Patent Application
20220080122
Therapeutic preparations can be delivered to a subject in various ways such as by way of enteral or parenteral delivery. For many delivery techniques, it can be helpful to be able to monitor characteristics of the delivery and the delivery environment.
Systems, devices and methods are provided for administering a therapeutic preparation within a subject. In an embodiment, a device includes a carrier including a therapeutic preparation, and a launch assembly to deploy the carrier by ejecting the carrier from the device and into internal tissue of the subject. The device detects a status of deployment of the carrier. In an embodiment, a system includes a delivery device, a carrier disposed in the delivery device, a launch assembly, and detection circuitry. The carrier includes a therapeutic preparation. The launch assembly causes the carrier to exit the delivery device so as to penetrate internal tissue of the subject. The system determines a status of deployment of the carrier using the detection circuitry. In an embodiment, a method includes introducing a launch assembly within the subject, the launch assembly coupled to a carrier that incorporates the therapeutic preparation; deploying, by the launch assembly, the carrier; and detecting a status of deployment of the carrier. Further details of these and other embodiments and aspects of the invention are described more fully below, with reference to the attached drawing figures.
The accompanying drawings are not intended to be drawn to scale. Like reference numbers and designations in the various drawings indicate like components. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:
When used in the present disclosure, the terms “e.g.,” “such as”, “for example”, “for an example”, “for another example”, “examples of”, “by way of example”, and “etc.” indicate that a list of one or more non-limiting example(s) precedes or follows; it is to be understood that other examples not listed are also within the scope of the present disclosure.
As used herein, the singular terms “a,” “an,” and “the” may include plural referents unless the context clearly dictates otherwise. Reference to an object in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.”
References to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms.
The term “in an embodiment” or a variation thereof (e.g., “in another embodiment” or “in one embodiment”) refers herein to use in one or more embodiments, and in no case limits the scope of the present disclosure to only the embodiment as illustrated and/or described. Accordingly, a component illustrated and/or described herein with respect to an embodiment can be used in another embodiment (e.g., in another embodiment illustrated and described herein, or in another embodiment within the scope of the present disclosure and not illustrated and/or not described herein).
The term “component” refers herein to one item of a set of one or more items that together make up a device, formulation, or system under discussion. A component may be in a solid, powder, gel, plasma, fluid, gas, or other form. For example, a device may include multiple solid components which are assembled together to structure the device and may further include a liquid component that is disposed in the device. For another example, a formulation may include two or more powdered and/or fluid components which are mixed together to make the formulation.
The term “design” or a grammatical variation thereof (e.g., “designing” or “designed”) refers herein to characteristics intentionally incorporated into a design based on, for example, estimates of tolerances related to the design (e.g., component tolerances and/or manufacturing tolerances) and estimates of environmental conditions expected to be encountered by the design (e.g., temperature, humidity, external or internal ambient pressure, external or internal mechanical pressure, external or internal mechanical stress, age of product, physiology, body chemistry, biological composition of fluids or tissue, chemical composition of fluids or tissue, pH, species, diet, health, gender, age, ancestry, disease, tissue damage, shelf life, or the combination of such); it is to be understood that actual tolerances and environmental conditions before and/or after delivery can affect such designed characteristics so that different components, devices, formulations, or systems with a same design can have different actual values with respect to those designed characteristics. Design encompasses also variations or modifications to the design, and design modifications implemented after manufacture.
The term “manufacture” or a grammatical variation thereof (e.g., “manufacturing” or “manufactured”) as related to a component, device, formulation, or system refers herein to making or assembling the component, device, formulation, or system. Manufacture may be wholly or in part by hand and/or wholly or in part in an automated fashion.
The term “structured” or a grammatical variation thereof (e.g., “structure” or “structuring”) refers herein to a component, device, formulation, or system that is manufactured according to a concept or design or variations thereof or modifications thereto (whether such variations or modifications occur before, during, or after manufacture) whether or not such concept or design is captured in a writing.
The term “body” refers herein to an animalia body.
The term “subject” refers herein to a body into which a delivery device is, or is intended to be, delivered. For example, with respect to humans, a subject may be a patient under the treatment of a health care professional.
The term “biological matter” refers herein to blood, tissue, fluid, enzymes, and other secretions of a body. The term “digestive matter” refers herein to biological matter along the GI tract in an animalia body, and other matter (e.g., food in an undigested or a digested form such as chyme) traversing the gastrointestinal tract.
The term “therapeutic preparation” refers herein to a medicinal preparation (e.g., including one component or a combination of components) intended for a therapeutic, diagnostic, or other biological purpose in any form. A therapeutic preparation may be in a liquid form, a powder form, or a condensed or a consolidated form such as a tablet or microtablet. Each therapeutic preparation can include one or more components, and a device or system can include one or more therapeutic preparations. A component of a therapeutic preparation can be, for example, a pharmacologically active agent, a deoxyribonucleic acid (DNA) or small interfering ribonucleic acid (SiRNA) transcript, a cell, a cytotoxic agent, a vaccine or other prophylactic agent, a nutraceutical agent, a vasodilator, a vasoconstrictor, a delivery enhancing agent, a delay agent, an excipient, a diagnostic agent, or a substance for cosmetic enhancement.
A pharmacologically active agent can be, for example, an antibiotic, a nonsteroidal anti-inflammatory drug (NSAID), an angiogenesis inhibitor, a neuroprotective agent, a chemotherapeutic agent, a peptide, a protein, an immunoglobulin (e.g., a TNF-alpha antibody), an interleukin in the IL-17 family of interleukins, an anti-eosinophil antibody, another antibody, a large molecule, a small molecule, or a hormone, or a biologically active variant or derivative of any of the foregoing.
A cell can be, for example, a stem cell, a red blood cell, a white blood cell, a neuron, or other viable cell. Cells can be produced by or from living organisms or contain components of living organisms. A cell can be allogeneic or autologous.
A vaccine can be, for example, against an influenza, a coronavirus, meningitis, human papillomavirus (HPV), or chicken pox. A vaccine can correspond to an attenuated virus.
A nutraceutical agent can be, for example, vitamin A, thiamin, niacin, riboflavin, vitamin B-6, vitamin B-12, another B-vitamin, vitamin C (ascorbic acid), vitamin D, vitamin E, folic acid, phosphorous, iron, calcium, or magnesium.
A vasodilator can be, for example, 1-arginine, sildenafil, a nitrate (e.g., nitroglycerin), or epinephrine.
A vasoconstrictor can be, for example, a stimulant, an amphetamine, an antihistamine, epinephrine, or cocaine.
