Blood and bone marrow fractionation device and method

Abstract

Apparatus, system, and method embodiments are disclosed that provide a fractionation device for fractionating or separating blood or bone marrow aspirate (BMA) into one or more constituent layers and efficiently collecting layers of interest. The fractionation device includes a generally cylindrical side wall, a top wall connected to an upper portion of the side wall, a bottom wall connected to a lower portion of the side wall, and an internal partition. The inner bulkhead includes an inclined portion that contacts the side wall and a vertical portion that contacts the top wall.

Description

Technical Field

[0001] Embodiments disclosed herein relate to apparatus, systems and methods for fractionating blood or bone marrow aspirates. Embodiments more particularly relate to systems, apparatus and methods for separating blood or bone marrow aspirates into one or more layers and providing a fractionation device that efficiently collects a specific layer. Background Art

[0002] A fractionation device is used to separate blood or bone marrow aspirate (BMA) into one or more component layers or fractions (e.g., a red blood cell layer, a plasma layer, a lipid layer, a platelet-rich sediment layer, etc.). The blood or BMA can be separated using a centrifuge in a fractionation device. As the centrifuge rotates, the blood or BMA is separated into its component layers, each of which can then be individually extracted and subsequently processed or utilized. The blood or BMA can undergo one or more cycles in the centrifuge to separate into one or more component layers. There are various known fractionation devices for separating blood or bone marrow aspirate (BMA) into one or more component layers.

[0003] However, it can be difficult to effectively separate and individually extract the desired blood or BMA layer. In addition, it can be difficult to visualize some layers within the fractionation device.

[0004] The embodiments disclosed herein are directed to overcoming one or more of the problems set forth above. Summary of the invention

[0005] Disclosed herein are apparatus, system, and method embodiments that provide a fractionation device for fractionating or separating blood or bone marrow aspirate (BMA) into one or more component layers or fractions (eg, a red blood cell layer, a plasma layer, a lipid layer, etc.).

[0006] One embodiment disclosed herein is a fractionation device or apparatus for fractionating or separating blood or BMA into one or more component layers or fractions. The fractionation device includes a generally cylindrical side wall, a top wall connected to the upper portion of the side wall, a bottom wall connected to the lower portion of the side wall, and an internal partition. The internal partition includes an inclined portion contacting the side wall and a vertical portion contacting the top wall. The fractionation device also includes: an upper chamber, which is defined by the internal partition, the top wall, and the upper portion of the side wall within the fractionation device; a lower chamber, which is defined by the internal partition, the upper surface of the plunger of the fixed plunger engaged with the side wall, and the lower portion of the side wall within the fractionation device, and a lower region of the upper chamber, which is defined by the inclined portion of the internal partition adjacent to the side wall. In addition, the fractionation device includes a threaded opening through the bottom wall.

[0007] Embodiments of the methods disclosed herein may include the steps of providing a fractionation device, obtaining blood or a bone marrow aspirate (BMA) from a patient, pre-treating the blood or BMA from the patient, adding the blood or BMA to a lower chamber of the fractionation device, and centrifuging the fractionation device to separate the blood or BMA into different layers. The method may continue by engaging a threaded rod with a threaded opening; and rotating the threaded rod within the threaded opening to raise a fixed plunger within the lower chamber of the fractionation device until the plasma layer overflows into the upper chamber of the fractionation device through an overflow window formed on a vertical portion of an internal partition, the overflow window providing a fluid path between an input channel and the upper chamber. In some cases, the method may also include removing at least a portion of the plasma layer from the upper chamber of the fractionation device. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a top, front perspective view of one embodiment of a fractionation apparatus as disclosed herein.

[0009] Figure 2 is a front elevation view of a fractionation apparatus as disclosed herein.

[0010] Figure 3 is a side elevation view of a fractionation apparatus as disclosed herein.

[0011] Figure 4 is a top, front perspective view of a fractionation apparatus as disclosed herein.

[0012] Figure 5 is a top, back, and side perspective view of a fractionation apparatus as disclosed herein.

[0013] Figure 6 is a rear elevation view of a fractionation apparatus as disclosed herein.

[0014] Figure 7 is a bottom, rear perspective view of a fractionation apparatus as disclosed herein.

[0015] Figure 8 is a cross-sectional perspective view of a fractionation apparatus as disclosed herein, wherein the cross section is taken along the front-to-back centerline plane.

[0016] 9A to 9C is a side elevation cross-sectional view of a fractionation apparatus as disclosed herein, wherein the cross section is taken along the front-to-back centerline plane.

[0017] Fig.10 is a side elevation cross-sectional view of an alternative embodiment of a fractionation apparatus as disclosed herein, wherein the cross section is taken along the front-to-back centerline plane.

[0018] Fig.11is a rear elevation cross-sectional view of an alternative embodiment of a fractionation apparatus as disclosed herein, wherein the cross section is taken along the Figure 3 The plane defined by the axis AA is intercepted.

[0019] Fig.12 is a top elevational cross-sectional view of a fractionation apparatus as disclosed herein, wherein the cross section is taken along the line Figure 2 The plane defined by the axis BB is intercepted.

[0020] Fig.13 is a top elevational cross-sectional view of a fractionation apparatus as disclosed herein, wherein the cross section is taken along the line Figure 2 The plane defined by the axis CC is intercepted.

[0021] Fig.14 yes Figure 1 To Figure 9, Fig.12 and Fig.13 A side elevation cross-sectional view of a fractionation apparatus showing the multiple layers of fractionated blood.

[0022] Fig.15 yes Fig.10 and Fig.11 A side elevation cross-sectional view of an alternative embodiment of a fractionation apparatus showing one or more layers of fractionated bone marrow aspirate.

[0023] Fig.16 yes Figure 1 To Figure 9, Fig.12 and Fig.13 Side elevation cross-sectional view of a fractionation device showing one or more layers of fractionated blood after a second centrifugation step.

[0024] Fig.17 is a front elevation view of a counterweight for use with a fractionation apparatus as disclosed herein.

[0025] Fig.18A and Fig.18B are side elevation cross-sectional views of the counterweight of the fractionation apparatus disclosed herein at different orientations, wherein the cross-section is taken along the front-to-back centerline plane.

[0026] Fig.19 is a side top cross-sectional perspective view of a counterweight for a fractionation apparatus as disclosed herein, wherein the cross section is taken along the front-to-back centerline plane.

[0027] Fig. 20A and Fig. 20B is used Figures 1 to 19 Flowchart of the fractionation apparatus and the method of balancing weights. DETAILED DESCRIPTION

[0028] Unless otherwise indicated, all numbers used in the specification and claims indicating quantities of ingredients, dimensions, reaction conditions, and the like should be understood as being modified in all instances by the term "about" or "approximately." In addition, unless otherwise indicated or limited, the terms "about" and "approximately" used herein with respect to a reference value or reference ratio refer to a variation of ±20% or less (e.g., ±15%, ±10%, ±5%, etc.) from the reference value or reference ratio, including the endpoints of the range.

