Abstract:
A material separation system and method is disclosed. The system may include a buoy having a volume that includes or houses a reacting component. The buoy may be placed in a container to hold the material to be separated during a separation procedure. The separated material may be used to various procedures following separation.

Description:
FIELD 
       [0001]    The subject disclosure relates to a system for separating materials, and particularly to a buoy system for separating a component from a multiple component material. 
       BACKGROUND 
       [0002]    This section provides background information related to the present disclosure which is not necessarily prior art. 
         [0003]    A multiple component material, such as whole blood, plasma, bone marrow aspirate, other suspensions, such as environmental water samples, mercury samples, and the like, may be selected to be separated. Various systems can be used to separate the whole material, such as a centrifuge system. A centrifuge system centrifuges a whole sample to cause a separation of the sample based upon densities and specific densities of materials within the whole material. For example, a centrifuge can be used to separate red blood cells from a whole blood sample. 
       SUMMARY 
       [0004]    This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features. 
         [0005]    A centrifuge system can be used to separate a selected component of a whole or multiple component sample, such as separating a selected portion of whole blood or separating a reaction product from a sample. According to various embodiments, a buoy system can be positioned within a separation container to assist in separation. For example, a buoy can be provided with a specific density that is equivalent to a selected component within a mixture such that the buoy will move to a position adjacent to the selected component to assist in separating and maintaining a separation of the selected component. The buoy may also include a plurality of portions such that the buoy may sequester a specific area between a first buoy portion and second buoy portion. 
         [0006]    Further, the buoy may include a volume that includes or houses a reacting component, such as glass beads, desiccating beads, a reagent, or the like. According to various embodiments, the buoy can include a first buoy member or portion that has a substantially hollow interior to house the reacting component, such as glass beads, and an opening that allows for selective entry of the selected component to interact with the beads housed within the buoy member. 
         [0007]    Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
     
    
     
       DRAWINGS 
         [0008]    The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure. 
           [0009]      FIG. 1  is a side plan view of a buoy system according to various embodiments; 
           [0010]      FIG. 2  is a cross-section view of the buoy system of  FIG. 1  along line  2 - 2 ; 
           [0011]      FIG. 3A-3C  schematically illustrate movement and/or alignment of a portion of the buoy system; 
           [0012]      FIGS. 4A-4E  illustrate an exemplary method of use of a system including the buoy system, according to various embodiments; 
           [0013]      FIG. 5A  is a side plan view of a buoy system with a blocking wall in a first position, according to various embodiments; and 
           [0014]      FIG. 5B  is a side plan view of a buoy system with a blocking wall in a second position, according to various embodiments. 
       
    
    
       [0015]    Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. 
       DETAILED DESCRIPTION 
       [0016]    Example embodiments will now be described more fully with reference to the accompanying drawings. 
         [0017]    With reference to  FIGS. 1 and 2 , a buoy system  20  is illustrated. The buoy system  20  can include portions that are similar to buoy systems included or disclosed in U.S. Pat. No. 7,179,391; 7,374,678; 7,832,566; 7,845,499; or 8,567,609; all of which are incorporated herein by reference; and in various devices, such as the Platelet Separate System GPS II® sold by Biomet, Inc., having a place of business in Warsaw, Ind. Generally, the buoy system  20  can include a first or upper buoy member  22  and a lower or second buoy member  24  that can be interconnected with a third buoy portion or member  26 . According to various embodiments, the first buoy member  22  can move relative to the second buoy member  24  such as by moving or sliding axially along the third buoy member  26  generally towards the second buoy member  24 . If the first buoy member  22  is provided to move relative to the second buoy member  24  a seal, such as a rubber or rubberized O-ring  28  can be provided to assist in providing a seal between an area or volume, such as a collection volume  30 . between the first buoy member  22  and the second buoy member  24  and the volume outside of the collection volume  30 , such as above the first buoy member  22  and below the second buoy member  24 . 