A delivery enhancement agent can be, for example, a permeation enhancer, an enzyme blocker, a peptide that permeates through mucosa, an antiviral drug such as a protease inhibitor, a disintegrant, a superdisintegrant, a pH modifier, a surfactant, a bile salt, a fatty acid, a chelating agent, or a chitosan. A delivery enhancing agent can, for example, serve as a delivery medium for delivery of a component of a therapeutic preparation, or serve to improve absorption of a component of a therapeutic preparation into the body. A delivery enhancing agent can prime an epithelium of the intestine (e.g., fluidize an outer layer of cells) to improve absorption and/or bioavailability of one or more other components included in the delivery device.
A delay agent can be, for example, poly(lactic acid) (PLA), poly(glycolic acid) (PGA), polyethylene glycol (PEG), poly(ethylene oxide) (PEO), poly (l-lactic acid) (PLLA), poly(D-lactic acid) (PDLA), another polymer, or a hydrogel. A delay agent can be included with (e.g., mixed with, or providing a structure around) one or more other component(s) in a therapeutic preparation to slow a release rate of the other component(s) from the therapeutic preparation.
An excipient can be, for example, a binder, a disintegrant, a superdisintegrant, a buffering agent, an anti-oxidant, or a preservative. Excipients can provide a medium for a component of a therapeutic preparation (e.g., for assisting in manufacture), or to preserve integrity of a component of a therapeutic preparation (e.g., during manufacture, during storage, or after ingestion prior to dispersion within the body).
A diagnostic agent can be, for example, a sensing agent, a contrast agent, a radionuclide, a fluorescent substance, a luminescent substance, a radiopaque-substance, or a magnetic substance.
The term “ingest” or a grammatical variation thereof (e.g., “ingesting” or “ingested”) refers herein to taking into the stomach, whether by swallowing or by other means of depositing into the stomach (e.g., by depositing into the stomach by endoscope or depositing into the stomach via a port).
The term “fluid” refers herein to a liquid, and encompasses moisture and humidity. The term “fluidic environment” refers herein to an environment in which one or more fluids are present.
The terms “substantially” and “about” are used herein to describe and account for small variations. For example, when used in conjunction with a numerical value, the terms can refer to a variation in the value of less than or equal to ±10%, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1%, less than or equal to ±0.5%, less than or equal to ±0.1%, or less than or equal to ±0.05%.
As used herein, a range of numbers includes any number within the range, or any sub-range if the minimum and maximum numbers in the sub-range fall within the range. Thus, for example, “<9” can refer to any number less than nine, or any sub-range of numbers where the minimum of the sub-range is greater than or equal to zero and the maximum of the sub-range is less than nine. Ratios may also be presented herein in a range format. For example, a ratio in the range of about 1 to about 200 should be understood to include the explicitly recited limits of about 1 and about 200, and also to include individual ratios such as about 2, about 35, and about 74, and sub-ranges such as about 10 to about 50, about 20 to about 100, and so forth.
Therapeutic preparations can be delivered to a subject in various ways such as by way of oral or enteral delivery, or such as by way of parenteral delivery (e.g., intravenous, rectal, subcutaneous, transdermal, or via implant). For many techniques of delivery, it can be useful to monitor aspects of the delivery, such as environmental conditions before, during, and/or after the delivery, time of delivery, information about the therapeutic preparation delivered, and/or delivery location.
The delivery device 102 can be structured to deliver a therapeutic preparation to a body in general without a specific target delivery site, or for delivering a therapeutic preparation to a specific location within the body. The delivery device 102 can incorporate any container or structure that can be inserted or otherwise introduced into the body. In an embodiment, the delivery device 102 can be designed and structured to be delivered and/or positioned adjacent to a delivery site 110 within the body where the therapeutic preparation is intended to be delivered. The delivery site 110 could be at a subcutaneous site, an intramuscular site, a site within a cavity or organ, a site within a lumen, or other site within a body.
In an embodiment, the delivery site 110 is within a gastrointestinal (GI) tract of the subject. In an embodiment, the delivery site 110 is along a wall of the stomach, small intestine or large intestine. In an embodiment, delivery is into, or through, a wall of the GI tract; for example, delivery may be into or through a mucosal layer, into or through a sub-mucosal layer, into or through a muscular layer, into or through the serosa, into or through the peritoneum, into the peritoneal cavity, or into the mesentery or another organ in the peritoneal cavity.
In an embodiment, injection or surgical placement is used to position the delivery device 102 at or adjacent to the delivery site 110.
In an embodiment, the delivery device 102 includes, or is incorporated into, a capsule that can be orally ingested by the subject.
In an embodiment, the delivery device 102 includes a launch assembly 112 to deliver a payload to the delivery site 110. The assembly 112 may in general refer to a collection of one or more components of the delivery device 102. The assembly may include a container (e.g., a chamber) in which one or more components of the delivery device 102 are disposed.
The assembly 112 can house a carrier 114 structured to deliver a payload 116 within a subject's body. The payload 116 can include a therapeutic preparation and/or electronics.
The carrier 114 can have a number of shapes and forms, including needle-shaped, dart-like, cylindrically-shaped, cone-like, diamond-shaped, pyramidal-shaped, box-shaped, or other shape. The carrier 114 can be solid, or can define a hollow portion within the carrier 114. In an embodiment, the carrier 114 is structured to penetrate tissue and thus includes an end having a tissue penetrating shape, for example a tapered or pointed end; in another embodiment, the carrier 114 is not structured to penetrate tissue. In an embodiment, the carrier 114 is structured to be adherent to tissue (e.g., has adhesive qualities due to an adhesive substance being applied, or has adhesive qualities due to surface characteristics such as roughness). In an embodiment, the carrier 114 contains the payload 116; in another embodiment, the carrier 114 is itself the payload 116, meaning that the therapeutic formulation of the payload 116 is formed into a shape that is the carrier 114.
In the embodiment illustrated in
The launch mechanism 118 can be structured to deploy (e.g., move, exit, reveal, release, and/or launch) the carrier 114 from the delivery device 102. For example, the launch mechanism 118 may cause the carrier 114 to fully exit the delivery device 102, or may position the carrier 114 at least partially out of the delivery device 102, or at least partially out of the assembly 112, or may reveal the carrier 114 to biological matter (or digestive matter) present at the delivery site.
In an embodiment, the launch mechanism 118 is structured to launch the carrier 114 out of the delivery device 102 and into tissue of the GI tract such as a wall of the GI tract (e.g., into a layer of the wall, or through one or more layers of the wall, or through the wall and into or through the peritoneal membrane).
In an embodiment, the detector 120 corresponds to one or more detectors that are structured to detect a deployment of the carrier 114.
