Title:
Blood component processing system, apparatus, and method
Document Type and Number:
Kind Code:
A1

Abstract:
A system and method are used in connection with processing of blood components. The processing of blood components may involve centrifugal separation and/or filtering of the blood components. In some examples, at least some blood components are centrifugally separated in a chamber and then filtered via a filter rotating along with a centrifuge rotor, wherein the filter is located closer than the chamber to an axis of rotation of the rotor. The filter may include a porous filtration medium configured to filter leukocytes, platelets, and/or red blood cells. Some examples include a pressure sensor sensing pressure of pumped blood components. The sensed pressure may be used in connection with controlling the pumping of the blood products and/or in connection with determining the location of an interface associated with the blood products. Other uses of the sensed pressure are also possible.

Representative Image:
Inventors:
Hogberg, Niclas (Karlskoga, SE)
Hallgren, Emanuel (Karlskoga, SE)
Pihlstedt, Peter (Stockholm, SE)
Holmes, Brian M. (Lakewood, CO, US)
Persson, Lars (Askersund, SE)
Strandberg, Lars (Gavle, SE)
Van Waeg, Geert (Brussels, BE)
Frank III, Null Corbin (Littleton, CO, US)
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Application Number:
10/414475
Publication Date:
02/12/2004
Filing Date:
04/16/2003
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Primary Class:
International Classes:
(IPC1-7): B04B003/00
Attorney, Agent or Firm:
Garrett & Dunner, L.L.P.,Finnegan, Henderson, Farabow (1300 I Street, N.W., Washington, DC, 20005-3315, US)
Claims:

What is claimed is:



1. A system for processing blood components, the system comprising: a separation chamber comprising a chamber interior in which blood components are centrifugally separated, and an outlet port for passing at least some of the centrifugally separated blood components from the chamber interior; a flow path in flow communication with the outlet port of the separation chamber; a filter comprising a filter inlet in flow communication with the flow path, a porous filtration medium configured to filter at least some of at least one blood component from centrifugally separated blood components passed to the filter via the flow path, and a filter outlet for filtered blood components; and a centrifuge rotor configured to be rotated about an axis of rotation, the rotor comprising a first portion configured to receive the separation chamber and a second portion configured to receive the filter, wherein the first and second portions are positioned with respect to one another so that when the separation chamber is received in the first portion and the filter is received in the second portion, the filter is closer than the interior of the separation chamber to the axis of rotation, wherein the system is configured so that the rotor rotates during filtering of at least some of said at least one blood component via the filter.

2. The system of claim 1, wherein the system is configured so that when the filter is received in the second portion, the filter is eccentric with respect to the axis of rotation.

3. The system of claim 2, wherein the system is configured so that when the filter is received in the second portion, the filter is at least close to the axis of rotation and wherein the axis of rotation does not intersect an interior flow path defined by the filter.

4. The system of claim 2, wherein the filter comprises a filter housing inflow port and a filter housing outflow port, and wherein the system is configured so that when the filter is received in the second portion, the filter housing outflow port is located closer than the filter housing inflow port to the axis of rotation.

5. The system of claim 2, wherein the system is configured so that when the filter is received in the second portion, the filter housing outflow port is closer than the porous filtration medium to the axis of rotation.

6. The system of claim 2, wherein the system is configured so that when the filter is received in the second portion, the filter housing outflow port is above the filter housing inflow port.

7. The system of claim 2, wherein the filter comprises a filter housing defining an interior space containing the porous filtration medium, wherein the filter inlet and filter outlet are in flow communication with the interior space, and wherein the system is configured so that when the filter is received in the second portion, the filter is positioned so that blood components flow in the interior space in a direction facing generally toward the axis of rotation.

8. The system of claim 7, wherein the filter housing defines a filter housing inflow port for passing blood components to the interior space and a filter housing outflow port for passing blood components from the interior space, and wherein the system is configured so that when the filter is received in the second portion, the filter housing outflow port is closer than the filter housing inflow port to the axis of rotation.

9. The system of claim 7, wherein the filter housing defines a filter housing inflow port for passing blood components to the interior space and a filter housing outflow port for passing blood components from the interior space, and wherein the system is configured so that when the filter is received in the second portion, the filter housing outflow port is closer than the porous filtration medium to the axis of rotation.

10. The system of claim 7, wherein the filter housing defines a filter housing inflow port for passing blood components to the interior space and a filter housing outflow port for passing blood components from the interior space, and wherein the system is configured so that when the filter is received in the second portion, the filter housing outflow port is above the filter housing inflow port.

11. The system of claim 1, wherein the second portion comprises at least one of a ledge and a slot configured to receive the filter, the at least one of a ledge and a slot being positioned under a top surface of the rotor.

12. The system of claim 1, wherein the rotor comprises a holder configured to hold the filter with respect to the rotor.

13. The system of claim 1, wherein the flow path comprises a first tubing portion having one end coupled to the outlet port of the separation chamber and another end coupled to the filter inlet, and wherein the system further comprises a second tubing portion having an end coupled to the filter outlet, wherein the second tubing portion extends in a direction facing generally away from the axis of rotation.

14. The system of claim 13, further comprising a third tubing portion downstream from the second tubing portion, wherein the third tubing portion extends in a direction facing generally toward the axis of rotation.

15. The system of claim 14, wherein the rotor comprises a groove configured to receive at least some of the second and third tubing portions.

16. The system of claim 1, wherein the system further comprises a collection container comprising an inlet in flow communication with the filter outlet, and wherein the second portion of the rotor comprises a cavity configured to receive the filter and the collection container.

17. The system of claim 1, wherein the axis of rotation extends through the second portion of the rotor.

18. The system of claim 1, wherein the chamber is configured so that the chamber interior has a variable volume.

19. The system of claim 1, wherein the separation chamber comprises a blood component separation bag.

20. The system of claim 19, wherein at least a portion of the blood component separation bag is formed of at least one of flexible and semi-rigid material so that the chamber interior has a variable volume.

21. The system of claim 19, wherein the bag has a generally annular ring shape defining a central opening.

22. The system of claim 19, wherein the chamber interior includes a tapered portion leading to the outlet port.

23. The system of claim 1, wherein the system comprises a tubing line having an end coupled to the filter outlet, and wherein the rotor comprises at least one support member configured to support the separation chamber, wherein the at least one support member comprises a guide groove configured to receive a portion of the tubing line and at least one of a controllable clamp and a welder associated with the groove.

24. The system of claim 23, wherein the separation chamber comprises at least one guide hole configured to receive the at least one support member.

25. The system of claim 1, wherein the rotor comprises a plurality of support members located in an asymmetric fashion with respect to the axis of rotation, and wherein the separation chamber comprises a plurality of guide holes, each of the guide holes being configured to receive a respective one of the support members.

26. The system of claim 1, wherein the separation chamber has a ring shape.

27. The system of claim 1, further comprising at least one valving member on the centrifuge rotor, the valving member being configured to control flow of at least some of the blood components during rotation of the rotor.

28. The system of claim 27, wherein the valving member comprises a tubing clamp.

29. The system of claim 1, further comprising at least one sealing member on the centrifuge rotor, the sealing member being configured to create a seal during rotation of the rotor.

30. The system of claim 29, wherein the sealing member comprises a tubing welder.

31. The system of claim 1, further comprising a pump configured to pump at least some of the centrifugally separated blood components from the chamber to the filter via the flow path.

32. The system of claim 31, wherein the system is configured so that the pump pumps blood components from the chamber during rotation of the centrifuge rotor.

33. The system of claim 31, wherein the chamber is configured so that the chamber interior has a variable volume, and wherein the pump is configured to reduce the volume of the chamber interior.

34. The system of claim 33, wherein the pump is configured to apply pressure to the chamber via hydraulic fluid.

35. The system of claim 34, further comprising a sensor configured to sense pressure of pumped blood components, wherein the sensor senses pressure of the hydraulic fluid.

