Intra-abdominal pressure monitoring device and method

• US 8,052,671 B2
• Filed: 10/11/2004
• Issued: 11/08/2011
• Est. Priority Date: 10/11/2004
• 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): HAND, MELANIE JO
• Application Number:
  US11/665,133
• Publication Number:
  US 20080114316A1
• Time in Patent Office: 2,584 Days
• Field of Search: 600/561, 600/591, 604/93.01, 604/540
• US Class Current: 604/540
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis

Abstract

An apparatus for monitoring the intra-abdominal pressure of a patient includes a urinary catheter (102) connected to a urine valve (250) providing selectable communication between a discharge end of the urinary catheter (102) and either a drain (224) or a fluid source (104). Preferably, the urine valve (250) is adapted for remote actuation and has a housing adapted to resist patient discomfort from leg-valve (250) contact. Plumbing structure desirably maintains fluid supply (225) and drain (223) conduits in a substantially parallel arrangement to assist routing those conduits (225, 223) between a patient'"'"'s legs. When the urine valve (250) is oriented to permit communication with the fluid source (104), an infusion pump (116′) may be used to infuse a known quantity of fluid through the urine valve (250) and into the patient'"'"'s bladder (216). A pressure transducer (218) desirably is connected in-circuit to indicate the fluid'"'"'s pressure and avoid pressure fluctuations induced by system components. To facilitate the infusion process, an automatic flow control device may be included in a fluid supply path (225) and arranged to permit repetitive operation of a syringe (116′) to inject a bolus of fluid into the patient'"'"'s bladder (216). Subsequent to making a pressure measurement, the urine valve (250) is returned to the bladder (216) draining position.

Claims

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

a catheter adapted for draining urine from the bladder;

a container of infusion fluid;

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

a pump disposed to urge fluid flow, under dynamic fluid flow conditions that inherently generate friction loss and consequently require elevated pressure, compared to true bladder pressure, to be induced by the pump to overcome the friction loss, through said first fluid path;

a pressure transducer disposed in fluid communication with the bladder and sufficiently hydraulically isolated from the pressure induced by said pump effective to generate a signal responsive substantially to true gage pressure of fluid in the bladder during operation of said pump to urge said fluid flow; and

a urine valve, arranged in-circuit effective at a first configuration to resist a draining discharge from said catheter while a bolus of said infusion fluid is infused into the bladder, and effective at a second configuration to permit a draining discharge from said catheter.

2. The apparatus of claim 1, wherein:

said pressure transducer is further substantially hydraulically isolated from a head pressure associated with said container of fluid.

3. The apparatus of claim 1, said urine valve being remotely actuatable to change a configuration of said valve from said first configuration to said second configuration, wherein:

a gate component of said valve is displaced, by a hydraulic input received from said pump, effective to resist said draining discharge.

4. The apparatus of claim 3, wherein:

a gate component of said valve is displaced, effective to permit said draining discharge, by a hydraulic input received from said pump.

5. The apparatus of claim 3, wherein:

a gate component of said valve is urged toward an open position, effective to permit said draining discharge, by a biased member of said valve.

6. The apparatus of claim 5, wherein:

said biased member comprises a resilient element disposed for biasing by action of said hydraulic input.

7. The apparatus of claim 6, further comprising:

a time-delay mechanism adapted to permit substantially autonomic opening of said valve to effect said draining discharge.

8. The apparatus of claim 3, wherein:

said urine valve comprises a remote-actuated conduit clamp valve.

9. The apparatus of claim 3, wherein:

said valve comprises a housing defining a chamber having a volume, with an infusion port and a drain exit port being in fluid communication with said chamber;

said gate component comprises a piston having a portion disposed to reciprocate between first and second positions in said chamber and operable to divide said chamber into at least a first subchamber and a second subchamber, said infusion port being in fluid communication with said first subchamber, said drain exit port being in fluid communication with said second subchamber, said piston further being associated with a drain entrance port and a bypass port;

wherein;

at said first position, structure of said valve is configured to permit fluid communication between said drain entrance port and said drain exit port while resisting fluid communication between said drain entrance port and said infusion port; and

at said second position, structure of said valve is configured to permit fluid communication between said drain entrance port and said infusion port by way of said bypass port while resisting fluid communication between said drain entrance port and said drain exit port.

