Drug delivery pen with event notification means

• US 7,713,229 B2
• Filed: 11/05/2004
• Issued: 05/11/2010
• Est. Priority Date: 11/06/2003
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Weber, Barry, Luther, Peter, McCluskey, Joseph, Bidegainberry, Jean, Veit, Eric D., Bylund, Adam
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US10/981,830
• Publication Number:
  US 20050182358A1
• Time in Patent Office: 2,013 Days
• Field of Search: 604/93.01, 604/187, 604/207, 604/20, 604/891.1, 128/903
• US Class Current: 604/65
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• 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 2205/60 with identification means
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Devices, systems and methods are provided for drug delivery and the monitoring thereof. The systems include a drug delivery device, a holder for the drug delivery device when the device is not in use, a detector for detecting the presence of the drug delivery device within or close to the holder, and at least one algorithm for querying and prompting a user of the drug delivery device, wherein the at least one algorithm is activated upon removal of the drug delivery device from the holder.

Claims

1. A drug delivery system comprising:

a microprocessor device including a glucose measurement unit;

a drug delivery device in communication with the microprocessor device, the drug delivery device configured to deliver a drug to a user;

a holder for the drug delivery device when the device is not in use;

a detector which detects the removal of the drug delivery device from the holder which causes the microprocessor device to prompt a user to conduct a glucose measurement with the glucose measurement unit, to provide a suggestion for dosage of the drug based on the user'"'"'s entered input parameters and recommendation from a health care provider previously stored or entered into a memory of the microprocessor device.

2. The system of claim 1, wherein the holder, the detector and the at least one algorithm are incorporated into a case for housing the system.

3. The system of claim 2, wherein the microprocessor device turns on upon removal of the drug delivery device from the holder.

4. The system of claim 1, further comprising means for communicating with a device for storing user information.

5. The system of claim 4, wherein the user information comprises drug dosing information.

6. The system of claim 4, means for communicating comprises wireless communication means.

7. The system of claim 1, wherein the detector is selected from the group consisting of a mechanical switch, a magnetic switch, a density switch, a capacitive switch, an electrical sensor and an optical sensor.

8. The drug delivery system of claim 1, further comprising:

a wireless transmitter and receiver to transmit information regarding the user to a remote device.

9. The drug delivery system according to claim 8 wherein the information comprises data on blood glucose measurements of the user and delivery of the drug, which is selected from the group consisting of drug dosage information and timing of drug delivery.

10. An insulin injection system comprising:

a meter adapted for the measurement of glucose concentration in a blood sample, the meter comprising a microprocessor;

an insulin injector;

and a storage case for said insulin injector, the storage case including a detector that activates the meter upon removal of the insulin injector from the storage case, so that the meter prompts a user to conduct a glucose measurement with the meter and provide a suggestion for dosage of the drug based on the user'"'"'s input parameters and a recommendation from a health care provider previously stored or entered into a memory of the microprocessor device.

11. The system of claim 10, wherein the storage case comprises a storage space to house the meter.

12. The system of claim 10, further comprising wireless communication unit to transmit and receive data to and from an external device.

13. The system of claim 12, wherein the wireless communication unit comprises RF signals.

14. A method of monitoring the use of a drug delivery device, the method comprising:

storing the drug delivery device when the device is not in use;

removing the drug delivery device from storage;

detecting the removal of the drug delivery device from storage;

upon detecting removal of the drug delivery device from storage, prompting a user to conduct a blood glucose measurement with a blood glucose measurement unit;

upon the user conducting a blood glucose measurement, suggesting a dosage of drug to be delivered by the drug delivery device based on the user'"'"'s input parameter and recommendations from the health care provider previously entered or stored in a memory of a microprocessor; and

requesting that the user enter a dosage actually delivered into the memory of the microprocessor.

15. The method of claim 14, further comprising turning on the blood glucose measurement unit;

and requesting that the user perform a glucose measurement.

16. The method of claim 14, further comprising recording the time at which the drug delivery device is removed from storage.

17. The method of claim 14, further comprising transmitting dosage actually delivered to a data storage device.

18. The method of claim 14 further comprising:

transmitting information on blood glucose measurements of the user to a remote device; and

transmitting information on dosage of drugs actually delivered to the remote device.

19. An insulin injection kit comprising:

a system comprising;

a meter adapted for the measurement of glucose concentration in a blood sample, the meter comprising a microprocessor;

an insulin injector; and

a storage case for said insulin injector, the storage case including a detector that activates the meter upon removal of the insulin injector from the storage case, so that the meter prompts a user to conduct a glucose measurement with the meter and provide a suggestion for dosage of the drug based on the user'"'"'s input parameters and recommendation from a health care provider previously stored or entered into a memory of the microprocessor device;

a plurality of devices selected from the group consisting of lancers, lancets, needles and test strips; and

instructions for using the system.

20. A method of diabetes management for a user, the method comprising:

storing a drug delivery device in a storage case;

upon removal of the drug delivery device from the storage case, prompting a user with a microprocessor device to measure blood glucose value of the user, the microprocessor including a memory having a drug dosage delivery instructions previously stored in the memory from a health care provider based on at least one of a blood glucose value and user'"'"'s input parameters;

upon the user conducting a measurement of blood glucose value, suggesting a drug dosage based on a measured blood glucose value and the instructions;

querying the user as to whether a dosage of drug was delivered upon removal of the drug delivery device from the storage case; and

verifying with the user of a dosage actually delivered to the user.

21. The method of claim 20, further comprising transmitting data on blood glucose measurements made and drug dosage actually delivered to a remote device.

22. The method of claim 20, further comprising receiving data drug dosage delivery instructions from a remote device.