Liquid collection and drug release system and method

Abstract

The present invention relates to a system and method for obtaining fluid and / or delivering a drug. The system for obtaining fluid and / or delivering a drug includes a capsule endoscope and a tether connected to the capsule endoscope. The tether includes a flexible member having a lumen, the lumen being fluidically connected to a port configured to allow fluid to pass therethrough. The port is located on the capsule endoscope or the tether. The method for obtaining fluid and / or delivering a drug includes: introducing the capsule endoscope into the gastrointestinal tract of a patient and navigating it to a target area, extracting a patient sample at the target area, and / or administering a therapeutic substance through the lumen (e.g., through the port).

Description

[0001] Cross-references

[0002] This application claims priority to U.S. patent application US62 / 831,447, filed on April 9, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to the field of medicine, and in particular to a liquid collection and drug release system for patients. Background Art

[0004] In the process of performing medical treatment on a patient, it may be important to directly access the patient's area of ​​interest, such as obtaining body samples (e.g., for diagnosis and / or monitoring the progress of treatment of the diseased area) or administering therapeutic agents (e.g., lesions). However, certain body cavities and other internal areas of the patient may be difficult to access. For example, at least some portions of the gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine, etc.) or other internal organs (e.g., pancreas, gall bladder, etc.) may be located relatively deep in the body. Accessing these sites for tissue interaction may require special tools and / or may cause tissue damage and endanger the patient's health.

[0005] As an illustrative example, it may be necessary to obtain pancreatic juice from a patient for biopsy to evaluate for mutations suggestive of pancreatic cancer. Conventional methods for obtaining pancreatic juice for biopsy include endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). However, these methods can lead to complications such as pancreatitis, infection, bleeding, and intestinal perforation.

[0006] Therefore, there is a need for new and improved non-invasive systems and methods for accessing a region of interest in a patient. Summary of the Invention

[0007] Typically, in some embodiments, a system for accessing a patient includes a capsule endoscope comprising an imaging system and a port configured to allow passage of a fluid. The system may further include a tether connected to the capsule endoscope, the tether comprising a flexible member, wherein the flexible member comprises a lumen in fluid communication with the port. Additionally, in some embodiments, the tether may include a clamp configured to engage the capsule endoscope, and the clamp may be configured to releasably engage the capsule endoscope. The system may further include a pressure source and / or a vacuum source (e.g., a syringe, a pump, etc.) arranged in fluid communication with the lumen.

[0008] In some embodiments, the capsule endoscope can be magnetically controllable, for example, with an external magnetic control system. The capsule endoscope can include one or more suitable compartments or other structures for conveying fluid between the lumen and the port. In some embodiments, the compartment can include an elongated channel having a proximal end in fluid communication with the lumen and a distal end in fluid communication with the port. The elongated channel can, for example, extend from a proximal portion of the capsule endoscope to a distal portion of the capsule endoscope. In some embodiments, the compartment can include a chamber. For example, the chamber can be located in the proximal portion of the capsule endoscope.

[0009] Furthermore, generally in some embodiments, a system for accessing a patient comprises: a capsule endoscope comprising an imaging system; a tether comprising a clamp configured to engage the capsule endoscope; and a flexible member comprising a lumen; wherein the clamp comprises a port in fluid communication with the lumen. In some embodiments, the imaging system may comprise a first lens on a proximal portion of the capsule endoscope and / or a second lens on a distal portion of the capsule endoscope. The capsule endoscope may be magnetically controlled. Furthermore, in some embodiments, the tether may comprise a clamp configured to engage the capsule endoscope, and the clamp may be configured to releasably engage the capsule endoscope. The system may further comprise a pressure source and / or a vacuum source (e.g., a syringe, a pump, etc.) arranged in fluid communication with the lumen.

[0010] In some embodiments, the clamp of the tether may include a sheath configured to surround at least a portion of the capsule endoscope. In some embodiments, the clamp may include an anchoring member connecting the sheath and the flexible member of the tether. In some embodiments, the port may be on the anchoring member and axially offset from the proximal portion of the capsule endoscope. For example, the anchor may include one or more arched structures connected to the sheath to provide an offset or window area between the port and the capsule endoscope. Additionally, in some embodiments, the clamp may include a housing defining a chamber between the sheath and the flexible member, and the port may be in the housing. In some variations of these embodiments, the housing may further include a valve (e.g., a one-way valve).

[0011] In addition, generally in some embodiments, a system for accessing a patient includes: a capsule endoscope including an imaging system having a field of view; and a tether including a flexible member having a port. The port can be within the field of view of the imaging system, and the port can be configured to allow fluid to pass through. In some embodiments, the imaging system can include a lens on the proximal portion of the capsule endoscope and / or the distal portion of the capsule endoscope. In some embodiments, the capsule endoscope can be magnetically controllable. The system can also include a pressure source and / or a vacuum source (e.g., a syringe, a pump, etc.) arranged to be in fluid communication with the lumen.

[0012] In some embodiments, the flexible member may be connected to the capsule endoscope.For example, the capsule endoscope may include a housing and at least a longitudinal portion of the flexible member may be connected to the housing.

[0013] Additionally or alternatively, in some embodiments, the flexible member can be connected to a portion of the tether, such as a clamp configured to engage the capsule endoscope. In these embodiments, at least a longitudinal portion of the flexible member can be connected to the clamp. For example, the clamp can be configured to releasably engage the capsule endoscope.

[0014] Generally, in some embodiments, a method of accessing a patient includes introducing a capsule endoscope into the patient's gastrointestinal tract, wherein the capsule endoscope is connected to a tether comprising a flexible member having a lumen, positioning the capsule endoscope at a target area, and administering a therapeutic substance to the target area through the lumen. Administering the therapeutic substance may, for example, include administering the therapeutic substance through a port in fluid communication with the lumen. For example, the port may be on the capsule endoscope or on the tether. The therapeutic substance may be at least partially administered by applying positive pressure to the lumen. In some embodiments, the method may further include detaching the capsule endoscope from the tether, and then administering the therapeutic substance after detaching the capsule endoscope from the tether.

[0015] In addition, in some embodiments, a method of accessing a patient includes introducing a capsule endoscope into the patient's gastrointestinal tract, wherein the capsule endoscope is connected to a tether comprising a flexible member having a lumen, positioning the capsule endoscope at a target area, and extracting a patient sample from the target area through the lumen. Extracting the patient sample may, for example, include extracting the patient sample through a port in fluid communication with the lumen. For example, the port may be on the capsule endoscope or the tether. The patient sample may be at least partially removed by applying negative pressure to the lumen. In some embodiments, the method may further include separating the capsule endoscope from the tether, and then removing the patient sample after separating the capsule endoscope from the tether. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Below in conjunction with accompanying drawing, specific embodiment of the present invention is described in detail:

[0017] Figure 1A This is a schematic diagram of a capsule endoscope system for entering a patient provided by an embodiment of the present application. Figure 1B This is a schematic diagram of a method for collecting fluid using a capsule endoscope system for entering a patient, provided in one embodiment of the present application. Figure 1C This is a schematic diagram of a method for drug release using a capsule endoscope system for entering a patient, provided in one embodiment of the present application.

[0018] Figures 2A-2CThey are respectively a perspective view, a longitudinal cross-sectional view and an exploded view of a capsule endoscope having a port at a distal end portion provided by an embodiment of the present application. Figure 2D yes Figures 2A-2C Schematic diagram of the size range of capsule endoscopes.

[0019] Figure 3 is included Figures 2A-2C Schematic diagram of the capsule endoscopy system of the capsule endoscopy.

[0020] Figure 4A is used Figures 2A-2C Schematic diagram of the method of fluid collection using capsule endoscopy. Figure 4B is used Figures 2A-2C Schematic diagram of the method of drug delivery via capsule endoscopy.

[0021] Figures 5A-5C 1 and 2 are respectively a perspective view, a longitudinal cross-sectional view and an exploded view of a capsule endoscope having a port at a distal end portion provided by another embodiment of the present application.

[0022] Figures 6A-6C 1 and 2 respectively show a side view, a partial longitudinal cross-sectional view, and a longitudinal cross-sectional view of a capsule endoscope having a port at a proximal end portion provided by yet another embodiment of the present application.

[0023] Figure 7 is included Figures 6A-6C Schematic diagram of the capsule endoscopy system of the capsule endoscopy.

[0024] Figure 8A is used Figures 6A-6C Schematic diagram of the method of fluid collection using capsule endoscopy. Figure 8B is used Figures 6A-6C Schematic diagram of the method of drug delivery via capsule endoscopy.

[0025] Figure 9 Schematic diagram of a capsule endoscope with an offset center of gravity provided by an embodiment of the present application.

[0026] Figure 10A This is a schematic diagram of a flexible component of a tether provided in one embodiment of the present application. Figure 10B This is a schematic diagram of the size range of the flexible component of the tether provided in one embodiment of the present application.

[0027] Figure 11A This is a schematic diagram of a tether of a clamp with a port provided in one embodiment of the present application. Figure 11B yes Figure 11A Side view of the tether. Figure 11C yes Figure 11A Schematic diagram of the size range of tethers. Figure 11D yes Figure 11ASchematic diagram of the field of view of the tether in the system. Figure 11E Schematic diagram of a tether with a clamp provided in another embodiment of the present application, wherein the clamp has multiple anchoring members with bow-shaped structures.

[0028] Figure 12 is included Figure 11A Schematic diagram of the tethered capsule endoscopy system.

[0029] Figure 13A is used Figure 11A Schematic diagram of the method of using a tether to obtain liquid. Figure 13B is used Figure 11A Schematic diagram of the method for drug release using a tether.