In an embodiment incorporating the transmitter 122, the transmitter 122 can transmit data to at least one communication device external to the subject. In an embodiment, the transmitter 122 includes a low-power oscillator circuit operating in the 10 megahertz (MHz) to 50 MHz range, more preferably in the 35 MHz to 45 MHz range, which may minimize radiofrequency (RF) wave absorption in the human body. In an embodiment, the transmitter 122 may include a tuned oscillator for amplitude modulation for improved specificity and thus improved detection of the signal.
In an embodiment incorporating the receiver 124, the receiver 124 can receive data from at least one communication device external to the subject (e.g., the first communication device 104 and/or the second communication device 106).
The memory device 126 can store data related to the delivery device, such as data received from the detector 120, one or more sensors 140 incorporated with the delivery device 102, the first communication device 104, and/or the second communication device 106. The memory device 126 can also store pre-loaded information, such as lot information of the therapeutic preparation (or payload 116), the assembly 112, the carrier 114, and/or the delivery device 102. Data in the memory device 126 may be subsequently retrieved, such as by a download of the data, or such as by the delivery device 102 transmitting the data by way of the transmitter 122.
The controller 128 can be programmed to control operation of various of the components of the assembly 112. The controller 128 may, for example, correspond to one or more of a microcontroller, an FPGA (field programmable gate array), an ASIC (application-specific integrated circuit), other integrated circuit, an analogue-based controller, or a combination of the foregoing. In an embodiment, the controller 128 includes the memory device 126. While not shown, the assembly 112 can include or otherwise be operatively coupled to a power source such as a battery. In particular embodiments, the battery may be or may include a lithium ion battery having a voltage of around 1.5 volts. At least one antenna (not shown) associated with the assembly 112 can be used to transmit signals to one or more devices external to the subject, and/or to receive signals from one or more devices external to the subject (e.g., the first communication device 104 and/or the second communication device 106).
In an embodiment, at least one antenna associated with the assembly 112 can be used to receive power from an external power source for powering one or more components associated with the system 100 (e.g., one or more of the launch mechanism 118, the detector 120, the transmitter 122, the receiver 124, the memory device 126, the controller 128, or the sensor(s) 140) and/or to recharge a battery operatively coupled to the assembly 112. In an embodiment, at least one antenna associated with the assembly 112 can both receive power and communicate signals.
In an embodiment, the assembly 112 can include an electronics module to incorporate, host, localize, interconnect and/or embed circuitry or electronics of at least one of the following: the launch mechanism 118, the detector 120, the transmitter 122, the receiver 124, the memory device 126, the controller 128, the sensor(s) 140, the power source, or the antenna(s). The electronics module can include one or more circuitry boards (e.g., printed circuited boards), integrated circuits, and/or discrete electronic components, and can couple to any portion of the assembly 112 or components thereof, or any portion of the delivery device 102.
In an embodiment, the electronics module corresponds to a printed circuit board that is substantially in the shape of a disc or annular ring (e.g., with respect to
In an embodiment, one or more of the sensors 140 can be coupled to the controller 128, such as to aid in timing, and/or monitoring, deployment of the carrier 114.
In an embodiment, the sensors 140 may be coupled to the assembly 112 or elsewhere on or within the delivery device 102. The sensors 140 can include, for example, one or more of, or a combination of, a pressure sensor, velocity sensor, accelerometer, orientation sensor, pH level sensor, torsion sensor for sensing torsion on walls of the delivery device 102, sensor for sensing breach or penetration or tension of a penetrable portion of the delivery device 102 (e.g., a breach surface such as the breach surface 230 in
In an embodiment, the controller 128 can be communicably coupled to the detector 120 and/or the sensors 140 to receive data or signals. The controller 128 can store the received data or signals in the memory device 126, and/or can cause the received date or signals to be transmitted by way of transmitter 122.
In an embodiment, the delivery device 102 can be an inflatable device that can be structured to unfurl and/or inflate when the delivery device 102 is in a desired position within the subject, such as in proximity to a delivery site 110 in a target region (e.g., a wall of the GI tract). A target region in the GI tract can be, for example, a region in an abdominal cavity, digestive system, large intestine region, cecum region, colon region, small intestine region, small bowel region, duodenum region, jejunum region, ileum region, ulcer region, cyst region, infection region, GI perforation region, intestinal lining region, or intestinal wall region. The inflatable device can inflate, align, and/or stabilize the assembly 112 in a desired position in relation to the delivery site 110 such that deployment of the carrier 114 from the assembly 112 will likely result in the carrier 114 making contact with the delivery site 110. In an embodiment, the delivery device 102 can include a launch mechanism 118 such as a compressed air source, an electromagnetic solenoid, a spring mechanism, or any other mechanism that can impart a propulsive force to eject the carrier 114 from the assembly 112 (e.g., a propulsive force against the base 236 in
In an embodiment, the delivery device 102 can further include a monitoring device structured to detect one or more predefined conditions, and to initiate deployment of the carrier 114 responsive to detecting the one or more predefined conditions. In an embodiment, a predefined condition is that a value of a parameter sensed by one of the sensors 140 is below or above a predefined threshold value. As an example, the delivery device 102 may sense a pH level of fluid outside the delivery device 102 to detect a current location of the delivery device 102. For instance, pH levels in the intestine can be greater than pH levels elsewhere in the GI tract preceding the intestine. When the delivery device 102 senses that pH levels have risen above a threshold value, the delivery device 102 can position, align, and/or stabilize the delivery device 102 or a portion thereof against a wall of the intestine (here, the delivery site 110), and can then activate the deployment mechanism to deploy the carrier 114 into the wall. The delivery device 102 can then detect the activation of the deployment mechanism and/or detect deployment of the carrier 114.
In an embodiment, the sensors 140 can include one or more sensors 140 to determine orientation of the delivery device 102 (e.g., a gyroscope, accelerometer, or microelectromechanical systems (MEMS) accelerometer). In use, an embodiment of the delivery device 102 can have at least one orientation sensor 140 that allows the delivery device 102 and/or the system 100 to detect motion of the delivery device 102 during traversal of the GI tract of the subject based on input from the orientation sensor; for example, by tracking motion, location, and/or orientation of the delivery device 102 within the GI tract over time, the sensors 140 can detect if the delivery device 102 has reached or is near a target region. The delivery device 102 can also monitor the orientation (e.g., up, down, or sideways) of the delivery device 102 in relation to the subject or some other frame of reference. As an example, in embodiments in which the delivery device 102 is an inflatable balloon and the carrier 114 is ejected from the assembly 112 into a wall of the GI tract, the delivery device 102 can ensure that upon inflation, an orientation of an ejection path of the assembly 112 is approximately perpendicular to the wall.
