Implantable fluid management system for the removal of excess fluid

• US 20040147871A1
• Filed: 11/03/2003
• Published: 07/29/2004
• Est. Priority Date: 02/25/2002
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: NovaShunt AG (Sequana Medical NV)
• Inventors: Burnett, Daniel R.
• Granted Patent: US 7,311,690 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 2039/248 Ball-valve
• CPC Class Codes: A61M 2205/103 rotating
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2205/8287 operated by an external magnetic or electromagnetic field
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/101 Pleural cavity
• CPC Class Codes: A61M 2210/1017 Peritoneal cavity
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 2210/106 Small intestine
• CPC Class Codes: A61M 2210/1064 Large intestine
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 27/002 : Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 27/006 : Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/24 : Check- or non-return valves
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Claims

1. An implantable fluid management system, comprising:

a first tube member having a first end, a second end, and a length which defines a lumen therethrough and having at least one opening at the first end or along the length;

a second tube member having a first end, a second end, and a length which defines a lumen therethrough;

a pump fluidly coupled to the first tube member and the second tube member for urging fluid through each tube member; and

a shunt connected to the second end of the second tube member, wherein the shunt is adapted to anchor the second end of the second tube member to a wall of a hollow body organ in a fluid-tight seal.

2. The device of claim 1 wherein the first tube member and the second tube member are detachably coupled to the pump.

3. The device of claim 1 wherein the first tube member defines a plurality of openings along the length of the first tube member for passing fluid therethrough.

4. The device of claim 1 wherein the at least one opening comprises a screen positioned over the opening.

5. The device of claim 1 wherein the first and the second tube members each comprise flexible tube members.

6. The device of claim 1 further comprising at least one valve positioned within the first tube member.

7. The device of claim 6 wherein the valve is adapted to permit unidirectional fluid flow therethrough.

8. The device of claim 6 wherein the valve is adapted to open when a threshold pressure is attained or surpassed by the fluid.

9. The device of claim 6 wherein the valve is adapted to actuate upon receiving a signal from a remotely located controller.

10. The device of claim 1 wherein the pump comprises an electromechanical or magnetically coupled pump.

11. The device of claim 10 further comprising a driver for actuating the pump, the driver comprising at least one drive magnet rotatably positioned within a housing which defines a receiving channel adapted to circumferentially surround a corresponding magnet within the pump.

12. The device of claim 10 wherein the pump is adapted to urge the fluid when exposed to a magnetic field which corresponds to the pump.

13. The device of claim 10 wherein the pump comprises a type selected from the group consisting of peristaltic pumps, gear pumps, turbine pumps, impeller pumps, radial-flow pumps, centrifugal pumps, and piston pumps.

14. The device of claim 10 wherein the pump comprises at least two counter-rotating or counter-oscillating elements adapted to balance a net torquing force generated by the pump.

15. The device of claim 1 wherein the pump is adapted to be implanted within a subcutaneous space or musculature of a user.

16. The device of claim 1 wherein the pump is adapted to urge the fluid uni-directionally through the tube members.

17. The device of claim 1 wherein the pump is adapted to be remotely activated.

18. The device of claim 1 wherein the pump further comprises at least one sensor.

19. The device of claim 18 wherein the sensor is adapted to detect a magnetic engagement between the pump and a remotely located driver.

20. The device of claim 18 wherein the sensor is adapted to detect fluid flow rate and/or fluid pressure.

21. The device of claim 18 wherein the sensor further comprises a transmitter for transmitting sensed information to a remotely located receiver.

22. The device of claim 18 wherein the sensor is adapted to detect a fluid pressure from within the hollow body organ.

23. The device of claim 1 wherein the pump is adapted to actuate when a threshold pressure is attained or surpassed by the fluid.

24. The device of claim 1 wherein the pump is adapted to actuate upon receiving a signal from a remotely located controller.

25. The device of claim 1 wherein the pump is adapted to be secured within a patient.

26. The device of claim 25 wherein the pump is anchored within the patient via at least one fastener selected from the group consisting of barbs, screws, staples, sutures, adhesives, pins, tissue growth promoting materials, and combinations thereof.

27. The device of claim 1 further comprising a biocompatible housing encasing the pump.

28. The device of claim 27 further comprising a covering or coating adapted to promote fibrotic in-growth over the housing.

29. The device of claim 27 further comprising an anti-bacterial covering or coating selected from the group consisting of bacteriostatic materials, bacteriocidal materials, antibiotic dispensers, antibiotic eluting materials, entrained radioisotopes, heating elements, bioactive plastics, epithelialization-promoting materials, bacterial adhesion-inhibiting materials, and combinations thereof.