[0030] Figure 14A Schematic diagram of a capsule endoscope with an offset center of gravity provided in another embodiment of the present application. Figure 14B yes Figure 14A Capsule endoscopy combined with Figure 11A Schematic diagram of the tether.

[0031] Figure 15A is included Figure 11A Schematic diagram of the tethered capsule endoscopy system. Figure 15B is used Figure 15A Schematic diagram of a method for obtaining fluid using a capsule endoscopy system. Figure 15C is used Figure 15A Schematic diagram of the method for drug delivery using a capsule endoscopy system.

[0032] Figure 16A Schematic diagram of a capsule endoscopy system including a tether with a suction cup provided in another embodiment of the present application. Figure 16B yes Figure 16A Force diagram of detachment between capsule endoscope and tether. Figure 16C yes Figure 16A Schematic diagram of the capsule endoscope with the tether detached.

[0033] Figure 17A is used Figure 16A Schematic diagram of the method for collecting fluid using a capsule endoscopy system. Figure 17B is used Figure 17A Schematic diagram of the method for drug release using a capsule endoscopy system.

[0034] Figure 18A and 18B They are respectively an exploded schematic diagram and a side cross-sectional schematic diagram of a tether with a housing and a port provided in another embodiment of the present application. Figure 18C yes Figure 18A and 18B Schematic diagram of the range of tether sizes.

[0035] Figure 19A Capsule endoscopy and Figure 18A and 18B Force diagram of the tether joint. Figure 19B yes Figure 18A and 18B Schematic diagram of the opening of the tether port.

[0036] Figure 20A and 20B It is a capsule endoscope and Figure 18A and 18B Schematic diagram of the detachment between the tethers.

[0037] Figure 21A and 21B This is a schematic diagram of a tether directly connected to a capsule endoscope provided in yet another embodiment of the present application. Figure 21C is included Figure 21A and 21B Schematic diagram of the tethered capsule endoscopy system.

[0038] Figure 22A is used Figure 21A and 21B Schematic diagram of the method of using a tether to obtain liquid. Figure 22B is used Figure 21A and 21B Schematic diagram of the method for drug release using a tether.

[0039] Figure 23A and 23B They are respectively a side view and a cross-sectional schematic diagram of a capsule endoscope with an offset center of gravity provided by yet another embodiment of the present application. Figure 23C yes Figure 23A and 23B Capsule endoscopy combined with Figure 21A and 21B Schematic diagram of the tether.

[0040] Figure 24A FIG. 1 is a schematic diagram of a tether including a clamp configured to engage or accommodate a capsule endoscope provided in accordance with another embodiment of the present application. Figure 24B and 24C is included Figure 24A Schematic diagram of the tethered capsule endoscopy system.

[0041] Figure 25A and 25B They are respectively a side view and a perspective schematic diagram of the internal magnetic component of a capsule endoscope provided by an embodiment of the present application.

[0042] Figure 26A and 26BThey are schematic diagrams of the internal magnetic components of a capsule endoscope provided in another embodiment of the present application.

[0043] Figures 27A-27C These are perspective, side, and top views of a radially polarized magnet, respectively.

[0044] Figures 28A-28C These are perspective, side, and top views of an axially polarized magnet, respectively.

[0045] Figure 29 This is a schematic diagram of an external magnetic control system provided by an embodiment of the present application.

[0046] Figure 30A and 30B 、 Figure 30A and 30B 、 Figure 31A and 31B as well as Figure 32A and 32B This is a schematic diagram of a capsule endoscope controlled by motion through an external magnetic control system provided by an embodiment of the present application.

[0047] Figure 33A and 33B They are schematic diagrams of a pressure regulator including a syringe and a pump provided by an embodiment of the present application.

[0048] Figure 34A This is a schematic diagram of a pressure regulator including a microfluidic injection pump provided in one embodiment of the present application. Figure 34B is used Figure 34A Schematic diagram of the pressure regulator method. DETAILED DESCRIPTION

[0049] Non-limiting examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings.

[0050] Typically, a system for accessing a patient (e.g., for obtaining fluids, delivering medications, etc.) may include a capsule endoscope and a tether connected to the capsule endoscope. For example, the capsule endoscope may include an imaging system that is capable of visualizing its surroundings (e.g., through still images, videos, etc.). In some embodiments, the capsule endoscope may include one or more magnets so that the capsule endoscope can be controlled at least in part by a magnetic control system. The tether connected to the capsule endoscope may include a flexible member having a lumen that is fluidically connected to a port configured to allow fluid to pass therethrough, and the port may be, for example, on the capsule endoscope or the tether. In some embodiments, the flexible member may be directly connected to the capsule endoscope, while in some embodiments, the flexible member may be connected to the capsule endoscope via a clamp or other suitable intermediate attachment.

[0051] For example, Figure 1A As shown, a system 100 for accessing a patient (also referred to as a capsule endoscopy system) may include a capsule endoscope 110 and a tether 120 comprising a flexible member connected to the capsule endoscope. A pressure regulator 130, such as a pressure source or vacuum source (e.g., a syringe or a pump), may be connected to the tether so as to be in fluid communication with a lumen of the flexible member and a port 140 for allowing fluid to pass therethrough. Figures 1A-1C The port 140 is located on the distal portion of the capsule endoscope 110, but it should be understood that in other embodiments, the port 140 can be located additionally or alternatively on other suitable portions of the capsule endoscope (e.g., on the proximal portion of the capsule endoscope, the central portion of the capsule endoscope 110). Furthermore, in other embodiments, at least one port can be located on the tether (e.g., on the distal portion of the flexible member, on the clamping member of the tether, etc.). Other embodiments of the system, including examples of suitable arrangements of ports, are described in detail below.

[0052] During use, the capsule endoscope can be introduced into a body cavity, such as the gastrointestinal tract of a patient, and the tether is dragged behind the capsule endoscope and extends outside the patient's body. The capsule endoscope can be advanced to a target area. The imaging system of the capsule endoscope can provide the operator with visibility of the position of the capsule endoscope relative to the target area, the surrounding conditions near the capsule endoscope (for example, for determining whether there is fluid for biopsy in the body cavity, to determine whether there is a lesion or other disease, etc.). In the target area, liquid or patient samples can be removed from the patient's body through a port for biopsy. For example, a vacuum source (e.g., a syringe with an extraction plunger, a vacuum pump, etc.) can be connected to the tether to introduce negative pressure in the tether, remove the liquid for biopsy through the port, and reach a collection unit outside the patient's body through the tether, such as Figure 1B Additionally or alternatively, a pressure source (e.g., a syringe with a depressed plunger, a pressure pump, etc.) can be connected to the tether to induce positive pressure in the tether to push a therapeutic substance (e.g., a drug) through the tether and the port to the target area (e.g., a lesion), as shown. Figure 1C Other exemplary aspects of methods of using the system are described below.

[0053] In general, the systems and methods described herein are comfortable and non-invasive for the patient, thereby reducing the risk of dangerous complications, such as infection, bleeding, and perforation. The systems and methods can be used in various applications for fluid extraction and / or drug delivery. For example, the system can be used to extract pancreatic juice from a patient, or to sample a patient's intestinal flora. As another example, the system can be used to deliver drugs to lesions (e.g., in the esophagus) or to one or more target areas in the small intestine to treat, for example, inflammatory bowel disorder (IBD) or other conditions. As yet another example, drug release can be performed simultaneously with the controlled movement of the capsule endoscope, for example, to spray or otherwise release drugs across a surface (e.g., an inner surface area of ​​the stomach).

[0054] Capsule endoscopy

[0055] Typically, a capsule endoscope may include a housing that surrounds various endoscopic components. For example, the capsule endoscope may include an imaging system, a lighting system, a communication module, and / or a power supply. In some embodiments, the capsule endoscope may include one or more magnets for facilitating motion control (e.g., navigation, rotation, etc.) of the capsule endoscope by a magnetic control system external to the patient, as will be described in detail below. The housing may also include other electronic devices, such as a posture sensor (e.g., a gyroscope), a controller, and the like. In addition, in some embodiments, the capsule endoscope may include a port that is configured to allow fluid to flow into and / or out of the capsule endoscope. As described in further detail below, the port may be located, for example, at the distal end of the capsule endoscope or at the proximal end of the capsule endoscope (or at other suitable locations). In some variations of these embodiments, the capsule endoscope may include a center of gravity that is biased toward the port so that gravity tends to immerse the port in the fluid to obtain liquid for biopsy. Additionally or alternatively, the capsule endoscope may include a buoyancy element located on an opposite side or end of the capsule endoscope relative to the port, such that the buoyancy element tends to submerge the port in fluid to obtain liquid for biopsy.

[0056] Typically, the housing provides the capsule endoscope with its overall housing and shape. The housing may have rounded or beveled edges to reduce the risk of tissue damage when the capsule endoscope is advanced through a patient's body cavity (e.g., the gastrointestinal tract). The housing may include one or more internal volumes within which the endoscope components may be located. The internal volumes may be fluid-tightly sealed, for example, by mechanical interference (e.g., press-fit) components and / or epoxy resins. The housing may include a biocompatible plastic that may be injection molded or formed in any suitable manner.

[0057] The imaging system of the capsule endoscope can, for example, assist in navigating the capsule endoscope within the patient's body and / or enable visual assessment of surrounding patient tissue (e.g., confirming the presence of fluid that can be used for biopsy, identifying lesions, etc.). The imaging system can include one or more suitable image sensors, such as CMOS image sensors, for acquiring images of the environment surrounding the capsule endoscope. For example, the one or more image sensors can have a viewing angle that includes the environment surrounding the capsule endoscope. The illumination system can include one or more suitable light sources, such as light emitting diodes (LEDs) arranged to illuminate the field of view of the imaging system.

