Orientationally-biased, capsule-based ingestible imaging device

Abstract

Introduced here is an ingestible device comprised of a capsule, a camera, and an antenna. The specialized weighting and buoyancy of the device ensures it maintains its orientation after swallow, providing reliable partial or full visualization of the stomach interior. The device is paired with an external receiving unit that allows communication with a computer or phone. The images may be transmitted to the electronic device in real time for review by an operator responsible for controlling the ingestible device. The operator can take appropriate action(s) based on the content of the images received from the ingestible device. For example, upon discovering an area of interest in an image, the operator may instruct the propulsion component to move the ingestible device so that the camera is oriented toward the area of interest.

Description

PATENT Attorney Docket No. 133552.8005. WO01ORIENTATIONALLY-BIASED, CAPSULE-BASED INGESTIBLE IMAGING DEVICE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Application No.63 / 801,795, titled “Orientationally-Biased, Capsule-Based Ingestible Imaging Device” and filed on May 7, 2025, US Provisional Application No. 63 / 798,475, titled “Orientationally-Biased, Capsule-Based Ingestible Imaging Device” and filed May 1, 2025, and US Provisional Application No. 63 / 762,273, titled “Orientationally-Biased Capsule-Based Ingestible Imaging Device” and filed on February 24, 2025, each of which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Various embodiments concern devices designed to generate images of biological structures located inside of a living body and then transmit the images to an electronic device located outside of the living body.BACKGROUND

[0003] An endoscopy is a procedure during which biological structures are visually examined with a camera that is affixed to the end of a flexible tube.Alternatively, an optical fiber exposed near the end of the flexible tube may carry light reflected by the biological structures to a camera located outside the living body. The flexible tube is used to position the camera or the optical fiber in a desired position. A medical professional can diagnose conditions that affect the living body by examining digital images generated by the camera. For example, during an upper endoscopy, the flexible tube is inserted through the mouth or nose so that the medical professional can examine the esophagus, stomach, or upper part of the small intestine (also referred to as the “duodenum”). During a lower endoscopy (also referred to as a “colonoscopy”), the flexible tube isPATENT Attorney Docket No. 133552.8005. WO01inserted through the rectum so that the medical professional can examine the large intestine (also referred to as the “colon”).

[0004] Advances have been made in the quality, reliability, and safety of endoscopies. For instance, improvements in camera resolution have allowed medical professionals to provide more informed (and thus more accurate) opinions. Endoscopies are invasive procedures, however, and therefore have several potential complications. Patients may suffer infection, unexpected reactions to sedation (including death), bleeding (e.g., due to the removal of tissue for testing as part of a biopsy test), or tearing of tissue (e.g., due to the friction of advancing the flexible tube through tortuosity), especially in cancer patients where chemotherapy drugs have weakened the tissues of the gastrointestinal (Gl) tract or pediatric patients whose anatomy is more fragile and / or physically smaller.

[0005] Despite these advances, there remain several important unmet needs in gastrointestinal visualization. Existing endoscopic procedures are inherently invasive, requiring the insertion of flexible, yet relatively large, tubes into the body’s natural orifices, often causing discomfort, anxiety, and physical trauma to patients. Even in the absence of procedural complications, the experience can be unpleasant and deter patients from seeking timely diagnosis and care.Additionally, sedation or anesthesia is commonly required to tolerate the procedure, introducing further risks, prolonging recovery, and creating logistical barriers such as the need for patient escorts and postoperative monitoring.

[0006] Accessibility to endoscopic procedures is also limited by infrastructure and specialist availability. Procedures must be performed in appropriately equipped medical centers, consuming substantial resources such as endoscopy suites, sterilization systems, trained personnel, and recovery rooms. This limits throughput and increases the overall cost burden to healthcare systems.Furthermore, in lower-resource settings or rural areas, or among underservedPATENT Attorney Docket No. 133552.8005. WO01populations, access to conventional endoscopy may be delayed or unavailable entirely, leading to late diagnoses and worsened outcomes.

[0007] Even when performed under optimal conditions, conventional endoscopy provides only a snapshot in time under sedation, limiting patient participation and dynamic assessment. Opportunities for real-time, physiologic observation - such as during natural gastric filling, voluntary movement, or meal digestion - are largely absent from current clinical workflows.PATENT Attorney Docket No. 133552.8005. WO01BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Various features of the technology will become more apparent to those skilled in the art from a study of the Detailed Description in conjunction with the drawings. Embodiments of the technology are illustrated by way of example and not limitation in the drawings, in which like references may indicate similar elements.

[0009] Figure 1A includes a side view of an example of an ingestible device designed to monitor in vivo environments as it travels through a living body, such as a human body or an animal body, under its own power.

[0010] Figure 1B shows the self-tipping tendency of an embodiment of an ingestible device.

[0011] Figure 1C shows examples of textured hemispherical tailcones of an embodiment of an ingestible device.

[0012] Figure 1D shows an alternative base shape to accommodate different resting viewing angles of an embodiment of an ingestible device.

[0013] Figure 1 E shows how a ballast-shifting mechanism may be controlled electrically using electromagnets.

[0014] Figure 1F shows how a motor-drive mechanism can mechanically move an eccentric weight to move the center of mass of an ingestible device.

[0015] Figure 2A includes a front perspective view of a payload section of an ingestible device.

[0016] Figure 2B includes a rear perspective view of the payload section of the ingestible device of Figure 2A.

[0017] Figure 3 includes a perspective view of a power section of an ingestible device.

[0018] Figure 4A depicts an example of a flexible printed circuit board assembly (PCBA) in an expanded form.PATENT Attorney Docket No. 133552.8005. WO01

[0019] Figure 4B depicts the flexible PCBA of Figure 4A in a folded form.

[0020] Figure 5 depicts a flow diagram of a process for monitoring an in vivo environment using a device designed for ingestion by a living body.

[0021] Figure 6 includes a flow diagram of a process, performed by a computer program, for guiding a subject and / or an operator of an ingestible device through an examination in which the ingestible device generates images following ingestion.

[0022] Figure 7 depicts an example of a communication environment that includes an ingestible device that is communicatively coupled to a controller.

[0023] Figure 8 is a block diagram illustrating an example of a processing system in which at least some operations described herein can be implemented.PATENT Attorney Docket No. 133552.8005. WO01DETAILED DESCRIPTION

[0024] Contemporary research has begun exploring how to monitor in vivo environments in a more effective manner. For example, several entities have developed cameras capable of capturing digital images (or simply “images”) of the digestive tract. Generally, these cameras are placed within vitam in-size capsules that can be swallowed by patients. The camera can generate hundreds or thousands of images as the capsule travels through the digestive tract, and these images can be wirelessly transmitted to an electronic device (also referred to as a “computing device”) carried by the patient. This procedure is referred to as “capsule endoscopy.”

[0025] Capsule endoscopy allows medical professionals to observe in vivo environments, such as the small intestine, that cannot easily be reached with conventional endoscopes. However, capsule endoscopy remains a relatively uncommon procedure. One reason for this is the lack of control over the camera following ingestion of the capsule. Areas of interest can be missed by the camera due to the orientation of the capsule as it naturally travels through the digestive tract. Another reason is that the capsules used for capsule endoscopy can take several hours to reach the target anatomy and then several more hours to record imagery. Then, the patient may need to return to a medical setting (e.g., a hospital or clinic) to deliver the recorded imagery.

[0026] In an effort to address the limited control of these capsules, proposals have been made to incorporate active movement mechanisms into the capsule itself. These proposals typically rely on motors, propellers, steering systems, or similar components to alter orientation or motion after ingestion. Although such mechanisms can provide some directional control, they materially increase complexity, cost, and power requirements, and often necessitate larger capsule form factors. Additionally, the inclusion of active movement mechanisms can introduce challenges with respect to regulatory compliance, including demonstrating safety, reliability, and predictable operation under applicablePATENT Attorney Docket No. 133552.8005. WO01standards. From a manufacturing and operational perspective, such mechanisms may also be difficult to control consistently within the variable conditions of the digestive tract, thereby limiting their practical effectiveness.

[0027] Introduced here, therefore, is an ingestible device (also referred to as an “ingestible pill,” or “ingestible capsule”) that comprises a capsule (also referred to as an “enclosure”), a camera, an antenna, and one or more orientation components (and, in some instances, orientation control elements).

[0028] The camera can generate images as the ingestible device traverses the gastrointestinal tract. The camera may be designed to capture images at a variety of frame rates, for example 2, 6, or 15 frames per second (fps). In some embodiments, the camera may capture more than 15 fps. The frame rate may vary based on the speed at which the ingestible device is traveling. For instance, the ingestible device may be designed to increase the frame rate as the speed increases. Images generated by the camera are forwarded to the antenna for transmission to an electronic device located outside of the living body. More specifically, a processor may transmit the images to a transceiver responsible for modulating the images onto the antenna for transmission to the electronic device. In some embodiments, the images are transmitted to the electronic device in real time so that a medical professional can take appropriate action(s) based on the content of the images. For example, the medical professional may discover an area of interest that requires further examination upon reviewing the images. In such a scenario, the orientation components can be designed and / or installed (or controlled using the orientation control elements) to orient the ingestible device so that the camera is focused on the area of interest. Such action may enable the ingestible device to gather additional data (e.g., in the form of images, biological measurements, etc.) regarding the area of interest.

[0029] The ingestible device described herein may be configured to provide a real-time video stream - with high enough frame rate and resolution - to be suitable for diagnostic evaluation of gastrointestinal conditions. In variousPATENT Attorney Docket No. 133552.8005. WO01embodiments, the transmitted imagery enables identification of (i) the presence, timing, and anatomical site of active bleeding; (ii) mucosal abnormalities, such as ulcers, polyps, angioectasias, varices, or neoplastic lesions; (iii) ingested foreign bodies; and (iv) residual gastric contents prior to administration of anesthesia.

[0030] To facilitate comprehensive visualization of a relatively large, distensible lumen - such as the stomach - the subject may ingest a predetermined volume of water to fluid-distend the organ. When so distended, the capsule’s orientationally-biased architecture permits systematic imaging of the entire gastric mucosa without reliance on external magnetic fields or complex patient-tilting protocols. Because the capsule is designed to maintain a predictable orientation, specific gastric landmarks can be inspected in a controlled sequence rather than in the random fashion characteristic of conventional, non-oriented capsules. The instilled water may further enhance image clarity by acting as an optical magnifier.

[0031] A passively ballasted capsule, as described herein, offers multiple advantages over motor-driven or actively propelled devices. The capsule can be made smaller, contains fewer components, and exhibits a reduced number of potential failure modes, thereby improving ease of swallowing, lowering manufacturing cost, and diminishing the likelihood of retention in patients with occult gastrointestinal strictures. This permits the ingestible device to be used by a larger portion of the population. Moreover, because the outer surface of the capsule is free of lumens and recesses that are typically required for thruster exhaust or mechanical linkages, the capsule is less susceptible to fouling by mucus, saliva or debris. The mass distribution - camera at one end and ballast at the opposite end - causes the heavier end to lead during ingestion and to overcome buoyant material that may accumulate near the fluid surface. This configuration mitigates the risk of visual obstruction or debris entrapment.

[0032] The camera is oriented substantially along the longitudinal axis of the capsule (i.e. , vertically relative to the centerline), in contrast to the transversePATENT Attorney Docket No. 133552.8005. WO01orientation of many existing devices. In a fluid-distended stomach, this vertical configuration affords an extended field of view across the organ. Because the capsule maintains a fixed orientation relative to gravity, the imaging direction -defined by the field of view of the camera - is adjusted indirectly by having the conscious, unsedated patient adopt one or more prescribed body positions under software guidance or physician instruction. A limited sequence of patient postures - for example, right lateral decubitus, supine, left lateral decubitus, and sitting upright - can thereby achieve mostly or entirely full visualization of all gastric landmarks without thrusters or other active steering mechanisms. Under the direction of a computer program (e.g., that implements artificial intelligence (Al) to keep track of what has been imaged and / or what should be visualized next) or live physician, the patient can shift her position as imaging takes place so as to provide for a managed, complete visualization of the stomach, including focusing on key landmarks as necessary. This method can provide visualization of the entire gastric mucosa without any external equipment necessary or added complexity, expense, and risk associated with using thrusters or other active methods of capsule movement. For example, positioning the patient on their right side provides a view of the greater curvature, while sitting upright permits a better view of the fundus and cardia. A simple series of positions can be used and transitioned through during an examination to gather visual imagery of all landmarks in an efficient manner. Note that the term “examination” may be used interchangeably with “procedure” and “imaging session,” even if the patient is not collocated with the healthcare professional (e.g., in the same healthcare facility) responsible for reviewing images generated by the ingestible device.

