Drug delivery device and methods therefor

• US 10,213,549 B2
• Filed: 07/28/2014
• Issued: 02/26/2019
• Est. Priority Date: 12/01/2011
• Status: Active Grant

• Current Assignee: PicoLife Technologies, LLC
• Original Assignee: PicoLife Technologies, LLC
• Inventors: Amirouche, Farid, Attar, Arash N., Cantwell, Matthew L.
• Primary Examiner(s): Stigell, Theodore
• Application Number:
  US14/444,153
• Publication Number:
  US 20140336614A1
• Time in Patent Office: 1,674 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/1422 with double acting or multiple pistons
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• 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: G16H 20/17 delivered via infusion or injection

Abstract

A drug delivery device for delivery of medicament having a delivery pump system and a cartridge system, the delivery pump system operating electromagnetically by driving two disk magnets that are housed within pump body inserts of the cartridge system. The displacement of the magnets and an elastomer membrane placed between the magnets of the cartridge system results in a volumetric change within two reservoirs and the flow of medicaments. The medicament flows from the reservoirs to the inlet/outlet members via the pump body inserts and discharged to a patient user'"'"'s body through an infusion set.

Claims

1. A drug delivery device, comprising:

a delivery pump system, said delivery pump system comprising a plurality of electromagnetic coils, a controller electrically coupled to said plurality of electromagnetic coils, and a power source;

a cartridge system, said cartridge system comprising;

a first reservoir and a second reservoir, said first reservoir and said second reservoir each having a substantially symmetrical body with a top end, and an opening formed in said top end;

a first inlet/outlet member securely engaged to said first reservoir, said first inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, said fluid receiving opening in fluid communication with said first reservoir and said fluid outlet component in fluid communication with said fluid discharge opening;

a second inlet/outlet member securely engaged to said second reservoir, said second inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, said fluid receiving opening in fluid communication with said second reservoir, and said fluid outlet component in fluid communication with said fluid discharge opening;

a first pump body insert having a fluid receiving opening, a fluid discharge opening, a plurality of inlet channels, and a plurality of outlet channels, said fluid receiving opening in fluid communication with said plurality of inlet channels, said plurality of inlet channels in fluid communication with said plurality of outlet channels, and said plurality of outlet channels in fluid communication with said fluid discharge opening;

a second pump body insert having a fluid receiving opening, a fluid discharge opening, a plurality of inlet channels, and a plurality of outlet channels, said fluid receiving opening in fluid communication with said plurality of inlet channels, said plurality of inlet channels in fluid communication with said plurality of outlet channels, and said plurality of outlet channels in fluid communication with said fluid discharge opening;

a pump membrane, said pump membrane being between said first pump body insert and said second pump body insert; and

a plurality of magnets, said plurality of magnets having a distal end, a proximal end and a cylindrical body connecting said distal and proximal ends, and said proximal end being in contact with said pump membrane and said distal end being housed within one of said first and second pump body inserts;

wherein said plurality of magnets and said plurality of electromagnetic coils are axially aligned,

wherein said fluid receiving opening of said first pump body insert is in fluid communication with said fluid receiving opening of said first inlet/outlet member, and said fluid discharge opening of said first pump body insert is in fluid communication with said fluid discharge opening of said first inlet/outlet member, and

wherein said fluid receiving opening of said second pump body insert is in fluid communication with said fluid receiving opening of said second inlet/outlet member, and said fluid discharge opening of said second pump body insert is in fluid communication with said fluid discharge opening of said second inlet/outlet member.

2. The device of claim 1, further comprising:

an infusion set, said infusion set comprising;

a conduit for delivery of medicament, said conduit having a distal end, a proximal end, and a substantially cylindrical body connecting said distal and proximal ends,

wherein said distal end of said conduit is securely attached to a luer slip on said proximal end of said fluid outlet component of said inlet/outlet member, and

wherein said proximal end of said conduit is securely engaged to a cannula and insertion mechanism.

3. The device of claim 2, wherein said cannula includes an insertion mechanism.

4. The device of claim 1, wherein said delivery pump system further comprises a blood glucose meter, said blood glucose meter being communicatively linked to said controller and said blood glucose meter comprising a port, wherein said port is capable of taking a blood glucose test strip, and said blood glucose meter is capable of computing blood glucose level using said blood glucose test strip.

5. The device of claim 1, wherein said delivery pump system further comprises a plurality of membrane switches, said plurality of membrane switches being communicatively linked to said controller, and said plurality of membrane switches having a plurality of buttons.

6. The device of claim 1, wherein said delivery pump system further comprises a touch screen, display and backlight assembly, said assembly being communicatively linked to said controller, and said touch screen being used to navigate menus, administer medicament, review saved data, modify user settings, or input general information to said device.

