HK1259003A1 - Lumen traveling device - Google Patents

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 travel device

All subjects of the priority claims are incorporated herein by reference to the extent that they do not contradict the text.

Attached Figure Description

Figure 1A is a partial view of the apparatus and system described herein.

Figure 1B is a partial view of the apparatus and system described herein.

Figure 1C is a partial view of the apparatus and system described herein.

Figure 2A is a partial view of the apparatus and system described herein.

Figure 2B is a partial view of the apparatus and system described herein.

Figure 3A is a partial view of the apparatus and system described herein.

Figure 3B is a partial view of the apparatus and system described herein.

Figure 4 is a partial view of the components of the apparatus and system described herein.

Figure 5 is a partial view of the components of the apparatus and system described herein.

Detailed Implementation

In the following detailed description, reference is made to the accompanying drawings, which form a part thereof. In the drawings, similar symbols generally indicate similar components unless otherwise specified. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein.

In one embodiment, the lumen-traveling device and system are adapted to travel within a natural or artificial lumen (e.g., catheter, shunt) within a subject. In one embodiment, the lumen-traveling device is partially or wholly disposable, biodegradable, or bioabsorbable, at least one of these. In one embodiment, the lumen-traveling device is sized and shaped according to the specifications of the specific lumen it is designed to travel through, or the specifications of the function or operation of the lumen-traveling device. In one embodiment, the lumen-traveling device has a fixed size or shape. In one embodiment, the lumen-traveling device is flexible. In one embodiment, the lumen-traveling device is spherical, cylindrical, conical, cubic, or any combination thereof. In one embodiment, the lumen-traveling device is sized and shaped for uptake. In one embodiment, the lumen-traveling device is sized and shaped for surgical introduction or implantation into a lumen. In one embodiment, the lumen-traveling device is sized and shaped for injection into a lumen or an organ having a lumen or catheter. In one embodiment, the lumen-traveling device is sized and shaped for introduction into a lumen via a catheter or cannula. In one embodiment, the lumen-traveling device is sized and shaped for injection into at least a portion of a conduit in the digestive tract, blood vessels, respiratory tract, urethra, reproductive tract, organs, etc. In one embodiment, the lumen-traveling device comprises all or part of a microrobot (e.g., a microrobot). In one embodiment, the lumen-traveling device comprises all or part of a capsule endoscope.

For example, in one embodiment, the length of the lumen travel device is about 50 mm or less, about 40 mm or less, about 30 mm or less, about 20 mm or less, about 10 mm or less, or about 5 mm or less. In one embodiment, the width or height (i.e., diameter) of the lumen travel device is about 20 mm or less, about 10 mm or less, or about 5 mm or less.

In one embodiment, the lumen-traveling device comprises layers of multiple materials. In one embodiment, at least one layer of the lumen-traveling device comprises a permeable or semi-permeable membrane. In one embodiment, the lumen-traveling device comprises at least one mesh surface. In one embodiment, the lumen-traveling device comprises an expandable or contractible material, such as a metal or plastic component capable of changing size or shape. In one embodiment, the lumen-traveling device comprises a shape memory alloy or an electroactive polymer. In one embodiment, at least one component of the lumen-traveling device comprises a metal, ceramic, paper, polymer (plastic, silicone, etc.), filament, or other suitable biocompatible material. In one embodiment, the lumen-traveling device can be manufactured using various technologies, including 3D printing, self-assembly, rapid prototyping, die-cutting, extrusion, injection molding, etc.

In one embodiment, the lumen-traveling device and system include at least one sensor. In one embodiment, the sensor is used to determine the position of the lumen-traveling device (e.g., based on parameters sensed at a specific location in the lumen). As described herein, at least one sensor is also present in the system for determining the position of the EADCD relative to the lumen-traveling device. In one embodiment, at least one sensor is used to determine at least one physiological parameter that can be used to determine medical treatment, treatment changes, or a diagnosis of the subject.

In one embodiment, the sensor includes at least one of the following: a pressure sensor, a temperature sensor, a flow sensor, a viscosity sensor, a shear sensor, a pH sensor, a gas sensor, a chemical sensor, an optical sensor, an acoustic sensor, a biosensor, an electrical sensor, a magnetic sensor, a clock, or a timer. In one embodiment, the sensor detects physiological conditions such as levels of blood components (e.g., pH, hormones, vitamins or minerals, cholesterol, oxygen, bilirubin, hemoglobin, etc.), the presence or number of cell types (red blood cells, white blood cells, immune cells, malignant tumor cells, necrotic cells, etc.), immune functions (e.g., inflammation, bleeding, infection, autoimmunity, etc.), the microbiome (e.g., levels of healthy or unhealthy microorganisms), blood pressure, or other conditions. In one embodiment, the sensor detects the integrity of the luminal surface (e.g., the presence of lesions, tumors, ulcers, fissures, wounds, etc.) associated with, for example, autoimmune diseases (e.g., Crohn's disease lesions), cancer or precancerous conditions (e.g., tumors or polyps), or vascular diseases (e.g., gastrointestinal bleeding or varicose veins). In one embodiment, the sensor detects analytes, such as physiological analytes. In one implementation, the sensor detects a tag (e.g., a contrast agent or colorimetric agent that binds to cells or cellular components or to other components of a biological fluid such as hemoglobin, insulin, etc. and can be used to detect or monitor a specific medical condition or disease).

In one 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, within a compartment of the lumen-traveling device, or at another location. In one embodiment, the lumen-traveling device and/or system includes at least one battery, microbattery, thin-film battery, or nuclear battery. In one embodiment, the lumen-traveling device and/or system includes at least one fuel cell or biofuel cell, such as at least one enzymatic, microbial, or photosynthetic fuel cell. In one embodiment, the power source includes a nanogenerator (e.g., DNA, piezoelectric wire, or other stretchable material).

In one embodiment, the power source includes at least one of an optical power source, an acoustic receiver, an electromagnetic receiver, or an electrical power source. In one embodiment, the power source is connected to the lumen travel device and/or system via a cable or physical link. In one embodiment, the lumen travel device and/or system is wireless.

In one embodiment, the lumen-traveling device (LTD) uses various sensors, as described herein, such as query sensing (reflection and time-of-flight) or passive sensing (LTD emitting signals) between the LTD and an externally alignable display and control device (EADCD) located within the subject's body. In one embodiment, a specific electromagnetic signal (e.g., RF or magnetic) is coupled between the LTD and the EADCD, and the LTD aligns with the strongest signal, thereby indicating alignment with the EADCD. In one embodiment, the time-of-flight value is used to determine the position of the LTD relative to the EADCD. In one embodiment, the EADCD has more than one receiver at different locations on the device, and a comparison of the signal strength at each receiver indicates which receiver the LTD is closer to, and allows for position determination.

In one embodiment, the lumen-traveling device and/or system includes at least one component for harvesting energy. In one embodiment, the lumen-traveling device and/or system includes at least one component for harvesting energy from the body, such as kinetic energy (e.g., from fluid flow or peristalsis) or thermal energy, and converting the energy into electrical energy. In one embodiment, the lumen-traveling device and/or system includes at least one component for harvesting energy from a source outside the body, such as infrared radiation from a dedicated source.

In one embodiment, the lumen traveling device or system includes at least one component for wireless power transfer. In one 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, electrical, or optical energy can be transmitted to the lumen traveling device from another location. In one embodiment, ultrasonic or microwave energy can be transmitted to the receiver and converted into an electric current. In one embodiment, the lumen traveling device includes at least one capacitively coupled link. In one embodiment, the lumen traveling device includes at least one inductively coupled link. In one embodiment, the lumen traveling device may include at least one receiving coil configured to receive energy from an external transmitting coil. In one embodiment, the lumen traveling device includes a plurality of receiving coils, which, for example, have a shape and/or configuration conducive to receiving power.

In one embodiment, other locations include, for example, another external device comprising, for example, at least one power transmitter or power receiver, and associated structures for using, storing, or retransmitting power at least one of these. Remote devices for the lumen travel device may also include a power transmitter or power receiver.

In one embodiment, the lumen traveling device and system include control circuitry, which may be part of an internal device assembly and/or part of a system outside the lumen traveling device itself (e.g., remote control or other computer device). In one embodiment, the control circuitry is implemented in logical form (e.g., analog or digital logic circuitry and software, or both). In some embodiments, the control circuitry is stored or implemented as a non-transitory machine-readable device. In one embodiment, data storage or use may include implementation as a non-transitory machine-readable device.

In one embodiment, the lumen-traveling device and system are configured for movement within a natural or artificial lumen of a subject's body. In one embodiment, the lumen-traveling device and system are configured for passive movement; for example, the device is shaped to facilitate movement with natural flow or lumen movement, such as peristalsis. In one embodiment, the lumen-traveling device and system are configured to utilize an external field, such as a magnetic field, to force the lumen-traveling device to move, for example, directly by applying a force to the device with a magnetic field, or indirectly by influencing an onboard controller. In one embodiment, the lumen-traveling device and system are configured for active movement within a natural or artificial lumen of a subject's body and include a component for movement.

In one embodiment, the lumen-traveling device may have rolling, crawling, or walking movements (e.g., with leg-like projections), swimming, inchworm-like movements, slippery movements, propulsive movements, or ciliary movements. In one embodiment, the lumen-traveling device and system are configured to move within a natural or artificial lumen of a subject's body according to a direction provided by a controller in response to one or more various sensors.

