EP3367875A1 - Lumen traveling device - Google Patents

Lumen traveling device

Info

Publication number
EP3367875A1
EP3367875A1 EP16860658.0A EP16860658A EP3367875A1 EP 3367875 A1 EP3367875 A1 EP 3367875A1 EP 16860658 A EP16860658 A EP 16860658A EP 3367875 A1 EP3367875 A1 EP 3367875A1
Authority
EP
European Patent Office
Prior art keywords
traveling device
lumen
lumen traveling
sensor
display
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16860658.0A
Other languages
German (de)
French (fr)
Inventor
Roderick A. Hyde
Wayne R. Kindsvogel
Stephen L. Malaska
Robert C. Petroski
Katherine E. SHARADIN
Elizabeth A. Sweeney
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Elwha LLC
Original Assignee
Elwha LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US14/926,202 priority Critical patent/US20170119236A1/en
Priority to US14/926,233 priority patent/US20170119278A1/en
Priority to US14/926,158 priority patent/US20170119235A1/en
Application filed by Elwha LLC filed Critical Elwha LLC
Priority to PCT/US2016/058796 priority patent/WO2017075009A1/en
Publication of EP3367875A1 publication Critical patent/EP3367875A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661Endoscope light sources
    • A61B1/0684Endoscope light sources using light emitting diodes [LED]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002Operational features of endoscopes
    • A61B1/00004Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00009Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
    • A61B1/000094Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope extracting biological structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/041Capsule endoscopes for imaging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/04Endoscopic instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/07Endoradiosondes
    • A61B5/073Intestinal transmitters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/742Details of notification to user or communication with user or patient ; user input means using visual displays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002Operational features of endoscopes
    • A61B1/00011Operational features of endoscopes characterised by signal transmission
    • A61B1/00016Operational features of endoscopes characterised by signal transmission using wireless means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147Holding or positioning arrangements
    • A61B1/00158Holding or positioning arrangements using magnetic field
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • A61B1/2676Bronchoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/31Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the rectum, e.g. proctoscopes, sigmoidoscopes, colonoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/06Biopsy forceps, e.g. with cup-shaped jaws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0216Sampling brushes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0214Operational features of power management of power generation or supply
    • A61B2560/0219Operational features of power management of power generation or supply of externally powered implanted units

Abstract

Various embodiments described herein relate to a lumen traveling device and/or system for real-time display of location of the device as it travels through a lumen in a subject's body. In an embodiment, alignment of the externally alignable display and control device with the lumen traveling device located in a lumen (natural or artificial) in a subject's body provides for tracking, memory display, and manipulation of the lumen traveling device.

Description

LUMEN TRAVELING DEVICE
All subject matter of the Priority Application(s) is incorporated herein by reference to the extent such subject matter is not inconsistent herewith. BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 A is a partial view of a device and system described herein.
FIG. 1 B is a partial view of a device and system described herein.
FIG. 1C is a partial view of a device and system described herein.
FIG. 2A is a partial view of a device and system described herein.
FIG. 2B is a partial view of a device and system described herein.
FIG. 3A is a partial view of a device and system described herein.
FIG. 3B is a partial view of a device and system described herein.
FIG. 4 is a partial view of a component of the device and system described herein.
FIG. 5 is a partial view of a component of the device and system described herein.
DETAILED DESCRIPTION
In the following detailed description, reference is made to the
accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise.
The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.
In an embodiment, a lumen traveling device and system are adapted for traveling within a natural or artificial (e.g. , catheter, shunt) lumen of a subject's body. In an embodiment, the lumen traveling device is at least one of disposable, biodegradable, or bioresorbable, in part or in total. In an embodiment, the lumen traveling device is sized and shaped according to specifications of the particular lumen it is designed to travel within, or the specifications of the function or operation of the lumen traveling device. In an embodiment, the lumen traveling device is of a fixed size or shape. In an embodiment, the lumen traveling device is flexible. In an embodiment, the lumen traveling device is spheroid, cylindrical, pyramidal, cuboid, or any combination thereof. In an embodiment, the lumen traveling device is sized and shaped for ingestion. In an embodiment, the lumen traveling device is sized and shaped for surgical introduction or implantation into a lumen. In an embodiment, the lumen traveling device is sized and shaped for injection into a lumen or an organ having lumen or duct. In an embodiment, the lumen traveling device is sized and shaped for introduction into a lumen via a catheter or cannula. In an embodiment, the lumen traveling device is sized and shaped for injection into at least a portion of an alimentary canal, a blood vessel, a respiratory tract, a urinary tract, genital tract, a duct of an organ, or the like. In an embodiment, the lumen traveling device comprises all or part of a micro-robot (e.g., microbot). In an embodiment, the lumen traveling device includes all or part of a capsule endoscope.
For example, in an embodiment, the lumen traveling device is
approximately 50 mm or less, approximately 40 mm or less, approximately 30 mm or less, approximately 20 mm or less, approximately 10 mm or less, approximately 5 mm or less in length. In an embodiment, the lumen traveling device is approximately 20 mm or less, approximately 10 mm or less, approximately 5 mm or less in width or height (i.e. diameter).
In an embodiment, the lumen traveling device includes layers of several materials. In an embodiment, at least one layer of the lumen traveling device includes a permeable or semi-permeable membrane. In an embodiment, the lumen traveling device includes at least one mesh surface. In an embodiment, the lumen traveling device includes expandable or contractible materials, for example metal or plastic components that are capable of being altered in size or shape. In an embodiment, the lumen traveling device includes a shape memory alloy or electroactive polymer. In an embodiment, at least one component of the lumen traveling device includes a metal, ceramic, paper, polymer (plastic, silicone, etc.), silk, or other suitable biocompatible materials. In an embodiment, the lumen traveling device can be manufactured according to various techniques, including 3-D printing, self-assembly, rapid-prototyping, die-cutting, extrusion, injection molding, or the like.
In an embodiment, the lumen traveling device and system includes at least one sensor. In an embodiment, the sensor is used to determine location of the lumen traveling device (e.g., based on the parameters sensed at a particular location of a lumen). As described herein, there is also at least one sensor in the system utilized to determine the location of the EADCD in relation to the lumen traveling device. In an embodiment, at least one sensor is used to determine at least one physiological parameter that may be used for determining a medical treatment, a change in treatment, or a diagnosis of the subject.
