Expandable members and ingestible devices, systems, and methods including the same

Abstract

An expandable member (201, 301) for an ingestible device (200, 300) includes a first section (202, 302) and a second section (204, 304). The first section includes a plurality of pockets (202a, 202b, 202c, 302a, 302b, 302c) partially separated from each other and fluidly coupled together by a foldable joint (202ab, 202bc, 302ab, 302bc) positioned therebetween. The plurality of pockets is configured to contain a first substance (212, 312). The second section includes a reservoir (204a, 304a) configured to contain a second substance (214, 314). The first section is configured to be folded via the foldable joint after being filled with the first substance such that the pockets are arranged in a rolled or an overlapping configuration. The expandable member is structured to expand to occupy a space in a GI tract of a subject upon ingestion of the ingestible device.

Description

EXPANDABLE MEMBERS AND INGESTIBLE DEVICES, SYSTEMS, AND METHODS INCLUDING THE SAMECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 609,721, filed December 13, 2023, the entire contents of which is hereby incorporated by reference.BACKGROUND

[0002] I ngestible devices have been proposed to orally deliver a payload such as a drug into a lumen wall of a gastrointestinal (Gl) tract of a subject. Some of these devices may include an expandable member, such as an inflatable balloon. Upon expansion, the expandable member may serve to actively deliver the payload from the device into the lumen wall and / or to align, or otherwise position, the device relative to the lumen wall to facilitate delivery of the payload into the lumen wall. Some expandable members may rely on one or more substances contained within the device to generate a gas to thereby cause the expandable member to expand.SUMMARY

[0003] Embodiments of the present disclosure relate generally to expandable members and ingestible devices, systems, and methods including the same.

[0004] In one aspect, an expandable member for an ingestible device includes a first section and a second section. The first section includes a plurality of pockets partially separated from each other and fluidly coupled together by a foldable joint positioned therebetween. The plurality of pockets is configured to contain a first substance. The second section includes a reservoir configured to contain a second substance. The first section is configured to be folded via the foldable joint after being filled with the first substance such that the pockets are arranged in a rolled or an overlapping configuration. The expandable member is structured to expand to occupy a space in a Gl tract of a subject upon ingestion of the ingestible device.

[0005] In another aspect, an ingestible device for delivering a payload into a lumen wall of a Gl tract of a subject includes an expandable member, a first substance, a second substance, and a separator. The expandable member includes a first section and a second section. The first section includes a plurality of pockets partially separated from each other and fluidly coupled together by a foldable joint positioned therebetween. The second section includes a reservoir. The first substance is disposed in the plurality of pockets. The second substance is disposed in the reservoir. The separator is coupled to the expandablemember between the first and second sections such that the reservoir is in selective fluid communication with the plurality of pockets. The first section is configured to be folded via the foldable joint such that the pockets are arranged in a rolled or an overlapping configuration.

[0006] In another aspect, a system for delivering a payload into a lumen wall of a Gl tract of a subject includes an ingestible enclosure, an expandable member, a first substance, a second substance, a separator, a delivery structure, and a payload. The expandable member is disposed in the ingestible enclosure. The expandable member includes a first section and a second section. The first section includes a plurality of pockets partially separated from each other and fluidly coupled together by a foldable joint positioned therebetween. The second section includes a reservoir. The first substance is disposed in the plurality of pockets. The second substance is disposed in the reservoir. The first section is folded via the foldable joint such that the pockets are arranged in a rolled or an overlapping configuration inside the ingestible enclosure. The separator is coupled to the expandable member between the first and second sections such that the reservoir is in selective fluid communication with the plurality of pockets. The delivery structure is operatively coupled to the expandable member such that, upon expansion of the expandable member, the delivery structure ejects the payload into the lumen wall.

[0007] In another aspect, a method of assembling an ingestible device is provided. The ingestible device includes an expandable member. The expandable member includes a first section including a plurality of pockets partially separated from each other and fluidly coupled together by a foldable joint positioned therebetween. The method further includes placing a first substance in the plurality of pockets. The method further includes folding the first section via the foldable joint such that the pockets are arranged in a rolled or an overlapping configuration. The method further includes coupling, after folding the first section, a retention member to the first section to hold the plurality of pockets in the rolled or overlapping configuration.

[0008] In another aspect, a method for delivering a payload into a lumen wall of a Gl tract of a subject is provided. The method may comprise administering to the subject by ingestion a system for delivering a payload as described herein.

[0009] In one or more embodiments of any of the foregoing aspects, the expandable member is an inflatable balloon.

[0010] In one or more embodiments of any of the foregoing aspects, the expandable member is a patch.

[0011] In one or more embodiments of any of the foregoing aspects, the expandable member has a bellows structure.

[0012] In one or more embodiments of any of the foregoing aspects, when folded via the foldable joint after being filled with the first substance, the plurality of pockets is structured to define an outer surface profile that is complementary to an inner surface profile of a swallowable capsule.

[0013] In one or more embodiments of any of the foregoing aspects, the plurality of pockets includes a first pocket and a second pocket, where the foldable joint includes a first foldable joint positioned between the first and second pockets.

[0014] In one or more embodiments of any of the foregoing aspects, the first pocket has a first pocket width, and the first foldable joint has a first joint width, wherein the first joint width is less than the first pocket width.

[0015] In one or more embodiments of any of the foregoing aspects, the first joint width is in a range of about 10% to about 75% of the first pocket width.

[0016] In one or more embodiments of any of the foregoing aspects, the first foldable joint is at least partially defined by a sealed edge between the first and second pockets.

[0017] In one or more embodiments of any of the foregoing aspects, the first foldable joint is at least partially defined by a notch or cutout between the first and second pockets.

[0018] In one or more embodiments of any of the foregoing aspects, the plurality of pockets further includes a third pocket and the foldable joint further includes a second foldable joint.

[0019] In one or more embodiments of any of the foregoing aspects, the first pocket is partially separated from, and is fluidly coupled to, the third pocket by the second foldable joint.

[0020] In one or more embodiments of any of the foregoing aspects, the second and third pockets each have a second pocket width, wherein the second pocket width is less than the first pocket width, and wherein the first section is configured to be: folded via the first foldable joint such that the second pocket overlaps an upper or a lower surface of the first pocket, and folded via the second foldable joint such that the third pocket overlaps the other of the upper or lower surface of the first pocket.

[0021] In one or more embodiments of any of the foregoing aspects, the third pocket is partially separated from, and is fluidly coupled to, the second pocket by a second foldable joint positioned therebetween.

[0022] In one or more embodiments of any of the foregoing aspects, the first, second, and third pockets are arranged linearly relative to each other.

[0023] In one or more embodiments of any of the foregoing aspects, the first section is configured to be folded via the first and second foldable joints each in the same rotational direction such that the first, second, and third pockets are arranged in a rolled configuration.

[0024] In one or more embodiments of any of the foregoing aspects, when folded via the first and second foldable joints after being filled with the first substance, the first, second, and third pockets cooperatively define an outer surface profile that is complementary to an inner surface profile of an ingestible enclosure.

[0025] In one or more embodiments of any of the foregoing aspects, the ingestible enclosure is a size 00 or size 000 swallowable capsule.

[0026] In one or more embodiments of any of the foregoing aspects, the plurality of pockets collectively define an interior volume configured to contain up to about 300 pl of fluid.

[0027] In one or more embodiments of any of the foregoing aspects, the first substance includes a reactant reactive with the second substance, or comprises an expandable substance.

[0028] In one or more embodiments of any of the foregoing aspects, the first substance includes a hydrogel.

[0029] In one or more embodiments of any of the foregoing aspects, the first substance includes water.

[0030] In one or more embodiments of any of the foregoing aspects, the first substance includes citric acid.

[0031] In one or more embodiments of any of the foregoing aspects, the second substance includes a reactant reactive with the first substance, or comprises an expandable substance.

