Drug delivery system

• US 8,556,866 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
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/203,694
• Publication Number:
  US 20110313350A1
• Time in Patent Office: 1,357 Days
• Field of Search: 604207-211, 604223-224, 604227-228, 604/181, 604/218, 604/186, 604/246, 604 65- 76
• 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. 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 reusage 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.

Claims

1. A drug delivery system comprising:

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 pen housing enclosing at least a portion of a plunger rod coupled to a drug cartridge disposed proximate the second end of the pen housing, the first end of the pen housing having a dosage selector coupled to the plunger rod;

an add-on module housing extending along a first longitudinal axis from a first add-on module housing end to a second add-on module housing end, the add-on module housing including first and second extensions that partially circumscribe a portion of the first end of the pen housing for attachment of the add-on module housing to the drug delivery pen; and

a dosage sensor coupled to the add-on module housing and located on one side of the first longitudinal axis,

in which the dosage sensor includes a longitudinal member movable along the longitudinal axis, the longitudinal member connected to a follower portion that extends from the add-on module housing proximate the second add-on module housing end;

a power source coupled to the add-on module housing, located on another side of the first longitudinal axis and spaced apart from the dosage sensor; and

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

5. The drug delivery system of one of claim 1, 2, or 3, in which the micro-controller comprises:

a memory;

a processor coupled to the memory;

an analog-to-digital converter coupled to the dosage sensor and the processor so as to provide data on displacement of a movable follower; and

a transceiver to transmit and receive data stored in memory.

6. The drug delivery system of one of claim 1, 2, or 3, in which the drug delivery pen comprises a disposable insulin pen.

7. The drug delivery system of one of claim 1, 2, or 3, in which the drug deliver pen comprises a reusable insulin pen.

11. The drug delivery system of one of claim 1, 2, or 3, 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 drug delivery system of one of claim 1, 2, or 3, further comprising a proximity detector disposed on an inner surface of the hollow bore to allow a determination of replacement of the drug delivery pen when the pen is inserted or removed from the hollow bore.

13. The drug delivery system of claim 12, in which the proximity detector is selected from a group consisting of an optical detector, ultrasound detector, mechanical detector, or combinations thereof.

14. The drug delivery system of claim 12, in which the longitudinal member comprises a slider disposed on a potentiometer, the slider being slidable on the potentiometer along the longitudinal axis between proximate the first housing end and the second housing end upon movement of the knob.

15. The drug delivery system of claim 14, further comprising a switch disposed proximate the first housing end, the switch configured to respond as a momentary switch upon the knob being moved towards a terminal position proximate the second housing end.

16. The drug delivery system of one of claim 1, 2, or 3, in which the microcontroller comprises:

a memory;

a microprocessor coupled to the memory;

an analog-to-digital converter coupled to the dosage sensor and the microprocessor so as to provide data on displacement of a follower portion; and

a transmitter to transmit data stored in memory.

17. The drug delivery system of claim 16, further comprising an inertial sensor disposed in the housing to allow for determination of mixing or priming of the drug delivery pen.

18. The drug delivery system of claim 16, further comprising a micro switch disposed in the hollow bore to provide a signal to the microcontroller indicative of insertion and removal of a drug delivery pen.

19. The drug delivery system of claim 16, in which the dosage sensor is selected from a group consisting of a rotary potentiometer, linear potentiometer, capacitive displacement sensor, optical displacement sensor, magnetic displacement sensor, encoder type displacement sensor, or combination thereof.

20. The drug delivery system of one of claim 1, 2, or 3, further comprising an inertial sensor disposed in the communication module housing to determine the orientation of the drug cartridge.

2. A drug delivery system comprising:

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 pen housing enclosing at least a portion of a plunger rod coupled to a plunger disposed in a drug cartridge located proximate the second end of the pen housing, the first end of the pen housing having a dosage selector coupled to the plunger rod; and

an add-on module housing having a primary communication module housing extending along a first longitudinal axis from a first communication module housing end to a second communication module end, in which the primary module housing includes;

a dosage sensor coupled to the primary communication module housing;

a follower portion connected to the dosage sensor and disposed for movement relative to the primary communication module housing; and

retention forks connected to the follower portion, the retention forks configured to capture a button of the dosage selector between the retention forks; and

a secondary communication module housing coupled to the primary housing module, the secondary communication module extending along a second axis to define at least a portion of a hollow bore, the at least a portion of a hollow bore configured for attachment over an actuation unit of a drug delivery pen.

8. The drug delivery system of one of claim 2, or 3, in which the dosage sensor is selected from a group consisting of resistance, capacitance, optical, magnetic or combination thereof.

9. The drug delivery system of one of claim 2, or 3, further comprising an inertial sensor disposed in the add-on module housing to determine the orientation of the drug cartridge.

10. The drug delivery system of one of claim 2, or 3, further comprising a micro-switch disposed in the add-on module housing to allow a determination of at least one of replacement or position of the drug delivery pen.

3. A drug delivery system comprising:

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 pen housing enclosing at least a portion of a plunger rod coupled to a plunger disposed in a drug cartridge located proximate the second end of the pen housing, the first end of the pen housing having a dosage selector coupled to the plunger rod; and

an add-on module housing extending along a longitudinal axis from a first add-on module housing end to a second add-on module housing end to define at least a portion of a hollow bore in which the hollow bore is configured for attachment over at least a portion of the first end of the drug delivery pen;

a casing connected to the add-on module housing and configured to enclose a portion of an outer surface of the add-on module housing, the casing being located asymmetrically with respect to the longitudinal axis to house electrical components;

a dosage sensor disposed in the casing located on one side of the first longitudinal axis in which the dosage sensor includes a longitudinal member movable along the longitudinal axis, the longitudinal member connected to a follower portion that extends from the add-on module housing proximate the second add-on module housing end;

a power source coupled to the add-on module housing, located on another side of the first longitudinal axis and spaced apart from the dosage sensor;

a micro-controller disposed in the add-on module housing proximate the first longitudinal axis;

a follower portion physically connected to the dosage sensor and disposed for movement relative to the add-on module housing; and

a knob mounted to the add-on module housing and physically connected to the dosage sensor via the follower portion so that a portion of the dosage sensor is movable in proportion to movement of the knob along the longitudinal axis.

4. The drug delivery system of claim 3, further comprising respective first and second locating tangs, each locating tang protrudes beyond each of the first and second extensions to locate the add-on module housing to the dosage indicator window.

21. A drug delivery system comprising:

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 pen housing enclosing at least a portion of a plunger rod coupled to a plunger disposed in a drug cartridge located proximate the second end of the pen housing, the first end of the pen housing having a dosage selector coupled to the plunger rod; and

an add-on module configured to attach to the drug delivery pen proximate the first end of the pen housing, the module including;

a module housing extending along a longitudinal axis from a first module housing end to a second module housing end to define at least a portion of a hollow bore disposed about the longitudinal axis in which the hollow bore is configured to couple over a portion of the first end of the pen housing; and

a casing connected to the module housing to enclose a portion of an outer surface of the module housing, the casing including means for determining either one of a dosage delivery or duration of dosage delivery or both upon actuation of the pen by a user.