In an embodiment, the sensor includes, for example, at least one of a pressure sensor, temperature sensor, flow sensor, viscosity sensor, shear sensor, pH sensor, gas sensor, chemical sensor, optical sensor, acoustic sensor, biosensor, electrical sensor, magnetic sensor, clock, or timer. In an embodiment, the sensor detects a physiological condition, such as level of a blood component (e.g., pH, hormone, vitamin or mineral, cholesterol, oxygen, bilirubin, hemoglobin, etc.), presence or number of a cell type (red blood cells, white blood cells, immune cells, malignant cells, necrotic cells, etc.), immune function (e.g., inflammation, bleeding, infection, auto-immunity, etc.), microbiome (e.g., levels of healthy or unhealthy microorganisms, etc.), blood pressure, or other condition. In an embodiment, the sensor detects lumen surface integrity (e.g., presence of a lesion, tumor, ulcer, fissure, wound, etc.), for example associated with an autoimmune disorder (e.g., Crohn's disease lesion), cancer or precancerous condition (e.g., a tumor or polyp), or vascular disorder (e.g., gastrointestinal bleeding or varices). In an embodiment, the sensor detects an analyte, for example, a physiological analyte. In an embodiment, the sensor detects a tag (e.g., a radiographic or colorimetric agent that binds to cells or components of cells or binds to other components of biological fluids, such as hemoglobin, insulin, etc. and that can be utilized to detect or monitor a specific medical condition or disease).
In an embodiment, the lumen traveling device and/or system includes at least one power source. For example, the power source may be located on the surface of the lumen traveling device, inside a compartment of the lumen traveling device, or other location. In an embodiment, the lumen traveling device and/or system includes at least one battery, microbattery, thin-film battery, or nuclear battery. In an embodiment, the lumen traveling device and/or system includes at least one fuel cell or biofuel cell, for example at least one enzymatic, microbial, or photosynthetic fuel cell. In an embodiment, the power source includes a nanogenerator (e.g. DNA, piezoelectric wires, or other tensile material).
In an embodiment, the power source includes at least one of an optical power source, acoustic receiver, electromagnetic receiver, or electrical power source. In an embodiment, the power source is connected to the lumen traveling device and/or system through a cable or physical link. In an embodiment, the lumen traveling device and/or system is wireless.
In an embodiment, the lumen traveling device (LTD) is located within the subject's body by way of various sensors, as described herein, for example by query sensing (reflected and time-of -flight) or passive sensing (LTD emitting signal) between the LTD and externally alignable display and control device (EADCD). In an embodiment, a specific electromagnetic signal (e.g. , RF or magnetic) is coupled between the LTD and EADCD, and the LTD is aligned with the strongest signal, indicating alignment with the EADCD. In an embodiment, the time-of -flight value is utilized to determine the location of the LTD from the
EADCD. In an embodiment, the EADCD has more than one receiver at different locations on the device, and a comparison of the strength of the signal at each receiver indicates which receiver the LTD is closer to, and allows for locational determination.
In an embodiment, the lumen traveling device and/or system includes at least one component for harvesting energy. In an embodiment, the lumen traveling device and/or system includes at least one component for harvesting energy from the body, for example kinetic energy (e.g. , from fluid flow or peristalsis) or thermal energy, and transducing the energy to power. In an embodiment, the lumen traveling device and/or system includes at least one component for harvesting energy from a source external to the body, for example infrared radiation from a dedicated source. In an embodiment, the lumen traveling device or system includes at least one component for wireless energy transfer. In an embodiment, the lumen traveling device includes at least one energy receiver configured to receive power from at least one external energy transmitter. For example, acoustic energy, electrical energy, or optical energy can be transmitted to the lumen traveling device from another location. In an embodiment, ultrasonic energy or microwave energy can be beamed to a receiver and converted into a current. In an
embodiment, the lumen traveling device includes at least one capacitive coupling link. In an embodiment, the lumen traveling device includes at least one inductive coupling link. In an embodiment, the lumen traveling device can include at least one receiving coil configured to receive energy from an external transmitting coil. In an embodiment, the lumen traveling device includes multiple receiving coils, for example in a topography and/or configuration conducive to receiving power.
In an embodiment, the other location includes, for example, another external device that includes, for example, at least one power transmitter or power receiver, and associated structures for at least one of using, storing, or retransmitting power. A remote device for the lumen traveling device may also include power transmitters or power receivers.
In an embodiment, the lumen traveling device and system include control circuitry that may be part of the internal device components, and/or part of the system that is external to the lumen traveling device itself (e.g., a remote control or other computing device). In an embodiment, the control circuitry is
implemented in logic forms (e.g., analog or digital logic circuitry and software, or both). In an embodiment, the control circuitry is stored as or implemented as non- transitory machine readable machinery. In an embodiment, data storage or usage can include implementation as non-transitory machine readable machinery.
In an embodiment, the lumen traveling device and system is configured for movement within a natural or artificial lumen of a subject's body. In an
embodiment, the lumen traveling device and system is configured for passive movement; for example, the device is shaped to promote movement with natural flow or lumen movements, e.g. , peristalsis. In an embodiment, the lumen traveling device and system is configured to utilize an external field, such as a magnetic field, to compel movement of the lumen traveling device, for example directly, as by a magnetic field exerting a force on the device, or indirectly, as in influencing an onboard controller. In an embodiment, the lumen traveling device and system is configured for active movement within a natural or artificial lumen of a subject's body and includes means for locomotion.
In an embodiment, the lumen traveling device may have a rolling motion, a crawling or walking motion (e.g., with leg-like protrusions), a swimming motion, an inchworm-like motion, a stick and slip motion, propelling motion, or a ciliated motion. In an embodiment, the lumen traveling device and system is configured for movement within a natural or artificial lumen of a subject's body according to direction provided by the controller in response to the one or more various sensors.
