METHOD AND APPARATUS FOR PERITONEAL HYPOTHERMIA AND/OR RESUSCITATION

• US 20070106247A1
• Filed: 10/23/2006
• Published: 05/10/2007
• Est. Priority Date: 10/21/2005
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Ceeben Systems Inc.
• Inventors: Burnett, Daniel, Blanton, Jared, Mangrum, Shane
• Granted Patent: US 8,672,884 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61F 2007/0094 using a remote control
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

Embodiments of the invention provide apparatus, systems and methods for introducing fluids into a body cavity for hypothermic, resuscitative, or other treatment. One embodiment provides an apparatus for introducing fluids into a peritoneal cavity comprising an access device for insertion into subcutaneous tissue, an infusion member and an advancement member. The access device includes a lumen, a proximal end, a tissue penetrating distal end and a stop for controlling the depth of the distal end into tissue. The infusion member includes an infusion lumen, a removal lumen and at least one sensor and is advanceable from a lumen of the access device into the peritoneal cavity. The advancement member is removably positionable in an infusion member lumen and has sufficient column strength to advance the infusion member tip through abdominal wall tissue into the peritoneal cavity. When the advancement member is removed, the infusion member tip is substantially atraumatic.

Claims

1. A method for delivering fluid to a body cavity of a patient, the method comprising:

inserting an access device a controlled depth into a tissue wall of the patient;

advancing an infusion member through the access device utilizing an advancement member positioned in the infusion member;

determining when the distal tip of the infusion member has entered into the body cavity;

signaling when the distal tip of the infusion member has entered into the body cavity so as prevent penetration injury of an organ in the cavity;

removing the advancement member from the infusion member so as to render the infusion member distal tip substantially atraumatic; and

infusing a solution into the cavity through the infusion member.

2. The method for claim 1, wherein the body cavity is a peritoneal cavity and the tissue wall is the abdominal wall.

3. The method for claim 1, wherein the entry of the distal tip into the cavity is determined by monitoring a flow rate through the infusion member or a pressure at the distal tip of the infusion member.

4. The method for claim 1, wherein the signal is an audio or a visual signal.

5. A method for inducing hypothermia in a patient, the method comprising:

inserting an access device a controlled depth into an abdominal wall of the patient;

advancing an infusion member through the access device and into the peritoneal cavity of the patient without injuring an organ in the peritoneal cavity;

monitoring a temperature of the patient at a selected location;

infusing a hypothermic infusate solution into the peritoneal cavity through the access device or an infusion member positioned within the access device, wherein an infusion parameter is controlled utilizing the monitored temperature;

cooling tissue in the peritoneal cavity with the hypothermic solution; and

reducing the temperature of the patient to a selected temperature.

6. The method for claim 5, wherein at least one of a rate of infusion or cooling is titrated to reduce an amount of coronary ischemic tissue injury resulting from myocardial infarction, cardiac arrest or other coronary ischemic event.

7. The method for claim 5, wherein at least one of a rate of infusion or cooling is titrated to reduce an amount of cerebral ischemic tissue injury resulting from stroke, cardiac arrest or other cerebral ischemic event.

8. The method for claim 5, wherein at least one of a rate of infusion or cooling is titrated to reduce an amount of ischemic tissue injury in a tissue extremity.

9. The method for claim 5, wherein at least one of a rate of infusion or cooling is titrated to reduce an inflammatory response resulting from a surgical procedure.

10. The method for claim 9, wherein the surgical procedure is a cardiovascular procedure, an open heart procedure, a valve repair or replacement procedure, an aneurysm repair procedure, a cerebral surgical procedure, a renal procedure or a hepatic surgical procedure.

11. The method for claim 5, further comprising:

inflating a peritoneal cavity so as to expand an exposed surface area of a peritoneal cavity organ; and

flowing the hypothermic fluid over the exposed surface area of the peritoneal cavity organ so as to exchange heat or gas with a peritoneal cavity organ.

12. The method for claim 5, wherein the infusion member is advanced using an advancement member positioned within the infusion member.

13. The method for claim 12, further comprising:

removing the advancement member once the infusion member has been positioned in the peritoneal cavity.

14. The method for claim 5, wherein a temperature of the solution is in the range of 10 to 20°

C.

