Fluid control devices and methods of using the same
A fluid control device includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device, which can produce a negative pressure differential between the outlet and the inlet. A sequestration portion is in fluid communication with the inlet and includes a first flow controller configured to transition from a first state to a second state to place the sequestration portion in fluid communication with the outlet when the negative pressure differential has a first magnitude. A sampling portion is in fluid communication with an outlet and includes a second flow controller configured to transition from a first state to a second state to place the sampling portion in fluid communication with the inlet when the negative pressure differential has a second magnitude greater than the first magnitude.
1 . A fluid control device, comprising:
a housing having an inlet configured to establish fluid communication with a bodily fluid source and an outlet configured to be coupled to a fluid collection device, the housing defining a sequestration flow path in fluid communication with the inlet and a sampling flow path in fluid communication with the outlet;
a first flow controller having a flow state and a non-flow state, the first flow controller in the flow state configured to facilitate, in response to a negative pressure differential between the inlet and the outlet, a flow of a bodily fluid into the sequestration flow path and a flow of a gas from the sequestration flow path, through the first flow controller, and to the outlet, the first flow controller in the non-flow state configured to sequester the sequestration flow path from the outlet; and
a second flow controller having a diaphragm that defines a portion of the sequestration flow path, the diaphragm configured to transition from a first configuration to a second configuration in response to an increase in a portion of the negative pressure differential between the inlet and the outlet that is applied across the diaphragm when the first flow controller is in the non-flow state, the second flow controller further having a barrier configured to be transitioned, at least in part by the diaphragm due to the diaphragm transitioning, from a first state in which the barrier separates at least a portion of the sampling flow path from the inlet to a second state in which the sampling flow path fluidically couples the inlet to the outlet.
2 . The fluid control device of claim 1 , wherein the first flow controller is configured to transition from the flow state to the non-flow state automatically.
3 . The fluid control device of claim 1 , wherein the diaphragm of the second flow controller is configured to transition from the first configuration to the second configuration automatically.
4 . The fluid control device of claim 1 , wherein the first flow controller includes a selectively permeable material configured to (1) allow the flow of the gas and prevent the flow of the bodily fluid through the selectively permeable material when the first flow controller is in the flow state and (2) prevent the gas and the bodily fluid from flowing through the selectively permeable material when the first flow controller is in the non-flow state.
5 . The fluid control device of claim 4 , wherein the first flow controller is configured to transition from the flow state to the non-flow state as a result of the sequestration flow path receiving an initial volume of the bodily fluid.
6 . The fluid control device of claim 5 , wherein the selectively permeable material is configured such that contact with at least a portion of the initial volume of the bodily fluid is operable to transition the first flow controller from the flow state to the non-flow state.
7 . The fluid control device of claim 1 , wherein the fluid control device is configured such that the portion of the negative pressure differential applied across the diaphragm has a first magnitude when the first flow controller is in the flow state and has a second magnitude greater than the first magnitude when the first flow controller is in the non-flow state.
8 . The fluid control device of claim 1 , wherein the diaphragm is configured to deform in response to the increase in the portion of the negative pressure differential applied across the diaphragm to transition the diaphragm from the first configuration to the second configuration.
9 . The fluid control device of claim 1 , wherein the barrier in the first state forms a seal with an inner surface of the housing defining at least the portion of the sampling flow path.
10 . The fluid control device of claim 1 , wherein the diaphragm is configured to transition the barrier from the first state to the second state by moving the barrier from a first position to a second position as the diaphragm transitions from the first configuration to the second configuration.
11 . The fluid control device of claim 1 , wherein the second flow controller further includes a piercing member coupled to the diaphragm, the diaphragm configured to transition the barrier from the first state to the second state by causing the piercing member to pierce the barrier as the diaphragm transitions from the first configuration to the second configuration.