In an embodiment, the lumen traveling device includes as a means for locomotion, a propulsion system. In an embodiment the lumen traveling device includes a magnetohydrodynamic propulsion system that propels the lumen traveling device in a determined direction by ejecting a fluid jet. In an
embodiment, the lumen traveling device includes an inertia-based propulsion system, for example an impulse-driven micromechanism having as a moving mass a permanent magnet that is driven by magnetic force achieved by applying a current to a coil. In an embodiment, the lumen traveling device includes a propeller. In an embodiment, a propeller can include a rotor driven by an electric or magnetic motor or actuator. In an embodiment, the lumen traveling device and system configured for movement according to direction includes a rudder, for example under control of a controller, to steer the device in a particular direction. In an embodiment, the lumen traveling device includes one or more appendages that function as paddles to propel the device, for example, through a fluid. In an embodiment, the lumen traveling device can include a linear actuator to drive paddle appendages in a manner so as to advance the device; combinations of paddles and their actuation can be used to induce movement in a particular direction. In an embodiment, the lumen traveling device can include internal permanent magnets configured to move a number of polymeric flaps or a single tail that provide thrust through the fluid. In an embodiment, the lumen traveling device can include a single tail of an electroactive polymer configured to provide thrust and direction.
In an embodiment, the lumen traveling device includes at least one locomotive mechanism configured to touch, grasp, grip, or otherwise engage the wall (e.g. surface) of a natural or artificial lumen of a subject's body. In an embodiment, the lumen traveling device includes at least one inchworm-like movement mechanism, in which at least a portion of the lumen traveling device intermittently engages and disengages from the wall of the lumen in a slip-and- stick fashion thereby traversing a distance. In an embodiment the lumen traveling device includes a vibratory locomotive mechanism, for example a mechanism inducing forced bending vibrations of continua of the lumen traveling device driven by actuators such as piezoelectric bending actuators. The locomotion direction of the lumen traveling device can be controlled by the excitation frequencies of the actuation element. In an embodiment, the lumen traveling device includes a sectional design, and each section is driven separately to engage or disengage the wall. In an embodiment, the lumen traveling device can include at least one actuator that drives the movement of the lumen traveling device and the engagement of the wall. In an embodiment, the lumen traveling device might include two-way linear actuators using a pair of springs made from a shape memory alloy. In an embodiment, the lumen traveling device might include a piezoelectric microactuator. In an embodiment, the lumen traveling device might include a micromotor. In an embodiment the lumen traveling device is jointed between sections of the lumen traveling device, and one or more actuators drive each section, for example, in a worm-like fashion. In an embodiment, the lumen traveling device includes an expandable bellow, for example, a pneumatic bellows that provides the locomotive mechanism. In an embodiment, the lumen traveling device includes surface-engaging protrusions, microprotrusions, adhesive micropilli, or clamps. In an embodiment, the lumen traveling device includes radially expandable portions that expand to engage and disengage the inner surface lumen of the lumen.
In an embodiment the lumen traveling device includes as a locomotive means an impelling mechanism configured to engage the wall (e.g., surface) and provide locomotion to the device; for example, an impelling device might comprise one or more appendages, legs, or wheels, with or without adhesive aspects such as micropilli. A number of mechanisms to actuate an impelling mechanism can be adapted for use with various embodiments described herein. In an embodiment, actuators and motors (micromotors) can be used to drive impelling devices.
Examples of actuators include piezoelectric, DC motors, electromagnetic, and electrostatic actuators. In addition, actuators can be formed from shape memory alloys or ionic polymer metal components. In an embodiment, jointed appendages and legs can be actuated to propel the device forward in a walking or crawling motion.
As another example, a meso-scale legged locomotion system can include a slot-follower mechanism driven via lead screw to provide propulsive force to a jointed leg. In an embodiment, multiple jointed legs, e.g. , of superelastic or other material, can be motivated to interact with the wall under control of a motor, e.g., a brushless minimotor. In an embodiment, appendages or legs can be formed from shape memory alloy and driven by the application of current. In an embodiment, appendages can act to engage the wall driven by rotational forces to provide locomotion. In an embodiment, wheels can be driven by motors or other actuators. In an embodiment, the lumen traveling device and system is configured to employ one or more impelling mechanisms in a manner to provide movement in a particular direction. In an embodiment, to change direction (e.g., as directed by a controller), only a portion of multiple appendages (or legs or wheels) can be actuated, thereby moving a portion of the device so that the device heads in a new direction and allowing the device to be steered.
In an embodiment, the lumen traveling device and system includes means for stabilization within the lumen, e.g. , for maintaining orientation or position within the lumen. In an embodiment, the lumen traveling device and system includes one or more masses that can be steadied by an external field, for example a pair of permanent magnets that can be steadied in a magnetic field. In an embodiment, the lumen traveling device and system includes one or more gyroscope or one or more accelerometer. In an embodiment, the lumen traveling device and system includes one or more self-expanding stabilizing devices such as appendages, balloons, or capsules. A self-expanding stabilizing device can further have functionality in expanding the lumen.
In an embodiment, the lumen traveling device and system includes at least one location sensor to determine localization and spatial information regarding the lumen traveling device, including its position in three-dimensional (3D) space, the distance it has travelled along the lumen, and the region of the lumen in which it is located. A variety of technologies are known in the art to acquire such
information, including but not limited to radio frequency (RF) triangulation, magnetic tracking, computer vision, and ultrasound. In an embodiment, the lumen traveling device and system includes an external device employing delivery of energy of one or more frequencies in the electromagnetic spectrum (e.g., radiowaves, microwaves, infrared, visible waves, ultraviolet waves, x rays, gamma rays) for tracking the lumen traveling device. In an embodiment, the lumen traveling device and system includes an imaging device (for example a magnetic resonance imager, x-ray imager, gamma camera, or the like) able to detect and track the lumen traveling device, which may be carrying a tag, for example a radiographic agent or contrast agent.
In an embodiment, the lumen traveling device and system includes a location sensor that is an ultrasound imaging device. In an embodiment an ultrasound imager housed in or otherwise associated with the externally alignable display and control device can be configured to utilize time of flight (ToF) between transmission of signals and reception of reflected signals to track the lumen traveling device, while the lumen traveling device is within the threshold of the location sensor. In an embodiment, the lumen traveling device is sensed when it is in the scanning plane, as determined by the location sensor. Alternatively or in addition, in an embodiment the lumen traveling device includes an ultrasound transducer that emits signals able to be received by one or more receivers, for example in the externally alignable display and control device or in an array of external receivers positioned on the body and in communication with the externally alignable display and control device.
