US 10,052,053 C1 (13,266th)
SYSTEMS AND METHODS FOR PARENTERALLY PROCURING BODILY-FLUID SAMPLES WITH REDUCED CONTAMINATION
Richard G. Patton, Seattle, WA (US)
Filed by Magnolia Medical Technologies, Inc., Seattle, WA (US)
Assigned to Magnolia Medical Technologies
Reexamination Request No. 90/019,756, Dec. 6, 2024.
Reexamination Certificate for Patent 10,052,053, issued Aug. 21, 2018, Appl. No. 15/829,023, Dec. 1, 2017.
Application 13/458,508 is a division of application No. 13/335,241, filed on Dec. 22, 2011, granted, now 8,231,546.
Application 90/019,756 is a continuation of application No. 15/457,082, filed on Mar. 13, 2017, granted, now 9,855,001.
Application 15/457,082 is a continuation of application No. 15/448,891, filed on Mar. 3, 2017, granted, now 9,861,306.
Application 15/448,891 is a continuation of application No. 15/435,684, filed on Feb. 17, 2017, granted, now 9,872,645.
Application 15/435,684 is a continuation of application No. 15/432,310, filed on Feb. 14, 2017, granted, now 9,855,002.
Application 15/432,310 is a continuation of application No. 15/088,842, filed on Apr. 1, 2016, abandoned.
Application 15/088,842 is a continuation of application No. 14/498,102, filed on Sep. 26, 2014, granted, now 10,299,713.
Application 14/498,102 is a continuation of application No. 14/089,267, filed on Nov. 25, 2013, granted, now 8,876,734.
Application 14/089,267 is a continuation of application No. 13/675,295, filed on Nov. 13, 2012, granted, now 8,647,286.
Application 13/675,295 is a continuation of application No. 13/458,508, filed on Apr. 27, 2012, granted, now 8,337,418.
Application 13/335,241 is a continuation of application No. 11/955,635, filed on Dec. 13, 2007, granted, now 8,197,420.
Claims priority of provisional application 60/870,599, filed on Dec. 18, 2006.
This patent is subject to a terminal disclaimer.
Ex Parte Reexamination Certificate issued on May 28, 2026.
Int. Cl. A61B 5/15 (2006.01); A61B 5/153 (2006.01); A61B 5/154 (2006.01); A61B 5/155 (2006.01); A61B 10/00 (2006.01); B01L 3/00 (2006.01); A61B 10/02 (2006.01)
CPC A61B 5/150221 (2013.01) [A61B 5/1438 (2013.01); A61B 5/15003 (2013.01); A61B 5/150099 (2013.01); A61B 5/150251 (2013.01); A61B 5/150343 (2013.01); A61B 5/150389 (2013.01); A61B 5/150473 (2013.01); A61B 5/150503 (2013.01); A61B 5/150755 (2013.01); A61B 5/150977 (2013.01); A61B 5/150992 (2013.01); A61B 5/153 (2013.01); A61B 5/154 (2013.01); A61B 5/1545 (2013.01); A61B 5/155 (2013.01); A61B 10/0045 (2013.01); A61B 10/0048 (2013.01); A61B 10/0051 (2013.01); A61B 10/007 (2013.01); B01L 3/502 (2013.01); A61B 5/1422 (2013.01); A61B 2010/0061 (2013.01); A61B 2010/0077 (2013.01); A61B 10/0096 (2013.01); A61B 10/0233 (2013.01); B01L 2200/026 (2013.01); B01L 2200/141 (2013.01); B01L 2300/0672 (2013.01); B01L 2400/082 (2013.01)]
OG exemplary drawing
AS A RESULT OF REEXAMINATION, IT HAS BEEN DETERMINED THAT:
The patentability of claims 1-37 is confirmed.
New claims 38-172 are added and determined to be patentable.
[ 38. The device of claim 1, wherein the junction comprises a solid barrier, and wherein sequestering the portion of the first volume of blood comprises setting apart, by the solid barrier, the portion of the first volume of blood from the second volume of blood.]
