Device for medical interaction with bodily tissues

Abstract

A device and method of use thereof is described having a housing and at least one internal compartment. A substrate having first and second ends and at least one electrode on the surface of the substrate is housed within the at least one compartment. The substrate is anchored to the housing within the at least one internal compartment.

Description

[0001] Attorney Docket No. 206030-0322-00 WO

[0002] TITLE OF THE INVENTION

[0003] Device for Medical Interaction with Bodily Tissues

[0004] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0005] This work was supported by the U.S. Department of Veterans Affairs, and the Federal government has certain rights in the invention.

[0006] CROSS-REFERENCE TO RELATED APPLICATIONS

[0007] This application claims priority to U.S. Provisional Application No. 63 / 686,478, filed on August 23, 2024, incorporated herein by reference in its entirety.

[0008] BACKGROUND OF THE INVENTION

[0009] Gastrointestinal disorders inflict physical, social, and financial burdens on those they affect. Thus, timely and accurate diagnosis and treatments of these conditions are crucial for improvement in quality of life.

[0010] Current gastrointestinal healthcare treatments frequently require high cost hospital visits or invasive procedures, including repeated efforts, and utilize multiple approaches. Additionally, these procedures typically involve a tradeoff between invasiveness and accuracy and effectiveness. Therapeutics for gastrointestinal disorders such as pharmacological drugs expose the whole body in hopes they act on the diseased tissue, increasing the risk of side effects.

[0011] Monitoring methods such as endoscopies and colonoscopies are anchored to a point outside of the patient through a natural orifice. The accessible region of the gastrointestinal tract is thus limited by physical properties of the tools used. The goal of an electrogastrogram is to measure electrical activity of the smooth muscle in the stomach and intestines, but in an electrogastrogram, signals are acquired from the surface of the abdomen. Epicutaneous measurements detect only local field potentials and are more susceptible to noise and other contaminating signals.

[0012] It is desirable to increase the specificity and spatial and temporal control of gastrointestinal healthcare methods to increase diagnostic accuracy and treatment Attorney Docket No. 206030-0322-00 WO effectiveness. There remains a need in the art for an ingestible device that monitors a patient’s gastrointestinal health and / or can provide therapy. The present invention satisfies this unmet need.

[0013] SUMMARY OF THE INVENTION

[0014] Aspects of the invention relate to a device having a housing with at least one internal compartment, a substrate having first and second ends and at least one electrode on a surface of the substrate, wherein the first end of the substrate is anchored to the housing within an internal compartment.

[0015] In some embodiments, the device further comprises a releasable covering positioned over the opening.

[0016] In some embodiments, the substrate of the device is compressed within a compartment of the device.

[0017] In some embodiments, the substrate of the device is configured to expand after the release of the covering.

[0018] In some embodiments, the substrate of the device is composed of one or more materials. In some embodiments, the one or more materials include one or more materials selected from the group consisting of: a bioresorbable material, a bioinert material, an elastic polymer, an electroactive polymer, or a dielectric elastomer.

[0019] In some embodiments, the device is ingestible.

[0020] In some embodiments, the expanded substrate of the device is configured to anchor the capsule to a surface of the gastrointestinal tract of a subject when ingested.

[0021] In some embodiments, the expanded substrate of the device is configured to exert a radial pressure on the gastrointestinal tract.

[0022] In some embodiments, the anchored first end of the substrate of the device is releasable from the housing.

[0023] In some embodiments, the substrate of the device is anchored to the housing within a compartment by a releasable linker.

[0024] In some embodiments, the substrate of the device is configured to expand when exposed to an electromagnetic field. Attorney Docket No. 206030-0322-00 WO

[0025] In some embodiments, the substrate of the device is configured to retract when exposed to an electromagnetic field.

[0026] In some embodiments, the one or more electrodes of the device are recording electrodes.

[0027] In some embodiments, the one or more electrodes of the device are stimulating electrodes.

[0028] In some embodiments, one or more electrodes of the device are recording electrodes and one or more electrodes of the ingestible device are stimulating electrodes.

[0029] In some embodiments, the device comprises one or more sensors.

[0030] In some embodiments, the one or more sensors include one or more sensors selected from the group consisting of: a pH sensor, a motion sensor, a pressure sensor, a biomolecule sensor, a microorganism sensor, a gas sensor, a chemical sensor, a microbiome sensor, an imaging sensor, and a temperature sensor.

[0031] In some embodiments, the device comprises a power source.

[0032] In some embodiments, the device comprises control and signal processing units.

[0033] In some embodiments, the device comprises a deliverable compound stored in at least one compartment.

[0034] In some embodiments, a stimulating electrode of the device is initiated by a wireless signal.

[0035] In some embodiments, a stimulating electrode of the device is initiated in response to a measurement of the recording electrode or sensor.

[0036] In some embodiments, the device comprises a propulsion mechanism.

[0037] In some embodiments, the releasable covering of the device is dissolvable, foldable, or retractable.

[0038] In some embodiments, the device comprises a data storage medium.

[0039] In some embodiments, the device comprises a bi-directional wireless transmission mechanism.

[0040] In some embodiments, the housing of the device comprises a spool positioned in the internal compartment, and the first end of the substrate is anchored to the spool.

[0041] In some embodiments, the length of the substrate extends through the opening and the second end of the substrate is anchored to an exterior surface of the housing. Attorney Docket No. 206030-0322-00 WO

[0042] In some embodiments, the spool is configured to rotate, thereby winding and unwinding the substrate around the spool.

[0043] In some embodiments, at least one electrode is positioned on a surface of the substrate facing away from the housing.

[0044] In some embodiments, the device is configured to be delivered to a subject via a catheter.

[0045] In some aspects, the invention relates to a catheter comprising the device.

[0046] In some aspects the invention relates to a method of monitoring the health of a subject comprising the step administering a device having a housing with at least one internal compartment, a substrate having first and second ends and at least one electrode on a surface of the substrate, wherein the first end of the substrate is anchored to the housing within an internal compartment, and a releasable covering enclosing the substrate and at least one electrode within the at least one compartment to a subject.

[0047] In some embodiments, the method comprises prompting the subject to swallow the device.

[0048] In some embodiments, the method comprises positioning the device in the subject via a catheter.

[0049] In some embodiments, the method further comprises the step of releasing the device from the catheter.

[0050] In some embodiments, the method further comprises the step of removing the device from the subject via the catheter.

[0051] BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The following detailed description of embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

[0053] Figure 1A through Figure 1C depict exemplary embodiments of an ingestible device. Figure 1A depicts an exemplary embodiment of an ingestible device in a closed Attorney Docket No. 206030-0322-00 WO state designed to monitor in vivo electrical and microbiome environments as it travels through the gastrointestinal tract of a living body. Figure IB depicts an alternative exemplary embodiment of the device in a closed state. Figure 1C depicts the cross section of the exemplary embodiment of an ingestible device.

[0054] Figure 2A through Figure 2B depict transparent perspectives of compartments at the end of an exemplary embodiment of an ingestible device.

[0055] Figure 3A through Figure 3D depict the open state of exemplary embodiments of an ingestible device.

[0056] Figure 4 depicts an embodiment of an ingestible device in a closed and open state within an intestinal lumen.

[0057] Figure 5 depicts an embodiment of an ingestible device in a closed and open state within an intestinal lumen.

[0058] Figure 6 depicts an embodiment of an ingestible device in a closed and open state within an intestinal lumen.

[0059] Figure 7 depicts an embodiment of an ingestible device in a closed and open state within an intestinal lumen.

[0060] Figure 8 depicts a schematic diagram of the electrical components of an exemplary embodiment of the device.

[0061] Figure 9 depicts a flow diagram of a process for monitoring an in vivo environment using a device designed for ingestion by a living body.

[0062] Figure 10 depicts an embodiment of a device for interaction with a bodily tissue that may be deployed via a catheter in a closed state.

[0063] Figure 11 depicts an embodiment of a device for interaction with a bodily tissue that may be deployed via a catheter in an open state.

[0064] Figure 12 depicts an embodiment of a device for interaction with a bodily tissue in a closed state associated with a catheter for deployment.

[0065] Figure 13 depicts an embodiment of a device for interaction with a bodily tissue in an open state associated with a catheter for deployment.

[0066] Figure 14 depicts a flow diagram of a process for monitoring an in vivo environment using a device configured for deployment via a catheter. Attorney Docket No. 206030-0322-00 WO

[0067] Figure 15 depicts an embodiment of an ingestible device in a closed and open state.

[0068] DETAILED DESCRIPTION

[0069] The following discussion omits or only briefly describes conventional features of devices for interaction with bodily tissues that are apparent to those skilled in the art. Those of ordinary skill may thus recognize that other elements may be desirable and / or necessary to implement the devices, systems, and methods described herein. It is noted that various examples are described in detail with reference to the drawings. Reference to these various examples does not limit the scope of the claims attached hereto.

[0070] Additionally, any examples set forth in this specification are intended to be nonlimiting and merely set forth some of the many possible implementations for the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations. As such, it is understood that the detailed description is exemplary and explanatory only and is not restrictive of the broad inventive concepts upon which the examples disclosed herein are based.

[0071] Unless otherwise specifically defined herein, all terms are to be given their broadest reasonable interpretation. This includes meanings implied from the specification as well as meanings understood by those skilled in the art and / or as defined in dictionaries, treatises, etc.

[0072] It is noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless otherwise specified. The terms “includes” and / or “including,” when used in this specification, specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0073] Relative terms such as “horizontal,” “vertical,” “up,” “down,” “top,” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then-described or as shown in the drawing figure under discussion. These relative terms are for convenience of description Attorney Docket No. 206030-0322-00 WO and normally are not intended to require a particular orientation in actuality. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The phrases “operatively” or “operably connected” indicates such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship.

[0074] Reference throughout the specification to “exemplary”, “one example”, “an example” or “some examples” means that a particular feature, structure, or characteristic described in connection with at least one example of the subject matter disclosed. Thus, the appearance of the phrases “in one example”, “in an example” or “in some examples” in various places throughout the specification is not necessarily referring to the same example. Further, the particular features, structures or characteristics of “one example”, “an example” or “some examples” may be combined in any suitable manner with each other to form additional examples of such combinations. It is intended that examples of the disclosed subject matter cover modifications and variations thereof. Terms such as “first,” “second,” “third,” etc., merely identify one of a number of portions, components, steps, operations, functions, and / or points of reference as disclosed herein, and likewise do not necessarily limit embodiments of the present disclosure to any particular configuration or orientation.

[0075] Moreover, throughout this disclosure, various aspects can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers Attorney Docket No. 206030-0322-00 WO within that range, for example, 1 , 2, 2.7, 3, 4, 5, 5.3, 6, and any whole and partial increments there between. This applies regardless of the breadth of the range. As used herein, the term “about” in reference to a measurable value, such as an amount, a temporal duration, and the like, is meant to encompass variations of plus or minus 20%, plus or minus 10%, plus or minus 5%, plus or minus 1%, and plus or minus 0.1% of the specified value, as such variations are appropriate.

[0076] The terms “proximal,” “distal,” “anterior,” “posterior,” “medial,” “lateral,” “superior,” and “inferior” are defined by their standard usage indicating a directional term of reference. For example, “proximal” refers to a position that is situated nearer to the center of a body or point of attachment or interest, while “distal” refers to a position that is situated away from the center of the body or point of attachment or interest. In another example, “anterior” refers to the front of a body or structure, while “posterior” refers to the rear of a body or structure, in relation to a relative viewpoint. In another example, “medial” refers to the direction towards the midline of a body or structure, and “lateral” refers to the direction away from the midline of a body or structure. In some examples, “lateral” or “laterally” may refer to any sideways direction. In another example, “superior” refers to the top of a body or structure, while “inferior” refers to the bottom of a body or structure. It should be understood, however, that the directional term of reference may be interpreted within the context of a specific body or structure, such that a directional term referring to a location in the context of the reference body or structure may remain consistent as the orientation of the body or structure changes.

[0077] As used herein, a “releasable” device component refers to a device component that may be configured to either sequester or expose a feature of a device to the external environment. A “releasable” device component may be dissolvable or otherwise detachable. A “releasable” device component may be configured to hinge, swing, fold, slide, pivot, lift, retract, screw, or unscrew.

[0078] Disclosed herein are novel systems and methods for monitoring patient health and / or providing therapy. Although exemplary devices for interaction with the gastrointestinal tract and / or other tissues are disclosed, it should be appreciated that aspects of the devices and methods disclosed herein may be operated in conjunction with other systems or devices, including ingestible systems or devices, gastrointestinal tract Attorney Docket No. 206030-0322-00 WO anchoring systems or devices, gastrointestinal health monitoring systems or devices, medical imaging systems or devices, drug administration systems or devices, surgical systems or devices, and / or surgical tools or instruments.

