system for inflating intragastric balloon

专利摘要:
SYSTEM AND METHOD FOR INFLATING AND DEFLATING THE INTRAGASTRIC BALLOON Devices and methods are provided to treat obesity. More particularly, intragastric devices and methods of manufacturing, employing, inflating, monitoring and restoring them are provided.
公开号:BR112013018254B1
申请号:R112013018254-7
申请日:2011-01-21
公开日:2020-07-07
发明作者:Mark C. Brister；Paul D. Faucher；Neil R. Drake；Andrew P. Rasdal；Matthew S. Lake；Dubravka Markovic；Amy D.L. Vandenberg；Antonio Llevares；Josefina Nider
申请人:Obalon Therapeutics, Inc.；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] Devices and methods for the treatment of obesity are provided. More particularly, intragastric devices and methods of manufacturing, implanting, inflating, monitoring and recovering them are provided. BACKGROUND OF THE INVENTION
[0002] Obesity is a serious health problem in developed countries. Obesity puts a person at a higher risk of developing high blood pressure, diabetes and many other serious health problems. In the United States, complications from overweight or obesity are estimated to affect about one in three American adults, with an annual medical cost of more than $ 80 billion and, including indirect costs, such as lost wages , a total annual economic cost of more than $ 120 billion. Except for rare pathological conditions, weight gain is directly related to overeating.
[0003] Non-invasive methods for weight reduction include increasing metabolic activity to burn calories and / or reducing caloric intake, either by behavioral modification or with pharmacological intervention to reduce the desire to eat. Other methods include surgery to reduce stomach volume, bandaging to limit the size of the stoma, and intragastric devices that reduce the desire to eat by taking up space in the stomach.
[0004] Devices that occupy intragastric volume provide the patient with a feeling of satiety after having consumed only small amounts of food. Thus, the caloric intake is decreased while the person is satisfied with the feeling of satiety. The volume occupancy devices currently available have many flaws. For example, complex gastric procedures are required to insert some devices.
[0005] The US Patent. 4,133,315, the content of which is hereby incorporated by reference in its entirety, describes an apparatus for the reduction of obesity, which comprises an inflatable, elastomeric bag and tube combination. The pouch can be inserted into the patient's stomach if swallowed. The end of the tube connected distally to the pouch remains in the patient's mouth. A second tube is snaking through the nasal cavity and into the patient's mouth. The ends of the tube located in the patient's mouth are connected to form a continuous tube for fluid communication through the patient's nose into the bag. Alternatively, the bag can be implanted by a gastric procedure. The bag is inflated through the tube to a desired degree before the patient eats so that the desire for food is reduced. After the patient has eaten, the bag is emptied. The tube extends out of the patient's nose or into the abdominal cavity, throughout the course of treatment.
[0006] US Patents. 5,259,399, 5,234,454 and 6,454,785, the contents of which are incorporated herein by reference in their entirety, describe devices for occupying intragastric volume for weight control that must be surgically implanted.
[0007] US Patents. 4,416,267, 4,485,805, 4,607,618, 4,694,827, 4,723,547, 4,739,758, and 4,899,747 and European Patent No. 246999, whose contents are hereby incorporated by reference in their entirety, refer to devices for occupying intragastric volume for weight control that can be introduced endoscopically. Of these, US Patents 4,416,267, 4,694,827, 4,739,758 and 4,899,747, the contents of which are incorporated herein by reference in their entirety, refer to balloons whose surface is configured in a certain way to achieve a desired effect . In US Patents. 4,416,267 and 4,694,827, the contents of which are incorporated herein by reference in their entirety, the balloon is torus-shaped with an enlarged central opening to facilitate the passage of solids and liquids through the stomach cavity. The balloon of the US Patent. 4,694,827, the content of which is incorporated herein by reference in its entirety, has a plurality of convex projections with a smooth surface. The protrusions reduce the amount of surface area that comes into contact with the stomach wall, thereby reducing the deleterious effects resulting from excessive contact with the gastric mucosa. The protrusions also define channels between the balloon and the stomach wall through which solids and liquids can pass. The balloon of the US Patent. 4,739,758, the content of which is incorporated herein by reference in its entirety, has bubbles on its periphery, which prevent it from settling firmly against the cardia or pylorus.
[0008] The balloons of the US Patents. 4,899,747 and 4,694,827, the contents of which are hereby incorporated by reference in their entirety, are inserted by pushing the empty balloon and tubing releasably connected through a gastric tube. Patent No. US. 4,723,547, the content of which is incorporated herein by reference in its entirety, discloses an insertion catheter specially adapted to position the balloon. In US Patent No. 4,739,758, the contents of which are incorporated by reference in their entirety, the filling tube inserts the balloon. In US Patent No. 4,485,805, the content of which is incorporated herein by reference in its entirety, the balloon is inserted into a finger that is connected by rope to the end of a conventional gastric tube, which is inserted into the patient's throat. The European Patent 246,999 balloon is inserted through an endoscope with integral forceps.
[0009] In US Patents. 4,416,267, 4,485,805, 4,694,827, 4,739,758, and 4,899,747 and in European Patent No. 246,999, the contents of which are hereby incorporated by reference in their entirety, the balloon is inflated with a fluid from a tube that extends downwards from the patient's mouth. In these Patents, the balloon is also provided with a self-insulating hole (US Patent 4,694,827, the contents of which are incorporated by reference in its entirety), injection site (US Patents 4,416,267 and 4,899,747, the contents of which are hereby incorporated by reference in their entirety), self-insulating inflation valve (US Patent 4,485,805, the content of which is incorporated herein by reference in its entirety), self-closing valve (European Patent 246,999, the content of which is incorporated herein by reference in its entirety), or duckbill valve (US Patent 4,739,758, the contents of which are hereby incorporated by reference in its entirety). Patent No. US. 4,723,547, the content of which is incorporated herein by reference in its entirety, uses a thick elongated fitting and the balloon is inflated by inserting a needle connected to an air source through the fitting.
[0010] Patent No. US. 4,607,618, the content of which is hereby incorporated by reference in its entirety, describes a dismountable apparatus formed by semi-rigid skeleton members joined together to form a dismountable hollow structure. The device is not inflatable. It is endoscopically inserted into the stomach using a specially adapted candle having an ejector rod to release the collapsed device. Once released, the device returns to its largest size and relaxed shape.
[0011] The US Patent. 5,129,915, the content of which is hereby incorporated by reference in its entirety, refers to an intragastric balloon intended to be swallowed and which automatically inflates under the effect of temperature. Three ways in which an intragastric balloon can be inflated by a change in temperature are discussed. A composition comprising a solid acid and carbonate or non-toxic bicarbonate is separated from the water by a coating of chocolate, cocoa mass or cocoa butter that melts at body temperature. Alternatively, citric acid and an alkaline bicarbonate coated with non-toxic vegetable or fusion of animal fat at body temperature and placed in the presence of water, can produce the same result. Finally, the non-toxic solid acid and carbonate or bicarbonate are isolated from the water by an insulating pouch of low-strength synthetic material that will be sufficient to rupture immediately before swallowing the bladder. Breaking the insulation pockets causes the acid, carbonate or bicarbonate and water to mix and the balloon starts to expand immediately. A disadvantage of triggering thermal inflation is that it does not allow the degree of control and reproducibility of the inflation time, which is desirable and necessary in a safe, self-inflating intragastric balloon. SUMMARY OF THE INVENTION
[0012] An intragastric, free-floating, volume-occupying device that can be inserted into the patient's stomach by swallowing it alone and let the peristalsis deliver it into the stomach in the same way as the food is provided, or by positioning the even with a catheter, it is desirable.
[0013] The devices for occupying the volume of methods for manufacturing, implanting, inflating, tracking, emptying and recovering such devices are provided. The devices and methods of the preferred modalities can be employed for the treatment of overweight and obese individuals. The methods using the device of the preferred modalities can be swallowed by a patient, with or without an attached catheter. Once inside the patient's stomach, the device is inflated with a pre-selected gas or mixture of gases to a pre-selected volume. After a predetermined period of time, the device can be removed using endoscopic tools or decreases in volume or emptying in order to pass through the rest of the patient's digestive tract.
[0014] Inflation can be achieved through the use of a removable catheter that initially remains in fluid contact with the device after being ingested by the patient.
[0015] The volume occupation subcomponent of the devices can be formed by injection molding, blowing or rotating 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 the volume occupancy subcomponent include, but are not limited to, silicon oxide (SiOx), gold or any noble metal, saran, insulating coatings and the like, when it is desired to reduce permeability. To improve the gas-impermeable characteristics of the device wall, if desired, the volume-occupying subcomponent can also be coated with one or more gas barrier compounds, or be formed by a Mylar or kelvalite, silver polyester film coating or aluminum as a metallized surface to form a gas-impermeable barrier.
[0016] In other embodiments, the device uses a delivery state in which the device is packaged in such a way that the device can be swallowed, producing the least discomfort to the patient. In a delivery state, the device can be packaged in a capsule. Alternatively, the device can be coated with an operable material to confine the device and facilitate swallowing. Various techniques can also be employed to facilitate swallowing of the device, including, for example, humidification, temperature treatment, lubrication and treatment with drugs, such as anesthetics.
[0017] In other modalities, the devices may incorporate a tracking or visualization component that allows doctors to determine the location and / or orientation of the device within the patient's body. Tracking subcomponents may include barium stripe or geometric shape on the volume occupancy subcomponent wall. Screening and visualization can also be achieved by incorporating a microchip, infrared LED label, ultraviolet absorption compounds, fluorescent or colored compounds and incorporation of metallized strips and patterns for the volume occupancy subcomponent or other subcomponents of the device. Such techniques can also be used to obtain certain information and specifications for a specific device, while the device remains inside the patient's body.
[0018] In a first aspect, a system is provided to inflate an intragastric balloon, comprising the system: an inflation catheter, the inflation catheter comprising a needle assembly comprising a hollow needle, a needle-shaped sleeve bell and a mechanism for separating the inflation catheter after inflation of an in vivo balloon is completed; an intragastric balloon comprising a polymeric wall, wherein the polymeric wall comprises one or more layers, and a balloon valve system comprising a self-insulating septum in a retention structure, the septum being configured for needle drilling, wherein the retaining structure comprises a concentric valve system with a smaller inner cylinder housing the septum and a larger outer cylinder housing a material that provides compressive forces against the bell-shaped needle sleeve of the inflation catheter for inflation and separation , where the material providing compressive forces is a durometer material harder than the septum, and where the smaller inner cylinder comprises an edge configured for an interference fit with the bell-shaped needle sleeve to provide a valve sealing to the inflation catheter sufficient to maintain the sealing during balloon inflation; an external balloon container; and an inflation source container, wherein the inflation source container is configured to attach to the inflation catheter; in which the inflation catheter connected to the intragastric balloon before inflation is of a size and shape configured for swallowing by a patient who needs it.
[0019] In a first aspect embodiment, the polymeric wall comprises a barrier material comprising nylon / polyethylene.
[0020] In a first aspect embodiment, the polymeric wall comprises a barrier material comprising nylon / polyvinylidene chloride / polyethylene.
[0021] In an embodiment of the first aspect, the outer container is selected from the group consisting of a press fit capsule, a package, and a band, and the outer container comprises a material selected from the group consisting of gelatin, cellulose, and collagen.
[0022] In the first aspect, the septum is cone-shaped.
[0023] In an embodiment of the first aspect, the inflation source container is configured to connect to the inflation catheter through an inflation connector or valve.
[0024] In an embodiment of the first aspect, the inflation catheter is from 1 French to 6 French in diameter, and is about 50 cm to about 60 cm in length.
[0025] In an embodiment of the first aspect, the inflation catheter is a double lumen catheter comprising an inflation lumen and a separation lumen, in which the inflation lumen is in fluid connection with the container of the inflation source , and where the separating lumen is configured for connection to a separating liquid source container, where the separating liquid comprises a compatible physiological liquid, and where the interference fit is not sufficient to maintain a seal upon application of a hydraulic pressure by the separating liquid, such that after applying the hydraulic pressure to the needle assembly it is ejected from the balloon valve.
[0026] In an embodiment of the first aspect, the inflation catheter comprises a single lumen and a structural member that provides greater tensile strength, and an inflation valve configured to connect the single lumen to the inflation source vessel and an inflation vessel. source of separation liquid, the separation liquid comprising a compatible physiological liquid, and in which the interference fitting is not sufficient to maintain a seal by applying hydraulic pressure to the separation liquid, such that by means of application of hydraulic pressure to the needle assembly is ejected from the balloon valve.
[0027] In a first aspect embodiment, the inner cylinder is configured to control the alignment of the needle assembly with the septum, provide a barrier for the needle that pierces the polymeric wall, and provides compression such that the septum is sealed again after inflation and needle removal.
[0028] In a first aspect embodiment, a plurality of intragastric balloons are connected to a single inflation catheter.
[0029] In an embodiment of the first aspect, the inflation catheter is of variable stiffness.
[0030] In an embodiment of the first aspect, the source of inflation comprises a syringe.
[0031] In an embodiment of the first aspect, the inflation source is configured to use information about the inflation pressure as a function of time, to provide feedback to a user, where the feedback indicates a condition selected from the group which consists of failure by a mechanical block, failure by restriction of the esophagus, failure by leakage of the inflation or separation catheter, and successful balloon inflation.
[0032] In a second aspect, a method is provided for inflating an intragastric balloon, the method comprising: providing an intragastric balloon in an external container, the intragastric balloon comprising a polymeric wall, the polymeric wall comprising one or more layers, and a balloon valve system comprising a self-insulating septum in a retaining structure, the retaining structure comprising a concentric valve system with a smaller inner cylinder housing the septum and a larger outer cylinder housing a material configured to provide forces compressive against a bell-shaped needle sleeve of an inflation catheter, the material providing compressive forces being a durometer material larger than the septum, and the smaller inner cylinder comprises an edge configured for a interference with the bell-shaped needle sleeve; providing an inflation catheter comprising a needle assembly, the needle assembly comprising a hollow needle, a bell-shaped needle sleeve; pierce the septum through the needle of an inflation catheter, through which an interference fit is created between the bell-shaped needle sleeve and the edge of the smaller inner cylinder; cause the intragastric balloon in an external container fixed by the interference fitting to the inflation catheter to be swallowed by a patient in need of it; degrade the external container in order to allow the inflating of the intragastric balloon; inflating the intragastric balloon in the patient's stomach through the inflation catheter, the inflating catheter being connected to an inflating fluid source container; and separating the intragastric balloon from the inflation catheter, whereby a separating liquid comprising a compatible physiological liquid is forced through the inflation catheter to apply hydraulic pressure to the needle assembly such that the interference fit between the edge and the needle sleeve bell-shaped is broken, the needle assembly is ejected from the balloon valve and the self-insulating septum seals again.
[0033] In an embodiment of the second aspect, the inflation catheter is a double lumen catheter comprising an inflation lumen and a separating lumen, in which the inflation lumen is configured for fluid connection with the supply source container. inflation, and where the separation lumen is configured to connect to a separating liquid source container for separating the balloon.
[0034] In a second aspect embodiment, the inflation catheter is a single lumen catheter comprising a structural member, providing greater tensile strength and an inflation valve configured to first connect the single lumen catheter to the container of the supply source. inflating and then to a detachment liquid source container for separating the balloon.
[0035] In a second aspect modality, in which the method further comprises the monitoring of the inflation pressure as a function of time and separation when a predetermined final pressure is obtained, in which the successful balloon inflation is indicated by obtaining the preselected final pressure, which is based on an initial pressure at the inflation source and an inflation volume of the balloon.
[0036] In a third aspect, a method is provided for deflating an intragastric balloon, the method comprising: providing an intragastric balloon in an intragastric environment in vivo, the intragastric balloon comprising a polymeric wall and a valve system, the valve system comprising a self-insulating valve, a case, an external sealing member, a rigid retaining structure, and a deflating component; the case having one or more ventilation paths and an edge configured to hold the external sealing member in place, the external sealing member being positioned to block one or more ventilation paths when in place, the structure being rigid retention provides support for the septum and the external sealing member and the disinflation component is located in the case and behind the retention structure; expose the deflating component to moisture inside the balloon via one or more ventilation paths, through which the deflating component expands, pushing the retaining structure and then the outer sealing member linearly after the case edge to open one or more ventilation paths in order to provide fluid communication between the gastric environment in vivo and a balloon lumen; and deflate the balloon through one or more ventilation paths.
[0037] In a third aspect embodiment, the deflating component comprises a solute material encapsulated in a binder material, in which the deflating component is further surrounded by moisture limiting material, which has a moisture vapor transmission rate preset.
[0038] In a third aspect embodiment, the solute material is a polyacrylamide.
[0039] In a third aspect embodiment, the rigid retaining structure and the case have a snap-on lock that prevents a rigid retaining structure from being expelled from the case after maximum displacement by the deflating component.
