Abstract:
A biological fluid collection cup for use with a centrifuge bucket to separate a biological fluid into its component parts is disclosed. It includes an hourglass shape with a large upper and lower portion and a narrow middle portion. A piston is to slide into and slideably be received in the lower portion and a side port is provided for withdrawal of a fluid from the narrow portion.

Description:
[0001]    This is a utility patent application claiming priority from and the benefit of U.S. Provisional Patent Application Ser. No. 61/807,519, filed Apr. 2, 2013; and U.S. Provisional Patent Application Ser. No. 61/880,500, filed Sep. 20, 2013, both of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    Biological fluid concentration assembly, namely, a fluid concentration cup assembly with an hourglass shape, a drive piston, and a side draw fluid removal port. 
       BACKGROUND OF THE INVENTION 
       [0003]    Biological fluid collection and concentration devices are known. Biological fluids, such as whole blood or bone marrow aspirate, may be collected and concentrated in an assembly, including a cup placed in a centrifuge, so as to separate out the biological fluid components by differing densities. Following centrifugation, a selected part or parts of the now separated biological fluid may be selected for removal from the concentration assembly. Typically, transfer of the biological fluid into the cup and removal after centrifugation of the selected biological fluid from the cup, which is subject to centrifugation, is typically accomplished through the top of the vessel. 
       SUMMARY OF THE INVENTION 
       [0004]    A fluids concentration cup assembly is disclosed having a cup with an open top to which a lid is removably engaged and an open bottom, which receives a moveable piston therein, in one embodiment, a bottom plate, and, in one embodiment, a piston drive screw. The walls of the cup include an upper portion, a lower portion, and a narrowed portion between the upper and lower portions. The upper and lower portions are typically cylindrical and part of the narrow portion may be cylindrical. In the narrowed portion, a side port, generally perpendicular to a longitudinal axis of the cup, is provided for the side draw of a separated fluid out of the collection cup following centrifugation of the biological fluid in the cup. 
         [0005]    In one embodiment of Applicant&#39;s device, the lid is configured for engaging a device, such as a syringe, to inject aspirate or biological fluid, such as whole blood or bone marrow aspirate, into the cup through the lid. After centrifuging, a moveable piston may be manually pushed or screw driven from the bottom up until a selected layer of the differentiated biological fluid is located adjacent the side port. A concentrate withdrawal device (such as a syringe) may be engaged with the side port for removal of the selected fluid. The proper fluid level is selected by pushing up the piston. In one embodiment, the selected fluid is buffy coat. 
         [0006]    Another embodiment of the biological fluids concentration cup assembly may include a drive piston assembly where the drive piston assembly includes a drive piston slideably engaging the lower portion of the cup and coupling threaded members, one manually rotated by the user and the other engaging the piston. Rotation of the one causes the piston to move up and down in the cup. 
         [0007]    A bottom plate may be provided for engaging the open bottom of the cup. The drive piston assembly may include a piston screw drive assembly for moving the piston longitudinally in the lower portion. The piston of the drive piston assembly includes a perimeter for fluid sealing against the walls off the cup, an upper and a lower surface, and wherein the lower surface may have a threaded member depending therefrom. The piston screw drive assembly includes a piston drive screw extending partly within the bottom portion of the cup to engage the depending threaded member and partly without the bottom plate. The piston drive screw goes through to the bottom plate through an aperture in the bottom plate. The piston drive screw has a base with a rim or perimeter, the base laying outside the bottom plate and adjacent thereto. Rotating the base causes the piston to rise up and down, forcing the concentrated (centrifuged) fluid above the piston to rise and fall with respect to the sideport. This allows selective withdrawal of fluid from the sideport. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         [0008]      FIG. 1  is a perspective view of Applicant&#39;s fluids concentration cup assembly. 