In one embodiment, the lumen traveling device includes a propulsion system as a component for movement. In one embodiment, the lumen traveling device includes a magnetohydrodynamic propulsion system that propels the lumen traveling device in a predetermined direction by jetting a fluid stream. In one embodiment, the lumen traveling device includes an inertial-based propulsion system, such as a pulse-driven micromechanic having a permanent magnet as a moving object, the permanent magnet being driven by magnetic force obtained by applying current to a coil. In one embodiment, the lumen traveling device includes a thruster. In one embodiment, the blade may include a rotor driven by an electric or magnetic motor or actuator. In one embodiment, the lumen traveling device and system configured for directional movement includes a rudder, which, for example, under the control of a controller, causes the device to move in a particular direction. In one embodiment, the lumen traveling device includes one or more attachments that act as a paddle to propel the device, for example, through a fluid. In one embodiment, the lumen traveling device may include a linear actuator to drive the paddle attachment in a manner to propel the device; the combination of the paddle and its actuation can be used to induce movement in a particular direction. In one embodiment, the lumen movement device may include an internal permanent magnet configured to move a plurality of polymer sheets or a single tail providing thrust through the fluid. In one embodiment, the lumen travel device may include a single tail of an electroactive polymer configured to provide thrust and direction.

In one embodiment, the lumen traveling device includes at least one moving mechanism configured to contact, grip, clamp, or otherwise engage the wall (e.g., surface) of a natural or artificial lumen on a subject's body. In one embodiment, the lumen traveling device includes at least one inchworm-like motion mechanism, wherein at least a portion of the lumen moving device intermittently engages and disengages from the lumen wall in a slip-adhesive manner, thereby traveling a distance. In one embodiment, the lumen traveling device includes a vibratory moving mechanism, such as a mechanism that causes forced bending vibrations of continuous portions of the lumen traveling device driven by an actuator (such as a piezoelectric bending actuator). The direction of movement of the lumen traveling device can be controlled by the excitation frequency of the actuating element. In one embodiment, the lumen traveling device includes a cross-sectional design, and each portion is individually driven to engage or disengage from the wall. In one embodiment, the lumen traveling device may include at least one actuator that drives the movement of the lumen traveling device and engagement with the wall. In one embodiment, the lumen traveling device may include a bidirectional linear actuator using a pair of springs made of shape memory alloy. In one embodiment, the lumen traveling device may include a piezoelectric micro-actuator. In one embodiment, the lumen traveling device may include a micromotor. In one embodiment, the lumen moving device engages, for example, in a worm-like manner between portions of the lumen moving device and one or more actuators that drive each portion. In one embodiment, the lumen traveling device includes an expandable bellows, such as a pneumatic bellows providing a moving mechanism. In one embodiment, the lumen traveling device includes surface-engaging protrusions, microprotrusions, adhesive microfibers, or clamps. In one embodiment, the lumen traveling device includes a radially expandable portion that expands to engage and disengage from the inner surface lumen of the lumen.

In one embodiment, the lumen traveling device includes a propulsion mechanism as a moving member, the propulsion mechanism being configured to engage a wall (e.g., a surface) and provide movement to the device; for example, the propulsion mechanism may include one or more attachments, legs, or wheels, such as microfibers, with or without an adhesive aspect. Multiple mechanisms for actuating the propulsion mechanism can be adapted for use with the various embodiments described herein. In one embodiment, an actuator and a motor (micromotor) may be used to drive the propulsion device. Examples of actuators include piezoelectric, DC motors, electromagnetic, and electrostatic actuators. Additionally, the actuator may be formed from shape memory alloys or ion-polymer metal components. In one embodiment, the engaged attachments and legs can be actuated to propel the device forward in a walking or crawling motion.

For example, a medium-sized legged mobility system may include a slotted servo mechanism driven by a lead screw to provide propulsion to the engaged legs. In one embodiment, multiple engaged legs, such as those made of a hyperelastic material or other materials, may be actuated to interact with a wall under the control of a motor, such as a brushless micromotor. In one embodiment, the attachment or leg may be formed of a shape memory alloy and driven by the application of an electric current. In one embodiment, the attachment may be used to engage a wall driven by rotational force to provide movement. In one embodiment, the wheel may be driven by a motor or other actuator. In one embodiment, the lumen traveling device and system are configured to utilize one or more actuating mechanisms in a manner to provide movement in a particular direction. In one embodiment, to change direction (e.g., guided by a controller), only a portion of multiple attachments (or legs or wheels) may be actuated, thereby moving a portion of the device so that the device head faces the new direction and allows the device to move forward.

In one embodiment, the lumen traveling device and system includes components for stabilization within the lumen, such as for maintaining orientation or position within the lumen. In one embodiment, the lumen traveling device and system includes one or more blocks that can be stabilized by an external field, such as a pair of permanent magnets that can be stabilized in a magnetic field. In one embodiment, the lumen traveling device and system includes one or more gyroscopes or one or more accelerometers. In one embodiment, the lumen traveling device and system includes one or more self-expanding stabilizing devices, such as attachments, airbags, or capsules. The self-expanding stabilizing devices may further have the function of expanding the lumen.

In one embodiment, the lumen-traveling device and system include at least one position sensor to determine positioning and spatial information about the lumen-traveling device, including its position in three-dimensional (3D) space, the distance it has traveled along the lumen, and the region of the lumen in which it is located. Various techniques 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 one embodiment, the lumen-traveling device and system include an external device that uses energy delivered at one or more frequencies in the electromagnetic spectrum (e.g., radio waves, microwaves, infrared, visible light, ultraviolet light, X-rays, gamma rays) to track the lumen-traveling device. In one embodiment, the lumen-traveling device and system include an imaging device (e.g., a magnetic resonance imaging system, an X-ray imaging system, a gamma camera, etc.) capable of detecting and tracking the lumen-traveling device, which may carry a tag such as a contrast agent or contrast agent.

In one embodiment, the lumen traveling device and system include a position sensor as an ultrasonic imaging device. In one embodiment, an ultrasonic imager housed in or otherwise associated with an externally alignable display and control device may be configured to track the lumen traveling device using the time-of-flight (ToF) between signal transmission and reception of reflected signals when the lumen traveling device is within a threshold of the position sensor. In one embodiment, the lumen traveling device is sensed when it is in the scanning plane, as determined by the position sensor. Alternatively or additionally, in one embodiment, the lumen traveling device includes an ultrasonic transducer that emits signals that can be received by one or more receivers, for example, in an externally alignable display and control device or in an external receiver array located on the body and communicating with the externally alignable display and control device.

In one embodiment, a method includes detecting at least one interaction between the lumen-traveling device and a subject's lumen using one or more sensors in or on a lumen-traveling device; generating at least one sensing signal based on the detection of at least one interaction between the lumen-traveling device and the lumen; determining whether the sensed signal exceeds the threshold of the at least one interaction; and generating at least one communication signal based on the determination that the sensed signal exceeds the threshold for the at least one interaction. In one embodiment, determining whether the sensed signal exceeds the threshold of the at least one interaction includes comparing the sensed signal with the reference data indicating the threshold. In one embodiment, the reference data is derived from at least one sensed signal, which is programmed by the user or set during use of the device or system. In this way, the interaction between the lumen-traveling device and the lumen itself is considered to be more valuable because information is obtained from such interactions if a threshold is exceeded. For example, if the lumen-traveling device is guided to sample the wall of the lumen, the lumen-traveling device determines whether, for example, the sample size, location, or type is sufficient to obtain the desired information. If such a threshold is exceeded, a sample is acquired and evaluated to provide the sought information. If the threshold is not met, the sample will be obtained at a different location, time, or manner, for example, instead of at that time or in that manner, so that the threshold assessment can be performed again.

In one embodiment, the lumen traveling device and system include a position sensor employing magnetic tracking of the lumen traveling device. In one example, the lumen traveling device includes at least one permanent magnet that can be tracked by a magnetic sensor (e.g., a magnetoresistive sensor) associated with and housed within an externally alignable display and control device (e.g., a skin-mounted array in communication with it). Alternatively or additionally, the magnetoresistive sensor within the lumen traveling device can measure the strength of an external magnetic field generated by an externally energized coil. In another example, for use with a lumen traveling device actively excited by a low-frequency magnetic field, a high-frequency magnetic field can also be used for positioning purposes.

In one embodiment, the lumen traveling device and system include a position sensor that employs inertial sensing to determine positioning. For example, the lumen traveling device and system include one or more accelerometers that may operate alone or in conjunction with an actuation field.

In one embodiment, the lumen traveling device and system include a position sensor utilizing radio frequency signals. In one embodiment, the lumen traveling device and system may include at least one external sensor array that evaluates RF signals (e.g., frequency and intensity) emitted by a transmitter housed within the lumen traveling device. The system may utilize information from the array to estimate distance and perform triangulation on the signal. Schemes for RF signal-based positioning methods include time of arrival (TOA), angle of arrival (AOA), time difference of arrival (TDOA), and received signal strength (RSS) signal processing. In one embodiment, the lumen traveling device may include an RFID tag. In one embodiment, the lumen traveling device may include an RFID tag comprising a bidirectional, tridirectional, or omnidirectional antenna. In one embodiment, the lumen traveling device and system include one or more software algorithms, such as those for addressing signal propagation and reception as well as noise reduction, which can be used to improve efficiency and accuracy. In one embodiment, the lumen traveling device and system employ hardware and software, along with linear least squares estimation or other software algorithms, to evaluate the phase difference of arrival at multiple signal frequencies to estimate the distance between the source and receiver.

In one embodiment, the lumen traveling device and system include hardware and software for determining the position of the lumen traveling device using image comparison. In one embodiment, the image (e.g., a Moving Picture Experts Group (MPEG)-7 image) is captured by the lumen traveling device. The image can be classified by hardware and software of a system utilizing, for example, vector quantization, principal component analysis and neural networks, and/or event boundary detection algorithms, to identify, for example, morphology, color, elasticity, etc.