[0079] Disclosed herein is a device for interaction with a fluid passageway or any cavity. In some embodiments, the fluid passageway or cavity comprises a bodily tissue. The device may monitor patient health and / or provide therapy. As contemplated herein the device may be positioned in contact with a bodily tissue via any noninvasive placement. For example, the device may be ingestible or may be deployable from an insertion member. Exemplary insertion members for insertion of the device into a subject include but are not limited to a catheter, a wire, a needle, or a cannula. The device can be deployed in a tissue directly or otherwise introduced to the body of a subject such that it comes in contact with any number of tissues or tissue surfaces, for example a lymph node, a blood vessel, a heart chamber, a nasal cavity, a urinary tract, the respiratory system, the reproductive system, or the gallbladder. The device may be configured to remain in contact with any tissue or tissue surface for any duration. The device may be configured to remain anchored or otherwise in contact to a lumen wall, for example gastrointestinal (GI) tract wall, while any biological fluids flow through the lumen. The device may be configured to be small enough such that it does not interfere or only minimally interferes with biological function of a tissue or biological system, for example the GI tract, while anchored to the tissue. For example, the device may be configured to be small enough such that fluid flow through a lumen in which it is placed or anchored, for example the GI tract, is not disturbed or only minimally disturbed.

[0080] In some embodiments, the device may be used as a stent. In some embodiments, the device comprises electrodes, chemical sensors, optical sensors, pressure sensors, and / or strain sensors. In some embodiments, the device may deliver a drug, provide radiation therapy to a subject or tissue thereof, and / or provide thermal ablation to a subject or tissue thereof. In some embodiments, a generic chemical sensor of the device aids in enabling the use of the device as a mini chemistry lab.

[0081] In some embodiments, the device is configured for use in non-biological applications. In some embodiments, the fluid passageway or cavity comprises a pipe. For example, the pipe may be part of any plumbing. For example, the pipe may be a water Attorney Docket No. 206030-0322-00 WO pipe. In some embodiments, the device may monitor and modulate water quality or pipe structural integrity.

[0082] In some examples, the device is an ingestible device for monitoring patient health and / or providing therapy. The ingestible device can provide multiple real time insights into the state of a patient’s gastrointestinal health and the ingestible device may also be capable of targeted neuromodulation. The invention may assist physicians or other device operators in diagnosis and / or treatment and may provide real-time interfacing with a subject’s gastrointestinal health drastically improving patient care. The option for closed loop or operator controlled methods for interacting with the gastrointestinal tract may improve the adaptability of medical care. For example, therapies can be adjusted or deployed based on measurements of the device. Since data gathered by the device can refer to specific areas of the gastrointestinal tract, some embodiments offer the capability of targeted local therapy or neuromodulation based on local measurements. For example, the device may be anchored to a specific location of the gastrointestinal tract after which it can collect local measurements and deliver local therapies optionally based on the measurements. The invention may rely on automated functions and may be self-powered reducing dependence on physicians and custom environments. Implemented methods for determining the location may depend on a variety of factors such as device function, location specificity, and function repeatability. In some embodiments, a localization method may involve simple factors including time since ingestion. Additionally, properties of the gastrointestinal tract like pH, lumen size, peristalsis pressure, frequency, and velocity, and presence or absence of specific microbiome or molecular components vary between regions of the gastrointestinal tract, so the combination of properties can be used to estimate location. Other imaging methods including x-ray, fluoroscopy, ultrasound, computed tomography (CT) may be used for more precise localization. Tracking methods include magnetic marker monitoring that use embedded magnetic particles detectable with external sensors. Additionally, triangulation-based localization systems can use an embedded transmitter (electromagnetic, RF, ultrasonic, magnetic, hybrid) within the device and multiple external receivers on something relatively stationary, for example a belt, to continuously track and trace position within the gastrointestinal tract in real-time. Attorney Docket No. 206030-0322-00 WO

[0083] The disclosed device can be a non-invasive and out-of-hospital alternative to hospital visits and specialized tools. The disclosed device may overcome limitations inherent to other devices or techniques that are used outside of the body including distortion or dampening of gastrointestinal signals by overlaying tissues. The disclosed device may overcome limitations inherent to other more invasive devices or techniques that disturb native biological processes. Signals accessible to being sensed or recorded by the disclosed device include but are not limited to intestinal pacemaker cells, slow waves, electromyography, and electrocardiogram. The disclosed device can sense signals derived from digestion activity or activity of the microbiome including motion, pressure, pH, and temperature. The disclosed device can utilize sensors including: a pH sensor, a motion sensor, a pressure sensor, a biomolecule sensor, a microorganism sensor, any acoustic sensors, an accelerometer, a gyroscope, and / or a temperature sensor. Combining means for local, targeted, adaptive, short-term and long-term sensing, neuromodulation, and / or drug delivery into a single non-invasive device may offer speed, accuracy, and specificity for digestive system related care. In some embodiments, the device comprises a mechanism for performing chemical reactions (i.e., a mini chemistry lab). In some embodiments, the device comprises a stimulator unit.

[0084] In some examples, the device is an ingestible capsule. The capsule may be capable of monitoring, diagnosing, and / or treating systemic conditions, conditions related to the gastrointestinal tract, and / or conditions related to surrounding tissues. The ingestible device includes a housing which may contain multiple compartments. The compartments may house electrodes, an electrode array, sensors, stimulators, a bioactive substance payload, a bioactive substance delivery system, a power source, a mechanism for anchoring to the gastrointestinal tract, a mechanism for maneuvering around the gastrointestinal tract and / or a transmittance mechanism for wireless signals. The covering of individual compartments can be permeable or semipermeable to provide sensors or other device components access to the gastrointestinal environment. The covering of individual components can be engineered such that the covering becomes permeable or dissolves at a certain location in the gastrointestinal tract or at some time after ingestion. The device may include a combination of sensors to gather information about the microbiomic processes involved in digestion. Microbiome sensing may include aptamer Attorney Docket No. 206030-0322-00 WO coatings on electrodes, biosensors that protrude from the device and directly interact with the microbiome or its environment, optical components capable of both triggering and detecting fluorescence or luminescence emitted by specific biomarkers, and microfluidic chips designed to react with the surrounding media. These components can determine the concentration or presence of specific microorganisms through their biomarkers or any type of nucleome, including all types of nucleic acid-based biomolecules such as DNA, RNA, and their related molecules or derivatives. The device may include an electrode array that is capable of recording and / or stimulating abdominal electrical activity. In some embodiments, the electrode array can be deployed from the device and may anchor the device to the gastrointestinal tract. Anchoring mechanisms can allow for continued sensing, neuromodulation and / or drug delivery at a specified location of the gastrointestinal tract. Medical professionals that can implement or adopt this device in their practice include, but are not limited to, gastroenterologists, urologists, neurologists, endocrinologists, and surgeons.

[0085] Referring now to Figure 1A, shown is an exemplary device or capsule 100 in its closed configuration and generally includes a body or housing 102 with one or more compartments. The device 100 can have any number of compartments, and the compartments may have any shape or be of any size. For example, the device 100 may have three compartments 110a, 110b, and 110c. In some examples, as shown in Figures 1A through 1C, compartment 110a may be at one end of the device, compartment 110b may be at the middle of the device, and compartment 110c may be at the opposite end of the device as 110a. The capsule may be designed to be swallowed. After ingestion, the device may traverse the gastrointestinal tract by peristalsis. The size of the capsule 100 may vary between embodiments but will be a safe size for ingestion. The capsule 100 may be any shape including pill-shaped, spherical, a random shape, or cuboidal. In some embodiments, the capsule 100 may be designed to particular specifications or a standard size, including, but not limited to, a 000, 00, 0, 1, 2, 3, 4, and 5, as well as larger veterinary capsules Su07, 7, 10, 12el, 11, 23, 13, 110 ml, 90 ml, and 36 ml. The capsule 100 may be symmetrical to optimize hydrodynamics on both ends to encourage the device 100 to traverse the gastrointestinal tract such that the length of the capsule 100 is parallel to the length of the gastrointestinal tract. In some embodiments, the capsule 100 Attorney Docket No. 206030-0322-00 WO may be symmetrical to optimize hydrodynamics on both ends to encourage it to traverse parallel to the gastrointestinal tract regardless of direction and / or orientation. Alternative embodiments of the capsule 100 may have asymmetrical ends, including fins or different roundness and radii, to encourage a particular travel direction. In some embodiments, asymmetries aid the functionality of some biosensors included in the device 100. An exemplary embodiment of the ends of the device 100 may be shaped to minimize tissue damage, such as the hemispherical domes shown in the exemplary embodiments in Figures 1A through Figure 1C.

[0086] In some embodiments, the whole body or housing 102 is composed of the same material. This material may be bioinert in the operating environment. At least some sections of the body or housing 102 may be configured to withstand physical pressure, gastric acids, and other potentially destructive properties or components of the gastrointestinal tract. The capsule 100 may be coated with one or more enteric coatings that at least partially prevent chemical reactivity in the gastric environment. Exemplary enteric coatings include but are not limited to cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate (HPMCP), methacrylic acid copolymers, and shellac. In some embodiments, the capsule 100 is coated with one or more materials that are beneficial for patient safety. Example materials that are beneficial for patient safety include but are not limited to antimicrobial coatings, biopolymers, biopolymers with antimicrobial properties, chitosan, quaternary ammonium compounds, silver and zinc nanoparticles, oils, other organic acids and enzymes, triclosan, and zinc oxide. In some embodiments, the capsule is coated with an enteric coating and an additional coating. Another purpose of the coating can be to enhance swallowability, improving surface slipperiness to reduce choking risk and discomfort. Example materials that can enhance these properties include gelatin, polyvinyl alcohol, polyethylene glycol, and silicon dioxide. Additionally, flavoring and taste masking compounds including oils, extracts, sweeteners, gelatin, Ethylcellulose, Polymethacrylates, or similar materials can improve user experience.

[0087] In some embodiments, portions of the body or housing 102 may comprise different materials. In some embodiments, the body or housing 102 may comprise a different material than coverings of different device compartments, for example device or Attorney Docket No. 206030-0322-00 WO capsule compartment covering 103. In some embodiments, the covering of a capsule compartment, for example compartment 110c, may contain a permeable or semipermeable portion, for example portion 106, that may be of a different material than the rest of the covering of the device compartment. Different materials may serve different purposes. In some embodiments, certain materials allow certain sections or compartments, for example compartments 110a, 110b, and 110c, of the device 100 that house a sensor or transmitter, for example transmitter 112a and sensor 112b, to remain protected or to access desired signals or tissues. The materials may be configured to allow access to signals at certain times after ingestion or at certain locations within the gastrointestinal tract. For example, some materials may dissolve or break away from the capsule 100 under certain conditions or at a certain time after ingestion. In some embodiments of the device 100, one end of the capsule 100 or certain coverings of device compartments or portions of device compartments, for example covering 103 or portion 106, may be permeable to specific molecules for sensing by an embedded sensor.

[0088] In some embodiments of the device 100, body or housing 102, a section of the body or housing 102, a capsule body portion, or a covering that surrounds a compartment, for example covering 103 or portion 106 is releasable. Releasable device components or features may be dissolvable or otherwise detachable to expose a device feature, a device compartment, or part of a device compartment to the environment. A releasable device component or feature may swing, hinge, fold, slide, pivot, lift, retract, screw, or unscrew to expose a device feature, a device compartment, or part of a device compartment to the environment. Release of a device component or feature may be triggered autonomously by the device, by a device operator, or as a result of environmental conditions. Release may allow for a housed device feature including an electrode array, a sensor, a transmitter, a drug payload, or any other feature to be expelled from the device. Release may also allow for external material including gastric gases, gastric liquids, gastric tissue, or any other gastric material to enter the device. In some embodiments, a releasable device component or feature may be configured to reseal after it is released. Resealing may occur by hinging, folding, sliding, pivoting, attaching, lifting, screwing, or unscrewing. Resealing may protect a device component or feature from the environment, may capture material from the gastric environment such that it Attorney Docket No. 206030-0322-00 WO may remain in the device 100 after the device is passed by the subject or otherwise retrieved, or increase the safety of the device as it passes through the subject.

[0089] In some embodiments of the device 100, body or housing 102, a capsule body portion, or a covering that surrounds a compartment, for example covering 103 or portion 106, will be dissolvable in a specified pH range, or dissolution can occur after a specific time after ingestion or at a specific location in the gastrointestinal tract. The specified pH range may be any pH range. In some examples, housing 102, covering 103, or portion 106 are dissolvable in pH ranges found in the intestine. For example, housing 102, covering 103, or portion 106 can be dissolvable in pH ranges of a healthy or diseased intestine. Housing 102, covering 103, or portion 106 can be dissolvable in slightly acidic to neutral pH ranges, for example pH ranging from 5 to 7, commonly found in healthy intestine. pH ranges in intestines in a disease state may change. In some examples, housing 102, covering 103, or portion 106 are dissolvable in a pH below 8.5, below 8, below 7.5, below 7, below 6.5, below 6, below 5.5, below 5, below 4.5, or below 4. Dissolution of these components can allow sensors or transmitters, for example transmitter 112a, sensor 112b or sensing electrodes, access to the gastrointestinal tract, release of a drug payload, or release / exposure of stimulating electrodes.

