Medical module for drug delivery pen

• US 8,556,865 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), LifeScan IP Holdings, LLC
• 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:
  US13/203,691
• Publication Number:
  US 20110313349A1
• 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 medical module are provided which includes a primary module housing, a secondary module housing, a dosage sensor, a power source, and a microcontroller. The module is configured to be attached to a disposable drug delivery pen or a reusable drug delivery pen so that the 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 medical module comprising:

a primary module housing extending along a first longitudinal axis from a first module housing end to a second module end;

a secondary module housing coupled to the primary module, the secondary 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;

a dosage sensor coupled to the primary module housing;

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

retention forks connected to the follower portion, the retention forks configured to capture an actuation button of a drug delivery pen between the retention forks;

a power source coupled to the primary module housing and spaced apart from the dosage sensor; and

a microcontroller disposed proximate the primary module housing and electrically coupled to both the dosage sensor and the power source.

2. The medical module of claim 1, in which the secondary module housing comprises:

first and second extensions that partially circumscribe the second longitudinal axis generally parallel to the first longitudinal axis.

3. The medical module of claim 2, in which each of the first and second extensions includes respective first and second locating tangs, each locating tang protruding beyond each extension.

4. The medical module of claim 3, in which the first locating tang is located at a position along the second longitudinal axis offset longitudinally with respect to the second locating tang.

5. The medical module of claim 2, in which each of the first and second extensions defines a generally circular cross-section of generally 30 degrees about the second longitudinal axis.

6. The medical module of claim 5, in which a portion of the secondary module housing circumscribes the second longitudinal axis to define a generally circular cross-section of generally 140 degrees about the longitudinal axis.

7. The medical module of claim 6, in which the portion of the secondary module housing is contiguous to both the first and second extensions to define a continuous surface that circumscribes generally 250 degrees about the second axis.

8. The medical module of claim 1, in which the dosage sensor includes a longitudinal member slidable along the longitudinal axis, the longitudinal member connected to a follower portion that extends from the primary module housing proximate the second module housing end.

9. The medical module of claim 8, in which the longitudinal member is configured for rotation about its axis.

10. The medical module of claim 1, in which the secondary module housing comprises a generally tubular extension circumscribing entirely the second longitudinal axis to define a hollow tubular member that extends along a length of the module housing.

11. The medical module of claim 1, 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 transceiver to transmit and receive data stored in memory.

12. The medical module of claim 1, in which the drug delivery pen comprises a disposable insulin pen.

13. The medical module of claim 1, in which the drug delivery pen comprises a reusable insulin pen.

14. The medical module of claim 1, 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.

15. The medical module of claim 1, further comprising an inertial sensor disposed in the primary module housing to determine the orientation of the drug cartridge.

16. The medical module of claim 1, further comprising a micro switch to allow a determination of replacement of the drug delivery pen.

17. A medical communication unit comprising:

a housing extending along a longitudinal axis from a first housing end to a second housing end to define at least a portion of a hollow bore in which the hollow bore is configured to couple over an actuation unit of a drug delivery pen;

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

a dosage sensor disposed in the casing;

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

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

18. The medical module of claim 17, 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 housing proximate the second housing end.

19. The medical module of claim 18, 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.

20. The medical module of claim 19, 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.

21. The medical module of claim 17, 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.

22. The medical module of claim 21, further comprising an inertial sensor disposed in the housing.

23. The medical module of claim 17, 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.

24. The medical module of claim 17, 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.

25. The medical module of claim 17, further comprising an inertial sensor disposed in the module housing to determine the orientation of the drug cartridge.

26. A dosage sensing module comprising:

a housing extending along a longitudinal axis from a first housing end to a second housing end to define an internal surface of at least a portion of a hollow bore disposed about the longitudinal axis, the internal surface defining the hollow bore capable of completely enclosing a cylindrical outer surface of a portion of a drug delivery pen in one mode, and the internal surface of the hollow bore being visible to an observer in another mode when the housing is separated from the drug delivery pen; and

means for measuring displacement of a dosage selector of the drug delivery pen.