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    • 专利摘要:
    abstract medical device for use with a filler material to occupy a space within a patient's body, and medical device for occupying a gastric space within a patient's body methods, devices and systems for administering an assembly of the device into a gastric space or another space within the body, allowing the device to expand to occupy the volume within the gastric space and, after an effective period of time, administering a substance or stimulus to begin interrupting the expanded device so that it can release from the body. 1/1
    公开号:BR112014020188A2
    申请号:R112014020188-9
    申请日:2013-02-21
    公开日:2020-02-27
    发明作者:K Gaur Shantanu；g levy Samuel；Wecker Jonathan；A Horwitz Bruce；Daniel Gwak Jinyoung
    申请人:Allurion Technologies, Inc.；
    IPC主号:
    专利说明:

    MEDICAL DEVICE FOR USE WITH A FILLING MATERIAL TO OCCUPY A SPACE WITHIN THE PATIENT'S BODY, AND MEDICAL DEVICE FOR OCCUPYING A GASTRIC SPACE WITHIN A PATIENT'S BODY
    CROSS REFERENCE TO RELATED ORDERS [001] This order is a non-provisional North American provisional order Nos .: No. 61 / 762,196 entitled Thermally Degradable Biocompatible Constructions and Methods of Degrading filed on February 7, 2013; 61 / 601,384 entitled Swallowed Intragastric Balloon Filled thourugh Narrow Extracorporeal Tube deposited on February 21, 2012; 61 / 645,601 entitled Delivery String for Gastrointestinal Applications filed on May 10, 2012; 61 / 647,730 entitled Hidrogel Driven Valve deposited on May 16, 2012; 61 / 663,433 entitled Fluid Transfer Device for Hydrogel Constructs deposited on June 22, 2012; 61 / 663,682 entitled Hidrogel Driven Valve deposited on June 25, 2012; 61 / 663,683 entitled Fluid Transfer Device for Hydrogel Constructs deposited on June 25, 2012; No. 61 / 674,126 entitled Payload Delivery System and Method deposited on July 20, 2012; and 61 / 699,942 entitled System for Rapid Hydrogel Construct Degradation deposited on September 12, 2012, the entirety of each of which is incorporated herein by reference.
    BACKGROUND OF THE INVENTION [002] The present invention generally relates to the field of devices that temporarily close the spaces within the body to provide a therapeutic effect.
    [003] According to data from the 2010 World Health Organization, 198 million Americans on age
    2/78 of 15 are overweight. Of these individuops, 89 million are considered overweight (25 <Body Mass Index <30) and 109 million are considered obese (Body Mass Index> 30). Worldwide, more than 1.4 billion adults aged 20 and above are overweight, and 500 million are obese. Obesity puts patients at high risk for several potentially disabled conditions including type 2 diabetes, heart disease, cerebral vascular disease, gallbladder disease, musculoskeletal disorders 1,2,3. Compared to healthy-weight adults, obese adults are more than three times more likely to have been diagnosed with diabetes or high blood pressure. In the United States it is estimated that one in five cancer-related deaths can be attributed to obesity in non-smoking women and one in seven non-smoking males (> = 50 years of age). On average, men and women who were obese at age 40 live 5.8 and 7.1 years less, respectively, than their healthy weight peers.
    [004] Gastric bypass surgery is the current gold standard treatment for patients with a Body Mass Index (BMI) greater than 40. Gastric bypass surgery is also an option for those with a BMI between 35-39 with related comorbidities obesity. While gastric bypass surgery results in reduced food consumption and weight loss for most beneficiaries, this requires permanent anatomical changes in life to the gastrointestinal tract and can result in severe complications. Gastric bypass procedures and related surgical procedures are also expensive, costing approximately $ 22,500 (by laparoscopy). Per
    3/78 For these reasons, only approximately 250,000 surgical obesity procedures are performed per year in the USA.
    [005] For most people overweight the obese population in which surgical obesity procedures are not appropriate, few interventions some effective and affordable interventions are currently available. Exercise and diet remain in the frontline approaches to obesity, however this approach has better accepted the growth of the epidemic. To date, drug therapies have side effects that limit the dose or have a significant lack of long-term effectiveness.
    [006] A less invasive intervention that has started to gain popularity is an intragastric balloon. Intragastric balloons can be placed endoscopically or positioned using other methods and generally must be removed by endoscopy or depend on the body's natural digestive processes and processes for removal.
    [007] The devices, methods, and systems discussed here are intended to provide an effect treatment for obesity, yet the devices, methods, and systems described here are not limited to any special patient and can be applied in clinical areas outside of obesity.
    SUMMARY OF THE INVENTION [008] The present invention relates to devices and methods for occupying space within a patient's body. In particular, devices and methods can be used within a gastric space. However, the devices and methods can be used anywhere on the body.
    4/78 [00 9] In a first example, a medical device in the present disclosure includes a device assembly comprising a skin, a fluid transfer member, and a release material, the skin forming a perimeter of the device assembly that defines a reservoir in it, where the release material is coupled to at least part of the skin so that the skin and release material are coupled to create a physical barrier over the reservoir, where the skin is impermeable to liquid and where the limb fluid transfer allows the administration of fluids to the reservoir through the physical barrier; the device set having an installation profile and an active profile, where the installation profile is smaller than the active profile and allows the installation of the device set within a gastric space in the patient's body; a filler material retained within the reservoir by the physical barrier and configured to expand as fluid is administered through the fluid transfer member to cause the device assembly to expand from the installation profile to the active profile so that the device assembly occupies at least part of the gastric space within the patient's body; wherein the exposure of the release material in an exogenous substance opens at least one passage in the physical barrier so that the filling material can pass to the patient's body resulting in the reduction of a size of the installation profile. As noted herein, an exogenous material, substance, and / or stimulus as used herein may comprise any material or substance that is not normally found within the patient's body (or has
    5/78 a condition not normally found within the patient's body, including duration). In most cases, the exogenous material, substance and / or stimuli originate outside the patient's body. In many variations, such an exogenous trigger allows control over the duration of time that the device is located inside the body. In some variations, exogenous material is the fluid used to fill the reservoir initially (for example, a fluid with a certain osmolarity). This benefit is that, as body chemistry varies between populations of potential patients, the use of exogenous triggers reduces the variability in the duration of device placement and improves patient outcomes as a result of the devices, methods, and systems that depend of these exogenous triggers.
    [010] Variations of the devices and methods here may include two possible manifestations: a) the degradation occurs over time, but is strangely controlled by the choice of filler fluid and release material and the initial conditions within the device; and / or b) degradation occurs on demand through the introduction of the exogenous stimulus after installation.
    [011] The fluid transfer member may include any number of components from a single orifice in a skin of the device, in a channel or member per wick. The fluid transfer member can also optionally include a sealable fluid passage.
    [012] In another variation of the device, the fluid transfer member further comprises a channel having a close end and an end of the
    6/78 device, where the end of the channel device is flexible to accommodate swallowing by the patient and the channel is coupled to the passage of the sealable fluid, where a length of the channel allows the administration of fluid to the reservoir when the device set is located inside the patient's body and the near end is positioned outside the patient's body. The device may further include a channel that is detachable from the sealable fluid passage when removed from the sealable passage, wherein the sealable passage is configured to form an effective seal in removing the channel.
    [013] In certain variations, the passage of the sealable fluid is configured to interrupt to be substantially sealed when the device assembly assumes the active profile and the channel is detached from the passage of the sealable fluid.
    [014] A further variation of the device further comprises an elongated channel having a close end and an end of the device, where the end of the device is flexible to accommodate swallowing by the patient, where the passage of the sealable fluid comprises a flexible elongated tunnel that extends from the reservoir to an outside of the skin, where the end of the channel device is removably located within the flexible elongated tunnel structure, so that upon removal of the channel the flexible elongated tunnel structure increases resistance to movement of substances through the formation of a seal.
    [015] The fluid transfer members described here may further comprise one element per wick
    7/78 where a first end of the wick element is in fluid communication with the reservoir and a second end of the wick element extends out of the sealable fluid passage so that when positioned within the patient's stomach, the wick extracts the fluid from the patient's stomach to the reservoir.
    [016] In some variations, the fluid passage is configured to compress the element by wick to seal the fluid passage as the device set assumes the active profile. In additional variations, the element per wick removes the reservoir as the device assembly assumes the active profile so that the fluid passage seals as the filling material expands inside the reservoir.
    [017] Variations of the device include skins having at least one opening and where at least each of the openings is covered by the release material. For example, the release material may comprise a plurality of discrete parts that cover a plurality of openings in the skin. At least a part of the release material can optionally comprise a shape that approximates a shape to the installation profile, reducing the amount of deformation of the release material.
    [018] In additional variations, a part of the skin that defines an opening is mechanically linked together by a part of the release material to close the physical barrier. For example, in certain embodiments, at least two edges of the skin are located inside an assembly of the device.
    [019]
    Devices of the present disclosure may
    8/78 include one or more release materials located within the reservoir so that the release material is physically separated from body fluids.
    [020] The filler material used in any of the devices or methods disclosed here may comprise, when expanded, a semi-solid consistency similar to natural substances within the body.
    [021] The present disclosure also includes methods for temporarily occupying space in a patient's body, such as in a gastric region or other area of the body. Such a method may include providing a device assembly having a channel comprising a flexible end part free of rigid and / or semi-rigid materials to allow swallowing of the device assembly and the flexible end part, where the flexible end part has an end which extends within a reservoir of the device assembly; install the device assembly within the gastric space (where the installation can optionally include directing or inducing a patient to swallow the device); administering a fluid through the feeding tube so that the device assembly expands to an active profile that occupies a sufficient volume within the gastric space to provide a therapeutic effect; and removing the feeding tube from the device assembly allowing the device assembly to self-seal and allowing the device assembly to remain within the gastric space for a period of time. In some variations, installation of the device includes directing a patient to swallow the device assembly while optionally maintaining control of the end near the channel outside the body.
    9/78 [022] The method described here may also include a device assembly that further comprises a liquid impermeable skin material that is coupled with a release material to form a physical barrier, the method further comprising administering an exogenous substance to the gastric space that causes the interruption of the release material and allows the whole of the device to reduce in size.
    [023] The exogenous substance can optionally comprise a fluid having a temperature higher than the body temperature. The exogenous substance can optionally comprise a material that raises a temperature within the gastric space, which causes the interruption of the release material. In additional variations, the exogenous substance may be present in the filler fluid, usually with the intention of causing a delayed but predicted trigger of the release material.
    [024] In another variation of the method, the device assembly further comprises a filler material within the reservoir that expands when combined with the fluid, where administering the fluid comprises administering the fluid until the combination of fluid and filler material expands the assembly device to the active profile.
    [025] Another variation of the method includes installing a plurality of sets of the device so that the plurality of sets of the device occupies a volume to provide the therapeutic effect.
    [026] In an additional variation, a method for temporarily occupying space in a patient's body may include: providing a device assembly having a
    10/78 hydroscopic member extending from an exterior of the device assembly in a reservoir of the device assembly, a filling material located within the reservoir where the device assembly and hydroscopic member can be swallowed by the patient; where after being positioned inside the gastric space, the hydroscopic member absorbs the fluids within the gastric space and administers the fluids to the reservoir so that the fluids combine with the filling material to expand the device assembly in an active profile to the autovedar device; and administering a substance to the gastric space to cause a part of the device assembly to degrade and allow the expanded filling material to escape from the reservoir and pass into the patient's body.
    [027] Another variation of a device of the present disclosure may include a device assembly comprising a skin, a fluid transfer member, the skin forming a perimeter of the device assembly that defines a reservoir therein, where the skin is impermeable to liquid and where the fluid transfer member comprises a flexible elongated fluid passage that allows the delivery of fluids to the reservoir; the device set having an installation profile and an active profile, where the installation profile is smaller than the active profile and allows to position the device set inside the patient's body by swallowing the device set; a filler material retained within the reservoir and configured to expand as the fluid is administered through the fluid transfer member to cause the device assembly to expand from the installation profile
    11/78 to the active profile so that the device assembly occupies at least a part of the gastric space within the patient's body; and an elongated channel having a near end and an end of the device, where the end of the device is flexible to accommodate swallowing by the patient, the elongated channel configured to deliver fluid through the fluid transfer member, where the device end of the channel it is removably located within the flexible elongated fluid passage, so that when removing the channel the flow resistance of the flexible elongated fluid passage is sufficient to prevent the filler material from escaping.
