Drug device configured for wireless communication

• US 9,662,392 B2
• Filed: 05/04/2015
• Issued: 05/30/2017
• Est. Priority Date: 06/03/2014
• Status: Active Grant

• Current Assignee: Pop Test Abuse Deterrent Technology, LLC
• Original Assignee: Pop Test Abuse Deterrent Technology, LLC
• Inventors: Altschul, Randice Lisa, Theise, Neil David, Rapkin, Myron, O'Brien, Rebecca, Ene, Razvan Andrei
• Primary Examiner(s): Schmidt, Emily
• Application Number:
  US14/703,163
• Publication Number:
  US 20150343144A1
• Time in Patent Office: 757 Days
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4343 Pregnancy and labour monitoring, e.g. for labour onset detection
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4845 Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3523 : using telemetric means
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8268 : Fuel storage cells
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2250/00 : Specially adapted for animals
• CPC Class Codes: 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
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/30 : for treating abuse or dependence
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: H05K 999/99 : dummy group
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

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

Claims

1. A method of tracking an ingestible drug delivery device from a manufacturer of the ingestible drug delivery device to a patient wherein the ingestible drug delivery device includes at least one bioactive substance, said method including enabling a health care provider to determine the origin of said drug delivery device and to confirm that at least one of the correct type and the correct dosage of the at least one bioactive substance was delivered to the patient, and to enable the ingestible drug delivery device to release the at least one bioactive substance within the patient, said method comprising:

providing said ingestible drug delivery device comprising;

a bioactive substance module comprising said at least one bioactive substance which comprises at least one narcotic, including a container for holding a volume and/or quantity of the at least one bioactive substance therein and a microactuator for dispensing the at least one bioactive substance from said container to a location outside of said ingestible drug delivery device;

said ingestible drug delivery device further comprising an electronics module, coupled to said bioactive substance module, capable of receiving data wirelessly via a wireless communication interface and wherein said electronics module comprises a processor and a memory for storing data;

storing in said memory a unique identifier that identifies said ingestible drug delivery device and the manufacturer of said ingestible drug delivery device, the type and amount of the at least one bioactive substance, said unique identifier being unalterable once stored;

storing in said memory the identity of the health care provider who enables said ingestible drug delivery device and the patient identity for whom the at least one bioactive substance is directed, said stored identity of the health care provider and said patient identity being unalterable once stored;

receiving patient identity data from a patient interface device associated with the patient that communicates with said ingestible drug delivery device at the time that said device is ingested by the patient; and

receiving information from data related to a healthcare provider that enables the release of at least one bioactive substance to a patient; and

/or

receiving the detected unique identity associated with the ingestible drug delivery device detected via a patient interface device and the confirmation of delivery of the medication to the patient via the ingestible drug delivery device, that optionally enables the release of at least one bioactive substance to a patient;

comparing, by said processor, said patient identity stored in said memory with said received patient identity data and said processor commanding said bioactive substance module to release the at least one bioactive substance if said stored patient identity and said received patient identity data match and said processor not commanding said bioactive substance module to release the at least one bioactive substance if said stored patient identity and said received patient identity data do not match; and

communicating, by said processor, with an interrogation unit, wherein said interrogation unit is operative to interrogate said ingestible drug delivery device and to receive said unique identifier of said ingestible drug delivery device to confirm the origin of the at least one bioactive substance and the type of the at least one bioactive substance.

2. The method of claim 1 wherein said processor is operative to communicate, via said wireless communication interface, with a datacenter database to at least one of retrieving medical information about the patient and of providing information related to the at least one bioactive substance to be administered to the patient.

3. The method of claim 1 wherein said processor is operative to validate at least one of the type and dosage of the at least one bioactive substance enabled selected by the health care provider prior to dispensing the at least one bioactive substance to the patient.

4. The method 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.

5. The method of claim 1 wherein said ingestible drug delivery device further comprises a deactivation module, coupled to said electronics module and to said bioactive substance module, comprising a container for holding a volume and/or quantity of a deactivator and a microactuator for dispensing said deactivator to said bioactive substance module, said method further comprising the step of said processor commanding said deactivation module to dispense said deactivator into said bioactive substance module if tampering of said ingestible drug delivery device is detected before ingesting.

6. The method of claim 5 wherein the deactivator is selected from the group consisting of an antagonist to the bioactive substance, and a pharmaceutical.