Ingestible device recovery system

Various embodiments are described herein for a recovery tool kit system including a recovery tool and an associated retrieval method for retrieving and storing an ingestible device.

FIELD

Various embodiments are described herein for an apparatus, kit and method that may be used to retrieve an ingestible device after it has been evacuated from a body.

BACKGROUND

Ingestible devices can be used to take physiological measurements (e.g., measure pH) or provide imaging capabilities within the body of a person or animal. For example, such devices may be used to identify diseased areas of the gastrointestinal (GI) tract or collect samples thereof. While some ingestible devices may be capable of transmitting physiological and imaging data wirelessly, a user may be required to wear additional equipment to receive such a generally weak signal. As such it may be preferable to equip the ingestible device with sufficient on-board storage so that the data acquired by the ingestible device may be downloaded upon recovering the device after it is passed through the gastrointestinal tract and exits the body. However, recovering the device after it has been evacuated may pose challenges especially for those who are not trained or are not used to handling waste samples as the device must be recovered from the waste that is also evacuated form the body at the same time as the device is evacuated from the body.

SUMMARY OF VARIOUS EMBODIMENTS

Various embodiments of a recovery toolkit including a recovery tool and associated recovery methods are provided according to the teachings herein. The embodiments described herein are generally used to recover an ingestible device after it has been evacuated from a user's body.

In a broad aspect, at least one embodiment described herein provides a recovery tool for retrieving and storing an ingestible device, wherein the recovery tool comprises a collection member with an open end, a closed end and a collection chamber therebetween for receiving the ingestible device after recovery; and a cap assembly releasably attachable to the open end of the collection member to seal the collection chamber, the cap assembly comprising a closure portion; a handle extending from the closure portion in a first direction; a shaft extending from the closure portion in a second direction that is opposite the first direction; an extension shaft moveably coupled to the shaft and having a distal end portion, the extension shaft being moveable between a retracted position in which the extension shaft is disposed within the shaft and an extended position in which the distal end portion of the extension shaft is extended away from the shaft in a telescopic manner; and a retriever being disposed at the distal end portion of the extension shaft and adapted to retrieve the ingestible device.

In at least one embodiment, the extension shaft is slidably coupled to the shaft allowing the extension shaft to be moveable in a telescopic fashion.

In at least one embodiment, the extension shaft comprises at least two sections that are pivotally coupled to one another to allow the extension shaft to be moveable in a pivotable fashion.

In at least one embodiment, the retriever comprises a magnet disposed in the distal end portion of the extension shaft and adapted to retrieve the ingestible device by applying a magnetic attraction force.

In at least one embodiment, the closed end of the collection member is shaped to align the ingestible device with the magnet to turn the ingestible device off.

In at least one embodiment, the closed end of the collection member comprises additional packaging to protect and/or to preserve samples within the ingestible device.

In at least one embodiment, the retriever comprises one of mechanical forceps, graspers, a pliable loop, adhesive means, a suction tip and a vacuum.

In at least one embodiment, the recovery tool further comprises a locking mechanism that maintains the extension shaft in the retracted position and is actuable to allow movement of the extension shaft to the extended position.

In at least one embodiment, the locking mechanism comprises a first aperture on a surface of the shaft, a second aperture on a surface of the extension shaft and a boss disposed within the shaft extension and positioned at the second aperture to engage and disengage the first aperture during use.

In at least one embodiment, the boss comprises a body having a leaf spring to maintain the boss in position within the extension shaft.

In at least one embodiment, when the extension shaft is in the extended position, the extension shaft is moveable to the retracted position by pushing the distal end of the cap assembly against an inner portion of the collection chamber.

In at least one embodiment, the recovery tool further comprises a controller to control one or more electronic aspects of the recovery tool; and at least one sensor coupled to the controller and operable to detect a parameter of the environment of the collection chamber after storage of the retrieved ingestible device.

In at least one embodiment, the at least one sensor comprises at least one of a pressure sensor, a temperature sensor and a humidity sensor.

In at least one embodiment, the controller is configured to monitor and record an elapsed time duration in which the retrieved ingestible device has been stored in the collection chamber.

In at least one embodiment, the recovery tool further comprises a transceiver coupled to the controller, the transceiver being configured for receiving a beacon signal from the ingestible device when the ingestible device is in close proximity to the recovery tool and also configured to transmit a second signal to the ingestible device to acknowledge the ingestible device has been detected.

In at least one embodiment, the controller is configured to operate the recovery tool is low power mode upon retrieval of the ingestible device.

In at least one embodiment, the controller is configured to operate the at least one sensor for monitoring a condition of the ingestible device upon retrieval of the ingestible device.

In at least one embodiment, the collection member and the cap assembly form a seal when releasably secured to one another to prevent any fluid from escaping from or entering into the collection chamber.

In another broad aspect, at least one embodiment described herein provides a recovery kit for retrieving an ingestible device after the ingestible device is evacuated from a user's body, wherein the recovery kit comprises a recovery tool as defined according to any of the teachings herein; and a carrying case dimensioned to receive the recovery tool.

In at least one embodiment, the recovery kit further comprises a shipping package for receiving the recovery tool after the ingestible device has been recovered and stored in the recovery tool and being useable for shipping the recovery tool with the recovered ingestible device to a processing/analysis facility.

In at least one embodiment, the shipping package and the recovery tool are made from materials that are compliant with UN3373 regulations related to medical packaging and shipment of category B materials.

In at least one embodiment, the recovery kit further comprises instructions for use of the recovery tool; a pair of gloves for handling the recovery tool during use; and a plastic bag for receiving the recovery tool after the ingestible device has been recovered and prior to placing the recovery tool with the stored ingestible device into the shipping package, where the plastic bag is watertight.

In at least one embodiment, the recovery kit further comprises a collection tray for collecting fecal matter that includes the ingestible device after the ingestible device has been evacuated from the user's body.

