated from water by a coating of chocolate, cocoa paste, or cocoa butter that melts at body temperature. Alternatively, alkaline bicarbonate coated with citric acid and a non-toxic vegetable or animal fat that dissolves at body temperature in the presence of water can produce the same result. Finally, the solid acid and non-toxic carbonate or bicarbonate are sequestered from the water by a low strength synthetic material isolation bag that only needs to be broken just prior to swallowing the bladder. Breaking the isolation bag causes the acid, carbonate, or bicarbonate and water to mix, causing the balloon to expand immediately. The disadvantage of inflation-induced heat is that it does not provide the degree of inflation timing control and reproducibility that is desirable in safe self-inflating intragastric balloons.

U.S. Pat. No. 4,133,315 US Pat. No. 5,259,399 US Pat. No. 5,234,454 US Pat. No. 6,454,785 US Pat. No. 4,416,267 US Pat. No. 4,485,805 U.S. Pat. No. 4,607,618 U.S. Pat. No. 4,694,827 U.S. Pat. No. 4,723,547 U.S. Pat. No. 4,739,758 U.S. Pat. No. 4,899,747 European Patent 246,999 US Pat. No. 5,129,915 US Patent Application Publication No. 2010-0100116-A1

  A floating gastric volume occupying device that can be inserted into the stomach by swallowing and peristally delivering into the stomach in the same manner that food is delivered or by positioning with a catheter is desirable.

  Volume occupying devices are provided, as well as methods of manufacturing, deploying, inflating, tracking, deflating, and removing such devices. The devices and methods of preferred embodiments can be employed to treat overweight and obese individuals. The method employing the device of the preferred embodiment can be swallowed by the patient with or without the catheter attached. After entering the patient's stomach, the device is inflated with a preselected gas or gas mixture to a preselected volume. After a predetermined period of time, the device may be removed using an endoscopic tool or volume reduction, or contracted to pass through the remainder of the patient's gastrointestinal tract.

  Inflation can be achieved by the use of a removable catheter that initially remains in fluid contact with the device after being swallowed by the patient.

The volume occupancy subcomponent of the device may be formed by injection molding, blow molding, or rotational molding of a flexible, gas impermeable, biocompatible material such as, for example, polyurethane, nylon, or polyethylene terephthalate. Materials that can be used to control the gas permeability / impermeability of volume occupancy subcomponents include, but are not limited to, silicon oxide (SiO _x ), gold or noble metals, saran when it is desirable to reduce permeability , Conformal coatings, and the like. In order to enhance the gas impermeable properties of the device wall, the volume occupied subcomponent may be further coated with one or more gas barrier compounds, if desired, or to provide a gas impermeable barrier It can be formed from a mylar polyester film coating or kelvalite, silver or aluminum as the metallized surface.

  In a further embodiment, the device employs a delivery state in which the device is packaged so that the device can be swallowed with minimal patient discomfort. In the delivery state, the device can be packaged in a capsule. Alternatively, the device can be coated with a material that is operable to contain the device and facilitate swallowing. Various techniques for facilitating swallowing of the device may also be employed including, for example, wetting, temperature treatment, lubrication, and treatment with pharmaceutical agents such as anesthetics.

  In other embodiments, the device can incorporate a tracking or visualization component that allows the physician to determine the placement and / or orientation of the device within the patient's body. The tracking subcomponent may include incorporating barium stripes or geometric shapes in the walls of the volume occupancy subcomponent. Tracking and visualization can also be achieved by incorporating microchips, infrared LED tags, ultraviolet absorbing compounds, fluorescent or colored compounds, and incorporating metallized strips and patterns into the device's volumetric or other subcomponents. Can be achieved. Such techniques can also be used to obtain specific device-specific information and specifications while the device remains in the patient's body.

  In a first aspect, a system is provided for inflating an intragastric balloon, the system comprising an inflation catheter, wherein the inflation catheter is a hollow needle, a bell-shaped needle sleeve, and inflating the balloon in vivo. An intragastric balloon with a polymer wall comprising a needle assembly with a mechanism for detaching the dilatation catheter after completion, wherein the polymer wall is self-sealing in one or more layers and a holding structure A balloon valve system comprising a septum, wherein the septum is configured to be pierced by a needle, wherein the retaining structure is a smaller inner cylinder containing the septum and inflation for inflation and desorption With a larger outer cylinder that houses a material that provides a compressive force against the bell-shaped needle sleeve of the catheter The material providing the compressive force with the heart valve system is a durometer material that is stiffer than the septum, where the smaller inner cylinder is a valve to the dilatation catheter sufficient to maintain a seal when the balloon is inflated A balloon outer catheter and a dilation source container, wherein the dilation source container includes a lip portion configured to provide an interference fit with the bell shaped needle sleeve to provide a seal of the dilation catheter. An inflation catheter configured to connect, wherein the inflation catheter is connected to the intragastric bar prior to inflation has a size and shape configured to allow swallowing by a patient in need thereof.

  In one embodiment of the first aspect, the polymer wall comprises a barrier material comprising one or more of nylon or polyethylene.

  In one embodiment of the first aspect, the polymer wall comprises a barrier material consisting of nylon / polyethylene.

  In one embodiment of the first aspect, the polymer wall comprises a barrier material consisting of nylon / polyvinylidene chloride / polyethylene.

  In one embodiment of the first aspect, the outer container is selected from the group consisting of push-in capsules, wraps, and bands, wherein the outer container is a material selected from the group consisting of gelatin, cellulose, and collagen. Is provided.

  In one embodiment of the first aspect, the septum is conical.

  In one embodiment of the first aspect, the inflation source container is configured to connect to the inflation catheter via a connector or an inflation valve.

  In one embodiment of the first aspect, the dilatation catheter has a diameter of 1 to 6 French and a length of about 50 cm to about 60 cm.

  In one embodiment of the first aspect, the inflation catheter is a dual lumen catheter comprising an inflation lumen and a desorption lumen, wherein the inflation lumen is fluidly connected to an inflation source container, wherein The desorption lumen is configured to connect to a desorption liquid source container, wherein the desorption liquid comprises a physiologically compatible liquid, wherein the interference fit is after application of water pressure by the desorption liquid. Insufficient to maintain the seal, so that water pressure is released from the balloon valve after being applied to the needle assembly.

  In an embodiment of the first aspect, the dilatation catheter connects a single lumen and structural member that provides increased tensile strength, and a single lumen to the dilation source container and the desorption liquid source container. Wherein the desorption liquid comprises a physiologically compatible liquid, wherein the interference fit is insufficient to maintain a seal after application of water pressure by the desorption liquid So that water pressure is released from the balloon valve after it is applied to the needle assembly.

  In one embodiment of the first aspect, the inner cylinder controls the alignment of the needle assembly and septum, forms a barrier to the needle that pierces the polymer wall, and the septum reseals after reinflation and needle withdrawal. Configured to provide compression.

  In one embodiment of the first aspect, multiple intragastric balloons are connected to a single dilatation catheter.

  In one embodiment of the first aspect, the dilatation catheter has a uniform stiffness.

  In one embodiment of the first aspect, the dilatation catheter has variable stiffness.

  In one embodiment of the first aspect, the inflation source comprises a syringe.

  In one embodiment of the first aspect, the expansion source is configured to provide feedback to the user utilizing information regarding the expansion pressure as a function of time, wherein the feedback is a fault due to mechanical occlusion, FIG. 5 illustrates a condition selected from the group consisting of esophageal restriction disorders, dilatation catheter leakage or desorption disorders, and successful balloon inflation.

  In a second aspect, a method for inflating an intragastric balloon is provided, the method comprising providing the intragastric balloon in an outer container, the intragastric balloon having a polymer wall, wherein one polymer wall is provided. Or a balloon valve system with a self-sealing septum in a holding structure, comprising a plurality of layers, wherein the holding structure resists a smaller inner cylinder that houses the septum and the bell needle sleeve of the inflation catheter. A central valve system with a larger outer cylinder containing a material configured to provide a compressive force, wherein the material providing the compressive force is a higher durometer material than the septum, wherein a smaller inner cylinder Comprises a needle assembly with a bell shaped needle sleeve and a lip configured to provide an interference fit. And a needle assembly comprising a hollow needle, a bell-shaped needle sleeve, piercing the septum with the needle of the dilatation catheter, and thereby a lip of the inner cylinder having a smaller interference fit with the bell-shaped needle sleeve. Causing the intragastric balloon in the outer container attached by an interference fit to the dilatation catheter to be swallowed by the patient in need and the outer container to the intragastric balloon Disassembling to allow for inflation, inflating an intragastric balloon in the patient's stomach via an inflation catheter, wherein the inflation catheter is connected to an inflation fluid source container Desorbing the intragastric balloon from the catheter, wherein the desorbing liquid comprising a physiologically compatible liquid comprises: Forced through the dilatation catheter to apply water pressure to the needle assembly, the interference fit between the lip and bell needle sleeve is broken, the needle assembly is released from the balloon valve, and the self-sealing septum reseals To do.

  In one embodiment of the second aspect, the inflation catheter is a dual lumen catheter comprising an inflation lumen and a desorption lumen, wherein the inflation lumen is fluidly connected to an inflation source container. Where configured, the desorption lumen is configured to connect to a desorption liquid source container for desorption of the balloon.

  In one embodiment of the second aspect, the dilatation catheter includes a structural member that provides increased tensile strength, a single lumen catheter first to the dilation source container, and then a desorption liquid source container for balloon desorption. A single lumen catheter comprising an inflation valve configured to connect to the device.

  In one embodiment of the second aspect, wherein the method further comprises monitoring expansion pressure as a function of time and desorbing when a predetermined end pressure is obtained, wherein Successful balloon inflation is indicated by the achievement of a preselected end pressure based on the starting pressure in the inflation source and the inflation volume of the balloon.

  In a third aspect, a method for deflating an intragastric balloon is provided, the method comprising providing the intragastric balloon in an in vivo intragastric environment, the intragastric balloon comprising a polymer wall and a valve system. The system comprises a self-sealing valve, a casing, an outer sealing member, a rigid retaining structure, and a shrinkable component, wherein the casing has one or more vent passages and an outer sealing member in place. A lip portion configured to hold, wherein the outer sealing member is positioned to occlude one or more vent passages when placed in place, wherein the rigid holding The structure provides support to the septum and the outer sealing member, where the shrink component is installed in the casing and behind the holding structure. Exposing the deflated component to moisture inside the balloon through a plurality of vent passages thereby expanding the deflated component and pushing the holding structure, and thus the outer sealing member, linearly to the casing lip. Deflating the balloon through the one or more vent passages to open the one or more vent passages beyond to provide fluid communication between the in vivo gastric environment and the lumen of the balloon.

  In one embodiment of the third aspect, the shrink component comprises a solute material encapsulated within a binder, wherein the shrink component is further surrounded by a moisture limiting material having a predefined water vapor transmission rate. It is.

  In one embodiment of the third aspect, the solute material is polyacrylamide.

  In one embodiment of the third aspect, the rigid retaining structure and the casing have a press-fit lock that prevents the rigid retaining structure from being expelled from the casing after maximum displacement due to the contracting component.

  In a fourth aspect, a method is provided for deflating an intragastric balloon, the method comprising providing the intragastric balloon in an in vivo intragastric environment, the intragastric balloon comprising a polymer wall, a self-sealing valve system, The shrinkage system comprises a casing, a sealing member, a plunger, and a shrinking component, wherein the casing has one or more vent passages and is secured with a polymer wall. Here, the plunger provides support to the sealing member and maintains the sealing member in place to occlude one or more vent passages in the casing when the contracting component is the casing. Moisture contracting components inside the balloon through one or more vent passages installed in and behind the plunger Exposing and thereby expanding the contraction component, pushing the plunger and thus the sealing member linearly through the casing to open one or more vent passages, and the in vivo gastric environment and balloon lumen Deflating the balloon through one or more vent passages that provide fluid communication therebetween.

  In one embodiment of the fourth aspect, the intragastric balloon further comprises a water retention material installed between the deflation component and the one or more vent passages, wherein the water retention material is a constant moisture content. It is configured to retain water to maintain the environment and to abut the surface of the shrink component.

1 is a perspective view of a head assembly of a self-sealing valve system that houses a self-sealing septum housed in a metal concentric cylinder. FIG. FIG. 3 is a side view of a head assembly of a self-sealing valve system that houses a self-sealing septum housed in a metal concentric cylinder. FIG. 3 is a top view of a head assembly of a self-sealing valve system that houses a self-sealing septum housed in a metal concentric cylinder. FIG. 3 is a cross-sectional view of a head assembly of a self-sealing valve system that houses a self-sealing septum housed in a metal concentric cylinder. The perspective view of a tube system provided with a ring. The side view of a tube system provided with a ring. Sectional drawing of a tube system provided with a ring. The top view of a tube system provided with a ring. This includes smaller cylinders of concentric metal holding structures, similar to the self-sealing valve system of FIGS. 1A-1D, into which a septum can be inserted or manufactured in some other way. Ring stop—similar to the self-sealing valve system of FIGS. 1A-1D, the distance of the inner cylinder to provide additional compression to ensure that the septum material has sufficient density to self-reseal. FIG. 6 is a perspective view of an additional ring that is placed at the distal end. Ring stop—similar to the self-sealing valve system of FIGS. 1A-1D, the distance of the inner cylinder to provide additional compression to ensure that the septum material has sufficient density to self-reseal. FIG. 6 is a side view of an additional ring placed at the top end. Ring stop—similar to the self-sealing valve system of FIGS. 1A-1D, the distance of the inner cylinder to provide additional compression to ensure that the septum material has sufficient density to self-reseal. FIG. 6 is a top view of an additional ring that is placed at the distal end. 1A is a perspective view of a head unit comprising an outer cylinder of a concentric valve housing with a durometer material higher than the inner cylinder, similar to the self-sealing valve system of FIGS. 1D is a side view of a head unit comprising an outer cylinder of a concentric valve housing with higher durometer material than the inner cylinder, similar to the self-sealing valve system of FIGS. 1C is a cross-sectional view of a head unit comprising an outer cylinder of a concentric valve housing with a durometer material higher than the inner cylinder, similar to the self-sealing valve system of FIGS. 1D is a top view of a head unit comprising an outer cylinder of a concentric valve housing with higher durometer material than the inner cylinder, similar to the self-sealing valve system of FIGS. 1 is a perspective view of a ring retainer—additional retaining ring to further enhance the seal between metal and valve silicone, similar to the self-sealing valve system of FIGS. 1B is a side view of a ring retainer—additional retaining ring to further enhance the seal between metal and valve silicone, similar to the self-sealing valve system of FIGS. 1B is a top view of a ring retainer—additional retaining ring to further enhance the seal between metal and valve silicone, similar to the self-sealing valve system of FIGS. The figure which shows the connector of a double lumen catheter. The figure which shows an expansion valve. FIG. 6 shows a universal balloon valve for connecting to an inflation catheter and a balloon contained in an outer container, and showing the valve coupled to the inflation catheter. FIG. 6 shows a universal balloon valve for connection to an inflation catheter and a balloon packaged in an outer container, and a valve further coupled to the packaged balloon. FIG. 6 is a side view of a dual lumen catheter coupled to a gel cap that encapsulates a balloon. FIG. 6 is a bottom view of a dual lumen catheter coupled to a gel cap that encapsulates a balloon. FIG. 6 is a top view of a dual lumen catheter coupled to a gel cap that encapsulates a balloon. The perspective view of a bell shaped needle sleeve. The side view of a bell shaped needle sleeve. The top view of a bell shaped needle sleeve. Sectional drawing of a bell-shaped needle sleeve. FIG. 4 illustrates various embodiments of a single lumen catheter and shows a single lumen catheter with a bell-shaped needle sleeve protecting the needle. 1 is a perspective cross-sectional view of a single lumen catheter showing various embodiments of a single lumen catheter and showing details of the needle, bell needle sleeve, and tension cord. FIG. Single lumen catheter showing various embodiments of a single lumen catheter and showing additional details of the needle and bell needle sleeve when installed in a head including the self-sealing valve system of FIGS. FIG. FIG. 6 is a perspective view of a needle sleeve configured to accept a larger bore tube. FIG. 3 is a side view of a needle sleeve configured to accept a larger bore tube. FIG. 3 is a top view of a needle sleeve configured to accept a larger bore tube. FIG. 3 is a cross-sectional view of a needle sleeve configured to accept a larger bore tube. FIG. 3 shows a variable stiffness catheter for administering an intragastric balloon. FIG. 14 shows an inflation fluid container system (FIG. 14A) including a connector (FIG. 14B) to a catheter and pressure gauge (FIG. 14C). FIG. 14 shows an inflation fluid container system (FIG. 14A) including a connector (FIG. 14B) to a catheter and pressure gauge (FIG. 14C). FIG. 14 shows an inflation fluid container system (FIG. 14A) including a connector (FIG. 14B) to a catheter and pressure gauge (FIG. 14C). The figure which shows a stainless steel expansion | swelling fluid container. The figure which shows the disposable type inflation fluid container with a cap. The figure which shows the disposable type inflation fluid container without a cap. A graph showing pressure (pressure decay) as a function of time, obtained from feedback from an expansion source container. FIG. 6 shows an expected decay curve for a pressure source using a spring mechanism or an intra-balloon balloon mechanism. The figure which shows the expansion fluid dispenser which has isolated. The figure which shows the expansion fluid dispenser connected with the expansion fluid container. 1 shows an inflation system for inflating an intragastric balloon. FIG. The top view of the balloon which shows the structure of the joint of the balloon for manufacturing the balloon which resists bursting in the living body. The side view of the balloon which shows the structure of the joint of the balloon for manufacturing the balloon which resists bursting in the living body. FIG. 4 shows various embodiments of corroding cores for achieving balloon contraction. FIG. 4 shows various embodiments of corroding cores for achieving balloon contraction. FIG. 4 shows various embodiments of corroding cores for achieving balloon contraction. FIG. 4 shows various embodiments of corroding cores for achieving balloon contraction. 22A (perspective view) and 22B (side view) show a corrosive wick with a protective barrier between the wick and the gastric environment. In another embodiment, the seal abuts against the housing in place with a corrosive wick (FIG. 22C). After the wick has corroded (FIG. 22D), the seal is released from contact with the housing. The figure which shows the seal | sticker integrated with the protective canopy. FIG. 5 shows a contraction mechanism that utilizes a corrosive core in a radial ring seal with a compression ring for expelling the seal after support from the corrosive core is removed. The figure which shows the contraction mechanism which utilizes a seal | sticker with a corrosion core and an extrusion spring. The figure which shows the water | moisture-swelling material which pulls out a partition from an appropriate place and shrinks a balloon. FIG. 5 is a compressed view showing a plug in the wall of the balloon containing the compressed pellets or outgassing pellets. FIG. 4 is an expanded view of a gas pellet showing a plug in the wall of the balloon that houses the compressed or outgassing pellet. A top view of the outermost layer of a balloon that has been “scratched” or hatched with a corrosive material to form a small channel that erodes over time. Several layers of material (see details in FIGS. 27A and 27A) that are slowly penetrated by water injected into the inside of the balloon in the manufacturing process or in the inflating process, later causing the rupture of the thin outer protective layer (FIG. 27C). FIG. 28B shows a composite wall of a balloon including FIG. 27B). Several layers of material (see details in FIGS. 27A and 27A) that are slowly penetrated by water injected into the inside of the balloon in the manufacturing process or in the inflating process, later causing the rupture of the thin outer protective layer (FIG. 27C). FIG. 28B shows a composite wall of a balloon including FIG. 27B). Several layers of material (see details in FIGS. 27A and 27A) that are slowly penetrated by water injected into the inside of the balloon in the manufacturing process or in the inflating process, later causing the rupture of the thin outer protective layer (FIG. 27C). FIG. 28B shows a composite wall of a balloon including FIG. 27B). Several layers of material (see details in FIGS. 27A and 27A) that are slowly penetrated by water injected into the inside of the balloon in the manufacturing process or in the inflating process, later causing the rupture of the thin outer protective layer (FIG. 27C). FIG. 28B shows the composite wall of the balloon comprising FIG. 27B), in which water can penetrate the hole. Several layers of material (see details in FIGS. 27A and 27A) that are slowly penetrated by water injected into the inside of the balloon in the manufacturing process or in the inflating process, later causing the rupture of the thin outer protective layer (FIG. 27C). FIG. 28 shows a composite wall of a balloon including FIG. 27B), wherein the balloon may include a weakened area of patch crimp to control the burst placement. FIG. 3 is a top view of a pressure sealed button that is adhesively crimped onto a perforation in a balloon material for deflation. FIG. 3 is a cross-sectional view of a pressure sealed button that is crimped with an adhesive over a perforation in a balloon material for deflation. FIG. 6 is a top view of a connection port in a septum attached to a balloon composite wall, where the port contains a water-soluble or acid-soluble material. FIG. 3 is a perspective view of a connection port in a septum attached to a balloon composite wall, where the port contains a water-soluble or acid-soluble material. FIG. 2 is a perspective view with internal details of a connection port in a septum attached to a balloon composite wall, where the port contains a water-soluble or acid-soluble material. Here is a connection port in a septum attached to a balloon composite wall where multiple ports and channels can be formed in a configuration utilizing an inflatable material and an extrusion component as shown in the system of the figure. FIG. 5 is a perspective view with internal details, wherein the port contains a water-soluble or acid-soluble material. Here is a connection port in a septum attached to a balloon composite wall where multiple ports and channels can be formed in a configuration utilizing an inflatable material and an extrusion component as shown in the system of the figure. FIG. 5 is a cross-sectional view of the port containing a water-soluble or acid-soluble material. FIG. 3 is a cross-sectional view of a mechanism with a seal that closes the outlet, showing a port surrounding the expansion and contraction mechanism in the same arrangement. FIG. 3 is a cross-sectional view of a mechanism with a displaced seal that allows fluid communication through the outlet, showing the ports surrounding the expansion and contraction mechanism in the same configuration. A contour image of a mechanism with a displaced seal allowing fluid communication through the outlet, showing the ports surrounding the expansion and contraction mechanisms in the same arrangement. A contour image of a mechanism positioned to inflate a balloon, showing the ports surrounding the inflated and deflated mechanisms in the same arrangement. Sectional drawing of a contraction mechanism provided with the seal | sticker which obstruct | occludes the discharge port which shows a contraction port. FIG. 3 is a cross-sectional view of a contraction mechanism with a displaced seal that allows fluid communication through the outlet, showing the contraction port. A contour image of a mechanism with a seal that closes the outlet, showing the contraction port. A contour image of a mechanism with a displaced seal that allows fluid communication through the outlet, showing the contraction port. FIG. 3 shows the placement of two balloons in a patient's stomach. FIG. 3 shows an Obalon intragastric balloon assembly. FIG. 34 shows an extension tube and plug with a three-way valve for use with the Obalon intragastric balloon assembly of FIG. FIG. 34 shows a Procedure Canister with a disposable nitrogen filling system for use with the Obalon intragastric balloon assembly of FIG. The figure showing the valve of the procedure canister in the “open” position. The figure which shows the luer lock stopper comprised so that the edge part of the gauge of a procedure canister may be covered. FIG. 4 shows a procedural canister valve in an “open” position and attached to an extension tube. FIG. 5 shows details of an extension tube plug with a three-way valve in the “closed” position. The figure which shows the detail of a disposable nitrogen filling system. FIG. 6 shows a procedural canister with a lever in an “open” position prior to receiving a disposable nitrogen filling system. FIG. 36 shows the procedure canister of FIG. 35 with the lever in a closed position after receiving a disposable nitrogen filling system. FIG. 3 shows a procedural canister valve in a “closed” position and a balloon release syringe and Obalon intragastric balloon assembly attached to an extension tube via a three-way valve. FIG. 4 shows catheter markings employed in connection with the placement of an Obalon intragastric balloon assembly. The figure which shows the connection of the catheter to a procedure canister. FIG. 5 shows details of the plug of the extension tube with the three-way valve in the “open” position. FIG. 3 shows a procedural canister valve in an “open” position and a balloon release syringe and Obalon intragastric balloon assembly attached to an extension tube via a three-way valve. FIG. 5 shows details of an extension tube plug with a three-way valve in the “closed” position.