[0032] In one or more embodiments of any of the foregoing aspects, the second substance includes a hydrogel.

[0033] In one or more embodiments of any of the foregoing aspects, the second substance includes potassium bicarbonate.

[0034] In one or more embodiments of any of the foregoing aspects, the second substance includes water.

[0035] In one or more embodiments of any of the foregoing aspects, the ingestible device includes a retention member coupled to the folded first section to hold the plurality of pockets in the rolled or overlapping configuration.

[0036] In one or more embodiments of any of the foregoing aspects, the retention member includes an adhesive.

[0037] In one or more embodiments of any of the foregoing aspects, the retention member includes a clip detachably coupled to the first section.

[0038] In one or more embodiments of any of the foregoing aspects, the retention member includes a sleeve slidably disposed over the first section.

[0039] In one or more embodiments of any of the foregoing aspects, the sleeve is a flexible polymeric band.

[0040] In one or more embodiments of any of the foregoing aspects, the retention member is configured to detach from the first section upon expansion of the expandable member.

[0041] In one or more embodiments of any of the foregoing aspects, the separator is a degradable clip configured to degrade upon exposure to a condition in the Gl tract.

[0042] In one or more embodiments of any of the foregoing aspects, the condition is exposure to a fluid in the stomach or small intestine.

[0043] In one or more embodiments of any of the foregoing aspects, the condition is a selected pH in the small intestine.

[0044] In one or more embodiments of any of the foregoing aspects, the delivery structure is configured to deliver a solid or fluid form of payload.

[0045] In one or more embodiments of any of the foregoing aspects, the delivery structure comprises a piston structured to eject the payload from the device into the lumen wall upon expansion of the expandable member.

[0046] In one or more embodiments of any of the foregoing aspects, upon expansion, the expandable member places the delivery structure proximate to the lumen wall.

[0047] The foregoing general description and following detailed description are provided by way of example and are intended to provide further explanation of the disclosure as claimed, without limiting the disclosure or the claims. Other objects, advantages, and novel features will be readily apparent to those skilled in the art from the following brief description of the drawings and detailed description of the disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Fig. 1 illustrates an embodiment of an ingestible device or system for delivering a payload into a Gl lumen wall of a subject in block diagrammatic form.

[0049] Fig. 2 illustrates a side view of an embodiment of the device of Fig. 1 without an ingestible enclosure or separator and prior to placing a substance in the device.

[0050] Fig. 3 illustrates the device of Fig. 2 after coupling a separator to, and placing a substance in, the device.

[0051] Fig. 4 illustrates the device of Fig. 3 after folding a section of the device and coupling a retention member to hold the section in the folded configuration.

[0052] Fig. 5 illustrates a cross-sectional view taken along line 5-5 in Fig. 4.

[0053] Fig. 6 illustrates a side view of another example of the device of Fig. 1 without an ingestible enclosure or separator and prior to placing a substance in the device.

[0054] Fig. 7 illustrates the device of Fig. 6 after coupling a separator to, and placing a substance in, the device.

[0055] Fig. 8 illustrates the device of Fig. 7 after folding a section of the device and coupling a retention member to hold the section in the folded configuration.

[0056] Fig. 9 illustrates a cross-sectional view taken along line 9-9 in Fig. 8.

[0057] Fig. 10 illustrates a cross-sectional view taken along line 10-10 in Fig. 8.

[0058] Fig. 11 illustrates a method of assembling an ingestible device according to some embodiments.DETAILED DESCRIPTION

[0059] Before discussing details of the expandable members, ingestible devices, assemblies, and methods of the present disclosure, a few conventions are provided for the convenience of the reader.

[0060] When used in the present disclosure, the terms "e.g.," "such as", "for example", "for an example", "for another example”, "examples of", "by way of example", and "etc." indicate that a list of one or more non-limiting example(s) precedes or follows; it is to be understood that other examples not listed are also within the scope of the present disclosure.

[0061] As used herein, the singular terms "a," "an," and "the" may include plural references unless the context clearly dictates otherwise. Reference to an object in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more."

[0062] As used herein, a phrase in the form "A / B" or in the form "A and / or B" means (A), (B), or (A and B); a phrase in the form "at least one of A, B, or C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C).

[0063] The term "in an embodiment" or a variation thereof (e.g., "in another embodiment" or "in one embodiment") refers herein to use in one or more embodiments, and in no case limits the scope of the present disclosure to only the embodiment as illustrated and / or described. Accordingly, a component illustrated and / or described herein with respect to an embodiment can be omitted or can be used in another embodiment (e.g., in another embodiment illustrated and described herein, or in another embodiment within the scope of the present disclosure and not illustrated and / or not described herein).

[0064] The term "component" refers herein to one item of a set of one or more items that together make up a device, a composition, or a system under discussion. A component may be in a solid, powder, gel, plasma, fluid, gas, or other constitution. For example, a device may include multiple solid components which are assembled together to structure the device and may further include a fluid component that is disposed in the device. For another example, a composition may include a single component, or two or more components which are mixed together to make the composition. A composition may be in the form of a fluid, a slurry, a powder, or a solid (e.g., in a condensed or a consolidated form such as a tablet ormicrotablet). A device or system can include one or more compositions and / or one or more other components.

[0065] The term "structured" or a grammatical variation thereof (e.g., "structure" or "structuring") refers herein to a component, device, composition, or system that is manufactured according to a concept or design or variations thereof or modifications thereto (whether such variations or modifications occur before, during, or after manufacture) whether or not such concept or design is captured in a writing.

[0066] The term "body" refers herein to an animalia body, unless the context plainly dictates otherwise.

[0067] The term "subject" refers herein to a body into which an embodiment of the present disclosure is, or is intended to be, delivered. For example, with respect to humans, a subject may be a patient under treatment of a health care professional. The terms "individual," "subject," and "patient" may be used interchangeably herein, and refer to any individual animalia subject (e.g., bovine, canine, feline, equine, or human). In specific embodiments, the subject, individual, or patient is a human.

[0068] The term "fluid" refers herein to a liquid or gas, and encompasses moisture and humidity. The term "fluidic environment" refers herein to an environment in which one or more fluids are present.

[0069] The term "ingest" or a grammatical variation thereof (e.g., "ingesting", "ingestion," or "ingested") refers herein to taking into the stomach, whether by swallowing or by other means of depositing into the stomach (e.g., by depositing into the stomach by endoscope or depositing into the stomach via a port).

[0070] The term "degrade" or a grammatical variation thereof (e.g., "degrading", "degraded", "degradable", and "degradation") refers herein to weakening, partially degrading, or fully degrading, such as by dissolution, chemical degradation (including biodegradation), decomposition, chemical modification, mechanical degradation, or disintegration, which encompasses also, without limitation, dissolving, crumbling, deforming, shriveling, or shrinking. The term "non-degradable" refers to an expectation that degradation will be minimal, or within a certain acceptable design percentage, for at least an expected duration in an expected environment.

[0071] The term "degradation rate" or a grammatical variation thereof (e.g., "rate of degradation") refers herein to a rate at which a material degrades. A designed degradation rate of a material in a particular implementation can be defined by a rate at which the material is expected to degrade underexpected conditions (e.g., in physiological conditions) at a target delivery site. A designed degradation time for a particular implementation can refer to a designed time to complete degradation or a designed time to a partial degradation sufficient to accomplish a design purpose (e.g., breach). Accordingly, for example, a designed degradation time can be specific to a component and / or specific to expected conditions at a target delivery site. A designed degradation time can be short or long and can be defined in terms of approximate times, maximum times, or minimum times.

[0072] The terms "substantially", "about", and similar terms are used herein to describe and account for small variations which may result from, for example, a manufacturing or assembly process. For example, when used in conjunction with a numerical value, the terms refer to a variation in the value of less than or equal to ±10%.