[0029] In this application and claims, unless otherwise specifically stated, the use of the singular includes the plural. In addition, unless otherwise stated, the use of "or" means "and / or". In addition, the use of the term "includes" and other forms (such as "includes" and "comprising") is not restrictive. In addition, unless otherwise specifically stated, terms such as "element", "structure" or "component" cover elements, structures and components that include one unit and elements, structures and components that include more than one unit. Unless otherwise stated or limited, the terms "mount", "connect", "support", "attach" and "couple" and their variations are used in a broad sense and cover direct and indirect mounting, connection, support and coupling.

[0030] As used herein, unless otherwise defined or limited, directional terms are used for convenient reference to discuss a particular figure or example. For example, reference to a downward (or other) direction or a top (or other) position may be used to discuss aspects of a particular example or figure, but does not necessarily require similar orientations or geometries in all installations or configurations.

[0031] In the present application and claims, references to blood, bone marrow, plasma, other blood derivatives including plasma, or other body fluids are not limiting and, in all cases, may include references to any of blood, bone marrow, other blood derivatives including plasma, or other body fluids.

[0032] A fractionation device can be used to separate blood, bone marrow aspirate (BMA), or other body fluids into one or more component layers or fractions. However, once a layer or layers have been separated, it may be difficult to extract the layer or layers from the fractionation device. Additionally, it may be difficult to visualize the layer or layers within the fractionation device.

[0033] Embodiments of the claims can address these or other problems. For example, embodiments of the various devices, systems, and methods disclosed herein provide a fractionation device that can be used to separate blood or BMA into one or more component layers and provide efficient extraction of one or more layers of interest from the fractionation device. Typically, the disclosed device includes a lower chamber and an upper chamber. After one or more centrifugation steps, the blood or BMA can be easily separated into one or more component layers (e.g., a red blood cell layer, a plasma layer, a lipid layer, a platelet-rich sediment layer, etc.) in one or both chambers. One or more ports connected to the upper chamber can be used to extract the layers of interest, including but not limited to a plasma layer, a white blood cell or white blood cell layer (buffy coat), and a platelet-rich sediment or layer. As disclosed below, in some embodiments, the lipid layer can be extracted using one or more ports attached to the lower chamber. Additionally, improvements include, but are not limited to, manufacturing the fractionation device from optically transparent materials, providing an upper chamber and a lower chamber, providing an inclined portion between the upper chamber and the lower chamber, and other improvements that allow a technician or other fractionation device user to more easily and efficiently visualize and extract one or more component layers of interest from the fractionated blood or BMA.

[0034] The term "fractionation" is defined herein as a process or method for separating blood, BMA or other body fluids into one or more component layers. For blood, these layers may include an erythrocyte layer or a red blood cell layer, a buffy coat or a leukocyte layer, a platelet-rich sediment or a platelet-rich layer, a leukocyte- and platelet-rich layer or a leukocyte- and platelet-rich sediment, a plasma layer, a platelet-containing plasma layer, etc. Blood is not limited to these layers, and may have more or fewer layers after fractionation, depending on the number of centrifugal cycles or the speed of the centrifugal cycles. For BMA, these layers may include an erythrocyte layer or a red blood cell layer, a buffy coat or a leukocyte layer, a platelet-rich sediment or a platelet-rich layer, a leukocyte- and platelet-rich layer or a leukocyte- and platelet-rich sediment, a plasma layer, a platelet-containing plasma layer, a fat or lipid layer, etc. BMA is not limited to these layers, and may have more or fewer layers after fractionation, depending on the number of centrifugal cycles or the speed of the centrifugal cycles.

[0035] Thus, embodiments herein generally include apparatus, systems, and methods that include a fractionation device for separating blood or BMA into one or more layers or fractions. Although the fractionation device will be described with respect to blood or BMA, the fractionation device can also be used for other body fluids and is not intended to be limited to blood or BMA. In addition, the disclosed device embodiments include structures, devices, or systems that facilitate efficient collection of fractions of interest.

[0036] Figures 1 to 16Several views of a fractionation apparatus 10 are shown according to various embodiments. Figure 8 Figure 9 Fig.14 and Fig.16 A fractionation device 10a or fractionation device 10aa is shown having some structure optimized for use with blood, while Fig.10 , Fig.11 and Fig.15 A fractionation apparatus 10b is shown having a structure optimized for use with BMA. Many components of the fractionation apparatus 10 overlap between the two embodiments of the fractionation apparatus 10 for blood and for BMA. Therefore, a single description and reference numerals of the fractionation apparatus 10 will be used for both fractionation apparatuses 10. Different reference numerals will be used to specifically describe the differences between the embodiments of the fractionation apparatus 10a, fractionation apparatus 10aa, and fractionation apparatus 10b, in which the fractionation apparatus 10a and fractionation apparatus 10aa are used for blood and the fractionation apparatus 10b is used for BMA.

[0037] The fractionation device 10 may include a sidewall 12. The sidewall 12 may be cylindrical or tubular. However, the sidewall 12 may also be other shapes (e.g., spherical, square, octagonal, etc.). The sidewall 12 may have a sidewall inner surface 14 ( Figures 8 to 10 ). The side wall 12 may further include an upper portion 16 of the side wall 12 and a lower portion 18 of the side wall 12 .

[0038] In some embodiments, the sidewall 12 is formed of an optically transparent material so that a user of the fractionation device 10 can see and observe the material (e.g., blood, a blood layer, BMA or a BMA layer, other body fluids, or other body fluid layers) contained within the fractionation device 10 through the sidewall 12. In addition, the sidewall 12 optionally has one or more scale lines 102 ( Figure 1 , Figure 2 , Figure 3 , Figure 5 and Figure 6 One or more graduations 102 may be used to display or measure the amount of blood, BMA, or other bodily fluid within the fractionation device 10.

[0039] The fractionation apparatus 10 also includes a top wall 20 connected to the upper portion 16 of the side wall 12. The top wall 20 is sealed to the upper portion 16 of the side wall 12 so that liquid or other materials cannot enter or escape through the top wall 20 except at predetermined locations described below. In some embodiments, the top wall 20 can be a cover that is removably coupled to the upper portion 16 of the side wall 12. Alternatively, the top wall 20 can be permanently combined with the side wall 12. For example, the top wall 20 can be glued, bonded, welded, or integrally formed with the side wall 12. The top wall 20 includes a top wall inner surface 22 ( Figures 8 to 10 ).