In one embodiment, the lumen traveling device and system include one or more position sensors for measuring distance. For example, the lumen traveling device may include a protrusion (e.g., a wheel) attached to a counter (e.g., an odometer) that measures the distance traveled by the device, for example, along the lumen wall. In one embodiment, the lumen traveling device may include a protrusion (e.g., a wing) attached to a counter that measures the distance traveled based on, for example, the duration of pressure, force, or intermittent pulses (e.g., from fluid flow). See the accompanying drawings for further details.

In one embodiment, the lumen traveling device and system are configured for at least temporary anchoring to the sidewall of the lumen. In one embodiment, the lumen traveling device may include a wall anchoring system having at least one of a hook, tether, stake, suction device, spring, or adhesive. In one embodiment, the lumen traveling device includes at least one reservoir containing one or more adhesives. See the accompanying drawings for further details.

In one embodiment, the lumen-traveling device is configured for easy removal from the lumen. In one embodiment, the lumen-traveling device can be removed as a whole. In one embodiment, the lumen-traveling device can be removed in batches, for example, after disintegration or degradation. In one embodiment, the lumen-traveling device is configured for manual removal. In one embodiment, the lumen-traveling device includes a tether or other surface design for removal via a guide path. In one embodiment, a capsule endoscope used for imaging or manipulating the esophagus may include a tether for pulling the capsule back through the mouth. In one embodiment, all or part of a lumen-traveling device introduced into the lumen via a needle or catheter may be configured for manual removal via a needle, catheter, etc., and may include magnetic or other attractive features. In one embodiment, all or part of the lumen-traveling device is expelled by natural elimination. In one embodiment, a capsule endoscope inserted through the intestine may be eliminated by natural digestion and expelled through the anus. In one embodiment, all or part of the lumen-traveling device may be expelled from the respiratory system via coughing. In one embodiment, all or part of a lumen-traveling device that has been introduced into a part of the genitourinary system may be expelled via the urethra. In one implementation, at the end of its lifespan, biochemical residues of the biodegradable lumen-traveling device that travels in the bloodstream can be eliminated by the liver.

In one embodiment, as described herein, at least a portion of the lumen-traveling device is disposable. In another embodiment, as described herein, at least a portion of the lumen-traveling device is biodegradable and therefore does not need to be retrieved from the subject.

In one embodiment, the lumen-traveling device includes at least one onboard instrument. In one embodiment, the lumen-traveling device includes one or more imaging devices. In one embodiment, the lumen-traveling device may include a camera, a CCD sensor, a CMOS sensor, a spectrophotometer (e.g., a camera for observing cells beneath the surface layer of tissue), etc. In one embodiment, the lumen-traveling device includes one or more biopsy tools. In one embodiment, the lumen-traveling device may include aspiration tools, biopsy clips, biopsy puncturists, curettes, etc. In one embodiment, the lumen-traveling device includes one or more dilation tools. In one embodiment, the lumen-traveling device may include a mechanism for dispensing surgical clips or staples to treatment sites within the lumen (e.g., to varicose veins). In one embodiment, the lumen-traveling device may include a mechanism for delivering a coil. In one embodiment, the lumen-traveling device includes a needle to deliver, for example, a therapeutic agent directly to a treatment site on the lumen tissue. In one embodiment, the lumen-traveling device includes an energy emitter. In one embodiment, the lumen-traveling device may include wires that transfer heat to cauterize tissue. In one embodiment, the lumen-traveling device may include a thermal tool for removing tissue. In one embodiment, the lumen travel device may include an ultrasonic transmitter, etc.

In one embodiment, as described herein, the lumen-traveling device includes at least one sampling member. In one embodiment, the lumen-traveling device includes a liquid collection device, such as a reservoir or adsorbent or absorbent material. In one embodiment, the sampling member is housed in a leg-like protrusion that engages with the lumen wall (e.g., a nano or micro caliper 375 configured to grasp cells or DNA from the lumen, or a suction cup-like base 385 including nano or micro tooth-like protrusions, bristles, or needles to sample cells or DNA from the lumen). In one embodiment, the sampling member is capable of obtaining small samples of blood, tissue, cells (including, for example, microorganisms or components thereof), nucleic acids, proteins, etc., from the lumen of a subject.

In one embodiment, the lumen traveling device and system are configured to image or map a lumen. In one embodiment, the lumen traveling device and system are configured to provide treatment within a lumen. In one embodiment, the lumen traveling device is tracked within the lumen in real-time and spatially aligned via an externally alignable display and control device (EADCD). In one embodiment, the lumen traveling device can be guided in real-time by the externally alignable display and control device to advance or return to a site within the lumen, and other actions of the lumen traveling device can be guided via the externally alignable display and control device. In one embodiment, the lumen traveling device and system are used to image, map, or provide treatment to a lumen including at least a portion of a duct, such as a digestive tract, blood vessel, respiratory tract, urinary tract, reproductive tract, or organ.

In one embodiment, the system includes a storage device configured to retrieve data associated with a specific location corresponding to a reference path previously traversed by the lumen-traversing device at the time of questioning. In one embodiment, data is not retrieveable unless the EADCD is within a proximity threshold (e.g., a 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 traversed in the lumen). In this way, the reference map is a predetermined path intended for the LTD to follow; however, the reference path is a map of the actual path taken by the LTD as it travels through the tube. Therefore, the reference path may not ideally follow an exact reference map of the lumen, but should be substantially similar. In one 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 portion of the subject's intestine). In this way, the LTD conserves power and can be manufactured using a lightweight, thin battery power source. In one embodiment, the LTD is programmable to not transmit data until it reaches a predetermined target location. In one implementation, the LTD can be remotely controlled to not transmit data until it reaches a predetermined target location. For example, the LTD emits a location beacon or signal to verify its position as it passes through the lumen, transmitting only 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 part of the digestive tract, such as the esophagus, stomach, small intestine, large intestine, etc., by ingestion or delivery (e.g., via conventional endoscopy or suppositories). For example, the lumen-traveling device can be used to image some or all of the digestive tract to look for abnormalities such as, but not limited to, polyps, tumors, varicose veins, bleeding, obstruction, inflammation, etc. In one embodiment, the lumen-traveling device can be used to treat, for example, gastrointestinal bleeding, in the digestive tract by delivering energy (e.g., thermal energy in ablation, freezing, or radiofrequency ablation) or by delivering a ligation (e.g., a clip or band) or by injecting a compound (e.g., cyanoacrylate or adrenaline). In one embodiment, the lumen-traveling device is tracked within the digestive tract in a real-time and spatially aligned manner via an externally aligned display and control device. In one embodiment, spatial alignment can be used to guide the lumen-traveling device forward or back to its location in the digestive tract in real time via the externally aligned display and control device, and other actions of the lumen-traveling device as described above can be guided via the externally aligned display and control device.

As described herein, the alignment of the EADCD can optionally be first aligned with an external marker (e.g., based on a reference sensor, etc.) and further aligned with the LTD (e.g., based on an LTD sensor) to retrieve data related to the location of the LTD or reference path.

In one embodiment, the lumen-traveling device is used to image, map, or deliver treatment to a lumen that is a blood vessel or lymphatic vessel. In one embodiment, the lumen-traveling device can be injected into a blood vessel and used to image the vessel to obtain, for example, the presence of plaque, stenosis, or narrowing, and, if necessary, to deliver treatment by delivering an expandable stent to the area. In one embodiment, the lumen-traveling device is used to image a vessel in response to the presence of an embolism and to deliver an agent to degrade the embolism. In one embodiment, the lumen-traveling device can be used to image a vessel in response to the presence of an aneurysm and, if necessary, to deliver treatment by delivering a clip or coil to the site. In one embodiment, the lumen-traveling device can be tracked in real time within the blood vessel via an externally alignable display and control device.

In one embodiment, the lumen-traveling device can be guided in real time by an external alignment display and control device to advance or return to a site within the blood vessel, and can also be guided by the external alignment display and control device for other actions of the lumen-traveling device as described above. In one embodiment, the lumen-traveling device is injected into a blood vessel in the lower limb of a patient experiencing limb pain and poor healing. The external alignment display and control device is used to guide the lumen-traveling device into multiple branches of the blood vessel through alignment and movement as described herein, while displaying the results in real time until a narrowed area is detected. The external alignment display and control device is then used to guide the lumen-traveling device to deploy an expandable stent using an extended attachment to expand the stent to fit the blood vessel. The external alignment display and control device is then used to guide the lumen-traveling device back to the inlet site by moving the external alignment display and control device onto the limb while observing the progress of the lumen-traveling device in real time, and the lumen-traveling device is retrieved via a syringe. Similarly, lymphatic vessels can be imaged or treated in the same manner as blood vessels. In one implementation, inflammation (e.g., associated with cancer or infection) can be monitored by a lumen-traveling device deployed in the lymphatic or vascular system.

In one embodiment, the lumen-traveling device and system are used for imaging, mapping, assisting in diagnosis, sampling, or providing treatment of a lumen that is part of the urethra. In one embodiment, in response to the presence of a tumor, stricture, bleeding, ulcer, stone, inflammation, infection, etc., the lumen-traveling device can be introduced into the urethra (e.g., via the catheters and/or movement aspects described herein) and used for imaging the urethra, bladder, ureter, and renal ducts. Furthermore, the lumen-traveling device can be used for treatments in the urinary tract, such as stone disintegration, tumor biopsy or removal, targeted killing of microorganisms, etc. In one embodiment, the lumen-traveling device is spatially tracked in the urinary tract in real time by aligning an externally alignable display and control device. In one embodiment, the lumen-traveling device can be guided in real time via the externally alignable display and control device to advance (e.g., to ensure the entire bladder has been observed) or return to a previously observed site in the bladder (e.g., by moving the externally alignable display and control device over the lateral abdomen), and can be guided via the externally alignable display and control device for other actions of the lumen-traveling device as described above.

