Manually operable portable infusion device

• US 8,267,921 B2
• Filed: 07/20/2008
• Issued: 09/18/2012
• Est. Priority Date: 07/20/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Perlman, Danna
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/452,763
• Publication Number:
  US 20100204657A1
• Time in Patent Office: 1,521 Days
• Field of Search: 604/890.1, 604/93.01, 604/151, 604/892.2, 604/30, 604/31, 604/34, 604/118, 604/123, 604/131, 604/133, 604/153, 60428801-28804
• US Class Current: 604/890.1
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/1424 Manually operated pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A portable therapeutic fluid delivery device and a method for delivering a therapeutic fluid into a body of a patient are provided. In one aspect the therapeutic fluid delivery device and the method can be implemented using at least one housing securable to the body of the patient, a reservoir coupled to the at least one housing, a therapeutic fluid dispensing mechanism, a memory component, a controller, at least one bolus delivery button configured to signal the controller to initiate the delivery of the therapeutic fluid into the body of the patient; and, an inadvertent initiation prevention mechanism adapted for preventing the patient from activating the at least one bolus delivery button.

Claims

1. A portable therapeutic fluid delivery device for delivering a therapeutic fluid into

a body of a patient comprising:

at least one housing securable to the body of the patient;

a reservoir for containing the therapeutic fluid;

a therapeutic fluid dispensing mechanism coupled to said reservoir;

a memory component adapted for storing a value corresponding to a therapeutic fluid delivery dose;

a controller adapted for initiating a delivery of the therapeutic fluid by activating the therapeutic fluid dispensing mechanism, said controller further adapted for limiting the delivery of the therapeutic fluid based on the value stored in the memory component;

two or more bolus delivery buttons configured to signal the controller to initiate the delivery of the therapeutic fluid into the body of the patient;

an inadvertent initiation prevention mechanism adapted for preventing the patient from inadvertently activating the two or more bolus delivery buttons;

wherein the inadvertent initiation prevention mechanism is configured to prevent the controller from initiating the delivery of the therapeutic fluid into the body of the patient unless the patient activates the two or more bolus delivery buttons according to an activation sequence.

2. The portable therapeutic fluid delivery device of claim 1, wherein the therapeutic fluid dispensing mechanism comprises a pump.

3. The portable therapeutic fluid delivery device of claim 1, wherein the activation sequence includes activating the two or more bolus delivery buttons substantially simultaneously.

4. The portable therapeutic fluid delivery device of claim 1, wherein the activation sequence is stored in the memory component.

5. The portable therapeutic fluid delivery device of claim 1, wherein the controller is further adapted to interrupt the delivery of the therapeutic fluid into the body of the patient in response to a command received from the patient.

6. The portable therapeutic fluid delivery device of claim 5, wherein the command is sent by the patient using at least one of the two or more bolus delivery buttons.

7. The portable therapeutic fluid delivery device of claim 1, further comprising a notification component adapted for sending a notification to the patient.

8. The portable therapeutic fluid delivery device of claim 7, wherein the notification includes at least one of the visual notification, audio notification and tactile notification.

9. The portable therapeutic fluid delivery device of claim 1, wherein at least one of the two or more bolus delivery buttons comprises a slidable portion.

10. The portable therapeutic fluid delivery device of claim 1, wherein at least one of the two or more bolus delivery buttons comprises a rotatable portion.

11. The portable therapeutic fluid delivery device of claim 1, wherein a first of the two or more bolus delivery buttons is positioned on a first side of the therapeutic fluid delivery device and a second of the two or more bolus delivery buttons is positioned on a second side of the therapeutic fluid delivery device.

12. The portable therapeutic fluid delivery device of claim 1,

wherein the memory component, the controller, the two or more bolus delivery buttons and at least a portion of the therapeutic fluid dispensing mechanism are positioned in a reusable part of the device;

and

wherein the reservoir is positioned in a disposable part of the device.

13. The portable therapeutic fluid delivery device of claim 1, wherein the device further comprises a cradle unit adherable to the skin of the patient and the at least one housing is securable to the body of the patient via the cradle unit.

14. The portable therapeutic fluid delivery device of claim 13, wherein the cradle unit comprises a dedicated fluid passage.

15. The portable therapeutic fluid delivery device of claim 1, wherein the device further comprises a remote control unit.

16. The portable therapeutic fluid delivery device of claim 1, wherein at least one of the two or more bolus delivery buttons comprises an electrical switch.

17. The portable therapeutic fluid delivery device of claim 1, wherein at least one of the two or more bolus delivery buttons includes one or more magnets.

18. The portable therapeutic fluid delivery device of claim 17, wherein at least one of the two or more bolus delivery buttons includes one or more Hall effect sensors.

19. The portable therapeutic fluid delivery device of claim 1, wherein at least one of the two or more bolus delivery buttons includes one or more capacitors.