           [0009]      FIG. 2  is a perspective view of Applicant&#39;s fluids concentration cup assembly. 
           [0010]      FIGS. 3A and 3B  are sectional views of Applicant&#39;s fluids concentration cup assembly with the piston in a collapsed and deployed position, respectively. 
           [0011]      FIG. 4  is a sectional view of Applicant&#39;s fluid concentration cup assembly showing a selected intermediate layer, following centrifuging, for removal through a side port thereof. 
           [0012]      FIG. 5  illustrates a manner in which a syringe or other concentrated fluid collection device may engage the side port for selective removal of a fluid layer from a centrifuged aspirate. 
           [0013]      FIGS. 6A and 6B  illustrate perspective views of Applicant&#39;s cup assembly showing the manner in which a syringe may transfer an aspirate to the cup assembly. 
           [0014]      FIG. 7  illustrates an alternate preferred embodiment of Applicant&#39;s device in an exploded perspective view. 
           [0015]      FIGS. 8A and 8B  illustrate cross sectional elevational views of alternate preferred embodiments of Applicant&#39;s device with a piston in a collapsed or lowered position ( FIG. 8A ) and a raised or upper position ( FIG. 8B ). 
           [0016]      FIGS. 9A and 9B  are cross sectional views illustrating an alternate preferred embodiment of Applicant&#39;s present invention showing the relationship of the piston to the walls of the container and the side port with the piston in the up position. 
           [0017]      FIG. 10  is an exploded perspective view of an alternative preferred embodiment of a piston drive mechanism having an anti-rotation feature. 
           [0018]      FIG. 11  is a cross sectional view showing the relationship of the Halkey, the Halkey adapter, the side port of the narrow portion and the piston top. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0019]    Applicant provides a first embodiment of a fluids concentration assembly  10 , which includes a cup  12  with an open top  20  having a lid  40  engageable thereof and a slideable piston  34  engageable with an open bottom  30  thereof. 
         [0020]    In one embodiment, Applicant&#39;s cup includes an upper portion  14 , a lower portion  16 , and a narrow portion  18 . Upper portion  14  is seen to have a general cylindrical shape, with side walls  22  and an open top  20 . Lower portion  16  is seen to be generally cylindrical and having side walls  28 , an open bottom  30 , which is adapted to slideable receive piston  34  therein. Narrow portion  18  may include sloped or cone-shaped top walls  25 , through opening  26 , a cylindrical waist portion  36 , and sloped or cone-shaped bottom walls  35 . 
         [0021]    Narrow portion  18  is seen to have walls defining a diameter or diameters that are less than those defining the upper and/or lower portion. Thus, the term “narrow portion” is, typically referring to a general cylindrical portion with a wider portion below and a wider portion above. The narrowed portion may include only sloped walls  25 / 35  in one embodiment or mixed slanted and generally cylindrical portions. By providing a narrow portion, the vertical dimension or may have longitudinal dimension of a given fluid displaced by piston  34  moving upward in the lower portion is magnified. That is to say, one milliliter of fluid displaced upward in lower portion  16  is exaggerated, in a vertical dimension by movement of the fluid up through the constricted walls of the narrow portion. Thus, a thin layer, such as a buffy coat layer BC, between a red blood cell RBC layer and plasma P, below and above buffy coat, respectively, may be exaggerated (see  FIG. 1 ), when BC comes up into the narrowed portion and lies adjacent a side port  38 . 