  The following description and examples detail a preferred embodiment of the invention. Those skilled in the art will appreciate that there are numerous variations and modifications that are within the scope of the invention. Accordingly, the description of a preferred embodiment should not be taken as limiting the scope of the invention.

  The term “degradable (possible)” as used herein is a broad term, given its ordinary and customary meaning to those skilled in the art (with special meaning or special conditions). (But not limited to combined meaning), but not limited, but the structural integrity of the balloon (eg, by chemical, mechanical, or other means (eg, light, radiation, heat, etc.) that causes shrinkage) It refers to the process of being damaged. Degradation processes can include corrosion, dissolution, separation, digestion, disintegration, delamination, grinding, and other such processes.

  The term “swallowing” as used herein is a broad term and given its ordinary and customary meaning to a person skilled in the art (according to a special meaning or special condition). Refers to balloon ingestion performed by the patient so that the outer capsule and its components are delivered to the stomach via normal peristalsis, without limitation. Although the systems of the preferred embodiments are swallowable, they are also configured to be ingested by methods other than swallowing. The swallowability of the system is derived at least in part by the outer container size for the self-inflating system and the catheter and outer container sizes for the manual inflation system. For a self-expanding system, the outer capsule is sufficient to accommodate the inner container and its components, the amount of active agent injected prior to administration, the balloon size, and the balloon material thickness. The system is preferably of a size smaller than the average standard esophageal diameter.

  Described herein are orally ingestible devices. In preferred embodiments, the device can traverse the digestive tract. The device can be useful, for example, as an intragastric volume occupancy device. The device overcomes one or more of the above-mentioned problems and disadvantages found in current gastric volume occupancy devices.

  In order to more clearly explain the subject matter of the preferred embodiment, different embodiments of the same subcomponent are described under a subheading with a single associated title. This organization is not intended to limit the manner in which different subcomponent embodiments may be combined in accordance with the present invention.

[Swallowable intragastric balloon system]
A swallowable self-inflating or inflatable intragastric balloon system according to selected preferred embodiments is a self-sealing valve system (“valve system”) for applying fluid as a component, to the lumen of the balloon, or to the inner container. A balloon in a deflated and compact state (“balloon”) and an outer capsule, container or coating (“outer container”) containing the balloon. For self-inflating balloons, an inner capsule or other container (“inner container”) containing one or more CO ₂ generating components is present inside the lumen of the balloon. For an inflatable balloon, an inflation fluid source, a catheter, and tubing ("inflation assembly") are provided for inflating the balloon after ingestion or placement in the stomach. In a self-expanding balloon configuration, the valve is preferably attached to the inner surface of the balloon by adhesive or other means (eg, welding) to inject the liquid active agent into the lumen of the balloon via the self-sealing valve. An inoculation spacer is provided to prevent puncture of the balloon and inner container wall by other needles or other means. The valve providing releasable attachment of the valve to the balloon is formed with an inflatable balloon configuration. Preferably, a self-sealing valve system attached to a balloon (eg, on its inner surface) in an inflatable configuration is “universal” or compatible with a swallowable catheter or a physician-assisted catheter. The valve system serves to allow balloon inflation using a small catheter that includes a needle assembly, and also includes a mechanism for catheter removal after inflation is complete.

The outer container preferably incorporates the balloon in a compact state (eg, folded and rolled), preferably sufficient to allow the activated liquid to be injected into the balloon in a self-expanding balloon configuration. Where the liquid activator generates CO ₂ upon contact with the separation, erosion, decomposition, and / or dissolution of the inner container and the expansion agent contained within the inner container, after which Initiate separation, corrosion, decomposition, and / or dissolution of the outer container by the pressure of the CO ₂ gas. In an inflatable balloon configuration, the outer container need only incorporate a compact balloon.

  Selected components of the swallowable intragastric balloon system of one preferred embodiment include a silicone head with a radiopaque ring, a trimmed 30D silicone septum, a nylon 6 inoculation spacer, a compressed balloon, and an inner A container (if self-expanding) and an outer container as a component of the unassembled system can be provided. Fully assembled outer container with vents aligned with bulkheads (if self-expanding) for puncturing and injecting liquid activator or ports (if inflatable) for connection with tubing obtain. As described further below, particularly preferred system components have the attributes described herein, but in some embodiments, systems that utilize components having other attributes and / or values. Can be employed.

  The device according to the preferred embodiment is intended for ingestion and deployment by the patient without having to rely on invasive methods. Accordingly, it is desirable that the device of the preferred embodiment be operable to accommodate a compact delivery state that can be swallowed by the patient with minimal discomfort. After entering the stomach, it is desirable for the device to be in a substantially larger deployed state. In order to achieve the transition from the delivery state to the deployed state, the device undergoes an inflation action.

  In order to treat obesity or assist individuals targeting weight loss, various embodiments of the intragastric device described herein are preferably delivered to the patient's stomach and in an inflated state. Preferably maintained in the patient's stomach for at least 30 days. In some embodiments, the expanded intragastric device is maintained in the patient's stomach for a treatment duration of 1 to 3 months, and in some embodiments, the device is in the patient's stomach for up to 6 months or more. Maintained. Multiple intragastric devices may be delivered to the patient's stomach for the duration of treatment. For example, in some embodiments, a maximum of two or more intragastric devices (of the same size or two or more different sizes) may be present in the patient's stomach at some point in time. At the end of treatment, the device can be removed with an endoscope. In other embodiments, the device can contract and pass through the lower gastrointestinal tract. One or more prescription drugs that the patient takes regularly while the inflated intragastric device is in the patient's stomach to maintain proper dilation and reduce patient discomfort and / or side effects Can be prescribed. For example, in some embodiments, proton pump inhibitors, antiemetics, and / or antispasmodics may be prescribed.

[Inner container]
In order to initiate expansion of a self-expanding configuration, the expansion subcomponent may require an external input such as an activator. The activator is preferably injected using a syringe having a needle with a reference diameter of 25 to 32. The needle length preferably produces a flow rate that allows for the delivery of the entire amount of expansion agent within 30 seconds, but in a manner / flow / flow that does not physically damage the inner container, thereby premature CO ₂ generation and It is about 0.25 inches (0.6 cm) to 1 inch (2.54 cm) long to cause expansion. The activator is preferably pure water or a solution containing anhydrous citric acid at a concentration of up to 50% at 20 ° C. or equivalent to that at a variable solution temperature based on the solubility of anhydrous citric acid. Preferably, the system is configured to have an occupying cavity in the central lumen of the balloon when in a compact configuration in an outer container of about 0.3 ml to about 4.5 ml, thereby providing a corresponding amount. The activator can be injected into the cavity.

In one embodiment, prior to folding, the floating inner container with the inflating agent to generate CO ₂ is preferably self-sealing so that the septum / intake spacer is placed directly over the tip of the capsule. Aligned vertically with the stop valve system. The balloon houses the inner container. The self-sealing valve system is glued to the inside of the balloon wall, and the inversion configuration of the balloon is effected by inversion through a patch-sealed hole. About 1/4 of the top of the balloon wall is folded over the inner capsule, and the fold where the capsule is located is creased in the same way as the fold formed in the second step of making the paper airplane, then to the left Or folded to the right. The bottom of the sphere, about 3/4, is then bellowed using no more than two folds and folded over the capsule. The left half is then folded over the right half of the capsule, or vice versa, so that the wing touches. The material is then wound until it becomes a tightly wound single roll. The device is then placed inside the outer container.

  In a self-expanding configuration, the balloon is folded to form a pocket around the inner capsule, ensuring that the liquid injected through the self-sealing valve system is contained in an area that is less than 10% of the total surface area of the balloon. To. Since no inner capsule is provided, it is not necessary to form a pocket in an inflatable configuration. The balloon is folded to minimize the total number of folds, thereby minimizing any damage or barrier properties that can occur to the outer material. The number of total folds is preferably less than 10. The balloon material is wrapped so that the number of folds required to fit the balloon into the outer container is minimized if possible. This is done in an attempt to prevent damage to the lumen material. The self-sealing valve is preferably fabricated off the center of the balloon so as to minimize the number of folds layered on top of each other.

In a self-expanding configuration, the material that forms the wall of the balloon maximizes reaction efficiency by localizing the initiator injected into the balloon so that it is maintained close to the reactants in the inner container. Are processed and folded. The balloon expands to create the maximum possible surface area from the folded state after the reaction begins and the outer container separates, preventing the balloon from easily passing through the pyloric sphincter Folded. The ratio of the reactants in the initiator to the activator is such that the pH of the residual liquid inside the balloon lumen is acidic and the pH is less than 6, allowing for leakage of the balloon or allowing gastric acid to enter. The tear is selected such that it does not cause additional CO ₂ generation and the resulting unintentional re-expansion.

In a self-expanding configuration, the inflating agent is compressed or formed into a shape that increases the surface area utilization for the CO ₂ generating reactant while minimizing the shape and / or volume sufficient to hold the inner container. Or held in some other way. Preferably, the inner container is about 0.748 inches (1.9 cm) to 1.06 inches (2.7 cm) long (longest dimension) and about 0.239 inches (0.6 cm) to about 0. A diameter or width of 376 inches (1 cm). The volume of the inner container is preferably from about 0.41 ml to about 1.37 ml. The inner container is preferably in the form of a standard push-in gelatin capsule, although gelatin tape can be used in place of the push-in capsule. To accommodate the swelling agent, preferably relies on a container, but additional seals or other encapsulations may be employed to control the timing of inflation. Gelatin is particularly preferred for use as an inner container, but other materials may be suitable for use, for example, cellulose. In order to minimize the internal volume of the system, it is generally preferred to include only a single inner container, but in some embodiments, two or more inner containers may be advantageously employed. . The timing of self-inflation is selected based on the normal esophageal transit time and the normal time of gastric emptying of large food particles, so the balloon can occlude the esophageal passage or pass quickly through the pyloric sphincter It does not expand to a size that can be lost. Timing is also controlled by compacting the balloon so that the activator is substantially localized within the balloon next to the inner capsule, which constitutes an efficient CO ₂ self-inflation method. Balloon inflation is initiated by the liquid activator, causing the inner container to decompose, thereby causing the expander in the inner container to contact the liquid activator, thereby initiating a gas generating reaction.

[Expansion assembly]
In some preferred embodiments, the volume occupancy subcomponent is subsequently desorbed and filled with fluid using tubing that is detached from the volume occupancy subcomponent. One end of the volume occupancy subcomponent has a port connected to a length of tubing that can span the entire length of the esophagus from the mouth to the stomach when unwound. This tubing is connected to the volume occupancy subcomponent with a self-sealable valve or septum that can be pulled away from the volume occupancy subcomponent and the self-seal after the volume occupancy subcomponent is inflated. A doctor or other medical professional secures one end of the tubing as the patient swallows the device. After the device settles in the stomach, the physician uses a tube to transfer fluids such as air, nitrogen, other gas (s), saline, pure water, or the like into the volume-occupied subcomponent Feed and inflate it. After the volume occupancy subcomponent is fully inflated, the tubing is released and can be withdrawn from the patient's body.

  The tube can be released in a number of ways. For example, the tubing can be detached by applying a slight force or pulling on the tubing. Alternatively, the tubing can be detached by actuating a release means at a remote location, such as a magnetic or electronic release means. Alternatively, the tubing can be released from the volume occupancy subcomponent by an automatic release mechanism. Such a release mechanism can be activated by the internal pressure of the expanded volume occupying subcomponent. For example, the release mechanism may be sensitive to a particular pressure, above which it opens to release excess pressure and simultaneously release the tube. This embodiment provides the desired function through a combination of a safety valve and tubing release that serves to avoid accidental overexpansion of the volume occupancy subcomponent in the patient's stomach.

  This automatic release embodiment also provides the advantage that the device expansion step can be monitored and controlled more precisely. Current technology generally considers a self-expanding gastric volume occupancy subcomponent that begins to expand within a 4 minute time frame after being injected with an activator such as citric acid. In this approach, the volume occupancy subcomponent, in some cases, begins to swell before it settles in the stomach (eg, in the esophagus) or suffers from gastric dumping syndrome or rapid gastric emptying disease In the patient, the volume occupancy subcomponent can end in the small intestine before the time when swelling occurs. Thus, in some embodiments, it may be desirable to inflate the volume occupancy subcomponent with instructions after confirming that the volume occupancy subcomponent is settled in the correct placement.

  In some embodiments, it may be advantageous for the volume occupancy subcomponent to expand step by step or over time. For example, if the gas escapes from the volume occupancy subcomponent before the desired expansion time is reached, it may be advantageous for the device to re-expand to remain expanded.

[Outside container]
The balloon is preferably provided in a deflated and folded state within a capsule or other holding, containing, or coating structure (“outer container”). The outer container is preferably in the form of a standard push-in gelatin capsule and relies on push to accommodate the deflated / folded balloon, although gelatin wrap is advantageously employed in some embodiments. Can be done. Gelatin is particularly preferred for use as an outer container, although other materials may be suitable for use, for example, cellulose, collagen, and the like. Preferably, the outer container is about 0.95 inches (2.4 cm) to 2.5 inches (6.3 cm) long (longest dimension) and about 0.35 inches (0.9 cm) to about 0. .9 inches (2.4 cm) in diameter or width. The volume of the outer container for the self-expandable version is preferably from about 1.2 ml to about 8.25 ml. In a self-expanding configuration, the outer container is preferably configured with one or more holes, slits, passages, or other outlets, preferably on each end, so that the expansion agent is present during processing. Premature separation of the inner container prior to 30 seconds after inoculation with the liquid activator, or the gas produced by exposure to condensate or other environmental moisture may adversely affect reaction efficiency, or It can work as an outlet so as not to cause decomposition. Such an outlet may also facilitate dissolution of the outer container in preparation for balloon inflation in an inflatable configuration. The process of disintegration of the outer capsule (eg, separation, dissolution, or some other form of opening) is facilitated by an increase in pressure caused by balloon inflation (self-inflation or inflation through a catheter). The outer capsule softens the material to reduce the time that elapses between swallowing and balloon inflation, but can be soaked in water for a short time so as not to release the balloon. In the inflatable configuration, the outer container includes a hole to accommodate the inflation tube needle assembly, wherein the diameter of the catheter needle housing includes a balloon that is accommodated to facilitate pushing or swallowing of the balloon assembly. It is mechanically matched to the diameter of the outer container hole so that the needle is inserted into the self-sealing valve while maintaining it. In a preferred embodiment, the outer container is a capsule. The distal half of the capsule can be flared to prevent wear of the balloon material due to the leading edge of the capsule when the compacted balloon is inserted into the capsule. The capsule may also include a folded balloon that is also provided with two portions that are held together with a gel band, allowing for faster separation of the capsule so that inflation occurs more quickly. The outer capsule breaks down (eg, separates, dissolves, or opens in some other way) upon contact with the ingested fluid intake (eg, ingested water), preferably with the balloon / catheter tube in place For some time it will degrade within 5 minutes, more preferably within 2 minutes, so as not to cause discomfort to the patient.

  In a preferred embodiment, the device is fitted into a standard size gelatin capsule. The capsule may be formed from a material having a known rate of degradation so that the device is not released from the capsule before it enters the stomach or is otherwise deployed. For example, the encapsulant material may include one or more polysaccharides and / or one or more polyhydric alcohols.

  Alternatively, the device may be coated with a substance that limits the device to its delivery state while also facilitating swallowing in its delivery state. The coating can be applied by dipping, sputtering, vapor deposition, or spraying processes that can be performed at ambient or positive pressure. The balloon can also be encapsulated by wrapping a gelatin tape around the balloon and then placing the wrapped balloon in the capsule if desired to do so.

  In some preferred embodiments, the encapsulated or coated device is lubricated or otherwise treated to facilitate swallowing. For example, the encapsulated or coated device can be wetted, heated, or cooled prior to swallowing by the patient. Alternatively, the encapsulated or coated device can be immersed in a sticky material that serves to lubricate the esophageal passage of the device. Examples of possible coatings may be substances having lubricious and / or hydrophilic properties, which are glycerin, polyvinylpyrrolidone (PVP), petrolatum, aloe vera, silicon-based materials (eg Dow 360), And tetrafluoroethylene (TFE). The coating can also be applied by sputtering, vapor deposition, or spraying processes.

  In additional embodiments, the coating or capsule is impregnated with or treated with one or more local anesthetics or analgesics to facilitate swallowing. Such anesthetics may include aminoamide group anesthetics such as articaine, lidocaine and trimecine and aminoester group anesthetics such as benzocaine, procaine and tetracaine. Such analgesics can include chloraceptic.

  In some embodiments, the capsule is at a particular end so that it is properly oriented when administered, moving down the esophagus, and / or when in the stomach. By the way, it can be weighted. The weighting component can include a polymeric material or an expanded reactant.

The swallowable self-expanding intragastric balloon is self-expanding to ensure early inflation while in the esophagus during swallowing and to ensure sufficient expansion to prevent passage through the pyloric sphincter after entering the stomach. A mechanism for reliably controlling the timing of expansion is provided. The normal esophageal transit time for large food particles is described in the literature as 4-8 seconds, and no gastric emptying of large food particles through the pylorus occurs for at least 15-20 minutes. The outer container is preferably separated, dissolved, broken down, eroded, and / or in some other form of deflated / folded balloon more than 60 seconds and within 15 minutes after inoculation with the liquid activator It is configured to allow it to begin to spread out from being folded into. The inner container is preferably sufficient CO ₂ can delay the initial CO ₂ generating chemical reaction so as not to available earlier than 30 seconds after the inoculation with a liquid activator to begin inflating the balloon At least 10% of the balloon's occupant volume is filled within 30 minutes, at least 60% of the balloon's occupant volume is filled within 12 hours, and at least 90% of the balloon's occupant volume is within 24 hours It is constructed chemically, mechanically, or a combination thereof so as to allow generation of sufficient CO ₂ so that it can be filled in. This timing allows the medical professional to inject the activator into the outer container, pass the device to the patient, and swallow the patient with normal peristaltic means. This timing also allows an uninflated balloon to potentially become a duodenum because the balloon is inflated to a sufficient size so that gastric emptying of the balloon is not facilitated because objects larger than 7 mm in diameter do not pass easily. It also prevents you from getting inside.