[0040] In a fourth aspect, a method is provided to deflate an intragastric balloon, the method comprising: providing an intragastric balloon in an intragastric environment in vivo, the intragastric balloon comprising a polymeric wall, a self-insulating valve system, and a disinflation system, the disinflation system comprising a case, a sealing member, a plunger, and a disinflation component; the case having one or more ventilation paths and being attached to the polymeric wall, the plunger providing support to the sealing member and keeping the sealing member in position to block one or more ventilation paths in the case when in place, and the disinflation component being located in the case and behind the plunger; exposing the deflating component to moisture inside the balloon via one or more ventilation paths, through which the deflating component expands, pushing the plunger and thus the sealing member linearly through the case to open one or more air paths. ventilation in order to provide fluid communication between the gastric environment in vivo and a balloon lumen; and deflate the balloon through one or more ventilation paths.
[0041] In a fourth aspect embodiment, the intragastric balloon further comprises a water retention material located between the deflating component and the one or more ventilation paths, in which the water retention material is configured to retain water and to hold it against a surface of the deflating component, in order to maintain a constant humidity environment. BRIEF DESCRIPTION OF THE DRAWINGS
[0042] FIGS, from IA to 1D show a perspective view (FIG. IA), a side view (FIG. 1B), a top view (FIG. IC) and a cross-sectional view (FIG. 1D) of a head assembly of a self-insulating valve system, which contains a self-insulating septum housed within a metallic concentric cylinder.
[0043] FIGS, 2A to 2D show a perspective view (FIG. 2A), a side view (FIG. 2b), a cross-sectional view (FIG. 2C), and a top view (FIG. 2C) , of the tube system with rings. It includes a smaller cylinder of a concentric metal retaining structure into which a septum can be inserted, or otherwise manufactured in, such as in the self-insulated valve system of FIGS. lAa D.
[0044] FIGS, 3A to 3C show a perspective view (FIG. 3A), a side view (FIG.3B), and a top view (FIG. 3C) of a ring stop - an additional ring placed at the distal end of an inner cylinder to provide additional compression to ensure that the septum material is sufficiently dense to re-seal, as in the self-isolating valve system of Figures IA to D.
[0045] FIGS, from 4A to 4D show a perspective view (FIG.4A), a side view (FIG.4B), a cross-sectional view (FIG.4C) and a top view (FIG.4D) of a head unit comprising an outer cylinder of a concentric valve housing comprising a durometer material larger than the inner cylinder, as in the self-insulating valve system of FIGS. IA to D.
[0046] FIGS, from 5A to 5C show a perspective view (FIG. 5A), a side view (FIG. 5B), and a top view (FIG. 5C), a ring retainer - an additional retaining ring to further improve the seal between the metal and the silicone of the valve, as in the self-insulating valve system of FIGS. IA to D.
[0047] FIG. 6 shows a connector for a double lumen catheter.
[0048] FIG. 7 represents an inflation valve.
[0049] FIGS, 8A to 8B show a universal balloon valve for connection to an inflation catheter and a balloon wrapped in an external container. FIG. 8A shows the valve coupled to the inflation catheter, and FIG. 8B describes the valve still coupled to the coated balloon.
[0050] FIGS, 9A to 9C show a side view (FIG.9B), a bottom view (FIG. 9B) and a top view (FIG. 9C) of a double lumen catheter coupled to a gel cap that encapsulates a balloon.
[0051] FIGS, 10A to 10D show a perspective view (FIG.10A), a side view (FIG. 10B), a top view (FIG. 10C), and a cross-sectional view (FIG. 10C) of a bell-shaped needle sleeve.
[0052] FIGS, 11A to 11C show various modalities of a single lumen catheter. FIG. 11A shows the single lumen catheter with bell-shaped needle sleeve protecting the needle. FIG. 11B shows a perspective cross-sectional view of the single lumen catheter showing the detail of the needle, the bell-shaped needle sleeve, and a pull cord. FIG. 11C shows a perspective cross-sectional view of the single lumen catheter showing additional details of the needle and bell-shaped needle sleeve when seated on the head, including the self-insulating valve system of FIGS IA to D.
[0053] FIGS, from 12A to 12D show a perspective view (FIG. 12A), a side view (FIG. 12B), a top view (FIG. 12C), and a cross-sectional view (FIG. 12C) needle sleeve configured to accommodate a larger diameter tube.
[0054] FIG. 13 describes a catheter with variable stiffness to deliver a gastric balloon.
[0055] FIGS, 14A to 14C illustrate an inflation fluid container system (FIG. 14A) that includes a connector (FIG. 14B) for the catheter and a pressure measurement (FIG. 14C).
[0056] FIG. 15 describes a stainless steel inflation fluid container.
[0057] FIG. 16 is a graph that describes pressure as a function of time (pressure drop), obtained from a return of a container from the source of inflation.
[0058] FIG. 17 represents the expected decay curve for pressure sources, using a spring mechanism, or a balloon mechanism inside the balloon.
[0059] FIGS, 18A to 18B show a top view (FIG. 18A) and side view (FIG. 18B) of a balloon showing the configuration of balloon seams for the manufacture of a balloon that resists bursting in vivo.
[0060] FIGS, from 19A to 19E illustrate various modalities of an erosion core to achieve balloon deflation. FIG. 19A (perspective view) and FIG. 19B (side view) describe an erosion nucleus with a protective barrier between the nucleus and the intragastric environment. In another embodiment, a seal is held in place against the housing by an erosion core (FIG. 19C). After the core has eroded (FIG. 19D), the seal is released against the housing.
[0061] FIG. 20 represents a one-piece seal with a protective cover.
[0062] FIG. 21A describes a deflating mechanism, using an erodible core in a radial ring seal, with the compression ring to expel the seal once the erodible core support is removed. FIG. 2 IB represents a disinflation mechanism, using a seal with the erosion core and a push spring. FIG. 21C shows a moisture expansion material that pulls the septum out of position to cause the balloon to deflate.
[0063] FIGS, 22A to 22B describe a fitting on the balloon wall that contains a compressed pellet or gas release pellet. FIG. 22A represents a compressed view and FIG. 22B shows an expanded view of the gas pellet.
[0064] FIG. 23 represents a top view of an outer layer of a balloon “classified” or incubated with erodible material to create small channels that wear out over time.
[0065] FIGS, 24A to 24E illustrate a balloon composite wall including several layers of material (FIG. 24A and FIG. 24B, which show the detail of FIG. 24A), which are slowly penetrated by the water that has been injected into the balloon, during the manufacturing process or during the inflation process, causing a thin external protector to rupture later (FIG. 24C). Water can penetrate through an orifice (FIG. 24D), and the balloon can include a weakened area of an adhesive bond to control the rupture site (FIG. 24E).
[0066] FIGS, from 25A to 25B show a top view (FIG. 25 A) and a cross section (FIG. 25B) of a pressure seal button, which is glued over a perforation in the balloon material for deflation .
[0067] FIGS, from 26A to 26B show a top view (FIG. 26A), perspective view (FIG. 26B) and perspective view with the internal detail (FIG. 26C) of the connecting doors within a fixed septum to the balloon composite wall, where the doors contain a water-dissolving or acid-dissolving material. A plurality of ports and channels can be provided in a configuration that uses an expansion material and an expelling component, as illustrated in the system of FIG. 26D (the perspective view with internal detail) and FIG. 26E (cross section).
[0068] FIGS, 27A to 27D represent a door comprising an inflating and deflating mechanism in the same location. FIG. 27A shows a cross section of the mechanism with blocking sealing of the openings. FIG. 27B represents a cross section of the mechanism, with the seal displaced, allowing fluid communication through the opening. An iso image of the mechanism with the seal displaced, allowing fluid communication through the opening is provided in FIG. 27C. An iso image of the mechanism positioned for inflating the balloon is provided in FIG. 27D.
[0069] FIGS, 28A to 28D show a deflation port. FIG. 28 A illustrates a cross section of the deflation mechanism with the seal blocking the openings. FIG. 28B represents a cross-section of the deflating mechanism with the seal displaced, allowing fluid communication through the opening. An iso image of the mechanism with the seal blocking the openings is provided in FIG. 28C. An iso image of the mechanism with the seal displaced, allowing fluid communication through ventilation, is provided in FIG. 28D. DETAILED DESCRIPTION OF THE PREFERRED MODE
[0070] The following description and examples illustrate a preferred embodiment of the present invention in detail. Those skilled in the art will recognize that there are numerous variations and modifications of the present invention that fall within its scope. Thus, the description of a preferred embodiment should not be construed as limiting the scope of the present invention.
[0071] The term “biodegradable” as used herein is a broad term, and is to be given its normal and usual meaning for a person skilled in the art (and should not be limited to a special or personalized meaning), and refers, without limitation, to a process by which the structural integrity of the balloon is compromised (for example, by chemical, mechanical or other means (for example, light, radiation, heat, etc.), in such a way that The process of degradation can include erosion, dissolution, separation, digestion, disintegration, lamination, spraying, and other such processes.
[0072] The term “swallowed”, as used here is a broad term, and is meant to be given its normal and usual meaning for a person skilled in the art (and not to be limited to a special or personalized meaning), and refers, without limitation, to the ingestion of a balloon by a patient so that the external capsule and its components are delivered to the stomach by means of normal peristaltic movement. While the systems of the preferred modalities are swallowed, they are also configured by ingestion by methods other than swallowing. The ability to be swallowed from the system is derived, at least in part, by the size of the outer container for the self-inflating system and the catheter and the size of the outer container for the manual inflation system. For the self-inflating system, the outer capsule is sufficient to contain the inner container and its components, an amount of the activating agent injected before administration, the size of the balloon and the thickness of the balloon material. The system is preferably of a size smaller than the average diameter of the normal esophagus.
[0073] An orally ingestible device is described here. In preferred embodiments, the device is able to pass through the alimentary canal. The device can be useful, for example, as an intragastric volume occupancy device. The device overcomes one or more of the problems described above and deficiencies found in current devices for occupying intragastric volume.
[0074] In order to more clearly describe the object of the preferred modalities, different modalities of the same subcomponent will be described under a single relevantly-titled subheading. This organization is not intended to limit the way in which modalities of the different subcomponents can be combined according to the present invention. SWALLOW INTRAGASTRIC BALLOON SYSTEM
[0075] An swallowing, self-inflating or inflatable intragastric balloon system according to the preferred modalities selected includes the following components: self-insulating valve system for adding fluid to the balloon lumen or to the inner container (“valve system”), a balloon in a deflated and compacted state (“balloon”) and an external capsule, container or liner (“external container”), which contains the balloon. For self-inflating balloons, an inner capsule or other container (“inner container”) that contains one or more components of CO2 generation is present in the inner lumen of the balloon. For inflatable balloons, a source of inflating fluid, a catheter and a tube (“inflation set”) are provided to inflate the balloon after ingestion or placement in the stomach. In the self-inflating balloon configuration, the valve is preferably attached to the inner surface of the balloon by means of adhesive or other means (for example, solder), and provided with an inoculation spacer to prevent puncture of the balloon wall and inner container by a needle or other means for injecting a liquid activating agent into the lumen of the balloon through the self-isolating valve. A valve that provides releasable attachment of the tube to the balloon is provided in the inflatable balloon configuration. Preferably, the self-insulating valve system attached to the balloon (for example, on its internal surface) in the inflatable configuration is "universal", or compatible with a swallowing catheter or a physician-assisted catheter. The valve system serves to allow the balloon to be inflated through a miniature catheter that includes a needle set and also provides a mechanism for separating the catheter after the inflation is complete.
[0076] The outer container preferably incorporates the balloon in a compacted state (for example, folded and rolled), preferably with sufficient space to allow the activation of the liquid to be injected into the balloon in the self-inflating balloon configuration, in which the liquid activating agent initiates the separation, erosion, degradation, and / or dissolution of the inner container and generation of CO2 in contact with the inflating agent contained within the inner container, which subsequently causes separation, erosion, degradation and / or dissolution of that of the external container due to the pressure of the CO2 gas. In the inflatable balloon configuration, the outer container only needs to incorporate the balloon in a compacted state.
[0077] Selected components of a preferred swallowing intragastric balloon system may include a silicone head with radioopacity ring, 30 D trimmed silicone septum, nylon 6 inoculation spacer, compressed balloon, inner container (if self-inflating ) and the outer container as components of the system in disassembled form. A fully assembled external container may include an orifice aligned with a puncture septum to inject the liquid activating agent (if self-inflating) or a port for pipe connection (if inflatable). As discussed below, the components of the particularly preferred systems have the attributes described here, however, in certain systems of the modalities they can be employed, which use components that have other attributes and / or values.
[0078] The devices according to the preferred modalities are intended for ingestion by a patient and implantation without the need to resort to invasive methods. Therefore, it is desirable that the device of the preferred embodiments be operable to correspond to a compact delivery state that can be swallowed by a patient with minimal discomfort. Once in the stomach, it is desirable for the device to assume a substantially greater implanted state. In order to achieve the transition from a state of delivery to an implanted state, the device is subjected to inflation. INTERNAL CONTAINER
[0079] To initiate inflation in the self-inflating configuration, the inflation subcomponent may require external inputs, such as an activation agent. The activating agent is preferably injected through a syringe with a needle with a gauge diameter of 25 to 32. The length of the needle is preferably about 0.25 inches (0.6 cm) to 1 inch (2 , 54 cm) in length, in order to create a flow rate that allows the delivery of the entire volume of the inflation agent within 30 seconds, but in a way / current / flow that does not physically damage the inner container, thus causing premature CO2 generation and inflation. The activating agent is preferably pure water, or in a solution containing up to 50% concentration of anhydrous citric acid at 20 ° C, or its equivalent at different solution temperatures based on the solubility of anhydrous citric acid. Preferably, the system is configured to have an empty space in the central lumen of the flask when compacted in the outer container of about 0.3 ml to about 4.5 ml, such that a corresponding volume of activation can be injected into the empty space.
[0080] In one embodiment, before folding, the internal free-floating container with an inflating agent for the generation of CO2 is preferably vertically aligned with the self-insulating valve system such that the septum / spacer of inoculation is placed directly over the tip of the capsule. The balloon includes an internal container. A self-insulating valve system is adhesively adhered to the inside of the balloon wall, and the inverted configuration of the balloon is provided by inversion through a hole sealed with an adhesive. The approximate top of V4 of the balloon wall is folded over the inner capsule, and the folds where the capsule is creased similar to the folds formed in the second step of making a paper plane, then folded to the left or right. The approximately 3A bottom of the sphere is then awakened using no more than two creases and folded over the capsule. The left half is then folded over the right half of the capsule, or vice versa, so that the wings touch. Then, the material is rolled until it creates a tight roll. The device is then placed inside the outer container.
[0081] In a self-inflating configuration, the balloon is folded to form a pocket around the inner capsule, to ensure that the liquid injected through the self-insulating valve system is contained in an area less than 10% of the entire area of the balloon's surface. It is not necessary to provide a pocket in the inflatable configuration, as no internal capsule is provided. The balloon is folded in such a way that the number of folds in total is minimized in order to minimize the possibility of damage to the external material or compromised barrier properties. The number of folds in total is preferably less than 10 folds. The balloon material is rolled up when possible in such a way that the number of pleats needed to fit the balloon in an external container is minimized. This is done in an effort to also prevent damage to the lumen material. The self-insulating valve is also preferably constructed outside the center of the balloon in order to minimize the number of folds that overlap each other.
[0082] In the self-inflating configuration, the material that forms the wall of the flask is processed and folded to maximize the reaction efficiency by the location of the initiating agent injected into the flask, so that it is kept close to the reagents inside the inner container. The balloon is folded in such a way that once the reaction is initiated and the outer container separates, the balloon unfolds in a way that creates the largest possible surface area, which prevents the balloon from passing readily through the pyloric sphincter . The proportion of the reagents in which the inflating agent and the activating agent are selected so that the pH of any liquid remaining in the inner lumen of the flask is acidic, with a pH below 6, such that any leakage from the flask or breakage that allows stomach acid to enter does not cause additional CO2 generation and does not result in intentional re-inflation.