[0058] The control signals and / or image data can be communicated to the capsule endoscope via a communication module within the capsule endoscope. For example, the communication module can be a wireless communication module including a suitable RF antenna arrangement on a processing circuit board. In other embodiments, the capsule endoscope can alternatively include a communication module configured to communicate via a wired connection, which can extend outside the patient's body, for example, via a tether.

[0059] One or more power supplies are used to power the various capsule endoscope components. For example, the power supply may include a suitable battery. In some embodiments, the controller may operate the power supply to provide different power states for the capsule endoscope, such as an inactive state in which the capsule endoscope is in low power (e.g., for storage, transportation, etc.) and an active state in which the capsule endoscope is in high power (e.g., for imaging).

[0060] In some embodiments, the capsule endoscope may include a photoelectric switch actuator mounted near the lighting system. The photoelectric switch actuator may be arranged adjacent to the light source and include, for example, a field effect transistor (FET) and an electronic switch connected to the FET. When the lighting unit generates light, the light is irradiated onto the photoelectric switch actuator, causing the electronic switch to be turned on or activated. This activation of the electronic switch can effectively switch the capsule endoscope from low power (e.g., during the advancement of the capsule endoscope) to working power (e.g., for imaging of the target area). For example, activation of the electronic switch can generate an open pulse that electrically connects the power supply to other components of the capsule endoscope (e.g., the imaging system, the wireless communication module 250, etc.). The capsule endoscope is further described in detail in U.S. patent application publication number US2015 / 0011829, which is incorporated herein by reference in its entirety.

[0061] Various exemplary variations of capsule endoscopes having different arrangements of endoscopic components are described in further detail below.

[0062] Figures 2A-2C A capsule endoscope 200 is shown having a port 218 at the distal end. Figure 2B and 2C The capsule endoscope 200 may include a housing 210 that encloses various endoscope components, such as an imaging system 230, an illumination system 220, one or more magnets 240, a wireless communication module 250, and / or one or more power supplies 260. Except as described below, the functions and / or descriptions of the imaging system 230, the illumination system 220, the wireless communication module 250, and the one or more power supplies 260 are as described above. In some embodiments, the housing 210 also includes other electronic devices, such as a posture sensor (e.g., a gyroscope), a controller, and the like.

[0063] like Figure 2D As shown, the housing 210 can be generally cylindrical with rounded or beveled edges. The housing 210 can include a generally cylindrical central portion that includes one or more internal volumes for housing endoscope components. The central portion can be capped at its proximal (rear) and distal (front) ends with a proximal cap 214 and a distal cap 212. Figures 2A-2D As shown, the proximal and distal caps can be substantially flat or planar. The proximal cap 214 and / or the distal cap 212 can comprise an optically transparent material (e.g., acrylic) so that an imaging system and an illumination system within the capsule endoscope can view and / or illuminate the environment outside the capsule endoscope. Exemplary dimensions of the housing are a length of between about 15 mm and about 30 mm and a diameter of between about 6 mm and about 12 mm. For example, the size can be small enough to allow passage of the capsule endoscope into the gastrointestinal tract without significant discomfort or pain, yet large enough to accommodate the components of the endoscope.

[0064] As described above, the capsule endoscope 200 may include one or more magnets 240. The one or more magnets 240 may be controlled by an external magnetic control system, as further described below. For example, the one or more magnets 240 may be configured to allow the capsule endoscope to be controlled with 6 degrees of freedom (DOF), including translational motion along three vertical axes, and rotational motion along three vertical axes (yaw, pitch, roll). However, in some embodiments, the capsule endoscope 200 may omit the magnets 240. For example, instead of being controlled by an external magnetic control system, the capsule endoscope may be advanced by peristalsis in the patient's gastrointestinal tract.

[0065] The imaging system 230 and / or the illumination system 220 may be similar to the imaging system and illumination system described above. Figure 2C As shown, the lighting system 220 may include three LEDs 222 arranged on a circuit board and emitting light (eg, white light) through a transparent window of the distal cover 212 of the housing 210. Figure 2C218 , it should be understood that any suitable number (e.g., one, two, four, five, or more) of LEDs may be included in the illumination system 220. The LEDs 222 may be distributed around the lens 232 of the imaging system 230 to provide visibility in the field of view of the imaging system 230. Furthermore, the LEDs 222 and the imaging system 230 may be arranged near the port 218 (e.g., on a distal portion of a capsule endoscope) such that the illuminated field of view provides visibility of the environment immediately surrounding the port 218. Thus, the imaging system 230 may be configured to provide images to confirm, for example, whether the port 218 is submerged in a sufficient amount of patient fluid to obtain a sample through the port 218, and / or whether the port 218 is sufficiently close to a target area (e.g., a lesion) to deliver a drug to the target area through the port 218.

[0066] like Figure 3 As shown, in system 300, capsule endoscope 200 can be connected to tether 320, which includes a flexible member having a lumen, and tether 320 can be connected to pressure regulator 330 (e.g., a pressure source or vacuum source, such as a syringe or pump). Tether 320 can include a lumen, such as in the flexible member, and can be connected to capsule endoscope 200 in any suitable manner, such as directly (e.g., using epoxy, using barb fittings or other fittings) or via a clamp. This will be described in detail below.

[0067] In some embodiments, the capsule endoscope 200 may include a compartment 216 that is defined separately from one or more electronic compartments containing the aforementioned electronic components. The compartment 216 may be in fluid communication between the lumen of the tether 320 and the port 218 to allow fluid to pass between the port and a portion of the tether 320 outside the patient's body (or vice versa). In other words, the compartment 216 may be combined with the lumen of the tether 320 and the port 218 to form a conduit. For example, Figures 2A-2C As shown, the compartment may include an elongated channel having a proximal end in fluid communication with the lumen of the tether 320 and a distal end in fluid communication with the port 218. The elongated channel may extend from a proximal portion of the capsule endoscope to a distal portion of the capsule endoscope. For example, the elongated channel may terminate at an opening 219 in the proximal cover 214 adjacent to the tether 320. The elongated channel may have a generally circular cross-section, but may alternatively include any suitable cross-sectional shape (e.g., football-shaped or elliptical, etc.). In some embodiments, the size and / or shape of at least some of the components in one or more electronic compartments may be designed to accommodate the cross-sectional area of ​​the channel extending along the capsule endoscope. For example, as Figure 2C As shown, the circuit boards of the wireless communication module 240, the imaging system 230, and / or the illumination system 220 may be generally crescent-shaped, with a crescent-shaped cutout to accommodate the cross-sectional area of ​​the passageway.

[0068] In some embodiments, the capsule endoscope 200 may have a center of gravity that is biased toward the distal end of the capsule endoscope so that gravity tends to submerge the port 218 (located at the distal portion of the capsule endoscope) to obtain liquid for biopsy in the pooled liquid. The center of gravity can be appropriately adjusted by, for example, distributing more weight (e.g., relatively dense magnets) toward the distal end of the capsule endoscope 200. However, the center of gravity can be adjusted in addition or alternatively by other suitable means, such as a non-uniform distribution of the shell material (e.g., the thickness of the shell can be greater, or the distal material of the shell can be heavier). Additionally or alternatively, a relatively buoyant element or feature (e.g., an air-containing compartment) can be located on the opposite end of the capsule endoscope relative to the port 218.

[0069] Example Uses of System 300 Figure 4A and 4B As shown. Figure 4A As shown, the system 300 can be introduced into a fluid environment (in pancreatic fluid). The imaging system of the capsule endoscope can be used to observe the patient fluid in the field of view of the imaging system to confirm whether the patient fluid is present near the port 218. When it is determined that sufficient patient fluid is present (e.g., it is determined that the port 218 is immersed in the patient fluid), a negative pressure provided by the pressure regulator 330 can be generated in the tether 320, the channel, and the port 218. This negative pressure causes the patient fluid to be drawn into the port 218, the channel of the capsule endoscope, the tether 320, and collected outside the patient's body into a collection unit (e.g., a syringe).

[0070] In addition, if Figure 4B As shown, the system 300 can be advanced to a target area including a lesion. The imaging system of the capsule endoscope can be used to observe the lesion in the field of view of the imaging system, thereby confirming that the port 218 is sufficiently close to the lesion (e.g., the capsule endoscope is in a suitable treatment position and / or orientation). When the treatment position and / or orientation of the capsule endoscope is determined, a drug (e.g., a therapeutic agent) can be delivered to the tether 320, and a positive pressure provided by the pressure regulator 330 can be formed in the tether 320, the channel, and the port 218. This positive pressure causes the drug to be pushed down along the tether, the channel, and the port 218 toward the lesion.

[0071] Figures 5A-5C The capsule endoscope 500 is shown with a port 518 at the distal end of the capsule endoscope 500. The capsule endoscope 500 may be similar to the above except as described below. Figures 2A-2D 、 Figure 3 and Figures 4A-4BThe capsule endoscope 200 is described above. The endoscope components of capsule endoscope 500 can be similar to the similarly numbered endoscope components of capsule endoscope 200. However, in contrast to the flat distal cap 212 of capsule endoscope 200, capsule endoscope 500 can include a transparent dome-shaped or spherical distal cap 512. The dome-shaped or spherical distal cap 512 can, for example, enforce a minimum viewing distance between the lens of the imaging system and the target area. By providing a minimum distance along the optical axis of the imaging system between the lens and one or more objects to be viewed, the capsule endoscope can ensure that the field of view is always sufficiently large.