36. The system of claim 31, further comprising a sensor configured to sense pressure of pumped blood components, wherein the system is configured to control the pump based on at least the pressure sensed by the pressure sensor.

37. The system of claim 36, wherein the system is configured to calculate a difference between pressures sensed by the pressure sensor in at least one time interval, determine when the calculated difference is at least a predetermined amount, and control the pump in response to at least the determination that the calculated difference is at least the predetermined amount.

38. The system of claim 36, further comprising an optical sensor, wherein the system is configured to control the pump based on at least information sensed by the optical sensor and pressure sensed by the pressure sensor.

39. A method of processing blood components, comprising: providing the system of claim 1; placing the separation chamber in the first portion of the rotor and the filter in the second portion of the rotor, wherein the filter is located closer than an interior of the separation chamber to the axis of rotation of the rotor; rotating the centrifuge rotor, the separation chamber, and the filter about the axis of rotation of the centrifuge rotor, wherein blood components are centrifugally separated in the chamber interior; removing at least some of the centrifugally separated blood components from the separation chamber via the outlet port; and filtering the removed blood components with the filter so as to filter at least some of at least one blood component from the removed blood components, wherein at least a portion of the filtering occurs during said rotating.

40. A method of processing blood components, comprising: placing a separation chamber in a first portion of a centrifuge rotor and a filter in a second portion of the rotor, wherein the filter is located closer than an interior of the separation chamber to an axis of rotation of the centrifuge rotor, and wherein the filter comprises a porous filtration medium; rotating the centrifuge rotor, the separation chamber, and the filter about the axis of rotation, wherein blood components are centrifugally separated in a chamber interior of the separation chamber; removing at least some of the centrifugally separated blood components from the separation chamber via an outlet port of the separation chamber; and filtering the removed blood components with the filter so as to filter at least some of at least one blood component from the removed blood components, wherein at least a portion of the filtering occurs during said rotating.

41. The method of claim 40, wherein the method further comprises passing the filtered blood components into at least one collection container.

42. The method of claim 40, wherein the blood components in the separation chamber are blood components of a buffy coat.

43. The method of claim 40, wherein whole blood is processed in the method.

44. The method of claim 40, wherein the filter comprises a filter housing defining an interior space containing the porous filtration medium, and wherein the method comprises flowing blood components in the interior space in a direction facing generally toward the axis of rotation.

45. The method of claim 40, further comprising causing at least one valving member on the centrifuge rotor to control flow of at least some of the blood components during rotation of the rotor.

46. The method of claim 45, wherein the valving member comprises a tubing clamp.

47. The method of claim 40, further comprising causing at least one sealing member on the centrifuge rotor to create a seal during rotation of the rotor.

48. The method of claim 47, wherein the sealing member comprises a tubing welder.

49. The method of claim 40, further comprising pumping at least some of the centrifugally separated blood components from the chamber to the filter.

50. The method of claim 49, wherein the pumping occurs during rotation of the centrifuge rotor.

51. The method of claim 49, wherein the pumping comprises reducing the volume of an interior of the chamber.

52. The method of claim 51, further comprising applying pressure to the chamber via hydraulic fluid.

53. The method of claim 49, further comprising sensing pressure of pumped blood components, and controlling the pumping based on at least the sensed pressure.

54. The method of claim 53, further comprising calculating a difference between pressures sensed in at least one time interval, determining when the calculated difference is at least a predetermined amount, and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.

55. The method of claim 53, further comprising optically sensing the pumped blood products, and controlling the pumping based on at least one of optically sensed information and sensed pressure.

56. An apparatus for use with a centrifuge for processing blood components, the apparatus comprising: a separation chamber comprising a chamber interior in which blood components are centrifugally separated, and an outlet port for passing at least some of the centrifugally separated blood components from the chamber interior; a flow path in flow communication with the outlet port of the separation chamber; and a filter comprising a filter inlet in flow communication with the flow path, a porous filtration medium configured to filter at least some of at least one blood component from centrifugally separated blood components passed to the filter via the flow path, and a filter outlet for filtered blood components, wherein the centrifuge for use with the apparatus comprises a rotor configured to be rotated about an axis of rotation, the rotor comprising a first portion configured to receive the separation chamber and a second portion configured to receive the filter, wherein the first and second portions are positioned with respect to one another so that when the separation chamber is received in the first portion and the filter is received in the second portion, the filter is closer than the interior of the separation chamber to the axis of rotation, and wherein the centrifuge is configured so that the rotor rotates during filtering of at least some of said at least one blood component via the filter.

57. The apparatus of claim 56, wherein the apparatus further comprises a collection container comprising an inlet in flow communication with the filter outlet, and wherein the second portion of the rotor comprises a cavity configured to receive the filter and the collection container.

58. The system of claim 56, wherein the chamber is configured so that the chamber interior has a variable volume.

59. The apparatus of claim 56, wherein the separation chamber comprises a blood component separation bag.

60. The apparatus of claim 59, wherein at least a portion of the blood component separation bag is formed of at least one of flexible and semi-rigid material so that the chamber interior has a variable volume.

61. The apparatus of claim 59, wherein the bag has a generally annular ring shape defining a central opening.

62. The apparatus of claim 59, wherein the chamber interior includes a tapered portion leading to the outlet port.

63. The apparatus of claim 56, wherein the separation chamber comprises at least one guide hole configured to receive at least one support member of the centrifuge.

64. The apparatus of claim 56, wherein the rotor comprises a plurality of support members located in an asymmetric fashion with respect to the axis of rotation, and wherein the separation chamber comprises a plurality of guide holes, each of the guide holes being configured to receive a respective one of the support members.

65. The apparatus of claim 56, wherein the apparatus is configured to be disposed after being used for processing of blood components from a single donor.

66. The apparatus of claim 56, wherein the separation chamber has a ring shape.

67. A system for processing blood components, comprising: a chamber comprising an interior configured to contain separated blood components, and an outlet port for passing at least some of the separated blood components from the interior; a flow path in flow communication with the outlet port of the chamber; a filter comprising a filter inlet in flow communication with the flow path, a porous filtration medium configured to filter at least some of at least one blood component from separated blood components passed to the filter via the flow path, and a filter outlet for filtered blood components; a pump configured to pump at least some of the separated blood components from the chamber to the filter via the flow path; and a pressure sensor configured to sense pressure of blood components pumped to the filter, wherein the system is configured to control the pump based on at least the pressure sensed by the pressure sensor.

68. The system of claim 67, wherein the pump comprises a portion of a centrifuge.

69. The system of claim 67, wherein the pump comprises at least a portion of a blood component expresser.

70. The system of claim 67, wherein the chamber comprises a separation chamber, wherein blood components are centrifugally separated in the interior of the container, and wherein the system further comprises a centrifuge rotor configured to be rotated about an axis of rotation, the rotor comprising a portion configured to receive the chamber.

71. The system of claim 70, wherein the system is configured so that the pump pumps blood components from the chamber during rotation of the centrifuge rotor.

72. The system of claim 70, further comprising at least one valving member on the centrifuge rotor, the valving member being configured to control flow of at least some of the blood components during rotation of the rotor.

73. The system of claim 72, wherein the valving member comprises a tubing clamp.

74. The system of claim 70, further comprising at least one sealing member on the centrifuge rotor, the sealing member being configured to create a seal during rotation of the rotor.

75. The system of claim 74, wherein the sealing member comprises a tubing welder.

76. The system of claim 70, wherein the rotor further comprises a portion configured to receive the filter, and wherein the system is configured so that the rotor rotates during filtering via the filter.

77. The system of claim 76, wherein the filter comprises a filter housing defining an interior space containing the porous filtration medium, wherein the system is configured so that when the filter is received in the portion of the rotor configured to receive the filter, the filter is positioned so that blood components flow in the interior space in a direction facing generally toward the axis of rotation.

