Urodynamic catheter and methods of fabrication and use

• US 6,447,462 B1
• Filed: 02/15/2000
• Issued: 09/10/2002
• Est. Priority Date: 02/15/2000
• Status: Expired due to Term

• Current Assignee: Laborie Medical Technologies, Corp. (2941881 Canada, Inc.)
• Original Assignee: Clinical Innovations Associates (Clinical Innovations)
• Inventors: Dixon, Richard A., Smith, Steven R., Cutler, Christopher A., Wallace, Wm. Dean
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/504,972
• Time in Patent Office: 938 Days
• Field of Search: 600/568-589, 600/588, 600/591, 600/433, 600/434, 600/435, 600/585, 606/192, 606/193, 604/915, 604/919, 604/920
• US Class Current: 600/561
• CPC Class Codes: A61B 5/02156 Calibration means
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A urodynamic catheter incorporating at least one balloon adjacent a distal end thereof and associated with a pressure lumen extending to a proximal end to be placed external to the body of a patient and usable with a transducer housing including a pressure transducer and a mechanism for alternatively venting an air column defined by the assembled pressure lumen and transducer housing to the ambient environment and closing the air column and charging it with air while reducing volume of the air column. One embodiment includes two, separately-chargeable balloons and a bladder fill tube, another embodiment includes a single balloon and a fill tube, and yet another embodiment, suitable for use as a reference catheter to measure abdominal pressure, includes only a single balloon and omits the fill tube. A novel catheter architecture and assembly technique are also disclosed, as are methods of using the inventive catheter.

Claims

1. A catheter system for use in detecting pressure changes within a body, comprising:

an elongated tube having at least one lumen extending therethrough to a port located proximate a distal end thereof;

a pressure-compliant balloon element secured to the elongated tube over the port and having an interior in communication therewith;

a pressure transducer removably operably coupled to a proximal end of the at least one lumen and including a sensor element in communication with an interior of the pressure-compliant balloon element through the at least one lumen; and

a charging structure for displacing a substantially predetermined volume of air into an air column extending between the pressure-compliant balloon element and the pressure transducer sensor element through the at least one lumen, the charging structure being configured, while the pressure transducer is operably coupled to the proximal end of the at least one lumen, to vent the air column to an ambient environment in a first mode, and to close the air column and effect displacement of the substantially predetermined volume of air in a second mode.

2. The catheter system of claim 1, wherein the charging structure includes a plunger longitudinally movable in a bore in communication with the air column, the plunger and bore being cooperatively configured to provide venting clearance between a side of the plunger and an interior wall of the bore in a first longitudinal plunger position, and to mutually seal in airtight relationship in a second longitudinal plunger position.

3. The catheter system of claim 2, wherein the venting clearance is provided by a portion of the interior wall of the bore including a longitudinally extending groove therein.

4. The catheter system of claim 2, wherein the first longitudinal plunger position comprises a relatively retracted position, and the second longitudinal plunger position includes a relatively extended position.

5. The catheter system of claim 4, wherein an end of the plunger received within the bore includes a deformable mass.

6. The catheter system of claim 5, wherein at least a portion of an inner end of the bore contracts to a relatively smaller cross-section, and the deformable mass is deformed into the at least a portion of the inner end of the bore in the second longitudinal plunger position.

7. The catheter system of claim 4, wherein the plunger includes a circumferential seal thereabout.

8. The catheter system of claim 4, wherein the charging structure further includes a movable plunger slide engageable with an outer end of the plunger to effect movement thereof between the first longitudinal plunger position and the second longitudinal plunger position.

9. The catheter system of claim 2, wherein the proximal end of the at least one lumen, the charging structure and the pressure transducer sensor element are in mutual communication through passages in a manifold block housing the bore, to which the pressure transducer is secured, and which includes a connector element configured for engagement with a connector element at the proximal end of the at least one lumen.

10. The catheter system of claim 9, wherein the charging structure and the pressure transducer are substantially contained within a housing on which is slidably mounted a plunger slide positioned and configured to move the plunger between the first longitudinal plunger position and the second longitudinal plunger position.

11. The catheter system of claim 10, wherein the plunger slide is oriented for movement substantially transverse to an orientation of the plunger and to traverse a path extending over the plunger to effect movement of the plunger between the first longitudinal plunger position and the second longitudinal plunger position by mutual contact of the plunger slide and the plunger.

12. The catheter system of claim 10, wherein the housing is sized and configured and the plunger slide is placed on the housing in a position to permit manipulation of the plunger slide with a thumb of a hand grasping the housing.

