Blood and bone marrow fractionation apparatus and method

Abstract

Embodiments of apparatus, systems, and methods are disclosed that provide a fractionation apparatus for fractionating or separating blood or bone marrow aspirate (BMA) into one or more component layers and efficiently collecting the layers of interest. The fractionation apparatus comprises a generally cylindrical side wall, an upper wall connected to the upper part of the side wall, a bottom wall connected to the lower part of the side wall, and an internal partition. The internal partition includes an inclined portion in contact with the side wall and a vertical portion in contact with the upper wall.

Description

Technical Field

[0001]

[0001] The embodiments disclosed herein relate to devices, systems, and methods for fractionation of blood or bone marrow aspirate. The embodiments are more particularly directed to a system, device, and method of a fractionation device for separating blood or bone marrow aspirate into one or more layers and efficiently collecting a particular layer.

[0002]

[0002] The fractionation device is used to separate blood or bone marrow aspirate (BMA) into one or more component layers or fractions (e.g., red blood cell layer, plasma layer, lipid layer, platelet-rich pellet layer, etc.). The blood or BMA may be separated within the fractionation device using a centrifuge. When the centrifuge rotates, the blood or BMA is separated into its constituent layers, and then each layer may be individually extracted and subsequently processed or utilized. The blood or BMA may be separated into one or more component layers through one or more cycles within the centrifuge. There are various known fractionation devices used to separate blood or bone marrow aspirate (BMA) into one or more component layers.

[0003]

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

[0004]

[0004] The embodiments disclosed herein are directed to overcoming one or more of the above-described problems.

Summary of the Invention

Problems to be Solved by the Invention

[0005]

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

[0006]

[0006] One embodiment disclosed herein is a fractionation apparatus or device for fractionating or separating blood or (BMA) into one or more component layers or fractions. The fractionation apparatus includes a generally cylindrical side wall, an upper wall connected to the upper part of the side wall, a bottom wall connected to the lower part of the side wall, and an internal partition. The internal partition includes an inclined portion in contact with the side wall and a vertical portion in contact with the upper wall. The fractionation apparatus further includes an upper chamber defined within the fractionation apparatus by the internal partition, the upper wall, and the upper part of the side wall, a lower chamber defined within the fractionation apparatus by the internal partition, the upper plunger surface of a fixed plunger engaging with the side wall, and the lower part of the side wall, and a lower region of the upper chamber defined by an inclined portion of the internal partition adjacent to the side wall. Furthermore, the fractionation apparatus includes a threaded opening penetrating the bottom wall.

[0007]

[0007] Embodiments of the method disclosed herein may include providing a fractionation apparatus, collecting blood or bone marrow aspirate (BMA) from a patient, pre-treating the blood or BMA from the patient, inserting the blood or BMA into the lower chamber of the fractionation apparatus, and separating the blood or BMA into different layers by centrifuging the fractionation apparatus. The method may be continued by engaging a threaded rod into a threaded opening and rotating the threaded rod within the threaded opening, thereby raising a fixed plunger in the lower chamber of the fractionation apparatus until the plasma layer overflows into the upper chamber of the fractionation apparatus through an overflow window formed in the vertical portion of the internal partition, and by providing a fluid path between the 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 apparatus. [Brief explanation of the drawing]