78. The system of claim 67, wherein the chamber comprises a bag formed of at least one of flexible and semi-rigid material so that the interior of the chamber has a variable volume.

79. The system of claim 78, wherein the bag has a generally annular shape defining a central opening.

80. The system of claim 67, wherein the chamber is configured so that the interior of the chamber has a variable volume.

81. The system of claim 80, wherein the pump is configured to reduce the volume of the chamber interior.

82. The system of claim 81, wherein the pump is configured to apply pressure to the chamber via hydraulic fluid.

83. The system of claim 82, wherein the sensor senses pressure of the hydraulic fluid.

84. The system of claim 67, wherein the system is configured to calculated a difference between pressures sensed by the pressure sensor in at least one time interval where blood components are pumped by the pump, determine when the calculated difference is at least a predetermined amount, and control the pump in response to at least the determination that the calculated difference is at least the predetermined amount.

85. The system of claim 67, further comprising an optical sensor, wherein the system is configured to control the pump based on at least information sensed by the optical sensor and pressure sensed by the pressure sensor.

86. The system of claim 85, wherein said optical sensor is positioned to sense blood components in the chamber.

87. The system of claim 85, wherein said optical sensor is positioned to sense blood components in a tubing line in flow communication with the filter.

88. The system of claim 85, wherein said optical sensor comprises a first optical sensor and a second optical sensor, the first optical sensor being positioned to sense blood components in the chamber and the second optical sensor being positioned to sense blood components in a tubing line in flow communication with the filter.

89. A method of processing blood components, comprising: providing the system of claim 67; pumping, via the pump, at least some of the separated blood components from the chamber; filtering the pumped blood components with the filter so as to filter at least some of at least one blood component from the pumped blood components; sensing, via the pressure sensor, pressure of blood components pumped to the filter; and controlling the pumping based on at least the pressure sensed by the pressure sensor.

90. A method of processing blood components, comprising: pumping at least some separated blood components from a chamber; filtering the pumped blood components with a filter so as to filter at least some of at least one blood component from the pumped blood components, wherein the filter comprises a porous filtration membrane; sensing pressure of blood components pumped to the filter; and controlling the pumping based on at least the pressure sensed by the pressure sensor.

91. The method of claim 90, further comprising rotating the chamber about an axis of rotation, wherein blood components are centrifugally separated in an interior of the chamber.

92. The method of claim 91, wherein the pumping occurs during rotation of the chamber.

93. The method of claim 91, wherein a centrifuge is used to rotate the chamber, and wherein said at least some separated blood components are pumped from the chamber while the chamber is received on a rotor of the centrifuge.

94. The method of claim 93, further comprising causing at least one valving member on the centrifuge rotor to control flow of at least some of the blood components during rotation of the rotor.

95. The method of claim 94, wherein the valving member comprises a tubing clamp.

96. The method of claim 93, further comprising causing at least one sealing member on the centrifuge rotor to create a seal during rotation of the rotor.

97. The method of claim 96, wherein the sealing member comprises a tubing welder.

98. The method of claim 91, wherein a centrifuge is used to rotate the chamber, and wherein said at least some separated blood components are pumped from the chamber after the chamber is removed from a rotor of the centrifuge.

99. The method of claim 90, further comprising rotating the filter about an axis of rotation during the filtering.

100. The method of claim 99, wherein the filter comprises a filter housing defining an interior space containing the porous filtration medium, and wherein the method comprises flowing blood components in the interior space in a direction facing generally toward the axis of rotation.

101. The method of claim 90, wherein the chamber is configured so that an interior of the chamber has a variable volume, and wherein the pumping comprises reducing the volume of the interior of the chamber.

102. The method of claim 101, further comprising applying pressure to the chamber via hydraulic fluid.

103. The method of claim 90, further comprising calculating a difference between pressures sensed in at least one time interval, determining when the calculated difference is at least a predetermined amount, and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.

104. The method of claim 90, further comprising optically sensing the pumped blood products, and controlling the pumping based on at least one of optically sensed information and sensed pressure.

105. The method of claim 104, wherein optically sensing comprises optically sensing blood components in the chamber.

106. The method of claim 104, wherein optically sensing comprises optically sensing blood components in a tubing line in flow communication with the filter.

107. The method of claim 104, wherein optically sensing comprises optically sensing blood components in the chamber and optically sensing blood components in a tubing line in flow communication with the filter.

108. The method of claim 90, wherein the method further comprises passing the filtered blood components into at least one collection container.

109. The method of claim 90, wherein the blood components in the chamber are blood components of a buffy coat.

110. The method of claim 90, wherein whole blood is processed in the method.

111. A system for processing blood components, comprising: a separation chamber comprising a chamber interior in which blood components are centrifugally separated, and an outlet port for passing at least some of the centrifugally separated blood components from the chamber interior; a flow path in flow communication with the outlet port of the separation chamber; a pump configured to pump at least some of the centrifugally separated blood components from the chamber and through the flow path; and a pressure sensor configured to sense pressure of blood components pumped by the pump; and a centrifuge rotor configured to be rotated about an axis of rotation, the rotor comprising a portion configured to receive the separation chamber, wherein the system is configured to calculate a difference between pressures sensed by the pressure sensor in at least one time interval, determine when the calculated difference is at least a predetermined amount, and control the pump in response to at least the determination that the calculated difference is at least the predetermined amount.

112. The system of claim 111, wherein the system is configured so that the pump pumps blood components from the chamber during rotation of the centrifuge rotor.

113. The system of claim 111, further comprising at least one valving member on the centrifuge rotor, the valving member being configured to control flow of at least some of the blood components during rotation of the rotor.

114. The system of claim 113, wherein the valving member comprises a tubing clamp.

115. The system of claim 111, further comprising a sealing member on the centrifuge rotor, the sealing member being configured to create a seal during rotation of the rotor.

116. The system of claim 115, wherein the sealing member comprises a tubing welder.

117. The system of claim 111, further comprising a filter comprising a porous filtration membrane configured to filter at least one blood component from the pumped blood products.

118. The system of claim 111, wherein the chamber comprises a bag formed of at least one of flexible and semi-rigid material so that the interior of the chamber has a variable volume.

119. The system of claim 118, wherein the bag has a generally annular shape defining a central opening.

120. The system of claim 111, wherein the chamber is configured so that the chamber interior has a variable volume,

121. The system of claim 120, wherein the pump is configured to reduce the volume of the chamber interior.

122. The system of claim 121, wherein the pump is configured to apply pressure to the chamber via hydraulic fluid.

123. The system of claim 122, wherein the sensor senses pressure of the hydraulic fluid.

124. The system of claim 111, further comprising an optical sensor, wherein the system is configured to control the pump based on at least information sensed by the optical sensor and pressure sensed by the pressure sensor.

125. The system of claim 124, wherein said optical sensor is positioned to sense blood components in the chamber.

126. The system of claim 124, wherein said optical sensor is positioned to sense blood components in a tubing line in flow communication with the filter.

127. The system of claim 124, wherein said optical sensor comprises a first optical sensor and a second optical sensor, the first optical sensor being positioned to sense blood components in the chamber and the second optical sensor being positioned to sense blood components in a tubing line associated with the flow path.

128. A method of processing blood components, comprising: providing the system of claim 111; rotating the centrifuge rotor and the chamber about the axis of rotation, wherein blood components are centrifugally separated in the chamber; pumping, via the pump, at least some separated blood components from the chamber; sensing, via the pressure sensor, pressure of pumped blood components; calculating a difference between pressures sensed in at least one time interval; determining when the calculated difference is at least a predetermined amount; and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.