13. A catheter for use in detecting pressure changes within a body, comprising:

an elongated outer tubing element comprising a bore defined within a circumferential side wall thereof;

at least one elongated pressure lumen tubing element extending at least partially within the bore of the elongated outer tubing element, extending through the side wall thereof proximate a distal end thereof and defining a port opening onto the side wall exterior;

a cured adhesive mass disposed within the bore where the at least one elongated pressure lumen tubing element extends through the side wall, securing the at least one elongated pressure lumen tubing element in place and sealing the bore from the side wall exterior; and

a pressure-compliant balloon element circumferentially surrounding the elongated outer tubing element, extending over the port of the at least one elongated pressure lumen tubing element and sealingly bonded to the side wall proximally and distally of the port.

14. The catheter of claim 13, wherein the cured adhesive mass is selected from the group comprising a UV-curable adhesive and an RTV adhesive.

15. The catheter of claim 13, wherein the pressure-compliant balloon element is formed of a heat-shrink material.

16. The catheter of claim 15, wherein the pressure-compliant balloon element is sealingly bonded to the side wall of the elongated outer tubing element by heat-induced contraction of ends of the pressure compliant balloon element about the elongated outer tubing element.

17. The catheter of claim 16, wherein a volume of the pressure-compliant balloon element has been stabilized by temperature elevation of the heat-shrink material.

18. The catheter of claim 13, wherein the elongated outer tubing exhibits a durometer lower than a durometer of the at least one elongated pressure lumen tubing element.

19. The catheter of claim 13, wherein the at least one elongated pressure lumen tubing element remains substantially unsecured to the elongated outer tubing element between a location of the cured adhesive mass and an exit location of the at least one elongated pressure lumen tubing element from the outer tubing element bore.

20. The catheter of claim 13, further including at least one fill tubing element extending at least in part through the bore of the elongated outer tubing element to a location proximate the distal end thereof and in communication with an exterior of the elongated outer tubing element through at least one aperture in the side wall, the at least one fill tubing element passing through the cured adhesive mass and being fixed in the bore thereby.

21. The catheter of claim 20, wherein the at least one elongated pressure lumen tubing element comprises two elongated pressure lumen tubing elements extending through the side wall of the elongated outer tubing element at longitudinally separated locations.

22. The catheter of claim 13, further including:

a pressure transducer removably operably coupled to a proximal end of the at least one elongated pressure lumen tubing element and including a sensor element in communication with an interior of the pressure-compliant balloon element through the at least one elongated pressure lumen tubing element; and

a charging structure for displacing a substantially predetermined volume of air into an air column extending between the pressure-compliant balloon element and the pressure transducer sensor element through the at least one elongated pressure lumen tubing element, the charging structure being configured, while the transducer is operably coupled to the proximal end of the at least one elongated pressure lumen tubing element, to vent the air column to an ambient environment in a first mode, and to close the air column and effect displacement of the substantially predetermined volume of air in a second mode.

23. The catheter of claim 22, wherein the charging structure includes a plunger longitudinally movable in a bore in communication with the air column, the plunger and bore being cooperatively configured to provide venting clearance between a side of the plunger and an interior wall of the bore in a first longitudinal plunger position, and to mutually seal in airtight relationship in a second longitudinal plunger position.

24. The catheter of claim 23, wherein the venting clearance is provided by a portion of the interior wall of the bore including a longitudinally extending groove therein.

25. The catheter of claim 23, wherein the first longitudinal plunger position comprises a relatively retracted position, and the second longitudinal plunger position includes a relatively extended position.

26. The catheter of claim 25, wherein an end of the plunger received within the bore includes a deformable mass.

27. The catheter of claim 26, wherein at least a portion of an inner end of the bore contracts to a relatively smaller cross-section, and the deformable mass is deformed into the at least a portion of the inner end of the bore in the second longitudinal plunger position.

28. The catheter of claim 25, wherein the plunger includes a circumferential seal thereabout.

29. The catheter of claim 25, wherein the charging structure further includes a movable plunger slide engageable with an outer end of the plunger to effect movement thereof between the first longitudinal plunger position and the second longitudinal plunger position.

30. The catheter of claim 23, wherein the proximal end of the at least one elongated pressure lumen tubing element, the charging structure and the pressure transducer sensor element are in mutual communication through passages in a manifold block housing the bore, to which the pressure transducer is secured, and which includes a connector element configured for engagement with a connector element at the proximal end of the at least one elongated pressure lumen tubing element.

31. The catheter of claim 30, wherein the charging structure and the pressure transducer are substantially contained within a housing on which is slidably mounted a plunger slide positioned and configured to move the plunger, responsive to movement of the plunger slide, between the first longitudinal plunger position and the second longitudinal plunger position.