20. The portable therapeutic fluid delivery device of claim 1, wherein at least one of the two or more bolus delivery buttons is coupled to a printed circuit board accommodated within the at least one housing.

21. The portable therapeutic fluid delivery device of claim 1, wherein at least a portion of at least one of the two or more bolus delivery buttons is resilient.

22. The portable therapeutic fluid delivery device of claim 1, wherein the value corresponding to a therapeutic fluid delivery dose is programmable by the patient.

23. The portable therapeutic fluid delivery device of claim 1, wherein said reservoir is coupled to the at least one housing.

24. A method for delivering a therapeutic fluid into a body of a patient comprising:

receiving a signal corresponding to an activation of two or more bolus delivery buttons according to an activation sequence by the patient, said activation being verified by an inadvertent initiation prevention mechanism;

receiving at least one value corresponding to a therapeutic fluid delivery dose stored, in a memory component;

initiating the delivery of the therapeutic fluid delivery dose into the body of the patient by activating a therapeutic fluid dispensing mechanism; and

,

limiting the delivery of the therapeutic fluid into the body of the patient based on the value stored in the memory component.

25. The method of claim 24, wherein the therapeutic fluid dispensing mechanism comprises a pump.

26. The method of claim 24, wherein the activation sequence includes activating at least two of the two or more bolus delivery buttons substantially simultaneously.

27. The method of claim 24, further comprising interrupting the delivery of the therapeutic fluid into the body of the patient in response to a command received from the patient.

28. The method of claim 27, wherein the command is sent by the patient using at least one of the two or more bolus delivery buttons.

29. The method of claim 24, further comprising sending a notification to the patient.

30. The method of claim 29, wherein the notification includes at least one of the visual notification, audio notification and tactile notification.

31. A portable therapeutic fluid delivery device for delivering a therapeutic fluid into

a body of a patient comprising:

at least one housing securable to the body of the patient;

a reservoir for containing the therapeutic fluid;

a therapeutic fluid dispensing mechanism coupled to said reservoir;

a memory component adapted for storing a value corresponding to a therapeutic fluid delivery dose;

a controller adapted for initiating a delivery of the therapeutic fluid by activating the therapeutic fluid dispensing mechanism, said controller further adapted for limiting the delivery of the therapeutic fluid based on the value stored in the memory component;

two or more bolus delivery buttons configured to signal the controller to initiate the delivery of the therapeutic fluid into the body of the patient;

an inadvertent initiation prevention mechanism adapted for preventing the patient from inadvertently activating the bolus delivery buttons;

wherein the inadvertent initiation prevention mechanism is configured to prevent the controller from initiating the delivery of the therapeutic fluid into the body of the patient unless the patient activates the two or more bolus delivery buttons substantially simultaneously.

32. The portable therapeutic fluid delivery device of claim 31, wherein said reservoir is coupled to the at least one housing.

33. A portable therapeutic fluid delivery device for delivering a therapeutic fluid into

a body of a patient comprising:

at least one housing securable to the body of the patient;

a reservoir for containing the therapeutic fluid, said reservoir being coupled to the at least one housing;

a therapeutic fluid dispensing mechanism coupled to said reservoir;

a memory component adapted for storing a value corresponding to a therapeutic fluid delivery dose;

a controller adapted for initiating a delivery of the therapeutic fluid by activating the therapeutic fluid dispensing mechanism, said controller further adapted for limiting the delivery of the therapeutic fluid based on the value stored in the memory component;

two or more bolus delivery buttons configured to signal the controller to initiate the delivery of the therapeutic fluid into the body of the patient;

an inadvertent initiation prevention mechanism adapted for preventing the patient from inadvertently activating the two or more bolus delivery buttons;

wherein the inadvertent initiation prevention mechanism is configured to prevent the controller from initiating the delivery of the therapeutic fluid into the body of the patient unless the patient activates the two or more bolus delivery buttons according to an activation sequence.

34. A portable therapeutic fluid delivery device for delivering a therapeutic fluid into

a body of a patient comprising:

at least one housing securable to the body of the patient;

a reservoir for containing the therapeutic fluid, said reservoir being coupled to the at least one housing;

a therapeutic fluid dispensing mechanism coupled to said reservoir;

a memory component adapted for storing a value corresponding to a therapeutic fluid delivery dose;

a controller adapted for initiating a delivery of the therapeutic fluid by activating the therapeutic fluid dispensing mechanism, said controller further adapted for limiting the delivery of the therapeutic fluid based on the value stored in the memory component;

two or more bolus delivery buttons configured to signal the controller to initiate the delivery of the therapeutic fluid into the body of the patient;

an inadvertent initiation prevention mechanism adapted for preventing the patient from inadvertently activating the bolus delivery buttons;

wherein the inadvertent initiation prevention mechanism is configured to prevent the controller from initiating the delivery of the therapeutic fluid into the body of the patient unless the patient activates the two or more bolus delivery buttons substantially simultaneously.