In one embodiment, a lumen-advancing device may be introduced into the male reproductive system via the urethra (e.g., through a catheter and/or mobility aspect described herein) for imaging or treatment of sites therein. In one embodiment, the lumen-advancing device is tracked in real-time within the male reproductive system via an externally alignable display and control device. In one embodiment, the lumen-advancing device can be spatially guided in real-time to advance or return to a site via the externally alignable display and control device, and other actions of the lumen-advancing device as described above can be guided via the externally alignable display and control device. In one embodiment, the lumen-advancing device is guided via the externally alignable display and control device to a site in the vas deferens of a subject who has undergone vasectomy to assess the effectiveness of the vasectomy procedure. If the vas deferens is not completely blocked, the lumen-advancing device is guided to deliver a clamp to completely block the lumen.

In one embodiment, a lumen-traveling device can be introduced into the female reproductive system via the vagina (e.g., through the direct delivery and/or movement aspects described herein) and used to image the vagina, cervix, uterus, and fallopian tubes for the presence of, for example, tumors, genital warts, stenosis, ectopic pregnancy, tubal ligation, abnormal bleeding, endometriosis, ulcers, inflammation, infection, etc. Furthermore, the lumen-traveling device can be used for treatments within the reproductive tract, such as tissue resection, tumor biopsy or removal, targeted killing of microorganisms, etc. In one embodiment, the lumen-traveling device is tracked in real-time within the reproductive tract via an externally alignable display and control device. In one embodiment, the lumen-traveling device can be guided in real-time by the externally alignable display and control device to advance (e.g., to ensure the entire uterus has been observed) or return to a previously observed site in the reproductive tract, and other actions of the lumen-traveling device as described above can be guided via the externally alignable display and control device. In one embodiment, the lumen-traveling device is guided to the fallopian tube via the externally alignable display and control device to assess the presence of endometrial tissue obstructing the fallopian tube and potentially prevent pregnancy. If an obstruction is detected, an alignment display and control device is used to guide the lumen-propelling device to emit thermal energy to remove tissue and open the duct. In one embodiment, an external alignment display and control device is then used to guide the lumen-propelling device to another fallopian tube by moving the external alignment display and control device onto the external abdomen while simultaneously observing the progress of the lumen-propelling device in real time.

In one embodiment, the externally alignable display and control device includes at least one projector or display. In one embodiment, the externally alignable display and control device includes a projector configured to project at least one hologram (e.g., on a subject's body, on a surface, or in the air).

In one embodiment, the externally alignable display and control device (EADCD) includes a liquid crystal display (LCD), a light-emitting diode display (LED), or a projection display. In one embodiment, the EADCD includes an organic light-emitting diode (OLED) or a similar device that includes a sterile surface and is sufficiently flexible to function despite folding or creases. In one embodiment, the organic light-emitting diode includes an anode, a cathode, an OLED organic material, and a conductive layer. In one embodiment, the OLED includes a bilayer structure with separate hole transport layers and electron transport layers, wherein a light-emitting layer is sandwiched between the two layers. In one embodiment, the EADCD includes multiple distinct display units forming one or more larger displays, wherein each display unit is notified and controlled by a processor and controller that may indicate sensing signals from sensors. In one embodiment, the EADCD may include a flexible backing, such as a rubber polymer, with discrete rigid display units (e.g., LCD, LED, or OLED). In one embodiment, information is displayed by combining multiple discrete display units (e.g., using LCD, LED, or OLED technology) to form an EADCD configured to provide displayed information; which information is displayed on which unit is optionally determined in real time using signals provided by sensors that determine the position of the EADCD on the subject's body and the position of the lumen-traveling device within the subject's body, and optionally the position of each relative to the others. In one embodiment, the EADCD is flexible, foldable, or capable of being otherwise rearranged (e.g., a foldable OLED display). In one embodiment, the EADCD includes at least one projector.

In one embodiment, a polymer light-emitting diode (PLED) can be used because it emits light under applied current. Typically, PLEDs utilize less energy than OLEDs to produce the same level of light emission. In one embodiment, the PLED comprises at least one derivative of poly(p-phenyleneethylene) and polyfluorene. In this example, the light originates from a monolayer of an electroluminescent polymer sandwiched between two transparent, elastic composite electrode layers.

In one embodiment, the EADCD includes a flexible or stretchable display comprising an inherently stretchable OLED formed of an elastic constituent material, such as a carbon nanotube (CNT)-polymer composite electrode sandwiching an electroluminescent polymer blend layer or an elastic electroluminescent blend having an ultrathin gold coating on a polydimethylsiloxane substrate, and a gallium-indium eutectic alloy liquid metal as a counter electrode. In one embodiment, the EADCD includes a flexible or stretchable display comprising an inherently stretchable PLED comprising an electroluminescent polymer layer sandwiched between a pair of transparent elastomeric composite electrodes based on a thin silver nanowire (AgNW) network. In one embodiment, the EADCD can provide real-time display of information (such as that controlled by a processor and controller and notified by sensors of a lumen travel device) or at least one physiological characteristic of a subject by utilizing specific pixels of the flexible display and combining them to form a cohesive image. In one embodiment, the image can be completed using discontinuous portions of the display (e.g., light-emitting diodes).

In one embodiment, the EADCD includes an organic light-emitting device (OLED). In another embodiment, the EADCD includes a flexible organic light-emitting diode (FOLED) combined with a flexible plastic substrate on which an electroluminescent organic semiconductor is deposited. In yet another embodiment, the EADCD includes other lighting devices such as silicon LEDs, LCDs, electroluminescent devices, incandescent lamps, or chemical devices.

In one embodiment, the EADCD includes a display based on flexible electronic paper. In another embodiment, the dynamic display includes a flexible plastic display with organic thin-film transistors (OTFTs).

In one embodiment, the EADCD includes a dedicated device (e.g., a device held between the thumb and forefinger, for example, the subject's own or a healthcare provider's). In one embodiment, the dedicated device is designed to be the size and shape of a mobile phone or tablet. In one embodiment, the EADCD itself includes a mobile phone or tablet. In one embodiment, the EADCD includes a user interface and circuitry configured to run at least one computer program for monitoring LTD. In one embodiment, the dedicated device is designed to be worn on the hand (e.g., a device worn like a glove, watch, bracelet, badge, etc.). In one embodiment, the dedicated device is designed to be worn on one or more fingers (e.g., a device worn as a ring).

In one embodiment, as described elsewhere herein, the EADCD includes at least one inertial sensor, accelerometer, proximity sensor, or landmark reader or reference reader (e.g., RFID, laser, etc.). In one embodiment, the EADCD includes at least one topography sensor (e.g., imaging sensor, optical sensor, etc.) for detecting landmarks on the skin surface. In one embodiment, the system further includes a component for aligning an externally alignable display and control device with the path previously traveled by the lumen travel device, said component including at least one of at least one inertial sensor, at least one reference sensor, at least one topography sensor, or at least one laser pointer. In one embodiment, the topography sensor includes at least one of an imaging sensor or an optical sensor. In one embodiment, the at least one reference sensor includes at least one optical sensor, radiographic sensor, radio frequency sensor, or magnetic sensor.

In one example, as the lumen-traveling device and system first pass through to image a site in the lower lumen and record the results in memory, the EADCD detects the topography of the skin region (e.g., by scanning the rough surface of the skin). Then, on subsequent passes, the EADCD scans the skin again and identifies the site using a comparison with the original scan, then controls the LTD to that site. In another example, the EADCD aligns with the body site using triangulation between reference points in the body (e.g., surgical staples) or on the body (e.g., placed on the skin at the start of surgery), then controls the LTD to the corresponding site in the lumen.

In one implementation, the LTD includes at least one wired or wireless connection between the LTD and one or more sensors (or sensor assemblies) via a processor and/or controller. For example, in one implementation, electronic circuitry receives information from one or more sensors or sensor assemblies and determines, for example, whether the LTD should change its speed, direction, or release a tag or therapeutic agent, or collect a biological sample from the lumen, and notifies the controller.

In one embodiment, the processor may be programmed to select specific locations along the lumen for sampling or treatment by releasing a therapeutic agent, or to mark for further analysis, or may be guided by a user (e.g., through a user interface), where the user includes the object itself, a healthcare worker, a computer, or other user. Therefore, the controller is configured to regulate the function of the LTD and/or EADCD, including their function relative to each other. In one embodiment, the processor may be configured to receive at least one signal from one or more sensors or sensor assemblies regarding at least one of the following: the location of the LTD, the status of any biological sampling obtained or planned to be obtained, and the release or release schedule of any therapeutic agent, based on information entered before the LTD begins its luminal travel path.

Turning to the accompanying drawings, as shown in FIG1A, in one embodiment, system 100 includes an LTD 110 that travels through a lumen 130 (e.g., the intestine) and senses the LTD when the EADCD 120 is laid flat adjacent to the LTD located inside the subject. As shown in FIG1B, although the LTD is located within the lumen 130 of the subject, the EADCD 120 and LTD 110 are also able to influence each other across the subject's body surface when the EADCD is laid flat adjacent to the LTD. In one embodiment, the LTD is configured to transmit 140 (e.g., RF transmission) through the surface of the lumen 130 and through the subject's skin 150 to the EADCD 120 located outside the subject's body. In one embodiment, as shown in FIG1C, the LTD 110 is capable of transmitting image data 170 (e.g., RF transmission) to the EADCD 120 through the subject's skin 150.