In an embodiment, the sensors 140 include one or more sensors (e.g., a proximity, pressure, and/or orientation sensor) to determine a position of the carrier 114 relative to that of the assembly 112, such as to detect if the carrier 114 has been deployed from the assembly 112, or if it is still held in place within the assembly 112.
In an embodiment, the sensors 140 can include one or more moisture sensors. For example, the delivery device 102 can be a capsule (e.g., a tablet, cylindrical, or low-drag form of capsule) that can be orally ingested by the subject. When the capsule reaches a target region, the capsule dissolves, causing fluid in the GI tract to make contact with other components of the delivery device 102. The delivery device 102 can detect the presence of moisture (e.g., due to the fluid in the GI tract), and can initiate deployment of the carrier 114. In an embodiment, an outer surface of the delivery device 102 can include one or more contacts that are coated with an enteric coating. The exposure of the delivery device 102 to the fluids in the GI tract can cause the enteric coating to dissolve, exposing the contacts. The delivery device 102 can detect exposure of the contacts to the moisture based on, for example, changes in one or more electrical characteristics of the contacts. The delivery device 102, responsive to detecting the exposure of the contacts to the moisture, can initiate a mechanism (e.g., inflation of a balloon) that can, for example, appropriately orient the assembly 112 in relation to the delivery site 110.
The first communication device 104 and/or the second communication device 106 can be positioned or located external to the subject, and each can be capable of communicating with the delivery device 102, and can be capable of communicating with each other.
The first communication device 104 can include a first communication device transmitter 130, a first communication device receiver 132, a first communication device memory device 134, and/or a first communication device controller 136. The second communication device 106 may be structured with components similar to those of the first communication device 104 (e.g., the second communication device 106 may include a transmitter, receiver, memory device, and controller), or may be structured with additional, fewer, or different components than the first communication device 104.
The first communication device 104 can be used to communicate with the delivery device 102 via transmittal from the transmitter 130 of the first communication device 104 to the receiver 124 of the delivery device 102, and/or via reception by the receiver 132 of the first communication device 104 from the transmitter 122 of the delivery device 102. Similarly, the second communication device 106 can be used to communicate with the delivery device 102.
The first communication device 104 can be used to communicate with the second communication device 106. Similarly, the second communication device 106 can be used to communicate with the first communication device 104.
The memory device 134 of the first communication device 104 can store data received from the delivery device 102 and/or from the second communication device 106.
In an example communication scenario, the assembly 112 (e.g., via transmitter 122 and an antenna) can communicate data collected and/or generated by the detector 120 and/or the sensor(s) 140 to the first communication device 104 and/or to the second communication device 106, and can receive data and/or power from the first communication device 104 and/or from the second communication device 106. The data received by the delivery device 102 can include commands or instructions to execute one or more actions, such as activating the launch mechanism 118. In an embodiment, the first communication device 104 can be positioned in close proximity to the subject, and can provide power to the delivery device 102 through electromagnetic induction. The first communication device 104 also can communicate with the delivery device 102 (e.g., via low power and/or short-range communications). In an embodiment, the first communication device 104 can relay data received from the delivery device 102 to the second communication device 106. In another embodiment, the second communication device 106 can communicate directly with the delivery device 102. The first communication device 104 and/or the second communication device 106 can communicate with a cloud database 108. For example, the first communication device 104 and/or the second communication device 106 can relay or communicate data received from the delivery device 102 to the cloud database 108 (e.g., for storage, logging, processing and/or analysis).
In an embodiment, the delivery device 102 includes one or more passive or active RF identification (RFID) devices; the first communication device 104 and/or the second communication device 106 can power and read the RFID(s) to identify various components of the delivery device 102 and/or to read a status provided by one or more of the RFID(s).
The first communication device controller 136 can be programmed to control the operation of the various components of the first communication device 104.
The delivery device 102, the assembly 112, and the launch mechanism 118 can take many forms.
The piston 232 includes a rod 234 and a base 236. One end of the rod 234 can be attached to and/or operates as a support or holder for the carrier 114, while the opposite end of the rod 234 can be attached to or supported by the base 236.
The assembly 112 includes a lower wall 224, an upper wall 226, and sidewalls 228 that extend between the lower wall 224 and the upper wall 226. The assembly 112 includes a breach surface 230. In the examples of
The assembly 112 in the examples of
The sidewalls 228 define a channel 240 or guiding structure within which the base 236 can move in a direction along a longitudinal axis 238 of the carrier 114. The movement of the base 236 can be provided by a mechanical or propulsive force to the base 236. The lower wall 224 of the assembly 112, for example, can define an opening or an aperture (not shown) through which the mechanical or propulsive force can be provided to the base 236, causing the base 236 to move away from the lower wall 224. The channel 240 can guide the base 236 in a direction that is along the longitudinal axis 238 of the carrier 114 and towards the upper wall 226. A sustained force to the base 236 can cause the base 236 to move through the channel 240 such that the carrier 114 breaches through the breach surface 230 and at least partially exits the assembly 112.
Movement or position of the base 236 or the carrier 114 or breach of the carrier 114 through the breach surface 230 (any of which are referred to in general herein for convenience as deployment of the carrier 114) can be detected by the detector 120 (
In an embodiment, responsive to detecting deployment of the carrier 114, the detector 120 can trigger or cause the controller 128 to send (via the transmitter 122) one or more signals to the first communication device 104 and/or the second communication device 106. An application (e.g., program or agent) executing on the first communication device 104 and/or the second communication device 106 may receive the one or more signals (e.g., via the first communication device receiver 132). In an embodiment, the application may record or store a timestamp, such as a date and/or a time of deployment of the carrier 114 (e.g., delivery of the payload 116).
In an embodiment, the first communication device 104 and/or the second communication device 106 may transmit received information to the cloud database 108. During clinical trials, for example, knowing the approximate or specific time of drug delivery can be helpful in pharmacokinetic studies with short half-life drugs (e.g., to indicate a starting point for blood analysis); or, during therapeutic treatment, knowing the approximate or specific time of drug delivery can be helpful to determine an expected amount of a component of a therapeutic formulation in the bloodstream over time for a single dose or multiple sequential doses. In addition, the cloud database 108 can collect and/or collate data from one or more subjects. Such information collected via the application(s) and/or the cloud database 108 can be used, for example, in post-market monitoring of a subject, during studies (e.g., Phase IV studies), or to collect usage information over a population of subjects. If it is detected that the subject is late or past a schedule for completion of drug delivery (e.g., forgets to take a capsule or pill incorporating the delivery device 102), the application can remind the subject via the first communication device 104 and/or the second communication device 106, hence facilitating and improving compliance by the subject.