[ 39. The device of claim 1, further comprising:
a solid barrier configured to separate the portion of the first volume of blood from the second volume of blood.]
[ 40. The device of claim 1, wherein sequestering the portion of the first volume of blood comprises setting apart the portion of the first volume of blood from the second volume of blood.]
[ 41. The device of claim 1, wherein sequestering the portion of the first volume of blood comprises separating the portion of the first volume of blood from the second volume of blood.]
[ 42. The device of claim 1, wherein sequestering the portion of the first volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 43. The device of claim 1, wherein sequestering the portion of the first volume of blood comprises avoiding fluid flow from the first volume of blood to the second fluid flow path.]
[ 44. The device of claim 1, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 45. The device of claim 9, wherein the junction comprises a solid barrier, and wherein sequestering the initial volume of blood comprises setting apart, by the solid barrier, the initial volume of blood from the subsequent flow of blood.]
[ 46. The device of claim 9, further comprising:
a solid barrier configured to separate the initial volume of blood from the subsequent flow of blood.]
[ 47. The device of claim 9, wherein sequestering the initial volume of blood comprises setting apart the initial volume of blood from the subsequent flow of blood.]
[ 48. The device of claim 9, wherein sequestering the initial volume of blood comprises separating the initial volume of blood from the subsequent flow of blood.]
[ 49. The device of claim 9, wherein sequestering the initial volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 50. The device of claim 9, wherein sequestering the initial volume of blood comprises avoiding fluid flow from the initial volume of blood to the second fluid flow path.]
[ 51. The device of claim 9, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 52. The device of claim 16, wherein the junction comprises a solid barrier, and wherein sequestering the initial volume of blood comprises setting apart, by the solid barrier, the initial volume of blood from the subsequent blood sample.]
[ 53. The device of claim 16, further comprising:
a solid barrier configured to separate the initial volume of blood from the subsequent blood sample.]
[ 54. The device of claim 16, wherein sequestering the initial volume of blood comprises setting apart the initial volume of blood from the subsequent blood sample.]
[ 55. The device of claim 16, wherein sequestering the initial volume of blood comprises separating the initial volume of blood from the subsequent blood sample.]
[ 56. The device of claim 16, wherein sequestering the initial volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 57. The device of claim 16, wherein sequestering the initial volume of blood comprises avoiding fluid flow from the initial volume of blood to the second fluid flow path.]
[ 58. The device of claim 16, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 59. The device of claim 27, wherein the diverter comprises a solid barrier, and wherein sequestering the portion of the first volume of blood comprises setting apart, by the solid barrier, the portion of the first volume of blood from the second volume of blood.]
[ 60. The device of claim 27, further comprising:
a solid barrier configured to separate the portion of the first volume of blood from the second volume of blood.]
[ 61. The device of claim 27, wherein sequestering the portion of the first volume of blood comprises setting apart the portion of the first volume of blood from the second volume of blood.]
[ 62. The device of claim 27, wherein sequestering the portion of the first volume of blood comprises separating the portion of the first volume of blood from the second volume of blood.]
[ 63. The device of claim 27, wherein sequestering the portion of the first volume of blood comprises restricting fluid flow between the device in the first state and the device in the second state.]
[ 64. The device of claim 27, wherein sequestering the portion of the first volume of blood comprises avoiding fluid flow from the portion of the first volume of blood to the second volume of blood.]
[ 65. The device of claim 27, wherein the device includes a branching connection between the device in the first state and the device in the second state.]
[ 66. The device of claim 31, wherein the junction comprises a solid barrier, and wherein sequestering the initial volume of blood comprises setting apart, by the solid barrier, the initial volume of blood from the subsequent flow of blood.]
[ 67. The device of claim 31, further comprising:
a solid barrier configured to separate the initial volume of blood from the subsequent flow of blood.]