As shown in Figure 2A, in one embodiment, LTD 210 is configured to transmit images 220 (e.g., NIR transmission) from the lumen to EADCD 230 in real time. In one embodiment, the real-time lumen image 240 is projected or otherwise displayed outside the subject's body. As shown in Figure 2B, EADCD 270 passes over the subject's body at a location marked 250 (e.g., via a reference or sensor, including an NIR position sensor, etc.) and is flat relative to the LTD's path of travel (including historical paths whose positions are stored data), and the stored lumen image 260 is projected or otherwise displayed outside the subject's body.

As shown in Figure 3A, in one embodiment, system 300 includes an LTD 310 that travels through a lumen by being propelled by a paddle or rudder 340 and/or leg-like projections 330 having optional suction cup bases 385 configured for biosampling of a organism from the lumen wall 330. In one embodiment, LTD 310 wirelessly communicates 380 with an EADCD 350 located outside the subject's body. Communication between LTD 310 and EADCD 350 can occur through the subject's skin 370 when the EADCD 350 is planarly aligned with LTD 310 and may include a contact with the outer surface 360 of the subject's skin. In one embodiment, one or more biosampling bases 385 may be configured to sample at different depths of the lumen wall, including outward toward the skin 360 or inward toward the inner wall 390 of the lumen. In one embodiment, LTD 310 includes a power source 395. In one embodiment (not shown), at least one therapeutic agent compartment is housed within the LTD and configured to release at least one therapeutic agent as the LTD moves through the lumen. As described herein, the release may be programmed at a specific location within the lumen, or at multiple predetermined time points or locations. In one embodiment, the release is gradual, at least partially along the path of travel of the lumen.

In one implementation, if an anti-inflammatory or coagulant is required along the lumen pathway, one or more anti-inflammatory or coagulant agents may be loaded into the LTD prior to deployment into the lumen, and subsequently, the release of one or more agents may be remotely guided by a user or guided by a computer program to a specific location. In one implementation, the therapeutic agents include, but are not limited to, anti-inflammatory agents, procoagulants, anticoagulants, anesthetics, analgesics, vitamins, minerals, chemotherapeutic agents, antibiotics, antimicrobial agents (e.g., antibiotics, antifungals, antiparasitics, or antivirals), vasodilators, vasoconstrictors, hormones, steroids, cytokines, chemokines, muscle relaxants, and antispasmodics.

In one embodiment (not shown), at least one onboard instrument is housed in the LTD and configured for use as the LTD moves through the lumen or at a specific location along the lumen. In one 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 surgical clips or staples), a needle, or an energy emitter.

As shown in Figure 3B, in one embodiment, system 300 includes an LTD 310 that moves through a lumen 320 in the direction of the arrow by contacting the inner wall of the lumen 320 with various leg-like protrusions 330, some of which include a clamp-like sampling device 375 for biosampling of the lumen. In one embodiment, the clamp-like sampling device 375 is configured to bring the lumen wall 370 close to the interior of the subject's body 390 or outward toward the skin 360. In one embodiment, LTD 310 wirelessly communicates 380 with an EADCD 350 outside the subject's body and optionally contacts the skin 360 in a planar position relative to LTD 310. As indicated elsewhere herein, LTD 310 may take various forms and shapes without losing the structural or functional characteristics of the device as described herein, although not all possible combinations are shown.

In one implementation, the method, system, apparatus, and/or computer program product relates to the various implementations disclosed herein.

Figure 4 illustrates an example diagram of processing circuitry 400 used to perform various embodiments of the systems and methods disclosed herein. In one embodiment, processing circuitry 400 is generally configured to accept input 402 from at least one sensor. Processing circuitry 400 may be configured to receive construction and reference data 412. Input 420 data may be received continuously or periodically. Processing circuitry 400 analyzes the data provided by one or more sensors to determine the next action of the LTD and instructs a controller (not shown). Based on the parameters detected as described herein, processing circuitry 400 may notify an EADCD, another external computer or computing system, or an onboard computing component to perform the next action. Processing circuitry 400 may also generate a real-time or updated map of the lumen in which the circuitry travels, or may instruct the LTD to stop, hover, attach to the lumen, change direction, release a therapeutic agent or label, etc. In determining the analyte, processing circuitry 400 may utilize machine learning, artificial intelligence, interaction with a database (including reference data), pattern recognition, recording, intelligent control, fuzzy logic, neural networks, etc.

In one embodiment, processing circuitry 400 includes processor 406, which in some cases may be a purpose-specific computer. In one embodiment, processor 406 is part of a general-purpose computer. In one embodiment, it includes an application-specific integrated circuit (ASIC), one or more field-programmable gate arrays (FPGAs), a digital signal processor (DSP), or group processing. In one embodiment, processing circuitry 400 includes memory 408. In one 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 to facilitate the various processes described herein. Memory 408 may be included as non-transient volatile memory or non-volatile memory. In one embodiment, memory 408 includes at least one of a database component, object code component, script component, or other information structure for supporting the various activities and information structures described herein. In one embodiment, memory 408 may be communicatively connected to processor 406 and may include computer code or instructions for a controller (not shown) for performing the processes described herein.

In one embodiment, memory 408 includes a storage buffer 410 configured to receive data from one or more sensors via input 402, and includes, for example, real-time data streams from one or more sensors. In one embodiment, data received via input 402 may be stored in storage buffer 410 until accessed by various modules of memory 408, including sensor module 414 or feedback module 416. In one embodiment, memory 408 includes configuration data 418 and may include, for example, information related to engaging other components (e.g., system sensors, the LTD itself, EADCD, etc.) and may include a set of commands for connecting to a computer system used to transmit user settings or otherwise establish the system (e.g., graphical user interface controls, menus, visual information, etc.). In one embodiment, configuration data 418 may include a set of commands required for connecting to communication components (e.g., a Universal Serial Bus (USB) interface, a Wi-Fi interface, Ethernet, etc.). In one embodiment, processing circuitry 400 may format data for output 404 to allow the user to configure the system as described herein. Processing circuitry 400 may also generate commands required to generate visual or audio warnings for display on the EADCD or its speaker. In one embodiment, the processing circuitry 400 also generates commands required to drive tactile or other mechanical feedback (e.g., vibration). In one embodiment, configuration data 418 may include information about how long input should be accepted from the sensor or determining default values required to trigger communication with the processing circuitry 400 or other systems described herein with sensors or other components.

In one embodiment, the processing circuitry 400 further includes an output 404 configured to provide an output to an EADCD or another output device or a component of a system as described herein. In one embodiment, a feedback module 416 generates feedback to produce an output via a feedback device (e.g., an EADCD), including output as information such as to a display, audio speaker, haptic response, or network signal. As described herein, in one embodiment, a non-transitory computer-readable medium has instructions stored thereon that form a program executable by the processing circuitry to instruct the LTD to perform the next action as disclosed herein.

As disclosed in Figure 5, system 500 includes a lumen travel device 510 capable of transmitting image data 570 through the subject's skin 550 (e.g., RF transmission) to an EADCD 530, 580, which is part of a glove 520 or ring 580. As shown, the EADCD includes a display 540 for the transmitted data 570 from the lumen travel device 510.

Prophecy Example 1:

Lumen imaging systems are used for real-time observation and localization of intestinal injuries, polyps, and tumors.

The lumen imaging system comprises a lumen traveling device (LTD) carrying a camera and a handheld externally alignable display and control device (EADCD). The EADCD functions like a computer interface with input (e.g., a computer mouse or graphical interface) and output (e.g., a monitor) capabilities. Intraluminal images transmitted by the LTD are received and displayed in real time by the handheld EADCD, but only when the EADCD is directly aligned with the LTD. Real-time display of images transmitted from the intraluminal location by the LTD provides immediate feedback to the physician, while wireless input functionality allows the physician to use the EADCD to guide the LTD to areas of interest or re-examine selected areas of the intestine. Records of the displayed images and their corresponding locations in the gastrointestinal tract are stored in the display device. The lumen imaging system allows the LTD to be controlled using the EADCD in a manner similar to controlling a screen cursor with a computer mouse. Furthermore, input capabilities on the EADCD (including graphical interfaces and touchscreens) allow for bidirectional communication with the LTD and access to internal memory to retrieve previously acquired images at specific locations.

The LTD, an ingestible capsule measuring approximately 11mm × 26mm, includes a camera, a light source, a transmitter, a receiver, control circuitry, memory, a position sensor, a battery, and a moving component that moves within the gastrointestinal tract. The camera, located at each end of the LTD, includes a complementary metal-oxide-semiconductor (CMOS) image sensor and an adjustable lens. Each lens is surrounded by light-emitting diodes (LEDs) to illuminate the intestinal wall. For example, a miniature camera with a 0.6mm color lens, a CMOS image sensor, and four white LEDs, with a magnetic coil for focus adjustment, is suitable for this embodiment. An application-specific integrated circuit (ASIC) is designed to process and transmit image data, receive command signals from a display device, and take action. For example, a transceiver chip capable of transmitting image data at 20Mbps over a 500MHz RF channel has been used with positioning devices in a patient's gastrointestinal system and is suitable for use with the embodiment described herein. The control circuitry for activating the camera, position sensor, and moving system includes memory to allow programming of the LTD.

