PROBE FOR FLUID LEAK DETECTION WITH SPECIFIC DISTAL PART

• US 20110071367A1
• Filed: 03/04/2009
• Published: 03/24/2011
• Est. Priority Date: 03/14/2008
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Court, Thierry, Anselmet, Jean Pierre, Goby, Jean Michel
• Granted Patent: US 8,217,218 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61F 2013/00412 for use with needles, tubes or catheters
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A disposable medical probe for detecting a leak of physiological fluid comprising a support layer, a conductive layer on top of the support layer, the conductive layer comprising two conducting electrodes both placed exclusively on each side of a longitudinal axis, the conductive layer defining two zones: a proximal zone with two proximal electrode parts being placed parallel to each other and being spaced apart by a constant distance d, and a distal zone with two distal electrode parts being spaced apart from each other by a gap e greater than said distance d, where the distal zone of the electrodes defines an increase in the gap between the distal parts of the electrodes, followed by a decrease in the gap between the distal parts of the electrodes.

Claims

1. A disposable medical probe for detecting a leak of physiological fluid through an opening made in the human body, by operating in conjunction with an electrical detection circuit, comprising the following layers:

a support layer,

a conductive layer on top of the support layer, the conductive layer comprising first and second conducting electrodes, said first conducting electrode being placed on one side of a longitudinal axis and said second conducting electrode being placed on the opposite side of the longitudinal axis, the conductive layer defining two zones;

a proximal zone, the end of which is configured to be connected to said circuit, said proximal zone comprising a proximal part of each of the first and second electrodes, the proximal parts of the first and second electrodes being placed parallel to each other and spaced apart by a distance

a distal zone configured to contact a fluid, said distal zone comprising a distal part of each of the first and second electrodes, the two distal parts of the first and second electrodes being spaced apart from each other by a gap, said gap being greater than said distance,

where the distal zone of the first and second electrodes defines, running from a border, positioned between the proximal zone and the distal zone, to the end of the distal zone,

an increase in the gap between the distal parts of the first and second electrodes,

followed by a decrease in the gap between the distal parts of the first and second electrodes.

2. A probe according to claim 1, wherein there is a constant gap between the distal parts of the first and second electrodes, positioned between said increase in the gap and said decrease in the gap.

3. A probe according to claim 1, wherein the longitudinal axis is an axis of symmetry of substantially the entirety of the first and second electrodes.

4. A probe according to claim 3, wherein the axis of symmetry of the first and second electrodes represents the axis of symmetry of substantially the entire probe.

5. A probe according to claim 1, wherein the length of the proximal zone of the conductive layer is greater than the length of the distal zone of the conductive layer.

6. A probe according to claim 5, wherein the length of the proximal zone of the conductive layer is approximately twice the length of the distal zone of the conductive layer.

7. A probe according to claim 1, wherein at least one of the increase in the gap and the decrease in the gap between each of the distal parts of the first and second electrodes has a frustoconical shape.

8. A probe according to claim 7, wherein at least one truncated cone is adjacent to first and second parallel portions of the distal parts of the first and second electrodes.

9. A probe according to claim 1, wherein at least one of the increase in the gap and the decrease in the gap between each of the distal parts of the first and second electrodes has a curved shape.

10. A probe according to claim 9, wherein the shape of the distal parts of the first and second electrodes is inscribed on an ellipse, the major axis of which is the longitudinal axis (A) of the conductive layer.

11. A probe according to claim 1, further comprising

the following two zones:

a proximal probe part and a distal probe part, and

wherein the proximal probe part is superimposed with the proximal zone of the conductive layer, and the distal probe part is superimposed with the distal zone of the conductive layer.

12. A probe according to claim 11, wherein the greater width of the distal part of the probe is substantially twice the constant width of the proximal part of the probe.

13. A probe according to claim 11, wherein the edges of the distal part of the probe have a substantially elliptical shape.

14. A probe according to claim 11 or 12, wherein the edges of the distal part of the probe have a substantially rectangular shape.

15. A probe according to claim 1, comprising a hydrophilic layer on at least a part of the conductive layer.

16. A probe according to claim 1, comprising a covering layer on at least a part of the conductive layer.

17. A probe according to claim 1, wherein the length of the proximal zone of the conductive layer is greater than the length of the distal zone of the conductive layer.

18. A probe according to claim 1, wherein the materials of which each layer are made are flexible materials.

19. A probe according to claim 1, wherein the first and second electrodes are in the form of conducting strips of substantially constant width.

20. A probe according to claim 11, wherein at least one notch is made on the edge of the distal part of the probe.

21. A probe according to claim 20, wherein at least said notch is placed on at least one axis among the following:

the axis of symmetry of the probe, an axis perpendicular to the axis of symmetry of the probe and passing substantially through the middle of the proximal zone of the probe.

22. A probe according to claim 1, comprising a capacitor layer positioned between the support layer and the conductive layer, said capacitor layer comprising:

a conductive first capacitor layer placed on the support layer,

an insulating second capacitor layer placed on the conductive first capacitor layer.

23. A probe according to claim 22, wherein the conductive first capacitor layer and the insulating second capacitor layer make up a single part having a conducting face and an insulating face.

24. A probe according to claim 22, wherein the capacitor layer at least partially covers the distal zone of the conductive layer.

25. A probe according to claim 24, wherein the capacitor layer covers a portion of the distal zone of the conductive layer in which the gap between the distal parts of the first and second electrodes is the greatest.

26. A probe according to claim 1, wherein the probe is sterilized.

27. A method for the manufacture of a disposable medical probe for detecting a leak of physiological fluid through an opening made in a human body, by operating in conjunction with an electrical detection circuit, comprising the following steps:

obtaining a support layer,

placing a conductive layer on top of the support layer, the conductive layer comprising first and second conducting electrodes, said first electrode positioned on one side of a longitudinal axis and said second electrode positioned on the opposite side of the longitudinal axis, the conductive layer defining the following two zones;

a proximal zone, the end of which is configured to be connected to said circuit, said proximal zone composed of a proximal part of each of the first and second electrodes, the proximal parts of the first and second electrodes being placed parallel to each other and being spaced apart by a substantially constant distance; and

a distal zone configured to contact a fluid, said distal zone composed of a distal part of each of the first and second electrodes, the distal parts of the first and second electrodes being spaced apart from each other by a gap being greater than said distance;

where the distal zone of the first and second electrodes defines, running from a border, positioned between the proximal zone and the distal zone, to the end of the distal zone;

an increase in the gap between the distal parts of the first and second electrodes,

followed by a decrease in the gap between the distal parts of the first and second electrodes.

28. A method according to claim 27, further comprising of cutting substantially all the edges of the probe by means of a single step of cutting the layers superimposed on one another.