Manually operable portable infusion device

• US 9,192,713 B2
• Filed: 11/24/2014
• Issued: 11/24/2015
• Est. Priority Date: 07/20/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Perlman, Danna
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US14/551,542
• Publication Number:
  US 20150080843A1
• Time in Patent Office: 365 Days
• US Class Current: 1/1
• 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:

a reservoir for containing the therapeutic fluid;

a dispensing mechanism for dispensing the therapeutic fluid from the reservoir toward the body of the patient;

a memory adapted for storing at least one value corresponding to a therapeutic fluid delivery dose;

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

at least one housing configured for securing to the body of the patient, the at least one housing accommodating the reservoir, the dispensing mechanism, the memory and the controller;

a bolus delivery button configured to signal the controller to initiate delivery of the therapeutic fluid into the body of the patient; and

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

wherein the bolus delivery button comprises a locking mechanism and 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 locking mechanism is put in an unlocked position.

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

3. The portable therapeutic fluid delivery device of claim 1, wherein the dispensing mechanism comprises a dispensing patch unit.

4. 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.

5. The portable therapeutic fluid delivery device of claim 4, wherein the command is sent by the patient using the bolus delivery button.

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

7. The portable therapeutic fluid delivery device of claim 6, wherein the notification component is selected from the group consisting of:

a buzzer, one or more lights, a vibration mechanism, and a combination thereof.

8. The portable therapeutic fluid delivery device of claim 1, wherein the bolus delivery button comprises a slidable portion.

9. The portable therapeutic fluid delivery device of claim 1, wherein the bolus delivery button comprises a rotatable portion.

10. The portable therapeutic fluid delivery device of claim 1, wherein:

the memory, the controller, the bolus delivery button and at least a portion of the dispensing mechanism are positioned in a reusable part of the device;

the reservoir is positioned in a disposable part of the device; and

the disposable part is connectable to the reusable part.

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

12. The portable therapeutic fluid delivery device of claim 1, wherein the cradle comprises a dedicated fluid passage.

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

14. The portable therapeutic fluid delivery device of claim 1, wherein the bolus delivery button comprises at least one electric button.

15. The portable therapeutic fluid delivery device of claim 1, wherein the bolus delivery button includes one or more magnets.

16. The portable therapeutic fluid delivery device of claim 15, wherein the bolus delivery button includes one or more Hall effect sensors.

17. The portable therapeutic fluid delivery device of claim 1, wherein the bolus delivery button includes one or more capacitors.

18. The portable therapeutic fluid delivery device of claim 1, wherein at least a portion of the bolus delivery button is resilient.

19. The portable therapeutic fluid delivery device of claim 1, wherein one or more of the at least one value are programmable by the patient.

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

providing a portable therapeutic fluid delivery device for delivering a therapeutic fluid into a body of a patient, the device comprising;

a reservoir for containing the therapeutic fluid;

a dispensing mechanism for dispensing the therapeutic fluid from the reservoir toward the body of the patient;

a memory adapted for storing at least one value corresponding to a therapeutic fluid delivery dose;

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

at least one housing configured for securing to the body of the patient, the at least one housing accommodating the reservoir, the dispensing mechanism, the memory and the controller;

a bolus delivery button configured to signal the controller to initiate delivery of the therapeutic fluid into the body of the patient; and

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

wherein the bolus delivery button comprises a locking mechanism and 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 locking mechanism is put in an unlocked position;

receiving a signal corresponding to activation of the bolus delivery button by the patient, the activation verified by the inadvertent initiation prevention mechanism;

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

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

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

21. The method of claim 20, wherein the dispensing mechanism comprises a pump.

22. The method of claim 20, further comprising interrupting the delivery of the therapeutic fluid into the body of the patient in response to a command received from the patient.

23. The method of claim 22, wherein the command is sent by the patient using the bolus delivery button.

24. The method of claim 20, further comprising sending a notification to the patient.

25. The method of claim 24, wherein the notification is at least one of visual notification, audio notification and tactile notification.

26. The method of claim 20, wherein one or more of the at least one value stored in the memory are programmable by the patient.