Drug delivery device and methods therefor

• US 8,790,307 B2
• Filed: 02/09/2012
• Issued: 07/29/2014
• 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 J
• Application Number:
  US13/370,091
• Publication Number:
  US 20130144254A1
• Time in Patent Office: 901 Days
• Field of Search: 604131-132, 604151-153, 604/66, 604/500, 604/504, 417/477.2
• US Class Current: 604/151
• 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 having a plurality of electromagnetic coils, a controller electrically coupled to the plurality of electromagnetic coils, and a power source; and

a cartridge system, wherein the cartridge system includes;

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

a first inlet/outlet member connected to the first reservoir, the first inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, the fluid receiving opening of the first inlet/outlet member in fluid communication with the first reservoir, and the fluid outlet component of the first inlet/outlet member in fluid communication with the fluid discharge opening of the first inlet/outlet member;

a second inlet/outlet member connected the second reservoir, the second inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, the fluid receiving opening of the second inlet/outlet member in fluid communication with the second reservoir, and the fluid outlet component of the second inlet/outlet member in fluid communication with the fluid discharge opening of the second inlet/outlet member;

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

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

a pump membrane positioned between the first pump body insert and the second pump body insert; and

a plurality of magnets, each of the plurality of magnets having a distal end, a proximal end, and a body extending between the distal and proximal ends, and at least one of the said proximal ends being in contact with the pump membrane, and at least one of the distal ends being housed within at least one of the said first and second pump body inserts,

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

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

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

2. The device of claim 1, further comprising:

an infusion set having a conduit for delivery of medicament, the conduit having a distal end, a proximal end, and a body extending between the distal and proximal ends,

wherein the distal end of the conduit is attached to a luer slip on the fluid outlet component of at least one of the first inlet/outlet member and the second inlet/outlet member, and

wherein the proximal end of the conduit is connected to a cannula and an insertion mechanism.

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

4. The device of claim 1, wherein the delivery pump system further comprises a blood glucose meter, the blood glucose meter being communicatively linked to the said controller, and the blood glucose meter having a port, wherein the port is capable of interacting with a blood glucose test strip, and the blood glucose meter is configured to compute a concentration of glucose based at least in part on the blood glucose test strip.

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

6. The device of claim 1, wherein the delivery pump system further comprises an input device, a display, and a backlight assembly, the backlight assembly being communicatively linked to the controller.

7. The device of claim 6, wherein the input device includes a touch screen.

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

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

10. The device of claim 1, wherein the cartridge system further comprises a plurality of reservoir shells and an insulation layer within at least one of the plurality of reservoir shells, wherein the first reservoir and the second reservoir are each mounted within one of the plurality of reservoir shells.

11. The device of claim 10, wherein the first reservoir and the second reservoir are mounted within the same reservoir shell.

12. The device of claim 10, wherein the first reservoir and the second reservoir are mounted within different reservoir shells.

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

14. The device of claim 13, wherein the first fluid medicament includes insulin, and the second fluid medicament includes glucagon.

15. The device of claim 1, further comprising a plurality of valve membranes, wherein each of the plurality of valve membranes is pre-stressed and made of silicone.

16. The device of claim 1, wherein the pump membrane is electromagnetically actuated and controlled by the controller using feedback control for delivery of medicament.

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

18. The device of claim 1, wherein the power source is rechargeable.

19. The device of claim 1, wherein at least one of the first reservoir and the second reservoir is pre-filled with at least one medicament.

20. The device of claim 1, wherein at least one of the first and the second reservoirs is refillable.

21. A method of delivering medicament using a drug delivery device, comprising:

loading a plurality of pre-filled reservoirs containing fluid medicament onto a cartridge system;

engaging the cartridge system and a delivery pump system;

selecting various one or more parameters using a user interface of the delivery pump system; and

connecting an infusion set to the drug delivery device, wherein the drug delivery device includes plurality of electromagnetic coils, a controller electrically coupled to the plurality of electromagnetic coils, and a power source,

wherein the cartridge system comprises;

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

a first inlet/outlet member connected to the first reservoir, the first inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, the fluid receiving opening of the first inlet/outlet member in fluid communication with the first reservoir, and the fluid outlet component of the first inlet/outlet member in fluid communication with the fluid discharge opening of the first inlet/outlet member;

a second inlet/outlet member connected to the second reservoir, the second inlet/outlet member having a fluid receiving opening, a fluid discharge opening, and a fluid outlet component, the fluid receiving opening of the second inlet/outlet member in fluid communication with the second reservoir, and the fluid outlet component of the second inlet/outlet member in fluid communication with the fluid discharge opening of the second inlet/outlet member;

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

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

a pump membrane positioned between the first pump body insert and the second pump body insert; and

a plurality of magnets, each of the plurality of magnets having a distal end, a proximal end, and body extending between the distal and proximal ends, and at least one of the proximal ends being in contact with the pump membrane, and at least one of the distal ends being housed within at least one of the first and second pump body inserts,

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

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

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

22. The method of claim 21, 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

turning on the drug delivery device.

23. The method of claim 21, further comprising:

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

transmitting blood glucose data to a controller within the delivery pump system; and

determining a rate of delivery of the fluid medicament based at least in part on the blood glucose data.