Abstract:
A system for separating components of a composition according to density. The system includes a torque generating device, a separation device, and a housing. The separation device separates the composition into different components according to density. The housing accommodates the separation device. The housing includes a base having an interface that transfers torque from the torque generating device to the separation device, a cover, and a conduit for introducing the composition into the separation device without opening the cover.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 12/062,801 filed on Apr. 4, 2008. The entire disclosure of the above application is incorporated herein by reference. 
    
    
     FIELD 
     The present disclosure relates to sterile devices, systems, and methods for separating components of a composition, such as blood. 
     BACKGROUND 
     The statements in this section merely provide background information related to the present disclosure and may not constitute prior art. 
     Whole blood includes a variety of different fractions or parts. For example, human whole blood includes platelet rich plasma (PRP), platelet poor plasma (PPP), red blood cells (RBCS), and white blood cells (WBCs). These different blood fractions have a variety of clinical and experimental uses. There is a need for devices and methods that separate and isolate the different fractions of whole blood. In particular, there is a need for devices and methods for separating and isolating different blood fractions in a non-sterile environment by non-sterile personnel for later use in a sterile environment. 
     SUMMARY 
     The present teachings provide for a system for separating components of a composition according to density. The system includes a torque generating device, a separation device, and a housing. The separation device separates the composition into different components according to density. The housing accommodates the separation device. The housing includes a base having an interface that transfers torque from the torque generating device to the separation device, a cover, and a conduit for introducing the composition into the separation device without opening the cover. 
     The present teachings further provide for a method for separating components of a composition according to density. The method includes: sealing a sterilized separation device within a container having a base and a cover such that the separation device is in cooperation with an interface at the base of the container; inserting the composition into the sterilized separation device sealed within the container by injecting the composition through a conduit that extends through the container and mates with the separation device; mating the container with a torque generating device, the interface in contact with both the torque generating device and the separation device; spinning the separation device using the torque generating device to separate the composition into different components according to density, the separation device is spun independent of the container and torque is transferred from the torque generating device to the separation device by the interface; removing the sterile separation device from the container; and withdrawing at least one of the different components from the separation device as necessary while the separation device is in the sterile environment. 
     The present teachings also provide for a container for housing a sterile separation device for separating components of a composition according to density. The container includes a container base, an interface, a cover, and a conduit. The container base has sidewalls extending from the container base to define a receptacle for accommodating the separation device. The interface is at the container base for transferring torque from a torque generating device to the separation device when the separation device is seated within the receptacle. The cover covers the receptacle and seals the sterile separation device within the receptacle to prevent contamination of the sterile separation device. The conduit extends through the container to the sterile separation device to permit delivery of blood through the container and into the sterile separation device when the sterile separation device is sealed within the receptacle. 
     Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
    
    
     
       DRAWINGS 
       The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. 
         FIG. 1  is a perspective view of a system for separating components of blood according to the present teachings; 
         FIG. 2  is an exploded side view of the system of  FIG. 1 ; 
         FIG. 3  is an assembled cross-sectional side view of the system of  FIG. 1 ; and 
         FIG. 4  is a cross-sectional side view of another system for separating blood components according to the present teachings. 
     
    
    
