US2018353117A1PendingUtilityA1

Fluid control devices and methods of using the same

Assignee: MAGNOLIA MEDICAL TECHNOLOGIES INCPriority: Jun 9, 2017Filed: Jun 11, 2018Published: Dec 13, 2018
Est. expiryJun 9, 2037(~10.9 yrs left)· nominal 20-yr term from priority
A61B 5/150503A61B 5/150992A61B 5/150213A61B 5/150755A61B 5/15003A61B 5/150389A61B 5/153A61B 5/150221A61B 5/15074A61B 5/150251A61B 5/150099A61B 5/150206A61B 10/0045A61B 10/0233A61B 10/00A61B 2010/009
55
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Claims

Abstract

An apparatus 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. A sequestration portion can be configured to receive an initial volume of bodily fluid. A flow controller disposed in the sequestration portion can be configured to transition from a first state to a second state in response to contact with the initial volume of bodily fluid. As the flow controller transitions, a negative pressure differential can be defined that is operable to draw the initial volume of bodily fluid into the sequestration portion. When the flow controller is in the second state, the negative pressure differential can be substantially equalized such that (1) the sequestration portion sequesters the initial volume and (2) a subsequent volume of bodily fluid can be transferred from the inlet to the outlet.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . An apparatus, comprising:
 an inlet configured to be placed in fluid communication with a bodily fluid source;   an outlet configured to be placed in fluid communication with a fluid collection device;   a sequestration portion configured to be in fluid communication with the inlet and configured to receive an initial volume of bodily fluid from the bodily fluid source; and   a flow controller disposed in the sequestration portion, the flow controller configured to transition from a first state to a second state in response to contact with a portion of the initial volume of bodily fluid, a negative pressure differential being defined between the sequestration portion and the inlet as the flow controller transitions from the first state to the second state and operable to draw the initial volume of bodily fluid from the inlet into the sequestration portion, the negative pressure differential being substantially equalized when the flow controller is in the second state such that (1) the sequestration portion sequesters the initial volume of bodily fluid and (2) a subsequent volume of bodily fluid can be transferred from the inlet to the outlet.   
     
     
         2 . The apparatus of  claim 1 , wherein the flow controller is configured to transition from the first state to the second state automatically. 
     
     
         3 . The apparatus of  claim 1 , wherein the flow controller includes a selectively permeable material. 
     
     
         4 . The apparatus of  claim 3 , wherein prior to being placed in the second state, the flow controller is configured to allow a flow of a gas through the flow controller and to prevent a flow of bodily fluid through the flow controller, 
     
     
         5 . The apparatus of  claim 4 , wherein the flow controller is configured to prevent a flow of gas and bodily fluid through the flow controller when in the second state. 
     
     
         6 . The apparatus of  claim 4 , wherein the flow controller is configured to be placed in the second state in response to a portion of the initial volume of bodily fluid saturating the selectively permeable material. 
     
     
         7 . The apparatus of  claim 1 , wherein the flow controller is configured to at least temporarily vent the sequestration portion to initiate a flow of the initial volume of bodily fluid from the bodily fluid source, through the inlet, and into the sequestration portion. 
     
     
         8 . The apparatus of  claim 1 , wherein the flow controller includes a hydrophilic material. 
     
     
         9 . The apparatus of  claim 1 , wherein the flow controller includes a set of capillaries. 
     
     
         10 . The apparatus of  claim 1 , wherein the flow controller includes a plunger, the plunger configured to move within the sequestration portion in response to the contact with the portion of the initial volume of bodily fluid. 
     
     
         11 . The apparatus of  claim 1 , wherein the fluid collection device defines a negative pressure operable to produce a pressure differential between the outlet and the inlet when the fluid collection device is placed in fluid communication with the outlet. 
     
     
         12 . The apparatus of  claim 11 , wherein the fluid collection device is at least one of a syringe and a sample reservoir. 
     
     
         13 . An apparatus, comprising:
 an inlet configured to be placed in fluid communication with a bodily fluid source;   an outlet configured to be placed in fluid communication with a fluid collection device;   a sequestration portion configured to be in fluid communication with the inlet and configured to receive an initial volume of bodily fluid from the inlet, the sequestration portion including a selectively permeable vent configured to at least temporarily vent the sequestration portion to initiate a flow of the initial volume of bodily fluid from the bodily fluid source, through the inlet, and into the sequestration portion; and   a flow controller disposed in the sequestration portion, the flow controller configured to transition from a first state to a second state in response to contact with a portion of the initial volume of bodily fluid, the transitioning of the flow controller configured to produce a negative pressure differential between the sequestration portion and the inlet such that the sequestration portion receives the initial volume of bodily fluid, the negative pressure differential being substantially equalized when the flow controller is in the second state such that (1) the sequestration portion sequesters the initial volume of bodily fluid and (2) a subsequent volume of bodily fluid can be transferred from the inlet to the outlet.   
     
