US 9,855,002 C1 (13,258th)
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, INC.
Reexamination Request No. 90/019,757, Dec. 6, 2024.
Reexamination Certificate for Patent 9,855,002, issued Jan. 2, 2018, Appl. No. 15/432,310, Feb. 14, 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 90/019,757 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 14, 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 1-28 is confirmed.
New claims 29-122 are added and determined to be patentable.
[ 29. The method of claim 1, wherein the sequestering the portion of the first volume of blood further comprises setting apart, by a solid barrier, the portion of the first volume of blood from the second volume of blood.]
[ 30. The method of claim 1, further comprising separating, by a solid barrier, the portion of the first volume of blood from the second volume of blood.]
[ 31. The method of claim 1, wherein the sequestering the portion of the first volume of blood further comprises setting apart the portion of the first volume of blood from the second volume of blood.]
[ 32. The method of claim 1, further comprising separating the portion of the first volume of blood from the second volume of blood.]
[ 33. The method of claim 1, wherein the sequestering the portion of the first volume of blood further comprises capturing the portion of the first volume of blood separate from the second volume of blood.]
[ 34. The method of claim 1, wherein the sequestering the portion of the first volume of blood further comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 35. The method of claim 1, wherein the sequestering the portion of the first volume of blood further comprises avoiding fluid flow from the portion of the first volume of blood into the second fluid flow path.]
[ 36. The method of claim 1, wherein the junction includes a branching connection between an inlet fluid flow path to the vasculature of the patient, the first fluid flow path, and the second fluid flow path.]
[ 37. The method of claim 10, wherein the sequestering the initial volume of blood further comprises setting apart, by a solid barrier, the initial volume of blood.]
[ 38. The method of claim 10, further comprising separating, by a solid barrier, the initial volume of blood and a second volume of blood associated with the second fluid flow path.]
[ 39. The method of claim 10, wherein the sequestering the initial volume of blood further comprises setting apart the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 40. The method of claim 10, further comprising separating the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 41. The method of claim 10, wherein the sequestering the initial volume of blood further comprises capturing the initial volume of blood separate from a second volume of blood associated with the second fluid flow path.]
[ 42. The method of claim 10, wherein the sequestering the initial volume of blood further comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 43. The method of claim 10, wherein the sequestering the initial volume of blood further comprises avoiding fluid flow the initial volume of blood into the second fluid flow path.]
[ 44. The method of claim 10, wherein the junction includes a branching connection between an inlet fluid flow path to the vasculature of the patient, the first fluid flow path, and the second fluid flow path.]
[ 45. The method of claim 17, wherein the sequestering the initial volume of blood further comprises setting apart, by a solid barrier, the initial volume of blood.]
[ 46. The method of claim 17, further comprising separating, by a solid barrier, the initial volume of blood and a second volume of blood associated with the second fluid flow path.]
[ 47. The method of claim 17, wherein the sequestering the initial volume of blood further comprises setting apart the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 48. The method of claim 17, further comprising separating the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 49. The method of claim 17, wherein the sequestering the initial volume of blood further comprises capturing the initial volume of blood separate from a second volume of blood associated with the second fluid flow path.]
[ 50. The method of claim 17, wherein the sequestering the initial volume of blood further comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 51. The method of claim 17, wherein the sequestering the initial volume of blood further comprises avoiding fluid flow the initial volume of blood into the second fluid flow path.]
[ 52. The method of claim 17, wherein the junction includes a branching connection between an inlet fluid flow path to the lumen-containing device, the first fluid flow path, and the second fluid flow path.]
[ 53. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
automatically transitioning at the junction configured to automatically transition to a second state as a result of receiving the first volume of blood from the patient such that a portion of the first volume of blood is sequestered in the first fluid flow path; and
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media,
whereby sequestering the portion of the first volume of blood sequesters contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 54. The method of claim 53, wherein establishing fluid communication with the vasculature of the patient includes inserting a needle having a lumen into the vasculature of the patient, the portion of the first volume of blood is greater than a volume of the lumen of the needle and less than 5 ml.]
[ 55. The method of claim 53, wherein establishing fluid communication with the vasculature of the patient includes inserting a needle having a lumen into the vasculature of the patient.]
[ 56. The method of claim 53, wherein the sample procurement device further includes 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 to the sample vessel, the transitioning at the junction includes the diverter transitioning from the first state to the second state after blood stops flowing from the patient.]
[ 57. The method of claim 56, wherein the diverter is a single diverter.]
[ 58. The method of claim 53, wherein the portion of blood is sequestered in a reservoir and not used for culture testing.]
[ 59. The method of claim 58, wherein the reservoir is integrated into the sample procurement device.]
[ 60. The method of claim 53, wherein the contaminants are dermally-residing microbes.]