     DETAILED DESCRIPTION 
     The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. 
     A system for separating components of a composition according to density is illustrated in  FIGS. 1-3  at reference numeral  10 . The system generally includes a component separation device  12 , a container  14  for accommodating the separation device  12 , a cover  16 , and a motorized rotating platform  18 . The system  10  can be used to separate components of a variety of compositions, such as whole blood as described herein. 
     The separation device  12  includes a main body  20  that defines a separation chamber  22 . The main body  20  includes a first end  24 , a second end  26 , and a cylindrical sidewall  27  that extends between the first end  24  and the second end  26 . The main body  20  is sized to fit within the container  14 . While the separation device  12  described herein is merely an exemplary device, the device  12  is based off the separation devices of Biomet Inc.&#39;s GPS system as described in, for example, U.S. Pat. No. 7,179,391 (filed May 23, 2003) and U.S. Publication Nos. 2005-0109716 (filed Sep. 2, 2004) and 2006-0273049 (filed May 25, 2006), which are hereby incorporated by reference. Differences between the device  12  and the separation tubes of the GPS devices include the location of the outlet ports  32  and  34  at the sidewall  27  and the presence of the locking details  48 . In addition to the separation devices of the GPS, any suitable separation device can be used after being modified to include the locking details  48  and the outlet ports  32  and  34 . 
     At the sidewall  27  is a first inlet port  28  and a second inlet port  30 . The first and the second inlet ports  28  and  30  extend through the sidewall  27  to permit the introduction of materials into the separation chamber  22 . As illustrated, the first and the second inlet ports  28  and  30  extend from the sidewall  27 . However, the first and the second inlet ports  28  and  30  can be recesses in the sidewall  27  or can be co-planar with the sidewall  27 , for example. 
     Also at the sidewall  27  is a first outlet port  32  and a second outlet port  34 . The first and the second outlet ports  32  and  34  extend through the sidewall  27  to permit withdrawal of materials from within the separation chamber  22 . As illustrated, the first and the second outlet ports  32 / 34  each extend from the sidewall  27  and are each covered with a removable cap. The first outlet port  32  includes a first outlet tube  36  and the second outlet port  34  includes a second outlet tube  38  that extends to within the separation chamber  22 . The first outlet tube  36  and the second outlet tube  38  can each be directed to different areas of the separation chamber  22  to facilitate withdrawal of components at different regions of the separation chamber  22 . 
     The separation device  12  can be configured to separate components of various different materials or substances by density. For example, the separation device  12  can be a blood component separation device to separate various components of whole blood by density, such as platelet rich plasma, red blood cells, platelets, and white blood cells. The separation device  12  is illustrated as an exemplary blood component separation device. 
     For example, as a blood component separation device the device  12  includes a separator (which includes a buoy  40  and a divider  44 ) and a counter-balance  41  at an end of the separation chamber  22  opposite to the buoy  40 . The buoy  40  has a shape that conforms to the interior shape of the separation chamber  22 . The buoy  40  has a tuned density that is configured to reach a selected equilibrium position in blood. For example, the buoy  40  can have a density tuned in the range from about 1.06 g/cc to about 1.11 g/cc, which is less than the density of red blood cells of whole blood. The buoy  40  has an access port  42  that extends through the buoy  40 . The first outlet tube  36  of the first outlet port  32  is connected to the access port  42  of the buoy  40 . 
     Mounted to the buoy  40  is the divider  44 . The divider  44  is mounted to an end of the buoy  40  opposite to an end where the first outlet tube  36  enters the buoy  40 . The divider  44  is mounted to the buoy  40  to create a collection compartment  46  between the divider  44  and the buoy  40 . Components present within the collection compartment  46  can be withdrawn from within the separation chamber  22  through the access port  42 , which extends to the collection compartment  46  and is in communication with both the first outlet tube  36  and the first outlet port  32 . 
     The buoy  40  is movable within the separation chamber  22  laterally with respect to the first end  24  and the second end  26 . When the separation device  12  is at rest, the buoy  40  forms an interference fit with the separation chamber  22  to hold the buoy at a position in the separation chamber  22 . When the device  12  is rotated upon the platform  18 , buoy  40  moves until it reaches an equilibrium within the composition being separated, such as whole blood. Material present in the separation chamber  22 , such as blood, is able to pass between the buoy  40 , as well as the divider  44 , and the inner walls of the separation chamber  22 . Alternatively, the buoy  40  and the divider  44  can have an opening to allow material to move through the buoy  40  and the divider  44 . 
     The sidewall  27  of the main body  20  further includes one or more locking details  48  that are located opposite to the outlet ports  32  and  34 . As illustrated, the locking details  48  protrude from sidewall  27 . However, the locking details  48  can be of any shape, size, or configuration to provide cooperation with the container  14  and the rotating platform  18  to transfer torque from the platform  18  to the separation device  12 . 