[0083] In a self-inflating configuration, an inflating agent is compressed, or formed or otherwise maintained in a form that provides good surface area availability for reagents for the generation of CO2, while minimizing space and / or volume enough to contain the inner container. Preferably, the inner container has a length (longest dimension) of about 0.748 inches (1.9 cm) to 1.06 inches (2.7 cm) and a width or diameter of about 0.239 inches (0.6 cm) to about 0.376 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 quick-release gelatin capsule, but a gelatin strip can be used instead of a quick-release capsule. The container is preferably supported on top to contain the inflation agent, however, an additional seal or other encapsulation can be used to control the timing of inflation. Gelatin is particularly preferred for use as the inner container, however other materials may also 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 internal container, however, in certain embodiments two or more internal containers can be advantageously employed. The time of self-inflation is selected based on the normal esophageal transit time and a normal gastric emptying time of large particles of food, such that the balloon does not inflate to a size that can block the esophageal passage or prematurely pass through the pyloric sphincter. Time is also controlled by compacting the balloon so that the activating agent is substantially located in the balloon next to the inner capsule, creating an efficient CO2 self-inflation method. The inflation of the balloon is initiated by the liquid activating agent causing the degradation of the internal container, in such a way that the inflating agent in the internal container comes into contact with the liquid activating agent, thus initiating the gas generation reaction. INFLATION SET
[0084] In certain preferred embodiments, the volume occupation subcomponent is filled with a fluid using the tubing which is subsequently removed and pulled out from the volume occupation subcomponent. One end of the volume-occupying subcomponent has a port attached to the tube of sufficient length that, when unrolled, can span the entire length of the esophagus, from the mouth to the stomach. This tube is connected to the volume occupation subcomponent with a self-insulating valve or septum that can tear from the volume occupation and self-insulating subcomponent once the volume occupation subcomponent is inflated. A doctor or other healthcare professional fixes one end of the tube while the patient swallows the device. Once the device is residing inside the stomach, the doctor uses the tube to transmit a fluid, such as air, other gas (s), saline, pure water, or the like, to the volume occupation subcomponent, and thus , inflate it. After the volume occupation subcomponent is fully inflated, the tube is released and can be pulled out of the patient's interior.
[0085] The tube can be released in a number of ways. For example, the tube can be separated by applying gentle force, or towing, to the tube. Alternatively, the tube can be removed by triggering a remote trigger, such as a magnetic or electronic release. In addition, the tube can be released from the volume occupation subcomponent by an automatic ejection mechanism. Such an ejection mechanism can be triggered by the internal pressure of the inflated volume occupation subcomponent. For example, the ejection mechanism may be sensitive to a certain pressure above which it opens, in order to release excess pressure and simultaneously release the tube. This modality provides a desirable release characteristic by combining the tube with a safety valve that serves to prevent accidents during the inflation of the volume occupation subcomponent in the patient's stomach.
[0086] This automatic release mode also offers the advantage that the inflation stage of the device can be more closely monitored and controlled. Current technology allows for a self-inflating intragastric volume occupation subcomponent that usually begins to fill within four minutes of injection, with an activating agent such as citric acid. In this approach, the volume occupation subcomponent may, in some cases, begin to fill before it resides in the stomach (for example, in the esophagus) or, in patients with gastric emptying syndrome or rapid gastric emptying, the volume occupation subcomponent it may end up in the small intestine before the time of inflation. Thus, in certain modalities it may be desirable to inflate the volume occupation subcomponent in the controller, since it is verified that the volume occupation subcomponent is resident in the correct place.
[0087] In certain modalities, it can also be advantageous for the volume occupation subcomponent to inflate gradually or in several phases over time. For example, if the gas escapes from the volume occupation subcomponent before the desired deflation time, it may be beneficial for the device to re-inflate in order to preserve it in its expanded state. EXTERNAL CONTAINER
[0088] The balloon is preferably supplied in a deflated state and folded into a capsule or other retention, containment or coating structure ("external container"). The outer container is preferably in the form of a standard quick-fit gelatin capsule, with the quick-fit relied on to contain the empty / folded balloon, however, a gelatin wrap can be advantageously employed in certain embodiments. Gelatin is particularly preferred for use as the outer container, however other materials may also be suitable for use, for example, cellulose, collagen and the like. Preferably, the outer container has a length (longest dimension) of about 0.95 inches (2.4 cm) to 2.5 inches (6.3 cm) and a width or diameter of about 0.35 inches ( 0.9 cm) to about 0.9 inches (2.4 cm). The volume of the inner container for the self-inflating version is preferably from about 1.2 ml to about 8.25 ml. In the self-inflating configuration, the outer container is preferably configured with one or more holes, slits, passages or other inlets, preferably at each end, which can act as openings such that any gas created due to exposure to the inflation agent for condensation or other moisture in the environment present during processing does not cause premature separation or degradation of the inner container before 30 seconds after inoculation of the liquid activating agent, which can have an undesirable effect on the efficiency of the reaction. Such graduates can also accelerate the dissolution of the outer container to prepare the balloon for inflation in the inflatable configuration. The degradation process of the outer capsule (for example, separates, dissolves, or otherwise opens) is facilitated by the increase in pressure caused by the inflation (self-inflation or inflation or via catheter) of the balloon. The outer capsule can be dipped in water for a short time to soften the materials, but do not release the flask before swallowing to minimize the time between swallowing and inflating the flask. In the inflatable configuration, the outer container is provided with a hole to accommodate the needle assembly of the inflation tube, where the diameter of the catheter needle casing is mechanically compatible with the hole diameter of the outer container such that the needle it can be inserted into the self-insulating valve, keeping the balloon housed there to facilitate pushing or swallowing the balloon assembly. In a preferred embodiment, the outer container is a capsule. The distal half of the capsule can be burned to prevent abrasion of the balloon materials by the capsule's leading edge while the compacted balloon is inserted into the capsule. The capsule can also comprise two parts held together with a gel band and encompassing the folded flask which allows for quick separation of the capsule so that inflation can occur more quickly. The outer capsule degrades (for example, separates, dissolves, or otherwise opens) due to contact with the ingested fluid intake (for example, water intake) and preferably degrades within 5 minutes or less, more preferably within 2 minutes or less, so as not to cause discomfort to the patient, while the balloon / catheter tube is in place.
[0089] In a preferred embodiment, the device is mounted in a standard size gelatin capsule. The capsule may be formed of a material that has a known rate of degradation in such a way that the device will not be released from the capsule, or otherwise distributed, before entering the stomach. For example, capsule materials can include one or more polysaccharides and / or one or more polyhydric alcohols.
[0090] Alternatively, the device, in its delivery state, can be coated with a substance that limits the device in its delivery state, while facilitating swallowing. The coating can be applied by immersion, sputtering, vapor deposition, or spraying, which can be conducted at ambient or positive pressure. The balloon can also be encapsulated by wrapping gelatin tape around the balloon and then placing the balloon wrapped in a capsule, if desired.
[0091] In certain preferred embodiments, the encapsulated or coated device is lubricated or otherwise treated, in order to facilitate swallowing. For example, the coated or encapsulated device can be wetted, heated or cooled, before swallowing by the patient. Alternatively, the encapsulated or coated device can be immersed in a viscous substance that will serve to lubricate the passage of the device through the esophagus. Examples of possible coatings can be any substances with lubricious and / or hydrophilic properties and include glycerin, polyvinylpyrrolidone (PVP), petroleum jelly, aloe vera, silicone based materials (eg Dow 360) and tetrafluoroethylene (TFE). The coating can also be applied by sputtering, vapor deposition or spraying.
[0092] In additional modalities, the coating or capsule is impregnated or treated with one or more local anesthetics or analgesics to facilitate swallowing. Such anesthetics may include anesthetics in the amino-amide group, such as articaine, lidocaine and trimecain, and anesthetics in the amino ester group, such as, for example, benzocaine, procaine and tetracaine. These can include chlorheptic painkillers.
[0093] In certain embodiments, the capsule can be weighed at a particular end, so that it is properly oriented when it is administered, while traveling down the esophagus, and / or when it is in the stomach. The weighing components can include polymeric materials or inflating reagents.
[0094] The self-inflating, swallowing intragastric balloon is provided with mechanisms to reliably control self-inflating timing such that premature inflation while in the esophagus during swallowing is avoided and sufficient inflation once in the stomach, in order to prevent passage through the pyloric sphincter is ensured. The normal esophageal transit time for large food particles has been documented as 4-8 seconds, and gastric emptying of large food particles through the pylorus does not occur for at least 15-20 minutes. The outer container is preferably configured to separate, dissolve, degrade, corrode, and / or otherwise allow the deflated / folded flask to begin unfolding not less than 60 seconds, but not more than 15 minutes after inoculation with the liquid activating agent. The inner container is preferably configured chemically, mechanically or a combination of these methods to delay the chemical reaction of initial CO2 generation such that sufficient CO2 to initiate balloon inflation is not available before 30 seconds after inoculation with the liquid activation, but to allow the generation of sufficient CO2 so that at least 10% of the balloon's occupable volume is filled within 30 minutes, at least 60% of the balloon's occupable volume is filled within 12 hours, and at least at least 90% of the balloon's occupable volume is filled within 24 hours. This time allows the injection of the activating agent into the external container by the medical professional, who passes from the device to the patient and swallowing by means of normal peristaltic movements by the patient. This timing also prohibits the potential passage of an uninflated balloon into the duodenum through the balloon to be inflated to a size large enough that gastric emptying of the balloon cannot be easy, while objects over 7 mm in diameter do not pass easily. . DELIVERY COMPONENTS
[0095] In certain modalities, it may be advantageous for a device administrator to use a delivery tool to deliver the device to the mouth or to facilitate its passage through the esophagus in the ideal orientation. A delivery tool may allow the device administrator to inject the device with one or more inflation agents while the device 10 is being administered to the patient. In a preferred embodiment, such an injection can be performed in the same mechanical action (s) as the administrator that are used to release the device from the delivery tool in the mouth or esophagus. For example, the delivery tool may include a plunger, a reservoir containing liquid, and an injection needle. The administrator pushes the plunger, either in sequence or at approximately the same time, forces the injection needle into the device and thus 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 to the desired location within the patient. In addition, the delivery tool may also include a subcomponent that delivers an anesthetic or lubricant into the mouth or esophagus to relieve the swallowing ability of the patient's device. BALLOON
[0096] The volume occupation subcomponent (“balloon”) of the preferred modalities is generally formed by a flexible material that forms a wall that defines an external surface and an internal cavity. Several of the subcomponents described above can be incorporated into any wall or internal cavity of the volume occupation subcomponent. As shown, the volume occupation subcomponent can vary in size and shape according to the patient's internal dimensions and the desired result. The volume occupation subcomponent can be manipulated to be semi-compatible, allowing the volume occupation subcomponent to stretch or expand with increasing pressure and / or temperature. Alternatively, in some embodiments, a compatible wall offering little resistance to swelling may be desirable.
[0097] Spherical volume occupation subcomponents are preferred in certain modalities. Alternatively, the volume occupancy subcomponent can be constructed to be circular in shape, with a hole in the middle of it, and can be weighed and shaped in such a way that it is oriented in the stomach to cover all or part of the sphincter pyloric, similar to a check valve. The hole in the middle of the volume occupation subcomponent can then serve as the main passage for the stomach contents to enter the small intestine, which limits the passage of food out of the stomach and induces satiety, reducing gastric emptying. The volume occupation subcomponent can be manufactured with different dimensions of holes according to the degree to which gastric emptying is desired to be reduced. The delivery, inflation and deflation of the volume occupation subcomponent can be accomplished by any of the methods described above.
[0098] It is advantageous, in certain modalities, for the volume occupancy subcomponent wall to be both high in strength and thin, in order to minimize the compacted volume of the device as it travels in the patient's esophagus. In certain embodiments, the wall materials of the volume occupation subcomponent are manufactured with a biaxial orientation that gives a high value of the module to the volume occupation subcomponent.
[0099] In one embodiment, the volume occupancy subcomponent is constructed of a polymeric substance such as polyurethane, polyethylene terephthalate, polyethylene naphthalate, polyvinyl chloride (PVC), nylon 6, nylon 12, or polyether block amide (PEBA). The volume occupation subcomponent can be coated with one or more layers of substances that modify (increase, reduce or alter over time) the gas barrier characteristics, such as a thermoplastic substance.
[0100] Preferably, gas barrier materials have a low permeability to carbon dioxide or other fluids that can be used to inflate the volume occupancy subcomponent. The barrier layers must have a good adhesion to the base material. Preferred biocompatible barrier coating materials include poly (hydroxyamino ethers), polyethylene naphthalate, polyvinylidene chloride (PVDC), Saran, ethylene vinyl alcohol copolymers, polyvinyl acetate, silicone oxide (SiOx), acrylonitrile copolymers or copolymers of terephthalic acid and isophthalic acid with ethylene glycol and at least one diol. Alternative gas barrier materials can include polyamine-polyepoxides. These materials are usually purchased as a water-based solvent or thermo-adjustable composition and are generally spray-coated over a preform and then heat cured to form the final barrier coating. Alternative gas barrier materials that can be used as coatings for the volume occupancy subcomponent include metals such as silver or aluminum. Other materials that can be used to improve the gas impermeability of the volume occupying subcomponent include, but are not limited to, gold, or any noble metal, PET coated with saran, insulating coatings and the like, for example, in Tables la-b.
[0101] In certain preferred embodiments, the volume occupation subcomponent is changed by injection, blow or rotation. Either immediately after such molding, or after a curing period, the gas barrier coating can be applied, if it is not already applied within the composite wall.
[0102] In another modality, the intragastric volume occupation subcomponent is formed using a Mylar polyester film that coats silver, aluminum or kelvalite as a metallized surface, to improve the gas impermeability of the volume occupation subcomponent.
[0103] In the case where the volume occupying subcomponent wall is composed of several layers of materials, it may be necessary to use certain substances or methods of bonding, fixing or maintaining these joined multiple layers. Such substances can include an ether-based solvent or adhesive. These various layers can also be linked together by heat. Since these layers are bonded together to form (for example), a sheet of material to be transformed into a volume occupying subcomponent, which may also be necessary to apply additional treatment steps for such material so that it can seal together (for example, by applying a certain degree of heat and pressure), in order to be transformed into a volume occupation subcomponent. Therefore, it may be advantageous to include certain sealing materials as an additional layer in the volume occupation subcomponent. For example, a volume occupancy subcomponent composed of a combination of PET and SiOx layers, which provide favorable mechanical and gas impermeability characteristics for the volume occupancy subcomponent, can be sealed by including a sealable polyethylene layer in such volume occupancy subcomponent.
[0104] According to another modality of the preferred modalities, the functionality of the volume occupation subcomponent and the deflation component are combined in part or in total. For example, the volume-occupying subcomponent may be formed from a substance that is degraded in the stomach for a desired period of time. Once the degradation process has formed a crack in the wall of the volume occupation subcomponent, the volume occupation subcomponent empties, continues to degrade and the rest passes through the digestive tract.
[0105] Preferably, an automated process is used that takes a fully constructed volume occupation subcomponent, evacuates all the air from inside the internal cavity and bends or compresses the volume occupation subcomponent in the desired delivery state. For example, the evacuation of air from the volume occupation subcomponent can be triggered by means of vacuum or mechanical pressure (for example, by rolling the volume occupation subcomponent). In certain modalities, it is desirable to minimize the number of creases produced in the volume occupation subcomponent, when delivered.
[0106] In another embodiment, the deflation of the volume occupation subcomponent can be achieved through one or more injection sites inside the wall of the volume occupation subcomponent can be achieved through one or more injection sites inside the volume occupancy subcomponent wall. For example, two self-insulating injection sites can be incorporated on opposite sides of the volume occupancy subcomponent. The volume occupation subcomponent can be positioned inside a device that uses two small gauge needles to evacuate the air from the volume occupation subcomponent.
[0107] In one embodiment, the self-insulating injection sites can also be used to insert chemical elements from the inflation subcomponent into the volume occupation subcomponent. After the injection of the chemical elements in the volume occupation subcomponent, the same needles can be used to evacuate the volume occupation subcomponent.
[0108] It may be desirable that the volume occupancy subcomponent be packaged in the state of delivery under, for example, negative vacuum pressure or positive external pressure.
[0109] The wall materials of the volume occupying subcomponents can also be manipulated to, since they are initially perforated or torn, they relatively easily tear from the point of such a hole or tear. These properties can, for example, be advantageous if the deflation of the volume occupation subcomponent is initiated by a tear or perforation of the volume occupation subcomponent wall, since that initial wear or puncture can then increase in scope, accelerating and / or maximizing the deflation process.
[0110] The volume occupation subcomponent can also be coated with a lubricating substance that facilitates its passage out of the body after deflating. Examples of possible coatings can be any substances with lubricious and / or hydrophilic properties and include glycerin, polyvinylpyrrolidone (PVP), petroleum jelly, aloe vera, silicone based materials (eg Dow 360) and tetrafluoroethylene (TFE). The coating can be applied by immersion, sputtering, vapor deposition or spraying which can be conducted at ambient or positive pressure.
[0111] The balloon composite wall materials may be of similar construction and composition, such as those described in US Patent Publication 2010-0100116-A1, the contents of which are hereby incorporated by reference in their entirety. The materials are capable of containing a fluid, preferably in the form of compressed or uncompressed gas, such as, for example, N2, Ar, O2, CO2, or mixture (s) thereof, or atmospheric air (composed of a mixture of N2, O2, Ar, CO2, Ne, CH4, He, Kr, H2 and Xe) that simulate the concentrations of gastric space. In certain embodiments, the balloon is capable of containing fluid (gas) and maintaining an acceptable volume for up to 6 months, preferably for at least 1 to 3 months after inflation. Particularly preferred inflation gases include large-molecule, non-polar gases that can be compacted for delivery.