In an embodiment, a method includes detecting at least one interaction of a lumen traveling device with a lumen of a subject by way of one or more sensors in or on a lumen traveling device; generating at least one sensed signal based on detection of the at least one interaction of the lumen traveling device with the lumen; determining if the sensed signal exceeds a threshold value for the at least one interaction; generating at least one communication signal based on the determination of whether the sensed signal exceeds the threshold value for the at least one interaction. In an embodiment, determining if the sensed signal exceeds a threshold value for the at least one interaction includes comparing the sensed signal to a reference data indicative of the threshold value. In an embodiment, the reference data is derived from at least one sensed signal, programmed by a user, or set while the device or system is in use. In this way, the interactions of the lumen traveling device with the lumen itself can be attributed more value, in that information is obtained from such interactions if a threshold is exceeded. For example, if the lumen traveling device is directed to sample the wall of the lumen, the lumen traveling device determines whether, for example, the sample size or location or type is sufficient to obtain the desired information. If such a threshold is exceeded, then the sample is taken and evaluated to provide the information sought. If the threshold is not satisfied, then the sample will not be taken at that time or location or in that manner, for example, and instead will be taken in another place, time, or manner, etc. so that the threshold evaluation can be conducted again.
In an embodiment, the lumen traveling device and system includes a location sensor that employs magnetic tracking of the lumen traveling device. In one example, the lumen traveling device includes at least one permanent magnet that is trackable by a magnetic sensor (e.g., magnetoresistive sensor) associated with (e.g., a skin-mounted array in communication with) or housed in the externally alignable display and control device. Alternatively or in addition, a magnetoresistive sensor inside the lumen traveling device can measure the intensity of the external magnetic field generated by external energized coils. In another example, for use with a lumen traveling device actively motivated by a low frequency magnetic field, a high frequency magnetic field can be used
simultaneously for location purposes. In an embodiment, the lumen traveling device and system includes a location sensor that employs inertial sensing to determine localization. For example, the lumen traveling device and system includes one or more
accelerometers, which may function alone or in concert with an actuation field.
In an embodiment, the lumen traveling device and system includes a location sensor that utilizes radio frequency signals. In an embodiment, the lumen traveling device and system can include at least one external sensor array that evaluates an RF signal (e.g., for frequency and strength) transmitted by a transmitter housed in the lumen travelling device. The system can utilize information from the array to estimate distance and triangulate the signal.
Approaches to RF signal-based localization methods include time-of-arrival (TOA), angle-of-arrival (AOA), time-difference-of-arrival (TDOA) and received- signal-strength (RSS) signal processing. In an embodiment, the lumen traveling device can include an RFID tag. In an embodiment, the lumen traveling device can include an RFID tag comprising a bidirectional, tridirectional, or
omnidirectional antenna. In an embodiment, the lumen traveling device and system includes one or more software algorithms, e.g., to address signal propagation and reception, as well as noise reduction, can be used to increase efficiency and accuracy. In an embodiment, the lumen traveling device and system employs hardware and software to evaluate the phase difference of arrival at multiple frequencies of a signal to estimate the distance of the source to a receiver, together with linear least square estimation or other software algorithms.
In an embodiment, the lumen traveling device and system includes hardware and software to employ image comparisons to determine the position of the lumen traveling device. In an embodiment, images (e.g., moving picture experts group (MPEG)-7 images) are captured by the lumen traveling device. Images can be classified by hardware and software of the system utilizing, for example, vector quantization, principal component analysis, and neural networks, and/or event boundary detection algorithms, e.g. , to identify topography, colors, elasticity, and the like.
In an embodiment, the lumen traveling device and system includes one or more location sensors that measure a distance. For example, a lumen traveling device can include a protrusion, (e.g., a wheel) attached to a counter (e.g. , an odometer) that measures the distance the device has traveled, e.g. , along a lumen wall. In an embodiment, a lumen traveling device can include a protrusion, (e.g. , a flap) attached to a counter that measures the distance the device has traveled based on, for example the duration, force, or intermittent pulse, of pressure e.g., from fluid flow. See figures for more details.
In an embodiment, the lumen traveling device and system is configured for anchoring, at least temporarily, to the side wall of a lumen. In an embodiment, the lumen traveling device may include a wall-anchoring system with at least one of a hook, tether, peg, suction, spring, or adhesive. In an embodiment, the lumen traveling device includes at least one reservoir containing one or more adhesives. See figures for more details.
In an embodiment, the lumen traveling device is configured for easy removal from the lumen. In an embodiment the lumen traveling device is removable as a whole. In an embodiment, the lumen traveling device is removable in portions, e.g. , after disintegration or degradation. In an embodiment, the lumen traveling device is configured for manual removal. In an embodiment, the lumen traveling device includes a tether, or other surface design, for removal through the introductory path. In an embodiment, a capsule endoscope used to image or treat the esophagus may include a tether for pulling the capsule back up through the mouth. In an embodiment, all or part of a lumen traveling device introduced into a lumen via a needle or catheter can be configured for manual removal via needle, catheter, etc., and may include magnetic or other attractive features. In an embodiment, all or part of the lumen traveling device is expelled via natural elimination. In an embodiment, a capsule endoscope traversing the gut can be expelled through the anus via natural digestive elimination. In an embodiment, all or part of a lumen traveling device can be expelled from a respiratory system via a cough. In an embodiment, all or part of a lumen traveling device having been introduced into a portion of a urogenital system, can be expelled via the urethra. In an embodiment, at the end of its life, biochemical remnants of a biodegradable lumen traveling device traveling in a blood stream can be eliminated via the liver. In an embodiment, as described herein, at least part of the lumen traveling device is disposable. In an embodiment, as described herein, at least part of the lumen traveling device is biodegradable, so no retrieval from the subject is required.