In at least one embodiment, the collection tray comprises a first pair of adhesive strips for attaching a pair of first portions of the collection tray to opposite arms of a toilet seat and a second pair of adhesive strips for attaching a pair of second portions of the collection tray to opposite sides of a toilet bowl.

In another broad aspect, at least one embodiment described herein provides a method of recovering an ingestible device after the ingestible device exits a user's body, wherein the method comprises separating a collection member from a cap assembly of a recovery tool; extending an extension shaft of the cap assembly from a retracted position to an extended position; retrieving the evacuated ingestible device using a distal end of the extension shaft; inserting the extension shaft with the ingestible device into a collection chamber of the collection member; moving the extension shaft from the extended position to the retracted position; and releasably mounting the cap assembly to the collection member, the collection member and the cap assembly providing a water tight environment for the ingestible device and the extension shaft disposed in the collection chamber.

In at least one embodiment, the method comprises mounting a collection tray to a toilet in order to receive excreted fecal matter including the evacuated ingestible device from the user, the act or mounting comprising attaching a first pair of adhesive strips on a first pair of bottom portions of the collection tray to opposite arms of a toilet seat; and attaching a second pair of adhesive strips on a second pair of bottom portions of the collection tray to opposite sides of a toilet bowl.

In at least one embodiment, the method further comprises placing the recovery tool with the stored ingestible device into a shipping package; and sending the shipping package to a processing/analysis facility.

In at least one embodiment, the method further comprises placing the recovery tool with the stored ingestible device into a plastic bag; placing the plastic bag with the recover tool and stored ingestible device into a shipping package; and sending the shipping package to a processing/analysis facility.

In at least one embodiment, the method comprises using a magnet at the distal end of the extension shaft to retrieve the evacuated ingestible device.

In at least one embodiment, the method comprises using one of mechanical forceps, graspers, a pliable loop, adhesive means, a suction tip and a vacuum at the distal end of the extension shaft to retrieve the evacuated ingestible device.

In at least one embodiment, the method further comprises receiving a beacon signal from the evacuated ingestible device using a transceiver that is electrically coupled with the recovery tool, the beacon signal indicating that the evacuated ingestible device is in close proximity to the recovery tool.

In at least one embodiment, the method further comprises using the transceiver to transmit a second signal to the evacuated ingestible device upon receiving the beacon signal to acknowledge that the ingestible device has been detected.

In at least one embodiment, the method further comprises operating the recovery tool in low power mode upon retrieval of the ingestible device.

In at least one embodiment, the method further comprises operating at least one sensor for monitoring a condition of the ingestible device upon retrieval of the ingestible device.

In at least one embodiment, the method further comprises using a humidity sensor for monitoring humidity of the collection chamber during storage and/or transportation of the recovered ingestible device.

In at least one embodiment, the method further comprises using a temperature sensor for monitoring temperature of the collection chamber during storage and/or transportation of the recovered ingestible device.

In at least one embodiment, the method further comprises using a counter or a controller for monitoring elapsed time for storage and/or transportation of the recovered ingestible device.

In at least one embodiment, the method comprises using a recovery tool as further defined in any one of teachings herein.

Other features and advantages of the present application will become apparent from the following detailed description taken together with the accompanying drawings. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the application, are given by way of illustration only, since various changes and modifications within the spirit and scope of the application will become apparent to those skilled in the art from this detailed description.

At least another embodiment described herein includes a recovery tool for retrieving and storing an ingestible device. The recovery tool includes a collection member having an open end, a closed end and a collection chamber between the open end and the closed end for receiving the ingestible device after recovery. The recovery tool further includes a cap assembly releasably attachable to the open end of the collection member to seal the collection chamber. In some embodiments, the cap assembly includes a sensor configured to receive a beacon signal from an ingestible device and detect a proximity of the ingestible device based on the beacon signal, a transceiver configured to transmit a signal to the ingestible device, and a shaft extending from the closure portion to retrieve the ingestible device.

At least another embodiment described herein includes a method of recovering an ingestible device after the ingestible device exits a user's body. A beacon signal is received, via a sensor at a recovery tool, from an ingestible device. The ingestible device is determined to be in proximity for recovery based at least in part on the beacon signal. A triggering signal is transmitted, via a transceiver at the recovery tool, to the ingestible device to initiate an action by the ingestible device. The ingestible device is then recovered, via the recovery tool.

In at least one embodiment, a first signal is transmitted to the ingestible device, and the first signal includes any of a light signal, an audio signal or a wireless electromagnetic signal.

In at least one embodiment, the beacon signal is received at a user device to notify the user that the ingestible device has been evacuated from a human body.

In at least one embodiment, the action by the ingestible device includes generating a visual signal or an audio signal by the ingestible device.

In at least one embodiment, the action by the ingestible device includes any of data transfer from the ingestible device to the recovery tool, or configuring a low power mode with the ingestible device.

Further aspects and features of the example embodiments described herein will appear from the following description taken together with the accompanying drawings.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Various embodiments in accordance with the teachings herein will be described below to provide an example of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices or methods having all of the features of any one of the devices or methods described below or to features common to multiple or all of the devices and or methods described herein. It is possible that there may be a device or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

It should also be noted that the terms “coupled” or “coupling” as used herein can have several different meanings depending in the context in which these terms are used. For example, the terms coupled or coupling can have a mechanical, magnetic or electrical connotation. For example, as used herein, the terms coupled or coupling can indicate that two elements or devices can be directly connected to one another or connected to one another through one or more intermediate elements or devices via a magnetic signal, an electrical signal or a mechanical element, depending on the particular context.

It should be noted that terms of degree such as “substantially”, “about” and “approximately” as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree may also be construed as including a deviation of the modified term if this deviation would not negate the meaning of the term it modifies.