         [0022]    In one embodiment, lower portion  16  is integral with bottom walls  35 , which may have open top  32 . In one embodiment of Applicant&#39;s cup  12 , side port  38 , which includes walls adapted to engage a collection vessel for concentrate out (see arrows,  FIG. 1 ), is adapted to be located near the bottom of waist portion  36 , where it engages the open apex of bottom walls  35 . Red blood cells then buffy coat may be drawn off when a buffy coat layer reaches above the top edge of side port  38 . The piston is pushed up (by hand or any suitable device) until the lower boundary of the buffy coat layer (the buffy coat/red blood cell boundary) is positioned and then the side port  38  may be opened to allow removal of the buffy coat and/or the selected portion of the other fluids therefrom. A cap  43  may be provided to the side port so that when the collection device is not engaged, no fluid will flow out. 
         [0023]    Scale lines are seen marked along the side of the outer walls of the container. They may be used to determine the volume of fluid and of the respective portions of separated concentrate. It will be seen that the gap between equal fluid markings will be larger where the volume is narrower or narrows, as the vertical axis if magnified of a fluid volume as it moves from the lower portion of the cone into the waist portion. 
         [0024]    In a second preferred embodiment ( FIGS. 2-6B ), Applicant provides a fluids concentration assembly  110 , which includes a cup  112  with an open top  120  having a lid  140  engageable therewith and a slideable piston  134  engageable with an open bottom  130  thereof of a lower portion  116 . 
         [0025]    In one embodiment, Applicant&#39;s cup includes an upper portion  114 , lower portion  116 , and/or a recessed or narrow portion  118 . Narrow portion  118  may include sloped or cone-shaped top walls  118   a  and sloped or cone-shaped bottom walls  118   b.  Upper portion  114  is seen to have a general cylindrical shape, with side walls  122 , and open top  120 . Lower portion  116  is seen to be cylindrical and having side walls  128  and open bottom  130 , which is adapted to receive slideable piston  134  therein. 
         [0026]    Narrow or recessed portion  118  is seen to have walls defining a diameter or diameters that are less than those defining upper  114  and/or lower portion  116 . Narrow portion  118  may include top walls  118   a  engaging the open bottom of upper portion, bottom walls  118   b  engaging the open top of the lower portion, and a cylindrical waist  136  (in one embodiment) engaging walls  118   a / 118   b.  Walls  118   a / 118   b  may be flat, cone shaped or any appropriate shape (but are typically sloped). By providing a narrow portion, the vertical dimension (longitudinal) dimension of a given fluid displaced by the piston moving upward in the lower portion is magnified. That is to say, one milliliter of fluid displaced upward in the lower portion would become “taller” as it is constricted in a vertical dimension by movement of the fluid up through the constricted walls. Thus, a thin layer, such as a buffy coat layer BC, between a red blood cell RBC layer and plasma P, below and above buffy coat, respectively, may be exaggerated (see  FIG. 4 ), when BC comes up into the narrowed portion and lies adjacent a side port  138 . This allows easy withdrawal of any selected portion by positioning the layers post-centrifuge. 
         [0027]    In one embodiment (see  FIGS. 2 and 5 ) of Applicant&#39;s cup  112 , the side port  138 , which includes walls adapted to engage a concentrate collection syringe  150  for concentrate out (see  FIG. 5 ), is adapted to be located near the bottom of waist  136 , where it engages or lays adjacent the open apex of walls  118   b.  In this manner, for example, plasma, buffy coat or any other selected fluid may be drawn off through side port  138 . For example, when a buffy coat layer reaches the lower edge of side port  138 , it may gravity feed out or suction be fed out into a collection syringe  150 . 
         [0028]    As seen in  FIGS. 2 and 5 , scale lines or other indicia  139  are seen marked along the side of the outer walls of the container, including waist  136 . They may be used to determine the volume of fluid and of the respective portions of separated concentrate. It will be seen that the gap between fluid markings will be spaced apart more where the volume is narrower or narrows, as the vertical axis if magnified of a fluid volume as it moves from the lower portion of the cone into the waist portion. 