In an embodiment the lumen traveling device includes at least one onboard instrument. In an embodiment the lumen traveling device includes one or more imaging devices. In an embodiment, the lumen traveling device can include a camera, a CCD sensor, a CMOS sensor, a spectroscopic camera (e.g., one that sees cells underneath the surface layer of tissue), or the like. In an embodiment the lumen traveling device includes one or more biopsy tool. In an embodiment, the lumen traveling device can include an aspiration tool, biopsy clip, biopsy punch, a curette, or the like. In an embodiment the lumen traveling device includes one or more deployment tool. In an embodiment, the lumen traveling device can include a mechanism for deploying a surgical clip or staple to a treatment site in the lumen (e.g., to a varix). In an embodiment, the lumen traveling device can include a mechanism for delivering a coil. In an embodiment the lumen traveling device includes a needle, for example to deliver a therapeutic agent directly to a treatment site on the lumen tissue. In an embodiment the lumen traveling device includes an energy emitter. In an embodiment, the lumen traveling device can include a wire that delivers heat to cauterize a tissue. In an embodiment, the lumen traveling device can include a thermal tool for ablating a tissue. In an embodiment, the lumen traveling device can include an ultrasound emitter or the like.
In an embodiment, the lumen traveling device includes at least one sampling means, as described herein. In an embodiment, the lumen traveling device includes a liquid capture device, for example a reservoir or adsorbent or absorbent material. In an embodiment, sampling means are housed in leg-like protrusions that engage the lumen wall (e.g., nano or micro calipers 375
configured to grasp cells or DNA of the lumen, suction cup feet-like bases 385 that include nano or micro teeth, bristles, or needles for sampling cells or DNA of the lumen). In an embodiment, the sampling means is able to obtain small samples of blood, tissue, cells (including, for example, microorganisms or components thereof), nucleic acids, proteins, etc. from the lumen of the subject.
In an embodiment, the lumen traveling device and system is configured to image or map a lumen. In an embodiment, the lumen traveling device and system is configured to provide treatment in a lumen. In an embodiment, the lumen traveling device is followed in the lumen by the externally alignable display and control device (EADCD) in real-time and spatial alignment. In an embodiment, the lumen traveling device can be directed to advance or return to a site in the lumen by the externally alignable display and control device in real-time, and further action by the lumen traveling device can be directed via the externally alignable display and control device. In an embodiment, the lumen traveling device and system is used to image, map, or provide treatment to a lumen that includes at least a portion of an alimentary canal, a blood vessel, a respiratory tract, a urinary tract, genital tract, a duct of an organ, or the like.
In an embodiment, a system includes a memory device wherein the memory device is configured to retrieve data associated with a specific location corresponding to a lumen reference path previously traveled by the lumen traveling device when queried. In an embodiment, the data is not retrievable unless the EADCD is within a proximity threshold from where the LTD actually traveled in the lumen (e.g., the proximity threshold includes at least one of approximately one millimeter, approximately ten millimeters, approximately 100 millimeters, approximately one centimeter, or approximately ten centimeters from the actual path traveled in the lumen. In this way, the reference map is a predetermined pathway intended for the LTD to follow, while the reference path is a map of the actual path the LTD took as it traveled through a lumen. Thus, the reference path may not ideally follow the exact reference map of the lumen, but should be approximately the same. In an embodiment, the LTD does not transmit data unless and until it enters a threshold range of a predetermined location (e.g., a specific location in the lumen such as a specific section of the intestinal tract of a subject). In this way, the LTD conserves power and can be manufactured with lightweight, thin battery power source. In an embodiment, the LTD is
programmable to not transmit data until it reaches the predetermined target location. In an embodiment, the LTD is remote controllable to not transmit data until it reaches the predetermined target location. For example, the LTD emits a location beacon or signal to verify its location as it travels through the lumen, only transmitting additional data about the condition of the lumen (e.g., biological tissue sampling, therapeutic agent delivery, etc.) until it reaches the predetermined target location.
For example, the lumen traveling device can be introduced into any portion of an alimentary canal, such as the esophagus, stomach, small intestine, large intestine, and the like, through ingestion or delivery (e.g. , by conventional endoscope or suppository). For example, the lumen traveling device can be used to image some or all of the alimentary canal to look for anomalies such as but not limited to polyps, tumors, varices, bleeding, obstructions, inflammation, and the like. In an embodiment, the lumen traveling device can be used to perform a treatment in the alimentary canal, such as treatment of a gastrointestinal bleed by delivering energy (e.g., thermal energy as in cauterizing or freezing or
radiofrequency ablation) or by delivering a ligature (e.g., clip or band) or by injecting a compound (e.g., cyanoacrylate or epinephrine). In an embodiment, the lumen traveling device is followed in the alimentary canal by the externally alignable display and control device in real-time and spatial alignment. In an embodiment, the lumen traveling device can be directed to advance or return to a site in the alimentary via the externally alignable display and control device in realtime using spatial alignment, and further action by the lumen traveling device as described above can be directed via the externally alignable display and control device.
As described herein, the alignment of the EADCD can optionally first be aligned with external markers (e.g., based on a fiducial sensor, etc.) and further aligned with the LTD (e.g., based on the LTD sensors) to retrieve data associated with the location of the LTD or the reference path.
In an embodiment, the lumen traveling device is used to image, map, or provide treatment to a lumen that is a blood vessel or lymphatic duct. In an embodiment, the lumen traveling device can be injected into a blood vessel and used to image the blood vessel for the presence of, e.g., plaque, stricture, or stenosis, and if necessary to provide treatment by delivering an expandable stent to the area. In an embodiment, the lumen traveling device used to image a blood vessel for the presence of an embolism and deliver an agent for degrading the embolism. In an embodiment, the lumen traveling device can be used to image a blood vessel for the presence of an aneurysm and if necessary provide treatment by delivering a clip or coil to the site. In an embodiment, the lumen traveling device can be followed in the blood vessel by the externally alignable display and control device in real time.
In an embodiment, the lumen traveling device can be directed to advance or return to a site in the blood vessel by the externally alignable display and control device in real time, and further action by the lumen traveling device as described above can be directed via the externally alignable display and control device. In an embodiment, a lumen traveling device is injected into a blood vessel in the lower extremity of a subject experiencing pain and poor healing in the limb. By alignment and movement as described herein, the externally alignable display and control device is used to direct the lumen traveling device into several branches of the blood vessel while displaying the results in real time until an area of stenosis is detected. The externally alignable display and control device is then used to direct the lumen traveling device to deploy an expandable stent utilizing extended appendages to expand the stent to fit the vessel. The externally alignable display and control device is then used to direct the lumen traveling device back to the site of entry by moving the externally alignable display and control device over the limb while viewing the progress of the lumen traveling device in real time, and the lumen traveling device is retrieved via a syringe.
