Integrated medicament delivery device for use with continuous analyte sensor

• US 10,278,580 B2
• Filed: 06/09/2014
• Issued: 05/07/2019
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark C., Quintana, Nelson, Llevares, Antonio C., Dobbles, John Michael, Yang, Richard C., Mensinger, Michael Robert
• Primary Examiner(s): Bouchelle, Laura A
• Application Number:
  US14/300,137
• Publication Number:
  US 20140288494A1
• Time in Patent Office: 1,793 Days
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2209/086 Docking stations
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• 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 5/31525 : Dosing burettes, pipettes B01L3/02
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Claims

1. An integrated system for monitoring and treating diabetes, the system comprising:

a medicament injection pen configured and arranged for injecting an amount of a medicament into a host;

an integrated receiver configured and arranged to receive sensor data from a continuous glucose sensor, wherein the sensor data is indicative of a glucose concentration of the host in vivo, wherein the integrated receiver comprises electronics configured and arranged to process the sensor data to calculate at least one of time of medicament therapy and amount of medicament therapy, and wherein the integrated electronics are configured and arranged to require validation of the calculated at least one of time of medicament therapy and amount of medicament therapy, when an evaluation step determines a potential risk is present, prior to injecting an amount of medicament into the host, and

a user interface configured and arranged for at least input of host information, wherein the user interface is further configured to display a graphical representation of at least sensor data and medicament delivery data, wherein the user interface further displays at least one of a target glucose concentration or a range.

2. The integrated system of claim 1, wherein the integrated receiver comprises a housing, wherein the medicament injection pen is integrally formed with the housing.

3. The integrated system of claim 1, wherein the integrated receiver comprises a housing, and wherein the medicament injection pen is detachably connectable to the housing.

4. The integrated system of claim 3, wherein communication between the medicament injection pen and the receiver is initiated based at least in part on detachable connection of the medicament injection pen and the housing.

5. The integrated system of claim 1, wherein the receiver is configured to communicate in at least one of wiredly with a single-point glucose monitor and wirelessly with a single-point glucose monitor.

6. The integrated system of claim 1, wherein the medicament injection pen comprises a motor.

7. The integrated system of claim 6, wherein the motor is configured to set the amount of medicament.

8. The integrated system of claim 6, wherein the motor is configured to control a rate of medicament injection into a host.

9. The integrated system of claim 6, wherein the receiver is configured to remotely control the motor.

10. The integrated system of claim 1, wherein the medicament injection pen and the receiver each comprise mutually engaging electrical contacts, and wherein the mutually engaging electrical contacts are configured to allow communication between the medicament injection pen and the receiver.

11. The integrated system of claim 10, wherein the system is configured to initiate communication between the medicament injection pen and the receiver in response to engagement of the electrical contacts.

12. The integrated system of claim 10, wherein the system is configured to communicate medicament delivery data between the medicament injection pen and the receiver in response to engagement of the electrical contacts.

13. The integrated system of claim 1, further comprising a receptacle configured and arranged to receive at least one of parts associated with the medicament injection pen and accessories associated with the medicament injection pen.

14. The integrated system of claim 1, wherein at least one of the parts associated with the medicament injection pen and accessories associated with the medicament injection pen comprise a medicament cartridge.

15. The integrated system of claim 1, further comprising a medicament injection pen kit, wherein the medicament injection pen kit is configured to receive the medicament injection pen, and wherein the medicament injection pen kit comprises a housing comprising a user interface, and wherein the integrated receiver is located within the housing and operably connected to the user interface.

16. The integrated system of claim 1, further comprising a remote monitor in signal communication with the integrated receiver, the remote monitor configured to display data from the integrated receiver.

17. The integrated system of claim 16, wherein the remote monitor is a cell phone.

18. The integrated system of claim 17, wherein the integrated receiver is configured to communicate data received from a continuous glucose sensor and information related to medicament therapy delivered to the host by transmitting this information to the remote monitor.

19. The integrated system of claim 1, wherein the receiver is a cell phone.

20. The integrated system of claim 1, wherein the processing of the sensor data is performed by software within the electronics of the integrated receiver.

21. An integrated system for monitoring and treating diabetes, the system comprising:

a receiver configured and arranged to receive sensor data from an operably connected continuous glucose sensor, wherein the continuous glucose sensor is configured and arranged to generate sensor data associated with a glucose concentration of a host, wherein the receiver includes a user interface configured and arranged for at least input of host information, wherein the user interface is further configured to display a graphical representation of at least sensor data and medicament delivery data, wherein the user interface further displays at least one of a target glucose concentration or a range;

integrated electronics configured to process the sensor data and to generate a medicament therapy, including to calculate at least one of time of medicament therapy and amount of medicament therapy, and wherein the integrated electronics are further configured and arranged to require validation of the calculated at least one of time of medicament therapy and amount of medicament therapy, when an evaluation step determines a potential risk is present, prior to injecting an amount of medicament into the host; and

a medicament injection pen configured to inject an amount of medicament into the host.