    [028] In another variation, a medical device to occupy a space within a patient's body comprises a device assembly comprising a skin, a fluid transfer member, and a release material, the surface layer forming a perimeter of the the device assembly that defines a reservoir therein, where the release material is coupled to at least part of the skin so that the skin and release material form a physical barrier over the reservoir and where the fluid transfer member comprises a flexible elongated valve extending into the reservoir; a channel having a close end extending outside the perimeter of the device assembly and an end of the flexible device extending through the flexible elongated valve, the end of the flexible device having a conformity to allow swallowing of the end of the device and device assembly; a filling material retained inside the reservoir by the physical barrier and configured
    12/78 to expand as fluid is administered through the fluid transfer member to cause the device assembly to expand from an installation profile into an active profile so that the device assembly occupies at least part of the gastric space inside the patient's body in the active profile; wherein the end channel of the device is removable from the flexible elongated valve upon assuming the active profile, where in removing the device end from the flexible elongated valve, a flow resistance of the flexible elongated valve prevents the filler material from escaping through it; and in which exposure of the release material to a substance not naturally produced in the body stops the release material in a predictable manner and opens at least one passage in the physical barrier.
    [029] Another variation of a medical device to occupy a gastric space within a patient's body comprises: a device assembly comprising a skin and a fluid transfer member, the surface layer forming a perimeter of the device assembly that defines a reservoir in it; a channel having a close end extending outside the perimeter of the device assembly and an end of the device extending through the fluid transfer member so that the channel is in fluid communication with the reservoir, wherein the channel comprises a hydroscopic material which pulls fluid from the gastric space to the reservoir; and a filler material retained within the reservoir by the physical barrier and configured to expand as the fluid is administered through the
    13/78 fluid transfer to cause the device assembly to expand from an installation profile to an active profile so that the device assembly occupies at least part of the gastric space within the patient's body in the active profile, where in the active profile, the expanded filling material causes the closing of the fluid transfer member to prevent the channel from pulling fluid to the reservoir.
    [030] In yet another variation, the entire skin can comprise a release material so that an exogenous trigger causes the interruption of every device to begin the interruption process.
    [031] Another variation of a device to occupy a space within a patient's body includes a device assembly comprising a skin, a fluid transfer member, and a release material, the skin forming a perimeter of the device assembly that defines a reservoir in it, where the release material is coupled to at least part of the skin so that the skin and release material are coupled to create a physical barrier over the reservoir, where the skin is impermeable to liquid and where the limb fluid transfer allows the administration of fluids to the reservoir through the physical barrier; the device set having an installation profile and an active profile, where the installation profile is smaller than the active profile and allows the installation of the device set within a gastric space in the patient's body; where fluid enters the reservoir it causes the device assembly to expand from the installation profile to the active profile so that the device assembly occupies at least part of the gastric space
    14/78 inside the patient's body; and in which the application of an exogenous substance opens at least one passage in the physical barrier these fluids leave the reservoir resulting in the reduction of a size of the installation profile.
    [032] The devices described here can also be used for the administration of drugs, pharmaceuticals, or other agents where these items can be administered on a device skin, inside a reservoir, in a device filler, or anywhere on the device . Such agents can be released over time.
    [033] The above features and other features of the invention including various details of novelty of construction and combinations of parts, and other advantages, will now be more particularly described with reference to the accompanying drawings and indicated in the claims. It will be understood that the particular method and device incorporating the invention is shown in the form of an illustration and not as a limitation of the invention. The principles and characteristics of this invention can be employed in various embodiments without departing from the scope of the invention.
    BRIEF DESCRIPTION OF THE DRAWINGS [034] Objects, characteristics and advantages of the methods, devices, and systems described above will be evident from the description together with the attached drawings, in which the reference characters refer to the same parts in all different views . The drawings are not necessarily to scale; the emphasis was placed on illustrating the principles of the invention. From the drawings:
    15/78 [035] Figure IA, illustrates an example of a set of the gastric device before assuming an active profile.
    [036] Figures IB and 1C show partial section views of examples of device assemblies for use in occupying space within a body.
    [037] Figure 1D illustrates the variation of the device shown in figure IA as the device set assumes an active profile.
    [038] Figure 1E shows a set of the device after it is inflated, expanded, or otherwise transacted to achieve a desired active profile.
    [039] Figure 1F illustrates a state of a device assembly after a doctor, patient, or other caregiver wishes to initiate the release of the device assembly from the body.
    [040] Figure 2 shows an assembly of the device or construction in an active or hydrated profile whose outer skin defines a material or pocket reservoir.
    [041] Figures 3A to 3E illustrate additional variations of device sets 100 having several active profiles.
    [042] Figure 4 illustrates a variation of a fluid transfer member also having a passage
    of the fluid sealable For use with device sets described on here. [043] The figure 5 shows a variation of one tunnel valve.[044] The figure 6A illustrates a partial view of
    16/78 a variation of an invaginated section of a skin of an assembly of the device.
    [045] Figures 6B and 6C illustrate a partial view of the interior of a device assembly comprising an invaginated section of the skin still having an energy storage element that assists in opening the device in response to an exogenous trigger.
    [046] Figure 6D provides a schematic illustration of another example of a device assembly having a release material located on a skin surface.
    [047] Figures 7A and 7B show an example of an enlarged view of that of a device assembly.
    [048] Figures 8A and 8B show an additional variation of part of a device assembly that provides control over the fluid-permeable passage through the impermeable material surface.
    [049] Figure 9A shows another aspect of devices as described here comprising one or more fluid transport members.
    [050] Figure 9B also illustrates a device having an administration system attached to it.
    [051] Figures 10A and 10B show an example of a valve driven by the expansion of filling material within a reservoir of the device assembly.
    [052] Figures 10C and 10D show another variation of a valve.
    [053] Figure 10E shows a hybrid valve in which each layer of hybrid flow control is generally
    17/78 rectangular and the impermeable and permeable region are triangular.
    [054] Figure 10F shows an enlarged view of a valve assembly, a permeable region in an individual flow control layer can be, for example, a circular region, and the impermeable region can be a ring arranged around the region circular permeable.
    [055] Figure 11A illustrates another variation of a device having a fluid transport member comprising a fluid wick extending into a reservoir of the device.
    [056] Figure 11B shows the outer segment of the liquid wick structure immersed in a liquid that causes the liquid to be extracted into the absorbent wick material of the liquid wick structure and still extracted from the wet wick.
    [057] Figure 12A shows an exemplary embodiment of the liquid wick structure fluidly coupled to a secondary inner pouch, pouch or other container.
    [058] Figure 12B illustrates another embodiment of a device having several liquid wick structures.
    [059] Figure 12C shows an interior segment of a single liquid wick structure that is divided into two or more subsegments.
    [060] Figure 12D shows a wick structure fixed to a part of the interior of the reservoir.
    [061] Figure 13A illustrates a variation of a tunnel valve as discussed above which forms a passage of the sealable fluid preventing material from escaping from the inside.
    18/78 of the device.
    [062] Figure 13B shows a cross-sectional view of the tunnel along line 13B-13B of figure 13A.
    [063] Figure 13C shows the closure of the tunnel.
    [064] Figure 14 shows an assembly of the compressed device to fit within an oral dosage form such as a pill, capsule, sleeve, or other shape that improves the ability to position the device through ingestion or swallowing without the help of another medical device.
    [065] Figure 15A shows hydrogels comprised of either cross-linked polyacrylic acid or cross-linked polyacrylamide, materials that are widely used in medical device applications.
    [066] Figure 15B shows cross-linked polyacrylic acid or cross-linked polyacrylamide, materials that are widely used in medical device applications.
    [067] Figure 15C describes the swallowing performance of a superporous hydrogel of chitosan / polyvinyl alcohol in solutions with different pHs.
    DETAILED DESCRIPTION OF THE INVENTION [068] The following illustrations are examples of the invention described here. It is observed that combinations of aspects of the achievements or specific combinations of the specific achievements themselves are within the scope of this disclosure. While the methods, devices, and systems described here are discussed as being used in the stomach or gastric space, the devices, methods, and systems of the present disclosure can be used in other ways.
    19/78 parts of the body where temporary occlusion of a space may be necessary or useful. The present disclosure relates to what is generally attributed to North American Order No. 2011/0295299 filed on March 2, 2011, all of which is incorporated by reference.
    [0 69] Figure 1A illustrates an example of a gastric device assembly 100. In this example, the gastric device assembly or construction 100 may reside in a stomach (typically from a mammal) for an extended period of time. A benefit of this device is that, when partially or completely installed, construction 100 occupies the volume inside the stomach to produce a therapeutic effect, for example, to stimulate the feeling of satiety, and resists the passage of the body by normal body function. As illustrated below, the construction generally comprises three states: a pre-installation configuration (figure IA); an installed or active configuration (figure ID, 1E); and a release configuration (figure 1F). As noted above, the device can also be used for therapeutic benefits that do not involve the volume of occupation (for example, administration of the drug, creation of a cavity separating the adjacent tissue, etc.).
    [070] Figure IA illustrates a variation of device 100 after placement within a stomach 2. As described here, the initial configuration of device 100 includes a compact state that allows placement within the body. The device can be in a pill type configuration or any other form that allows swallowing. Alternatively, device 100 can be positioned by the
    20/78 use of a scope, catheter, or other medical positioning device.
    [071] For a device used in the digestive tract / gastric space, the device set 100 can be positioned inside the body either by natural ingestion or the use of a delivery system (such as a catheter, endoscope, or other medical device). The delivery system may optionally comprise an oral dosage form, not shown, which facilitates the ingestion of a relatively large object. In other embodiments, the system comprises a rope that allows the manipulation or control of the construction placed outside the body. The set 100 can also be placed in the stomach for more invasive surgical procedures or endoscopic procedures.
    [072] In figure IA, device 100 is shown shortly after being installed inside stomach 2 and is ready to be activated. As noted here, device 100 can be installed in the configuration shown. Alternatively, the device can be contained within a capsule or capsule-like coating that allows swallowing by a patient. Once swallowed, the coating will readily dissolve or break resulting in the configuration shown. Once in place in the stomach, the set 100 begins to expand in order to occupy volume / space within the body. Expansion can occur through manual inflation, including hydration or other activation of a filling material (as shown optionally using a catheter, inflation tube or other delivery system), through the absorption of body fluids, through the remote activation of a substance already located within the set of
    21/78 device, and / or administration of a fluid to the set, where the fluid itself causes the expansion. Variations of the device also include a combination of these expansion means.
    [073] The variation shown in figure IA includes a member 110 that extends from device 100 outside the patient. In this variation shown, member 110 comprises a fluid transport member that is fluidly coupled to an interior of device 100 allowing administration of substances and / or fluids within device 100. Figure 1A shows an exemplary fluid source 90 that can be coupled to a variation of a fluid transport member 110 so that fluid delivery causes a filler material 108 within the device to expand. In the illustrated example, the fluid transport member comprises a channel. However, alternating variations of the devices described here include fluid transport members that reside within the patient's body. Alternating variations of the device 100 also include members 110 that function as delivery or positioning systems to ensure correct placement of the device 100 within the body. These delivery systems may or may not be fluidly coupled to an interior of the device. In the variations discussed below, the device may include one or more fluid transport members that remain within the body, but still conduct fluid to device 100 to allow the device to assume an active profile.
    [074] Figure 1B shows a partial sectional view of an example of a device assembly 100 for use in the occupancy space within a body. In this variation,
    22/78 the device assembly 100 includes a surface of the material or skin 102 that forms a reservoir or pocket 104 that can hold a variety of substances, including, but not limited to, fluids, solid substances, semi-solid substances, etc. In the illustrated variation, reservoir 104 supports a filling material 108 as dehydrated hydrogel granules which can increase in size in addition to a fluid. However, any number of substances can be contained within reservoir 104. Alternating variations of the device and / or method include assemblies that do not include a filler; other filling material can be deposited within the reservoir 104 once the assembly is installed. Alternatively, or in combination, the reservoir can be filled with a gas, liquid or other gel-like substance.
    [075] In other variations, the device assembly 100 may include an empty reservoir that can be installed in the body and subsequently filled with a filling material or other substance. For example, these variations may include a liquid filling material that is delivered to the reservoir through a channel. The volume of liquid required to expand the device to a desired active profile can be predetermined. In some variations, the volume can be determined by measuring the back pressure in the channel or pressure inside the reservoir using any number of pressure sensing elements.
    [076] Figure 1B also illustrates a variation of a sealable fluid passage 112 coupled and / or forming part of the fluid transfer member. In this example, the
    23/78 sealable fluid passage 112 extends outside the skin perimeter 102 of device 100. Additional variations of device 100 may include significantly shorter sealable fluid passages 112. In other additional variations, device assembly 100 may omit the passage of the sealable fluid 112.
