Pressure catheter device with enhanced fluid monitoring features

• US 6,231,524 B1
• Filed: 05/11/1999
• Issued: 05/15/2001
• Est. Priority Date: 09/03/1996
• Status: Expired due to Fees

• Current Assignee: Clinical Innovations LLC (Clinical Innovations)
• Original Assignee: Clinical Innovations Associates (Clinical Innovations)
• Inventors: Smith, Steven R., Wallace, Wm. Dean, Cutler, Christopher A.
• Primary Examiner(s): YU, JUSTINE ROMANG
• Application Number:
  US09/309,332
• Time in Patent Office: 735 Days
• Field of Search: 600/561, 600/587, 600/591, 600/593, 600/576, 600/585, 600/159, 600/190, 600/170, 600/176, 600/104, 600/156, 600/158
• US Class Current: 600/587
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor

Abstract

A pressure catheter for monitoring changes in pressure within the body is comprised of an outer tube containing a fluid channel and a closed air column having a pressure-compliant member which is deformable upon an increase in pressure. A change in pressure deforms the pressure-compliant member, which modifies the pressure in the air column, and is translated to a pressure sensor, which converts the pressure change data to an electrical signal recognizable by a fetal monitor. The outer tube employs a window extending along at least a portion of the side thereof for viewing of bodily fluids moving through the fluid channel from the body in which the catheter is inserted toward the proximal catheter end. The pressure catheter of the present invention is particularly suitable for intrauterine pressure monitoring during labor. Viewing of amniotic fluid through the window facilitates verification of proper catheter tip placement within the amniotic fluid space. Venting closures for facilitating venting of fluid through the channel are also disclosed.

Claims

1. A catheter for detecting changes in pressure within a body comprising;

an elongated outer tube defined by a circumferential wall, having a first, distal end and a second, proximal end and encompassing a fluid channel extending longitudinally through an interior of said elongated outer tube, at least one aperture formed through said circumferential wall of said elongated outer tube proximate said first, distal end providing communication between an exterior of said elongated outer tube and said fluid channel, at least a portion of said circumferential wall of said elongated outer tube lying between said fluid channel and the exterior of said elongated outer tube located at least in part remote from said first, distal end and including at least a medial portion of said elongated outer tube being formed of a light-transmissive material comprising at least one window along a length of said elongated outer tube; and

a structure for detecting changes in fluid pressure external to said first, distal end of said elongated outer tube.

2. The catheter of claim 1, further including a housing having a port therethrough in fluid communication with said fluid channel, said port having an exterior outlet.

3. The catheter of claim 2, further including a venting closure configured for attachment to said housing over said exterior outlet.

4. The catheter of claim 3, wherein said venting closure includes a pin-hole communicating between said port and an exterior of said venting closure.

5. The catheter of claim 3, wherein said venting closure includes a porous element disposed between said port and an exterior of said venting closure, said porous element being permeable to gases and substantially impermeable to liquids.

6. The catheter of claim 5, wherein said porous element is substantially impermeable to pathogens.

7. The catheter of claim 5, wherein said venting closure further includes a sealing member disposable over a surface of said porous element exposed on said exterior of said venting closure.

8. The catheter of claim 1, wherein said light-transmissive material of said at least one window is substantially transparent.

9. The catheter of claim 1, wherein said at least one window comprises a plurality of longitudinally-spaced windows of light-transmissive material.

10. The catheter of claim 1, wherein said at least one window of light-transmissive material extends through about a 75 degree arc circumferentially of said elongated outer tube circumferential wall.

11. The catheter of claim 1, wherein said at least a portion of said elongated outer tube circumferential wall which is formed of light-transmissive material comprises substantially an entire wall of said elongated outer tube.

12. The catheter of claim 1, further comprising a soft, pliant tip formed on said first distal end of said elongated outer tube for insertion within a body.

13. An intrauterine pressure catheter comprising:

an elongated outer tube having a plurality of holes formed at a distal end thereof, said elongated outer tube having a fluid channel located therein in communication with an exterior of said elongated outer tube through said plurality of holes, at least a portion of a wall of said elongated outer tube lying between said fluid channel and an exterior surface of said elongated outer tube located at least in part remote from the distal end thereof and including at least a medial portion thereof comprising at least one window of light-transmissive material along a length of said elongated outer tube;

a soft, pliant tip attached to said distal end of said elongated outer tube;

a pressure detection device for detecting pressure changes external to said distal end of said elongated outer tube; and

structure for transmitting pressure detection signals generated by said pressure detection device to a fetal monitor.