[0073] The term "lumen" refers herein to the inside space of a tubular structure. Examples of lumens in a body include arteries, veins, and tubular cavities within organs.

[0074] The term "lumen wall" refers to a wall of a lumen, where the wall includes all layers from an inner perimeter to an outer perimeter of the lumen, such as, with respect to lumens in a body, the mucosa, submucosa, muscularis, serosa, and an outer wall of the lumen, with the constituent blood vessels and tissues.

[0075] The term "gastrointestinal tract" or "Gl tract" refers herein to the intake / expulsion system of a body including, for example, the mouth, pharynx, esophagus, stomach, pylorus, small intestine, cecum, large intestine, colon, rectum, anus, and valves or sphincters therebetween.

[0076] The term "Gl lumen" refers generally to any lumen of the Gl tract (e.g., a lumen of the esophagus, stomach, small intestine, large intestine, or colon) and the term "Gl lumen wall" refers to a lumen wall of a Gl lumen.

[0077] As used herein, the terms "comprising", "comprise", "comprises", "includes", and "including" are intended to mean that the systems, devices, and methods include the recited elements, but do not exclude others.

[0078] Referring generally to the Figures, disclosed herein are embodiments relating to expandable members and ingestible devices, assemblies, and methods including the same. The expandable members disclosed herein are each structured to change from a non-expanded configuration (e.g., folded configuration) to an expanded configuration (e.g., unfolded configuration) to occupy a space within a Gllumen to facilitate delivery of a payload, such as a drug, into the Gl lumen wall or surrounding tissue (e.g., peritoneum or peritoneal cavity) of the Gl tract of a subject. The expandable members are further structured to be disposed in an ingestible enclosure, such as a swallowable capsule, to allow for ingestion of the device and subsequent delivery to a desired location of the Gl tract.

[0079] In some examples, the expandable members disclosed herein each include a section that defines a plurality of pockets which are partially separated from each other and are fluidly coupled together by a foldable joint positioned therebetween. The pockets are each structured to contain one or more substances therein. In some examples, the one or more substances can be used to cause the expandable member to expand at a desired location in the Gl tract to thereby facilitate delivery of the payload into the Gl lumen wall or surrounding tissue thereof. In some examples, the pockets may contain a first substance (e.g., a first reactant) and a second section of the expandable member may comprise a reservoir that contains a second substance (e.g., a second reactant reactive with the first reactant), and the first and second sections may be temporarily separated from each other via a separator, wherein upon release of the separator, the first substance and the second substance may come into contact with each other, resulting in expansion of the expandable member, e.g., via a chemical reaction comprising evolution of a gas and / or via swelling / expansion of one substance due to contact with the other, as discussed in more detail below.

[0080] After placing the substance(s) in the pockets, the section of the expandable member can be advantageously structured to be folded via the foldable joint(s) such that the pockets are arranged in a rolled or overlapping configuration. Prior to assembly into an ingestible enclosure, a retention member may be coupled to the folded section to hold the pockets in the rolled or overlapping configuration. The folded section is, advantageously, sized and shaped to fit within an ingestible enclosure, such as a standard sized swallowable capsule (e.g., a size 00 capsule, size 000 capsule, or other size capsule), so as to allow for oral ingestion of the expandable member. The pockets may be sized and shaped such that the folded section defines an outer surface profile that is complementary to an inner surface profile of the ingestible enclosure.

[0081] In this manner, the expandable members disclosed herein may help to maximize the amount of substance(s) contained therein, minimize complexity during the manufacturing process, and facilitate ease of assembly into an ingestible enclosure. Maximizing the amount of substance(s) contained in the expandable members may help to, for example, meet certain device performance requirements after prolonged storage of the device and to ensure consistent deployment of the expandable members indifferent Gl lumen environments so as to achieve delivery of a therapeutically effective amount of payload to a subject.

[0082] FIG. 1 illustrates in block diagrammatic form an example of an ingestible device or system 100 according to one or more embodiments of the present disclosure. Device 100 includes an enclosure 102, an expandable member 104, a separator 106, a delivery structure 108, and a payload 110.

[0083] According to a non-limiting example, enclosure 102 can degrade at a desired location in the Gl tract (e.g., stomach, small intestine, large intestine) of a subject for delivery of payload 110. In response to at least partial degradation of enclosure 102, separator 106 releases to allow one or more substances contained in expandable member 106 to undergo a reaction resulting in expansion of expandable member 104. Expansion of expandable member 104 within the Gl lumen causes delivery structure 108 to be positioned proximate to (e.g., adjacent or in contact with) the lumen wall for subsequent delivery of payload 110 into the lumen wall or surrounding tissue thereof.

[0084] Enclosure 102 is structured to allow for ingestion of device 100 and to temporarily protect the contents of device 100 from degradation within one or more portions of the Gl tract of a subject. Enclosure 102 may take a variety of different forms and shapes, such as a standard sized swallowable capsule (e.g., a size 00 capsule, a size 000 capsule, or other standard sized capsule), or any other structure that is suitable for ingestion by a subject and can house or contain one or more of the components of device 100 therein.

[0085] Enclosure 102 may include a coating (e.g., an enteric coating) applied to an outer surface thereof.

[0086] Enclosure 102 may include two or more sections coupled (e.g., press-fit) together to define enclosure 102. For example, enclosure 102 may be structured as a capsule including a first section at least partially overlapping a second section in a press-fit arrangement to define enclosure 102. The first and second sections may be detachably coupled together so as to allow for separation of the two sections. In one or more embodiments, expandable member 104, separator 106, delivery structure 108, and payload 110 are each structured to be contained within an interior of enclosure 102.

[0087] In one or more embodiments, enclosure 102 can degrade under certain conditions. Further, different portions of enclosure 102 may be structured to degrade under different conditions or at different degradation rates depending on a target site within the Gl tract for delivering payload 110. For example, a portion of, or all of, enclosure 102 may be constructed of a material that degrades in water (e.g., in thepresence of water in the form of humidity or moisture in an ambient environment, such as within the body) and / or degrades when exposed to solutions with a pH level above a particular threshold or within a particular range (e.g., a pH level associated with a desired location or portion of the Gl tract for delivery of payload 110).

[0088] Expandable member 104 is a flexible and adjustable structure. In one or more embodiments, expandable member 104 is structured to expand from a non-expanded configuration (e.g., folded, rolled, flattened) to an expanded configuration within a desired location of a Gl lumen of a subject for delivery of payload 110. Expandable member 104 has a size and shape to occupy a space in a Gl lumen upon expansion of expandable member 104 to allow for delivery of payload 110 into the Gl lumen wall. For example, upon expansion of expandable member 104, an outer periphery of expandable member 104 pushes against a surface of the lumen wall. The pressure exerted by expandable member 104 may be sufficient to temporarily hold expandable member 104 relative to the lumen wall for delivery of payload 110.

[0089] Expandable member 104 may have a variety of different shapes, sizes, and configurations for being temporarily stored in enclosure 102 and for being deployed within a lumen of the Gl tract of a subject. Expandable member 104 may be structured as any one of, or a combination of, an inflatable balloon, a bellows / accordion structure, an expandable patch, expandable wings, or any other structure that can adjust from a non-expanded configuration to an expanded configuration.

[0090] Expandable member 104 defines an interior volume for containing various components of device 100. Expandable member 104 can contain one or more substances within the interior volume. In one example, expandable member 104 may include a first substance (e.g., a first reactant) disposed in a first section of expandable member 104 and a second substance (e.g., a second reactant) disposed in a second section of expandable member 104. The first substance may be temporarily separated from the second substance via separator 106. Upon release of separator 106, the first substance and the second substance may mix resulting in a reaction to cause expansion of expandable member 104.