    [077] As noted here, skin 102 includes a release material 10 6 coupled to it, where release material 106 allows the release of body assembly 100 to begin shortly after degradation, activation, or interruption of the release material. Once the device set 100 is in the active profile, it can remain in the active profile for a predetermined period of time or until the patient has a desired therapeutic effect. To initiate the release of the device assembly 100 from the body, an exogenous material, substance or stimulus is administered to the patient. The substance can comprise a fluid or other activating agent having properties that act directly or indirectly on the release material to break the barrier and allow the contents of the reservoir to be exposed to the body. For example, the exogenous substance may comprise a heated fluid that melts the release material. Alternatively, the exogenous material can change a temperature and / or acidity of fluids in the stomach so that the improved properties of the fluids begin to act, both directly and indirectly, on the release materials. In additional variations, the release material may comprise a material or materials that effectively form a barrier as discussed here and are separated or disengaged by the use of an exogenous stimulus (for example,
    24/78 magnetic field, ultrasound, IR heating, coherent light, electromagnetic signals, microwave field, etc.).
    [078] Figure 1B also illustrates a variation where the release material 106 is in the shape that approximates the shape and / or size of the liner used to administer the device 100 (in this example the release material 106 is in a pill form) . A benefit of this configuration is that the release material 106 can be positioned within the liner without excessive bending or tilting.
    [079] Figure 1C illustrates a cross-sectional view of another variation of an assembly of device 100. In this variation, the release material 106 connects or otherwise joins the edges of the skin from inside the reservoir 104. Such a configuration protects the material from release 106 of the local environment of the body (for example, fluids within the stomach or digestive tract). The release material can also be activated and / or degraded by adding the exogenous material to the body as described here. However, positioning the release material within the reservoir allows the skin 102 to serve as an additional layer of protection to prevent inadvertent release of the device assembly 100. The release material 106 may comprise a layer that connects the edges of the skin together.
    [080] Figure 1C also illustrates a variation of a sealable fluid passage 112. In this example, the sealable fluid passage 112 does not extend outside the perimeter of the skin 102. Additional variations of device 100 may include significantly sealable fluid passages shorter 112. Even in the additional variations, the device set 100 may omit the
    25/78 passage of the sealable fluid 112.
    [081] Figure 1D illustrates the variation of device 100 shown in figure IA as the set of device 100 assumes an active profile. An active profile includes any profile far from the installation state and where the profile allows the device to achieve the desired effect of the volume of occupation or space within the body to produce a therapeutic effect. In the illustrated example, a doctor or other healthcare professional administers the fluid through the fluid transport member 110, comprising a channel 114 in this variation, and to the reservoir 104 causing a filler material 108 to increase. As noted here, other variations include device assemblies without filler where channel 114 simply delivers fluid and or other substances that allow the device assembly to reach an active profile.
    [082] When using a channel 114 that extends outside the body, a doctor can administer a moisturizing liquid, such as water or distilled water through channel 114. Generally, a predetermined volume of liquid can be manually or mechanically pumped at the outer end of the channel in which the volume of liquid is predetermined based on a particular size of the device assembly or based on a desired active state. In some variations, the volume of liquid may also depend on the length of the channel.
    [083] Channel 114 can be used to transfer a substance to reservoir 1014 of the device. In the illustrated variation, channel 114 transfers fluid from outside the patient's body to reservoir 104 after
    26/78 the installation of the device assembly 100 inside the body. Alternatively, or in combination, a fluid transfer member may comprise a wick-like device that transfers liquids or other fluids from within the body to the reservoir.
    [084] Figure 1E shows the device set 100 after it is inflated, expanded, or otherwise transacted to achieve a desired active profile. A physician can monitor the profile of the device assembly 100 either using a scope positioned inside the stomach (not shown) or the non-invasive image such as an ultrasound image or a radiograph. Alternatively, or in combination, the active profile can be obtained after a predetermined volume of fluid, liquid and / or gas is administered to reservoir 104. In addition, variations in the device may include one or more markers (such as radiopaque markers) 116 allowing a physician to determine the orientation and / or size of the device assembly 100.
    [085] As noted above, this particular variation of the set 100 includes a channel 114 that is coupled to the skin 102 through the passage of fluid 112 and extends to reservoir 104. Alternatively, a channel 114 can be directly coupled to the skin. When the device assembly 100 reaches the active state, channel 114 can be pulled from device assembly 100. For these variations that employ a sealable fluid passage 112, removal of channel 114 causes the sealable fluid passage 112 to interrupt or compressed in this way preventing the contents of the reservoir 104 from escaping from the device assembly 100. Alternatively, or in combination, the passage of the fluid
    Sealable 27/78 112 located inside the reservoir 104 can be sealed due to the high pressure inside the reservoir. In other words, the same pressure inside the reservoir 104 that causes the expansion of the device 100 also causes the passage of the sealable fluid 112 to close compress or otherwise reduce in diameter to a sufficient degree that the material cannot escape from the reservoir through the passage of the sealable fluid 112.
    [086] In certain variations, channel 114 is held in place when the sealable fluid 112 passes through the friction itself. Removal of the channel occurs by pulling on the channel in a direction away from the device 100. During the early stages of this removal activity the expanded device 100 generally moves upward with the channel in the stomach, until the expanded device 100 reaches the esophageal sphincter. With the device assembly contained from the upward movement by the sphincter, the channel 114 can then be removed from the fluid and patient passage by the additional tractive force.
    [087] When removing channel 114, the fluid passage effectively seals, as described here, and prevents the migration of fluids or other substances in and out of the reservoir. In certain variations, the passage of the fluid is blocked after the removal of a channel or other member located in it. In additional variations, the hydrostatic pressure and / or pressure caused by the expanded filler acting along the length of the fluid passage can assist in sealing the fluid passage.
    [088] Figure 1F illustrates a state of the device assembly 100 after a physician or patient wishes to initiate the release of the device assembly 100 from the body.
    28/78
    As discussed above, an exogenous material 120 is administered in the stomach (or another part of the body as applicable). As the exogenous material 120 (or exogenously activated body fluids) engages the release material 106, the release material rules the conditions with the exogenous material and begins to degrade, melt, break, or otherwise become unstable so that the physical skin barrier 102 is compressed. As noted above, additional variations of the devices can be used with an exogenous stimulus in place or in addition to an exogenous material. For example, the exogenous substance can directly act on the release material as providing a substance at an elevated temperature and / or pH level that causes the interruption of the release material to allow the filling material to interact with the fluids in the stomach and / or pass from the reservoir to the stomach. Alternatively, exogenous material can interact with fluids within the body to directly or indirectly activate and / or degrade the release material.
    [089] In alternating variations, the release material, or additional areas of the skin degrade or become unstable due to the passage of time in the normal gastric environment. In these cases, the additional areas can serve as a security mechanism to guarantee the release of the device after a predetermined period of time. For example, in the variation shown in figure 1F, one area of the release material 106 may be reactive to exogenous stimulus or exogenous materials while the other release material 106 may break down over time. Alternatively, or in combination, as shown in figure 1F
    29/78 an exogenous stimulus can be used in combination with exogenous material 120 to cause interruption of the release material. In another variation, the exogenous stimulus 130 can be used to act directly on the release material 106 (without any exogenous material) to cause the release material 106 to stop and begin the process of releasing the patient's device assembly 100.
    [090] Figure 1F illustrates the filling material 108 escaping from the reservoir 104 as the assembly of the device 100 reduces its active profile to allow the passage of the skin 102 and the filling material 108 of the body. In certain variations, the consistency of the outlet filler material 108 is similar to or similar to the consistency of a food cake. The combination of the consistency of the filler material in the naturally occurring particles that travels within the body facilitates the passage of the filler material 108 through the rest of the digestive tract. In certain situations, the instability or degradation of the release material 106 allows the body fluids to mix with the contents of the reservoir 104, which liquefies the filling material and accelerates the reduction of the device set 100 of an active profile or state. Although not shown, as the device assembly reduces in profile, the peristaltic movement of the muscles in the digestive tract works to expel the materials out of the device 100, allowing the skin 102 of the device 100 to pass through the digestive tract until it is finally excreted from the body. Certain variations of the device assembly can be made to have a light, lubricable and / or pliable configuration to assist
    30/78 in the passage through the gastrointestinal tract.
    [091] Figures IA to 1F are intended to illustrate variations in devices and methods for occupying space within a patient's body, especially devices for use within a gastric space. However, the principles described above can be used with any number of variations of the device as described below. As noted here, combinations of different variations of devices, as well as combinations of aspects of these variations are considered to be within the scope of this disclosure where these combinations do not contradict each other.
    [092] In the embodiment shown in figure 2, construction 1000 is in an active or hydrated profile and comprises a generally flattened spherical structure whose outer ρθΐθ defines a material reservoir or pocket 1010. Reservoir 1010 is connected by a surface of the material or skin thin and flexible 1013 that involves an interior volume 1015 to retain the substances that keep the construction in the active profile. In this variation, the reservoir 1010 contains a filling material 1200, which can be a liquid or semi-solid or gel-like material. In general, the volume of filling material 1200 is initially low, that is, when construction 1000 is in its initial pre-installation condition. The volume of filler 1200 increases after installation of the construction. Construction 1000 in figure 2 illustrates the fully expanded or active state, but only for clarification a representative part of the filler 1200 is shown.
    [093] The transition from state building has not
    31/78 initial expansion 1000 to the active state can be carried out by increasing the volume of the filling material 1200 closed in the reservoir 1010. Additionally, the volume can be expanded by expanding and / or swelling the filling material already inside the reservoir 1010. For example, as described in the generally assigned US patent application publication number US2011 / 0295299, a filler material of exemplary embodiment 1200 in the initial state is a predetermined volume of dry hydrogel granules. Dry hydrogel granules may swell, for example
    example, in between 10 and 400 times the your volume dry When exposed to a liquid appropriate, usually an solution watery. [094] At variation shown in figure 2, once
    As the healthcare professional or user installs construction 1000 in the stomach, the aqueous liquid in the stomach migrates to reservoir 1010 and creates a substantially fully hydrated liquid and hydrogel paste. As is well known, hydrogels absorb water from their surroundings causing swelling of the hydrogel. In the realization of figure 2, the volume of dry hydrogel is pre-selected to have a completely swollen unchecked volume that slightly exceeds the volume of the 1010 reservoir. Under restriction, hydrogels cannot swell to a greater volume than the volume limits. restriction; however, retracted hydrogels can and do exert pressure against the restriction. Thus, reservoir 1010 becomes a structurally independent structure when filled with an excess of swollen hydrogel (i.e., when the limited volume of the swollen hydrogel is greater than the closed interior volume 1015). In other achievements, the
    32/78 reservoir 1010 is filled and pressurized with another filler. In its expanded state, reservoir 1010 may be sufficiently elastic to deform under external pressure and return to its pre-deformation form when pressure is removed. In other additional variations, the filler material can be selected so that it hardens after a period of time to become its own skeletal structure or to support the skin. Such filler can be selected to eventually degrade based on the environment in the stomach or digestive tract.
    [095] Sets 1000 in the present disclosure may comprise a surface of the material or skin 1013 which is substantially impermeable to liquids and / or gases. In these embodiments, the filling material 1200 can be a liquid or a gas, respectively. In addition, filler 1200 may be a fluid-expandable material such as hydrogel, which, when hydrated, becomes a solid, semi-solid or gel of the fluid or paste type. As shown in Figure 2, the embodiments comprising a substantially impermeable skin 1010 still comprise a fluid transport member 1100 that allows fluid to migrate through the skin. In some examples, as noted above, the fluid transport member includes a sealable fluid passageway that may or may not be coupled to an additional fluid channel. In further variations, the fluid transport member may include a located liquid transfer member 1100 which is arranged in an orifice 1020 through the skin 1013 and facilitates the migration of the fluid between the inside and outside of the reservoir 1010. One of this example can be found in the provisional patent application
    33/78
    North American with the title Resorbable Degradation System serial number 61 / 723,794 deposited on 11/08/2012, all of which are incorporated by reference.
    [096] As noted above, in certain variations, where the device assembly 1000 comprises a material surface substantially impermeable to the fluid, a construction 1000 in the expanded active profile may remain in the stomach or other body part indefinitely until released. Thus, as noted above, the devices of the present disclosure may include material
    1400 release, what allow the construction 1000 for reduce the size of the active profile and finally pass fur body. Such material configuration release active 1400 allows release under demand construction. According noted above, a turn activated, degraded, or in another way made unstable , O material release allows the
    migration of the filling material from the reservoir and device assembly. In some variations, activation of the release material opens a passage in the skin 1013 of the device 1000. Alternatively, or in combination, activation of the release material can result in reduced skin integrity forming the barrier over the reservoir. Once the barrier is compromised, the filling material can safely pass through the body. Regardless of the means, the activation of the release material and release of the filling material interrupts the device 1000 leading to the exit or removal of the device 1000 through the body (in this variation through the lower gastrointestinal passage). As noted above, variations on the devices described here include a release material that is activated by exposure
    34/78 in an exogenous substance.
