Leak detection system and method of using the same

• US 20030009131A1
• Filed: 07/03/2002
• Published: 01/09/2003
• Est. Priority Date: 03/13/2000
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Moberg, Sheldon B., Talbot, Cary D., Van Antwerp, William P.
• Granted Patent: US 6,752,785 B2
• Time in Patent Office: Days
• US Class Current: 604/111
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

In a fluid delivery system for delivering a fluid into an individual'"'"'s body, a leak detection system indicates that the fluid has leaked outside a normal fluid path of the fluid delivery system, such as near an infusion site or a fluid-filled reservoir. Preferably, the leak detection system includes a chemical positioned near the infusion site that reacts with preservatives in the leaking fluid to generate a highly visible, brightly colored, chemical complex. Alternatively, mechanical, electro-optical, electrochemical, electrical or other chemical systems may be used to detect the presence of fluid that is leaking near the infusion site. Further, the leak detection systems may be used to detect the presence of fluid that is leaking from or near other locations within the fluid delivery system, such as on or near a fluid-filled reservoir, or a flexible tube coupled between the reservoir and the infusion site.

Claims

1. In a fluid delivery system for delivering a fluid into an individual'"'"'s body, a leak detection system to detect the presence of the fluid that has leaked outside a normal fluid path of the fluid delivery system, the leak detection system comprising:

a fluid containing element adapted to be filled with the fluid to be delivered into the individual'"'"'s body and placed in a device for delivering the fluid into the individual'"'"'s body;

a delivery element configured to penetrate the individual'"'"'s body and establish fluid communication between the fluid containing element and the individual'"'"'s body so that the fluid can travel along the normal fluid path from the fluid containing element through the delivery element into the individual'"'"'s body; and

at least one chemical, positioned near the fluid containing element, that reacts with at least one component within the fluid when the fluid is present near an exterior surface of the fluid containing element.

2. A leak detection system according to claim 1, wherein a product of a chemical reaction, between the at least one chemical positioned near the fluid containing element and the at least one component within the fluid, is a colored complex.

3. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element contains at least 4-amino-antipyrine and potassium ferricyanide.

4. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element contains at least 4-amino-antipyrine and potassium ferricyanide and horse radish peroxidase (HRP).

5. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element contains at least ninhydrin.

6. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element contains at least Coomassie Brilliant Blue.

7. A leak detection system according to claim 1, wherein the at least one chemical positioned fluid containing element is encapsulated in micro-spheres.

8. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element is a component of a gel.

9. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element is a component of an adhesive.

10. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element is associated with starch granules.

11. A leak detection system according to claim 1, wherein the fluid containing element is a reservoir.

12. A leak detection system according to claim 1, wherein the fluid containing element is a tube coupled between the delivery element and the device for delivering the fluid into the individual'"'"'s body.

13. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element is deposited on the exterior surface of the fluid containing element.

14. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element is associated with a label applied onto the exterior surface of the fluid containing element.

15. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element is deposited on a portion of the device for delivering the fluid into the individual'"'"'s body.

16. A leak detection system according to claim 1, wherein the at least one chemical positioned near the fluid containing element is associated with a label applied onto a portion of the device for delivering the fluid into the individual'"'"'s body.

17. A leak detection system according to claim 1, wherein the device for delivering the fluid into the individual'"'"'s body is an infusion pump.

18. A leak detection system according to claim 1, wherein the device for delivering the fluid into the individual'"'"'s body is a pen injector.

20. A leak detection system according to claim 19, wherein the light conducting element is at least one fiber optic cable.

21. A leak detection system according to claim 19, wherein the light conducting element is a window on the device for delivering the fluid into the individual'"'"'s body.

22. A leak detection system according to claim 19, wherein the leak detection system includes an alarm system, controlled by the output signal, to notify the individual when a leak is detected.

23. A leak detection system according to claim 22, wherein the alarm system produces an audible sound when a leak is detected.

24. A leak detection system according to claim 22, wherein the alarm system activates a vibrator when a leak is detected.

25. A leak detection system according to claim 22, wherein the alarm system activates a light when a leak is detected.

26. A leak detection system according to claim 22, wherein the alarm system transmits a notification signal to another device when a leak is detected.

27. A leak detection system according to claim 22, wherein the alarm system indicates on a display when a leak is detected.

29. A leak detection system according to claim 28, wherein the rosette is a closed circuit, such that the impedance across the rosette decreases as fluid leaks near the fluid containing element.