[0090] In some embodiments, any number of electrodes are positioned on an exterior surface of the body or housing 102. Any embodiment of electrode 114 described herein for positioning on an electrode array 104 may also be configured to be positioned on an exterior surface of the body or housing 102. For example, a reference electrode may be positioned on an exterior surface of the body or housing 102. Electrodes positioned on an exterior surface of the body or housing 102 may be in communication with any other components of the device.

[0091] In some embodiments a compartment 110a,b,c may house at least one electrode array 104. For example, one or more electrode arrays may be more anterior, one or more electrode arrays may be in the middle, and one or more electrode arrays may be more posterior. In some embodiments, the electrode array 104 is a cable-style electrode array as shown in Figure 3B. Cable style electrode arrays may be packed within device compartments 110a,b,c. In some embodiments a silicone membrane, a thin silicone membrane, a polytetrafluoroethylene membrane, a gore-tex membrane, a microporous Attorney Docket No. 206030-0322-00 WO polymer membrane, or microporous polymers may be used to allow the device or sections of the device to be permeable to gasses but impermeable to liquids and solids. Other exemplary materials for constructing the body or housing 102, compartment covering 103, and portion 106 or any other capsule 100 sections include bioinert polymers and metals.

[0092] In some embodiments, coatings of capsule 100 can be layered. For example, the device may have an outer coating that is dissolvable. Layering of different dissolvable coatings can allow for systematic or sequential release or exposure of different device components and / or features. The body or housing 102, compartment covering 103, and portion 106 or any other capsule 100 sections can also be dissolvable. Additionally, the device may have a dissolvable coating in the interior of the body or housing 102, compartment covering 103, and / or portion 106 or any other capsule 100 section. The interior dissolvable coating may separate a device component, for example at least one electrode array, or any other sensor from the body or housing 102, compartment covering 103, and / or portion 106 or any other capsule section.

[0093] Now referring to Fig. IB, in some embodiments, the body or housing 102, covering of a capsule compartment 103, or a portion of a covering of a capsule compartment 106 may include an opening, doorway, or hatch 108. The opening 108 may be sealed with a releasable, a dissolvable or otherwise removable covering. In some embodiments, the covering may be removed by sliding back into the device 100, hinging back into the device 100, or folding back into the device 100 revealing opening 108 and / or releasing any components within the compartment optionally including releasing electrode array 104. The covering that seals the opening 108 may have a hinge. A hinged covering can allow for folding of the covering or resealing of the opening. Opening 108 may be any shape, including a rectangular slot or slit, circular, square, triangular, or a random shape. The opening 108 may allow components of the gastrointestinal tract including gasses, liquids, or solid components to pass into the underlying compartment 110a,b,c within the housing 102 for sensing. Additionally, sensing or stimulating components of the device may be housed within a compartment 110a,b,c and fed through or ejected through the opening 108 to interface with the gastrointestinal tract. An additional coating may be added to the compartment covering 103 to add thickness Attorney Docket No. 206030-0322-00 WO making the compartment covering 103 flush with the body or housing 102. Tn some embodiments, the body or housing 102 and the covering of a capsule compartment 103 are flush. In an alternative embodiment, the capsule 100 may not include a covering of a capsule compartment and the body or housing 102 may be the whole capsule exterior. In some embodiments, the opening 108 may be built into the body or housing 102. The housed transmitter 112a, sensor 112b, or housed electrode array 104 and protective coating of the compartment sitting flush with the remaining capsule body reduces drag and tissue damage after ingestion.

[0094] Now referring to Figure 1C. Shown is a transparent perspective of a longitudinal cross-section of an embodiment of device 100. In some embodiments, the device has any number of compartments, for example compartments 110a, 110b and 110c. The compartments may be any shape and may house any number of the device components including an electrode array 104, transmitter 112a, and sensor 112b. In some embodiments, the electrode array 104 is coiled, wound, wrinkled, compressed, or folded within a compartment 110a,b,c. The compartment covering 103 can prevent early deployment of the electrode array 104, transmitter 112a, and sensor 112b for safe ingestion by the patient. The electrode array 104, transmitter 112a, and sensor 112b may be flush against the compartment covering 103. In some embodiments, different compartments 110a,b,c of the device are sealed off from the outside environment and / or each other. For example, a battery power supply 113 may be sealed within a compartment 110a,b,c in addition to the compartment covering 103 to further prevent leakage into the gastrointestinal tract. Any sensors, transmitters, electrode arrays, or any other electrical components of device 100 may be sealed from the gastrointestinal tract. A seal may prevent any gas or liquid from being exchanged between the device compartment housing sensors, transmitters, electrode arrays, or any other electrical components of device 100 and the gastrointestinal tract.

[0095] In some embodiments, compartments 110a,b,c comprise semipermeable membranes or portions, for example portion 106, to enable the exposure of housed sensors to select properties of the gastrointestinal tract. For example, sensor 112b may be a gas sensor and may have access to the outside environment through a membrane or portion of a covering 106 that allows for fast diffusion of gastric gasses including Attorney Docket No. 206030-0322-00 WO oxygen, carbon dioxide, methane, and others. In some embodiments, multiple components such as a gas sensor and a metal-air battery in a compartment are separated by a single semipermeable membrane. In some embodiments, multiple components such as a gas sensor and metal-air battery in a compartment are separated by a single semipermeable membrane and an additional membrane that is selectively permeable to a subset of molecules for example oxygen and hydrogen. Referring now to Figure 1C, shown is a longitudinal cross section of device 100 in the closed conformation. The closed, compressed, wound, coiled, or folded electrode array 104 is constrained such that it is flush with the compartment covering 103. Compartments 110a,b,c may be separated by membranes that are impermeable, semipermeable, or permeable.

[0096] Printable circuit boards (PCBs) or other circuitry 1 I la and 11 lb can be housed in the device 100. Any PCB or circuitry can be used in the device 100. PCBs or other circuitry 11 la,b may be positioned to separate compartments 110a, b,c of the device 100. PCBs or other circuitry 11 la,b may be any PCB or circuitry. For example, substrate materials of a PCB can be FR-4, CEM-1, Polyimide, Teflon, Aluminum, Copper, Polyethylene Terepthalate, Napthalate, or Silicone. The conductive layer or layers of a PCB can be Copper, Gold, silver, electroactive polymers, indium tin oxide, or PEDOT. The insulative layer or layers of a PCB can be a solder mask layer composed of epoxy piqued, liquid photoimageable solder mask, or flexible solder mask.

[0097] For example, as in Figure 1C, the device 100 may include a first compartment 110a at an end of the device 100 that houses a transmitter 112a. The device 100 may also include a middle compartment 110b that houses a compressed, coiled, wound, or folded electrode array 104. The electrode array 104 of the middle compartment 110b may include a compartment covering 103 that may be dissolvable. The middle compartment 110b may also include a space 122. The space 122 may house sensors, circuitry connections, wirings, PCBs, or can be empty space. Any space in the device 100 not otherwise occupied by another component may be filled before ingestion with a specific gas or liquid or solid material or combination of materials, such as saline or weight filling beads. The filler materials may function to influence or balance travel direction, buoyancy, thermal insulation, stability, and / or avoid disrupting the environment when a compartment opens for example by introducing bubbles to the environment. The device Attorney Docket No. 206030-0322-00 WO

[0098] 100 may also include a third compartment 110c at another end of the device 100. Compartment 110c may contain a gas-permeable portion 106 and may house a gas sensor 112b. The compartments 110a, b,c may be separated by membranes. Circuitry or PCBs 111 a,b may also be housed by the device 100.

[0099] Now referring to Figure 2 A, shown is a transparent perspective view of an exemplary embodiment of a compartment 110c at an end region of device 100. The compartment 110c of the device may include a gas sensor 112b or any other kind of sensor, power source, electrode array, transmitter, or drug payload. Now referring to Figure 2B, shown is a transparent perspective of an exemplary embodiment of a compartment 110a at an end region of device 100. The compartment 110a of the device may include a transmitter 112a or any other kind of sensor, power source electrode array, or drug payload. The transmitter 112a and sensor 112b or any other housed sensor of any compartment may obtain or transmit more information about properties of the microbiome or the gastrointestinal environment. Sensors or transmitters may be housed in any compartment of the device. Sensors or transmitters may gather and / or transmit information while the device 100 traverses the gastrointestinal tract or while the device is anchored to the gastrointestinal tract. For example, sensors or transmitters can be housed in the ends of a capsule as in Figures 1C, 2A, and 2B, and / or in the middle of the device, and / or on the surface of the device. In some embodiments, sensors are chemical and / or physical sensors. In some embodiments, sensors measure properties including acidity, temperature, gas, gas content, pressure, and capsule orientation. In some embodiments, the device 100 may act as a closed-loop diagnostic or treatment tool wherein any combination of sensor outputs triggers a function of the device 100 including electrode deployment, electrode array deployment, electrode stimulation or neuromodulation, electrode recording, or release of a drug payload. For example, a pH sensor detecting an increase in pH indicative of the device entering the small intestine may trigger the deployment of an electrode array or neuromodulation. In some embodiments, sensors may include components exposed to the exterior of the device. In some embodiments, sensors are built into the capsule body or a compartment covering or are on the surface of the capsule body or compartment covering. The device 100 may have any number of sensors. Attorney Docket No. 206030-0322-00 WO

[0100] Now referring to Figure 3 A, shown is an exemplary embodiment 100 of the device in a configuration in which the electrode array 104 is deployed otherwise referred to as the “open state”. Electrodes 114 optionally in the form of an electrode array 104 may be initially housed within a compartment 110a, 110b, and / or 110c. The electrodes 114 or electrode array 104 may be deployed some time after ingestion to perform a function including monitoring, sensing, or treatment. The electrode array 104 may be deployed from within the device, optionally by decompression, unwinding, or unfolding at some time after ingestion as the device traverses the gastrointestinal tract.

[0101] The electrode array 104 may be capable of recording and stimulating electrical activity of or within the abdomen, gastrointestinal tract, cells of the gastrointestinal tract, nervous system, adipose tissue, or muscle tissue. The electrode array 104 or other sensors may record, gather, and / or transmit information regarding breathing for example a diaphragm EMG. The electrode array 104 or other sensors may record, gather, and / or transmit information regarding a subject’s heartbeat. For example, an acoustic sensor may be used to gather information about and / or record aspects of a subject’s breathing or heart rate. For example, an acoustic sensor may sense and / or record sounds that relate to a subject’s breathing, breathing rate, heartbeat, pulse, and / or heart rate. For example, an acoustic sensor may sense and / or record sounds that relate to heart function of a subject. In some examples, the electrode array 104 is capable of stimulating, directly or indirectly, the sympathetic, parasympathetic, enteric, and / or central nervous systems. The electrode array 104 may stimulate, directly or indirectly, the sympathetic, parasympathetic, enteric, and / or central nervous systems by applying electrical stimulation to any bodily tissue including any portion of the GI tract. The electrode array 104 or other sensors may record, gather, and / or transmit information regarding processes involved in digestion including but not limited to peristalsis, slow waves, and endothelial permeability. Generally, the electrode array 104 may interface with the electrical activity of cells surrounding the intestinal lumen as the device 100 traverses through the gastrointestinal tract and / or while the device 100 is anchored to the gastrointestinal tract.

[0102] The electrode array 104 may have any number or size of electrodes 114. The electrode array 104 may access a portion of or the entire circumference of the gastrointestinal tract where the electrode array 104 is deployed. The size and shape of the Attorney Docket No. 206030-0322-00 WO electrodes 114 of the electrode array 104 may be optimized for desired properties including charge density and number of cells accessed. The electrodes 114 may have any diameter. In some embodiments, the electrodes 114 are 5 mm to 8 mm in diameter. In some embodiments, the electrodes 114 are about 0.3 mm in diameter. In some embodiments, the electrodes 114 are about 0.5 mm in diameter. In some embodiments, the electrodes 114 are about 1mm in diameter. In some embodiments, the electrodes 114 are about 2 mm in diameter. In some embodiments, the electrodes 114 are about 3 mm in diameter. In some embodiments, the electrodes 114 are about 4 mm in diameter. In some embodiments, the electrodes 114 are about 5 mm in diameter. In some embodiments, the electrodes 114 are about 6 mm in diameter. In some embodiments, the electrodes 114 are about 7 mm in diameter. In some embodiments, the electrodes 114 are about 8 mm in diameter. In some embodiments, the electrodes 114 are about 9 mm in diameter. In some embodiments, the electrodes 114 are about 10 mm in diameter. In some embodiments, the electrodes 114 of the electrode array 104 are spaced evenly along the electrode array 104. In some embodiments, the electrodes 114 of the electrode array 104 are spaced with a variable spacing along the electrode array 104. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about any distance apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 30 mm apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 4 mm apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 25 mm apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 20 mm apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 20 mm apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 15 mm apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 10 mm apart. In some embodiments, the electrodes 114 of the electrode array 104 are spaced about 5 mm apart.