[0033] The live video feed is another differentiating factor from traditional capsules. As further discussed below, the ingestible device described herein may be designed to allow for immediate, simple screening of the stomach, providing medical information in real time, allowing doctors to react to what they see and alter the examination process if unexpected results are found. Specifically, as images are generated by the camera, the corresponding image data can bePATENT Attorney Docket No. 133552.8005. WO01provided to a transceiver that modulates the image data prior to transmission, by an antenna, to a receiver that is external to the patient. Such flexibility enhances capabilities for diagnostics, as the physician can ensure they are satisfied with the information captured before ending the examination. The real-time data feed also enhances the patient experience over traditional capsules, as they are not required to retrieve the capsule after it has passed. A physician could employ this ingestible device to identify gross pathology such as ulcers or precancerous lesions, or to quickly confirm that no such serious conditions exist. It may also be used to identify bleeding. Traditional capsules typically only give a binary signal if they detect blood; however, this ingestible device could provide the specific location and severity of this bleeding. It may also be used without any sedation, drugs, or equipment. This allows for it to be used as a pre-screening tool for other procedures that may require sedation. The device may also be used to determine if a foreign object is still present in the stomach. Currently, when an object is swallowed, X-ray or computed tomography (CT) imaging is used to determine if the object is still in the stomach or has already passed. By instead ingesting the device described herein, that question could be answered without the need for expensive capital equipment and would provide doctors with additional information about the object's shape, size and current location.Because the ingestible device could easily be brought into prescribed telemedicine, direct-to-consumer, and / or over-the-counter use cases, it could markedly expand access to entry-level gastrointestinal (Gl) care.

[0034] Note that while the embodiments may be described in the context of having a physician guide ingestion and / or review images captured by the ingestible device, those embodiments are generally applicable to healthcare professionals. These healthcare professionals could be general practitioners, specialists (e.g., a surgeon or a gastroenterologist), nurses, physician assistants, or technologists who are responsible for managing the ingestible device as it travels through the living body. Unlike conventional endoscopies, however, the healthcare professional need not be located in close proximity to the patient (alsoPATENT Attorney Docket No. 133552.8005. WO01referred to as a “subject”) undergoing examination. For example, a healthcare professional may examine images generated by the camera of an ingestible device on an electronic device that is located in a remote hospital while the patient lies in another environment, such as a home, battlefield, etc. In this way, capabilities of a traditional Gl department may be extended using the technologies described herein.

[0035] Embodiments may be described with reference to certain capsule shapes, orientation components, sensors, networks, etc. However, those skilled in the art will recognize that the features of these embodiments are equally applicable to other capsule shapes, orientation components, sensors, networks, etc. For example, although a feature may be described in the context of an ingestible sensor that has a given ballasted tailcone design, the feature may be embodied in an ingestible device that has a different ballasted tailcone design.Ingestible Device Overview

[0036] Figure 1A includes a side view of an example of an ingestible device 100 designed to monitor in vivo environments from within a living body, such as a human body or an animal body. The ingestible device 100 includes a capsule 102 with a cylindrical body 104 and hydrodynamic, atraumatically shaped ends 106a-b. One end of the device 100 comprises a weighted ballasted tailcone 114, while the other end comprises a lens assembly 112. One example of a hydrodynamic atraumatically shaped end is a rounded shape that does not cause damage upon contacting living tissue, such as the roughly hemispherical ends shown in Figure 1 A. This geometric shape may be referred to as a “spherocylinder.” While the ingestible device 100 shown in Figure 1A has roughly hemispherical ends, other hydrodynamically-shaped ends may be included in other embodiments. For example, at least one end of the capsule 102 may be a dome with a flat portion through which light can be guided toward an optical sensor. As another example, at least one end of the capsule 102 mayPATENT Attorney Docket No. 133552.8005. WO01be a truncated cone. At least one end of the capsule 102 may also feature one or more fillets that leave flat or minimally curved surfaces along those end(s). The cylindrical body 104 and hemispherical ends 106a-b may collectively be referred to as the “structural components” of the capsule 102. To avoid contamination of a cavity defined by the cylindrical body 104 and / or hemispherical ends 106a-b, the structural components may be hermetically sealed to one another.

[0037] In the present embodiment, the ingestible device has an overall length of approximately 20.5 millimeters and a maximum diameter of approximately 13 millimeters. In alternative embodiments, the length of the device may range from approximately 14 millimeters to approximately 22 millimeters, and the diameter may range from approximately 8 millimeters to approximately 13 millimeters, depending on the desired internal volume, component configuration, and swallowing tolerability.

[0038] In some embodiments, the mass of the ingestible device 100 is approximately 2.4 grams. In other embodiments, the mass may vary between approximately 1 gram and approximately 3.5 grams. The specific mass may be selected based on the intended buoyancy, tissue interaction profile, and imaging stability requirements.

[0039] In some embodiments, the ingestible device 100 has a center of buoyancy that is located between 1 and 2 millimeters (and preferably approximately 1.5 millimeters) above the center of mass along the longitudinal axis of the capsule. This spatial offset creates a restoring torque when the device is submerged in fluid, thereby resisting rotational displacement and enabling the capsule to return to a stable, upright orientation. In other embodiments, the magnitude of the separation between the center of buoyancy and the center of mass may be increased or decreased to modulate the strength of the corrective moment, and to tune the device’s orientational stability based on anatomical, procedural, or fluid dynamic factors.PATENT Attorney Docket No. 133552.8005. WO01

[0040] It is understood that the specific values for length, diameter, mass, and the positional relationship between the center of buoyancy and the center of mass provided herein are not intended to be limiting, and may be adjusted within the disclosed ranges to accommodate various functional requirements, patient populations, or manufacturing constraints.

[0041] In an embodiment, the ingestible device 100 is weighted to either negative (i.e. , where the optical sensor 110 is pointing up) or positive (i.e. , where the optical sensor 110 is pointing down) buoyancy, causing it to sink to the bottom of the stomach, or float to the top when ingested. In this disclosure, the terms “up” and “down” refer to directional vectors extending from either end of the capsule 102 along the central longitudinal axis of the capsule 102. The components in the cylindrical body 104 may be arranged so that there is a significant weight difference between the two ends of the capsule 102. This asymmetry in weight causes the ingestible device 100 to naturally right itself (i.e., return to a desired predetermined orientation relative to the Earth’s gravity vector) due to the position of its centers of buoyancy and gravity. In that respect, the capsule 102 can be said to be orientationally biased. For example, placing weight near the tailcone hemisphere’s lowest point creates a weighted tailcone 11 , which causes the device’s center of gravity to be lower than its center of buoyancy.

[0042] This creates a relatively strong natural restoring force into the vertical position, as shown in Figure 1B. In Figure 1B, “CB” represents center of buoyancy and “CG” represents center of gravity. Such a weighting scheme causes the capsule 102 to roll back to the designated upright position regardless of temporary misalignment. Furthermore, the differential arrangement of masses may itself be dynamically adjusted as part of the ingestible device’s design. This could be achieved through arrangement of internal components, alternative placement of dedicated ballast material, weighting of the external capsule, or a combination of these methods. While embodiments may generally be designed such that the center of buoyancy is above the center of gravity - along thePATENT Attorney Docket No. 133552.8005. WO01central longitudinal axis of the capsule 102 - as shown in the middle illustration of Figure 1 B, there may be scenarios where the center of buoyancy is offset from the central longitudinal axis as shown in the left and right illustrations of Figure 1 B. Such a design will cause the ingestible device 100 to have a natural semiupright position, which could be useful for imaging certain anatomy.

[0043] In an embodiment, the capsule 102 comprises a cylindrical body 104 with hemispherical end caps, measuring approximately 20.5 millimeters in overall length and approximately 13 millimeters in diameter at its widest point. The internal components may be arranged such that the center of buoyancy is located superior to the center of mass along the longitudinal axis of the ingestible device 100, thereby creating an orientationally-biased configuration.

[0044] For example, the center of buoyancy may be positioned approximately 10.57 millimeters from the bottom-most point of the capsule, while the center of mass may be positioned approximately 9.03 millimeters from the same reference point, resulting in a vertical separation of approximately 1.54 millimeters between the two. This spatial offset generates a passive restoring moment when the device is displaced from its equilibrium position, causing the capsule to self-right in a fluid medium. This spatial offset will vary depending on the design of the capsule 102 and arrangement of components within the capsule 102, but it may be between 1 millimeter and 4 millimeters. Generally, a larger spatial offset will generate a larger passive restoring moment, resulting in the non-ballasted end of the capsule 102 exhibiting less “wiggle.” An appropriate amount of “wiggle” may depend on, among other things, the anatomical lumen being imaged, and the appropriate amount of “wiggle” could be established through testing in different fluid-based environments.

[0045] In the aforementioned configuration, the upward buoyant force exerted at the center of buoyancy is measured at approximately 21.8 millinewtons (mN), while the downward gravitational force (weight) centered at the center of mass is approximately 23.6 mN (corresponding to an ingestible device mass ofPATENT Attorney Docket No. 133552.8005. WO01approximately 2.41 grams). In the alternative view, the vertical separation between the center of buoyancy and the center of mass is similarly observed, with the center of buoyancy located at approximately 10.27 millimeters from the base and the center of mass at approximately 8.74 millimeters, yielding a separation of approximately 1.53 millimeters. The respective forces in this configuration are approximately 21.7 mN (buoyancy) and 22.8 mN (gravitational), corresponding to an ingestible device mass of approximately 2.32 grams.

[0046] This differential between buoyant and gravitational forces, along with the measured offset in vertical position, generates a net corrective torque that maintains the ingestible device 100 in a vertically upright orientation during operation. The magnitude of the restoring moment may be tuned by adjusting the internal mass distribution, the buoyant volume, or the geometry of the capsule shell. These values are illustrative and not limiting, and may be modified within defined tolerances to suit specific use cases, target anatomies, or performance requirements.

[0047] In an alternative embodiment having positive buoyancy, rather than being weighted, the tailcone assembly may comprise air or some other fluid that is less dense than its surrounding material (e.g., stomach bile or water). This would result in the tailcone assembly orienting in the opposite direction of the center of gravity. For example, the density of water is approximately 1,000 kilograms per cubic meter (kg / m3) while the density of stomach bile is approximately 1 ,000-1 ,050 kg / m3. Assuming the stomach is filled with some combination of water and stomach bile, filling the tailcone assembly with a fluid having a density less than approximately 1 ,000 kg / m3(and preferably less than approximately 990, 950, or 900 kg / m3) would yield an ingestible device that is weighted to positive buoyancy. Examples of such fluids include oils (e.g., olive oil, sunflower oil, corn oil, cottonseed oil, coconut oil), medium-chain triglycerides, isopropyl myristate, limonene, hydrocarbon solvents, and hydrogels. Examples of solids with densities lower than approximately 1 ,000 kg / m3include polyethylene (PE) and ultra-high molecular weight polyethylenePATENT Attorney Docket No. 133552.8005. WO01(UHMWPE), polypropylene (PP), polycaprolactone (PCL), silicone elastomers, and polyurethane foams and other foams. While not necessarily required, it may be beneficial to select a biocompatible material to limit harm should the capsule 102 unexpectedly crack or rupture.