14. The intrauterine pressure catheter of claim 13, wherein said pressure detection device includes a pressure transducer.

15. The intrauterine pressure catheter of claim 13, further including a housing having an amnio port opening onto an exterior thereof and in communication with said fluid channel.

16. The intrauterine pressure catheter of claim 15, further including a venting closure configured for attachment to said housing over said amnio port.

17. The intrauterine pressure catheter of claim 16, wherein said venting closure includes a pin-hole communicating between said amnio port and an exterior of said venting closure.

18. The intrauterine pressure catheter of claim 16, wherein said venting closure includes a porous element disposed between said amnio port and an exterior of said venting closure, said porous element being permeable to gases and substantially impermeable to liquids.

19. The intrauterine pressure catheter of claim 18, wherein said porous element is substantially impermeable to pathogens.

20. The intrauterine pressure catheter of claim 18, wherein the venting closure further includes a sealing member disposable over a surface of said porous element exposed on the exterior of said venting closure.

21. The intrauterine pressure catheter of claim 13, wherein said at least one window is substantially transparent.

22. The intrauterine pressure catheter of claim 13, wherein said at least one window comprises a plurality of longitudinally-spaced windows.

23. The intrauterine pressure catheter of claim 13, wherein said at least one window extends through about a 75 degree arc circumferentially of said elongated outer tube wall.

24. The intrauterine pressure catheter of claim 13, wherein substantially an entire wall of said elongated outer tube comprises a light-transmissive material.

25. A pressure catheter for detecting changes in pressure within a body comprising:

an elongated tube structure defining first and second lumens extending longitudinally therethrough from proximate a first, distal end of said elongated tube structure to proximate a second, proximal end thereof, said first lumen opening to an exterior of said pressure catheter proximate said first, distal end of said elongated tube structure, and said elongated tube structure including a wall disposed between said first lumen and an exterior surface of said elongated tube structure, at least a portion of said wall located at least in part remote from said first, distal end of said elongated tube structure and including at least a medial portion of said elongated tube structure comprising a light-transmissive material providing at least one light-transmissive window along a length of said elongated tube structure; and

a pressure detection device associated with said second lumen of said elongated tube structure for detecting changes in fluid pressure external to said first end of said elongated tube structure.

26. The pressure catheter of claim 25, wherein said second lumen lies substantially within an inner tube, and said first lumen lies substantially between the exterior of said inner tube and an interior of an outer tube within which said inner tube is at least partially disposed.

27. The pressure catheter of claim 25, wherein said first and second lumens are defined by mutually adjacent first and second tubes.

28. The pressure catheter of claim 25, wherein said pressure detection device comprises a pressure detection sensor positioned in communication with said second lumen to detect a pressure change communicated through said second lumen.

29. The pressure catheter of claim 25, further including a housing having a port therethrough in fluid communication with said first lumen, said port having an outlet on an exterior of said housing.

30. The pressure catheter of claim 29, further including a venting closure configured for attachment to said housing over said outlet on said exterior of said housing.

31. The pressure catheter of claim 30, wherein said venting closure includes a pin-hole communicating between said port and an exterior of said venting closure.

32. The pressure catheter of claim 30, wherein said venting closure includes a porous element disposed between said port and the exterior of said venting closure, said porous element being permeable to gases and substantially impermeable to liquids.

33. The pressure catheter of claim 32, wherein said porous element comprises a hydrophobic material.

34. The pressure catheter of claim 32, wherein said porous element is substantially impermeable to pathogens.

35. The pressure catheter of claim 32, wherein the venting closure further includes a sealing member disposable over a surface of said porous element exposed on the exterior of said venting closure.

36. The pressure catheter of claim 25, wherein said at least one light transmissive window is substantially transparent.

37. The pressure catheter of claim 25, wherein said at least one light transmissive window comprises a plurality of longitudinally-spaced windows.

38. The pressure catheter of claim 25, wherein said at least one light transmissive window extends through about a 75 degree arc circumferentially of said wall.

39. The pressure catheter of claim 25, wherein the at least one light-transmissive wall portion comprises substantially an entire exterior wall of said elongated tube structure.

40. The pressure catheter of claim 25, further comprising a soft, pliant tip formed on said first distal end of said elongated tube structure.