INTRA-ABDOMINAL PRESSURE MONITORING SYSTEM

• US 20090221933A1
• Filed: 07/13/2006
• Published: 09/03/2009
• Est. Priority Date: 07/14/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Solunin, Anatoly, Shamray, Alexander, Hanson, Robin J., Ferguson, Scott D., Nishtala, Vasu, Nagao, Rex
• Granted Patent: US 8,337,411 B2
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure

Abstract

Described herein are devices, systems, kits and methods for measuring intra-abdominal pressure (IAP) from a patient catheterized with a urinary catheter system. Devices may include a bypass lumen configured to connect to a pressure transducer, a sampling port connector connected to the bypass lumen, a drain tube housing configured to at least partially enclose a portion of the drain tube of a urinary catheter system, and a clamp mechanism. The sampling port connector may be configured for removable attachment to the sampling port of the urinary catheter system to form a fluid connection between the urinary catheter system and the bypass lumen of the IAP device. The clamp mechanism may be configured to controllably occlude the lumen of the urinary catheter system drain tube.

Claims

1. A device for measuring intra-abdominal pressure, comprising:

a bypass lumen configured to connect to a pressure transducer;

a sampling port connector connected to the bypass lumen and configured to be removably attached to a sampling port of a urinary catheter system to form a fluid connection between the urinary catheter system and the bypass lumen;

a drain tube housing, configured to at least partially enclose a portion of a drain tube of the urinary catheter system; and

a clamp mechanism in communication with the drain tube housing, the clamp mechanism configured to controllably occlude a lumen of a drain tube of the urinary catheter system.

2. The device of claim 1, further comprising a selector configured to control the operation of the clamp mechanism.

3. The device of claim 1, wherein the bypass lumen is in fluid communication with a first fluid pathway configured to connect to a pressure transducer and a second fluid pathway configured to connect to a fluid infusing device.

4. The device of claim 1, wherein the bypass lumen is in fluid communication with a fluid pathway configured to connect to both a pressure transducer and a fluid infusing device.

5. The device of claim 1, further comprising a pressure transducer connected to the bypass lumen.

6. The device of claim 1, further comprising a fluid source in fluid communication with the bypass lumen.

7. The device of claim 1, further comprising a fluid infusing device connected to the bypass lumen.

8. The device of claim 7, wherein the fluid infuser comprises a metered fluid reservoir.

9. The device of claim 7, wherein fluid infuser is fluidly connected to a fluid source.

10. The device of claim 7, wherein the fluid infuser is controlled by the selector.

11. The device of claim 7, wherein the fluid infuser comprises a pump.

12. The device of claim 7, wherein the fluid infuser comprises a syringe.

13. The device of claim 1, wherein the sampling port connector comprises an auto valve.

14. The device of claim 1, further comprising an auxiliary sampling port, wherein the auxiliary sampling port is configured to allow sampling of urine from the urinary catheter system when the device is attached to the sampling port of the urinary catheter.

15. The device of claim 1, wherein the drain tube housing comprises a channel configured to hold at least a portion of a drain tube.

16. The device of claim 1, wherein the drain tube housing comprises a first housing region and a second housing region, wherein the first housing region is at least partly separable from the second body housing region.

17. The device of claim 1, further comprising an indicator indicating whether the catheter drain tube is occluded by the clamp mechanism.

18. The device of claim 17 wherein the indicator comprises a color indicator.

19. The device of claim 1, further comprising operational instructions printed on the device.

20. The device of claim 1, wherein the clamp mechanism comprises a pinch valve.

21. The device of claim 1, wherein the clamp mechanism is further configured to controllably occlude the bypass lumen.

22. The device of claim 3, wherein the selector is selected from the group consisting of:

knob, button, dial, slider, switch, toggle, and lever.

23. The device of claim 2, wherein the selector comprises settings corresponding to occluding the catheter drain tube and occluding the bypass lumen.

24. The device of claim 1, further comprising a holdfast.

25. The device of claim 24, wherein the holdfast is selected from the group consisting of:

strap, belt, adhesive, or tie.

26. A device for measuring intra-abdominal pressure, comprising:

a bypass lumen configured to fluidly connect to a pressure transducer;

a sampling port connector connected to the bypass lumen, the sampling port connector configured to be removably attached to the sampling port of a urinary catheter system to form a fluid connection between the urinary catheter system and the bypass lumen;

a housing, configured to at least partially enclose a portion of the drain tube of the urinary catheter;

a fluid reservoir within the housing, wherein the fluid reservoir is in fluid communication with the bypass lumen;

a fluid infuser configured to apply fluid from the fluid reservoir into the urinary catheter; and

a clamp mechanism at least partly within the housing, the clamp mechanism configured to controllably occlude the lumen of the urinary catheter system drain tube.