30. The device of claim 1 wherein the pump is adapted to prevent clogging within the pump via an ultrasonic transducer.

31. The device of claim 1 wherein the shunt is anchored to the wall of the hollow body organ via a mechanical fastener selected from the group consisting of flanges, screw threads, staples, sutures, adhesives, barbs, interstitial cell growth-promoting materials, and combinations thereof.

32. The device of claim 1 wherein the shunt is adapted for unidirectional flow therethrough into the hollow body organ.

33. The device of claim 32 wherein the shunt comprises a valve which is biased to close the shunt and open when the fluid surpasses a threshold pressure.

34. The device of claim 32 wherein the valve is a ball valve.

35. The device of claim 32 wherein the valve is actuatable via a remotely located controller.

36. The device of claim 1 wherein the shunt comprises an anti-bacterial covering or coating selected from the group consisting of bacteriostatic materials, bacteriocidal materials, antibiotic dispensers, antibiotic eluting materials, entrained radioisotopes, heating elements, bioactive plastics, epithelialization-promoting materials, bacterial adhesion-inhibiting materials, and combinations thereof.

37. The device of claim 1 further comprising a filter adapted to retain particulate matter within the fluid while permitting fluid flow therethrough.

38. The device of claim 36 wherein the filter comprises a semi-permeable membrane.

39. The device of claim 1 wherein the hollow body organ comprises a urinary bladder.

40. The device of claim 1 wherein the hollow body organ comprises a vein or artery.

41. The device of claim 1 wherein the hollow body organ comprises a stomach.

118. The method of claim 117, wherein the host is a human.

119. The method of claim 117, wherein the host is a non-human mammal.

42. A method of removing excess fluid from within a body space, comprising:

drawing the excess fluid through at least one opening defined in a first tube member which is positioned within the body space;

urging the fluid through the first tube member with an implanted electromechanical or magnetically coupled pump; and

passing the fluid through a second tube member in fluid communication with a urinary bladder.

43. The method of claim 42 wherein drawing the excess fluid comprises creating a negative pressure within the first tube member with the pump.

44. The method of claim 42 wherein drawing the excess fluid comprises drawing the fluid through a plurality of openings defined in the first tube member.

45. The method of claim 42 further comprising positioning the first tube member within a peritoneal cavity prior to drawing the excess fluid.

46. The method of claim 42 further comprising positioning the first tube member within a pleural cavity prior to drawing the excess fluid.

47. The method of claim 42 further comprising positioning the first tube member within a cerebrospinal region prior to drawing the excess fluid.

48. The method of claim 42 wherein drawing the excess fluid further comprises filtering the fluid.

49. The method of claim 42 wherein urging the fluid further comprises metering the fluid via a valve.

50. The method of claim 49 wherein metering the fluid comprises metering the fluid via a passive valve.

51. The method of claim 49 wherein metering the fluid comprises metering the fluid via an actively controlled valve.

52. The method of claim 42 wherein urging the fluid comprises uni-directionally forcing the fluid through the first tube member.

53. The method of claim 42 further comprising remotely actuating the pump via a corresponding driver prior to drawing the excess fluid.

54. The method of claim 53 wherein actuating the pump comprises exposing the pump to a magnetic field from the corresponding driver.

55. The method of claim 54 further comprising detecting whether magnetic engagement has occurred between the pump and the driver.

56. The method of claim 42 further comprising detecting a fluid flow rate and/or fluid pressure while urging the fluid.

57. The method of claim 42 further comprising transmitting sensed information from the fluid to a remotely located receiver while urging the fluid.

58. The method of claim 42 further comprising sensing whether a threshold pressure has been attained or surpassed by the fluid prior to drawing the excess fluid.

59. The method of claim 42 further comprising implanting the pump within a subcutaneous space or musculature of a user prior to drawing the excess fluid.

60. The method of claim 42 further comprising anchoring the second tube member to a wall of the urinary bladder via a shunt.

61. The method of claim 60 further comprising remotely controlling a valve to actuate within the shunt.

62. The method of claim 60 further comprising sensing a fluid pressure within the urinary bladder via the shunt.

63. The method of claim 60 further comprising filtering the fluid via the shunt.

64. An implantable fluid management device, comprising:

an electromechanical or magnetically coupled pump designed to increase fluid flow into the urinary bladder, having an inflow port and an outflow port, said pump being unidirectional in operation, whereby fluid flow from the inflow port to the outflow port is increased, and fluid flow from the outflow port to the inflow port is reduced;

an anchor, whereby such anchor stabilizes the pump;

a first tube, attachable to and in fluid communication with the inflow port of the. pump, whereby such first tube is capable of being placed at the desired site of fluid collection;

a second tube, attachable to and in fluid communication with the outflow port of the pump, whereby such first tube is capable of being placed into the urinary bladder;

a bladder-anchor, attached to the second tube, such that the second tube may be attached to the bladder, and may be in fluid communication with the interior of the bladder.

a transdermal communicator, whereby the pump can be externally monitored, controlled and/or powered;

sensors in communication with the lumen of the first and/or second tube capable of sensing changes in pressure or chemical composition.