[0112] Before placing in the external container, the balloon is deflated and folded. In the inverted configuration in an emptied state, the balloon is flat, with the inverted seam extending around the perimeter of the balloon. The self-insulating valve system is attached to the inner wall of the lumen near the center of the empty balloon, with the inner container positioned adjacent to the self-insulating valve system. The balloon walls are then folded. As part of the balloon design, the self-insulating valve system is manufactured in such a way that it can be, and is preferably placed "off center", to minimize the number of folds on itself (for example, duplication or triplication) ) needed to adjust the balloon in the outer container. For example, the self-insulating valve system can be advantageously placed 7> r + 74 r from the center of the balloon, where r is the radius of the balloon along a line extending from the center of the balloon through the septum . SUBCOMPONENT FOR TRACKING AND VIEWING
[0113] It can also be beneficial to implement tracking and visualization features on devices according to the present invention. Due to the non-invasive nature of the present device, physicians may wish to determine or confirm the location and orientation of the device before inflation or during the course of treatment.
[0114] Alternatively, the marker can be applied to the volume occupation subcomponent, when the volume occupation subcomponent is in a wrinkled or folded state such that when the volume occupation subcomponent is in its deflated state appears concentrated when viewed on the visualization equipment, and when the volume occupation subcomponent is inflated the marker appears less concentrated, when viewed on the visualization equipment. Alternatively, the marker can be applied or incorporated into the volume occupation subcomponent, in order to facilitate the identification and location of the various subcomponents of the device, such as a valve, head, or weight. The marker can be printed or painted on a surface of the volume occupation subcomponent or between the layers of material that form the volume occupation subcomponent. Alternatively, a metal coating as described below, can be used as a marker to identify and / or locate the volume occupancy subcomponent. Metal coatings to visualize the volume occupancy subcomponent may include silver, gold, tantalum or any noble metal. Alternatively, the marker can be applied to an elastomeric sleeve, which covers all or part of the volume occupation subcomponent.
[0115] In another modality, the volume occupation subcomponent incorporates a subcomponent that changes mechanically by inflating the volume occupation subcomponent, whose mechanical alteration can be visualized using x-rays or other visualization equipment. For example, a mechanical portion of the volume occupancy subcomponent containing a visualization marker may be stretched by increasing the pressure in the volume occupancy subcomponent.
[0116] Alternatively, a marker can be formed using a metallized mesh located between the layers of the material from which the volume occupation subcomponent is constructed. The pattern or patterns formed by the embedded marker will appear when the volume occupancy subcomponent is in an inflated employed state.
[0117] It is envisaged that marker materials can be incorporated into the volume occupation subcomponent to facilitate various visualization techniques such as, for example, MRI, CT and ultrasound.
[0118] The volume occupation subcomponent can also contain a dye or a marker, which is released after deflating to indicate that the volume of the occupying subcomponent cavity has been violated. Such a dye or marker may, for example, be evident in the patient's urine as an indication that the volume of the subcomponent occupying has started to drain.
[0119] In yet other modalities, microchips and other components that employ electronic modalities can be used to locate and identify a device. Microchips analogous to those used to identify pets can be used to communicate the specific information of the device and its approximate location. For example, a Wheatstone circuit or other bridge circuit can be incorporated into the device and, in conjunction with RF “ping and listen” RF technology, it can be used as part of a system to determine the approximate location of the device and measure and communicate the specific device information. Such device-specific information may include the internal pressure of the volume occupation subcomponent, which may indicate the degree of inflation of the volume occupation subcomponent.
[0120] In yet other modalities, mechanical, chemical, visual and other sensors can be included as part of the device to measure, record and / or transmit information related to the device and / or the patient's internal environment. For example, the device can contain a camera or any of the other imaging and streaming components of a PillCam device. As an additional example, the device may contain sensors that measure, record and / or transmit information related to stomach pH, stomach pressure, hormone levels, organ health and organ safety. VALVE SYSTEM
[0121] In the preferred embodiments, a self-insulating valve system is connected to the balloon (for example, on its internal surface) that is “universal”, or compatible with the swallowing catheter and a physician-assisted catheter. The valve system serves to allow the balloon to be inflated through a miniature catheter that includes a needle set and also provides a mechanism for separating the catheter after the inflation is complete.
[0122] FIGS. IA to D represent views that represent a design of a self-insulating valve system that contains a self-insulating septum housed within a metallic concentric cylinder is provided. In the inflatable configuration, the self-insulating valve system is preferably adhered to the bottom of the balloon material so that only a portion of the valve protrudes slightly off the balloon's surface to ensure a smooth surface. The valve system for the inflatable configuration can use the same self-insulating septum designed for the self-inflating configuration. The septum preferably consists of a material having a hardness of 20 Shore A to 60 Shore D. The septum is inserted into or otherwise manufactured in the smaller cylinder of the concentric metal retention structure (FIGS. 2A to D), which is preferably cylindrical in shape. The smaller cylinder inside the larger cylinder controls the alignment of the needle sleeve of the catheter / needle assembly with the septum, provides a difficult barrier so that the catheter needle does not pierce the balloon material (needle stop mechanism), and provides compression in such a way that the valve / septum re-seals after inflating and withdrawing the subsequent needle.
[0123] The concentric valve system can also provide radio opacity during implantation and is preferably titanium, gold, stainless steel, MP35N (nickel-cobalt-chromium-non-magnetic molybdenum alloy) or similar. Non-metallic polymeric materials can also be used, for example, an acrylic, epoxy, polycarbonate, nylon, polyethylene, PEEK, ABS or PVC or any thermoplastic elastomer or thermoplastic polyurethane, which is manufactured to be visible under x-ray ( for example, incorporated with barium).
[0124] The septum can be cone-shaped, so that the compressive forces are maximized for self-isolation after inflation. The self-insulating septum allows the processing / compacting of the air to be evacuated from the balloon and insertion into the outer container, and allows for piercing by an inflating agent syringe needle (self-inflating configuration) or inflating catheter needle (configuration inflatable) and then later withdrawal of the needle from the inflation agent syringe or separation of the inflation catheter and withdrawal of the catheter needle significantly limiting gas leaks outside the balloon during the process of inflating and withdrawing the needle / catheter separation. The septum is inserted into the valve using a mechanical locking mechanism to provide compression. An additional ring (FIGS. 3A to C) can be placed at the distal end of the inner cylinder to provide additional compression to ensure that the septum material is pre-loaded in order to reseal itself. The ring is preferably metallic in nature, but it can also be a non-metallic polymeric material, such as an acrylic, epoxy, or thermoplastic elastomer or thermoplastic polyurethane. The material of the ring is preferably the same material as the cylinder, titanium, but it can also be gold, stainless steel, MP35N or the like.
[0125] In an inflatable configuration, a larger, outer cylinder (FIGS. 4A to D) of the concentric valve housing contains a material of slightly harder hardness than the inner cylinder (50 Shore A or more), but it is also, preferably silicone. The purpose of using a material of harder hardness is to guarantee the sealing, when connected to the needle sleeve for inflation. The silicone located 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 edge of this same material is provided that is slightly larger than the diameter of the inner cylinder and extends to the outer surface of the balloon. The rim is compatible with the bell shaped needle mandrel and provides a seal to increase the connection of the valve to the catheter to withstand the applied inflation pressures and also to increase the ejection distance or catheter binding force. This silicone edge preferably does not protrude from the balloon surface after more than 2 mm to ensure that the balloon surface remains relatively smooth and does not cause abrasion or ulceration of the mucosa. It is designed to provide compressive forces against the catheter needle sleeve for inflation and separation whereby, when connected to the inflation catheter needle sleeve, the connection coupling can preferably withstand a pressure of 35 PSI during inflation. The seal is then broken during detachment using hydraulic pressure, which is preferably greater than 40 PSI, but less than 200 psi to separate the coupling. An additional retaining ring (FIGS. 5A to C), preferably made of the same material as the concentric valve, can be included in the valve system to further increase the seal between the metal and the valve silicone and provide mechanical support additional to ensure an adequate mechanical adjustment and designed to disturb the slip of the silicone material from the hard (metallic) valve system (causing an increase in the tractive force).
[0126] The valve structure for the inflatable configuration uses a mechanical locking mechanism to provide the functions of the self-insulating valve for inflation by the catheter and posterior separation of the catheter, however, the primer and / or adhesive can be used to provide additional support in the construction of the complex. The configuration can be changed by modifying the surfaces of the metal components, making them more sticky or slippery, for example, more or less conducive to adhesion, to provide the desired mechanical / interference fit. The interference fit between the valve and the catheter can be modified to change the inflation and / or separation pressure requirements. The assemblies may include overmolding of the metal portions or the silicone concentric system in such a way that the additional support rings ensure mechanical adjustment and tensile strength and the forces necessary to maintain the assembly during catheter inflation and separation can be omitted .
[0127] The total valve diameter in the inflatable configuration is designed to fit a miniature catheter system that does not exceed 8 French (2.7 mm, 0.105 inches) in diameter. The total diameter does not exceed 1 inch (2.54 cm) and is preferably less than 0.5 inches (1.27 cm), to facilitate swallowing. Valves can be added, if desired, however, it is generally preferred to employ a single valve in order to keep the volume of the balloon deflated / folded (and therefore the dimensions of the outer container) as small as possible. The valve system is preferably connected to the balloon and connected in such a way that a shear force greater than 9 pounds (40 N) is required to displace the valve system.
[0128] In a self-inflating configuration, the valve system can be attached to the balloon (for example, on its internal surface), without the use of an opening, orifice, or other channel in the balloon wall. The valve system can use a septum with a hardness of 20 Shore A to 60 Shore D. The valve can be inserted, or otherwise manufactured in a retaining structure that has a higher hardness, for example, 40 Shore D a 70 Shore D, or more. The retention structure can be manufactured from silicone, rubber, flexible plastic or any suitable non-metallic polymeric material, such as acrylic, epoxy, thermoplastic elastomer or thermoplastic polyurethane. Preferably, a structure, such as a ring, which can be metallic or non-metallic, but radio opaque (e.g., barium) and visible in X-rays, can be incorporated into the retention structure. Using a mechanical fitting mechanism of the two structures of different durometers, a softer one (septum) with a large diameter, can be inserted in a perfect fit, a structure of greater hardness creates compressive forces in the hole, once opened, to allow the CO2 retention and to reduce susceptibility to CO2 gas leaks. The metal radio-opacity ring also helps to withstand the compressive forces in the septum. The self-insulating septum allows air to be evacuated from the balloon for processing / compaction and insertion into the external container and also allows the inflation agent to be injected into the external container to initiate inflation. Additional septa can be provided, if desired, however, it is generally preferred to employ a single septum, in order to minimize the volume of the deflated / inflated balloon (and thus the outer capsule) to the smallest possible. The valve system is preferably connected to the interior of the balloon, such that a shear force greater than 9 pounds (40 N) is required to displace the valve system. A silicon head and opaque radio ring from a self-insulating valve system can be used, as well as a wedge-shaped septum.
[0129] In the self-inflating configuration, an inoculation spacer is preferably incorporated to guide a needle into the self-insulating valve for injection of the liquid activating agent into the lumen of the balloon and to prevent the needle from penetrating the balloon wall deflated / folded elsewhere in such a way that the pressure inside the balloon lumen cannot be maintained. The inoculation spacer also makes it easier to prevent the liquid activating agent from penetrating the inner container or the folded flask material, thus focusing the activating agent in a suitable way to properly mix the reagents for CO2 generation according to the criteria described above. The inoculation spacer is generally in the form of a tube or cylinder. The inoculation spacer is preferably connected to the internal container and / or the self-insulating valve system with an adhesive means or other fixation means, however, in certain embodiments the inoculation spacer can be “free-floating” and held in position by bending or rolling the balloon walls. The inoculation spacer can comprise any suitable material that can be passed after separation, erosion, degradation, digestion, and / or dissolution of the outer container, however, preferred materials include non-metallic materials with a minimum Shore D hardness of 40 or more, any metallic material, or a combination thereof. A cup-shaped needle stop (inoculation spacer) can be used in the preferred modalities. BALLOON
[0130] In a preferred embodiment, a self-inflating balloon is completely sealed around 360 degrees. In the self-inflating configuration, with the injection of an inflating agent through a needle syringe, there are preferably no external openings or holes for the central lumen. In the inflatable configuration, a valve structure (either protruding, recessed, or aligned with the surface of the balloon) is provided to supply an inflation fluid to the central lumen. The balloon can have a “not inverted”, “inverted”, or “overlapped” configuration. In a "not inverted" configuration, the seams or welds and seam allowance, if any, are on the outside of the inflated balloon. In a "superimposed" configuration, the layers are superimposed, optionally with one or more folds, and secured to each other by means of welds, a seam, adhesive or the like, resulting in a smooth outer surface. In an "inverted" configuration, the balloon has a smooth outer surface, with seams, weld, adhesive spheres, or the like, inside the inflated balloon. In order to create with a balloon with an inverted configuration, eg, a balloon with no external seam tolerance (no wall material between the balloon's edge and the weld, seam, or other feature that joins the sides), two halves of the balloon are joined in some way (for example, adhered with adhesive or heat or the like, based on the balloon material used). One of the halves of the balloon includes an opening to allow the balloon to be pulled through itself after the two halves adhere and to have the seams of the balloon inside. The opening created is preferably circular, but may be of any similar shape, the diameter of the opening preferably does not exceed 3.8 centimeters, however, in certain embodiments a larger diameter may be acceptable. A patch of material is adhered (adhesive, heat-welded, or the like, based on the material used) to cover the opening of half of the original balloon. The inversion hole thus created which is subsequently patched is small enough that the forces exerted during inflation do not compromise the material used to maintain the fluid in the balloon. The preferred shape for the inflated balloon in the final set is ellipsoid, preferably spheroid, flat spheroid, with nominal radii from 1 inch (2.5 cm) to 3 inches (7.6 cm), a nominal height of 0.25 inches (0.6 cm) to 3 inches (7.6 cm), a volume of 90 cm3 to 350 cm3 (at 37 ° C and at internal nominal pressure and / or full inflation), an internal nominal pressure (at 37 ° C) from 0 psi (0 Pa) to 15 psi (103421 Pa), and a weight of less than 15 g. The self-inflating balloon is configured for self-inflating with CO2 and is configured to retain more than 75% of the initial nominal volume for at least 25 days, preferably for at least 90 days, when it resides in the stomach. The inflatable balloon is configured for inflation with an appropriate mixture of gases to provide a pre-selected volume profile over a pre-selected period of time (including one or more of the volume increase periods, the periods volume decrease, or the steady state volume periods).
[0131] The preferred shape for the inflated balloon in the final assembly is ellipsoid, preferably spheroid or flat spheroid, with a nominal radius of 1 inch (2.5 cm) to 3 inches (7.6 cm), a nominal height of 0.25 inches (0.6 cm) to 3 inches (7.6 cm), a volume of between 90 cm3 to 350 cm3 (at 37 ° C and at internal nominal pressure and / or full inflation), an internal nominal pressure (at 37 ° C) from 0 psi (0 Pa) to 15 psi (103421 Pa), and a weight of less than 15 g. In certain embodiments where a stable volume over the life of the device is preferred, the balloon is configured to maintain a volume of at least 90% to 110% of its initial nominal volume. In other modalities, it may be desirable for the balloon to increase and / or decrease the volume over its useful life (eg, in a linear form, in a step-by-step fashion, or in another non-linear mode). INTERNAL CONTAINER
[0132] The inner container for the self-inflating balloon is contained within the lumen of the balloon and contains the CO2 generator for the self-inflating balloon. The CO2 generator comprises a mixture of inflating agent, housed within the container. Preferably, from about 10% to about 80% of the total inflating agent used comprises powdered citric acid, with the remainder comprising powdered sodium bicarbonate. Sufficient inflation agent is supplied in such a way that after the completion of the CO2 generation reaction, the balloon reaches inflation at the nominal inflation pressure described above. Preferably, a total of about 0.28 to 4 grams of the inflation agent mixture is employed, depending on the size of the balloon to be inflated; preferably up to 1.15 grams of sodium bicarbonate is used with the remainder, with powdered citric acid to generate 300 cm3 of CO2 at nominal pressure. INFLAGE SET
[0133] An intragastric balloon system that is manually inflated by a miniature catheter can be used in certain modalities. The system remains, preferably "swallowed". The delivery balloon is in a compacted state and is attached to a flexible miniature catheter, preferably with a diameter no larger than 4 French (1.35 mm). The catheter is designed in such a way that a portion of the catheter can be bundled or rolled over itself, for delivery with the encapsulated balloon, allowing the patient to swallow both the catheter and the balloon for delivery to the stomach. The balloon may contain a self-insulating valve system for fixing the catheter and inflating the balloon once it reaches the stomach cavity. The proximal end of the catheter can be left outside the patient's mouth, allowing connection to an inflation fluid container, which can house the preferred inflation fluid (gas or liquid). After inflation, the catheter can be removed from the balloon valve and pulled back through the mouth. This method allows the intragastric balloon to maintain its ability to be swallowed, but allows inflation by a fluid source or a mixture of fluid sources through the catheter. Alternatively, a more rigid push system can be employed, in which the balloon valve is compatible with either the flexible, swallowing catheter or the rigid, pushable catheter assembly.