[ 61. The method of claim 53, wherein the sample procurement device further includes a diverter that defines the first fluid flow path such that the portion of blood can flow from a needle to the sample procurement device, and the second fluid flow path such that the second volume of blood can flow from the needle to the sample vessel, the diverter configured to cause transition of blood flow from the first fluid flow path to the second fluid flow path after sequestration of the portion of blood flow from the patient.]
[ 62. The method of claim 53, wherein the sequestering the portion of the first volume of blood further comprises setting apart, by a solid barrier, the portion of the first volume of blood from the second volume of blood.]
[ 63. The method of claim 53, further comprising separating, by a solid barrier, the portion of the first volume of blood from the second volume of blood.]
[ 64. The method of claim 53, wherein the sequestering the portion of the first volume of blood further comprises setting apart the portion of the first volume of blood from the second volume of blood.]
[ 65. The method of claim 53, further comprising separating the portion of the first volume of blood from the second volume of blood.]
[ 66. The method of claim 53, wherein the sequestering the portion of the first volume of blood further comprises capturing the portion of the first volume of blood separate from the second volume of blood.]
[ 67. The method of claim 53, wherein the sequestering the portion of the first volume of blood further comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 68. The method of claim 53, wherein the sequestering the portion of the first volume of blood further comprises avoiding fluid flow from the portion of the first volume of blood into the second fluid flow path.]
[ 69. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device via the first fluid flow path; and
automatically transitioning at the junction configured to automatically transition to a second state in response to substantially filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that subsequent flow of blood flows to a sample vessel via the second fluid flow path, the sample vessel containing a culture media, 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 flowing to the sample vessel to be used as the blood sample for the culture testing.]
[ 70. The method of claim 69, wherein the initial volume of blood is less than 5 ml.]
[ 71. The method of claim 69, wherein establishing fluid communication with the vasculature of the patient includes inserting a needle having a lumen into the vasculature of the patient, the initial volume of blood is greater than a volume of the lumen of the needle and less than 5 ml.]
[ 72. The method of claim 69, wherein the initial volume of blood is 0.5 ml to 5 ml.]
[ 73. The method of claim 69, wherein the sample procurement device further includes 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 to the sample vessel. the transitioning at the junction includes the diverter transitioning from the first state to the second state after blood stops flowing from the patient.]
[ 74. The method of claim 69, wherein the sample vessel is a vacuum-sealed vessel.]
[ 75. The method of claim 69, wherein the contaminants are dermally-residing microbes.]
[ 76. The method of claim 69, wherein the sequestering initial volume of blood further comprises setting apart, by a solid barrier, the initial volume of blood.]
[ 77. The method of claim 69, further comprising separating, by a solid barrier, the initial volume of blood and a second volume of blood associated with the second fluid flow path.]
[ 78. The method of claim 69, wherein the sequestering the initial volume of blood further comprises setting apart the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 79. The method of claim 69, further comprising separating the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 80. The method of claim 69, wherein the sequestering the initial volume of blood further comprises capturing the initial volume of blood separate from a second volume of blood associated with the second fluid flow path.]
[ 81. The method of claim 69, wherein the sequestering the initial volume of blood further comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 82. The method of claim 69, wherein the sequestering the initial volume of blood further comprises avoiding fluid flow the initial volume of blood into the second fluid flow path.]
[ 83. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:
establishing fluid communication between a lumen-containing device and the patient;
establishing fluid communication between the lumen-containing device and a first fluid flow path;
receiving an initial volume of blood from the patient;
automatically transitioning at a junction between the first fluid flow path and a second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient such that the initial volume of blood is sequestered and such that fluid communication is established between the lumen-containing device and a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
receiving a subsequent blood sample into the sample vessel.]
[ 84. The method of claim 83, whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood flowing to the sample vessel.]
[ 85. The method of claim 84, wherein the contaminants are dermally-residing microbes.]
[ 86. The method of claim 83, wherein the initial volume of blood is greater than a volume of the lumen of the lumen-containing device and less than 5 ml.]
[ 87. The method of claim 83, wherein the initial volume of blood is sequestered in a reservoir.]
[ 88. The method of claim 87, wherein the reservoir is integrated into the sample procurement device.]
[ 89. The method of claim 87, wherein the reservoir is configured to contain less than 5 ml of blood.]
[ 90. The method of claim 87, wherein the sample procurement device further includes 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 to the sample vessel.]
[ 91. The method of claim 83, wherein the sample procurement device further includes a diverter that transitions from a first state to a second state, the first state operable to transfer 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 cause transition between the first state and the second state in response to the sequestration of the initial volume of blood flow from the patient.]
[ 92. The method of claim 83, wherein the sample procurement device further includes a diverter that transitions from a first state to a second state, the first state operable to transfer 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.]
