Drug delivery management systems and methods
Various embodiments of a “smart” drug delivery pen are provided which include a drug delivery pen having an inertial sensor or accelerometer. A system is also provided that includes the smart drug pen in conjunction with a data management unit(s) DMU. Various exemplary methods for use of the pens and systems are also described and illustrated.
1. A drug delivery pen for confirming a dosage delivery protocol, the pen comprising:
a pen housing that extends from a first end to a second end along a longitudinal axis, the housing being coupled to a drug cartridge disposed proximate the first end, the drug cartridge including a volume of one or more drugs disposed therein;
a microprocessor disposed in the housing and operatively connected to a power source and a memory; and
an inertial sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the inertial sensor by:
determining whether the housing has been shaken back and forth a predetermined number of times along the longitudinal axis to mix the one or more drugs disposed in the cartridge; and
determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.
2. A drug delivery pen for confirming a dosage delivery protocol, the pen comprising:
a pen housing that extends from a first end to a second end along a longitudinal axis, the housing being coupled to a drug cartridge disposed proximate the first end, the drug cartridge including a volume of one or more drugs disposed therein;
a plunger rod having a portion disposed in the housing and at least a portion of the plunger rod coupled to the drug cartridge;
a dosage selector mounted to the housing and coupled to the plunger rod;
a microprocessor disposed in the housing and operatively connected to a power source and a memory;
a momentary switch coupled to the plunger rod and electrically connected to the microprocessor so that actuation of the plunger rod to deliver drug causes the switch to be actuated and allows the microprocessor to detect actuation of the plunger rod; and
an acceleration sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the acceleration sensor by:
determining whether the housing has been shaken back and forth a predetermined number of times along the longitudinal axis to mix the one or more drugs disposed in the cartridge; and
determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.
3. The drug delivery pen of one of claim 1 or claim 2 , in which the drug cartridge contains a drug selected from a group consisting of long acting insulin, rapid acting insulin, long and rapid acting mixed insulin, neutral protamine Hagedorn (NPH), growth hormone, glucagon-like peptide (GLP-1) analogs, pramlintide, or combinations thereof.
4. The drug delivery pen of claim 1 , further comprising:
at least a portion of a plunger rod coupled to the drug cartridge; and
a dosage selector coupled to the plunger rod.
5. The drug delivery pen of one of claim 1 or claim 2 , further comprising a transceiver disposed in the housing and coupled to the microprocessor to transmit and receive data relating to dosage delivery of a drug dosage in the drug cartridge to a data management unit remote from the drug delivery pen.
6. The drug delivery pen of one of claim 1 or claim 2 , further comprising a dosage indicator display provided on the pen housing, the dosage indicator display providing a representation of dosage selected by a user of the drug delivery pen.
7. The drug delivery pen of one of claim 1 or claim 2 , further comprising a Radio-Frequency-Identification tag coupled to the drug cartridge and configured to store information selected from a group including type of drug(s) in the cartridge, volume of drug in the cartridge, expiration date, batch date, lot number, manufacturer identification or combinations thereof.
8. The drug delivery pen of claim 2 , further comprising a dosage sensor attached to the dosage selector of the pen and coupled to the microprocessor so as to provide dosage delivery data upon displacement of the dosage selector.
9. A diabetes management system comprising:
a data management unit including:
a memory;
a processor coupled to the memory;
a display coupled to the processor; and
a transceiver to receive and transmit data; and
a drug delivery pen for confirming a dosage delivery protocol, the pen comprising:
a pen housing that extends from a first end to a second end along a longitudinal axis, the housing being coupled to a drug cartridge disposed proximate the first end, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;
a memory;
a microprocessor coupled to the memory of the pen; and
an inertial sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the inertial sensor by:
determining whether the housing has been shaken back and forth a predetermined number of times along the longitudinal axis to mix the one or more drugs disposed in the cartridge; and
determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.
10. The system of claim 9 , further comprising a dosage sensor attached to the dosage selector of the pen and coupled to the processor so as to provide data upon displacement of the dosage selector.
11. The system of claim 10 , wherein the transceiver transmits and receives data relating to dosage delivery of a drug dosage in the drug cartridge to the data management unit.
12. The system of claim 9 , in which the drug cartridge contains a drug selected from a group consisting essentially of long acting insulin, rapid acting insulin, long and rapid acting mixed insulin, neutral protamine Hagedorn (NPH), growth hormone, glucagon-like peptide (GLP-1) analogs, pramlintide, or combinations thereof.
13. The system of claim 9 , in which the data management unit further comprises an analyte sensor coupled to the processor to provide signals indicative of analyte value in a user's biological fluid.
14. The system of claim 9 , in which the data management unit comprises a mobile phone.
15. The system of claim 9 , in which the data management unit comprises a mobile computer.
16. The system of claim 9 , in which the data management unit comprises a network server located at a remote location from the communication module.
17. The system of claim 9 , further comprising a radio-frequency-identification (RFID) tag being coupled to the drug cartridge to store data selected from a group including a type of drug(s) in the cartridge, volume of drug in the cartridge, expiration date, batch date, lot number, manufacturer identification or combinations thereof.
18. The system of claim 17 , further comprising a radio-frequency-identification tag (RFID) reader disposed on one of the pen and the data management unit to interrogate the RFID tag for transfer of the information stored on the RFID tag.
19. A diabetes management system comprising:
a data management unit including:
a memory;
a processor coupled to the memory;
a display coupled to the processor; and
a transceiver to receive and transmit data;
a radio-frequency-identification reader; and
a drug delivery pen comprising:
a pen housing that extends from a first end to a second end along a longitudinal axis, the housing being coupled to a drug cartridge disposed proximate the first end, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;
a memory;
a microprocessor coupled to the memory of the pen;
a radio-frequency-identification tag attached to the drug cartridge and configured to store data selected from a group including a type of drug(s) in the cartridge, volume of drug in the cartridge, expiration date, batch date, lot number, manufacturer identification or combinations thereof; and
an inertial sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the inertial sensor by:
determining whether the housing has been shaken back and forth a predetermined number of times along the longitudinal axis to mix the one or more drugs disposed in the cartridge; and
determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.