[0134] The inflation catheters (swallowed or pushable assisted by administrator) described here are configured to deliver the balloon device orally and without additional tools. The administration procedure does not require conscious sedation or other similar sedation procedures or requires endoscopy tools for delivery. However, other versions of the device can be used in conjunction with endoscopy tools for visualization or can be adapted in such a way that the balloon device can be delivered nasogastrically as well.
[0135] In operation, the proximal end of the inflation catheter is connected to a valve or a connector that allows connection to the inflation source or disconnected source, this is preferably an inflation connector or valve (FIG. 6 and FIG. 7., respectively). The bonding materials can consist of polycarbonate or similar and can connect to a single-lumen or multi-lumen catheter tube. The distal end of the inflation catheter is connected to the universal balloon valve of the balloon that has been compacted and housed within a gelatin capsule or compacted using gelatin bands (FIG. 8A-B). 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 the inflation valve or connector) and cross the esophagus downwards, at least in the middle of the stomach, approximately 50 to 60 cm. Measurement signals can be added to the tube or catheter to assist in identifying where the end of the tube is located. The time for inflation can be started by having the tube containing a pH sensor, which determines a difference in location between the esophagus (pH 5 to 7) and the stomach (pH 1 to 4) based on different pH values between the two anatomical sources, or can be derived or verified from the expected pressure in a container (ie, esophagus) versus a less restricted space (for example, stomach). The tube can also contain nitinol which has an adjustable transmission for body temperature, taking into account the time for swallowing. The tube can also be connected to a series of encapsulated or compressed balloons in a single catheter. Each can be inflated and released separately. The number of balloons launched can be adjustable to the patient's needs and desired weight loss.
[0136] In certain embodiments, a catheter with the balloon at the distal end (inflated with air) is employed to temporarily and firmly fix the balloon in place. A small, empty balloon catheter can be positioned through the gastric balloon head (for example, “a balloon inside the balloon”), and then inflated with air during delivery to firmly hold the capsule and balloon in place and avoid spontaneous balloon separation from the catheter. This balloon catheter can incorporate a double channel that can also allow the larger gastric balloon to be inflated (by gas or liquid). Once the gastric balloon has been satisfactorily inflated, the small air balloon catheter can be deflated and pulled out of the valve (allowing the valve to seal), and out of the body, leaving the inflated gastric balloon in the stomach .
[0137] In other modalities, the catheter can be coated to improve the ability to be swallowed or is impregnated or treated with a flavored version and / or one or more local anesthetics or analgesics to relieve swallowing. Such anesthetics may include anesthetics in the amino-amide group, such as articaine, lidocaine and trimecain, and anesthetics in the amino ester group, such as, for example, benzocaine, procaine and tetracaine. These can include chlorheptic painkillers. Double Lumen Catheter
[0138] In a preferred embodiment, a double-swallowable lumen catheter is provided. The double lumen catheter (FIGS. 9A to C) has two lumens, with a diameter of the complete set not greater than 5 French (1.67 mm), preferably not greater than 4 French (1.35 mm). The inner lumen preferably does not exceed 3 French (1 mm) and functions as the inflation tube, and the outer lumen preferably does not exceed 5 French (1.67 mm) and works as the disconnect tube. The catheter assembly is connected to a needle assembly, described in more detail below, at the distal end and to a double port inflation connector at the proximal end. The tubing that the catheter assembly employs is flexible for the ability to be swallowed, is resistant to torsion, can withstand body temperature, is resistant to acid, and is biocompatible like the tube that passes through the alimentary canal in the stomach cavity. The tube materials are preferably soft and flexible and have moderate tensile strength and a significant amount of grip strength to deal with the applied pressures. The lumens are preferably round and coaxial and free floating in order to provide flexibility. The double lumen set also preferably does not require any adhesive or glue. Alternative lumen configurations can include two D- lumens or a combination of a D- lumen and round lumen, and can be used in harder configurations of the final catheter assembly. Preferred pipe materials include a heat-resistant polyethylene pipe, such as PEBAX®, or a heat-resistant polyurethane pipe, such as PELLETHANE ™, PEEK or Nylon. The tubing can also be manufactured from bioabsorbable materials such as polylactic acid (PLA), poly-L-aspartic acid (PLAA), polylactic / glycolic acid (PLG), polycaprolactone (PCL), DL-lactide-co-E -caprolactone (DL-PLCL) or similar, where the tube can be released after inflation and separation and swallowed as normal.
[0139] At the distal end of the catheter assembly, the inner lumen or inflation tube is attached to the needle assembly that is used to pierce the balloon's self-insulating valve, preferably located at one of the balloon's vertices housed inside an gelatin capsule as an external container. The outer lumen is attached to the needle sleeve and provides a bonding force between the balloon catheter assembly and provides the pulling force to withstand starting inflation pressures, preferably up to 10 psi and preferably not more than 35 PSI , while holding the assembly together. The needle sleeve is configured to be mechanically coupled to the balloon valve assembly. The needle is preferably made of metal, preferably of stainless steel or similar, with a maximum size of 25 gauge (0.455 millimeter), preferably not less than 30 gauge (0.255 millimeter), for the purpose of synchronizing inflation. The needle sleeve is preferably a soft material, such as nylon or the like, or it can also be made of polycarbonate, polyethylene, PEEK, ABS or PVC. The needle sleeve covers the entire length of the needle, such that the body is protected against the needle and the needle can pierce only the balloon's septum. Preferably, the needle sleeve is level or extends slightly more than the length of the needle. The needle is inserted into the septum of the balloon before swallowing and maintains a holding force of approximately 0.5 1b, when coupled to the silicone area of the balloon valve. The needle sleeve is preferably slightly bell-shaped (FIGS. 10A to D) or contains a circular relief, or edge so that when inserted into the silicone area of the valve a locking and wrench mechanism is created to increase the resistance to the traction of the set and improve the seal for inflation.
[0140] At the proximal end, the catheter assembly is connected to a Y-adapter assembly, preferably made of polycarbonate. The Y-adapter is “switched” so that the inflation gas and the connecting fluid are connected to the catheter assembly approximately and travel through the correct lumen.
[0141] Prior to inflation, priming the disconnecting lumen can be used using a liquid. For example, the outer lumen is first washed with 2 cc of water, saline, deionized water or the like before inflating the balloon. After that, the inflation source container is connected to the connector that leads to the internal lumen. The inflation source container works with the premise of the ideal gas law and a pressure drop model. For a given compressed gas formulation, the device is designed to equalize in such a way that a higher initial pressure is used to inflate the balloon than the final pressure resulting from the balloon. The initial pressure and volume are dependent on the selected gas formulation, as well as the length of the catheter and the starting temperature (room temperature, typically), and the final temperature (usually the body temperature).
[0142] After inflation, the balloon is separated from the catheter assembly using hydraulic pressure. The syringe filled with water, deionized water, or preferably saline, is attached to the female end of the Y-set. The syringe contains 2 cc of liquid and when the syringe plunger is pushed in, sufficient hydraulic pressure is exerted in such a way that the needle is ejected from the balloon valve. Single Lumen Catheter
[0143] To further reduce the diameter of the inflation catheter, thereby increasing the comfort of the ability to swallow the balloon capsule and the catheter, a single lumen (FIG. 1 IA to C) can be used, which does not exceed 3 French (1.0 mm) in diameter (0.033 inches).
[0144] The needle / needle sleeve assembly is similar in design to that of the double lumen catheter described here. However, with the single lumen system, the distal end of the catheter lumen connects to the needle sleeve only and there is no second catheter inside. Instead, a single segment connected to a needle hub runs coaxially along the length of the catheter to assist in tensile strength for separation and overall flexibility.
[0145] The needle sleeve is slightly bell-shaped or contains a circular relief, or edge so that when inserted into the valve's silicone head a key and lock mechanism is created to increase the tensile strength of the assembly, increases the seal for inflation, and since this is a single lumen set, the rim increases the force required to remove the needle from the valve so that this does not happen by chance during the inflation process.
[0146] The proximal end of the catheter is connected to an inflation valve (FIG. 7), preferably a 3-way valve, or any valve that allows the use of an exclusion method for inflating and separating the balloon. The distal end of the catheter comprises the needle sleeve, which is made of nylon or another similar source. The needle is metallic and, preferably, stainless steel.
[0147] The tubing that employs the catheter assembly is flexible for swallowing capacity, is resistant to torsion, can withstand body temperature, is resistant to acid, and is biocompatible like the tube that passes through the alimentary canal in the cavity of the stomach. The tube materials are preferably soft and flexible and resistant to deformation or stretching or bending. For a single-lumen system, the catheter tube is preferably made of PEBAX® or PELLETHANE® (an ether-based polyurethane elastomer), but it can also comprise bioabsorbable materials such as PLA, PLAA, PLG, PCL DL -PLCL or similar, where the tube can be released after inflation and separated and swallowed normally. The filiform thread (FIG. 11 B) inside the catheter tube attached to the needle is preferably a nylon monofilament, but Kevlar or nitinol thread or other suitable materials can also be used.
[0148] To inflate the balloon, the distal end of the catheter is connected to the balloon capsule where the needle protrudes through the self-insulating valve (FIG. 11C). The container is swallowed and a portion of the inflation catheter remains outside the mouth. The inflation source container is connected to the proximal end of the inflation valve, where the port for the inflation gas is chosen by excluding the other ports. The inflation fluid (preferably compressed nitrogen gas, or a mixture of gases) travels through the lumen of the single catheter, through which the inflation gas selects the path of least resistance or, more specifically, through the needle cavity and inwards of the balloon. The balloon is inflated, preferably in less than 3 minutes.
[0149] To separate and remove the needle from the balloon valve, 2 cc or other appropriate volume of water or other liquid is injected into the catheter at high pressure. Since the water has a high surface tension and viscosity, it obstructs the needle path and the pressure is transferred to the outer needle sleeve, thereby breaking the fit between the needle sleeve and the balloon valve.
[0150] If it is desired to place a substance inside the flask, such as water or acid or any alternative liquid, it can be done using a lower pressure to inject the liquid. Miniature Hard Body Inflation Catheter
[0151] In certain modalities, a hard-bodied inflation catheter can be used, which can be placed orally or transnasally. This system can be from 1 French (0.33 mm) to 10 French (3.3 mm), preferably 8 French (2.7 mm) in diameter. A larger diameter is generally preferred to increase the ability to push, with the thickness of the wall also contributing to the ability to push and resistance to torsion. The length of the tube can be approximately 50 to 60 cm. As discussed above, measurement signals can be added to the tubing to identify where the end of the tube is located, or a pH or pressure sensor on the catheter can be employed to detect the location of the balloon.
[0152] This system for inflation / separation is similar to the double lumen system described above, but with a larger needle sleeve to accommodate the larger diameter of the tube (FIGS. 12A to D). Materials that can be used in the lumen include, for example, expanded polytetrafluoroethylene (EPTFE) for the outer lumen and polyetheretherketone (PEEK) for the inner lumen. To improve the ability to push as well, a strain relief device can be added to the proximal and distal ends. It is particularly preferred to have tension relief at the distal end, for example, 1 to 8 inches, preferably 6 inches, to ensure that the catheter bypasses the larynx and goes into the esophagus. The proximal end may have tension relief, as well, for example, to ensure the connector fits. The preferred material for stress relief is a polyolefin. The method for inflation / separation is the same as for the double lumen configuration, where the outer lumen connects to the needle sleeve and the inner lumen connects to the needle. Hardening members are strategically placed along the length of the catheter shaft to provide the right amount of flexibility and pushability to correctly place the device on the patient. As part of the process, the patient can swallow water or another suitable liquid, in order to stretch the esophageal tissue for good descent of the device. Patients can also be given an anesthetic at the back of the throat, to anesthetize the area to decrease the vomiting reflex.
[0153] The tube can also be connected to a series of encapsulated or compressed balloons in a single catheter in such a way that the total volume of up to 1000 cc or more can be administered, as needed. Each can be inflated and released separately. The number of balloons released can be adjustable to the patient's needs and desired weight loss.
[0154] In addition, a catheter can be used to administer a gastric balloon, which is similar to the balloon catheters used in angioplasty called "over-the-wire" or rapid exchange catheters (FIG. 13). In this case, where patients try to swallow the catheter, but cannot because the catheter is suture - or the doctor-assisted catheter can slide over the flexible catheter and the balloon can be pushed down in the same way as the doctor-assisted catheter. Different materials can be used to provide varying degrees of flexibility or a material that is manufactured with different diameters along the length to vary the degree of stiffness can be used. Inflation Fluid Container
[0155] The inflation fluid container is used to control the amount or volume of fluid placed inside the balloon. This can be in the form of a can, for example, PVC, stainless steel, or other suitable material. The container can also be in the form of a syringe. The materials used are capable of containing a fluid, preferably in the form of gas, for example, N2, Ar, O2, compressed or uncompressed CO2, or mixture (s) thereof, or compressed or uncompressed atmospheric air (a mixture of N2, O2 Ar, CO2, Ne, CPU, He, Kr, H2 and Xe). The balloon composite wall materials and respective diffusion gradients and gas permeability characteristics are used to select a fluid for inflating the intragastric balloon. The materials of the inflation fluid container are selected to ensure that there is no diffusion or leakage of fluid before it is connected to the connector or valve of the inflation catheter. The inflation fluid container system (FIGS. 14A to C) includes a connector (FIG. 14B) for the catheter and a pressure gauge (FIG. 14C). The inflation fluid container can be manufactured from any suitable material, for example, stainless steel (FIG. 15). It may also contain a smart chip, which notifies the healthcare professional if inflation has been successful or if the balloon should be removed due to a system error.
[0156] To maintain the balloon's “swallowing capacity” and to ensure patient comfort during the procedure, it is preferable to minimize the amount of time the catheter is placed in the mouth / esophagus. Inflation time can be selected to minimize time in place. The external container-catheter assembly, once ingested, takes approximately 4-8 seconds to reach the stomach. Once in the stomach, the inflation source container can be connected to the valve or port of the catheter system. The inflation time can be controlled by choosing the length of the catheter, the diameter of the catheter tube, the starting temperature, and the starting pressure. Using the Ideal Gas Law for nitrogen and Boyle's Law (PiVi = P2V2) the amount of the starting / pressure volume can be derived, where the temperature is controlled inside the container of the inflation source to match that of the body. It is desirable to have an inflation time after swallowing of less than 5 minutes, and preferably 2-3 minutes, before separating the balloon and removing the catheter. The inlets used to derive the balloon inflation (preferably in less than 3 minutes) include the volume of the inflation vessel, the type of inflation fluid (preferably a compressed gas, or compressed gas mixture), starting pressure , length and diameter of the catheter, and the desired final volume and balloon pressure. Thus, due to differences in diameter, a French 2 catheter system requires a higher initial pressure to reach the same volume as the target balloon and pressure in the same period of time, assuming the use of the same compressed gas formulation. In general, it is understood that, from a higher pressure, with the same flow / volume it can decrease the inflation time.
[0157] The inflation source container provides feedback to the end user based on a pressure drop system. Where there is an expected initial pressure and the expected final pressure to indicate whether the balloon is properly inflated, there is no need for endoscopic visualization (see FIG 16.). Each scenario of the expected pressure outlets represented in FIG. 16 can have its own tolerances around it to reduce the possibility of false positives, and the inflation fluid container can provide feedback based on these tolerances as to the state of inflation and balloon separation. This is achieved based on the ideal gas law, where there is an expected final pressure, based on the fixed volume of the balloon. If the pressure remains high and does not decay as expected, which may indicate a system failure (for example, the balloon container has not dissolved, the balloon is expanding in the esophagus because there is, for example, a twist in the tube or another failure of the catheter system). For example, for a successful decay using nitrogen only as an inflation fluid, the initial pressure is 22 PSI to inflate a 250 cc and 1.7 psi (0.120 kg / cm2) balloon for a nylon-based material. To indicate successful balloon inflation, a math chip can be added to the inflation source container, which provides at least one of a visual, audible, or tactile notification, or otherwise transmits a notification to a professional health or administrator if inflation is successful or if there is an error in the system according to the pressure curve and a predetermined set of pressure tolerances and expected inflation time.