[ 93. The method of claim 83, wherein the sample procurement device further includes a diverter that transitions from a first state to a second state, the first state operable to transfer 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.]
[ 94. The method of claim 83, further comprising sequestering the portion of the first volume of blood by setting apart, by a solid barrier, the initial volume of blood.]
[ 95. The method of claim 83, further comprising separating, by a solid barrier, the initial volume of blood and a second volume of blood associated with the second fluid flow path.]
[ 96. The method of claim 83, wherein the sequestering the initial volume of blood further comprises setting apart the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 97. The method of claim 83, further comprising separating the initial volume of blood from a second volume of blood associated with the second fluid flow path.]
[ 98. The method of claim 83, wherein the sequestering the initial volume of blood further comprises capturing the initial volume of blood separate from a second volume of blood associated with the second fluid flow path.]
[ 99. The method of claim 83, wherein the sequestering the initial volume of blood further comprises restricting fluid flow between the first fluid flow path and the second fluid flow path.]
[ 100. The method of claim 83, wherein the sequestering the initial volume of blood further comprises avoiding fluid flow the initial volume of blood into the second fluid flow path.]
[ 101. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
the junction including a branching connection between the first fluid flow path and the second fluid flow path, and configured to transition to a second state as a result of receiving the first volume of blood from the patient such that a portion of the first volume of blood is sequestered in the first fluid flow path; and
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media,
whereby sequestering the portion of the first volume of blood sequesters contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 102. The method of claim 101, wherein the branching connection is between an inlet fluid flow path to the vasculature of the patient, the first fluid flow path, and the second fluid flow path.]
[ 103. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
transitioning, by the junction, to a second state as a result of receiving the first volume of blood from the patient, wherein a portion of the first volume of blood is sequestered in the first fluid flow path, and wherein the sequestered portion of the first volume of blood includes a patient tissue fragment;
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
sequestering the portion of the first volume of blood including contaminants present in the first volume of blood and the patient tissue fragment, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 104. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
automatically transitioning, by the junction, to a second state as a result of receiving the first volume of blood from the patient, wherein a portion of the first volume of blood is sequestered in the first fluid flow path, and wherein the sequestered portion of the first volume of blood includes a patient tissue fragment;
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
sequestering the portion of the first volume of blood including contaminants present in the first volume of blood and the patient tissue fragment, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 105. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
automatically transitioning, by the junction, to a second state as a result of receiving the first volume of blood from the patient, wherein a portion of the first volume of blood is sequestered in the first fluid flow path, and wherein the sequestered portion of the first volume of blood includes a patient tissue fragment;
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
sequestering the portion of the first volume of blood including contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 106. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
automatically transitioning, by diverting blood flow from the first fluid flow path to the second fluid flow path at the junction, to a second state as a result of receiving the first volume of blood from the patient, wherein a portion of the first volume of blood is sequestered in the first fluid flow path, and wherein the sequestered portion of the first volume of blood includes a patient tissue fragment;
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
sequestering the portion of the first volume of blood including contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 107. The method of claim 106, wherein the junction includes a branching connection between an inlet fluid flow path to the vasculature of the patient, the first fluid flow path, and the second fluid flow path.]
[ 108. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
automatically transitioning, by diverting blood flow from the first fluid flow path to the second fluid flow path at the junction, to a second state as a result of receiving the first volume of blood from the patient, wherein a portion of the first volume of blood is sequestered in the first fluid flow path, and wherein the sequestered portion of the first volume of blood includes a patient tissue fragment;
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
sequestering the portion of the first volume of blood including contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 109. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing a blood flow via fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
diverting, at the junction, from the first fluid flow path to the second fluid flow path and based on receiving a first volume of blood in a reservoir, the blood flow, wherein the junction is configured to transition to a second state as a result of receiving the first volume of blood from the patient such that a portion of the first volume of blood is sequestered in the first fluid flow path;
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
sequestering the portion of the first volume of blood including contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 110. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing a blood flow via fluid communication with the vasculature of the patient;
receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;
diverting, based on receiving a first volume of blood in a reservoir, at the junction comprising a switchable valve, the blood flow, wherein the junction is configured to transition to a second state as a result of receiving the first volume of blood from the patient such that a portion of the first volume of blood is sequestered in the first fluid flow path;
receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
sequestering the portion of the first volume of blood including contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.]
[ 111. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device via the first fluid flow path; and
the junction including a branching connection between the first fluid flow path and the second fluid flow path, and configured to transition from a first state to a second state in response to substantially filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that subsequent flow of blood flows to a sample vessel via the second fluid flow path, the sample vessel containing a culture media, 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 flowing to the sample vessel to be used as the blood sample for the culture testing.]