[0040] The fractionation apparatus 10 also includes a bottom wall 24 connected to the lower portion 18 of the side wall 12. The bottom wall 24 is sealed to the lower portion 18 of the side wall 12 so that liquid or other materials cannot enter or escape through the bottom wall 24. In some cases, the bottom wall 24 is a cover that is removably coupled to the lower portion 18 of the side wall 12. Alternatively, in other cases, the bottom wall 24 is permanently coupled to the side wall 12. For example, the bottom wall 24 can be glued, bonded, welded, or integrally formed with the side wall 12. The bottom wall 24 has a bottom wall inner surface 26 ( Figures 8 to 10 In some cases, the bottom wall inner surface 26 does not completely enclose the lower portion 18 of the side wall 12. In some cases, the bottom wall 24 also includes an opening 28 ( Figures 7 to 10 ). The opening 28 may be threaded and capable of receiving a threaded rod or screw 30 (FIGS. 9 and Fig.10 ). In other cases, the threaded rod 30 and the opening 28 may not be threaded. The threaded rod 30 may include a knob 32 attached to one end of the threaded rod 30. The threaded rod 30 has one or more prongs 34 to help grasp the knob 32 and turn the threaded rod 30 within the opening 28.

[0041] In some embodiments, the captive plunger 36 ( Figures 8 to 10 2) can be received within the lower portion 18 of the sidewall 12, above the bottom wall inner surface 26 of the bottom wall 24. Once the bottom wall 24 is attached to the lower portion 18 of the sidewall 12, the fixed plunger 36 can be removably received within the fractionation apparatus 10 or permanently received within the fractionation apparatus 10 (e.g., the fixed plunger 36 cannot be removed from the fractionation apparatus 10 without modifying the fixed plunger 36 or the fractionation apparatus 10 in some manner). The fixed plunger 36 can be formed of rubber, silicone, or other materials capable of sealing to the sidewall inner surface 14 of the sidewall 12. In some cases, the fixed plunger 36 has one or more O-rings 38, gaskets, machined surfaces, or other sealing structures capable of forming a liquid-tight seal with the sidewall inner surface 14 of the sidewall 12. Preferably, in some cases, the stationary plunger 36 has two O-rings 38 a and 38 b to provide stability to the stationary plunger 36 and prevent the stationary plunger 36 from tilting within the sidewall 12 as the stationary plunger 36 moves within the fractionation apparatus 10 .

[0042] The fixed plunger 36 includes a fixed plunger bottom surface 40 and a fixed plunger upper surface 42. The fixed plunger bottom surface 40 of the fixed plunger 36 may initially contact or be close to the bottom wall inner surface 26. Fig.10, the threaded rod 30 is capable of contacting a fixed plunger bottom surface 40 via an opening 28 in the bottom wall 24. When the threaded rod 30 is twisted or rotated within the opening 28 or pushed into the opening 28 and contacts the fixed plunger bottom surface 40 of the fixed plunger 36, the fixed plunger 36 is pushed upward within the fractionation device 10, causing the blood, BMA or other body fluid to rise within the fractionation device 10. In some cases, the size or spacing of the threads of the opening 28 and the threaded rod 30 can be designed so that turning the threaded rod 30 a specific amount causes the fixed plunger 36 to rise a specific amount. Additionally or alternatively, one or more prongs 34 of the knob 32 can be spaced or oriented so that turning the knob 32 relative to the prongs 34 by a specific amount (e.g., a quarter turn, a half turn, a full turn, etc.) causes the fixed plunger 36 to rise a specific amount.

[0043] In various embodiments, once the threaded rod 30 raises the fixed plunger 36 a specific amount, the fixed plunger 36 can be configured to descend. In some cases, the fixed plungers 36 of the fractionation apparatus 10a and the fractionation apparatus 10b can be configured to descend using a high-speed rotation cycle of the centrifuge. In other words, rotating the fractionation apparatus 10a and the fractionation apparatus 10b at a specific speed in the centrifuge can move the fixed plunger 36 downward until the fixed plunger 36 reaches a specific or selected position (e.g., the fixed plunger bottom surface 40 contacts the bottom wall inner surface 26 of the fractionation apparatus 10, etc.).

[0044] In other cases, such as Fig. 9B and Fig. 9C As shown in the fractionation apparatus 10aa in FIG. 1 , one or more additional parts or elements (e.g., a column 37, an internal rod 31, etc.) may be provided to lower the fixed plunger 36. It should be noted that although the parts or elements for lowering the fixed plunger 36 are described for the fractionation apparatus 10aa, similar parts or elements may also be used in the fractionation apparatus 10a and the fractionation apparatus 10b, and the internal rod 31 and the column 37 should not be limited to the fractionation apparatus 10aa.

[0045] To lower the fixed plunger 36, the fixed plunger 36 may also include a post 37 coupled to the fixed plunger 36 or the fixed plunger bottom surface 40 of the fractionation device 10aa. In various cases, the post 37 may be integrated with the fixed plunger bottom surface 40 or the fixed plunger 36, attached (e.g., glued, coupled, etc.) to the fixed plunger bottom surface 40, at least partially or completely embedded within the fixed plunger bottom surface 40 or the fixed plunger 36, formed or molded with the fixed plunger bottom surface 40 or the fixed plunger 36, may be an opening within the fixed plunger 36, etc. The post 37 may include one or more threads 39 formed on the interior of the post 37, or in some cases, the post 37 may not be threaded.

[0046] In various cases, such as Fig. 9CAs shown in , the threaded rod 30 may also include an inner rod 31 at least partially or completely embedded in the threaded rod 30, and a second knob 33 coupled to the inner rod 31 and / or the knob 32. In some cases, the inner rod 31 may include one or more threads 35. The one or more threads 35 may be configured to couple or engage with one or more threads 39 of the column 37. In various cases, when the threaded rod 30 is twisted or rotated within the opening 28 of the fractionation device 10aa or pushed into the opening 28 of the fractionation device 10aa, the inner rod 31 may be coupled or engaged with the column 37. In some cases, the inner rod 31 may be configured to couple with the column 37 by rotating the threaded rod 30 and engage the one or more threads 35 of the inner rod 31 with the one or more threads 39 of the column 37. In other cases, the inner rod 31 may be configured to couple with the column 37 by rotating the second knob 33 and engage the one or more threads 35 of the inner rod 31 with the one or more threads 39 of the column 37. Alternatively, the inner rod 31 may be configured to couple or engage with the post 37 in other ways, such as being press-fitted into the post 37 , inserted into the post 37 , or the like.