[ 68. The device of claim 31, wherein sequestering the initial volume of blood comprises setting apart the initial volume of blood from the subsequent flow of blood.]
[ 69. The device of claim 31, wherein sequestering the initial volume of blood comprises separating the initial volume of blood from the subsequent flow of blood.]
[ 70. The device of claim 31, wherein sequestering the initial volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 71. The device of claim 31, wherein sequestering the initial volume of blood comprises avoiding fluid flow from the initial volume of blood to the second fluid flow path.]
[ 72. The device of claim 31, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 73. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a sample vessel containing a culture media;
a first fluid flow path configured to receive a first volume of blood from the patient;
a second fluid flow path in fluid communication with the sample vessel; and
a junction in fluid communication with the first fluid flow path and the second fluid flow path, the device configured to automatically transition at the junction from a first state, in which the first volume of blood can flow from the patient via the first fluid flow path, to a second state, in which a second volume of blood can flow from the patient via the second fluid flow path, a portion of the first volume of blood being sequestered in the first fluid flow path when the device is in the second state,
wherein sequestering the portion of the first volume of blood sequesters contaminants present in the first volume of blood and reduces contamination in the blood used as the blood sample in the culture testing.]
[ 74. The device of claim 73, further comprising:
a lumen-containing device configured to be inserted into the vasculature of the patient to establish fluid communication between the device and the vasculature of the patient, the portion of the first volume of blood being greater than the volume of a lumen of the lumen-containing device and less than 5 ml.]
[ 75. The device of claim 73, further comprising:
a first lumen-containing device configured to be inserted into the vasculature of the patient to establish fluid communication between the device and the vasculature of the patient; and
a second lumen-containing device configured to be removably insertable into the sample vessel to establish fluid communication between the device and the sample vessel.]
[ 76. The device of claim 73, further comprising:
a diverter having a first state operable to allow sequestration of contaminants present in the first volume of blood, and a second state operable to allow the second volume of blood to flow via the second fluid flow path,
whereby the transitioning at the junction is the diverter transitioning from the first state to the second state after the first fluid flow path has received the first volume of blood.]
[ 77. The device of claim 76, wherein the diverter is a single diverter.]
[ 78. The device of claim 73, further comprising:
a reservoir configured to fluidically isolate the portion of the first volume of blood.]
[ 79. The device of claim 78, wherein the reservoir is integrated into the device.]
[ 80. The device of claim 73, wherein the contaminants are dermally-residing microbes.]
[ 81. The device of claim 73, wherein the junction comprises a solid barrier, and wherein sequestering the portion of the first volume of blood comprises setting apart, by the solid barrier, the portion of the first volume of blood from the second volume of blood.]
[ 82. The device of claim 73, further comprising:
a solid barrier configured to separate the portion of the first volume of blood from the second volume of blood.]
[ 83. The device of claim 73, wherein the sample vessel is a vacuum-sealed vessel.]
[ 84. The device of claim 73, wherein sequestering the portion of the first volume of blood comprises setting apart the portion of the first volume of blood from the second volume of blood.]
[ 85. The device of claim 73, wherein sequestering the portion of the first volume of blood comprises separating the portion of the first volume of blood from the second volume of blood.]
[ 86. The device of claim 73, wherein sequestering the portion of the first volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 87. The device of claim 73, wherein sequestering the portion of the first volume of blood comprises avoiding fluid flow from the first volume of blood to the second fluid flow path.]
[ 88. The device of claim 73, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 89. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a sample vessel containing a culture media;
a first fluid flow path in fluid communication with a reservoir integrated into the device, the reservoir configured to receive an initial volume of blood from the patient via the first fluid flow path;
a second fluid flow path in fluid communication with the sample vessel; and
a junction configured to automatically transition in response to filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that a subsequent flow of blood flows via the second fluid flow path, the sequestered initial volume not being used as the blood sample in the culture testing,
wherein sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood and reduces contamination in the blood used as the blood sample in the culture testing.]