Ingestible devices may be swallowed by a person or animal (hereafter referred to as a user) and be used to perform analysis or physiological measurements, collect biological samples or deliver therapeutic agents as it passes through the digestive or GI tract of the user's body. Accordingly, the term ingestible device, as used herein, is meant to cover an electronic-based or mechanical-based ingestible device which may be in the form of a capsule or a similar size as some larger pharmaceutical capsules. In circumstances in which an ingestible device is used for any of the above purposes, or for environmental considerations, there may be a desire to retrieve the ingestible device after the ingestible device has been evacuated, excreted or exited (hereafter referred to as evacuated) from the user's body.

The process of retrieving the ingestible device from excreted waste may pose a challenge for sanitary and other reasons. Additionally, if the ingestible device was recovered outside of a laboratory/facility equipped to retrieve and process the ingestible device, the retrieved device may also have to be transported to a processing/analysis facility or laboratory in a manner that complies with local laws and regulations with respect to the transportation of biological samples. In accordance with the teachings herein, various embodiments are provided of a device, a method and a kit that may be used for the efficient and safe recovery and transportation of an ingestible device.

Referring now toFIGS. 1A to 1D, illustrated therein is a diagram are various side views of an example embodiment of a recovery tool100for recovering an ingestible device in accordance with the teachings herein. In particular,FIG. 1Ashows the recovery tool100in a closed configuration before use,FIGS. 1B and 1Cshow the recovery tool in an open configuration before use andFIG. 1Dshows the recovery tool in a closed position after use (i.e. after the ingestible device has been recovered).

The recovery tool100comprises a collection member102and a cap assembly104. The collection member102has an open end portion102a, a closed end portion102band a collection chamber102cfor receiving and storing the recovered ingestible device (shown in hashed lines as device115inFIG. 1D). The cap assembly104can be releasably attached or secured to the collection member102to close the open end portion102aof the collection member102. The collection member102and the cap assembly104are made using water-resistant materials such that they make a water-tight seal when secured to one another.

In some embodiments, the collection member102may be a tube made of a biologically compatible material such as polyethylene or polystyrene material. For example, the collection member102may be a conical centrifuge tube such as a Falcon™ 50 mL conical centrifuge tube. The closed end portion102bof the collection member102may have a conical end to provide room for the recovered ingestible device when a distal portion of the cap assembly104includes the recovered ingestible device and is being inserted into the collection member102. In some embodiments, the closed end portion102bof the collection member102may be cylindrical. In other embodiments, the closed end portion102bof the collection member102may be round or spherical. In other embodiments, the closed end portion102bmay have one or more of solid portions to provide additional packaging to protect and/or to preserve samples within the ingestible device. Alternatively, or in addition thereto the closed end portion102bmay have structural features and/or be shaped to position or align the recovered ingestible device with a magnet at the extension shaft which acts as a magnetic off switch to turn the ingestible device off after it has been recovered.

The open end102aof the collection member102may be releasably sealed by the cap assembly104using different mechanisms. In this example embodiment, the exterior surface of the open end portion102ahas threads106aand a closure portion108of the cap assembly104has corresponding grooves or internal threading106b(shown as element122inFIG. 2) so that the cap assembly104can be screwed (i.e. releasably secured) onto the open end portion102aof the collection member102to seal the collection chamber102c. This particular closure mechanism of using threads and grooves allows the collection member102to be sealed more securely by the cap assembly104. In some embodiments, the closure portion108may be regarded as a modified screw-on cap that is normally associated with a collection tube (e.g. the Falcon™ 50 mL conical centrifuge tube).

Alternatively, in other embodiments, other closure elements can be used. For example, the exterior of the open end portion102aof the collection member102and the closure portion108of the cap assembly104may be dimensioned to provide a friction fit. For example, the exterior portion of the open end portion102acan have a flange that acts as a stop mechanism when the closure portion108of the cap assembly104is releasably mounted to the collection member102. The inner surface of the closure portion104can have a smooth surface. Alternatively, the inner surface of the closure portion104can have a fingers or tabs for releasably engaging the flange of the open end portion102a. Alternatively, other press-fitting mechanisms such as, but not limited to, ball detents or any means for securely fastening a cap to a tube or container, for example, may be used for at least one of the open end portion102aof the collection member102and the closure portion108of the cap assembly104.

The cap assembly104further comprises a handle110and a shaft112. The handle110extends away from the collection member102and provides a gripping surface for a user to handle the recovery tool100and attach or detach the cap assembly104from the collection member102, as will be described in more detail below. The shaft112extends from the closure portion108towards the collection member102. The shaft112is used to recover the ingestible device from excreted waste, as will be described in more detail below.

The shaft112may be cylindrical or it may have a different cross-sectional shape in other embodiments such as, but not limited to, rectangular, square, triangular or cross-shaped, for example. The outer circumference of the shaft112is smaller than the inner circumference of the collection chamber102cso that the shaft112fits inside the collection chamber102cwhen the cap assembly104is releasably secured to the collection member102. Likewise, the length of the shaft112is chosen so that it is shorter than the length of the collection chamber102c. In doing so, the shaft112can be inserted into the collection chamber102cwhen the cap assembly104is releasably secured to the collection member102, as shown inFIG. 1A. However, it can be noted that the shaft112, as denoted by hashed lines, does not occupy the entire volume of the collection chamber102c. Additional space114may be reserved so as to provide room for the recovered ingestible device115as well as a portion of excreted waste that may be attached to the recovered ingestible device115.

