WO2008115906A1 - Drug delivery device which monitors patient compliance - Google Patents

Drug delivery device which monitors patient compliance Download PDF

Info

Publication number
WO2008115906A1
WO2008115906A1 PCT/US2008/057315 US2008057315W WO2008115906A1 WO 2008115906 A1 WO2008115906 A1 WO 2008115906A1 US 2008057315 W US2008057315 W US 2008057315W WO 2008115906 A1 WO2008115906 A1 WO 2008115906A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug
drug delivery
patient
delivery device
patient compliance
Prior art date
Application number
PCT/US2008/057315
Other languages
French (fr)
Inventor
Sean Race
Original Assignee
Xigo Nanotools Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Xigo Nanotools Llc filed Critical Xigo Nanotools Llc
Publication of WO2008115906A1 publication Critical patent/WO2008115906A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the invention relates to a drug delivery device comprising a means to monitor patient compliance prior to, during and/or after delivery of the drug.
  • the drug delivery device is particularly useful in monitoring patient compliance during clinical trials .
  • Patient compliance with drug delivery instructions is essential to successful treatment with the drug.
  • Patient compliance during clinical trials of a drug is particularly important to achievement of meaningful and accurate clinical trial outcomes.
  • the present invention provides a drug delivery device capable of monitoring and recording data relevant to administration of the drug via the device.
  • the device of the present invention thus comprises a means for drug delivery and a means for monitoring and recording data relevant to administration of the drug.
  • the present invention also provides a method for monitoring patient compliance with drug delivery instructions which comprises administration of the drug to the patient via the drug delivery of the present invention and monitoring and recording data relevant to administration of the drug to the patient with the drug delivery device of the present invention.
  • Figure 1 provides a cross-sectional side view of an exemplary embodiment of a vaginal drug delivery device of the present invention.
  • the present invention provides drug delivery devices which deliver the drug to a patient and monitor and record data in the patient indicative of the patient's compliance with delivery of the drug.
  • the devices of the present invention comprise a means for delivery of a drug and a means to monitor patient compliance prior to, during and/or after delivery of the drug.
  • the device of the present invention may further measure and/or monitor physiological parameters in the patient.
  • Various drug delivery means can be used including, but in no way limited to, single and multiple use applicators, syringes, metered dose inhalers, spray bottles, nebulizers and infusion pumps.
  • the means to monitor patient compliance is incorporated into the drug delivery device.
  • Said means must have the capability of monitoring and recording data measured in the patient indicative of the patient's compliance with delivery of the drug.
  • said means is an electronics module comprising a switch, a microprocessor, a transmitter and a power supply, incorporated into the drug delivery device.
  • switches and microprocessors can be used and are selected based upon the drug delivery device.
  • transmitters useful in the device include, but are not limited to, light emitting diode (LED) , radio frequency identification (RFID) and universal serial bus (USB) interfaces to transmit the data from the electronics module .
  • LED light emitting diode
  • RFID radio frequency identification
  • USB universal serial bus
  • Examples of power supplies include, but are in no way limited to conventional batteries and antenna/capacitor transponders .
  • the drug delivery device of the present invention comprises a microprocessor that is activated when the dose is dispensed and continues to record data until the device is returned to the clinic where the microprocessor data is retrieved from the device and the time and date of drug dispensation is recorded.
  • the microprocessor is activated prior to delivery of the device to the patient and drug dispensation terminates the microprocessor timekeeping. The elapsed time from microprocessor activation to termination is read from the device when it is returned to the clinic and the time and date of drug dispensation is recorded.
  • the electronics module may further comprise one or more sensors for monitoring and recording a physiological parameter or parameters in the patient.
  • sensors for monitoring and recording a physiological parameter or parameters in the patient.
  • sensors which can be used in the present invention include, but are not limited to, thermocouples, thermistors, RTDs, pH sensors, and conductivity sensors.
  • the microprocessor has integrated into it one or more sensors and associated electronics that enable other parameters such as the ambient temperature to be monitored.
  • the microprocessor and associated sensor or sensors measure physiological parameters of the patient such as body temperature, pH, electrical conductivity, and/or other physical parameters.
  • the sensors are capable of measuring physiological parameters of the patient indirectly through the drug product or portions of the delivery device without requiring direct contact with the patient. Even more preferred is use of sensors capable of measuring physiological parameters of the patient and collecting physiological samples that can be used to determine the site of drug delivery.
  • the drug delivery device of the present invention preferably further comprises a means to identify the patient actuating the dispensing device either manually via, for example, a pressure sensitive gel on the surface of the device into which an impression of the patient's fingerprint is recorded, or electronically via, for example, an electronic fingerprint.
  • the drug delivery devices of the present invention are useful in monitoring patient compliance with drug delivery instructions. These devices are particularly useful in monitoring patient compliance with drug administration instructions for drugs in clinical trials.
  • the electronics of the device may be configured to produce an audible beep when the dose should be administered and/or to prevent dispensing of the drug until a specific time.
  • the device is not only useful in monitoring patient compliance but also in assisting the patient in complying with drug administration instructions .
  • the following nonlimiting example is provided to further illustrate the present invention.
  • Figure 1 depicts a vaginal applicator appropriate for dispensing microbicides, antifungal creams, gels, or other vaginal products, equipped with a microprocessor and sensors to monitor temperature.
  • This drug delivery means comprises a barrel 7, a device plunger 5, a piston 6 and a drug product reservoir 4. Drug product prior to dosing is located in the drug product reservoir 4. Drug is dispensed by depressing the device plunger 5 toward the piston 6 in the barrel 7 so that the drug product in the drug product reservoir 4 is pushed out of the device. In this embodiment, depressing of the device plunger also closes the device switch 3 and initiates the acquisition of temperature data measured by the temperature sensor 2.
  • the microprocessor and associated electronics 1 acquire temperature data for a predetermined time or until the device switch 3 is activated indicating complete dose delivery.
  • a clock in the microprocessor continues to operate in a low level mode until the contents of the memory residing within the electronics is read. Upon reading of this stored date, patient compliance with dosing instructions can be determined.
  • vaginal applicator can be used for alternative drug delivery devices including, but not limited, syringes, inhalers, spray bottles, nebulizers and infusion pumps.”