    [097] In certain variations, the device set 1000, in the active profile, comprises a highly flattened spheroid in which the skin 1013 can be a thin film type material that is soft, tear resistant, flexible, substantially inelastic, and not self-adhesive. These characteristics can be useful for a device that must be compressed into a small oral dosage form for administration. In certain examples, skin 1013 comprised a 0.0015 inch thick polyurethane / polyester film. In a simple variation, a flattened spheroid can be created from the skins forming a surface of the upper material and a surface of the lower material, where the surface of the upper material and the surface of the lower material are sealed together as shown by junction 1004 in figure 2. One of this means for sealing the device 1000 comprises an ultrasonic welding around the periphery of the joining materials. As will be described in more detail below, in a possible method of assembly, the surfaces of the lower and upper material are formed as nominally identical, substantially disk-shaped material shapes, welded in a band around most of the circumferences, the set it is then inverted (turned inside out) through a non-welded section. Once the set is inverted, the welded material forms the junction 1004 that it protects.
    [098] Figures 3A to 3E illustrate additional variations of device sets 100 having several active profiles. It is understood that the shapes shown in the illustrations shown here are examples of possible
    35/78 variations of the device. Figure 3A illustrates a device 100 having a thread shape (i.e., a flattened shape with an opening 103 within or near a center of the device assembly 100). Figure 3B shows an assembly of the device 100 having a rectangular or square shape. Figure 3C illustrates a triangular-shaped assembly of device 100. Again, the illustrated variation includes an optional opening 103. Some variations may have a contiguous surface, while others may incorporate one or more openings 103 as shown. Figure 3D illustrates an assembly of device 100 having a shape comprising a plurality of protrusions 132 that form the assembly of device 100. The number and direction of protrusions may vary from those shown. Figure 3E shows a variation of an assembly of device 100 having an increasing shape.
    [099] The devices shown in figures 3A to 3E also show the release materials 106, whether located inside an opening 103 or outside the form. The variations shown in figure 3A to 3E may also include the additional characteristics of the device assemblies described here.
    [0100] Alternatively, the release material may comprise a filament, clamp, band, cover, or other structure that mechanically closes the edges of the skin. Also, as described below, a stored energy source, such as a spring-loaded or compressed sponge or other material, can be included in the release set, where this kinetic energy is also released upon activation of the release material and which can improve the performance of this set.
    36/78 [0101] Figure 4 illustrates a variation of a fluid transfer member 1100 also having a sealable fluid passage 1110 for use with the device assemblies described here. In this example, the fluid transfer member 1100 also includes an elongated fluid channel, or tube, that passes through a tunnel valve that functions as a sealable fluid passage 1110. The tunnel valve 1110 can be positioned in a hole in the top surface 1014 or less 1016 of the materials or in an opening at a junction 1004 of the device assembly. This variation of the tunnel valve 1110 comprises an elongated part 1022 which extends within the reservoir of the device assembly. In some variations, the tunnel valve may extend beyond junction 1004 or beyond the outer surface of the device assembly as discussed above.
    [0102] As shown in figure 4, the fluid transport member part includes a tunnel valve 1110 which can comprise two layers forming an orifice 1020. The orifice 1020 forms a fluid passage that allows the rest of the fluid transport member fluid 1100 administer the fluids to the reservoir. In this variation the fluid transport member 1100 still comprises a channel. However, as noted herein, the fluid transport member may comprise a wick-type device or any fluid source that allows fluid to be delivered to the device reservoir. As is further noted here, a variation of the device allows a portion of the fluid transport member 1100 to be detachable from the tunnel valve 1110 where the landing allows the tunnel valve 1110 to prevent the outlet of fluids or other substances
    37/78 from inside the reservoir. The sealing of the 1110 tunnel valve can occur through an increase in pressure inside the reservoir. Alternatively, or in combination, a number of other mechanisms can result in the sealing or closing of orifice 1020 in the tunnel valve 1110. For example, in additional variations the surfaces forming the orifice 1020 can seal under the contact or length of the tunnel valve. 1110 combined with its flexible nature can simply make it difficult for substances, such as an expanded hydrogel, to travel through the elongated part 1022 of the tunnel valve.
    [0103] Figure 4 also shows channel 1100 extending through tunnel valve 1110 so that it extends to the reservoir. However, in alternating variations, the device end of channel 1100 may remain within an orifice 1020 of tunnel valve 1110.
    [0104] In a variation of the tunnel valve 1110, as shown in figure 5, the tunnel valve 1110 formed approximately as the uppercase letter T, in which the vertical stem of the T comprises the elongated passage 1022 and in which the crossbar of the T, in part, it forms a raised fixation surface that can be attached to the skin as noted above. As can be seen in figure 5, the tunnel valve 1110 can be arranged through an opening at junction 1004.
    [0105] Some examples of materials used to form a tunnel valve include thin film type materials. For example, variations include tunnel valve materials that have properties similar to the material used on the surface of the material or skin of the device.
    38/78
    Additional materials include, but are not limited to, polyurethane, nylon-12, and polyethylene. These layers can be between, 001 '' and 0.1 '' thick. In one example, a tunnel valve included a thickness of, 0015 '' [0106] As discussed above, variations of a device assembly include a release material that is attached to a part of the skin to form a barrier to retain substances within a reservoir of the device. Figure 6A illustrates a partial view of a variation of an invaginated section 126 of a skin 102 of a device assembly 100. As discussed here, skin 102 can include a first surface 122 and second surface 124 joined at a joint 118. Junction 118 can include any number of split sections that are directed to function as release areas 128. In the illustrated example, release area 128 is connected by an invaginated section 126 of skin 102. Invaginated section 126 of skin may comprise a pique, fold, pucker, overhang, extension, etc. on the skin 102. Alternatively or
    additional, the invalid section 126 can be formed within in a first 122 or second instead of inside a junction 124118. skin surface 102 to [0107] The area in section release 128 invaginated 126 normally forms a passage that is fluidly sealed by a release material 106. 0
    release material may comprise a mechanical closure (such as a clamp-like structure or a filament that associates with the damaged structure). Alternatively, or in combination, the release material 106 may comprise a temporary seal or other junction of the edges of the section
    39/78 invaginated 126. In additional variations, the release material may extend outside an outer skin surface. In some variations, the release material 106 is disposed on the invaginated part 126 sufficiently close to the skin to be affected by an increase in temperature caused by the administration of the exogenous substance.
    [0108] Other variations of a device assembly 100 include an energy storage element that encourages a quicker and more complete opening of release area 128. Figure 6B illustrates a partial view of the interior of a device assembly 100 comprising a section skin 126. As discussed in relation to the variation in figure 6A, the release material 106 in this variation forms a temporary seal tying the invaginated section 126. In this variation, an energy storage element 127 is disposed within the invaginated section 126 of the release area 128 and is further arranged to be within the region tied with the release material 106.
    [0109] The energy storage element 127 is generally a compressible elastic material, for example, a latex foam. In some variations, the energy storage element 127 is generally cylindrical with a diameter at least fractionally smaller than the diameter of the invaginated section 126. As shown in figure 6A, when the device 100 is installed in the body, the release material 106 is tied tightly around the invaginated section 126 in the position of the energy storage element, thus simultaneously sealing the invagination and compression of the energy storage element. It is
    40/78 compression of the elastic material in the energy storage element 127 generates a tension in the release material tied around the invaginated section 126 which is greater than the tension in the loop of the release material used to seal an invagination alone.
    [0110] Figure 6C illustrates the invagination section 126 after an exogenous trigger was used to activate the release material 106. As shown in the figure, the release material is broken into several small segments, allowing the invaginated section 126 to open and release the filling material, not illustrated for clarification. The high stress generated by the energy storage element encourages the release material to break faster, faster and more completely than it would otherwise.
    [0111] Examples of the release material may include polycaprolactone or PCL. In these variations, PCL softens, melts and weakens the above predetermined temperature. In some cases the predetermined temperature is higher than the normal body temperature. Certainly, in these variations, the exogenous substance can comprise a heated fluid that can increase the temperature of the PCL without causing damage to the adjacent areas of the body. As the PCL release material degrades, the structural integrity of the bonded region of the release section (such as the invaginated section 126) is reduced. In one example, the release material is a modified PCL, where the modification comprises reducing the melting point of unmodified PCL from its normal melting temperature to a tolerable human temperature.
    [0112]
    For example, a degradation construction
    41/78 on-demand made of nylon-12 can be constructed first by making a 1.5 '' Pollethane circular ring, also known as 55DE Lubrizol 2363 polyurethane polyester (available from Specialty Extrusions Inc. of Royersford, PA, USA). A circular degradable polycaprolactone (PCL) stain (with a melting point, T m , equal to ~ 47 ° C; available from Zeus Industrial Products of Charleston, SC, USA) can be RF welded on the Pellethane ring, covering the orifice, creating a T m modified PCL stain surrounded by a Pollethane ring. The Pollethane ring can then be RF welded on a nylon-12 blade, which can then be used for another construction.
    [0113] Examples of release materials can include manufactured biocompatible polymers. Table 1 is a compilation of some pertinent properties of various biocompatible materials that can be extruded or otherwise made into filaments and that can also be degraded. Some of these materials, polyvinyl alcohol are stable in dry environments, but dissolve myth quickly in humid environments. Other materials dissolve both quickly in caustic solutions (for example, extremely alkaline) and melt quickly at high temperatures, but these conditions exceed those that can be tolerated by humans. Some biocompatible polymers, for example, copolymers of methacrylic and methyl-methacrylate, dissolve in liquids having physiologically relevant pHs. For example, they remain stable at pH <7.0, but
    dissolve in pH > 7.0. Polymer Type Condition Mode Run Time
    Μ / ΊΖ
    degradation indegradation degradation Acidpolyglycolic Bioabsorbable Hydrolysisgradual Exposure to water or acid 2-3 months Polydioxanone Bioabsorbable Hydrolysisgradual Exposure to water or acid 6-8 months Lactic acid-glycolic acid Bioabsorbable Hydrolysisgradual Exposure to water or acid 2 months Polyvinyl alcohol Bioabsorbable Rapid dissolution Exposure to any aqueous solution Seconds Copolymers of methyl methacrylate and methacrylic acid Bioabsorbable Hydrolysis; pH-dependent dissolution on demand Exposure to alkaline pH Days at near-neutral pH and minutes at hours at alkaline pH Polycaprolactone Bioabsorbable Hydrolysis;on demand inhigher temperatures thanthat 60 ° C Exposure to heat 6 months at temperatures below the melting point, seconds at or above the melting point Polyester No-bioabsorbable none none AT Polypropylene No-bioabsorbable none none AT Nylon No-bioabsorbable none none AT [0114] Such as release section opens the
    43/78 reservoir in the environment surrounding the opening provides an open passage outside the device assembly. The open passage allows the contents of the device as a whole, such as the filling material, to be exposed to gastric contents and to freely leave the reservoir. When positioned inside the stomach, a normal gastric beat helps to empty the contents of the device set, allowing the entire device with its contents to pass from the body. In some variations, the membrane that forms the skin will provide little or no structural support. This configuration allows the natural tightening resistance of the body to be sufficient to expel any reasonably viscous substance out of the device assembly.
    [0115] Figure 6D provides a schematic illustration of another example of a device assembly 100 having a release material 106 located on a skin surface 102. An example of this release material comprises a degradable stain 106 which, when degraded, opens the physical barrier surrounding the reservoir 104 to allow the filling material 108 (swollen or not swollen) to exit the device assembly 100. The device assembly 100 comprises a skin material into which the release material 106 can be joined ( for example, by heat sealing, RF welding, impulse heating, or any other means). In certain variations, the degradable stain / release material 106 comprises a material or combination of materials that remains impermeable to water and hydrogel after installation and can be degraded on demand in response to an exogenous substance or in response to a condition created within the environment. body being the result of
    44/78 administration of the exogenous substance.
    [0116] In one example, the release material can vary from 25 microns in thickness; up to 2.5 mm thick. In another example, the release material is a modified polycaprolactone with melting point T M = 47 ° C (available from Zeus Industrial Products of Orangeburg, SC USA). In additional embodiments, the degradable stain 106 may be polyglycolic acid or poly (L-lactide) acid (available from Poly-Med, Inc danderson, South Carolina).