[ 90. The device of claim 89, wherein the initial volume of blood is less than 5 ml.]
[ 91. The device of claim 89, further comprising:
a lumen-containing device configured to be inserted into the vasculature of the patient to establish fluid communication between the device and the vasculature of the patient, the initial volume of blood is greater than the volume of a lumen of the lumen-containing device and less than 5 ml.]
[ 92. The device of claim 89, wherein the initial volume of blood is 0.5 ml to 5 ml.]
[ 93. The device of claim 89, further comprising:
a diverter having a first state operable to allow sequestration of contaminants present in the initial volume of blood, and a second state operable to allow blood to flow via the second fluid flow path, the transitioning at the junction includes the diverter transitioning from the first state to the second state.]
[ 94. The device of claim 89, wherein the sample vessel is a vacuum-sealed vessel.]
[ 95. The device of claim 89, wherein the contaminants are dermally-residing microbes.]
[ 96. The device of claim 89, wherein the junction comprises a solid barrier, and wherein sequestering the initial volume of blood comprises setting apart, by the solid barrier, the initial volume of blood from the subsequent flow of blood.]
[ 97. The device of claim 89, further comprising:
a solid barrier configured to separate the initial volume of blood from the subsequent flow of blood.]
[ 98. The device of claim 89, wherein sequestering the initial volume of blood comprises setting apart the initial volume of blood from the subsequent flow of blood.]
[ 99. The device of claim 89, wherein sequestering the initial volume of blood comprises separating the initial volume of blood from the subsequent flow of blood.]
[ 100. The device of claim 89, wherein sequestering the initial volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 101. The device of claim 89, wherein sequestering the initial volume of blood comprises avoiding fluid flow from the initial volume of blood to the second fluid flow path.]
[ 102. The device of claim 89, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 103. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a lumen-containing device configured to establish fluid communication between the patient and the device;
a first fluid flow path in fluid communication with the lumen-containing device, the first fluid flow path configured to receive an initial volume of blood from the patient;
a second fluid flow path configured to be placed in fluid communication with the lumen-containing device; and
a sample vessel containing a culture media, the sample vessel in fluid communication with the second fluid flow path,
wherein the device is configured to automatically transition at a junction between the first fluid flow path and the second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient such that (a) the initial volume of blood is sequestered and (b) the sample vessel can receive a subsequent blood sample via the second fluid flow path.]
[ 104. The device of claim 103, wherein sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood and reduces contamination in the blood used as the blood sample in the culture testing.]
[ 105. The device of claim 104, wherein the contaminants are dermally-residing microbes.]
[ 106. The device of claim 103, wherein the initial volume of blood is greater than the volume of a lumen of the lumen-containing device and less than 5 ml.]
[ 107. The device of claim 103, further comprising:
a reservoir configured to fluidically isolate the initial volume of blood.]
[ 108. The device of claim 107, wherein the reservoir is integrated into the device.]
[ 109. The device of claim 107, wherein the reservoir is configured to contain less than 5 ml of blood.]
[ 110. The device of claim 107, further comprising:
a diverter that defines the first fluid flow path such that the initial volume of blood can flow from the lumen-containing device to the reservoir, and the second fluid flow path such that blood can flow from the lumen-containing device toward the sample vessel.]
[ 111. The device of claim 103, further comprising:
a diverter that transitions from a first state to a second state, the first state operable to allow the transfer of the initial volume of blood from the patient to a reservoir, the second state operable to sequester the initial volume of blood in the reservoir, the diverter configured to transition between the first state and the second state in response to the transfer of the initial volume of blood to the reservoir.]
[ 112. The device of claim 103, further comprising:
a diverter that transitions from a first state to a second state, the first state operable to allow the transfer of the initial volume of blood from the patient to a reservoir, the second state operable to establish fluid communication between the lumen-containing device and the sample vessel via the second fluid flow path.]