15. The method for claim 5, wherein the selected temperature is in the range of about 20 to 35°

C.

16. The method for claim 5, wherein the infusion comprises infusing a bolus of solution.

17. The method for claim 16, wherein a volume of the bolus is in the range of about 0.5 to 3 liters.

18. The method for claim 16, wherein the infusion further comprises infusing fluid at a controlled rate after completion of the bolus infusion.

19. The method for claim 18, wherein the controlled rate is controlled to maintain the core temperature of the patient at a hypothermic level.

20. The method for claim 5, wherein at least one of the rate or volume of infusate is configured to increase a mean patient blood pressure.

21. The method for claim 5, wherein the infusion parameter is at least one of a flow rate, a pressure, a total infused volume, an inflow duty cycle or a hypothermic solution temperature.

22. The method for claim 5, wherein the selected location is at least one of a tympanic membrane, an intravenous site, an epidermal site, a subcutaneous site or an oral site.

23. The method for claim 5, wherein the selected location includes a plurality of locations and the monitored temperature comprises a composite temperature from the plurality of locations.

24. The method for claim 5, wherein the infusate is infused using a driving force from at least one of a compressed gas source, a gravitational head pressure or a pump.

25. The method for claim 24, wherein the compressed gas source is an oxygen source which is configured to oxygenate the infusate solution.

26. The method for claim 5, further comprising:

determining an entry point of the infusion member into the peritoneal cavity utilizing a sensor output.

28. The method for claim 26, further comprising:

signaling an entry point event to a medical practioner performing the method.

29. The method for claim 5, wherein the depth of insertion of the access device into the peritoneal cavity is controlled.

30. The method for claim 29, wherein the insertion depth is controlled through use of a stop positioned on the access device.

31. The method for claim 5, further comprising:

monitoring a pressure within the peritoneal cavity or the infusion member; and

titrating the infusate flow rate responsive to the monitored pressure.

32. The method for claim 31, wherein the monitored pressure is utilized to prevent over-filling of the peritoneal cavity.

33. The method for claim 31, wherein the infusate flow rate is titrated responsive to the monitored pressure exceeding a threshold or a rate of increase.

34. The method for claim 5, wherein the access device has a tissue penetrating configuration and a non-tissue penetrating safety configuration.

35. The method for claim 34, wherein the access device assumes the safety configuration after insertion through the abdominal wall.

36. The method for claim 34, wherein the access device includes a slidable sheath that slides over a tissue penetrating portion of the introducer to achieve the safety configuration.

37. The method for claim 34, wherein the access device includes a shearable issue penetrating portion which when sheared assumes the safety configuration.

38. The method for claim 34, wherein the safety configuration is achieved by pressurizing the access device.

39. The method for claim 32, further comprising:

inserting the access device through tissue in the tissue penetrating configuration; and

converting to the safety configuration when a distal portion of the access device penetrates the distal side of the abdominal wall.

40. The method for claim 5, further comprising:

withdrawing at least a portion of the infusate from the peritoneal cavity.

41. The method for claim 40, further comprising:

utilizing the withdrawn solution as a heat sink for cooling the infusate solution infused into the peritoneal cavity.

42. The method for claim 41, wherein cooling is performed using a peltier effect device.

43. The method for claim 40, wherein the infusate is withdrawn using a vacuum pressure.

44. The method for claim 40, wherein the infusate is withdrawn at the same access point in the abdominal wall used for infusion.

45. The method for claim 40, wherein the infusate is withdrawn responsive to at least one of an infusion inflow rate, a peritoneal pressure, or a peritoneal temperature.

46. The method for claim 40, wherein at least one of the infusion or withdrawal of the infusate is pulsated.

47. The method for claim 40, wherein the pulsation is synchronized to a heart rate or a respiration rate.

48. The method for claim 40, wherein the infusion and the withdrawal of the infusate are performed in substantially sequential periods.

49. The method for claim 40, wherein the duration and waveform of the infusion withdrawal are configured to optimize at least one of heat transfer with the peritoneal organs, rate of body cooling to a selected core temperature, maintenance of body core temperature at the selected temperature and oxygenation of the peritoneal organs.

50. The method for claim 46, wherein there is an interval between each period of infusion and withdrawal.

51. The method for claim 5, further comprising:

oxygenating the infusate solution before infusion into the patient.