         [0029]    In a preferred embodiment, the volume of the cup in the space between a bottom surface  140   b  of a lid  140  and an upper surface  134   a  of piston  134  when the piston is in the collapsed, lowered or Bottom Dead Center (BDC) position is about 80 ml. With this volume, sufficient aspirate (or other biological fluid to be centrifuged) may be received through the lid as set forth herein, for example, about 60 ml. Note that this may leave an air space of about 20 ml, in one embodiment, above the surface of the aspirate and of the concentrated fluids, so as to allow the piston to be driven upward so as to place the bottom of the buffy coat adjacent side port  138  as seen in  FIG. 4 . In a preferred embodiment, waist portion  136  has a volume of about 2-10 ml or about 4-8 ml, preferably 6 ml, and a diameter of about 0.778 inches. 
         [0030]    In one method of use, pre-centrifuge, the piston is placed in a low position and an undifferentiated biological fluid is added through the lid by way of a syringe. The unit is then placed in a centrifuge cup and spun until the fluid separates and then it is removed. Upon removal, the piston is raised until a selected layer, such as a buffy coat layer, is adjacent the side port typically with the red blood cells below the side port. A collection syringe is attached to the Halkey and the buffy coat withdrawn. A typical 60 ml of aspirate (in one case) may yield about 2 ml or less of buffy coat. This buffy coat (or other selected fluid) will be placed in the narrow portion, typically the cylindrical waist, and withdrawal may commence, drawing the selected fluid out the side port. 
         [0031]    Lid  140  is seen to have one or more vents  140   a  therethrough that may be sealed with vent caps  141 . Vents will vent a pressure differential across the lid. Lid  140  is typically sealingly engaged, as by gluing or the like to open top  120 . Rim  140   b  of lid  140  is seen to be notched so as to engage rim  119  of open top  120 . Upper surface  140   c  of the lid may be flat and lower surface  140   d  may be slightly concave, as best seen in  FIG. 3B . Having a concave lower surface  140   d  will mean that the entire assembly  110  may be inverted and a Halkey  148  with channel  148   b  therethrough may act as a drain to drain fluids from within the cup. Halkey  148  may have a threaded section  148   a  for engagement with a syringe  152  (see  FIGS. 6A and 6B ). Halkey  148  may also have a foam  148   c,  which may act as a fluid barrier under neutral pressures but, under increased pressures, as by that provided by a syringe  152  attached to threaded section  148   a,  will be responsive with fluid flow therethrough. 
         [0032]    As seen in  FIG. 2 , side port  138  is seen to include walls defining a channel  138   a.  Channel  138   a  is open to the space within narrow portion  118  and is typically dimensioned to receive snugly and fluidly sealing a Halkey valve  146  (a fluid device interface) therein. Halkey  146  may include foam  146   c,  a threaded portion  146   a  for engagement with syringe  150  (see  FIG. 5 ). A channel  146   b  in Halkey  146  is provided for withdrawal of fluids through side port  138 . The side port is removably sealed, as by cap  143  (see  FIG. 8A ) threadably engaging threaded portion  146   a.  For example, cap  143  may be positioned snugly against the Halkey when assembly  110  is in a centrifuge. Similarly, a cap (not shown) may removably engage threaded portion  148   a  of Halkey  148 . An alternate embodiment of side port  138  as seen in  FIGS. 7-11  illustrate the use of a Halkey adapter  160  to engage Halkey  146  to channel  138   a.  Details of this embodiment are set forth below. 
         [0033]    Turning now to  FIGS. 2-4 , it is seen that a bottom plate  142  may be sealingly engaged to bottom rim  131  of open bottom  130  of lower portion  116 . More specifically, it is seen that a notched rim  142   a  may fit snugly such that an upper surface  142   b  of the rim effectively seals the open bottom accepting a central opening  142   d  in the bottom plate  142 . Central opening  142   d  extends between upper surface  142   b  and lower surface  142   c.  