Referring now toFIG. 1C, the shaft112comprises an extendable extension shaft112′ with a lip116at its distal end. The extension shaft112′ can be in a retracted position (seeFIGS. 1B and 1D) in which the extension shaft112′ resides coaxially within the shaft112. The extension shaft112′ can also be in an extended position (seeFIG. 1C) in which the lip116is extended away from the shaft112. The lip116may be gripped by a user of the recovery tool100to manually pull the extension shaft112′ to move the extension shaft from the retracted position to the extended position. The extendable shaft112′ thus provides a telescoping “wand” or telescoping “arm” to help improve access to the ingestible device when the ingestible device must be recovered from evacuated fecal matter. In this way, the recovery tool100with the extended shaft112′ reduces risk of the user coming in contact with the evacuated fecal matter. Accordingly, the extension shaft112′ is slidably coupled to the shaft112allowing the extension shaft112′ to be moveable in a telescopic fashion.

In an alternative embodiment, the extension shaft112′ may comprise at least two sections that are pivotally coupled to one another to allow the extension shaft to be moveable in a pivotable fashion. In an alternative embodiment, the extension shaft112′ may include several extensible sections that are connected telescopically or pivotally such that the extension shaft112′ may be further extended.

The length of the extension shaft112′ can be chosen such that that when the extension shaft112′ is retracted, the lip116sits flush with the open edge of an outer wall of the shaft112as shown inFIG. 1B. Alternatively, in other embodiments, the extension shaft112′ may have a length such that the lip116is disposed away from the outer wall of the shaft112when the extension shaft112′ is in the retracted position but the lip116can still fit within the collection chamber102cwhen the cap assembly104is secured to the collection member102. However, the cap assembly104can be used with the extension shaft in either the retracted position or the extended position depending on the user's preference. Alternatively, in other embodiments, the shaft112may not have the extension shaft112′ and the length of the shaft112is to maintain separation between the excreted fecal matter and the retrieval person during the retrieval process.

The shaft112and the extension shaft112′ may be dimensioned such that there is a friction fit between these two elements that allows the user to move the extension shaft112′ relative to the shaft112from a first position to a second position and stay in the second position while the user uses the recovery tool100to recover the evacuated ingestible device.

Alternatively, as shown inFIGS. 1A-1D, the shaft112may comprise an opening or aperture118through which a boss (i.e. a button, tab, or post)120located on the outer wall of the extension shaft112′ may extend, when the extension shaft112′ is fully moved to the extended position, as the user pulls on the lip116with one hand and holds onto the handle110with their other hand. When the extension shaft112′ is fully extended the boss protrudes through the opening118and provides a locking mechanism to maintain the extension shaft112′ in the extended position. Conversely, the boss120on the outer wall of the extension shaft112′ provides resistance against the inner wall of the shaft112, when the extension shaft112′ is in the retracted position. In this way, the extension shaft112′ is secured within the shaft112, and does not unintentionally slip away from the shaft112. To retract the extension shaft112′, the user depresses the boss120and exerts a force on an end of the extension shaft112′ (i.e. at a portion of the lip116) to slide the extension shaft112′ back into the shaft112.

In an alternative embodiment, the boss120may extend through the aperture118to secure a retracted position, e.g., when the extension shaft112′ is at least partially within the shaft112. The user may depress the boss120and pull the extension shaft112′ away from the shaft112into the extended position. At the extended position, the boss120is disposed within the extension shaft112′ and provides an outward force to hold the extension shaft112′ in place. The user can then retrieve the evacuated ingestible device. Once the ingestible device is obtained, a force may be exerted on a portion of the lip116to move the extension shaft112′ back into the retracted position at which point the boss120may protrude through the aperture118to hold the extension shaft112′ in the retracted position.

The distal end portion of the extension shaft112′ (i.e. near the lip116) may be equipped with a collection mechanism. For example, for retrieving an ingestible device with a built-in magnet or ferromagnetic materials, the distal end portion of the extension shaft112′ may comprise a recovery magnet (shown as element124inFIG. 2) that is used to collect the ingestible device using magnetic attraction. In some embodiments, a disk magnet can be embedded into the distal end of the extension shaft112′ to provide the necessary magnetic force. Alternatively, the recovery magnet can be mounted onto the end of the extension shaft112′ using a suitable bonding agent.

The recovery magnet is selected to provide a certain amount of pull force that is sufficient given the dimensions and weight of the ingestible device that is to be retrieved. For example, a D83 disk magnet with a diameter of 0.5 inches may be used to impart about 9 lbs of pull force. Alternatively, a D96 disk magnet with a diameter of 0.5 inches may be used to impart about 16.5 lbs of pull force. In another alternative, a Dx82 disk magnet with a diameter of 1.5 inches may be used to impart about 20.4 lbs of pull force. In yet another alternative, a Dx84 disk magnet with a diameter of 1.5 inches may be used to impart about 34 lbs of pull force.

The entire recovery tool100can be made to be relatively compact, since the cap assembly104and the collection chamber102ccan be combined into a single unit as shown inFIG. 1Aprior to use as well as during transportation after the ingestible device has been recovered and stored within the recovery tool100as is shown inFIG. 1D. The collection chamber102ccan have various dimensions to accommodate different sized ingestible devices. For example, the collection chamber102cmay have a length of about 5 mm to about 120 mm, a diameter of about 12 mm to about 30 mm and a volume of about 15 ml to about 50 ml but it may be sized differently in different embodiments. Furthermore, the recovery tool100can be made of materials that can be sterilized such as, but not limited to, polypropylene, for example.

Referring now toFIG. 2, shown therein is an exploded view of the recovery tool100and its various components. Visible inFIG. 2is the boss120, and internal threading122of the closure portion108that allows the cap assembly104to releasably engage (i.e. screw onto) the threaded surface106of the collection member102. The locking mechanism to maintain the extension shaft112′ in the retracted position within the shaft112comprises the first aperture118on a surface of the shaft112, a second aperture119on a surface of the extension shaft and the boss120. The boss120has a body120bthat provides a friction fit within the shaft112to keep the boss120in place. In this embodiment, the body120bof the boss120is a leaf spring that has a tip120tthat can be mounted to an internal portion of the shaft112(e.g. there may be a groove on an internal surface of the shaft112that can be engaged by the tip120tof the boss120. Furthermore, recovery magnet124is installed at the distal end of the extension shaft112′ (or the shaft portion112in embodiments in which there is no extension shaft112′). The recovery magnet124may be disposed within a channel124cand in place using a friction fit at the distal end of the extension shaft112′ near the lip116.