10. The apparatus of claim 9, wherein:

said piston is biased toward said first position such that said bypass port is occluded by structure associated with said housing substantially upon cessation of flow of said infusion fluid through said infusion port and into said first subchamber.

11. The apparatus of claim 9, further comprising:

a time-delay mechanism adapted to permit substantially autonomic opening of said valve to effect said draining discharge, said time-delay mechanism comprising;

a bleed-down port having a cross-section sized to provide restricted fluid flow therethrough between said first subchamber and said second subchamber; and

a resilient member biased to urge said piston toward said second configuration.

12. A method for measuring hydraulic pressure in the bladder of a medical patient to infer intra-abdominal pressure in that patient, the method comprising:

a) providing a catheter adapted for draining urine from the bladder, a container of infusion fluid, a pump, a pressure transducer; and

a urine valve;

b) placing said urine valve in-circuit between a drain portion of said catheter and a receptacle;

c) placing said pump in-circuit between said urine valve and said container;

d) placing said pressure transducer in-circuit with said catheter effective to substantially hydraulically isolate said pressure transducer from pressure fluctuations associated with actuation of said valve;

e) bleeding air from the circuit;

f) placing said urine valve into a draining configuration, for a first period of time, to permit flow between said catheter and said receptacle while resisting flow between said container and said catheter;

g) placing said urine valve into an infusion configuration, for a second period of time, to resist flow between said catheter and said receptacle while permitting flow between said container and said catheter;

h) infusing a desired bolus of said infusion fluid into the bladder during said second period of time;

i) measuring a pressure in the bladder at least once during a third period of time while said urine valve is in a pressure-reading configuration; and

j) returning said urine valve to said draining configuration subsequent to lapse of said third period of time.

13. The method of claim 12, wherein step d) further comprises, in any order:

applying a first pressure, above atmospheric pressure, to said infusion fluid; and

placing said pressure transducer in-circuit in a first fluid path effective substantially to isolate said pressure transducer from said first pressure and to permit a low-rate fluid flow in the first fluid path without requiring fluid flow in a second fluid path extending to the pump.

14. The method of claim 12, wherein during step g):

operating said pump for a portion of said second period of time is effective to cause a gate member of said urine valve to displace operably to place said urine valve into said infusion configuration.

15. The method of claim 14, wherein during step j):

operating said pump is effective to cause a gate member of said urine valve to displace operably to return said urine valve to said draining configuration.

16. The method of claim 14, wherein during step j):

a gate member of said urine valve is configured and arranged in harmony with a time-delay mechanism effective to maintain said urine valve in said pressure-measuring configuration during said third period of time and then effective autonomically to return said urine valve to said draining configuration.

17. The method of claim 12, further comprising, prior to step e):

applying a pressure above atmospheric pressure to said infusion fluid.

18. The method of claim 13, wherein step e) comprises:

actuating a flow restriction device disposed in-circuit between said container and said pressure transducer operably to permit an increased flow rate through said flow restriction device.

19. An apparatus for measuring hydraulic pressure through a catheter adapted to drain urine from the bladder of a medical patient to infer intra-abdominal pressure in that patient, the apparatus comprising:

structure defining a first fluid path to provide fluid communication between a container of infusion fluid and a drain end of said catheter;

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

structure adapted to place a pressure transducer in fluid communication with fluid downstream of said pump; and

a urine valve, arranged in-circuit effective at a first configuration to resist a draining discharge from said catheter while a bolus of infusion fluid is infused into the bladder, and effective at a second configuration to permit a draining discharge from said catheter, said urine valve comprising a time-delay mechanism adapted to permit said urine valve to resist said draining discharge for a first period of time comprising at least about 20 seconds subsequent to termination of a valve-closing command input and, subsequent to expiration of said first period of time, to autonomically return to said second configuration.

20. The apparatus according to claim 19, wherein:

said time-delay mechanism comprises;

a biased seal member displaceable beyond a first-sealed position to entrap a volume of timing fluid, said first-sealed position occluding a drain path from said catheter; and

a bleed-down aperture sized to provide restricted fluid flow there-through and arranged in an escape path for said timing fluid, said timing fluid being urged toward said bleed-down aperture by said biased seal member.