27. The device of claim 26, further comprising a selector configured to control the clamp mechanism and the fluid infuser so that the drain tube may be occluded while applying fluid into the urinary catheter.

28. A device for measuring intra-abdominal pressure, comprising:

a bypass lumen configured to fluidly connect to a pressure transducer;

a sampling port connector in fluid connection with the bypass lumen, the sampling port connector configured to be removably attached to the sampling port of a urinary catheter system to form a fluid connection between the urinary catheter system and the bypass lumen;

a housing, configured to at least partially enclose a portion of the drain tube of the urinary catheter system and a portion of a the bypass lumen;

a clamp mechanism at least partly within the housing, the clamp mechanism configured to controllably occlude the lumen of the urinary catheter system drain tube and the bypass lumen; and

a selector configured control the operation of the clamp mechanism.

29. A system to measure intra-abdominal pressure, comprising:

a urinary catheter system having a first lumen in fluid communication with a sampling port and a drain tube;

a urinary catheter system bypass device configured to connect to the sampling port, wherein the urinary bypass device comprises;

a bypass lumen configured to fluidly connect to a pressure transducer;

a drain tube housing, configured to at least partially enclose a portion of the drain tube of the urinary catheter system; and

a clamp mechanism in communication with the drain tube housing, wherein the clamp mechanism is configured to controllably occlude the lumen of the urinary catheter system drain tube;

a fluid infusion device; and

a pressure transducer, wherein the fluid infusion device and the pressure transducer are in fluid communication with the first lumen of the catheter through the bypass lumen of the urinary catheter system bypass device.

30. The system of claim 29, wherein the fluid infusion device is a syringe and the pressure transducer is attached to the syringe.

31. The system of claim 29, wherein the clamp mechanism comprises a pinch vice.

32. The system of claim 29, further comprising an output device connected to the pressure transducer and configured to provide a pressure measurement.

33. The system of claim 29, wherein the urinary catheter system bypass device comprises an auto valve configured to connect to the sampling port of the catheter.

34. The system of claim 29, wherein the bypass lumen comprises a fluid injection line.

35. The system of claim 29, wherein the bypass lumen comprises an auxiliary sampling port.

36. The system of claim 29, further comprising a fluid infusion pathway in fluid connection with the bypass lumen.

37. The system of claim 36 further comprising a fluid source configured to communicate with the fluid infusion pathway.

38. The system of claim 29, wherein the clamp mechanism comprises a bend clamp configured to occlude the catheter drain tube by bending the catheter drain tube.

39. The system of claim 38, wherein the linking member comprises a flexible arm configured so that bending the bend clamp presses the flexible arm into the tube.

40. The system of claim 39, wherein the clamp mechanism comprises a bottom support member and a top attachment member that together connect the clamp mechanism to the tube.

41. A system for measuring intra-abdominal pressure (IAP) without breaking a closed catheter system, the closed catheter system including a catheter, a sampling port and a drain tube, the system comprising:

a means for preventing fluid flow through the drain tube,

a means for injecting fluid into the catheter through the sampling port; and

a means for measuring fluid pressure in the IAP system following fluid injection into the catheter.

42. A method of measuring intra-abdominal pressure without breaking a closed urinary catheter system, comprising:

inserting the drain tube of a urinary catheter system into the drain tube housing of a urinary catheter system bypass device, wherein the urinary catheter system bypass device comprises;

a sampling port connector fluidly connected to a bypass lumen;

a drain tube housing, configured to at least partially enclose a portion of the drain tube of the urinary catheter; and

a clamp mechanism in communication with the drain tube housing, the clamp mechanism configured to controllably occlude the lumen of the urinary catheter system drain tube;

attaching the urinary catheter system bypass device to the sampling port of the urinary catheter;

occluding the drain tube of the urinary catheter;

infusing fluid into the urinary catheter; and

detecting intra-abdominal pressure.

43. The method of claim 42, further comprising opening the drain tube of the urinary catheter.

44. The method of claim 43, wherein the step of opening the drain tube further comprises occluding the bypass lumen.

45. The method of claim 42, wherein inserting the drain tube of the urinary catheter system into the drain tube housing comprises separating a first region of the drain tube housing from a second region of the drain tube housing and inserting the drain tube between the first and second regions of the drain tube housing.

46. The method of claim 42 wherein occluding the drain tube of the urinary catheter system comprises activating the clamp mechanism of the urinary catheter system bypass device to occlude the drain tube.