[0072] Figures 6A-6C The capsule endoscope 600 is shown with a port 618 at the proximal end of the capsule endoscope 600. The capsule endoscope 600 may be similar to the above except as described below. Figures 2A-2D 、 Figure 3 and Figures 4A-4B The capsule endoscope 200 . The endoscopic components of the capsule endoscope 600 may be similar to the similarly numbered endoscopic components of the capsule endoscope 200 .

[0073] The housing 610 of the capsule endoscope 600 may include a proximal cover 614 and a distal cover 612. Figure 6B The generally cylindrical structures shown are connected and have a fluid tight seal. The fluid seal can be formed, for example, by applying epoxy 613 or other adhesive around the abutting surfaces of the end cap and the cylindrical structure. In addition, the housing 610 can define a housing for Figure 6C The electronics compartment 611 of the endoscope assembly is shown. The electronics compartment 611 may be defined, for example, by a generally cylindrical structure, a distal cover 612, and an optically transparent proximal wall 615.

[0074] Different from the capsule endoscope 200, the capsule endoscope 600 may include multiple imaging systems and multiple lighting systems. Figure 6C As shown, the capsule endoscope 600 may include a proximal imaging system 630a and a proximal lighting system 620a, which are arranged at the proximal end of the capsule endoscope 600 to observe and illuminate a field of view adjacent to the proximal end of the capsule endoscope 600. The capsule endoscope 600 may also include a distal imaging system 630b and a distal lighting system 620b, which are arranged at the distal end of the capsule endoscope 600 to observe and illuminate a field of view adjacent to the distal end of the capsule endoscope 600. Figure 6C While two imaging systems are shown, it should be understood that in some embodiments, only one imaging system may be included in the capsule endoscope 600 (eg, at the proximal end of the capsule endoscope 600 , near the port 618 ).

[0075] Furthermore, unlike the capsule endoscope 200, the capsule endoscope 600 may include a compartment 616 having a chamber, such as Figure 6B and 6C As shown. The chamber can be located at the proximal portion of the capsule endoscope. Similar to the compartment 216 described above, the compartment 616 can be in fluid communication between a lumen in the tether 720 and a port 618 to provide a conduit for fluid removal and / or drug delivery. The compartment 616 can include a chamber, wherein a sidewall or other surface of the chamber can define the port 618. Figure 6B As shown, in some embodiments, the chamber can be at least partially defined by a transparent proximal wall 615 and a proximal cover 614.

[0076] like Figure 7 As shown, in system 700, capsule endoscope 600 can be connected to a tether 720 that includes a flexible member having a lumen, and tether 720 can be connected to a pressure regulator 730 (e.g., a pressure source or vacuum source, such as a syringe or pump). Tether 720 can include a lumen, such as in the flexible member, and can be connected to capsule endoscope 600 in any suitable manner, such as directly using (e.g., as Figure 6A The epoxy 722 is shown, with barbed fittings or other fittings) or secured by a clamp, as described in further detail below.

[0077] An exemplary use of system 700 is as follows Figure 8A and 8B As shown. Figure 8A As shown, system 700 can be introduced into a fluid environment (e.g., in pancreatic fluid). One or more imaging systems in the capsule endoscope can be used to navigate the capsule endoscope to a target area and / or to observe patient fluids. For example, the distal (front) imaging system can be primarily used to position and / or orient the capsule endoscope to and approach the target area, while the proximal (rear) imaging system near port 618 can be used to assess the position of port 618 relative to the patient fluid (and assess the presence of patient fluid). As another example, in an embodiment where only the proximal imaging system is located near port 618 at the proximal end of the capsule endoscope, the proximal imaging system can also be used to roughly position and / or orient the capsule endoscope to the target area, assess the position of the port relative to the patient fluid, and assess the presence of patient fluid. When sufficient patient fluid is determined to be present (e.g., when the port is determined to be submerged in the patient fluid), a negative pressure provided by pressure regulator 730 can be established in tether 720, compartment 616, and port 618. The negative pressure causes the patient fluid to be drawn into the port 618, the compartment 616 in the capsule endoscope, the tether 720, and out of the patient into a collection unit (eg, a syringe).

[0078] In addition, if Figure 8B As shown, the system 700 can be advanced to a target area including a lesion. Figure 8AAs described above, one or more imaging systems of the capsule endoscope can be used to navigate the capsule endoscope to the target area and / or can be used to observe the target area (e.g., lesions). In other words, one or more imaging systems can be used to confirm when the port 618 is close to the target area for treatment (e.g., the capsule endoscope is in a suitable treatment position and / or direction). When the treatment position and / or direction of the capsule endoscope is determined, a drug (e.g., a therapeutic agent) can be delivered to the tether 720, and a positive pressure provided by the pressure regulator 730 can be formed in the tether 720, the compartment 616, and the port 618. This positive pressure causes the drug to be pushed down toward the lesion along the tether, the compartment 616, and the port 618.

[0079] In some embodiments, as Figure 9 As shown, the capsule endoscope 600 may have a center of gravity 920 that is biased toward the proximal end of the capsule endoscope so that gravity may tend to immerse the port 618 (located at the proximal portion of the capsule endoscope) in the pooled fluid to obtain liquid for biopsy. Figure 9 As shown, the center of gravity 920 can be axially offset from the center 910 (toward the proximal end of the capsule endoscope 600). The center of gravity can be appropriately adjusted by, for example, distributing more weight (e.g., relatively dense magnets 640) toward the proximal end of the capsule endoscope 600. However, additionally or alternatively, the center of gravity can be adjusted by other suitable means, such as a non-uniform distribution of the shell material (e.g., the thickness of the shell can be greater, or the shell can have heavier material at the proximal end). Additionally or alternatively, a relatively buoyant element or feature (e.g., an air-containing compartment) can be located on the opposite end of the capsule endoscope relative to the port 618.

[0080] tether

[0081] Typically, a tether is used to maintain the capsule endoscope in the desired target area (e.g., to prevent reduced dwell time in the esophagus due to peristalsis, etc.) and to provide a conduit for delivering fluids to and / or from the capsule endoscope, for example, to extract fluids from the capsule endoscope for biopsy or to deliver medications to the capsule endoscope. As described above, the proximal portion of the tether can extend outside the patient's body and can be connected to a pressure regulator (e.g., a pressure source or vacuum source) to control the flow of fluid through the tether using positive or negative pressure. The proximal portion of the tether can also be connected to a collection unit (e.g., a syringe or other container) to collect fluids extracted from the patient through the tether, and / or to a source of medication (e.g., a syringe or other container) to be delivered to the patient through the tether. In some embodiments, the proximal portion can be branched and include one end connected to a vacuum source (and / or medication source) and another end connected to a pressure source (and / or collection unit). In some variations of these embodiments, one or more valves or other fluid control systems switch between introducing negative and positive pressure into the tether.

[0082] The tether can be removably connected to the capsule endoscope. For example, as the capsule endoscope advances within the patient's body, the tether can be connected to the capsule endoscope to follow the movement of the capsule endoscope (e.g., down the patient's gastrointestinal tract). In addition, the tether can be detached from the capsule endoscope to allow the capsule endoscope to move forward (e.g., naturally, such as by intestinal peristalsis), and then the tether can be withdrawn from the patient's body. In some embodiments, a port for obtaining fluid for biopsy and / or drug delivery can be located on a portion of the tether. Alternatively, the tether can be withdrawn from the patient's body while the capsule endoscope remains connected to the tether to remove the capsule endoscope from the patient's body.

[0083] like Figure 10A and 10B As shown, in some embodiments, the tether 1000 may include a flexible member having a lumen 1010. Typically, the flexible member may be an elongated tubular member configured to be safely and comfortably advanced into the patient's body cavity. In some embodiments, the length of the flexible member may be between about 2 mm and about 10 mm, or within 9 mm in length. The flexible member may include a soft, flexible material, such as a silicone elastomer (e.g., a Shore A hardness between about 35 and about 65, or about 50). In addition, in an exemplary embodiment, the flexible member may have an inner diameter of about 0.5 mm (e.g., between about 0.4 mm and about 0.6 mm) and an outer diameter of about 1 mm (e.g., between about 0.9 mm and about 1.3 mm), with a wall thickness of about 0.25 mm. However, in other embodiments, the flexible member may include a combination of other lengths, material types, and / or sizes.

[0084] Various exemplary variations of tethers having different arrangements of tether components are described in detail below.

[0085] Figures 11A-11D A tether 1120 is shown. The tether 1120 includes a flexible member 1122 and a clamp 1124 for connecting the flexible member 1122 to a capsule endoscope. The clamp 1124 includes a port 1128 in fluid communication with the lumen of the flexible member 1122. Furthermore, the clamp 1124 can be adapted for use with a "dual-lens" capsule endoscope having a proximal imaging system at the proximal end of the capsule endoscope and a distal imaging system at the distal end of the capsule endoscope.

[0086] like Figure 11DAs shown, the clamp 1124 may include a sheath 1125 configured to at least partially surround and attach to at least a portion of the capsule endoscope 1110, thereby connecting the tether 1120 to the capsule endoscope 1110. The sheath 1125 may include an open proximal end and a distal end, wherein the open proximal end forms a window to provide a visual gap (i.e., not significantly obstructed) for a proximal imaging system at the proximal end of the capsule endoscope. Figure 11A As shown, the sheath 1125 can surround the entire circumference of the proximal portion of the capsule endoscope 1110. However, in other embodiments, the sheath may not surround the entire circumference, for example, the sheath may have a "C" cross-sectional shape.