Referring now toFIG. 3, shown therein is an alternative example embodiment of an ingestible device recovery tool300. The elements that are common to both recovery tools100and300are shown using similar reference numbers. The recovery tool300can be regarded as being substantially similar to the recovery tool100in terms of physical structural elements and features. However, the handle310of the recovery tool300comprises electronic components to assist in the identification of the excreted ingestible device as well as the monitoring of certain conditions. In other embodiments, the electronic components may be embedded within other areas of the recovery tool300. In yet other embodiments, the electronic components may be a separate device that can be attached to the recovery tool300. In this regard, in an alternative embodiment a separate attachable device that provides the functionality of these electronic components may be used in conjunction with the recovery tool100.

The electronic components may be soldered onto a printed circuit board (not shown) that is small enough to fit into the handle310. In some embodiments the circuit board may be a flexible circuit board to permit easier disposition of the electronic components within the handle310. The electronic components generally comprise a power source320, memory332, a transceiver334, one or more sensors336and a controller338.

The power source330may be a battery such as a button battery that can fit within a confined space. In some cases the power source330may be rechargeable. The power source330is selected to provide sufficient power for the operation of the other electronic components.

One or more sensors336may be included to monitor the conditions inside and outside the collection chamber302c, for example, when the recovered ingestible device is stored inside the collection member302and during transportation to a processing facility. For example, the sensors336may comprise at least one of a temperature sensor, a pressure sensor and a humidity sensor for determining the environmental conditions of the stored recovered ingestible device in order to determine if the environmental parameters are suitable for the recovered ingestible device (i.e. to monitor the temperature and/or humidity to see if they are within acceptable ranges or are too high or too low). In some embodiments, the controller338may have an onboard temperature to monitor ambient temperature during storage of the recovered ingestible device as well as shipping of the recovered ingestible device. The monitored conditions may be recorded and saved to the memory332and retrieved at a processing facility for quality control or record keeping. The memory332can be implemented using any suitable memory technology that provides sufficient storage capacity and speed of access for environmental data or other data that is recorded and/or accessed by the controller338.

The controller338can be implemented using a processor, an Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or Digital Signal Processor (DSP) that can provide sufficient processing power for the operation of the recovery tool100. The controller338may be programmed to coordinate the monitoring and recording of the environmental conditions, and also to track the time at which the recordings are made. The recorded environmental conditions can later be evaluated to determine if the samples have been stored and shipped correctly under proper conditions. In addition thereto, or alternatively, in some embodiments, the controller338may activate the transceiver334to transmit a signal upon determining that the environmental conditions are not suitable for the stored recovered ingestible device and that corrective action is required. Additionally, the controller338may also track the elapsed time since the evacuated ingestible device has been stored in the recovery tool300and/or the elapsed time that the recovery tool with the evacuated ingestible device has spent while being shipped to the processing/analysis facility. In some embodiments, a counter may be used to determine the elapsed time. In some embodiments, the controller338may also be configured to track the charge level of the power source330. If the time spent in storage or shipping is too long and/or the battery power is at critical low levels, the controller338may active the transceiver334for transmitting this data to the processing facility so that corrective action may be taken. While the various electronic components are depicted separately inFIG. 3, it may be noted that two or all of the components can be combined into a single integrated circuit such as a System-on-a-Chip (SoC) device to further save on space use.

The sensors336may further include an exit sensor to assist with identifying and locating the ingestible device after it has evacuated the user's body and is being recovered using the recovery tool300. When the exit sensor has located the evacuated ingestible device, the controller338can instruct the transceiver334to send a first signal to the ingestible device. In some embodiments, the ingestible device may be programmed to generate and transmit a second signal, such as a beacon signal, when it has received the first signal from the recovery tool300. The first signal may be a light signal (e.g. infrared, near infrared or visible light), an audio signal or a wireless electromagnetic signal such as an RF signal that can be detected by the ingestible device. The type of signal that is transmitted by the recovery tool300depends on the type of sensors used by the ingestible device. For example, the ingestible device may have various LED sensors and the recovery tool may generate a light signal (in this case the ingestible device comprises a light generator, not shown) having a particular color that is detectable by the ingestible device.

In an alternative embodiment, as illustrated inFIG. 8, at801the beacon signal may be generated (i.e. triggered) and transmitted from the ingestible device to the recovery tool after the ingestible device has been evacuated from the human body, e.g., without the recovery tool sending the first signal to the ingestible device. Alternatively, the ingestible device may optionally send the beacon signal to another device (a “user device”) such as, but not limited to, a computer, a laptop, a tablet, a smart phone, and a wearable device to notify a retrieval person that the ingestible device has been evacuated. For example, the user device may receive the beacon signal such that a retrieval person may bring the recover tool to a proximity of the ingestible device, at802. The ingestible device may generate and transmit the beacon signal when it determines that it has bene evacuated which may be determined when the temperature detected by the ingestible device suddenly drops. In other cases the beacon signal may be generated and transmitted when the temperature surrounding the ingestible device no longer corresponds to temperatures that are expected within the user's body. In another embodiment, the beacon signal may be generated and transmitted by the ingestible device when an increase in ambient light is detected. Alternatively, in another embodiment, the beacon signal may be generated and transmitted by the ingestible device when a decrease in temperature and an increase in ambient light have been detected. In another embodiment, the beacon signal may be generated and transmitted when the ingestible device detects a series of pressure changes consistent with the ingestible device exiting the body, for example, as described in U.S. Pat. No. 8,696,602. The device that receives and detects the beacon signal may be configured to notify the user that a beacon signal has been detected. At803, upon receiving the beacon signal from the ingestible device, the recovery tool may determine that the ingestible device has been detected, e.g., at804.