[0048] In an alternative embodiment, the orientationally-biased capsule is configured to maintain or return to an upright vertical orientation even when not fully immersed in fluid. This feature may be advantageous when the stomach is dry, inadequately distended, or contains only a minimal volume of fluid, such as in patients who have fasted, vomited, or who have undergone partial gastric evacuation. In this alternative embodiment, the capsule can include a lower hemisphere containing a concentrated ballast mass and may feature an optimized external geometry - such as a flattened or textured base - to increase surface friction and stability when in contact with the gastric mucosa. The center of gravity is positioned below the central longitudinal midpoint of the capsule, and the center of buoyancy is either minimally offset or absent in cases where buoyancy is negligible due to low surrounding fluid. The mass asymmetry alone produces a gravitational restoring force sufficient to reorient the capsule into a vertical pose when resting on the gastric wall, even in the absence of hydrostatic displacement forces.

[0049] To enhance this effect, the capsule 102 may incorporate surface features such as micro-textures, radial ridges, or adhesive coatings to resist lateral sliding on the mucosal surface. These design elements allow the capsule to tip upright after ingestion and to remain stable in a vertical configuration despite minor peristaltic movements, breathing-induced shifts, or patient repositioning. In certain configurations, the base of the capsule may include circumferential grooves, asymmetric bump patterns, or compliant surface protrusions designed to conform to the irregular topography of the gastric wall, thereby increasing static friction and minimizing translational drift. Additional design features may include edge flanges or segmented footings that slightlyPATENT Attorney Docket No. 133552.8005. WO01deform upon contact with mucosa to anchor the capsule in place under gentle pressure.

[0050] In another variation of this embodiment, the capsule 102 adopts a longitudinal configuration, wherein the imaging system is centrally located and directed upward along the capsule’s vertical axis. This geometry allows for symmetrical mass distribution along the longitudinal plane, while still enabling a lower-positioned ballast to generate a strong gravitational moment. By situating the camera at or near the midline, above the center of gravity, the system achieves enhanced orientational stability and consistent imaging alignment. The vertical axis of the capsule 102 is maintained passively through internal mass asymmetry, while the structural form factor - elongated and possibly having a rounded cylindrical form - further resists tipping or lateral rolling when in contact with mucosa under low-fluid conditions.

[0051] In some embodiments, these structural components are comprised of the same material. For example, the structural components may be comprised of plastic (e.g., PE, polyvinyl chloride (PVC), polyetheretherketone (PEEK), acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, etc.), stainless steel, titanium-based alloy, or another biocompatible material. Biocompatible polymers may be three-dimensional (3D) printed, machined, sintered, injection molded, or otherwise formed around components of the ingestible device 100. In other embodiments, these structural components are comprised of different materials. For example, the hemispherical end 106a in which an optical sensor 110 is mounted may be comprised of a transparent plastic, while the other hemispherical end 106b and cylindrical body 104 may be comprised of a polymer or metallic alloy. Moreover, these structural components may include a coating that inhibits exposure of the structural components themselves to the in vivo environment. For example, these structural components may be coated with silicone rubber, diamond-like carbon, Teflon, or some other biocompatible, hydrophobic, or hydrophilic coating that aids in safety, durability, or operational efficiency of the ingestible device 100. Additionally or alternatively, thesePATENT Attorney Docket No. 133552.8005. WO01structural components may be coated with an antibacterial material, such as antibiotic-loaded polymethyl methacrylate (PMMA).

[0052] As shown in Figure 1A, at least one hemispherical end 106a can include an opening 108 through which the field of view of an optical sensor 110 extends. In some embodiments, the opening 108 is filled with a transparent material, such as glass or plastic. Alternatively, the optical sensor 110 may be positioned such that its outermost lens substantially aligns with the exterior surface of the hemispherical end 106a, or the optical sensor 110 may be positioned such that the focal length of the lens is similar to the radius of the hemispherical end 106a such that focus is ensured for any anatomy that directly contacts the ingestible device 100. While the hemispherical end 106a shown in Figure 1 includes a single opening, other embodiments of the hemispherical end 106a may include multiple openings (e.g., for multiple optical sensors, biometric sensors, or combinations thereof). In some embodiments, the hemispherical end 106a is entirely comprised of a transparent material. In such embodiments, the hemispherical end 106a may not include a dedicated opening for the optical sensor 110 since the optical sensor 110 can generate image data using electromagnetic radiation that has penetrated the transparent material. The hemispherical end 106a may include surface features that diffuse or direct illumination leaving the ingestible device 100. Moreover, a portion of the hemispherical end 106a may be rendered substantially opaque to inhibit or eliminate interval reflections of light that may interfere with the optical sensor 110.

[0053] In yet another embodiment, the imaging system of which the camera 110 is a part may be mechanically actuated via one or more actuation mechanisms - for example, internal micromotors, voice coil motors (VCMs), shape-memory alloy (SMA) actuators, piezoelectric motors, micro-electro-mechanical systems (MEMS) actuators, servo / stepper motors, or linear actuators / solenoids - and / or one or more drive mechanisms configured to rotate the camera or optical assembly about the central longitudinal axis of the capsule.PATENT Attorney Docket No. 133552.8005. WO01In an end-mounted camera configuration, rotational motion about the capsule’s axis enables a full 360-degree panoramic view of the upper gastric cavity while the capsule remains in a fixed vertical pose. This facilitates comprehensive anatomical surveys without requiring translational motion, thereby preserving positional stability. In configurations where the camera is centrally located within the body of the capsule and oriented outward radially, a similar rotational mechanism enables 180-degree directional scanning. This approach offers a controlled sweep of the environment in high-resolution detail while minimizing energy consumption and mechanical complexity compared to multi-camera systems.

[0054] Due to the convenience in manufacturing, the opening 108 will often be circular. However, the opening 108 could have other forms. For example, in some embodiments the opening 108 is rectangular, while in other embodiments the opening 108 has a rectangular portion with circular endpoints. These circular endpoints may be oriented on opposing sides of the hemispherical end 106a so that optical sensors positioned beneath the circular endpoints can observe the in vivo environment along both sides of the ingestible device 100.

[0055] As shown in Figure 1 C, the hemispherical tailcone may have its exterior surface textured to adjust the movement properties of the capsule when resting on the surface of the stomach. This surface texture, in combination with the weighted ballast and buoyancy, provides the device with different modalities of operation. Heavily textured surfaces provide stability for the capsule inside the stomach as they increase friction between the capsule and stomach. The embodiments shown in Figure 1C are textured with different arrangements of ridges 180. The ridges 180 interact with the interior surface of the stomach and help prevent sliding of the capsule during peristalsis. In addition to helping maintain orientation during natural stomach movement, the ridges 180 make the procedure easier by keeping the capsule 102 still even if the patient position varies slightly. Without the ridges 180, small movements of the patient can potentially result in losing the desired view, as the base of the capsule 102 mayPATENT Attorney Docket No. 133552.8005. WO01slip down a sloped portion of the stomach. The ridges 180 steady the capsule in the event the patient is unable to remain completely still, serving as a passive adhesion mechanism that inhibits, but does not prevent, movement of the capsule 102 with respect to the stomach lining. Ridges 180 may also be oriented to prevent rotation of the capsule. Such deliberate ridge arrangement keeps the view steady, enabling easier visual examination.

[0056] As shown in Figure 1 D, different embodiments of the device may contain various lower hemisphere 106b shapes - potentially ellipses, hyperellipses, or other non-spherical geometries. The resting camera angle may be adjusted by manipulating the shape of the lower sphere, as well as the center of buoyancy and center of gravity of the ingestible device 100. These characteristics may be optimized for different capsule objectives, as each unique combination could enable visualization of a specific region of the stomach. This adaptability could be especially helpful for patients unable to move their body to all positions required for complete visualizations of the stomach. In such instances, adjusting shape and ballast would accommodate limitations and ensure physicians’ needs are met.

[0057] Some embodiments of the ingestible device may also include a moveable ballast and an actuation mechanism to drive ballast movement. Like the actuation mechanism for the imaging system described above, the actuation mechanism could be or include an internal micromotor, VCM, SMA actuator, piezoelectric motor, MEMS actuator, servo / stepper motor, or linear actuator / solenoid. The actuation mechanism may be controlled based on inputs provided by an operator (e.g., via a physical controller) or based on outputs produced by an algorithm or machine learning model (e.g., based on an analysis of the images produced by the camera) to allow panning and tilting of the camera view, despite a fixed camera location. By shifting the location of the ballast relative to the camera, the combination of shape and ballast location will drive the capsule to a predictable orientation relative to gravity, allowing for augmentation of the camera view. As shown in Figure 1E, this ballast-shifting actuationPATENT Attorney Docket No. 133552.8005. WO01mechanism may be controlled electrically using electromagnets 190 which moves the ballast weights 193. In another embodiment shown in Figure 1F, a motor-drive mechanism 191 can mechanically move an eccentric weight 192 to move the center of mass. Alternative embodiments can move the center of mass mechanically using stored tension in a spring, SMA, or elastic material.

[0058] The capsule 102 may be a variety of different sizes, such as those listed in Table I.

[0059] In Figure 1A, the ingestible device 100 can include two sections having different responsibilities: a payload section 200 and a power section 300. These sections are described in greater detail below. While these sections are illustrated as being distinct from one another as separated by a dotted line, the component(s) associated with each section may not necessarily be located within areas demarcated by the dotted line shown in Figure 1 A. For example, the power section 300 may include a power distribution unit that extends into the payload section 200 to deliver power to component(s) in that section.

[0060] Figure 2A includes a front perspective view of the payload section 200 of the ingestible device, while Figure 2B includes a rear perspective view of the payload section 200 of the ingestible device. The payload section 200 can include an optical sensor 202, a power and data bus 204, a control unit 206, a manipulator controller 208, a hermetic seal 210, and an illumination source 212. Embodiments of the ingestible device can include some or all of these components, as well as other components not shown here. For example, if the ingestible device has been designed solely for imaging and not for manipulatingPATENT Attorney Docket No. 133552.8005. WO01the surrounding environment, then the payload section 200 may not include a manipulator controller 208 since no manipulation will be performed. As another example, if the ingestible device includes one or more actuation mechanisms - to actuate the optical sensor 202 and / or the ballast - then the payload section 200 may include an actuation controller that may take the place of the manipulator controller 208.

[0061] The optical sensor 202 can generate image data based on electromagnetic radiation reflected by structures located in the gastrointestinal tract. For example, if the optical sensor 202 is a camera, then images or video may be captured as the ingestible device travels through the body. Other examples of optical sensors 202 include infrared sensors, ultrasonic sensors (also referred to as “sonar sensors”), etc. An illumination source 212 (also referred to as an “ilium inant” or “light source”) housed in the ingestible device will typically be responsible for generating the electromagnetic radiation. An example of an illumination source 212 is a light-emitting diode (LED). Here, the illumination source 212 is arranged so that the electromagnetic radiation is emitted through the same aperture in the capsule through which the reflected electromagnetic radiation is received. In other embodiments, the illumination source 212 is arranged so that the electromagnetic radiation is emitted through a first aperture in the capsule while the reflected electromagnetic radiation is received through a second aperture in the capsule. Note that multiple illumination sources could be present in some embodiments. For example, a pair of apertures may be arranged on opposing sides of a primary aperture aligned with the optical sensor 202, and each of the pair of apertures may be aligned with a different one of a pair of illumination sources. As another example, multiple illumination sources - and multiple apertures - may be arranged radially around a circumference of the capsule. Such a design may ensure that the surrounding environment is more uniformly illuminated.

[0062] Similarly, the orientationally-biased capsule could be equipped with multiple cameras arranged radially around its circumference to providePATENT Attorney Docket No. 133552.8005. WO01panoramic imaging of the gastrointestinal tract, particularly within the stomach. Unlike conventional devices that rely on a single forward-facing or axial camera, this embodiment includes a plurality of optical sensors distributed along the perimeter of the capsule. As the capsule rests or moves within a fluid-distended gastric environment, each camera can independently capture images from a different angular orientation, thereby enabling simultaneous visualization of multiple sides of the gastric mucosa - and in some instances, simultaneous visualization of anatomical features from different angles.

