Patent Application
20210322273
The present disclosure relates generally to medical devices and more particularly to a drug delivery system for controlled delivery of medication with confirmation thereof.
One challenge faced in the healthcare field takes place at home, where patients manage their own care and medication compliance. Healthcare providers often cannot know for certain if patients have faithfully taken medication at proper intervals and with the correct doses. Healthcare professionals also cannot be present to prevent accidental overdose or to ensure that the correct medication is administered.
In at least the case of medical trials, these issues take on a different importance, where drug development relies on the observation and confirmation that the medication has been correctly administered.
According to an embodiment of the present invention, a drug delivery device includes a capsule, a logic circuit disposed within the capsule, and an actuator connected to the logic circuit and configured to expose an interior of the capsule to an exterior of the capsule upon activation by the logic circuit.
According to an embodiment of the present invention, a method of controlling a drug delivery device comprising a capsule, a logic circuit disposed within the capsule, and an actuator connected to the logic circuit includes sensing a location of the drug delivery device, determining entry of the drug delivery device into an intestine using the location, communicating an authorization request to an external computer system upon determining entry into the intestine, receiving an authorization from the external computer system, and activating, by the logic circuit, the actuator to expose an interior of the capsule to an exterior of the capsule upon receipt of the authorization.
According to an embodiment of the present invention, a method of controlling a drug delivery device comprising a capsule, a logic circuit disposed within the capsule, and an actuator connected to the logic circuit includes sensing a location of the drug delivery device, determining entry of the drug delivery device into an intestine using the location, communicating an authorization request to an external computer system upon determining entry into the intestine, determining an authorization fail from the external computer system, and activating, by the logic circuit, the actuator to render a medication containing with the capsule insert upon receiving the authorization fail upon determination of the authorization fail.
As used herein, “facilitating” an action includes performing the action, making the action easier, helping to carry the action out, or causing the action to be performed. Thus, by way of example and not limitation, instructions executing on one processor might facilitate an action carried out by instructions executing on a remote processor, by sending appropriate data or commands to cause or aid the action to be performed. For the avoidance of doubt, where an actor facilitates an action by other than performing the action, the action is nevertheless performed by some entity or combination of entities.
One or more embodiments of the invention or elements thereof can be implemented in the form of a computer program product including a computer readable storage medium with computer usable program code for performing the method steps indicated. Furthermore, one or more embodiments of the invention or elements thereof can be implemented in the form of a system (or apparatus) including a memory, and at least one processor that is coupled to the memory and operative to perform exemplary method steps. Yet further, in another aspect, one or more embodiments of the invention or elements thereof can be implemented in the form of means for carrying out one or more of the method steps described herein; the means can include (i) hardware module(s), (ii) software module(s) stored in a computer readable storage medium (or multiple such media) and implemented on a hardware processor, or (iii) a combination of (i) and (ii); any of (i)-(iii) implement the specific techniques set forth herein.
Techniques of the present invention can provide substantial beneficial technical effects. For example, one or more embodiments may provide one or more of the following advantages:
These and other features and advantages of the present invention will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.
Preferred embodiments of the present invention will be described below in more detail, with reference to the accompanying drawings:
Embodiments of the present invention relate to an oral drug delivery system that records the administration of medication to a patient, controls the delivery of the medication, and reports or logs information about the administration and release of the medication (e.g., to healthcare professionals). According to one or more embodiments of the present invention, the drug delivery system includes a drug delivery device, wherein the system determines a consumption status of the drug delivery device, and once the drug delivery device has passed the patient's stomach (and can no longer be regurgitated or vomited), controls medication delivery in adherence to a prescription, thereby preventing overdose, abuse, or delivery of incorrect medication. According to one or more embodiments of the present invention, the drug delivery device is configured to detect attempts to extract medication from the device.
Referring to
According to one or more embodiments of the present invention, the drug delivery device includes a pH sensor. Since the intraluminal pH rapidly changes from highly acidic stomach (e.g., with a pH between about 1.5 to 3.5) to about pH 6 in the duodenum, the drug delivery device can use the pH sensor to confirm passage into the small intestine 103.
According to at least one embodiment of the present invention, the pH sensor includes a measuring electrode, a reference electrode, and a temperature sensor. A signal output by the pH sensor can be processed (e.g., applied through preamplifier) and communicated to an external (to the patient) computer system for analysis, confirming a sufficient drop in pH to confirm the drug delivery device's location outside the stomach.
The drug delivery device communicates with the external computer system, confirming consumption once past stomach 103. The drug delivery device includes a wireless communication package for communicating with the external computer system. According to an exemplary embodiment of the present invention, the drug delivery device measures exogenous pH levels. The confirmation can be performed by the drug delivery device itself or by the external computer system.