[0103] In some embodiments, the electrodes 114 are any shape. In some embodiments, the electrodes 114 are a circle, an oval, a square, or a rectangle. Electrodes 114 of a round shape can be used to reduce charge density at comers. Microneedles can be incorporated into the electrodes 114 for better penetration into gastrointestinal tract tissue. Electrodes Attorney Docket No. 206030-0322-00 WO

[0104] 114 can have any surface roughness. For example, the surface roughness of the electrodes 114 can be high for better anchoring friction against the gastrointestinal tract.

[0105] The electrode array 104 can be any length. The electrode array 104 expanded length can be designed such that the array spans the whole circumference or at least half of the circumference of the gastrointestinal tract at a specific location. The electrode array 104 expanded length can be 4 cm to 10 cm. The electrode array 104 expanded length can be about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, or about 14 cm.

[0106] The electrode array 104 can be any shape. For example, the electrode array 104 can be a flat rectangular strip as in figure 3A, cylindrical, or a thin wire as in figure 3B.

[0107] The electrodes 114 may interface through recording, stimulation, or a combination of the two. The electrode array 104 may record electrical activity originating from motility such as from innervated smooth muscle, peristalsis pacemaker cells or Interstitial Cells of Cajal, the autonomic nervous system, or the enteric nervous system. The electrode array 104 may stimulate through electrical activity, electrical stimulation, or neuromodulation by targeting innervated smooth muscle, peristalsis pacemaker cells or Interstitial Cells of Cajal, the autonomic nervous system, or the enteric nervous system. Electrical stimulation or neuromodulation of target systems, tissues, or cells may function to excite peristalsis optionally to clear blockages, inhibit sympathetic activity optionally to increase the breakdown of adipose tissue, regulate gastric dysrhythmias, measure endothelial permeability, regulate neuro-immune interactions including the brain-gut axis or autonomic balance, regulate microbiome production, or regulate vascular activity.

[0108] A transmitter 112a, or any other transmittance mechanism of the device 100 may wirelessly send electrical recordings or wirelessly receive electrical stimulation protocols. These wireless signals may either be a continuous stream of data points or intermittent packets of values. Some electrodes 114 of the device or of an electrode array 104 may record and others may stimulate. In some embodiments, a microcontroller within the device may enable electrodes 114 to transition between recording and stimulation states. The transition of electrodes 114 between states may be autonomous optionally in response to specific signals or triggers sensed by the device 100. The transition of Attorney Docket No. 206030-0322-00 WO electrodes 114 between states may also be controlled by an operator or medical professional optionally through wireless signaling to the device.

[0109] The electrodes 114 may be constructed out of any materials or any combination of materials. In some embodiments, different electrodes on the array may be constructed of different materials. In some embodiments, materials that may be better suited for recording including platinum, gold, iridium oxide, carbon-based materials including graphene or carbon nanotubes, and titanium may be used. In some embodiments, materials that may be better suited for stimulating including platinum, iridium oxide, and iridium alloys may be used. In some embodiments materials that may be better suited to function as both recording and stimulating electrodes may be used including titanium, tantalum, and other alloys, conductive polymers including PEDOT, and diamond-like carbon. In some embodiments, any combination of these materials or others are used for the electrodes 114. Electrode 114 materials better suited for stimulating may also be used for recording, and electrode 114 materials better suited for recording may also be used for stimulating. In some embodiments, electrodes 114 have a surface coating or surface treatment. Surface coatings or surface treatments can include titanium nitride, iridium oxide, diamond-like carbon, conductive polymers including PEDOT, and hydrogels.

[0110] The electrodes 114 may be positioned in any orientation on the electrode array 104. In some embodiments, the electrode array 104 is in the form of a ring or a partial ring after deployment. In some embodiments, the deployed electrode array 104 is in the form of a linear arm or any other shape. In some embodiments, the electrodes 114 are positioned along the electrode array 104 to span the circumference or at least a portion of the circumference of the gastrointestinal tract lumen. In some embodiments, the orientation of electrodes 114 allows the entire circumference of the intestinal wall at any specific location or at the anchored device 100 location to be stimulated by electrodes or for recording data that refers to an entire circumference of the gastrointestinal tract. In some embodiments, the electrodes 114 are oriented so that one or more electrodes 114 are more proximal and one or more electrodes 114 are more distal in the gastrointestinal tract. More proximal and distal electrodes 114 may allow for the acquisition of signals to determine the velocity of peristalsis contractions propagating down the gastrointestinal tract. In some embodiments, a sensor of the device 100 determines the device orientation Attorney Docket No. 206030-0322-00 WO before electrode array 104 deployment. In some embodiments, the electrode array is deployed when the device 100 exhibits a desired orientation so that the desired orientation of the electrode array 104 with respect to the gastrointestinal tract can be achieved. In some embodiments, device 100 can be reoriented autonomously or by an operator to achieve the desired orientation before electrode array 104 deployment.

[0111] Now referring to Figure 3B, shown is an exemplary embodiment 100 of the device in a configuration in which the electrode array 104 is deployed otherwise referred to as the “open state”. The electrode array 104 may be cylindrical or a thin wire. Shown is a cross section of an exemplary cylindrical or wire electrode array 104. In some embodiments, the electrode array 104 can be arranged as a bundle of cables within a larger cable. In some examples, each cable in the bundle corresponds to one or more of the electrodes 114. The opening 108 may be a circle such that a cylindrical wire can be deployed through the opening. In some embodiments, the device 100 contains multiple cables that can be fed through the opening 108. In some embodiments, the electrode array 104 can be a cable that houses many electrodes 104. In some embodiments, a cylindrical or thin wire electrode array is deployed after the dissolution of a device compartment covering.

[0112] Now referring to Figure 3C, shown is an exemplary embodiment 100 of the device in a configuration in which the electrode array 104 is deployed otherwise referred to as the “open state”. In some embodiments, the expanded electrode array 104 can be in the shape of a ring with one or more wing regions 105 extending outward from the ring. Wing regions allow for signals to be acquired by electrodes in locations spanning the gastrointestinal tract circumferentially and longitudinally. For example, electrodes in the ring portion of the electrode array 104 can span the circumference of the gastrointestinal tract, while the electrodes on the wing region can span more proximal and distal regions of the gastrointestinal tract. In some embodiments, the wing regions of the electrode array 104 are attached to the ring portion of the electrode array 104 by a dissolvable linker.

[0113] The electrode array 104 may also be branched and may have any number of branches. The branches may extend in any direction. Wing regions 105, or branches of the electrode array 104 may be folded, wound, or compressed to be housed within the capsule 100. Attorney Docket No. 206030-0322-00 WO

[0114] Now referring to Figure 3D, shown is an exemplary embodiment 100 of the device in a configuration in which the electrode array 104 is deployed otherwise referred to as the “open state”. In some embodiments, the electrodes 114 of the electrode array 104 can be positioned on either side of electrode array 104. For example, the electrode array 104 may be a flat strip and in the expanded position may be in the form of a ring. Electrodes 114 may be placed along the circumference of the ring or may be placed on either side of the strip such that electrodes span the circumference of the gastrointestinal tract and also span more proximal and more distal regions of the gastrointestinal tract.

[0115] Now referring to Figure 4 through Figure 7, shown are transparent views of embodiments of device 100 when transitioning between the closed and open state in an intestinal lumen. In some embodiments, the electrode array 104 is deployed to transition the device from the closed state to the open state. The electrode array may be deployed from within a compartment, for example compartment 110a, 110b, or 110c, of the device 100, optionally by decompression, unwinding, or unfolding at some time after ingestion as the device 100 traverses the gastrointestinal tract. In some embodiments, the electrode array may be deployed from within a compartment, for example compartment 110a, 110b, or 110c, of the device 100, by being pushed optionally by a motor. In some embodiments, the electrode array may be deployed from within a compartment, for example compartment 110a, 110b, or 110c, of the device 100, by being pulled optionally by the intestinal wall after attachment. The electrode array 104 may be deployed after the compartment covering 103 to the compartment 110b housing the electrode array 104 is dissolved or mechanically released. In some embodiments, the electrode array 104 may be deployed after the opening 108 is mechanically released or dissolved.

[0116] In some embodiments, different materials surround the electrode array 104, enabling a variety of deployment mechanisms. These materials may be included as the compartment covering 103 to the compartment 110b housing the electrode array 104. For example, a material surrounding the electrode array 104 may retain structure and contain the electrode array 104 within a compartment 110a, 110b, or 100c of the device in the upper gastrointestinal tract, but may dissolve in the small intestine due to the higher pH therefore exposing the electrode array 104 to the environment when the capsule 100 reaches the small intestine. Exemplary material coatings that may dissolve in response to Attorney Docket No. 206030-0322-00 WO time since ingestion, environmental pH, or other properties specific to certain gastrointestinal locations include hydroxypropyl methylcellulose acetate succinate, Eudragit L100-55, poly(methacrylic acid-co-methyl methacrylate), cellulose acetate phthalate, and other cellulose derivates with similar polyelectrolyte nature to cellulose acetate phthalate.

[0117] In some embodiments, the compartment covering 103 of the compartment 110b housing the electrode array 104 is not dissolvable. The electrode array 104 may be exposed to the gastrointestinal tract by mechanical removal of a compartment covering 103. The compartment covering 103 may be removed by sliding back into the device 100, hinging back into the device 100, or folding back into the device 100 revealing an opening and releasing the electrode array 104. The compartment covering 103 may also be then subsequently replaced by sliding back over the compartment, hinging back into place over the compartment, or folding back in place over the compartment. The compartment covering 103 may also be configured to break away from the capsule 100 releasing the electrode array 104. In some embodiments, as in Figure 7, the electrode array 104 may be deployed through an opening 108, optionally a slot opening, in the body or housing 102 or an opening in the compartment covering 103 of the compartment 110b housing the electrode array 104.

[0118] A number of mechanisms may transition the electrode array 104 from the “closed state” in which the effective size of the electrode array 104 is reduced and housed within the capsule 100 or a compartment 110a, b,c within the capsule 100, to the “open state” in which the electrode array 104 is exposed to the gastrointestinal tract. In some embodiments, the electrode array 104 includes a substrate 116. Various embodiments employ different materials, or combinations of materials, for the substrate 116 of the electrode array 104 to control certain aspects of electrode array 104 deployment such as effective anchoring to the gastrointestinal wall, repeatability of deployment and retraction, and number of possible deployments and retractions.

[0119] In some embodiments, the substrate 116 is comprised of an elastic polymer. The elastic polymer may be designed such that while compressed it may fit into a compartment 110a,b,c of the device 100 and such that while uncompressed it may take on a shape having a circumference that matches or exceeds the diameter of a lumen within Attorney Docket No. 206030-0322-00 WO the gastrointestinal tract. Elastic polymer materials suitable for the electrode array 104 substrate 116 include but are not limited to a polyimide or silicone rubber. In some embodiments, the electrode array substrate 116 comprises an electroactive polymer. Exemplary electroactive polymers include but are not limited to silicone and acrylic elastomers. In response to an electrical signal, an initially closed electrode array 104 that includes an electroactive polymer substrate 116 will open. Upon termination of the electrical signal, the electrode array 104 that includes the electroactive polymer substrate 116 will retract to the closed state. In some embodiments, the electrode array 104 is a ring and the inner side of the electrode array substrate 116 is an electroactive polymer or has embedded electroactive polymer particles. Upon an applied voltage the electroactive polymer can expand, therefore increasing the radius of the electrode array 104 ring or straightening the electrode array ring 104. In some embodiments, the electrode array 104 containing an electroactive polymer as at least part of the electrode array substrate 116 shrinks, curls, straightens, expands, or retracts in response to an applied voltage. In some embodiments, the electrode array substrate 116 is a gel or fluid sandwiched between two electrodes and the gel or fluid can change shape or volume with applied voltage. The electrical signal can originate from a medical professional externally operating the device 100 or can be an automatic response to another onboard sensor. In some embodiments, the electrode array 104 includes a dielectric elastomer substrate 116. In response to the presence of an electric field, an electrode array 104 that includes a dielectric elastomer substrate 116 can change between flat and coiled configurations. In other words, an electrode array 104 that includes a dielectric elastomer substrate 116 can deploy or retract in response to the presence of an electric field.