Similarly, a lymphatic duct can be imaged or treated in the same manner as a blood vessel. In an embodiment, inflammation (e.g., associated with cancer or infection, etc.) can be monitored by a lumen traveling device deployed in the lymph system or the vasculature.
In an embodiment, the lumen traveling device and system is used to image, map, assist in diagnosis, sample, or provide treatment to a lumen that is part of a urinary tract. In an embodiment, a lumen traveling device can be introduced into a urinary tract via the urethra (e.g., by catheter and/or locomotive aspects described herein) and used to image the urethra, bladder, ureters, and kidney ducts for the presence of, In an embodiment, tumors, strictures, bleeding, ulcers, stones, inflammation, infection, or the like. In addition, the lumen traveling device can be used to perform a treatment in a urinary tract such as disintegration of a stone, biopsy or removal of a tumor, directed killing of a microorganism or the like. In an embodiment, the lumen traveling device is followed spatially in real time in the urinary tract by aligning the externally alignable display and control device. In an embodiment, the lumen traveling device can be directed via the externally alignable display and control device in real time to advance (e.g., to ensure the entire bladder has been viewed) or to return to a previously viewed site in the bladder (e.g., by moving the externally alignable display and control device across the external abdomen), and further action by the lumen traveling device as described above can be directed via the externally alignable display and control device.
In an embodiment, a lumen traveling device can be introduced into a male reproductive system via the urethra (e.g. , by catheter and/or locomotive aspects described herein) to image or treat a site therein. In an embodiment, the lumen traveling device is followed in the male reproductive system by the externally alignable display and control device in real time. In an embodiment, the lumen traveling device can be directed spatially via the externally alignable display and control device in real time to advance or to return to a site, and further action by the lumen traveling device as described above can be directed via the externally alignable display and control device. In an embodiment, a lumen traveling device is directed by the externally alignable display and control device to advance to a site in the vas deferens of a subject who has undergone a past vasectomy to evaluate the efficacy of the vasectomy procedure. If the vas deferens is not fully occluded, the lumen traveling device is directed to deliver a clip to completely block the lumen.
In an embodiment, a lumen traveling device can be introduced into a female reproductive system via the vagina (e.g., by direct delivery and/or locomotive aspects described herein) and used to image the vagina, cervix, uterus, and fallopian tubes for the presence of, for example, tumors, genital warts, strictures, tubal pregnancy, tubal ligation, abnormal bleeding, endometriosis, ulcers, inflammation, infection, or the like. In addition, the lumen traveling device can be used to perform a treatment in a reproductive tract such as ablation of tissue, biopsy or removal of a tumor, directed killing of a microorganism or the like. In an embodiment, the lumen traveling device is followed in the reproductive tract by the externally alignable display and control device in real time. In an
embodiment, the lumen traveling device can be directed via the externally alignable display and control device in real time to advance (e.g., to ensure the entire uterus has been viewed) or to return to a previously viewed site in the reproductive tract, and further action by the lumen traveling device as described above can be directed via the externally alignable display and control device. In an embodiment, the lumen traveling device is directed via the externally alignable display and control device to the fallopian tube to evaluate the presence of endometrial tissue occluding the fallopian tube and potentially preventing pregnancy. If occlusion is identified, the externally alignable display and control device is used to direct the lumen traveling device to emit thermal energy to ablate the tissue and open the tube. In an embodiment, the externally alignable display and control device is then used to direct the lumen traveling device to the other fallopian tube by moving the externally alignable display and control device over the external abdomen while viewing the progress of the lumen traveling device in real time.
In an embodiment, the externally alignable display and control device includes at least one projector or display. In an embodiment, the externally alignable display and control device includes a projector configured to project at least one hologram (e.g., on the subject's body, on a surface, or into air).
In an embodiment, the externally alignable display and control device (EADCD) includes a liquid crystal display (LCD), light-emitting diode display (LED), or a projection display. In an embodiment, the EADCD includes an organic light emitting diode (OLED) or similar device that includes a sterile surface, and sufficient flexibility to function despite folds or creases. In an embodiment, an organic light emitting diode includes an anode, cathode, OLED organic material, and a conductive layer. In an embodiment, the OLED includes a double layer structure with separate hole transporting and electron-transporting layers, with light emission sandwiched in between the two layers. In an embodiment, the EADCD includes multiple distinct display units forming one or more larger displays, with each display unit informed and controlled by the processor and controller, which may be indicating the sensed signals from the sensors. In an embodiment, the EADCD may include a flexible backing, e.g., a rubber polymer, with discrete rigid display units (LCD, LED, or OLED, for example). In an embodiment, information is displayed through multiple distinct display units (e.g., having LCD, LED, or OLED technology) combining to form an EADCD configured to provide displayed information; which information is displayed on which unit is determined optionally in real-time by the processor and controller using signals provided by sensors determining the location of the EADCD on the subject's body and the location of the lumen traveling device inside the subject's body, and optionally the location of each relative to the other. In an embodiment, the EADCD is flexible, foldable, or otherwise able to be rearranged (e.g., a foldable OLED display). In an embodiment, the EADCD includes at least one projector.
In an embodiment, a polymer light emitting diode (PLED) can be utilized, since it emits light under an applied electric current. Typically, a PLED utilizes less energy than an OLED to produce the same level of luminescence. In an embodiment, the PLED includes at least one of a derivative of poly(p-phenylene vinylene) and polyfluorene. In this example, the light comes from a single layer of electroluminescent polymer, which is held between two transparent elastic composite electrode layers.
