Disposable infusion device

• US 6,485,461 B1
• Filed: 04/04/2000
• Issued: 11/26/2002
• Est. Priority Date: 04/04/2000
• Status: Expired due to Term

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Mason, Duane R., Brooks, John L. III
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/542,777
• Time in Patent Office: 966 Days
• Field of Search: 604/132, 604/142, 604/153, 604/131
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate

Abstract

A disposable device is provided which accurately and reliably delivers an infusable liquid to a patient. The infusion device includes a housing which defines a bladder chamber. A compressible bladder is disposed in the bladder chamber and is compressed by the housing upon filling the bladder with an infusable liquid to create a pressurized bladder. The infusion devices further includes a delivery system for subcutaneously delivering the infusable liquid to a body. The delivery system includes a collapsible member that supports an injection needle and a cannula. The injection needle is used to insert the cannula into the skin of the body being treated. The cannula is in communication with the bladder during delivery of the infusable liquid. The housing includes microfluidic passageways that allow communication between fluid in the bladder and the cannula.

Claims

1. A disposable infusion device, comprising:

a housing defining a bladder chamber;

a compressible bladder disposed in the bladder chamber, the bladder being compressed by the housing upon filling the bladder with an infusable liquid to create a pressurized bladder; and

a delivery system for subcutaneously delivering the infusable liquid to a body, including a cannula and a plurality of passageways extending between the bladder and the cannula.

2. The device of claim 1, wherein the delivery system includes a collapsible member that supports an injection needle for inserting the cannula into the body.

3. The device of claim 2, wherein the housing includes an adhesive thereon for attaching the infusion device to the skin of the body.

4. The device of claim 3, wherein the adhesive forms a seal around the inserted cannula.

5. The device of claim 1, wherein the passageways that allow communication between the bladder and the cannula are microfluidic.

6. The device of claim 1, wherein the infusable liquid is insulin.

7. The device of claim 1, wherein the housing includes a member that compresses the bladder to create the pressurized bladder.

8. The device of claim 1, further comprising an alarm to warn the user when the bladder is substantially empty.

9. The device of claim 8, wherein the alarm is an audible alarm.

10. The device of claim 8, wherein the alarm is a vibrational alarm.

11. The device of claim 1, further comprising an occlusion alarm to warn the user when a predetermined amount of the infusable liquid fails to be delivered to the body.

12. The device of claim 1, further comprising a controller for controlling operation of the infusion device.

13. The device of claim 12, wherein the controller is a microcontroller.

14. The device of claim 12, wherein the controller is programmable for injecting predetermined amounts of the infusable liquid into the body.

15. The device of claim 14, further comprising a remote control device for programming the controller.

16. The device of claim 15, wherein the device includes a signaling mechanism to confirm programming by the remote control device.

17. The device of claim 15, wherein the remote control device includes a memory storage device to store the programmed instructions sent to the device and the amount of the infusable liquid delivered to the body by the infusion device.

18. The device of claim 14, wherein the predetermined amounts of the infusable liquid are selectable by a user input.

19. The device of claim 12, further comprising a power source for powering the controller, wherein the power source is permanently attached to the housing.

20. The device of claim 1, wherein each passageway includes a switch for opening the passageway and providing fluid communication through the passageway and between the cannula and the bladder.

21. The device of claim 20, wherein the switches are manually operable.

22. The device of claim 1, wherein the passageways are of varied dimensions.

23. A disposable infusion device for subcutaneously delivering an infusable liquid to a body, comprising:

a housing defining a bladder chamber;

a bladder disposed in the bladder chamber and being compressed by the housing for expelling the infusable liquid contained therein; and

a cannula insertable into the skin of the body for delivering the infusable liquid to the body;

wherein the housing includes a microfluidic passageways that independently provide fluid communication between the cannula and the bladder.

24. The device of claim 23, further comprising control means for controlling the amount of infusable liquid delivered to the body.

25. The device of claim 24, wherein the amount of the infusable liquid is selectable by a user input.

26. The device of claim 23, further comprising a controller for controlling the amount of the infusable liquid injected into the body, the controller being programmable for injecting predetermined amounts of the infusable liquid into the body.

27. The device of claim 23, wherein each passageway includes a switch for opening the passageway and providing fluid communication through the passageway and between the cannula and the bladder.

28. The device of claim 27, wherein the switches are manually operable.

29. The device of claim 23, wherein the passageways are of varied dimensions.

30. An infusion device for delivering an infusable liquid to a body, comprising:

a housing compressing a bladder to create a pressurized bladder, the bladder being pressurized upon filling he bladder with the infusable liquid;

an injection needle for inserting a cannula into the body, the cannula for subcutaneously delivering the infusable liquid to the body;

microfluidic passageways in the housing that each provide fluid communication between the cannula and the bladder; and

a control system for opening each of the passageways and controlling the amount of infusable liquid delivered to the body.

31. The device of claim 30, wherein the passageways are of varied dimensions.

32. A method for delivering an infusable liquid to a body with an infusion device, the device having a housing defining a bladder chamber and a bladder disposed therein, the bladder containing the infusable liquid therein, comprising:

connecting the bladder to a cannula through a plurality of passageways;

compressing the bladder to create a pressurized bladder[, the bladder being compressed by the housing upon filling the bladder with the infusable liquid];

attaching the housing to the body; and

inserting the cannula into the body; and

subcutaneously delivering the infusable liquid to the body by opening at least one of the passageways.

33. The method of claim 32, further comprising compressing the bladder with the housing upon filling the bladder with the infusable liquid.

34. A method of delivering an infusable liquid to a body, comprising:

compressing a bladder to create a pressurized bladder, the bladder being disposed within a housing of an infusion device, the housing compressing the bladder upon filling the bladder with the infusable liquid;

inserting a cannula into the body, the cannula connected to the bladder through a plurality of passageways and subcutaneously delivering the infusable liquid to the body when in fluid communication with the pressurized bladder;

providing fluid communication between the cannula and the bladder by opening at least one of the passageways during delivery of the infusable liquid; and

controlling the amount of infusable liquid delivered to the body by varying dimensions of the passageways.

35. An infusion device, comprising:

a bladder;

a cannula for insertion into a body; and

a plurality of passageways extending between the bladder and the cannula,

wherein each passageway includes a switch for opening the passageway and providing fluid communication through the passageway and between the cannula and the bladder.

36. The device of claim 35, wherein the switches are manually operable.

37. The device of claim 35, wherein the passageways are of varied dimensions.

38. The device of claim 35, wherein the bladder is compressed.