[0120] In some embodiments, a mechanical mechanism may deploy and / or retract the electrode array 104. In some embodiments, a motor or spring may deploy and retract the electrode array 104 on command. For example, a motor or spring may be deployed to rotate an attachment point of the electrode array 104 to the device 100, therefore winding or unwinding the electrode array 104. In some embodiments, the device comprises a propulsion unit to drive a motor.

[0121] To hold the array in the closed state, some embodiments can utilize a rigid compartment covering with a small opening 108, optionally a slot opening, for the Attorney Docket No. 206030-0322-00 WO electrode array 104. The electrode array 104 may be anchored on one end or two ends to the device 100 creating an electrode array 104 in the form of a ring when in the open state. The electrode array 104 can be retracted and redeployed based on activity of a motor or release of a spring. The motor or spring may be housed within the capsule 100 or within a capsule compartment 110a,b,c. In some embodiments, the magnitude of radial pressure exerted by the electrode array 104 during deployment or while in the open state is adjustable and facilitates electrode array contact, interaction, and / or anchoring with or to gastrointestinal tract lumens of different size. The magnitude of radial pressure of the deployed electrode array 104 may be controlled by the degree of electrode array unwinding 104 controlled by the activity of a motor or spring. For example, the number of rotations of the attachment point of the electrode array 104 to the body may be optimized for a certain degree of unwinding and / or a certain degree of radial pressure exerted by the electrode array. In some embodiments, a sensor in the motor can detect when sufficient rotation has occurred to push the electrode array against the intestinal wall. In some embodiments, a sensor to monitor current consumption by the motor detects when the electrode array meets resistance expanding against the intestinal wall. For example, a force sensor may detect resistance against further unwinding of the array and trigger the motor to stop unwinding. In some embodiments, a device operator optionally a physician may control the winding and unwinding of the array. The readings of a force sensor and / or current sensor may be transmitted to the device operator to aid in decision-making when unwinding or winding the array. In some embodiments, electrode array 104 may comprise any sensor(s) positioned near or at any contact point between electrode array 104 and a lumen wall. The sensor(s) positioned near or at a contact point may be configured to detect undesired and / or improper electrode array 104 deployment, for example, non-perpendicular attachment to a lumen wall.

[0122] In some embodiments, the electrode array 104 includes a substrate 116 that is constructed of a flexible polymer, a shape memory polymer, an electroactive material, a dielectric elastomer, and / or a biodegradable polymer. In some embodiments, triboelectric, piezo-electric, or magneto-electric properties can be built into the electrode array 104 for manometric detection. Attorney Docket No. 206030-0322-00 WO

[0123] The electrode array 104 may also function to anchor the device to the gastrointestinal tract, optionally at a specified location within the gastrointestinal tract that is predetermined or with the specified location optionally being set in response to properties sensed by sensors of the device 100, or with the specified location optionally being set in real time by an operator of the device 100. The deployment of a separate gastrointestinal tract anchoring system may also anchor the device to the gastrointestinal tract for some time. The device 100 may be anchored to the gastrointestinal tract for any amount of time including an indefinite amount of time. The device 100 may be anchored to the gastrointestinal tract for up to 30 minutes to up to 7 days. The device 100 may be anchored to the gastrointestinal tract for up to about 30 minutes, up to about 1 hour, up to about 2 hours, up to about 3 hours, up to about 4 hours, up to about 5 hours, up to about 6 hours, up to about 7 hours, up to about 8 hours, up to about 9 hours, up to about 10 hours, up to about 11 hours, up to about 12 hours, up to about 13 hours, up to about 14 hours, up to about 15 hours, up to about 16 hours, up to about 17 hours, up to about 18 hours, up to about 19 hours, up to about 20 hours, up to about 21 hours, up to about 22 hours, up to about 23 hours, up to about 24 hours, up to about 1.5 days, up to about 2 days, up to about 3 days, up to about 4 days, up to about 5 days, up to about 6 days, and up to about 7 days. The anchoring system may release the device 100 or components of device 100 including the electrode array 104 from the gastrointestinal tract after some time. In some embodiments, the electrode array or other anchoring system may be redeployed after retraction to anchor the device again at another location within the gastrointestinal tract.

[0124] Referring now to Figures 4 through Figure 6, shown is a transparent perspective view of an embodiment of device 100 in closed and open configurations within an intestinal lumen. In the open state the electrode array 104 is deployed and may anchor the device 100 to the intestinal wall. In the closed state, the electrode array 104 is compressed within a compartment by compartment covering 103. Referring now to Figure 4, in some embodiments, the electrode array 104 is attached to the body 102 at the center 118 of the body 102. Referring now to Figure 5, in some embodiments, the electrode array 104 is attached to the body 102 at periphery attachment point 120 of the body 102. In some embodiments, periphery attachment point 120 is on an interior surface, and exterior surface or against the lateral side of an edge of body 102. For Attorney Docket No. 206030-0322-00 WO example, as depicted in Figures 5 and 6, periphery attachment point 120 may be on a portion of body 102 that extends partially over an open compartment or other opening of the device.

[0125] Referring now to Figure 6, in some embodiments, the electrode array 104 is attached to the body 102 at two locations, at the center 118 and at the periphery attachment point 120. In the “open state” in which the compartment covering 103 is released or dissolved and the electrode array 104 is deployed, the electrode array 104 may anchor the device to the intestinal wall. The electrode array 104 may be compressed within the compartment 110b and maintained in place by the compartment covering 103 in the closed state and may expand upon release of compartment covering 103 in the open state. In the case of an electrode array 104 including a substrate 116 constructed of an electroactive material, the electrode array 104 can be retracted from the open state upon an electrical signal i.e. a current. In the case of electrode arrays that include substrates constructed of flexible polymers and / or shape memory polymers, the electrode array 104 may dissolve to be passed by the subject.

[0126] In some embodiments, as in Figures 6, 7, and 15 a spring or a motor can unwind the electrode array 104 to expand and allows the electrode array 104 to access the intestinal lumen. For example, a motor or spring may control the rotation of an attachment point of the electrode array 104 to the body or housing 102 or any other component of device 100. Retraction of the electrode array 104 can be powered by a motor. The electrode array 104 may be retracted to the initial coiled position. The electrode array 104 can be extended to contact a portion of or the entire circumference of the intestinal lumen in the open state. The electrode array 104 can be wound or unwound by more or fewer rotations of an attachment point to the device 100 to exert different magnitudes of pressure on the intestinal wall. The magnitude of radial pressure exerted against the intestinal wall may control the anchoring of the electrode array 104 to the intestinal wall in the open state. In embodiments that use a motor or spring to retract or deploy the electrode array 104, a compartment covering 103 may restrain the electrode array 104 when in the closed state and may not be dissolvable. In embodiments that use a motor or spring to retract or deploy the electrode array 104, the electrode array may be retracted back to the closed state of device 100 such that the electrode array may then be Attorney Docket No. 206030-0322-00 WO redeployed. Embodiments in which there are two attachment points of the electrode array to the device 100 may promote proper retraction of the electrode array 104 to the closed state. A dissolvable coating may protect the electrode array from acidic gastric fluids.

[0127] Referring now to Figure 7, shown is a transparent perspective of an embodiment of device 100 in closed and open configurations within an intestinal lumen. In some embodiments, the capsule body further comprises an opening 108. The electrode array 104 is attached to the body 102 at the center 118 of the body 102. To transition from the closed state to the open state the electrode array 104 is deployed through the opening 108 in the compartment covering 103 or body 102. The electrode array 104 is unwound by the rotation of the attachment point 118 of the device 100 located at the center axis. As depicted in Figures 6 and 7, attachment point 118 may be part of a spool such that electrode array 104 may wrap around the spool and the spool may rotate to wind and unwind the electrode array 104. The rotation may be driven by a motor or spring contained within the device 100. In this embodiment, the electrode array 104 can be a flexible polymer. The compartment covering 103 or the compartment 110b of the electrode array 104 can include additional guides.

[0128] A spool may be any structure that rotates about itself. In some embodiments, a spool comprises a gear. Electrode array 104 may be wound around a spool any number of rotations in open or closed configurations of device 100. A spool may have any diameter. For example, a larger diameter spool may aid in guidance of electrode array 104. For example, a smaller diameter spool may take up less space within device 100. In some embodiments, a spool may be hollow and may contain any device components within the hollow cavity of the spool.

[0129] Now referring to Figure 15, shown is a cross section of an embodiment of device 100 in closed and open configurations. In some embodiments, in the closed state electrode array 104 is at least partially in contact with an exterior surface of body 102 of device 100. For example, electrode array 104 may be attached at one end of the array to attachment point 118 positioned in the interior of the device 100 and at one end to periphery attachment point 120 positioned on an exterior surface 102. In this embodiment, electrode array 104 may be positioned such that the electrode array 104 passes through an opening that connects the interior and exterior of device 100, for Attorney Docket No. 206030-0322-00 WO example opening 108. In this embodiment, any electrodes 114 or other sensors may be positioned on the electrode array 104 such that the electrodes 114 face the exterior of the device. Therefore, the electrodes 114 may be exposed to the device environment in both closed and open configurations. This may allow for sensing, recording, or stimulation of the device 100 environment via electrodes 114 in both the open and closed configurations of device 100.

[0130] As depicted in Figure 15, a spool comprising attachment point 118 may be rotated to wind or unwind electrode array 104, thereby transitioning electrode array 104 between open and closed configurations. For example, the electrode array 104 may travel through opening 108 such that more or less of the electrode array 104 is exposed to the exterior of the device. In some embodiments, the interior of a spool may comprise a spacing 122. As described herein spacing 122 may be configured to house any components or sensors of device 122. For example, as depicted in Figure 15, spacing 122 may comprise any PCBs or other circuitry 111. In some embodiments, device 100 comprises a track 124 on an exterior surface of body 102 configured such that electrode array 104 may rest against track 124 in the open configuration. Track 124 may also aid in the guidance of electrode array 104 through opening 108 while transitioning between open and closed configurations.

[0131] In some embodiments, additional guides may be used such that the electrode array 104 does not become tangled, twisted, stuck, or conform to any undesired shapes. In some embodiments, track 124 is incorporated into device 100 in addition to any other additional guides and / or additional supports. Additional guides or additional supports may also be built into the electrode array 104. For example, additional guides or supports of the electrode array 104 may act as bumpers or guide wires. Bumpers or guide wires may be used to ensure the electrode array 104 flexes radially and does not flex longitudinally.

[0132] In some embodiments, the device is anchored to the gastrointestinal tract. In some embodiments, the device is anchored to the gastrointestinal tract by way of the electrode array anchoring to the gastrointestinal tract after deployment. In some embodiments, the deployed electrode array is anchored to the gastrointestinal tract for some time, while the rest of device 100 traverses the gastrointestinal tract. In some embodiments, the deployed Attorney Docket No. 206030-0322-00 WO electrode array acts to anchor the capsule 100 or components of the capsule 100 to the gastrointestinal tract. In some embodiments, the deployed electrode array is physically attached to the body or housing 102 or any other device 100 component. In some embodiments, the deployed electrode array 104 maintains contact stability with and / or remains anchored to the gastrointestinal tract during contractions and expansions of smooth muscle. In some embodiments, the deployed electrode array 104 maintains contact stability with and / or remains anchored to the gastrointestinal tract while chyme flows through the gastrointestinal tract. In some embodiments, there are no gaps formed between the electrodes 114 and the gastrointestinal tract wall. In some embodiments, the deployed electrode array maintains contact stability with or remains anchored to the gastrointestinal tract lumen wall by exerting radial pressure on the gastrointestinal tract lumen wall. The amount of radial pressure exerted by the deployed electrode array 104 may be controlled by the dimensions of the relaxed state of the electrode array 104. For example, an electrode array substrate 116 made of an elastic polymer may be designed so that the relaxed state is a ring with larger circumference than the gastrointestinal tract lumen. In this case, the elastic polymer substrate will exert a radial pressure on the gastrointestinal tract wall after deployment. The amount of radial pressure exerted by the deployed electrode array 104 may be optimized for the desired level of contact stability. The electrode array substrate 116 material may have any Young’s modulus. The electrode array 104 may be designed such that it can roll up tightly in the closed state and exert outward pressure in the open state.