129. A method of processing blood components, comprising: rotating a chamber about an axis of rotation, wherein blood components are centrifugally separated in the chamber; pumping at least some separated blood components from the chamber; sensing pressure of pumped blood components; calculating a difference between pressures sensed in at least one time interval; determining when the calculated difference is at least a predetermined amount; and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.

130. The method of claim 129, wherein the pumping occurs during rotation of the chamber.

131. The method of claim 129, wherein the chamber is rotated via a centrifuge rotor, and wherein the method further comprises causing at least one valving member on the centrifuge rotor to control flow of at least some of the blood components during rotation of the rotor.

132. The method of claim 131, wherein the valving member comprises a tubing clamp.

133. The method of claim 129, wherein the chamber is rotated via a centrifuge rotor, and wherein the method further comprises causing at least one sealing member on the centrifuge rotor to create a seal during rotation of the rotor.

134. The method of claim 133, wherein the sealing member comprises a tubing welder.

135. The method of claim 129, further comprising filtering the pumped blood components with a filter so as to filter at least some of at least one blood component from the pumped blood components, wherein the filter comprises a porous filtration membrane.

136. The method of claim 135, wherein the rotating further comprises rotating the filter about the axis of rotation.

137. The method of claim 136, wherein the filter comprises a filter housing defining an interior space containing the porous filtration medium, and wherein the method comprises flowing blood components in the interior space in a direction facing generally toward the axis of rotation.

138. The method of claim 129, wherein the chamber is configured so that an interior of the chamber has a variable volume, and wherein the pumping comprises reducing the volume of the interior of the chamber.

139. The method of claim 138, further comprising applying pressure to the chamber via hydraulic fluid.

140. The method of claim 129, further comprising optically sensing the pumped blood products, and controlling the pump based on at least one of optically sensed information and sensed pressure.

141. The method of claim 140, wherein optically sensing comprises optically sensing blood components in the chamber.

142. The method of claim 140, wherein optically sensing comprises optically sensing blood components in a tubing line in flow communication with the filter.

143. The method of claim 140, wherein optically sensing comprises optically sensing blood components in the chamber and optically sensing blood components in a tubing line.

144. The method of claim 129, wherein the method further comprises passing at least some of the pumped blood components into at least one collection container.

145. The method of claim 129, wherein the blood components in the chamber are blood components of a buffy coat.

146. The method of claim 129, wherein whole blood is processed in the method.

147. A method of determining a location of at least one interface during processing of blood components, comprising: pumping at least some centrifugally separated blood components from a chamber; sensing pressure of the pumped blood components; and determining a location of at least one interface based on the sensed pressure, wherein the interface is associated with the pumped blood components.

148. The method of claim 147, wherein the interface comprises at least one of an interface between blood components and air, and an interface between differing blood components.

149. The method of claim 147, further comprising rotating a chamber about an axis of rotation, wherein blood components are centrifugally separated in the chamber.

150. The method of claim 149, wherein the pumping occurs during rotation of the chamber.

151. The method of claim 149, wherein the chamber is rotated via a centrifuge rotor, and wherein the method further comprises causing at least one valving member on the centrifuge rotor to control flow of at least some of the blood components during rotation of the rotor.

152. The method of claim 151, wherein the valving member comprises a tubing clamp.

153. The method of claim 149, wherein the chamber is rotated via a centrifuge rotor, and wherein the method further comprises causing at least one sealing member on the centrifuge rotor to create a seal during rotation of the rotor.

154. The method of claim 153, wherein the sealing member comprises a tubing welder.

155. The method of claim 149, further comprising filtering pumped blood components with a filter so as to filter at least some of at least one blood component from the pumped blood components, wherein the filter comprises a porous filtration membrane.

156. The method of claim 155, wherein the rotating further comprises rotating the filter about the axis of rotation.

157. The method of claim 156, wherein the filter comprises a filter housing defining an interior space containing the porous filtration medium, and wherein the method comprises flowing blood components in the interior space in a direction facing generally toward the axis of rotation.

158. The method of claim 147, further comprising filtering pumped blood components with a filter so as to filter at least some of at least one blood component from the pumped blood components, wherein the filter comprises a porous filtration membrane.

159. The method of claim 147, wherein the chamber is configured so that an interior of the chamber has a variable volume, and wherein the pumping comprises reducing the volume of the interior of the chamber.

160. The method of claim 159, further comprising applying pressure to the chamber via hydraulic fluid.

161. The method of claim 147, further comprising optically sensing the pumped blood products, and wherein the location of the location of the at least one interface is based on the sensed pressure and optically sensed information.

162. The method of claim 147, wherein the blood components in the chamber are blood components of a buffy coat.

163. The method of claim 147, wherein whole blood is processed in the method.

Description:

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) of the following U.S. provisional patent applications: No. 60/373,083, filed Apr. 16, 2002, and No. 60/405,667, filed Aug. 23, 2002.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to a system, apparatus, and method for processing components of blood. In particular, some aspects of the invention relate to processing blood components through the use of centrifugal separation, filtration, and/or any other form of processing.

[0004] 2. Description of the Related Art

[0005] Whole blood consists of various liquid components and particle components. The liquid portion of blood is largely made up of plasma, and the particle components include red blood cells (erythrocytes), white blood cells (leukocytes), and platelets (thrombocytes). While these constituents have similar densities, their average density relationship, in order of decreasing density, is as follows: red blood cells, white blood cells, platelets, and plasma. In terms of size, the particle constituents are related, in order of decreasing size, as follows: white blood cells, red blood cells, and platelets. Most current separation devices rely on density and size differences or surface chemistry characteristics to separate blood components.

[0006] Separation of certain blood components is often required for certain therapeutic treatments involving infusion of particular blood components into a patient. For example, in a number of treatments involving infusion of platelets, there is sometimes a desire to separate out at least some leukocytes and/or red blood cells before infusing a platelet-rich blood component collection into a patient.

[0007] For these and other reasons, there is a need to adopt approaches to processing components of blood.

SUMMARY

[0008] In the following description, certain aspects and embodiments of the present invention will become evident. It should be understood that the invention, in its broadest sense, could be practiced without having one or more features of these aspects and embodiments. It should also be understood that these aspects and embodiments are merely exemplary.

[0009] One aspect of the invention relates to a system for processing blood components. The system may comprise a separation chamber including a chamber interior in which blood components are centrifugally separated and an outlet port for passing at least some centrifugally separated blood components from the chamber interior. A flow path may be in flow communication with the outlet port of the separation chamber. The apparatus may further comprise a filter including a filter inlet in flow communication with the flow path, a porous filtration medium configured to filter at least some of at least one blood component (e.g., leukocytes, platelets, and/or red blood cells) from centrifugally separated blood components passed to the filter via the flow path, and a filter outlet for filtered blood components. The system may further comprise a rotor configured to be rotated about an axis of rotation. The rotor may comprise a first portion configured to receive the separation chamber and a second portion configured to receive the filter, wherein the first and second portions may be positioned with respect to one another so that when the separation chamber is received in the first portion and the filter is received in the second portion, the filter is closer than the interior of the separation chamber to the axis of rotation. The system may be configured so that the rotor rotates during filtering of at least one blood component via the filter.

[0010] In another aspect, the system may be configured so that when the filter is received in the second portion, the filter is eccentric with respect to the axis of rotation. For example, the system may be configured so that the filter is at least close to the axis of rotation (i.e., close to the axis of rotation or intersecting the axis of rotation at least partially) and so that the axis of rotation does not intersect an interior flow path defined by the filter. In some examples, when the filter is received in the second portion, the filter may be offset from the axis of rotation so that the axis of rotation does not intersect the filter. In some examples, the filter is eccentrically positioned so that blood components exit a housing of the filter (and/or enter the filter itself) at a location that is at least close to the rotor's axis of rotation, as compared to the location where the blood components enter the filter housing (and/or where the blood components exit the filter itself).