[Delivery component]
In some embodiments, it may be advantageous for the device administrator to use a delivery tool to deliver the device to the mouth or to facilitate optimally oriented esophageal passage. The delivery tool may allow the device administrator to inject the device with one or more swelling agents when the device 10 is being administered to a patient. In a preferred embodiment, such infusion can be accomplished with the same mechanical action (s) of the employer employed to release the device from the delivery tool and enter the mouth or esophagus. For example, the delivery tool can include a plunger, a reservoir with liquid, and an injection needle. The admin, either in sequence or nearly simultaneously, pushes the needle into the device with force, thereby pushing the plunger that injects the liquid contained in the reservoir into the device. Subsequent application of force to the plunger pushes the device out of the delivery tool and into the desired position within the patient. In addition, the delivery tool can also include a subcomponent that administers an anesthetic or lubricant into the patient's mouth or esophagus to reduce the swallowability of the device.

[balloon]
The volume occupying subcomponent (“balloon”) of the preferred embodiment is generally formed from a flexible material that forms a wall that defines an outer surface and an inner cavity. Various of the above-described subcomponents can be incorporated into either the wall or internal cavity of the volume occupancy subcomponent. As shown, the volume occupancy subcomponent may vary in size and shape depending on the patient's internal method and the desired outcome. The volume occupancy subcomponent may be designed to be semi-compliant, thereby allowing the volume occupancy subcomponent to expand or expand with increasing pressure and / or temperature. Alternatively, in some embodiments, a compliant wall that has little resistance to volume increase may be desirable.

  A spherical or ellipsoidal volume occupation subcomponent is preferred in some embodiments. Alternatively, the volume-occupiing subcomponent is fabricated to be a donut shape with a hole in the middle and, like a check valve, is weighted to take an orientation in the stomach that covers all or part of the pyloric sphincter And can be shaped. The central hole in the volumetric subcomponent then acts as a temporary passage for stomach contents as they enter the small intestine, restricting the passage of food out of the stomach and inducing satiety by reducing gastric emptying can do. The volume occupancy subcomponent can be manufactured with different sized donut holes according to the degree to which gastric emptying is desired to be reduced. Delivery, expansion, and contraction of the volume occupancy subcomponent can be accomplished by any of the methods described above.

  In some embodiments, it is advantageous for the volume occupancy subcomponent wall to have both high strength and thinness, thereby minimizing the compacted volume of the device as it passes through the patient's esophagus. In some embodiments, the wall material of the volume occupied subcomponent is manufactured to have a biaxial orientation that imparts a high modulus value to the volume occupied subcomponent.

  In one embodiment, the volume occupancy subcomponent is made of a polymeric material such as polyurethane, polyethylene terephthalate, polyethylene naphthalate, polyvinyl chloride (PVC), nylon 6, nylon 12, or polyether block amide (PEBA). It is done. The volume occupancy subcomponent may be coated with one or more layers of a material that modifies (increases, decreases, or changes over time) gas barrier properties, such as a thermoplastic material.

Preferably, the gas barrier material has low permeability to carbon dioxide or other fluid that can be used to expand the volume occupancy subcomponent. The barrier layer should have good adhesion to the base material. Preferred barrier coating materials are biocompatible poly (hydroxyaminoether), polyethylene naphthalate, polyvinylidene chloride (PVDC), Saran, ethylene vinyl alcohol copolymer, polyvinyl acetate, silicon oxide (SiO _x ), acrylonitrile copolymer Or a copolymer of terephthalic acid and isophthalic acid with ethylene glycol and at least one diol. Alternative gas barrier materials may include polyamine polyepoxides. These materials are usually obtained as solvent or aqueous based thermosetting compositions and are generally spray coated onto a preform and then heat cured to form the final barrier coating. Alternative gas barrier materials that can be applied to the volume occupancy subcomponent as a coating include metals such as silver or aluminum. Other materials that can be used to improve the gas impermeability of the volume occupancy subcomponents include, but are not limited to, gold or noble metals, saran coated, such as listed in Tables 1a-b Includes PET, conformal coatings, and the like.

  In some preferred embodiments, the volume occupancy subcomponent is injection molded, blow molded, or rotational molded. Either immediately after such molding or after curing for a period of time, the gas barrier coating can be applied if not already applied within the composite wall.

  In another embodiment, the gastric volume occupancy subcomponent is formed using Mylar polyester film coated silver, aluminum, or Kelvalite as the metallized surface to improve the gas impermeability of the volume occupancy subcomponent.

  If the wall of the volume occupancy subcomponent consists of multiple layers of material, it may be necessary to connect, attach, or hold together such multiple layers using several substances or methods. Such materials can include solvents or ether-based adhesives. Such multiple layers can be crimped by heat sealing. After such layers are attached together to form a sheet of material that will be (for example) a volume-occupied subcomponent, additional treatment steps are applied to such material (eg, some heat and pressure). Can be sealed together and made into volume-occupying subcomponents. Thus, it may be advantageous to include some material that seals within the volume occupied subcomponent as an additional layer. For example, a volume occupancy subcomponent consisting of a combination of PET and SiOx layers that imparts advantageous mechanical and gas impervious properties to the volume occupancy subcomponent may be a polyethylene sealable within such a volume occupancy subcomponent. It can be sealed by including a layer.

  According to another of the preferred embodiments, the functions of the volume occupancy subcomponent and the contraction component are combined either in part or in whole. For example, the volume occupancy subcomponent may be formed from a material that degrades in the stomach over a desired period of time. After the degradation process forms a tear in the wall of the volume occupancy subcomponent, the volume occupancy subcomponent contracts, continues to decompose, and passes through the remainder of the digestive tract.

  Preferably, an automated process is employed that receives a fully configured volume occupancy subcomponent, exhausts any air in the internal cavity, and folds or compresses the volume occupancy subcomponent to the desired delivery state. For example, exhausting air from the volume occupancy subcomponent can be actuated by vacuum or mechanical pressure (eg, rolling the volume occupancy subcomponent). In some embodiments, it is desirable to minimize the number of folds created in the volume occupancy subcomponent when in delivery.

  In another embodiment, contraction of the volume occupancy subcomponent may be achieved through one or more injection sites in the wall of the volume occupancy subcomponent. For example, two self-sealing injection sites can be incorporated on opposite sides of the volume occupancy subcomponent. The volume occupancy subcomponent may be positioned in a fixture that employs two small gauge needles to exhaust air from the volume occupancy subcomponent.

  In one embodiment, the self-sealing injection site can be further used to insert the chemical component of the expansion subcomponent within the interior of the volume occupancy subcomponent. After injecting the chemical element into the volume occupancy subcomponent, the same needle can be used to perform the ejection of the volume occupancy subcomponent.

  The volume occupancy subcomponent may be desirable to be packed and delivered, for example, under negative vacuum pressure or under positive external pressure.

  The material of the volume occupying subcomponent wall can also be designed to rip relatively easily from the point of such puncture or tear after first puncturing or tearing. Such a characteristic is, for example, that if the shrinkage of the volume occupancy subcomponent is initiated by a tear or puncture of the volume occupancy subcomponent wall, such initial tear or puncture then widens the range and speeds up the shrinkage process. And / or maximized, which may be advantageous.

  The volume occupancy subcomponent can also be coated with a lubricating material that facilitates exiting the body following its contraction. Examples of possible coatings may be substances having lubricious and / or hydrophilic properties, which are glycerin, polyvinylpyrrolidone (PVP), petrolatum, aloe vera, silicon-based materials (eg Dow 360), And tetrafluoroethylene (TFE). The coating can be applied by dipping, sputtering, vapor deposition, or spraying processes that can be performed at ambient or positive pressure.

The material of the balloon composite wall may be similar in structure and composition as described in US Patent Publication No. 2010-0100116-A1, which is incorporated herein by reference. These materials are fluids, preferably N ₂ , Ar, O 2, CO ₂ , or mixtures thereof, or the atmosphere (N ₂ , O ₂ , Ar, CO ₂ , Ne, for simulating gastric space concentrations, for example. , CH ₄ , He, Kr, H ₂ , and a mixture of Xe) or the like. In some embodiments, the balloon can retain fluid (gas) and maintain an acceptable volume for up to 6 months after inflation, preferably for at least 1 to 3 months. Particularly preferred fill gases include nonpolar macromolecular gases that can be compressed for delivery.

  Prior to placement in the outer container, the balloon is deflated and folded. In the inverted configuration of the deflated state, the balloon is flat and the inverted seam extends over the outer circumference of the balloon. The self-sealing valve system is affixed to the inner wall of the lumen near the center of the deflated balloon and the inner container is positioned adjacent to the self-sealing valve system. The balloon wall is then folded. As part of the balloon design, the self-sealing valve system “off-center” to minimize the number of folds (eg, double or triple) that it takes to fit the balloon into the outer container. And is preferably manufactured in such a manner that it is indwelled. For example, the self-sealing valve system may be advantageously placed at 1 / 2r ± 1 / 4r from the center of the balloon, where r is a straight line exiting the balloon center and passing through the septum. Is the radius of the balloon along.

Tracking and visualization subcomponent
It may also be beneficial to implement tracking and visualization functions according to the present invention in a device. Due to the non-invasive nature of the device of the present invention, the physician may wish to determine or confirm the placement and orientation of the device prior to inflation or during the course of treatment.

  X-ray imaging markers may be applied to the volume occupancy subcomponent when the volume occupancy subcomponent is in a creased or folded state, so that the volume occupancy subcomponent is in a contracted state. At some point, the marker appears dark when displayed on the visualization device, and when the volume occupancy subcomponent is deflated, the marker appears to be less dark when displayed on the visualization device. Alternatively, markers are applied or incorporated at multiple locations within the volume occupancy subcomponent, thereby identifying the various subcomponents of the device, such as valves, heads, or weights, and The arrangement can be made smooth. The markers can be printed or painted on the surface of the volume occupancy subcomponent or between layers of material forming the volume occupancy subcomponent. Alternatively, a metal coating as described below can be used as a marker to identify and / or position the volume occupancy subcomponent. The metal coating for visualizing the volume occupancy subcomponent can include silver, gold, tantalum, or any precious metal. Alternatively, the marker can be applied to an elastomeric sleeve that covers all or part of the volume occupancy subcomponent.

  In another embodiment, the volume occupancy subcomponent incorporates subcomponents that change mechanically after expansion of the volume occupancy subcomponent, and mechanical changes can be visualized using X-rays or other visualization devices. For example, the mechanical portion of the volume occupancy subcomponent that includes the visualization marker can stretch after an increase in pressure within the volume occupancy subcomponent.

  Alternatively, the markers can be formed using a metallized mesh placed between layers of material used when the volume occupancy subcomponent is fabricated. The pattern or patterns formed by the implanted marker are visible when the volume occupancy subcomponent is in an expanded state.

  It is contemplated that the marker material can be incorporated within the volume occupancy subcomponent to facilitate various visualization techniques such as, for example, MRI, CT, and ultrasound.

  The volume occupancy subcomponent may also include a dye or marker that is released after contraction to indicate that the cavity of the volume occupancy subcomponent has been breached. Such a dye or marker, for example, may be visible in the patient's urine as an indication that the volume occupancy subcomponent has begun to contract.

  In further embodiments, microchips and other components that employ electronic modalities can be used to position and identify the device. A microchip similar to that used for pet identification can be used to convey device-specific information and its approximate location. For example, Wheatstone or other bridge circuitry is incorporated into the device and, in conjunction with RF “ping and listen” technology, determines the approximate placement of the device and as part of the system to measure and communicate device-specific information. Can be used. Such device specific information may include the internal pressure of the volume occupied subcomponent, which can indicate the degree of expansion of the volume occupied subcomponent.

  In further embodiments, mechanical, chemical, visual, and other sensors are part of the device to measure, record, and / or transmit information related to the device and / or the patient's internal environment. Can be included as For example, the device may include any of a camera or other imaging and transmission components of a Pillcam device. As an additional example, the device may contain sensors that measure, record, and / or transmit information related to gastric pH, gastric pressure, hormone levels, organ health, and organ safety. it can.

[Valve system]
In preferred embodiments, the self-sealing valve system is “universal” or attached to a balloon (eg, on its inner surface) that is compatible with swallowable and physician-assisted catheters. The valve system serves to allow balloon inflation using a small catheter that includes a needle assembly, and also includes a mechanism for catheter removal after inflation is complete.

  1A-1D are diagrams representing the design of a self-sealing valve system that houses a self-sealing partition housed in a metal concentric cylinder. In the inflatable configuration, the self-sealing valve system is preferably adhered to the underside of the balloon so that only a portion of the valve protrudes slightly outside the surface of the balloon and the surface is smooth. The valve system for the inflatable configuration can utilize the same self-sealing septum designed for the self-expanding configuration. The septum is preferably made of a material having a durometer of 20 Shore A to 60 Shore D. The septum is inserted into a smaller cylinder of a concentric metal holding structure (FIGS. 2A-2D), preferably cylindrical in shape, or is made in some other way. The smaller cylinder within the larger cylinder controls the alignment of the catheter needle sleeve / needle assembly with the septum, provides a stiff barrier (needle stop mechanism) that prevents the catheter needle from puncturing the balloon material, and the valve / septum Is compressed so that it reseals after expansion and subsequent needle removal.

  The concentric valve system may also be radiopaque when implanted, preferably titanium, gold, stainless steel, MP35N (non-magnetic, nickel cobalt chrome molybdenum alloy), or the like. Non-metallic polymer materials such as acrylic, epoxy, polycarbonate, nylon, polyethylene, PEEK, ABS, or thermoplastic elastomers or heat manufactured to be visible under PVC or X-ray (eg embedded with barium) Plastic polyurethanes can also be used.

  The septum can be conical, so the compressive force is maximized to self-seal after expansion. The self-sealing septum allows air to be expelled from the balloon for processing / compacting and insertion into the outer container, and an inflation agent needle (self-expanding configuration) or an inflation catheter needle (expandable configuration) Puncture, followed by withdrawal of the inflation agent injection needle or removal of the inflation catheter and removal of the catheter needle and needle withdrawal / desorption that significantly limits gas leakage outside the balloon during the inflation process. The septum is inserted into the valve using a mechanical fitting mechanism to effect compression. An additional ring (FIGS. 3A-3C) is placed at the distal end of the inner cylinder, thereby providing additional compression and ensuring that the septum material is pre-loaded to self-reseal. be able to. The ring is preferably metal in nature, but may be acrylic, epoxy, or non-metallic polymeric materials such as thermoplastic elastomers or thermoplastic polyurethanes. The ring material is preferably the same material as the cylinder, titanium, but may be gold, stainless steel, MP35N, or the like.

  In the inflatable configuration, the larger outer cylinder (FIGS. 4A-4D) of the concentric valve housing contains a slightly stiffer durometer material (50 Shore A or higher) than the inner cylinder, but is preferably also silicone. The purpose of using a stiffer durometer material is to ensure a seal when connected to the needle sleeve for expansion. Silicone placed in the outer ring of the concentric valve is adhered to the balloon from the inner surface. The entire outer cylinder is filled and a small circular lip of this same material is provided that extends slightly to the outer surface of the balloon, slightly larger than the diameter of the inner cylinder. The lip is compatible with the bell-shaped needle sleeve, provides a seal that enhances the connection between the valve and the catheter to withstand the applied inflation pressure, and also increases the discharge distance or attachment force of the catheter. The silicone lip preferably does not protrude beyond 2 mm from the balloon surface to ensure that the balloon surface remains relatively smooth and does not cause mucosal wear or ulceration. It is designed to apply a compressive force to the catheter needle sleeve for inflation and desorption, so that when connected to the inflation catheter needle sleeve, the connection coupling is preferably inflated. Sometimes it can withstand a pressure of 35 PSI. The seal is then broken upon desorption using a water pressure preferably greater than 40 PSI and less than 200 PSI to separate the coupling. An additional retaining ring (FIGS. 5A-5C), preferably made of the same material as the concentric valve, is provided in the valve system, thereby enhancing the seal between the metal and the silicone of the valve and providing appropriate It is intended to provide additional mechanical support to ensure mechanical fit and to prevent displacement of the silicone material from a rigid (metal) valve system (causing increased tension).

  The valve structure for the inflatable configuration uses a mechanical mating mechanism to achieve the function of a self-sealable valve for catheter inflation and subsequent catheter detachment, but with primers and / or adhesives Can be used to provide additional support during assembly fabrication. The configuration is modified by modifying the surface of the metal component, thereby making it sticky or slippery, e.g., making it easier or less difficult to adhere, providing the desired mechanical / tight fit. Can bring. The interference fit between the valve and the catheter can be modified to change the pressure requirements for inflation and / or desorption. The additional assembly is a metal part or concentric system with silicone so that an additional support ring can be omitted to ensure mechanical fit and tensile strength and the force required to maintain the assembly during catheter inflation and desorption Overmolding.

  All valve dimensions in the inflatable configuration are designed to fit into small catheter systems that do not exceed 8 French in diameter (2.7 mm, 0.105 inches). To facilitate swallowing, the total diameter does not exceed 1 inch (2.54 cm) and is preferably less than 0.5 inch (1.27 cm). Although additional valves can be added, it is generally preferred to employ a single valve to keep the volume of the deflated / folded balloon (and thus the outer container dimensions) as small as possible. The valve system is preferably attached to the balloon and crimped so that a shear force in excess of 9 lbs (40 N) is required to remove the valve system.

In a self-expanding configuration, the valve system can be attached to the balloon (eg, on its inner surface) without using openings, orifices, or other conduits within the balloon wall. The valve system can utilize a septum having a durometer of 20 Shore A to 60 Shore D. The valve may be inserted into a holding structure having a higher durometer, e.g., 40 Shore D to 70 Shore D or higher, or made in some other way. The retaining structure can be made from a suitable non-metallic polymeric material such as silicone, rubber, soft plastic, or acrylic, epoxy, thermoplastic elastomer, or thermoplastic polyurethane. A structure, such as a ring, that is preferably metallic or non-metallic but has radiopacity (eg, barium) and is visible under x-rays can be embedded within the retaining structure. By using the mechanical mating mechanism of two structures of different durometers, a softer one with larger diameter (partition) is neatly inserted, and a higher durometer structure is placed in an orifice once opened A compressive force can be generated to enable CO ₂ retention and reduce sensitivity to CO ₂ gas leakage. A metal ring against radiopacity also helps to maintain the compressive force on the septum. The self-sealing septum allows air to be expelled from the balloon for processing / compacting and insertion into the outer container, and an inflating agent is inserted into the outer container to initiate inflation Also make it possible. Although additional septa can be provided if necessary, it is generally preferred to employ a single septum to minimize the volume of the deflated / folded balloon (and thus the outer capsule) as small as possible. . The valve system is preferably mounted inside the balloon such that a shear force of over 9 lbs (40 N) is required to disengage the valve system. The silicone head and radiopaque ring of the self-sealing valve system can be employed like a wedge shaped septum.

In a self-expanding configuration, the inoculation spacer is preferably incorporated, which guides the needle into the self-sealing valve to inject liquid activator into the balloon lumen and the needle contracts elsewhere. Incorporated to prevent the pressure inside the lumen of the balloon from being maintained through the wall of the punctured / folded balloon. The inoculation spacer prevents the liquid activator from penetrating the inner container or the folded balloon material, thereby concentrating the activator in an appropriate manner and producing CO ₂ according to the criteria described above. It also facilitates proper mixing of the reactants. The inoculation spacer generally takes the form of a tube or cylinder. The inoculation spacer is preferably attached to the inner container and / or self-sealing valve system with an adhesive or other securing means, but in some embodiments, the inoculation spacer may be "floating" Can be maintained in place by folding or rolling the wall of the balloon. The inoculation spacer can comprise any suitable material that can be passed after separation, corrosion, degradation, digestion, and / or dissolution of the outer container, although preferred materials are non-metallic materials having a minimum Shore D durometer of 40 or more , Metallic materials, or combinations thereof. A cup-shaped needle stop (inoculation spacer) may be employed in the preferred embodiment.