[0133] In some embodiments, the electrode array 104 is unwound for deployment and, as in Figures 6, 7, and 15, the degree of unwinding is related to the radial pressure exerted on the gastrointestinal tract wall after deployment. In some embodiments, the roughness of the electrode array substrate 116 is optimized for the desired level of contact stability or anchoring stability with the gastrointestinal tract wall. In some embodiments, the friction coefficient of the electrode array substrate 116 is greater than 0.5. In some embodiments, the friction coefficient of the electrode array substrate 116 is greater than 0.4. In some embodiments, the friction coefficient of the electrode array substrate 116 is greater than 0.3. In some embodiments, the friction coefficient of the electrode array substrate 116 is greater than 0.2. In some embodiments, the friction coefficient of the Attorney Docket No. 206030-0322-00 WO electrode array substrate 116 is greater than 0.1 . In some embodiments, surface patterns are employed on electrode array substrate 116 materials including silicone, polyurethane, and PDMS to modulate the roughness and / or friction coefficient. In some embodiments, surface patterns are used to optimize roughness similarly to surface patterns that are used to optimize roughness in stents.

[0134] In some embodiments, the properties of the deployed electrode array 104 including stiffness and flexibility allow the creation of enough outward pressure to anchor the device to the gastrointestinal tract without puncturing or injuring tissue. For example, the exerted outward pressure may be enough to overcome peristaltic pressures or to match a peristaltic pressure. Peristaltic pressure may vary depending on the subject and disease state of the subject. Surface properties including roughness, microhooks, and / or adhesive layers may also be present on either side of the electrode array 104 to secure the electrode array and device to the gastrointestinal tract. In some embodiments, a protrusion that is optionally dissolvable extends outward from the electrode array 104 in the open state that attaches to the intestinal wall.

[0135] In some embodiments of the device, a releasable component attaches the deployed electrode array 104 to the rest of the capsule 100. Dissolvable components allow for components of the device 100 including the body 102 and electrode array 104 to break apart to release the capsule 100 from the electrode array 104 or break the device 100 into any number of smaller pieces that can be easily passed by the subject. The dissolvable components may be designed to dissolve after a desired time after ingestion or at a certain pH. In some embodiments, mechanical or electrical signals trigger the retraction of the electrode array 104. The retraction of the electrode array 104 may release the device 100 from being anchored to the gastrointestinal tract. In some embodiments, the anchored electrode array 104 is released from the gastrointestinal tract by force derived from smooth muscle activity or chyme flowing through the gastrointestinal tract. In some embodiments, retraction of the electrode array 104 is triggered by an electrical or mechanical signal. In some embodiments an electrical or mechanical signal releases the electrode array 104 and / or other components or from the device 100.

[0136] Retraction, dissolution, folding, wrinkling, winding or some other release mechanism of the electrode array anchoring system or other anchoring system may Attorney Docket No. 206030-0322-00 WO release the device from the gastrointestinal tract after some time. In some embodiments, the electrode array or other anchoring system may be redeployed after retraction to anchor the device again at another location within the gastrointestinal tract.

[0137] In some embodiments, the device manipulates the surrounding tissue and fluids while traversing the gastrointestinal tract or while anchored to the gastrointestinal tract. In some embodiments, electronic stimulation protocols are applied to surrounding cells by the electrodes 114 in or more locations. The electrodes 114 for applying stimulation may be positioned anywhere on device 100 for example the may be positioned on electrode array 104 and / or on the body or housing 102 of device 100. In some embodiments, compartments 110a,b,c or any other compartments of the device 100 or cavities of the device 100 are functionalized for drug delivery. In some embodiments, a cavity, compartment, or reservoir of the device contains a pharmaceutical agent payload. In some embodiments, a drug payload is released into the intestine. In some embodiments, a drug payload is injected using microneedles. In some embodiments, a drug payload is delivered through mechanical, chemical, or biological mechanisms. For example, the drug payload may be an engineered virus or other mechanism for gene editing. In some embodiments the drug is mixed within a polymer for long-term release. In some embodiments, a coating of the device 100 or any compartment of device 100 has integrated molecules for long-term release.

[0138] In some embodiments, any motion sensor may be incorporated in the device. A motion sensor may gather record, or sense any information related to the motion of the device or the orientation of the device. For example, a motion sensor may sense velocity, rotation, or orientation of the device 100. Exemplary motion sensor include but are not limited to an accelerometer or a gyroscope.

[0139] In some embodiments, the device 100 is propelled in addition to passive motion through the gastrointestinal tract. In some embodiments, device 100 comprises a spatial navigator unit. In some embodiments, the device is configured to be propelled such that it may be dislodged from the gastrointestinal tract in the event of gastrointestinal track blockage. The device 100 may be propelled by thrusters. The thrusters may include physical mechanisms such as propellers or fins. The thrusters may also include chemical mechanisms such as gas expulsion. In some embodiments, a group of motors may be Attorney Docket No. 206030-0322-00 WO used for directional and velocity control when operating. In some embodiments, fins or rudders of the device 100 are used to control the device propulsion direction. The device 100 may be maneuvered by wheels, crawler tracks, or something similar. In some embodiments, the fins, rudders, wheels, or crawler tracks of the device are retractable. Components useful for device 100 propulsion may be contained in a compartment and may be deployed, retracted, or redeployed by any release mechanism at any point.

[0140] In some embodiments, the device is configured to dislodge any blockages in a lumen in which the device is positioned. The blockage may be any blockage. In some embodiments, the blockage may be derived from the device itself. In some embodiments, electrode array 104 provides radial pressure against a lumen, for example the GI tract, in which the device is positioned to widen the lumen to relieve a lumen blockage in a subject. In some embodiments, electrode array 104 provides radial pressure against a lumen, for example the GI tract, in which the device is positioned to provide force to dislodge the device itself from the GI tract. In some embodiments, electrode array 104 may provide stimulation and / or neuromodulation to a GI tract such that the GI tract may activate secretory functions to lubricate the endoluminal wall for easier passage. In some embodiments, neuromodulation can activate smooth muscle and / or ICCs (pacemaker cells in the GI tract) to increase motility forces to move the device itself and / or any lumen blockage through the GI tract.

[0141] Referring now to Figure 8 in some embodiments, the device 100 contains electrical components or a circuit. In some embodiments, biopotentials are measured. The multiplexer B can be applied to record electrical signals derived from the electrodes A without applying stimulation protocols L across them. K is electrical impedance probe signals. Both injected current but El probe signals should be below the threshold to proceed to activate some function. In some embodiments, it is advantageous for El probe signals to go through a dedicated impedance analyzer unit.

[0142] Any number of electrodes inputs A may be multiplexed by a multiplexer B to simplify the signal processing and transmission in an efficient space. The system may rely on amplification C, band pass filtering D, signal acquisition by the microcontroller F, storage G, and posterior communication through the Bluetooth or other wireless component H to communicate with an external device or other external receiver O and Attorney Docket No. 206030-0322-00 WO show the results. Gain and comer frequencies may be determined based on the specific acquired signal. In some embodiments, the microcontroller will also receive inputs from other sensors J on the device and transmit them accordingly.

[0143] In some embodiments, neuromodulation is performed by the device 100. The multiplexer B can distribute neuromodulatory protocols L to the appropriate electrodes A in stimulating environments. In some embodiments, stimulation is initiated by a closed- loop and / or directed process. In some embodiments, the system utilizes an impedance analyzer E for a more detailed impedance analysis of surrounding tissues. In some embodiments, as shown in Figure 8, the command to start the impedance analysis is received through the same process as neuromodulation. In some embodiments, commands are initiated by a physician. In some embodiments, commands are initiated by an autonomous process. The impedance analyzer E sends a probe signal K through the appropriate multiplexers B and then to the electrodes A. All electrodes A may be able to communicate directly with each multiplexer B such that the response signal is then analyzed to determine the voltage through the different pairs of electrodes A in parallel. In embodiments with many different electrodes available for collecting measurements, circuits may comprise a multiplexer to select among measurement channels. In some embodiments, to save space and reduce costs, only two multiplexers are used, one for each of two distinct electrode signals, which then have their outputs connected to an impedance analyzer E. The response signal through electrodes may be multiplexed in all possible combinations through to the impedance analyzer, allowing a simulation of all electrodes being measured in reference to each other, and / or in reference to an injected signal, without requiring the extra hardware of many impedance analyzers for one device. When signals such as neuromodulation protocols L or probe signals K are to be sent through different electrodes A, they first pass through a multiplexer B. In some embodiments, one multiplexer handles the input signal, while another handles the response signal or current sink. Each response signal can also be amplified and / or filtered before being sent to the microcontroller.

[0144] In some embodiments, the system is configured to use a mobile device. The mobile device may be a smartphone, computer, smartwatch, tablet, or other similar device. The mobile device connects via any type of wireless communication including Attorney Docket No. 206030-0322-00 WO

[0145] Bluetooth, WiFi, Ultra-Wideband, Zigbee, Human Body Communication, or other communication protocol. The command I to start stimulating, recording, or impedance analysis is received by the wireless communication circuit H and then transmitted to a microcontroller or microprocessor F. The microcontroller or microprocessor may be FPGA / DSP / MCU, an application-specific IC, or custom IC. The microcontroller or microprocessor may log the command in the memory G. Based on the processed command, the device can either stimulate, record, or analyze impedance. For example, if the command is to analyze impedance, a specific arrangement of multiplexing would activate to send a probe signal K through each electrode and record the signal through all pairs of electrodes A. To accurately calculate intestinal permeability, the probe signal response N is recorded through all permutations of the electrode pairs using the multiplexer B. Signals are amplified after passing through the multiplexer to increase the signal-to-noise ratio. Amplified signals may be filtered for the frequencies of interest using a bandpass filter D after the signal is read by the microcontroller F and stored in memory G. Measurements may then be processed and then sent through wireless communication H to an external mobile device O and further analyzed to aid physician care. In some embodiments, the device comprises a DC unit after a filter block.

[0146] In some embodiments, a motor driver P controls the direction, acceleration, deceleration through modulating current and voltage to motor that deploys and retracts electrode array 104. Sensors P may monitor the motor’s rotation. Rotational sensors P may provide feedback to the microcontroller F to manage how far electrode array 104 deploys or retracts.

[0147] In some embodiments, power components or sources may be set up to supply power to any components of the capsule 100. Components of the device 100 that may be powered include sensors, processors and microcontrollers, communication components, mechanical components, and stimulation components. Batteries may be optimized for properties including power density, manufacturing constraints, or safety considerations.

[0148] In some embodiments, the power supply is entirely contained in a device compartment 110a,b,c, thereby sealing it off from gastric fluids. In some embodiments, the power supply is comprised of thin fdm lithium batteries. Thin film lithium batteries can be manufactured to appropriate dimensions to be contained within a device Attorney Docket No. 206030-0322-00 WO compartment 110a,b,c. Thin film lithium batteries may employ lithium cobalt oxide (LiCoCh) for cathode and graphite for the anode. A layer or coating may be deposited around the battery to decrease toxicity or otherwise enhance safety. A layer or coating may protect the subject from any battery or power source leakage. For example, dissolvable battery coatings may be used for power supplies that are exposed to the gastric environment. The layer or coating may be a pH sensitive polymer such as Eudragit.

[0149] In some embodiments, a power supply is used that has features exposed to the gastric environment to acquire power from the gastric contents. In some embodiments, the power supply is a Microbial Fuel Cell (MFC). Microbial Fuel Cells use the bacteria in the gut environment, such as Escherichia coli, and convert the organic matter into electrical energy. A semipermeable membrane may be used to contain the bacteria that is accessed by the MFC. In some embodiments, the power supply utilizes ions such as sodium, potassium, chloride, bicarbonate, or other ions commonly found in gastric fluid. In some embodiments, the power supply functions similarly to a seawater battery. In some embodiments, biocompatible materials are used for the anode and cathode. Suitable biocompatible materials may include manganese, zinc, silver chloride, and manganese dioxide. In some embodiments, a pH-sensitive coating is applied to restrict exposure of the power supply to hostile stomach acids, dissolve in intestinal fluids, or otherwise optimize power supply exposure to gastric environments.

[0150] In some embodiments, triboelectric, piezoelectric, magnetoelastic, or pyroelectric generators are built into the body or housing 102, on the exterior of device 100, into the electrode array 104, or into any other components of the device 100. These generators can act doubly as pressure sensors as well as a power source in the body or housing 102 or in the electrode array 104. For example, more deformation of the generator is a signal of more pressure. These generators leverage natural peristaltic movements of the intestines to provide a continuous source of energy that does not rely on chemical reactions. In some embodiments, the device 100 receives power from a source outside of the body of a subject. The source outside of the body of a subject may generate an electromagnetic field that may be received by the ingested device 100 through inductive charging or capacitive coupling. Attorney Docket No. 206030-0322-00 WO

[0151] In some embodiments, signals originating from the ingestible device 100 including electrical activity derived from intestinal pacemaker and smooth muscle cells and biomolecule concentrations go through an internal preprocessing step before being exported. Preprocessing may take effect in real time or introduce a delay. In some embodiments, an onboard circuit of the device 100 includes hardware that performs filtering and amplification of signals recorded by the electrodes 114. The hardware may be composed of different components including but not limited to multiplexers, microcontrollers, power management, active filters, passive filters, amplifiers, communication components, signal generating IC / DDS, ADC IC, DAC IC, capacitors, resistors, inductors, op-amps, impedance analyzers, and motors. The hardware components may be built into printable circuit boards. In some embodiments, several layers of printable circuit boards are utilized to optimize use of the available space within the device 100. In some embodiments, the circuit integrates the use of a low power Bluetooth / WiFi component capable of processing and transmitting data wirelessly outside the body of the subject. In some embodiments, the communication component also receives biomodulation protocols from an external device. In some embodiments, filtering and amplification of signals is performed by software built into a microcontroller within the device 100. In some embodiments, tools including spike sorting are implemented into processing algorithms for recording applications. In some embodiments, a combination of hardware and software is used. In some embodiments, data may be stored onboard the device for extraction after the device is passed by the subject, is surgically extracted from the subject, or otherwise leaves the body of the subject.

