Apparatus for monitoring intra-abdominal pressure

• US 20060058702A1
• Filed: 09/01/2005
• Published: 03/16/2006
• Est. Priority Date: 03/04/2003
• Status: Active Grant

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Wolfe TORY Medical Incorporated
• Inventors: Denton, Marshall T., Croll, Perry W., Kimball, Edward J., Christensen, Mark A., Wolfe, Timothy R.
• Granted Patent: US 7,892,181 B2
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis

Abstract

An improved apparatus for monitoring the intra-abdominal pressure of a hospitalized patient includes a urinary catheter connected to a urine valve having selectable communication positions between a discharge end of the urinary catheter and either a drain or a fluid source. Preferably, the urine valve has a housing adapted to resist patient discomfort from leg-valve contact. One operable protective housing may be embodied as a separate tray component. Plumbing structure desirably maintains fluid supply and drain conduits in a substantially parallel arrangement to assist routing those conduits between a patient'"'"'s legs. When the urine valve is oriented for communication to the fluid source, an infusion pump may be used to introduce a known quantity of fluid through the urine valve and into the patient'"'"'s bladder where the fluid'"'"'s pressure can be measured. Desirably, a double check valve is included in a fluid supply path and arranged to permit repetitive operation of a syringe to inject a bolus of fluid into the patient'"'"'s bladder. Subsequent to making a pressure measurement, the urine valve is returned to the bladder draining position.

Claims

1. An apparatus for measuring hydraulic pressure in the bladder of a medical patient to infer intra-abdominal pressure, comprising:

a catheter adapted for draining urine from said patient;

a container of fluid;

a first fluid path comprising conduit disposed for fluid communication between said container and a drain portion of said catheter;

a pump disposed to urge fluid flow through said first fluid path;

a pressure transducer arranged to measure a pressure of said fluid in said first fluid path; and

an automatic flow-control device actuated, at least in part, by fluid pressure effected by said pump, said flow-control device being disposed in said first fluid path and operable to permit flow of said fluid from said container toward said pump and to resist flow of said fluid from said pump toward said container.

2. The apparatus of claim 1, wherein:

said flow-control device further comprises a portion adapted to permit flow of said fluid through said first fluid path in a direction from said pump toward said catheter and to resist flow of said fluid in a direction from said pressure transducer toward said pump.

3. The apparatus of claim 1, wherein:

said flow-control device comprises a double check valve; and

said pump is disposed to effect a cyclic fluid pressure at a staging area between first and second check valve portions of said double check valve.

4. The apparatus of claim 1, wherein:

said flow-control device comprises a check-bypass valve; and

said pump is disposed to effect a cyclic fluid pressure at a staging area between a check valve seal and a bypass valve seal.

5. The apparatus of claim 4, wherein:

said pump comprises a syringe; and

structure of said check-bypass valve is adapted for attachment to a discharge end of said syringe.

6. The apparatus of claim 1, further comprising:

a urine valve arranged to provide;

a first flow portion disposed in said first fluid path;

a second flow portion disposed in a second fluid path operable as a drain for fluid discharged from said catheter; and

a third flow portion disposed for fluid communication with a urine discharge end of said catheter;

wherein;

said urine valve is operable selectively to resist fluid flow between said third flow portion and said second flow portion.

7. The apparatus of claim 6, wherein:

said urine valve is operable selectively to resist fluid flow between said first flow portion and said third flow portion.

8. The apparatus of claim 6, wherein:

said first and second flow portions of said urine valve provide structure configured to permit connection to respective first and second substantially parallel conduits to facilitate routing said substantially parallel conduits in a space between a patient'"'"'s legs.

9. The apparatus of claim 6, wherein:

said first, second, and third flow portions of said urine valve comprise substantially parallel conduit sections.

10. The apparatus of claim 6, wherein:

connection structure is provided in fluid communication with each of said first, second, and third flow portions of said urine valve for connection of first, second, and third substantially parallel conduits thereto, effective to facilitate routing said substantially parallel conduits in a space between a patient'"'"'s legs.

11. The apparatus of claim 6, wherein:

a body of said urine valve comprises a housing structured to resist imparting contact injury to a patient.

12. The apparatus of claim 11, wherein:

a preferential flow path through said urine valve is selected by rotating a first valve structure with respect to a second valve structure.

13. The apparatus of claim 12, said urine valve being actuated to select a fluid flow path by rotating a first portion of said housing with respect to a second portion of said housing.

14. The apparatus of claim 13, wherein:

said first and second portions of said housing are sealed against infiltration by external contaminants.

15. The apparatus of claim 11, wherein:

said housing comprises smooth surfaces and rounded corners to resist formation of crevices in which contaminants might be shielded, to facilitate cleaning fecal matter from an exterior surface of said housing.

16. The apparatus of claim 6, wherein:

said urine valve is structured as a gate valve.