[0047] In various cases, once the inner rod 31 is coupled or engaged with the post 37, the threaded rod 30 can be rotated within the opening 28 to lower the fixed plunger 36. In other words, when the threaded rod 30 is removed from the fractionation device 10aa, the inner rod 31 engaged with the post 37 pulls the fixed plunger 36 downward until the fixed plunger 36 reaches a specific or selected position (e.g., the fixed plunger bottom surface 40 contacts the bottom wall inner surface 26 of the fractionation device 10aa, etc.). Once the fixed plunger 36 reaches the specific or selected position, the inner rod 31 can be uncoupled or disengaged from the post 37 (e.g., by rotating the threaded rod 30, by rotating the second knob 33, etc.).

[0048] The fractionation device 10 also includes an internal baffle 44 ( Figures 8 to 12 ). The interior partition 44 has a vertical portion 46 that contacts the top wall inner surface 22 of the top wall 20 and an inclined portion 48 that contacts the side wall inner surface 14. In some cases, the vertical portion 46 extends parallel to the side wall 12. The inclined portion 48 can be inclined from about 1 degree to 89 degrees, or more typically 20 degrees to 70 degrees, or preferably 20 degrees to 30 degrees relative to a horizontal plane extending through the top wall 20 or the bottom wall 24. The interior partition 44 includes an interior partition upper surface 50 and an interior partition lower surface 52.

[0049] The fractionation device 10 includes an upper chamber 54 and a lower chamber 56 ( Figures 8 to 11). An upper chamber 54 within the fractionation apparatus 10 is defined by the inner baffle upper surface 50 of the inner baffle 44, the top wall inner surface 22 of the top wall 20, and the side wall inner surface 14 of the upper portion 16 of the side wall 12. A lower chamber 56 within the fractionation apparatus 10 is defined by the inner baffle lower surface 52 of the inner baffle 44, the fixed plunger upper surface 42 of the fixed plunger 36, and the side wall inner surface 14 of the lower portion 18 of the side wall 12.

[0050] The fractionation apparatus 10 also includes a lower region 58 of the upper chamber 54. The lower region 58 of the upper chamber 54 is defined by the location where the inner baffle upper surface 50 of the inclined portion 48 is adjacent to or in contact with the sidewall inner surface 14 of the sidewall 12. In some cases, the lower region 58 includes a flat portion 60 that is flat or parallel to a horizontal plane extending through the top wall 20 or the bottom wall 24. Alternatively, in other cases, the inner baffle upper surface 50 of the lower region 58 is inclined from about 1 degree to 89 degrees, or more typically 20 degrees to 70 degrees, or preferably 20 degrees to 30 degrees relative to a horizontal plane extending through the top wall 20 or the bottom wall 24.

[0051] In some embodiments, the fractionation device 10 includes one or more inclined recesses 62 in the sidewall 12. In some cases, the fractionation device 10 includes two inclined recesses 62a and 62b ( Figure 6 , Figure 7 and Fig.11 ). The inclined recesses 62 define the inclined portion 48 of the inner partition 44. In a non-limiting example, when the inclined portion 48 approaches the lower region 58, the inclined recesses 62a and 62b limit the horizontal cross-section of the inclined portion 48, making the inclined portion 48 narrower toward the lower region 58 ( Fig.11 and Fig.12 In other words, the inclined portion 48 is wider toward the vertical portion 46 of the inner partition 44 and narrower toward the lower region 58 of the inner partition 44. By narrowing the inclined portion 48 as it approaches the lower region 58, the platelet-rich sediment layer of blood or BMA and / or the leukocyte- and platelet-rich sediment layer 100 ( Fig.16 In addition, by narrowing the inclined portion 48 as it approaches the lower region 58, it is easier to collect the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer 100 because the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer 100 is concentrated at the narrow portion of the lower region 58 rather than being dispersed over a larger surface.

[0052] Furthermore, to help visualize the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer 100 in the blood or BMA concentrated in the lower region 58, the fractionation device 10 may further include an observation window 64 ( Figure 6 and Figure 7 ). The viewing window 64 optionally includes a magnifying lens to enhance visualization of the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer 100 in the blood or BMA.

[0053] The fractionation apparatus 10 includes an input channel 66 extending from the top wall 20 into the lower chamber 56. The input channel 66 is defined in part by the vertical portion 46 of the internal baffle 44 and the sidewall inner surface 14 of the sidewall 12. The input channel 66 may also be defined by one or more channel notches 68 that limit the horizontal cross-section ( Figure 1 , Figure 2 and Figure 4 ). One or more channel recesses 68 extend from the sidewall inner surface 14 and contact the vertical portion 46 on the internal partition 44. In some cases, the one or more channel recesses 68 include a first channel recess 68a and a second channel recess 68b, so that the input channel 66 is defined and limited on four sides by the sidewall inner surface 14 of the sidewall 12, the vertical portion 46 of the internal partition 44, the first channel recess 68a and the second channel recess 68b.

[0054] In various cases, the side wall 12 may optionally have a side wall recess 70 ( Figures 8 to 10 ), so that a portion of the side wall 12 or a portion of the side wall inner surface 14 in the input channel 66 extends toward the vertical portion 46 of the inner partition 44. By adding the side wall notch 70, blood, BMA or other body fluids can easily flow down along the side wall notch 70 into the input channel 66, thereby reducing hemolysis of the blood, BMA or other body fluids and reducing the number of bubbles formed in the blood, BMA or other body fluids.

[0055] The fractionation apparatus 10 includes an overflow window 72 ( Figures 8 to 10 4 ), the overflow window 72 is formed in the vertical portion 46 of the interior partition 44 and provides a fluid path between the input channel 66 and the upper chamber 54. When the threaded rod 30 is twisted within the opening 28 in the bottom wall 24, contacting the fixed plunger bottom surface 40 of the fixed plunger 36, the fixed plunger 36 rises within the fractionation device 10, causing blood, BMA, or other body fluid to rise through the input channel 66 and eventually overflow from the lower chamber 56 into the upper chamber 54 through the overflow window 72. In other words, when the user twists the threaded rod 30, the user turns the layers (e.g., Fig.14 and Fig.15The input channel 66 is defined and limited on four sides by the sidewall inner surface 14 of the sidewall 12, the vertical portion 46 of the internal partition 44, the first channel recess 68a and the second channel recess 68b. The input channel 66 defined and limited on four sides constrains the input channel 66 and creates a small cross-sectional area, so that the user can more precisely and accurately control and visualize the amount of each layer (e.g., layer 92 and / or layer 94) or the type of layer (e.g., layer 92 and / or layer 94) that overflows through the overflow window 72 to the upper chamber 54.