    [0117] Figures 7A and 7B show an example of an enlarged view of the assembly of a device assembly 100 (where a fluid transport member is omitted for clarification). As shown, the device assembly 100 may include a skin of the material comprising two layers of material that form an upper skin 122 and a lower skin 124. As noted herein, the layers can be joined to form a joint. Clearly, the presence of a joint is optional and some variations of devices in the present disclosure will not include a joint or have similar types of joined regions of material to preserve the skin as a physical limit to the contents of the reservoir. Again, the device assembly 100 is shown in the shape that eventually takes on a flattened spheroid. However, other forms are within the scope of this disclosure. In one variation, the skin substantially comprises non-elastic materials 122 and 124 which are joined around a perimeter leaving the openings as discussed here. It will be understood that the shape of the device is referred to as a flattened spheroid for descriptive purposes. In other realizations where one or more devices can be joined to
    45/78 comprising a set of several bodies, each individual device can be mounted by one or more blades of the film-like material which are cut in a pre-designed shape. Figure 7A shows the device 100 in a reverse configuration in the middle assembly. As shown, the damaged part 12 6 can be secured with a filament release material 106 and / or a seal release material 106 located within a release area 128. Figure 7B illustrates an enlarged view of the construction of figure 7A after the structure is inverted and a filler material is inserted into a reservoir formed by the skin materials 122 and 124.
    MATERIAL OR SKIN SURFACE [0118] The type of material or skin will depend on the targeted application. In some variations, the skin will be chosen as a balance to select a sufficiently thick film-like material that has adequate strength. For example, in some variations, cut resistance may be preferred to allow the finished construction to be compressed into a capsule of the lowest volume possible. The inventors have determined that thin films with a thickness ranging from 0.5 mils to 4 mils are generally suitable. However, the devices described here can comprise a wider range of thicknesses depending on the particular application, including a range of thicknesses in different parts of the same construction. In some embodiments, the film-like material must be welded or adhered to other materials as can be used on the 1110 valves, filling material release mechanisms 1400, and / or fixing interfaces as described
    46/78 here.
    [0119] In additional embodiments, the film-like material exhibits a low transmission rate of the filling material, both before and after the expansion of the device. In some embodiments, the film-like material exhibits a low rate of moisture vapor transmission. In addition, some film-like materials also exhibit high chemical resistance to the changing conditions found in the stomach. These conditions include low pH, high salt, high concentrations of detergent (usually in the form of reflux of bile salt), enzymatic activities (such as pepsin), and variable chemicals that depend on the nature and content of the food consumed. For these devices used in the gastric space, the material must also be comprised of biocompatible materials that can safely be in contact with the gastric mucosa for the duration of the treatment.
    [0120] The devices described here can use various thermoplastic elastomers, thermoplastic olefins and thermoplastic urethanes that can be expelled or fused into single or multiple layer films that are suitable for the gastric device realizations. Exemplary base resins that can be used include polypropylene, high density polyethylene, low density polyethylene, linear low density polyethylene, polyester, polyamide, polyurethane polyester, polyurethane polyester, polyurethane polycarbonate, biaxially oriented polypropylene, polyvinylidene chloride, copolymers of ethylene and vinyl alcohol, and ethylene vinyl acetate. Some achievements include
    47/78 single layer films while other embodiments comprise multilayer films. Other embodiments consist of multilayer films including one or more layers of lashing to prevent separation of the layer.
    [0121] In some embodiments, the film-like material can be coated with other materials. For example, in some embodiments, hyaluronic acid coatings can be used to improve softness and without lubrication. In other embodiments, coatings such as Parylene® can be applied to improve the chemical resistance of the surface of the film exposed to the gastric mucosa. In some embodiments, wax coatings, PVDC coatings, vacuum metallization, or Parylene® coatings may be applied to the film surface to reduce its moisture vapor transmission rate.
    [0122] In one example, the film-like material used comprised a 1.5 mil polyurethane polyester film. In other embodiments, the film-like material is a 1000 nylon 12 film or a 1.5 thousand LLDPE film. In another example, the film-like material consisted of a multilayer structure comprising an outer layer of polyurethane, a middle layer of PVDC or EVOH, and an inner layer of polyurethane.
    FILLING MATERIAL [0123] Generally, a filling material that has a high swelling capacity and achieves a semi-solid consistency is useful in allowing the finished construction to be compressed in an initial state of the lowest possible volume, but still maintains rigidity one instead expanded. However, unless specifically noted,
    48/78 variations of the device may employ several different types or combinations of filler materials. During several experiments, it has been determined that superabsorbent hydrogel polymers with a mass: mass swelling capacity between 100 and 1000 are generally suitable, where a mass: mass swelling capacity of 100 is defined here to mean that 1.0 g of dry hydrogel will absorb the water and will swell to become a semi-solid mass of 100, Og.
    [0124] Typically, suitable hydrogels swell to the maximum in the presence of distilled water and a number of these hydrogels also deflate (release water) in the presence of the variable environmental parameters found in the stomach. For example, parameters such as pH, salt concentration, concentrations of emulsifying agents (usually in the form of reflux of bile salt), enzyme activities (such as pepsin), and variable chemicals, which depend on the nature and content of the food consumed, can affect the swelling / swelling behavior of certain hydrogels. Typical periods of swelling of the hydrogel vary between 5 minutes and 1 hour. In one variation, the hydrogel swells completely in 15 minutes and completely deflates in less than 10 minutes after exposure in certain environments. Many hydrogels are supplied with particle sizes between 1 and 850 microns. In certain variations, gastric applications benefit from the use of hydrogel particle sizes between 1 and 100 microns. In addition, the hydrogel must also be comprised of biocompatible materials that can be safely in contact and excreted through the gastrointestinal tract. Examples of these biocompatible superabsorbent hydrogel polymers that have the ability to
    Swelling, swelling periods, and swelling periods suitable for gastric construction achievements include polyacrylic acid, polyacrylamide, or polyacrylic acid and polyacrylamide copolymers. Another of this material that can be used as a filler is a cross-linked polyacrylic acid with a particle size distribution ranging from 1-850 microns and a swelling capacity of 400. FORMS [0125] As discussed above, certain variations of the device approximate a highly flattened spheroid comprising a diameter in the XY plane and a thickness along the Z axis as shown in figure 2. In certain variations, the expanded dimensions of the device assembly can vary in diameter between 2 inches and 10 inches. In another embodiment, the construction diameter is approximately 4.6 inches. The thickness of the Z axis can vary between 2 inches and 5 inches. However, the device assembly, unless otherwise claimed, is not limited to any special dimensions. The data below the construction parameters come from the experimentally determined dimensions of two constructions having the shape of a flattened spheroid.
    Parameter Construction 1 Construction 2 Non-expanded diameter (inches) 4.7 5, 8 ' Maximum volume of swelling 300 ml 500 ml Expanded diameter(inches) 3.64 4.63
    50/78
    Expanded thickness(inches) 2.40 2.46
    LIQUID TRANSFER VALVES [0126] Figure 8A shows a further variation of part of a device assembly, in other embodiments the liquid transfer member comprises a valve 150, where valve 150 is arranged in orifice 148 and provides a control over the fluid-permeable passage through another surface of impermeable material 102. In some embodiments, valve 150 comprises a multilayer material structure composed of regions of permeability 152 juxtaposed against regions of impermeability 154, where the fluid can transmigrate between the outside and the inside of the reservoir when the permeability 152 and impermeability regions 154 are not pressed together in strict juxtaposition and where the fluid is inhibited from transmigration when regions 152, 154 are pressed together tightly. In some embodiments, valve 150 is self-closing. That is, valve 150 changes dexiate the fluid transmission to inhibit fluid transmission without external activation. In one embodiment, valve 150 closes in response to increasing pressure from the expander filler material or increasing pressure within the reservoir, for example, to swell the hydrogel by pressing regions 152, 154 close enough together to form a barrier.
    [0127] As noted above, the device assemblies described here may include a wick-like structure that serves as a source for administering fluids to the reservoir. An example of such a wick includes a
    51/78 filamentary material that can lead a liquid from one end to the other by capillary action. The wick can be used independently or with a self-closing valve.
    [0128] In still other embodiments, the 1100 liquid transfer mechanism comprises a mechanical valve. Mechanical valves of suitably small dimensions, comprising biocompatible materials, are well known in the art and are commercially available. A mechanical valve that serves as a liquid transfer mechanism 1100 comprises a one-way or check valve design that allows fluid to enter reservoir 1010, but prevents fluid from leaving the reservoir. Alternatively, a mechanical valve that serves as a liquid transfer mechanism 1100 may have a normally open state, but that self-closes when the internal pressure of the fluid is greater than the external pressure of the fluid.
    [0129] Figure 9A shows another aspect of the devices as described here, for example, construction 200 may comprise one or more fluid transport members 208. As discussed here, liquid supply sources 208 are configured to allow the fluid enters the reservoir to combine with a filling material 202 disposed in an unexpanded device assembly 200. In some variations, the fluid transport member 208 can be coupled to a valve 210 that reduces, blocks or stops transporting liquid when the filler material 202 is substantially hydrated as shown in figure 9B. This closing capacity
    52/78 is useful, as it reduces the likelihood of filling material 202 being contaminated by gastric contents when the device set is in the active profile. Examples of these closing mechanisms are described here. Figures 9A and 9B also illustrate variations of device assemblies 200 as including a rope 214 or other delivery system coupled to a fixture interface 216. Figure 9A also illustrates two areas on the skin of the device having sections of release materials 206. As noted here, the release material is reactive to an exogenous substance that causes degradation, melting, and / or other instability of the release material to allow the reservoir to be exposed to the body. This allows the contents of the reservoir to pass through the device and eventually allows the device to pass through the body.
    [0130]
    9A and 9B also illustrate device 200 having an administration system 214, 216 attached to it. The delivery system 214, 216 may comprise a filament cord 214, that is, generally attached to the body of the device 200 via an interface 216. The attachment interface 216 can be designed as a structurally inherent part of the delivery system (or that is, it cannot be removed from the body device as a separate, independent item). Alternatively, interface 216 can be designed as an element that is added to device 200.
    VALVES [0131]
    Figures 10A and 10B illustrate an example of a valve driven by the expansion of filling material 234 within a reservoir 236 of the
    53/78 device 230. Valve 232 is positioned or otherwise arranged in an orifice 238 on the surface of the material or skin 232. This allows fluid to flow into or out of reservoir 236 when valve 232 is in a configuration open. In some variations, orifice 238 typically comprises a small percentage of the total surface area of material 228. The surface of material 228 is generally impermeable or of limited permeability to the fluid in which device 230 is typically immersed. The orifice 238 can be an opening in the barrier of another form tightened by the fluid formed by the skin 232.
    [0132] Figure 10A also illustrates a predetermined amount of filler material 234 within reservoir 236. In some variations, the predetermined amount is generally measured by the dry mass. The dry mass of the filler 234 is determined by the amount of filler 234 needed to fill the known volume of the expanded device 230 when the filler is fully hydrated. When expanded, the filling material applies pressure within reservoir 236, which provides a restoring force in a way that resists externally applied deformation forces.
    [0133] Figure 10A also shows valve 232 that covers orifice 238. This variation of valve 232 includes one or more flow control layers 240 that assist in closing the valve in action by filler 234. Figure 10B illustrates expansion of the filling material 234, which increases the pressure against the valve 232 and closes the fluid passage by compressing the control layers
    54/78 flow 240 [0134] Returning to figure 10A, before filling material 234 expands, valve 232 is fully opened; that is, it allows the fluid to pass through the valve both inward and outward. On the other hand, after the filling material 234 expands, typically through hydration, valve 232 closes completely, as shown in figure 10B.
    [0135] In some embodiments, valve 232 comprises a containment layer of filler material 242. Generally, containment layer 242 is at least partially permeable to the fluid and simultaneously capable of containing filler material 234 in its dry state or hydrated, within construction 230. In some embodiments, the filler layer 242 is also a flow control layer; that is, a single layer on valve 230 can simultaneously be part of the flow control function of valve 232 and perform the containment function of the filler of the containment layer 240.
    [0136] Figures 10C and 10D show another variation of a valve 232. In this example, valve 232 comprises more than one layer. As shown, this hybrid valve 232 comprises two layers of semilunar flow control 248, each layer having a hybrid construction being permeable in some generally semicircular (viz., Semilunar) regions 250 and impermeable in other regions 252. Impermeable regions 252 of one layer are at least complementary to the permeable regions of the second layer; that is, where one layer has a permeable region the other layer has an impermeable region;
    55/78 there will generally be regions in which both layers are impermeable. Examples of the materials include a permeable stain comprising a polyester mesh and a semicircular impermeable stain comprising latex.
    [0137] As shown in Figure 10D, hybrid valve 232 comprises two substantially identical hybrid flow control layers, one on top of the other, in which the two layers are oriented so that the impermeable region 252 of a first layer of hybrid control is aligned with the fluid permeable region 250 of a second layer of hybrid flow control. By symmetry, the impermeable region 252 of the second hybrid flow control layer is aligned with the fluid permeable region 250 of the first hybrid flow control layer. The two layers are affixed, typically with glue, around their periphery only, thus allowing the central areas of the two layers to move freely.