[ 113. The device of claim 103, further comprising:
a diverter that transitions from a first state to a second state, the first state operable to allow the transfer of the initial volume of blood from the patient to a reservoir, the second state operable to (a) to sequester the initial volume of blood in the reservoir, and (b) establish fluid communication between the lumen-containing device and the sample vessel via the second fluid flow path.]
[ 114. The device of claim 103, wherein the junction comprises a solid barrier, and wherein sequestering the initial volume of blood comprises setting apart, by the solid barrier, the initial volume of blood from the subsequent blood sample.]
[ 115. The device of claim 103, further comprising:
a solid barrier configured to separate the initial volume of blood from the subsequent blood sample.]
[ 116. The device of claim 103, wherein the sample vessel is a vacuum-sealed vessel.]
[ 117. The device of claim 107, wherein the subsequent blood sample is used for culture testing.]
[ 118. The device of claim 103, wherein sequestering the initial volume of blood comprises setting apart the initial volume of blood from the subsequent blood sample.]
[ 119. The device of claim 103, wherein sequestering the initial volume of blood comprises separating the initial volume of blood from the subsequent blood sample.]
[ 120. The device of claim 103, wherein sequestering the initial volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 121. The device of claim 103, wherein sequestering the initial volume of blood comprises avoiding fluid flow from the initial volume of blood to the second fluid flow path.]
[ 122. The device of claim 103, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 123. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a sample vessel containing a culture media;
a first fluid flow path in fluid communication with a reservoir integrated into the device, the reservoir configured to receive an initial volume of blood from the patient via the first fluid flow path;
a second fluid flow path in fluid communication with the sample vessel; and
a junction configured to automatically transition in direct response to filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that a subsequent flow of blood flows via the second fluid flow path, the sequestered initial volume not being used as the blood sample in the culture testing,
wherein sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood and reduces contamination in the blood to be used as the blood sample for the culture testing.]
[ 124. The device of claim 123, wherein the initial volume of blood is less than 5 ml.]
[ 125. The device of claim 123, further comprising:
a lumen-containing device configured to be inserted into the vasculature of the patient to establish fluid communication between the device and the vasculature of the patient, the initial volume of blood is greater than the volume of a lumen of the lumen-containing device and less than 5 ml.]
[ 126. The device of claim 123, wherein the initial volume of blood is 0.5 ml to 5 ml.]
[ 127. The device of claim 123, further comprising:
a diverter having a first state operable to allow sequestration of contaminants present in the initial volume of blood, and a second state operable to allow blood to flow toward the sample vessel via the second fluid flow path, the transitioning at the junction includes the diverter automatically transitioning from the first state to the second state.]
[ 128. The device of claim 123, wherein the sample vessel is a vacuum-sealed vessel.]
[ 129. The device of claim 123, wherein the contaminants are dermally-residing microbes.]
[ 130. The device of claim 123, wherein the junction comprises a solid barrier, and wherein sequestering the initial volume of blood comprises setting apart, by the solid barrier, the initial volume of blood from the subsequent flow of blood.]
[ 131. The device of claim 123, further comprising:
a solid barrier configured to separate the initial volume of blood from the subsequent flow of blood.]
[ 132. The device of claim 123, wherein sequestering the initial volume of blood comprises setting apart the initial volume of blood from the subsequent flow of blood.]
[ 133. The device of claim 123, wherein sequestering the initial volume of blood comprises separating the initial volume of blood from the subsequent flow of blood.]
[ 134. The device of claim 123, wherein sequestering the initial volume of blood comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 135. The device of claim 123, wherein sequestering the initial volume of blood comprises avoiding fluid flow from the initial volume of blood to the second fluid flow path.]
[ 136. The device of claim 123, wherein the junction includes a branching connection between the first fluid flow path and the second fluid flow path.]