In some embodiments, upon evacuation, the ingestible device may generate a visual signal (i.e. flashing lights) or an audio signal (beeping sound) that is to allow the person retrieving the ingestible device to visually or to acoustically identify the location of the evacuated ingestible device to make retrieval easier. Or alternatively, the recovery tool may send a first signal to the ingestible device at805. In response to the first signal, the ingestible device may be triggered to generate such visual or audio signals when a first signal is received from the recovery tool, e.g., the recovery tool is within proximity to recover the ingestible device, at806.

In some embodiments, the sensors336include a proximity sensor (or the exit sensor may also operate as a proximity sensors) and the beacon signal that is generated by the evacuated ingestible device can also be used to determine whether the extension shaft312′ is in close proximity to the ingestible device for retrieval. Various methods of proximity sensing can be implemented, including but not limited to metal/magnetic means, electrical, sound/vibration (e.g. an audio signal), light (e.g. a color, visible light or infrared signal), electromagnetic radiation (e.g. an RF signal). As such the beacon signal, depending on the implementation, can be any one of these categories of signals. Proximity can also be determined, for example, based on the strength of the detected beacon signal which can be correlated to a distance with respect to the extension shaft312′.

In some embodiments, at806, the first signal that is sent to the ingestible device by the transceiver334can be used to optionally trigger the ingestible device to perform one or more functions such as (a) data transfer, (b) power mode selection and/or (c) sensing mode section. For the data transfer function, the controller338configures and sends the first signal, via the transceiver334, to instruct the ingestible capsule to transmit data files to the recovery tool300or another suitable device. For the power mode section function, the controller338configures and sends the first signal, via the transceiver334, to instruct the ingestible capsule to select a lower power mode to maintain power during shipment. For the sensing mode selection function, the controller338configures and sends the first signal, via the transceiver334, to instruct the ingestible device to use only temperature sensors to monitor temperature during storage and/or shipping.

In some embodiments, the recovery tool300can also be configured to execute one or more functions once the ingestible device has been recovered such as entering a certain power mode and/or monitoring mode. For example, the controller338may be configured to operate the recovery tool300in low power mode upon retrieval of the ingestible device. Alternatively, the controller338may be configured to operate at least one of the sensors336for monitoring a condition of the ingestible device. As another example, the recovery tool300can be controlled by the controller338to enter a low power mode for transport and a temperature monitoring mode for monitoring the temperature of the ingestible device during transport.

Referring now toFIG. 4, shown therein is a flowchart showing an example embodiment of a recovery method400that can be used with the recovery tool100or300for recovering an evacuated ingestible device.FIGS. 5A-5Mare the accompanying illustrations for the recovery method400where the illustrations depict the physical actions that can be performed when an ingestible device is being recovered using one the recovery tools described herein. For ease of illustration, the method400will be described with respect to using recovery tool300.

The method400begins upon expecting that the ingestible device will soon be evacuated and therefore a person wishing to retrieve the ingestible device, who may be the user who has ingested the ingestible device, hereafter referred to as the retrieval person, prepares a collection tray and mounts it on a toilet as is shown inFIG. 5A. The user who ingested the ingestible device then has a bowel movement and defecates on the collection tray. In some cases, the retrieval person may use a device, such as a smart phone, or their visual or auditory senses, depending on the form of the beacon signal, to detect that a beacon signal has been generated and emitted when the ingestible device detects that it has evacuated the user's body and is now included in the excreted fecal matter. Alternatively, the retrieval person can visually inspect the evacuated fecal matter to determine if the ingestible device has evacuated the user's body.

At act402, once it has been determined that the ingestible device has evacuated the user's body, the retrieval person separates the cap assembly304from the collection member302, as shown inFIG. 5B. The collection member302and the cap assembly304may initially be releasably secured together by being screwed together to be a compact unit. As such the retrieval person has to unscrew the cap assembly304from the collection member302. For other embodiments in which other securing mechanisms have been used to releasably secure the cap assembly304to the collection member302, the retrieval person will have to perform a corresponding action to remove the cap assembly304from the collection member302.

At act404, the extension shaft312′ may be extended into the extended position by the retrieval person who pulls the lip316away from the shaft312while holding onto the handle310of the cap assembly304as shown inFIG. 5C. The shaft312′ exits the shaft312by moving outwardly away from the closure portion308until the boss320protrudes through the opening318of the shaft312to secure the extension shaft312′ in place as shown inFIG. 5C. In some embodiments, the retrieval person may prefer not to extend the extension shaft312′ and may choose to recover the ingestible device with the extension shaft312′ in its retracted position (or this may be done because there may be some embodiments in which there is no extension shaft312′). Act404may be slightly different if the locking mechanism provided by the boss320is implemented differently as explained previously.

At act406, the ingestible device is located among the excreted bowel movement. As described earlier, the sensors336can include a proximity sensor to determine the proximity of the evacuated ingestible device. For example, the proximity sensor can determine the strength of a beacon signal that is transmitted by the evacuated ingestible device. The signal strength may be proportionate to a separation distance separating the evacuated ingestible device and the cap assembly304. In some cases, the ingestible device may generate a visual signal (i.e. flashing lights) or an audio signal (beeping sound) so as to allow the retrieval person to visually or aurally identify the location of the evacuated ingestible device. As shown inFIG. 5Dthe use of extension shaft312′ may be advantageous as the retrieval person may engage the extension shaft312′ to separate the excreted fecal matter resting in the toilet-mounted collection tray if the evacuated ingestible device may be located under or within a layer of fecal matter.