    [0138] It will be obvious to a person skilled in the art that the circular shape of the exemplary hybrid valve is a design choice made primarily to simplify alignment during assembly and installation. The principle of operation of a hybrid valve - that the two flow control layers have complementary permeable and impermeable regions is independent of the peripheral shape of the valve or the hole in which the shape and size of the valve are combined. For example, another exemplary hybrid valve is illustrated in figure 10E in which each hybrid flow control layer 248 is generally rectangular and the impermeable region 252 and the permeable region 250 are triangular.
    [0139] In addition, the permeable region 250 and
    56/78 waterproof region 252 on any individual flow control layer need not have identical shapes. For example, as shown in figure 10F, which shows an enlarged view of a valve assembly, a permeable region in an individual flow control layer can be, for example, a circular region, and the impermeable region can be an arranged ring around the circular permeable region. However, the two layers of any hybrid valve must at least have complementary permeable and impermeable regions; that is, when the two layers are superimposed there is no permeable area in communication with the exterior of the device.
    [0140] In this exemplary embodiment of a hybrid valve, the flow control layer disposed on the inner side of the valve can preferably also function as the containment layer of the filling material, with the containment being achieved by the mesh comprising permeable stain. Alternatively, a separate innermost filler layer must be added to the assembly.
    [0141] In other embodiments, the hybrid flow control layer is manufactured by joining a stain of permeable material and a stain of the entire impermeable surface, where the joint can be a rear joint, for example, or an overlap joint, for a second example, where the outer periphery of the materials joined by the edge is designed to fill or plug the hole. In another exemplary embodiment of a hybrid valve, the skin itself can serve as one of the flow control layers.
    57/78
    FLOOR EXCHANGES [0142] Figure 11A illustrates another variation of a device 300 having a fluid transport member comprising a fluid wick 302 that extends into a reservoir 304 of the device 300. Typically, a fluid wick structure conducts fluids from a wet end to a dry end (or dryer) by capillary action. For example, if one end of the liquid wick structure 302 is immersed in a liquid while the other end of the liquid wick structure 302 is disposed in the air, then the liquid moves through the wick structure 302 from the end immersed to the end in air, the end of which will typically be absorbed by a filler. The liquid will continue to flow through the liquid wick structure until such time as the end in the air is also immersed in the liquid (that is, typically, immersed in a pool of accumulated fluid).
    [0143] The liquid wick structure 302 can optionally comprise a strip or thread of water-absorbent material, for example, an absorbent matrix of cotton paste (for example, as in a hygienic tissue), polyvinyl acetate (for example , as in a wick for eyes), polyvinyl alcohol sponge (for example, as in the wicks of the ear), or other materials typically used, for example, in surgical sponges. Alternatively, the liquid wick structure 302 may comprise a multifilament strip or yarn of non-water-absorbent material, for example, nylon or capillary channeled polyester, in which small capillaries are formed between the inner walls of the non-absorbent material. O
    58/78 wick may also comprise oxidized cellulose (available from Jinan Vincent Medical Products Co., Ltd, 122 # East Toutuo Street Huangyan, Jinan, Shandong, China). Oxidized cellulose is known to absorb water, but as it is a polysaccharide, it eventually solubilizes after prolonged immersion in water.
    [0144] In one variation, a wick structure 302 may have a substantially circular cross-section, the cross-section generally being greater than 2 mm in diameter and less than 8 mm in diameter, although both wicks have a larger and smaller diameter they may be appropriate for larger or smaller constructions respectively, the limits being determined by practicality and convenience rather than functionality.
    [0145] The structure of the wick 302 is designed to conduct the fluid from the outside to the inside of the device 300, through a hole in the surface of the material 306; its length is preferably the sum of a convenient outer segment, perhaps 2 cm, and an SKG2100 inner segment that is long enough to reach from hole 308 to the innermost space in which the filler material can be arranged. For some variations of the device, an inner segment of the wick 302 is approximately 6 cm, so a typical liquid wick structure 302 can be up to approximately 8 cm in length. In other embodiments the liquid wick structure 302 is between 4 cm and 12 cm in length. However, any range of wick length is within the scope of this disclosure.
    [0146] In a variation, the liquid wick structure 302 is inserted through an orifice 308 in the
    59/78 device 300, where device 300 is otherwise impervious to the fluid. The orifice 308 can be designed with a diameter that is approximately 50% of the diameter of the liquid wick structure 302 to ensure that the liquid wick structure 302 fits tightly and securely to the orifice 308 when the liquid wick structure 302 is dry . In some embodiments, orifice 308 may also have a diameter that is less than 50% of the diameter of the liquid wick structure 302. The minimum diameter for orifice 308 is limited by the construction of the capillary action on the liquid wick structure 302 That is, depending on the internal structure of the liquid wick structure 302 and its material properties, a very small orifice will substantially close the transmission of fluid through the liquid wick structure.
    [0147] Alternatively, in some embodiments, the orifice 308 may have a diameter that is greater than 50% of the diameter of the liquid wick structure, particularly if the liquid wick structure 302 is being safely maintained by other means . With a large (greater than 50% orifice in the diameter of the liquid wick structure), the liquid wick structure 302 can be heat sealed, glued, or otherwise fixed in place in the orifice 308 to prevent it from being displaced from its operational disposition.
    [0148] As shown in figure 11B, when the construction, or at least the outer segment of the liquid wick structure 302 is immersed in a liquid, the liquid is initially drawn into the absorbent wick material of the liquid wick structure 302 and is still removed from the
    60/78 wet wick material towards wick material until the inner segment of the liquid wick structure 302 is substantially saturated. The liquid, upon reaching the surface of the liquid wick structure 302 (and in particular the end of the inner segment), can be poured by dripping or can be removed by contact with the dry absorbent filler. The filling material 306 swells as it absorbs the liquid. The predetermined amount of dry filler material, when fully expanded, fills the construction at slightly positive pressure and wraps the inner segment in a hydrated mass 234. This mass is the functional equivalent of a liquid bath. With both ends of the liquid wick structure 302 immersed in the fluid, the capillary action of the liquid wick structure stops or slows down considerably, thereby ending the movement of the fluid between the exterior and the interior of construction 300.
    [0149] As shown in figure 12A, some exemplary embodiment of the liquid wick structure 302 is fluidly coupled to a secondary inner pouch, pouch, or other container 310 to ensure that the inner segment of the wick 302 is in direct contact with the material filler 234 located inside container 310.
    [0150] As the filling material 234 swells, the container 310 releases the filling material 234 to the reservoir of the device 300, where it continues to receive the liquid wick structure hydration 302. In an embodiment illustrated in figure 12A, the bag secondary 310 is water-soluble, dissolving rapidly as the partially hydrated hydrogel swells within it. In others
    61/78 embodiments the secondary pocket 310 comprises one or more weakened joints, the weakened dividing joints open as the hydrogel swells against them. In still other embodiments, the entire secondary pocket 310 comprises a structurally weak permeable material, capable of containing the increasing hydrogel pressure. In still other embodiments, the secondary pocket 310 comprises closed suture junctions, the sutures being inherently weak or soluble in water. Any part of a wick can be attached to a container, not just the ends of the wick. For example, a wick can be folded so that the folded end is positioned within the container.
    [0151] The wick 302 can be held in place inside the container 310 as described above for the orifice. Alternatively, it can be sealed closed by heat sealing, bonding or other means so that the tip of the inner segment is arranged in direct contact with the filling material 234.
    [0152] In some embodiments, the liquid wick structure 302 can be manufactured from a material that dissolves or degrades in the liquid comparably more slowly with respect to the time it takes for the filler material to expand completely. The material selected for this embodiment maintains its integrity and the ability to drain long enough to completely hydrate the filler 234, but then degrades and disappears once the filler is completely expanded. Examples of these materials include thin materials, derived from cellulose, with porous or non-woven fabric and 'strings' made from smaller tubes, including combinations of nanotubes.
    62/78 [0153] Figure 12B illustrates another embodiment of a device 300 having multiple liquid wick structure. This embodiment comprises a double wick structure in which a single wick structure 302 delivers the fluid to the reservoir through both ends. As shown, a wick is threaded through both sides of the device's skin so that the wick is exposed on both sides. These two segments of the outer wick absorb the fluid and conduct the fluid between an exterior of the device and the reservoir. Clearly, two or more wick structures can be used instead of both ends of a single wick structure.
    [0154] As shown in figure 12C, in other embodiments the interior segment of a single liquid wick structure 302 is divided into two or more subsegments. Sub-segments of the wick structure 302 can be directed to different locations in the device reservoir to distribute the hydration fluid 1105 more efficiently, or, as discussed above, each end can be directed into a secondary container.
    [0155] In another aspect, a wick structure 302 can be attached to a part of the interior of the reservoir as shown in figure 12D. As shown above, the wick initially extends outside the device. In the swelling of the filling material, as the device expands, the section of the wick that is initially outside the device is pulled into the device assembly because it is fixed or stuck inside the reservoir.
    [0156] Clearly, variations of the wick structure can be combined with other aspects and
    63/78 features described here. Yet, any realization revealed here can be combined with the aspects of the alternating realizations or with the realization itself. For example, the wicks described here can be combined with the valve mechanisms described here and / or can be combined with the release materials discussed throughout the specification.
    [0157] Figure 13A illustrates a variation of a tunnel valve as discussed above. As shown, the tunnel valve forms a sealable fluid passageway that prevents material from escaping from inside the device. Figure 13A illustrates an example of a device with a tunnel valve forming the passage of the sealable fluid. As shown, device assembly 326 contains a valve member 330 comprising a fluid impermeable material that can be safely wetted to the skin 328 in any conventionally known manner or by those discussed here (including, but not limited to, bonding, welding, heat sealing , or other means). Examples of useful materials for the tunnel valve include polyurethane, nylon-12, and polyethylene. The tunnel valve 330 can include any number of fluid transport members 332. In the illustrated variation, the valve is coupled to a channel. However, variations include a wick-type device located inside the tunnel valve.
    [0158] Figure 13B shows a cross-sectional view of tunnel 330 along line 13B-13B of figure 13A. As shown, the tunnel valve 330 forms part of the fluid transport member 332 allowing the transport of fluids between the interior / reservoir and interior of the device assembly. In certain variations, the tunnel valve 330 can
    64/78 be detachable from the rest of the fluid transport member 332. Upon removal, the layers of the tunnel valve 330, as shown in figure 13C, close to an extension that the tunnel valve effectively closes and prevents the migration of the filling material from the reservoir. In certain variations, tunnel valve 330 closes completely, while in other variations, tunnel 330 may remain slightly open. Variations of tunnel valves include assemblies of an extruded tube or two layers that are joined by gluing, welding, heat sealing, or other means at their two edges. In some variations, the tunnel valve has a wall thickness between, 001 '' and 0.1 ''. An example of a tunnel valve included a thickness of .0015 ''. In additional variations, the tunnel valves can be flexible, compressible and / or deformable. In additional variations, layers of the tunnel valve can be reopened by passing a structure (for example, a channel or other fluid transport structure).
    [0159] As noted above, the tunnel valve allows separation from the rest of the fluid transport member at any time, but typically once a sufficient amount of fluid is administered to the device. Removal can occur by applying tension to a part of the fluid transport member. Variations of the tunnel valve may employ permeable membranes, filters or valves placed at the end of the tunnel valve to prevent dry hydrogel or other fillers from entering the tunnel and affecting the ability of the tunnel valve to seal. In some embodiments, the membrane or filter may comprise a permeable fabric such as polyester, nylon, or cellulose. In other achievements, a
    65/78 valve is placed at the end of the tube comprised of a one-way duckbill or umbrella valve (available from MiniValve of Oldenzaal, Netherlands). Alternatively or additionally, the filling material 234 can be contained in a container as discussed above, which prevents the filling material from entering the tunnel valve and swelling in the liquid infusion, thereby blocking the valve.
    ADMINISTRATION SYSTEM [0160] As shown in figure 14, in certain variations, the device assembly can be compressed to fit within an oral dosage form 3 52 such as a pill, capsule, sleeve, or other shape that improves the ability to position the device through ingestion or swallowing without the help of another medical device. In this case, the device 350 is contained within the oral dosage form 352 and can optionally include a string 356. It should be noted that the channels described above can also be used as a string or vice versa. In any case, the 356 string allows you to control the location of the 350 device installation within the gastrointestinal tract by manipulating the 356 string, and finally completing the administration procedure by releasing the 350 device control, by releasing the 356 string for the patient to swallow or, more typically, by separating the string from the device 350 or oral dosage form. Figure 14 also shows a string 356 as having two ends to allow greater control in the positioning of the device 350.
