DELIVERY DEVICE FOR USE WITH A THERAPEUTIC DRUG

• US 20110166512A1
• Filed: 09/08/2009
• Published: 07/07/2011
• Est. Priority Date: 09/10/2008
• Status: Active Grant

• Current Assignee: Hoffmann-La Roche Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Pearson, Allen, Shergold, Oliver, Liniger, Juerg, Oester, Fabio, Galbraith, Sandra, Both, Marcel, Scherrer, Dominik, Kaufmann, Heiner, Siegenthaler, Roger, Peter, Daniel, Scheurer, Simon, Friedli, Kurt
• Granted Patent: US 8,303,535 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/005 Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: A61M 2005/3117 Means preventing contamination of the medicament compartment of a syringe
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence

Abstract

A compact and one time use, self-administration device (10) for administering medication is disclosed. The device includes a housing (12) having a start button (26), a status indicator (28), a window (30), and a surface removably attachable to a user. The device (10) has a cartridge holder (34) providing in an aseptic environment a cartridge (32) containing the medication. The cartridge (32) is viewable through the cartridge holder (34) and the window (30). An included drive unit (42) provides a movable plunger (126) that breaks through a sterile barrier (130) of the cartridge holder (34) to dispense the medication from the cartridge (32) to an hollow needle (38) for administering the medication into the user. The device (10) provides means (36, 44) for extending and retracting the hollow needle (38) and an electronic control unit (40) which controls the drive unit (42), the extending and retracting means (36, 44), and interfaces with the start button (26), the status indicator (28), and the body sensor (24) to automatically administer the medication.

Claims

1. A drug delivery device for pumping medication into the body of a user, the device comprising:

a housing having a start button and a status indicator;

a cartridge holder having a sterile barrier at a first end thereof and arranged in the housing;

a cartridge containing a volume of the medication to be dispensed;

a drive unit having a plunger, the plunger being movable from a first position adjacent the sterile barrier to a second position in which the plunger has moved through the sterile barrier and the plunger has dispensed the volume of the medication from the cartridge;

a transfer unit providing a delivery conduit for the volume of medication from the cartridge to an included hollow needle, the transfer unit being connected to a second end of the cartridge holder and together providing an aseptic environment for the cartridge, the transfer unit being configured to extend the hollow needle beyond the housing and retract the hollow needle back into the housing after the hollow needle has been extended and the medication has been dispensed from the cartridge; and

an electronic control unit which controls the drive unit, and interfaces with the start button and the status indicator, the electronic control unit being configured such that after the start button has been pressed longer than a requisite amount of time, the electronic control unit causes the transfer unit to extend the hollow needle and powers the drive unit such that the plunger moves from the first position to the second position.

2. The drug delivery device of claim 1 wherein the transfer unit has a cartridge needle for passing through a septum closure of the cartridge and fluidly connected to the hollow needle.

3. The drug delivery device of claim 1 wherein the transfer unit has a second sterile barrier which provides a sterile environment for the hollow needle within the transfer unit.

4. The drug delivery device of claim 1 further comprising an actuator unit which triggers the transfer unit to extend the hollow needle when caused to move in a first direction by the control unit and to retract the hollow needle when caused to move in a second direction by the control unit.

5. The drug delivery device of claim 1 wherein the electronic control unit after expiration of a dwell period further causes the transfer unit to retract the hollow needle when the plunger is at the second position and provides an okay-to-remove status signal via the status indicator after the hollow needle is retracted.

6. The drug delivery device of claim 1 further comprising a body sensor and wherein the electronic control unit causes the transfer unit to extend the hollow needle and powers the drive unit such that the plunger moves from the first position to the second position if the body sensor indicates contact with the body of the user to the control unit.

7. The drug delivery device of claim 1 wherein the electronic control unit provides a dispensing status signal via the status indicator when the plunger moves from the first position to the second position.

8. The drug delivery device of claim 1 wherein the housing further includes a window, and the cartridge has a movable stopper that is viewable through the cartridge holder and the window of the housing.

9. The drug delivery device of claim 1 wherein the housing is formed of top and bottom portions connected together, and a window is provided on a side formed between the top and bottom portions.

10. The drug delivery device of claim 1 wherein the housing is formed of top and bottom portions connected together, wherein the top portion provides the start button and the status indicator.

11. The drug delivery device of claim 1 wherein the housing is formed of top and bottom portions connected together, wherein the bottom portion provides a body sensor.

12. The drug delivery device of claim 1 wherein the cartridge holder comprises a transparent tube providing the sterile barrier at the first end.

13. The drug delivery device of claim 1 wherein the cartridge holder has a movable support which supports neck portion of the cartridge from movement therein.

14. The drug delivery device of claim 1 wherein the aseptic environment for the cartridge is provided by the sterile barrier at the first end of the cartridge holder and a substrate to substrate firmly bonded connection between the docking port (184) of the transfer unit and the cartridge holder.

15. The drug delivery device of claim 1 wherein the plunger is linearly displaced.

16. The drug delivery device of claim 1 wherein the plunger provides a piercing surface.

17. The drug delivery device of claim 1 wherein the plunger is a lead-screw driven by a gear set connected to a motor, and has a flange.

18. The drug delivery device of claim 2 wherein the cartridge needle is fixed to the transfer unit and passes through a septum closure of the cartridge by the plunger moving the cartridge towards the transfer unit after breaking through the sterile barrier.