[balloon]
In a preferred embodiment, the self-inflating balloon is completely sealed around 360 degrees. In the self-expanding configuration, when infusing the inflating agent with a needle syringe, there is preferably no external opening or orifice to the central lumen. In the inflatable configuration, a valve structure (protruding, recessed, or flush with the surface of the balloon) is provided to deliver inflation fluid to the central lumen. The balloon may take a “non-inverted”, “inverted”, or “superposed” configuration. In the “non-inverted” configuration, the seam or weld and seam edge, if any, are outside the inflated balloon. In the “overlap” configuration, the layers are overlaid and optionally provided with one or more folds and secured together via welds, seams, adhesives, or the like, so that a smooth outer surface is achieved. It is formed. In the “inverted” configuration, the balloon has a smooth outer surface with seams, welds, adhesive beads, or the like inside the inflated balloon. To create a balloon in an inverted configuration, such as a balloon without an outer seam edge (no balloon material between the balloon edge and the weld, seam, or other feature that joins the sides) The two halves are joined together in some way (eg, glued using glue or heat or the like based on the balloon material used). One of the two halves of the balloon includes an opening that allows the balloon to be pulled through itself after bonding the two halves so that the balloon seam is inside. The formed opening is preferably circular but may be of a similar shape, and the diameter of the opening is preferably 3.8 cm or less, but in some embodiments a larger diameter. May be acceptable. A patch of material is glued (with an adhesive based on the material used, with heat welding, or similar means) covering the half opening of the original balloon. The reversal holes thus formed that are subsequently patched are small enough that the force applied during inflation does not damage the material used to maintain the fluid in the balloon. The preferred shape of the inflated balloon in the final assembly is an ellipsoid, preferably a spheroid or oblate, with a nominal radius of 1 inch (2.5 cm) to 3 inches (7.6 cm) and a nominal height The thickness is from 0.25 inch (0.6 cm) to 3 inches (7.6 cm), the volume is from 90 cm ³ to 350 cm ³ (37 ° C., internal nominal pressure and / or full expansion) and the internal nominal pressure (37 ° C) is from 0 psi (0 Pa) to 15 psi (103421 Pa) and the weight is less than 15 g. The self-inflating balloon is configured to self-inflate with CO ₂ and is configured to retain more than 75% of the original nominal volume for at least 25 days, preferably at least 90 days, when remaining in the stomach. The inflatable balloon is adapted to deliver a preselected volume profile over a preselected time period (including one or more of a volume increase period, a volume decrease period, or a steady state volume period). Configured to swell with a fresh mixture.

The preferred shape of the inflated balloon in the final assembly is an ellipsoid, preferably a spheroid or oblate, with a nominal radius of 1 inch (2.5 cm) to 3 inches (7.6 cm) and a nominal height The thickness is from 0.25 inch (0.6 cm) to 3 inches (7.6 cm), the volume is from 90 cm ³ to 350 cm ³ (37 ° C., internal nominal pressure and / or full expansion) and the internal nominal pressure (37 ° C) is from 0 psi (0 Pa) to 15 psi (103421 Pa) and the weight is less than 15 g. In some embodiments where a stable volume is preferred over the useful life of the device, the balloon is configured to maintain a volume of at least 90% to 110% of the original nominal volume. In other embodiments, it is desirable for the balloon to increase and / or decrease in volume over its useful life (eg, in a linear fashion, a stepped fashion, or another non-linear fashion).

[Inner container]
The inner container of the self-inflating balloon is housed within the balloon lumen and contains a CO ₂ generator for balloon self-inflation. The CO ₂ generator comprises a swelling agent mixture housed in a container. Preferably, about 10% to about 80% of the total swelling agent used comprises powdered citric acid and the remainder comprises powdered sodium bicarbonate. After completion of the CO ₂ evolution reaction, the balloon is provided with sufficient inflating agent to achieve inflation at the nominal inflation pressure described above. Preferably, a total of about 0.28 to 4 grams of inflating agent mixture is employed, preferably up to 1.15 grams of sodium bicarbonate, with the remainder powdered, depending on the size of the balloon to be inflated Citric acid, which generates 300 cm ³ of CO ₂ at nominal pressure.

[Expansion assembly]
An intragastric balloon system that is manually inflated with a small catheter may be employed in some embodiments. The system preferably remains “swallowable”. The balloon for delivery is in a compact state, preferably attached to a flexible small catheter having a diameter of 4 French (1.35 mm) or less. The catheter is designed so that a portion of the catheter can be bundled or wrapped on itself for delivery with the encapsulated balloon, allowing the patient to swallow both the catheter and balloon and deliver to the stomach Is done. The balloon can contain a self-sealable valve system for attaching the catheter after reaching the gastric cavity and inflating the balloon. The proximal end of the catheter may be left just outside the patient's mouth and allow connection to an inflation fluid container that can contain the preferred inflation fluid (gas or liquid). After inflation, the catheter can be detached from the balloon valve and pulled back through the mouth. This method allows the intragastric balloon to maintain its swallowability, but allows inflation by mixing the fluid source or fluid source through the catheter. Alternatively, a more rigid pushable system may be employed, where the balloon valve is compatible with either a swallowable flexible catheter or a pushable rigid catheter assembly.

  The dilatation catheter (swallowable or administrable pushable) described herein is configured to deliver a balloon device orally without additional tools. Dosing procedures do not require conscious sedation or other similar sedation procedures or require an endoscopic tool for delivery. However, other versions of the device can be used in conjunction with an endoscopic tool for visualization, or can be adapted so that the balloon device can also be delivered nasally.

  In operation, the proximal end of the inflation catheter is connected to a valve or connector that allows connection to an inflation source or a cutting source, which is preferably a connector or an inflation valve (FIGS. 6 and 7, respectively). The connector material may consist of polycarbonate or the like and can be connected to a single or multi-lumen catheter tube. The distal end of the dilatation catheter is compacted and housed in a gelatin capsule or connected to a balloon universal balloon valve that is compacted using a gelatin band (FIGS. 8A-8B). The catheter tube is preferably 1 French (0.33 mm) to 6 French (2 mm) in diameter. The catheter is preferably long enough to extend beyond the mouth (connected to an inflation connector or valve) and traverses the esophagus to at least the middle of the stomach—about 50-60 cm—down. Measurement ticks are added to the tubing or catheter, thereby assisting in identifying where the end of the tube is to be placed. The timing of inflation is by allowing the tube to contain a pH sensor that determines the placement difference between the esophagus (pH 5-7) and the stomach (pH 1-4) based on the different pH between the two anatomical sources. It can be initiated or derived from the expected pressure in the contained space (ie, the esophagus) and the less constrained space (ie, the stomach) or verified. The tube can also contain nitinol with a transmission that can be adjusted to body temperature, taking into account timing for swallowing. The tube can also be connected to a series of encapsulated or compacted balloons on a single catheter. Each can be individually inflated and released. The number of balloons released can be adjusted to the patient's needs and the desired weight loss.

  In some embodiments, a catheter with a balloon at the distal end (air inflation) is employed to temporarily hold the balloon firmly in place. A small deflated balloon catheter is positioned through the head of a gastric balloon (eg, a “balloon in a balloon”) and then inflated with air upon delivery to hold the capsule and balloon firmly in place so that the balloon is removed from the catheter. It can prevent desorption naturally. The balloon catheter can incorporate a dual flow path that allows a larger gastric balloon to be inflated (by gas or liquid). After the gastric balloon is fully inflated, a small air balloon catheter is deflated and can be deflated from the valve (which can self-seal the valve) and withdrawn from the body and inflated into the stomach Can leave.

  In other embodiments, the catheter can be coated to enhance swallowability, or impregnated with a flavored version and / or one or more local anesthetics or analgesics to facilitate swallowing. Or treated with them. Such anesthetics may include aminoamide group anesthetics such as articaine, lidocaine and trimecine and aminoester group anesthetics such as benzocaine, procaine and tetracaine. Such analgesics can include chloraceptic.

[Double lumen catheter]
In a preferred embodiment, a swallowable dual lumen catheter is realized. The dual lumen catheter (FIGS. 9A-9C) has two lumens with a finished assembly diameter of 5 French (1.67 mm) or less, preferably 4 French (1.35 mm) or less. The inner lumen is preferably 3 French (1 mm) or less and functions as an inflation tube, and the outer lumen is preferably 5 French (1.67 mm) or less and functions as a cutting tube. The catheter assembly is connected at the distal end to the needle assembly described in more detail below and at the proximal end to the dual port inflation connector. The tubing employed by the catheter assembly is flexible enough to be swallowable, difficult to kink, can withstand body temperature, is acid resistant, and the tube crosses the digestive tract and enters the gastric cavity Sometimes biocompatible. The tube material is preferably soft and flexible, has a moderate tensile strength, and has a significant hoop strength that can handle the applied pressure. The lumen is preferably round and coaxial and floats to provide flexibility. The dual lumen assembly also preferably does not require an adhesive or adhesive. Alternative lumen configurations may include two D lumens or a combination of D and round lumens, and may be used in a more rigid configuration of the final catheter assembly. Preferred materials for tubing include heat resistant polyethylene tubing such as PEBAX® or heat resistant polyurethane tubing such as PELLETHANE ™, PEEK, or nylon. Tubing also includes polylactic acid (PLA), poly-L-aspartic acid (PLAA), polylactic acid / glycolic acid (PLG), polycaprolactone (PCL), DL-lactide-co-ε-caprolactone (DL-PLCL). , Or the like, where the tube can be released after inflation and desorption and swallowed as normal.

  At the distal end of the catheter assembly, the lumen or inflation tube punctures a pearl self-sealing valve, preferably located at one of the apexes of a balloon housed inside a gelatin capsule as an outer container Is attached to the needle assembly used. The outer lumen is connected to the needle sleeve and provides a connection force between the catheter assembly and the balloon, preferably up to 10 psi, and preferably less than 35 PSI when maintaining the assembly together Provides tensile strength to withstand. The needle sleeve is configured to mechanically couple with the balloon valve assembly. The needle is preferably made of metal, preferably stainless steel, or the like, with a maximum size of 25 gauge (0.455 mm), preferably 30 gauge (0.255 mm) or more for purposes of expansion timing. The needle sleeve is preferably a soft material such as nylon or the like, or may be polycarbonate, polyethylene, PEEK, ABS, or PVC. The needle sleeve covers the needle over its entire length, which protects the body from the needle and allows the needle to puncture only the balloon septum. Preferably, the needle sleeve is coplanar or extends out slightly longer than the needle length. The needle is inserted into the balloon septum prior to swallowing and maintains a holding force of about 0.5 lb when bonded to the silicone region of the balloon valve. The needle sleeve is preferably slightly bell shaped so that when inserted into the silicone area of the valve, a locking and keying mechanism occurs to increase the tensile strength of the assembly and enhance the seal against expansion. (FIGS. 10A-10D) or contain a circular relief or lip.

  At the proximal end, the catheter assembly is connected to a Y adapter assembly, preferably made from polycarbonate. The y-adapter is “keyed” so that inflation gas and connecting fluid are properly connected to the catheter assembly and travel down the correct lumen.

Prior to inflation, a cutting lumen priming using liquid may be employed. For example, the outer lumen is first flushed with 2 cm ³ of water, saline, DI water, or the like before balloon inflation. The inflation source container is then attached to the connector leading to the inner lumen. The expansion source vessel operates based on the ideal gas law and the preconditions of the pressure decay model. For a given compressed gas formulation, the device is designed to equilibrate such that a starting pressure higher than the resulting final pressure of the balloon is used to inflate the balloon. The starting pressure and volume depend on the selected gas formulation, as well as the length and starting temperature (typically ambient temperature) and ending temperature (typically body temperature) of the catheter.

After inflation, the balloon is detached from the catheter assembly using hydraulic pressure. A syringe filled with water, DI water, or preferably saline is attached to the female end of the Y assembly. The syringe contains 2 cm ³ of liquid and sufficient water pressure is applied to release the needle from the balloon valve when the syringe plunger is pushed.

[Single lumen catheter]
In order to further reduce the diameter of the dilatation catheter, thereby increasing the swallowability comfort of the balloon capsule and catheter, a single lumen catheter (3 mm French (1.0 mm) (0.033 inches) or smaller) ( 11A-11C) may be employed.

  The needle / needle sleeve assembly is similar in design to the dual lumen catheter described herein. However, when a single lumen system is used, the distal end of the catheter lumen is connected only to the needle sleeve and the second catheter is not inside. Instead, a single thread attached to the needle hub runs coaxially over the length of the catheter, assisting in tensile strength for desorption and overall flexibility.

  The needle sleeve is slightly bell shaped so that when inserted into the silicone head of the valve, a locking and keying mechanism occurs to increase the tensile strength of the assembly and enhance the seal against expansion, Or because it contains a circular relief or lip and this is a single lumen assembly, the lip increases the force required to remove the needle from the valve, and therefore this happens by chance during the expansion process There is nothing.

  The proximal end of the catheter is connected to an inflation valve (FIG. 7), preferably a three-way valve, or a valve that allows the use of exclusion methods for balloon inflation and desorption. The distal end of the catheter houses a needle sleeve made from nylon or other similar source. The needle is made of metal, preferably stainless steel.

  The tubing used by the catheter assembly is flexible enough to be swallowed, difficult to kink, can withstand body temperature, has acid resistance, and the tube crosses the digestive tract into the stomach cavity Biocompatible when entering. The tube material is preferably soft and flexible and resistant to necking or buckling or kinking. In single lumen systems, the catheter tubing is preferably made from PEBAX® or PELLETHANE® (ether based polyurethane elastomer), but PLA, PLAA, PLG, PCL, DL-PLCL, or Bioabsorbable materials such as the like can also be provided, where the tube can be released after inflation and desorption and swallowed as normal. The wire, such as the inner thread of the catheter tubing attached to the needle (FIG. 11B) is preferably a nylon monofilament, although Kelber or Nitinol wire or other suitable material may also be used.

  To inflate the balloon, the distal end of the catheter is fitted with a balloon capsule where the needle protrudes through a self-sealable valve (FIG. 11C). The container is swallowed and a portion of the dilatation catheter remains out of the mouth. The inflation source container is connected to the proximal end of the inflation valve, where the inflation gas port is selected by excluding other ports. The inflation fluid (preferably compressed nitrogen gas or a mixture of gases) travels down a single catheter lumen so that the inflation gas passes through the least resistive path, or more specifically the needle cavity. Select the path that goes into the balloon. The balloon is preferably inflated within 3 minutes.

To detach and remove the needle from the balloon valve, 2 cm ³ or other suitable volume of water or other liquid is injected into the catheter under high pressure. Since water has a high surface tension and viscosity, it occludes the needle path and pressure is transmitted to the outer needle sleeve, thereby breaking the fit between the needle sleeve and the balloon valve.

  If it is desired to place a substance, such as water or acid or an alternative liquid, inside the balloon, this can be done by injecting the liquid using a lower pressure.

[Small rigid body inflation catheter]
In some embodiments, a rigid dilatation catheter is employed, which can be placed orally or nasally. The system may be 1 French (0.33 mm) to 10 French (3.3 mm) in diameter, preferably 8 French (2.7 mm). Larger diameters are typically preferred to increase indentability, and wall thickness also contributes to indentation and kink resistance. The length of the tube may be about 50-60 cm. As explained above, a measurement tick is added to the tubing, which identifies where the end of the tube is placed, or a pH or pressure sensor on the catheter is used to place the balloon. Can be employed to detect.

  This system for inflation / desorption is similar to the dual lumen system described above, but has a larger needle sleeve to accept larger diameter tubes (FIGS. 12A-12D). Materials that can be used in the lumen include, for example, expanded polytetrafluoroethylene (EPTFE) for other lumens and polyetheretherketone (PEEK) for the inner lumen. Also, strain relief devices can be added to the distal and proximal ends to enhance pushability. In order to ensure that the catheter bypasses the larynx and subsequently enters the esophagus, it is particularly preferred to have a strain relief at the distal end, for example 1 to 8 inches, preferably 6 inches. The proximal end can also have a strain relief, for example, to ensure a connector fit. A preferred material for the strain relief is a polyolefin. The method for inflation / desorption is the same method as the dual lumen configuration, where the outer lumen connects to the needle sleeve and the inner lumen connects to the needle. The rigid member is strategically placed along the length of the catheter shaft to provide the correct amount of flexibility and pushability and to properly place the device in the patient. As part of the procedure, the patient can swallow water or other suitable liquid to spread the esophageal tissue and smoothly lower the device. The patient can also be administered anesthetic in the back of the throat to lose sensation in the area and weaken the pharyngeal reflex.

The tube can also be connected to a series of encapsulated or compacted balloons on a single catheter so that a total volume of up to 1000 cm ³ or more is administered as needed. Each can be individually inflated and released. The number of balloons released can be adjusted to the patient's needs and the desired weight loss.

  In addition, the catheter can be used to administer an intragastric balloon similar to the balloon catheter used in “over-the-wire” or high-speed exchange catheters referred to as angioplasty (FIG. 13). In this case, the patient tries to swallow the catheter but fails, so the rigid catheter or doctor assistance catheter slides over the flexible catheter and the balloon can be pushed down in the same manner as the doctor assistance catheter. . Different materials can be used to provide varying degrees of flexibility, or a single material manufactured with different diameters over length can be used to vary the degree of stiffness.

[Expanded fluid container]
An inflation fluid container is employed to control the amount or volume of fluid that is placed inside the balloon. The inflation fluid container may take the form of a canister made of, for example, a polymeric material such as polyvinyl chloride (PVC), tin-coated steel, stainless steel, aluminum, aluminum alloy, brass, or other suitable material. The container can also take the form of a syringe. The materials employed are preferably fluids, preferably in gaseous form, eg compressed or uncompressed N ₂ , Ar, O ₂ , CO ₂ , or mixtures thereof, or compressed or uncompressed atmosphere (N ₂ , O ₂ , A mixture of Ar, CO ₂ , Ne, CH ₄ , He, Kr, H ₂ , and Xe). The composite wall material of the balloon and the respective diffusion gradient and gas permeability properties are used to select the fluid for inflation of the intragastric balloon. The inflation fluid container material is selected to ensure that there is no fluid diffusion or leakage before it is connected to the inflation catheter connector or valve. The inflation fluid container system (FIGS. 14A-14C) includes a connector (FIG. 14B) to a catheter and pressure gauge (FIG. 14C). The inflation fluid container may be manufactured from a suitable material, such as stainless steel (FIG. 15). It may also contain a smart chip that informs the medical professional whether the inflation was successful or whether the balloon should be removed due to an error in the system.

  In some embodiments, for example in FIGS. 16A and 16B, the inflation fluid container is a canister or container (flexible or rigid), squeezable bag, compliant balloon-like tube, or the like Take the form of things. As with the other embodiments described above, the canister or container has a wall formed from stainless steel, pure aluminum, aluminum alloy, brass, or other suitable barrier material. The wall surrounds and defines the inner reservoir or cavity. The canister connects an actuator that allows the delivery system to be activated to supply gas, a valve cup configured to hold the valve component in configuration, a spring, and the actuator and spring Holds a stem, a stem gasket that seals the opening around the stem, a tube or straw that extends from the valve to the bottom of the can and allows gas under pressure to flow out of the canister, and a spring And a housing connecting a tube or straw to the valve assembly. The opening is typically disposed in one of the walls and constitutes an opening to the inner reservoir. The canister includes a cap (FIG. 16A) configured to seal the opening and prevent fluid from leaking out of the inner reservoir during storage. When the cap is removed, the straw is visible (FIG. 16B). A portion of the straw protrudes out of the canister, and the remaining portion of the straw passes through the opening and penetrates into the inner reservoir. The straw can be formed from polypropylene, polyethylene, nylon, or other suitable polymeric material. The canister of some embodiments is configured to release inflation fluid from the inner reservoir via a straw when the low pressure gradient fluid path opens toward the balloon.

In some embodiments, it may be desirable to inflate the intragastric balloon using an inflation fluid container having a known internal pressure or amount of gas. For example, in some embodiments, an expansion configured to have a volume of, for example, 50 cm ³ or less to 400 cm ³ or more, or 100 cm ³ to 200 cm ³ or 300 cm ³ , or 125 cm ³ to 175 cm ³ , or about 150 cm ^3. It is desirable to start with a fluid container. In other embodiments, other volumes of gas may be selected. In some embodiments, the inflation fluid container is operated by, for example, connecting the inflation fluid container to a compressed gas tank prior to the procedure and filling the inflation fluid container until a desired volume or pressure is reached. It is filled at the site. The pressure can be monitored using a pressure gauge. In other embodiments, the inflation fluid container is provided with a desired amount of fluid pre-filled. In such an embodiment, the altitude of the location (and the resulting atmospheric pressure) should be taken into account in order to provide an inflation fluid container with the desired volume of gas. The inflation fluid containers can be designed with different sizes, colors, or other clearly distinguishable markings that each indicate the range of altitudes that are modified.