    [0161] According to the method of administration, a health professional, typically an agent trained by
    66/78 doctors such as a doctor, physician assistant, or nurse administer the payload encapsulated, on the rope, in a mammal, here referred to as the patient. The method comprises the simultaneous steps of directing the patient to swallow the oral dosage form while controlling the rope. In some embodiments, controlling the rope involves using a tube to transport the liquid to the device, the method also includes infusing liquid through the tube using a syringe, pump, or other means of administering liquid. Generally, the step to control the rope comprises, first, ensuring that the end close to the rope is retained within the patient and then assisting the patient in inserting the rope into the patient's mouth and throat at a rate consistent with ingestion of the shape. oral dosing 352. That is, the agent typically adjusts the rate of insertion of the string so the progress of the oral dosage form 352 below the esophagus is not impeded by the string-induced drag while at the same time the patient does not feel that the string is accumulating in your mouth. In additional variations, the healthcare professional can also use the rope by securing the section of the rope located outside the patient's body (ie, in an installation in the room or in a part of the patient).
    [0162] The method also comprises an optional step to control the distance of administration of the device. The administration distance is essentially the distance the gastrointestinal tract the device is allowed to travel. Typical devices are designed to be installed in the stomach although some devices can be designed to target only the esophagus while other devices can be targeted to target the pylorus or
    67/78 beyond. The step to control the administration distance is best performed with a device attached to a marked rope, whereby the length of the ingested rope corresponds to the distance of the instantaneous administration, the length of which is being directly readable from a marked rope. Part of this optional step to control delivery distance is stopping rope intake.
    [0163] In certain variations, the oral dosage form 352 dissolves when it reaches the stomach and the fluids in it. Once free of the oral dosage form, device 350 is free to expand in the installed state or an active profile. Alternatively, device 350 expands in its active profile in the infusion of a hydration fluid through the fluid transfer member.
    FILLING MATERIAL RELEASE [0164] A technician on the subject will note that the human GI tract is unique among the abdominal viscera, as it is periodically exposed to very hot and very cold substances during daily food. For example, the stomach temperature is known to rise to 44 ° C after eating a hot meal heated to 58 ° C, but it quickly returns to internal body temperature (37-39 ° C) in 20 minutes. Also, the stomach temperature can rise as high as 48 ° C in 1-2 minutes if 500 millimeters of running water at 55 ° C is consumed quickly (in 2 minutes) on an empty stomach. Thus, a biocompatible material that could be eliminated by fusion would remain ideally stable at the body's internal temperature (37-39 ° C), but melt in response to a planned intervention that increased
    68/78 the temperature in the vicinity of the biocompatible material to the melting point of the material. In the GI tract, such earth material can withstand daily fluctuations in gastric temperature (for example, after eating a hot meal) and remain stable at temperatures between 37 ° C and 44 ° C, but melt in response to a planned intervention ( for example, consuming 500 millimeters of running water at 55 ° C).
    [0165] In some examples it has been observed that a material, polycaprolactone (PCL), has been extruded into a strong monofilament (Japanese publication JP-A05-59611 A) and has a natural melting point of 60 ° C, a melting point that it is probably not usable in human stomachs. However, PCL can be modified to reduce its melting point to a more physiologically acceptable temperature. In addition, the modified polymer can also be extruded into a strong monofilament suitable for suturing and sewing a film suitable for heat welding on a membrane. PCL filamentary material with reduced melting temperatures (T M ) is available from Zeus Industrial Products of Orangeburg, SC, where 60 ° C> T M > 45 ° C by specification.
    ADMINISTRATION OF THE EXOGENOUS THERMAL SUBSTANCE [0166] In some variations the degradable material used as release material 106 is allowed to degrade in its rate of natural degradation in the mammalian gastric environment. In other variations, degradation is triggered or carried out by the intentional introduction of an exogenous substance 120. In additional embodiments, exogenous substance 120 is introduced orally and at least
    69/78 partially in a liquid format in the stomach. In the stomach, the exogenous substance 120 mixes with the resident gastric fluid to become an immersion fluid that substantially bathes the construction. Alternatively, exogenous substance 120 can be introduced to the stomach in a solid state, as in a tablet or capsule, typically accompanied by a liquid, where the solid is dissolved and becomes the immersion fluid, particularly when mixed with fluids gastric. In certain embodiments, the extracorporeal stimulus of exogenous substance 120 can be used.
    [0167] In many variations, the release material comprises modified PCL material, either as a thin film for degradable stain or as a filamentary material. In general, the modified PCL melts at a specified melting temperature, T M and the stomach temperature, T s , remains below T M. The exogenous agent for PCL thus comprises a liquid with a high temperature at the temperature T L - which increases T s above T M. The temperature of the exogenous agent T L required to increase T s above T M is based on the design details of the entire system; that is, the means for administering the exogenous substance 120, the design of the release material (i.e., for example, sutures, stain or stitch), and the specified melting temperature, T M , of the modified PCL.
    [0168] For example, an intragastric construction comprising T M = 48 ° C modified PCL will degrade after rapid ingestion of a large volume of water with T L = 55 ° C. Clearly, the location of the release PCL material can affect the rate and / or temperature at which the PCL degrades. THE
    70/78 temperature of the extracorporeal exogenous substance 120 T L is higher than the melting temperature of the PCL to consider cooling the formulation during transit to the stomach and due to mixing with the present stomach fluids and for placing the release material . In one example, it was observed that the rapid ingestion of approximately 500 millimeters of water at 55 ° C raises the stomach temperature T s to at least 48 ° C, high enough to dissolve / degrade the modified PCL and allow the device to open and release its hydrogel contents.
    [0169] In another example, an intragastric construction comprising modified PCL T M = 50 ° C will degrade after the rapid endoscopic infusion of 500 mm of running water with T L = 65 ° C, a temperature that is too hot for oral ingestion comfortable, but that is tolerated by the stomach when the liquid is administered directly to the stomach. Alternatively, exogenous substance 120 can be administered directly to the stomach through a nasogastric tube, again avoiding the comfort limitations of oral intake.
    [0170] In another variation, an exogenous substance can be used to raise the temperature or otherwise change the conditions of body fluids to effect the release of the device. Additional variations allow the use of an external power source to raise the temperature of the area around the device. For example, a patient can ingest a sufficient volume of fluid, followed by the application of an external energy source (for example, radio frequency or ultrasound) to the patient's abdomen to
    71/78 heat the fluid inside the stomach to the desired T M. In another variation, the exogenous substance, for example, elemental magnesium, causes an exothermic reaction to occur in the stomach.
    [0171] Yet another approach provides an exogenous substance 120 in an intragastric device comprising T M = 50 ° C Modified PCL is the intake of 500mL of alkaline solution (eg saturated sodium bicarbonate) preheated to 55 ° C. Said solution initiates an exothermic reaction in neutralization with stomach acid, heating the stomach contents above the melting point of PCL to 50 ° C.
    EMPTYING AND DESINCHING DEGRADATION [0172] Certain embodiments of the present invention comprise a system for the rapid degradation and volume reduction of a medical device containing intragastric hydrogel. The system disclosed here consists of three paired materials: a degradable device structure element, a hydrogel solution and a tuned dissolution (or swelling) selected to degrade the structural element and swelling of the particular hydrogel according to its adjacent chemical properties. The system is used as follows: first, an intragastric device containing a hydrogel is swallowed, ingested or inserted into a patient's stomach. The hydrogel swells when exposed to fluid and the space in the stomach lumen. Following sufficient residence time determined by the patient or a healthcare professional, a hydrogel de-swelling agent is ingested or administered to the patient. The swelling agent (which can be in the form of a solid, liquid, or
    72/78 gas) causes the device to release the closed hydrogel by degrading a structural element (suture, a suture line, a joint, a glue, a stain, a connector, or other structural elements known in the art). The swelling agent then quickly reduces the volume of the hydrogel to facilitate the pyloric passage and transit of the safe distal GI tract.
    [0173] Various structural elements susceptible to degradation after exposure to particular aqueous conditions are known in the art. Examples include the polycaprolactone polymer that can be extruded into plates, films, monofilaments, plugs, and other structural elements. Polycaprolactone (available from DURECT Corporation, Birmingham, AL) has a melting temperature of approximately 60 ° C and can be thermoformed, molded, or extruded into various structural elements known in the art. Modified PCL with melting temperatures ranging from -40-60 ° C (available from Zeus Industrial Products of Orangeburg, SC) can also be thermoformed, molded or extruded into various structural elements known in the art.
    [0174] Structural elements of the device can also be produced from materials that selectively dissolve when exposed to high pH conditions, but remain substantially structurally intact when exposed to lower pH conditions. For example, fibers removed by extension can be produced from poly (methyl methacrylate-co-methacrylic acid), available as EUDRAGIT S-100, or copolymer of poly (methyl methacrylate-co-methacrylic acid), available as EUDRAGIT FS
    73/78
    30D, both from Evonik Industries of Darmstadt, Germany. These polymers can be formulated with Triethylcitrate (TEC) and extruded into filaments that can be used to close the joints of an intragastric device. For example, a mixture of 70% EUDRAGIT S-100 and 30% Triethylcitrate (available from Samrudhi Pharmachem of Mumbai, India) can be mixed and extruded into the fiber using a single extruder. The resulting filament can then be used to sew a joint of a hydrogel-filled intragastric device. The resulting fiber and joint remain substantially structurally stable (for example, having mechanical properties such as strength that do not change over time), but degrade rapidly (for example, by dissolving) at a pH greater than approximately 7.
    [0175] Some hydrogels can be dehydrated by exposure to an aqueous solution comprising a high concentration of salts. Figure 15 illustrates this swelling effect and shows the degree of swelling for various cross-linked polyacrylic acid and cross-linked polyacrylamide hydrogels after exposure to solutions containing various solutes in various concentrations. Each hydrogel was loaded into a permeable polyester mesh bag and exposed sequentially to the listed environments.
    [0176] Bags were created from 9, 5cm x 22.0cm pieces of polyester mesh (available from China Silk by Lincoln Ryco, RI), folded in half by the long edge, closed along the long edge and a short edge with glue fabric (available from Bish's Tear Mender of Cambridge, MA True Value Hardware), and filled with 1.0 gram of a
    74/78 of the following superabsorbent hydrogels: Waste Lock 770 (available from M2 Polymer Technologies, Inc.), Waste Lock PAM (available from M2 Polymer Technologies, Inc.), Tramfloc 1001A (available from Tramfloc of Tempe, AZ), Water Crystal K (available from WaterCrystals.com), Hydrosource (available from Castle International Resources of Sedona, AZ), coacrylic acid polyacrylamide potassium salt (available from Sigma-Aldrich), and Soil Moist (available from JRM Chemical of Cleveland, OH ). The bags were closed with the remaining short edge with three square points of a heavy polyester thread, placed in a beaker filled with 350mL of running water, and incubated at 37 ° C for 1 hour. The bag was weighed after 30 minutes and 1 hour in running water. The bag was then immersed in a beaker incubated at 37C containing 350mL of 2% sodium chloride, mixed canine food (150 grams of Hill's Science Diet Advanced Fitness Dry Dog Food mixed in 50mL of simulated gastric fluid [2 grams of chloride sodium, 3.2 grams of pepsin, 7mL hydrochloric acid, placed in 1 liter with running water], and placed in IL under running water), buffer with pH 3 (available from Hydrion pH 3 buffer from Micro Essential Laboratory of Brooklyn, NY ), and 2.5% calcium chloride for 3.5 hours each. Between each of these incubations, the bags were immersed in a beaker containing 350mL of running water incubated at 37C. The pouch was weighed after each incubation. The bags became lighter after each incubation in a different medium, but recovered most of the mass after incubation under running water. However, in 2.5% calcium chloride, each pouch lost a significant amount of mass and could not recover mass after incubation in water
    75/78 current (data not shown).
    [0177] The hydrogels shown in figure 15A are comprised of cross-linked polyacrylic acid or cross-linked polyacrylamide, materials that are widely used in medical device applications. As evidenced by the data, administration of a swelling solution comprised 2.5% calcium chloride could quickly reduce the volume of hydrogel by 10 times or more. Thus, any of the hydrogels shown in figure SGL7 compared to a 2.5% calcium chloride dehulling solution constitute a system for building degradation based on ionic resistance.
    [0178] The hydrogels shown in figure 15B are comprised of cross-linked polyacrylic acid or cross-linked polyacrylamide, materials that are widely used in medical device applications. As evidenced by these data, the administration of a deflating solution comprised of 2.5. The composition and manufacture of this hydrogel is reported in the literature (Gemeinhart, et al., 2000). As evidenced by the data, the extent of swelling of this hydrogel rapidly increases above pH 3. This hydrogel is comprised of highly biocompatible materials and is thus suitable for ingestion by a patient as part of a space-occupying device. The hydrogel will deflate a normal gastric environment. When the device is ready to be disposed of, a low pH deflating solution could be administered to the patient to quickly deflate the hydrogel.