The controller 128 can also send information associated with each delivery of the payload 116, and information for traceability and/or compliance purposes. The information (e.g., for traceability and/or compliance purposes) can help avoid or track an expired or expiring lot, and help identify manufacturing concerns by lot number.
In an embodiment, the controller 128 can detect, collect and/or store parameter profiles (e.g., deployment, motion, location, orientation, temperature, pressure, pH, and/or gas flow information) over one or more time instances, to internal memory (e.g., the memory device 126), and can transmit the information as well as other data (e.g., type of therapeutic formulation, part number, lot number) to the application of the first communication device 104 and/or the second communication device 106. Such information can be further relayed to or stored at the cloud database 108. This information can also be used to initiate proper delivery of the payload 116, by allowing the application or user to identify suitable conditions and a time instance to remotely trigger deployment of the carrier 114 via a signal from the first communication device 104 and/or the second communication device 106. This information can be monitored before, during, and after delivery of the payload 116, to check for or ensure proper delivery of the payload 116. This information can be used to monitor compliance to a therapy regimen and schedule (e.g., to ensure that a capsule is swallowed), the required schedule is adhered to (e.g., via recorded timestamps), and the proper therapeutic preparation is administered (e.g., via transmission of pre-loaded part number or lot number).
In an embodiment, the stored and/or transmitted information can be used to characterize a target region (e.g., the GI tract). For example, in an embodiment in which the delivery device 102 is a capsule containing a deployable balloon and an embodiment of the assembly 112, the information can include a log of ambient temperature (e.g., inside and/or outside the capsule, inside and/or outside the balloon), ambient pressure (e.g., inside and/or outside the capsule, inside and/or outside the balloon), applied forces (e.g., on the capsule, on the balloon), pH (e.g., inside and/or outside the capsule, inside and/or outside the balloon), orientation and/or motion data (e.g., of the capsule, balloon, chamber, carrier) such as velocity, acceleration, gyroscopic conditions (e.g., yaw, pitch, roll), or video data.
In an embodiment, the stored and/or transmitted information can be used to perform one or both of diagnostics and therapy. For example, the information can be used to detect a previously-applied marker (e.g., ink or other dye, radiopaque mark, metal staple, metal plate, or metal piece) or implant. The information can be also used to monitor surroundings of such implant or marker. For example, the information can be used to detect indications of swelling or infection, identify the marker, and deliver the payload 116 (e.g., the therapeutic preparation or electronics) at the marker. The information can further be used to compare the GI tract data of the subject to previously-acquired characteristic data for that subject to monitor for changes. For example, information on such changes may be used to titrate or otherwise adjust (e.g., cease) the delivery of a given therapeutic preparation.
The information can be used to compare the GI tract data of the subject to previously-acquired characteristic data for a patient population with respect to a certain condition, to identify whether the subject has a likelihood of that condition (e.g., by training a machine learning model and/or using a machine learning model). The information can be used to compare the GI tract data of the subject to previously-acquired characteristic data of a patient population in general, to identify potential anomalies (e.g., by using a trained machine learning model).
In an embodiment, the information can be used to detect the presence of a chemical or other substance, including one or more metabolic analytes and/or biomarkers (e.g., insulin, glucose, partial pressure of oxygen (PO2), hemoglobin (including oxy and deoxy hemoglobin), iron, glucose, bile, or cholesterol) as well as cells indicative of a disease or condition, or indicative of a change in such a disease or condition.
In an embodiment, the information can be used to detect presence of temperature anomalies (e.g., high temperature relative to body temperature), or high variations in temperature, or other characteristic.
Information such as parameter profile(s) can correspond to reporting of various characteristics and/or occurrences. Such information can be used to determine proper or successful delivery of therapeutic preparation to the subject, including proper operation of a delivery device (e.g., the delivery device 102) as expected, confirmation of a location of the device in the GI tract, and/or location of a delivered therapeutic preparation (e.g., into an intestinal wall, into a peritoneal cavity).
Attention is now directed to the specific examples illustrated in
During deployment, the movement of the base 236 towards the upper wall 226 can cause a reduction in a distance or separation between the detector 220 and the defined portion 222. In an embodiment, deployment of the carrier 114 can be defined as a position of the base 236 where the base 236 is in close proximity to or in contact with the upper wall 226. For example, when a propulsive force is applied to the base 236, the base 236 moves towards the upper wall 226. The continuous application of the propulsive force can cause the base 236 to continue to move toward the upper wall 226 until the upper wall 226 (or another impediment provided by a design of the assembly 112) causes the base 236 to stop moving. At this position, the proximity and/or contact of the detector 220 and the defined portion 222 can be communicated to the controller 128; for example, one or both of the detector 220 and the defined portion 222 can include conductors such that they form a portion of a detection circuitry in electrical communication with the controller 128. The detection circuitry can detect the proximity or contact of the detector 220 and the defined portion 222 by way of a change in a received voltage or current, or by a switching mechanism. For instance, the detector 220 can include an electrical switch (e.g., an electric contact switch), an electro-mechanical sensor (e.g., including a piezoelectric transducer, limit switch, actuator, or a resistive sensor), a pneumatic sensor, a magnetic sensor, an inductive sensor (e.g., an inductive proximity switch), a capacitive sensor, a photoelectric sensor (e.g., a diffuse sensor), a reflective sensor, a through-beam sensor, an infrared (IR) photodetector, or an ultrasonic sensor (e.g., using surface acoustic wave absorption).
In an embodiment, deployment of the carrier 114 can be defined as a position of the base 236 intermediate to a position that is nearest to the lower wall 224 and a position that is nearest to the upper wall 226. In an embodiment, the detector 220 is a proximity detector that detects the proximity of the detector 220 to the defined portion 222 in comparison to a threshold value. The proximity detector can be a magnet sensor, a capacitive sensor, an inductive sensor, an optical sensor, a photoelectric sensor, an ultrasonic sensor, a diffuse sensor, a reflective sensor, a through-beam sensor, or any other proximity measuring or detecting sensor. The controller 128 can be structured to measure an appropriate parameter to determine whether the detector 220 is in contact with or in close proximity to the defined portion 222. The position of the detector 220 can be different from that shown in
In an embodiment, the detection circuitry can include sensor(s) for the voltage, the current, or both at the switch 264 to detect activation of the switch 264. In an embodiment, the switch 264 or the detection circuitry can be connected to an input-output (I/O) port of the controller 128, and the controller 128 can detect the activation of the switch 264.