[0056] In some cases, the input channel 66 and / or the side wall 12 have one or more scale lines 102 formed on the side wall 12. The one or more scale lines 102 can be used to help the user determine how much to raise the fixed plunger 36 and / or the layer (e.g., layer 92 and / or layer 94) to have a predetermined amount of each layer (e.g., layer 92 and / or layer 94) overflow through the overflow window 72 to the upper chamber 54. In addition, constraining the input channel 66 on four sides allows the user to more easily visualize the amount of each layer (e.g., layer 92 and / or layer 94) or the type of layer (e.g., layer 92 and / or layer 94) overflowing through the overflow window 72 to the upper chamber 54. In a non-limiting example, the first scale line 102a ( Figure 2 ) can be used by a user to add a plasma layer 94 (containing platelets) to the upper chamber 54 to form a platelet-rich precipitate layer 100, and a second graduation line 102b ( Figure 2 ) can be used by a user to add a buffy coat or white blood cell layer 92 in the upper chamber 54 to form a sediment layer 100 rich in white blood cells and platelets.

[0057] In some embodiments, the fractionation device 10 has a first port 74 extending through the top wall 20 and leading to the input channel 66. The first port 74 is configured to allow blood, BMA, or other body fluids to enter the lower chamber 56 via the input channel 66. The first port 74 can have a silicone seal or other type of hypodermic seal to seal the opening into the input channel 66 so that liquid or other materials cannot enter or escape through the first port 74. A needle, syringe, or needle-free Luer lock syringe, etc., can be configured to deliver blood, BMA, or other body fluids into the lower chamber 56 via the first port 74 and the input channel 66.

[0058] In the case of the fractionation apparatus 10b for BMA, the lipid layer collection tube 76 ( Fig.10 The lipid layer collection tube 76 may be configured to extend from the first port 74 toward the lower chamber 56. The lipid layer collection tube 76 may be configured to collect or extract at least a portion of the lipid layer 96 of the BMA from the lower chamber 56 ( Fig.12 ). A needle, syringe, or needle-free Luer lock syringe, etc., can be configured to extract at least a portion of the lipid layer 96 from the lower chamber 56 via the first port 74 and the lipid layer collection tube 76. In some embodiments, the lipid layer collection tube 76 is added to the fractionation device 10 after BMA has been added to the fractionation device 10. Alternatively, the lipid layer collection tube 76 is configured to add BMA to the fractionation device 10b via the first port 74 and the input channel 66.

[0059] In some cases, in order to more easily extract the lipid layer 96 via the lipid layer collection tube 76, as Fig.10 As shown in FIG. 1 , the fixed plunger upper surface 42 is located above the two O-rings 34a and 34b of the fractionation device 10b. By positioning the fixed plunger upper surface 42 above the two O-rings 34a and 34b of the fractionation device 10b, the lipid layer 96 is moved closer to the lipid layer collection tube and is taken out through the lipid layer collection tube 76. Alternatively, in the fractionation device 10a for blood, the fixed plunger upper surface 42 of the fixed plunger 36 may be located between the two O-rings 34a and 34b of the fractionation device 10a, as shown in FIG. Figure 8 and as shown in FIG9 .

[0060] The fractionation device 10 also includes a second port 78 leading to the upper chamber 54, which is adjacent to the vertical portion 46 of the internal partition 44 and spaced apart from the lower region 58 of the upper chamber 54. The second port 78 can have a silicone seal or other type of hypodermic seal to seal the opening into the upper chamber 54 so that liquid or other materials cannot enter or escape through the second port 78. A plasma layer collection tube 80 can be configured to extend from the second port 78 into the upper chamber 54. The plasma layer collection tube 80 is configured to collect or extract at least a portion of the upper chamber plasma layer 98 of blood or BMA from the upper chamber 54 ( Fig.13 ). A needle, syringe, or needle-free Luer lock syringe, etc., may be configured to extract at least a portion of the upper chamber plasma layer 98 of blood or BMA from the upper chamber 54 via the second port 78 and the plasma layer collection tube 80.

[0061] The fractionation device 10 also includes a third port 82 leading to the upper chamber 54, which is adjacent to the side wall inner surface 14 of the side wall 12 and directly above the lower area 58 of the upper chamber 54. The third port 82 can have a silicone seal or other type of hypodermic seal to seal the opening into the upper chamber 54 so that liquid or other materials cannot enter or escape through the third port 82. The platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer collection tube 84 can be configured to extend from the third port 82 into the upper chamber 54. The platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer collection tube 84 is configured to collect or extract at least a portion of the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer 100 in the blood or BMA from the upper chamber 54 ( Fig.13 ). In some cases, the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer collection tube 84 can be optionally used to resuspend the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer 100 in or mix with at least a portion of the upper chamber plasma layer 98. A needle, syringe, or needle-free Luer lock syringe, etc. can be configured to extract at least a portion of the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer 100 from the upper chamber 54 via the third port 82 and the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer collection tube 84.

[0062] In some cases, the flat portion 60 of the lower region 58 is sized to be approximately the same width, diameter, or area as the first end 86 of the platelet-rich sediment layer and / or the leukocyte- and platelet-rich sediment layer collection tube 84. Fig.10 By making the flat portion 60 approximately the same size as the first end 86 of the platelet-rich precipitate layer and / or the leukocyte- and platelet-rich precipitate layer collection tube 84, at least a portion of the platelet-rich precipitate layer and / or the leukocyte- and platelet-rich precipitate layer 100 can be more easily extracted from the fractionation device 10.

[0063] In some cases, the fractionation apparatus 10 includes an air exchange hydrophobic filter 88. The air exchange hydrophobic filter 88 can allow air to flow into and out of the upper chamber 54 of the fractionation apparatus 10 without allowing liquid to enter or leave the fractionation apparatus 10.

[0064] In various embodiments, Figures 1 to 16 The fractionation device 10 may include Figures 17 to 19200. Alternatively, the weight 200 may be provided separately from the fractionation device 10. The weight 200 is configured to balance or weight the fractionation device 10 in a centrifuge. In other words, the weight 200 is configured to balance the fractionation device 10 when the fractionation device 10 is filled with blood or BMA, placed in a centrifuge, and processed through one or more high-speed spin cycles in the centrifuge. The weight 200 may be formed from a solid piece of material (e.g., plastic, metal, rubber, etc.).

[0065] Because the fractionation device 10 is configured to centrifuge in the first state when the blood or BMA is in the lower chamber 56 (eg, Fig.14 and Fig.15 ), and centrifugation in a second state when a portion of the blood or BMA is in the upper chamber 54 (and optionally a portion of the blood or BMA is in the lower chamber 56), the fractionation device 10 has a first center of gravity in the first state, and has a second center of gravity in the second state. The counterweight 200 is configured to balance the first center of gravity of the fractionation device 10 in the first state and the second center of gravity in the second state. Fig.18A In the first orientation shown in FIG. , the counterweight 200 is configured to balance the fractionation apparatus 10 in a first state (e.g., blood or BMA in the lower chamber 56). Fig.18B In the second orientation shown, the counterweight is configured to balance the fractionation device 10 in a second state (eg, with a portion of the blood or BMA in the upper chamber 54).