[0091] In another example, expandable member 104 may include a section with a substance disposed therein that can expand in response to a stimulus (e.g., contact with a fluid, a pH value, a temperature value) applied to the substance to thereby cause expandable member 104 to expand. For example, the substance may be a hydrogel or a sponge material that can expand in response to selective contact with fluid in the Gl tract. In these embodiments, expandable member 104 may include a moisturepermeable portion to allow fluid from the Gl tract to enter the section of expandable member 104 containing the substance to cause the substance to expand. In another example, separator 106 may release from expandable member 104 to allow fluid (e.g., water) contained in another section of expandable member 104 to enter into the section of expandable member 104 with the expandable substance to contact the substance to cause the substance to expand.

[0092] Expandable member 104 may include one or more sections for containing one or more substances. At least one section of expandable member 104 defines a plurality of pockets that are each partially separated from, and are in fluid communication with, each other via one or more foldable joints. The pockets each define a volume for containing a substance. The pockets are advantageously structured to be folded via the foldable joint(s) such that the pockets are arranged in a rolled or overlapping configuration after the pockets are filled (partially or fully) with the substance(s). A retention member may be coupled to the folded pockets to temporarily hold the pockets in the rolled or overlapping configuration. The folded pockets are advantageously sized and shaped to fit within enclosure 102 after being filled with the substance(s). The folded pockets may have a size and shape such that, when folded, define an outer surface profile that is complementary to an inner surface profile of enclosure 102 to further optimize the amount of substance(s) contained in expandable member 104.

[0093] Expandable member 104 may further include a structure for contracting expandable member 104 upon delivery of payload 110 to facilitate excretion of expandable member 104 from a subject. Expandable member 104 is structured to stretch a defined amount without perforation upon expansion.

[0094] Expandable member 104 may be formed from one or more materials. Examples of suitable materials for expandable member 104 include hydroxypropyl methylcellulose (HPMC), polyvinyl acetate (PVA), lactide, glycolide, lactic acid, glycolic acid, par-dioxanone, trimethylene carbonate, caprolactone, and mixtures and copolymers thereof. Expandable member 104 may include one or more layers of material. Expandable member 104 may be a monolithic structure. In other embodiments, expandable member 104 may be composed of one or more sections that are coupled (e.g., sealed) together.

[0095] Separator 106 is a chemical, mechanical, electrical, electro-mechanical, electro-chemical, chemo-mechanical, or electro-mechanical-chemical structure. Separator 106 may be structured to temporarily separate (e.g., fluidly separate) different sections or compartments within the interior of expandable member 104. Separator 106 may be structured to allow for selective fluid communication between the Gl tract and the interior of expandable member 104. Separator 106 may be structured to bereleased (e.g., degrade, break, move, open, detach) from expandable member 104 in response to a condition in the Gl tract so as to cause expansion of expandable member 104. Separator 106 may be, for example, a clip, a plug, a coating, a band, or any other structure that can otherwise selectively release from expandable member 104. Separator 106 may be structured to degrade upon contact with fluid (e.g., Gl fluid) or in response to a particular pH value. In these and other embodiments, separator 106 may be made from a biodegradable material, such as an enteric material.

[0096] Delivery structure 108 is a chemical, mechanical, electrical, electro-mechanical, electrochemical, chemo-mechanical, or electro-mechanical-chemical structure. Delivery structure 108 is structured to eject payload 110 from device 100 into a Gl lumen wall or surrounding tissue thereof. For example, delivery structure 108 may be structured to eject a solid projectile (e.g., needle shaped structure) formed from, or containing, payload 110. In other embodiments, delivery structure 108 may include a hollow needle, or a jet orifice, for ejecting a semi-fluid or fluid form of payload 110. Delivery structure 108 may include one or more components for actively ejecting payload 110 from device 100 into the Gl lumen wall. For example, delivery structure 108 may include one or more of a spring mechanism, a release mechanism, a piston, a cylinder, a needle, a jet orifice, a nozzle, a bladder, a valve member, or other component for actively delivering payload 110 from device 100 into a Gl lumen wall of a subject.

[0097] In one or more embodiments, delivery structure 108 is structured to be coupled to, and disposed in (partially or fully), expandable member 104. In other embodiments, delivery structure 108 may be separate from, and operatively coupled to (e.g., fluidly coupled), expandable member 104. In one or more embodiments, expansion of expandable member 104 within a Gl lumen can cause delivery structure 108 to be positioned proximate to the Gl lumen wall to facilitate delivery of payload 110 into the lumen wall. In one or more embodiments, expansion of expandable member 104 may result in an internal pressure that is sufficient to act as an energy source for delivery structure 108 to actively deliver payload 110 from device 100 into a Gl lumen wall. Device 100 may include one or more delivery structures 108 coupled to expandable member 104 to allow for delivery of multiple payloads, which payloads 110 may be the same or different from each other.

[0098] Payload 110 includes one or more components and is intended for a therapeutic, diagnostic, or other biological purpose. Payload 110 may be in a solid, a semi-solid, a semi-fluid, or a fluid form. Semifluid and fluid forms may include a liquid, a slurry, a gel, a suspension (e.g., including a colloidal suspension), a gas, a powder, or any combination thereof. Payload 110 may include one or morecomponents including one or more therapeutic agents, such as a pharmacologically active agent (e.g., a drug, a small molecule, a protein, a peptide, a polypeptide, an antibody, a hormone, a nucleic acid, a blood clotting factor), a DNA or SiRNA transcript, a cell, a cytotoxic agent, a vaccine or other prophylactic agent, a nutraceutical agent, a vasodilator, or a vasoconstrictor, a delivery enhancing agent, a delay agent, an excipient, a diagnostic agent, or a substance for cosmetic enhancement. Payload 110 may include a therapeutically effective amount of one or more therapeutic agents as well as suitable amounts of other components (e.g., excipients) to achieve a desired therapeutic effect in a subject.

[0099] One or more components of device 100 (e.g., enclosure 102, expandable member 104, separator 106, delivery structure 108) may be formed from, or otherwise include, one or more biodegradable materials to facilitate degradation of such components to, for example, allow for passage through the remainder of the intestinal tract of a subject after delivery of payload 110. Examples of biodegradable materials that may be suitable for use with various components of device 100 include, for example, hydroxypropyl methylcellulose (HPMC), polyvinyl acetate (PVA), lactide, glycolide, lactic acid, glycolic acid, par-dioxanone, trimethylene carbonate, caprolactone, and mixtures and copolymers thereof.

[0100] The preceding description is an overview of ingestible device 100 and expandable member 104. The following description with reference to Figs. 2-6 relates to examples of various features and aspects of device 100 and expandable member 104. These examples are illustrative of, and not limiting on, device 100 and expandable member 104.

[0101] Referring to Fig. 2, a side view of a device or system 200 (an embodiment of device / system 100) is illustrated in the X-Y plane. It should be noted that the X-Y-Z coordinate system is used for ease of reference only and the illustrated designations were arbitrarily selected. Device 200 is shown in an unfolded, flattened configuration prior to being filled with a substance. Device 200 is illustrated without an embodiment of enclosure 102. However, device 200 may be folded, rolled, and / or otherwise manipulated to be disposed within an embodiment of enclosure 102 (e.g., a standard sized swallowable capsule) to allow for ingestion of device 200 and subsequent delivery into the Gl tract.

[0102] Device 200 is shown to include an expandable member 201 (an embodiment of expandable member 104), a delivery structure 206 (an embodiment of delivery structure 108), and a payload 208 (an embodiment of payload 110).