In order to maintain the “swallowability” of the balloon and ensure patient comfort during the procedure, it is preferable to minimize the amount of time that the catheter is placed in the mouth / esophagus. The timing of inflation can be selected to properly reduce time. The outer container canister assembly takes about 3 to 120 seconds to reach the stomach after being swallowed. After entering the stomach, the inflation fluid container can be attached to a valve or port of the catheter system. Inflation timing can be controlled by selecting the length of the catheter, the diameter of the catheter tube, the starting temperature, and the starting pressure. By using the ideal gas law for nitrogen and Boyle's law (P ₁ V ₁ = P ₂ V ₂ ), the amount of starting volume / pressure may be derived, where the body temperature Consider the final target pressure at. It is desirable to have an inflation time after less than 5 minutes and preferably 2-3 minutes of swallowing, before balloon desorption and catheter withdrawal. The inputs used to derive the inflation of the balloon (preferably less than 3 minutes) include the inflation container volume, the type of inflation fluid (preferably compressed gas or compressed gas mixture), the starting pressure, the catheter Includes length and diameter and the desired final volume and pressure of the balloon. Thus, due to the difference in diameter, smaller diameter 1 French or 2 French catheter systems have lower starting pressures to achieve the same target balloon volume and pressure within the same time frame as larger diameter 4 or 5 French catheters. Required, but assuming the use of the same compressed gas recipe. In general, it is understood that starting with a lower pressure at the same flow rate / volume may increase the expansion time.

The inflation source container can provide feedback to the end user based on the pressure damping system. If there is an expected start pressure and an expected end pressure indicating whether the balloon is properly inflated, endoscope visualization is not necessary (see FIG. 17). Each scenario of expected pressure output shown in FIG. 17 can have its own tolerances with respect to it to reduce the possibility of false positives, and the inflation fluid container is in a balloon inflation and desorption situation. Feedback based on these tolerances can be provided. The inflation container is opened to determine device placement and then contains an additional low volume bolus of pressure followed by a second larger bolus intended to inflate the balloon. Outgassing may be performed on 1, 2, 3, or multiple boluses based on the event that is intended to be detected. This is derived based on the ideal gas law, where there is an expected end pressure based on the fixed volume of the balloon. If the pressure remains high and does not decay as expected, this may indicate that there is a failure in the system (eg, the balloon container has not dissolved, the balloon is, for example, in a catheter system) Because of tube kinks or other obstructions that extend into the esophagus) For example, for successful damping using only nitrogen as the inflation fluid, the balloon may be 250 cm ³ and 1-2.5 psi (0.120 kg / cm ²⁾ for nylon-based materials with an initial pressure of 22-30 PSI. ). Provide at least one visual, audible, or tactile notification to indicate successful balloon inflation, or whether the inflation was successful in some other manner, or pressure curve and a predetermined pressure tolerance and A mass tip may be added to the inflation source container that transmits a notification to the medical professional or administrator of whether there is an error in the system based on the expected inflation timing set.

  Alternatively, the balloon can be filled based on the starting pressure by using a spring mechanism, an intra-balloon balloon mechanism, or other pressure source. These mechanisms potentially exhibit a predictable / consistent pressure decay curve as a result, and again may have a certain tolerance associated with the feedback to the end user. FIG. 18 shows the expected decay curves for these methods of the pressure source, which again will have the given tolerances associated with the feedback to the end user.

[Expanding fluid dispenser]
In some embodiments, a canister, such as the canister of FIGS. 16A and 16B, is coupled to an inflation fluid dispenser, thereby delivering inflation fluid to an intragastric balloon or other inflatable intragastric device. One such inflation fluid dispenser is shown in FIGS. 19A and 19B. The inflation fluid dispenser includes a housing configured to couple to the canister. Some embodiments are configured to couple and secure a securement latch, a receiving space adapted to receive a canister, a threaded engagement feature, and / or a housing to an aerosol canister Other features.

  The housing may also include a spring positioned to contact the aerosol canister straw when the aerosol canister is in a fixed position within the housing. In such an embodiment, when the canister is moved to a fixed position, the spring applies a force to the straw in the direction of the canister, causing a preliminary amount of inflation fluid to be released from the canister. In some embodiments, the release of the preliminary amount of inflation fluid is designed to reduce the inflation fluid in the aerosol canister to a desired starting volume or pressure. In some embodiments, the material, size, and strength of the spring are selected such that the amount of force applied by the spring and the resulting preliminary amount of inflation fluid that is released are predetermined. The material, size, and strength of the spring can be selected according to the altitude and average atmospheric pressure where the inflation fluid dispenser is used. In this manner, the inflation fluid dispenser is calibrated for use within a specific area or altitude range, and standard sizes and fill volumes can be used regardless of placement.

  The housing can also have an inner wall defining a flow path that at least partially penetrates the housing. In such an embodiment, the proximal inlet of the channel is positioned around the canister's straw when the canister is coupled and secured to the housing. The spring, if present, can be disposed within the proximal inlet. The distal outlet of the channel is positioned at the distal end of the inflation fluid dispenser and is configured as a port to which a catheter or other flexible tubing can be connected. In various embodiments, the valve is disposed in the flow path between the proximal inlet and the distal outlet and is configured to transition between a closed position and an open position. In the closed position, the valve blocks fluid flow between the proximal inlet and the distal outlet. In the open position, fluid flow is not blocked. Thus, in the open position, inflation fluid is coupled from the inner reservoir of the aerosol canister, through the canister straw and inflation fluid dispenser, to the catheter, intragastric device, and / or port from the distal outlet. May leak into the components.

  In some embodiments, the inflation fluid dispenser comprises a lever disposed on the outer surface of the housing and mechanically coupled to the valve. The medical professional can move the lever between a first position and a second position to transition the valve between an open position and a closed position. In other embodiments, the inflation fluid dispenser can include a button, key, toggle, or switch disposed on the outer surface of the housing and electrically coupled to the valve. When operated by a medical professional, a button, key, toggle, or switch can send an electrical signal to the valve to open and close. In still other embodiments, a suitable valve control mechanism configured for user operation may be present in the inflation fluid dispenser.

  In some embodiments, a pressure gauge is coupled to the housing and configured to detect cage pressure in the flow path between the valve and the distal outlet. In some such embodiments, the pressure gauge comprises a digital display, and in other embodiments, the pressure gauge has a card and a mechanical dial indicator.

  In some embodiments, the inflation fluid dispenser and canister (or other inflation fluid container) form part of a larger inflation system used to deliver inflation fluid to the inflatable intragastric device. An example of an inflation system is presented in FIG. In some such embodiments, the flexible tubing and the substantially encapsulated intragastric device are coupled to an inflation fluid dispenser and an inflation fluid container. The flexible tubing can comprise a catheter, a synthetic rubber extension tube, or other bent, elongated device having an inner lumen. In some embodiments, the flexible tubing comprises both an extension tube and a catheter connected via a plug spoke having a three-way valve. The syringe can be connected to the third spoke of the three-way valve. Each of these components of the system is described in detail above.

  In one method of delivering an inflatable intragastric device into a patient's stomach, an inflation fluid dispenser is first coupled to an inflation fluid container. In some embodiments, this coupling is performed with the dispenser valve in the open position. The inflation fluid dispenser may contain a pressure compensating valve that takes into account temperature, altitude, and starting pressure, where the balloon is set to its target pressure (constant but 1-5 psi based on the current altitude setting). To adjust the final starting gas moles required to expand to This compensation is done at the time of coupling, and the inflation fluid container contacts a spring positioned within the proximal inlet of the flow path based on the difference between the manufacturing setting environment and the current environment (eg, altitude) in which the device is utilized. However, when subjected to the force of the spring, a preliminary amount of inflation fluid may be expelled from the distal outlet of the flow path. In some embodiments having a pressure gauge, the pressure of the inflation fluid container can be monitored when the valve is open. In some embodiments, it is desirable for the inflation fluid to be expelled from the inflation fluid container until the pressure in the container reaches 250 kPa, 300 kPa, or any value therebetween. In other embodiments, the desired pressure in the inflation fluid container is between 257 and 297 kPa, including this value. After the inflation fluid container is coupled and secured to the dispenser and the desired pressure is reached, the valve can be closed.

  In some embodiments, the extension tube, stopper, catheter, syringe, and at least partially encapsulated intragastric device are attached to each other, and the proximal end of the extension tube is above the distal end of the dispenser. It is attached to the port. When the plug's three-way valve is in a position that allows fluid connection between the extension tube and the catheter, fluid can flow through the flow path of the dispenser (downstream from the dispenser valve), extension tube, catheter, And between the encapsulated intragastric device until equilibrium is reached. The pressure gauge reading should generally reflect the pressure in the intragastric device.

  In some methods of delivering an inflatable intragastric device into the patient's stomach, the patient swallows the substantially encapsulated intragastric device and delivers it to the stomach. In various embodiments, the catheter remains connected to the intragastric device and from the stomach through the esophagus and at least into the patient's mouth. In some embodiments, swallowing and positioning of the intragastric device is monitored using x-ray imaging, such as, for example, fluoroscopy.

After entering the stomach, the capsules surrounding various embodiments of the intragastric device begin to dissolve. In some embodiments, the capsule dissolves within 10 minutes. In some embodiments, the capsule dissolves within 30 seconds to 4 minutes. In some embodiments, the detected pressure drops below 10 kPa as the capsule dissolves. In some embodiments, the detected pressure drops below 7 kPa after lysis. In various embodiments, the process of filling the inflatable gastric device can begin after dissolution of the capsule. To fill the inflatable intragastric device with inflation fluid, the dispenser valve is transitioned to the open position. The inflation fluid flows substantially from the relatively high pressure inner reservoir of the inflation fluid container to the relatively low pressure inner cavity of the inflatable gastric device until an equilibrium pressure is reached in the system. . In some embodiments, about 150 cm ³ of gas in an unconstrained atmosphere is constrained to 28 psi or about 450 cc at atmospheric pressure. For example, N ₂ is transferred into the intragastric device. In some embodiments, the intragastric device achieves a final volume in the stomach of about 250 cc. In other embodiments, the intragastric device achieves a final volume in the stomach of 50 to 400 cc, and preferably 90 to 300 cc, or discrete values or ranges therebetween. The gastric device of some embodiments achieves a final pressure of 5 kPa, 20 kPa, or any value in between. In a preferred embodiment, the final pressure in the intragastric device is between 8.3 kPa and 17.2 kPa, more preferably the final pressure of the intragastric device is 13.8 kPa. In some embodiments, the intragastric device reaches the desired final pressure within 5 minutes. In some embodiments, the final pressure is reached in about 2 minutes.

  In some embodiments of the method, after the system pressure stabilizes and equilibrium is reached, the catheter can be detached from the intragastric device and removed from the patient. In some embodiments, a syringe is used to separate the catheter from the intragastric device. The three-way valve is moved to a position where the syringe is in fluid connection with the catheter and intragastric device. The syringe plunger is quickly pushed to force fluid from the syringe into the internal cavity of the balloon with sufficient force to displace the catheter from the intragastric device.

[Composite wall]
The material selected for the composite wall of the balloon is optimized to maintain the original inflation gas without significant diffusion, or into the gastric environment after the balloon is placed in the stomach. The deployed gas can be diffused, for example, CO ₂ , O ₂ , argon, or N ₂ can diffuse through the balloon wall to partially or fully inflate the balloon. The fluid (liquid or gas) is applied to the inside of the balloon using the dilatation catheter (s) described herein, so that it becomes stationary when and in the direction of diffusion of the balloon composite wall. It can also vary based on the internal and external environment.

Intragastric balloons that are inflated by nitrogen, CO ₂ gas, a single fluid (gas), or a mixture of gases have barrier properties (fluid retention) and pH and moisture conditions in the stomach environment or the environment within the central lumen of the balloon. A composite wall is employed that has properties that impart resistance to urine and structural properties that resist intragastric kinetic forces, wear of balloon walls in vivo, and damage during balloon manufacture and folding. Some materials employed in balloon materials can withstand the harsh stomach environment that is designed to break up foreign bodies (eg, food particles). Some of the variables encompassed by the stomach environment are: gastric fluid pH of 1.5-5, temperature of about 37 ° C, relative humidity of 90-100%, gastric space gas entry, and food in the stomach. Constant gastric motility external pressure of 0-4 psi at variable frequency and cycle time based on the condition of External pressure provided by gastric motility can also cause wear on the balloon surface. The inside of the balloon lumen may contain moisture from the solution injected into the balloon for the timing of autocontraction, or moisture across the membrane due to an external moist environment. In addition to these environmental stresses, the wall material meets biocompatibility requirements, the wall (barrier material) is made compact in thickness and can be swallowed (“outer container” without significant damage or slippage). ]) To be thin enough to be placed inside. The outer container is small enough to exceed the esophagus (having a diameter of about 2.5 cm). The wall or barrier material is also thermoformable and sealable due to the balloon configuration, the internal gas pressure generated by the initial inflation pressure up to 10 psi, and the gastric cavity until the gas environment of the system reaches a quiescent state The pressure strength that can include pressure due to gas molecules entering from the inside is maintained. The film properties evaluated to determine whether it is suitable for use in a balloon composite wall are: pH resistance, water vapor transmission rate, gas barrier properties, mechanical strength / wear properties, temperature resistance, moldability , Bend crack resistance (Gelbo) resistance, surface energy (wetting) compliance, and thermocompression latency.

Various layers within the composite wall can impart one or more desirable properties to the balloon (eg, fluid retention, moisture resistance, acid environment resistance, wettability for processing, and structural strength). A list of polymer resins and coatings that can be combined into a multi-layer preform system (“composite wall”) is presented in Tables 1a-1b. These films can be crimped with an adhesive, co-extruded, bonded via a tie layer, or bonded in combination, as described below, with composite walls The desired combination of properties for can be obtained. The material identified as film coating in Tables 1a-1b is provided as a coating applied to the base polymer film, such as PET, nylon, or other structural layer.

[Fluid retention layer]
In preferred embodiments, blended polymer resins using multiple layers are employed to maintain the shape and volume of the inflated balloon by holding the inflation fluid for the intended duration of use. . Certain barrier films, widely used in the food packaging and PET bottle industries, can be advantageously employed for this purpose in the composite walls of balloons. Preferably, the barrier material has low permeability to carbon dioxide (or other gas, liquid, or fluid used alternatively or additionally to expand the volume occupancy subcomponent). These barrier layers preferably have good adhesion to the base material. Preferred barrier coating materials and films include polyamides such as polyethylene terephthalate (PET), linear low density polyethylene (LLDPE), ethylene vinyl alcohol (EVOH), nylon (PA) and nylon 6 (PA-6), polyimide (PI ), Liquid crystal polymer (LCP), high density polyethylene (HDPE), polypropylene (PP), biocompatible poly (hydroxyamino ether), polyethylene naphthalate, polyvinylidene chloride (PVDC), saran, ethylene vinyl alcohol copolymer, polyvinyl acetate, silicon oxide (SiO _x), silicon dioxide (SiO _2), aluminum oxide (Al ₂ O _3), polyvinyl alcohol (PVOH), nanopolymers (e.g., nanoclay), polyimide thermoset film, VALCA EVAL EF-XL, Hostaphan GN, Hostaphan RHBY, RHB MI, Techbarrier HX (SiOx coated PET), Triad Silver (silver metallized PET), Oxyshield 2454, Bicor terephthalic acid, acrylic terelic acid, acrylic acid And a copolymer of ethylene glycol and at least one diol. Alternative gas barrier materials include polyamine polyepoxides. These materials are typically provided as solvent-based or aqueous-based thermosetting compositions, and are typically spray coated onto preforms and then thermoset to provide the final barrier. Form a coating. Alternative gas barrier materials that can be applied to the volume occupancy subcomponent as a coating include metals such as silver or aluminum. Other materials that can be used to improve the gas impermeability of volume occupancy subcomponents include, but are not limited to, gold or noble metals, saran-coated PET, and conformal coatings.

  One method used in the packaging industry to retard the diffusion of inflation fluid is to thicken the material. Thickening the material is generally undesirable, since the total thickness of the composite wall is preferably no more than 0.004 inches (0.010 cm) so that the balloon can be folded to the desired delivery container size for swallowing by the patient. It is.

  Multilayer polymer films that can withstand the stomach environment during the life of the balloon include linear low density polyethylene (LLDPE) that is pressure bonded to nylon 12 film with an adhesive. Alternatively, an additional film layer with barrier properties, such as PVDC, can be added to the composite wall.

  The layer that provides gas barrier properties is preferably placed as an inner layer in the composite wall because it is less mechanically rugged than resins considered "structural" such as nylon and the like. .

[Structural layer]
A layer such as polyurethane, nylon, or polyethylene terephthalate (PET) may be added to the composite wall for structural purposes, preferably the outermost (proximal to the stomach environment or the central lumen of the balloon) Placed as a proximal layer, provided that the pH resistance of such layer can withstand the acidic environment of the central lumen of the stomach or balloon.

[Manufacture of composite walls]
The various layers of the composite wall, including the gas barrier layer, do not need to be placed in a particular order, but those with good resistance to acid, temperature, mechanical wear, and good biocompatibility profiles are preferred Adopted as a layer in contact with stomach environment. For example, those with excellent resistance to acidity and temperature are preferably employed as the layer in contact with the central lumen of the balloon.

  The various layers of the wall can include a single layer or up to 10 or more different monolayers, but with a film thickness of 0.001 inch (0.0254 cm) to 0.004 inch (0.010 cm). Desirably, the resulting balloon is compact and fits within a swallowable capsule. The resulting composite wall preferably has good performance specifications for each category listed in Tables 1a-1b.

  Coextruded films are advantageously employed because some adhesives can contain exudates that are undesirable from a biocompatibility standpoint. In addition, coextrusion blends more appropriately so that the materials maintain their original properties when combined in this manner and are less likely to cause delamination when exposed to the power of intragastric movement. Make it possible to do.

Combining films with similar properties, for example two film layers with excellent gas barrier properties, in a composite wall can be a gastric balloon that contains nitrogen, oxygen, CO ₂ , or a mixture thereof as an inflation gas, Alternatively, it is advantageous for use in a place where the external environment in which the product is placed contains a gas mixture containing CO ₂ , for example in the stomach. A major advantage of such a composite film is that restrictions on film thickness can be obeyed without sacrificing gas barrier properties. Such a configuration also contributes to reducing the effects of damage due to exposure to in-process damage (eg, manufacturing and compacting) and in vivo conditions (eg, gastric motility).

  In one particularly preferred embodiment, the composite wall includes multiple layers. The first layer is an outer protective layer that is configured for exposure to the stomach environment. This layer is resistant to mechanical forces, exposure to water (steam), wear, and high acidity levels. Nylon or more specifically nylon 12 is particularly preferred for layers exposed to the stomach environment and is particularly resistant to mechanical forces.

  In an alternative embodiment, the polyurethane is RF welded to Saran to produce a 6-7 mil thick composite wall. In another embodiment, a five layer system is provided comprising one layer of saran sandwiched between two polyurethane layers. There is a tie layer between each of the saran layer and the polyurethane layer. The layers can be welded, coextruded, or bonded using an adhesive. A tie layer is then coextruded on each side of the nylon and then a final sealing layer (polyethylene or the like) is added to one of the nylon layers for the entire composite wall. Representative examples of commercially available or manufacturable material combinations are presented in Table 2. Layer orientation (innermost-in contact with the central balloon lumen, or outermost-in contact with the gastric environment) when more than two layers are described as supporting the proposed composite wall Is also shown.

Most of the film resins listed in Table 2 provide some gas barrier properties. Thus, many can only be used to form the balloon wall as a monolayer film, but they also have the desired gas retention and lifetime for the balloon's useful life based on the inflation gas and the external environment in which the balloon is placed. Can be used with other film resins to meet mechanical specifications. These film resins can also be coated with the gas barrier coating materials listed in Tables 1a-1b. Additional film layers can be added to form a full composite wall. Such additional layers may not provide substantial barrier properties, but over other layers of the composite wall that are sensitive to structural and / or mechanical properties, water vapor, humidity, pH, or the like. It may provide protection or other desirable properties. Film layers can be assembled using various adhesives, via coextrusion, via lamination, and / or using tie layers and the like, with specified gas retention properties A composite wall can be formed that meets the requirements of an intragastric balloon that is suitable for use for at least 25 days or up to 90 days or longer. Table 2 presents a list of layers and layer combinations suitable for use in a composite wall for an intragastric balloon. Listed are composite descriptions, resin abbreviations, configurations (single layer, double layer, triple layer, or the like), and commercial combination trademarks. The number of layers shown does not include the adhesive layer or tie layer used to make the composite wall, and the 6-layer composite wall is, for example, two or three adhesive layers that make up the entire composite wall And / or may have a tie layer, so the total number of layers may be 8 or 9 in the final form. The term “layer” as used herein is a broad term and is given its ordinary and customary meaning to those skilled in the art (in a special sense or in a sense tailored to special conditions). (But not limited to), but not limited to, a single thickness of a homogeneous material (eg, a coating such as SiOx, or a layer such as PET), as well as a support layer having a coating thereon (where “ “Coating” is, for example, a material typically employed in conjunction with a substrate that provides structural support to the coating layer). For example, reference is made herein to a PET-SiOx “layer”, wherein a layer of Si—Ox is provided on a supporting PET layer.