47. The method of claim 46, wherein occluding the drain tube comprises pinching the drain tube.

48. The method of claim 46, wherein occluding the drain tube comprises bending the drain tube.

49. A system to measure intra-abdominal pressure, comprising:

a catheter, including a first lumen;

a connection member, including a proximal end and a distal end, the proximal end being connected to the catheter and the distal end being connected to a tube, the connection member comprising a sampling port, including a valve member;

a fluid infusion device; and

a pressure transducer, the fluid infusion device and pressure transducer each being in fluid communication with the first lumen of the catheter when the system is in an activated state.

50. The system according to claim 49, wherein the fluid infusion device is a syringe and the pressure transducer is attached to the syringe.

51. The system according to claim 49, the connection member further comprising means to prevent fluid flow to the tube.

52. The system according to claim 49, wherein the fluid flow preventing means comprises a stopcock.

53. The system according to claim 49, wherein the fluid flow preventing means comprises a pinch vice.

54. The system according to claim 49, wherein the fluid flow preventing means comprises a valve.

55. The system according to claim 49, further comprising an output device connected to the pressure transducer to provide a pressure measurement to a user.

56. The system according to claim 49, further comprising a clamping mechanism configured to be positioned around the tube adjacent the connection member.

57. The system according to claim 56, wherein the clamping mechanism comprises an insertion member configured to open the valve member of the sampling port.

58. The system according to claim 56, wherein the clamping mechanism comprises a proximal section and a distal section, the proximal section including an auto valve and a fluid injection line.

59. The system according to claim 58, wherein the clamping mechanism comprises a linking member connecting the proximal section to the distal section, the linking member permitting movement of the proximal section with respect to the distal section.

60. The system according to claim 59, wherein the linking member is comprised of two spaced apart arms.

61. The system according to claim 59, wherein the linking member is comprised of a single flexible arm, wherein upon movement of the proximal section toward the connection member, the arm presses into the tube.

62. The system according to claim 56, wherein the clamping mechanism comprises a bottom support member and a top attachment member that together connect the clamping mechanism to the tube.

63. The system according to claim 62, wherein the clamping mechanism comprises an activation arm including a slot along a length thereof, the activation arm comprising an auto valve and a fluid injection line, the auto valve and fluid injection line being in fluid communication.

64. The system according to claim 63, wherein the bottom support member comprises a rail member to interact with the activation arm slot to permit sliding movement of the activation arm with respect to the bottom support member.

65. The system according to claim 63, wherein the activation arm comprises an enlarged section at a distal portion thereof, the enlarged portion preventing fluid flow between the catheter and tube when the system is in the activated state.

66. The system according to claim 56, wherein the clamping mechanism is permanently attached to the sampling port, the clamping mechanism comprising a stopcock valve member and a occlusion member.

67. The system according to claim 56, wherein the clamping mechanism comprises a sampling port.

68. The system according to claim 56, wherein the clamping mechanism is permanently attached to the sampling port, the clamping mechanism comprising an activation member.

69. The system according to claim 68, wherein the activation member is attached to a spindle valve member and an occlusion member.

70. The system according to claim 69, wherein movement of the activation member from a rest state to an activated state enables fluid flow from a fluid injection line to an auto valve and occludes the tube.

71. The system according to claim 49, wherein the connection member further comprises an integral valve positioned in a fluid path between the catheter and the tube, the integral valve preventing fluid flow therethrough when the system is in the activated state.

72. The system according to claim 71, wherein the integral valve is connected to an activation arm, the activation arm comprising an auto valve.

73. A system for measuring intra-abdominal pressure (IAP) without breaking a closed catheter system, the closed catheter system including a catheter, a drain tube and a connection member connecting the catheter to the drain tube, the connection member including a sampling port with an integral valve, the IAP system comprising means to prevent fluid flow between the catheter and the drain tube, means for providing fluid to the IAP system, means for injecting the fluid into the system under pressure and means for measuring fluid pressure in the IAP system following fluid injection therein.

74. A clamping mechanism configured for attachment to a tube of a Foley catheter system, comprising an auto valve configured for connection to a sampling port of the Foley catheter system and a fluid injection line.

75. The clamping mechanism according to claim 74, including a proximal section and a distal section, the proximal and distal sections being connected by a linking member.

76. The clamping mechanism according to claim 75, wherein the linking member is selected from the group consisting of a pair of spaced apart arms, a pivoting member and a single flexible arm.

77. The clamping mechanism according to claim 74, including a bottom support member and a top attachment member that together connect the clamping mechanism to the tube.

78. The clamping mechanism according to claim 77, wherein the clamping mechanism comprises an activation arm including a slot along a length thereof, the auto valve and fluid injection line being positioned on the activation arm.

