Abstract:
A mechanically-actuated vacuum-controlled fluid collection system includes a mechanically-actuated vacuum controller (MAVC) to draw fluid into a chamber through the opening to the chamber. The system may include a releasable seal to seal the opening, and the MAVC may include a spring-loaded plunger to create a vacuum within the chamber when sealed. The system includes multiple fluid chambers, and may further include a single actuator or multiple corresponding actuators. The system may be configured to add a pre-loadable reagent to fluid drawn into the one or more chambers, and may be configured to add the reagent in proportion to a volume of the fluid. The system may be controllable to release collected fluid to another device, such as for assay and/or transport. The system may be configured to draw a liquid biological sample such as urine, and may include a fluid interface to draw fluid from a biological sample container.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 61/733,516, filed Dec. 5, 2012, which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    Conventional fluid collection devices are not portable, mechanically actuated, and/or designed to collect a measured amount of liquid, interface with a liquid biological sample container, a transport device, and/or an assay device, and/or to add a pre-loaded reagent to collected fluid. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0003]      FIG. 1A  illustrates a fluid collection device having a built-in sample collection interface to collect liquid or fluid. 
           [0004]      FIG. 1B  is a front view of the fluid collection device of  FIG. 1A . 
           [0005]      FIG. 1C  is a side profile of the fluid collection device of  FIG. 1A . 
           [0006]      FIG. 2  is a cut-away front view of another fluid collection device. 
           [0007]      FIG. 3  is a cut-away front view of another fluid collection device after one of two syringe units has been activated. 
           [0008]      FIG. 4  is a cut-away front view of another fluid collection device that is preloaded with a reagent. 
           [0009]      FIG. 5  is a cut-away front view of another fluid collection device that is preloaded with a reagent. 
           [0010]      FIG. 6A  is a cut-away front-view view of another fluid collection device having a two-stage plunger system and a preloaded reagent which may be added to a collected fluid in multiple installments. 
           [0011]      FIG. 6B  is a cut-away side-view of an embodiment of the fluid collection device of  FIG. 6A . 
           [0012]      FIG. 6C  is a cut-away side-view of another embodiment of the fluid collection device of  FIG. 6A . 
       
    
    
       [0013]    In the drawings, the leftmost digit(s) of a reference number identifies the drawing in which the reference number first appears. 
       DETAILED DESCRIPTION 
       [0014]    Disclosed herein are mechanically actuated vacuum fluid collection systems and methods. 
         [0015]      FIG. 1A  illustrates a fluid collection device  1000  having a built-in sample collection interface  100 , to collect liquid or fluid  105 . Fluid collection device  1000  may be configured and/or serve as a fluid collection device, such as to collect a biological fluid, such as urine, from a container or cup. 
         [0016]      FIG. 1B  is a front view of fluid collection device  1000 , including syringe units  110  and  115  and triggers  120  and  125  that are mechanically activated to initiate fluid collection by syringe units  110  and  115 , respectively. A sample port  130  connects to sample collection interface  100  ( FIG. 1A ), to permit fluid communication between fluid sample  105  ( FIG. 1A ) and syringe units  120  and  125  when activated. Sample port  130  may include, without limitation, a straw, a pierce-able membrane, a Luer lock, and/or or a one-way valve. 
         [0017]      FIG. 1C  is a side profile of fluid collection device  1000 , including sample port  130 , syringe unit  110 , and corresponding trigger  120 . 
         [0018]    Fluid collection device  1000  may be configured as described with respect to one or more examples described below. Fluid collection device  1000  is not, however, limited to any of the examples below. 
         [0019]      FIG. 2  is a cut-away front view of a fluid collection device  2000 , including an outer case  200 , which may be removable. Outer case  200  may be shorter, relative to device  1000 , than illustrated in  FIG. 2 . 
         [0020]    Triggers  205  and  210  have openings  215  and  220  at their centers that, when corresponding triggers  205  and  210  are mechanically actuated, allow plungers  225  and  230  to rise, respectively. 
         [0021]    Device  2000  may include springs spring  235  and  245  to provide a force for fluid collection. When trigger  205  is activated, spring  235  extends and pushes plunger  225  up through an opening  215  to create a vacuum to draw a fluid sample into a chamber, illustrated here as a syringe unit  240 . When trigger  210  is activated, spring  245  extends and pushes plunger  230  up through opening  220  to create a vacuum to draw fluid into syringe unit  250 . Triggers  205  and  210  may be actuated in tandem or in series. 