[ 112. The method of claim 111, wherein the branching connection is between an inlet fluid flow path to the vasculature of the patient, the first fluid flow path, and the second fluid flow path.]
[ 113. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device via the first fluid flow path;
transitioning, by the junction, from a first state to a second state in response to substantially filling the reservoir; and
in response to the transitioning, sequestering in the reservoir the initial volume of blood and contaminants present in the initial volume of blood, such that subsequent flow of blood flows to a sample vessel via the second fluid flow path, thereby reducing contamination in the blood flowing to the sample vessel to be used as the blood sample for the culture testing, the sample vessel containing a culture media, and the sequestered initial volume not being used as the blood sample in the culture testing.]
[ 114. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device via the first fluid flow path;
transitioning, by the junction, from a first state to a second state in response to substantially filling the reservoir with the initial volume of blood, wherein the initial volume of blood comprises a patient tissue fragment; and
in response to the transitioning, sequestering in the reservoir the initial volume of blood and contaminants comprising the patient tissue fragment, such that subsequent flow of blood flows to a sample vessel via the second fluid flow path, thereby reducing contamination in the blood flowing to the sample vessel to be used as the blood sample for the culture testing, the sample vessel containing a culture media, and the sequestered initial volume not being used as the blood sample in the culture testing.]
[ 115. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:
establishing fluid communication with the vasculature of the patient;
receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device via the first fluid flow path;
diverting, at the junction, from a first state to a second state in response to substantially filling the reservoir with the initial volume of blood; and
in response to the diverting, sequestering in the reservoir the initial volume of blood and contaminants present in the initial volume of blood, such that subsequent flow of blood flows to a sample vessel via the second fluid flow path, thereby reducing contamination in the blood flowing to the sample vessel to be used as the blood sample for the culture testing, the sample vessel containing a culture media, and the sequestered initial volume not being used as the blood sample in the culture testing.]
[ 116. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:
establishing fluid communication between a lumen-containing device and the patient;
establishing fluid communication between the lumen-containing device and a first fluid flow path;
receiving an initial volume of blood from the patient;
transitioning at a junction at a branching connection between the first fluid flow path and a second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient such that the initial volume of blood is sequestered with a patient tissue fragment and such that fluid communication is established between the lumen-containing device and a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
receiving a subsequent blood sample into the sample vessel.]
[ 117. The method of claim 116, wherein the branching connection is between the lumen-containing device, the first fluid flow path, and the second fluid flow path.]
[ 118. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:
establishing fluid communication between a lumen-containing device and the patient;
establishing fluid communication between the lumen-containing device and a first fluid flow path;
receiving an initial volume of blood from the patient;
transitioning at a junction between the first fluid flow path and a second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient such that the initial volume of blood is sequestered with a patient tissue fragment and such that fluid communication is established between the lumen-containing device and a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
receiving a subsequent blood sample into the sample vessel.]
[ 119. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:
establishing fluid communication between a lumen-containing device and the patient;
establishing fluid communication between the lumen-containing device and a first fluid flow path;
receiving, into a reservoir, an initial volume of blood from the patient, wherein the initial volume of blood comprises a patient tissue fragment;
transitioning at a junction between the first fluid flow path and a second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient such that the initial volume of blood is sequestered with the patient tissue fragment and such that fluid communication is established between the lumen-containing device and a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
receiving a subsequent blood sample into the sample vessel.]
[ 120. The method of claim 119, wherein the junction includes a branching connection between an inlet fluid flow path to the lumen-containing device, the first fluid flow path, and the second fluid flow path.]
[ 121. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:
establishing fluid communication between a lumen-containing device and the patient;
establishing fluid communication between the lumen-containing device and a first fluid flow path;
receiving, into a reservoir, an initial volume of blood from the patient, wherein the initial volume of blood comprises a patient tissue fragment;
diverting the initial volume of blood, using a physical barrier at a junction between the first fluid flow path and a second fluid flow path, and as a result of the first fluid flow path receiving the initial volume of blood from the patient, such that the initial volume of blood is sequestered with the patient tissue fragment and such that fluid communication is established between the lumen-containing device and a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
receiving a subsequent blood sample into the sample vessel.]
[ 122. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:
establishing fluid communication between a lumen-containing device and the patient;
establishing fluid communication between the lumen-containing device and a first fluid flow path;
receiving an initial volume of blood from the patient comprising a patient tissue fragment;
transitioning the initial volume of blood, using a physical barrier at a junction between the first fluid flow path and a second fluid flow path, and as a result of the first fluid flow path receiving the initial volume of blood from the patient, such that the initial volume of blood is sequestered with the patient tissue fragment and such that fluid communication is established between the lumen-containing device and a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and
receiving a subsequent blood sample into the sample vessel.]