Sensors are incorporated into the LTD to identify the device's location. For example, an image analyzer is used to identify intestinal locations (e.g., duodenum, ileocecal valve, cecum), or sites of lesions, polyps, tumors, or inflammation, and records these locations in a storage device. Additional location sensors may include a pH sensor to determine the pH level in the intestine or a time-keeping device to record the delivery duration of the LTD. Intraluminal images transmitted in real-time to a display device are informationally associated with the same location identifier. For example, a series of images of small bowel inflammation are encoded to be associated with the corresponding delivery duration of the LTD. A momentary display of an image of the intestine of interest (e.g., an image showing small bowel inflammation) can indicate the need for re-examination or exploration of the inflamed area. By querying the LTD with the EADCD regarding the location identifier associated with the display of the inflamed area (e.g., the duration of delivery, image analysis, and pH results) and subsequent instructions to the LTD, a physician can guide the LTD back to the site for further analysis.

An EADCD is used to control the movement of the LTD in the intestinal region. The LTD has a movement system and position control circuitry that respond to signals from the EADCD. The movement system includes about one, two, three, or more legs that allow movement through the intestine by alternately supporting the intestinal wall and extending in the direction of travel. For example, a device with engaging legs that can move in tubes containing bends and obstructions is suitable for use with this embodiment in a patient's lumen. For example, a capsule endoscope device with multiple legs for the digestive system has been described and is suitable for use with this embodiment in a patient's lumen. The articulated legs are moved by a leg control device including circuitry and motors to actuate the legs in response to signals from a physician (or system operator) relayed by a display device. Motion control circuitry connecting the sensors and motion mechanism of the microrobot is suitable for use with this embodiment. The movement and the associated images captured by the LTD are informationally correlated with its position in the intestine, such as by image recognition (intestinal landmarks), pH, travel time, or other location identifiers. The movement of the LTD is controlled by the physician/operator using the EADCD. Real-time imaging informs the operator about the direction of the moving LTD, and the movement of the EADCD sends signals to actuate the articulated legs on the LTD. Other external systems for controlling the movement of the capsule endoscope may be adapted for use with this embodiment.

An externally alignable display and control device (EADCD) receives images transmitted from the LTD. Image data transmitted at radio frequencies is received by a transceiver in the display device, but the signal is filtered to allow reception only of transmissions immediately emitted by the EADCD (see Figures 1A-C). Calculation methods for filtering signals and locating the medical device in the digestive tract are applicable to various embodiments described herein. In one embodiment, position-dependent signal parameters include: angle of arrival, time of arrival, and received signal strength, which are used to assess the position of the transmitting device and can be used to filter signals received from the LTD. In this embodiment, the image is displayed by the EADCD only when the EADCD is directly above the LTD.

Image data and corresponding location data are stored in memory on the LTD until the LTD exits the patient's intestines. Once the LTD is out of the anus, as the temperature drops below body temperature, a temperature sensor in the LTD monitors the ambient temperature and signals the control circuitry. The control circuitry supplies current to the storage unit on the device and erases any imaging, location, and patient identification data. A temperature control assembly for a computer memory including a temperature sensor and resistors has been described and is suitable for use with this embodiment.

Prophecy Example 2:

A lumen imaging system with a position-specific display storing intraluminal images is used to monitor lung cancer.

The intraluminal imaging system includes a lumen-traveling device (LTD) and an externally alignable display and control device (EADCD) capable of retrieving images acquired at a specific luminal location. For monitoring lung cancer, initial intraluminal images of the lung cancer tumor are obtained by introducing the LTD into the bronchial tree via inhalation or bronchoscopy. Images of any tumor and its location in the airway are transmitted to the EADCD and stored in memory. Several weeks later, after chemotherapy, the LTD is reintroduced into the airway, and the system is used for repeated imaging of the tumor location. The current images are compared to images acquired before chemotherapy. An LTD movement system and real-time image display and position sensing are used to guide the movement of the lumen-traveling device using a handheld EADCD.

LTDs are made from biodegradable components, such as filaments or paper. The lifespan of the device can be based on changes in the crystalline structure of the filaments, which determines the rate at which water enters and degrades the filament structure. In this way, the device can be designed for a lifespan of minutes, days, months, or even years. Similarly, magnesium or silicone resins can also be used, depending on the specific design parameters required for the biodegradable device.

Patients with suspected lung cancer nodules are imaged using a luminal imaging system that uses an LTD (Large-Level Device) and an EADCD (External Advanced Digital Imaging Device) introduced into the airway to display local images in real time and control the movement of the LTD. The capsule LTD has a diameter of approximately 7 mm and a length of 23 mm, and includes a camera, a light source, a transmitter, a receiver, control circuitry, memory, a position sensor, a battery, and a moving component. The high-resolution camera, responsive to external signals, includes a CMOS image sensor, an adjustable lens, and circuitry for real-time processing and transmission of image data. For example, a miniature camera with a 0.6 mm color lens with a magnetic coil for focusing, a CMOS image sensor, and four white LEDs may be suitable for a particular implementation. Imaging devices, high-performance electronics, and radio frequency electronics formed from bioabsorbable materials may be suitable for various implementations. When the EADCD is directly above the LTD, the intraluminal image transmitted by the LTD is received and transmitted solely by the EADCD. See Figure 1.

Methods for filtering signals and locating medical devices in the digestive tract are suitable for use with this embodiment. For example, position-dependent signal parameters (including angle of arrival, time of arrival, and received signal strength) are used to evaluate the position of the transmitting device and can be used to filter signals received from the LTD. Image data transmitted from the airway by the LTD is received by the EADCD and stored in memory along with relevant position sensing data.

An EADCD is a handheld device (e.g., a smartphone) with a transceiver, display capability, and position sensor to display images within the lumen in real time and remember its position within the body. Image data transmitted at radio frequencies is received by the transceiver in the EADCD, but the signal is filtered to allow reception only of transmissions immediately emitted by the EADCD (see Figure 1C). A method for filtering signals and calculating the positioning of the medical device in the digestive tract is described and is adaptable for use with this embodiment. In one embodiment, position-dependent signal parameters, including angle of arrival, time of arrival, and received signal strength, are used to evaluate the position of the transmitting device, which can be used to filter signals received from the LTD. In this embodiment, the image is displayed by the EADCD only when the EADCD is directly above the LTD.

EADCDs have position sensors to identify body location when displaying images. In one embodiment, the EADCD may have near-infrared (NIR) sensors to detect subsurface features in the lungs, such as patterns of the vascular system or patterns of blood within the vascular system, which act as markers to identify location in the lungs. See Figure 2A.

Methods and systems for acquiring and storing landmark features can be adapted for use with this embodiment, for example, where an image of the landmark feature (location identifier) is associated with an intraluminal image simultaneously delivered from the LTD. Alignment circuitry on the EADCD identifies landmark features previously stored in memory and retrieves the associated intraluminal image. In one embodiment, a handheld EADCD passing over the location of a lung tumor previously imaged using the LTD will retrieve the LTD image associated with the landmark feature (e.g., a vascular pattern at the tumor site). See Figure 2B.

By using a NIR sensor to move the EADCD across the entire body surface, multiple intraluminal airway images and their associated landmarks can be accessed. Furthermore, initial intraluminal images can be compared with images acquired later. In one embodiment, intraluminal imaging using the LTD is performed before and after chemotherapy for lung tumors. Re-accessing the same sites in the airway is guided by stored landmark features. Alignment of the EADCD and LTD using landmark features at the tumor site allows for comparison of images acquired before and after chemotherapy.

Using a handheld EADCD, a physician, caregiver, or patient guides the LTD to be steered and positioned within the airway lumen. The EADCD guides the movement of a magnetic field and positions the LTD within the airway lumen. The LTD includes a magnetic component that responds to an externally applied magnetic field. If the device is designed to be biodegradable, it may include removable magnetic iron filings or legs. In one embodiment, the iron filings are coated in silicone and are biodegradable overall. In another embodiment, the removable magnetic component is non-biodegradable but can be retrieved by a magnet or endoscope, or expelled naturally by coughing once the remainder of the device has biodegraded.

An EADCD can be guided by a changing magnetic field to move the LTD. For example, a magnetic steering and positioning system for an intraluminal capsule is described, and it is applicable to this embodiment. In one embodiment, circuitry and position sensors in the EADCD apply a variable magnetic field through the movement of the EADCD to steer the LTD within the airway. In an embodiment examining branches of the bronchial tree, the EADCD moves laterally at the bronchial junction to steer the LTD downward along the lumen of the branch.

LTD steering is guided by real-time endobronchial images displayed by the EADCD. Repeat bronchial tree imaging after chemotherapy to re-examine the tumor can be guided by landmark images stored in the EADCD. To steer the LTD to the location of a previously imaged tumor, landmark images (from NIR-sensed vascular system patterns) at the tumor site can be retrieved from the EADCD storage. In one embodiment, stored endobronchial images previously transmitted by the LTD can be searched for tumor images, and the corresponding relevant landmarks (NIR patterns of the subsurface vascular system) obtained from the EADCD are used to identify the tumor location.

The EADCD moves above the body surface until it locates a landmark pattern, alerting physicians, nurses, patients, or other operators. The LTD is guided to the tumor site as the EADCD moves above the body surface and displays the tumor location in real time once it reaches that position. Comparison of images obtained before and after chemotherapy can indicate the tumor's status: stable, shrinking, or growing. The LTD is removed from the airway by applying a variable magnetic field and moving the EADCD upwards along the bronchus into the trachea. If the device is non-biodegradable, the LTD can be expelled by coughing or retrieved using a bronchoscope.