52. The method for claim 51, further comprising:

utilizing the infusate solution to diffuse sufficient oxygen through the peritoneal tissue to at least partially meet the oxygen requirements of the patient.

53. The method for claim 51, wherein the infusate solution comprises a fluorocarbon.

27. The method for claim 426, wherein the entry point is determined by monitoring a flow rate of infusate solution into the peritoneal cavity.

54. An apparatus for accessing and introducing fluids into a peritoneal cavity of a patient for producing hypothermia, the apparatus comprising:

an access device configured to be inserted into subcutaneous tissue, the device including a lumen, a proximal end, a tissue penetrating distal end and a stop, the stop configured to control the penetration depth of the distal tip into tissue;

an infusion member positioned within a lumen of the access device and advanceable into the peritoneal cavity, the infusion member including a first lumen and a second lumen for the infusion and removal of fluid into and out of the peritoneal cavity;

the infusion member having a tissue penetrating distal end; and

an advancement member removably positionable in at least one of the two lumens, the advancement member having sufficient column strength to advance the infusion member through abdominal wall tissue and into the peritoneal cavity by manipulation of a proximal portion of the infusion member or the advancement member.

55. The apparatus of claim 54, wherein the distal tip is sufficiently flexible to be substantially atraumatic when the advancement member is removed from the infusion member.

56. The apparatus of claim 54, wherein the first or second lumen is sized to deliver sufficient fluid to the cavity to reduce patient body temperature by at least about 3°

C. through heat exchange with peritoneal tissue.

57. The apparatus of claim 54, wherein the distal end of the access device is configured to be shearable through the application of a force applied to an internal wall of the distal tip, the sheared distal end having a non-tissue penetrating configuration.

58. The apparatus of claim 57, wherein the advancement member has sufficient column strength to advance the infusion member into the distal end of the access device to shear the distal end of the access device.

59. The apparatus of claim 54, wherein the first lumen is configured for infusion of fluid into the peritoneal cavity and the second lumen is configured for removal of fluid from the cavity.

60. The apparatus of claim 59, wherein the infusion member includes at least one aperture positioned on a wall of the infusion member.

61. The apparatus of claim 60, wherein the at least one aperture opens to the second lumen.

62. The apparatus of claim 60, wherein the at least one aperture includes a plurality of apertures distributed along a distal portion of the infusion member.

63. The apparatus of claim 60, wherein the at least one aperture opens to the first lumen.

64. The apparatus of claim 63, wherein the at least one aperture is positioned to reduce an incidence of tissue obstruction during advancement of the infusion member.

65. The apparatus of claim 63, wherein the at least one aperture is protected from tissue obstruction during advancement of the infusion member by a barrier coupled to the infusion member.

66. The apparatus of claim 54, wherein a proximal portion of the advancement member includes a handle.

67. The apparatus of claim 54, wherein the advancement member is a rod, a metal rod or a guide-wire.

68. The apparatus of claim 54, wherein a proximal portion of the infusion member includes at least one fitting configured to be coupled to at least one of a liquid, gas or vacuum source.

69. The apparatus of claim 54, wherein a proximal portion of the advancement member includes a handle.

70. The apparatus of claim 54, wherein the first lumen extends through to a distal end of the infusion member and the second lumen is closed at the distal end of the infusion lumen.

71. The apparatus of claim 54, further comprising a valve positioned at a proximal portion of the infusion member, the valve having an opening for insertion of an advancement member, the opening configured to tighten and form a fluidic seal around the advancement member.

72. The apparatus of claim 54, wherein the stop comprises a flange, a flange circumscribing a perimeter of the access device, or a pair of opposing flanges.

73. The apparatus of claim 54, wherein the stop includes at least one of a suture site or an adhesive surface portion, the adhesive surface portion having sufficient area to laterally stabilize the access device on the abdominal surface.

74. The apparatus of claim 54, wherein the infusion member is a catheter, a dual lumen catheter or a multi-lumen catheter.

75. The apparatus of claim 54, further comprising a sensor positioned at a distal portion of the infusion member or the access device.

76. The apparatus of claim 54, wherein the sensor is a temperature, pressure or flow sensor.

77. The apparatus of claim 54, wherein the sensor generates a signal indicating entry of a distal portion of the infusion member into the peritoneal cavity.

