Infusion site leak detection system and method of using the same

• US 6,461,329 B1
• Filed: 03/13/2000
• Issued: 10/08/2002
• Est. Priority Date: 03/13/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Moberg, Sheldon B., Van Antwerp, William P.
• Primary Examiner(s): RIVELL, JOHN A
• Application Number:
  US09/524,021
• Time in Patent Office: 939 Days
• Field of Search: 604/111, 604/151, 604/180, 604/174, 340/605
• 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

An infusion leak detection system indicates that a fluid to be delivered into an individual'"'"'s body has leaked near an infusion site. The infusion site is at a location where a delivery element, such as a cannula, needle, or the like, penetrates an individual'"'"'s body. Preferably, one end of the delivery element is attached to a delivery device and the other end is inserted through an individual'"'"'s skin terminating in an individual'"'"'s subcutaneous tissue. The delivery element establishes fluid communication between the delivery device and the individual'"'"'s subcutaneous tissue. In alternative embodiments, the delivery element may terminate in an other tissue such as, muscle, organ, inter-peritoneal, intra-peritoneal, or the like. The delivery device is attached to the surface of the individual'"'"'s skin. In preferred embodiments of the present invention, the 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. In alternative embodiments, 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. Preferred embodiments are for use with human beings; however, alternative embodiments may be used with animals or fluid flow applications where detection of small amounts of a leaking fluid is important.

Claims

1. A leak detection system to detect the presence of a fluid to be delivered into an individual'"'"'s body that has leaked near an infusion site, the leak detection system comprising:

a delivery device adapted for attachment to the individual'"'"'s body;

a delivery element configured to penetrate the individual'"'"'s body at the infusion site and establish fluid communication between the delivery device and the individual'"'"'s body, so that the fluid can travel from the delivery device into the individual'"'"'s body; and

at least one chemical, positioned near the infusion site, that reacts with at least one component within the fluid when the fluid is present near the infusion site.

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 infusion site 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 infusion site 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 infusion site 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 infusion site contains at least ninhydrin.

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

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

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

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

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

11. A leak detection system according to claim 1, wherein the delivery device includes a base, and wherein the at least one chemical positioned near the infusion site is embedded in the base of the delivery device.

12. A leak detection system according to claim 1, wherein the at least one chemical positioned near the infusion site is deposited on the individual'"'"'s body.

13. A leak detection system according to claim 1, wherein the delivery device is an infusion set.

14. A leak detection system according to claim 1, wherein the delivery device is an infusion pump.

15. A leak detection system to detect the presence of a fluid to be delivered into an individual'"'"'s body that has leaked near an infusion site, the leak detection system comprising:

a delivery device adapted for attachment to the individual'"'"'s body;

a delivery element configured to penetrate the individual'"'"'s body at the infusion site and establish fluid communication between the delivery device and the individual'"'"'s body, so that the fluid can travel from the delivery device into the individual'"'"'s body;

an adhesive tape that is applied to a portion of the individual'"'"'s body to hold the delivery device on the individual'"'"'s body; and

at least one chemical associated with the adhesive tape that reacts with at least one component within the fluid when the fluid is present near the infusion site.

16. A leak detection system according to claim 15, wherein a product of a chemical reaction between the at least one chemical associated with the adhesive tape and the at least one component within the fluid is a colored complex.

17. A leak detection system according to claim 15, wherein the at least one chemical associated with the adhesive tape is included with the adhesive on the adhesive tape.

18. A leak detection system to detect the presence of a fluid to be delivered into an individual'"'"'s body that has leaked near an infusion site, the leak detection system comprising:

a delivery device adapted for attachment to the individual'"'"'s body;

a delivery element configured to penetrate the individual'"'"'s body at the infusion site and establish fluid communication between the delivery device and the individual'"'"'s body, so that the fluid can travel from the delivery device into the individual'"'"'s body;

at least one chemical positioned near the infusion site that reacts with at least one component within the fluid when the fluid is present near the infusion site;

a product of a chemical reaction between the at least one chemical positioned near the infusion site 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 infusion site to the optical receiver.

19. A leak detection system according to claim 18, wherein the light conducting element is at least one fiber optic cable.

20. A leak detection system according to claim 18, wherein the light conducting element is a flexible tube filled with the fluid.

21. A leak detection system according to claim 18, wherein the leak detection system includes an alarm system, controlled by the output signal, to notify the individual when a leak is detected.

22. A leak detection system according to claim 21, wherein the alarm system produces an audible sound when a leak is detected.

23. A leak detection system according to claim 21, wherein the alarm system activates a vibrator when a leak is detected.

24. A leak detection system to detect the presence of a fluid to be delivered into an individual'"'"'s body that has leaked near an infusion site, the leak detection system comprising:

a delivery device adapted for attachment to the individual'"'"'s body wherein the delivery device includes a delivery device base;

a delivery element configured to penetrate the individual'"'"'s body at the infusion site and establish fluid communication between the delivery device and an individual'"'"'s body, so that the fluid can travel from the delivery device into the individual'"'"'s body;

a rosette positioned on the delivery device base to substantially surround the delivery 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.

25. A leak detection system according to claim 24, wherein the rosette is a closed circuit, such that the impedance across the rosette decreases as fluid leaks near the infusion site.

26. A leak detection system according to claim 24, wherein the rosette is a closed circuit before a leak occurs, and at least portions of the rosette dissolve in the presence of the fluid, such that the impedance across the rosette increases as the at least portions of the rosette dissolve.

27. A leak detection system according to claim 24, wherein the rosette is an open circuit, such that the circuit is closed when fluid leaks near the infusion site.

28. A leak detection system according to claim 27, wherein one or more chemicals are positioned near the infusion site and wherein leaking fluid near the infusion site triggers an electrochemical reaction with the chemicals.

29. A leak detection system according to claim 24, wherein the at least one electrical component detects voltage across the rosette.

30. A leak detection system according to claim 24, wherein the at least one electrical component detects impedance across the rosette.

31. A leak detection system according to claim 24, wherein the at least one electrical component detects capacitance across the rosette.

32. A leak detection system according to claim 24, wherein the leak detection system includes an alarm system, coupled to the battery and the at least one electrical component, to notify and indicate when a leak is detected.

33. A leak detection system according to claim 32, wherein the alarm system produces an audible sound when a leak is detected.

34. A leak detection system according to claim 32, wherein the alarm system activates a vibrator when a leak is detected.

35. A leak detection system to detect the presence of a fluid to be delivered into an individual'"'"'s body that has leaked near an intended delivery site, the leak detection system comprising;

a delivery attachment element adapted for attachment to the delivery site and a delivery element;

the delivery element configured to penetrate the delivery site and establish fluid communication between the delivery attachment element and the individual'"'"'s body, so that the fluid can travel from the delivery attachment element and into the individual'"'"'s body; and

at least one reactive element positioned near the delivery site and coupled to at least one of the delivery attachment element and the delivery element so that when the fluid is present near the delivery site, the at least one reactive element reacts with at least one component within the fluid.