[0008] [Figure 1] This is a top and front perspective view of one embodiment of a fractionation apparatus disclosed herein. [Figure 2] This is a front view of the fractionation apparatus disclosed herein. [Figure 3]This is a side view of the fractionation apparatus disclosed herein. [Figure 4] This is a top and front perspective view of the fractionation apparatus disclosed herein. [Figure 5] These are top, rear, and side perspective views of the fractionation apparatus disclosed herein. [Figure 6] This is a rear view of the fractionation apparatus disclosed herein. [Figure 7] This is a rearward perspective view of the bottom of the fractionation apparatus disclosed herein. [Figure 8] This is a perspective cross-sectional view of the fractionation apparatus disclosed herein, where the cross-section is taken along the centerline plane in the front-to-back direction. [Figure 9A] This is a side cross-sectional view of the fractionation apparatus disclosed herein, where the cross-section is taken along the centerline plane in the front-rear direction. [Figure 9B] This is a side cross-sectional view of the fractionation apparatus disclosed herein, where the cross-section is taken along the centerline plane in the front-rear direction. [Figure 9C] This is a side cross-sectional view of the fractionation apparatus disclosed herein, where the cross-section is taken along the centerline plane in the front-rear direction. [Figure 10] This is a side cross-sectional view of another embodiment of the fractionation apparatus disclosed herein, where the cross-section is taken along the centerline plane in the front-rear direction. [Figure 11] This is a rear cross-sectional view of an alternative embodiment of the fractionation apparatus disclosed herein, the cross-section being taken along the plane defined by axis AA in Figure 3. [Figure 12] This is a top cross-sectional view of the fractionation apparatus disclosed herein, the cross-section being taken along the plane defined by axis BB in Figure 2. [Figure 13] This is a top cross-sectional view of the fractionation apparatus disclosed herein, the cross-section being taken along the plane defined by axis CC in Figure 2. [Figure 14] Figures 1-9, 12, and 13 are side cross-sectional views of the fractionation apparatus, showing multiple layers of fractionated blood. [Figure 15]Figures 10 and 11 are side cross-sectional views of alternative embodiments of the fractionation apparatus, showing one or more layers of fractionated bone marrow aspirate. [Figure 16] Figures 1-9, 12, and 13 are side cross-sectional views of the fractionation apparatus, showing one or more layers of fractionated blood after the second centrifugation step. [Figure 17] This is a front view of a counterweight for a fractionation apparatus disclosed herein. [Figure 18A] This is a side cross-sectional view showing the counterweight of the fractionation apparatus disclosed herein in a different orientation, with the cross-section taken along the centerline plane in the front-rear direction. [Figure 18B] This is a side cross-sectional view showing the counterweight of the fractionation apparatus disclosed herein in a different orientation, with the cross-section taken along the centerline plane in the front-rear direction. [Figure 19] This is a side-top perspective cross-sectional view of a counterweight for a fractionation apparatus disclosed herein, where the cross-section is taken along the centerline plane in the front-rear direction. [Figure 20A] Figures 1-19 are process diagrams illustrating the method using the fractionation apparatus and counterweights. [Figure 20B] Figures 1-19 are process diagrams illustrating the method using the fractionation apparatus and counterweights. [Modes for carrying out the invention]

[0009]

[0028] Unless otherwise specified, all numerical values ​​used in this specification and in the claims to represent quantities, dimensions, reaction conditions, etc., of components are understood in all cases to be modified by the term "about" or "approximately." Furthermore, unless otherwise specified, the terms "about" and "approximately" used herein with respect to reference values ​​or ratios refer to variations of no more than ±20% (e.g., ±15%, ±10%, ±5%) from the reference value or ratio, including the endpoints of the range.

[0010]

[0029] In this application and the claims, unless otherwise specified, the use of the singular form shall include the plural form. Further, the use of "or" shall mean "and / or" unless otherwise stated. Also, the use of the term "including" and other forms such as "includes" and "included" is not limiting. Also, terms such as "element", "structure", "component", etc. include elements, structures, components that constitute one unit and elements, structures, components that constitute multiple units, unless otherwise specified. Unless otherwise defined or limited, terms such as "attached", "connected", "supported", "mounted", "coupled" and their variants are used in a broad sense and include both direct and indirect attachment, connection, support, and coupling.

[0011]

[0030] Unless otherwise defined or limited, the directional terms used in this specification are used for convenience when referring to the description of a specific figure or example. For example, references to downward (or other directions) or upward (or other positions) may be used to describe the sides of a specific example or figure, and the same direction or shape is not necessarily required in all installations or configurations.

[0012]

[0031] In this application and the claims, any reference to blood, bone marrow, plasma, other blood derivatives including plasma, or other body fluids is not limiting and, in all cases, can include reference to any of blood, bone marrow, plasma, other blood derivatives including plasma, or other body fluids.

[0013]

[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 one or more layers are separated, it may be difficult to extract the one or more layers from the fractionation device. Further, it may be difficult to visualize one or more layers within the fractionation device.

[0014]

[0033] Embodiments of the claims can address these or other problems. For example, embodiments of various devices, systems, and methods disclosed herein provide fractionation devices that can be used to separate blood or BMA into one or more component layers, enabling efficient extraction of one or more layers of interest from the fractionation device. Generally, the disclosed devices include a lower chamber and an upper chamber. After one or more centrifugation steps, 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 pellet layer, etc.) in one or both chambers. Layers of interest, including but not limited to a plasma layer, a leukocyte or leukocyte layer (buffy coat layer), a platelet-rich pellet or layer, etc., may be extracted using one or more ports connected to the upper chamber. In some embodiments, as disclosed below, a lipid layer may be extracted using one or more ports attached to the lower chamber. Furthermore, enhancements including, but not limited to, manufacturing the fractionation apparatus from optically transparent materials, providing upper and lower chambers, providing a sloping section between chambers, and other functional enhancements make it easier and more efficient for technicians or other users of the fractionation apparatus to visualize and extract one or more target component layers from the fractionated blood or BMA.