65. An implantable fluid management device, comprising:

an electromechanical or magnetically coupled pump designed to increase fluid flow into the urinary bladder, having an inflow port and an outflow port, said pump being unidirectional in operation, whereby fluid flow from the inflow port to the outflow port is increased, and fluid flow from the outflow port to the inflow port is reduced.

66. An implantable fluid management device as recited in claim 65, further comprising a pump-anchor, attached to the pump, whereby such anchor stabilizes the pump during operation.

67. An implantable fluid management device as recited in claim 65, further comprising a valve, attached to and in fluid communication with the inflow port of the pump, whereby fluid flow from the pump to the outside environment through the inflow port is reduced.

68. An implantable fluid management device as recited in claim 65, further comprising a valve, attached to and in fluid communication with the outflow port of the pump, whereby fluid flow from outside environment into the pump through the outflow port is reduced.

69. An implantable fluid management device as recited in claim 65, wherein said pump is unidirectional, whereby the flow of fluid traveling from the outflow port to the inflow port is reduced.

70. An implantable fluid management device as recited in claim 65, further comprising:

a first tube, attachable to and in fluid communication with the inflow port of the pump, whereby such first tube is capable of being placed at the desired site of fluid collection;

a second tube, attachable to and in fluid communication with the outflow port of the pump, whereby such first tube is capable of being placed into the urinary bladder.

71. An implantable fluid management device as recited in claim 70, further comprising a tube-anchor, attached to the second tube.

72. An implantable fluid management device as recited in claim 70, further comprising a flange, attached to the second tube.

73. An implantable fluid management device as recited in claim 70, wherein said first tube is perforated.

74. An implantable fluid management device as recited in claim 70, further comprising a transdermal communicator, whereby the pump can be externally monitored, programmed, activated and/or powered.

75. An implantable fluid management device as recited in claim 70, further comprising sensors in communication with the lumen of the first and second tube capable of sensing changes in pressure.

76. An implantable fluid management device as recited in claim 70, further comprising sensors in communication with the lumen of the first and second tube capable of sensing chemical composition.

77. An implantable fluid management device as recited in claim 65, further comprising a tube, having a first and a second lumen, such first lumen being attached to and in fluid communication with the inflow port of the pump, and such second lumen being attached to and in fluid communication with the outflow port of the pump.

78. An implantable fluid management device as recited in claim 77, further comprising a tube-anchor, attached to the second lumen.

79. An implantable fluid management device as recited in claim 77, further comprising a flange attached to the tube.

80. An implantable fluid management device as recited in claim 77, wherein said first lumen is perforated.

107. A method for draining excess fluid into the bladder of a living host, comprising:

implanting the second tube of the device of claim 70 into the wall of the bladder, whereby the second tube is in fluid communication with the interior of the bladder;

implanting the first tube of the device of claim 70 into the region to be drained;

operating the pump to drain fluid from the region to be drained into the bladder.

108. The method of claim 107, wherein the region to be drained is the pleural cavity.

109. The method of claim 107, wherein the region to be drained is the cerebrospinal cavity.

110. The method of claim 107, wherein the region to be drained is the peritoneal cavity.

111. The method of claim 107, wherein the host is a human.

112. The method of claim 107, wherein the host is a non-human mammal.

113. The method of claim 107, wherein the host is equine.

114. The method of claim 107, wherein the host is bovine.

115. The method of claim 107, wherein the host is feline.

116. The method of claim 107, wherein the host is canine.

117. A method for draining excess peritoneal fluid into the bladder of a living host, comprising:

implanting the second lumen of the tube of the device of claim 70 into the wall of the bladder, whereby the second lumen is in fluid communication with the interior of the bladder;

operating the pump to drain fluid from the region to be drained into the bladder.

120. The method of claim 117, wherein the host. is equine.

121. The method of claim 117, wherein the host is bovine.

122. The method of claim 117, wherein the host is feline.

123. The method of claim 117, wherein the host is canine.

81. An implantable fluid management device for draining bodily fluids, comprising:

a pump, having an inflow port and an outflow port;

a means for actuating the pump;

a means for conveying fluid to the pump.

82. An implantable fluid management device as recited in claim 81, further comprising a means for conveying fluid from the pump to the bladder.

83. An implantable fluid management device as recited in claim 81, wherein said means for conveying fluid to the pump is a tube.

84. An implantable fluid management device as recited in claim 81, wherein said means for conveying fluid to the pump is a flexible tube.