According to at least one embodiment of the present invention, the drug delivery device releases 104 a medication according to prescribed dosage, timed release, and/or digestive location based release. The release is communicated to the external computer system where the release is logged 105.
According to an embodiment of the present invention, the drug delivery device can communicate with the external computer system to confirm adherence to a prescription. For example, the external computer system stores information about dosage and timing defined by a certain prescription. In a case where the patient incorrectly takes an incorrect drug delivery device, the drug delivery device will request an authorization from the external computer system (e.g., upon confirming consumption) for release of its contents. According to an embodiment of the present invention, the confirmation 103 includes an authorization request. In this case the drug delivery device is denied authorization from the external computer system when the external computer system communicates an authorization fail to the drug delivery device, and the contents are not released or are rendered inert. The request for authorization 103 from the drug delivery device can include information about the type of medication and/or dosage, which are to be confirmed by the external computer system by comparing this information with the stored prescription. Similarly, the external computer system can capture information about the number of drug delivery devices consumed, and make decisions about which, if any, devices to grant authorization to release contents.
According to an embodiment of the present invention, the electronics package can determine an authorization fail (see block 104,
It should be understood that the external computer system can embodiment a variety of logic for comparing information received from the drug delivery device to stored information (e.g., prescriptions, drug interactions, etc.) in making authorization decisions.
One of ordinary skill in the art would recognize that the drug delivery device may contain, or may itself be, a placebo.
According to at least one embodiment of the present invention, the drug delivery device continuously monitors its own integrity 106. If the drug delivery device is disturbed, a signal indicating a breach (or possible breach) in integrity is communicated by the drug delivery device to the external computer system where the activity is logged 107. Further, in at least one embodiment of the present invention, the drug delivery device confirms release of its contents at 106, where the external computer system can log 107 a successful delivery.
According to at least one embodiment of the present invention, the drug delivery device 200 (see
According to at least one embodiment of the present invention, the power supply can include an electronic power supply, a kinetic power supply, a biochemical power supply and the like. For example, when power is supplied through mechanical potential energy, such as a compressed spring, miniaturization problems can be alleviated. These miniaturization problems can be a barrier to ingested devices. According to an embodiment of the present invention, when safely housed within the compartment 208, the actuation within the intestine can be triggered by a chemical sensor sensing pH in the stomach and intestine, biochemical sensors, timers, etc.
According to at least one embodiment of the present invention, the drug delivery device 300 (see
According to at least one embodiment of the present invention, the drug delivery device 400 (see
According to at least one embodiment of the present invention, the electroactive polymer 404 is activated by a voltage applied by the electronics package 409, which causes the electroactive polymer 404 to contract. According to at least one embodiment of the present invention, the resilient member 405 does not compress during contraction, as it is already fully compressed. According to at least one embodiment of the present invention, a threshold adhesion device 410 is configured to withstand a force of the resilient member 405 alone, and to break upon the contraction of the electroactive polymer 404.
According to at least one embodiment of the present invention, the electronics package 209/409 includes an accelerometer switch. The switch is sensitive to shock. A possible breach in the drug delivery device can be sensed upon breaking an acceleration sensitive filament disposed in a fuse. In this way, the fuse, including the acceleration sensitive filament can be a powerless accelerometer switch. A change in the switch's condition (upon breaking the filament) can be indicative of a possible breach in the drug delivery device.
According to at least one embodiment of the present invention, the drug delivery device can comprise a conductive cage 500. The conductive cage can be disposed in a portion of a shell of the drug delivery device. The conductive cage can be connected to the electronics package 209/409 of the drug delivery device, where the electronics package 209/409 is configured to sense a break in the conductive cage 500. According to at least one embodiment of the present invention, the cage is used to detect an intrusion into the drug delivery device. The cage can be formed from a semi-conductor material, wherein resistance between at least two vertices of the cage would change upon a break in the cage. According to at least one embodiment of the present invention, the electronics package 209/409 includes a logic circuit to detect such a disruption.
According to at least one embodiment of the present invention, the drug delivery device 400 includes a switch (S). The switch is pressure sensitive, and is configured to detect a loss of pressure applied by the resilient member 405. The switch 411 sends a signal if drug delivery device 400 is opened prior to consumption (e.g., passing the patient's stomach).