[0015]

[0034] In this specification, the term “fractionation” is defined as a process or method of separating blood, BMA, or other body fluids into one or more component layers. In the case of blood, these layers may include a red blood cell layer, a buffy coat layer, a white blood cell layer, a platelet-rich pellet layer or platelet-rich layer, a white blood cell and platelet-rich layer, or a white blood cell and platelet-rich pellet, a plasma layer, a platelet-containing plasma layer, etc. Blood is not limited to these layers, and the number of layers after fractionation may increase or decrease depending on the number and speed of the centrifugation cycles. In the case of BMA, these layers may include a red blood cell layer, a buffy coat layer, a white blood cell layer, a platelet-rich pellet layer or platelet-rich layer, a white blood cell and platelet-rich layer, or a white blood cell and platelet-rich pellet, a plasma layer, a platelet-containing plasma layer, a fat layer, a lipid layer, etc. BMA is not limited to these layers, and the number of layers after fractionation may increase or decrease depending on the number and speed of the centrifugation cycles.

[0016]

[0035] Accordingly, embodiments of this specification generally include apparatus, systems, and methods that include fractionation apparatuses used to separate blood or BMA into one or more layers or fractions. Although fractionation apparatuses are described in relation to blood or BMA, fractionation apparatuses can be used with other body fluids and are not limited to blood or BMA. Furthermore, embodiments of the disclosed devices include structures, apparatuses, or systems that facilitate the efficient collection of the fraction in question.

[0017]

[0036] Figures 1–16 show several diagrams of the fractionation apparatus 10 according to various embodiments. Figures 8, 9, 14, and 16 show fractionation apparatus 10a or 10aa having a specific structure optimized for use with blood, and Figures 10, 11, and 15 show fractionation apparatus 10b 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 number, fractionation apparatus 10, is used for both fractionation apparatus 10. The differences between the embodiments of fractionation apparatus 10a, 10aa, and 10b are specifically described throughout this application using different reference numbers: fractionation apparatus 10a and 10aa for blood and fractionation apparatus 10b for BMA.

[0018]

[0037] The fractionation apparatus 10 may include a side wall 12. The side wall 12 may be cylindrical or tubular. However, the side wall 12 may have other shapes (e.g., spherical, square, octagonal, etc.). The side wall 12 may have an inner side wall surface 14 (shown in Figures 8-10) located inside the fractionation apparatus 10. The side wall 12 may further include an upper part 16 and a lower part 18.

[0019]

[0038] In some embodiments, the side wall 12 is formed from an optically transparent material, allowing the user of the fractionation apparatus 10 to see through the side wall 12 and observe the material contained within the fractionation apparatus 10 (e.g., blood, a layer of blood, BMA, or a layer of BMA, other body fluids, or other layers of body fluids). Furthermore, optionally, the side wall 12 has one or more graduation lines 102 formed on the side wall 12 (as shown in Figures 1, 2, 3, 5, and 6). One or more graduation lines 102 can be used to display or measure the amount of blood, BMA, or other body fluids in the fractionation apparatus 10.

[0020]

[0039] The fractionation apparatus 10 further comprises an upper wall 20 connected to the upper part 16 of the side wall 12. Because the upper wall 20 is sealed to the upper part 16 of the side wall 12, liquids and other substances cannot enter or leak from the upper wall 20 except in predetermined locations described below. In some embodiments, the upper wall 20 may be a lid that is removably coupled to the upper part 16 of the side wall 12. Alternatively, the upper wall 20 may be permanently bonded to the side wall 12. For example, the upper wall 20 may be bonded, joined, welded, or integrally molded with the side wall 12. The upper wall 20 includes an inner upper wall surface 22 (shown in Figures 8-10) located inside the fractionation apparatus 10.