  In particularly preferred embodiments, the composite wall has a thickness of 0.005 inches or less (5.0 mils or less), although in some embodiments, thicker composite walls may be acceptable. Generally, it is preferred that the composite wall has a thickness of 0.004 inches (4.0 mils) or less.

[Manufacture of balloons]
In order to ensure good mechanical strength of the balloon, the balloon is preferably formed and sealed such that the edges of the parts used to form the balloon overlap. This can be accomplished by any suitable method. For example, two flat sheets of material can be placed in the frame so that the magnetized edges hold the two sheets in place. Slack is added to the film pieces and the material can be oriented to maintain the properties after the formation process. The frame can be placed on a mold that represents the hemisphere of the balloon. The material reorients the material so that it is more evenly distributed around the shape of the hemisphere, with the slack applied before pressure is applied. The material is preferably thickest in the middle and thinner at the side, where it is welded to the second part to form a sphere or ellipsoid having a substantially uniform wall thickness. For example, starting with a 0.0295 "film, the middle or subsequent apex of the film has an end film thickness of 0.0045" and the edges are 0.0265 "so that they are subsequently overlapped in the welding process. Having an end thickness.

  The valve may be bonded to one (eg, polyethylene, PE) side of the hemisphere and protrude from the opposite (eg, nylon) side. One hemisphere is typically made of nylon as the outermost layer and the second hemisphere typically has polyethylene (sealing web) as the outermost layer. The edges of the two hemispheres are preferably aligned to overlap at least 1 mm, 5 mm or less. The alignment and superposition of the two hemispheres is performed to compensate for thinning at the edges during the thermoforming process, and then suppresses in vivo seam rupture. Each half of the spheroid is left on the fixture and the excess from the forming process is trimmed. On the multilayer film, the sealing layer, PE, or similar layer is crimped to the half sealing layer of the second film. To do this, the hemispherical film exposing nylon to the outside environment is crimped to the hemisphere by polyethylene on the outermost layer (see FIGS. 21A-21B). (See).

  The two film parts are then sealed using a roller crimping device or a band heating device. In a roller crimping device, a pneumatic cylinder performs compression, a heating device heats the seal, and a motor that moves the crimping device around the area controls the time required to ensure proper sealing To do. Within the band heating device is a heating element, an expandable plug for compression, and a timer. The band is made of metal, preferably copper, and performs the compression that requires a spool-like fixture. By using film layers with different melting temperatures, the integrity of the barrier layer of the final balloon configuration can be ensured. Insulators can be employed when two similar materials are welded together. In one preferred embodiment, one sphere comprises an outwardly facing nylon layer and the second sphere has an outwardly facing PE layer.

[Balloon that resists spontaneous contraction]
The greatest percentage of intragastric balloon failure is due to spontaneous contraction. Spontaneous contractions are: (1) external puncture of the intragastric balloon due to the force of gastric motility, (2) balloon over-inflation due to increased internal pressure of the balloon from ingestion of gas and water vapor in the gastric environment, and (3) excess material Fatigue and underinflation of the balloon leading to subsequent puncture of the balloon. By managing these two variables and adjusting them to withstand the dynamic gastric environment, ensure that the balloon system is reworked and remains inflated for the entire useful life Can do. This spontaneous contraction within the intragastric balloon can be minimized by selecting the starting inflation gas in conjunction with the choice of composite wall material and structure. By selecting the permeability characteristics for water vapor permeation and the gas permeability of the composite wall to take advantage of the characteristics of the gastric space contents, the rate of gas diffusion into and out of the balloon is controlled. Can make it possible. This method allows an adjustable method for the prevention of under-expansion and over-expansion.

  Another phenomenon seen in intragastric balloons and generally obesity is gastric adaptation. In the process of gastric adaptation, the stomach grows to adapt to space-occupying devices or excess food consumed. During the process of gastric adaptation, the volume of the stomach containing the intragastric balloon increases with time, and the patient becomes more hungry. However, by controlling the gas diffusion and water vapor permeation over the balloon that occurs over time, the size of the balloon also affects the permeability characteristics of the film's starting inflation gas (s), water and other in vivo gases. It can be increased over time by choosing to maintain weight loss. In addition to spontaneous contraction, by selecting the permeability characteristics of the composite wall in conjunction with the starting gas and taking advantage of the gas and water transport inside the balloon from the gastric environment, the balloon responds to gastric adaptation. It can be designed to increase over its useful life.

Experiments have been performed, where various starting inflation gases were selected in conjunction with gastric gas and a changing external gas environment that mimics the in-vivo water environment. The stomach environment consists of water (hydrochloric acid), a mixture of gases, and sputum (a semi-digested food semi-fluid that is expelled by the stomach into the duodenum). Gastric gas is usually generated by swallowing air during a meal. The composition of the air is nitrogen (N ₂ ) 78.084%, oxygen (O ₂ ) 20.9476%, argon (Ar) 0.934%, carbon dioxide (CO ₂ ) 0.0314%, neon (Ne) 0 .001818%, methane (CH ₄ ) 0.0002%, helium (He) 0.000524%, krypton (Kr) 0.000114%, hydrogen (H ₂ ) 0.00005%, and xenon (Xe) 0.0000087 %.

N ₂ , O ₂ , CO ₂ , H ₂ , and methane constitute over 99% of the gas in the gastrointestinal tract, with nitrogen accounting for the majority. Gastric pCO ₂ closely resembles local (visceral) arterial and draining venous blood pCO ₂ values. Gastric acid neutralization can also generate gas. For example, when gastric acid reacts with bicarbonate in the digestive fluid (eg, as it exists in certain antacids), a chemical process generates CO ₂ that is normally absorbed into the bloodstream. Intestinal food digestion generates CO ₂ , H ₂ , and methane exclusively through fermentation by colonic bacteria. Microorganisms appear to be all single sources of hydrogen and methane produced in the gut. These arise from the fermentation and digestion of nutrients (polysaccharides from fruits and vegetables are not digested in the small intestine). Small amounts of other gases can also be generated, including hydrogen sulfide, indole, and ammonia.

Controlled self-inflation of an intragastric balloon in a biological environment uses a semi-permeable or permeable composite wall in the balloon and first a preselected single gas, such as N ₂ or O ₂ , into the balloon It can be achieved by filling. The balloon takes advantage of the gas concentration difference and the water concentration difference between the internal balloon environment and the in vivo external environment (GI / stomach) to increase volume and / or pressure over time, And / or decrease. To achieve a controlled decrease in volume and / or pressure, the permeability to a single gas used to inflate the balloon is relatively higher than other gases present in the in vivo gastrointestinal environment Walls can be employed. For example, when nitrogen gas is employed as the inflation gas, over time in the in vivo environment, the volume and / or pressure in the balloon decreases as nitrogen diffuses through the oxygen permeable wall into the in vivo environment. . Similarly, when oxygen gas is employed as the inflation gas, the volume and / or pressure within the balloon decreases over time in the in vivo environment as oxygen diffuses into the in vivo environment through the oxygen permeable wall. To do. The difference between the partial pressure of the single gas in the balloon (high) versus the partial pressure of the in vivo environment (low) drives this process until equilibrium or homeostasis is reached. To achieve a controlled increase in volume and / or pressure, it is relatively less permeable to a single gas used to inflate the balloon than other gases present in the in vivo gastrointestinal environment Walls can be employed. For example, when nitrogen gas is employed as the inflation gas, the volume and / or pressure within the balloon increases over time in the in vivo environment as CO ₂ or the like diffuses into the balloon through the CO ₂ permeable wall. To do. The difference between the partial pressure of the permeable gas in the balloon (low) versus the partial pressure of the in vivo environment (high) drives this process until equilibrium is reached.

In addition, maintaining and / or controlling balloon inflation can also increase or decrease the internal balloon environment and balloon volume / pressure as needed to extend the useful life of the product. This can be done using the difference in concentration from the environment. One reason for reducing the pressure is to first add a balloon, a larger but more diffusible / soluble gas such as CO ₂ with more inert gas such as nitrogen to pre-stretch the balloon. Dissolved gas, which is inflated with molecules, diffuses out of the balloon and other gases not originally present in the balloon enter and fill the balloon.

The inflation gas can be selected to start with the majority of the gas in the balloon comprising a large, inert gas or a gas having a low diffusivity through the selected composite wall. The inert gas may be combined with the less inert gas (es) that are more soluble in the gastric environment to provide a starting balloon inflation gas composition. The patient's diet and medication may also affect / control the balloon inflation situation, mainly due to the CO ₂ concentration effect caused in the stomach environment. In addition, gastric pH also affects CO ₂ concentration. This particular method is based on composite wall materials, for example barrier / non-barrier and the lifetime of the device based on whether the gas diffusing into it with the barrier against the non-barrier is maintained longer in the balloon. Adjustments to a greater degree of lifetime may also be possible. This particular form of self-inflation can be a self-expanding intragastric balloon (eg, initially inflated by a gassing reaction in the balloon initiated after swallowing), or an inflatable intragastric balloon (eg, with endoscopic assistance) Other delivery methods), with or without, inflated using a catheter, delivered between the nose and stomach. This method can be used with intragastric balloons, including swallowable balloons and balloons that are placed in the stomach, for example, by endoscopy. This method is particularly preferred when used in connection with intragastric devices, but can also be applied, for example, for use with pulmonary wedge catheters and urinary incontinence balloon devices. The advantages of this technique include the ability to compensate for gastric adaptation, allowing the balloon to be adapted to the stomach, which can cause an increase in volume over time, thereby maintaining patient satiety. It also allows starting with a smaller amount of inflation gas component for the self-inflating balloon. This can prevent spontaneous inflation by utilizing a diffusion gradient between the intragastric balloon system and the in vivo gastric environment.

In a particularly preferred embodiment used in connection with N ₂ (with or without CO ₂ ) as a swelling agent, a multilayer coextrusion blend for the wall layer is employed. A particularly preferred configuration is nylon 12 / ethyl methyl acrylate / polyvinylidene chloride / ethyl methyl acrylate / nylon 12 / linear low density polyethylene + low density polyethylene (also referred to as coextruded nylon 12 encapsulated PVDC nylon 12-LLDPE + LDPE multilayer. Is). Another particularly preferred configuration is coextruded multilayer nylon 12 / linear low density polyethylene + low density polyethylene. The choice of resin for the composite wall structure (and also the choice of coextrusion method or adhesive) is to ensure compliance (stretchability), puncture resistance, thickness, adhesion, sealing to produce specific effects. It can be varied to control coercive strength, orientation, acid resistance, and gas and water vapor permeability characteristics.

[Automatic contraction of intragastric balloon system]
Self-inflating (also referred to as automatic inflation) or inflatable (also referred to as manual inflation) intragastric balloons include a mechanism for reliably controlling the timing of deflation. In a preferred embodiment, the balloon self-deflates at the end of a given useful life (involuntary), preferably between 30 and 90 days, passes through the stomach, passes through the lower gastrointestinal tract and exits the body. But can be timed to contract within 6 months. In preferred embodiments described below, the timing of deflation is via the extragastric environment (eg, by temperature, humidity, solubility, and / or pH conditions) or within the lumen of an inflated balloon. It can be achieved through the environment. It is consistently preferred to control the onset of the self-deflation process by manipulating the internal balloon environment.

  In other embodiments, patches applied to allow inverted seams as described above and / or other structures added to one or more additional patches or balloon structures are Made from corrosive, degradable, or soluble materials (natural or synthetic) and incorporated into the wall of the balloon. The patch (s) are of sufficient size to ensure an opening with a sufficient surface area to rapidly contract and prevent reinflation due to gastric fluid permeating into the balloon. The balloon patch (s) comprise a material that can be applied to the balloon such that a substantially smooth surface is maintained, and preferably comprises a single layer or multi-layer material. The patch (s) are corrosive, disintegrating, preferably a material that degrades into a tissue compatible and non-toxic product or slowly hydrolyzes and / or dissolves over time. , Degradable, or manufactured using other such materials (eg, poly (lactic acid-glycolic acid copolymer) (PLGA), poly (lactide-glycolide copolymer) (PLG), polyglycol Acid (PGA), polycaprolactone (PCL), polyesteramide (PEA), polyhydroxyalkanoate (PHBV), polybutylene succinate succinate (PBSA), aromatic copolyester (PBAT), poly (lactide-caprolactone co-polymer) Combined) (PLCL), polyvinyl alcohol (PVOH), polylactic acid (PLA), poly-L-lactic acid LAA, pullulan, polyethylene glycol (PEG), polyanhydrides, polyorthoesters, poly aryl ether ketone (PEEK), multiblock polyether esters, Porigurekapuron, polydioxanone, polytrimethylene carbonate and other similar materials). These corrosive, disintegratable, or degradable materials can be used alone or in combination with other materials, or cast / coextruded in conjunction with non-corrosive polymers (eg, PET or the like) Molded, laminated, and / or dip coated and can be employed within the structure of a balloon. Degradation / corrosion occurs in the stomach environment, is initiated and / or controlled by the stomach environment (eg, depending on temperature, humidity, solubility, and / or pH conditions), or what the patch is exposed to Based on this, it is controlled within the lumen of the balloon (eg, depending on humidity and / or derived pH conditions). Environments that affect polymer thickness, as well as degradation and exposure time, can also facilitate the setting of degradation timing. Degradation / corrosion is timed to occur after a given balloon's useful life has expired (eg, inflation is maintained in the stomach in vivo for 25 to 90 days, after which degradation / corrosion results in contraction. Opening is made possible). Instead of (or in connection with) using a degradable material for the patch, the patch is adhered to the balloon using a similar fluid retention barrier film or weak adhesive, or after a specified period of time. It can be provided with the same film as the remaining wall on the balloon to be peeled from the patched area and welded or glued so that it can be deflated by creating an opening for inflation fluid discharge. Alternatively, the entire composite wall of the balloon can be made from a corrosive material if deemed necessary for rapid contraction. Mechanisms that use corrosive materials, or materials that mechanically decay after a pre-specified time, are similar for all embodiments for the shrinkage mechanism described below. The timing of degradation or erosion can be controlled using the extragastric environment (eg, depending on temperature, humidity, solubility, and / or pH conditions) and / or controlled by conditions within the lumen of the balloon (eg, Depending on the humidity and / or pH conditions of the residual liquid in the balloon).

  In other embodiments, one or more plugs (as appropriate, in conjunction with another releasable retention structure) are incorporated into the balloon structure and are all and only partially similar to those described above. It may consist of highly corrosive, disintegratable, or some other form of degradable synthetic or natural polymer (eg, PLGA, PLAA, PEG, or the like). Plugs can be pre-selected for corrosive polymers and have various shapes (eg, cylindrical shapes as shown in FIGS. 22A-22D) to obtain various surface / volume ratios to provide a predictable bulk degradation pattern. Or a radial shape). The plug can incorporate a release mechanism that can be initiated chemically after decomposition / corrosion has begun, so that the septum or plug material can jump out of the balloon or fall into the balloon, thereby releasing the fluid and thereafter A passage for the deflation of the balloon can be formed. Mechanical additions that can be used in conjunction with the plug are housed within a degradable / corrosive / collapseable material or holding structure or plug structure that holds the plug in place (eg, of non-corrosive or corrosive material). With a compressed spring. More specifically, a preferred embodiment for achieving shrinkage may comprise a housing, a radial seal, a solid corrosion core, and a protective film attached to the outer surface of the corrosion core (FIGS. 22A-22). 22B). The inside of the corroding core is exposed to the inner balloon liquid. The core generates a compressive force that holds the seal against the housing. As the wick erodes, the compression between the housing and the radial seal is reduced until there is a gap between the housing and the seal. Once the gap is made, the gas can freely move from the inside of the balloon to the outside environment (FIG. 24A). The seal can exit the housing and fall into the balloon. The diameter, length, and material type can be adjusted to produce shrinkage at a desired time. Exemplary materials for each component used to achieve this contraction mechanism may be as follows: Housing—A biocompatible structural material that can withstand radial forces sufficient to form a hermetic seal. The material may include polyethylene, polypropylene, polyurethane, UHMWPE, titanium, stainless steel, cobalt chrome, PEEK, or nylon. Radial seal—consists of a biocompatible elastic material that can form a liquid and gas barrier to an acidic environment. The material can include silicon, polyurethane, and latex. Corrosion core—a material that can decay at a predictable rate in a given environmental condition. The material may include PLGA, PLA, or other materials listed above that provide other polyanhydride or corrosive properties that can lose integrity over time.

  For a spring mechanism, after the material has decomposed, the spring is released and / or the plug / septum is drawn into or withdrawn from the balloon, thereby forming the orifice by the release of the spring mechanism The fluid is released and pushed out or pushed out of the plug (FIG. 24B).

  Shrinkage mechanism using partition walls and moisture absorption expansion material and moisture corrosion material. The corrosive material will slowly corrode when exposed to moisture, eventually exposing the moisture absorbing extension material. When the moisture expanding material begins to absorb moisture, the expansion causes the partition to be pulled within the head by pushing the partition lip or a ring attached to the partition. Pulling the septum and shifting the position causes immediate balloon deflation (FIG. 24C). In order to protect the expansion material from moisture until the desired point in time, the expansion material may be coated with a water barrier material, such as parylene, or even a material that slowly degrades with water. Moisture contact can be controlled by a small inlet port. The inlet port can be a small hole or a wick material that draws moisture while being controlled. The desired shrinkage time is achieved through a combination of corrosive material, barrier material and inlet port sizing.

In some embodiments, the balloon can incorporate one or more plugs within the balloon wall that contain compressed pellets (FIGS. 25A-25B) or outgassing pellets. The pellet may consist of a combination of components that release CO ₂ gas when activated (eg, sodium bicarbonate and citric acid, or potassium bicarbonate and citric acid, or the like). The pellets are preferably corrosive, disintegrating, having tissue compatibility and degrading into non-toxic products or slowly hydrolyzing and / or dissolving similar to the plugs and patches described above. Or may take the form of tablets or rods protected by degradable materials (eg, poly (lactic acid-glycolic acid copolymer) (PLGA), polyvinyl alcohol (PVOH), polylactic acid (PLA), poly-L-lactic acid PLAA , Pullulan, polyethylene glycol, polyanhydride, polyorthoester, polyaryletherketone (PEEK), multiblock polyetherester, polygrecaprone, polydioxanone, polytrimethylene carbonate, and other similar materials). Plug decomposition / corrosion initiates the reaction of the two chemicals in the pellet, followed by the formation of a gas (eg, CO ₂ ). As sufficient gas is captured or increased, sufficient pressure eventually develops, pushing out the soft polymer material and creating a larger flow path through which the CO ₂ gas in the balloon leaks. External pressure (eg, squeezing) applied to the balloon by the stomach can contribute to the process of forming a larger flow path. The dimensions and characteristics (diameter, thickness, composition, molecular weight, etc.) of the plug made of a polymer are driving forces for the timing of decomposition.

  In other embodiments, plugs or patches of different shapes or sizes similar to those described above can be employed in the balloon lumen in a multilayer configuration including a semi-permeable membrane that facilitates balloon contraction. . The plug or patch is made of a similar degradable / corrosive / dissolvable material as described above (eg, poly (lactic acid-glycolic acid copolymer) (PLGA), polyvinyl alcohol (PVOH), polylactic acid ( (PLA), PLAA, pullulan, and other similar materials) that contain a concentrated solution of solutes or osmolytes (glucose, sucrose, other sugars, salts, or combinations thereof) The compartment enclosed by the light is impervious). As the plug or patch begins to break down or corrode, water molecules descend the water gradient by osmotic action from the higher water concentration region to the lower water concentration region, across the semipermeable membrane and into the hypertonic liquid in the compartment. Moving. The compartment containing the osmolite swells and eventually ruptures, extruding the membrane and disassembled plug or patch, thereby rapidly losing gas through the newly formed flow path or region.

  In some embodiments, a balloon is employed consisting of a septum, a moisture eroding material inside the inlet port, and a moisture absorbing and expanding material. The corrosive material will slowly corrode when exposed to moisture, eventually exposing the moisture absorbing extension material. When the moisture expanding material begins to absorb moisture, the expansion causes the partition to be pulled within the head by pushing the partition lip or a ring attached to the partition. Pulling the septum and shifting the position causes immediate deflation of the balloon. In order to protect the expansion material from moisture until the desired time is reached, the expansion material may be coated with a water barrier material, such as parylene, or even a material that slowly degrades with water. Moisture contact can be controlled by a small inlet port. The inlet port can be a small hole or a wick material that draws moisture while being controlled. The desired shrinkage time is achieved through a combination of corrosive material, barrier material and inlet port sizing.