30. A leak detection system according to claim 28, wherein the rosette is a closed circuit before a leak occurs, and at least one portion of the rosette dissolves in the presence of the fluid, such that the impedance across the rosette increases as the at least one portion of the rosette dissolves.

31. A leak detection system according to claim 28, wherein the rosette is an open circuit, such that the circuit is closed when fluid leaks near the fluid containing element.

32. A leak detection system according to claim 31, wherein one or more chemicals are positioned near the fluid containing element and wherein leaking fluid near the fluid containing element triggers an electrochemical reaction with the chemicals.

33. A leak detection system according to claim 28, wherein the at least one electrical component detects voltage across the rosette.

34. A leak detection system according to claim 28, wherein the at least one electrical component detects impedance across the rosette.

35. A leak detection system according to claim 28, wherein the at least one electrical component detects capacitance across the rosette.

36. A leak detection system according to claim 28, wherein the leak detection system includes an alarm system, coupled to the battery and the at least one electrical component, to notify the individual when a leak is detected.

37. A leak detection system according to claim 36, wherein the alarm system produces an audible sound when a leak is detected.

38. A leak detection system according to claim 36, wherein the alarm system activates a vibrator when a leak is detected.

39. A leak detection system according to claim 36, wherein the alarm system activates a light when a leak is detected.

40. A leak detection system according to claim 36, wherein the alarm system transmits a notification signal to another device when a leak is detected.

41. A leak detection system according to claim 36, wherein the alarm system indicates on a display when a leak is detected.

19. In a fluid delivery system for delivering a fluid into an individual'"'"'s body, a leak detection system to detect the presence of the fluid that has leaked outside a normal fluid path of the fluid delivery system, the leak detection system comprising:

a fluid containing element adapted to be filled with the fluid to be delivered into the individual'"'"'s body and placed in a device for delivering the fluid into the individual'"'"'s body;

a delivery element configured to penetrate the individual'"'"'s body and establish fluid communication between the fluid containing element and the individual'"'"'s body so that the fluid can travel along the normal fluid path from the fluid containing element through the delivery element into the individual'"'"'s body;

at least one chemical positioned near the fluid containing element that reacts with at least one component within the fluid when the fluid is present near an exterior surface of the fluid containing element;

a product of a chemical reaction between the at least one chemical positioned near the fluid containing element and the at least one component within the fluid is a colored complex;

an optical receiver that detects a change in light when the colored complex is created by the chemical reaction and provides an output signal indicating that a leak is detected; and

a light conducting element that guides light from a point near the fluid containing element to the optical receiver.

28. In a fluid delivery system for delivering a fluid into an individual'"'"'s body, a leak detection system to detect the presence of the fluid that has leaked outside a normal fluid path of the fluid delivery system, the leak detection system comprising:

a fluid containing element adapted to be filled with the fluid to be delivered into the individual'"'"'s body and placed in a device for delivering the fluid into the individual'"'"'s body;

a delivery element configured to penetrate the individual'"'"'s body and establish fluid communication between the fluid containing element and the individual'"'"'s body so that the fluid can travel along the normal fluid path from the fluid containing element through the delivery element into the individual'"'"'s body;

a rosette positioned near the fluid containing element;

at least one electrical component coupled to the rosette to detect a change in at least one electrical characteristic associated with the rosette when a leak occurs; and

a battery to supply power to the at least one electrical component.

42. In a fluid delivery system for delivering a fluid into an individual'"'"'s body, a leak detection system to detect the presence of the fluid that has leaked outside a normal fluid path of the fluid delivery system, the leak detection system comprising:

a device for delivering the fluid into the individual'"'"'s body;

a fluid containing element adapted to be filled with the fluid to be delivered into the individual'"'"'s body and placed in the device for delivering the fluid into the individual'"'"'s body;

a delivery element configured to penetrate the individual'"'"'s body and establish fluid communication between the fluid containing element and the individual'"'"'s body so that the fluid can travel along the normal fluid path from the fluid containing element through the delivery element into the individual'"'"'s body; and

at least one chemical, positioned near the fluid containing element, that reacts with at least one component within the fluid when the fluid is present near an exterior surface of the fluid containing element; and

at least one reactive element positioned near the fluid containing element and coupled to at least one of the delivery device and the fluid containing element so that when the fluid is present near an exterior surface of the fluid containing element, the at least one reactive element reacts with at least one component within the fluid.