[0066] To balance the first center of gravity of the fractionation apparatus 10 in the first state, the middle portion 202 of the counterweight 200 is a first distance D1 from the bottom 204 of the counterweight 200 in the first orientation. To balance the second center of gravity of the fractionation apparatus 10 in the second state, the middle portion 202 of the counterweight 200 is a second distance D2 from the bottom 204 of the counterweight 200 in the second orientation. In this way, the counterweight 200 can be used to balance the centrifuge when the fractionation apparatus 10 is in the first state or the second state.

[0067] Fig. 20A and Fig. 20B An alternative embodiment shown in FIG. 1 is to implement the Figures 1 to 16 The fractionation device 10 and / or Figures 17 to 19 The method 2000 of the counterweight 200 will also refer to Figures 14 to 16 to illustrate the different layers or fractions of blood, BMA or other bodily fluid contained within fractionation apparatus 10 after some method steps. Additionally, although method 2000 will be described below with respect to blood or BMA, other bodily fluids may be processed using fractionation apparatus 10 in a similar manner.

[0068] At block 2002, the method (eg, a manual operation) includes providing Figures 1 to 16 At block 2004, method 2000 includes obtaining blood or BMA from a patient. In some embodiments, the blood or BMA is drawn from the patient and then processed in fractionation device 10. Alternatively, the blood or BMA is drawn from the patient at an earlier date and stored prior to processing in fractionation device 10.

[0069] The blood or BMA may then be pre-treated (optional block 2006). Pre-treatment of the blood or BMA may include diluting the blood or BMA or adding an anticoagulant to the blood or BMA. Once pre-treatment is complete, at block 2008, the blood or BMA is added to the lower chamber 56 of the fractionation device 10. The blood or BMA is added to the lower chamber 56 via the first port 74 and the input channel 66. A technician or user of the fractionation device 10 may add the blood or BMA by directing the blood or BMA toward the sidewall inner surface 14 and allowing at least a portion of the blood or BMA to flow downwardly into the lower chamber 56 along the sidewall notch 70. Flowing the blood or BMA along the sidewall notch 70 reduces hemolysis of the blood or BMA or reduces the formation of bubbles within the blood or BMA, and makes the blood or BMA easier to handle.

[0070] Once the blood or BMA is collected in the lower chamber 56, at block 2010, the method 2000 includes centrifuging the fractionation device 10 to separate the blood or BMA into different layers or fractions. For blood, these layers include Fig.11 90, buffy coat or white blood cell layer 92, and plasma layer 94. For BMA, these layers include Fig.12 90, buffy coat or white blood cell layer 92, plasma layer 94, and lipid layer 96. Sometimes platelets are located in plasma layer 94, in other cases platelets are located in buffy coat or white blood cell layer 92, and in other cases platelets are located in plasma layer 94 and buffy coat or white blood cell layer 92. During the first centrifugation cycle, the weight 200 ( Fig.18A ) can be used to balance the fractionation device 10 in the centrifuge.

[0071] At block 2012 , the method 2000 includes engaging the threaded rod 30 with the opening 28 in the bottom wall 24 , and at block 2014 , rotating the threaded rod 30 within the opening 28 to raise the stationary plunger 36 within the lower chamber 56 of the fractionation apparatus 10 .

[0072] For BMA, the fixed plunger 36 rises until the lipid layer 96 contacts the lipid layer collection tube 76 of the fractionation device 10b. Then, at optional block 2016, the method includes extracting at least a portion or all of the lipid layer 96 from the fractionation device 10b using the lipid layer collection tube 76.

[0073] For blood or for BMA (after at least a portion or all of the lipid layer 90 has been extracted from the fractionation device 10b), at block 2018, the method includes rotating the threaded rod 30 within the opening 28 to raise the fixed plunger 36 within the lower chamber 56 of the fractionation device 10 until at least a portion or all of the plasma layer 94 overflows into the upper chamber 54 of the fractionation device 10 through the overflow window 72 formed on the vertical portion 46 of the internal partition 44, which provides a fluid passage between the input channel 66 and the upper chamber 54. Graduation lines 102 may be formed on the fractionation device 10 for the user to use to measure the amount of the plasma layer 94 overflowing into the upper chamber 54.

[0074] In various situations, a technician or user of the fractionation device 10 may only want to extract at least a portion or all of the plasma layer 94. In this case, at optional block 2020, the technician may extract at least a portion or all of the plasma layer 94 from the fractionation device 10 via the plasma layer collection tube 80 and the second port 78.

[0075] In other cases, a technician or user of the fractionation device 10 may want to extract platelets from the plasma layer 94. In this case, the first scale line 102a can be used to determine the amount of the plasma layer 94 (containing platelets) that overflows into the upper chamber 54. In a non-limiting example, the threaded rod 30 can be rotated until the lower portion of the plasma layer 94 reaches the first scale line 102a. This allows most of the plasma layer 94 (containing platelets) to overflow into the upper chamber 54 while minimizing the amount of white blood cells from the buffy coat 92 from entering the upper chamber 54. In some cases, the threads on the threaded rod 30 and / or the orientation of the tip 34 on the knob 32 can be used to cause a predetermined amount of the plasma layer 94 (containing platelets) to overflow into the upper chamber 54.

[0076] Next, at optional block 2022, the method may include centrifuging the plasma layer to separate the plasma layer 94 into Fig.16 The upper chamber plasma layer 98 and platelet-rich precipitate layer 100 are shown in FIG. The inclined portion 48 and one or more inclined notches 62 in the side wall 12 of the fractionation apparatus 10 work with the centrifuge to collect the platelet-rich precipitate layer 100 in the lower region 58. During this second centrifugation cycle, the weight 200 ( Fig.18B ) can be used to balance the fractionation device 10 in the centrifuge.

[0077] In various cases, during the centrifugation cycle, the fixed plunger 36 can be configured to automatically lower to a specific or selected position. In a non-limiting example, when the centrifuge is rotated at a high speed to separate the plasma layer 94 into the upper chamber plasma layer 98 and the platelet-rich sediment layer 100, the fixed plunger 36 is configured to descend until the fixed plunger bottom surface 40 contacts the bottom wall inner surface 26 of the fractionation device 10, etc.

[0078] In other cases, the fixed plunger 36 can be configured to be manually lowered before or after the centrifugation cycle to separate the plasma layer 94 into the upper chamber plasma layer 98 and the platelet-rich sediment layer 100. To manually lower the fixed plunger 36, the threaded rod 30 can be engaged in the opening 28, and the inner rod 31 of the threaded rod 30 can be coupled or engaged with the column 37. Then, the threaded rod 30 can be rotated in the opening 28 to lower the fixed plunger 36. In other words, when the threaded rod 30 is removed from the fractionation device, the inner rod 31 engaged with the column 37 pulls the fixed plunger 36 downward until the fixed plunger 36 reaches a specific or selected position (e.g., the fixed plunger bottom surface 40 contacts the bottom wall inner surface 26 of the fractionation device 10aa, etc.). Once the fixed plunger 36 reaches the specific or selected position, the inner rod 31 can be uncoupled or disengaged from the column 37 (e.g., by rotating the threaded rod 30, by rotating the second knob 33, etc.).