  Another mechanism for self-shrinkage is to create a forced delamination mechanism that can result in a larger surface area that ensures rapid shrinkage. For example, in a balloon having a three-layer wall, the outermost layer is substantially strong enough to hold the inflation fluid (eg, polyethylene terephthalate (PET) or the like) and the intermediate layer is all corrosive. Made of material (eg, PVOH or similar), but the inner layer is made of a weaker material (eg, polyethylene (PE) or the like). The PET or outermost layer is “scratched” or hatched with a corrosive material to form a small channel that erodes over time (FIG. 23). This forms a flow path so that gastric fluid begins to penetrate into the layer of the balloon and break down the fully corrosive material. When the corrosive layer decomposes or dissolves, the material with the innermost layer also corrodes, decomposes or dissolves because it is not strong enough to naturally withstand the gastric force / environment. The balloon then collapses on itself and eventually passes through the lower digestive tract. By sandwiching the corrosive layer between a strong and weak layer, the timing of corrosion is set smoothly by creating a longer path length than the corrosive plug or patch affected by the stomach environment. The distance between the scratches or openings can also be selected to provide the desired rate of contraction.

  In another embodiment that causes the balloon to undergo rapid deflation after a desired time period has elapsed, a composite wall or a section of the composite wall (patch) of the entire balloon is injected inside the balloon during manufacturing or during inflation. It includes several layers of material that are slowly penetrated by the formed water (FIGS. 27A-27E). This water penetrates the layers and eventually reaches the substantially expanding material, rupturing the thin outer protective layer, forming a large hole for gas to escape and the balloon to contract (FIG. 27D). . The water expansion material is protected from the liquid through a coating or sheath, such as parylene, that allows a controllable amount of moisture exposure. When the water reaches the expansion material, it applies force to the protective outer layer and ruptures it. The outer layer is formed by a weak crimped area (FIG. 27E), a partially scratched area, or other method that ensures the desired rupture location and facilitates the setting of the desired timing at which automatic shrinkage occurs. obtain. There can be any number of layers between the moisture environment and the moisture expansion center. Each material layer can have a different corrosion rate (eg, fast or slow) and is selected according to a predetermined time (eg, after 30 days, 60 days, or more days) at which shrinkage is desired. obtain. By changing the number of layers on the circumference, the thickness and the respective speed, the time to shrinkage can be precisely controlled.

  Alternatively, a pressure sealing button that is glued over the perforations in the balloon material can be provided for deflation (FIGS. 28A and 28B). The adhesive crimping the button will corrode over time when it comes into contact with moisture from gastric juice or injected inside the balloon. After the adhesive no longer crimps and no longer forms a hermetic seal between the adhesive and the button, the balloon quickly deflates. By controlling the hole size and the moisture exposure of the adhesive, the corrosion time can be accurately predicted.

  Shrinkage can also be facilitated by forming a series of connection ports in the septum or on another similar structure attached to the balloon composite wall. Ports can be made using a biocompatible, low-permeability material that dissolves in water or acid, such as gelatin (FIGS. 29A-29B). The hole diameter, number of holes, channel width, and channel length can all be adjusted to control the dissolution parameters. When the material in the port and flow path is dissolved, there is an unobstructed path for the gas trapped in the balloon to escape, and eventually the balloon is deflated. The water is gastric fluid or can be controlled internally by putting water inside the balloon during the assembly or inflation process. There may be multiple port openings that ensure gas permeation. In addition, there are several variables that can be adjusted to control the dissolution time: the size of the port opening, the number of port openings, the length of the internal flow path, the width of the internal flow path, and the material dissolution rate. is there. The port / flow path layout design can ensure that only a small amount of surface area is exposed to moisture at a particular time, thereby controlling the corrosion rate and ultimately the shrinkage. In an alternative embodiment shown in FIGS. 29C-29E, an expandable material is employed to displace the extruded component to initiate contraction.

  One preferred embodiment of a manual inflation balloon that also has a mechanism for self-deflation is a port that includes the inflation and deflation mechanism in the same arrangement (see FIG. 30A). The device comprises a nylon or plastic catheter needle sleeve that is attached to an inflation tube when filled, for example, sealing to a silicone part. This further comprises a silicon head that seals to the needle sleeve, allowing inflation and desorption from the catheter. The silicon head also seals to part # 6 until it is pushed away by expanding part # 7. For example, a needle made from stainless steel inflates the balloon. The compression seal between part # 6 and part # 2 exhausts the internal gas when displaced. An inert material such as titanium, for example, provides imaging visibility (FIG. 30B) and also forms a rigid support for part # 2 and part # 4, coherently locks, slip fits and press fits on part # 6. For example, a silicon septum seals to part # 3 when expanded. For example, a PEEK or hard plastic casing is crimped to the outer film of the balloon to form a sealing surface to part # 2. This accommodates the outlet from the inside of the balloon to the outside of the balloon after part # 7 is expanded. Expansion devices, such as polyacrylamide in binders surrounded by controlled water vapor transmission materials (various blends of polyurethanes of varying thicknesses) are utilized inside the balloon to ingest and inflate size Use possible moisture. The press fit between part # 5 and part # 6 holds the part firmly in place until part # 7 begins to expand from moisture intake.

  In a preferred embodiment, the present invention includes a self-sealing valve that is compatible with an inflation catheter that houses a needle and a needle sleeve. The self-sealing valve is sealed to the needle sleeve during the expansion process. Distal to the self-sealing valve are titanium, stainless steel, MP35N, or other radiopaque rigid material inserts that provide imaging visibility and even mechanical support during the expansion process. Below the insert is a contraction mechanism consisting of an expansion device. The expansion device consists of a solute material, i.e. a polyacrylamide material or the like encased in a binder surrounded by a moisture limiting material having a defined water vapor transmission rate (MVTR). Examples of moisture limiting materials include, but are not limited to, various blends of polyurethanes of various thicknesses. A hard plastic casing, such as PEEK, includes a self-sealing valve, a radiopaque insert, an expansion material, and a moisture limiting material. The hard plastic case contains an outlet that allows fluid to flow between the inside and outside of the balloon if the outer seal is not in place. The radiopaque insert is coupled to the hard plastic casing via mechanical means such as press fit that allows linear movement but does not allow it to be expelled from the hard plastic casing. The second outer sealing valve forms a hermetic seal to the rigid plastic casing, shuts off the casing outlet, and moves linearly as the expansion device increases in volume. Moisture placed inside the balloon is absorbed by the contributing device and even contributed moisture from the extragastric environment. After the moisture has moved, the expansion material generates sufficient pressure over the lip of the casing as the outer sealing valve is pushed linearly. This opens the outlet path and allows the internal inflation fluid to quickly depressurize and deflate the balloon. The deflated balloon can pass through the pylorus and through the rest of the digestive tract. One or more inflation / deflation ports on the surface of the balloon may be employed.

  An alternative embodiment in which the inflation port and the deflation port are separate entities is shown in FIG. The device comprises, for example, a seal of Buna rubber or similar sealing material and forms a hermetic seal between parts # 1 and # 3. This slides along the surface of part # 3 until the hermetic seal is weak and allows internal air to escape. The outlet allows gas to flow from the balloon after the seal has been displaced. Also on balloon film via titanium plunger, water retainer (cotton or sponge-like material that can retain water and keep in contact with the surface of part # 4 and maintain constant moisture environment), and adhesive Also included is a PEEK or other hard material casing that provides sealing and rigid containment for parts # 1, # 2, # 4, and # 5. This design also allows drainage between the inner and outer balloon environments and also allows water entry into part # 4 which forces part # 4 to expand in one direction. Polyacrylamide in binders surrounded by expansion devices, controlled water vapor transmission materials (various blends of polyurethanes of different thicknesses) use the moisture available inside the balloon to ingest . The device consists of a rigid outer casing made of rigid plastic or metal, an expansion device consisting of a superabsorbent core surrounded by a water vapor permeation limiting membrane, and linearly while the moisture expansion device is increasing in volume. And a hermetic seal that can move. The expansion device expands at a given rate based on how much moisture is available. In order to control the expansion rate, a membrane such as polyurethane is used, thereby controlling the desired water vapor transmission rate available for the superabsorbent device. The water vapor transmission rate can be adjusted by material formulation or material thickness. In order to maintain constant moisture contact to the water vapor limiting membrane, a sponge-like material such as cotton can be used as a moisture reservoir for the expansion device. When the expansion device pushes the seal and exceeds the lip of the rigid outer casing, fluid is expelled from the inside of the balloon to the outside environment, causing the balloon to contract, pass through the pylorus, and pass through the rest of the digestive tract Make it. The balloon can have at least one deflation port, but can only have as much deflation as is necessary to deflate so that no residual inflation fluid remains that causes ileus (ie, partial deflation). ).

  Mechanisms that facilitate passage involve an erosion mechanism that allows the balloon to be sized to have a higher probability of tearing and predictably passing through the lower gastrointestinal system. Preferably, the size of the balloon when deflated is less than 5 cm long and 2 cm thick (predictably similar to various foreign objects of similar size that have been shown to easily pass through the pyloric sphincter To do). This can be accomplished by providing a balloon with a “corrosive seam”. One seam that splits the balloon (at least) into two halves, or more seams, is provided so that multiple smaller balloon pieces are produced in the dissociation reaction (FIG. 18). The number of seams used can be selected based on the original surface area of the balloon and what is required to dissociate the balloon into pieces of a size that can more easily and predictably pass through the digestive tract. The corrosion rate of the seam can be controlled, for example, by using materials that are affected by extragastric environment pH, fluid, humidity, temperature, or combinations thereof. The seam may be a single layer consisting only of corrosive material or multiple layers. The timing of self-shrinking can be further controlled by seam layer design, for example, by making the reaction and / or degradation of the seam material dependent on the balloon's internal environment rather than the external environment. By manipulating the reaction so that erosion or degradation is initiated by the internal environment (eg, the internal pH of the balloon, humidity, or other factors), gastric variability from person to person (pH) that can affect corrosion timing. , Etc.) is minimized. The internal balloon environment can be manipulated by adding excess water at the time of infusion to form a humid internal environment, or the amount of components added to manipulate pH, etc. can be varied.

[Example]
A disposable nitrogen filling system and procedural canister device is provided as an accessory to the Obalon intragastric balloon (OGB). In use, the cap is removed from the valve of the disposable nitrogen filling system. The disposable nitrogen filling system is inserted into the procedural canister and the lever is closed to engage the valve on the disposable canister. Because there is no lower pressure gradient fluid path, no fluid is released. The procedural canister is attached to the accessory kit via a luer fitting. The 3-port, 2-port valve on the accessory kit is confirmed to be closed before opening the 90 ° valve. Appropriate pressure is confirmed via the digital gauge, then the standard OGB system inflation procedure begins and the fluid pathway is opened to the balloon in the body. After this procedure, the disposable nitrogen filling system is removed from the procedural canister and properly disposed of. The procedural canister may be reused and have a useful life of at least one year.

The nitrogen filling system is of a suitable size that fits into a canister dispenser, for example, the main outer diameter of a valveless canister is 45 ± 1 mm. The nitrogen filling system is of a suitable size that fits into a canister dispenser, for example, the height of a valveless canister is 115 ± 1 mm. The nitrogen filling system has a pressure resistance, for example a pressure resistance of 18 bar. The internal volume of the nitrogen filling system is sufficient to fill the balloon kit with a suitable filling pressure, for example, the full volume of a valveless canister is 161 ± 3 cm ³ . The nitrogen filling system is accurately pressurized, for example, the sampling direct pressure measurement is ± 1 psi or ± 7 KPa. The assembled nitrogen filling system is free of bubble leaks, for example, pressurized disposable canisters are visually inspected for leaks in the aquarium bubble detection test. The volume of the canister can be inflated with sufficient pressure not to rupture the catheter, for example, the pressure of a fully pressurized canister should be 75 psi or less. The procedure canister has a function of connecting to the balloon kit. The procedural canister houses a luer fitting that connects to a swallowing catheter. The procedural canister has a valve that is effective for inflation. The nitrogen filling system has a quarter turn valve. The valve is designed for gas and has an operating pressure range that includes 1 to 75 psi. The procedural canister displays the pressure accurately. The procedure canister houses a digital gauge with a resolution of 0.01 psi or a resolution of 0.1 KPA. The pressurized nitrogen filling system is free of air bubbles, for example, no air bubbles in a 1.5 minute air bubble test in a 130 ° F. water bath. The nitrogen filling system fills the balloon to the appropriate pressure, for example, 2.0 ±. Set to 5 psi. The pressure is held sufficiently effectively by the assembled nitrogen filling system to keep the balloon filling pressure out of specification. The amount of gas contained shall not drop more than <5 psi over a year. The procedural canister remains reliable for at least one year, and the procedural canister is good for at least 1000 operating cycles. The procedural canister is compatible with a nitrogen filling system. The dynamic components of the procedural canister can circulate within the intended range of motion with the disposable canister inserted.

  The procedural canister opens the disposable canister valve when the receiver is closed. The procedure canister dispenses the contents of the nitrogen filling system and can support a total system procedure time goal of 5-10 minutes. A fully pressurized nitrogen filling system can be dispensed within 30 seconds. The procedure canister's digital gauge provides advance notice of low battery power. The digital gauge contains a low battery indicator. The battery life of the Procedure Canister digital gauge shall be valid for the lifetime of the device. The battery life of a digital gauge is rated at least 2000 hours. The battery is standard and can be replaced in the field as needed. The digital gauge maintains battery power when not in use, for example, by automatically turning off 60 minutes after the button was last pressed. The procedural canister seals the nitrogen filling system to prevent leakage. The nitrogen filling system engaged in the procedural canister does not leak more than 0.1 psi over 5 minutes. Procedure canister digital pressure gauges are electromagnetically compatible. The procedural canister gauge reading is easy to read, eg, the gauge size is at least 3 ″ in diameter on the digital display. The procedural canister pressure gauge can be operated intuitively, eg, the gauge is clearly shown The actuator on the procedural canister for inflating the balloon is intuitive, for example, a colored valve lever with only an on, off position is the initial from the procedural canister. Used for balloon filling, nitrogen filling systems are easily inserted into the procedural canister, for example, the opening of the procedural canister is large and clearly visible.

  The amount of nitrogen contained by the nitrogen filling system is suitable to achieve the desired final balloon pressure, for example, a nitrogen filling system sample is weighted before and after filling, 0.52 ±. Guarantees 01 grams of gas. The procedural canister has a sufficiently accurate digital gauge to ensure that the final balloon pressure is achieved. For example, the procedural canister's digital gauge has an accuracy of 0.25% of full scale. The procedural canister has a digital gauge that maintains accuracy over its useful life, for example, a procedural canister digital gauge has 0.25% full scale accuracy after 1000 cycles of 0 psi to 30 psi or 0 KPa to 26 Kpa. The nitrogen filling system preferably operates under reasonable environmental conditions, such as a temperature of -18 ° C to 55 ° C and a relative humidity of 30% to 85%. The altitude classification system is used at altitudes of <2000 m (61 to 101 KPa).

  The Obalon intragastric balloon system ("system" or OGB) is designed to assist in weight loss by partially filling the stomach and inducing a feeling of fullness. The system consists of up to 3 intragastric balloons placed non-invasively in the stomach (via the catheter capsule assembly) and staying in the stomach for up to 3 months (12 weeks). For administration, each balloon is housed in a medical grade porcine gelatin capsule attached to a small catheter. Balloon capsules deliver balloons in the same manner that drug capsules deliver drug products. The catheter arrives pre-attached to a compacted balloon radiopaque reseal valve. To administer (indwell) the device, the catheter / capsule is swallowed by the patient. The catheter is then attached to a procedural canister that houses a disposable nitrogen filling system used to fill the balloon. After the patient swallows the balloon capsule, radiographs confirm that the balloon is in the stomach after swallowing (visualized by a radiopaque marker). A preferred radiography method is fluoroscopy because it uses low levels of radiation to provide a real-time image of the balloon. A fully inflated single balloon is an ellipsoid with a volume of about 250 cc. If three balloons are indwelled, the total balloon volume is 750 cc. The dosing procedure does not require sedation. After inflation is complete, the catheter is manually withdrawn from the balloon valve and removed by the physician, leaving the balloon in the patient's stomach for up to 3 months.

  For balloon use, simultaneous use of a proton pump inhibitor for the duration of use, for example, 40 mg / day pantoprazole or an equivalent dose of similar dosing may be employed. This is likely to be an effective treatment for existing undiagnosed esophagitis and gastritis that will increase the durability of the indwelling device. Antiemetics and antispasmodics may be given immediately after balloon placement and may be given as needed while the balloon (s) are in the stomach.

  Clinical trials have shown that it is preferable to place one balloon first, and later balloons to be placed later within a three month period (FIG. 32). The determination of whether a patient needs additional volume should be based on the patient's weight loss progress and reported satiety level. The additional balloon is placed in the same manner as the placement of the first balloon, and only X-ray imaging is required at the time of placement.

  The balloon helps the patient to eat less food per seat. Only the selection of low-calorie foods in addition to the balloon (s) will help facilitate weight loss. The balloon is intended to remain in the stomach for 3 months (12 weeks) from the time the first balloon is placed. All indwelling balloons are removed at the end of 3 months using standard endoscopy. The device (s) are removed by a trained medical professional who is proficient in gastroscopy.

  In medical environments where the device is used, fluoroscopy or digital x-rays can be utilized when the device is administered, confirming balloon / capsule placement in the stomach prior to inflation. In addition, the designated physician can immediately access the endoscope unit and personnel who are proficient in gastroscope and foreign body removal if problems occur during administration. Personnel trained in gastroscopic equipment and foreign body removal are employed for device removal.

  The Obalon intragastric balloon system ("system") is indicated for temporary use for weight loss in overweight obese adults with a BMI of 27 or more that have already failed the monitored weight management program. The Obalon intragastric balloon system is intended to be used in conjunction with diet and behavioral therapy. Up to three Obalon intragastric balloons can be placed in the stomach for 3 months (12 weeks) based on individual weight loss progress and satiety levels. The maximum indwelling period for the Obalon intragastric balloon (s) is 3 months (12 weeks) and all balloons must then be removed previously.

All components are supplied without disinfection. The system may include a placebo capsule assembly that includes a capsule of the same material, size, shape, and weight as the actual device, but does not contain a balloon or catheter. The capsule is a food grade sugar for simulating device weight and one folded, housed in a swallowable gelatin capsule and attached to one disposable flexible catheter delivery system (FIG. 33) An Obalon intragastric balloon assembly including a balloon, two 3 cm ³ syringes, an accessory kit including an extension tube and a three-way valve (FIG. 34), an accessory kit including a 60 cm ³ syringe, and a reusable component, digital It is filled with a procedure canister (FIG. 35) used in conjunction with a disposable nitrogen filling system fitted with a pressure gauge, two AAA batteries, and a nitrogen filling system filled with 150 cm ³ of nitrogen. Other articles that may be used in conjunction with administering and / or removing the system include small clean bowls, bottled water, timers / clocks, digital x-ray or fluoroscopy devices, vacuum suction sources, gastroscopes A gastroscope injection needle (minimum length may be 6 mm and a minimum needle gauge size may be 23) that fits the working flow path of the gastroscope, and a toothed tooth with a crocodile gripping forceps (minimum opening) Width can be 15 mm), or other commercially available endoscope extraction tools such as a bifurcated grasper that fits the working flow path of the gastroscope.

The procedural canister is used by first ensuring that the procedural canister is correct for the altitude of the equipment and accommodates an atmospheric pressure compensation valve to adjust the starting pressure to ensure proper balloon final pressure Be prepared to do it. Failure to use the correct procedural canister can result in deflation or overinflation of the balloon. The procedural canister valve is in the open position (FIG. 36). When the “on” button is pressed, the procedure canister gauge is turned on. The plug with extension tube and three-way valve is removed from the accessory kit packaging. The luer lock plug is removed from the end of the procedure canister gauge (FIG. 37). After the luer lock plug is saved and the procedure is complete, return it to the procedure canister so that the procedure canister is free of foreign objects. The proximal end of the luer connector of the extension tube (from the accessory kit) is connected to the procedure canister (FIG. 38) with the valve open. The plug valve is in the closed position to stop the gas flow (FIG. 39). The cap is removed from the disposable canister. The canister is configured not to fit into the canister dispenser unless the cap is removed (FIG. 40). With the lever in the “open” position, the disposable nitrogen filling system is inserted straight down into the canister dispenser (FIG. 41). The lever is set in the “closed” position to secure the disposable nitrogen filling system in place (FIG. 42). The initial reading on the gauge is confirmed to be between 257 kpa and 297 kpa, thereby ensuring proper balloon inflation. The valve on the procedural canister is closed by rotating the valve clockwise (right) (FIG. 43). The procedural canister valve is in a closed position before proceeding to the next step, which ensures proper positioning and status of the balloon capsule before proceeding to the balloon filling step. A 3 cm ³ syringe is removed from the packaging and filled with 1.5 ml of room temperature water and set aside. Fill the middle of a small clean bowl with water. The Obalon intragastric balloon capsule and catheter delivery system are removed from the packaging.

