Apparatus for monitoring intra-abdominal pressure

• US 7,892,181 B2
• Filed: 09/01/2005
• Issued: 02/22/2011
• Est. Priority Date: 03/04/2003
• Status: Active Grant

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Abviser Medical, LLC (ConvaTec Group Plc)
• Inventors: Denton, Marshall T., Croll, Perry W., Kimball, Edward J., Christensen, Mark A., Wolfe, Timothy R.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/219,319
• Publication Number:
  US 20060058702A1
• Time in Patent Office: 2,000 Days
• Field of Search: 600/561, 604/33, 604/77, 604/167.04, 604/167.03, 604/248, 604/339, 604/39, 604/45, 137/625.46, 137/45, 137/21
• 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 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 discharge end 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 defining, at most, two fluid flow paths there-through, each such flow path extending from a valve housing entrance to a valve housing exit and being configurable to permit uninterrupted flow of fluid the entire length there-between, the drain valve being 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, the valve comprising structure configured to cause routing of a length of the first path, on the container-side of the valve and in the vicinity of the valve, to be disposed substantially in parallel with both of;

a first length of the drain conduit at a valve entrance, and;

a second length of the drain conduit at a valve exit.

2. The apparatus of claim 1, 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 resist access of ambient air into the second flow portion during conventional operation of the valve.

3. The apparatus of claim 2, 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 (0.01 ml).

4. The apparatus of claim 1, said drain valve further comprising:

a proximal body portion comprising a single valve entrance port through which fluid may communicate on a path extending through said valve, a first alignment structure, and an axial connection structure;

a distal body portion structured in harmony with said proximal body portion to permit relative motion there-between subsequent to assembly of said valve, said 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 distal fluid port through which fluid may communicate on a path extending through said valve; and

a second aperture in fluid communication with a second distal fluid port through which fluid may communicate on a path extending through said valve;

a rotatable valve gate comprising a conduit having a third aperture disposed on a distal gate surface and in fluid communication with said valve entrance 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.

5. The apparatus of claim 4, 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.

6. The apparatus of claim 4, further comprising:

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

7. The apparatus of claim 6, wherein:

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

8. The apparatus of claim 4, further comprising:

fluid-flow position indicating structure comprising;

a first area disposed on said proximal body portion and having a first color;

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

a third area disposed on said distal body portion 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.

9. The apparatus of claim 4, 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.

10. The apparatus of claim 9, wherein:

said vibration inducing structure comprises structure associated with a positive stop structure disposed to resist displacement of said gate beyond a fully actuated position.

11. The apparatus of claim 9, 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.

12. The apparatus of claim 9, wherein:

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

13. The apparatus of claim 4, further comprising:

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

14. The apparatus of claim 4, 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.

18. The apparatus according to claim 1, further comprising:

a second fluid path defined by structure configured to permit fluid communication between said drain portion of said catheter and a fluid receiver;

wherein;

first and second apertures, opening to portions of respective first and second flow paths through said drain 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 through either of said first aperture and said second aperture, said third aperture opening to a portion of a flow path extension for either of said first flow path and said second flow path; and

said leak resistant seal comprises;

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

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

15. 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;

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

a second conduit having a first end coupled to said infusion pump and a second end mechanically associated with said urine valve;

a transducer connector coupled to said second conduit, configured and arranged to couple with a pressure transducer to permit placing said pressure transducer into fluid communication with said saline solution in said second conduit; and

said urine valve being configured at a valve entrance end to removably couple for fluid communication with said catheter, said urine valve defining, at most, two fluid flow paths there-through, each such flow path extending from a valve housing entrance to a valve housing exit and being configurable to permit uninterrupted flow of fluid the entire length there-between, said valve being coupled to a urine drain conduit and operable to occlude a drain path for urine from said catheter, the urine valve comprising structure configured to cause routing of a length of the pressurized fluid path, on the fluid source-side of the urine valve and in the vicinity of the urine valve, to be disposed substantially in parallel with both of a first length of the drain conduit at a valve entrance, and a second length of the drain conduit at a valve exit.

16. The apparatus of claim 15, 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.

17. The apparatus of claim 15, said urine valve comprising:

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

a distal body portion structured in harmony with the proximal body portion to permit relative motion therebetween subsequent to assembly of the valve, the 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 entrance port and selectively positionable for fluid communication with either of said first and second apertures, a perimeter of said gate being trapped, to permit rotation of the gate about an axis passing in an axial direction through both of the proximal body portion and the distal body portion, 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 of 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.

19. An apparatus for measuring hydraulic pressure inside the urinary bladder of a medical patient, the apparatus comprising:

a first fluid pathway in fluid communication with a source of fluid on a first end thereof and a catheter on a second end thereof, said catheter being structured for draining urine from a medical patient'"'"'s urinary bladder into a drain conduit;

a pump intercooperated with first fluid pathway disposed to urge flow of fluid through said first fluid pathway;

a pressure transducer in fluid communication with said first fluid pathway for measuring fluid pressure of fluid within said first fluid pathway at a location disposed downstream of said pump; and

a drain valve, coupled to said first fluid pathway, operable to resist fluid flow through said drain conduit, the drain valve defining, at most, two fluid flow paths there-through, each such flow path extending from a valve housing entrance to a valve housing exit and being configurable to permit uninterrupted flow of fluid the entire length there-between, the valve comprising structure configured to cause routing of a length of the first fluid pathway, on the fluid source-side of the valve and in the vicinity of the valve, to be disposed substantially in parallel with both of

a first length of the drain conduit at a valve entrance, and;

a second length of the drain conduit at a valve exit.

20. The apparatus according to 19, wherein:

a first portion of said first fluid pathway comprises a first length of lumen disposed adjacent a control location at which said drain valve may act to resist fluid flow through said drain conduit;

said drain conduit comprises a second length of lumen structured to permit at least intermittent communication of fluid through said control location, wherein;

downstream fluid flow through said first length of lumen and extending through said second length of lumen causes fluid flow through said first length of lumen that is, from the point of view of an external observer, substantially parallel to, and in the opposite direction from, fluid flow through said second length of lumen.

21. The apparatus according to 20, further comprising:

structure configured and arranged effective to hold said first length of lumen in a substantially fixed relationship in space with respect to said second length of lumen.

22. The apparatus according to 19, wherein:

the valve housing entrance is carried on a distal valve body portion of a valve housing;

a valve housing exit is carried on a proximal valve body portion of the valve housing; and

the distal valve body portion is structured in harmony with the proximal valve body portion to permit relative motion there-between subsequent to assembly of the valve.