19. The drug delivery device of claim 2 wherein the cartridge needle of the transfer unit is configured to pass through a septum closure of the cartridge via a spring force.

20. The drug delivery device of claim 4 wherein the transfer unit has first and second springs, the first spring being under compression and the second spring not being under compression in a non-use state of the device, wherein when the actuator unit triggers the transfer unit to extend the hollow needle the compression of the first spring is released compressing the second spring, and wherein the compression of the second spring is then released when the actuator unit triggers the transfer unit to retract the hollow needle.

21. The drug delivery device of claim 4 wherein the transfer unit has first and second springs both under compression, the compression of the first spring being released when the actuator unit triggers the transfer unit to extend the hollow needle, and the compression of the second spring being released when the actuator unit triggers the transfer unit to retract the hollow needle.

22. The drug delivery device of claim 21 wherein a cartridge needle is configured to pass through a septum closure of the cartridge via a third spring which is also under compression, the compression of the third spring being released when the actuator unit moves in the first direction but before the hollow needle is extended.

23. The drug delivery device of claim 22 wherein the second spring is mounted to a carrier which engages protruding portions of the transfer unit when the compression of the first spring is released such that the carrier can resist a torque provided by the actuator unit when moving in the second direction, thereby causing a catch element to be released to cause the compression of the second spring to be released.

24. The drug delivery device of claim 4 wherein the actuator unit comprises a second motor, a push rod and gears, the second motor turns the gears to drive the push rod which triggers the transfer unit to extend the hollow needle when driven in the first direction and triggers the transfer unit to retract the hollow needle when driven in the second direction.

25. The drug delivery device of claim 24 wherein the second motor turns the gears to drive the push rod through a second sterile barrier of the transfer unit in the first direction to trigger the transfer unit to extend the hollow needle.

26. The drug delivery device of claim 6 wherein the body sensor comprises a switch which send a signal to the electronic control unit in a condition selected from an engaged condition and a disengaged condition.

27. The drug delivery device of claim 26 wherein the switch is a single pole, single throw microswitch.

28. The drug delivery device of claim 6 wherein the drive unit includes a motor which is automatically stopped if the body sensor sends a signal to the electronic control unit indicating no body contact.

29. The drug delivery device of claim 6 wherein the electronic control unit comprises a LED and phototransistor pair to create a light beam switch, wherein the body sensor in a pressed condition cause a condition selected from breaking a light beam between the LED and phototransistor pair to signal device contact with the body of the user to the electronic control unit and permitting a light beam to pass between the LED and phototransistor pair to signal device contact with the body of the user to the electronic control unit.

30. The drug delivery device of claim 6 wherein the body sensor include a magnet and the electronic control unit include a reed switch which causes a condition selected from opening the reed switch in the presence of the magnet when the body sensor is pressed to signal device contact with the body of the user to the electronic control unit and closing the reed switch in the presence of the magnet when the body sensor is pressed to signal device contact with the body of the user to the electronic control unit.

31. The drug delivery device of claim 1 wherein the start button contacts an electromechanical switch of the electronic control unit.

32. The drug delivery device of claim 1 further comprising a power pack providing power to the device, the power pack being removable from the housing.

33. The drug delivery device of claim 1 further comprising an adhesive layer for attaching the device to the body of the user;

and a release liner for protecting the adhesive layer in a non-use condition, wherein removing the release liner from the adhesive layer also removes a sterile cover of transfer unit.

34. The drug delivery device of claim 1 wherein the status indicator comprises a light pipe in the form of a translucent ring provided around the start button.

35. The drug delivery device of claim 1 wherein the status indicator comprises a light pipe and LEDs, and the LEDs provide a constant light to the light pipe for both the ready-to-start status signal and the okay-to-remove status signal, and a flashing light the light pipe for the dispensing status signal.

36. The drug delivery device of claim 35 wherein the LEDs are arranged about the start button in a way that each position of the LEDs also helps the user to interpret a provided signal.

37. The drug delivery device of claim 1 wherein the electronic control unit is further configured to wait after the pressing of the start button for the start button to be pressed again in order to proceed with the drug delivery process.

38. The drug delivery device of claim 37 wherein, if the start button is not pressed by elapse of a wait period, the device automatically powers off.

39. The drug delivery device of claim 1 wherein if the start button is pressed for more longer than a time window during the movement of the plunger from the first position to the second position, the control unit will stop administering the drug and automatically cause the hollow needle to retract and power off.

40. The drug delivery device of claim 39 wherein if the start button is pressed for a duration that falls within the time window, the control unit will temporarily stop administering the drug, and will resume the administering the drug upon the start button being pressed again for a period that again falls within the time window.

41. The drug delivery device of claim 1 further comprising a dedicated panic button which can be used to stop the drug delivery process immediately, retract the hollow needle and have the device power off.

42. The drug delivery device of claim 1 wherein the electronic control unit provides a ready-to start signal via the status indicator and causes the transfer unit to extend the hollow needle and powers the drive unit such that the plunger moves from the first position to the second position if start-up checks provide no errors.

43. The drug delivery device of claim 33 wherein the adhesive layer has a ring portion to facilitate easier removal of the device from the body of the user.

44. The drug delivery device of claim 1 wherein the transfer unit comprises a further sterile barrier to be pierced by the cartridge needle.