[0063] This radial configuration allows for continuous observation of all aspects of the stomach lining, including posterior surfaces, folds, and recessed crevices that may not be accessible to single-camera devices. The use of multiple fields of view reduces blind spots and increases the likelihood of detecting focal lesions, such as ulcers, tumors, erosions, or areas of inflammation.

[0064] To produce a unified panoramic image, the output from each radial camera may be processed in real time or near-real time using one or more image-stitching algorithms. These algorithms are designed and / or trained to align overlapping visual data, correct for capsule orientation and movement, and compensate for lens distortion or lighting variability. The resulting output is a continuous, high-resolution 360-degree visual map of the gastric interior.

[0065] This multi-camera configuration may be particularly advantageous when used in conjunction with the capsule's self-righting architecture, as it provides a stable platform for radial visualization regardless of capsule rotation or drift. The enhanced coverage improves diagnostic yield and offers clinicians a more comprehensive view of the gastric environment, all while maintaining a non-invasive, patient-friendly profile.

[0066] Accordingly, the capsule may be used in methods comprising: (i) administering a radially-imaging, orientationally-biased capsule to a subject; (ii) capturing simultaneous image data from multiple cameras disposedPATENT Attorney Docket No. 133552.8005. WO01circumferentially around the capsule body; (iii) combining the image streams into a continuous panoramic representation of the stomach; and (iv) reviewing the panoramic imagery to detect and assess mucosal pathology. This configuration expands the diagnostic capabilities of ingestible devices and may reduce the need for follow-up procedures due to incomplete visualization.

[0067] The brightness of the LEDs may be adjusted remotely in real time to provide optimal lighting conditions for the specific region of the stomach.Software may be integrated into the device to automatically adjust the lighting conditions (e.g., brightness) and ensure optimal camera exposure. The lighting setting may be processed on the device or externally with lighting adjustments transmitted back to the ingestible device. Some embodiments may use an image sensor with a wide-angle lens fixture, but other embodiments may also be used. Other embodiments of the camera may contain one or more light sources that emit electromagnetic radiation not in the visible range (e.g., in the infrared, near infrared, or ultraviolet range) and / or one or more light sources that emit - or cause to be emitted - fluorescence, and appropriate image sensors that are able to detect that electromagnetic radiation whose imaging highlights specific tissue properties, multi-camera arrays, three-dimensional (3D) stereoscopic cameras for reconstruction and better depth estimation, or single lenses that themselves act as a sealed external barrier. Furthermore, the lens and camera fixture may contain motors or other methods of physical adjustment to manipulate focus, pointing direction, and zoom.

[0068] Some embodiments of the ingestible device include multiple optical sensors 202. For example, an ingestible device may include a camera equipped with a charge-coupled device (CCD) or a complementary metal-oxide-semiconductor (CMOS) sensor assembly capable of detecting electromagnetic radiation in the visible range and an infrared sensor capable of detecting electromagnetic radiation in the infrared range. These optical sensors can generate distinct sets of data that collectively provide meaningful information that may be useful in rendering diagnoses, as well as assisting with spatialPATENT Attorney Docket No. 133552.8005. WO01positioning. Here, for instance, the infrared sensor may be able to measure the heat emitted by objects that are included in the colored images captured by the camera.

[0069] The power and data bus 204 (also referred to as a “bus” or “bus connector”) may be responsible for distributing data and / or power to various components in the ingestible device. For example, the bus 204 may forward image data generated by the optical sensor 202 to the control unit 206, and the control unit 206 may forward the image data to a transceiver configured to modulate the data onto an antenna for transmission to a receiver located outside of the body. As further described below, the receiver may be part of an electronic device on which an individual can view images corresponding to the image data, control the ingestible device, etc. The bus 204 may include cables, connectors, wireless chipsets, processors, etc. In some embodiments, the bus 204 manages data and power on separate channels. For example, the bus 204 may manage data using a first set of cables and power using a second set of cables. In other embodiments, the bus 204 manages data and power on a single channel (e.g., with components capable of simultaneously transferring data and power).

[0070] The control unit 206 may be responsible for managing other components in the ingestible device. For example, the control unit 206 may be responsible for parsing inputs received by the antenna and then providing appropriate instructions to other components in the ingestible device. As further described below, an individual may provide the input using a controller device (or simply “controller”) located outside of the body. The input may be representative of a request to begin generating image data using the optical sensor 202, begin transmitting image data using the antenna, cease generating image data using the optical sensor 202, cease transmitting image data using the antenna, or move the ingestible device to a desired location. The control unit 206 may include a central processing unit (CPU), graphics processing unit (GPU), application-specific integrated circuit (ASIC), field-programmable gate arrayPATENT Attorney Docket No. 133552.8005. WO01(FPGA), microcontroller, logic assembly, or any combination of other similar processing units.

[0071] To prevent fluids from entering the capsule, the payload section 200 and power section 300 may be hermetically sealed to one another. Accordingly, a hermetic seal 210 may be secured along the interface between the payload section 200 and power section 300. The hermetic seal 210 may be comprised of epoxy resin, metal, glass, plastic(s), rubber(s), ceramic(s), glue, or another sealing material. One factor in determining whether the material(s) used to form the hermetic seal 210 are appropriate is whether the surface energy of those material(s) is similar to the surface energy of the substrate to which the hermetic seal 210 is bound. Accordingly, the composition of the hermetic seal 210 may depend on the composition of the structural components of the capsule. For example, if the structural components of the capsule are comprised of stainless steel, then the hermetic seal 210 may be comprised of an epoxy resin having metal (e.g., stainless steel) particles suspended therein. Alternatively, the hermetic seal 210 may be formed using a flexible gasket, adhesive film, weld, seal, etc.

[0072] Figure 3 includes a perspective view of the power section 300 of the ingestible device. The power section 300 can include a power component 302, a power distribution unit 304, and a hermetic seal 306a-b secured along each end. The hermetic seals 306a-b may be substantially similar to the hermetic seal 210 secured to the payload section 200 as described with respect to Figure 2.Moreover, the hermetic seal 210 secured to the lower end of the payload section 200 may be the same seal as the hermetic seal 306a secured to the upper end of the power section 300. Thus, a single hermetic seal may join the payload section 200 and power section 300.

[0073] The power component 302 (also referred to as an “energy storage component”) can be configured to supply power to other components of the ingestible device, such as any optical sensor(s), biometric sensor(s),PATENT Attorney Docket No. 133552.8005. WO01processor(s), communication components (e.g., transmitters, receivers, transceivers, and antennas), and any other components requiring power. For example, the power component 302 may be responsible for providing power needed by an optical sensor (e.g., optical sensor 202 of Figure 2) to generate image data. As another example, the power component 302 may be responsible for generating the driving energy to be applied to an antenna to cause wireless transmission of the image data to a receiver located outside of the body.

[0074] The power component 302 could be a silver-oxide battery, nickelcadmium battery, lithium battery (e.g., with liquid cathode cells, solid cathode cells, or solid electrolyte cells), capacitor, fuel cell, piezoelectric component, or another energy-capture and / or -storage device. In some embodiments, the power component 302 includes one or more battery plates that are exposed to the fluid(s) through which the ingestible device travels. In such embodiments, the power component 302 can be designed to run on a fluid (e.g., a bodily fluid such as stomach acid) that is readily accessible within the in vivo environment for which the ingestible device is designed. Normally, a battery operates by shuttling ions with a positive charge from one place to another through a solution called an electrolyte that has positively and negatively charged particles. In the case of exposed battery plates, however, a pair of metal electrodes can be secured to the exterior surface of the ingestible device. One metal electrode (e.g., comprised of zinc) can emit ions into the fluid that acts as the electrolyte by carrying a small electric current to the other metal electrode (e.g., comprised of copper).

[0075] In some embodiments, the power component 302 is designed such that it can wirelessly receive power from a source located outside of the body. In such embodiments, the source can generate a time-varying electromagnetic field that transmits power to the power component 302. The power component 302 can extract power from the electromagnetic field and then supply the power to the other components in the ingestible device as necessary. The power may be received using either the same antenna as is used for data transmission or usingPATENT Attorney Docket No. 133552.8005. WO01a different antenna, inductively coupled coil, or capacitively coupled structure. The source could be the controller used for controlling the ingestible device, the electronic device used for reviewing image data, or some other electronic device (e.g., a mobile phone or a wireless charger belonging to the patient).Alternatively, the wireless power source may be included in an article, such as a belt or band, that can be worn such that the wireless power source is located near the ingestible device as it travels through the living body. Such a wearable article may include a battery pack that is integrated within the article itself or attached to the patient. Moreover, such a wearable article may include one or more antennas for data transmission.

[0076] The power component 302 may be designed to fit in a particular segment of the ingestible device. Here, for example, the power component 302 has a button cell form that permits the power component 302 to be secured within the cylindrical body of the capsule. However, other embodiments of the power component 302 may be designed to fit within a hemispherical end of the capsule or another area within the capsule.

[0077] As noted above, the power distribution unit 304 may be responsible for distributing power stored in the power component 302 to other components in the ingestible device. Accordingly, component(s) of the power distribution unit 304 may extend into the payload section 200, drive section 400, and / or propulsion section 500. For example, the power distribution unit 304 may include cables that are connected to the optical sensor, bus connector, control unit, control sensors, and / or manipulator controller that may be located in the payload section 200. The power distribution unit 304 may also include component(s) for regulating, stabilizing, or modifying the power to be distributed. Examples of such components include voltage regulators, converters (e.g., DC-to-DC converters), metal-oxide-semiconductor field-effect transistors (MOSFETs), capacitors, transformers, resistors, or inductors.PATENT Attorney Docket No. 133552.8005. WO01

[0078] In addition to a camera, some embodiments may also contain other forms of sensors to allow additional data capture. These sensors can leverage the same transmission components that the video stream uses to send data back to the user for real time diagnosis. These may include pH, ultrasound, lidar, ultrasonic, biological, or other relevant sensor types. Sensors may be located inside the body of the capsule, with ports allowing for access to the stomach environment, or externally outside the body of the capsule.

[0079] Other embodiments of the device may include a gimbaled camera and lens inside the upper portion of the capsule. A gimbal may be used to orient the camera in a specific direction.

[0080] This system allows the user to adjust the view of the camera, expanding the available viewing area without having to physically move the capsule. This gimbal can be driven by a small electric motor or series of motors, allowing the camera to move in additional degrees of freedom as additional motors are added. A spring or other elastic material may also be used to drive movement of a camera.

[0081] Additional embodiments of the device may have positive buoyancy, allowing them to float on top of the water volume. In these embodiments, the device would be designed and weighted so the camera would face downward, giving a top-down view of the stomach. This embodiment would be able to remain in the stomach for an extended period of time, as long as the subject continues to drink water.

[0082] Data captured by the camera is processed and transmitted to a “dongle” receiver located outside of the patient. The receiver receives the data and connects to a monitor, allowing the display of the video, sensor data, and pointing direction relative to the patient’s torso, as well as the status of the device including battery current, voltage and power, acceleration, orientation relative to gravity or magnetic fields, and temperature. The receiver also has an inertial measurement unit (IMU) contained inside of it which, if attached to the patient,PATENT Attorney Docket No. 133552.8005. WO01can be used to track and manage the position of the patient throughout the procedure. This data can be used to model the patient’s movements on the graphical user interface (GUI) and give instructions on how best to complete the procedure.

[0083] Some or all of the electronic components described herein as being contained within an ingestible device may be mounted on flexible printed circuit board assemblies (PCBAs). Figures 4A-B depict an example of a flexible PCBA 400 in its expanded and folded forms, respectively. As shown in Figure 4A, the flexible PCBA can include at least two rigid areas 402 that serve to provide support to components 404 mounted thereon and accompanying solder joints, as well as help define the structure of the PCBA 400 as a whole. These rigid areas 402 may be connected by flexible areas 406 that can be folded to allow the PCBA 400 to fit within the ingestible device. The PCBA 400 may include conductive connections between the electronic components to allow for the transfer of power and / or data therebetween. More specifically, the PCBA 400 may include one or more conductive layers that serve as connections between the electronic components mounted to the rigid areas 402. Each pair of conductive layers may be separated by an insulating layer (also referred to as a “non-conductive layer”) comprised of a non-conductive material such as polyimide.