Central opening  142   d  is seen to engage a vertical neck  145  of a captured piston drive screw  144  which, along with drive piston  134 , constitutes a drive assembly for driving the piston upward or downward in the lower portion  116  (see, for example,  FIGS. 3A and 3B ). That is to say, piston  134  may be driven between the collapsed (lower) and deployed (upper) positions ( FIGS. 3A and 3B , respectively) by rotation of a base  147 . Piston drive screw  144  is captured on bottom plate  142  as by the action of resilient wedges  145   c  (see  FIG. 3B , for example). Wedges  145   c  ride on top surface  142   b  of the bottom plate  142  when the base  147  is rotated. Base  147  may have a notched rim  147   a  which dimension is typically not greater than the diameter of lower portion  116 . Base  147  typically has a flat bottom surface  147   b  and a flat top surface  147   c,  and is integral with vertical neck  145 . Neck  145  typically has an outer surface  145   a  and a threaded inner surface or threaded inner walls  145   b.    
         [0034]    Turning to piston  134 , piston  134  is seen to have upper surface  134   a,  lower surface  134   c,  and a rim  134   b.  Rim  134   b  may include a cup shape portion for receipt of an elastomeric O-ring  137  (preferably two, see  FIG. 7 ) thereon and piston  134  with O-ring thereon is dimensioned to be fluidly sealing and slidably received within the lower portion  116 , such that the O-ring contacts the inner walls and slides up and down thereon between collapsed or lowered ( FIG. 3A ) and deployed or raised ( FIG. 2B ) positions. Upper surface  134   a  of piston  134  may be flat or domed (see  FIG. 7 ), and lower surface  134   c  may be flat or recessed (see  FIG. 8A ) or suitably shaped. Threaded member  134   d  extends downward into engagement with threaded inner walls  145   b  of neck  145  of the piston drive screw  144 . 
         [0035]      FIG. 4  illustrates the use of the fluids concentration cup assembly  110 . Typically, the piston will be in the collapsed or lowered position when bone marrow aspirate or other fluid is received through the lid (see  FIGS. 6A and 6B ). After centrifuging, the piston may be deployed as seen in  FIG. 4  to place, for example, the bottom surface of the buffy coat layer adjacent the side port  138 . Withdrawal syringe  150  may be used to engage threaded portion  146   a  of Halkey  146  as seen in  FIG. 5  to withdraw the buffy coat.  FIGS. 6A and 6B  illustrate the use of a second or aspirate carrying syringe  152  to transfer a bone marrow aspirate or other fluid, before centrifuging, into the cup  112  by engagement of syringe with Halkey  148  in lid  140 . 
         [0036]      FIGS. 7 ,  8 A, and  8 B illustrate that the upper surface of  134   a  of piston  134  may be dome or conically shaped, such that it fits within conical or sloped walls  118   b  in a snug relationship when the piston is at top dead center (TDC) (see  FIG. 9A ). The dome shape of the piston is seen to be a truncated conical shape with a flat top surface that will lay above the lowest most portion of channel  38   a / 138   a  (see  FIGS. 9A and 9B ). The flat top portion of the piston is seen relationally to the bottom of the side port channel and, when the two are close, it allows for the efficient withdrawal of the buffy coat (or other liquid) as the buffy coat rests on top of the red blood cell and below the plasma, after whole blood has been centrifuged. 
         [0037]    In a preferred embodiment, the narrow portion  18 / 118  includes sloped upper walls on  116  and sloped lower walls on  114 , which meet at a cylindrical waist portion  136 . The side port  138  has a channel  138   a,  which is typically cylindrical and whose lowermost portion is right at the top of where the cone portion adjacent open top  132 . Walls  118   a  of narrow portion  118  may be angled downward from the horizontal in a range of 20-60°, most preferred 40-50°, and most preferred about 45° from the horizontal. The cup may be made of rigid polycarbonate, especially a clear hydrophobic polycarbonate and may have a height of about 4.875 inches or a preferred range of 3½ to 5¼ inches. The waist portion  136 , in a preferred embodiment, is cylindrical and has a volume preferably between about 2 and about 10 milliliters, more preferred about 5 to about 7 milliliters, and most preferred about 6 milliliters. 
         [0038]    When the piston is at top dead center and bottom dead center, the dimensions set forth in the table may be used, as measured from the upper surface of the piston to the bottom of the tip of the lid. 
         [0000]    
       