At act408, the evacuated ingestible device is located and recovered using the distal end of the shaft312(if the extension shaft312′ is in the retracted position) or the distal end of the extension shaft312′ if the extension shaft312′ is in the extended position. As described previously, a magnet may be embedded at the distal end of the shaft312/extension shaft312′ to apply a magnetic force to the evacuated ingestible device so that the retrieval person can pick up the evacuated ingestible device without having to directly contact the excreted fecal matter.

It should be noted that in alternative embodiments, the recovery tool300can have other implementations for the means that is used to retrieve the ingestible device, hereafter referred to as a retriever. For example, the retriever can include the magnet124. Alternatively, the retriever can include a mechanical means such as extending mechanical forceps, graspers or a pliable loop having a diameter slightly smaller than that of the ingestible device to grab the ingestible device during recovery, adhesive means such as tape for attaching to the ingestible device during recovery, or a suction tip or a vacuum for sucking up the ingestible device during recovery. Alternatively, the retriever may include at least two of the retrieval means previously mentioned.

In an alternative embodiment, after the ingestible device has been retrieved using the recovery tool300, a rotation function can be optionally performed with the recovery tool300to rotate the shaft312(and/or the extended shaft312′) to allow for cleaning of the ingestible device (e.g., when the toilet flushes, etc.) or positioning of ingestible device in the collection chamber302c. In this case, the recovery tool has a rotational actuation member (not shown) that can be actuated by the user to perform the rotating function. The rotational actuation member can be implemented using a gear assembly in the upper portion of the cap assembly304.

At act410, the recovered ingestible device, being now attached to the distal end of the shaft portion312, is placed into the collection chamber302c, as shown inFIG. 5E, when the retrieval person inserts the extension shaft312′ while in extended position (or in a retracted position depending on how the retrieval person has used the recovery tool300to pick up the evacuated ingestible device) into the collection chamber302c. If the extension shaft312′ is in the extended position, then the retrieval person may have to depress the boss320, as is shown inFIG. 5F, so that the extension shaft312′ slides into the shaft312as the retrieval person is placing the extension shaft312′ into the collection chamber302cand the distal end of the extension shaft312′ is pushed against an inner wall of the collection chamber302c, as is shown inFIG. 5G. Alternatively, in other embodiments, the extension shaft may be spring loaded in such that when the button320is depressed, the extension shaft312′ may automatically retract. The retraction may be dampened to minimize excess force being exerted onto the recovered ingestible device.

In some alternative embodiments of the recovery tool300, after act410, power may be provided to the ingestible device from the power source330. For example, wireless charging may be used.

Alternatively, or in addition to providing power to the ingestible device, in some alternative embodiments of the recovery tool300, data may be downloaded from the ingestible device to the memory332. In these embodiments, the transceiver334receives the data to be downloaded from the ingestible device when the ingestible device has been retrieved by the recovery tool300or when the ingestible device has been located by the recovery tool300(as explained previously through various signaling mechanisms) and the ingestible device is in close enough proximity so that the transceiver334can accurately receive the data from the ingestible device.

At act412, the collection chamber302cis sealed by securing the closure portion308of the cap assembly304to the collection member302. For a screw-on cap embodiment, the cap assembly304may be secured onto the collection member302, as is shown inFIG. 5H, by mounting the closure portion308onto the threaded portion306of the collection member302and performing a turning motion in the same manner as screwing on a bottle cap, for example.

If the retrieval of the evacuated ingestible device is done at a location that is remote relative to the processing/analysis facility where the evacuated ingestible device is analyzed, then the retrieval person may insert the recovery tool300containing the evacuated ingestible device into a plastic bag at act414, as is shown inFIG. 5Ifor transport to the processing/analysis facility.

In instances where the recovery tool300containing the evacuated ingestible device must be shipped to the processing/analysis facility, the retrieval person may insert the plastic bag into a shipping package at act416, as is shown inFIG. 5J. The materials used to recover the evacuated ingestible device can then be disposed of and the retrieval person may wash their hands and clean up, as is shown inFIGS. 5K and 5L. The shipping package can then be sent in the mail, as is shown inFIG. 5M, or by courier or some other transport method to the processing/analysis facility.

The shipping package along with the ingestible device recovery tool300may be required to be compliant with rules and regulations respecting the shipment of biological samples. For example, in the present embodiment, the shipping package may be selected and the recovery tool100and300may be made using materials that are compliant with UN3373 regulations related to medical packaging and shipment of category B materials (human or animal specimens).

Referring now toFIGS. 6A-6B, shown therein are diagrams of an example embodiment of an ingestible device recovery kit600comprising the recovery tool100or300and associated items for recovering an ingestible device. For example, the kit600comprises a package or carrying case602, instructions604for using the recovery tool100or300, gloves606for handling the recovery tool100or300during the evacuated device retrieval process, a plastic bag or package608for holding the recovery tool100or300when it is containing the retrieved ingestible device and a shipping package610. The instructions604may be printed on paper. The carrying case602can be made from suitable natural or synthetic materials. The contents of the ingestible device recovery kit600may be collectively referred to as an ingestible device recovery system.

Although not shown inFIGS. 6A-6B, the kit600may further comprises a collection tray that can be mounted on the toilet before for collecting fecal matter than contains the evacuated ingestible device. In an alternative embodiment, the kit600may also include sturdy packaging materials such as one or two thin layers of bubble-wrap or one or two thin layers of foam that can be included in the “shipping package” and between which the recovery tool300may be inserted for shipping. Accordingly, the sturdy packaging materials can be used to protect the recovery tool and the retrieved ingestible device during shipping. Alternatively, the shipping package610may be made of a sturdy material.