85. An implantable fluid management device as recited in claim 81, wherein said means for conveying fluid to the pump is a catheter.

86. An implantable fluid management device as recited in claim 82, wherein said means for conveying fluid from the pump to the bladder is a tube.

87. An implantable fluid management device as recited in claim 82, wherein said means for conveying fluid from the pump to the bladder is a flexible tube.

88. An implantable fluid management device as recited in claim 82, wherein said means for conveying fluid from the pump to the bladder is a catheter.

89. An implantable fluid management device as recited in claim 81, further comprising a means for preventing the passage of solids through the means for conveying fluid to the pump.

90. An implantable fluid management device as recited in claim 89, wherein said means for preventing the passage of solids through the means for conveying fluid to the pump is a series of perforations.

91. An implantable fluid management device as recited in claim 89, wherein said means for preventing the passage of solids through the means for conveying fluid to the pump is a mesh.

92. An implantable fluid management device as recited in claim 81, further comprising a means for stabilizing the pump.

93. An implantable fluid management device as recited in claim 92, wherein said means for stabilizing the pump is a screw.

94. An implantable fluid management device as recited in claim 92, wherein said means for stabilizing the pump is a suture.

95. An implantable fluid management device as recited in claim 92, wherein said means for stabilizing the pump is a flange.

96. An implantable fluid management device as recited in claim 92, wherein said means for stabilizing the pump is a porous solid promoting interstitial cell growth.

97. An implantable fluid management device as recited in claim 81, further comprising an anti-infective means.

98. An implantable fluid management device as recited in claim 97, wherein said anti-infective means is a surface which encourages epithelialization.

99. An implantable fluid management device as recited in claim 97, wherein said anti-infective means is a bacteriocidal material.

100. An implantable fluid management device as recited in claim 97, wherein said anti-infective means is one or more antibiotic dispensers.

101. An implantable fluid management device as recited in claim 97, wherein said anti-infective means is an entrained radioisotope.

102. An implantable fluid management device as recited in claim 81, further comprising an anti-clogging means.

103. An implantable fluid management device as recited in claim 102, wherein said anti-clogging means is an active ultrasound component.

104. An implantable fluid management device as recited in claim 102, wherein said anti-clogging means is an inner and outer lumen.

105. An implantable fluid management device as recited in claim 102, wherein said anti-clogging means is a surface which promotes epithelialization.

106. An implantable fluid management device as recited in claim 102, wherein said anti-clogging means is an enzyme eluting material.

124. A method of removing excess fluid from within a body space, comprising:

drawing the excess fluid through at least one opening defined in a first tube member which is positioned within the body space;

urging the fluid through the first tube member with an implanted electromechanical or magnetically coupled pump; and

passing the fluid through a second tube member in fluid communication with a vein or artery.

125. The method of claim 124 wherein drawing the excess fluid comprises drawing the fluid through a plurality of openings defined in the first tube member.

126. The method of claim 124 further comprising positioning the first tube member within a peritoneal cavity prior to drawing the excess fluid.

127. The method of claim 124 wherein urging the fluid further comprises metering the fluid via a valve.

128. The method of claim 127 wherein metering the fluid comprises metering the fluid via a passive valve.

129. The method of claim 127 wherein metering the fluid comprises metering the fluid via an actively controlled valve.

130. The method of claim 124 wherein urging the fluid comprises uni-directionally forcing the fluid through the first tube member.

131. The method of claim 124 further comprising remotely actuating the pump via a corresponding driver prior to drawing the excess fluid.

132. The method of claim 124 further comprising anchoring the second tube member to a wall of the vein or artery via a shunt.

133. A method of removing excess fluid from within a body space, comprising:

drawing the excess fluid through at least one opening defined in a first tube member which is positioned within the body space;

urging the fluid through the first tube member with an implanted electromechanical or magnetically coupled pump; and

passing the fluid through a second tube member in fluid communication with a stomach.

134. The method of claim 133 wherein drawing the excess fluid comprises drawing the fluid through a plurality of openings defined in the first tube member.

135. The method of claim 133 further comprising positioning the first tube member within a peritoneal cavity prior to drawing the excess fluid.

136. The method of claim- 133 wherein urging the fluid further comprises metering the fluid via a valve.

137. The method of claim 136 wherein metering the fluid comprises metering the fluid via a passive valve.

138. The method of claim 136 wherein metering the fluid comprises metering the fluid via an actively controlled valve.

139. The method of claim 133 wherein urging the fluid comprises uni-directionally forcing the fluid through the first tube member.

140. The method of claim 133 further comprising remotely actuating the pump via a corresponding driver prior to drawing the excess fluid.

141. The method of claim 133 further comprising anchoring the second tube member to a wall of the vein or artery via a shunt.