32. The catheter of claim 31, wherein the plunger slide is oriented for movement substantially transverse to an orientation of the plunger and to traverse a path extending over the plunger to effect movement of the plunger between the first longitudinal plunger position and the second longitudinal plunger position by mutual contact of the plunger slide and the plunger.

33. The catheter of claim 31, wherein the housing is sized and configured, and the plunger slide is placed on the housing in a position to permit manipulation of the plunger slide with a thumb of a hand grasping the housing.

34. The catheter of claim 23, wherein the plunger and bore are sized and cooperatively configured to provide a charge of ˜

15 μ

liters of air to the air column when the plunger is in the second longitudinal plunger position.

35. The catheter of claim 34, wherein the elongated outer tubing element is of about 7 French diameter and the balloon element exhibits a diameter of about 8 French when the air column is charged.

36. The catheter of claim 13, wherein the at least one elongated pressure lumen tubing element has an inner diameter of about 0.005 to 0.010 inch.

37. The catheter of claim 13, wherein the elongated outer tubing element has an outer diameter of about 7 French.

38. A method for conducting a urodynamic procedure, comprising:

inserting an end of a catheter carrying a pressure responsive element into a patient'"'"'s bladder through the patient'"'"'s urethra;

at least partially inflating the pressure responsive element with air such that the pressure responsive element is in substantially complete circumferential contact with an interior of the urethra;

adding fluid to the patient'"'"'s bladder through the catheter to elevate bladder pressure; and

withdrawing the catheter from the patient'"'"'s bladder through the urethra while measuring the bladder pressure and measuring urethral pressure using the pressure responsive element in substantially complete circumferential contact with the interior of the urethra during the withdrawal of the catheter.

39. The method of claim 38, wherein using a pressure responsive element in substantially complete circumferential contact with the interior of the urethra comprises using a balloon element extending circumferentially about the catheter.

40. The method of claim 39, wherein measuring the urethral pressure further comprises substantially continuously transmitting air pressure in the balloon element through a closed air column to a transducer located external to the patient while withdrawing the catheter.

41. A method of fabricating a catheter including at least one pressure

lumen and an associated balloon element, the method comprising:

forming an aperture in a side wall of an elongated tubing element proximate a distal end thereof;

inserting an elongated pressure lumen tubing element of smaller diameter than the elongated tubing element through the side wall aperture into a bore of the elongated tubing element and threading the elongated pressure lumen tubing element proximally through the bore to a desired location;

introducing an adhesive mass into the bore of the elongated tubing element to surround the aperture and the elongated pressure lumen tubing element; and

curing the adhesive mass.

42. The method of claim 41, further comprising:

removing a portion of the elongated pressure lumen tubing element extending through the aperture and outside the elongated tubing element;

placing a sheath of heat-shrinkable material over the aperture to extend distally and proximally therefrom; and

heat-shrinking distal and proximal ends of the sheath to sealingly bond the ends to the distal and proximal elongated tubing element to define a balloon extending circumferentially thereabout.

43. The method of claim 42, further comprising threading an elongated fill tubing element distally from a proximal end of the elongated tubing element to a location proximate the distal end thereof before introducing the adhesive mass.

44. The method of claim 43, further including forming another aperture through the side wall of the elongated tubing element at a location longitudinally spaced therefrom, inserting a second elongated pressure lumen tubing element into the bore through the another aperture and threading the second elongated pressure lumen tubing element proximally to the desired location, introducing another adhesive mass into the bore of the elongated tubing element to surround the another aperture and the second elongated pressure lumen tubing element and curing the another adhesive mass.

45. The method of claim 44, further comprising:

removing a portion of the second elongated pressure lumen tubing element extending through the another aperture and outside the elongated tubing element;

placing a second sheath of heat-shrinkable material over the another aperture to extend distally and proximally therefrom; and

heat-shrinking distal and proximal ends of the second sheath to sealingly bond the distal and proximal ends of the second sheath to the elongated tubing element to define a second balloon extending circumferentially thereabout.

46. The method of claim 45, further comprising subjecting the sheath and the second sheath to an elevated temperature for a selected period of time to stabilize an internal volume of the balloon and the second balloon.

47. The method of claim 46, wherein curing the adhesive mass and the another adhesive mass is effected by exposure to UV wavelength radiation.

48. The method of claim 42, further comprising subjecting the sheath to an elevated temperature for a selected period of time to stabilize an internal volume of the balloon.

49. The method of claim 41, wherein curing the adhesive mass is effected by exposure to UV radiation.