According to at least one embodiment of the present invention, the drug delivery device and the external computer system device enable enrollment, which can be administered by an independent party trusted by all the stakeholders. According to at least one embodiment of the present invention, enrollment includes a patient swallowing a drug delivery device (possibly a placebo), which securely relays an activation signature to a trusted external computer system (e.g., a local computer, a remote server, a cloud service, etc.). Upon receipt of the activation signature, the trusted computer system generates an encrypted tamper-proof device signature and communicates the device signature to the drug delivery device, where it is stored in a memory device.
According to at least one embodiment of the present invention, the drug delivery device and the external computer system can report status information, for example, of the drug delivery device not opening, etc.
According to at least one embodiment of the present invention, after the drug delivery device is swallowed, all sensor activations are signed using the device signature. Each sensor activation includes the device signature, which is compared with the device signature stored by the external computer system. The external computer system can trigger an action upon a match or a mismatch according to user needs, for example, generating an alarm if the signatures do not match.
According to at least one embodiment of the present invention, the drug delivery device includes an additional medication or substance, such as a contaminant 412 (C) to foil attempts to reverse engineer the medication or a chemical compound to render the medication inert in the case of an attempt to misuse the medication. According to at least one embodiment of the present invention, the contaminant can be released 104 by an actuator under the control of the logic circuit, for example, upon determination of an authorization fail 103.
Recapitulation:
According to at least one embodiment of the present invention, a drug delivery device 200 includes a capsule 201-202, a logic circuit 209 disposed within the capsule, and an actuator 210 connected to the logic circuit and configured to expose an interior of the capsule to an exterior of the capsule upon activation by the logic circuit.
According to an embodiment of the present invention, a method of controlling a drug delivery device comprising a capsule, a logic circuit disposed within the capsule, and an actuator connected to the logic circuit includes sensing a location of the drug delivery device 102, determining entry of the drug delivery device into an intestine using the location 102, communicating an authorization request to an external computer system upon determining entry into the intestine 103, receiving an authorization from the external computer system 104, and activating, by the logic circuit, the actuator to expose an interior of the capsule to an exterior of the capsule upon receipt of the authorization 104.
According to an embodiment of the present invention, a method of controlling a drug delivery device comprising a capsule, a logic circuit disposed within the capsule, and an actuator connected to the logic circuit includes sensing a location of the drug delivery device 102, determining entry of the drug delivery device into an intestine using the location 102, communicating an authorization request to an external computer system upon determining entry into the intestine 103, determining an authorization fail from the external computer system 104, and activating, by the logic circuit, the actuator to render a medication containing with the capsule insert upon receiving the authorization fail upon determination of the authorization fail 104.
The methodologies of embodiments of the disclosure may be particularly well-suited for use in an electronic device or alternative system. Accordingly, embodiments of the present invention may take the form of an entirely hardware embodiment or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “processor,” “circuit,” “module” or “system.”
Furthermore, it should be noted that any of the methods described herein can include an additional step of providing a computer system for controlling a drug delivery device comprising a capsule, a logic circuit disposed within the capsule, and an actuator connected to the logic circuit. Further, a computer program product can include a tangible computer-readable recordable storage medium with code adapted to be executed to carry out one or more method steps described herein, including the provision of the system with the distinct software modules.
Referring to
In different applications, some of the components shown in
The processor 601 may be configured to perform one or more methodologies described in the present disclosure, illustrative embodiments of which are shown in the above figures and described herein. Embodiments of the present invention can be implemented as a routine that is stored in memory 602 and executed by the processor 601 to process the signal from the media 607. As such, the computer system is a general-purpose computer system that becomes a specific purpose computer system when executing routines of the present disclosure.
Although the computer system described in
The present invention may be a system, a method, and/or a computer program product at any possible technical detail level of integration. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present invention.
The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, a mechanically encoded device such as punch-cards or raised structures in a groove having instructions recorded thereon, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.
Computer readable program instructions described herein can be downloaded to respective computing/processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and/or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and/or edge servers. A network adapter card or network interface in each computing/processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing/processing device.
Computer readable program instructions for carrying out operations of the present invention may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, configuration data for integrated circuitry, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++, or the like, and procedural programming languages, such as the “C” programming language or similar programming languages. The computer readable program instructions may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present invention.
Aspects of the present invention are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.
These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. These computer readable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and/or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function/act specified in the flowchart and/or block diagram block or blocks.
The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block or blocks.
The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative implementations, the functions noted in the blocks may occur out of the order noted in the Figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated.
This application is a continuation of U.S. patent application Ser. No. 15/848,169 filed Dec. 20, 2017, the complete disclosure of which is expressly incorporated herein by reference in its entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15848169 | Dec 2017 | US |
| Child | 17361535 | US |