[0087] The clamp may further include an anchor member 1126 configured to connect the clamp to the flexible member. The anchor member 1126 may be integrally formed with the sheath 1125, or formed separately and connected to the sheath 1125 via one or more suitable fasteners and / or mechanical fittings. Furthermore, the anchor member 1126 may be connected to the distal end of the flexible member 1122, for example, via mechanical fittings and / or epoxy. Alternatively, the anchor member 1126 may be integrally formed with the distal end of the flexible member 1122, for example, via an injection molding process.

[0088] like Figure 11B As shown, the anchoring member 1126 may be generally arcuate (e.g., "C" or "U" shaped) so that the clamp and the flexible member can be connected at a position away from the capsule endoscope so as not to significantly block the field of view of the proximal imaging system of the capsule endoscope. Figure 11B As shown, the anchor member 1126 can provide a window region 1127 that, together with the open proximal end of the sheath 1125, can allow a substantial portion of the proximal imaging system's field of view to remain unobstructed. Figure 11C As shown, the side profile of the anchor member 1126 can be smaller than the diameter of the sheath 1125. Figure 11D As shown, the clamp 1124 can provide an effective (unobstructed) field of view for the proximal imaging system that is no smaller or narrower than the field of view without the clamp 1124 attached. Figure 11C Exemplary dimensions of the clamp 1124 are shown, including a sheath diameter between about 5 mm and about 9 mm, a sheath length between about 3 mm and about 5 mm, and an anchor member width between about 2 mm and 5 mm. Figure 11D As shown, when used in conjunction with a clamp 1124 of these size ranges, an endoscope having a field of view of approximately 120 degrees (e.g., between approximately 100 degrees and approximately 140 degrees) can be reduced by only approximately 20 degrees (e.g., between approximately 10 degrees and approximately 30 degrees). Thus, the resulting effective field of view is substantially unobstructed by the clamp 1124.

[0089] In some embodiments, the anchoring member 1126 may comprise a single component forming an arcuate structure that extends through the opening of the sheath (i.e., an integrally formed arcuate segment). Alternatively, however, the anchoring member may comprise multiple components, each forming a separate portion of the arcuate structure. For example, in some embodiments, the anchoring member 1126 may comprise two or more separate arcuate segments that are connected end-to-end (or longitudinally overlapped) to form a structure similar to Figure 11A The single arcuate structure of the anchor member 1126 is shown. For example, the anchor member 1126 can include two opposing arcuate segments extending from opposing sides of the proximal end of the sheath 1125 toward the apex of the anchor member 1126. The two opposing arcuate segments can be of approximately equal length and intersect at the apex of the anchor member 1126 (e.g., near the port 1128), or can be of unequal length and intersect on either side of the anchor member 1126.

[0090] Furthermore, in some embodiments, the anchoring member may include multiple arcuate structures oriented in different planes (e.g., forming a dome shape with multiple window areas). Figure 11E A tether 1120' is shown including an anchoring member 1126' having four arcuate segments oriented in orthogonal planes (i.e., segments distributed approximately 90 degrees circumferentially around the anchoring member 1126' and sheath 1125) and forming a plurality of window regions. The arcuate segments can be evenly distributed around the anchoring member 1126' and sheath 1125 (e.g., such that the anchoring member 1126' is substantially radially symmetric), or they can be unevenly distributed. In some embodiments, the additional arcuate segments can, for example, improve the structural integrity of the anchoring member (e.g., multidirectional and / or torsional stiffness). Furthermore, the additional arcuate segments distributed around the anchoring member 1126' and sheath 1125 (e.g., when evenly distributed) can improve force balance when the tether is connected to and interacts with the capsule endoscope (e.g., pulled). It should be understood that tethers similar to tethers 1120 and 1120' can include any suitable number of arcuate segments (e.g., 3, 5, or more). The width of the segments can be reduced as the number of segments increases to maintain a sufficiently clear field of view for the capsule endoscopy imaging system.

[0091] The anchoring member 1126 may further include a port 1128 in fluid communication with the lumen of the flexible member. The port 1128 may be an opening that is configured to be axially offset from the proximal portion of the capsule endoscope, for example, opposite the proximal imaging system, so that the proximal imaging system can observe the environment around the port 1128 (e.g., confirm whether there is sufficient patient fluid near the port 1128 to withdraw the patient fluid through the port, confirm the location of the target area relative to the port 1128 to receive medication through the port, etc.).

[0092] For example, Figure 12 As shown, in system 1200, capsule endoscope 1110 can be connected to tether 1120 via clamp 1125. For example, capsule endoscope 1110 can be similar to Figures 6A-6C The capsule endoscope 600 is described, with the exception that the capsule endoscope 1110 omits the port, and has a proximal imaging system and a distal imaging system. The tether 1120 can be connected to a pressure regulator 1130 (e.g., a pressure source or vacuum source, such as a syringe or pump). The tether 1120 can include a lumen, such as in a flexible member, and the clamp 1125 can include a port in fluid communication with the lumen.

[0093] An exemplary use of system 1200 is as follows Figure 13A and 13B Reference Figure 13A , the system 1200 can be introduced into a fluid environment (e.g., in pancreatic fluid). The distal imaging system and / or the proximal imaging system of the capsule endoscope can be used to observe the patient fluid surrounding the capsule endoscope to confirm whether the patient fluid is present near the port 1128. When it is determined that sufficient patient fluid is present (e.g., it is determined that the port 1128 is immersed in the patient fluid), a negative pressure provided by the pressure regulator 1130 can be formed in the tether 1120 and the port 1128. This negative pressure causes the patient fluid to be drawn into the port 1128 and the tether 1120 and removed from the patient into a collection unit (e.g., a syringe).

[0094] In addition, if Figure 13B As shown, the system 1200 can be advanced to a target area including a lesion. The distal imaging system and / or the proximal imaging system of the capsule endoscope can be used to observe the lesion, thereby confirming whether the port 1128 is close enough to the lesion (e.g., the capsule endoscope is in a suitable treatment position and / or direction). When the treatment position and / or direction of the capsule endoscope is determined, a drug (e.g., a therapeutic agent) can be delivered to the tether 1120, and a positive pressure provided by the pressure regulator 1130 can be formed in the tether 1120 and the port 1128. This positive pressure causes the drug to move down the tether and flow out of the port toward the lesion.

[0095] In some embodiments, as Figure 14A and 14B As shown, the capsule endoscope 1100 may have a center of gravity 1420 that is biased toward the proximal end of the capsule endoscope so that gravity may tend to immerse the port 1428 (located on a tether connected to the proximal end of the capsule endoscope 1110) in the pooled fluid for obtaining liquid for biopsy. Figure 14AAs shown, the center of gravity 1420 can be axially offset from the center 1410 (toward the proximal end of the capsule endoscope 1100). The center of gravity can be appropriately adjusted by, for example, distributing more weight (e.g., relatively dense magnets 1440) toward the proximal end of the capsule endoscope 1100. However, additionally or alternatively, the center of gravity can be adjusted by other suitable means, such as a non-uniform distribution of the shell material (e.g., the thickness of the shell can be greater, or the shell can have heavier material at the proximal end). Additionally or alternatively, a relatively buoyant element or feature (e.g., an air-containing compartment) can be located on the opposite end of the capsule endoscope relative to the port 1428.

[0096] Figures 15A-15C 15. In another embodiment, system 1500 includes a tether 1520 comprising a flexible member and a clamp for connecting the flexible member to a capsule endoscope 1510, wherein the clamp includes a port 1528 in fluid communication with a lumen of the flexible member. System 1500 may be similar to Figure 12 、 Figures 13A-13B and Figures 14A-14B In system 1500, the fixture may be adapted for use with a "single lens" capsule endoscope having a proximal imaging system only at the proximal end of the capsule endoscope. Figure 15B As shown, the proximal imaging system in the capsule endoscope can have a field of view that is substantially unobstructed by the clamp of the tether, including the area around port 1528. Thus, when sufficient patient fluid is determined to be present, a negative pressure provided by pressure regulator 1530 is established in tether 1520 and port 1528. This negative pressure causes the patient fluid to be drawn into port 1528 and tether 1520 and expelled from the patient into a collection unit (e.g., a syringe). Similarly, as Figure 15C As shown, the proximal imaging system of the capsule endoscope can be used to determine whether the port 1528 is close enough to the lesion. When the treatment position and / or direction of the capsule endoscope is determined, the drug can be delivered to the tether 1528, and a positive pressure provided by the pressure regulator 1530 can be formed in the tether 1520 and the port 1528. This positive pressure causes the drug to be pressed down from the tether and out of the port toward the lesion.

[0097] like Figure 16A and 16B As shown, in some embodiments, the tether 1620 may include a port configured to allow fluid to pass through after being separated from the capsule endoscope. Figure 16A As shown, the tethering system 1600 may include a tether 1620 releasably connected to a capsule endoscope 1610 and a pressure regulator 1630 (e.g., a syringe or pump). Figure 16BAs shown, similar to the tethers described above, the tether 1620 may include a flexible member 1622 having a lumen 1623. However, in this embodiment, the tether 1620 may include a port 1628 in fluid communication with the lumen 1623, and the port 1628 leads to a suction cup 1624 that houses the capsule endoscope 1610. The suction cup 1624 may be soft and flexible and may be formed, for example, from the same or similar material as the flexible member 1622 (e.g., silicone). In some embodiments, the interior shape of the suction cup 1624 may be smooth and generally complementary to (e.g., corresponding to) the shape of the housing of the capsule endoscope 1610.