78. The apparatus of claim 54, wherein the signal is a pressure or a flow signal.

79. The apparatus of claim 54, further comprising a memory resource device coupled to the apparatus, the memory resource device including a control module for controlling the temperature and infusion and removal of fluid to and from the peritoneal cavity to produce a selected hypothermic profile to treat a medical condition, wherein the memory resource device interfaces with an external device.

80. The apparatus of claim 79, wherein the memory resource device is a flash memory device or a non-volatile memory device.

81. The apparatus of claim 79, wherein the external device is an external station or a temperature or flow control device.

82. The apparatus of claim 79, wherein the hypothermic profile includes a rate of cooling and a selected hypothermic temperature.

83. The apparatus of claim 79, wherein the hypothermic profile is configured to treat one of a coronary, cerebral or tissue extremity ischemic event.

84. An apparatus for accessing and introducing fluids into a peritoneal cavity of a patient for producing hypothermia, the apparatus comprising:

an access device configured to be inserted through the abdominal wall and into the peritoneal cavity, the device including a lumen, a proximal and distal end, the distal end having a tissue penetrating configuration and a non-tissue penetrating safety configuration;

the device transformable to the safety configuration upon penetration through an abdominal wall; and

an infusion member positionable within a lumen of the access device and advanceable into the peritoneal cavity, the infusion member including at least one lumen for the infusion or removal of fluid into or out of the peritoneal cavity;

the lumen sized to deliver sufficient fluid to the cavity to reduce patient body temperature by at least about 3°

C. through heat exchange with peritoneal tissue.

85. The apparatus of claim 84, wherein the at least one lumen comprises a first and a second lumen, the first lumen for infusion of fluid into the peritoneal cavity and the second lumen for removal of fluid from the cavity.

86. The apparatus of claim 85, wherein the infusion member includes at least one aperture positioned on a wall of the infusion member.

87. The apparatus of claim 86, wherein the at least one aperture opens to the second lumen.

88. The apparatus of claim 86, wherein the at least one aperture includes a plurality of apertures distributed along a distal portion of the infusion member.

89. The apparatus of claim 84, further comprising:

an advancement member removably positionable in the at least one lumen, the advancement member having sufficient column strength to advance the perfusion member into the peritoneal cavity from manipulation of a proximal portion of the advancement member.

90. The apparatus of claim 89, wherein a proximal portion of the advancement member includes a handle.

91. The apparatus of claim 89, wherein the advancement member has sufficient column strength to advance the infusion member through a closed distal end portion of the access device.

92. The apparatus of claim 84, further comprising a valve positioned at a proximal portion of the infusion member, the valve having an opening for insertion of an advancement member, the opening configured to tighten and form a fluidic seal around the advancement member.

93. The apparatus of claim 84, further comprising a stop positioned on an exterior surface of the access device, the stop configured to control a penetration depth of the access device into the peritoneal cavity.

94. The apparatus of claim 93, wherein the stop includes at least one of a suture site or an adhesive surface portion, the adhesive surface portion having sufficient area to laterally stabilize the access device on the abdominal surface.

95. The apparatus of claim 84, further comprising a sensor positioned at a distal portion of the infusion member or the access device.

96. The apparatus of claim 95, wherein the sensor is configured to provide an input for regulating fluid flow through the infusion member and detecting entry of the infusion member into the peritoneal cavity.

97. A system for producing hypothermia in a patient, the system comprising:

an access device configured to be inserted through the abdominal wall and into the peritoneal cavity, the device including a lumen, a proximal and distal end, the distal end having a tissue penetrating configuration and a non-tissue penetrating safety configuration;

an infusion member positionable within a lumen of the access device and advanceable into the peritoneal cavity, the infusion member including at least one lumen for the infusion or removal of fluid into or out of the peritoneal cavity;

a fluid reservoir operatively coupled to the infusion member;

a pressure source for delivering fluid from the reservoir through the infusion member and into the peritoneal cavity, the pressure source operatively coupled to the reservoir;

a vacuum source for removing fluid from the peritoneal cavity, the vacuum source operatively coupled to the infusion member;

at least one sensor operatively coupled to at least one of the pressure source, the vacuum source or the infusion member; and

a control unit for controlling the infusion of fluid into the peritoneal cavity, the control unit operatively coupled to at least one of the pressure source, the vacuum source, the infusion member or the at least one sensor.