79. The clamping mechanism according to claim 78, wherein the bottom support member comprises a rail member to interact with the activation arm slot to permit sliding movement of the activation arm with respect to the bottom support member.

80. The clamping mechanism according to claim 79, wherein the activation arm comprises an enlarged section at a distal portion thereof, the enlarged portion preventing fluid flow between the catheter and tube when the system is in the activated state.

81. The clamping mechanism according to claim 74, being configured for permanent attachment to the sampling port of the Foley catheter system, the clamping mechanism comprising a stopcock valve member and an occlusion member.

82. The clamping mechanism according to claim 81, further comprising a sampling port.

83. The clamping mechanism according to claim 74, the clamping mechanism being configured for permanent attachment to the sampling port of the Foley catheter system, the clamping mechanism comprising an activation member.

84. The clamping mechanism according to claim 83, wherein the activation member is attached to a spindle valve member and an occlusion member.

85. The clamping mechanism according to claim 84, wherein movement of the activation member from a rest state to an activated state enables fluid flow from a fluid injection line to an auto valve and occludes the tube.

86. A system to measure intra-abdominal pressure, comprising:

a catheter, including a first lumen;

a connection member, including a proximal end and a distal end, the proximal end being connected to the catheter and the distal end being connected to a tube, the connection member comprising a sampling port and an integral valve member, the integral valve member being positioned in a fluid path between the catheter and the tube;

a fluid infusion device; and

a pressure transducer, the fluid infusion device and pressure transducer each being in fluid communication with the first lumen of the catheter when the system is in an activated state.

87. The system according to claim 86, further comprising an activation arm connected to the integral valve, the activation arm comprising an auto valve and a fluid injection line, wherein connection of the auto valve to the sampling port closes the fluid path from the catheter to the tube and opens a fluid path from the fluid injection line to the catheter.

88. A system for continuous and automatic measuring of intra-abdominal pressure (IAP), comprising a catheter including an inflatable element positioned at a distal end thereof, the inflatable element including a sensor to detect and transmit bladder pressure information to a device positioned outside of a patient'"'"'s body.

89. The system according to claim 88, wherein the device is a pressure transducer.

90. The system according to claim 88, wherein the device comprises a fluid compensation chamber and a pressure sensor.

91. The system according to claim 88, further comprising a proximal connection member including a sampling port.

92. A system for continuous and automatic measuring of intra-abdominal pressure (IAP), comprising:

a catheter, including a first lumen;

a proximal connection member connected to the catheter, the member being in fluid communication with the first lumen;

a pressure transducer;

an programmable valve connected to a proximal end of the proximal connection member and a distal end of a drain tube, the valve programmed to regulate fluid flow from the first lumen to the drain tube; and

a urine detector connected to the drain tube.

93. The system according to claim 92, wherein the pressure transducer is positioned at a distal end of the catheter such that it resides within a patient'"'"'s bladder upon insertion of the catheter therein.

94. The system according to claim 93, wherein the pressure transducer is in the form of a fiber optic probe connected externally to a signal conditioner.

95. The system according to claim 93, wherein the pressure transducer communicates via radio frequency to a base unit positioned outside of the patient'"'"'s body.

96. A system for measuring intra-abdominal pressure (IAP), comprising:

a catheter, including a first lumen;

a proximal connection member connected to the catheter, the member being in fluid communication with the first lumen;

a fluid source connected to a fluid conduit, the fluid conduit configured for insertion into a patient;

a regulator connected to the fluid source; and

an IAP sensing element connected to both the regulator and the proximal connection member, the IAP sensing element monitoring input of fluid from the fluid source to the patient and excretion of urine from the patient through the first lumen.

97. A system for measuring intra-abdominal pressure (IAP) without breaking a closed catheter system in an operational state, the closed catheter system including a catheter, a sampling port and a drain tube, the drain tube receiving unimpeded fluid flow from the catheter, the system comprising:

an clamping mechanism configured to prevent fluid flow through the drain tube by compressing a section of the drain tube;

a fluid line connection assembly, including a sampling port connector attached to an end of a tubing in fluid communication with a fluid infuser, a first valve controlling fluid communication between the fluid infuser and the tubing, the fluid infuser in fluid communication with a fluid source; and

a pressure transducer connected to the fluid line connection assembly.

98. The system according to claim 97, wherein the first valve comprises a stopcock.

99. The system according to claim 97, further comprising a second valve controlling fluid communication between the fluid infuser and the fluid source.

100. The system according to claim 97, wherein the clamping mechanism is included in a housing with a channel configured to receive the drain tube, a selector on the housing configured to toggle the clamping mechanism into and out of the channel.