Drug delivery management systems and methods

• US 8,556,867 B2
• Filed: 01/27/2010
• Issued: 10/15/2013
• 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, Wilk, Robert, Kraft, Ulrich, Savage, Donna, Foley, Nick, Glencross, James, Shepherd, David, Sieh, Zara, Price, David
• Primary Examiner(s): Stigell, Theodore J
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/203,697
• Publication Number:
  US 20120004637A1
• Time in Patent Office: 1,357 Days
• Field of Search: 604207-211, 604223-224, 604227-228, 604/181, 604/218, 604/186, 604/246
• US Class Current: 604/223
• 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, 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, and further 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, 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, the processor being disposed in the add-on housing proximate the first longitudinal axis,

and further 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, 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 follower portion comprises a locator fork.

3. The system of claim 1, in which the follower portion comprises a rotary knob in a nested configuration with the dosage selector.

4. The system of claim 1, in which the

first and second extensions 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.

6. The system of one of claim 1 or claim 5, in which the drug delivery pen comprises a disposable insulin pen.

7. The system of any one of claim 1 or claim 5, in which the drug delivery pen comprises a reusable insulin pen.

9. The system of one of claim 1 or claim 5, further comprising an inertial sensor disposed in the add-on housing to determine the orientation of the drug cartridge.

10. The system of one of claim 1 or claim 5, 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.

11. The system of one of claim 1 or claim 5, 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.

12. The system of one of claim 1 or claim 5, 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.

13. The system of one of claim 1 or claim 5, in which the data management unit comprises a mobile phone.

15. The system of one of claim 1 or claim 5, in which the data management unit comprises a network server located at a remote location from the communication module.

5. 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, 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 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, 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, with the processor being disposed in the add-on housing,

and further 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, 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.

8. The system of claim 5, in which the dosage sensor is selected from a group consisting of resistance, capacitance, optical, magnetic or combination thereof.

14. The system of claim 5, in which the data management unit comprises a mobile computer.