98. The system of claim 97, wherein the access device is transformable to the safety configuration upon penetration through an abdominal wall.

99. The system of claim 97, wherein the infusion member is a catheter, a dual lumen catheter or a multi-lumen catheter.

100. The system of claim 97, wherein the at least one lumen includes a first lumen for the infusion of fluid into peritoneal cavity, and a second lumen for the removal of fluid from the cavity.

101. The system of claim 100, wherein the infusion member includes a plurality of apertures coupled to at least one of the first or the second lumens.

102. The system of claim 97, wherein the pressure source is a compressed gas source, an oxygen pressure source, a compressed oxygen source, a pump or a gravity generated pressure source.

103. The system of claim 97, wherein the pressure source is an oxygen pressure source configured to oxygenate fluid from the fluid reservoir.

104. The system of claim 103, further comprising an oxygenation device operatively coupled to an oxygen pressure source.

105. The system of claim 97, further comprising at least one valve operatively coupled to at least one of the infusion member, the pressure source, the vacuum source or the fluid reservoir.

106. The system of claim 105, wherein the at least one valve is operatively coupled to the control unit and one of the infusion member or the pressure source, the valve configured to control fluid flow into or from the peritoneal cavity, responsive to a signal from the control unit.

107. The system of claim 105, wherein the at least one valve is a control valve or an electronic control valve.

108. The system of claim 105, wherein the at least one valve is controlled in response to a signal from the at least one sensor

109. The apparatus of claim 97, wherein the sensor generates a signal indicating entry of a distal portion of the infusion member into the peritoneal cavity.

110. The system of claim 97, wherein the at least one sensor is a temperature sensor positioned on the infusion member and operatively coupled to the control unit, the sensor configured to measure at least one of a peritoneal cavity temperature or a temperature of fluid existing the infusion member.

111. The system of claim 97, wherein the at least one sensor is a temperature sensor positioned on a fluid reservoir and operatively coupled to the control unit.

112. The system of claim 105, wherein the at least one sensor is a pressure sensor positioned on the infusion member and operatively coupled to the control unit, the sensor configured to measure at least one of a pressure in the infusion member or a pressure in the peritoneal cavity.

113. The system of claim 105, further comprising a cooling device or a peltier cooling device operatively coupled to the fluid reservoir or the infusion member.

114. The system of claim 105, wherein the cooling device is a peltier device having a cooling surface operatively coupled to the fluid reservoir or the infusion member and a heat release surface operatively coupled to fluid that has existed from the peritoneal cavity.

115. The system of claim 105, wherein the control unit includes a software module for controlling the inflow and outflow of fluid from the peritoneal cavity.

116. The system of claim 105, wherein the module includes an inflow and outflow duty cycle algorithm.

117. The system of claim 105, wherein the duty cycle algorithm is configured to produce pulsatile inflow and outflow of fluid to enhance heat and gas exchange with peritoneal cavity tissue.

118. A system for delivering fluids to a tissue cavity of a patient, the system comprising:

a fluid reservoir configured to be coupled to an infusion member;

a pressure source for delivering fluid from the fluid reservoir through the infusion member and into the tissue cavity;

the pressure source operatively coupled to the reservoir;

a vacuum source for removing fluid from the cavity, the vacuum source configured to be coupled to the infusion member;

at least one sensor operatively coupled to at least one of the reservoir, the pressure source or the vacuum source; and

a control unit operatively coupled to at least one of the pressure source, the vacuum source or the at least one sensor and configured to be coupled to the infusion member, the control unit configured to control the infusion of fluid into the tissue cavity responsive to an input from the least one at least one sensor to control a temperature and pressure within the cavity for the delivery of a medical treatment utilizing at least one heat or mass transfer characteristic of the infused fluid.

119. The system of claim 118, wherein the at least one sensor is a pressure sensor or a temperature sensor.

120. The system of claim 118, wherein the treatment is a hypothermic or resuscitative treatment.

121. The system of claim 118, wherein the control unit is configured to signal an entry point of the infusion member into the tissue cavity and to