    [0179] Figure 15C describes the swallowing performance of a chitosan / alcohol superporous hydrogel
    76/78 polyvinyl in solutions at different pHs. The composition and manufacture of this hydrogel are reported in the literature (Gupta, et al., 2010). As shown in figure 150, the extent of swelling of this hydrogel quickly reduces above pH
    3. This hydrogel is comprised of highly biocompatible materials and could be swallowed by a patient as part of a space-occupying device. This hydrogel is swollen with a solution at low pH (below 3). When the device is ready to be disposed of, a high pH deflating solution (pH> 3) is administered to the patient to quickly deflate the hydrogel.
    [0180] Exemplary embodiment 1: an embodiment of the system for rapid degradation of the hydrogel construction comprises an intragastric device containing hydrogel and de-swelling agent that can simultaneously open the device and de-hydrate the hydrogel. The construction in this exemplary embodiment is manufactured using the following materials: Bags are created from 9, 5cm x 22.0cm pieces of polyester mesh (available from China Silk of Ryco of Lincoln, RI), folded in half along the long, closed edge long edge and short edge with fabric glue (available from Bish's Tear Mender of True Value Hardware of Cambridge, MA), and filled with 1.0 gram of Waste Lock 770 hydrogel (available from M2 Pollymer Technologies, Inc.). The pouch (s) are closed by the remaining short edge with, for example, three square stitches of the modified Polycaprolactone yarn (available from Zeus Industrial Products of Orangeburg, SC) processed to melt at 47 ° C. The corresponding dissolution solution comprises a 2.5% aqueous solution of calcium chloride heated to 55 ° C. This solution
    77/78 degrades the structural element of modified polycaprolactone (points that hold the bags closed) and deflates the salt-sensitive hydrogel.
    [0181] Additional exemplary realization: additional exemplary realization of the system for rapid degradation of the hydrogel construction is manufactured similarly to exemplary realization 1. The different realizations comprise different combinations of the device material, that is, the wire used to close the bags , hydrogel material, and dissolution formulation. The table below reveals these combinations. The following combinations are for illustrative purposes only and should not be for limiting unless specifically claimed.
    Polymer Type Degradation mode Degradation condition Degradation time Polyglycolic acid Bioabsorbable Gradual hydrolysis Exposure to water or acid 2-3 months Polydioxanone Bioabsorbable Gradual hydrolysis Exposure to water or acid 6-8 months Lactic acid-glycolic acid Bioabsorbable Gradual hydrolysis Exposure to water or acid 2 months Polyvinyl alcohol Bioabsorbable Rapid dissolution Exposure to any aqueous solution Seconds Copolymers of methyl methacrylate and methacrylic acid Bioabsorbable Hydrolysis; pH-dependent dissolution on demand Exposureat alkaline pH Days at almost neutral pH and minutes in hours at
    78/78
    alkaline pH Polycaprolact in Bioabsorbable Hydrolysis; on demand intemperatures higher than 60 ° C Exposure to heat 6 monthsat temperatures less than the melting point, seconds at or above the melting point Polyester No-bioabsorbable none none AT Polypropylene No-bioabsorbable none none AT Nylon No-bioabsorbable none none AT
    1/6
    权利要求:
    Claims (17)
    [1]
    1. MEDICAL DEVICE FOR USE WITH A FILLING MATERIAL TO OCCUPY A SPACE WITHIN THE PATIENT'S BODY, the medical device being characterized by comprising:
    a device assembly comprising— a closed reservoir, a fluid transfer member, and a release section comprising an elongated structure extending to the reservoir, wherein a lumen of the elongated structure provides a passage of the fluid outside the closed reservoir;
    where the closed reservoir is impermeable to the fluid;
    the fluid transfer member is configured to allow administration of the filler material to the closed reservoir to expand the device assembly towards an active profile;
    where a release material is located inside the reservoir and compresses an exterior of the elongated structure to prevent fluid from flowing through the fluid passage; and where the elongated structure separates the release material from the fluid passage so that the release material remains completely outside the fluid passage and is physically separated from an environment within the patient's body until the structural integrity of the release material is reduced open the elongated structure to open the fluid.
    [2]
    2. DEVICE, according to claim 1, characterized by the passage of the sealable fluid being configured
    2/6 to seal when the device assembly assumes the active profile and the channel disengages from the passage of the sealable fluid.
    [3]
    DEVICE, according to claim 1, wherein the channel is characterized by comprising a sliding fit with the passage of the sealable fluid.
    [4]
    4. DEVICE, according to claim 1, being further characterized by comprising a fillable material expandable in the closed reservoir.
    [5]
    DEVICE, according to claim 4, wherein the expandable filler material is characterized by comprising a hydrogel.
    [6]
    6. MEDICAL DEVICE TO OCCUPY A GASTRIC SPACE WITHIN THE PATIENT'S BODY, the medical device being characterized by comprising:
    a device assembly comprising a skin, and a fluid transfer member, the skin forming a perimeter of the device assembly that defines a reservoir therein, where the skin is impermeable to liquid and where the fluid transfer member comprises a passage flexible elongated fluid that allows the administration of fluids to the reservoir;
    where the skin forms an investigated section having a passage that extends into the reservoir;
    a release material located inside the reservoir and disposed completely outside the passage of the investigated section where the release material compresses a part of the investigated section to seal the passage so that the release material is physically separated from the gastric space until the reduction in integrity structural release material causes the passage to open in an outside
    3/6 of the device set;
    the device set having an installation profile and an active profile, in which the installation profile is smaller than the active profile and allows to position the device set within the patient's body;
    where the fluid transfer member is configured to administer a filler to the reservoir to cause the device assembly to expand from the installation profile to the active profile so that the device assembly occupies at least part of the gastric space within the body patient; and an elongated channel having a near end and an end of the device, where the end of the device is flexible to accommodate swallowing by the patient, the elongated channel configured to deliver fluid through the fluid transfer member, where the end of the The channel device is removably located within the flexible elongated fluid passage, so that when removing the channel a flow resistance of the flexible elongated fluid passage is sufficient to prevent the filler material from escaping.
    [7]
    DEVICE, according to claim 6, wherein the channel is characterized by comprising a sliding fit with the sealable passage.
    [8]
    8. DEVICE, according to claim 6, characterized by the part of the section investigated forming the passage to be mechanically connected by the release material.
    [9]
    9. DEVICE, according to claim 8, characterized in that the whole of the device can be reduced to at least 5 ml of volume when in the installation profile.
    4/6
    [10]
    10. DEVICE, according to claim 8, characterized in that the release material is mechanically coupled to the part of the investigated section forming the passage.
    [11]
    A DEVICE, according to claim 1, wherein the fluid transfer member is characterized by comprising both a sealable fluid passage and a removable channel located therein, the channel having a close end and an end of the device, wherein a length of the channel allows the administration of the filler material to the reservoir when the device assembly is located inside the patient's body and the near end is positioned outside the patient's body, where the channel allows the administration of the filler material to the reservoir; and wherein the passage of the sealable fluid is configured to seal to prevent the flow of filler material through it in removing the channel.
    [12]
    12. MEDICAL DEVICE TO OCCUPY A SPACE WITHIN THE PATIENT'S BODY, the medical device being characterized by comprising:
    a device assembly having an installation profile and an active profile, in which the installation profile is smaller than the active profile and allows the installation of the device assembly within the space in the patient's body;
    the device assembly comprising:
    a closed reservoir configured to be impermeable to the fluid;
    a fluid transfer member configured to allow the administration of a filler material to the
    5/6 closed reservoir;
    a release section that provides a fluid passage outside the closed reservoir; and a release material that is located completely outside a fluid passage of the release section and compresses a portion of the release section to prevent fluid from flowing through the fluid passage, so that the release material is physically separated from an environment inside the patient's body through the closed reservoir and remains physically separated from the environment inside the patient's body until the reduction of a structural integrity of the release material allows the opening of the fluid passage allowing the release of the filling material from the closed reservoir.
    [13]
    13. DEVICE, according to claim 12, wherein the fluid transfer member is characterized by comprising a sealable fluid passage and a removable channel located therein, the removable channel having a close end and an end of the device, wherein a length of the removable channel allows the administration of the filler material to the closed reservoir when the device assembly is located inside the patient's body and the near end is positioned outside the patient's body, where the removable channel allows the administration of the filler material to the patient. reservoir to cause the device assembly to expand from the installation profile to the active profile so that the device assembly occupies at least part of the space within the patient's body; and where the passage of the sealable fluid is configured to seal to prevent the flow of filler material
    6/6 through it in removing the removable channel.
    [14]
    14. DEVICE, according to claim 13, characterized in that the passage of the sealable fluid is configured to seal when the device assembly assumes the active profile and the removable channel disengages from the passage of the sealable fluid.
    [15]
    DEVICE, according to claim 13, wherein the removable channel is characterized by comprising a sliding fit with the passage of the sealable fluid.
    [16]
    16. DEVICE, according to claim 13, is characterized by comprising an expandable filler material in the closed reservoir.
    [17]
    17. DEVICE, according to claim 16, wherein the expandable filler material is characterized by comprising a hydrogel.
    类似技术:
    公开号 | 公开日 | 专利标题
    ES2608629T3|2017-04-12|Devices for deployment and release of a temporary implant in the body
    US10307279B2|2019-06-04|Ingestible delivery systems and methods
    US8974483B2|2015-03-10|Methods and devices for deploying and releasing a temporary implant within the body
    CN107530538B|2020-10-02|Method and apparatus for deploying and releasing a temporary implant in a body
    AU2019203304A1|2019-05-30|Methods and devices for deploying and releasing a temporary implant within the body
    BR112016009538B1|2021-11-30|MEDICAL DEVICE FOR USE WITH A LIQUID FILLING MATERIAL AND TO OCCUPY A SPACE INSIDE A PATIENT&#39;S BODY
    EP2916904B1|2018-03-28|Anatomically adapted ingestible delivery systems
    同族专利:
    公开号 | 公开日
    IN2014DN07768A|2015-05-15|
    EP3189817A1|2017-07-12|
    EP2817062B1|2016-11-02|
    US8814898B2|2014-08-26|
    US10786379B2|2020-09-29|
    EP2817062A4|2015-12-30|
    WO2013126593A1|2013-08-29|
    MX349195B|2017-07-18|
    US8870907B2|2014-10-28|
    US20130218190A1|2013-08-22|
    CN104168945B|2016-12-14|
    AU2017204386A1|2017-07-20|
    JP2015510437A|2015-04-09|
    KR20140133874A|2014-11-20|
    US9387107B2|2016-07-12|
    JP6311936B2|2018-04-18|
    US9827129B2|2017-11-28|
    KR101872064B1|2018-07-31|
    US20130345736A2|2013-12-26|
    US20160278957A1|2016-09-29|
    CA2865056C|2021-07-20|
    ES2704775T3|2019-03-19|
    RU2014137127A|2016-04-10|
    IL262857D0|2018-12-31|
    EP3189817B1|2018-10-17|
    MX2014009878A|2015-03-19|
    AU2013222419B2|2017-03-30|
    US20180042747A1|2018-02-15|
    SG11201404821UA|2014-09-26|
    IL234139A|2018-11-29|
    ES2608629T3|2017-04-12|
    EP2817062A1|2014-12-31|
    RU2601995C2|2016-11-10|
    EP3494938A1|2019-06-12|
    US20130267984A1|2013-10-10|
    CN104168945A|2014-11-26|
    AU2017204386B2|2019-09-12|
    CA2865056A1|2013-08-29|
    US20140296903A1|2014-10-02|
    AU2013222419A1|2014-10-09|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-04-28| B25G| Requested change of headquarter approved|Owner name: ALLURION TECHNOLOGIES, INC. (US) |
    2020-05-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-09-08| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-10-13| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    2022-03-03| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US201261601384P| true| 2012-02-21|2012-02-21|
    US61/601,384|2012-02-21|
    US201261645601P| true| 2012-05-10|2012-05-10|
    US61/645,601|2012-05-10|
    US201261647730P| true| 2012-05-16|2012-05-16|
    US61/647,730|2012-05-16|
    US201261663433P| true| 2012-06-22|2012-06-22|
    US61/663,433|2012-06-22|
    US201261663682P| true| 2012-06-25|2012-06-25|
    US201261663683P| true| 2012-06-25|2012-06-25|
    US61/663,683|2012-06-25|
    US61/663,682|2012-06-25|
    US201261674126P| true| 2012-07-20|2012-07-20|
    US61/674,126|2012-07-20|
    US201261699942P| true| 2012-09-12|2012-09-12|
    US61/699,942|2012-09-12|
    US201361762196P| true| 2013-02-07|2013-02-07|
    US61/762,196|2013-02-07|
    PCT/US2013/027170|WO2013126593A1|2012-02-21|2013-02-21|Methods and devices for deploying and releasing a temporary implant within the body|
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