12 . The fluid control device of claim 1 , wherein the sequestration flow path has a first volume when the diaphragm is in the first configuration and has a second volume when the diaphragm is in the second configuration, the second volume being greater than the first volume.
13 . A method of using a fluid control device to obtain a bodily fluid sample with reduced contamination, the method comprising:
coupling a fluid collection device to an outlet of the fluid control device to produce a negative pressure differential between the outlet and an inlet of the fluid control device;
receiving an initial volume of a bodily fluid from the inlet and into a sequestration flow path of the fluid control device in response to the negative pressure differential when a first flow controller of the fluid control device is in a flow state;
transitioning the first flow controller from the flow state to a non-flow state in response to the receiving such that the first flow controller sequesters the sequestration flow path from the outlet;
transitioning a diaphragm of a second flow controller from a first configuration to a second configuration in response to an increase in a portion of the negative pressure differential between the inlet and the outlet that is applied across the diaphragm caused by the transitioning of the first flow controller to the non-flow state, the diaphragm defining a portion of the sequestration flow path;
transitioning a barrier of the second flow controller, at least in part by the diaphragm due to the diaphragm transitioning, from a first state in which the barrier separates a sampling flow path of the fluid control device from the inlet, to a second state in which the sampling flow path fluidically couples the inlet to the outlet; and
transferring a subsequent volume of the bodily fluid from the inlet to the outlet via the sampling flow path.
14 . The method of claim 13 , wherein the transitioning of the first flow controller from the flow state to the non-flow state includes automatically transitioning the first flow controller from the flow state to the non-flow state.
15 . The method of claim 13 , wherein the transitioning of the diaphragm from the first configuration to the second configuration includes automatically transitioning the diaphragm from the first configuration to the second configuration due to the increase in the portion of the negative pressure differential between the inlet and the outlet that is applied across the diaphragm.
16 . The method of claim 13 , wherein the first flow controller includes a selectively permeable material configured to (1) allow a flow of a gas and prevent a flow of the bodily fluid through the selectively permeable material when the first flow controller is in the flow state and (2) prevent the gas and the bodily fluid from flowing through the selectively permeable material when the first flow controller is in the non-flow state.
17 . The method of claim 13 , further comprising:
establishing fluid communication between the inlet and a bodily fluid source, wherein the initial volume of the bodily fluid contains contaminants associated with the establishing of the fluid communication between the inlet and the bodily fluid source.
18 . The method of claim 17 , wherein the initial volume of the bodily fluid and the contaminants are sequestered within the sequestration flow path when the first flow controller is in the non-flow state, and
the transferring of the subsequent volume of the bodily fluid from the inlet to the outlet via the sampling flow path includes bypassing the initial volume of the bodily fluid and the contaminants in the sequestration flow path.
19 . The method of claim 13 , wherein the fluid control device is configured such that the portion of the negative pressure differential applied across the diaphragm has a first magnitude when the first flow controller is in the flow state and has a second magnitude greater than the first magnitude when the first flow controller is in the non-flow state.
20 . The method of claim 13 , wherein the barrier in the first state forms a seal with an inner surface of the fluid control device that at least partially defines the sampling flow path.
21 . The method of claim 13 , wherein the transitioning the diaphragm from the first configuration to the second configuration includes deforming the diaphragm in response to the increase in the portion of the negative pressure differential applied across the diaphragm.
22 . The method of claim 13 , wherein the transitioning of the barrier from the first state to the second state includes moving the barrier from a first position to a second position based on the diaphragm transitioning from the first configuration to the second configuration.
23 . The method of claim 13 , wherein the second flow controller further includes a piercing member coupled to the diaphragm, the transitioning of the barrier from the first state to the second state includes piercing the barrier as the diaphragm transitions from the first configuration to the second configuration.
24 . The method of claim 13 , wherein the sequestration flow path has a first volume when the diaphragm is in the first configuration and has a second volume when the diaphragm is in the second configuration, the second volume being greater than the first volume.