DRUG DELIVERY MANAGEMENT SYSTEMS AND METHODS

• US 20110313395A1
• Filed: 01/27/2010
• Published: 12/22/2011
• Est. Priority Date: 02/27/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Krulevitch, Peter, Kraft, Ulrich, Wilk, Robert, Sieh, Zara, Zhao, Mitch
• Granted Patent: US 9,724,475 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/215 Tilt detection, e.g. for warning or shut-off
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2209/04 : Tools for specific apparatus
• CPC Class Codes: A61M 5/24 : Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3146 : Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/315 : Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/31525 : Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31551 : including axial movement of dose setting member
• CPC Class Codes: G01D 5/1655 : more than one point of contact or actuation on one or more tracks
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

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.

Claims

1. 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 one of the first and second ends, 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 memory; and

an inertial sensor connected to the housing and in electronic communication with the microprocessor so that the microprocessor is able to determine from output signals of the inertial sensor as to 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 or whether the pen housing including the cartridge is oriented topmost and generally vertically with respect to the ground in a priming position.

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 essentially of long acting insulin, rapid acting insulin, long and rapid acting mixed insulin, NPH, growth hormone, GLP-1 analogs, Symlin, or combinations thereof.

4. The drug delivery pen of one of claim 1 or 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.

5. 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.

6. The drug delivery pen of one of claim 1 or claim 2, further comprising a transceiver disposed in the housing and coupled to the processor 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.

7. 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 the user.

10. 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.

2. 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 one of the first and second ends, 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 memory; and

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.

8. The drug delivery pen of claim 2, further comprising an inertial sensor connected to the housing and in electronic communication with the microprocessor so that the microprocessor is able to determine from output signals of the inertial sensor as to 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 or whether the pen housing including the cartridge is oriented topmost and generally vertically with respect to the ground in a priming position.

9. The drug delivery pen of claim 2, further comprising an acceleration sensor connected to the housing and in electronic communication with the microprocessor so that the microprocessor is able to determine from output signals of the acceleration sensor as to 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.

11. 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 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 one of the first and second ends, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;

a memory;

a processor coupled to the memory; and

an inertial sensor disposed in the housing and in communication with the processor to allow for determination of 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 or whether the pen housing including the cartridge is oriented topmost and generally vertically with respect to the ground in a priming position.

12. The system of claim 11, 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

13. The system of claim 12, further comprising a transceiver to transmit and receive data relating to dosage delivery of a drug dosage in the drug cartridge to the data management unit

14. The system of claim 11, 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, NPH, growth hormone, GLP-1 analogs, Symlin, or combinations thereof.

15. The system of claim 11, 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.

16. The system of claim 11, in which the data management unit comprises a mobile phone.

17. The system of claim 11, in which the data management unit comprises a mobile computer.

18. The system of claim 11, in which the data management unit comprises a network server located at a remote location from the communication module.

19. The system of claim 11, 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.

20. The system of claim 19, 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.

21. 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 one of the first and second ends, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;

a memory;

a processor coupled to the memory;

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.

22. The system of claim 21, in which the pen further comprises an inertial sensor disposed in the housing and in communication with the processor to allow for determination of 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 or whether the pen housing including the cartridge is oriented topmost and generally vertically with respect to the ground in a priming position.

23. A method of managing diabetes of a user with a glucose meter and a drug delivery pen, the glucose meter having a microprocessor, memory, display and a wireless transceiver of data, the delivery pen having a pen housing that extends from a first end to a second end, the first end of the housing enclosing a plunger coupled to a drug cartridge disposed proximate the second end of the housing, the first end of the pen housing having a dosage indicator window and a dosage selector coupled to the plunger, the pen further including a processing unit and a transceiver disposed in the housing, the method comprising:

loading a therapeutic administration protocol based on therapeutic requirements of the user into a controller of the glucose meter, the administration protocol including protocol information specific to at least a drug type, dosage, and schedule for administration of the drug with the dosage based on at least glucose level of a user;

storing in the controller of the glucose meter a plurality of measured glucose level in the user'"'"'s biological fluid;

displaying a recommended drug dosage based on the plurality of measured blood glucose level;

determining whether the drug delivery pen has been primed;

delivering the recommended dosage of a drug to a user via activation of the plunger with respect to the drug cartridge;

measuring the actual dosage of the drug being delivered to the user; and

storing data related to the actual dosage of the drug with a memory of the communication module;

transmitting the data to the glucose meter via the transceiver of the communication module; and

displaying information indicative of compliance to the therapeutic administration protocol.

24. The method of claim 23, in which the storing comprises flagging a date and time to the dosage of drug actually delivered.

25. The method of claim 23, in which the measuring comprises determining whether a mixture of drugs in the drug delivery cartridge has been mixed.

26. The method of claim 23, further comprising determining:

(a) whether the drug delivery pen has been rotated into a priming position, or

(b) a small amount of drug has been ejected from the cartridge in the priming position.

27. The method of claim 23, further comprising warning the user that no priming of the drug delivery pen has been made in the absence of (a) the pen housing including the cartridge being oriented topmost and generally vertically with respect to the ground in a priming position or (b) a small amount of drug being ejected from the drug cartridge or the absence of both (a) and (b).

28. The method of claim 23, further comprising interrogating an RFID tag provided with the drug cartridge to provide information stored on the RFID tag including at least one of 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.

29. The method of claim 26, further comprising:

comparing the protocol information with the information stored on the RFID tag; and

alerting at least one of the user or HCP in the event that there is a mismatch between the protocol information and the information stored on the RFID tag.

30. The method of claim 26, further comprising:

upon activation of the pen or the data management unit, setting a reminder on a screen upon to check for insulin type,

Entering insulin type selected from one of rapid acting insulin, long acting insulin, or premixed insulin,

31. The method of claim 30, further comprising

setting safety check feature on the DMU for rapid acting insulin, and

Reminding the user to take some actions to minimize the effect of the overdose of insulin.

32. 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 one of the first and second ends, 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 memory; and

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.