[0011] In a further aspect, the system may be configured so that when the filter is received in the second portion, a filter housing outflow port is located closer than a filter housing inflow port and/or the porous filtration medium to the axis of rotation. In another aspect, the filter housing outflow port may be above the filter housing inflow port.

[0012] In an additional aspect, the filter may comprise a filter housing defining an interior space containing the porous filtration medium, wherein the filter inlet and filter outlet may be in flow communication with the interior space, and wherein the system may be configured so that when the filter is received in the second portion, the filter is positioned so that blood components flow in the interior space in a direction facing generally toward the axis of rotation. In some examples, the filter housing defines a filter housing inflow port for passing blood components to the interior space and a filter housing outflow port for passing blood components from the interior space. The system may be configured so that when the filter is received in the second portion, the filter housing outflow port is closer than the filter housing inflow port (and/or the porous filtration medium) to the axis of rotation. In an exemplary arrangement, the filter housing outflow port is above the filter housing inflow port.

[0013] In a further aspect, the second portion may comprise at least one of a ledge and a slot configured to receive the filter, the at least one of a ledge and a slot being positioned under a top surface of the rotor. Alternatively (or additionally), the rotor may comprise a holder configured to hold the filter with respect to the rotor.

[0014] There are many possible arrangements for the flow path. In some examples, the flow path may include tubing. For example, the flow path may include a first tubing portion having one end coupled to the outlet port of the separation chamber and another end coupled to the filter inlet. In addition, the apparatus may also include a second tubing portion having an end coupled to the filter outlet, wherein the second tubing portion extends in a direction facing generally away from the axis of rotation. Further, the system may include a third tubing portion downstream from the second tubing portion, wherein the third tubing portion extends in a direction facing generally toward the axis of rotation.

[0015] In one more aspect, the rotor may comprise a groove configured to receive at least some of the tubing (e.g., at least some of the second and third tubing portions).

[0016] One other aspect relates to an apparatus for use with a centrifuge for processing blood components. The apparatus could be configured in a number of different ways. According to one aspect, the apparatus may comprise the separation chamber, the flow path, and the filter. In some embodiments, the apparatus is configured to be disposed after being used for processing of blood components.

[0017] In some embodiments, the rotor's axis of rotation may extend through the second portion of the rotor.

[0018] In another aspect, the system may comprise at least one valving member on the centrifuge rotor, the valving member being configured to control flow of at least some of the blood components during rotation of the rotor. In some examples, the valving member may comprise a tubing clamp.

[0019] In a further aspect, the system may comprise at least one sealing member on the centrifuge rotor, the sealing member being configured to create a seal during rotation of the rotor. For example, the sealing member may comprise a tubing welder.

[0020] In one further aspect, the rotor may comprise at least one support member configured to support the chamber, wherein the at least one support member may comprise a guide groove configured to receive a portion of the tubing line and a controllable clamp and/or welder associated with the groove. For example, the clamp may be configured to controllably occlude flow of blood components through the tubing line. In some examples, the chamber may comprise at least one guide hole configured to receive the at least one support member.

[0021] In some embodiments, the rotor may comprise a plurality of support members located in an asymmetric fashion with respect to the axis of rotation, and the chamber may comprise a plurality of guide holes, each of the guide holes being configured to receive a respective one of the support members.

[0022] According to another aspect, the system may further comprise a pump configured to pump at least some blood components from the chamber. The system may also comprise a pressure sensor configured to sense pressure of the pumped blood components, wherein the system may be configured to control the pump based on at least the pressure sensed by the pressure sensor.

[0023] A further aspect relates to a system comprising a chamber (e.g., a blood separation chamber) that may comprise an interior configured to contain separated blood components, and an outlet port for passing at least some of the separated blood components from the interior. A flow path may be in flow communication with the outlet port of the chamber. The system may further comprise a filter comprising a filter inlet in flow communication with the flow path, a porous filtration medium configured to filter at least some of at least one blood component from separated blood components passed to the filter via the flow path, and a filter outlet for filtered blood components. In addition, the system may also comprise a pump configured to pump at least some of the separated blood components from the chamber to the filter via the flow path, and a pressure sensor configured to sense pressure of blood components pumped to the filter. The system may be configured to control the pump based on at least the pressure sensed by the pressure sensor.

[0024] In some embodiments, the pump may comprise a portion of a centrifuge and/or at least a portion of a blood component expressor.

[0025] According to another aspect, the system may be configured such that the system calculates a difference between pressures sensed by the pressure sensor in at least one time interval, determines when the calculated difference is at least a predetermined amount, and controls the pump in response to at least the determination that the calculated difference is at least the predetermined amount.

[0026] In yet another aspect, there is a system that may comprises a separation chamber comprising a chamber interior in which blood components are centrifugally separated, and an outlet port for passing at least some of the centrifugally separated blood components from the chamber interior. A flow path may be in flow communication with the outlet port of the separation chamber. The system also may comprise a pump configured to pump at least some of the centrifugally separated blood components from the chamber and through the flow path, and a pressure sensor configured to sense pressure of blood components pumped by the pump. In addition, the system may comprise a centrifuge rotor configured to be rotated about an axis of rotation, the rotor comprising a portion configured to receive the separation chamber. The system may be configured such that the system calculates a difference between pressures sensed by the pressure sensor in at least one time interval, determines when the calculated difference is at least a predetermined amount, and controls the pump in response to at least the determination that the calculated difference is at least the predetermined amount.

[0027] Many different types of chambers are possible. In some embodiments, the chamber may have a ring shape.

[0028] According to another aspect, the chamber may comprise a bag (e.g., a blood component separation bag). For example, at least a portion of the bag may be formed of at least one of flexible and semi-rigid material so that the chamber interior has a variable volume. In some embodiments, the bag may have a generally annular ring shape defining a central opening.

[0029] In another aspect, the chamber interior may include a tapered portion leading to the outlet port.

[0030] In a further aspect, the chamber may be configured so that the chamber has a variable volume, and the pump may be configured to reduce the volume of the chamber interior. In one example, the pump may be configured to apply pressure to the chamber via hydraulic fluid. Such an example may also include a sensor configured to sense pressure of pumped blood products, wherein the sensor may be configured to sense pressure of the hydraulic fluid. Certain aspects of the invention could be practiced with or without a pump and/or pressure sensor, and when such structure is present, there are many possible forms of pumping and sensing configurations that could be used.

[0031] In an even further aspect, the system may further comprise an optical sensor, and the system may be configured to control the pump based on at least one of information sensed by the optical sensor and pressure sensed by the pressure sensor. In one example, an optical sensor may be positioned to sense blood components in the chamber, and/or an optical sensor may be positioned to sense blood components at another location, such as a location associated with the flow path (e.g., at a tubing line in flow communication with the filter).

[0032] In another aspect, the system may be configured so that the pump pumps blood components from the chamber during rotation of the centrifuge rotor.

[0033] In a further aspect, the apparatus may further comprise a collection container comprising an inlet in flow communication with the filter outlet and/or the flow path, and/or a portion of the rotor may further comprise a cavity configured to receive the collection container and possibly also the filter. In some examples, there may be more than one collection container and/or at least one collection container may be located outside of a centrifugal field during blood component processing.

[0034] One more aspect of the invention relates to a method of processing blood components.

[0035] Some exemplary methods may include providing a system disclosed herein. The term “providing” is used in a broad sense, and refers to, but is not limited to, making available for use, manufacturing, enabling usage, giving, supplying, obtaining, getting a hold of, acquiring, purchasing, selling, distributing, possessing, making ready for use, forming and/or obtaining intermediate product(s), and/or placing in a position ready for use.