[ 137. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a first fluid flow path configured to receive a first volume of blood from the patient, wherein a portion of the first volume of blood including a patient tissue fragment;
a second fluid flow path configured to be placed in fluid communication with a sample vessel, the sample vessel containing a culture media; and
a junction in fluid communication with the first fluid flow path and the second fluid flow path, the device configured to automatically transition at the junction from a first state, in which the first volume of blood can flow from the patient via the first fluid flow path, to a second state, in which a second volume of blood can flow from the patient via the second fluid flow path, the portion of the first volume of blood being sequestered in the first fluid flow path when the device is in the second state,
wherein sequestering the portion of the first volume of blood sequesters contaminants, including the patient tissue fragment, present in the first volume of blood and reduces contamination in the blood used as the blood sample in the culture testing.]
[ 138. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a first fluid flow path in fluid communication with a reservoir integrated into the device, the reservoir configured to receive an initial volume of blood from the patient via the first fluid flow path, wherein the initial volume of blood includes a patient tissue fragment;
a second fluid flow path configured to be placed in fluid communication with a sample vessel containing a culture media; and
a junction configured to automatically transition in response to filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that a subsequent flow of blood flows via the second fluid flow path, the sequestered initial volume not being used as the blood sample in the culture testing,
wherein sequestering the initial volume of blood sequesters contaminants, including the patient tissue fragment, present in the initial volume of blood and reduces contamination in the blood flowing via the second fluid flow path to be used as the blood sample for the culture testing.]
[ 139. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a lumen-containing device configured to establish fluid communication between the patient and the device;
a first fluid flow path in fluid communication with the lumen-containing device, the first fluid flow path configured to receive an initial volume of blood from the patient, wherein a portion of the initial volume of blood includes a patient tissue fragment;
a second fluid flow path configured to be placed in fluid communication with the lumen-containing device, the second fluid flow path configured to be in fluid communication with a sample vessel containing a culture media; and
the device being configured to automatically transition at a junction between the first fluid flow path and the second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient, wherein the initial volume of blood including the patient tissue fragment is sequestered and wherein the sample vessel can receive a subsequent blood sample via the second fluid flow path.]
[ 140. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a lumen-containing device configured to establish fluid communication between the patient and the device;
a diverter in fluid communication with the lumen-containing device, the diverter configured to (a) receive a first volume of blood from the patient when the diverter is in a first state and (b) sequester a portion of the first volume of blood as a result of receiving the first volume of blood, wherein the portion of the first volume of blood includes a patient tissue fragment; and
a sample vessel containing a culture media, the sample vessel configured to be placed in fluid communication with the diverter to receive a second volume of blood when the diverter is in a second state after the portion of the first volume of blood is sequestered, the diverter configured to automatically transition from the first state to the second state to sequester the portion of the first volume of blood and divert the second volume of blood away from the sequestered portion of the first volume of blood,
wherein the sequestered portion of the first volume of blood reduces contamination including the patient tissue fragment in the blood used as the blood sample in the culture testing.]
[ 141. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a first fluid flow path in fluid communication with a reservoir integrated into the device, the reservoir configured to receive an initial volume of blood from the patient via the first fluid flow path, wherein a portion of the initial volume of blood includes a patient tissue fragment;
a second fluid flow path configured to be placed in fluid communication with a sample vessel containing a culture media; and
a junction configured to transition without manual intervention in direct response to filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that a subsequent flow of blood flows via the second fluid flow path, the sequestered initial volume not being used as the blood sample in the culture testing,
wherein the sequestered initial volume reduces contamination including the patient tissue fragment in the blood to be used as the blood sample for culture testing.]
[ 142. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a first fluid flow path configured to receive a first volume of blood from the patient;
a second fluid flow path configured to be placed in fluid communication with a sample vessel, the sample vessel containing a culture media; and
a junction in fluid communication with the first fluid flow path and the second fluid flow path, the junction configured to automatically transition from a first state, in which the first volume of blood can flow from the patient via the first fluid flow path, to a second state, in which a second volume of blood can flow from the patient via the second fluid flow path, a portion of the first volume of blood being sequestered in the first fluid flow path when the junction is in the second state,
wherein the first fluid flow path is configured to sequester contaminants present in the first volume of blood and reduce contamination in the blood used as the blood sample in the culture testing.]