[0021]

[0040] The fractionation apparatus 10 further includes a bottom wall 24 connected to the lower part 18 of the side wall 12. The bottom wall 24 is sealed to the lower part 18 of the side wall 12 so that liquids or other substances cannot enter or leak from the bottom wall 24. In some cases, the bottom wall 24 is a lid that is removably coupled to the lower part 18 of the side wall 12. Alternatively, in other cases, the bottom wall 24 is permanently bonded to the side wall 12. For example, the bottom wall 24 can be bonded, joined, welded, or integrally molded with the side wall 12. The bottom wall 24 has an inner bottom wall surface 26 (shown in Figures 8-10) located inside the fractionation apparatus 10. In some cases, the inner bottom wall surface 26 may not completely enclose the lower part 18 of the side wall 12. In some cases, the bottom wall 24 further includes an opening 28 (shown in Figures 7-10). The opening 28 may be threaded and can receive a threaded rod or screw 30 (shown in Figures 9 and 10). In other cases, the threaded rod 30 and the opening 28 do not have to 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 projections 34 that help to grasp the knob 32 and rotate the threaded rod 30 within the opening 28.

[0022]

[0041] In some embodiments, a fixed plunger 36 (shown in Figures 8 to 10) is housed within the lower part 18 of the side wall 12 above the inner bottom wall surface 26 of the bottom wall 24. The fixed plunger 36 may be removably housed within the fractionation apparatus 10 or permanently housed within the fractionation apparatus 10 once the bottom wall 24 is attached to the lower part 18 of the side wall 12 (for example, the fixed plunger 36 cannot be removed from the fractionation apparatus 10 unless the fixed plunger 36 or the fractionation apparatus 10 is modified in some way). The fixed plunger 36 may be formed from rubber, silicone, or other material that can seal to the inner side wall surface 14 of the side wall 12. In some cases, the fixed plunger 36 includes one or more O-rings 38, gaskets, machined surfaces, or other sealing structures that can form a fluid seal with the inner side wall surface 14 of the side wall 12. Preferably, the fixed plunger 36 may have two O-rings 38a and 38b to provide stability to the fixed plunger 36 and to prevent the fixed plunger 36 from tilting within the side wall 12 when the fixed plunger 36 is moved within the fractionation device 10.

[0023]

[0042] The fixed plunger 36 includes a bottom fixed plunger surface 40 and an upper fixed plunger surface 42. The bottom fixed plunger surface 40 of the fixed plunger 36 may initially be in contact with or close to the inner bottom wall surface 26. Furthermore, as shown in Figures 9 and 10, the threaded rod 30 may contact the bottom fixed plunger surface 40 through an opening 28 in the bottom wall 24. When the threaded rod 30 is twisted, rotated, or pushed into the opening 28 and contacts the bottom fixed plunger surface 40 of the fixed plunger 36, the fixed plunger 36 is pushed upward within the fractionation apparatus 10, causing blood, BMA, or other bodily fluids to rise within the fractionation apparatus 10. In some cases, the size and spacing of the threads in the opening 28 and the threaded rod 30 may be set so that a certain number of rotations of the threaded rod 30 causes the fixed plunger 36 to rise by a certain amount. Furthermore, or alternatively, one or more protrusions 34 on the knob 32 may be spaced apart or oriented such that when the knob 32 is rotated a certain amount relative to the protrusions 34 (e.g., a quarter turn, a half turn, a full turn, etc.), the fixed plunger 36 rises by a certain amount.

[0024]

[0043] In various embodiments, the threaded rod 30 can be configured to raise the fixed plunger 36 by a specific amount, and then lower the fixed plunger 36. In some cases, the fixed plungers 36 of the fractionation devices 10a and 10b can be configured to be lowered using the rotation cycle of the centrifuge. In other words, when the fractionation devices 10a and 10b are rotated at a specific speed within the centrifuge, the fixed plunger 36 may move downward until it reaches a specific or selected position (for example, when the bottom surface 40 of the fixed plunger contacts the inner bottom wall surface 26 of the fractionation device 10).

[0025]

[0044] In other cases, as shown in the fractionation apparatus 10aa in Figures 9B and 9C, one or more additional parts or elements (e.g., a post 37, an internal rod 31, etc.) may be provided to lower the fixed plunger 36. Although the parts or elements for lowering the fixed plunger 36 are described in reference to fractionation apparatus 10aa, it should be noted that similar parts or elements can be used in fractionation apparatuses 10a and 10b, and the internal rod 31 and post 37 are not limited to fractionation apparatus 10aa only.