The trigger 262 can be shaped and/or positioned anywhere on the base 236 that can allow the trigger 262 to move or be initiated when the base 236 is in a position that corresponds to deployment of the carrier 114. As an example, the trigger 262 may include a trigger pin. When the carrier 114 is deployed to the top of the assembly 112, the trigger pin may come in contact with the upper wall 226 of the assembly 112, and can be pushed through the base 236 by continued momentum of the base 236 towards the upper wall 226. The trigger pin, when pushed through (or relative to) the base 236, can activate the switch 264 which indicates deployment of the carrier 114.
In an embodiment, instead of (or in addition to) the standoff 290, the conductive bridge 276 can include memory metal that has a memory in the non-contact state. In a normal or non-contact state, the trigger 272 can be positioned on one end of the electrically conductive bridge 276, the other end of which can be attached to the first contact surface 278 of the switch 274. The second contact surface 280 may be positioned on the top surface of the switch 274 below the end of the conductive bridge 276 on which the trigger 272 is positioned. The second contact surface 280 and the first contact surface 278 may be separated by an insulating material. When the trigger 272 is pressed towards the top surface of the switch 274, the conductive bridge 276 can bend downwards (e.g., against the memory of the memory metal). With sufficient force on the trigger 272, the end of the conductive bridge 276 near the trigger 272 can make contact with the second contact surface 280, causing a conductive path between the first contact surface 278 and the second contact surface 280.
In an embodiment, the switch 274 can be implemented using, or can be replaced by, one or more of an electrical switch, a piezoelectric switch, a capacitive transducer, a resistive transducer, and/or other type of switch discussed herein.
In an embodiment, the material 521 can be made of a thin layer of metal or alloy (e.g., a thin layer of aluminum foil) or other conductive material that can be breached (e.g., torn, disrupted, disintegrated, or perforated) when the carrier 114 is deployed. In an embodiment, the material 521 is a conductive or non-conductive material incorporating one or more conductive wires, traces, fibers, threads, or inks that can be broken when the carrier 114 is deployed.
One or more wires 522 can be connected to the material 521 such that the material 521 and the wires form a portion of detection circuitry of the delivery device 102 to detect a breach of the material 521 by detecting a change in one or more electrical characteristics of the material 521, such as detection of a circuit break due to the carrier 114 tearing through or disrupting the material 521 or breaking the conductive wires, traces, fibers, threads, or inks incorporated in the material 521. The breach of the material 521 can result in a change in one or more electrical characteristics of the material 521. The detection circuitry can be structured to detect these changes. For example, the breach of the material 521 can break a circuit or increase the resistance of the material 521, which change can be detected by the detection circuitry, such as by the controller 128.
In an embodiment, the detection circuitry can compare the measured electrical characteristic of the material 521 with a characteristic curve (e.g., across one or more lots of the material 521 and/or one or more lots of the assembly 112). In certain embodiments, the detection circuitry can compare the measured electrical characteristic of the material 521 with a characteristic curve which can have values corresponding to various states of the material 521. The various states can include, for example: no deployment of the carrier 114 (e.g., intact material 521), partial deployment of the carrier 114, and/or deployment of the carrier 114 (e.g., material 521 fully breached). Comparison of the measured value with the value on the characteristic curve can indicate the state of the material 521. The electrical characteristic of the material 521 measured by the detection circuitry can be, for example, a resistance, a capacitance, or an inductance of the material 521. Multiple such electrical characteristics may be measured by the detection circuitry.
In an embodiment, the wires 522 can be painted or printed on the breach surface 530. In an embodiment, the wires 522 can be laid over or under the breach surface. In an embodiment, all, or a portion of, the detection circuitry (e.g., including the wires 522) can be located or embedded in a neck region of the assembly 112 defined by sidewalls that extend between the breach surface 530 and an upper wall 526. Multiple wires 522, and/or multiple conductive wires, traces, fibers, threads, or inks, can be used to allow for more resolution in determining where a breach occurs in the material 521 (e.g., by using a ladder resistance circuit, or a matrix resistance circuit).
In particular, the detector 620 can include an air flow or a gas flow detector that can detect a flow 622 of gas or air into the assembly 112. In an embodiment, the flow 622 into the assembly 112 is due to gas or air drawn or pulled into the assembly 112 when the base 636 moves through a trajectory for deployment of the carrier 114. In an embodiment, the flow 622 into the assembly 112 is used to provide a propulsive force to the base 636. The propulsive force can cause the base 636 to move in a direction along a longitudinal axis 638 of the carrier 114. A sustained propulsive force can cause the base 636 to continue its motion in the channel 640 and thereby cause the carrier 114 to breach the breach surface 630 of the assembly 112.
The detector 620 can include an air flow or gas flow sensor (e.g., located within the assembly 112), that determines a magnitude of air or gas flow (for example, in standard cubic centimeter per minute (SCCM) units) entering the assembly 112. The detector 620 may form a portion of a detection circuitry which can correlate the air flow measurement by the detector 620 with a predicted position or movement of the base 636 and/or the carrier 114. For example, the controller 128 (
In an embodiment, other example detectors, alternatively or in addition to the ones discussed above in relation to
In an embodiment, detectors can include electrical switches, electro-mechanical sensors, pneumatic sensors, magnetic sensors, inductive sensors, capacitive sensors, photoelectric sensors, or ultrasonic sensors. Measurements from one or more of these detectors can be used to determine the successful deployment of the carrier 114.
The carrier 714 has a first end 770 and a second end 772. The carrier 714 has a shape where the cross-sectional area, measured normal to a longitudinal axis 738 of the carrier 714, increases with an increase in distance from the first end 770. The carrier 714 can include a housing 774 that defines a cavity 776, which houses an antenna 716 (e.g., which may be a wire wrapped circularly within the cavity 776 such that ends of the wire appear as circles in the cross-section as illustrated) and electrical components 778, for example disposed on a circuit board 779.
The electrical components 778 can include sensors and/or a therapeutic preparation deployment mechanism. In an embodiment, the electrical components 778 can include a detector, such as for detecting deployment of the carrier 714 out of the assembly 112. For example, the carrier 714 can include detector(s) for determining a proximity or location of the carrier 714 relative to the assembly 112. This information may also be used in conjunction with information regarding one or more environmental conditions of the carrier 714 or the delivery device 102 (e.g., temperature, pressure, pH) in comparison with a characteristic or expected profile (e.g., a characteristic curve) or threshold, such as for determining an orientation or motion of the carrier 714 relative to the assembly 112. In an embodiment, the carrier 714 can include additional circuitry that, in response to detecting deployment of the carrier 714, can activate deployment of a therapeutic preparation included in the carrier 714 as part of the payload 116 into the delivery site 110 and/or activate transmission of data from within the carrier 714. The antenna 716 (in conjunction with communication electronics such as one or more of the electrical components 778) can be used to transmit data from the carrier 714 to the delivery device 102, and/or to the first communication device 104, and/or to the second communication device 106. The antenna 716 (in conjunction with communication electronics such as one or more of the electrical components 778) can further be used to receive information from the delivery device 102, the first communication device 104, and/or the second communication device 106; such as data from which the carrier 714 determines a time at which to release the therapeutic formulation from the carrier 714, or such as instructions to release the therapeutic formulation from the carrier 714.