[ 143. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a lumen-containing device configured to establish fluid communication between the patient and the device;
a first fluid flow path in fluid communication with the lumen-containing device, the first fluid flow path configured to receive an initial volume of blood from the patient;
a second fluid flow path configured to be placed in fluid communication with the lumen-containing device, the second fluid flow path configured to be in fluid communication with a sample vessel containing a culture media; and
a junction being configured to automatically transition between the first fluid flow path and the second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient, wherein the sample vessel is configured to receive a subsequent blood sample, and wherein automatically transitioning at the junction sequesters contaminants present in the initial volume of blood via the first fluid flow path.]
[ 144. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a lumen-containing device configured to establish fluid communication between the patient and the device;
a first fluid flow path in fluid communication with the lumen-containing device, the first fluid flow path configured to receive an initial volume of blood from the patient; and
a second fluid flow path configured to be placed in fluid communication with the lumen-containing device, the second fluid flow path configured to be in fluid communication with a sample vessel containing a culture media; and
a junction in fluid communication with the first fluid flow path and the second fluid flow path, the device configured to automatically transition at the junction between the first fluid flow path and the second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient, wherein the sample vessel is configured to receive a subsequent blood sample, and wherein the device automatically transitioning at the junction sequesters contaminants present in the initial volume of blood via the first fluid flow path.]
[ 145. The device of claim 1, wherein the junction comprises a switchable valve, and wherein sequestering the portion of the first volume of blood comprises operating the switchable valve around a pivot point associated with the junction.]
[ 146. The device of claim 1, wherein the junction comprises a switchable valve, and wherein sequestering the portion of the first volume of blood comprises creating a seal associated with the switchable valve.]
[ 147. The device of claim 1, further comprising:
a switchable valve configured to operate around a pivot point to separate the portion of the first volume of blood from the second volume of blood.]
[ 148. The device of claim 1, further comprising:
a switchable valve configured to be automatically switchable between the first state and the second state based on a sensed change in a condition associated with the device.]
[ 149. The device of claim 9, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises operating the switchable valve around a pivot point associated with the junction.]
[ 150. The device of claim 9, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises creating a seal associated with the switchable valve.]
[ 151. The device of claim 9, further comprising:
a switchable valve configured to operate around a pivot point to separate the initial volume of blood from the subsequent flow of blood.]
[ 152. The device of claim 9, further comprising:
a switchable valve configured to be automatically switchable between the first fluid flow path and the second fluid flow path based on a sensed change in a condition associated with the device.]
[ 153. The device of claim 16, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises operating the switchable valve around a pivot point associated with the junction.]
[ 154. The device of claim 16, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises creating a seal associated with the switchable valve.]
[ 155. The device of claim 16, further comprising:
a switchable valve configured to operate around a pivot point to separate the initial volume of blood from the subsequent blood sample.]
[ 156. The device of claim 16, further comprising:
a switchable valve configured to be automatically switchable between the first fluid flow path and the second fluid flow path based on a sensed change in a condition associated with the device.]
[ 157. The device of claim 27, wherein the diverter comprises a switchable valve, and wherein sequestering the portion of the first volume of blood comprises operating the switchable valve around a pivot point associated with the diverter.]
[ 158. The device of claim 27, wherein the diverter comprises a switchable valve, and wherein sequestering the portion of the first volume of blood comprises creating a seal associated with the switchable valve.]
[ 159. The device of claim 27, further comprising:
a seal configured to operate around a pivot point to separate the portion of the first volume of blood from the second volume of blood.]
[ 160. The device of claim 27, further comprising:
a switchable valve configured to be automatically switchable between the first state and the second state based on a sensed change in a condition associated with the device.]