         
               
             
               
               
               
             
               
               
               
               
             
           
               
                   
               
               
                 CUP VOLUME mL (to lowest part of lid) 
               
             
          
           
               
                   
                 Piston at TDC 
                 Piston at BDC 
               
               
                   
                   
               
             
          
           
               
                   
                 Broadest Range (approx . . . ) 
                 5-25 mL 
                 10-80 mL 
               
               
                   
                 Next (approx . . . ) 
                 7-20 mL 
                 35-65 mL 
               
               
                   
                 Preferred (approx . . . ) 
                 10-15 mL  
                 45-60 mL 
               
               
                   
                   
               
             
          
         
       
     
         [0039]    In a method of use, a surgeon or other healthcare professional withdraws a bodily fluid, such as whole blood or bone marrow aspirate. The piston is set at BDC and the undifferentiated fluid is injected into the cup through the lid. The cap is centrifuged and then removed. At this point, the user will adjust the bottom of the piston, such that, after centrifugation, the bottom of the buffy coat layer will typically be near the preferred level for withdrawal. 
         [0040]      FIGS. 7-11  show a Halkey adapter  160  with facing walls  160   c  with a mouse hole shape (see  FIGS. 9A and 9B ), such that fluid is funneled into channel  146   b  of Halkey  146 .  FIGS. 9A and 9B  also show how channel  146   b  in the Halkey adapter  160  meets the piston top in flush relation when the piston is in the raised position. It is seen how fluid withdrawn through Halkey  146  (arrows in  FIG. 11 ) is funneled to the channel by the sloped facing walls  160   c.    
         [0041]      FIGS. 7-11  illustrate an alternate embodiment adapted to help channel a selected fluid, post-centrifuge, into channel  146   b  of Halkey  146 . While the term “channel” is used, a Halkey valve typically, does not have a visible channel under neutral pressure. Indeed, it appears to be filled with a foam-like substance. However, when a pressure differential of a set value is exceeded on the Halkey, such as by a syringe device in withdrawing the fluid from the cup, a channel is provided for a fluid to pass through. More information regarding the Halkey may be found at www.halkeyroberts.com. One Halkey that may be used, with this assembly, is Halkey Roberts Part No. e.245501024 (a bondable, one or two-way needleless valve). In any case, a nose of the Halkey will fit in channel  160   a  through Halkey adapter  160  to hold the Halkey in place and grooves  160   b  on either side of the side walls will engage ridges  138   b  on either side of channel  138   a,  so that Halkey  146  fits snugly to Halkey adapter  160  and the adapter is glued or otherwise affixed in the channel such that the facing walls  160   c  (see  FIGS. 9A ,  9 B, and  11 ) place the lower edge of channel  160   a  adjacent (or just above) the upper flat top of piston  134  when piston  134  is at top dead center. Facing walls  160   c  are funnel-shaped (see  FIG. 11 ), acting to funnel fluid going through Halkey  146  into channel  146   b.  This allows for a smooth, non-turbulent and complete flow of liquid above the piston top when it is at top dead center to flow through channel  146   b  into a collection device, such as a syringe  150 , attached to threaded portion  146   a  (see  FIG. 11 ). 
         [0042]      FIGS. 7-11  illustrate an alternate preferred embodiment of a drive piston assembly for moving the piston  134  longitudinally in the cup. Here, base  147  is seen to be split into two halves  147   d / 147   e  that are both manufactured in the same mold (so there is no left or right) and may clip together with resilient prongs and slots as seen in  FIGS. 7 and 10 . Lid  164  is seen to have a neck  166 , the lid for sealing the bottom of the cup as by gluing, for example. Threaded section  168  is rigidly attached to base  147   d / 147   e  and is seen to engage an inner depending threaded leg  170  (see  FIG. 9A ) attached to the bottom of the piston. Threaded leg  170  has threads on inner walls thereof. Threaded section  168  is glued or otherwise affixed to base halves  147   d / 147   e  as in  FIG. 9A , so that rotation of base  147   d / 147   e  causes threaded section  168  (which couples with the thread on threaded leg  170 ) to rotate, moving piston  134  up and down. Neck  166  of lid  164  is seen to have an upper portion  166   a  and a lower portion  166   b  that may be above and below a flat portion  166   c.  Flat portion  166   c  may have a notched perimeter as seen in  FIG. 9A , the notched perimeter for engaging (fluid tight) the bottom rim of the cup. Outer walls of upper portion  166   a  snugly and telescopically engage the outer walls of threaded leg  170 , which is seen to be partly recessed in recessed portion on the underside of piston  134 . Multiple anti-rotation ridges  166   d  on the cylindrical inner surface of neck  166  project inward and longitudinally and engage multiple anti-rotation grooves  170   a  on the outer surface of threaded leg  170 , such that rotation of the base and threaded section  168  will force the piston to go up and down and prevent it from rotating (a piston anti-rotation feature). The only structure that rotates in this embodiment is base  147  and threaded section  168  of the base. The structure that moves up and down is piston  134  and threaded leg  170 . Thus, threaded members of the piston and rotatable base couple, as do anti-rotation members. 
         [0043]    Although the invention has been described with reference to a specific embodiment, this description is not meant to be construed in a limiting sense. On the contrary, various modifications of the disclosed embodiments will become apparent to those skilled in the art upon reference to the description of the invention. It is therefore contemplated that the appended claims will cover such modifications, alternatives, and equivalents that fall within the true spirit and scope of the invention.