[0098] Typically, the vacuum state within the lumen 1623 holds the capsule endoscope 1610 within the suction cup 1624. Figure 16B , the lumen 1623 is pressurized (e.g., by inflation from a connected pressure source), the suction cup 1624 can expand radially outward as indicated by arrow P, and / or the axial thrust F3 can provide a thrust on the capsule endoscope 1610, thereby releasing the capsule endoscope 1610 from the suction cup 1624. Figure 16C An exemplary method of separating the capsule endoscope 1610 from the suction cup 1624 is shown. In this example, a catheter can be extended from a pressure source (syringe 1632), through the lumen of the flexible member 1622, and through a port leading to the suction cup 1624. When the pressure source provides positive pressure in the catheter (e.g., by depressing a plunger on the syringe 1632), the expansion of the suction cup 1624 and / or the thrust through the catheter can cause the suction cup 1624 to detach, thereby releasing the capsule endoscope 1610. After the capsule endoscope 1610 is released, the port 1628 can allow fluid exchange between the lumen of the flexible member 1622 and the environment in which the port 1628 is located.

[0099] Disconnection between the capsule endoscope and the tether may occur at target areas such as areas where patient fluids may need to be obtained for biopsy and / or where medication may be delivered through a port. Figure 17A As shown, system 1600 can be introduced into a fluid environment (e.g., in pancreatic fluid). One or more imaging systems in the capsule endoscope can be used to navigate the capsule endoscope to the target area and / or can be used to observe patient body fluids. When it is determined that there is enough patient fluid, the capsule endoscope can be detached from the tether as described above. Thereafter, a negative pressure provided by a pressure regulator (e.g., syringe 1632) can be formed in the tether and port 1628. This negative pressure causes the patient fluid to be sucked into port 1628, enter the tether, and be discharged from the patient into a collection unit (e.g., syringe). In addition, the separated capsule endoscope 1610 can be controlled (e.g., via an external magnetic control system as described below) so that its imaging system observes the biopsy process and can confirm that the sample is properly obtained.

[0100] As another example, Figure 17B As shown, system 1600 can be advanced to the target area including the lesion. Similar to the above, one or more imaging systems in the capsule endoscope can be used to navigate the capsule endoscope. When the capsule endoscope has been navigated to the desired target area, the capsule endoscope can be detached from the tether as described above. Thereafter, a positive pressure provided by a pressure regulator (e.g., syringe 1632) can be formed in the tether and port 1628. This positive pressure causes the drug to be pushed downward along the tether and toward the lesion through port 1628. In addition, the separated capsule endoscope 1610 can be controlled (e.g., by an external magnetic control system as described below) so that its imaging system observes the effect of drug delivery and can confirm that the drug is properly delivered.

[0101] Figures 18A-18C Another tether 1820 for attaching to a capsule endoscope is shown, wherein the tether 1820 includes a housing having a port for allowing fluid to pass therethrough. The tether 1820 includes a clamp including a flexible, resilient sheath 1824 for releasably engaging the capsule endoscope, and a housing 1826 including a chamber between the sheath 1824 and the flexible member 1822. For example, the sheath 1824 can be attached to the housing 1826 via adjacent circumferential surfaces 1825 (e.g., by mechanical interfitting, epoxy, etc.) or any other suitable feature. Furthermore, the housing 1826 can be attached to the flexible member 1822 via adjacent circumferential surfaces 1827 (e.g., by mechanical interfitting, epoxy, etc.) or any other suitable feature. Figure 18C An exemplary range of dimensions for the sheath 1824 is shown, which may have a length between about 5 mm and about 10 mm, an outer diameter between about 5 mm and about 9 mm, and a wall thickness between about 0.05 mm and about 0.5 mm.

[0102] like Figure 18A and 18B As shown, housing 1826 may further include port 1828. Port 1828 may be selectively covered by valve 1830 to regulate flow through port 1828. In some embodiments, valve 1830 may be a one-way valve that allows one-way flow. Additionally or alternatively, valve 1830 may be biased toward a closed state, for example, using spring 1832 (e.g., a torsion spring, a flexible member that functions similarly to a spring, etc.). Exemplary operation of port 1828 and valve 1830 will be described in further detail below.

[0103] In some embodiments, the sheath 1824 and the housing 1826 can cooperate to connect the capsule endoscope to the tether 1820. Figure 19AAs shown, the sheath 1824 is elastically deformable to shrink and engage around the capsule endoscope 1810, thereby generating a pressure P that generates a friction force F1 on the contact surface between the sheath 1824 and the capsule endoscope 1810. The engagement between the capsule endoscope 1810 and the sheath 1824 is substantially fluid-tight. The friction force F1 tends to keep the capsule endoscope 1810 within the sheath 1824. Figure 19A As shown, under ambient pressure (e.g., peristaltic pressure from the digestive tract muscles), the sheath 1824 generates a force F2 (counteracting the friction force F1). As long as F1>F2, the capsule endoscope is retained in the sheath 1824.

[0104] When the capsule endoscope 1810 is retained in the sheath 1824, a controlled pressure differential between the interior of the housing 1826 and the exterior of the housing 1826 can open or close the valve 1830 covering the port 1828. Figure 19B As shown, the chamber of housing 1826 can be in fluid communication with the lumen of flexible member 1822 such that a vacuum source connected to flexible member 1822 can create a sufficient pressure drop within the chamber to overcome the spring force that closes valve 1830. In other words, once the pressure inside the housing drops below the pressure outside the housing (by a difference sufficient to overcome the spring force), valve 1830 opens to allow fluid to pass through port 1828. The open state is shown in FIG. Figure 19B As shown, fluid from outside the housing 1826 can enter the housing 1826, flow into the chamber, flow into the lumen of the flexible member 1822, and flow into the collection unit outside the patient's body.

[0105] For example, in a method of obtaining fluid for biopsy, the capsule endoscope 1810 can be advanced to the target area and the imaging system of the capsule endoscope can be used to observe the surrounding patient fluid. When it is determined that sufficient patient fluid is present, sufficient negative pressure can be generated in the housing 1826 to open the valve 1830 and allow the patient fluid to enter the housing 1826 through the open port 1828. The negative pressure further allows the patient fluid to be drawn into the flexible member and into the collection unit.

[0106] Figure 20A and 20B An exemplary process for detaching a capsule endoscope 1810 from a tether 1820 is shown. Figure 20A As shown, positive pressure can be introduced into housing 1826 through the lumen of the flexible member (e.g., using a syringe, pump, or other suitable pressure source). The increased pressure in the chamber of housing 1826 can close valve 1830 (if valve 1830 was previously open). Similar to the above with respect to Figure 16B As described above, further increase in pressure within the housing may cause the flexible sheath 1824 to expand radially and reduce the friction force F1, and / or generate a forward / distal thrust that pushes the capsule endoscope distally. Figure 20B As shown, this increased pressure within the housing 1826 can cause the capsule endoscope 1810 to detach from and be released from the tethered sheath 1824. For example, the released capsule endoscope can then naturally pass through the patient's digestive tract.

[0107] In some embodiments, the endoscope system may include a port located on the flexible member. Figure 21A As shown, the tether 2120 may include a flexible member 2122 having a port 2128 at its distal end. The flexible member 2122 may be connected to the capsule endoscope 2110 (e.g., a housing of the capsule endoscope including a distal imaging system at its distal end and / or a proximal imaging system at its proximal end, as described above). For example, Figure 21A As shown, the longitudinal segments of the flexible member can be longitudinally connected to the capsule endoscope 2110. The flexible member 2122 can be connected to the capsule endoscope 2110 in any suitable manner. For example, the flexible member 2122 can be bonded to the capsule endoscope 2110 using a suitable epoxy resin. As another example, the flexible member 2122 can be fixed by one or more fittings (e.g., eyes or rings) arranged along the outer surface of the capsule endoscope 2110 and axially fixed with epoxy resin and / or flanges. In addition, although Figure 21A The flexible member 2122 extends substantially in a straight line. In other embodiments, the flexible member 2122 may be wound around the capsule endoscope 2110 in any suitable manner (e.g., serpentine, spiral, etc.). As another example, at least a portion of the flexible member 2122 may be co-extruded with features of the capsule endoscope 2110 to form an integral body.

[0108] like Figure 21B As shown, in some embodiments, the distal end of the flexible member 2122 can be arranged so that the port 2128 is visible within the field of view of the distal imaging system, for example, so that the distal imaging system can observe the activities around the port 2128 (for example, liquid enters the flexible member through the port 2128 during liquid collection, leaves the flexible member through the port 2128 during drug delivery, etc.). Figure 21B As shown, the distal end of the flexible member 2122 can extend between approximately 3 and 5 degrees into the viewing angle of the distal imaging system such that the port 2128 is within the field of view. However, in other embodiments, the distal end of the flexible member 2122 can extend further (e.g., between approximately 5 and 10 degrees, or more) or less (e.g., between approximately 1 and approximately 3 degrees).

[0109] like Figure 21CAs shown, in system 2100, capsule endoscope 2110 can be connected to a tether (connected to a flexible member 2122 having a port 2128) as described above. Capsule endoscope 2110, for example, can be similar to the one in FIG. Figures 6A-6C The capsule endoscope 600 has a proximal imaging system and a distal imaging system, except that the capsule endoscope 2110 may omit the port. The flexible member 2122 may be connected to a pressure regulator 2130 (eg, a pressure source or vacuum source, such as a syringe or a pump).