[ 161. The device of claim 31, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises operating the switchable valve around a pivot point associated with the junction.]
[ 162. The device of claim 31, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises creating a seal associated with the switchable valve.]
[ 163. The device of claim 31, further comprising:
a switchable valve configured to operate around a pivot point to separate the initial volume of blood from the subsequent flow of blood.]
[ 164. The device of claim 31, further comprising:
a switchable valve configured to be automatically switchable between the first fluid flow path and the second fluid flow path based on a sensed change in a condition associated with the device.]
[ 165. The device of claim 123, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises operating the switchable valve around a pivot point associated with the junction.]
[ 166. The device of claim 123, wherein the junction comprises a switchable valve, and wherein sequestering the initial volume of blood comprises creating a seal associated with the switchable valve.]
[ 167. The device of claim 123, further comprising:
a switchable valve configured to operate around a pivot point to separate the initial volume of blood from the subsequent flow of blood.]
[ 168. The device of claim 123, further comprising:
a switchable valve configured to be automatically switchable between the first fluid flow path and the second fluid flow path based on a sensed change in a condition associated with the device.]
[ 169. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a first fluid flow path configured to receive a first volume of blood from the patient;
a sample vessel containing a culture media;
a second fluid flow path in fluid communication with the sample vessel; and
a junction in fluid communication with the first fluid flow path and the second fluid flow path, the device configured to automatically transition at the junction from a first state, in which the first volume of blood can flow from the patient via the first fluid flow path, to a second state, in which a second volume of blood can flow from the patient via the second fluid flow path, a portion of the first volume of blood being sequestered in the first fluid flow path when the device is in the second state,
whereby sequestering the portion of the first volume of blood sequesters contaminants present in the first volume of blood, thereby reducing contamination in the blood used as the blood sample in the culture testing.]
[ 170. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a lumen-containing device configured to establish fluid communication between the patient and the device;
a first fluid flow path in fluid communication with the lumen-containing device, the first fluid flow path configured to receive an initial volume of blood from the patient;
a sample vessel containing a culture media; and
a second fluid flow path configured to be placed in fluid communication with the lumen-containing device, the second fluid flow path in fluid communication with the sample vessel,
whereby the device is configured to automatically transition at a junction between the first fluid flow path and the second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient such that (a) the initial volume of blood is sequestered and (b) the sample vessel can receive a subsequent blood sample via the second fluid flow path.]
[ 171. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a lumen-containing device configured to establish fluid communication between the patient and the device;
a diverter in fluid communication with the lumen-containing device, the diverter configured to (a) receive a first volume of blood from the patient when the diverter is in a first state and (b) sequester a portion of the first volume of blood as a result of receiving the first volume of blood; and
a sample vessel containing a culture media, the sample vessel connected to the diverter while the first volume of blood is received, and the sample vessel configured to be placed in fluid communication with the diverter to receive a second volume of blood when the diverter is in a second state after the portion of the first volume of blood is sequestered, the diverter configured to automatically transition from the first state to the second state to sequester the portion of the first volume of blood and divert the flow of blood away from the sequestered portion of the first volume of blood,
whereby sequestering the portion of the first volume of blood sequesters contaminants present in the first volume of blood, thereby reducing contamination in the blood used as the blood sample in the culture testing.]
[ 172. A device for obtaining a blood sample with reduced contamination from a patient to reduce false results in culture testing of the blood sample, the device comprising:
a sample vessel containing a culture media;
a first fluid flow path in fluid communication with a reservoir integrated into the device, the reservoir configured to receive an initial volume of blood from the patient via the first fluid flow path;
a second fluid flow path in fluid communication with the sample vessel; and
a junction configured to transition without manual intervention in direct response to filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that a subsequent flow of blood flows via the second fluid flow path, the sequestered initial volume not being used as the blood sample in the culture testing,
whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood to be used as the blood sample for the culture testing.]