Drug delivery management systems and methods

• US 9,724,475 B2
• Filed: 01/27/2010
• Issued: 08/08/2017
• 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
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Darb, Hamza
• Application Number:
  US13/203,707
• Publication Number:
  US 20110313395A1
• Time in Patent Office: 2,750 Days
• Field of Search: 604207-211
• 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 for confirming a dosage delivery protocol, the 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 the first end, 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 a memory; and

an inertial sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the inertial sensor by;

determining 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; and

determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.

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 of long acting insulin, rapid acting insulin, long and rapid acting mixed insulin, neutral protamine Hagedorn (NPH), growth hormone, glucagon-like peptide (GLP-1) analogs, pramlintide, or combinations thereof.

4. 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.

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

6. 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 a user of the drug delivery pen.

7. 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 for confirming a dosage delivery protocol, the 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 the first end, 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 a memory;

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 rod; and

an acceleration sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the acceleration sensor by;

determining 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; and

determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.

8. The drug delivery pen of 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.

9. 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 for confirming a dosage delivery protocol, the 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 the first end, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;

a memory;

a microprocessor coupled to the memory of the pen; and

an inertial sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the inertial sensor by;

determining 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; and

determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.

10. The system of claim 9, 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.

11. The system of claim 10, wherein the transceiver transmits and receives data relating to dosage delivery of a drug dosage in the drug cartridge to the data management unit.

12. The system of claim 9, 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, neutral protamine Hagedorn (NPH), growth hormone, glucagon-like peptide (GLP-1) analogs, pramlintide, or combinations thereof.

13. The system of claim 9, 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.

14. The system of claim 9, in which the data management unit comprises a mobile phone.

15. The system of claim 9, in which the data management unit comprises a mobile computer.

16. The system of claim 9, in which the data management unit comprises a network server located at a remote location from the communication module.

17. The system of claim 9, 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.

18. The system of claim 17, 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.

19. 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 the first end, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;

a memory;

a microprocessor coupled to the memory of the pen;

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; and

an inertial sensor connected to the housing and in electronic communication with the microprocessor, wherein the microprocessor confirms the dosage delivery protocol from output signals of the inertial sensor by;

determining 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; and

determining whether the pen housing, including the cartridge, has been oriented topmost and generally vertically with respect to a ground during a priming operation, wherein the microprocessor distinguishes whether the pen has delivered a priming shot or a dosage of the one or more drugs.