[0103] In the embodiment shown, expandable member 201 has a balloon structure defined by a flexible sheet of material having one or more layers, where the sheet has been folded and sealed (e.g., heat sealed) along a periphery 201' thereof to define an enclosed interior volume. In other examples, expandable member 201 may include multiple sheets of material that are sealed, or otherwise coupled, together to define an interior volume. Expandable member 201 is shaped to define a first section 202 and a second section 204 separated by a boundary C. As shown in Fig. 3, a separator 210 (an embodiment of separator 106) is configured to be coupled between first section 202 and second section 204 at boundary C to temporarily fluidly separate the interior volumes of first section 202 and second section 204, respectively.

[0104] As shown in Fig. 2, first section 202 includes a first pocket 202a, a first foldable joint 202ab, a second pocket 202b, a second foldable joint 202bc, a third pocket 202c, a first fill arm 202d, and a first fill port 202d'. It should be appreciated, however, that first section 202 may have more than three pockets, according to other examples. First pocket 202a, second pocket 202b, and third pocket 202c each have a generally rectangular shape in the X-Y plane with substantially the same width XI and height Yl, although other sizes and shapes (e.g., square, circular, elliptical, pentagonal, hexagonal, or other shape) are contemplated for each of the pockets. First pocket 202a, second pocket 202b, and third pocket 202c are arranged linearly relative to each other along the Y direction in the X-Y plane. Each of first pocket 202a, second pocket 202b, and third pocket 202c defines a compartment having a volume for containing a substance therein. First pocket 202a, second pocket 202b, and third pocket 202c may collectively hold up to about 300 pl of a substance. After being filled with a substance, first pocket 202a, second pocket 202b, and third pocket 202c can be contained in a standard sized swallowable capsule (e.g., a size 000 capsule) by folding first section 202, so as to facilitate oral delivery of expandable member 201.

[0105] First pocket 202a is partially separated from, and is in fluid communication with, second pocket 202b via first foldable joint 202ab positioned therebetween. First foldable joint 202ab defines a fluid passageway for a substance to pass through. First foldable joint 202ab further defines a first folding axis A for folding first section 202 about after filling with a substance, the details of which are discussed below with respect to Figs. 3-5. First foldable joint 202ab is at least partially defined by a portion of sealed edge 201' such that first foldable joint 202ab has a first joint width JW1 that is about 50% of width XI of each of the pockets. In other examples, first joint width J W1 may be in a range of about 10% to about 75% of width XI. This structural configuration of first foldable joint 202ab can help to facilitate folding of firstsection 202 about first folding axis A after filling first pocket 202a and second pocket 202b with a substance.

[0106] Still referring to Fig. 2, second pocket 202b is partially separated from, and is in fluid communication with, third pocket 202c via second foldable joint 202bc positioned therebetween. Second foldable joint 202bc defines a fluid passageway for a substance to pass through. Second foldable joint 202bc defines a second folding axis B for folding first section 202 about after filling with a substance, the details of which are discussed below with respect to Figs. 3-5. Like first foldable joint 202ab, second foldable joint 202bc is at least partially defined by another portion of sealed edge 201' such that the second foldable joint 202bc has a second joint width JW2 that is about 50% of width XI of each of the pockets. In other examples, second joint width JW2 may be in a range of about 10% to about 75% of width XI. Second joint width JW2 may be the same or different from first joint width JW1. This structural configuration of second foldable joint 202bc can help to facilitate folding of first section 202 about second folding axis B after filling second pocket 202b and third pocket 202c with a substance.

[0107] First fill arm 202d extends outwardly from first pocket 202a and includes a first fill port 202d' disposed therein. First fill port 202d' can allow for filling of first pocket 202a, second pocket 202b, and third pocket 202c with a first substance 212 (see Fig. 3). For example, a syringe or other device may be used to inject or otherwise place first substance 212 into the first fill port 202d' through first fill arm 202d and into pockets 202a-202c. First substance 212 may include a reactant such as a powder or a liquid (e.g., citric acid, water). Alternatively, first substance 212 may include an expandable substance such as a hydrogel, a sponge material, or other substance that can expand in response to contact with a stimulus (e.g., contact with Gl fluid), or that can react with one or more additional substances contained in expandable member 201 (e.g., water), to thereby cause expansion of expandable member 201.

[0108] Still referring to Fig. 2, second section 204 includes a reservoir 204a. Reservoir 204a can contain at least a portion of delivery structure 206, payload 208, and a second substance 214 (see Fig. 3) therein. Second section 204 includes a second fill arm 204b extending outwardly therefrom. Second fill arm 204b includes a second fill port 204b' disposed therein for filling (e.g., partially or fully) reservoir 204a with second substance 214. For example, like first fill port 202d', a syringe or other device may be used to inject or otherwise place second substance 214 into second fill port 202b' through second fill arm 202b and into reservoir 204a. Second substance 214 may be a solid, a liquid, or a powder. For example, second substance 214 may include a reactant, such as water, potassium bicarbonate, sodium bicarbonate, or other substance that can react with first substance 212 to cause expansion of expandable member 201.In other examples, second substance 214 may include an expandable substance that can expand in response to a stimulus, or in response to contact with one or more additional substances contained in expandable member 201, as described herein with respect to first substance 212, to thereby cause expandable member 201 to expand. In specific embodiments, first substance 212 includes a reactant reactive with second substance 214, wherein contacting the first and second substances results in a reaction that causes expansion of expandable member 201, e.g., via evolution of a gas. In other specific embodiments, first substance 212 or second substance 214 includes an expandable substance and second substance 214 or first substance 212 (respectively) comprises a fluid (e.g., water) such that contacting the first and second substances results in swelling / expansion of the expandable substance that causes expansion of expandable member 201. In yet other specific embodiments, one or both of first substance 212 and second substance 214 includes an expandable substance configured to expand in response to contact with, e.g., Gl fluid.

[0109] Second section 204 further includes a deflation valve 204a' structured to cause deflation of expandable member 201 upon completion of delivery of payload 208 into the Gl lumen wall or surrounding tissue thereof. In this way, deflation valve 204a' can facilitate passage of device 200 through the remainder of the Gl tract to exit the anus of the subject. Deflation valve 204a' may be structured as a degradable plug which temporarily covers an opening leading into reservoir 204a. The degradable plug may be structured to degrade in response to contact with fluid in the Gl tract (e.g., bodily fluid) to thereby allow gas, or other substance contained in reservoir 204a, to exit through the opening. For example, deflation valve 204a' may be formed from, or include, an enteric material. In other examples, deflation valve 204a' may be structured as a flap, a clip, or other structure that can selectively cause deflation of expandable member 201. Deflation valve 204a' is shown located on second section 204, but deflation valve 204a' may be located elsewhere on expandable member 201 according to other embodiments. Further, expandable member 201 may include more than one deflation valve 204a'.

[0110] Delivery structure 206 is coupled to expandable member 201 and is at least partially disposed in reservoir 204a along with payload 208. Delivery structure 206 is configured to deliver payload 208 into the Gl lumen wall or surrounding tissue thereof in a subject upon expansion of expandable member 201. For example, delivery structure 206 may include a piston disposed in a cylinder and a needle for penetrating Gl tissue. The cylinder may include a first section that is disposed inside reservoir 204a and a second section that protrudes outwardly from an outermost edge of expandable member 201, as shown in Fig. 2. The needle may be formed from or contain a solid form of payload 208 and may be substantiallysealed within a compartment of the cylinder to protect payload 208 from contact with fluids in the Gl lumen environment. In other examples, the needle may be hollow and be in fluid communication with a drug reservoir or other chamber disposed in, or otherwise coupled to, expandable member 201, which drug reservoir or other chamber contains a fluid form of payload 208. Expansion of expandable member201 may generate an internal pressure or force sufficient to move the piston to cause the needle to extend outwardly from the second section of the cylinder to penetrate the Gl lumen wall and to inject payload 208.