[0158] Alternatively, the balloon can be inflated based on an initial pressure using a spring mechanism, a balloon mechanism inside a balloon, or another pressure source. These mechanisms can potentially result in more predictable / consistent pressure drop curves, and, again, may have predetermined follow-up tolerances for return to the end user. FIG. 17 represents the expected decay curve for these pressure source methods, and, again, we would have predetermined follow-up tolerances for return to the end user. COMPOSITE WALL
[0159] The materials chosen for the balloon composite wall can be optimized to maintain the initial inflation gas, without significant diffusion, or it can also allow the diffusion of gases located in the gastric environment, for example, CO2, O2, argon, or N2 to diffuse through the balloon wall to inflate, partially or fully, once the balloon is placed in the stomach. A fluid (liquid or gas) can also be added inside the balloon using the inflation catheter (s) described here to change the direction of diffusion of the balloon's composite wall and when it reaches stasis based on the internal and external environment .
[0160] A gastric balloon inflated by nitrogen, CO2 gas, a single fluid (gas), or a mixture of gases employs a composite wall that provides barrier properties (fluid retention), properties that confer pH resistance and moisture in the gastric environment or the environment within the central lumen of the balloon, and the structural properties to withstand the forces of gastric motility, abrasion of the balloon wall in vivo, and damage during balloon manufacture and bending. Some materials used in balloon materials are able to withstand a hostile gastric environment designed to break foreign objects (for example, food particles). Some of the variables that the gastric environment encompasses are as follows: gastric fluid pH of 1.5 to 5; temperature of approx. 37 ° C, relative humidity from 90 to 100%; entry of gas content from the gastric space and external pressures of constant gastric motility from 0 to 4 psi at variable frequencies and cycle times based on the fed state of the stomach. The external pressure transmitted by gastric motility can also cause abrasions on the surface of the balloon. The inner lumen of the flask may contain moisture from a solution injected into the flask for the time of self-deflation or any moisture that has transferred through the membrane, due to the external humid environment. In addition to these environmental stresses, the wall materials meet the requirements for biocompatibility and are constructed in such a way that the total wall thickness (barrier material) is thin enough to be compacted and placed in a swallowable size container ("external container" ), without significant damage or deposition. The outer vessel is small enough to overcome the esophagus (which is approximately 2.5 cm in diameter). The wall or barrier material is also heat moldable and sealable for balloon construction and maintains a bonding force that can contain the internal gas pressures up to 10 psi generated by the initial inflation pressure, as well as the pressure due to the penetration of the gas molecules from the stomach cavity until the system gas environment reaches stasis. The film properties that are evaluated to determine suitability for use in the balloon wall composition include pH resistance, water vapor transmission rate, gas barrier properties, mechanical resistance / abrasion properties, temperature resistance , formability, flexible crack resistance (Gelbo), conformity with surface energy (wettability), and potential heat bonding.
[0161] The various layers of the composite wall can impart one or more desirable properties to the flask (for example, fluid retention, moisture resistance, resistance to the acidic environment, wettability for processing, and structural resistance). A list of polymeric resins and coatings that can be combined in a pre-formed multi-layer system (“composite wall”) is provided in Tables la-b. These films can be glued together, co-extruded, or adhered through bonding layers or a combination of these to obtain the desired combination of properties for the composite wall, as discussed below. The materials identified as film coatings in Tables la-b are provided as coatings applied to a polymer based film, for example, PET, nylon, or another structural layer. Table la. Film Resins
Table 1b. Film Coatings
Fluid Retention Layers
[0162] In preferred embodiments, a polymer resin mixed with multiple layers is used to maintain the shape and volume of the inflated balloon while retaining the inflation fluid for the intended duration of use. Some barrier films, which are widely used in the food packaging and plastic bottling industries, can advantageously be employed for this purpose on the balloon composite wall. Preferably, the barrier materials have a low permeability to carbon dioxide (or other gases, liquids or fluids that are used alternatively or additionally to inflate the volume occupying subcomponent). These barrier layers preferably have good adhesion to the base material. Preferred barrier coating materials and films include polyethylene terephthalate (PET), linear low density polyethylene (LLDPE), ethylene-vinyl alcohol (EVOH), polyamides such as nylon (PA) and nylon-6 (PA- 6), polyimide (PI), liquid crystal polymer (LCP), high density polyethylene (HDPE), polypropylene (PP), biocompatible poly (hydroxyamino ethers), polyethylene naphthalate, polyvinylidene chloride (PVDC), Saran, copolymers of ethylene-vinyl alcohol, polyvinyl acetate, silicone oxide (SiOx), silicone dioxide (SiO2), aluminum oxide (AI2O3), polyvinyl alcohol (PVOH), nanopolymers (eg nano-clay), polyimide film thermo-adjusted, EVALCA EVAL EF-XL, Hostaphan GN, Hostaphan RHBY, RHB MI, Techbarrier HX (SiOx- coated with PET), Silver Triad (PET metallized with silver), Oxyshield 2454, Bicor 84 AOH, acrylonitrile copolymers, and copolymers terephthalic acid and isophthalic acid with ethylene glycol and at least a diol. Alternative gas barrier materials include polyamine-polyepoxides. These materials are typically supplied as a solvent-based or water-based thermoset composition and are usually spray-coated in a preform and then heat cured to form the final barrier coating. Alternative gas barrier materials that can be applied as coatings for the volume occupancy subcomponent include metals such as silver or aluminum. Other materials that can be used to improve the gas impermeability of the volume occupying subcomponent include, but are not limited to, gold, or any noble metal, PET coated with Saran and insulating coatings.
[0163] One method that is used in the packaging industry to delay the diffusion of the inflation fluid is to thicken the material. Thickening of the material is generally not preferred, since the wall thickness of the total composite is preferably not more than 0.004 inches (0.010 cm) in order for the balloon to be dismountable to the size of the desired distribution container for the swallowing by a patient.
[0164] A multilayer polymer film that is able to withstand the gastric environment during the life of the balloon includes linear low density polyethylene (LLDPE), glued to a nylon film 12. Alternatively, a film layer additional barrier properties such as PVDC can be added to the composite wall.
[0165] The layers that provide gas barrier properties are preferably situated as internal layers in the composite wall as they are less mechanically robust than resins that are considered "structural", such as nylon and the like. Structural Layers
[0166] Layers such as polyurethane, Nylon or polyethylene terephthalate (PET) can be added to the composite wall for structural purposes, and are preferably placed as more outer layers (proximal to the gastric environment or proximal to the central lumen of the balloon) , since the resistance of such layers to pH can withstand the acidic environment of the stomach or the central lumen of the balloon. Composite Wall Fabrication
[0167] The various layers of the composite wall, including the gas barrier layers, need not be located in any particular order, but those of superior acidity, temperature, mechanical abrasion and biocompatibility profile are preferably employed as layers of contact with the gastric environment. Those with a resistance greater than, for example, acidity and temperature, are preferably used as contact layers with the central lumen of the balloon.
[0168] The various layers of the wall may include a single layer or up to 10 or more different monolayers, however, a film thickness of 0.001 inches (0.0254 cm) to 0.004 inches (0.010 cm) thick is desirable as such so that the resulting compressed balloon fits into a swallowable capsule. The resulting composite wall preferably has good performance specifications with respect to each category listed in Tables la-b.
[0169] Films that are co-extruded are advantageously employed, as some adhesives may contain leachables that are undesirable from the point of view of biocompatibility. In addition, co-extrusion allows for a better mixing so that the materials retain their original properties when combined in this way and are less likely to be subject to delamination when exposed to the forces of gastric motility.
[0170] The combination of films with similar properties, for example, two layers of film, with excellent gas barrier properties, in a composite wall is advantageous, for use in a gastric balloon containing nitrogen, oxygen, CO2 or a mixture of them, as the inflation gas or where the external environment the product must be placed in, contains a mixture of gases, including CO2, for example, in the stomach. A major advantage of these composite films is that restrictions on film thickness can be observed without sacrificing gas barrier properties. Such a configuration also contributes to reducing the effects of processing damage (for example, manufacturing and compaction), and damage due to exposure to in vivo conditions (for example, the forces of gastric motility).
[0171] In a particularly preferred embodiment, the composite wall includes a plurality of layers. The first layer is an external protective layer that is configured for exposure to the gastric environment. This layer is resistant to mechanical forces, exposure to water (steam), abrasion, and high levels of acidity. Nylon or, more specifically, Nylon 12 is particularly preferred for the layer exposed to the gastric environment and is especially resistant to mechanical forces.
[0172] In an alternative modality, polyurethane is welded by RE to saran to create a 6-7 mil thick composite wall. In another embodiment, a five-layer system is provided comprising a layer of Saran sandwiched between two layers of polyurethane. Between the saran layer and each of the polyurethane layers is a bonding layer. The layers can be welded together, coextruded or bonded using an adhesive. This tri-layer is then co-extruded into the Nylon on each side, and then a final sealing layer (polyethylene or similar) is added to one of the nylon layers for the total composite wall. A representative example of combinations of materials that are commercially available or manufactured is provided in Table 2. The orientation of the layers (innermost - in contact with the central balloon lumen, or outermost - in contact with the gastric environment) is also indicated if more than two layers are described to support a suggested composite wall.
[0173] Most film resins listed in Table 2 have some degree of gas barrier properties. Therefore, many can be used exclusively to form the balloon wall as a monolayer film, however they can also be used in conjunction with other film resins to satisfy the desired gas retention and mechanical specifications for the balloon's life with based on the inflation gas and the external environment of the balloon must be placed inside. These film resins can also be coated with gas barrier coatings listed in Tables la-b. Additional layers of film can be added to form the total composite wall. Although these additional layers may confer non-substantial barrier properties, they can provide structural and / or mechanical protection properties, for other layers of the composite wall that are sensitive to water vapor, moisture, pH, or the like, or other properties desirable. The film layers can be assembled using various adhesives, through co-extrusion, through lamination, and / or using bonding layers and such to create a composite wall that satisfies the requirements of an intragastric balloon suitable for use during at least at least 25 days, or up to 90 days or more, with the specified gas retention properties. Table 2 presents a list of layer and layer combinations suitable for use on composite walls for an intragastric balloon. The composite description, abbreviation for resin, configuration (single layer, bilayer, triple layer, or the like) and the commercial name of commercially available combinations are listed. The number of layers indicated does not include any adhesive layers or bonding layers used to manufacture the composite wall, such that a 6-layer composite wall can, for example, have two or three adhesive layers and / or layers of bond that form the total composite wall, and therefore the total number of layers can be eight or nine in the final form. The term “layer” as used herein is a broad term, and is meant to be given its normal and usual meaning to a person skilled in the art (and not to be limited to a special or personalized meaning), and if, without limitation to a single thickness of a homogeneous substance (for example, a coating such as SiOx, or a layer such as PET), as well as a backing layer having a respective coating (where a "coating" is, for example, example, a material normally used in conjunction with the substrate that provides structural support to the coating layer). For example, a PET-SiOx "layer" is referred to herein, wherein a Si-Ox layer is provided on top of a supporting PET layer. Table 2.

[0174] In particularly preferred embodiments, the composite wall has a thickness of 0.005 inches or less (5.0 mil or less), however, in certain embodiments a thicker composite wall may be acceptable. It is generally preferred that the composite wall has a thickness of no more than 0.004 inches (4.0 mil). Balloon Manufacturing
[0175] To guarantee good mechanical resistance of the balloon, the balloon is preferably formed and sealed so that the edges of the parts used to form the balloon overlap. This can be done by any suitable method. For example, two flat sheets of material can be placed in a frame with magnetized edges to hold the two sheets in place. A gap can be added to the film part to orient the material in such a way that it retains its properties after the forming process. The frame can be placed on a mold, which represents a hemisphere of the balloon. The material, with clearance placed on it before the pressure is applied, reorients the material in such a way that it is more evenly distributed around the hemisphere shape. The material is preferably thicker in the middle and is made thinner on the sides where it will be welded to a second piece to create a sphere or ellipsoid, with a substantially uniform wall thickness. For example, starting with 0.0295 ”film, the rear film or vertex medium has a final film thickness of 0.0045” and the edges have a final thickness of 0.0265 ”for subsequent overlap during the welding.
[0176] The valve can be attached to the side (for example, polyethylene, PE) of one of the hemispheres and protrudes outside the opposite side (for example, nylon). One hemisphere typically consists of nylon as the outermost layer and the second hemisphere typically has polyethylene (sealing weft) as the outermost layer. The edges of the two hemispheres are preferably aligned so that they overlap by at least 1 mm and no more than 5 mm. The alignment and overlap of the two hemispheres is done to compensate for the thinning at the extremities, during the thermoforming process, which in turn inhibits stitch overflow in vivo. Each half of the spheroid is placed on a support and the excess from the formation process is trimmed. In a multi-layer film, the sealing layer, a layer of PE or similar is bonded to the sealing layer of the second half of the film. For this, the hemisphere film that has the nylon exposed to the external environment is folded upwards along the edges of the sphere in half (see FIGS. 18A to B), in such a way that it can be connected to the hemisphere with polyethylene in the outermost layer.
[0177] The two pieces of film are then sealed with a rolling binder or a band heater. In the rolling binder, a pneumatic cylinder provides compression, the heater provides the sealing heat, and a motor that moves the binder around the area controls the time that is required to ensure an adequate seal. In the band heater, there is a heating element, an expandable fitting that provides compression, and a timer. The band is a metal, preferably copper and a fastening element similar to the spool provides the necessary compression. Using the layers of film of different melting temperatures helps to ensure the integrity of the barrier layers of the final balloon configuration. If two similar materials are welded, then an insulator can be employed. In a preferred embodiment, a sphere is provided with the nylon layer facing outwards and the second sphere has a PE layer facing outwards. Balloons with Resistance to Spontaneous Deflation
[0178] The highest percentage of malfunctions of the intragastric balloon is due to spontaneous deflation. Spontaneous disinflation can occur due to (1) external puncture of the intragastric balloon, due to gastric motility forces, (2) during balloon inflation, due to the increase in the internal pressure of the balloon absorbing the gastric environment of gases and vapor water and (3) under balloon inflation which leads to fatigue of the surplus material and posterior puncture of the balloon. By managing these two variables and adjusting these variables to support the dynamic gastric environment, the balloon system can be adapted to ensure that it remains inflated throughout its useful life. Cases of spontaneous deflation in this intragastric balloon can be minimized by selecting the starting inflation gas in conjunction with the selection of composite and construction wall materials. The selection of the permeability characteristics in relation to the transmission of water vapor and permeability to the gases of the composite wall, in order to take advantage of the properties of the contents of the gastric space can enable the rate of diffusion of the gases in and out of the balloon is controlled. This method allows for an adjustable method for preventing low inflation and excess inflation.
[0179] Another phenomenon seen with gastric balloons and obesity, in general, is the accommodation of the stomach. In the process of accommodating the stomach, the stomach grows to accommodate the device for occupying excess space or food, which is ingested. In the process of accommodating the stomach, the volume of a stomach containing an intragastric balloon grows over time, so that the patient becomes more hungry. However, by controlling the diffusion of gas and the transmission of water vapor through the wall of the balloon over time, the size of the balloon can also be increased over time by selecting the starting inflation gas and water and other in vivo gas permeability characteristics of the film, in order to maintain weight loss. In addition to spontaneous deflating, the selection of the permeability characteristics of the composite wall in conjunction with the starting gases and the use of gas and water transfer inside the balloon of the gastric environment, the balloon can be designed to grow during its lifetime helpful in response to accommodation in the stomach.
[0180] The experiments were carried out in which several starting inflation gases were selected in conjunction with different external gas environments that mimic the stomach gas and water environment in vivo. The stomach environment consists of water, acid (hydrochloric acid), a mixture of gases, and chyme (the semi-liquid mass of partially digested food expelled from the stomach into the duodenum). The gas in the stomach usually arises from the swallowing of air during the meal. The composition of the air is nitrogen (Na), 78.084%, oxygen (O2) 20.9476%, argon (Ar), 0.934%, carbon dioxide (CO2) 0.0314%, neon (Ne), 0.001818% , methane (CH4), 0.0002%; helium (He) 0.000524%, krypton (Kr) 0.000114%, hydrogen (H2) 0.00005% and xenon (Xe) 0.0000087%.
[0181] Five gases make up more than 99% of the gases in the gastrointestinal system: N2, O2, CO2, H2 and methane, with a predominance of nitrogen. The gastric pCÜ2 is closely parallel to the local arterial values (esplanquinic) and PCO2 drainage from venous blood. Neutralizing stomach acid can also generate gas. For example, when stomach acid reacts with bicarbonates (for example, as they are present in certain antacids) in digestive juices, the chemical process creates CO2, which is normally absorbed into the bloodstream. Digestion of food in the intestine, mainly through fermentation by colon bacteria, generates CO2, H2 and methane. Microbes appear to be the sole source of all hydrogen and methane produced in the intestine. These arise from fermentation and digestion of nutrients (polysaccharides from fruits and vegetables are not digested in the small intestine). Small amounts of some other gases, such as hydrogen sulphide, indoles, and ammonia can also be generated.