In an embodiment, the EADCD includes a flexible or stretchable display including intrinsically stretchable OLEDs formed by elastic constituent materials, for example carbon nanotube (CNT)-polymer composite electrodes sandwiching an electroluminescent polymer blend layer or an elastic electroluminescent blend with an ultrathin gold coating on polydimethylsiloxane substrate and gallium- indium eutectic alloy liquid metal as the opposite electrode. In an embodiment, the EADCD includes a flexible or stretchable display comprising intrinsically stretchable PLEDs including an electroluminescent polymer layer sandwiched between a pair of transparent elastomeric composite electrodes based on a thin silver nanowire (AgNW) network. In an embodiment, the EADCD can provide real-time display of information by utilizing specific pixels of a flexible display and combining them to form a cohesive image, as controlled by the processor and controller and informed by sensors detecting the lumen traveling device, or at least one physiological characteristic of the subject. In an embodiment, noncontiguous portions of a display may be utilized (e.g., light-emitting diodes emitting light) in such a manner as to complete an image.
In an embodiment, the EADCD includes an organic light emitting device (OLED). In an embodiment, the EADCD includes a flexible organic light emitting diode (FOLED) that incorporates a flexible plastic substrate on which the electroluminescent organic semiconductor is deposited. In an embodiment, the EADCD includes other illumination devices, such as silicon LEDs, LCD, electroluminescent devices, incandescent, or chemical devices.
In an embodiment, the EADCD includes a flexible electronic paper based display. In an embodiment, the dynamic display includes a plastic flexible display with an organic thin film transistor (OTFT).
In an embodiment, the EADCD includes a dedicated device (e.g., a device held, for example, between the thumb and forefinger of the subject itself or a healthcare provider). In an embodiment, the dedicated device is sized and shaped like a cell phone, or tablet. In an embodiment, the EADCD includes a cell phone or tablet itself. In an embodiment, the EADCD includes a user interface, and circuitry configured for running at least one computer program for monitoring the LTD. In an embodiment, the dedicated device is sized and shaped to be worn on a hand (e.g., a device worn like a glove, watch, bracelet, badge, etc.). In an embodiment, the dedicated device is sized and shaped to be worn on one or more fingers (e.g., a device worn as a ring).
In an embodiment, as described herein elsewhere, the EADCD includes at least one inertial sensor, accelerometer, proximity sensor, or landmark reader or fiducial reader (e.g., RFID, laser, etc.). In an embodiment, the EADCD includes at least one topography sensor for detecting landmarks on a skin surface (e.g., an imaging sensor, optical sensor, etc.). In an embodiment, the system further includes means to align the externally alignable display and control device with the path previously traveled by the lumen traveling device, including at least one of at least one inertial sensor, at least one fiducial sensor, at least one
topographical sensor, or at least one laser pointer. In an embodiment, the topographical sensor includes at least one of an imaging sensor, or optical sensor. In an embodiment, the at least one fiducial sensor includes at least one optical sensor, radiographic sensor, radiofrequency sensor, or magnetic sensor.
In one example, the EADCD detects the topography of the skin area (e.g., by scanning the rough surface of the skin) as the lumen traveling device and system makes a first pass at imaging a site in the underlying lumen and records the results in memory, then on a subsequent pass, the EADCD scans the skin again and using comparison to the original scan identifies the site, then controls the LTD to the site. In another example, the EADCD uses triangulation between fiducials in the body (e.g., surgical staples) or on the body (e.g., placed on the skin at the beginning of the procedure) to align with a body site, then the EADCD controls the LTD to the corresponding site in the lumen.
In an embodiment, the LTD includes at least one wired or wireless connection between the one or more sensors (or sensor assemblies) and the EADCD, by way of a processor and/or controller. For example, in an
embodiment, the electronic circuitry receives information from the one or more sensors or sensor assemblies and determines if, for example, the LTD should change speed, direction, or release a tag or therapeutic agent, or take a biological sample of the lumen, and informs the controller.
In an embodiment, the processor can be programmed to select a particular location along the lumen to sample or treat by release of a therapeutic agent, or to tag for further analysis, or can be directed by the user (e.g., by a user interface), where the user includes the subject itself, a healthcare worker, a computer, or other user. Thus, the controller is configured to adjust the function of the LTD and/or EADCD including their function relative to each other. In an embodiment, a processor can be configured to receive at least one signal from the one or more sensors or sensor assemblies regarding at least one of location of the LTD, the status of any biological sampling obtained or scheduled to be obtained, the release of any therapeutic agents or schedule of release based on what was put on board before the LTD began the lumen travel path.
Turning to the Figures, as shown in Figure 1 A, in an embodiment, a system 100 includes a LTD 1 10 traveling through a lumen 130 (e.g. , intestinal tract), the LTD being sensed when the EADCD 120 is placed in planar proximity to the LTD that is located internal to the subject. As shown in Figure 1 B, the EADCD 120 and LTD 1 10 are able to cross-talk through the body surface of the subject when the EADCD is placed in planar proximity to the LTD, even though the LTD is located in a lumen 130 of the subject. In an embodiment, the LTD is configured to transmit 140 (e.g. , RF transmission) through the lumen 130 surface and through the subject's skin 150, to the EADCD 120 that is external to the subject's body. In an embodiment, as set forth in Figure 1 C, the LTD 1 10 is able to transmit image data 170(e.g. , RF transmission) to the EADCD 120 through the skin 150 of the subject.
As shown in Figure 2A, in an embodiment, the LTD 210 is configured to transmit 220 (e.g. , NIR transmission) images to the EADCD 230 in real time from a lumen. In an embodiment, the real-time lumen image 240 is projected or otherwise displayed externally to the subject's body. As shown in Figure 2B, the EADCD 270 is passed over a location of the subject's body that is marked 250 (e.g. by fiducials or sensors, including NIR location sensors, etc.) and is planar to the travel path of the LTD (including a historical travel path, the location of which is stored data), and the stored lumen image 260 is projected or otherwise displayed externally to the subject's body.
As shown in Figure 3A, in an embodiment, the system 300 includes a LTD 310 that travels through a lumen by propelling itself with a paddle or rudder 340, and/or leg-like protrusions 330, which have optional suction cup bases 385 configured for biological sampling of the lumen wall 320. In an embodiment, the LTD 310 is in wireless communication 380 with the EADCD 350 outside of the subject's body. Communications between the LTD 310 and EADCD 350 can occur through the skin 370 of the subject, when the EADCD 350 is aligned planar to the LTD 310 and can include contact with the outer surface 360 of the subject's skin. In an embodiment, one or more biological sampling base 385 can be configured to sample at various depths of the lumen wall, including outward toward the skin 360 or inward toward the inner wall 390 of the lumen. In an embodiment, a power source 395 is included in the LTD 310. In an embodiment (not shown) at least one therapeutic agent compartment is contained in the LTD and configured for release of the at least one therapeutic agent as the LTD moves through the lumen. As described herein, the release can be programmed to be at a specific location along the lumen, or at multiple scheduled time points or locations. In an embodiment, the release is gradually along at least part of the lumen traveling path.