  It is recommended that the patient first swallow the placebo capsule before swallowing the functioning device. The purpose of this procedure is to determine which patients are suitable candidates for placement of the actual device and which are not. Placebo capsules should be easy to descend. If the patient swallows the placebo capsule without problems, it is recommended to proceed to balloon therapy.

  Obalon balloon capsules are administered to the patient using conventional pill swallowing methods. An endoscope is not required for placement. Fluoroscopy (or digital x-ray) is employed in the indwelling procedure to confirm placement of the balloon in the stomach prior to device inflation. Prior to swallowing another capsule, an existing balloon is also imaged to confirm its integrity. The total indwelling time is less than 15 minutes for each indwelling balloon.

  If the patient has a strong pharyngeal reflex, a local anesthetic may be administered just prior to capsule administration. In order to place the balloon, the patient preferably does not apply lipsticks, brighteners or emollients to the lips that may affect the administration process. The patient is preferably standing or sitting with his back straight and drinking water three times in preparation for capsule administration. The patient may be instructed not to bite the catheter, close his mouth on the catheter, hold the catheter by hand, or grasp the catheter. The capsule / catheter is wetted by being submerged in a bowl of water for at least 10 seconds. Within 1 minute of submerging the capsule in the water, the patient is handed the capsule / catheter and is instructed to immediately place the capsule in his mouth and swallow the capsule with another large glass of water. . The proximal catheter port is held outside the patient's mouth. The time for the capsule / catheter to remain in the mouth for swallowing is documented. The patient is given additional water or juice (at least 100 ml) after swallowing. The patient continues to sit for a while, standing or standing for the time from start to finish. If it cannot be confirmed that the balloon is in the stomach, the patient is constantly required to drink water or juice to facilitate the peristaltic movement of the capsule / catheter. After being swallowed, the proximal end of the capsule / catheter assembly remains outside the patient's mouth until after the balloon is filled. The catheter is used as a reference guide to help determine how far the catheter has moved after swallowing, with or without radiographic confirmation, with or without measurement results provided by a digital gauge Can have markings used in If the “target” marking is on the patient's teeth, this indicates that the balloon is about 45 cm below the esophagus and fluoroscopy is used at this time to determine if the balloon is in the stomach (FIG. 44). A preferred method for confirming proper balloon placement prior to inflation is to use a radiograph (fluoroscopy / digital x-ray). Catheter marking can be used as an additional criterion for when to properly take radiographs, or it can be used alone to confirm the length moved into the stomach.

  A procedural canister with an extension tube from the accessory kit is connected to the balloon catheter by connecting the catheter to a male luer port on the three-way plug of the extension line already connected to the procedural canister (FIG. 45). The luer fitting is tightened with fingers. The valve on the procedural canister is in the closed position before proceeding to the next step, which ensures proper positioning and status of the balloon capsule before proceeding to balloon filling.

About 1 to 2 minutes after swallowing, digital X-ray or fluoroscopy is performed with the patient standing or sitting with the back stretched to determine the placement of the radiopaque balloon marker in the stomach To do. At least 3-5 minutes after swallowing, a second confirmation of device placement is performed using the procedural canister. This presses the “on” button, turns on the gauge backlight, presses the “on” button again, turns the three-way valve on the stopper counterclockwise 90 °, the valve stops and the gas from the extension tubing to the balloon This is accomplished by turning on the procedural canister digital gauge by turning the flow until it opens (FIG. 46). The pressure first drops on the pressure gauge by about 20 kPa and then drops further below 7 kPa as the capsule dissolves. This takes about 45 seconds but within 4 minutes. If the pressure remains above 7 kPa, the capsule is not fully dissolved or the catheter is kinked. Capsule dissolution can be facilitated by allowing the patient to drink more liquid. The pressure is monitored for up to 4 minutes. After this time, if the pressure has not dropped below 7.0 kPa, the capsule is not dissolved or the catheter is kinked. The balloon filling step does not begin until the radiopaque balloon valve is visualized in the stomach and the procedural canister pressure gauge reading is less than 7.0 kPa. Upon inflation, if there is an indication of inflation within the constrained space (due to pressure readings or patient symptoms), the gas flow is shut off by closing the valve on the procedure canister, the catheter is detached from the procedure canister, and 60 cm ³ Exhaust the gas from the balloon with a syringe. The balloon can then be removed with an endoscope. If the gauge reading is less than 7.0 kPa, the balloon may be filled. The balloon is not cut from the catheter before the balloon filling is complete. If there was an early cut, the catheter is removed by withdrawing it, and then the balloon is punctured with an endoscope and removed.

The disposable nitrogen canister contains 150 cm ₃ of nitrogen that is transferred into the balloon to fill a single balloon to a volume of 8.3 to 17.2 kPa and 250 cm ³ . If the gauge is constant after decreasing from the default inflation pressure, the balloon is filled to a desired volume of 250 cm ^{3 at} a desired pressure of 13.8 kPa within about 2 minutes. To fill the balloon, the procedural canister valve is turned to the on / open position (FIG. 47). Equilibrium is observed about 2 minutes after opening the valve (expansion time). The final read pressure on the procedure canister digital gauge is confirmed to be stable and the reading is 8.3 to 17.2 kPa. If the pressure is outside the specified range, the balloon is removed by the endoscope. A pre-filled syringe is attached to a stopper with a three-way valve. The plug with the three-way valve is rotated 90 degrees back to close the gas flow from the procedural canister (FIG. 48). The three-way valve plug is not rotated until it is attached to a pre-filled syringe to prevent reducing the final starting pressure in the balloon so that the balloon cannot maintain its volume for 3 months. The gauge is not zeroed by holding the zero button while pressure is transmitted to avoid the need to remove the balloon with an endoscope at that time.

The canister is removed by pushing the 1.5 cm ³ filled syringe plunger with one rapid, intentional movement, thereby detaching the catheter from the balloon valve in the stomach. If the catheter does not detach after the first attempt, a second 1.5 cm ³ water-filled syringe can be used to attempt to remove the catheter again. In a second trial, it is confirmed that the catheter is straight (no kinks) and the plunger has been pushed with a rapid, intentional movement. This step is not performed slowly to avoid the force being used when pushing the syringe and the catheter not being properly drained. If the catheter remains attached to the balloon, the second 3 ml syringe may be filled halfway with water and desorption can be attempted again. To facilitate desorption, the patient lifts his jaw to help reduce pharyngeal reflexes, and then the catheter is slowly withdrawn from the patient's mouth. The needle inside the catheter and needle sleeve is visualized (white protective hub attached to the capsule device) to ensure that the needle is intact. If the needle is not inside the needle sleeve, the balloon is removed. The catheter is separated from the plug with the three-way valve by loosening the luer lock. Balloon placement can be reconfirmed using X-rays or fluoroscopy.

  The disposable nitrogen filling system can be removed from the procedure canister and discarded. To remove, the procedure canister lever is moved to the “open” position and the nitrogen filling system is pushed up from the opposite side of the procedure canister or the procedure canister is turned over and the disposable hydrogen filling system falls off naturally. The procedural catheter is reused for the next balloon placement.

  Patients can be advised to drink liquid for the first 24 hours and move to soft solids for the next 24 hours (within the first 48 hours after placement). The patient is instructed not to drink alcohol, soda, or other “bubble” or carbonated drinks. After 3 days, the patient can return to solid food and follow the diet and behavioral therapy provided by the doctor.

  While the placement of the balloon does not require an endoscope, trained endoscopists can easily find out if there is a problem with swallowing the balloon or if an undiscovered swallowing disease is detected during the procedure. It may be desirable to be available. The following points should be considered when a patient is unsuccessful in his first placement attempt: If the device does not pass through the pharynx in the patient's mouth after trying a 30 second swallow, the capsule is removed from the mouth. A new wet balloon capsule / catheter assembly is used. If the patient fails both attempts, the problem is discussed with the patient to determine if the patient is still an appropriate candidate for this therapy. If the swallowing failure is due to anxiety, standard methods to reduce patient anxiety can be used. The esophageal passage of the device can be facilitated by using a clear carbonated beverage.

  Patients are advised to report changes in satiety (ie, increased feeling of hunger) and / or weight gain because this may be a sign that additional balloons for therapy can be warranted. If multiple balloons are in place and the patient reports a change in satiety level (ie, a decrease in early satiety), this may be an indication of balloon deflation. Balloon contraction can be assessed using X-ray photographs (film X-rays, digital X-rays, or fluoroscopy) and a gastroscope as appropriate. Patients are advised to contact a physician if the frequency of adverse events received is greater than expected or unbearable. The simultaneous use of proton pump inhibitors is used in that it is likely to be an effective treatment for existing undiagnosed esophagitis and gastritis that can increase the durability of the indwelling device. It may be desirable for similar dosages of duration, eg, 40 mg / day pantoprazole or equivalent doses. Antiemetics and antispasmodics may be given immediately after balloon placement and may be given as needed while the balloon (s) are in the stomach.

After 12 weeks of use, one or more balloons are removed from the patient. The procedure is performed using an endoscope with a working length of less than 1200 mm and the inner diameter is compatible with the proposed accessory tools for balloon puncture and removal. The proposed tool is a needle instrument, e.g. a needle holder, e.g. a needle holder in a Teflon sleeve 23G x 6 mm or similar with a suction lumen, a crocodile mouth or two jaw gripping forceps ( Minimum opening width 15 mm), or a bifurcated gripper with the same minimum opening. Other removal tools may be acceptable for removing the balloon. The extraction procedure is generally performed according to the instruction manual of the gastroscope manufacturer for extracting the foreign matter. The endoscopic procedure performed is similar to that of interventional or therapeutic procedures, but it is recommended to rework the endoscopic approach according to the specific product features, for example, the balloon should be punctured only once Therefore, the maximum amount of gas may be drawn from them (via vacuum), and the lower the degree of gastric inflation (the less air blows), the easier the balloon can be punctured. A typical capsule may contain as ingredients: porcine gelatin, water, methylparaben, propylparaben, and sodium lauryl sulfate. A typical balloon can be made from nylon and polyethylene (as the wall material), silicone (in the valve), and titanium (as the radiopaque component). Procedure canisters are typically made from stainless steel, 6061AL, brass, acetal, and silicone. The nitrogen filling system contains 18 bar of 150 cm ³ of nitrogen.

  Preferably, the patient is fasted for at least 24 hours, or according to a hospital protocol, to ensure that the stomach is emptied for the gastroscopic procedure and therefore the balloon (s) are easily visible. . Patients are anesthetized according to hospital and physician recommendations for gastroscopic procedures. A gastroscope is inserted into the patient's stomach and a clear image of the filled balloon is obtained through the gastroscope. A needle instrument is inserted down the working channel of the gastroscope. A balloon valve is placed and the balloon is punctured once with a needle (if possible at the opposite end of the valve to facilitate removal). Suction is applied and balloon gas is aspirated using a large syringe (60 cc) or suction tube. The needle is removed from the working channel and a gripper is inserted through the working channel. The balloon is gripped by the gripper at the opposite end of the valve. By firmly grasping the balloon, the balloon is slowly pulled up through the esophagus and removed through the mouth. The removal procedure is repeated for the remainder of the balloon, if any.

  The present invention has been described above with reference to specific embodiments. However, embodiments other than those described above are equally possible within the scope of the present invention. Steps different from those described above may be given within the scope of the invention. Different features and steps of the invention may be combined in combinations other than those described. The scope of the invention is limited only by the appended claims.

  All references cited herein are hereby incorporated by reference. In the event that publications and patents or patent applications incorporated herein by reference contradict the disclosure contained herein, this specification supersedes and / or supersedes such conflicting material. Shall.

  In the event that publications and patents or patent applications incorporated herein by reference contradict the disclosure contained herein, this specification supersedes and / or supersedes such conflicting material. Shall.

  Unless otherwise defined, all terms (including technical and scientific terms) are given their ordinary and customary meaning to those of ordinary skill in the art, and unless expressly defined as such herein The meaning is not limited to a special meaning or a special condition.

  The terms and phrases used in this application, and variations thereof, unless otherwise explicitly defined, should be construed as unconstrained, as opposed to limiting. As an example of the foregoing, the word “comprising” should be read to mean “including without limitation” or similar phrases, and the word “comprising” as used herein is “ Is a synonym of “includes”, “contains”, or “characterized”, is inclusive or non-restrictive, and does not exclude other uncited elements or method steps; A word is used to give an example rather than an exhaustive or limiting list of items in a description, and an adjective such as “known”, “normal”, “standard”, etc. , And words of similar meaning should not be construed as limiting the item being described to items available for a given time period or currently available for a given time, but are available instead It can be Should be read to encompass known, normal, or standard techniques that may be known at any point in time, now or in the future, "preferably", "preferred", "desired" The use of words such as “of”, “desirable” and similar meaning means that some features are critical, essential or even more important to the structure or function of the invention. It should not be understood to be implied, but instead is understood to be merely intended to highlight alternative or additional features that may or may not be utilized in certain embodiments of the invention. Should be. Similarly, a group of items linked by the conjunction “and” should not be read as requiring that every item in the group be present in the group, but rather is not clearly defined separately. As long as it should be read as "and / or". Similarly, a group of items linked by the conjunction “or” should not be read as requiring that they be mutually exclusive, but rather “unless otherwise specified” Should be read as "and / or". In addition, as used in this application, the original English articles “a” and “an” are one or more (ie, at least one) of the grammatical objects of the article in the English original text. Should be construed to indicate, and is not particularly translated in Japanese translations. By way of example, “an element” (“element”) means one element or more than one element.

  If a broadening word is present in some cases, such as “one or more”, “at least one”, “but not limited”, or other similar phrases, this may be narrower Is not intended to be construed as meaning or required in instances where such broadening phrases may not exist.

  As used herein, all numbers expressing amounts of ingredients, reaction conditions, etc. should be understood to be modified in all cases by the word “about”. Thus, unless stated otherwise, the numerical parameters described are approximate and may vary depending on the desired characteristics to be obtained. At the very least, it is not intended to limit the application of the claimed equivalent principle of any application claiming priority of this application, but the numeric parameters shall be Should be interpreted in the light of numbers.

Moreover, while the foregoing has been described in some detail using illustrations and examples for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced. Accordingly, the descriptions and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather are appended to the true scope and spirit of the invention. All such modifications and alternatives are to be construed as intended.
The matters described in the claims at the beginning of the application are appended as they are.
[1] A system for inflating an inflatable intragastric device, the system comprising an inflation fluid container having an inflation fluid container opening and a reservoir for holding inflation fluid, an inflation fluid dispenser, The inflation fluid dispenser is coupled and secured to the inflation fluid container and is positioned at a proximal inlet coupled to the inflation fluid container opening and a distal end of the inflation fluid dispenser A housing having an inner surface defining a flow path having an outlet, a valve disposed in the flow path and configured to transition between a closed state and an open state, and coupled to the valve; A valve control configured for user manipulation to transition the valve between the closed state and the open state, and to measure the pressure in the flow path between the valve and the distal outlet And a pressure gauge configured in the expansion fluid container An inflation pressure dispenser comprising: an atmospheric pressure compensation valve configured to discharge a portion of the inflation fluid from the inflation fluid container through an outlet to achieve a target start volume; An inflatable intragastric device having a lateral opening; and coupled to the inflatable intragastric device and positioned between a channel of the inflation fluid dispenser and the proximal opening of the inflatable intragastric device A system for inflating an inflatable gastric device comprising a catheter having a lumen and in fluid connection.
[2] The system according to [1], wherein the catheter is sized and shaped according to placement in a patient's esophagus.
[3] The system according to [1] or [2], wherein the internal cavity of the inflatable intragastric device is defined by an oval wall of the inflatable intragastric device.
[4] The system according to any one of [1] to [3], wherein the inflatable intragastric device is at least partially disposed within a dissolvable capsule configured for swallowing by a patient.
[5] The system according to any one of [1] to [4], wherein the inflation fluid dispenser is a highly durable medical device product.
[6] The system according to any one of [1] to [5], wherein the inflation fluid container is a disposable type.
[7] The system according to any one of [1] to [6], wherein the expansion fluid is pure nitrogen.
[8] The system of any one of [1]-[7], wherein the target starting volume is selected to achieve an internal volume of 90 to 300 cc in the inflatable intragastric device after inflation.
[9] The atmospheric pressure compensation valve receives an input to the current temperature, the current altitude, the current atmospheric pressure, or a combination thereof, and discharges a part of the expansion fluid based on the input [1] to [ 8] The system according to any one of [1].
[10] A method for delivering an inflatable intragastric device to a patient's stomach, comprising an inflation system, the inflation system having an inflation fluid container opening and an internal reservoir for holding inflation fluid An expansion fluid container and an inner surface defining a flow path in fluid communication with the reservoir of the expansion fluid container and configured to transition between a closed position and an open position An inflatable fluid dispenser having a valve disposed in the device, an inflatable intragastric device having an internal cavity and a proximal opening at least partially encapsulated in the capsule, and coupled to the inflatable intragastric device And a catheter having a lumen positioned between the flow path of the inflation fluid dispenser and the proximal opening of the inflatable intragastric device and in fluid connection therewith. Before realizing the system, Delivering the inflatable intragastric device and the capsule into the patient's mouth and toward the patient's stomach with a valve in the closed position; and a first of the inflatable intragastric device; A first pressure value of the inflatable gastric device, wherein the first pressure value provides feedback to an end user indicating the current placement of the inflatable gastric device. Monitoring the pressure value and transitioning the valve to the open position when a first target pressure value is reached, wherein transitioning the valve to the open position is the expansion. Transitioning the valve to the open position when a first target pressure value is reached, causing fluid to flow from the reservoir of the inflation fluid container to the cavity of the inflatable intragastric device; Swelling Monitoring a second pressure value of the expandable intragastric device, wherein the second pressure value provides feedback to the end user indicating successful or failed expansion of the expandable intragastric device. A method of delivering an inflatable intragastric device to a patient's stomach comprising monitoring a second pressure value and removing the catheter from the patient.
[11] The method of [10], further comprising separating the catheter from the inflatable intragastric device.
[12] The method of [11], wherein the proximal opening of the inflatable intragastric device self-seals after separation from the catheter.
[13] Any of [10]-[12], wherein the first pressure value of 7.0 kPa or less indicates that the inflatable gastric device is placed in the patient's stomach and is ready for inflation The method according to 1.
[14] A second pressure value between 8.3 kPa and 17.2 kPa indicates any successful expansion of the inflatable gastric device according to any one of [10] to [13]. the method of.
[15] A method of treating obesity, comprising the method of [10] and maintaining the inflatable intragastric device in the stomach of a patient for a treatment duration.
[16] The method according to [15], wherein the treatment duration is between 30 days and 90 days.
[17] Further comprising prescribing a prescription drug for periodic administration throughout the treatment duration, wherein the prescription drug is selected from the group consisting of proton pump inhibitors, antiemetics, and antispasmodics [15] Or the method as described in [16].
[18] The method according to any one of [15] to [17], further comprising taking out the expandable intragastric device with an endoscope when the treatment duration has ended.
[19] The method of any one of [15]-[18], further comprising delivering an additional inflatable intragastric device into the stomach of the patient during the treatment duration.

Claims (8)

A inflation fluid dispenser system for inflating an inflatable intragastric device,
Comprising a housing having an inner surface defining a channel having a distal outlets positioned proximal inlet and Rise distal end of Zhang fluid dispenser that is configured so that coupled to the inflation fluid container opening The flow path is configured to fluidly connect with a lumen of a catheter coupled to a proximal opening of an inflatable intragastric device having an internal cavity;
A valve disposed in the flow path and configured to transition between a closed state and an open state;
A valve controller coupled to the valve and configured for user operation to transition the valve between the closed state and the open state;
A pressure gauge configured to measure the pressure in the flow path between the valve and the distal outlet;
And atmospheric pressure compensating valve configured to release a portion of the bulging Zhang fluid from the inflation fluid container through the outlet in order to achieve the target starting volume of Rise Zhang fluid container,
An inflation fluid dispenser system comprising: The catheter is sized and shaped matching the placement in the esophagus of a patient, according to claim 1 system. It said inflatable said interior cavity of the intragastric device is defined by an oval wall of the inflatable intragastric device system according to claim 1 or 2. The inflatable intragastric device is at least partially disposed within the soluble capsule which is configured for swallowing by the patient, according to claim 1 system. It said inflation fluid container is a disposable, according to any one of claims 1 to 4 systems. The inflation fluid is pure nitrogen, the system according to any one of claims 1-5. Wherein the target initiation body product is selected from 90 of the inflatable intragastric the device after expansion to achieve an internal volume of 300 cc, the system according to any one of claims 1-6. The atmospheric pressure compensating valve, current temperature, current altitude, receives input for the current atmospheric pressure or a combination thereof, to release a portion of the inflation fluid based on the input, either of claims 1-7 The system according to claim 1.