     
         14 . The apparatus of  claim 13 , wherein the selectively permeable vent is configured to transition from a first state in which the selectively permeable vent is configured to allow a flow of a gas through the selectively permeable vent and to prevent a flow of bodily fluid through the selectively permeable vent, to a second state in which the selectively permeable vent is configured to prevent a flow of gas and bodily fluid through the selectively permeable vent. 
     
     
         15 . The apparatus of  claim 14 , wherein the selectively permeable vent is configured to be placed in the second state in response to a portion of the initial volume saturating the selectively permeable vent. 
     
     
         16 . The apparatus of  claim 13 , wherein the selectively permeable vent is configured to at least temporarily vent the sequestration portion such that a pressure within the sequestration portion is less than a pressure within a fluid flow path defined between the inlet and the outlet. 
     
     
         17 . The apparatus of  claim 13 , wherein the flow controller is configured to automatically transition from the first state to the second state in response to contact with the portion of the initial volume of bodily fluid. 
     
     
         18 . The apparatus of  claim 13 , wherein the flow controller includes a plunger, the plunger is configured to move within the sequestration portion between a first position and a second position in response to the contact with the portion of the initial volume of bodily fluid. 
     
     
         19 . The apparatus of  claim 18 , wherein movement of the plunger from the first position to the second position produces the negative pressure within the sequestration portion, the flow controller configured to be in the second state when the plunger is in the second position. 
     
     
         20 . A method of using a flow control device to obtain a bodily fluid sample with reduced contamination, the method comprising:
 establishing fluid communication between a bodily fluid source and an inlet of the flow control device;   venting a sequestration portion of the flow control device to produce a first negative pressure differential between the sequestration portion and the inlet;   receiving a portion of an initial volume of bodily fluid from the inlet and into the sequestration portion in response to the first negative pressure differential;   transitioning a flow controller disposed in the sequestration portion from a first state to a second state in response to the flow controller being placed in contact with the portion of the initial volume of bodily fluid, the transitioning of the flow controller configured to produce a second negative pressure differential between the sequestration portion and the inlet such that the sequestration portion receives the initial volume of bodily fluid from the inlet;   sequestering the initial volume of bodily fluid in the sequestration portion when the flow controller is placed in the second state; and   transferring a subsequent volume of bodily fluid from the inlet to an outlet in fluid communication with a fluid collection device.   
     
     
         21 . The method of  claim 20 , wherein the sequestration portion includes a selectively permeable vent. 
     
     
         22 . The method of  claim 21 , wherein the selectively permeable vent is configured to vent the sequestration portion such that a pressure within the sequestration portion is less than a pressure within a fluid flow path defined between the inlet and the outlet. 
     
     
         23 . The method of  claim 21 , wherein the selectively permeable vent is configured to transition from a first state in which the selectively permeable vent is configured to allow a flow of a gas through the selectively permeable vent and to prevent a flow of bodily fluid through the selectively permeable vent, to a second state in which the selectively permeable vent is configured to prevent a flow of gas and bodily fluid through the selectively permeable vent. 
     
     
         24 . The method of  claim 20 , wherein the flow controller is configured to automatically transition from the first state to the second state in response to contact with the portion of the initial volume of bodily fluid. 
     
     
         25 . The method of  claim 20 , wherein transitioning the flow controller from the first state to the second state includes moving a plunger from a first position within the sequestration portion to a second position within the sequestration portion. 
     
     
         26 . The method of  claim 25 , wherein moving the plunger from the first position to the second position is configured to produce the second negative pressure differential. 
     
     
         27 . The method of  claim 25 , wherein placing the plunger in the second position substantially equalizes a pressure differential between the inlet and the sequestration portion. 
     
     
         28 . The method of  claim 20 , wherein the flow controller includes a hydrophilic material configured to absorb at least a portion of the initial volume to transition the flow controller from the first state to the second state. 
     
     
         29 . The method of  claim 20 , wherein the sequestration portion is substantially filled when the initial volume of bodily fluid is in the sequestration portion. 
     
     
         30 . The method of  claim 20 , wherein the sequestering of the initial volume of bodily fluid sequesters contaminants within the sequestration portion such that the subsequent volume of bodily fluid is substantially free of contaminants. 
     
     
         31 . The method of  claim 20 , further comprising:
 establishing fluid communication between the outlet and the fluid collection device after the sequestering of the initial volume of bodily fluid and prior to transferring the subsequent volume.

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