[0026]

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

[0027]

[0046] In various examples, as shown in Figure 9C, the threaded rod 30 may further include an internal rod 31 at least partially or completely embedded within the threaded rod 30, and a second knob 33 coupled to the internal rod 31 and / or the knob 32. In some cases, the internal rod 31 may include one or more threads 35. One or more threads 35 may be configured to couple to or engage with one or more threads 39 of the post 37. In various cases, the internal rod 31 may couple to or engage with the post 37 when the threaded rod 30 is twisted, rotated, or pushed into the opening 28 of the fractionation device 10aa. In some cases, the internal rod 31 may be configured to couple with the post 37 by rotating the threaded rod 30 to engage one or more threads 35 of the internal rod 31 with one or more threads 39 of the post 37. In other cases, the internal rod 31 can be configured to connect to the post 37 by rotating the second knob 33 to engage one or more threads 35 of the internal rod 31 with one or more threads 39 of the post 37. Alternatively, the internal rod 31 can be configured to connect to or engage with the post 37 in other ways, such as by press-fitting it into the post 37 or by inserting it into the post 37.

[0028]

[0047] In various cases, when the internal rod 31 is coupled to 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 internal rod 31 engaged with the post 37 pulls down the fixed plunger 36 until it reaches a specific or selected position (for example, when the bottom surface 40 of the fixed plunger contacts the inner bottom wall surface 26 of the fractionation device 10aa). Once the fixed plunger 36 reaches a specific or selected position, the internal rod 31 is disengaged or released from the post 37 (for example, by rotating the threaded rod 30 or by rotating the second knob 33).

[0029]

[0048] The fractionation device 10 further includes an internal partition 44 (shown in Figures 8-12) located inside the fractionation device 10. The internal partition 44 has a vertical portion 46 that contacts the inner upper wall surface 22 of the upper wall 20 and an inclined portion 48 that contacts the inner side wall surface 14. In some cases, the vertical portion 46 extends parallel to the side wall 12. The inclined portion 48 may be inclined at about 1 to 89 degrees, more typically 20 to 70 degrees, or preferably 20 to 30 degrees, with respect to a horizontal plane extending through the upper wall 20 or the lower wall 24. The internal partition 44 includes an upper internal partition surface 50 and a lower internal partition surface 52.

[0030]

[0049] The fractionation device 10 includes an upper chamber 54 and a lower chamber 5 (shown in Figures 8-11). The upper chamber 54 is defined within the fractionation device 10 by the upper internal partition surface 50 of the internal partition 44, the inner upper wall surface 22 of the upper wall 20, and the inner side wall surface 14 of the upper part 16 of the side wall 12. The lower chamber 56 is defined within the fractionation device 10 by the lower internal partition surface 52 of the internal partition 44, the upper fixed plunger surface 42 of the fixed plunger 36, and the inner side wall surface 14 of the lower part 18 of the side wall 12.

[0031]

[0050] The fractionation apparatus 10 further includes a lower region 58 of the upper chamber 54. The lower region 58 of the upper chamber 54 is defined by the position where the upper internal partition surface 50 of the inclined portion 48 is adjacent to or in contact with the inner side wall surface 14 of the side wall 12. In some cases, the lower region 58 includes a flat portion 60 that is flat with respect to or parallel to a horizontal plane extending through the upper wall 20 or the lower wall 24. Alternatively, in other cases, the upper internal partition surface 50 of this lower region 58 is inclined with respect to a horizontal plane extending through the upper wall 20 or the lower wall 24 at an angle of about 1 to 89 degrees, more typically 20 to 70 degrees, or preferably 20 to 30 degrees.

[0032]

[0051] In some embodiments, the fractionation apparatus 10 includes one or more inclined recesses 62 in the side wall 12. In some cases, the fractionation apparatus 10 includes two inclined recesses 62a and 62b (shown in Figures 6, 7, and 11). The inclined recesses 62 define the inclined portion 48 of the internal partition 44. In non-limiting examples, as 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, causing the inclined portion 48 to narrow toward the lower region 58 (shown in Figures 11 and 12). In other words, the inclined portion 48 widens toward the vertical portion 46 of the internal partition 44 and narrows toward the lower region 58 of the internal partition 44. The narrowing of the inclined portion 48 toward the lower region 58 facilitates visualization of the platelet-rich pellet layer and / or leukocyte and platelet-rich pellet layer 100 (shown in Figure 16) of blood or BMA collected in the lower region 58. Furthermore, as the inclined portion 48 narrows as it approaches the lower region 58, the platelet-rich pellet layer and / or the leukocyte and platelet-rich pellet layer 100 are concentrated in the narrow portion of the lower region 58 rather than spreading across a wide surface, making it easier to collect the platelet-rich pellet layer and / or the leukocyte and platelet-rich pellet layer 100.