[0111] In another example, delivery structure 206 may include a jet nozzle without a needle. For example, the jet nozzle may be coupled to, or integrally formed with, the second section of the cylinder. The jet nozzle may be in fluid communication with a drug reservoir or other chamber disposed in, or otherwise coupled to, expandable member 201, which drug reservoir or other chamber contains a fluid form of payload 208. Expansion of expandable member 201 may generate an internal pressure or force sufficient to move the piston or other actuator to cause payload 208 to eject as a fluid jet from the jet nozzle at a sufficiently high fluidic pressure to penetrate the Gl lumen wall tissue.

[0112] In another example, expansion of expandable member 201 in a Gl lumen causes delivery structure 206 to be placed in close proximity to the Gl lumen wall and device 200 includes a separate energy source or actuation mechanism (e.g., a spring, an electronic actuator, a shape memory material, a stimuli-responsive material) to actively deliver payload 208 from device 200 into the Gl lumen wall. The separate energy source or actuation mechanism may be actuated independently from the expansion of expandable member 201. For example, device 200 may include a spring mechanism that is held in a compressed state by a release mechanism that can degrade in response to a condition in the Gl tract, such as exposure to fluid or a selected pH in the Gl tract. The release mechanism can degrade to cause the spring mechanism to expand and thereby move a piston or other mechanism to eject payload 208.

[0113] Referring now to Fig. 3, device 200 is shown in a partially assembled state in which separator 210 has been coupled to expandable member 201 at boundary C (shown in Fig. 2) between first section202 and second section 204. Separator 210 is shown as a degradable clip in Fig. 3. However, separator 210 may be substantially non-degradable or include substantially non-degradable portions. Further, separator 210 may be structured differently, such as a plug, a band, a valve, or other structure that can selectively release from expandable member 201.

[0114] After coupling separator 210 to expandable member 201, first section 202 is filled (e.g., partially or fully) with first substance 212 via first fill arm 202d such that one or more or all of first pocket 202a, second pocket 202b, and third pocket 202c contain a volume of first substance 212. The volume of first substance 212 in pockets 202a-202c may be up to about 300 pl. Optionally, second section 204 is filled, or otherwise loaded (e.g., partially or fully), with second substance 214 via second fill arm 204d such that reservoir 204a contains second substance 214. After placing first and optional second substances 212, 214 into expandable member 201, each of first fill arm 202d and second fill arm 204d may be removed (e.g., cut) from expandable member 201 and expandable member 201 is sealed along a periphery thereof to enclose first section 202 and second section 204, as shown in Fig. 3.

[0115] Separator 210 is structured to substantially fluidly separate pockets 202a-202c from reservoir 204 such that first substance 212 is substantially prevented from mixing with second substance 214 (when present). In response to a condition in the Gl tract (e.g., a selected pH, an exposure time, a temperature), at least a portion of separator 210 is structured to degrade to cause separator 210 to release from expandable member 201 to thereby allow fluid communication between pockets 202a-202c and reservoir 204. As a result, first substance 212 can mix with second substance 214 resulting in a reaction to cause expansion of expandable member 201. For example, first substance 212 may be an acid (e.g., citric acid) and second substance may be a carbonate (e.g., potassium bicarbonate) which when mixed, results in the formation of a gas (e.g., CO2) to cause expansion of expandable member 201.

[0116] Referring now to Figs. 4-5, device 200 is shown in a partially folded state. Specifically, first section 202 is shown folded into a rolled configuration by folding second pocket 202b relative to first pocket 202a about first folding axis A (shown in Fig. 2) and folding third pocket 202c relative to second pocket 202b about second folding axis B (shown in Fig. 2) in the same direction as second pocket 202b such that a distal end of third pocket 202c contacts first pocket 202a. In this way, the rolled first section 202 has a generally ovular or circular cross-sectional shape in the Y-Z plane, as shown in Fig. 5. First section 202 is shown being held in a folded state by a retention member 216, which is illustrated as a flexible band (e.g., a polymeric tube, such as a silicone tube).

[0117] The generally ovular or circular cross-sectional shape of the folded first section 202 may be complementary to an interior surface profile 220 of an ingestible enclosure, such as of a standard sized swallowable capsule (e.g., a size 00 or size 000 capsule). This structural configuration of first section 202 can, advantageously, help to maximize the amount of first substance 212 contained in expandable member 201, which may help to achieve sufficient expansion of expandable member 201 (e.g., afterprolonged storage of device 200) and subsequent delivery of payload 208 into the Gl lumen wall or surrounding tissue.

[0118] In the embodiment of Figs. 4-5, retention member 216 is detachably coupled to first section 202 by being slidably disposed over an outer surface of first section 202 after being folded. Retention member 216 is structured to detach, or otherwise release (e.g., break, rupture, move), from the folded first section 202 upon release of separator 210 and subsequent expansion of expandable member 201. For example, release of separator 210 from boundary C causes first substance 212 to mix with second substance 214 resulting in a reaction (e.g., a chemical reaction resulting in formation of a gas) that causes expandable member 201 to expand. This expansion can cause retention member 210 to detach (e.g., slide, break, move) from first section 202 to thereby allow partial or complete unfolding of first section 202.

[0119] In other examples, retention member 210 may elastically deform upon expansion of expandable member 201 and may remain coupled to expandable member 201. For example, retention member 210 may be structured as a band formed from an elastic polymer, such as a medical grade rubber or other flexible polymeric material.

[0120] In other examples, retention member 210 may be an adhesive (e.g., a glue, a tape, a bonding agent) coupled to first section 202. For example, after folding, the adhesive may be placed between first pocket 202a and third pocket 202b to temporarily hold first section 202 in a rolled configuration. The adhesive may be structured to degrade (e.g., upon contact with fluid in the Gl tract), detach, or otherwise separate from first section 202 to allow partial or complete unfolding of first section 202 upon expansion of expandable member 201.

[0121] In other examples, retention member 210 may be structured as a clip detachably coupled to first section 202. For example, the clip may be structured as a spring clip or other style clip that is detachably coupled to the folded first section 202. Upon expansion of expandable member 201, the clip may detach, break, or otherwise separate from first section 202 to allow partial or complete unfolding of first section 202.

[0122] Referring to Figs. 6-10, a device or system 300 (another embodiment of device 100) is shown according to another example. Device 300 is identical to device 200 discussed above but includes an expandable member 301 with a first section 302 having a different structural configuration than the corresponding first section 202 of device 200. Thus, for the sake of efficiency, the following description will focus only on the structure of first section 302. The description of the other components / features ofdevice 200 applies to the corresponding components / features of device 300, which components have the same reference numerals but are increased by an order of 100 (e.g., retention member 216 corresponds to retention member 316).

[0123] As shown in Figs. 6-10, first section 302 includes a first pocket 302a, a first foldable joint 302ab, a second pocket 302b, a second foldable joint 302bc, a third pocket 302c, a first fill arm 302d, and a first fill port 302d'. First pocket 302a, second pocket 302b, and third pocket 302c each have a generally rectangular shape in the X-Y plane, although other shapes (e.g., circular, elliptical, pentagonal, hexagonal, or other shape) and sizes are contemplated for each pocket. First pocket 302a has a first pocket width XI' and a first pocket height Yl'. Second pocket 302b and third pocket 302c each have a second pocket width X2' and a second pocket height Y2'. In one example, the second pocket width X2' is less than the first pocket width XI', and the second pocket height Y2' is less than the first pocket height Yl'. As discussed below with reference to Figs. 10-11, this relative difference in size between first pocket 302a and second / third pockets 302b-c can allow expandable member 301 to closely mimic the interior surface profile (e.g., hemispherical profile) of an ingestible enclosure when first section 302 is folded via first and second foldable joints 302ab-302bc, which may further help to maximize the amount of substance contained in first section 302.