[0079] At optional block 2024, the method 2000 then includes removing at least a portion or all of the upper chamber plasma layer 98 via the plasma layer collection tube 80 and the second port 78. Next, the method 2000 includes optionally resuspending the platelet-rich precipitate 100 in or mixing with a portion of the upper chamber plasma layer 98 (optional block 2026), and removing at least a portion of the platelet-rich precipitate layer 100 (optionally mixed with at least a portion of the upper chamber plasma layer 98) from the upper chamber 54 via the platelet-rich precipitate layer and / or leukocyte- and platelet-rich precipitate layer collection tube 84 and the third port 82 (optional block 2028). In a non-limiting example, the platelet-rich precipitate layer 100 may be mixed with at least a portion of the upper chamber plasma layer 98 using the platelet-rich precipitate layer and / or leukocyte- and platelet-rich precipitate layer collection tube 84 prior to being removed. In some cases, one or more graduation lines 102 may be formed on the sidewall 12 of the upper chamber 54 to help the user determine the amount of the upper chamber plasma layer 98 mixed with the platelet-rich precipitate layer 100. Alternatively, only at least a portion or all of the platelet-rich precipitate layer 100 may be removed with no or a minimal amount of the upper chamber plasma layer 98.

[0080] In other cases, a technician or user of the fractionation device 10 may wish to include at least a portion or all of the buffy coat or platelet and leukocyte layer 92 and the plasma layer 94 in the upper chamber 54. In this case, at optional block 2030, the method 2000 includes further rotating the threaded rod 30 so that red blood cells rich in leukocytes and platelets (e.g., at least a portion or all of the buffy coat or platelet and leukocyte layer 92) enter the upper chamber 54 of the fractionation device 10 through the overflow window 72. The second scale line 102b can be used to determine the amount of the plasma layer 94 (containing platelets or platelet-poor) and the buffy coat or leukocyte layer 92 (containing platelets or platelet-poor) overflowing into the upper chamber 54. In a non-limiting example, the threaded rod 30 can be rotated until the lower portion of the plasma layer 94 reaches the second scale line 102b. The threaded rod 30 can then be oriented so that the tip 34 faces the user. Next, the threaded rod 30 may be rotated (e.g., a quarter turn, a half turn, etc.) such that a certain amount of the buffy coat or white blood cell layer 92 enters the upper chamber 54. This allows the plasma layer 94 and at least a portion of the buffy coat or white blood cell layer 92 to overflow into the upper chamber 54 while minimizing the amount of red blood cells from the red blood cell layer 90 that enter the upper chamber 54. In some instances, the threads on the threaded rod 30 and / or the orientation of the tip 34 of the knob 32 may be used to cause a predetermined amount of the plasma layer 94 and / or a certain amount of the buffy coat or white blood cell layer 92 to overflow into the upper chamber 54.

[0081] After rotating the threaded rod 30 so that the red blood cells rich in leukocytes and platelets enter the upper chamber 54, at optional block 2032, the method continues by removing the threaded rod 30 from the fractionation device 10 and centrifuging the fractionation device 10 to separate the plasma layer 94 and the red blood cells rich in leukocytes located in the upper chamber 54 into one or more layers, the one or more layers comprising an upper chamber plasma layer 98 and a precipitate layer 100 rich in leukocytes and platelets, Fig.16 The inclined portion 48 and one or more inclined notches 62 in the sidewall 12 of the fractionation apparatus 10 work with the centrifuge to collect the leukocyte and platelet rich sediment layer 100 in the lower region 58. During this second centrifugation cycle, the weight 200 ( Fig.18B ) can be used to balance the fractionation device 10 in the centrifuge.

[0082] At optional block 2034, the method 2000 then includes removing at least a portion or all of the upper chamber plasma layer 98 via the plasma layer collection tube 80 and the second port 78. Next, the method 2000 includes optionally resuspending the leukocyte and platelet rich precipitate 100 in or mixing with a portion of the upper chamber plasma layer 98 (optional block 2036), and removing at least a portion of the leukocyte and platelet rich precipitate layer 100 (optionally mixed with at least a portion of the upper chamber plasma layer 98) from the upper chamber 54 via the platelet rich precipitate layer and / or leukocyte and platelet rich precipitate layer collection tube 84 and the third port 82 (optional block 2038). In some cases, the leukocyte and platelet rich precipitate layer 100 may be mixed with at least a portion of the upper chamber plasma layer 98 using the platelet rich precipitate layer and / or leukocyte and platelet rich precipitate layer collection tube 84 prior to being removed. In some cases, one or more graduation lines may be formed on the sidewall 12 of the upper chamber 54 to help the user determine the amount of the upper chamber plasma layer 98 mixed with the leukocyte- and platelet-rich sediment layer 100. Alternatively, only at least a portion or all of the leukocyte- and platelet-rich sediment layer 100 may be removed without or with a minimal amount of the upper chamber plasma layer 98.

[0083] Various embodiments of the present disclosure may also include arrangements of the various elements recited in the claims, as if each dependent claim were a plurality of dependent claims containing the limitations of each of the preceding dependent claims and the independent claim. Such arrangements are clearly within the scope of the present disclosure.

[0084] The previous description of the disclosed embodiments is provided to enable those skilled in the art to make or use the invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the concept or scope of the invention. Therefore, the present invention is not intended to be limited to the embodiments shown herein, but is to be given the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A fractionation device comprising: a generally cylindrical sidewall; a top wall connected to an upper portion of the side wall; a bottom wall connected to the lower portion of the side wall; An internal partition, the internal partition comprising: contacting the inclined portion of the side wall; and a vertical portion contacting the top wall; an upper chamber defined within the fractionation apparatus by the internal baffle, the top wall, and the upper portion of the side walls; a lower chamber defined within the fractionation apparatus by the internal baffle, an upper surface of a fixed plunger engaged with the side wall, and the lower portion of the side wall; a lower region of the upper chamber, the lower region being defined by the inclined portion of the interior partition adjacent the side wall; and A threaded opening is formed through the bottom wall.

2. The fractionation device according to claim 1, further comprising: an input channel extending from the top wall to the lower chamber; as well as An overflow window is formed on the vertical portion of the inner partition and provides a fluid passage between the input channel and the upper chamber.

3. The fractionation device according to claim 2, wherein: The input channel is defined in part by the vertical portion of the interior partition and the upper portion of the side wall.