17. The apparatus of claim 6, wherein:

first and second apertures, opening to portions of respective first and second flow paths through said valve, are disposed on a first surface; and

a valve core element comprises a second surface structured in cooperation with said first surface such that a third aperture disposed on said second surface can be aligned to form a leak resistant seal for fluid communication with either of said first and second apertures, said third aperture opening to a portion of a flow path in common to said first and said second flow paths.

18. The apparatus of claim 17, wherein said leak resistant seal comprises:

a first O-ring disposed on said first surface and arranged to encompass said first aperture; and

a second O-ring disposed on said first surface and arranged to encompass said first aperture and said second aperture.

19. The apparatus of claim 6, wherein:

structure carried on a housing of said urine valve is adapted to provide visual indication of a currently selected flow path.

20. The apparatus of claim 6, in combination with:

a tray operable as a protective housing and having blunt corners and areas of gradual transition in curvature to resist imparting injury to a patient arising from contact therewith, said housing defining a socket operable to space structure received in said socket apart from a patient, said socket being structured to receive said urine valve.

21. The combination of claim 20, wherein:

said socket further accommodates a discharge end portion of structure associated with said catheter.

22. The combination of claim 21, wherein:

said socket is adapted to hold said discharge end portion in a preferred orientation operable to assist a health practitioner in inserting a needle into an aspiration port associated with said catheter.

23. An apparatus for measuring hydraulic pressure in the bladder of a medical patient, comprising:

a catheter adapted for draining urine from said patient into a drain conduit;

a container of fluid;

a first fluid path between said container of fluid and a drain portion of said catheter;

a pump disposed to effect a pressure on fluid in said first fluid path;

a pressure transducer arranged to measure a pressure of said fluid in said first fluid path at a location downstream of said pump; and

a drain valve operable to occlude said drain conduit while permitting fluid flow through said first fluid path, said valve being configured to remain in association with said drain conduit when said valve is in a configuration to permit fluid flow through said drain conduit.

24. The apparatus of claim 23, said valve comprising:

a multi-way valve comprising;

a first flow portion disposed in said first fluid path and arranged to receive fluid from said container;

a second flow portion disposed in a second fluid path configured as a drain for said catheter; and

a third flow portion disposed in said first fluid path for fluid communication with a urine discharge end of said catheter;

wherein;

said multi-way valve is operable selectively to resist fluid flow between said third flow portion and said second flow portion; and

said multi-way valve is configured to provide a streamlined plumbing arrangement to facilitate substantially parallel routing of fluid conduits between a patient'"'"'s legs.

25. The apparatus of claim 24, wherein:

a urine draining lumen forming a flow path through said valve has a substantially uniform diameter in excess of about 3/16 inches (4.8 mm), and;

a sealing element of said multi-way valve is structured to contain a dead volume of less than about 0.0006 cubic inches (10 ml).

26. The apparatus of claim 23, said drain valve further comprising:

a proximal body portion comprising a valve entrance port, a first alignment structure, and axial connection structure;

a distal body portion comprising;

a second alignment structure disposed for cooperation with said first alignment structure to indicate a valve fluid-flow configuration;

a first aperture in fluid communication with a first valve discharge port; and

a second aperture in fluid communication with a second valve discharge port;

a rotatable valve gate comprising a conduit having a third aperture disposed on a distal gate surface and in fluid communication with said valve inlet port and selectively positionable for fluid communication with either of said first and second apertures, a perimeter of said gate being trapped by structure permanently affixed to said distal body portion effective to maintain said gate in a substantially fixed axial relation to said distal body portion, with structure associated with said gate being permanently affixed to said axial connection structure carried by said proximal body portion; and

valve seal structure disposed selectively to form a leak resistant seal for fluid communicating between said first aperture and said third aperture, and between said second aperture and said third aperture.

27. The apparatus of claim 26, further comprising:

a valve body seal disposed between said proximal body portion and said distal body portion to resist contaminant infiltration into an interior of said valve.

28. The apparatus of claim 26, further comprising:

positive stop structure disposed to resist displacement of said gate beyond a fully actuated position.

29. The apparatus of claim 28, wherein:

said positive stop structure comprises a distally protruding orientation post carried by said gate and cooperating structure associated with said distal body portion.

30. The apparatus of claim 26, further comprising:

fluid-flow position indicating structure comprising;

a first area disposed on said proximal housing and having a first color;

a second area disposed on said distal housing and having said first color; and

a third area disposed on said distal housing and having a second color;

wherein;

alignment of said first and second areas corresponds to said valve being at a preferred fluid-flow orientation, and alignment of said first area and said third area corresponds to said valve being at a second fluid-flow configuration.

31. The apparatus of claim 26, further comprising:

vibration inducing structure disposed to provide tactile feedback to a user operable to indicate complete actuation of said valve to a fluid-flow configuration.