         [0018]    Further, according to various embodiments, the second buoy member  24  can be provided of a single or multiple materials in single or multiple sections. Multiple sections may all be made of the same material as well. Further, the second buoy member  24  can be substantially solid. The second buoy member  24  can include a density or specific gravity, as discussed further herein, that in combination with the other portions of the buoy system  20  can be formed to reach a selected region or section within a separation container, as discussed further herein. Further, the second buoy member can include a non-flat or non-planar bottom surface  34 , such that the bottom surface  34  may include an apex or point  36  that can assist with initial movement of the buoy member or assembly  20  during the separation, again as discussed further herein. 
         [0019]    The buoy assembly  20  can include the collection area  30  that is bounded at least on two sides by the buoy assembly  20 . On a first side, a bottom wall  40  of the first buoy  22  can be formed and extend from the third buoy member  26  to an edge of the first buoy member  22 . On a second side, a second wall  42 , formed as a top surface of the second buoy  24  may extend out from the third member  26  to an edge of the second buoy member  24 . The first wall  40  may extend at an angle  44  from a central or long axis  46  of the buoy assembly  20 . The second wall  42  can extend at an angle  48  relative to the long axis  46 . The angles  44  and  48  may be substantially complimentary such that the first wall  40  may mate with the second wall  42  if the first buoy member  22  is configured to move relative to the second buoy member  24 . As illustrated, the first wall  40  may be convex and the second wall  42  may be concave. Accordingly, the collection area  30  can be substantially closed or eliminated by the contact of the first wall  40  with the second wall  42 , such as during withdrawal of a material from the collection volume  30 . 
         [0020]    The third buoy member  26  may have central bore  50  that can extend to terminate in an access bore or extending bore  52 . Accordingly, material that is collected within the collection of volume  30  can be withdrawn through the collection bore  52  and the central bore  50  through a collection tube or assembly  54 , as discussed further herein. The central bore  50  can be in communication with a bore or passage  56  of the collection tube  54  to assist in withdrawal of material from the collection volume  30 . 
         [0021]    The first buoy  22  and/or the second buoy member  24  can house a selected material such as glass beads, desiccating beads, a reagent, or other selected material. As exemplarily illustrated in  FIG. 2 , a desiccating bead  70  or a plurality of desiccating beads  70  can be contained within a containment volume  72  of the first buoy  22 . The containment volume  72  can be formed to be an entire volume within the first buoy  22  or any selected portion of the volume within the first buoy  22 . The first wall  40  may define a plurality of passages  80  through the wall  40  such that a material within the collection area  30  can move into the volume  72  of the first buoy member  22 . 
         [0022]    With reference to  FIG. 3A  and continuing reference to  FIGS. 1 and 2 , the first wall  40  including the passages  80  can also include a wall or blocking member  90  that may have one or more complimentary or equivalent passages  92 . The blocking wall  90  in a first position, as illustrated in  FIG. 3A , has the passages  80  through the first wall  40  completely blocked by the blocking wall  90  due to the offset or displacement of the blocking wall passages  92  from the passages  80 . In a selected embodiment, as discussed further herein, the blocking wall  90  can be moved to a second position, such as in the direction of arrows  94  such that the blocking wall passages  92  can be aligned in the second position with the passages  80  in the first wall  40 , as illustrated in  FIG. 3   b . With reference to  FIG. 3C , the passages  80  and the blocking wall passages  92  can be aligned such that material can generally freely move from the collection reservoir  30  into the volume  72  of the first buoy member  22 . 
         [0023]    As illustrated in  FIG. 3C , when the passage  80  in the first wall is aligned with the blocking wall passage  92  in the blocking wall  90  in the second position, an open passage from the collection area  30  into the volume  72  of the first buoy  22  is made. The blocking wall  90 , therefore, can be manipulated to either open or close the wall passages  80  through the first wall  40  to allow material to move into the volume  72  of the first buoy member  22 . The blocking wall  90  can also be moved to block or hold the material within the volume  72  of the first buoy member  22  by manipulating the blocking wall  90 . In various embodiments, the blocking wall  90  may move in a track or groove that is formed on or in the buoy member  22 . 
         [0024]    The passages  80  can have a selected diameter or dimension, such as diameter  100  that is sized to ensure that the beads  70  are maintained within the volume  72  even when the passages  80  are in the open configuration, as illustrated in  FIG. 3C . Accordingly, a diameter  100  can be equal to, smaller than, or at a dimension selected such that a plurality of the beads will not pass through the passages  80  in the open configuration. For example, the dimension  100  can be about 5 micrometers (μm) to about 1 mm. 