A lumen imaging system can be used to image and evaluate presumed tumor nodules ranging in size from 9 to 20 mm in diameter (based on computed tomography (CT) scans). A lumen imaging device (LTD) is administered to the patient for inhalation; the LTD is programmed to transmit data to an external endovascular diagnostic device (EADCD) only upon reaching a nodule site. A position sensor on the LTD sends a signal indicating arrival at the nodule site and alerts the operator to move the EADCD over the LTD to allow image data transmission. The LTD then moves towards the next nodule during the CT scan via the EADCD and is instructed to locate the nodule site using location identifiers (e.g., image analysis). The operator receives a warning and moves the EADCD until it is aligned with the LTD and image data is transmitted to the EADCD. Each nodule site is then located by the LTD using location identifiers and the corresponding landmark vascular pattern is imaged via the EADCD. Limited transmission via LTD preserves its battery, and stored location identifiers (e.g., intraluminal images) and surface landmarks (e.g., vascular system patterns) allow for retrieval of each nodule. Furthermore, analysis of stored nodule images can determine malignancy, the growth status of presumed tumor nodules, and their spread.

The current level of technology has progressed to the point where there is virtually no difference between hardware, software, and/or firmware implementations of various aspects of a system; the use of hardware, software, and/or firmware is often (but not always, as the choice between hardware and software may become important in some cases) a design choice representing a trade-off between cost and efficiency. Various tools (e.g., hardware, software, and/or firmware) exist that can implement the processes and/or systems and/or other technologies described herein, and the preferred tools will vary depending on the environment in which the processes and/or systems and/or other technologies are deployed. In one embodiment, if the implementer determines that speed and accuracy are important, the implementer may choose primarily hardware and/or firmware tools; or, if flexibility is important, the implementer may choose primarily software implementations; or again, optionally, the implementer may choose some combination of hardware, software, and/or firmware in one or more machines, material compositions, and articles of manufacture. Therefore, there are several possible tools that can implement the processes and/or devices and/or other technologies described herein, none of which is inherently superior to another, because any tool to be used depends on the choice of the environment in which the tool will be deployed and the implementer's specific concerns (e.g., speed, flexibility, or predictability), any of which can vary. Those skilled in the art will recognize that the implemented optical aspects will typically employ optically oriented hardware, software, and/or firmware.

In some implementations described herein, logic and similar implementations may include software or other control structures. For example, electronic circuits may have one or more current paths constructed and arranged to implement the various functions described herein. In some implementations, one or more media may be configured to carry a device-detectable implementation when such media holds or transmits device-detectable instructions operable to be performed as described herein. In some variations, for example, the implementation may include updates or modifications to existing software or firmware, or updates or modifications to gate arrays or programmable hardware, such as by receiving or transporting one or more instructions relating to one or more operations described herein. Alternatively or additionally, in some variations, the implementation may include dedicated hardware, software, firmware components, and/or general-purpose components that perform or otherwise invoke dedicated components. Specifications or other implementations may be transmitted via one or more instances of the tangible transmission media described herein, optionally via packet transmission or otherwise via a distributed medium at different times.

Alternatively or additionally, implementation may include a dedicated sequence of instructions or circuitry for executing one or more of the functional operations described herein to enable, trigger, coordinate, request, or otherwise cause the occurrence of virtually any of the functional operations described herein. In some variations, the operational or other logical descriptions herein may be directly represented as source code and compiled or otherwise invoked as a sequence of executable instructions. In some cases, for example, C++ or other code sequences may be directly compiled or otherwise implemented in a high-level descriptor language (e.g., a logic synthesizable language, a hardware description language, hardware design simulation, and/or other similar expressions). Alternatively or additionally, prior to physical implementation in hardware, particularly for basic operations or timing-critical applications, some or all of the logical expressions may be represented as a hardware description or other circuit model of Verilog type.

The foregoing detailed description has illustrated various embodiments of the apparatus and/or processes using block diagrams, flowcharts, and/or examples. Each function and/or operation in these block diagrams, flowcharts, or examples can be implemented individually and/or collectively by a wide range of hardware, software, firmware, or virtually any combination thereof, provided that such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations. In one embodiment, several portions of the subject matter described herein can be implemented using an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a digital signal processor (DSP), or other integration format. However, those skilled in the art will recognize that some aspects of the embodiments disclosed herein can be implemented, in whole or in part, equivalently in an integrated circuit as: one or more computer programs running on one or more computers (e.g., one or more computer programs running on one or more computer systems), one or more programs running on one or more processors (e.g., one or more programs running on one or more microprocessors), firmware, or virtually any combination thereof, and that designing the circuits and/or writing the software and/or firmware code according to this disclosure will be within the technical skill of those skilled in the art. Furthermore, the mechanisms of the subject matter described herein can be distributed as various forms of program products, and the illustrative embodiments of the subject matter described herein are applicable regardless of the specific type of signal-bearing medium used to actually perform the distribution.

In a general sense, the various embodiments described herein can be implemented individually and/or collectively by various types of electromechanical systems having a wide range of electrical components (e.g., hardware, software, firmware, or virtually any combination thereof) and a wide range of components that can impart mechanical force or motion (e.g., rigid bodies, springs or torsional bodies, hydraulic devices and electromagnetic actuators, or virtually any combination thereof). Therefore, as used herein, “electromechanical system” includes, but is not limited to: circuits operatively coupled to transducers (e.g., actuators, electric motors, piezoelectric crystals, microelectromechanical systems (MEMS) etc.), circuits having at least one discrete circuit, circuits having at least one integrated circuit, circuits having at least one application-specific integrated circuit, circuits forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially performs the processes and/or apparatus described herein, or a microprocessor configured by a computer program that at least partially performs the processes and/or apparatus described herein), circuits forming a storage device (e.g., in the form of memory (e.g., random access, flash memory, read-only, etc.)), circuits forming a communication device (e.g., modem, communication switch, or optoelectronic device etc.), and any non-electrical analogues thereof (e.g., optical analogues or other analogues). Examples of electromechanical systems include, but are not limited to, various consumer electronics systems, medical devices, and other systems (e.g., electric transportation systems, factory automation systems, security systems, and/or communication/computing systems). As used herein, an electromechanical system is not necessarily limited to systems having both electro-actuated and mechanically actuated functions, unless the context otherwise requires.

In a general sense, the various aspects described herein can be implemented individually and/or collectively by a wide range of hardware, software, firmware, and/or any combination thereof, and can be considered as consisting of various types of “circuits.” Therefore, “circuit” as used herein includes, but is not limited to: circuits having at least one discrete circuit, circuits having at least one integrated circuit, circuits having at least one application-specific integrated circuit, circuits forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially performs the processes and/or devices described herein, or a microprocessor configured by a computer program that at least partially performs the processes and/or devices described herein), circuits forming a storage device (e.g., in the form of memory (e.g., random access, flash memory, read-only, etc.)), and/or circuits forming a communication device (e.g., a modem, communication switch, or optoelectronic device, etc.). The subjects described herein can be implemented in analog or digital mode or some combination thereof.

Regarding the use of virtually any plural and/or singular terms in this document, conversion from plural to singular and/or from singular to plural forms may be made depending on the context and/or application. For clarity, various singular/plural substitutions are not explicitly elaborated here.

The topics described herein sometimes illustrate different components contained within or connected to different other components. It should be understood that the architectures described in this way are merely exemplary, and many other architectures that achieve the same functionality can actually be implemented. In a conceptual sense, any arrangement of components that achieve the same functionality is effectively “associated” to achieve the desired functionality. Therefore, any two components combined herein to achieve a particular function can be considered “associated” with each other to achieve the desired functionality, regardless of the architecture or intermediate components. Similarly, any two such associated components can also be considered “operably connected” or “operably coupled” to each other to achieve the desired functionality, and any two components that can be suchly associated can also be considered “operably coupled” to each other to achieve the desired functionality. Specific examples of operably coupled components include, but are not limited to: physically pairable and/or physically interactive components, and/or wirelessly interactive and/or logically interactive and/or logically interactive components.

In some cases, one or more components may be referred to herein as “configured as,” “configurable by,” “configurable,” “operable/operable,” “adaptable/adaptable,” “capable of,” “adaptable/adaptable,” etc. Those skilled in the art will recognize that, unless the context otherwise requires, these terms (e.g., “configured as”) may generally encompass active state components and/or inactive state components and/or standby state components.

Generally, the terminology used herein, particularly in the appended claims (e.g., the body of the appended claims), is intended to be “open-ended” (e.g., the term “comprising” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “including” should be interpreted as “including but not limited to,” etc.). If there is an intent to introduce a specific number of the objects of a claim, such an intent will be explicitly stated in the claim, and without such a statement, such an intent does not exist. For example, to aid understanding, the appended claims below may contain the introductory phrases “at least one” and “one or more” to introduce the objects of a claim. However, the use of such phrases should not be construed as implying that introducing the object of a claim by the indefinite article “a” or “an” limits any particular claim containing such an introduced object to an invention containing only one such object, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” or “an” should typically be interpreted as meaning “at least one” or “one or more”); the same applies to the use of definite articles used to introduce the object of a claim. Furthermore, even when a specific number of the introduced objects of a claim is explicitly stated, those skilled in the art will recognize that such objects should generally be interpreted as meaning at least the stated number (e.g., the unmodified expression “two objects” without other modifiers generally means at least two objects, or two or more objects). Furthermore, in cases where idiomatic expressions such as "at least one of A, B, and C" are used, this structure generally refers to the conventional meaning understood by a person skilled in the art (e.g., "a system having at least one of A, B, and C" includes, but is not limited to: a system having only A, a system having only B, a system having only C, a system having both A and B, a system having both A and C, a system having both B and C, and/or a system having both A, B, and C, etc.). In cases where idiomatic expressions such as "at least one of A, B, or C" are used, this structure generally refers to the conventional meaning understood by a person skilled in the art (e.g., "a system having at least one of A, B, or C" includes, but is not limited to: a system having only A, a system having only B, a system having only C, a system having both A and B, a system having both A and C, a system having both B and C, and/or a system having both A, B, and C, etc.). Generally, disjunctive terms and/or phrases that provide two or more alternatives, whether in the specification, claims, or drawings, should be understood to imply the possibility of including one, any, or both of the terms, unless the context otherwise requires. For example, the phrase "A or B" should generally be understood to include the possibility of including "A" or "B" or "A and B".