[0033]

[0052] Furthermore, to aid in the visualization of the platelet-rich pellet layer and / or the leukocyte- and platelet-rich pellet layer 100 of blood or BMA collected in the lower region 58, the fractionation apparatus 10 may further be provided with an observation window 64 (shown in Figures 6 and 7). The observation window 64 optionally includes a magnifying glass to enhance the visibility of the platelet-rich pellet layer and / or the leukocyte- and platelet-rich pellet layer 100 of blood or BMA.

[0034]

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

[0035]

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

[0036]

[0055] The fractionation apparatus 10 includes an overflow window 72 (shown in Figures 8-10) formed in the vertical portion 46 of the internal partition 44, providing a fluid path between the input channel 66 and the upper chamber 54. When the threaded rod 30 is twisted within the opening 28 of the bottom wall 24 and contacts the bottom fixed plunger surface 40 of the fixed plunger 36, the fixed plunger 36 rises within the fractionation apparatus 10, causing blood, BMA, or other bodily fluids 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 passes layers (e.g., layers 92 and 94 in Figures 14 and 15) through to the input channel 66, which is defined and restricted by the inner sidewall 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. By defining and restricting the input channel 66 on four sides, the input channel 66 becomes narrower and its cross-sectional area smaller, allowing the user to more accurately and precisely control and visualize the amount or type of each layer (such as layers 92 and / or 94) overflowing into the upper chamber 54 through the overflow window 72.

[0037]

[0056] In some cases, the input channel 66 and / or the side wall 12 has one or more tick marks 102 formed on the side wall 12. One or more tick marks 102 can be used to help the user determine how far to raise the fixed plunger 36 and / or the layers (e.g., layers 92 and / or 94) so ​​that a predetermined amount of each layer (e.g., layers 92 and / or 94) overflows into the upper chamber 54 through the overflow window 72. Furthermore, narrowing the input channel 66 on all four sides makes it easier for the user to visualize the amount of each layer (e.g., layers 92 and / or 94) or the type of layer (e.g., layers 92 and / or 94) overflowing into the upper chamber 54 through the overflow window 72. As a non-limiting example, the first scale line 102a shown in Figure 2 may be used by the user to add a plasma layer 94 (containing platelets) to form a platelet-rich pellet layer 100 in the upper chamber 54, and the second scale line 102b shown in Figure 2 may be used by the user to add a buffy coat layer or a leukocyte layer 92 to form a leukocyte and platelet-rich pellet layer 100 in the upper chamber 54.

[0038]

[0057] In some embodiments, the fractionation apparatus 10 has a first port 74 that extends through the upper wall 20 and opens into an input channel 66. The first port 74 is configured to allow blood, BMA, or other bodily fluids to enter the lower chamber 56 through the input channel 66. The first port 74 may be equipped with a silicone seal or other type of subcutaneous injection seal to seal the opening to the input channel 66 so that liquid or other substances cannot enter or leave the first port 74. A needle, syringe, or needleless Luer lock syringe, etc., may be configured to allow blood, BMA, or other bodily fluids to flow into the lower chamber 56 through the first port 74 and the input channel 66.

[0039]

[0058] In the case of the fractionation apparatus 10b for BMA, the lipid layer collection tube 76 (shown in Figure 10) 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 (shown in Figure 12) of the BMA from the lower chamber 56. A needle, syringe, or needleless Luer lock syringe, etc., may 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 inserted into the fractionation apparatus 10 after the BMA has been inserted into the fractionation apparatus 10. Alternatively, the lipid layer collection tube 76 is configured to insert the BMA into the fractionation apparatus 10b via the first port 74 and the input channel 66.

[0040]

[0059] In some cases, to facilitate the extraction of the lipid layer 96 via the lipid layer collection tube 76, the upper fixed plunger surface 42 is positioned above the two O-rings 34a and 34b of the fractionation device 10b, as shown in Figure 10. By positioning the upper fixed plunger surface 42 above the two O-rings 34a and 34b of the fractionation device 10b, the lipid layer 96 is brought closer to the lipid layer collection tube and removed via the lipid layer collection tube 76. Alternatively, in the blood fractionation device 10a, the upper fixed plunger surface 42 of the fixed plunger 36 may be positioned between the two O-rings 34a and 34b of the fractionation device 10a, as shown in Figures 8 and 9.

[0041]

[0060] The fractionation apparatus 10 further includes a second port 78 adjacent to the vertical portion 46 of the internal partition 44 and opening into the upper chamber 54 spaced apart from the lower region 58 of the upper chamber 54. The second port 78 may be equipped with a silicone seal or other type of subcutaneous injection seal to seal the opening to the upper chamber 54 so as not to allow liquid or other substances to enter or exit the second port 78. A plasma layer collection tube 80 may be configured to extend from the second port 78 to 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 (shown in Figure 13) of blood or BMA from the upper chamber 54. A needle, syringe, or needleless 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.