[0036] In one more aspect, a method may comprise placing a separation chamber in a first portion of a centrifuge rotor and a filter in a second portion of the rotor, wherein the filter is located closer than an interior of the separation chamber to the axis of rotation of the rotor, and wherein the filter comprises a porous filtration medium. The method may further comprise rotating the centrifuge rotor, the separation chamber, and the filter about the axis of rotation of the centrifuge rotor, wherein the blood components are centrifugally separated in the chamber interior. In addition, the method may comprise removing at least some of the centrifugally separated blood components from the separation chamber, and filtering the removed blood components with the filter so as to filter at least some of at least one blood component (e.g., leukocytes, platelets, and/or red blood cells) from the removed blood-components, wherein at least a portion of the filtering occurs during said rotating.

[0037] In another aspect, the method may further comprise pumping at least some of the centrifugally separated blood components from the chamber to the filter. A further aspect may include sensing pressure of pumped blood components, and controlling the pumping based on at least the sensed pressure.

[0038] In yet another aspect, there is a method comprising pumping at least some separated blood components from a chamber (e.g., a blood separation chamber or any other type of chamber structure), filtering the pumped blood components with a filter so as to filter at least some of at least one blood component from the pumped blood components, sensing pressure of blood components pumped to the filter, and controlling the pumping based on at least the pressure sensed by the pressure sensor. In some examples, the chamber may be rotated (e.g., via a centrifuge) and separated blood components may be pumped from the chamber while the chamber is received on a centrifuge rotor and/or after the chamber is removed from a centrifuge rotor.

[0039] A further aspect relates to a method of determining a location of at least one interface during processing of blood components, wherein the method comprises pumping at least some centrifugally separated blood components from a chamber, sensing pressure of the pumped blood components, and determining a location of at least one interface based on the sensed pressure, wherein the interface is associated with the pumped blood components. For example, the interface may be an interface between blood components and air, and/or an interface between differing blood components.

[0040] In another aspect, the method may comprise calculating a difference between pressures sensed in at least one time interval, determining when the calculated difference is at least a predetermined amount, and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.

[0041] According to another aspect, there is a method of processing blood components, comprising rotating a chamber about an axis of rotation, wherein blood components are centrifugally separated in the chamber, pumping at least some separated blood components from the chamber, sensing pressure of pumped blood components, calculating a difference between pressures sensed in at least one time interval, determining when the calculated difference is at least a predetermined amount, and controlling the pumping in response to at least the determination that the calculated difference is at least the predetermined amount.

[0042] In another aspect, the method may further comprise passing blood components (e.g., filtered blood components) into at least one collection bag.

[0043] In a further aspect, the blood components in the chamber may be blood components of a buffy coat. Buffy coat blood components are generally blood components that result from a procedure where platelets and leukocytes along with some amount of red blood cells and plasma have been separated from whole blood. Alternatively, any other substance containing one or more blood components could be processed.

[0044] In some examples, whole blood may be processed in the method. For example, whole blood may be introduced into the chamber (e.g., from one/or more donors, and/or from one or more containers containing blood donated by one or more donors). In the processing of whole blood, any number of blood components may be centrifugally separated, filtered, and/or processed in any other way. For example, components of whole blood may be separated and pumped into separate, respective containers (optionally while being filtered via one or more filters).

[0045] In one more aspect, when blood components are pumped, the pumping may comprise reducing the volume of an interior of the chamber. For example, the method may comprise applying pressure to the chamber via hydraulic fluid.

[0046] In another aspect, the pumping may occur during rotation of a centrifuge rotor.

[0047] In yet another aspect, the method may comprise optically sensing pumped blood products, and controlling the pumping based on at least one of optically sensed information and sensed pressure. For example, the optically sensing may comprise optically sensing blood components in the chamber and/or optically sensing blood components in a tubing line (e.g., a tubing line in flow communication with a filter).

[0048] In another aspect, the method may further comprise causing at least one valving member on the centrifuge rotor to control flow of at least some of the blood components during rotation of the rotor. As mentioned above, the valving member may comprise a tubing clamp.

[0049] In a further aspect, the method may further comprise causing at least one sealing member on the centrifuge rotor to create a seal during rotation of the rotor. As mentioned above, the sealing member may comprise a tubing welder.

[0050] Aside from the structural and procedural arrangements set forth above, the invention could include a number of other arrangements such as those explained hereinafter. It is to be understood that both the foregoing description and the following description are exemplary only.

BRIEF DESCRIPTION OF THE DRAWINGS

[0051] The accompanying drawings are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments and, together with the description, serve to explain some principles of the invention. In the drawings,

[0052] FIG. 1 is a schematic cross-section view of an embodiment of a system in accordance with the present invention;

[0053] FIG. 1A is a view similar to that of FIG. 1 showing an alternate embodiment of the system;

[0054] FIG. 1B is a top plan view of another alternative embodiment of the system;

[0055] FIG. 2 is a top plan view of a portion of an apparatus including a chamber and filter for use with the systems of FIGS. 1, 1A , and 1 B, wherein line I-I of FIG. 2 represents the plane for the cross-section views of the chamber portion shown in FIGS. 1 and 1 A;

[0056] FIG. 3 is partially schematic view of an embodiment of an apparatus including the chamber and filter of FIG. 2 ;

[0057] FIG. 4 is an isometric view of a system including the apparatus of FIG. 3 ;

[0058] FIG. 5 is a graph showing pressure plotted over time in connection with an example involving the embodiment of FIG. 1B ;

[0059] FIG. 6 is a top, partially schematic view of an alternative embodiment of a separation chamber;

[0060] FIG. 7 is a schematic view of an example of a controller communicating with various possible system components;

[0061] FIG. 8 is a schematic, partial cross-section view illustrating the configuration of a filter and separation chamber associated with the system embodiment of FIG. 1B ;

[0062] FIG. 8 a is a schematic, partial cross-section view of an alternative filter configuration;

[0063] FIG. 8 b is a schematic, partial cross-section view of another alternative filter configuration;

[0064] FIG. 9 is a schematic view of a hydraulically operated pump and pressure sensor associated with the system embodiments of FIGS. 1, 1A , and 1 B;

[0065] FIG. 10 is a schematic view of an alternative embodiment of a system associated with a centrifuge;

[0066] FIG. 11 is a schematic view of an alternative embodiment of a system associated with a blood component expresser;

[0067] FIG. 12 is a schematic view of an alternative embodiment of a system associated with a blood component expressor; and

[0068] FIG. 13 is a schematic view of an embodiment of a system configured to process whole blood.

DESCRIPTION OF A FEW EXEMPLARY EMBODIMENTS

[0069] Reference will now be made in detail to a few exemplary embodiments of the invention. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts.

[0070] FIG. 1 shows an embodiment of a system for processing blood components. The system includes a centrifuge 34 in combination with an apparatus including a filter 31 and a chamber 4 in the form of a blood component separation bag having a ring shape. The centrifuge 34 has a rotor 1 including a first rotor portion defining a ring-shaped area 3 receiving the chamber 4 and a second rotor portion defining a center cavity 2 where the filter 31 and possibly also a collection container 33 (e.g., a bag used to contain blood components processed by the system) may be located during a blood component processing operation.

[0071] The chamber 4 has an interior 8 in which blood components are centrifugally separated during rotation of the rotor 34 about an axis of rotation X. As described in more detail below, at least some of the blood components centrifugally separated in the chamber 4 are passed via a tubing line 21 to a filter 31 where at least some of at least one blood component (e.g., leukocytes, platelets, and/or red blood cells) is filtered before passing the filtered blood component(s) to the collection container 33 .

[0072] As described in more detail below, hydraulic fluid in a space 5 located beneath the chamber 4 exposes the chamber 4 to an external pressure that causes at least some centrifugally separated blood components to be pumped from the chamber 4 . The centrifuge rotor 1 also has an inner lid 6 adapted to rotate along with a remainder of the rotor 1 and the separation chamber 4 . The lid 6 is optionally configured to at least partially secure the chamber 4 , for example, in a clamping fashion along a line 7 shown in FIG. 2 . This may be an effective way to fix the position of the chamber 4 in the centrifuge rotor 1 and limit the stresses on the inner edge of the bag 1 . The centrifuge lid 6 optionally defines a central opening 53 possibly allowing center cavity 2 to be accessible externally even when the inner lid 6 is in a closed position.