[0110] Figure 22A An exemplary use of system 2100 is shown, wherein system 2100 is introduced into a fluid environment (e.g., in pancreatic fluid). The distal imaging system of capsule endoscope 2110 can be used to observe the patient fluid surrounding the capsule endoscope, thereby confirming the presence of patient fluid near port 2128. When sufficient patient fluid is confirmed to be present (port 2128 is confirmed to be immersed in the patient fluid), a negative pressure provided by pressure regulator 2130 is generated in flexible member 2122 and port 2128. This negative pressure causes the patient fluid to be drawn into port 2128 and flexible member 2122 and removed from the patient's body to a collection unit (e.g., a syringe).

[0111] In addition, if Figure 22B As shown, the system 2100 can be advanced to a target area including a lesion. The distal imaging system in the capsule endoscope 2110 can be used to observe the lesion and confirm whether the port 2128 is in a suitable position and / or whether the capsule endoscope is in a suitable treatment direction. When the suitable position and / or direction are determined, a drug (e.g., a therapeutic agent) can be delivered in the flexible member 2122, and a positive pressure provided by a pressure regulator can be formed in the flexible member 2122 and the port 2128. This positive pressure causes the drug to be pushed downward along the flexible member and discharged from the port toward the lesion.

[0112] In some embodiments, as Figure 23A and 23B As shown, the center of gravity of the capsule endoscope 2110 can be biased toward the side of the capsule endoscope including the port 2128 so that gravity can tend to immerse the port 2128 in the pooled fluid to obtain liquid for biopsy. Figure 23A and 23BAs shown, the center of gravity can be radially offset from the center, for example, toward the port side of the capsule endoscope 2110. The center of gravity can be adjusted by, for example, distributing more weight (e.g., relatively dense magnets 2140) toward the port side of the capsule endoscope 2110. However, additionally or alternatively, the center of gravity can be adjusted by other suitable means, such as a non-uniform distribution of the shell material (e.g., a greater thickness of the shell, or the shell having heavier material on the side closer to the port 2128). Additionally or alternatively, a relatively buoyant element or feature (e.g., an air-containing compartment) can be located on the opposite side of the capsule endoscope relative to the port 2128. As shown in FIG. Figure 23C As shown, the shift in center of gravity and / or the effects of buoyancy may cause the capsule endoscope 2110 to rotate so as to submerge the distal end of the flexible member 2122 (and port 2128 ) in the patient fluid.

[0113] Figures 24A-24C Another embodiment of a tether 2420 is shown, which can be similar to the tether 2120 described in Figures 21-23, except as described below. Whereas the tether 2120 of Figures 21-23 was directly connected to the capsule endoscope, the tether 2420 here can be directly connected to the clamp 2424. For example, the longitudinal segment of the flexible member 2422 can be connected to the clamp 2424 in any suitable manner. The clamp 2424 can include a sheath or suction cup similar to those described above, which can, for example, provide for substantially unobstructed viewing of the distal imaging components of the capsule endoscope. The port 2328 on the distal end of the flexible member 2422 can be within the field of view of the distal imaging system, similar to Figure 21C As described. Figure 24B and 24C As shown, the fixture 2424 can be configured to accommodate the capsule endoscope 2410. Additionally, like the capsule endoscope 2110, the capsule endoscope 2410 can include a center of gravity that is biased toward the side of the fixture 2424 that includes the port 2328.

[0114] Magnetic control system

[0115] As described above, in some embodiments, the capsule endoscope can be controlled at least in part by a magnetic control system. For example, a capsule endoscope (e.g., as described above) Figure 2B and 2C 、 Figure 5B and 5C and Figure 6C ) may include one or more internal magnets that may be controlled by an external magnetron system. The internal magnets may, for example, be permanent magnets (e.g., rare earth magnets, neodymium magnets).

[0116] In some embodiments, the capsule endoscope may include at least one internal magnet configured to achieve six degrees of freedom (translation and rotation in each of three axes). For example, the capsule endoscope may include an internal magnetic assembly comprising a first magnet and a second magnet connected to the first magnet, wherein the first magnet has a polarity along a first direction and the second magnet has a polarity along a second direction. The second direction is different from the first direction (e.g., the second direction may be perpendicular to the first direction). An external magnetic control system may provide a magnetic force acting on the first and second magnets in series, thereby achieving translation and rotation along three axes. Thus, the internal magnet may allow complex and delicate manipulation of the capsule endoscope by the external magnetic control system, including maintaining a point position of the capsule endoscope while rotating the capsule endoscope about its longitudinal axis (tumbling motion), as described below.

[0117] Figure 25A and 25B An internal magnetic assembly 2500 of one embodiment is shown, comprising a first magnet 2510r and a second magnet 2510a, wherein the first magnet 2510r may be radially polarized ( Figures 27A-27C ), and the second magnet 2510a may be axially polarized ( Figures 28A-28C ). The first and second magnets may be generally disc-shaped and attached to one another along adjacent faces (e.g., using epoxy or other adhesives, fasteners, etc.) such that their polarities are orthogonal to one another. Although Figure 25A and 25B The first magnet 2510r and the second magnet 2510a are disc-shaped, but may alternatively be of any suitable shape. Figure 25A and 25B As shown, the first and second magnets can have substantially the same size and shape, but in other embodiments, their size (eg, width or diameter, thickness, etc.) and / or shape can be different. Figure 26A and 26B Another embodiment of an internal magnetic assembly 2600 including a first magnet 2510r and a second magnet 2510a is shown. The internal magnetic assembly 2600 is similar to the internal magnetic assembly 2500, except that the internal magnetic assembly 2500 ( Figures 25A-25B ) is arranged so that its north pole is away from the first magnet 2510r, and the internal magnetic assembly 2600 ( Figures 26A-26B )'s second magnet 2510a is arranged with its north pole pointing toward the first magnet 2510r.

[0118] The pose (position, orientation, etc.) of the capsule endoscope can be at least partially controlled by an external magnetic control system, e.g. Figure 29In some embodiments, the external magnetron system 2900 can be similar to the systems described in US Pat. No. 10,076,234 and US Pat. No. 10,070,854, the entire contents of which are incorporated herein by reference.

[0119] For example, the external magnetic control system 2900 can include a spherical magnet 2910 (e.g., a permanent magnet or an electromagnet) that is controllable within a frame structure to provide a rotatable external magnetic field. Changes in the direction of the external magnetic field can cause the internal magnetic assembly (and the capsule endoscope) to change position and / or orientation.

[0120] Spherical magnet 2910 can translate and / or rotate in three-dimensional space. For example, spherical magnet 2910 can be attached to a lower frame portion 2920 of a frame structure, and the frame structure can translate vertically and / or horizontally in a front-to-back and / or left-to-right direction (e.g., by actuating an arm, or along a track, etc.). Spherical magnet 2910 can be mounted on an axis that can be rotated by actuation of a first motor 2930, such that the first motor 2930 provides vertical rotation of spherical magnet 2910 about a horizontal axis. Furthermore, by actuation of a second motor 2940, lower frame 2920 (to which spherical magnet 2910 can be mounted) can be rotated relative to upper frame portion 2922 of the frame structure, such that the second motor 2940 provides horizontal rotation of spherical magnet 2910 about a vertical axis. In other embodiments, spherical magnet 2910 can be translated and / or rotated in any suitable manner. In some embodiments, a user interface control (e.g., a control handle 2950) can be attached to the frame structure to enable operation of the aforementioned motions. For example, Figure 29 As shown, the control handle 2950 may include one or more buttons (e.g., button 2932 for controlling horizontal rotation, button 2942 for controlling vertical rotation), knobs, or other suitable controls. A magnetic control system for operating a spherical magnet to control a magnet within a patient's body is described in U.S. Patent No. 10076234 and U.S. Patent No. 10070854, the contents of which are incorporated herein by reference.

[0121] Figures 30A-32B An exemplary controlled motion of a capsule endoscope using an external magnetic control system is shown. Figure 30A and 30B As shown, the translational movement of the external magnet (M) causes a corresponding translational movement of the internal magnetic assembly (m) of the capsule endoscope. Figure 30A ) or stay away from ( Figure 30B ) to control the distance between the external magnet (M) and the internal magnetic assembly (m). In addition, Figure 31AAs shown, the pitching motion of the outer magnet (M) can cause a corresponding pitching motion of the inner magnetic assembly (m). Figure 31B As shown, the deflection movement of the external magnet (M) can cause a corresponding deflection movement of the internal magnetic component (m). Figure 32A and 32B As shown, the combination of pitch and yaw motion of the spherical external magnet (M) can cause a corresponding rolling motion of the internal magnetic assembly (m) in either direction. Therefore, due to the interaction between the magnetic control system and the internal magnetic assembly, the translational and rotational motion of the capsule endoscope can be controlled.

[0122] pressure regulator

[0123] As described above, a system for accessing a patient can include at least one pressure regulator connected to a tether and configured to reduce pressure on the tether and / or increase pressure on the tether to withdraw and / or push fluid through a port (e.g., in the tether, in a capsule endoscope, etc.). The pressure regulator can be a pressure source and / or a vacuum source that is placed in fluid communication with the tether (e.g., a lumen of a flexible member of the tether).

[0124] For example, Figure 33A As shown, the pressure regulator can include a syringe 3330 that is fluidically connected to the flexible member of the tether 3320. The plunger of the syringe 3330 can be withdrawn to create negative pressure in the tether and withdraw fluid (e.g., for obtaining fluid for a biopsy) through a port (not shown) and through the tether 3320. The withdrawn fluid can be collected with the syringe 3330 and / or collected with another container that is fluidically connected to the tether, similar to the following description of Figure 33B Additionally, the plunger of syringe 3330 can be depressed to create positive pressure in the tether, e.g., to push fluid through tether 3320 and a port (not shown) (e.g., for drug delivery, for disconnection of a capsule endoscope from the aforementioned clamping member, etc.).