4. The fractionation device according to claim 3, further comprising: One or more notches located on the sidewall at the input channel to limit a horizontal cross-section of the input channel.

5. The fractionation device according to claim 3, further comprising: A plurality of ports extend through the top wall.

6. The fractionation device according to claim 5, further comprising: a first port leading to the input channel; as well as The notch in the side wall extends a portion of the side wall within the input channel and below the first port toward the vertical portion of the internal partition.

7. The fractionation device according to claim 6, further comprising: A lipid layer collection tube extends from the first port toward the lower chamber.

8. The fractionation device according to claim 7, further comprising: a second port opening into the upper chamber and adjacent the vertical portion of the interior baffle; as well as A plasma layer collection tube extends from the second port to a position within the upper chamber.

9. The fractionation device according to claim 8, further comprising: a third port opening into the upper chamber adjacent the sidewall and above the lower region of the upper chamber; as well as A leukocyte and platelet layer collection tube extends from the third port to a position above the lower region of the upper chamber.

10. The fractionation device according to claim 1, wherein: The lower region of the upper chamber defined by the inclined portion of the inner partition adjacent to the side wall includes a flat portion configured to collect a platelet-rich sediment layer or a leukocyte- and platelet-rich sediment layer.

11. The fractionation device according to claim 1, wherein: The side walls are made of optically transparent material.

12. The fractionation apparatus according to claim 1, further comprising: A threaded rod has threads sized to engage the threaded opening.

13. A method of collecting a fraction of blood or bone marrow aspirate (BMA), the method comprising: A fractionation device is provided, the fractionation device comprising: a generally cylindrical sidewall; a top wall connected to an upper portion of the side wall; a bottom wall connected to the lower portion of the side wall; An internal partition, the internal partition comprising: contacting the inclined portion of the side wall; and a vertical portion contacting the top wall; an upper chamber defined within the fractionation apparatus by the internal baffle, the top wall, and the upper portion of the side walls; a lower chamber defined within the fractionation apparatus by the internal baffle, an upper surface of a fixed plunger engaged with the side wall, and the lower portion of the side wall; a lower region of the upper chamber, the lower region being defined by the inclined portion of the interior partition adjacent the side wall; and a threaded opening through the bottom wall; Obtain blood or bone marrow aspirate (BMA) from the patient; pre-processing blood or BMA from the patient; adding the blood or the BMA to the lower chamber of the fractionation device; centrifuging the fractionation device in a first centrifugation cycle to separate the blood or the BMA into different layers; engaging the threaded rod with the threaded opening; rotating the threaded rod within the threaded opening to raise the fixed plunger within the lower chamber of the fractionation device until the plasma layer overflows into the upper chamber of the fractionation device through an overflow window formed on the vertical portion of the internal partition, the overflow window providing a fluid passage between an input channel and the upper chamber; and At least a portion of the plasma layer is removed from the upper chamber of the fractionation device.

14. The method according to claim 13, wherein: The blood or the BMA is added to the fractionation device via the input channel extending from the top wall to the lower chamber.

15. The method according to claim 13, wherein: When using the BMA, firstly rotating the threaded rod to raise the lipid layer to a lipid layer collection tube extending from a first port toward the lower chamber, wherein the first port leads to the input channel, the method further comprising: At least a portion of the lipid layer is removed from the fractionation device via the lipid layer collection tube.

16. The method according to claim 13, further comprising: Rotating the threaded rod in the threaded opening to raise the fixed plunger in the lower chamber of the fractionation device until the plasma layer overflows into the upper chamber of the fractionation device through the overflow window, and further rotating the threaded rod to allow red blood cells rich in white blood cells and platelets to enter the upper chamber; After rotating the threaded rod so that the red blood cells rich in leukocytes and platelets enter the upper chamber, removing the threaded rod from the fractionation device and centrifuging the fractionation device in a second centrifugation cycle to separate the plasma layer and the red blood cells rich in leukocytes and platelets into one or more layers containing a precipitate rich in leukocytes and platelets; removing at least a portion of the plasma layer from the upper chamber; and At least a portion of the leukocyte- and platelet-rich pellet is removed from the upper chamber.

17. The method according to claim 16, wherein: At least a portion of the plasma layer is removed from the upper chamber of the fractionation device via a second port that opens into the upper chamber and is adjacent to the vertical portion of the internal partition and via a plasma layer collection tube that extends from the second port to a position within the upper chamber.

18. The method according to claim 17, wherein: At least a portion of the leukocyte and platelet-rich precipitate is removed via a third port and via a leukocyte and platelet layer collection tube, wherein the third port opens into the upper chamber, is adjacent to the side wall and is above the lower region of the upper chamber, and the leukocyte and platelet layer collection tube extends from the third port to a position above the lower region of the upper chamber.

19. The method according to claim 18, wherein: The at least a portion of the leukocyte- and platelet-rich precipitate is collected in the lower region of the upper chamber.

20. The method according to claim 19, wherein: The lower region of the upper chamber defined by the inclined portion of the internal partition adjacent to the side wall includes a flat portion configured to collect the leukocyte- and platelet-rich precipitate, and wherein at least a portion of the leukocyte- and platelet-rich precipitate collected in the lower region of the upper chamber is located on the flat portion of the inclined portion of the internal partition.

21. The method of claim 16, further comprising: providing a counterweight configured to balance the fractionation apparatus having a first center of gravity in a first orientation and a second center of gravity in a second orientation; wherein during the first centrifugation cycle, the counterweight is in the first orientation, and during the second centrifugation cycle, the counterweight is in the second orientation.

22. A system comprising: A fractionation device, the fractionation device comprising: a generally cylindrical sidewall; a top wall connected to an upper portion of the side wall; a bottom wall connected to a lower portion of the side wall; An internal partition, the internal partition comprising: contacting the inclined portion of the side wall; and a vertical portion contacting the top wall; an upper chamber defined within the fractionation apparatus by the internal baffle, the top wall, and the upper portion of the side walls; a lower chamber defined within the fractionation apparatus by the internal baffle, an upper surface of a fixed plunger engaged with the side wall, and the lower portion of the side wall; a lower region of the upper chamber, the lower region being defined by the inclined portion of the interior partition adjacent the side wall; and a threaded opening through the bottom wall; a centrifuge configured to receive the fractionation apparatus; and a counterweight configured to be positioned in the centrifuge opposite the fractionation device to balance the fractionation device having a first center of gravity in a first orientation and a second center of gravity in a second orientation, providing a counterweight configured to balance the fractionation apparatus having a first center of gravity in a first orientation and a second center of gravity in a second orientation; wherein during a first centrifugation cycle, the counterweight is in the first orientation, and during a second centrifugation cycle, the counterweight is in the second orientation.

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