7. The device of claim 1, wherein said delivery pump system further comprises a port, said port being communicatively linked to said controller and said port enabling said drug delivery device to communicate with a computer.

8. The device of claim 1, wherein said delivery pump system further comprises a front-top case and a rear-top case, said front-top case and said rear-top case being designed to provide a housing.

9. The device of claim 1, wherein said cartridge system further comprises a plurality of reservoir shells;

and an insulation and sealed layer provided inside each of said plurality of reservoir shells, wherein said first reservoir and said second reservoir is each mounted within one of said plurality of reservoir shells.

10. The device of claim 1, wherein said first reservoir contains a first fluid medicament and said second reservoir contains a second fluid medicament.

11. The device of claim 10, wherein said first medicament is insulin, and second medicament is glucagon.

12. The device of claim 1, further comprising a plurality of valve membranes, said valve membrane being pre-stressed and made of a material from the group consisting of Silastic Q7-4840.

13. The device of claim 1, wherein said pump valves are electromagnetically actuated and actively controlled by said controller of said delivery pump system using feedback control for delivery of medicament.

14. The device of claim 1, wherein said delivery pump system further comprises a continuous blood glucose sensor, said continuous blood glucose sensor being communicatively linked to said controller.

15. The device of claim 1, wherein said power source is capable of being recharged using a charging port.

16. The device of claim 1, wherein said first reservoir and said second reservoir of said cartridge system are pre-filled with medicaments.

17. The device of claim 1, wherein said first and second reservoirs of said cartridge system are each filled by a user using an instrument.

18. A method of delivering medicament, comprising:

providing a drug delivery device comprising a delivery pump system, said delivery pump system comprising a plurality of electromagnetic coils, a controller electrically coupled to said plurality of electromagnetic coils, and a power source; and

a cartridge system, said cartridge system comprising;

a first reservoir and a second reservoir, said first reservoir and said second reservoir each having a substantially symmetrical body with a top end, and an opening formed in said top end;

a first inlet/outlet member securely engaged to said first reservoir, said first inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, said fluid receiving opening in fluid communication with said first reservoir and said fluid outlet component in fluid communication with said fluid discharge opening;

a second inlet/outlet member securely engaged to said second reservoir, said second inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, said fluid receiving opening in fluid communication with said second reservoir, and said fluid outlet component in fluid communication with said fluid discharge opening;

a first pump body insert having a fluid receiving opening, a fluid discharge opening, a plurality of inlet channels, and a plurality of outlet channels, said fluid receiving opening in fluid communication with said plurality of inlet channels, said plurality of inlet channels in fluid communication with said plurality of outlet channels, and said plurality of outlet channels in fluid communication with said fluid discharge opening;

a second pump body insert having a fluid receiving opening, a fluid discharge opening, a plurality of inlet channels, and a plurality of outlet channels, said fluid receiving opening in fluid communication with said plurality of inlet channels, said plurality of inlet channels in fluid communication with said plurality of outlet channels, and said plurality of outlet channels in fluid communication with said fluid discharge opening;

a pump membrane, said pump membrane being between said first pump body insert and said second pump body insert,

a plurality of magnets, said plurality of magnets having a distal end, a proximal end and a cylindrical body connecting said distal and proximal ends, and said proximal end being in contact with said pump membrane and said distal end being housed within one of said first and second pump body inserts; and

wherein said plurality of magnets and said plurality of electromagnetic coils are axially aligned,

wherein said fluid receiving opening of said first pump body insert is in fluid communication with said fluid receiving opening of said first inlet/outlet member, and said fluid discharge opening of said first pump body insert is in fluid communication with said fluid discharge opening of said first inlet/outlet member, and

wherein said fluid receiving opening of said second pump body insert is in fluid communication with said fluid receiving opening of said second inlet/outlet member, and said fluid discharge opening of said second pump body insert is in fluid communication with said fluid discharge opening of said second inlet/outlet member;

loading said first reservoir and said second reservoir, each containing pre-filled fluid medicament, to said cartridge system;

engaging securely said cartridge system and said delivery pump system;

selecting various parameters on a user interface of said delivery pump system including selecting pre-determined values or specifying user-defined values for the parameters; and

connecting an infusion set to said drug delivery device.

19. The method of claim 18, further comprising:

placing an inset of the infusion set on a body part of a patient;

attaching the infusion set to the patient'"'"'s body;

connecting the infusion set to the drug delivery device; and

switching on said drug delivery device.

20. The method of claim 18, further comprising:

using an integrated glucose meter to determine a patient user'"'"'s blood glucose level;

transmitting blood glucose data result to a controller on said delivery pump system; and

determining basal or bolus rate based on said data result.