[0152] In some embodiments, control of the functional components of the device 100 such as initiating stimulation, initiating neuromodulation, initiating biomodulation, deploying or retracting electrode array 104, or releasing a drug payload can be autonomous, initiated by the direction of a medical professional, or a combination of both. In some embodiments, the device 100 comprises an antenna to receive signals originating from an external source or relayed from a medical professional through an external source. In some embodiments, the device 100 comprises an antenna capable of simultaneous wireless power transmission and data transfer to increase efficiency of Attorney Docket No. 206030-0322-00 WO space utilization within the device 100. In some embodiments, signals are sent in intervals, continuously, or in response to a specific event such as an abnormality. For example, data export or other autonomous actions can be triggered by the dissolution of a device component coating by gastric acids or by reading of a pH sensor component of the device. In some embodiments, complicated processes governed by machine learning may enable closed loop treatment of gastrointestinal conditions. For example, a pressure sensor detecting irregularities in peristalsis contractions may trigger a model trained on GI electrical activity to coordinate the best protocol and location to stimulate Interstitial Cells of Cajal, rapidly recovering regularity in peristalsis.

[0153] For example, any algorithm, may be used to enable closed loop treatment, monitoring, or other activities of device 100 and / or portions or sensors thereof. For example, any known properties or aspects of gastrointestinal tissue, gastrointestinal fluids, and / or other bodily tissues that relate to any disease or dysregulation may be incorporated as inputs into an algorithm. An algorithm may calculate the presence or probability of any disease or dysregulation and may trigger device 100 to provide any treatment in a closed loop manner.

[0154] Aspects of the invention relate to various methods of using a device designed for ingestion by a living body. Now referring to Figure 9, shown is an exemplary method 200 for short term monitoring of intestinal slow waves using a device designed for ingestion by a living body. In some embodiments, method 200 comprises the steps of 210 administering an ingestible device (e.g. device 100 disclosed herein) to a subject for swallowing; 220 dissolving the electrode array cover (e.g. compartment covering 103 of device 100 disclosed herein) in intestinal fluid; 230 anchoring the device to the intestinal wall by expanding the electrode array (e.g. electrode array 104 of device 100 disclosed herein); 240 recording and processing electrical data; 250 storing the electrical data in a memory located in the ingestible device; 260 causing wireless transmission of at least some of the electrical data to a receiver; and 270 releasing the anchored device from the gastrointestinal tract through retraction of the electrode array. In some embodiments, device 100 may not have an electrode array cover and step 220 may not be needed. For example, device 100 may comprise an opening 108 that remains open throughout method 200 through which the electrode array may be deployed. Attorney Docket No. 206030-0322-00 WO

[0155] In some embodiments of the method 200, first, a subject ingests the device as directed by a medical professional. The device then traverses the gastrointestinal tract due to peristalsis eventually reaching the small intestine. In the closed state, the electrode array 104 is constrained by a pH dissolvable compartment covering 103. The compartment covering 103 dissolves at the higher pH of the small intestine relatively quickly and electrode array 104 unravels laying flush with the inside of the intestinal wall. The elastic force of the electrode array polymer substrate 116 anchors the position of the device 100 in the gastrointestinal tract while the electrodes 114 begin gathering electrical signals. After some period of time, the polymer of the electrode array substrate dissolves, releasing the remaining capsule components to pass through the rest of the gastrointestinal tract. The degradation speed of the electrode array substrate 116 may be adjusted through thickness or material blends. The device 100 may be designed so that the remaining capsule components are released in as short as a few minutes or as long as hours or days after the electrode array 104 anchors to the gastrointestinal tract. In some embodiments, the device 100 may have additional or alternative components such that the process is different than illustrated.

[0156] In some embodiments, the device is deployable from an insertion member. The device may be configured to maintain attached to the insertion member or be released from the insertion member. For example, the device may be configured to be placed via an insertion member similarly to the placement of a stent via a catheter. In some embodiments, the device is configured to be positioned via an insertion member for any amount of time. The device may be transitioned between open and closed states any number of times while attached to the insertion member. The device may then be removed while still attached to the insertion remember by removing the insertion member from the subject. In some examples, any portions of device 100 are built into a catheter or other insertion member. In some embodiments, electrode array 104 is exposed to the bodily tissue in the open state and / or closed state. Exemplary insertion members may comprise a wire, needle, cannula, or catheter.

[0157] Ingestible embodiments of device 100 configured for interaction with the gastrointestinal tract may also be suitable for placement in a subject via an insertion member and may similarly interact with other tissues of a subject. For example, the Attorney Docket No. 206030-0322-00 WO device may be placed in any lumen, cavity, or other passageway of a subject optionally via a catheter. The device may interact with fluid within the lumen, cavity, or other passageway similarly to interaction with gastric fluid. The device may interact with tissues that may form at least part of the wall of the lumen, cavity, or other passageway similarly to interaction with the gastrointestinal tract. The device may be anchored to any tissue that may form at least part of the wall of the lumen, cavity, or other passageway in which it is deployed via any mechanism described herein for anchoring of device 100 to the gastrointestinal tract. For example, the device may be placed in the heart, for example in a heart chamber, in a blood vessel, in a nasal cavity, in the gallbladder, in a urinary tract, in the respiratory system, in the reproductive system, or in the colon of a subject. For example, the device may interact with fluids including blood as in the blood vessel or heart, air or mucus as in the nasal cavity, stool as in the colon, or bile as in the gallbladder. For example, the device may interact with tissue including blood vessel walls, heart chamber walls, nasal cavity lining, colon tissue, or gallbladder tissue.

[0158] Now referring to Figure 10, depicted is an exemplary device 300 for interaction with a bodily tissue that may be deployable via a catheter. In some embodiments, device 300 comprises an embodiment of electrode array 104. In some embodiments, device 300 may comprise any number of compartments. For example, device 300 may comprise an embodiment of compartment 110a, compartment 110b, and / or compartment 110c. Any embodiment of compartments 110a, 110b, or 110c described for ingestible device 100 may be included in device 300. In some examples, as shown in Figures 10 and 11, compartment 110a may be at one end of the device, compartment 110b may be at the middle of the device, and compartment 110c may be at the opposite end of the device. In some embodiments of device 300, compartment 110a, compartment 110b, and / or compartment 110c are hollow such that it may hold any components, sensors, and / or electrode array 104 within. In some embodiments of device 300, compartment 110a, compartment 110b, and / or compartment 110c are solid. In some embodiments of device 300, some compartments are hollow and some compartments are solid. In some embodiments of device 300, any of compartments 110a, 110b, and / or 110c comprise an electrode array 104 and do not comprise an exterior wall or coating such that the electrode array 104 is exposed to the device 300 exterior in closed and open states. For Attorney Docket No. 206030-0322-00 WO example, as depicted in Figure 10, compartment 110b may comprise an electrode array 104 that is exposed to the device 300 exterior in closed and open states. In some embodiments, device 300 is configured to interact with fluids such as blood, bile, saliva, or air, therefore device 300 may have none or minimal protection of the closed electrode array 104 before deployment since these fluids may be less harsh than gastric fluid.

[0159] Any sensors, transmitters, or other components of device 100 described herein for interaction with the gastrointestinal tract or fluids within the gastrointestinal tract may be similarly employed in device 300 for interaction with other bodily tissues and / or fluids. For example, electrode array 104 may be configured to interact with, sense, stimulate, and / or modify electrical signals of heart tissue, gallbladder, nasal cavity, blood vessel wall, colon wall, urinary tract tissue, reproductive system tissue, or respiratory system tissue. For example, a gas sensor may be incorporated into device 300, for example in any compartment of device 300. For example, circuitry or PCBs may be incorporated into device 300, for example in any compartment of device 300. For example, a transmitter may be incorporated into device 300, for example in any compartment of device 300. The transmitter may optionally be in communication with any circuitry or PCBs of device 300. For example, a power source may be incorporated into device 300, for example in any compartment of device 300. The power source may be in communication with a transmitter and / or any circuity or PCBs of device 300. For example, a drug payload may be incorporated into device 300, for example in any compartment of device 300. In some embodiments, similarly to device 100, device 300 may act as a closed-loop diagnostic or treatment tool wherein any combination of sensor outputs triggers a function of the device 100 including electrode deployment, electrode array deployment, electrode stimulation or neuromodulation, electrode recording, and / or release of a drug payload. In some examples, device 300 including any components thereof are in communication with any power source, circuitry, transmitters, or any controller via an insertion member of device 300. For example, device 300 may be wired via the catheter such that device 300 is in communication with any outside power source, circuitry, processor, transmitter, or controller. For example, an insertion member operator may trigger any function of device 300 via a controller or other mechanism in communication with an insertion member, for example a catheter. In this embodiment, the device 300 may be configured to remain Attorney Docket No. 206030-0322-00 WO attached to the insertion member or may be releasable from the insertion member. In some embodiments, the device 300 may function autonomously after release from the insertion member.

[0160] In some embodiments, electrode array 104 of device 300 may be deployed (i.e., transitioned from a closed state to an open state) during, shortly after, or some time after placement to perform a function including monitoring, sensing, or treatment. In some embodiments of device 300, electrode array 104 when deployed aids in the anchoring of device 300 to a blood vessel wall, heart chamber wall, nasal cavity wall, lymph node wall, colon wall, and / or gallbladder wall. Therefore, electrode array 104 may be deployed before disengagement of device 300 from a catheter or other placement device such that device 300 remains secured in a desired position and / or location of the subject. In some embodiments, the device 300 is anchored to a tissue wall, optionally via electrode array 104, in response to a signal via a device operator, automatically upon release from a catheter or other delivery device, or automatically upon the sensing of a signal from one or more sensors of the device 300.

[0161] The size of device 300 and any components thereof, for example electrode array 104, may be determined based on the desired location of the subject for deployment. For example, the size of device 300 may be configured to be small enough not to interfere with any biological function.

[0162] Now referring to Figure 11, depicted is an exemplary embodiment of device 300 in an open configuration in which electrode array 104 is deployed. The electrode array 104 may be configured to be a size such that in the open configuration it spans at least some of a tissue wall of any tissue or tissue portion, including a heart chamber, blood vessel, nasal cavity, colon, or gallbladder.

[0163] Now referring to Figure 12, depicted is an embodiment of device 300 in a closed configuration being positioned by a catheter. In some embodiments, any components, portions, or compartments described for device 100 may be incorporated directly into a catheter. In some embodiments, electrode array 104 remains exposed to the catheter exterior in open as well as closed configurations. In some examples, device 300 may be maintained in a closed position until a catheter operator appropriately positions device 300. In some examples, device 300 may be transitioned between open and closed Attorney Docket No. 206030-0322-00 WO configurations such that a device operator may perform any functions of device 300 at any number of locations of a subject during a single procedure or any number of procedures. In some embodiments, a catheter operator may release device 300 from a catheter after device 300 is appropriately positioned. In some embodiments, device 300 may not be released from the catheter and may therefore be removed from the subject in conjunction with removal of the catheter from the subject. In some embodiments, device 300 may be released from a catheter and then may be retrieved and removed from the subject via a catheter at some later time point as part of the same procedure or a second procedure at a later time. Device 300 when in a closed configuration may have a size such that it fits within a catheter 300 or such that when placed at the end of a catheter it does not increase the diameter of the catheter.

[0164] Now referring to Figure 13, depicted is an embodiment of device 300 in an open configuration being positioned by a catheter. In some embodiments, device 300 is transitioned to an open configuration after device 300 is placed in a desired location. The open configuration may aid in anchoring device 300 in the desired location. The catheter may optionally be released from device 300 while device 300 transitions from a closed configuration to an open configuration. The catheter may optionally be released from device 300 any time before or after device 300 transitions from a closed configuration to an open configuration. In some embodiments, the catheter and device are configured such that the device is not releasable from the catheter.