         [0022]    Device  2000  may be configured to interface with a fluid collection container such as, for example, a urine collection container. Device  2000  may include stoppers  255  and  260  to form seals around inlets of syringe units  240  and  250 , respectively. 
         [0023]    Device  2000  may include adaptors  265  and  270  to connect syringe units  240  and  250  to sample port  275  via fluid channels  280  and  285 , respectively. Adaptors  265  and  270  may include a Luer interface with fluid channels  280  and  285 , respectively. Sample port  275  may include a rubber septum. 
         [0024]    Fluid collection device  2000  may be configured as described with respect to one or more other examples described herein. Fluid collection device  2000  is not, however, limited to other examples herein. 
         [0025]      FIG. 3  is a cut-away front view of a fluid collection device  3000  after one of two syringe units has been activated. 
         [0026]    A plunger  305  has been extended by expansion of a spring  310  through an opening  315  following activation of a trigger  320 . A stopper  325  has been drawn through syringe unit  330  and fluid sample  335  has been collected by suction. 
         [0027]    An adaptor  340  connects a body of a syringe unit to a channel  345  that interfaces with a sample port  350 , which is in fluid communication with a fluid sample. 
         [0028]    Components of device  3000  may be contained within outer case  300 . 
         [0029]    Fluid collection device  3000  may be configured as described with respect to one or more other examples described herein. Fluid collection device  3000  is not, however, limited to other examples herein. 
         [0030]      FIG. 4  is a cut-away front view of a fluid collection device  4000  that is preloaded with a reagent and includes a variation of an activation trigger. When activated, a trigger  405  releases a plunger  410  and a force from spring  415  causes it to extend and create a vacuum in a syringe unit  420 . When a trigger  425  is activated, it allows a spring  430  to push up on a plunger  435 , extending it and creating a vacuum in a syringe unit  440 . 
         [0031]    Syringe units  420  and  440  may be sealed with stoppers  445  and  450 , respectively. In  FIG. 4 , syringe unit  420  contains a reagent  455 , and syringe unit  440  contains reagent  460 . As fluid is drawn into the syringe units, the fluid combines with reagents  455  and  460  to create a homogenous mixture. Syringe units  420  and  440  may be actuated in tandem or in series. 
         [0032]    In an embodiment a volume of the fluid collected may be predetermined and/or measured. 
         [0033]    In an embodiment a volume of the reagent may be predetermined and/or measured. 
         [0034]    In  FIG. 4 , an adaptor  465  connects fluid channel  470  to syringe unit  420 , and an adaptor  475  connects fluid channel  480  to syringe unit  440 . Fluid channels  470  and  480  interface with sample port  485 , which is in fluid communication with the fluid sample. 
         [0035]    Components of device  4000  may be contained within outer case  400 . 
         [0036]    Fluid collection device  4000  may be configured as described with respect to one or more other examples described herein. Fluid collection device  4000  is not, however, limited to other examples herein. 
         [0037]      FIG. 5  is a cut-away front view of a fluid collection device  5000  that is preloaded with a reagent and includes a variation of a trigger after one syringe unit has been activated. A plunger  505  has been extended by a spring  510  following mechanical activation of a trigger  515 . A stopper  520  has been drawn up through syringe unit  525 , filling it with fluid sample  530 . A preloaded reagent mixes with a fluid  530  as it is drawn into syringe unit  525 , to provide a homogenous solution of sample and reagent. 
         [0038]    Components of device  5000  may be contained within outer case  500 . 
         [0039]    Fluid collection device  5000  may be configured as described with respect to one or more other examples described herein. Fluid collection device  5000  is not, however, limited to other examples herein. 
         [0040]      FIG. 6A  is a cut-away front-view view of a fluid collection device  6000 , having a two-stage plunger system and a preloaded reagent which may be added in multiple installments. Fluid collection device  6000  may be configured as described below with reference to  FIG. 6B  and/or  FIG. 6C . 