[0084] In some embodiments, the rigid areas 402 each comprise an alternating stack of conductive layers and insulating layers over a substrate. Take a single rigid area 402, that includes multiple components 404 mounted thereon, as an example: a first layer of the rigid area 402 can be a substrate, a second layer on top of the first layer can be a conductive layer, a third layer on top of the second layer can be an insulating layer, and additional layers can continue alternating between conductive layers and insulating layers. The components 404 can be mounted on the last insulating layer placed on top of the last conductive layer of the alternating stack. Each component can have its own via to electrically connect the component to one of the conductive layers. AsPATENT Attorney Docket No. 133552.8005. WO01such, if there are three conductive layers in the rigid area 402, three components can be mounted to the rigid area 402, and three different vias can electrically couple one of the components to one of the conductive layers.

[0085] Generally, each of the conductive layers and insulating layers can have a surface that is substantially circular, substantially similar to the shape of the rigid areas 402 as shown in Figures 4A-B, or substantially similar to a shape of the substrate. However, the disclosed technology is not so limited. Thus, in some embodiments, one or more of the conductive layers or insulating layers are shaped differently from other conductive layers, insulating layers, or the substrate of the alternating stack. For example, one conductive layer may have a surface area smaller than that of the substrate of the rigid area 402.

[0086] Continuing the example of the single rigid area 402, each conductive layer can be electrically connected to another conductive layer of one or more additional rigid areas 402. These electrical connections can be made through flexible areas 406. Generally, the flexible areas 406 comprise alternating layers of additional conductive and insulating materials. The flexible areas 406 are flexible - when compared to the rigid areas 402 - because the flexible areas 406 do not include a substrate. Each conductive layer of the flexible areas 406 can electrically couple one conductive layer of the single rigid area 402 to another conductive layer of an additional rigid area 402. For example, the flexible area 406 that is connected to the single rigid area 402 can have a conductive layer that electrically couples the second layer (a conductive layer) of the single rigid area 402 to a conductive layer of a second rigid area 402.

[0087] The flexibility of the flexible areas 406 allows multiple rigid areas 402 to be folded on top of one another as shown in Figure 4B. As shown in Figure 4B, each of the rigid areas 402 are folded such that the surfaces where components 404 are mounted are positioned substantially parallel to each other. Such positioning is expected to allow the PCBA 400 to be suitable in a cavity of the ingestible device. Further, the PCBA 400 of Figure 4A-B is expected to increasePATENT Attorney Docket No. 133552.8005. WO01the surface area within the ingestible device to mount components 404 (e.g., electrical components such as sensors, cameras, processors, batteries) when compared to conventional PCBA structures used in ingestible devices today.

[0088] Figure 5 depicts a flow diagram of a process 500 for monitoring an in vivo environment using a device designed for ingestion by a living body. Initially, a subject ingests the ingestible device as part of a capsule endoscopy procedure for observing the gastrointestinal tract (step 501 ). The ingestible device (and its controlling software) may support several different data collection modes. For instance, the ingestible device may support a “general mode” suitable for open navigation and / or a “swallow mode” suitable for one-way trips through the esophagus.

[0089] An optical sensor included in the ingestible device can then begin generating image data as the ingestible device travels through the living body (step 502). In some embodiments, the ingestible device causes the optical sensor to begin generating image data in response to receiving an instruction to do so. The instruction may be submitted, for example, by an operator through a controller that is communicatively coupled to the ingestible device. In other embodiments, the ingestible device causes the optical sensor to automatically generate image data in response to determining that a predetermined criterion has been met. For example, the ingestible device may cause the optical sensor to begin generating image data in response to determining that the ingestible device has entered a particular in vivo environment. The ingestible device may reach such a determination by examining biometric data generated by a biometric sensor. For instance, the ingestible device could establish whether it is presently within the stomach by examining biometric data representative of pH measurements. The images may be captured with various resolutions, such as 48x48 pixels, 320x240 pixels, or 640x480 pixels. In other embodiments, images may be captured with higher or lower resolutions. The image data may be stored, at least temporarily, in memory located in the ingestible device (step 503).PATENT Attorney Docket No. 133552.8005. WO01

[0090] The ingestible device can then cause wireless transmission of at least some of the image data to a receiver located outside of the living body via an antenna (step 504). In some embodiments, the receiver is housed within an electronic device associated with the subject. For example, the image data may be transmitted to a mobile phone associated with the subject, and the mobile phone may forward the image data to another electronic device for review by the operator responsible for controlling the ingestible device. In some embodiments, image data is transmitted to the receiver on a periodic basis (e.g., every 3 seconds, 5 seconds, 30 seconds, 60 seconds, etc.). In other embodiments, image data is transmitted to the receiver in real time. That is, the ingestible device may stream image data to the receiver as the image data is being generated by the optical sensor.

[0091] To reduce the amount of raw data that must be transferred across the bus or wireless link, the image data (as well as identifying data, telemetry data, etc.) may be compressed in such a way as to reduce the quantity without significantly affecting user perception of quality. For example, algorithms may be employed that reduce color / hue differently than intensity or reduce high-frequency content differently than low-frequency content. Standardized image and / or video compression algorithms such as JPEG, H.264 (MPEG), H.265, and the like may be employed to compress the data. To further reduce the amount of data, the image resolution may be reduced before it is compressed and transmitted. For example, the optical sensor may generate an image with 640x480 pixel resolution, but the image may be downsampled to 320x240 pixel resolution prior to JPEG compression. The resolution may be adjusted during operation to achieve a desired tradeoff between image quality and frame rate (e.g., image quality may be reduced in order to increase frame rate while the ingestible device travels through the esophagus). Other compression algorithms may be used after the data has been transmitted over the wireless link, such as in the case where the data is transmitted to a controller that has computing and memory resources available for executing more demanding compressionPATENT Attorney Docket No. 133552.8005. WO01algorithms than is feasible to perform on the ingestible device itself. This additional compression may be used to reduce the size of data that is stored on the controller or some other electronic device. Data may be encrypted on the ingestible device, the controller, or some other electronic device to prevent unauthorized third-party access of patient identifying information (PI I) or medically sensitive information.

[0092] For embodiments of the device that are powered using an onboard battery, it is generally desirable to minimize battery discharge before the device is ready to be used in order to maximize the amount of power available during operation. To avoid battery drain during shipping and storage prior to deployment, the device may enter a low-power inactive state where current draw from the battery is minimized or the battery is disconnected from other components (e.g., with a mechanical switch, a transistor such as a MOSFET, or some other means). To leave this state, the device may be activated by a sensor.

[0093] Some embodiments of the device employ a photosensor that prompts activation when light is detected. The photosensor may be configured to generate readings indicative of the level of visible, infrared, or ultraviolet light that is presently detectable. In these embodiments, the device may be shipped and stored in a substantially opaque package to prevent the photosensor from being activated inadvertently or prematurely. When the package is opened, the photosensor will be exposed to light and the device can be activated. Other embodiments of the device employ a low-power magnetic sensor that activates when the device is exposed to a magnetic field. Alternatively, the device may include a low-power magnetic sensor that activates when the device is not exposed to a magnetic field. For instance, a magnet may be included in the packaging so that the device is exposed to a magnetic field at all times while being shipped and stored. This embodiment has several advantages. First, there is minimal risk of premature activation since the packaging is likely to accompany the device until deployment is imminent. Second, the individualPATENT Attorney Docket No. 133552.8005. WO01responsible for deploying the device does not need to introduce an activation signal such as a magnetic field. Other embodiments of the device may use a reed relay as a mechanical power switch to activate the device upon being exposed to a magnetic field. In embodiments where the device is activated by exposure to a magnetic field, a single- or multiple-use magnetic fixture could be used to facilitate activation by holding the magnet in the correct orientation with respect to the device. Other embodiments of the device may be activated by a mechanical element (e.g., a switch or button) that is sealed to prevent fluid ingress but is located along the exterior surface of the enclosure so as to be accessible.

[0094] As discussed above, the device may have built-in features for performing self-diagnostic tests such as sensors, software, and the like. Using these built-in features, health and performance functions of the device can be regularly tested. These built-in features can also help in debugging and exploring new operational regimes. Examples of self-diagnostic tests include checksum errors, software versioning, battery voltage, power draw per motor, tests of other major components, etc. Alternately or additionally, the camera may be commanded to generate a test image (e.g., of packaging) to be transmitted to a destination (e.g., the controller), where it may be compared to an expected reference image. Successful transmission of the test image would require that the device be functioning properly. If the test image is not received or is not correct, it could signify a defect (e.g., in the device, communication channel, etc.) for which an alert may be generated that indicates that the device should not be deployed.

[0095] Figure 6 includes a flow diagram of a process 600, performed by a computer program, for guiding a subject and / or an operator of an ingestible device through an examination in which the ingestible device generates images following ingestion. While the computer program may be described as being executed by the controller, the computer program - or at least elements of it -PATENT Attorney Docket No. 133552.8005. WO01could be executed by another electronic device via which instructions can be relayed to the subject and / or the healthcare professional.

[0096] Initially, a computer program may receive first input indicative of an instruction to initiate an examination in which a Gl tract of a subject is to be imaged (step 601). This first input could be provided by an operator (e.g., a healthcare professional) via a controller, or this first input could be generated by the ingestible device itself - in which case an indication of the input could be transmitted from the ingestible device to the computer program. For example, as mentioned above, the ingestible device may infer that the examination will commence imminently in response to detecting a change in lighting conditions (e.g., that is reflective of the ingestible device being removed from its packaging). As another example, the ingestible device may infer that the examination will commence imminently in response to detecting a change in a nearby magnetic field, which may be provided by a magnet included in the packaging so that the ingestible device is exposed to the magnetic field while being shipped and stored.

[0097] Thereafter, the computer program can receive and display images that are generated by the camera of the ingestible device (step 602). Preferably, the images are streamed from the ingestible device in real time or near-real time. The computer program could then receive second input indicative of an acknowledgement that an anatomical feature or region of interest has not been captured or is not currently being captured by the camera (step 603). For example, the operator may indicate, through the controller, that an anatomical region (e.g., a portion of the stomach lining) has not been imaged. As another example, the operator may indicate, through the electronic device via which the images are displayed, that the anatomical region has not been imaged.

[0098] In such a scenario, the computer program may identify an appropriate adjustment to image the anatomical region (step 604) and then present an instruction to have the subject make an appropriate adjustment of her body (stepPATENT Attorney Docket No. 133552.8005. WO01605). In some embodiments, rather than instructing the subject to move her body, the instruction could instead be made to the operator to assist the subject in moving her body. Generally, the appropriate adjustment is established by identifying, through analysis of the existing images, the anatomical region and determining location - in two- or three-dimensional space - of the anatomical region with respect to imaged anatomical regions and the ingestible device in a fluid-distended organ (e.g., the stomach). For example, the computer program may establish that to image the anatomical region, the field of view of the camera of the ingestible device must be shifted in a given direction (e.g., toward the anterior or posterior side of her body). This knowledge allows the computer program to recommend an appropriate adjustment of her body (e.g., leaning forward or backward) so that the field of view is shifted to capture the anatomical region. In this way, some degree of imaging control can be provided even if the ingestible device has no movement mechanisms of its own.Communication Environment

[0099] Figure 7 depicts an example of a communication environment 700 that includes an ingestible device 702 that is communicatively coupled to a controller 704. An operator can control the ingestible device 702 using the controller 704. Moreover, the ingestible device 702 can be configured to transmit data (e.g., image data or biometric data) to one or more electronic devices. Examples of electronic devices include monitors 706, computer servers 708, and mobile phones 710. The ingestible device 702, controller 704, and electronic device(s) may collectively be referred to as the “networked devices.”