         [0025]    Turning to  FIGS. 4A-4E , the buoy assembly  20  can be implemented in a separation and collection system  200 . The collection system  200  can include a collection or separation container  202  that can be a container of any appropriate type. For example, the container  202  can be similar to the centrifuge or collection container disclosed in U.S. Pat. No. 7,179,391; 7,374,678; 7,832,566; 7,845,499; or 8,567,609; all of which are incorporated herein by reference. The container  202  can be any appropriate container operable with the buoy system  20  to affect separation of a material positioned therein. Accordingly, the container  202  can be a container known to those skilled in the art. Briefly, the container  202  can include a bottom wall  204 , a side wall, such as a cylindrical side wall  206 , and a top wall  208 . Each of the walls  204 - 208  can be formed as a single portion or can be interconnected to form the separation container  202 . For example, as illustrated in  FIG. 4A , the top wall  208  can be included in a cap that is separable from the side wall  206 . 
         [0026]    The top wall  208  can include an introduction or first passage or valve  210  and a second withdrawal passage or valve  212 . In selected configurations, such as a cap  214  can be provided to cap either or both of the passages  210  and  212 . The ports  212  and  214  allow for introduction and/or withdrawal of material from the container  202 . 
         [0027]    Generally, a whole material, such as any appropriate material including whole blood, can be introduced into the separation container  202 . The whole material  220  can be introduced through the introduction passage  210  into the volume of the container  202 . The buoy system  20  can be initially positioned in the appropriate location within the separation container  202 , such as near the bottom wall  204 . Further, the introduction system that introduces the whole material  220  can be any appropriate system such as a syringe  222  that includes a plunger  224  that can be pushed in the direction of an arrow  226  to deliver the material to within the separation container  202 . 
         [0028]    With reference to  FIG. 4B , the container  202  including the whole material  220  can be subjected to a separation force, such as within a centrifuge including those generally known in the art, for example the 755VES Centrifuge system, sold by The Drucker Company having a place of business at Port Matilda, Pa. and including those described in U.S. Pat. No. 7,179,391; 7,374,678; 7,832,566; 7,845,499; or 8,567,609; all of which are incorporated herein by reference. After centrifugation, the whole material  220  can be separated into two or more components or fractions, such as including three fractions. Three fractions can include a first fraction  230 , a second fraction  232 , and a third fraction  234 . During a centrifugation, the heaviest fraction  230  can move towards the bottom wall  204  if the separation container  202  is positioned within the centrifuge such that the centripetal force is towards the bottom wall  204 . The second fraction  232  can be a middle density fraction and the third fraction  234  can be a substantially light fraction. Further, as illustrated in  FIG. 4B , the buoy system  20  can move to a selected area between or amongst the fractions  230 - 234 . For example, the buoy system  20  can move such that the collection volume  30  substantially collects, or is positioned at the location of, the second fraction  232 . 
         [0029]    The buoy system  20  can be designed and include a selected density such that the collection volume  30  is positioned at the level of the second fraction  232 . For example, the density of the second fraction  232  can be known or selected and the buoy system  20  can be formed to include a similar density. The buoy system  20 , for example, may have a density of about 1.059 grams per cubic centimeter (g/cm 3 ) to about 1.061 g/cm 3 . Further, according to various embodiments, the second fraction  232  can have a density that is slightly greater (such as about 0.5% to about 5% greater) than the density of the buoy system  20  and include materials such as a buffy coat of whole blood. The buffy coat of whole blood can include platelets, white blood cells, and interleukin-1 receptor antagonist (IL-1RA or IRAP). IRAP is a protein generally encoded in humans. 
         [0030]    After separation of the whole material into the selected fractions, the blocking wall  90  may be moved to allow for the opening of the passages  80  through the first buoy  22  into the volume  72 . The movement may include sliding or lifting of the blocking wall. Further, the movement may include linear and/or rotational movement. 