[0182] Controlled self-inflation of the intragastric balloon in the in vivo environment can be achieved by means of a semi-permeable or permeable composite wall in the balloon and initially filling the balloon with a previously selected single gas, such as N2 or O2. The balloon uses differences in gas concentrations and differences in water concentration between the interior environment of the balloon and the external environment, in vivo (Gl / stomach) to increase and / or decrease the volume and / or pressure along the time. To achieve a controlled reduction in volume and / or pressure, a wall can be employed that has a relatively higher permeability for the only gas used to inflate the balloon than other gases present in the gastrointestinal environment in vivo. For example, if nitrogen gas is used as an inflation gas, over time in the in vivo environment, the volume and / or pressure in the balloon will decrease as nitrogen diffuses out into the in vivo environment through the wall. permeable to oxygen. Likewise, if oxygen gas is used as an inflation gas, over time in the in vivo environment, the volume and / or pressure in the balloon will decrease as the oxygen diffuses out into the in vivo environment. , through the oxygen permeable wall. The differential in the partial pressure of the gas in the single balloon (higher) in relation to the in vivo environment (lower) will control the process until equilibrium or homeostasis is reached. To achieve a controlled increase in volume and / or pressure, a wall can be used that has a relatively low permeability for the only gas used to inflate the balloon than other gases present in the gastrointestinal environment in vivo. For example, if nitrogen gas is used as an inflation gas, over time in the in vivo environment, the volume and / or pressure in the balloon will increase, as CO2, etc. diffuses into the balloon through the CO2 permeable wall. The differential in the partial pressure of the permeable gas in the balloon (lower) in relation to the in vivo environment (upper) will control the process until equilibrium is reached.
[0183] In addition, maintenance and / or control of balloon inflation can also be done using differences in concentrations between the internal balloon environment and the external gastric environment, whose balloon / pressure volume can be increased or decreased as needed , to extend the life of the product. One reason to decrease the pressure may be to first inflate the balloon with a large, but highly diffusible / soluble gas molecule such as CO2, in addition to a more inert gas such as nitrogen to pre-stretch the balloon with the gas soluble diffusing out of the balloon and other gases not originally present in the balloon that migrates to fill the balloon.
[0184] The inflation gases can be selected to start, with most of the balloon gas comprising a large, inert gas or a gas that has a low diffusivity through the selected composite wall. An inert gas together with a lower inert gas which are more soluble in the gastric environment, can be combined to understand the composition of the inflating gas in the starting balloon. The patient's diet and medications can also affect / control the state of balloon inflation - mainly due to the effects of CO2 concentration produced in the gastric environment. In addition, gastric pH also affects the concentration of CO2. This particular method can also allow for a greater degree of adjustment of the life of the device based on the composite wall material, for example, the barrier / non-barrier and if the diffusing gas is kept longer in the balloon if there is a barrier wall against a non-barrier wall. This particular form of self-inflation can be employed using a self-inflating gastric balloon (for example, initially inflated through a gas generation reaction in the balloon initiated after swallowing) or an inflatable gastric balloon (for example, using an inflated catheter, with or without endoscopic assistance, delivered nasogastrically or any other delivery method). The method can be used with any gastric balloon, including ingestible balloons and balloons placed in the stomach by, for example, endoscopic methods. The method is particularly preferred for use in connection with intragastric devices; however, it can also be applied for use in, for example, pulmonary wedge catheters and urinary incontinence balloon devices. The advantages of this technology include the ability to compensate for accommodation in the stomach, allowing the balloon to adapt to a stomach that can swell over time, thus maintaining the patient's satiety. It also allows you to start with a smaller amount of inflating gas components for a self-inflating balloon. It can prevent spontaneous deflation by using diffusion gradients between gastric balloon systems and gastric environment in vivo.
[0185] In a particularly preferred embodiment, used in connection with N2 (with or without CO2) as the inflating agent, a co-extruded multi-layer mixture for the wall layers to be 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 Nylon 12 co-extruded multilayer encapsulated with PVDC Nylon 12 + LLDPE LLDPE). Another particularly preferred configuration is a multi-layer co-extruded Nylon 12 / Linear low density polyethylene + Low Density Polyethylene. The selection of resins for the construction of the composite wall (as well as the selection of the use of a coextrusion method or adhesives) can be varied to control conformity (elasticity), puncture resistance, thickness, adhesion, resistance to the sealing bond , orientation, acid resistance, and gas and water vapor permeability characteristics to achieve a certain effect. AUTOMATIC DEFLECTING OF INTRAGASTRIC BALLOON SYSTEMS
[0186] The self-inflating (also referred to as automatic inflation) or inflatable (also referred to as manual inflation) intragastric balloon is provided with mechanisms to control the reliability of deflation time. In the preferred modes, the balloon deflates automatically and passes through the stomach, through the lower gastrointestinal tract and out of the body at the end of its predetermined (non-spontaneous) life, preferably between 30 and 90 days, but can be programmed to empty within 6 months. In the preferred embodiments described below, the emptying time can be performed through the external gastric environment (for conditions of temperature, humidity, solubility, and / or pH, for example), or through the environment within the lumen of the inflated balloon. It is preferable for consistency to control the initiation of the self-deflation process by manipulating the internal environment of the balloon.
[0187] In other embodiments, the adhesive applied to allow inverted seams as described above and / or one or more additional patches or other structures added to the balloon construction are made of a corrosive, degradable, or soluble material (natural or synthetic) and are embedded in the balloon wall. The adhesive (s) are of sufficient size to ensure the opening of a sufficient surface area to cause rapid deflation, and to prevent re-inflation by infiltrating fluid from the stomach into the balloon. The balloon patch (s) comprises materials that can be applied to the balloon in such a way that a substantially smooth surface is preferably maintained, comprising a single layer or multi-layer material. The adhesive (s) are constructed using an erodible, disintegrable, degradable or other such material that is preferably compatible with the fabric and degrades into non-toxic products or is a material that slowly hydrolyzes and / or dissolves over time (e.g. poly (lactic-co-glycolic acid) (PLGA), poly (lactide-co-glycolide) (PLG), polyglycolic acid (PGA), polycaprolactone (PCL), polyesteramide (PEA), polyhydroxyalkanoate (PHBV), polybutylene succinate adipate (PBSA), aromatic copolyesters (PBAT), poly (lactide-co-caprolactone) (PLCL), polyvinyl alcohol (PVOH), polylactic acid (PLA), poly-L-lactic acid PLAA, pullulan, polyethylene glycol (PEG), polyanhydrides, polyorthoesters, polyarylethylketones (PEEK), multi-block polyetheresters, polyglicaprone, polydioxanone, polymethylene carbonate, and other similar materials). These erodible, disintegrable or degradable materials can be used alone, or in combination with other materials, or can be converted to / co-extruded, laminated, and / or dipped coated in conjunction with non-degradable polymers (for example, PET or similar) and employed in the construction of the balloon. Degradation / erosion occurs, is initiated by, and / or is controlled by the gastric environment (for example, temperature, humidity, solubility and / or pH conditions, for example), or is controlled within the balloon lumen (for example, for humidity conditions and / or derived pH, for example) based on what the adhesive is exposed to. The thickness of the polymer, as well as the environment that affects the degradation and the exposure time can also facilitate the degradation time. Degradation / erosion is timed so that they occur once the predetermined life of the balloon is filled (for example, inflation is maintained for 25-90 days inactive in the stomach before the degradation / erosion results in the formation of an opening that allows disinflation). As an alternative to (or in connection with) the use of a biodegradable material for the transdermal patch, the adhesive may comprise a similar fluid retention barrier film or the same film as the remainder of the balloon wall, which is glued to the balloon using a weak adhesive, or welded or adhered in such a way that after a specified period of time the adhesive delaminates the applied area and allows an opening for the release of inflation fluids for deflation. Or, if deemed necessary for the rapid emptying of the entire composite wall of the balloon, it may be made of corrosive material. The mechanism for using an erodible material or a material that fails mechanically after a predetermined time is similar for all modalities for the disinflation mechanisms described below, too. The time of degradation or erosion can be controlled using the external gastric environment (for example, conditions of temperature, humidity, solubility, and / or pH, for example) and / or can be controlled by conditions in the inner lumen of the balloon (for example , by the humidity and / or pH conditions of the residual liquid in the flask).
[0188] In other embodiments, a fitting or fittings (optionally in conjunction with another degradable retention structure) may be incorporated into the balloon construction and may consist, in whole or in part, of an erodible, disintegrable or synthetic synthetic or natural polymer another degradable method similar to those described above (for example, PLGA, PLAA, PEG, or the like). The socket can be formed in several ways (for example, cylinder shape or radial shape, as shown in FIG. 19A to D) to obtain various surface-volume ratios, in order to provide a pattern of degradation of large amounts pre- selected and predictable for the erodible polymer. The fitting may incorporate a release mechanism that can be initiated after chemical degradation / erosion begins, such that the material in the septum or plug jumps out of the balloon or descends inside the balloon, thus creating a passageway for release of fluid and subsequent deflation of the balloon. Mechanical additions that can be used in conjunction with a fitting include a degradable / erodible / disintegrable material that holds a fitting (for example, a non-biodegradable or degradable material) in place or a compressed spring housed within the retaining structure or the filling structure. More specifically, a preferred embodiment for achieving deflation can comprise an enclosure, a radial seal, a solid erosion core, and a protective layer attached to the outer surface of the eroded core (FIGS. 19A to B). The interior of the erosion core is exposed to the internal liquid in the balloon. The core creates a compressive force that maintains the seal against the housing. As the core is eroded, the compression between the housing and the radial seal is reduced until there is clearance between the housing and the seal. Since there is no gap, the gas can move freely from the inside of the balloon to the external environment (FIG. 21A). The seal may fall out of the housing and into the balloon. The diameter, length and types of material can be adjusted to create deflation at a desired point in time. Examples of materials for each component used to achieve this deflation mechanism can be as follows. Casing - biocompatible structural material, capable of resisting sufficient radial force to form an airtight seal. Materials can include polyethylene, polypropylene, polyurethane, UHMWPE, titanium, stainless steel, cobalt-chromium, PEEK, or nylon. Radial seal - composed of an elastic, biocompatible material, capable of providing liquid and gas barrier to acidic environments. Materials can include silicone, polyurethane, and latex. Erosion Core - a material capable of breaking down at a predictable rate under certain environmental conditions. The materials can include PLGA, PLA, or other polyanhydrides that are capable of losing integrity over time, or any materials listed above that provide erodible characteristics.
[0189] For the spring mechanism, once the material decomposes the spring is released and / or the obturator / septum is pulled into the balloon or pushed out of the balloon, thus releasing, once a hole of fluid was created by releasing the spring mechanism and pushing out or pulling on the fitting (FIG. 21B).
[0190] The mechanisms of disinflation, using a septum and expansion material of moisture absorption and a material of erosion of moisture. Erosion materials slowly wear out when exposed to moisture, eventually exposing the expansion material by absorbing moisture. When the moisture expansion material begins to absorb moisture, the expansion of the septum pulls out of position on the head by an edge pushing against the septum or a ring attached to the septum. Pulling the septum out of position causes an immediate deflation of the balloon (FIG. 21C). In order to protect the expansion material from moisture for a desired time, the expansion material can be coated with blocking materials, such as water, parylene, as well as materials that degrade slowly in water. The moisture contact can be controlled by small entry doors. Entrance doors can be small holes, or a wire material, which removes moisture in a controlled manner. The desired deflation time is achieved through a combination of erosion materials, blocking materials, and dimensioning of the entrance door.
[0191] In certain embodiments, the balloon may incorporate one or more grooves in the balloon wall, which contain a compressed pellet (FIGS. 22A to B) or gas release pellet. The pellet can consist of any combination of components that, when activated, release CO2 gas (for example, sodium bicarbonate and citric acid, or potassium bicarbonate and citric acid, or the like). The pellet may be in the form of a tablet or rod shape protected by an erodible, disintegrable or degradable material that is preferably compatible with the fabric and degrades into non-toxic products or that slowly hydrolyzes and / or dissolves similar to the inserts and adhesives described above (for example, poly (lactic-co-glycolic acid) (PLGA), polyvinyl alcohol (PVOH), polylactic acid (PLA), poly-L-lactic acid PLAA, pullulan, polyethylene glycol, polyanhydrides, polyorthoesters, polyarylethylketones (PEEK), multi-block polyetheresters, polyglicaprone, polydioxanone, polymethylene carbonate, and other similar materials). Degradation degradation / erosion initiates the reaction of two chemicals in the pellet and subsequently leads to the formation of the gas (eg CO2). As sufficient gas is trapped or built, sufficient pressure is eventually generated to push the softened polymer material and create a larger channel for CO2 gas to escape into the balloon. The external pressure applied by the stomach to the balloon (for example, squeezing), can contribute to the process of creating a larger canal. The dimensions and properties of the fitting (diameter, thickness, composition, molecular weight, etc.) of the polymer compound lead to synchronism of degradation.
[0192] In other embodiments, fittings or adhesives of different shapes or sizes similar to the fittings described above can be used within the lumen of the balloon in a multi-layer configuration including a semi-permeable membrane to facilitate deflating the balloon. The insert or adhesive is made of soluble / erodible / dissolvable degradable material similar to that described above (for example, poly (lactic-co-glycolic acid) (PLGA), polyvinyl alcohol (PVOH), polylactic acid (PLA), PLAA, pullulan , and other similar materials) and contains a compartment closed by a semi-permeable membrane (impermeable to an osmolyte) that contains a concentrated solution of a solute or osmolyte (such as glucose, sucrose, other sugars, salts, or a combination thereof) ). Once the insert or adhesive starts to degrade or corrode, the water molecules osmosis down the water gradient from the region of highest water concentration to the region of low water concentration through the semi-membrane permeable in the hypertonic solution in the compartment. The compartment containing the osmolyte waves and eventually explodes, pushing the membranes and the degraded or adhesive fitting out, thus allowing rapid gas loss through newly created channels or areas.
[0193] In certain embodiments, a balloon consisting of a septum, moisture erosion material inside an entrance door, and expansion material by moisture absorption is employed. Erosion materials slowly wear out when exposed to moisture, eventually exposing the expansion material by absorbing moisture. When the moisture expansion material begins to absorb moisture, the expansion pulls the septum out of position on the head by pushing against an edge of the septum or a ring attached to the septum. Pulling the septum out of position causes an immediate deflation of the balloon. In order to protect the expansion material from moisture until a desired time point is reached, the expansion material can be coated with blocking materials, such as water, parylene, as well as materials that degrade slowly in water. The moisture contact can be controlled by small entry doors. Entrance doors can be small holes, or a wire material, which removes moisture in a controlled manner. The desired deflation time is achieved through a combination of erosion materials, blocking materials, and dimensioning of the entrance door.
[0194] Another mechanism for self-deflation is to create a forced delamination regime, which can provide a larger surface area to ensure rapid deflation. In, for example, a balloon that has a three-layer wall, the outermost layer is substantially strong enough to hold the inflation fluid (for example, polyethylene terephthalate (PET), or similar), the middle layer is made up entirely by an erodible material (for example, PVOH or similar) while the inner layer is composed of a weaker material (for example, polyethylene (PE) or similar). The PET or outermost layer is "classified" or incubated with erodible material to create small channels that wear out over time (FIG. 23). This creates channels in such a way that the gastric fluid seeps into the layers of the balloon and begins to degrade the fully erodible material. When the erodible layer degrades or dissolves, the material that makes up the innermost layer is also corroded, degrades or dissolves, as it is not strong enough to withstand gastric forces / the environment on its own. The balloon then collapses on itself and eventually passes through the lower gastrointestinal tract. Having an erodible layer sandwiched between a strong and weak layer facilitates the synchronization of erosion by creating a longer path length than a plug or erodible patch affected by the gastric environment. The distance between the points or openings can also be selected to provide a desired rate of deflation.
[0195] In another embodiment that provides abrupt deflation of the balloon after a desired period of time has elapsed, the composite wall of the entire balloon or a section of the composite wall (path) includes several layers of materials that are slowly penetrated by the water that was injected into the balloon during the manufacturing process or during the inflation process (FIGS. 24A to 24E). This water penetrates through the layers, eventually reaching a material that expands substantially, breaking a thin external protection afterwards, and creating a large orifice (FIG. 24D) for the gas to escape and to empty the balloon. The water expansion material is protected from liquid by means of a coating or liner, such as parylene, which allows for a controllable amount of exposure to moisture. Once the water reaches the expansion material, it exerts a force on the outer protective layer, causing it to rupture. The outer layer can be created with a weakened connection area (FIG. 24E), a partially marked area, or other methods to ensure a desired rupture site and to facilitate the desired distribution for self-deflation to occur. There can be any number of layers between the humid environment and the center of expansion of moisture. Each layer of material can have different rates of erosion (for example, fast or slow) and can be selected by the predetermined time deflation that is expected to occur (for example, after 30 days, 60 days or more). By varying the number, thickness and rate of each of the peripheral layers, the deflation time can be precisely controlled.
