Modular drug delivery device for administering discrete doses of a medicament

• US 8,414,532 B2
• Filed: 08/04/2008
• Issued: 04/09/2013
• Est. Priority Date: 08/07/2007
• Status: Active Grant

• Current Assignee: Sensile Medical AG (Gerresheimer AG)
• Original Assignee: Sensile Pat Ag
• Inventors: Brandt, Derek, Calasso, Irio
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/672,003
• Publication Number:
  US 20110196337A1
• Time in Patent Office: 1,709 Days
• Field of Search: 604/890.1, 604/131, 604140-143, 604/151, 604/21, 604/65, 604/93.01, 604/891.1
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

There provided a drug delivery device adapted for providing a plurality of discrete doses of a medicament including a disposable delivery unit (2) adapted to be worn by a user, comprising a reservoir (10b) for holding a medicament to be delivered, an injection member (22) adapted for trans-dermal drug delivery, and a pump (12) adapted for pumping the medicament to be delivered from the reservoir (10b) to the injection member (22); and a separate reusable base unit (4) comprising a drive module for driving the pump (12). The pump in the disposable delivery unit is activated to deliver a dose of the medicament by bringing the base unit temporarily into communication with the delivery unit.

Claims

1. A drug delivery device for providing a plurality of discrete doses of a medicament comprising:

a disposable delivery unit configured to be worn by a patient, comprising a reservoir for holding a medicament to be delivered, an injection member adapted for trans-dermal drug delivery, a pump for pumping the medicament to be delivered from the reservoir to the injection member, and an outer docking interface; and

a separate reusable base unit configured to be carried separately from the disposable delivery unit between administration of said plurality of discrete doses of a medicament while the delivery unit is worn by the patient and to be temporarily placed in contactless power communication with the delivery unit for administration of said discrete doses of a medicament, comprising a drive module providing power for driving the pump to deliver a dose of the medicament, and a complementary outer docking interface configured for placement against the outer docking interface of the delivery unit, such that the base unit is guided when it is temporarily positioned over the delivery unit for bringing the base unit into electromagnetic or magnetic power communication with the delivery unit without mechanical attachment between the delivery unit and base unit.

2. The drug delivery device according to claim 1, wherein the delivery unit comprises an adhesive base adapted for adhesive mounting of the delivery unit on a patient'"'"'s skin.

3. The drug delivery device according to claim 2, wherein the base unit comprises a memory device adapted to monitor one or more of the amounts of at least a last delivered dose, the time elapsed since one or more doses, and/or the number and/or amount of doses administered over a certain time period.

4. The drug delivery device according to claim 3, wherein the memory device comprises an alarm function.

5. The drug delivery device according to claim 3, wherein the memory device comprises a reminder function.

6. The drug delivery device according claim 1, wherein the base unit comprises a power supply and electronics for controlling operation of the pump and a user interface.

7. The drug delivery device according to claim 1, wherein the injection member is an injection needle or a canula.

8. The drug delivery device according to claim 1, wherein the delivery unit contains a capacitor adapted to activate an alarm if a parameter of the delivery unit is outside a predefined range.

9. The drug delivery device according to claim 1, wherein the pump comprises a drive module comprising a rotor with permanent magnets.

10. The drug delivery device according to claim 9, wherein the drive module comprises electromagnets for driving the permanent magnets disposed on the rotor of the delivery unit pump, or for inducing electrical current in one or more coils in the delivery unit.

11. The drug delivery device according to claim 9, wherein the drive module comprises permanent magnets on a rotor and a motor configured to drive the rotor in rotation, for driving the permanent magnets disposed on the rotor of the delivery unit pump, or for inducing electrical current in one or more coils in the delivery unit.

12. The drug delivery device according to claim 9, wherein the rotor and drive module operate as a stepping motor.

13. The drug delivery device according to claim 1, wherein the delivery unit comprises a transformer coil or coils configured to receive power from a varying magnetic field generated by the base unit.

14. The drug delivery device according to claim 1, wherein the base unit comprises a lower application face with a cavity portion substantially complementary in shape to an upper non-mounting face of the delivery unit, such that the base unit can be positioned and guided over the delivery unit.

15. The drug delivery device according to claim 1, wherein the reservoir is a collapsible reservoir or a coil reservoir.

16. The drug delivery device according to claim 1, wherein the medicament is insulin.

17. A method of operating a drug delivery device adapted for pumping discrete doses of a medicament, comprising:

removably fixing to a patient'"'"'s skin a disposable delivery unit comprising a reservoir for holding a medicament to be delivered, an injection member adapted for transdermal drug delivery, and a pump adapted for pumping the medicament to be delivered from the reservoir to the injection member;

placing a separate reusable base unit, comprising a power source and a drive module for driving the pump, temporarily against the delivery unit into electromagnetic or magnetic power communication such that the pump is activated to pump a dose of medicament, without mechanical attachment between the delivery unit and the base unit; and

removing the separate reusable base unit from the delivery unit after pumping of the discrete dose of medicament while the delivery unit remains fixed against the patient'"'"'s skin.

18. A method for the treatment of a condition or disease requiring the administration of discrete doses of a medicament, comprising:

fixing to the skin of a patient in need thereof a disposable delivery unit comprising a reservoir for holding a medicament to be delivered, an injection member adapted for transdermal drug delivery, and a pump adapted for pumping the medicament to be delivered from the reservoir to the injection member;

docking the base unit temporarily against the delivery unit without mechanical attachment between the delivery unit and the base unit, said base unit comprising a power source and a drive module for driving the pump to deliver a dose of the medicament to the patient;

transferring power in an electromagnetic or magnetic manner from the base unit to the delivery unit and actuating the pump to deliver a discrete dose of the medicament; and

removing the separate reusable base unit from the delivery unit after delivery of the dose of medicament while the delivery unit remains fixed against the patient'"'"'s skin.

19. The method according to claim 18 further including the steps of monitoring dosage and time of administration of at least a last administration and storing monitored values in a memory of the base unit.

20. The method according to claim 18 wherein the medicament is insulin.

21. A method of bolus administration of a medicament to a patient in need thereof comprising:

providing a disposable delivery unit adapted to be fixed against a patient'"'"'s skin, said delivery unit comprising a reservoir for holding a medicament to be delivered, an injection member adapted for trans-dermal drug delivery, and a pump adapted for pumping the medicament to be delivered from the reservoir to the injection member,

providing a separate reusable base unit, said base unit comprising a drive module for driving the pump,

removably fixing said diposable delivery unit to a patient'"'"'s skin;

docking the base unit temporarily against the delivery unit without mechanical attachment between the delivery unit and the base unit;

activating the pump to deliver a dose of the medicament to the patient; and

removing the separate reusable base unit from the delivery unit after delivery of the dose of medicament while the disposable delivery unit remains fixed against the patient'"'"'s skin.

22. The method according to claim 21 further including the steps of monitoring dosage and time of administration of at least a last administration and storing monitored values in a memory of the base unit.

23. The method according to claim 21 wherein the medicament is insulin.