32. The apparatus of claim 31, wherein:

said vibration inducing structure comprises structure associated with said positive stop structure.

33. The apparatus of claim 31, wherein:

said vibration inducing structure is arranged to form a structural interference between an element associated with said distal housing and an element associated with said gate.

34. The apparatus of claim 31, wherein:

said vibration inducing structure comprises ramp structure associated with said distal housing and arranged to form a structural interference with said orientation post.

35. The apparatus of claim 26, further comprising:

lockout structure arranged for actuation only when said valve is in a particular fluid-flow configuration.

36. The apparatus of claim 26, further comprising:

a return mechanism structured and arranged automatically to return said gate to a urine-draining configuration subsequent to lapse of a defined period of time from actuation of said valve to a drain occluding position.

37. A method, for measuring hydrostatic pressure in the bladder of a medical patient, comprising the steps of:

a) installing a urinary catheter in said patient to provide fluid communication on a first fluid path comprising a stretch between said bladder and a discharge portion of said catheter;

b) disposing an inlet port of a urine valve in fluid communication with said first fluid path, said urine valve comprising a drain orientation and a measure orientation, said drain orientation providing communication between said inlet port and a second fluid path directed from said urine valve toward a drain receptacle, said measure orientation permitting communication between said inlet port and a third fluid path between said urine valve and a source of fluid while resisting fluid flow in a direction from said inlet port along said second fluid path;

c) connecting said source of fluid to a pump operable to urge a fluid along said third fluid path toward said catheter;

d) disposing a pressure transducer to measure pressure of fluid between said pump and said bladder;

e) placing said urine valve into said measure orientation and operating said pump to introduce a bolus of said fluid into said bladder;

f) using said pressure transducer to measure a hydrostatic pressure of said fluid; and

g) placing said urine valve into said drain orientation.

38. The method of claim 37, wherein steps e) through g) are repeated in sequence as an intra-abdominal pressure measurement procedure performed a plurality of instances that are spaced apart in time.

39. The method of claim 37, wherein operation of said pump in step e) comprises actuation of a syringe to cause cyclic pressure fluctuation at a staging area of an automatic valve arrangement operable to permit fluid flow from said fluid source toward said catheter and to resist fluid flow in a reverse direction.

40. The method of claim 38, wherein:

said pump and said urine valve are under operable control of a programmable mechanized apparatus; and

information adduceable from said hydrostatic pressure is displayed on a terminal.

41. The method of claim 40, said terminal being remote from a room in which said patient resides.

42. A preassembled apparatus adapted to assist in measuring the pressure in a bladder of a patient to infer the intra-abdominal pressure of that patient through a urinary catheter installed in the patient, comprising:

a bag connector operable to couple to a saline bag effective to drain saline solution from said bag;

a first conduit in fluid communication with said bag connector and operable to transport said saline solution to an infusion pump;

a said infusion pump configured and arranged to urge said saline solution in a pressurized fluid path toward a urine valve;

a transducer connector configured and arranged to couple with a pressure transducer to permit placing said pressure transducer into fluid communication with said saline solution in said pressurized fluid path; and

a said urine valve configured at a valve entrance end to couple with structure associated with said catheter, said valve being affixed to a urine drain conduit and operable to occlude a drain path for urine from said catheter.

43. The apparatus of claim 42, further comprising a package of material arranged to hold said assembly and operable to maintain sterility of said assembly during storage and transport of said assembly inside said package.

44. The apparatus of claim 42, said urine valve comprising:

a proximal body portion comprising a valve entrance port, a first alignment structure, and axial connection structure;

a distal body portion comprising;

a second alignment structure disposed for cooperation with said first alignment structure to indicate a valve fluid-flow configuration;

a first aperture in fluid communication with a first valve discharge port; and

a second aperture in fluid communication with a second valve discharge port;

a rotatable valve gate comprising a conduit having a third aperture disposed on a distal gate surface and in fluid communication with said valve inlet port and selectively positionable for fluid communication with either of said first and second apertures, a perimeter of said gate being trapped by structure permanently affixed to said distal body portion effective to maintain said gate in a substantially fixed axial relation to said distal body portion, with structure associated with said gate being permanently affixed to said axial connection structure carried by said proximal body portion; and

valve seal structure disposed selectively to form a leak resistant seal for fluid communicating between said first aperture and said third aperture, and between said second aperture and said third aperture.

45. The apparatus of claim 42, said urine valve comprising a combination of:

a male fitting adapted at one end to couple with a discharge of a urinary catheter, and having a saline port providing fluid communication to said pressurized fluid path; and

an occluding device arranged to remain attached to said drain conduit between pressure measurements and operable to occlude a drain path from said catheter at a location downstream from said saline port.

46. The apparatus of claim 45, said occluding device comprising:

a body disposed to encompass a flexible conduit portion of said drain path; and

a lever actuator operable to compress said flexible conduit portion against said body.