# US 10,441,762 B2 · Drug device configured for wireless communication

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- Number: US 10,441,762 B2
- Document ID: US10441762B2
- Status: Granted
- Kind: B2
- Application number: 16/259,308
- Filed: 2019-01-28
- Published: 2019-05-23
- Granted: 2019-10-15
- Earliest claimed: 2014-06-03
- Assignees: Pop Test Abuse Deterrent Technology LLC
- Applicants: Pop Test Abuse Deterrent Technology LLC
- Inventors: Randice Lisa Altschul; Neil David Theise; Razvan Andrei Ene; Myron Rapkin; Rebecca O'Brien
- Web page: https://patentgrep.com/patent/US10441762B2

## CPC

- G16H 20/13: delivered from dispensers
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/073: {Intestinal transmitters}
- A61B 5/14539: {for measuring pH}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/4343: {Pregnancy and labour monitoring, e.g. for labour onset detection}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/4845: {Toxicology, e.g. by detection of alcohol, drug or toxic products (A61B5/4848 takes precedence)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0097: {Medicinal compositions released by microdevices, e.g. microelectromechanical systems [MEMS], microdevices comprising chips or microdevices on silicon}
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/30: for treating abuse or dependence
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/0531: Measuring skin impedance
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 2560/0214: of power generation or supply
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3303: Using a biosensor
- A61M 2205/3306: Optical measuring means
- A61M 2205/3523: using telemetric means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/50: with microprocessors or computers
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/8206: battery-operated
- A61M 2205/8268: Fuel storage cells
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/20: Blood composition characteristics
- A61M 2230/201: Glucose concentration
- A61M 2230/208: pH-value
- A61M 2230/50: Temperature
- A61M 2250/00: Specially adapted for animals
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 40/63: for local operation
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

This invention relates to an ingestible drug delivery device configured for wireless communication with other ingestible drug delivery devices.

## Claims

### Claim 1

An ingestible drug delivery device, formed by a device manufacturer, and configured for wireless communication, said drug delivery device comprising:
a capsule body comprising:
a sensor for sensing at least one biologic condition within a patient, said sensor comprising at least one binding element that is configured to bind an analyte present in the patient for detecting the at least one biologic condition;
a bioactive substance module comprising a container for holding a volume and/or quantity of bioactive substance therein and a microactuator for dispensing said bioactive substance from said container to a location outside of said capsule body;
an electronics module, coupled to said sensor and said bioactive substance module, said electronics module comprising a processor, a transponder and a memory, said memory configured for storing data related to a unique device ID and to a patient identification and configured for storing respective flags set by the device manufacturer and a pharmacist, said sensor providing said processor with a signal indicative of said detected at least one biologic condition;
a power source coupled to said sensor, said bioactive substance module and said electronics module; and
wherein said processor activates said microactuator to dispense said bioactive substance only if said processor verifies the following conditions:
(a) a first flag is set by the device manufacturer;
(b) a second flag is set by the pharmacist; and
(c) a match exists between said patient identification stored in said memory and a patient identification transmitted from an external patient interface device that communicates with said ingested drug device; and
wherein said processor does not activate said microactuator to dispense said bioactive substance if any one of said conditions (a)-(c) is not verified.

### Claim 2 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said second flag can only be set if said first flag is set.

### Claim 3 (depends on 2)

The ingestible drug delivery device of claim 2 wherein the pharmacist uses a programming terminal to communicate with said ingestible drug device to set said second flag and to store said patient identification within said memory.

### Claim 4 (depends on 3)

The ingestible drug delivery device of claim 3 wherein the pharmacist uses said programming terminal to store data related to the pharmacist in said memory.

### Claim 5 (depends on 4)

The ingestible drug delivery device of claim 4 wherein said data related to the pharmacist comprises a digital signature of the pharmacist.

### Claim 6 (depends on 4)

The ingestible drug delivery device of claim 4 wherein said ingestible drug delivery device is configured to be tracked from the device manufacturer to the patient that ingests said device based on: (a) said unique device ID; (b) data related to the device manufacturer stored in said memory when said unique device ID is stored therein; (c) said data related to the pharmacist; and (d) said patient identification stored in said memory.

### Claim 7 (depends on 6)

The ingestible drug delivery device of claim 6 wherein the processor is operative to communicate with said programming terminal to a datacenter database to at least one of retrieve medical information about the patient and to provide information related to the bioactive substance to be administered to the patient.

### Claim 8 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said unique device ID of said ingestible drug delivery device is established by the device manufacturer.

### Claim 9 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said processor is operative to receive biometric parameters from said patient interface device, wherein the biometric parameters can identify the patient.

### Claim 10 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said sensor is capable of detecting the concentration of bioactive substance in the patient, and can prevent release of additional bioactive substance when contraindicated even if said conditions are verified.

### Claim 11 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said sensor is capable of detecting pregnancy, and can prevent release of bioactive substance when the patient is determined to be pregnant even if said conditions are verified.

### Claim 12 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said sensor is selected from the group consisting of electronic, biological, chemical, digital sensors, and combinations thereof.