[0042]

[0061] The fractionation apparatus 10 also includes a third port 82 adjacent to the inner sidewall surface 14 of the sidewall 12 and opening into the upper chamber 54, directly above the lower region 58 of the upper chamber 54. The third port 82 may be equipped with a silicone seal or other type of subcutaneous injection seal to seal the opening to the upper chamber 54, preventing liquid or other substances from entering or leaving the third port 82. A collection tube 84 for the platelet-rich pellet layer and / or the leukocyte and platelet-rich pellet layer may be configured to extend from the third port 82 to the upper chamber 54. The platelet-rich pellet layer and / or the leukocyte and platelet-rich pellet layer collection tube 84 is configured to collect or extract at least a portion of the platelet-rich pellet layer and / or the leukocyte and platelet-rich pellet layer 100 (shown in Figure 13) of blood or BMA from the upper chamber 54. In some cases, the platelet-rich pellet layer and / or leukocyte- and platelet-rich pellet layer collection tube 84 may optionally be used to resuspend or mix the platelet-rich pellet layer and / or leukocyte- and platelet-rich pellet layer 100 with at least a portion of the upper chamber plasma layer 98. A needle, syringe, or needleless Luer-lock syringe, etc., may be configured to extract at least a portion of the platelet-rich pellet layer and / or leukocyte- and platelet-rich pellet layer 100 from the upper chamber 54 via the third port 82 and the platelet-rich pellet layer and / or leukocyte- and platelet-rich pellet layer collection tube 84.

[0043]

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

[0044]

[0063] In some cases, the fractionation device 10 includes an air exchange hydrophobic filter 88. The air exchange hydrophobic filter 88 may allow air to flow into and out of the upper chamber 54 of the fractionation device 10 without liquid entering or leaving the fractionation device 10.

[0045]

[0064] In various embodiments, the fractionation apparatus 10 shown in Figures 1-16 may be included in a kit equipped with a counterweight 200 as shown in Figures 17-19. Alternatively, the counterweight 200 may be provided separately from the fractionation apparatus 10. The counterweight 200 is configured to balance or counterbalance the fractionation apparatus 10 within the centrifuge. In other words, the counterweight 200 is configured to balance the fractionation apparatus 10 when it is filled with blood or BMA, placed in the centrifuge, and processed in one or more rotational cycles within the centrifuge. The counterweight 200 may be formed from a solid material (e.g., plastic, metal, rubber, etc.).

[0046]

[0065] The fractionation apparatus 10 is configured to centrifuge blood or BMA in a first state (e.g., the state shown in Figures 14 and 15) with blood or BMA in the lower chamber 56, and to centrifuge a portion of the blood or BMA in a second state (e.g., the state shown in Figure 16) with a portion of the blood or BMA in the upper chamber 54 (and optionally with a portion of the blood or BMA in the lower chamber 56). Therefore, the fractionation apparatus 10 has a first center of gravity in the first state and a second center of gravity in the second state. The counterweight 200 is configured to balance both the first center of gravity in the first state and the second center of gravity in the second state of the fractionation apparatus 10. In the first orientation shown in Figure 18A, the counterweight 200 is configured to balance the fractionation apparatus 10 in the first state (e.g., with blood or BMA in the lower chamber 56). In the second orientation shown in Figure 18B, the counterweight is configured to balance the fractionation apparatus 10 in the second state (e.g., with a portion of the blood or BMA in the upper chamber 54).

[0047]

[0066] To balance the first center of gravity of the fractionation device 10 in the first state, the middle portion 202 of the counterweight 200 is located at 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 device 10 in the second state, the middle portion 202 of the counterweight 200 is located at 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 device 10 is in the first or second state.

[0048]

[0067] One alternative embodiment shown in Figures 20A and 20B is Method 2000 implemented to use the fractionation apparatus 10 of Figures 1-16 and / or the counterweight 200 of Figures 17-19. See also Figures 14-16 to see different layers or fractions of blood, BMA, or other body fluid contained within the fractionation apparatus 10 after several method steps. Furthermore, although Method 2000 is described below with respect to blood or BMA, other body fluids may be processed in a similar manner using the fractionation apparatus 10.