[0073] The centrifuge rotor 1 may include one or more supports 9 , 10 , 11 shown in FIGS. 1B, 2 , and 4 (for example, three to five supports). (The view of FIG. 1 shows only support 9 .) Optionally, the supports extend wholly or partially in the center cavity 2 and thus may define the cavity 2 . The above-mentioned clamping of the chamber 4 by the inner lid 6 may limit, through its greater contact area, the load on the inner edge of the chamber 4 and assist in preventing it from slipping over or being released in some other way from supports 8 , 9 , and 10 during centrifuge rotor rotation. As shown in FIGS. 1B and 2 , e.g., the respective supports 9 - 11 are optionally somewhat asymmetric (e.g., about the rotational axis X), and may thus assist in defining the position of the chamber 4 and its associated tubes in the rotor 1 while holding the chamber 4 in position during centrifuging.

[0074] Each of the support members 9 - 11 may define a respective guide groove, such as groove 12 shown in FIG. 1 , which is defined in support 9 . The groove may be shaped to receive one or more different tubes passing blood components or other fluids in the system. One or more of the supports 9 - 11 may be configured so that the guide grooves may be selectively reduced (and/or increased) in size to clamp (and/or unclamp) tubing placed in the grooves, and thereby accomplish valving for regulating the flow of fluids in the apparatus. For example, a portion of the support 9 could be configured to move in a clamping/unclampling fashion in the direction of arrow 13 shown in FIG. 1 so as to function as a clamp valve for tubing 21 in guide groove 12 .

[0075] One or more of the supports 9 - 11 may be configured to weld and/or cut tubes extending in grooves defined in the supports 9 - 11 . For example, electric power to perform welding via supports 9 - 11 may be passed to the supports 9 - 11 via an electrical contact between the rotor 34 and a centrifuge stand. Various different components of the centrifuge may also be supplied with power via contact(s). In the embodiment of FIG. 1 , the electric power is conveyed via electrical slip ring connectors 14 , 15 between the rotor and stand portions of the centrifuge, wherein connector 14 is a rotating part of the centrifuge and connector 15 is a secured part in the centrifuge stand. As shown in FIG. 1 , the centrifuge 34 may include a centrifuge motor 16 coupled to the rotor 1 so as to rotate the rotor 1 about the axis of rotation X. For example, the motor 16 may be coupled to the centrifuge rotor 1 by a driving belt 47 disposed in operative communication with a motor driving pulley 48 and a centrifuge driving pulley 49 . A centrifuge rotation bearing 50 may cooperate with a rotating guide 51 .

[0076] As shown schematically in FIG. 1 , both the collection container 33 and filter 31 may be received in the center cavity 2 . The filter 31 may be disposed in the cavity 2 in any number of different fashions. In one example, shown in FIG. 1 , the filter 31 may be arranged in the cavity 2 so that components passing through the filter flow in a direction facing generally toward the axis of rotation X. In the embodiment of FIG. 1 A, the filter 31 is oriented to position a filter inlet 31 a above a filter outlet 31 b . Due to centrifugal forces generated during rotation of the rotor 1 , substances flowing through the filter 31 of FIG. 1 A may flow in a horizontal direction (as viewed in FIG. 1A ) as well as in the vertical direction.

[0077] As shown in FIG. 1 A, the filter 31 is optionally disposed in a generally lateral orientation on a small ledge 32 extending into the cavity 2 . A covering member such as inner lid 6 may be configured to contact and/or otherwise cover and hold filter 31 in place. For example, a projection 66 extending from the lid 6 and the ledge 32 may define a holder for the filter 31 . Alternatively, the ledge 32 could be moved upwardly from the position shown in FIG. 1 A and/or an inner part of the lid could extend slightly lower. In another alternative arrangement, the filter 31 may be positioned in the cavity 2 without being restrained, such as in the embodiment shown in FIG. 1 .

[0078] FIG. 1B shows another embodiment including an alternative placement of filter 31 . The filter 31 of FIG. 1B is positioned in a generally lateral orientation with the filter 31 being eccentric with respect to the axis of rotation X. In addition, the filter 31 of the embodiment of FIG. B is offset slightly from the rotational axis X so that the axis X does not intersect an interior of the filter 31 . The filter 31 is positioned so that substances flowing through the filter 31 flow in a direction 95 generally facing toward the axis of rotation X.

[0079] FIG. 8 schematically shows an example of how the filter 31 of FIG. 1B may be configured. (In FIG. 8 , the filter 31 and separation 4 are not drawn to scale.) As shown in that figure, the filter 31 has a filter inlet 31 a and a filter outlet 31 b at the respective ends of L-shaped tubing segments connected to a filter housing 31 d defining an interior space containing a porous filtration medium 31 c . The filter outlet 31 b is located above the filter inlet 31 a ; and the filter inlet 31 a is located closer than both the filter outlet 31 b and filtration medium 31 c to the axis of rotation X. The filter housing 31 d defines a filter housing inflow port 31 e and a filter housing outflow port 31 f above the inflow port 31 e . The filter housing outflow port 31 f is closer than the filter housing inflow port 31 e to the axis of rotation X. The filter housing outflow port 31 f is also closer than the filtration medium 31 c to the axis of rotation X.

[0080] In some examples, such as that of FIG. 8 , the relative positioning of the filter inlet 31 a , filter outlet 31 b , housing inflow port 31 e , housing outflow port 31 f , and/or medium 31 c , as well as the eccentric (and possibly also offset) positioning of the filter 31 , may assist in clearing most (if not all) air from the interior of the filter, as compared to alternative filtering arrangements which might potentially cause air to be “locked” therein.

[0081] FIG. 8 a shows another example of a filter 31 that could be used in the system. As shown in that figure, filter outlet 31 b is located above filter inlet 31 a ; and filter inlet 31 a is closer than both filter outlet 31 b and filtration medium 31 c to the axis of rotation X. In this example, rather than having the L-shaped tubing segments shown in FIG. 8 , filter housing 31 d defines flow passages leading to and from filter outlet 31 b and filter inlet 31 a , respectively, such that filter housing outflow port 31 f is located closer than both filter housing inflow port 31 e and medium 31 c to the axis of rotation x. In addition, outflow port 31 f is above inflow port 31 e.

[0082] FIG. 8 b shows a further example of a filter 31 that could be used in the system. For this example, housing inflow port 31 e and housing outflow port 31 f are at substantially the same relative positions as filter inlet 31 a and filter outlet 31 b , respectively. In contrast to the filter shown in FIG. 8 a , filter housing outflow port 31 f is closer than both filter housing inflow port 31 e and filtration medium 31 c to the axis of rotation X. In addition, the inlet 31 a , inflow port 31 e , outflow port 31 f , and outlet 31 b are at substantially the same level. Further, filter outlet 31 b is closer than both filter inlet 31 a and filtration medium 31 c to the axis of rotation X.

[0083] One feature in common with the filter examples of FIGS. 8, 8 a , and 8 b is that blood components flowing in an interior space containing filtration medium 31 c flow in a direction 95 facing generally toward the axis of rotation X.

[0084] As partially shown in FIG. 1 B, the filter 31 may be positioned at least partially in a slot 57 offset from the axis of rotation X. The slot 57 may be wholly or partially defined in lid 6 . Alternatively, the slot 57 could be defined using a shelf and projection similar to those shown in FIG. 1A .

[0085] Although the embodiments of FIGS. 1, 1A , and 1 B show the filter positioned beneath the top surface of the rotor 34 , the filter 31 could alternatively be arranged partially or completely above the rotor's top surface. In some alternate embodiments, the filter may even be positioned at a location that is not within the centrifugal field generated by rotation of the rotor 1 .