This disclosure has been made with reference to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications can be made to the embodiments without departing from the scope of this disclosure. For example, depending on the specific application or considering any number of cost functions associated with the operation of the system, various operational steps and the components used to perform the operational steps may be implemented in an alternative manner; for example, one or more steps may be deleted, modified, or combined with other steps.

Furthermore, as those skilled in the art will recognize, the principles of this disclosure, including components, can be reflected in a computer program product on a computer-readable storage medium having computer-readable program code elements embodied therein. Any tangible, non-transitory computer-readable storage medium can be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and/or the like. These computer program instructions can be loaded onto a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to produce a machine, such that instructions executable on the computer or other programmable data processing apparatus create elements for performing a specified function. These computer program instructions can also be stored in a computer-readable storage medium that can direct the computer or other programmable data processing apparatus to operate in a particular manner, such that instructions stored in the computer-readable storage medium produce an article of writing, including an execution element that performs the specified function. The computer program instructions can also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer-executed process, such that instructions executable on the computer or other programmable apparatus provide steps for performing the specified function.

The foregoing specific embodiments have been described with reference to various implementations. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, this disclosure should be considered illustrative rather than restrictive, and all such modifications are intended to be included within its scope. Similarly, beneficial effects, other advantages, and solutions to problems have been described above with reference to various implementations. However, any beneficial effects, advantages, solutions to problems, and any elements that may cause any beneficial effect, advantage, or solution to occur or become more apparent should not be construed as critical, essential, or fundamental features or elements. As used herein, the terms “comprising,” “including,” and any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article of manufacture, or apparatus that includes a list of elements includes not only those elements but may also include other elements not expressly listed or inherent to such process, method, system, article of manufacture, or apparatus.

In one embodiment, the system is integrated as a unique system operating specifically configured to run one or more of the systems described herein (e.g., utilizing the tube travel device, etc.), and any associated computing devices of the system operate as dedicated computers for the claimed system, rather than general-purpose computers. In another embodiment, at least one associated computing device of the system operates as a dedicated computer for the claimed system, rather than a general-purpose computer. In yet another embodiment, at least one of the associated computing devices of the system is hardwired to a specific ROM to command at least one computing device. In this embodiment, those skilled in the art will recognize that the systems described herein (e.g., utilizing the tube travel device, etc.) and associated systems/devices achieve improvements at least in the field of tube travel devices. The various embodiments described herein contribute to the medical field by allowing visualization of internal locations in a subject that are otherwise difficult to access, specifically for the diagnosis and/or treatment of diseases, or the maintenance of health. In this regard, in one embodiment, a unique computer and/or system is required.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting, wherein the true scope and spirit are indicated by the following claims.

Claims (47)

1. A system comprising: A lumen travel device that is communicatively coupled to an externally alignable display and control device; The lumen travel device includes at least one power source, at least one of a transmitter, receiver, or transceiver, and at least one position sensor. The externally alignable display and control device includes at least one of a transmitter, receiver, or transceiver operatively coupled to a controller, the controller operating only within an alignment threshold relative to the lumen travel device; and The processor is operatively coupled to at least one of the lumen travel device or the externally alignable display and control device, and is configured to receive signals from at least one of the lumen travel device or the externally alignable display and control device. 2. The system of claim 1, wherein the power source comprises at least one battery. 3. The system of claim 1, wherein the power source comprises at least one of a fuel cell or a biofuel cell. 4. The system of claim 1, wherein the power source comprises at least one of a nanogenerator, an optical power source, an acoustic receiver, an electromagnetic receiver, or an electrical power source. 5. The system according to claim 1, wherein the power source comprises at least one of internally acquired energy harvesting or wireless power transmission. 6. The system of claim 1, further comprising a component for movement. 7. The system of claim 6, wherein the component for movement includes a controller having control circuitry. 8. The system of claim 7, wherein the component for movement is programmable. 9. The system of claim 8, wherein the moving component comprises at least one of an actuator, a motor, a shape memory material, an electroactive material, a magnetic actuator, and an electronic actuator. 10. The system of claim 1, further comprising a steering component. 11. The system of claim 1, wherein the sensor comprises one or more of an imaging sensor, a chemical sensor, a pH sensor, a time sensor, a counter, or an accelerometer. 12. The system of claim 1, wherein the lumen travel device further comprises at least one instrument, the instrument comprising at least one imaging device, biopsy tool, unfolding tool, needle or energy emitter. 13. The system of claim 1, wherein the lumen travel device is a wireless endoscope capsule. 14. The system of claim 1, wherein the size and shape of the lumen traveling device are designed for traveling through at least a portion of one or more of the gastrointestinal tract, blood vessels, urethra, reproductive tract, bronchus, nasal or sinus passages, ear canal, umbilical cord, or artificial lumen. 15. The system of claim 14, wherein the artificial lumen comprises at least one of a conduit or a port. 16. The system of claim 1, wherein the lumen travel device comprises at least one compartment containing at least one therapeutic agent or label. 17. The system of claim 1, further comprising at least one data erasure component configured to operate at a temperature threshold. 18. The system of claim 17, wherein the at least one data erasure component comprises hardware or software configured to initiate data destruction upon activation. 19. The system of claim 1, wherein the processor is configured to determine at least one of the rate, speed, direction, or angle of travel of the lumen traveling device. 20. The system of claim 1, wherein the externally alignable display and control device comprises at least one projector or display. 21. The system of claim 20, wherein the display comprises at least one of an LED, LCD, or OLED display. 22. The system of claim 1, wherein the externally alignable display and control device is configured to be worn on at least a portion of the hand. 23. The system of claim 1, wherein the component for movement comprises at least one of a propulsion system, a hydrodynamic propulsion system, a fluid displacement system, a thruster, a blade, a vibration system, a cavity wall joining system, or a pneumatic bellows system. 24. The system of claim 1, further comprising at least one controller configured to guide the lumen travel device in response to a decision by the processor based on one or more sensing signals. 25. A system comprising: A lumen travel device that is communicatively coupled to an externally alignable display and control device; The lumen traveling device includes at least one component for movement, at least one power source, at least one of a transmitter, receiver or transceiver, and at least one position sensor; The externally alignable display and control device includes at least one of a transmitter, a receiver, or a transceiver; and The processor is operatively coupled to at least one of the lumen travel device or the externally alignable display and control device, and is configured to receive a signal from at least one of the lumen travel device or the externally alignable display and control device only when the lumen travel device enters at least one predetermined position threshold. 26. The system of claim 25, wherein the predetermined location threshold corresponds to a specific time or space threshold. 27. The system of claim 25, further comprising at least one transmitter to transmit at least one signal, the at least one signal defining the travel of the lumen traveling device within the at least one predetermined position threshold. 28. The system of claim 25, further comprising at least one storage device operatively coupled to the processor. 29. The system of claim 25, further comprising a component for aligning the externally alignable display and control device with a previously traveled path of the lumen travel device, comprising at least one of an inertial sensor, at least one reference sensor, at least one topography sensor, or at least one laser pointer. 30. The system of claim 29, wherein the sensor comprises at least one of an imaging sensor, a chemical sensor, a pH sensor, a time sensor, or an accelerometer. 31. The system of claim 25, wherein the power source comprises at least one battery. 32. The system of claim 25, wherein the component for movement includes a controller having control circuitry. 33. The system of claim 32, wherein the controller for the moving component is programmable. 34. The system of claim 25, wherein the sensor comprises one or more of an imaging sensor, a chemical sensor, a pH sensor, a time sensor, or an accelerometer. 35. The system of claim 25, wherein the lumen travel device is a wireless endoscope capsule. 36. The system of claim 25, wherein the size and shape of the lumen traveling device are designed for traveling through at least a portion of one or more of the gastrointestinal tract, blood vessels, urethra, reproductive tract, bronchus, nasal or sinus passages, ear canal, umbilical cord, or artificial lumen. 37. The system of claim 36, wherein the artificial lumen comprises at least one of a conduit or a port. 38. The system of claim 37, wherein the lumen travel device comprises at least one compartment containing at least one therapeutic agent or label. 39. The system of claim 25, further comprising at least one storage device configured to store data relating to the operation of the lumen travel device. 40. The system of claim 25, wherein the processor is configured to determine at least one of the rate, speed, direction, or angle of travel of the lumen traveling device. 41. The system of claim 25, wherein the externally alignable display and control device comprises at least one projector or display. 42. The system of claim 41, wherein the display comprises at least one of an LED, LCD, or OLED display. 43. The system of claim 41, wherein the externally alignable display and control device is configured to be worn on at least a portion of the hand. 44. The system of claim 25, wherein the component for movement comprises at least one of a propulsion system, a hydrodynamic propulsion system, a fluid displacement system, a thruster, a blade, a vibration system, a cavity wall joining system, or a pneumatic bellows system. 45. The system of claim 25, wherein the component for movement comprises at least one of an actuator, a motor, a shape memory material, an electroactive material, a magnetic actuator, and an electronic actuator. 46. The system of claim 25, further comprising at least one steering component. 47. The system of claim 25, further comprising at least one controller configured to guide the lumen travel device in response to a decision by the processor based on one or more sensing signals.