         [0041]      FIG. 6B  is a cut-away side-view of an embodiment of fluid collection device  6000 . When a trigger  600  is mechanically activated, it moves to allow a plunger  605  to pass through an opening  610  in trigger  600 . A spring  615  extends plunger  605  until it comes into contact with a trigger  620 , which has not yet been activated. A stopper  625  is drawn back by this action and a syringe unit  630  fills with a first portion of fluid sample. A reagent  635  mixes with the sample as is enters syringe unit  630 . The amount of sample and/or reagent may be measured and/or predetermined. 
         [0042]    Trigger  620 , when pushed, activates a second stage of the plunge. It allows plunger  605  to pass through an opening  640  and further extend using force from a spring  615 . As stopper  625  moves past a reagent deposit  645 , an additional portion of fluid is drawn up and added to the previously-collected portion of sample. 
         [0043]    Triggers  600  and  620  may be actuated sequentially, in that order, or trigger  600  only may be actuated. 
         [0044]      FIG. 6C  a cut-away side-view of another embodiment of fluid collection device  6000 , having a preloaded reagent that is added proportionally to the fluid sample being collected. 
         [0045]    When a trigger  650  is actuated, a plunger  655  extends through an opening  660  by force of a spring  665 . This draws back a stopper  670  and fills a syringe unit  675  with fluid sample. A reagent  680  is forced out of a hollowed plunger  655  as it moves upward into a solid plunger  685 , which is fixed to an outer device case  690 . As this happens, a one-way valve  695  adds reagent  680  proportionally to the fluid sample to provide a mixed solution. Valve  695  may include a stopper. 
         [0046]    A trigger  697  activates a second stage of the plunge and collection of an additional portion of fluid sample by allowing plunger  655  to pass through an opening  698  by the force of spring  665 . Upward movement of hollowed plunger  655  moves it upward onto solid plunger  685 , which pushes reagent  680  out of one-way valve  695 . Reagent  680  is forcibly mixed with the fluid sample to provide a homogenous mixture. 
         [0047]    Triggers  650  and  697  may be activated sequentially, in that order, or trigger  650  alone may be activated. 
         [0048]    A device as disclosed herein may be configured to collect a liquid or fluid that includes a biological sample such as, without limitation, a urine sample. 
         [0049]    A device as disclosed herein may include a push-button to actuate a trigger. 
         [0050]    A device as disclosed herein may include retractable plunger to create a vacuum in the device in order to collect a fluid. 
         [0051]    A device as disclosed herein may include a spring configured to provide sufficient for to fill the device. 
         [0052]    A device as disclosed herein may be configured to draw up portions of fluid in sequence and/or in parallel, and may be configured to accommodate one or more of a variety of volumes, which may include a measured volume and/or a predetermined volume. 
         [0053]    A device as disclosed herein may include one or more sealable chambers for collection of fluid samples. The device may be configured, for example, to seal the samples for transport. A sealable chamber(s) may have more than one stop, with each stop collecting a portion of fluid. A sealable chamber may include a syringe. 
         [0054]    In some embodiments, reagent may be added to these portions. The sample and reagent may be forcibly mixed in the sample collection chamber. In some embodiments the addition of reagent may be proportional to the amount of fluid collected. 
         [0055]    A device as disclosed herein may be preloaded with a liquid reagent. 
         [0056]    A device as disclosed herein may be preloaded with a dry reagent. 
         [0057]    A device as disclosed herein may be configured to release and/or expel collected fluid, such as for assay and/or transport. 
         [0058]    A device as disclosed herein may be configured to release and/or expel a portion of collected fluid. 
         [0059]    A device as disclosed herein may be configured to release and/or expel a measured and/or adjustable amount of collected fluid. 
         [0060]    A device as disclosed herein may include an openable external case to provide access to collected fluid. 
         [0061]    A device as disclosed herein may be configured to release collected fluid by pushing a plunger. 
         [0062]    A device as disclosed herein may include membrane or rubber septum, which may be punctured to release or expel collected fluid. 
         [0063]    A device as disclosed herein may include a fluid interface to transfer collected fluid to a diagnostic or transport system. 
         [0064]    A device as disclosed herein may include a fluid interface to draw fluid from a urine collection cup. 
         [0065]    Methods and systems are disclosed herein with the aid of functional building blocks illustrating functions, features, and relationships thereof. At least some of the boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries may be defined so long as the specified functions and relationships thereof are appropriately performed. While various embodiments are disclosed herein, it should be understood that they are presented as examples. The scope of the claims should not be limited by any of the example embodiments disclosed herein.