[0100] The networked devices can be connected to one another via one or more networks. The network(s) can include personal area networks (PANs), local area networks (LANs), wide area networks (WANs), metropolitan area networks (MANs), cellular networks, the Internet, etc. Additionally or alternatively, the networked devices may communicate with one another over aPATENT Attorney Docket No. 133552.8005. WO01short-range communication protocol, such as Bluetooth®, near-field communication (NFC), Wi-Fi, ZigBee®, LoRa®, another commercial point-to-point protocol, or a proprietary point-to-point protocol. For example, the ingestible device 702 may be communicatively coupled to the controller 704 via a Bluetooth® communication channel, and the ingestible device 702 may be communicatively coupled to the electronic device(s) via a WiFi or LoRa communication channel.

[0101] The communication channels established between the networked devices may be bidirectional or unidirectional. For example, the controller 704 may be permitted to transmit data to the ingestible device 702 even though the ingestible device 702 may be unable to transmit data to the controller 704.Similarly, the ingestible device 702 may be permitted to transmit data to the electronic device(s) even though the electronic device(s) may be unable to transmit data to the ingestible device 702.

[0102] Embodiments of the communication environment 700 may include some or all of the networked devices. For example, some embodiments of the communication environment 700 include an ingestible device 702 and a single device (e.g., a mobile phone, tablet computer, or mobile workstation) that serves as the controller and the electronic device on which image data is reviewed. As another example, some embodiments of the communication environment 700 include an ingestible device 702 and a computer server 708 on which the image data is stored for subsequent review. In such embodiments, because the image data will be reviewed at some later point in time, the communication environment 700 need not include a controller 704. As another example, some embodiments of the communication environment 700 include a dedicated input device without display capabilities that serves as the controller 704 and an electronic device, such as a tablet computer or a mobile phone, on which image data is reviewed. In such embodiments, the dedicated input device may be communicatively coupled to the ingestible device and / or the electronic device.PATENT Attorney Docket No. 133552.8005. WO01

[0103] Since the ingestible device 702 can operate in vivo, the close proximity to fluids, tissue, and the like may affect the electromagnetic operating characteristics of the antenna. To address this, the antenna may be designed and / or selected to minimize the effects of nearby materials having relative dielectric constants that are significantly different from free space. As an example, an embodiment could use a small loop antenna with one or more turns, which primarily interacts with magnetic field components in the near field, and is therefore less strongly affected by the proximity of high-dielectric materials.Alternatively, the antenna may be designed and / or selected to compensate for the effect of the fluid(s) inside the living body. As an example, an embodiment could use a straight, bent, curved or meandered monopole antenna where the effective electrical antenna length is between one-eighth and one-third of the transceiver operating wavelength when the ingestible device 702 is surrounded by fluid or anatomy of the living body. For instance, an embodiment could use a monopole or “whip” antenna that is significantly shorter than a free-space quarter wavelength. While this antenna would not be tuned optimally in air, proximity to the high-dielectric fluid(s) may cause the antenna to behave electrically as if it were significantly longer and tuned properly to the frequency of interest. Such an approach also has the benefit of allowing the use of a significantly smaller antenna than would be optimal for operation in dry air. The mechanical structure of the antenna may be designed to conform to the enclosure of the ingestible device 702.

[0104] The antenna and transceiver circuitry may be designed such that a single antenna is used for both transmitting and receiving data. Alternatively, multiple antennas may be used. For example, different antennas may offer superior performance in certain orientations or fluid conditions, and the performance of each antenna may be monitored during operation in order to select the antenna with the highest performance at any given point in time. In embodiments that use wireless power transmission, the ingestible device 702 may be configured to use a single antenna for both power and data transmissionPATENT Attorney Docket No. 133552.8005. WO01to eliminate the need for an additional antenna. Alternatively, different antennas or electromagnetically coupled structures may be used for power and data transmission, allowing each to be optimized for its respective task.

[0105] To allow multiple ingestible devices to operate within close proximity (e.g., multiple patients undergoing treatment in the same room or building), the communication channels discussed above may be established using a pairing feature. Pairing features may be employed to ensure that each ingestible device communicates with a single controller. To accomplish this, each ingestible device may be assigned a unique identification number during manufacturing. When a communication channel is established by an ingestible device, the ingestible device may transmit its identifier to establish whether the communication channel was established with the appropriate controller.Additionally or alternatively, the ingestible device may append the identifier (or a shortened, amended, or obfuscated version of the identifier) as a label to data packets to designate the appropriate controller. Accordingly, each controller may assume that data packets without the correct identifier are meant to be received by another controller and thus can be ignored. As part of this process, the ingestible device and corresponding controller may elect to switch to a different communication channel or frequency to avoid having to share time and bandwidth with other pairs of ingestible devices and controllers. The ingestible device and corresponding controller may elect to change communication frequency as needed during operation to avoid competing with interfering devices, a strategy known as “frequency hopping.”Alternative Embodiments for Expanded Mechanical Responsiveness:

[0106] To further expand the range of mechanical responsiveness, the capsule may incorporate one or more soft robotic external structures - such as inflatable bladders, shape-memory elements, or fluidic actuators - that are connected to, or embedded within, the capsule’s outer wall or keel-like appendages. These components may be called “malleable orientationPATENT Attorney Docket No. 133552.8005. WO01mechanisms,” as there is sufficient malleability so as to not harm the tissue against which the capsule is likely to brush as it travels along the Gl tract. These components may be selectively actuated to induce controlled deflections or shifts in the capsule’s orientation. For example, an extendable soft keel may be deployed on one side of the capsule to adjust the pitch or roll angle of the camera, either temporarily or cyclically, thus enhancing control over the field of view without requiring full-body repositioning.

[0107] In addition, the soft robotic system may dynamically modify the surface texture of the capsule. In one mode, a compliant, smooth external layer may be expanded to minimize friction and facilitate translation across the gastric lining. In another mode, textured microstructures (e.g., ridges, bumps, or suction elements) may be deployed to increase mucosal grip and resist motion. These surface transformations may be reversible and actuated in response to environmental cues (e.g., pH, pressure, or image-based triggers) or commanded via wireless control. The ability to toggle between low-friction and high-friction surface states enhances both navigation and positional retention, depending on the clinical objective.

[0108] In certain embodiments, the soft robotic system further includes suction-based anchoring mechanisms. These may comprise collapsible chambers, microvalves, or flexible diaphragms located along the base or periphery of the capsule. When the capsule is pressed gently against the gastric wall, these features may be actuated to create a temporary vacuum cavity between the capsule surface and the mucosa, forming a localized suction force. This negative pressure anchoring enables the capsule to remain fixed in a targeted location for prolonged observation, imaging, or diagnostic assessment, even in the presence of motility or fluid shifts. The suction may be released on demand by restoring internal pressure, retracting the chamber, or reversing actuation, allowing repositioning or retrieval as needed.PATENT Attorney Docket No. 133552.8005. WO01

[0109] In yet further embodiments, the soft robotic elements may be employed to actively modulate the total volume of the capsule in a fluid-filled environment. Expandable chambers, inflatable membranes, or bellows-like structures integrated into the capsule body may be actuated to increase or decrease the capsule’s effective displacement volume. This in turn changes its buoyancy relative to the surrounding fluid, allowing the capsule to rise or sink within the stomach. Such volumetric control may be used to adjust imaging altitude, avoid obstacles, or reach different regions of the gastric chamber.Volume changes may be achieved through controlled fluid transfer, pneumatic actuation, or thermally activated shape-memory expansion. This functionality enables vertical mobility without the need for external propulsion systems, enhancing navigational precision and reducing power requirements.

[0110] The inclusion of active soft robotic components allows the capsule to achieve hybrid behaviors - combining passive self-righting with controllable mechanical responses - to better adapt to varied gastric geometries and motion patterns. These features further extend the utility of the capsule to non-traditional or impaired gastrointestinal environments. Accordingly, the capsule may be used in methods including: (i) administering the capsule to a subject whose stomach contains little or no fluid; (ii) allowing the capsule to settle onto the mucosal surface; (iii) passively achieving and maintaining vertical orientation through internal mass distribution and external surface stabilization features; (iv) dynamically scanning the gastric environment using motorized camera rotation; (v) actuating soft robotic elements to adjust camera orientation, surface interaction state, or vacuum-based suction anchoring; and (vi) modulating the volume of the capsule to adjust buoyancy and enable controlled vertical movement in fluid-filled environments. This embodiment ensures consistent image framing, tunable locomotion or fixation, and enhanced adaptability to complex internal environments without compromising patient comfort or safety.Example 1 - Illustrative Clinical Protocol Demonstrating a Method of Detecting Retained Gastric ContentsPATENT Attorney Docket No. 133552.8005. WO01

[0111] An illustrative clinical investigation was conducted to demonstrate that the orientationally-biased imaging capsule described herein can be employed, without sedating a patient, to determine the presence of retained gastric contents (RGC) immediately before procedures that require anesthesia or moderate sedation. Healthy adult volunteers were recruited; individuals with known gastrointestinal strictures, swallowing disorders, or implanted electronic devices were excluded. A prespecified exploratory subgroup included participants receiving glucagon-like peptide-1 (GLP-1) receptor agonists or other agents known to slow gastric emptying.

[0112] Each subject fasted for at least eight hours from solid food and two hours from clear liquids and was then randomized in a one-to-one ratio to a fasted cohort or a fed cohort. Subjects in the fasted cohort (Cohort A) continued the fast throughout the evaluation period, whereas subjects in the fed cohort (Cohort B) received, after an initial endoscopic examination, 1.5 milliliters per kilogram body weight of a standardized test meal. In both cohorts, a conventional sedated esophagogastroduodenoscopy (EGD) was first performed and digitally recorded to establish a reference standard. Once each participant achieved full recovery from sedation, as indicated by a modified Aldrete score of nine or greater, the participant swallowed the imaging capsule with approximately fifty milliliters of water. The capsule thereafter streamed continuous video to an external receiver for a minimum of fifteen minutes.

[0113] During capsule operation the unsedated subject was prompted, via a software application, to adopt a sequence of body positions - namely, right lateral decubitus, supine, left lateral decubitus, and sitting upright - so that the orientationally-biased capsule could survey the entire gastric mucosa. Blinded reviewers later examined the recorded capsule video and classified the stomach as empty, containing less than fifty milliliters of content, containing fifty to two hundred milliliters of content, or containing more than two hundred milliliters of content. For subjects in Cohort A, the EGD served as the ground-truth indicator of gastric emptiness. For subjects in Cohort B, the known volume of thePATENT Attorney Docket No. 133552.8005. WO01administered liquid meal served as the ground-truth indicator of a non-empty stomach. The primary end point was the sensitivity and specificity with which the capsule detected any RGC exceeding fifty milliliters relative to the appropriate reference standard. Secondary measures included agreement on semiquantitative volume categories, completion of the four-position imaging sequence, and the incidence of device-related adverse events such as retention, obstruction, or aspiration. Performance in GLP-1 agonist users was assessed as an exploratory outcome.

[0114] Forty participants (twenty per cohort) completed the study, including six individuals receiving GLP-1 receptor agonists. All subjects successfully ingested and passed the capsule, and every participant completed the four-position sequence without difficulty. No device-related serious adverse events were observed. The capsule correctly classified gastric emptiness in twenty of twenty fasted subjects as well as twenty of twenty fed subjects, yielding overall accuracy, sensitivity, and specificity values of one-hundred percent. In the exploratory subgroup, the capsule identified residual gastric contents of the GLP-1 agonist users, thereby demonstrating particular utility in populations at elevated risk for delayed gastric emptying.

[0115] This example shows that the orientationally-biased imaging capsule may be deployed as a non-invasive, unsedated screening tool to assess gastric emptiness immediately before an anesthetized or sedated intervention. By enabling rapid identification of occult gastric contents, the disclosed method can reduce the risk of peri-procedural aspiration, especially in patients receiving medications that slow gastric motility.Additional Use Cases

[0116] The disclosed technology is additionally applicable in emergencydepartment settings where patients, such as trauma victims, intoxicated individuals, or those requiring urgent intubation, may have unknown gastric contents but must nonetheless undergo rapid sedation or general anesthesia.PATENT Attorney Docket No. 133552.8005. WO01Because the capsule can be swallowed without procedural delay and yields realtime imaging within minutes, it can enable clinicians to verify gastric emptiness (or to quantify residual volume) and thereby reduce the risk of aspiration before emergent airway manipulation or operative intervention.