     The container  14  includes a container base  50  and cylindrical container sidewalls  52  that extend around the base  50 . The base  50  and the sidewalls  52  define a receptacle sized to receive the separation device  12 . The base  50  includes an interface  54 . The interface  54  cooperates with the rotating platform  18  and receives the separation device  12  to transfer torque from the rotating platform  18  to the separation device  12 . Between the interface  54  and the container  14  is a bushing to allow the interface  54  to rotate independent of the container  14 . In particular, the interface  54  includes one or more receptacles  56  at a first end and a bottom portion  58  at a second end that is opposite to the receptacles  56 . The receptacles  56  receive the locking details  48  of the separation device  12 . The bottom portion  58  cooperates with the platform  18  to transfer torque from the platform  18  to the separation device  12 . 
     The rotating platform  18  can be any suitable torque generating device. For example, the rotating platform  18  can be a Vortech type base by Biomet Biologics, Inc. of Warsaw, Ind. 
     The cover  16  includes an upper portion  60  and a lower portion  62 . Side portions  64  extend between the upper portion  60  and the lower portion  62 . A first conduit  66  and a second conduit  68  both extend through the cover  16 . The first conduit  66  can include a first cap  70  and the second conduit  68  can include a second cap  72 . As illustrated in  FIG. 2 , when the separation device  12  is seated in the container  14  and the cover  16  is on the container  14 , the first conduit  66  is aligned with and connected to the first inlet port  28  and the second conduit  68  is aligned with and connected to the second inlet port  30 . The connections between the conduits  66 / 72  and the ports  28 / 30  provide passages through the cover  16  to permit the introduction of blood, for example, through the cover  16  and into the separation device  12  when the cover  16  is in place over the device  12 . The cover  16  can be independent of the container  14  or mounted to the container  14 , such as with a hinge. 
     As illustrated in  FIG. 3 , the sidewalls  52  of the container  14  include locking details  74  at the ends of the sidewalls that are opposite to the container base  50 . The locking details  74  of the container  14  cooperate with locking details  76  of the cover  16 . Thus, the cover  16  is mounted to the container  14 . To permit the separation device  12  to freely rotate within the container  14  when the cover  16  is in place, the conduits  66  and  68  are slidably removed to detach the cover  16  from the separation device  12 , but not completely removed from the cover  16 . In this regard, the passageway through the cover  16  that the conduits  66  and  68  are seated in remains filled so as to restrict the passage of bacteria and non-sterile materials through the cover  16 . The cover  16  can also be mounted to the container  14  with a hinge at the sidewalls  52 . 
     With reference to  FIG. 4 , the system  10  can alternatively be provided with a cover  16  that is directly attached to the separation device  12 . As a result, the cover  16  can rotate with the separation device  12  and the first and second conduits  66  and  68  do not need to be detached from the separation device  12  to permit rotation of the separation device  12 . A bushing is provided between the cover  16  and the walls  52  of the container to reduce friction and allow the cover  16  to freely rotate within the container  14 . 
     In use, the device  12 , the container  14 , and the cover  16  are sterilized. The sterile separation device  12  is placed in the sterile container and the sterile cover  16  is seated over the separation device  12  to prevent contamination of the separation device  12 . With the separation device  12  sealed within the container  14 , the container  14  can be handled by non-sterile personnel. For example, non-sterile personnel can transport the separation device  12  and/or load the separation device  12  with a composition to be separated, such as blood. For example, blood can be inserted into the separation device  12  through the first and/or second ports  28  and  30  using the first and/or second conduits  66  and  68 . 
     After the separation device  12  is filled with blood, the container  14  is seated on the rotating platform  18 . The separation device  12  is spun by the platform  18  for a suitable time at a suitable speed to generate a force of about 593×g. After the device  12  is spun as appropriate, the different components of blood will be separated according to density. For example, red blood cells typically settle between the divider  44  and the second end  26 , a buffy coat of white blood cells and blood platelets typically settles in the collection compartment  46  between the buoy  40  and the divider  44 , and platelet poor plasma typically settles between the counterbalance  41  and the buoy  40 . 
     The sterile container  12  can then be opened and the separation device  12  can be removed by sterile personnel in the sterile environment or simply dumped into the sterile environment, such as onto a sterile tray. The desired blood fraction can be extracted through the first and/or the second outlet ports  32  and  34 . For example, if blood platelets are desired to be extracted they can be extracted using the first outlet port  32  because the first outlet port  32 , via the first outlet tube  36 , extends to the collection compartment  46  where the platelets settle. Using the first outlet port  32 , the red blood cells can be subsequently extracted after extraction of the platelets as the red blood cells can be withdrawn through and/or past the divider  44 . If the platelet poor plasma is to be extracted, the second outlet port  34  can be used because the second outlet tube  38  extends to the region where the platelet poor plasma typically settles. 
     Thus, when sealed within the container  14 , the sterile separation device  12  can be filled and spun by non-sterile personnel in a non-sterile environment. The container  14  can then be opened and the sterile separation device  12  can be removed and transferred to the sterile environment where the separated components can be withdrawn from the device  12  as necessary. Thus, while in the container  14  the sterility of the device  12  can be maintained even though the device is in a non-sterile environment, which offers greater flexibility for use and transport of the device  12 . 
     The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.