[0165] Aspects of the invention relate to various methods of placing and / or using a device designed for placement in a subject via an insertion member, for example a catheter, needle, cannula, wire, or any other placement mechanism. Now referring to Figure 14, shown is an exemplary method 400 for placing and / or using a device designed for placement in a subject via an insertion member including a catheter or other placement mechanism. In some embodiments, method 400 comprises the steps of 410 positioning a device for interaction with a bodily tissue and / or fluid (e.g., device 300 disclosed herein) via an insertion member in a subject, and 420 transitioning the device between a closed state to an open state. In some embodiments, the device is anchored to a tissue wall in the open state. In some embodiments, method 400 further comprises the step of 430 releasing the device from the insertion member. In some embodiments, the Attorney Docket No. 206030-0322-00 WO method further comprises the step of 440 releasing the anchored device from the tissue wall. In some embodiments, method 400 further comprises the step of 450 retrieving the device from the subject.

[0166] In some embodiments, step 410 comprises positioning the device in a blood vessel, heart chamber, gallbladder, colon, or nasal cavity. Any method known in the art for positioning a device in a subject via an insertion member may be used. Any method known the art for positioning a distal end of an insertion member or any device associated with the distal end of an insertion member in a subject may be used. For example, any method known in the art for positioning a device in a subject via a catheter may be used. For example, any method known in the art for positioning a stent via a catheter may be used.

[0167] In some embodiments, step 420 comprises manipulating an electrode array of the device. For example, step 420 may comprise deploying and / or retracting an electrode array 104 of device 300. Deploying an electrode array may comprise any method for transitioning the electrode array from a closed to an open configuration. In some embodiments, step 420 comprises retracting the electrode array subsequent to deploying the electrode array. In some embodiments, step 420 comprises deploying and retracting an electrode array of the device any number of times. Step 420 may conclude with the device in the open or closed configuration. In some embodiments, step 420 comprises anchoring the device to a tissue wall. In some embodiments, step 420 further comprises releasing the device from a tissue wall. For example, any electrode array deployment may further comprise anchoring the device to a tissue wall. For example, any electrode array retraction may comprise releasing the device from a tissue wall. Step 420 may conclude with the device anchored or not anchored to a tissue wall.

[0168] In some embodiments, step 420 is performed prior to, in conjunction with, shortly after, or any time after step 430. In other words, the device may be released from the insertion member prior to, during, shortly after, or any time after any manipulation of the electrode array of the device. In some embodiments, step 430 is not performed and the device remains attached to the insertion member throughout the method. In some embodiments, step 430 comprises releasing the device from the insertion member and subsequently reattaching the device to the insertion member. Release or reattachment of Attorney Docket No. 206030-0322-00 WO the device to an insertion member may be performed during or between any individual electrode manipulations, including deployment, retraction, anchoring to a tissue wall, and release from a tissue wall, of step 420.

[0169] Step 430 may comprise any method of releasing or reattaching a device from an insertion member. For example, any methods known by one skilled in the art for the releasing or retrieving a stent from via a catheter after stent positioning may be used.

[0170] Step 440 may be performed in embodiments of the method in which step 420 or step 430 concludes with the device anchored to a tissue wall. In some embodiments, step 440 comprises transitioning an electrode array of the device from an open to a closed configuration. Step 440 may be performed while the device is released from an insertion member or while the device is attached to an insertion member. Step 440 may be performed autonomously by the device, for example in response to a measurement by a sensor of the device. In some embodiments, an anchoring component of the device, for example an electrode array, dissolves, disintegrates, or otherwise disengages from a tissue wall after some time. In some embodiments, a device operator may provide a signal to release the device from the tissue wall. For example, a transmitter of the device may receive a signal from the operator. In some embodiments, step 440 is performed via an insertion member. In some embodiments, the device is released from or attached to an insertion member while step 440 is performed. In some embodiments, step 440 is triggered by an insertion member that may be used shortly after for removal of the device from the subject.

[0171] In some embodiments, step 450 comprises retrieving the device via an insertion member, for example, a catheter or any minimally invasive retrieval mechanism. In some embodiments, step 450 comprises a second procedure at a second time to retrieve the device. In some embodiments, step 450 is performed during the same procedure as when the device was positioned. In some embodiments, step 450 is performed via the same insertion member or a different insertion member than was used to place the device. In some embodiments, the device remains attached to the insertion member throughout the method and step 450 comprises simply removing the insertion member from the subject.

[0172] In some embodiments, the device is configured for placement in plumbing or other tubing and / or a tank. Ingestible embodiments of device 100 for interaction with the Attorney Docket No. 206030-0322-00 WO gastrointestinal tract may also be suitable for placement in plumbing or other tubing or tank and may similarly interact with the wall or surface of the tubing or tank and / or fluid within the tubing or tank. For example, the device may be placed at the entrance of a tube or tank and may travel through the tube or tank due to fluid flow within a lumen or cavity of the tube or tank. The device may be configured to be anchored at any portion of plumbing or tubing or a tank. Embodiments of device 300 for deployment via a catheter may be similarly placed in any portion of plumbing or tubing or a tank via any tool known by one skilled in the art. For example, a wire may be used to place an embodiment of device 300 within a plumbing or tube or tank. In some examples, the device may be configured to aid in and / or monitor water filtration and / or structural integrity of any plumbing, tubing, or a tank. For example, the device may be configured to modulate, improve, and / or monitor water quality. For example, the device may be configured to modulate, improve, and / or monitor fuel systems or fuel quality.

[0173] The device configured for placement in plumbing or other tubing and / or a tank may be anchored to a wall or surface of a tube via any mechanism described herein for anchoring of device 100 to the gastrointestinal tract and / or anchoring of device 300 to any bodily tissue.

[0174] The device configured for placement in plumbing or other tubing and / or a tank may comprise a portion that is dissolvable in any pH range. For example, any body or housing, a device body portion, or a covering that surrounds any device compartment may be dissolvable in a specified pH range similarly to device 100. However, the device configured for placement in plumbing or other tubing and / or a tank may comprise portions configured to be dissolvable in any pH ranges found in plumbing, a water system, a water filtration system, a fuel tank, or a fuel monitoring system. For example, the device configured for placement in plumbing or other tubing and / or a tank may comprise portions configured to be dissolvable in basic or acidic environments.

[0175] Any sensors, transmitters, or other components of device 100 described herein for interaction with the gastrointestinal tract or fluids within the gastrointestinal tract may be similarly employed in a device configured for placement in plumbing for interaction with a tubing wall, a tank wall, and / or any fluids within the plumbing. For example, a gas sensor, circuity or PCBs, a transmitter, and / or a power source may be incorporated into Attorney Docket No. 206030-0322-00 WO an embodiment of the device configured for placement in plumbing. The power source, transmitter, and / or any circuitry or PCBs may be in communication with each other or any other sensors or components of the device configured for placement in plumbing. For example, a payload of any chemical for water filtration and / or water quality modulation may be incorporated into the device configured for placement in plumbing. In some embodiments, similarly to device 100, an embodiment of a device configured for placement in plumbing may act as a closed-loop diagnostic or treatment tool of water quality, water filtration, and / or pipe, tube, or tank structural integrity, wherein any combination of sensor outputs triggers a function of the device for placement in plumbing including electrode deployment, electrode array deployment, electrode stimulation or electrode recording, and / or release of a chemical payload.

[0176] In some embodiments, the device configured for placement in plumbing is anchored to a tubing wall or tank wall, optionally via an electrode array, in response to a signal via a device operator, automatically upon release from a wire or other delivery device, or automatically upon the sensing of a signal from one or more sensors of the device.

[0177] The size of a device configured for placement in plumbing and any components thereof, for example an electrode array, may be determined based on the desired location of the plumbing for deployment. For example, the size of the device may be based on the tubing and / or tank size desired for placement. For example, the device may be a size small enough not to interfere with fluid flow in the plumbing.

[0178] Aspects of the invention relate to various methods of placing and / or using a device designed for placement in plumbing. Any method known in the art for placing a device in a tubing, a tank, and / or specifically plumbing may be used. In some embodiments, the device may be placed in a tube entrance and may travel through the plumbing and / or tubing via flow. In some embodiments, the method comprises administering the device at a plumbing entrance or placing the device at a desired location within a plumbing system. In some embodiments, the method further comprises the step of anchoring the device to a plumbing wall including a tubing wall or a tank wall. In some embodiments, the method further comprises releasing the device from the plumbing wall including a tank wall or tubing wall. In some embodiments, the method Attorney Docket No. 206030-0322-00 WO further comprises the step of retrieving the device from the plumbing. Any method known in the art for retrieving a device or other material from a plumbing system may be used.

[0179] In some embodiments, the device may be anchored during, shortly after, or any time after placing the device in the entry way of a plumbing system. In some embodiments, the device may be anchored during, shortly after, or any time after positioning the device in a desired location in the plumbing.

[0180] The disclosures of each and every patent, patent application, and publication cited herein are hereby each incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

Attorney Docket No. 206030-0322-00 WOCLAIMSWhat is claimed is:

1. A device, comprising: a housing having at least one internal compartment and at least one opening fluidly connecting the internal compartment to the exterior of the device; a substrate having first and second ends and at least one electrode on a surface of the substrate, wherein the first end of the substrate is anchored to the housing within the at least one internal compartment.

2. The device of claim 1, wherein the device comprises a releasable covering positioned over the opening.

3. The device of claim 1, wherein the substrate is compressed within the compartment.

4. The device of claim 2, wherein the substrate is configured to expand after the release of the releasable covering.

5. The device of claim 1, wherein the substrate comprises one or more materials selected from the group consisting of: a bioresorbable material, a bioinert material, an elastic polymer, an electroactive polymer, or a dielectric elastomer.

6. The device of claim 1, wherein the device is ingestible, wherein the substrate has a compressed configuration and an expanded configuration, and wherein the substrate is configured to anchor the capsule to a surface of the gastrointestinal tract of a subject when ingested and when the substrate is expanded.

7. The device of claim 6, wherein the substrate is configured to exert a radial pressure on the gastrointestinal tract when expanded.Attorney Docket No. 206030-0322-00 WO8. The device of claim 1 , wherein the anchored first end of the substrate is releasable from the housing.

9. The device of claim 8, wherein the substrate is anchored to the housing within the at least one compartment by a releasable linker.

10. The device of claim 1, wherein the substrate is configured to expand when exposed to an electromagnetic field.

11. The device of claim 10, wherein the substrate is configured to retract when exposed to an electromagnetic field.

12. The device of claim 1, wherein the at least one electrode is a recording electrode.

13. The device of claim 1, wherein the at least one electrode is a stimulating electrode.

14. The device of claim 1, wherein at least one electrode is a recording electrode and at least one electrode is a stimulating electrode.

15. The device of claim 1, further comprising one or more sensors.

16. The device of claim 15, wherein the one or more sensors is selected from the group consisting of: a pH sensor, a motion sensor, a pressure sensor, a biomolecule sensor, a microorganism sensor, a gas sensor, a chemical sensor, a microbiome sensor, an imaging sensor, and a temperature sensor.

17. The device of claim 1, further comprising a power source.

18. The device of claim 1, further comprising control and signal processing units.Attorney Docket No. 206030-0322-00 WO19. The device of claim 1 , further comprising a deliverable compound stored in the at least one compartment.

20. The device of claim 13, wherein the stimulating electrode is initiated by a wireless signal.

21. The device of claim 14, wherein the stimulating electrode is initiated in response to a measurement of the recording electrode or a sensor.

22. The device of claim 1, further comprising a propulsion mechanism.

23. The device of claim 2, wherein the releasable covering is dissolvable, foldable, or retractable.

24. The device of claim 1, wherein the device further comprises a data storage medium.

25. The device of claim 1, wherein the device further comprises a bi-directional wireless transmission mechanism.

26. The device of claim 1, wherein the housing comprises a spool positioned in the internal compartment, and wherein the first end of the substrate is anchored to the spool.

27. The device of claim 26, wherein the length of the substrate extends through the opening, and wherein the second end of the of the substrate is anchored to an exterior surface of the housing.

28. The device of claim 26, wherein the spool is configured to rotate, thereby winding and unwinding the substrate around the spool.Attorney Docket No. 206030-0322-00 WO29. The device of claim 27, wherein at least one of the at least one electrode is positioned on a surface of the substrate facing away from the housing.

30. The device of claim 1, wherein the device is configured to be placed via a catheter.

31. A catheter comprising the device of claim 1.

32. A method for monitoring the health of a subject comprising the steps of administering the device of claim 1 to the subject.

33. The method of claim 32, wherein the administration step comprises prompting the subject to swallow the device.

34. The method of claim 32, wherein the administration step comprises positioning the device of claim 1 in a subject via a catheter.

35. The method of claim 34, further comprising the step of: releasing the device from the catheter.

36. The method of claim 34, further comprising the step of: removing the device from the subject via the catheter.

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