[0117] Another emerging use case involves the deployment and confirmation of gastrointestinal implants, such as stents, spacers, balloons, and other therapeutic devices, without the need for fluoroscopy or other ionizing radiation. Traditionally, gastric and esophageal implants are positioned under radiographic guidance to ensure correct placement within the stomach or duodenum. This approach, while effective, requires access to fluoroscopy suites, exposes patients and providers to radiation, and may necessitate the use of contrast agents or guidewires.

[0118] The orientationally-biased capsule described herein may be ingested following implant placement to confirm real-time location and orientation of the deployed device using video imaging alone. Because the capsule naturally rights itself in a fluid-distended stomach and can scan the mucosa from a stable vertical perspective, it can be used to inspect key anatomical landmarks, assess proximity of the implant to the gastroesophageal junction or pylorus, and detect early signs of malposition, obstruction, or tissue trauma.

[0119] In some embodiments, the capsule may be used during the same procedural session as implantation - eliminating the need for fluoroscopic confirmation - thereby streamlining workflow in settings without interventional radiology or full endoscopic capabilities. This approach could be particularly valuable for stent deployment in rural or ambulatory surgery centers, during humanitarian missions, or in facilities lacking dedicated imaging infrastructure.

[0120] Additionally, the capsule may provide continuous or periodic postplacement monitoring over the ensuing hour(s), allowing clinicians to verify that the implant has remained in place after the patient has resumed movement or oral intake. This capability offers a low-cost, low-risk method of intraoperative and early postoperative confirmation of gastrointestinal implant positioning.PATENT Attorney Docket No. 133552.8005. WO01

[0121] Accordingly, the capsule may be used in methods including: (i) deploying a gastric or duodenal implant into a patient, (ii) fluid-distending the stomach or relevant lumen, (iii) administering the orientationally-biased capsule to the patient, and (iv) obtaining and interpreting video images from the capsule to confirm proper implant positioning, all without the need for radiographic imaging.

[0122] In another use case, the orientationally-biased imaging capsule may be used to support esophageal dilation procedures in patients with stenosis, strictures, or narrowing of the esophageal lumen. These procedures are commonly performed to relieve dysphagia in conditions such as radiation-induced strictures, peptic strictures, or eosinophilic esophagitis. Conventionally, esophageal dilation involves advancing a guidewire across the stenotic segment, confirming wire position radiographically, and then passing a dilating catheter, balloon, or bougie over the guidewire.

[0123] This process typically requires fluoroscopy to visualize the guidewire as it traverses the narrowing and to confirm appropriate placement prior to dilation. However, in many settings - including outpatient clinics, rural hospitals, and developing regions - real-time X-ray imaging may be unavailable, costly, or undesired due to radiation exposure.

[0124] The disclosed capsule offers a non-radiographic alternative. Once the guidewire has been advanced across the stenosis, the orientationally-biased capsule may be introduced orally and maneuvered to track the guidewire visually as it traverses the esophageal lumen. Because the capsule provides continuous video imaging in a forward-facing, self-righting orientation, the physician may directly visualize the path of the guidewire and confirm that it has entered the stomach or passed safely through the targeted stricture. This real-time confirmation may reduce reliance on X-ray, eliminate the need for contrast agents, and simplify workflows in facilities that lack fluoroscopy.

[0125] Furthermore, in cases where the stenosis is subtotal or borderline passable, the capsule may help identify mucosal characteristics, assess residualPATENT Attorney Docket No. 133552.8005. WO01lumen diameter, or detect bleeding or injury before or after dilation. This added diagnostic insight enhances procedural safety and may inform choice of dilator size or technique.

[0126] Accordingly, the capsule may be used in methods including: (i) introducing a guidewire through the esophagus of a patient with suspected or confirmed stenosis, (ii) administering the orientationally-biased capsule into the esophagus or stomach, (iii) obtaining and reviewing live video to confirm guidewire position without fluoroscopy, and (iv) proceeding with dilation based on visual confirmation. In this manner, the capsule may help obviate the need forX-ray guidance in esophageal stricture dilation procedures.

[0127] The orientationally-biased imaging capsule may also be employed to perform targeted, non-invasive surveys of known or suspected gastric or esophageal pathologies, including ulcers, tumors, and previously placed medical devices such as stents, clips, or sutures. These use cases are particularly relevant for ongoing disease monitoring, post-procedural surveillance, or the evaluation of treatment response.

[0128] For example, patients with previously identified gastric ulcers or mucosal erosions often require serial endoscopic evaluations to assess healing, rule out malignancy, or document the absence of active bleeding. Similarly, gastric or esophageal tumors may require interval imaging between diagnostic endoscopy and surgical intervention, or to monitor progression in patients undergoing medical therapy. In each case, the capsule can be swallowed and guided using patient positioning alone to visualize and document the area of interest, without requiring sedation or invasive endoscopy.

[0129] The capsule may further be used to inspect the position and integrity of previously placed foreign bodies such as self-expanding metal stents, bariatric balloons, clips placed for bleeding control or resection margins, or retained foreign objects. For example, a physician may use the capsule to confirm that a stent remains patent and correctly oriented, to assess tissue overgrowth or obstruction, or to determine whether a device has migrated.PATENT Attorney Docket No. 133552.8005. WO01

[0130] Because the capsule provides real-time video, is easy to deploy, and can be repositioned through patient movement, it offers a practical solution for point-of-care evaluation of localized gastric pathology. It may be used in hospital, clinic, or even telemedicine settings, and does not require retrieval after use.

[0131] Thus, the capsule may be employed in methods including: (i) administering the orientationally-biased capsule to a patient with a known or suspected gastric or esophageal lesion or implant, (ii) obtaining a series of live or stored video images of the region of interest by adjusting patient position, and (iii) interpreting the images to assess lesion progression, healing status, implant location, or surrounding mucosal changes. These methods may enhance patient follow-up, reduce the need for repeat sedated endoscopy, and expand access to diagnostic Gl imaging.

[0132] In another embodiment, the orientationally-biased imaging capsule may be utilized to provide an auxiliary visual perspective during endoscopic procedures. Traditionally, diagnostic or interventional procedures within the gastrointestinal tract are performed using a flexible endoscope, which includes a single camera located at its distal tip. This camera provides a close-up, forwardfacing view that is often limited in field of vision, particularly when the endoscope is maneuvered in tight spaces or directed at focal lesions.

[0133] By concurrently deploying the capsule within the same anatomic region, such as the stomach or esophagus, the physician can access a second, complementary camera angle that operates independently of the endoscope. The capsule, free-floating or resting in a fluid-distended cavity, maintains a stable orientation and provides a wide-angle, gravity-aligned view of the operative field. This secondary perspective can significantly enhance spatial awareness, facilitate tool guidance, and allow the endoscopist to visualize surrounding structures while performing precise tasks such as clipping, injecting, ablating, or dissecting tissue.PATENT Attorney Docket No. 133552.8005. WO01

[0134] For instance, while the endoscope provides a detailed, proximal view of a bleeding lesion or tumor margin, the capsule may simultaneously provide a broader overview of the surrounding anatomy, allowing the physician to track tissue deformation, assess procedural progress, and detect unintentional injury or collateral effects. The capsule's live video feed may be displayed in parallel with the endoscopic image on a split screen, enabling real-time multiangle visualization during complex maneuvers.

[0135] Accordingly, the capsule may be used in methods including: (i) performing a conventional endoscopic procedure within the gastrointestinal tract; (ii) concurrently deploying the orientationally-biased capsule into the same or adjacent lumen; (iii) acquiring live video from the capsule during the procedure; and (iv) using the capsule video as an auxiliary view to supplement the primary endoscopic image. Such multi-axis visualization enhances procedural safety, improves navigation, and may enable novel workflows that were previously limited by single-view instrumentation.

[0136] The orientationally-biased imaging capsule may also be employed to assist in the detection, characterization, and monitoring of gastrointestinal fistulas, postoperative leaks, and anastomotic sites following surgical intervention. In the setting of bariatric surgery (e.g., sleeve gastrectomy, gastric bypass), esophagectomy, or tumor resection, there exists a clinical need to verify the integrity of surgical junctions and to assess for early signs of dehiscence or fluid leakage into adjacent compartments.

[0137] Traditionally, such evaluations require the use of contrast-based imaging (e.g., upper Gl series with fluoroscopy or CT scan) or repeat endoscopy, which may be invasive, costly, or unavailable in urgent or resource-limited settings. In contrast, the orientationally-biased capsule can be administered orally and positioned to visualize relevant mucosal junctions, staple lines, or suture sites directly.

[0138] The capsule’s passive vertical alignment and real-time video feed allow for the identification of subtle defects, tissue inflammation, pooling of fluid,PATENT Attorney Docket No. 133552.8005. WO01or the presence of extraluminal contrast previously administered. In patients who have undergone prior procedures with known risk of complications, such as leaks at the gastrojejunostomy or esophagogastric junction, the capsule may serve as a non-invasive method of surveillance or triage, helping determine which patients require escalation to more invasive diagnostics.

[0139] Accordingly, the device may be used in methods including: (i) administering the capsule to a post-surgical patient with known or suspected Gl tract alteration; (ii) capturing video data of a target anatomical site including anastomoses or resection margins; and (iii) interpreting the imaging data to assess for signs of fistula formation, leakage, or incomplete healing. This approach may reduce unnecessary repeat procedures and improve early detection of surgical complications.

[0140] The orientationally-biased imaging capsule may also be used to evaluate gastric motility and assess the dynamics of gastric emptying in patients with suspected functional disorders. Conditions such as gastroparesis, functional dyspepsia, and diabetic autonomic neuropathy often impair gastric contractility and delay the transit of solids and liquids from the stomach to the duodenum. Accurate assessment of gastric motility is clinically important for diagnosis, treatment selection, and monitoring therapeutic response.

[0141] Traditional methods of evaluating gastric emptying, such as scintigraphy, breath testing, or manometry, can be time-consuming, technically complex, or dependent on specialized equipment. The disclosed capsule offers a non-invasive alternative that allows for direct visualization of gastric content mixing, retention, and exit into the small intestine.

[0142] In some embodiments, the capsule may be administered along with a standardized meal or test solution. The capsule remains in the stomach for a defined observation period, during which it streams live video showing the behavior of gastric contents, peristaltic activity, and the timing of content clearance. By noting the persistence or absence of material in the visual fieldPATENT Attorney Docket No. 133552.8005. WO01over time - and correlating with the capsule's orientation and motion - the physician may infer gastric contractility, fluid dynamics, and outflow efficiency.

[0143] This application is especially valuable for differentiating between true mechanical obstruction and functional delay, for assessing the effect of prokinetic drugs, and for evaluating patients taking medications known to slow gastric emptying, such as opioids or GLP-1 receptor agonists.

[0144] The orientationally-biased imaging capsule may also be employed as a rapid screening tool for upper gastrointestinal (Gl) bleeding, particularly in emergency or resource-limited settings where endoscopy is not immediately available. Upper Gl bleeding, often caused by peptic ulcers, varices, or erosive gastritis, requires timely diagnosis to guide triage and intervention. However, conventional esophagogastroduodenoscopy (EGD) may be delayed due to lack of equipment, trained personnel, or anesthesia support.

[0145] In such scenarios, the capsule may be administered to a hemodynamically stable patient presenting with hematemesis or melena to determine whether active bleeding or high-risk stigmata are visible in the stomach or proximal duodenum. The capsule, once ingested, can visualize pooled blood, clots, or ongoing hemorrhage in real time. Its passive orientational stability allows reliable imaging of gravity-dependent areas where blood typically settles, such as the greater curvature and fundus, with minimal need for patient cooperation or positioning expertise.

[0146] This early assessment may inform critical decisions such as whether to initiate transfusions, transfer the patient to a higher level of care, or prioritize endoscopic intervention. In low-resource environments, the capsule may serve as the only available diagnostic tool and may reduce unnecessary transfers or empiric therapies when no bleeding is visualized.