### Claim 13 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said sensor is selected from the group consisting of a pH sensor, a temperature sensor, a glucose sensor, a pregnancy sensor, a drug sensor, a phenylalanine sensor, and combinations thereof.

### Claim 14 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said sensor comprises a drug sensor for analytes selected from the group consisting of alcohol, nicotine, caffeine, cocaine (including crack cocaine), cannabis, amphetamines (including crystal methamphetamine), opiates and opiate analogues (including heroine, oxycodone, hydrocodone, hydromorphone, methadone), dextromethorphan, benzodiazepines, ecstasy (MDMA), GHB, barbiturates, khat, kratom, PCP, LSD, ketamine, peyote, mescaline, psilocybin, rohypnol, Salvia divinorum, antidepressants, anti-anxiety medications, sleep aids, allergy medications, and combinations thereof, and can prevent release of bioactive substance when contraindicated even if said conditions are verified.

### Claim 15 (depends on 1)

The ingestible drug delivery device of claim 1 wherein the bioactive substance has abuse resistant technology.

### Claim 16 (depends on 1)

The ingestible drug delivery device of claim 1 wherein the processor is operative to validate at least one of the type and dosage selected by the pharmacist prior to dispensing the bioactive substance to the patient.

### Claim 17 (depends on 1)

The ingestible drug delivery device of claim 1 further comprising a deactivation module within said capsule body and coupled to said electronics module and to said bioactive substance module, said deactivation module comprising a container for holding a volume and/or quantity of a deactivator and a second microactuator for dispensing said deactivator to said bioactive substance module, said processor commanding said deactivation module to dispense said deactivator into said bioactive substance module.

### Claim 18 (depends on 17)

The ingestible drug delivery device of claim 17 wherein the deactivator is selected from the group consisting of an antagonist to the bioactive substance and a pharmaceutical.

### Claim 19 (depends on 1)

The ingestible drug delivery device of claim 1 wherein said bioactive substance is a composition comprising:
(i) first therapeutic agent which is a GCR antagonist comprising ORG34517, or pharmaceutically acceptable salts thereof;
(ii) separated from the first therapeutic agent, at least one or possibly more additional therapeutic agent(s) selected from the group consisting of opiod analgesics and combinations thereof; and
(iii) at least one pharmaceutically acceptable carrier, wherein the first and second therapeutic agents are each present in an amount which, in combination, is therapeutically effective amount for treatment of withdrawal from narcotics and subsequent prevention of relapse of narcotic use in a patient in need of such treatment.

### Claim 20 (depends on 19)

The ingestible drug delivery device of claim 19 wherein the second therapeutic agent is selected from the group consisting of at least one narcotic selected from the group consisting of opioid analgesics, morphine, codeine, buprenorphine, tramadol, fentany, hydromonorphone, morphine, oxycodone/ naloxone, opiate, opium, acetyldihydrocodeine, alfentani, allylprodine, alphamethylfentanyl, alphaprodine, benzylmorphine, betaprodine, bezitriamide, buprenorphine, butorphanol, bremazocine, carfentan (carfentanyl), contin, dextromoramide, dextropropoxyphene, dezocine, diacetylmorphine, diamorphine, dihydrocodeine, dihydromorphine, dihydromorphone, diphenoxyl ate, dipipanone, enadoline, ethylketazocine, ethylmorphine, etonitazene, etorphine, fentanyl, heroin, hydrocodone, hydromorphin (hydromorphine), hydromorphone, ketazocine, ketobemidone, lefetamine, levomethadon, levomethadyl, levomethorphan, levor-phanol, loperamide, meperidine, meptazinol, methadone, methadyl, methylmorphine, morphin (morphine), nalbuphine, narcotic, nicocodeine, nicomorphine, normorphine, noscapin, ohmefentanyl, oripavine, oxycodone, oxycontin, oxymorphone, papaveretum, papaverin, pentazocine, percocet, peronine, pethidine, phenazocine, phencyclidine, pholcodine, piritramid (priitramidine), prodine, promedol, propoxyphene, remifentanil, sufentanil, tapentadol, thebaine, tilidine, tramadol, ultracet, and combinations thereof.

### Claim 21 (depends on 20)

The ingestible drug delivery device of claim 20 wherein the GCR antagonist is selected from the group consisting of ORG 34517, 11-(substituted phenyl)-estra-4,9-diene derivatives, and 11-(substituted phenyl)-estra-4,9-diene derivatives of formula I
wherein A is a residue of a 5- or 6-membered ring containing 2 heteroatoms which are not connected to each other and independently selected from O and S, the ring being optionally substituted with one or more halogen atoms, or A is a residue of a 5- or 6-membered ring wherein no double C—C bonds are present, containing 1 heteroatom selected from O and S, which heteroatom is connected to the phenyl group at the position indicated with an asterisk, the ring being optionally substituted with one or more halogen atoms; R1 is H or 1-oxo(1-4C)alkyl; R2 is H, (1-8C)alkyl, halogen or CF3; X is selected from (H,OH), O, and NOH; and the interrupted line represents an optional bond.