The second example carrier 814 is similar to the first example carrier 714 in many respects, and like components have been labeled with like reference numerals. The carrier 814 includes a first end 870 and a second end 872. However, unlike the carrier 714, the cross-sectional area of the carrier 814 measured normal to the longitudinal axis 738 first increases with an increase in a distance from the first end 870 up to an intermediate portion 880, and then decreases past the intermediate portion 880. The carrier 814 can function in a manner similar to that discussed in relation to the carrier 714.
In an embodiment, the first communication device 104 can further include a user control and notification module that includes I/O and peripheral devices such as keyboard and/or display screen (e.g., a touchscreen) for receiving user input and providing user notifications. The first communication device 104 can also include additional communication interfaces, such as a network interface module (e.g., Ethernet, Wi-Fi, Bluetooth, 2G, 3G, 4G, 5G) to communicate data to the cloud database 108 and/or to the second communication device 106. In an embodiment, the power supply 150 can include a battery, a battery charger, and/or a power management circuitry that provides power in the form of one or more voltage potentials or currents to various components of the first communication device 104.
Referring again to
By way of an example, the electronics of the assembly 112 can include an active RFID device that includes the transmitter 122 with a power source (e.g., a battery such as a lithium-ion battery), so that the transmitter 122 can send information (e.g., detected and/or stored by the sensor(s) 140 and/or the detector 120) to the first communication device 104. In an embodiment, the assembly 112 can include a passive RFID device that has no battery. The passive RFID device can draw power from an RFID reader (e.g., the first communication device 104) which sends out electromagnetic waves that induce a current in the passive RFID device's antenna. By drawing power from the RFID reader, the passive RFID device can transmit information (e.g., detected and/or stored by the sensor(s) 140 and/or the detector 120) to the first communication device 104.
Various embodiments also contemplate use of external antennas and associated receiver devices that can receive signals from the transmitter 122. In an embodiment, such antennas and receiver devices may be structured to be wearable by the user, and the antenna and the first receiver device can be integrated into a wearable structure. In an embodiment, the wearable structure can include a stretchable belt or band worn around the waist, chest, wrist, or other portion of the body; the belt or band can be structured to allow for a substantially one-size-fits-all design. Such embodiments can be achieved through the use of elastic fabric and other elastic materials.
In an embodiment, optionally a PCB 1006 is attached at an end portion 1008 or 1010 of the belt 1000. In an embodiment, the PCB 1006 or other circuitry may be attached in other locations along the belt 1000 such as at central portion of the belt, or the belt 1000 may be attached to connections on the first communication device 104. The PCB 1006 provides a location to house electronics and/or battery, or provides an electrical connection between the antenna 1104 and the first communication device 104.
In the deployed or stretched position, the belt 1000 can be worn by the subject by coupling the end portions 1008, 1010 to the first communication device 104, or by coupling the end portion 1008 to the end portion 1010 of the belt 1000 (e.g., where the first communication device 104 is integrated with the belt 1000). End portions 1008 and 1010 may include a magnetic buckle or other fastening means so as to allow the user to easily buckle or fasten the end portions 1008 and 1010 together. During operation, the antenna 1004 can receive signals from the assembly 112 or the delivery device 102 and such signals can be provided to the first communication device 104 or other circuitry of the belt 1000. In an embodiment, components (e.g., the first communication device 104 or other circuitry) on the belt 1000 can be structured to process the signals to extract data embedded in the signals. In these and other embodiments, such components can also be structured to process the data and store the data in memory or relay the data to the second communication device 106 (e.g., a smartphone, tablet computing device, laptop, or other computing device) and/or to the cloud database 108. In use, embodiments of the belt 1000 allow the user to easily and unobtrusively receive signals from the transmitter 122, such as regarding the status of deployment of the carrier 114.
The belt 1000 is discussed herein as illustrative, and is by no means limiting in any way. Many other embodiments are also contemplated. For example, the first communication device 104 can be or be included as part of any type or form of device worn on the subject, such as on a lanyard or necklace (e.g., as a pendant device), an arm band (e.g., which may include or be incorporated into a fitness or health tracker device, or smartphone), a wristband (e.g., such as a smartwatch or exercise monitoring device), or attached to any type of belt. For example, an antenna can be implemented in any of the foregoing lanyard, necklace, arm band, wristband, belt or strap, and electrically coupled to the first communication device 104. As further examples, the first communication device 104 can include any type or form of device (e.g., smartphone, tablet computer, or the like) carried by the subject, for instance in a pocket, pouch, bag, or backpack. In additional or alternative embodiments, the first communication device 104 can include any type or form of device located proximate to the subject (e.g., connected to or in a vehicle, seat, bed, machine or computer operated by, occupied by, or otherwise used by the subject). In an embodiment, the belt 1000 can be structured to be a replacement belt or strap that can be used with or coupled to an existing belt loop, belt buckle, or strap holder.
The process 1100 can further include deploying (at 1104) the carrier by guiding the carrier (e.g., in a direction along a longitudinal axis of the carrier) to cause the carrier to at least partially exit the launch assembly. In an embodiment, a propulsive force can be provided to the launch assembly, which causes the carrier to move within a channel (e.g., the channel 240 or the channel 640) in a direction along a longitudinal axis of the carrier. In an embodiment, a continuous application of the propulsive force can cause the carrier to breach a penetrable portion (e.g., the breach surface 230 or the breach surface 630) of the launch assembly, which causes the carrier to partially or fully exit the launch assembly.
The process 1100 can further include detecting (at 1106) deployment of the carrier. In an embodiment, the launch assembly and/or the carrier include detectors that can detect deployment of the carrier. In an embodiment, the process 1100 includes the launch assembly detecting contact with or proximity to a defined portion of the launch assembly indicative of deployment of the carrier (e.g., using the detector 220, the detector 260, the detector 520, the detector 620, and/or other detectors). The determination that deployment has occurred may be relayed by the delivery device 102 to the first communication device 104 and/or the second communication device 106.