Abstract

Drug delivery devices which deliver a drug and monitor patient compliance with drug delivery instructions are provided.

Description

DRUG DELIVERY DEVICE WHICH MONITORS PATIENT COMPLIANCE
This patent application claims the benefit of priority from U.S. Provisional Patent Application Serial No. 60/895,548, filed March 19, 2007, teachings of which are hereby incorporated by reference in their entirety.
FIELD OF INVENTION
The invention relates to a drug delivery device comprising a means to monitor patient compliance prior to, during and/or after delivery of the drug. The drug delivery device is particularly useful in monitoring patient compliance during clinical trials .
BACKGROUND OF INVENTION
Patient compliance with drug delivery instructions is essential to successful treatment with the drug. Patient compliance during clinical trials of a drug is particularly important to achievement of meaningful and accurate clinical trial outcomes.
Unfortunately for many drug therapies it is difficult to monitor patient compliance with drug delivery instructions, and in particular compliance with clinical trial protocols. Clinical trials are expensive, accounting for a significant portion of drug development costs. Failure to comply with clinical trial protocol can lead to premature trial termination. Further, repeating trials may be financially impossible for drug development companies have limited financial resources available to conduct multiple trials. Unfortunately, failed trials due to patient non- compliance of trial protocols which cannot be repeated due to expense can lead to termination of drug development programs of drug products that may otherwise have been proven to be both safe and efficacious.
Accordingly, there is a need for devices and methods to monitor patient compliance with drug delivery instructions and in particular clinical trial protocols.
SUMMARY OF THE INVENTION
The present invention provides a drug delivery device capable of monitoring and recording data relevant to administration of the drug via the device. The device of the present invention thus comprises a means for drug delivery and a means for monitoring and recording data relevant to administration of the drug.
The present invention also provides a method for monitoring patient compliance with drug delivery instructions which comprises administration of the drug to the patient via the drug delivery of the present invention and monitoring and recording data relevant to administration of the drug to the patient with the drug delivery device of the present invention.
BRIEF DESCRIPTION OF THE DRAWING
Figure 1 provides a cross-sectional side view of an exemplary embodiment of a vaginal drug delivery device of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides drug delivery devices which deliver the drug to a patient and monitor and record data in the patient indicative of the patient's compliance with delivery of the drug. In simplest form the devices of the present invention comprise a means for delivery of a drug and a means to monitor patient compliance prior to, during and/or after delivery of the drug. The device of the present invention may further measure and/or monitor physiological parameters in the patient.
Various drug delivery means can be used including, but in no way limited to, single and multiple use applicators, syringes, metered dose inhalers, spray bottles, nebulizers and infusion pumps.
The means to monitor patient compliance is incorporated into the drug delivery device. Said means must have the capability of monitoring and recording data measured in the patient indicative of the patient's compliance with delivery of the drug. In one embodiment, said means is an electronics module comprising a switch, a microprocessor, a transmitter and a power supply, incorporated into the drug delivery device.
Various commercially available switches and microprocessors can be used and are selected based upon the drug delivery device.
Examples of transmitters useful in the device include, but are not limited to, light emitting diode (LED) , radio frequency identification (RFID) and universal serial bus (USB) interfaces to transmit the data from the electronics module .
Examples of power supplies include, but are in no way limited to conventional batteries and antenna/capacitor transponders .
In one embodiment, the drug delivery device of the present invention comprises a microprocessor that is activated when the dose is dispensed and continues to record data until the device is returned to the clinic where the microprocessor data is retrieved from the device and the time and date of drug dispensation is recorded. In another embodiment, the microprocessor is activated prior to delivery of the device to the patient and drug dispensation terminates the microprocessor timekeeping. The elapsed time from microprocessor activation to termination is read from the device when it is returned to the clinic and the time and date of drug dispensation is recorded.