The kit600comprises all of the necessary components to ensure the shipping of a human, clinical sample is compliant with federal and local requirements, including the use of a watertight primary receptacle, a watertight secondary receptacle, and absorbent material. In some embodiments the shipping package610comprises appropriate markings. The recovery tool300acts as the watertight primary receptacle and the plastic bag/package608acts as the watertight secondary receptacle in accordance with UN3373 regulations. Accordingly, the recovery tool100/300is made according to UN 3373 regulations. In embodiments, which include the sturdy packaging materials, they can be also be made of an absorbent material or include an absorbent layer to absorb fluids in case there is a leak. Alternatively, the shipping package610may be include an absorbent material that is absorbs fluids in case there is a leak.

Referring now toFIGS. 7A-7C, shown therein are diagrams of an example embodiment of a collection tray612that can be used to collect fecal matter than contains an ingestible device after it has evacuated the user's body.FIGS. 7A-7Bshow views of the upper and lower surfaces of the collection tray612when unfolded.FIG. 7Cshows a view of the collection tray612in a folded configuration that is used when the collection tray612is in the kit600. The collection tray612is a paper sheet that is thick enough to provide the strength to collect fecal matter but is also thin enough to allow it to be easily flushed in the toilet after the ingestible device has been retrieved. In alternative embodiments, the collection tray612can be made from a rigid or semi-rigid material that can be collapsed so that the collection tray612can fit within the kit600. In some embodiments, the instructions may be printed on a surface of the collection tray612.

In some embodiments, the kit600may include an additional collection item (not shown) to provide support for the collection tray612. The additional collection item may be in the form of a mesh, a net or a screen that allows liquid and solid waste to pass therethrough but not the ingestible device. The additional collection item may be placed on the central portion of the collection tray612after the collection tray has been attached to a toilet or other fecal collector.

In some embodiments, the collection tray610may not be included in the kit600such as in cases where the recovery kit is used to recover evacuated ingestible devices from animals.

The collection tray610has a top surface612aand a bottom surface612b. The bottom surface612bcomprises several adhesive strips612s(only one of which is labelled for simplicity) that are covered with removable backings (made of paper or coated plastic, for example). The backings are removed to expose the adhesion portion of the adhesive strips612sand the bottom surface612bof the collection tray612is mounted on a toilet seat such that the adhesive strips stick to the top of the toilet seat and a mid-portion of the collection tray612hangs below the upper surface of the toilet seat, as is shown inFIG. 5A, such that there is enough room for the user of the ingestible device to defecate onto the collection tray612without the evacuated fecal matter contacting the user as it is deposited onto mid-portion of the collection tray612. The collection tray612also comprises removal tabs612t(only one of which is labelled for simplicity) that the retrieval person may pull on when removing the collection tray612from the toilet seat. The collection tray612may then be flushed down the toilet. Accordingly, the collection tray612is generally foldable and may be flushable.

In this example embodiment, there are four adhesive strips612sto provide a stronger and more stable attachment between the collection tray612and the toilet. This is done by using the two inner adhesive strips to attach portions of the collection tray612to the toilet seat and using the two outer adhesive strips to attach portions of the collection tray to the toilet bowl. Accordingly, the backings of the two inner adhesive strips are removed first to expose the inner adhesive surfaces which are then adhered to the toilet seat by pressing firmly on the portions of the top surface612aof the collection tray612that are directly over the inner adhesive strips to attach these two adhesive strips on top of corresponding sides of the toilet seat. The backings of the two outer inner adhesive strips are then removed to expose the inner adhesive surfaces which are then adhered to the toilet bowl by pressing firmly on the portions of the top surface612aof the collection tray612that are directly over the outer adhesive strips to attach these two adhesive strips to corresponding sides of the toilet bowl.

Various components of the kit600(e.g.: the recovery tool, the shipping package, and the collection tray) can be designed and packaged in a discrete way so that the kit600is inconspicuous if seen by others who are not using the kit600. For example, the kit600can be designed and packaged to resemble a toiletry bag or a neoprene laptop case. The packaging of the kit600and some of the internal components may also be varied for male and female users so that it is appealing and publically discrete. For example, the recovery tool can be designed to appear similar to a tooth brush or other toiletry that may go unnoticed in public settings.

At least one of the example embodiments of the recovery tool and the associated recovery methods and kits described herein may make it easier to retrieve an evacuated ingestible device and send it to a processing/analysis facility since. For example, there are a reduced number of steps which also makes it less likely for the retrieval person to fail recovering the ingestible device. The recovery tool also makes it possible for the retrieval person to recover the evacuated ingestible device without having direct contact with fecal matter. The ingestible device recovery kit is also portable, discrete, and usable in public facilities.

In another alternative embodiment, after the retriever has retrieved the evacuated ingestible device and prior to inserting the extension shaft into the collection chamber, for embodiments in which the recover tool comprises a rotational actuator member, the retrieval person may rotate or gently spin the extension shaft to remove some of the fecal matter on the outer housing of the retrieved ingestible device. The retriever may be inserted into the toilet bowl water and the extension shaft rotated to aid in this cleansing act. Alternatively, or in addition thereto, when the retriever is in the toilet bowl water, the toilet bowl may be flushed to aid in cleansing the outer surface of the recovered ingestible device. Alternatively a separate container may be filled with a cleansing fluid (e.g. water) and poured onto the recovered ingestible device to wash it. This acts of inserting the retriever in the toilet bowl water, possibly flushing the toilet and possibly using a separate container to pour cleansing fluid onto the recovered ingestible device may be performed for embodiments of the recovery tool which do not include a rotational actuation member.

While the applicant's teachings described herein are in conjunction with various embodiments for illustrative purposes, it is not intended that the applicant's teachings be limited to such embodiments as the embodiments described herein are intended to be examples. On the contrary, the applicant's teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments described herein, the general scope of which is defined in the appended claims.