DRUG DELIVERY MANAGEMENT SYSTEMS AND METHODS

• US 20120004637A1
• Filed: 01/27/2010
• Published: 01/05/2012
• Est. Priority Date: 02/27/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifes-Can Incorporated
• Inventors: Krulevitch, Peter, Wilk, Robert, Kraft, Ulrich, Savage, Donna, Foley, Nick, Glencross, James, Shepherd, David, Sieh, Zara, Price, David
• Granted Patent: US 8,556,867 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 system are provided which includes an add-on module and a reusable or disposable drug pen in conjunction with a data management unit(s) DMU. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reuse of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module. Methods of using the drug delivery system are also described.

Claims

1. 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 system including;

a drug delivery pen comprising;

a generally tubular pen housing that extends from a first end to a second end, the housing enclosing at least a portion of a plunger rod 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;

an add-on communication unit comprising;

an add-on housing extending along a first longitudinal axis from a first housing end to a second housing end, the add-on housing including an engagement portion that circumscribes at least a portion of the pen housing and capable of being separated from the drug delivery pen, and in which the housing includes;

a memory unit;

a processor coupled to the memory;

an analog-to-digital converter coupled to a dosage sensor attached to the dosage selector of the pen, the converter being coupled to the processor so as to provide data upon displacement of the dosage selector; and

a transceiver to transmit and receive data relating to dosage delivery of a drug dosage in the drug cartridge to the data management unit.

2. The system of claim 1, in which the engagement portion comprises first and second extensions, each of the extensions having first and second locating tangs, each locating tang protrudes beyond each of the first and second extensions to fix the add-on housing to the dosage indicator window.

3. The system of claim 2, in which the dosage sensor is disposed in the add-on housing and located on one side of the first longitudinal axis;

a power source disposed in the housing, located on another side of the first longitudinal axis and spaced apart from the dosage sensor; and

a micro-controller disposed in the housing proximate the first longitudinal axis and located between dosage sensor and the power source.

4. The system of claim 3, in which the dosage sensor comprises a longitudinal member slidable along the longitudinal axis, the longitudinal member connected to a follower portion that extends from the add-on housing proximate the second housing end, and the follower portion being coupled to the dosage selector of the drug delivery pen so as to move longitudinally upon rotation of the dosage selector with respect to the pen housing.

5. The system of claim 4, in which the follower portion comprises a locator fork.

6. The system of claim 4, in which the follower portion comprises a rotary knob in a nested configuration with the dosage selector.

7. The system of claim 1, in which the add-on housing comprises:

first and second extensions that partially circumscribe a second longitudinal axis generally parallel to the first longitudinal axis so that the first and second extensions are in frictional contact with the outer surface of the drug delivery pen.

8. The system of claim 1, in which the add-on housing comprises a generally tubular extension circumscribing a second longitudinal axis to define a hollow bore that extends through a portion of the generally tubular extension of the housing to allow the drug delivery pen to be inserted into the hollow bore.

9. The system of claim 1, in which the drug delivery pen comprises a disposable insulin pen.

10. The system of claim 1, in which the drug delivery pen comprises a reusable insulin pen.

11. The system of claim 1, in which the dosage sensor is selected from a group consisting of resistance, capacitance, optical, magnetic or combination thereof.

12. The system of claim 1, further comprising an inertial sensor disposed in the add-on housing to determine the orientation of the drug cartridge.

13. The system of claim 1, further comprising a micro-switch disposed in the add-on housing to allow a determination of replacement and/or correct positioning of the drug delivery pen.

14. The system of claim 1, 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 1, 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 1, in which the data management unit comprises a mobile phone.

17. The system of claim 1, in which the data management unit comprises a mobile computer.

18. The system of claim 1, in which the data management unit comprises a network server located at a remote location from the communication module.

19. A method of delivering drug to a user with a drug delivery pen having a generally tubular 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 method comprising:

mounting a communication module to one of the first and second ends of the drug delivery pen;

delivering a dosage of drug to a user via activation of the plunger;

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

storing data related to the actual dosage of a drug delivered from the drug cartridge in a memory of the communication module.

20. The method of claim 19, in which the mounting comprises:

inserting the first end of the drug delivery pen into a hollow bore of the communication module; and

coupling the dosage selector to a rotatable knob of the communication module.

21. The method of claim 19, in which the measuring comprises:

connecting the plunger to a displacement sensor disposed in the communication module such that the displacement sensor and the plunger are configured to move as a single unit; and

correlating the movement of the plunger to the dosage of a drug actually delivered to the user.

22. The method of claim 21, in which the storing comprises flagging a date and time to the dosage of drug actually delivered.

23. The method of claim 19, in which the storing comprises transmitting the data to a remote receiver unit.

25. The method of one of claim 19 or 24, in which the mounting comprises:

inserting the first end of the drug delivery pen into a hollow bore of the communication module; and

coupling the dosage selector to a rotatable knob of the communication module.

26. The method of one of claim 19 or 24, in which the measuring comprises:

connecting the plunger to a portion of a displacement sensor disposed in the communication module such that the portion of the displacement sensor and the plunger are configured to move as a single unit; and

correlating the movement of the plunger to the dosage of drug actually delivered to the user.

27. The method of claim 26, in which the storing comprises flagging a date and time to the dosage of drug actually delivered.

28. The method of one of claim 19 or 24, in which the measuring comprises determining whether the drug delivery device has been primed.

29. The method of one of claim 19 or 24, in which the measuring comprises determining whether a mixture of drug in the drug delivery cartridge has been mixed.

30. The method of one of claim 19 or 24, further comprising warning the user that no priming of the drug delivery device has been made.

31. The method of one of claim 19 or 24, further comprising warning the user to change needle.

32. The method of one of claim 19 or 24, further comprising timing a drug delivery event upon actuation of the dosage delivery button, counting down a predetermined time, and warning the user if a drug delivery time was insufficient.

33. The method of one of claim 19 or 24, further comprising:

reminding the user of when to perform a drug delivery;

warning that a drug delivery has been missed;

or

warning of an inappropriate dosage.

34. The method of one of claim 19 or 24, further comprising tracking one of:

a duration of a pen in use by the user;

amount left of time until the drug cartridge will be expired;

or

amount of drug remaining in the drug cartridge.

36. The method of one of claim 19 or 24, in which the drug is selected from a group consisting essentially of slow acting insulin, fast acting insulin, growth hormone, GLP-1 analogs, Symlin, or combinations thereof.

24. 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 generally tubular 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 method comprising:

loading a therapeutic administration protocol based on therapeutic requirements of the user into controller of the glucose meter;

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;

mounting a communication module to one of the first and second ends of the drug delivery pen, the communication module having a processing unit and a transceiver;

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.

35. The method of claim 24, further comprising:

locating a misplaced glucose meter by activation of a locate switch on the communication module;

or

locating a misplaced communication module by activation of a locate switch on the glucose meter.

37. The method of claim 24, further comprising the steps of:

turning the meter the off; and

upon turning the meter on, displaying information of the last dosage delivery and time of the last data communication from the communication module and the meter.