         [0031]    The movement of the blocking wall  90  can be performed according to various mechanisms. In various embodiments the blocking wall  90 , as illustrated in  FIG. 4C , may be moved by engaging a portion of the buoy assembly  20 , such as near a withdrawal port  250  with a key or lever  252 . The lever  252  can be passed through the port  210  to engage a portion, such as the withdrawal port  250 , to rotate the blocking wall  90  around an axis  46  to allow for alignment of the blocking wall passages  92  with the wall passages  80  of the wall  40  of the first buoy member  22 . For example, the lever  252  can be rotated generally in the direction of arrow  256  around the axis  46  to move the blocking wall  90  relative to the first buoy  22 . In rotating the lever  252 , an extension or a movable wall member  258  that can be interconnected with the withdrawal port  250  can be moved to rotate the blocking wall  90 . Accordingly, the blocking wall  90  can be moved to allow opening or forming the complete passages through passages  80  into the volume  72  of the first buoy  22 . 
         [0032]    Once the blocking wall  90  has been moved to align the blocking wall passages  92  and the first wall passages  80 , the container  202  can be manipulated, such as inverted, to cause the second fraction  232  to move generally in the direction of arrows  260  such that the second fraction  232  moves into the volume  72  within the first buoy  22 . As the second fraction  232  moves into the volume  72 , it may contact and interact with the beads  70  positioned within the volume  72  of the first buoy member  22 . As discussed above, the beads  70  can be any appropriate bead, such as a glass bead, a desiccating bead, or the like. Accordingly, for example, if the beads  70  are desiccating beads, then a portion of the water or aqueous portion of the second fraction  232  can be drawn into the desiccating beads  70 . This allows the second fraction  232  to be dried and concentrated to concentrate non-water portions of the second fraction  232 . This may decrease an overall volume of the second fraction  232  and allow for an optimization of the withdrawal and collection of the non-water portions of the second fraction  232 . 
         [0033]    After a selected passage of time, the container  202  can be reoriented such that the bottom wall  204  is moved or positioned generally in the direction of the force of gravity to allow a desiccated or dried portion  232   a  of the second fraction  232  to be moved back into the collection volume  30 . The desiccated fraction  232   a  may also be an augmented fraction, it is understood that an augmented fraction may be augmented in various manners. For example, a fraction separated from the whole material may be reacted with a chemical agent in the buoy member  22 . It is understood that the container  202  can be repositioned into a centrifuge to allow for centrifugation to assist in the removal of the dried portion  232   a  from the desiccating beads  70  within the volume  72 . According to various embodiments, after a selected period of time, removal of the dried portion  232   a  of the second fraction  232  from the volume  72  may occur through withdrawal by way of the withdrawal bore  50  and withdrawal tube  54  to a withdrawal syringe  270 . 
         [0034]    The withdrawal syringe  270  can interconnect with the withdrawal port  212  and a plunger  272  or other mechanism, such as a pump or vacuum, can be used to withdraw the desiccated fraction  232   a  into the syringe  270 . A water or aqueous portion  232   b  can be captured or maintained in the volume  72  of the first buoy member  22  such that the withdrawn desiccated fraction  232   a  is substantially concentrated relative to the initial second fraction  232 . The collected fraction  232   a  can have a higher concentration of IRAP, such as about 10,000 picograms/milliliter (pg/ml) to about 110,000 pg/ml relative to the initial second fraction  232 . Further, the collected fraction  232   a  can have a higher concentration of IRAP, such as about 5% higher to about 1,000% higher relative to the initial second fraction  232  (including about 10,000 picograms/milliliter IRAP to about 40,000 picograms/milliliter IRAP). 
         [0035]    Turning reference to  FIGS. 5A and 5B , the buoy assembly  20  illustrated therein may include the first buoy member  22 , the second buoy member  24 , and the third buoy portion or connecting portion  26 . The buoy assembly  20  can be substantially similar to the buoy assembly  20  discussed above and can include a volume  72  formed within the first buoy member  22 . The buoy assembly  20 , therefore, can also be used with a separation container  202  and any system and method as described above. The buoy assembly  20 , as illustrated in  FIGS. 5A and 5B , may include a blocking plate  300  rather than the blocking plate  90 . The blocking pate  300  may include the blocking passages  302  that can be moved from an unaligned first position to an aligned position second position relative to the passages  80  in the first buoy member  22  through the first wall  40 . The blocking plate  300  can include a configuration, such as a magnetic configuration or portion. The magnetic portion includes a south pole at a first end  310  and a north pole at a second end  312 . The north and south poles can be magnetic poles and allow for an external magnet  320  to interact with the poles  310 ,  212  of the blocking plate  300 . 