[0196] Alternatively, a pressure seal button, which is glued over a perforation in the balloon material, can be provided for deflation (FIG. 25 A and B). The adhesive connection of the button erodes over time, when it comes in contact with the moisture derived from the gastric fluid, or that was injected into the balloon. Since the glue can no longer bond and create an airtight seal between the adhesive and the button, the balloon will quickly empty. By controlling the size of the hole and exposure to moisture in the adhesive, the erosion time can be accurately predicted.
[0197] Deflation can also be facilitated by creating a series of connecting ports inside the septum or in another similar structure connected to the balloon's composite wall. Doors can be constructed using a biologically compatible, low-permeability, water-dissolving or acid-dissolving substance, such as gelatin (FIG. 26A to 26B). The orifice diameter, number of orifices, channel width and channel length can be adjusted to control the dissolution parameters. Once the material in the doors and channel is dissolved, there is a free path for the gas trapped in the balloon to escape, eventually resulting in an exhausted balloon. Water can be gastric fluid or internally controlled by including water inside the balloon in the set or during the inflation process. There may be a plurality of inlet openings to ensure transmission of the gas. In addition, there are several variables that can be adjusted to control the dissolution time: size of the entrance openings, number of door openings; internal channel length; internal channel width, and the dissolution rate of the material. The design of the door / channel scheme can ensure that only a small amount of surface area is exposed to moisture at any particular time, thereby controlling the rate of erosion and, ultimately, deflation. In an alternative embodiment, shown in FIGS. 26D to 26E, an expandable material is used to move an impulse component outwards, in order to initiate deflation.
[0198] A preferred embodiment of the manually inflated balloon, which also has a mechanism for self-deflation, would be a door comprising an inflation and deflation mechanism in the same location (see FIG. 27A.). The device comprises a catheter needle sleeve, for example, of nylon or plastic that seals silicone parts, which is attached to the inflation tube during inflation. It also includes a silicone head that seals to the needle sleeve, allowing inflation and separation of the catheter. The silicone head also seals part # 6 until it is pushed out of position by expanding part # 7. The needle, for example, made of stainless steel, inflates the balloon. A compression seal between part # 6 and # 2 expels internal gas when displaced. An insert, for example, of titanium, provides image visibility (FIG. 27B), and provides rigid support for parts # 2 and # 4, and interference locks, sliding fittings and pressure fittings to part # 6. One septum, for example, of silicone, seals part # 3 during inflation. The liner, for example, PEEK or hard plastic, attaches to the outer balloon film and provides a sealing surface for part # 2. This contains openings from inside the balloon out of the balloon after part # 7 expands. The expansion device, for example, polyacrylamide, in a binder material surrounded by a controlled moisture vapor transmission rate material (mixed mixtures of polyurethanes in varying thicknesses) uses the available moisture inside the flask for absorption and swelling in size. The press fit between parts # 5 and # 6 keeps the parts firmly in position until part # 7 starts to expand from moisture absorption.
[0199] In preferred embodiments, the invention includes a self-isolating valve that is compatible with an inflation catheter, which contains a needle and a needle sleeve. The self-insulating valve is sealed to the needle sleeve during the inflation process. Distant to the self-isolating valve is titanium, stainless steel, MP35N, or any other insertion of rigid radio-opaque material that provides visibility of images, as well as mechanical support during the inflation process. Under the insertion is the emptying mechanism which consists of an expansion device. The expansion device consists of a solute material, that is, polyacrylamide or similar material wrapped in a binder material surrounded by moisture limiting material, which has a defined moisture vapor transmission rate (MVTR). Examples of moisture rate limiting material include, but are not limited to, varied mixtures of polyurethanes in varying thicknesses. A hard plastic coating, such as PEEK, includes self-insulating valves, radio-opaque insertion, expansion material, and moisture rate limiting material. The rigid plastic box contains openings that allow fluid to flow between the inside and outside of the balloon if the outer seal is not in position. The radio-opaque insertion is coupled to the rigid plastic housing by mechanical means, such as a pressure fitting, which allows linear movement, but does not allow expulsion from the rigid plastic housing. A second external sealing valve creates an airtight seal for the rigid plastic housing, obstructing the housing openings, and moves linearly as the expansion device gains volume. The moisture placed inside the balloon is absorbed by the expansion device, as well as contributing to the humidity of the external gastric environment. Once the moisture is transferred, the expansion material develops sufficient pressure such that the outer sealing valve is pushed linearly past the edge of the housing. This opens a ventilation path that allows the internal inflation fluid to quickly decompress and deflate the balloon. An empty balloon allows passage through the pylorus and through the rest of the alimentary canal. One or more inflating / deflating ports on the balloon's surface can be used.
[0200] An alternative modality in which the inflating port and deflating port are separate entities, is shown in FIG. 28. The device comprises a seal, for example, of Buna rubber or similar seal material, to provide an airtight seal between parts # 1 and # 3. It slides along the surface of part # 3 until the hermetic seal fails and allows the internal air to come out. Ventilation allows gas to flow from the balloon once the seals move. Also included are a titanium plunger, a water retainer (cotton or sponge-like material that is able to retain water and hold it against the surface of part # 4, in order to maintain a constant humidity environment) and an enclosure PEEK or other rigid material that seals through adhesive to the balloon film and provides rigid containment for parts # 1, 2, 4 and 5. The design also allows ventilation between the internal and external balloon environment, and inlet of water for part # 4, which forces part # 4 to expand in one direction. An expansion device, polyacrylamide in a binder material surrounded by a controlled moisture vapor transmission rate material (mixed polyurethanes in varying thicknesses) uses the available moisture inside the flask for absorption. The device may include a rigid outer shell made of hard plastic or metal, an expansion device consisting of a super-absorbent core surrounded by a moisture vapor rate limiting membrane, and an airtight seal that is capable of move linearly, while the moisture expansion device grows in volume. The expansion device expands at a given rate based on the amount of moisture that is available to it. In order to control the expansion rate, a membrane, such as polyurethane, is used to control the desired moisture vapor transmission rate, which is available for the super absorbent device. The rate of moisture vapor transmission can be adjusted through material formulation or material thickness. In order to maintain constant moisture contact for the moisture vapor limiting membrane, a sponge-like material, such as cotton, can be used as a moisture reservoir for the expansion device. Since the expansion device pushes the seal past the edge of the rigid outer shell, the fluid can be vented from the inside of the balloon to the outside, causing the balloon to empty and pass through the pylorus and the rest of the alimentary canal. . The balloon may have at least one deflation hole, but it may have as many as deemed necessary to deflate the balloon such that it deflates completely and no residual inflation fluid that remains would cause an obstruction in the intestine (i.e., partial deflation).
[0201] A mechanism to facilitate passage involves an erosion mechanism, which allows the balloon to be divided into a size that has a greater probability of predictable passage through the lower gastrointestinal system. Preferably, the size of the deflated balloon is less than 5 cm in length and 2 cm in thickness (similar to several foreign objects of similar size which have been shown to pass predictably and easily through the sphincter of the pylorus). This can be accomplished by providing the balloon with “erodible seams”. A seam that breaks the open balloon into (at least) two halves, or more seams is provided so that a plurality of smaller pieces of the balloon 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 that is necessary to separate the balloon into pieces that are of a size that can predictably pass through the gastrointestinal tract more easily. The rate of erosion of the seam can be controlled by the use of an affected material, for example, by the gastric pH of the external environment, liquid, humidity, temperature, or a combination of them. The seams can be single layer composed only of erodible materials, or multi-layer. The time of self-deflation can also be controlled by the design of the sewing layers, for example, making the reaction and / or degradation of the sewing material dependent on the internal environment of the balloon, instead of the external environment. When manipulating the reaction such that erosion or degradation is initiated internally (for example, the pH of the inner balloon, humidity or other factors), any impact of gastric variability person-to-person (pH, etc.), which may affect erosion time is minimized. The internal environment of the flask can be manipulated by adding excess water at the injection site to create a more humid internal environment, or the amount of additional components can be varied to manipulate the pH, etc.
[0202] The present invention has been described above with reference to specific embodiments. However, modalities other than those described above are also possible within the scope of the invention. Different process steps than those described above can be provided within the scope of the invention. The different characteristics and stages of the invention can be combined in other combinations than those described. The scope of the invention is limited only by the attached patent claims.
[0203] All references cited herein are hereby incorporated by reference in their entirety. To the extent that publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to replace and / or take precedence over any contradictory material.
[0204] Insofar as publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to replace and / or take precedence over any contradictory material.
[0205] Unless otherwise defined, all terms (including technical and scientific terms) must be given their normal and usual meaning for a person skilled in the art and should not be limited to a special or personalized meaning to unless it is expressly defined here.
[0206] The terms and phrases used in this application and variations thereof, unless expressly stated to the contrary, should be interpreted as open-ended as opposed to the limiting one. As examples of the above, the term "including" should be read as meaning "including, without limitation" or similar, the term "comprising", as used here is synonymous with "including", "'containing", or "characterized by" and is inclusive or open-ended and does not exclude additional elements, not cited or steps in the method, the term “example” is used to provide exemplary cases of the item under discussion, not an exhaustive or limiting list of them; adjectives such as "known", "normal", "standard" and terms of similar meaning should not be interpreted as limiting the item described to a certain period of time or to a product available from a given time, but instead , should be read as including known, normal or standard technologies that may be available or known now or at any time in the future and the use of terms such as “preferred”, “preferred”, “desired” or “desirable” and words of Similar meaning should not be understood as implying that certain characteristics are critical, essential or still important to the structure or function of the invention, but rather as merely intended to highlight alternative or additional characteristics that may or may not be used in the particular modality of the invention. invention. Likewise, a group of items related to the conjunction “e” should not be read as requiring that each of these items be present in the group, but should be read as “and / or”, unless expressly stated otherwise. Likewise, a group of items related to the conjunction "or" should not be read as requiring mutual exclusivity between that group, but should be read as "and / or" unless expressly stated otherwise. In addition, as used in this application, the articles “one” and “one” must be interpreted as referring to one or more of one (that is, at least one) of the grammatical objects of the article. For example, “an element” means an element or more than one element.
[0207] The presence in some cases of expansion of words and phrases such as "one or more", "at least", "but not limited to" or other similar phrases should not be understood in the sense that the more restricted case is intentional or required in cases where these broader sentences may be missing.
[0208] All numbers that express quantities of ingredients, reaction conditions and so on used in the specification are to be understood as being modified in all cases by the term "about". Therefore, unless otherwise indicated, the numerical parameters established here are approximations, which may vary depending on the desired properties sought to obtain. At a minimum, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any Claim in any claim that claims priority for the present claim, each numerical parameter should be interpreted with a view to the number of significant figures and approaches of common rounding.
[0209] Furthermore, although the previous one has been described in some detail by means of illustrations and examples for the sake of clarity and understanding, it is evident to those skilled in the art that certain changes and modifications can be practiced. Therefore, the description and examples should not be interpreted as limiting the scope of the invention to the specific modalities and examples described here, but also to cover all modifications and alternatives that come with the true scope and spirit of the invention.

权利要求:
Claims (15)
[0001]
1. System for Inflating Intragastric Balloon, the system comprising: an inflation catheter (820), characterized in that the inflation catheter (820) comprises a needle assembly comprising a hollow needle (1100), a needle-shaped sleeve bell (1000) and a mechanism for separating the inflation catheter (820) after the inflation of an in vivo balloon is completed; an intragastric balloon comprising a polymeric wall, wherein the polymeric wall comprises one or more layers and a balloon valve system (100) comprising a self-insulating septum (114) in a retaining structure, wherein the septum (114) is configured to be punctured by the needle (1100), wherein the retaining structure comprises a concentric valve system with a smaller inner cylinder shell (118 '), the septum (114) and a larger outer cylinder shell (118 ”) , a material (110) that provides compressive forces against the bell-shaped needle sleeve (1000) of the inflation catheter (820) for inflation and separation, wherein the material (110) that provides compressive forces is a durometer material harder than the septum (114) and where the material (110) comprises an edge (110 ') configured for an interference fit with the bell-shaped needle sleeve (1000) to provide valve sealing (100) to the inflation catheter (820) enough to maintain the sealing during balloon inflation; an external balloon container (810); and an inflation source container (1410), wherein the inflation source container (1410) is configured to connect to the inflation catheter (820); wherein the inflation catheter (820) connected to the intragastric balloon prior to inflation is of a size and shape configured for swallowing by a patient in need of it.
[0002]
2. System for Inflating Intragastric Balloon, according to Claim 1, characterized in that the polymeric wall comprises a barrier material composed of nylon / polyethylene.
[0003]
3. Intragastric Balloon Inflating System according to Claim 1, characterized in that the polymeric wall comprises a barrier material composed of nylon / polyvinylidene chloride / polyethylene.
[0004]
4. System for Inflating Intragastric Balloon, according to Claim 1, characterized in that the external container (810) is selected from the group consisting of a pressure plug capsule, a wrapping and a band and in which the external container (810) comprises a material selected from the group consisting of gelatin, cellulose and collagen.
[0005]
5. Intragastric Balloon Inflating System, according to Claim 1, characterized in that the septum (114) is cone-shaped.
[0006]
6. Intragastric Balloon Inflating System according to Claim 1, characterized in that the inflating source container (1410) is configured to connect to the inflating catheter (820) via a connector (1420) or a pressure valve inflation (1470).
[0007]
7. Intragastric Balloon Inflating System according to Claim 1, characterized in that the inflation catheter (820) is from 1 French to 6 French in diameter and is 50 cm to 60 cm in length.
[0008]
An Intragastric Balloon Inflating System according to Claim 1, characterized in that the inflation catheter (820) is a double lumen catheter (920) comprising an inflation lumen (821) and a separation lumen (822) , where the inflation lumen (821) is fluidly connected to the inflation source container (1410) and where the separation lumen (822) is configured for connection to a separation liquid source container, where the separating liquid comprises a physiological compatible liquid and in which the interference fit is insufficient to maintain a seal by applying hydraulic pressure to the separating liquid, such that by applying hydraulic pressure to the needle assembly it is ejected from the valve the balloon (100).
[0009]
9. Intragastric Balloon Inflating System according to Claim 1, characterized in that the inflation catheter (820) comprises a single lumen and a structural member (1120) that provides increased tension resistance and an inflation valve configured to connect the single lumen to the inflation source container (1410) and a separation liquid source container, in which the separation liquid comprises a physiological compatible liquid and in which the interference fit is insufficient to maintain a seal by applying a hydraulic pressure through the separation liquid, such that, by applying hydraulic pressure to the needle assembly, it is ejected from the balloon valve (100).
[0010]
10. Intragastric Balloon Inflating System according to Claim 1, characterized in that the inner cylinder (118 ') is configured to control the alignment of the needle assembly with the septum (114), providing a barrier for the needle (1100 ) that pierces the polymeric wall and provide compression in such a way that the septum (114) seals again after inflation and withdrawal of the needle (1100).
[0011]
11. Intragastric Balloon Inflating System according to Claim 1, characterized in that a plurality of intragastric balloons is connected to a single inflation catheter (820).
[0012]
12. System for Inflating Intragastric Balloon, according to Claim 1, characterized in that the inflation catheter (820) is of variable stiffness (1300).
[0013]
13. Intragastric Balloon Inflating System according to Claim 1, characterized in that the source of inflation comprises a syringe (710).
[0014]
14. Intragastric Balloon Inflation System, according to Claim 1, characterized in that the source of inflation is configured to use information about the inflation pressure as a function of time to provide feedback to a user, where the feedback indicates a condition selected from the group consisting of failure by mechanical block, failure by esophageal restriction, failure by leakage or separation of the inflation catheter (820) and successful balloon inflation.
[0015]
15. Intragastric Balloon Inflating System according to Claim 1, characterized in that the edge (110 ') is silicone and does not protrude beyond the balloon's surface more than 2 mm to ensure that the balloon's surface remains relatively smooth and do not cause abrasion or ulceration of the mucosa.

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法律状态:
2017-02-07| B08F| Application fees: application dismissed [chapter 8.6 patent gazette]|

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2017-04-11| B08G| Application fees: restoration [chapter 8.7 patent gazette]|

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2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-09-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-05-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-07-07| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/01/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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PCT/US2011/022165|WO2012099609A1|2011-01-21|2011-01-21|Intragastric device|

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