The electronics module may further comprise one or more sensors for monitoring and recording a physiological parameter or parameters in the patient. Examples of commercially available sensors which can be used in the present invention include, but are not limited to, thermocouples, thermistors, RTDs, pH sensors, and conductivity sensors. In this embodiment, the microprocessor has integrated into it one or more sensors and associated electronics that enable other parameters such as the ambient temperature to be monitored. In a preferred embodiment the microprocessor and associated sensor or sensors measure physiological parameters of the patient such as body temperature, pH, electrical conductivity, and/or other physical parameters. Preferably, the sensors are capable of measuring physiological parameters of the patient indirectly through the drug product or portions of the delivery device without requiring direct contact with the patient. Even more preferred is use of sensors capable of measuring physiological parameters of the patient and collecting physiological samples that can be used to determine the site of drug delivery.
The drug delivery device of the present invention preferably further comprises a means to identify the patient actuating the dispensing device either manually via, for example, a pressure sensitive gel on the surface of the device into which an impression of the patient's fingerprint is recorded, or electronically via, for example, an electronic fingerprint.
The drug delivery devices of the present invention are useful in monitoring patient compliance with drug delivery instructions. These devices are particularly useful in monitoring patient compliance with drug administration instructions for drugs in clinical trials.
Alternatively, or in addition, the electronics of the device may be configured to produce an audible beep when the dose should be administered and/or to prevent dispensing of the drug until a specific time. In this embodiment, the device is not only useful in monitoring patient compliance but also in assisting the patient in complying with drug administration instructions . The following nonlimiting example is provided to further illustrate the present invention. EXZWMPLE Example 1
Figure 1 depicts a vaginal applicator appropriate for dispensing microbicides, antifungal creams, gels, or other vaginal products, equipped with a microprocessor and sensors to monitor temperature. This drug delivery means comprises a barrel 7, a device plunger 5, a piston 6 and a drug product reservoir 4. Drug product prior to dosing is located in the drug product reservoir 4. Drug is dispensed by depressing the device plunger 5 toward the piston 6 in the barrel 7 so that the drug product in the drug product reservoir 4 is pushed out of the device. In this embodiment, depressing of the device plunger also closes the device switch 3 and initiates the acquisition of temperature data measured by the temperature sensor 2. The microprocessor and associated electronics 1 acquire temperature data for a predetermined time or until the device switch 3 is activated indicating complete dose delivery. A clock in the microprocessor continues to operate in a low level mode until the contents of the memory residing within the electronics is read. Upon reading of this stored date, patient compliance with dosing instructions can be determined.
As will be understood by the skill artisan upon reading this disclosure, similar configurations as described for the vaginal applicator can be used for alternative drug delivery devices including, but not limited, syringes, inhalers, spray bottles, nebulizers and infusion pumps."

Claims

What is Claimed is:
1. A drug delivery device comprising a means to deliver a drug and a means to monitor patient compliance prior to, during and/or after delivery of the drug.
2. The drug delivery device of claim 1 wherein said means to monitor patient compliance is an electronics module comprising a switch, a microprocessor, a transmitter and a power supply, incorporated in the means to deliver the drug.
3. The drug delivery device of claims 1 or 2 further comprising one or more sensors capable of measuring physiologic parameters in the patient, said sensors electronically connected to the microprocessor.
4. The drug delivery device of claims 1, 2 or 3 further comprising a means to identify the patient actuating the drug delivery means.
5. A method for monitoring patient compliance with drug delivery instructions comprising administering a drug to a patient via the drug delivery device of any of claims 1 through 4 and monitoring and recording data relevant to administration of the drug to the patient with said drug delivery device.
PCT/US2008/057315 2007-03-19 2008-03-18 Drug delivery device which monitors patient compliance WO2008115906A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US89554807P 2007-03-19 2007-03-19
US60/895,548 2007-03-19