         [0036]    For example, as illustrated specifically in  FIG. 5A , the external magnet  320  can have a north pole  322  that is positioned near the south pole  310  of the blocking plate  300 . Due to the magnetic interaction, exemplarily illustrated by the arrows  324 , the blocking plate  300  can generally move in the direction of the arrow  326  to an unaligned or blocking orientation. The movement of the blocking plate or wall  300  may be substantially linear and transverse to the axis  46 . Also, a track or groove may be formed in the buoy member  22  to guide the movement of the blocking wall  300 . As discussed above, the buoy assembly  20  can then be used to assist in separation of various fractions of the whole material, including the separation of the second fraction  232  into the collection volume  30 . 
         [0037]    The buoy assembly  20  can then have an external magnet  320  oriented such that a south pole  330  is positioned near the south pole  310  of the blocking plate  300 . Due to the magnetic interaction, illustrated by the arrows  332 , the south pole  330  of the external magnet  320  can repel the south pole  310  of the blocking plate  300  to move the blocking plate  300  generally in the direction of arrow  334 . Upon moving the blocking plate  300  the blocking plate passages  302  may be aligned with the passages  80 . In this way, the collection volume  30  can be open to the internal volume  72  within the first buoy member  22 , similar to the manner discussed above. 
         [0038]    It is understood that various indicia may be used to indicate orientation of the blocking wall  300  relative to the buoy member  22 . For example, the blocking wall  300  may be positioned and held in the buoy member  22  such that the south pole end  310  is near an “S” indicia on the buoy member  22 . The container  202  may be clear or transparent such that the “S” may be seen through the container wall  206 . Similarly the buoy member  22  may include an “N” indicia near the north pole  312  of the blocking wall  300 . The external magnet  320  may also include a “N” indicia near the north pole end  322  and a “S” near the south pole end  330 . Thus, a user will be able to read the indicia and determine the appropriate end of the external magnet  320  to place near the selected end of the blocking wall  300  to move the blocking wall  300  in the selected direction. The blocking wall  300 , for example, may be rotationally fixed relative to the axis  46  but able to slide transversally relative thereto. 
         [0039]    Accordingly, the external magnet  320  can be oriented relative to the blocking plate  300  positioned within the or relative to the first buoy member  22  to move the blocking plate  300 . By moving the blocking plate  300 , the blocking plate passages  302  can be selectively aligned or unaligned with the passages  80  through the first surface  40  of the first buoy member  22 . As discussed above, this can allow for access to the internal volume  72  within the first buoy member  22  to allow a material to interact with the reactant in the volume  72 , such as the beads or material positioned within the volume  72 . Thus, the material positioned within the collection volume  30  can be moved or allowed to access the volume  72  within the first buoy member  22  by passing through aligned passages and a blocking plate with the passages  80  in the first buoy member. 
         [0040]    According to various embodiments, the beads  70  positioned within the volume  72  can include polyacrylamide beads. The polyacrylamide beads can be used to desiccate or remove water from the second fraction  232  positioned within the collection volume  30  and moved into the volume  72  within the first buoy member  22 . The fraction  232 , as discussed above, can include a buffy coat fraction of whole blood. Further, the second fraction  232  can include a fraction including various components of bone marrow aspirate, adipose tissue, and the like. Generally, the desiccation of the second fraction  232  can concentrate and/or release free IRAP. The IRAP can be released and or concentrated with the desiccation of the second fraction  232 . Accordingly, once the desiccated fraction  232   a  is removed from the first buoy member  22 , as discussed above, and withdrawn from the collection container  202 , the concentrated IRAP can be removed and used for various procedures, such as those generally known in the art. 
         [0041]    Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail. 
         [0042]    The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.