[0125] As another example, Figure 33B As shown, the pressure regulator can include a vacuum pump 3332 fluidically connected to the flexible member of the tether 3320. A collection unit 3340 (e.g., a container) can be fluidically connected to the tether such that when the vacuum pump 3332 is turned on and negative pressure is generated in the tether to draw fluid (e.g., to obtain fluid for a biopsy) into the tether 3320, the drawn fluid is transferred to the collection unit 3340. In addition, a pressure pump can be similarly fluidically connected to the tether 3320 to generate positive pressure in the tether (e.g., for drug delivery, for disconnecting the capsule endoscope from the aforementioned clamping member, etc.). Alternatively, a vacuum pump or a pressure pump can be selectively connected to the tether and switched between vacuum and pressure modes.

[0126] In another embodiment, if Figure 34A and 34B As shown, the system for accessing a patient may include a pressure regulator including a microfluidic syringe pump 3430. The microfluidic syringe pump can be connected to a tether 3420 as described above, and the tether 3420 can be connected to the capsule endoscope 3410 by any suitable means as described above. After the capsule endoscope 3410 is advanced to the target area (e.g., a lesion) and the port is brought into proximity with the target area, the microfluidic syringe pump 3430 can be activated to deliver the drug via the tether 3420 and the port (not labeled). The microfluidic syringe pump 3430 (the combination of the capsule endoscope and the tether as described above) can achieve a long-lasting therapeutic effect by continuously releasing microdoses of the drug to the target area. In some embodiments, the capsule endoscope can be controlled (e.g., by an external magnetic control system as described above) so that an imaging system can observe the delivery of the drug through the port to the target area. After the treatment is completed, the capsule endoscope can be released from the tether and passed through the patient's gastrointestinal tract, and the tether can be withdrawn and removed from the patient.

[0127] Method of access to patients

[0128] Various methods for accessing a patient may include the use of one or more capsule endoscopes, such as any of the capsule endoscopes in the above-described embodiments. For example, in some embodiments, a method for obtaining one or more substances from a patient may include: introducing a capsule endoscope into a body cavity (e.g., the gastrointestinal tract) of the patient, wherein the capsule endoscope is connected to a tether, the tether comprising a flexible member having a lumen; positioning the capsule endoscope at a target area, and extracting a patient sample from the target area through the lumen (e.g., by creating a negative pressure in the lumen). The capsule endoscope may be advanced by an external magnetic control system and / or by peristalsis, etc. The patient sample may be extracted through a port in fluid communication with the lumen. The port may be located in any one or more structures in or around the capsule endoscope and / or the tether, such as any of the capsule endoscopes described above that include a tether.

[0129] Generally, the target area can be any suitable location in the gastrointestinal tract and / or other features of the digestive system, such as the mouth, esophagus, stomach, small intestine, large intestine, anus, liver, pancreas, gallbladder, etc. However, the target area can be any suitable body cavity or other area of ​​the patient.

[0130] The method can be used for obtaining a patient sample as a fluid sample from a body cavity (for example, taking a liquid for biopsy). For example, an exemplary application of the method is to obtain a pancreatic juice sample from a patient, which can for example analyze whether there is a mutation indicating the presence of cancer in the pancreatic juice. Another exemplary application of the method is to obtain a sample of intestinal flora (for example, bacteria), which can for example be analyzed to assess intestinal health. Although any suitable amount of fluid can be extracted (for example, depending on the application of sample availability or method), in some embodiments, the method can include the sample amount extracted between about 0.5mL and about 15mL, between about 0.5mL and about 10mL, between about 0.5mL to about 5mL, between about 5mL to about 10mL, between about 1mL to about 3mL, more than about 10mL or more than about 15mL etc.

[0131] Additionally or alternatively, the method can include obtaining any suitable material from a patient's body cavity. For example, the method can be used to obtain particulate patient samples and / or foreign particles that may be present in a fluid or that may be small and / or light enough to be extracted through a port. Exemplary particles can include, for example, cancer cells, debris and / or cystic bodies shed from cancer cells and / or immune cells, other suitable biomarkers, and the like.

[0132] As another example, in some embodiments, a method for delivering one or more substances may include: introducing a capsule endoscope into a patient's body (e.g., the gastrointestinal tract), wherein the capsule endoscope is connected to a tether, the tether comprising a flexible member having a lumen; positioning the capsule endoscope at a target area, and administering a therapeutic substance to the target area through the lumen (e.g., by creating a positive pressure in the lumen). The capsule endoscope may be advanced by an external magnetic control system and / or by peristalsis, etc. The drug may be delivered through a port in fluid communication with the lumen. The port may be located in any one or more structures in or around the capsule endoscope and / or the tether, such as any of the capsule endoscopes including a tether described above. In some embodiments, the capsule endoscope may remain stationary in a single position and orientation during substance delivery, while in other embodiments, the capsule endoscope may move (e.g., rotate about an axis, translate, etc.) while delivering the substance to coat or spray a larger area of ​​the treatment surface.

[0133] The method can be used to deliver one or more therapeutic substances to the patient's body cavity. For example, an exemplary application of the method is to deliver one or more drugs to the intestinal area of ​​the target to treat inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. Exemplary drugs that can be delivered include thrombin, norepinephrine, batroxobin, etc., and suitable drug combinations (for example, a combination of about 240,000 units of gentamicin and about 50 ml to about 100 ml of 5% GNS, about 5 mg to about 10 mg of dexamethasone and about 1.2 grams of metronidazole). As another example, the method can be used to deliver one or more drugs to the esophageal region to treat one or more lesions, such as targeted therapy using nanoparticles, such as composite nanoparticles suitable for imaging, characterization and treatment (for example, optical biopsy based on SERS, photothermal therapy, photodynamic therapy, etc.). Exemplary particles for these applications include gold or silver nanoparticles, carbon nanotubes, and gold nanorods, etc. As yet another example, the method can be used to spray medications or other therapeutic substances, such as for stopping or reducing gastrointestinal bleeding (e.g., in the esophagus, stomach, small intestine, colon, etc.). Exemplary medications for spraying include Endoscopic Hemostatics (Cook Medical, Winston-Salem, NC, USA), Ankaferd Blood Stopper (Ankaferd Health Products Ltd., Istanbul, Türkiye), Polysaccharide hemostatic system (EndoClot Plus, Santa Clara, California, USA), etc.

[0134] In other embodiments, the methods described herein can be used to deliver and / or extract suitable substances using a capsule endoscope system as described above. For example, the method can be used to release a fluid (e.g., a gas such as air or nitrogen, a liquid such as saline or water, etc.) through a capsule endoscope system having a port that can be used to expand at least a portion of the gastrointestinal tract (e.g., the stomach, small intestine, large intestine, colon, etc.). This expansion can be useful, for example, to facilitate visibility of imaging within the gastrointestinal tract using the same endoscopic device or other suitable imaging devices. As another example, the method can be used to facilitate nanoscale drug delivery by releasing nanoparticle drug carriers (e.g., liposomes, carbon nanotubes, dendrimers, polymer nanoparticles, gold-based nanoparticles, etc.). Suitable drugs for delivery can include anti-inflammatory agents, anti-infective agents, etc.

[0135] In some embodiments, the same capsule endoscope can be used to obtain patient samples and deliver medications during surgery. For example, after the capsule endoscope is advanced to the target area, negative pressure can be created in the tether to extract the patient sample or other substance through the port, and then positive pressure can be created in the tether to deliver the medication or other substance through the port. Alternatively, positive pressure can be created before negative pressure is created.

[0136] For the purpose of illustration, the foregoing description uses specific nomenclature to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that specific details are not required to practice the present invention. Therefore, the foregoing description of specific embodiments of the present invention is presented for the purpose of illustration and description and is not intended to be exhaustive or to limit the present invention to the precise form disclosed; it is clear that many modifications and variations based on the above teachings are possible. The embodiments are selected and described in order to explain the principles of the present invention and their practical application, and various changes may be included for these multiple embodiments without departing from the principles and spirit of the present invention. All changes made within the meaning and scope equivalent to the claims are within the scope of the present invention.

Claims

1. A system, characterized in that: include: Capsule endoscopes, including imaging systems; and Tether, including: a clamp configured to engage the capsule endoscope; and a flexible member including a lumen; wherein the clamp includes a port configured to be in fluid communication with the lumen and an environment external to the clamp when the clamp is engaged with the capsule endoscope, and The lumen of the flexible member terminates at and is coaxial with a port of the clamp; The clamp includes a sheath configured to surround at least a portion of the capsule endoscope, the clamp including a shell forming a chamber between the sheath and the flexible member, the shell including a port and a valve, the port of the shell being selectively covered by the valve to regulate flow through the port of the shell, so as to open or close the valve covering the port of the shell according to a pressure difference between the inside and outside of the shell.

2. The system according to claim 1, wherein: The imaging system includes a first lens located at a proximal portion of the capsule endoscope.

3. The system according to claim 2, characterized in that The imaging system includes a second lens located at a distal portion of the capsule endoscope.

4. The system according to claim 1, wherein: Also included is at least one of a pressure source and a vacuum source configured to be in fluid communication with the lumen.

5. The system according to claim 4, characterized in that At least one of the pressure source and the vacuum source comprises a syringe.

6. The system according to claim 4, characterized in that At least one of the pressure source and the vacuum source comprises a pump.

7. The system according to claim 1, wherein: The clamp is configured to releasably engage a capsule endoscope.

8. The system according to claim 1, wherein: The capsule endoscope is magnetically controllable.

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