In an embodiment, the process 1100 includes the carrier detecting its own deployment, such as by detecting proximity to the launch assembly, or such as by detecting motion of the carrier; the proximity and/or motion over time may be compared to predefined characteristic curves stored in a memory of the carrier to identify when the carrier comes to rest after initiation of deployment. An example of such characteristic curve indicates an increasing motion from an initial value, crossing a predefined threshold value as motion increases, reaching a peak value of motion, decreasing motion, and crossing the threshold value or another predefined threshold value as motion decreases. Another example of such characteristic curve indicates an increasing motion from an initial value to a peak value followed by a decreasing motion, where a determination of deployment includes determining that motion has decreased by a predefined percentage of the peak value, or that a ratio of rise time to fall time of the motion curve reaches or crosses a predefined threshold ratio. Another example of such characteristic curve indicates an initial proximity to the launch assembly with a subsequent decreasing distance from the launch assembly to a predefined threshold value. In an embodiment, two or more determinations are made, such as determining that the carrier is remote from the launch assembly and determining that the carrier is no longer in motion. The determination that deployment has occurred may be relayed by the carrier to the delivery device 102, the first communication device 104, and/or the second communication device 106.
The process 1200 can include guiding (at 1204) the carrier (e.g., in a direction along a longitudinal axis of the carrier) and deploying the carrier, after the inflatable portion of the delivery device is inflated to cause the carrier to at least partially exit the delivery device. In an embodiment, the inflatable portion of the delivery device can be inflated to position the launch assembly in proximity with a target delivery site (e.g., the delivery site 110). In an embodiment, once the inflatable portion of the delivery device is inflated, the carrier can be deployed by providing a propulsive force or other force within the delivery device. In an embodiment, the inflation of the inflatable portion provides the propulsive force.
The process 1200 can include detecting (at 1206) a status of deployment of the carrier. Detection can be, for example, as described with respect to
The process 1300 can include detecting (at 1306) a status of deployment of the carrier. Detection can be, for example, as described with respect to
In an embodiment, the processes discussed above in relation to
The processes can further include receiving commands or instructions from the external devices (e.g., to inflate the delivery device, or to launch the carrier). Responsive to receiving the command or instructions, the processes can include for instance initiating deployment of the carrier by applying a propulsive force within the launch assembly.
The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatuses can also be implemented as, special purpose logic circuitry (e.g., an FPGA or an ASIC).
A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. A computer program may, but need not, correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub-programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.
Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. A computer includes a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data (e.g., magnetic, magneto-optical disks, or optical disks). However, a computer need not have such devices. Moreover, a computer can be embedded in another device (e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device such as a USB flash drive). Devices suitable for storing computer program instructions and data (e.g., the memory device 126, the memory device 134, and on or more devices of the second communication device 106) include all forms of volatile or non-volatile memory, media and memory devices, including by way of example semiconductor memory devices (e.g., non-volatile memory such as EPROM, EEPROM, or flash memory devices, or volatile memory such as RAM, FRAM, MRAM, or DRAM); magnetic disks (e.g., internal hard disks or removable disks); magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry. The memory device 126 and the memory device 134 may each be implemented in a single device or across multiple devices, such that each of the memory device 126 and the memory device 134 can have one or more of any of the above-mentioned devices suitable for storing computer program instructions and data.
To provide for interaction with a user, implementations of the subject matter described in this specification can be implemented on a computer having a display device (e.g., a CRT (cathode ray tube), plasma, or LCD (liquid crystal display)) for displaying information to the user, a keyboard, and a pointing device (e.g., a mouse or a trackball) by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can include any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form, including acoustic, speech, or tactile input. In addition, a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; for example, by sending web pages to a web browser on a user's client device in response to requests received from the web browser.
Implementations of the subject matter described in this specification can be implemented in a computing system that includes a back-end component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front-end component (e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification), or any combination of one or more such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network (LAN) and a wide area network (WAN), an inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
Embodiments of the present disclosure include, without limitation, the following aspects:
The foregoing aspects, and aspects of other embodiments, may include without limitation one or more of the following features:
Having now described some illustrative implementations, it is apparent that the foregoing is illustrative and not limiting, having been presented by way of example. In particular, although many of the examples presented herein involve specific combinations of method acts or system components, those acts and those components may be combined in other ways to accomplish the same objectives. Acts, components and features discussed only in connection with one implementation are not intended to be excluded from a similar role in other implementations or implementations.
While operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results.
The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including” “comprising” “having” “containing” “involving” “characterized by” “characterized in that” and variations thereof herein, is meant to encompass the items listed thereafter, equivalents thereof, and additional items, as well as alternate implementations consisting of the items listed thereafter. In one implementation, the systems and methods described herein consist of one, each combination of more than one, or all of the described acts or components.
Any references to implementations of components or acts of the systems and methods herein referred to in the singular may also embrace implementations including a plurality of these components, and any references in plural to any implementation or element or act herein may also embrace implementations including only a single element. References in the singular or plural form are not intended to limit the presently disclosed systems or methods, their components or acts, to single or plural configurations. References to any act or element being based on any information, act or element may include implementations where the act or element is based at least in part on any information, act, or element.
Where technical features in the drawings, detailed description or any claim are followed by reference signs, the reference signs have been included for the sole purpose of increasing the intelligibility of the drawings, detailed description, and claims. Accordingly, neither the reference signs nor their absence has any limiting effect on the scope of any claim elements.
The systems and methods described herein may be embodied in other specific forms without departing from the characteristics thereof. The foregoing implementations are illustrative rather than limiting of the described systems and methods. Also, components, characteristics, or acts from one embodiment can be readily recombined or substituted with one or more components, characteristics or acts from other embodiments to form numerous additional embodiments within the scope of the invention. Moreover, components that are shown or described as being combined with other components, can, in various embodiments, exist as standalone components. Further still, embodiments of the invention also contemplate the exclusion or negative recitation of an element, feature, therapeutic preparation, characteristic, value or step wherever said element, feature, chemical, therapeutic preparation, characteristic, value, step or the like is positively recited. Hence, the scope of the present invention is not limited to the specifics of the described embodiments, but is instead limited solely by the appended claims, and changes that come within the meaning and range of equivalency of the claims are embraced therein.
This application is a continuation of U.S. National Phase of PCT Application No. PCT/US2020/034883 filed on May 28, 2020 which, in turn, claims the benefit of U.S. Provisional Application No. 62/854,101 filed on May 29, 2019, the disclosures of which are hereby incorporated in their entirety by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 62854101 | May 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2020/034883 | May 2020 | US |
| Child | 17536342 | US |