[0086] In the embodiments of FIGS. 1, 1A , and 1 B, the portion of the centrifuge rotor defining the ring-shaped area 3 and the portion of the centrifuge rotor defining the center cavity 2 are positioned with respect to one another so that when the chamber 4 is received in the area 3 and the filter 31 is received in the cavity 2 , the filter 31 is closer than the chamber interior 8 to the axis of rotation X, as schematically illustrated in FIG. 8 . Such a positioning may avoid the filter 31 from being subjected to relatively high centrifugal forces while permitting substances being centrifugally separated in the chamber interior 8 to be subjected to such high forces. In some instances, it may be desired for such a reduced amount of centrifugal force to be applied to the filter 31 . For example, in certain filter arrangements, exposure to relatively high centrifugal forces might cause certain potential problems associated with bursting of the filter housing, or perhaps negatively affect the filtration efficacy. For some filters, such as those that might not be significantly impacted by centrifugal forces, alternative positioning of the filter might be possible.

[0087] The filtration medium 31 c shown in FIGS. 1A, 8 , 8 a , and 8 b may be any form of porous medium, such as fibers combined together in a woven or unwoven form, loose fibers, foam, and/or one or more membranes, for example. The filtration medium 31 c may be configured to filter leukocytes, platelets, and/or red blood cells.

[0088] The filter 31 could be configured in any known form. In some embodiments, the filter 31 may be a leukoreduction filter configured to filter leukocytes from blood components including a concentration of platelets. One example of such a filter is the LRP6 leukoreduction filter marketed by the Pall Corporation of Glen Cove, N.Y. Another example is the Sepacell PLS-10A leukocyte reduction filter marketed by Baxter Healthcare Corp. of Deerfield, Ill. A further example is the IMUGARD filter marketed by Terumo of Japan. It should be understood that other known leukoreduction filters could also be used and such filters optionally may be selected depending upon the process being undertaken.

[0089] As shown in FIG. 1 B, the inner lid 6 includes one or more grooves 60 defined therein for receiving one or more tubing lines. A first tubing portion 21 a places the blood component separation chamber (not shown in FIG. 1B ) and filter 31 in flow communication with one another. Tubing 21 is flow coupled to the outlet of filter 31 . The tubing 21 includes a second tubing potion 21 b coupled to an outlet of the filter 31 and extending in a direction facing generally away from the rotation axis X. The tubing 21 also includes a third downstream portion 21 c extending in a direction generally facing the axis of rotation X. The groove(s) 60 may be configured to receive at least some of the second and third tubing portions 21 b and 21 c.

[0090] In some embodiments, there may be lids (not shown) other than the lid 6 to account for a plurality of processes which may alternatively be performed by the system. As shown in FIG. 1 B, the groove(s) 60 may be arranged to associate the tubing 21 with one or more other features of the embodiment. For example, the groove(s) 60 may be arranged to place the tubing 21 in cooperation/communication with the groove 12 of member 9 (and/or with an optical sensor 55 described below), among other things.

[0091] As shown in FIG. 2 , the chamber 4 is optionally in the form of a bag defined by two sheets of a suitable plastic material (e.g., flexible and/or semi-rigid plastic material) joined together by circumferentially welding radially inner and outer edges 17 and 18 . Between the welded edges 17 and 18 , there is an open, ring-shaped chamber interior in which blood components are separated. The chamber 4 includes a central opening (e.g., aperture) 19 which primarily corresponds to the center cavity 2 opening. Such a structure may simplify access to the center cavity 2 . The chamber 4 shown in FIG. 2 has respective guide holes 109 , 110 , and 111 for receiving supports 9 - 11 , respectively, and thus positioning the chamber 4 with respect to the supports 9 - 11 . The bag material surrounding the guide holes 109 , 110 , and 111 may be welded to strengthen the material around the holes. The guide holes 109 , 110 , and 111 optionally have an asymmetric arrangement (about rotational axis X) that is like that of the optional asymmetric orientation of the supports 9 , 10 , and 11 so as to facilitate orienting the chamber 4 .

[0092] At least a portion of the chamber 4 may be formed of flexible and/or semi-rigid material so that the interior of the chamber 4 has a variable inner volume. For example, the chamber 4 may be formed of material permitting external pressure to be applied to the chamber so as to reduce the inner volume of the chamber 4 . In some exemplary arrangements, the chamber 4 and possibly the other parts of the apparatus 100 may be formed of material comprising inert plastic.

[0093] The chamber 4 includes an inlet port 4 a for passing blood components to the interior of the chamber 4 and an outlet port 4 b for passing at least some centrifugally separated blood components from the chamber interior. Inflow tubing 20 and outflow tubing 21 are placed in flow communication with the ports 4 a and 4 b , respectively, on opposite facing sides of the chamber 4 via welded sleeve couplings 24 . Each sleeve coupling 24 may be a securing part in the form of a short piece of tubing with a diagonally arranged flat securing collar which may be welded to the chamber 4 , while permitting the respective tubing 20 and 21 to be welded to the coupling 24 . Instead of being secured via such a sleeve coupling, the tubing could alternatively be secured to (and/or in) each respective welded edge, i.e. within welded edges 17 and 18 .

[0094] An alternative embodiment of a chamber 4 is shown in FIG. 6 , wherein, a sort of bay 75 is positioned at the outlet port leading to tube 21 . This bay 75 is defined by a gradually tapered portion formed by weld portions 61 and 62 extending in a generally radial direction from the outlet port. (The chamber 4 shown in FIG. 2 may have a similar bay.) This type of arrangement may enable platelets to be received in a relatively non-abrupt or otherwise non-disruptive process. This may enhance the quality of the harvested platelets.

[0095] Referring again to FIG. 6 , an inlet area 65 in the region of an inlet port leading from tube 20 does not have a tapered portion defined by weld portions 63 , 64 . This configuration may alleviate any potential capture of platelets (or some other desired product) so as to permit platelets to be available for harvesting at the outlet area 75 .

[0096] When the chamber 4 is formed in a ring shape, as shown in the drawings, the chamber 4 and at least certain aspects of the centrifuge 34 may be configured like the separation chambers and associated centrifuges disclosed in one or more of the following patent documents: WO 87/06857, U.S. Pat. No. 5,114,396, U.S. Pat. No. 5,723,050, WO 97/30715, and WO 98/35757, for example. Many alternative arrangements are also possible.

[0097] Although the embodiments shown in the drawings include a separation chamber in the form of a ring-shaped bag, it should be understood that there are many alternative forms of separation chamber configurations that could be used. For example, the separation chamber could be in the form of a bag other than a ring-shaped bag. Alternatively, the separation chamber could be in other non-bag forms, such as, for example, in the form of one of the separation vessels disclosed in U.S. Pat. No. 6,334,842.

[0098] In one alternative embodiment (not shown), a filter similar to (or identical to) filter 31 could be positioned in tubing 20 to filter at least some blood components (e.g., leukocytes, platelets, and/or red blood cells) from substances being passing into the chamber 4 .

[0099] FIG. 3 shows an embodiment of an apparatus 100 including the chamber 4 and filter 31 shown in FIG. 2 . This exemplary apparatus 100 is in the form of a bag set for producing platelets from a buffy coat collection. The apparatus 100 further includes a bag 23 containing diluting solution, a solution tube 30 , four connecting tubes 25 - 28 intended to be coupled (e.g., via welding) to respective bags containing previously prepared buffy coat products (not shown), and a multi-way connector 29 connecting the tubes 25 - 28 and 30 to the inflow tubing 20 coupled to the inlet port of chamber 4 . From the chamber 4 , the tubing 21 having filter 31 in-line is coupled to an inlet 33 a of collection container 33 , which is in the form of a bag. In an area whe