In an embodiment, if an anti-inflammatory or coagulant is desired along the lumen pathway, one or more can be loaded into the LTD prior to deployment into the lumen, and subsequently can be remotely directed by the user to release the one or more agents at specific locations, or can be directed by computer program. In an embodiment, the therapeutic agent includes, but is not limited to, an anti- inflammatory agent, coagulant, anti-coagulant, anesthetic, analgesic, vitamin, mineral, chemotherapy agent, antibiotic, antimicrobial (e.g., antibiotic, antifungal, antiparasitic, or antiviral agent), vascular dilator, vascular constrictor, hormone, steroid, cytokine, chemokine, muscle relaxant, anti-spasmodic.
In an embodiment (not shown) at least one onboard instrument is contained in the LTD and configured for use as the LTD moves through the lumen or at a particular site along the lumen. In an embodiment, the at least one onboard instrument includes, but is not limited to an imaging device, a biopsy tool, a deployment tool (e.g., for deploying a surgical clip or staple), a needle, or an energy emitter.
As shown in Figure 3B, in an embodiment, a system 300 includes a LTD
310 moving in the direction of the arrow, through the lumen by contacting the inner walls of the lumen 320 with the various leg-like protrusions 330, some of which include caliper-like sampling devices 375 for biological sampling of the lumen. In an embodiment, the caliper-like sampling devices 375 are configured to access the lumen wall 370 to the inner part of the subject's body 390 or outward toward the skin 360. In an embodiment, the LTD 310 is in wireless
communication 380 with the EADCD 350 that is outside of the subject's body, and optionally contacting the skin 360 in a planar location relative to the LTD 310. As indicated elsewhere herein, the LTD 310 can take various forms and shapes without losing the character of the structure or function of the device as described herein, even though not all possible combinations are illustrated.
In an embodiment, a method, system, device, and/or computer program product relate to various embodiments disclosed herein.
As illustrated in Figure 4, a diagram of an example of a processing circuit 400 for completing various embodiments of the systems and methods disclosed herein is shown. In an embodiment, the processing circuit 400 is generally configured to accept input 402 from at least one sensor. The processing circuit 400 can be configured to receive configuration and reference data 412. Input 420 data can be accepted continuously or periodically. The processing circuit 400 analyzes data provided by one or more sensors, to determine the next action for the LTD, and instruct the controller (not shown). Based on the detected parameters as described herein, the processing circuit 400 may notify the
EADCD, another external computer or computing system, or an on-board computing component to execute the next action. The processing circuit 400 can also generate real-time or updated maps of the lumen in which it is traveling, or can instruct the LTD to stop, hover, attach to the lumen, change direction, release a therapeutic agent or tag, etc. In determining the analysis, the processing circuit 400 can make use of machine learning, artificial intelligence, interactions with databases (including reference data), pattern recognition, logging, intelligent control, fuzzy logic, neural networks, etc.
In an embodiment, the processing circuit 400 includes a processor 406, which can be a specific use computer in certain instances. In an embodiment, the processor 406 is part of a general use computer. In an embodiment, an application of specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGAs), digital-signal-processor (DSP), group processing is included. In an embodiment, the processing circuit 400 includes memory 408. In an embodiment, memory 408 is one or more devices (e.g. , RAM, ROM, Flash memory, hard disk storage, etc.) for storing data and/or computer code for facilitating the various processes described herein. Memory 408 may be included as non-transient volatile memory or non-volatile memory. In an embodiment, memory 408 includes at least one of database components, object code components, script components, or other information structure for supporting the various activities and information structures described herein. In an embodiment, memory 408 can be communicably connected to the processor 406 and can include computer code or instructions to the controller (not shown) for executing the processes described herein.
In an embodiment, the memory 408 includes memory buffer 410 configured to receive data from one or more sensors via input 402, and includes, for example, a real-time data stream from one or more sensors. In an embodiment, the data received via the input 402 can be stored in memory buffer 410 until it is accessed by various modules of the memory 408, including a sensor module 414 or feedback module 416. In an embodiment, the memory 408 includes
configuration data 418 and can include, for example, information related to engaging with other components (e.g., sensors of the system, the LTD itself, the EADCD, etc.) and can include a command set for interfacing with a computer system used to transfer user settings or otherwise set up the system (e.g., graphical user interface controls, menus, visual information, etc.). In an embodiment, the configuration data 418 can include a command set needed to interface with communication components (e.g., a universal serial bus (USB) interface, Wi-Fi interface, Ethernet, etc.). In an embodiment, the processing circuit 400 can format data for output 404 to allow a user to configure the system as described herein. The processing circuit 400 can also generate commands needed to generate visual or audio warnings for display on the EADCD, or a speaker thereof. In an embodiment, the processing circuit 400 also generates commands needed to drive haptic or other mechanical feedback (e.g., vibration). In an embodiment, the configuration data 418 can include information as to how often input should be accepted from a sensor or determine the default values required to initiate communication with sensors or other components of the processing circuit 400 or other systems described herein.
In an embodiment, the processing circuit 400 further includes output 404 configured to provide output to the EADCD or another output device, or components of the system as described herein. In an embodiment, the feedback module 416 generates feedback to produce output via a feedback device (e.g., EADCD), including output as information to a display, audio speaker, haptic response, or network signal. As described herein, in an embodiment, a non- transitory computer-readable medium having instructions stored thereon, the instructions forming a program executable by a processing circuit to instruct the LTD of a next action as disclosed herein.
As disclosed in Figure 5, the system 500 includes a lumen traveling device 510 is able to transmit image data 570(e.g., RF transmission) to the EADCD 530, 580 as part of a glove 520 or ring 580 through the skin 550 of the subject. As indicated, the EADCD includes a display 540 of transmitted data 570 from the lumen traveling devic