[0147] Accordingly, the capsule may be used in methods including: (i) administering the device to a patient with signs or symptoms of upper Gl bleeding; (ii) capturing and reviewing live video to detect the presence, volume, and characteristics of intragastric blood; and (iii) using the visual findings to guidePATENT Attorney Docket No. 133552.8005. WO01further clinical management, triage, or treatment planning. This approach enables accessible, radiation-free bleeding assessment at the point of care.

[0148] Accordingly, the capsule may be used in methods including: (i) administering the capsule in conjunction with a meal or test solution; (ii) capturing and reviewing video data over a defined observation period to monitor gastric content dynamics; and (iii) using the findings to assess gastric motility, diagnose gastroparesis or related disorders, or evaluate treatment response. This technique provides a practical, patient-friendly approach to studying real-time gastrointestinal function.

[0149] Analogous benefits extend to veterinary practice. Companion animals and wildlife frequently present with nonspecific abdominal signs or suspected foreign-body ingestion. The orientationally-biased capsule can be administered orally to a dog, cat, or other mammal to visualize the stomach and proximal small intestine, detect mucosal pathology (ulcers, masses, parasites), or localize ingested foreign objects - all without the need for endoscopic equipment, general anesthesia, or ionizing-radiation imaging. Thus, the methods described herein encompass administering the capsule to a non-human animal, obtaining live gastric video while the conscious animal is gently repositioned by the clinician, and interpreting the imagery to diagnose disease or confirm the presence or absence of foreign material.

[0150] Collectively, these human and veterinary use cases illustrate that the orientationally-biased imaging capsule provides a versatile, non-invasive tool for rapidly assessing gastric contents or pathology across a wide range of clinical scenarios, including elective procedures, emergency care, and animal health. Processing System

[0151] Figure 8 is a block diagram illustrating an example of a processing system 800 in which at least some operations described herein can be implemented. For example, some components of the processing system 800 may be hosted on an ingestible device (e.g., ingestible device 100 of Figure 1A).PATENT Attorney Docket No. 133552.8005. WO01As another example, some components of the processing system 800 may be hosted on an electronic device or a controller that is communicatively coupled to the ingestible device via a wireless communication channel.

[0152] The processing system 800 may include a processing unit (“processors”) 802, main memory 806, non-volatile memory 810, wireless transceiver 812, input / output device 818, control device 820 (e.g., a keyboard, pointing device, joystick, or some other control mechanism), drive unit 822 including a storage medium 824, and signal generation device 828 that are communicatively connected to a bus 816. The bus 816 is illustrated as an abstraction that represents one or more physical buses and / or point-to-point connections that are connected by appropriate bridges, adapters, or controllers. The bus 816, therefore, can include a system bus, a Peripheral Component Interconnect (PCI) bus or PCI-Express bus, a HyperTransport or industry standard architecture (ISA) bus, a small computer system interface (SCSI) bus, a universal serial bus (USB), IIC (l2C) bus, or an Institute of Electrical and Electronics Engineers (IEEE) standard 1394 bus (also referred to as “Firewire”), as examples.

[0153] The processing system 800 may share a similar computer processor architecture as that of a desktop computer, tablet computer, mobile phone, game console, wearable electronic device (e.g., a watch or fitness tracker), network-connected (“smart”) device (e.g., a television or home assistant device), virtual or augmented reality system (e.g., a head-mounted display), or another electronic device capable of executing instructions that specify action(s) to be taken by the processing system 800.

[0154] While the main memory 806, non-volatile memory 810, and storage medium 824 (also called a “machine-readable medium”) are shown to be a single medium, the term “machine-readable medium” and “storage medium” should be taken to include a single medium or multiple media (e.g., a centralized / distributed database and / or associated caches and servers) that stores one or more sets ofPATENT Attorney Docket No. 133552.8005. WO01instructions 804, 808, 826. The terms “machine-readable medium” and “storage medium” shall also be taken to include any medium that is capable of storing, encoding, or carrying instructions for execution by the processing system 800.

[0155] In general, the routines executed to implement the embodiments of the disclosure may be implemented as part of an operating system or a specific application, component, program, object, module, or sequence of instructions (collectively referred to as “computer programs”). The computer programs typically comprise instructions (e.g., instructions 804, 808, 826) set at various times in various memory and storage devices in an electronic device. When read and executed by the processor 802, the instructions cause the processing system 800 to perform operations to execute elements involving the various aspects of the disclosure.

[0156] Moreover, while embodiments have been described in the context of fully functioning electronic devices, those skilled in the art will appreciate that the various embodiments are capable of being distributed as a program product in a variety of forms. The disclosure applies regardless of the particular type of machine or computer-readable media used to actually cause the distribution.

[0157] Further examples of machine-readable storage media, machine-readable media, or computer-readable media include recordable-type media such as volatile and non-volatile memory devices 810, removable disks, hard disk drives, optical disks (e.g., Compact Disk Read-Only Memory (CD-ROMS), Digital Versatile Disks (DVDs)), cloud-based storage, and transmission-type media such as digital and analog communication links.

[0158] The wireless transceiver 812 enables the processing system 800 to mediate data in a network 814 with an entity that is external to the processing system 800 through any communication protocol supported by the processing system 800 and the external entity. The wireless transceiver 812 could be representative of, or included in, a network adaptor card, a wireless network interface card, a router, an access point, a wireless router, a switch, a multilayerPATENT Attorney Docket No. 133552.8005. WO01switch, a protocol converter, a gateway, a bridge, a bridge router, a hub, a digital media receiver, or a repeater.

[0159] The techniques introduced here can be implemented by programmable circuitry (e.g., one or more microprocessors), software, firmware, special-purpose, hard-wired (i.e., non-programmable) circuitry, or a combination of such forms. Special-purpose, hardwired circuitry can be in the form of one or more application-specific integrated circuits (ASICs), programmable logic devices (PLDs), field-programmable gate arrays (FPGAs), etc.Remarks

[0160] The foregoing description of various embodiments has been provided for the purposes of illustration. It is not intended to be exhaustive or to limit the claimed subject matter to the precise forms disclosed. Many modifications and variations will be apparent to one skilled in the art. Embodiments were chosen and described in order to best describe the principles of the invention and its practical applications, thereby enabling those skilled in the relevant art to understand the claimed subject matter, the various embodiments, and the various modifications that are suited to the particular uses contemplated.

[0161] Although the Detailed Description describes various embodiments, the technology can be practiced in many ways no matter how detailed the Detailed Description appears. Embodiments may vary considerably in their implementation details, while still being encompassed by the specification.Particular terminology used when describing certain features or aspects of various embodiments should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the technology with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the technology to the specific embodiments disclosed in the specification, unless those terms are explicitly defined herein. Accordingly, the actual scope of thePATENT Attorney Docket No. 133552.8005. WO01technology encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the embodiments.

[0162] The language used in the specification has been principally selected for readability and instructional purposes. It may not have been selected to delineate or circumscribe the subject matter. It is therefore intended that the scope of the technology be limited not by this Detailed Description, but rather by any claims that issue on an application based hereon. Accordingly, the disclosure of various embodiments is intended to be illustrative, but not limiting, of the scope of the technology as set forth in the following claims.

Claims

PATENT Attorney Docket No. 133552.8005. WO01CLAIMSWhat is claimed is:

1. A device designed for ingestion by a living body, the device comprising:a capsule that has(i) a first atraumatically shaped end with a first cavity defined therein,(ii) a second atraumatically shaped end with a second cavity defined therein, and(iii) a cylindrical segment interconnected between the first and second atraumatically shaped ends;an image sensor that is contained within the first cavity and is arranged to capture digital images based on light that transmits through the first atraumatically shaped end; anda ballast that is contained within the second cavity and that causes the device to be weighted to negative buoyancy, such that the device naturally sinks toward a surface of an anatomical lumen that is at least partially filled with fluid.

2. The device of claim 1 , wherein the capsule is entirely free of lumens and recesses.

3. The device of claim 1 ,wherein the capsule has a central axis defined longitudinally through the first atraumatically shaped end, the cylindrical segment, and the second atraumatically shaped end, andwherein the image sensor is oriented substantially along the central axis, such that when the capsule is ballasted with the second atraumatically end along the surface of the anatomical lumen, a field of view of the image sensor extends away from the surface.PATENT Attorney Docket No. 133552.8005. WO014. The device of claim 1 , wherein the ballast causes the capsule to maintain a fixed orientation relative to gravity while in the fluid, such that a field of view of the image sensor is adjusted by the living body adopting one or more predetermined positions.

5. The device of claim 1 , wherein a mass of the device is between 1 gram and 3.5 grams.

6. The device of claim 1 ,wherein the capsule has a central axis defined longitudinally through the first atraumatically shaped end, the cylindrical segment, and the second atraumatically shaped end, andwherein the device has a center of buoyancy that is located between 1 millimeter and 2 millimeters above a center of mass along the central axis.

7. The device of claim 1 , wherein the first atraumatically shaped end has a different form than the second atraumatically shaped end.

8. The device of claim 7, wherein the first atraumatically shaped end has a flat surface that is joined to the cylindrical segment by a rounded edge, and wherein the second atraumatically shaped end has a roughly hemispherical form.

9. The device of claim 1 , wherein the second atraumatically shaped end has raised ridges that define a texture along an outer surface.

10. The device of claim 1 , further comprising:one or more malleable orientation mechanisms that are embedded within, or connected to, the capsule and that are controllably actuatable to induce deflections or shifts in orientation of the device.PATENT Attorney Docket No. 133552.8005. WO0111. The device of claim 1 , wherein an outer surface of the capsule includes microstructures that are controllably actuatable to provide texture.

12. A device designed for ingestion by a living body, the device comprising:a capsule that has(i) a first atraumatically shaped end with a first cavity defined therein,(ii) a second atraumatically shaped end with a second cavity defined therein, and(iii) a cylindrical segment interconnected between the first and second atraumatically shaped ends;an image sensor that is contained within the first cavity and is arranged to capture digital images based on light that transmits through the first atraumatically shaped end; anda ballast that is contained within the second cavity and that causes the device to be weighted to positive buoyancy, such that the device naturally floats in an anatomical lumen that is at least partially filled with fluid.

13. The device of claim 12,wherein the capsule has a central axis defined longitudinally through the first atraumatically shaped end, the cylindrical segment, and the second atraumatically shaped end, andwherein the device further comprises:an actuation mechanism that, in operation, is able to rotate the image sensor about the central axis.

14. The device of claim 13, wherein the actuation mechanism is an internal micromotor, a voice coil motor (VCM), a shape-memory alloy (SMA) actuator, a piezoelectric motor, or a micro-electro-mechanical systems (MEMS) actuator.PATENT Attorney Docket No. 133552.8005. WO0115. The device of claim 12,wherein the capsule has a central axis defined longitudinally through the first atraumatically shaped end, the cylindrical segment, and the second atraumatically shaped end, andwherein the device further comprises:an actuation mechanism that, in operation, is able to shift a location of the ballast relative to the central axis.

16. The device of claim 15, wherein the actuation mechanism is electrically controlled using one or more electromagnets.

17. The device of claim 15, wherein the actuation mechanism is a motor-drive mechanism that is able to mechanically move an eccentric weight that serves as the ballast.

18. The device of claim 12,wherein the image sensor is able to detect electromagnetic radiation in a visible range, andwherein the device further comprises:a second image sensor that is contained within the first cavity and is arranged to capture digital images based on non-visible light that transmits through the first atraumatically shaped end.

19. A device designed for ingestion by a living body, the device comprising:a capsule that has(i) a first atraumatically shaped end with a first cavity definedtherein,PATENT Attorney Docket No. 133552.8005. WO01(ii) a second atraumatically shaped end with a second cavity defined therein, and(iii) a cylindrical segment interconnected between the first and second atraumatically shaped ends;multiple image sensors that are contained within the first cavity and that are radially arranged about the first atraumatically shaped end to capture digital images of different parts of an anatomical lumen; anda ballast that is contained within the second cavity.

20. The device of claim 19, further comprising:multiple illuminants that are radially arranged about either the first atraumatically shaped end or the cylindrical segment.

Images