[0124] Each of first pocket 302a, second pocket 302b, and third pocket 302c defines a compartment having a volume for containing a substance therein. First pocket 302a, second pocket 302b, and third pocket 302c may collectively hold up to about 300 pl of a substance. After being filled with a substance, first pocket 302a, second pocket 302b, and third pocket 302c can be contained in a standard sized swallowable capsule (e.g., a size 000 capsule) after being folded via foldable joints 302ab-302bc to facilitate oral delivery of expandable member 301.

[0125] First pocket 302a is partially separated from, and is in fluid communication with, second pocket 302b via first foldable joint 302ab positioned therebetween. In the orientation shown in Fig. 6, second pocket 302b extends downwardly in the Y direction from first pocket 302a. First foldable joint 302ab defines a fluid passageway for a substance to pass through. First foldable joint 302ab further defines a first folding axis A' for folding first section 302 about after filling with a substance, the details of which are discussed below with respect to Figs. 8-10. First foldable joint 302ab is at least partially defined by a cutout or recess along sealed edge 301' such that first foldable joint 302ab has a first joint width JW1' that is about 50% of first pocket width XI' of first pocket 302a. In other embodiments, first joint width JW1' may be in a range of about 10% to about 75% of first pocket width XI'. This structural configurationof first foldable joint 302ab can help to facilitate folding of first section 302 about first folding axis A' after filling first pocket 302a and second pocket 302b with a substance.

[0126] Still referring to Figs. 6-10, first pocket 302a is also partially separated from, and is in fluid communication with, third pocket 302c via second foldable joint 302bc positioned therebetween. In the orientation shown in Fig. 6, third pocket 302c extends laterally in the X direction from first pocket 302a. Second foldable joint 302bc defines a fluid passageway for a substance to pass through. Second foldable joint 302bc further defines a second folding axis B' for folding first section 302 about after filling with a substance, the details of which are discussed below with respect to Figs. 8-10. Like first foldable joint 302ab, second foldable joint 302bc is at least partially defined by a cutout or recess along sealed edge 301' such that second foldable joint 302bc has a second joint width JW2' that is about 50% of first pocket width XI'. In other embodiments, second joint width JW2' may be in a range of about 10% to about 75% of first pocket width XI'. This structural configuration of second foldable joint 302bc can help to facilitate folding of first section 302 about second folding axis B' after filling first pocket 302a and third pocket 302c with a substance.

[0127] In another example, first foldable joint 302ab and / or second foldable joint 302bc may be at least partially defined by sealed edge 301' itself, as discussed above with respect to section 202 of device 200. Likewise, first foldable joint 202ab and / or second foldable joint 202bc of device 200 may be at least partially defined by a cutout or recess along sealed edge 201' instead of by sealed edge 201', as discussed above with respect to section 302 of device 300.

[0128] As shown in Fig. 6, first fill arm 302d extends outwardly from third pocket 302c and includes a first fill port 302d' disposed therein. First fill port 302d' can allow for filling of first pocket 302a, second pocket 302b, and third pocket 302c with a first substance 312 (see Fig. 7). For example, a syringe or other device may be used to inject or otherwise place first substance 312 into first fill port 302d' through first fill arm 302d and into pockets 302a-302c. First substance 312 may be a powder, a liquid (e.g., citric acid, water), a hydrogel, a sponge material, or other substance that can expand in response to contact with a stimulus, or react with one or more additional substances contained in expandable member 301, to thereby cause expansion of expandable member 301.

[0129] Referring now to Figs. 8-10, device 300 is shown in a partially folded state. Specifically, first section 302 is shown folded into an overlapping configuration by folding second pocket 302b relative to first pocket 302a in a first direction about first folding axis A' (shown in Fig. 7) and folding third pocket302c relative to first pocket 302a in a second direction, opposite the first direction, about second folding axis B' (shown in Fig. 7), such that second pocket 302b is positioned adjacent an upper or a lower surface of first pocket 302a, and third pocket 302c is positioned adjacent the other of the upper or lower surface of first pocket 302a. In this way, the folded first section 302 has a generally ovular or circular cross- sectional shape in the Y-Z plane, as shown in Fig. 9, and a generally elongated cross-sectional shape in the X-Z plane, as shown in Fig. 10. Folded first section 302 further defines a generally three-dimensional hemispherical end, as shown in Fig. 10. First section 302 is shown being held in the folded, overlapping configuration by retention member 316, which is illustrated as a flexible band (e.g., a polymeric tube, such as a silicone tube). However, it should be appreciated that retention member 316 may have a different structure, such as one or more of the structures discussed above with respect to retention member 216 of device 200.

[0130] The generally ovular or circular cross-sectional shape of folded first section 302 in the X-Y plane and the generally elongated cross-sectional shape in the X-Z plane along with the hemispherical end may be complementary to an interior surface profile 320 of an ingestible enclosure, such as that of a standard sized swallowable capsule (e.g., a size 00 or size 000 capsule). This complementary structure is due, in part, to the relative difference in sizes between pockets 302a-302c, according to one example. Further, such a structural configuration of first section 302 may, advantageously, help to maximize the amount of first substance 312 contained in expandable member 301, which may help to achieve sufficient expansion of expandable member 301 (e.g., after prolonged storage of device 300) and subsequent delivery of payload 308 into the Gl lumen wall or surrounding tissue.

[0131] Referring now to Fig. 11, a method 400 of assembling an ingestible device 200,300 is illustrated. Method 400 will be discussed with reference to Figs. 1-10. In a first step (402), expandable member 201,301 is obtained. Expandable member 201,301 includes first section 202,302 having pockets 202a-202c, 302a-302c, where the pockets are partially separated from each other, and are fluidly coupled together, by respective foldable joints 202ab-202bc, 302ab-302bc positioned therebetween. In a second step (404), first substance 212,312 is placed in one or more or all of pockets 202a-202c, 302a-302c. For example, first substance 212,312 may be a fluidic substance that is injected into pockets 202a-202c, 302a- 302c via first fill port 202d', 302d'. In a third step (406), after filling with first substance 212,312, fill arm 202d,302d is trimmed and sealed. In a fourth step (408), first section 202,302 is folded via foldable joints 202ab-202bc, 302ab-302bc such that the pockets are in a rolled configuration (e.g., pockets 202a-202c) or in an overlapping configuration (e.g., pockets 302a-302c). For example, the pockets may be foldedmanually by a person (e.g., by hand and / or by using various tools / equipment) or the pockets may be folded automatically by a machine / fixture. In an optional fifth step (410), retention member 216,316 may be coupled to the folded first section 202,302 after filling with first substance 212,312. For example, retention member 216,316 may be a flexible band that is slid over the folded first section 202,302 to temporarily hold the folded first section 202,302 in the rolled or overlapping configuration for subsequent assembly into an ingestible enclosure. In a sixth step (412), second substance 214,314 (if being used) is placed in reservoir 204a, 304a via second fill port 204b'. In a seventh step (414), after placing second substance 214,314 in reservoir 204a, 304a (if being used), second fill arm 204b, 304b is trimmed and sealed. In an eighth step (416), the folded first section 202,302 and second section 204,304 are inserted into an ingestible enclosure, such as a standard sized swallowable capsule. For example, the ingestible enclosure may be a size 000 capsule having two separate sections that cooperatively define a generally cylindrical body with hemispherical ends. The folded first section 202,302 may fit within one of, or both of, the sections of the capsule. Likewise, second section 204,304 can be folded, rolled, or otherwise manipulated to fit within the other section, or both sections of the capsule.

[0132] The foregoing description of various embodiments has been presented for purposes of illustration and description. It is not intended to limit the invention to the precise forms disclosed. Many modifications, variations and refinements will be apparent to practitioners skilled in the art. For example, embodiments of the device can be sized and otherwise adapted for various pediatric and neonatal applications as well as various veterinary applications. Also, those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of the present disclosure.