Publications (1)

Publication Number Publication Date
WO2008115906A1 true WO2008115906A1 (en) 2008-09-25

Family

ID=39766392

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/057315 WO2008115906A1 (en) 2007-03-19 2008-03-18 Drug delivery device which monitors patient compliance

Country Status (1)

Country Link
WO (1) WO2008115906A1 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8332020B2 (en) 2010-02-01 2012-12-11 Proteus Digital Health, Inc. Two-wrist data gathering system
US8419638B2 (en) 2007-11-19 2013-04-16 Proteus Digital Health, Inc. Body-associated fluid transport structure evaluation devices
US9014779B2 (en) 2010-02-01 2015-04-21 Proteus Digital Health, Inc. Data gathering system
US9084566B2 (en) 2006-07-07 2015-07-21 Proteus Digital Health, Inc. Smart parenteral administration system
US9125979B2 (en) 2007-10-25 2015-09-08 Proteus Digital Health, Inc. Fluid transfer port information system
US10019555B2 (en) 2013-10-19 2018-07-10 Cohero Health, Inc. Interactive respiratory device usage tracking system
US11424017B2 (en) 2013-10-19 2022-08-23 Aptargroup, Inc. Respiratory system and method that monitors medication flow

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6198394B1 (en) * 1996-12-05 2001-03-06 Stephen C. Jacobsen System for remote monitoring of personnel

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6198394B1 (en) * 1996-12-05 2001-03-06 Stephen C. Jacobsen System for remote monitoring of personnel

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9084566B2 (en) 2006-07-07 2015-07-21 Proteus Digital Health, Inc. Smart parenteral administration system
US9125979B2 (en) 2007-10-25 2015-09-08 Proteus Digital Health, Inc. Fluid transfer port information system
US8419638B2 (en) 2007-11-19 2013-04-16 Proteus Digital Health, Inc. Body-associated fluid transport structure evaluation devices
US8332020B2 (en) 2010-02-01 2012-12-11 Proteus Digital Health, Inc. Two-wrist data gathering system
US9008761B2 (en) 2010-02-01 2015-04-14 Proteus Digital Health, Inc. Two-wrist data gathering system
US9014779B2 (en) 2010-02-01 2015-04-21 Proteus Digital Health, Inc. Data gathering system
US10376218B2 (en) 2010-02-01 2019-08-13 Proteus Digital Health, Inc. Data gathering system
US10019555B2 (en) 2013-10-19 2018-07-10 Cohero Health, Inc. Interactive respiratory device usage tracking system
US11335447B2 (en) 2013-10-19 2022-05-17 Aptargroup, Inc. Tracking module securable to respiratory device
US11424017B2 (en) 2013-10-19 2022-08-23 Aptargroup, Inc. Respiratory system and method that monitors medication flow
US11848088B2 (en) 2013-10-19 2023-12-19 Aptargroup, Inc. Respiratory device tracking system
US11875886B2 (en) 2013-10-19 2024-01-16 Aptargroup, Inc. Reusable respiratory device monitoring system

Similar Documents

Publication Publication Date Title
WO2008115906A1 (en) Drug delivery device which monitors patient compliance
TWI803476B (en) Syringe system
EP2182456B1 (en) A method for monitoring the operation of a medication delivery device, an electronic module, and a medication delivery system
EP3137038B1 (en) Unobtrusive wireless electronic systems for monitoring and facilitating patient compliance
CN210750665U (en) Medicament injection device
CN109497960B (en) Integrated injection system, integrated injection device and method of monitoring an injection event
CN208229182U (en) measuring device, monitoring device and monitoring system
US8961458B2 (en) Device and method for drug delivery
CN105050566B (en) Drug delivery capsule with external intelligence
US11660388B2 (en) High precision syringe with removable pump unit
US10946143B2 (en) Detection and communication of plunger position using induction
US9248235B2 (en) Core apparatus connectable to a variety of sensors, fluid delivery devices and other devices to form a system, such as for diabetes management system
EP4240445A1 (en) Medication fluid delivery device
CA3007858C (en) Injection device for injecting dosed amounts of a liquid therapeutic agent
EP4124354A1 (en) Drug administration with sensor system and remote coupling unit

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 08743989

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 08743989

Country of ref document: EP

Kind code of ref document: A1