[0133] While the present disclosure has been described and illustrated with reference to specific embodiments thereof, these descriptions and illustrations do not limit the present disclosure. It can be clearly understood that various changes can be made, and equivalent components can be substituted within the embodiments, without departing from the true spirit and scope of the present disclosure as defined by the appended claims. Also, components, characteristics, or acts from one embodiment can be readily recombined or substituted with one or more components, characteristics or acts from other embodiments to form numerous additional embodiments within the scope of the invention. Moreover, components that are shown or described as being combined with other components, can, in various embodiments, exist as standalone components. Further, for any positive recitation of a component,characteristic, constituent, feature, step or the like, embodiments of the invention specifically contemplate the exclusion of that component, value, characteristic, constituent, feature, step or the like. The illustrations may not necessarily be drawn to scale. There can be distinctions between the artistic renditions in the present disclosure and the actual apparatus, due to variables in manufacturing processes and such. There can be other embodiments of the present disclosure which are not specifically illustrated. The specification and drawings are to be regarded as illustrative rather than restrictive. Modifications can be made to adapt a particular situation, material, composition of matter, method, or process to the objective, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure. While the methods disclosed herein have been described with reference to particular operations performed in a particular order, it can be understood that these operations can be combined, sub-divided, or re-ordered to form an equivalent method without departing from the teachings of the present disclosure. Therefore, unless specifically indicated herein, the order and grouping of the operations are not limitations of the present disclosure.

Claims

What is claimed is:

1. An expandable member for an ingestible device, the expandable member comprising: a first section including a plurality of pockets partially separated from each other and fluidly coupled together by a foldable joint positioned therebetween, wherein the plurality of pockets is configured to contain a first substance; and a second section including a reservoir configured to contain a second substance; wherein the first section is configured to be folded via the foldable joint after being filled with the first substance such that the pockets are arranged in a rolled or an overlapping configuration; and wherein the expandable member is structured to expand to occupy a space in a gastrointestinal (G I) tract of a subject upon ingestion of the ingestible device.

2. The expandable member of claim 1, wherein the expandable member is structured as one or more of an inflatable balloon, a patch, expandable wings, or a bellows structure.

3. The expandable member of claim 1 or claim 2, wherein when folded via the foldable joint after being filled with the first substance, the plurality of pockets is structured to define an outer surface profile that is complementary to an inner surface profile of a swallowable capsule.

4. The expandable member of any one of claims 1-3, wherein the plurality of pockets includes a first pocket and a second pocket, and wherein the foldable joint includes a first foldable joint positioned between the first and second pockets.

5. The expandable member of claim 4, wherein the first pocket has a first pocket width, wherein the first foldable joint has a first joint width, and wherein the first joint width is less than the first pocket width.

6. The expandable member of claim 5, wherein the first joint width is in a range of about 10% to about 75% of the first pocket width.

7. The expandable member of any one of claims 4-6, wherein the first foldable joint is at least partially defined by a sealed edge between the first and second pockets.

8. The expandable member of any one of claims 4-7, wherein the first foldable joint is at least partially defined by a notch or cutout between the first and second pockets.

9. The expandable member of any one of claims 4-8, wherein the plurality of pockets further includes a third pocket and the foldable joint further includes a second foldable joint.

10. The expandable member of claim 9, wherein the first pocket is partially separated from, and is fluidly coupled to, the third pocket by the second foldable joint.

11. The expandable member of claim 10, wherein the second and third pockets each have a second pocket width, wherein the second pocket width is less than the first pocket width, and wherein the first section is configured to be folded via the first foldable joint such that the second pocket overlaps an upper or a lower surface of the first pocket, and folded via the second foldable joint such that the third pocket overlaps the other of the upper or lower surface of the first pocket.

12. The expandable member of claim 9, wherein the third pocket is partially separated from, and is fluidly coupled to, the second pocket by a second foldable joint positioned therebetween.

13. The expandable member of claim 12, wherein the first, second, and third pockets are arranged linearly relative to each other, such that the first pocket is partially separated from and fluidly coupled to the second pocket by the first foldable joint, and the second pocket is partially separated from and fluidly coupled to the third pocket via the second foldable joint.

14. The expandable member of claim 13, wherein the first section is configured to be folded via the first and second foldable joints each in the same rotational direction such that the first, second, and third pockets are arranged in a rolled configuration.

15. The expandable member of any one of claims 9-14, wherein when folded via the first and second foldable joints after being filled with the first substance, the first, second, and third pockets cooperatively define an outer surface profile that is complementary to an inner surface profile of an ingestible enclosure.

16. The expandable member of claim 15, wherein the ingestible enclosure is a size 00 or size 000 swallowable capsule.

17. The expandable member of any one of the preceding claims, wherein the plurality of pockets collectively define an interior volume configured to contain up to about 300 pl of fluid.

18. The expandable member of any one of the preceding claims, further comprising the first substance, wherein the first substance includes a reactant (e.g., reactive with the second substance), or comprises an expandable substance.

19. The expandable member of claim 18, wherein the first substance includes one or more of citric acid, water, or a hydrogel.

20. The expandable member of any one of the preceding claims, further comprising the second substance, wherein the second substance includes a reactant (e.g., reactive with the first substance), or comprises an expandable substance.

21. The expandable member of claim 20, wherein the second substance includes one or more of potassium bicarbonate, water, or a hydrogel.

22. The expandable member of any one of the preceding claims, further comprising a retention member coupled to the first section to hold the plurality of pockets in a rolled or overlapping configuration when the first section is in a folded state.

23. The expandable member of claim 22, wherein the retention member includes one or more of an adhesive, a clip detachably coupled to the first section, or a sleeve slidably disposed over the first section.

24. The expandable member of claim 22 or 23, wherein the retention member is configured to detach from the first section upon expansion of the expandable member.

25. An ingestible device comprising: an expandable member of any one of claims 1-24, comprising the first substance disposed in the plurality of pockets, and, optionally, the second substance disposed in the reservoir; and a separator coupled to the expandable member between the first and second sections such that the reservoir is in selective fluid communication with the plurality of pockets via the separator; wherein the first section is folded via the foldable joint such that the pockets are arranged in a rolled or an overlapping configuration.

26. A system for delivering a payload into a lumen wall of a Gl tract of a subject, the system comprising:an ingestible enclosure; an expandable member of any one of claims 1-24 disposed in the ingestible enclosure; a separator coupled to the expandable member between the first and second sections such that the reservoir is in selective fluid communication with the plurality of pockets via the separator; a payload disposed in the enclosure; and a delivery structure operatively coupled to the expandable member such that, upon expansion of the expandable member, the delivery structure ejects the payload into the lumen wall or surrounding tissue thereof.

27. The system of claim 26, wherein the delivery structure is structured to deliver a solid or fluid form of payload.

28. The system of claim 26 or 27, wherein the delivery structure comprises a piston structured to eject the payload from the device into the lumen wall or surrounding tissue thereof upon expansion of the expandable member.

29. The system of any one of claims 26-28, wherein upon expansion, the expandable member places the delivery structure proximate to the lumen wall.

30. The device or system of any one of claims 25-29, wherein the separator includes a degradable clip configured to degrade upon exposure to a condition in the Gl tract.

31. The device or system of claim 30, wherein the condition is exposure to a fluid in the stomach or small intestine.

32. The device or system of claim 30, wherein the condition is a selected pH in the small intestine.

33. A method for delivering a payload into a lumen wall of a Gl tract of a subject, comprising administering to the subject by ingestion a system according to any one of claims 26-32.

34. A method of assembling an ingestible device, the method comprising: placing a first substance in the plurality of pockets of an expandable member of any one of claims 1-24;folding the first section via the foldable joint such that the pockets are arranged in a rolled or an overlapping configuration; and coupling, after folding the first section, a retention member to the first section to hold the plurality of pockets in the rolled or overlapping configuration.

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