[0049]

[0068] This method includes providing the fractionation apparatus 10 shown in Figures 1-16 in block (e.g., manual operation) 2002. Block 2004 of Method 2000 includes collecting blood or BMA from a patient. In a particular embodiment, the blood or BMA is collected from the patient and then processed in the fractionation apparatus 10. Alternatively, the blood or BMA is collected from the patient earlier and stored before being processed in the fractionation apparatus 10.

[0050]

[0069] Subsequently, the blood or BMA may 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. After pre-treatment, the blood or BMA is inserted into the lower chamber 56 of the fractionator 10 in block 2008. The blood or BMA is inserted into the lower chamber 56 via the first port 74 and input channel 66. A technician or user of the fractionator 10 may insert the blood or BMA by guiding the blood or BMA toward the inner wall surface 14 and allowing at least a portion of the blood or BMA to flow into the lower chamber 56 along the side wall recess 70. Allowing the blood or BMA to flow along the side wall recess 70 reduces hemolysis of the blood or BMA and the formation of air bubbles within the blood or BMA, making the processing of the blood or BMA easier.

[0051]

[0070] Once blood or BMA is collected in the lower chamber 56, method 2000 includes centrifugation of the fractionation apparatus 10 in block 2010 to separate the blood or BMA into different layers or fractions. In the case of blood, as shown in Figure 11, the layers consist of a erythrocyte layer or red blood cell layer 90, a buffy coat layer or white blood cell layer 92, and a plasma layer 94. In the case of BMA, as shown in Figure 12, the layers consist of a erythrocyte layer or red blood cell layer 90, a buffy coat layer or white blood cell layer 92, a plasma layer 94, and a lipid layer 96. Platelets may be located in the plasma layer 94, or in other examples, in the buffy coat layer or white blood cell layer 92, or platelets may be located in both the plasma layer 94 and the buffy coat layer or white blood cell layer 92. During this first centrifugation cycle, a counterweight 200 (shown in Figure 18A) in a first orientation may be used to balance the fractionation apparatus 10 in the centrifuge.

[0052]

[0071] Method 2000 includes engaging the threaded rod 30 in block 2012 with an opening 28 in the bottom wall 24, and rotating the threaded rod 30 in block 2014 within the opening 28 to raise the fixed plunger 36 within the lower chamber 56 of the fractionation device 10.

[0053]

[0072] In the case of BMA, the fixed plunger 36 rises until the lipid layer 96 contacts the lipid layer collection tube 76 of the fractionation apparatus 10b. The method then includes extracting at least a portion or all of the lipid layer 96 from the fractionation apparatus 10b using the lipid layer collection tube 76 in any block 2016.

[0054]

[0073] In the case of blood or BMA (after at least some or all of the lipid layer 90 has been extracted from the fractionation device 10b), the method involves rotating the threaded rod 30 in the opening 28 in block 2018, causing the fixed plunger 36 to rise in the lower chamber 56 of the fractionation device 10, and continuing this until at least some or all of the plasma layer 94 overflows into the upper chamber 54 of the fractionation device 10 through the overflow window 72 formed in the vertical portion 46 of the internal partition 44, providing a fluid path between the input channel 66 and the upper chamber 54. A scale line 102 may be formed on the fractionation device 10 for the user to measure the amount of plasma layer 94 overflowing into the upper chamber 54.

[0055]

[0074] In various cases, the technician or user of the fractionation device 10 may wish to extract only a portion or all of the plasma layer 94. In this case, 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 in any block 2020.

[0056]

[0075] In other cases, a technician or user of the fractionation apparatus 10 may wish to extract platelets from the plasma layer 94. In this case, the first scale line 102a may be used to determine the amount of plasma layer 94 (containing platelets) that overflows into the upper chamber 54. In a non-limiting example, the threaded rod 30 may be rotated until the bottom 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 leukocytes from the buffy coat layer 92 entering the upper chamber 54. In some cases, the orientation of the threads of the threaded rod 30 and / or the projection 34 of the knob 32 may be used to cause a predetermined amount of plasma layer 94 (containing platelets) to overflow into the upper chamber 54.

[0057]

[0076] Next, the method may include centrifugation of the plasma layer in any block 2022 to separate the plasma layer 94 into an upper chamber plasma layer 98 and a platelet-rich pellet layer 100, as shown in Figure 16. The inclined portion 48 and one or more inclined recesses 62 of the side wall 12 of the fractionation device 10 work in conjunction with the centrifuge to collect the platelet-rich pellet layer 100 into the lower region 58. During this second centrifugation cycle, a counterweight 200 (shown in Figure 18B) in a second orientation may be used to balance the fractionation device 10 in the centrifuge.

[0058]

[0077] In various cases, during this centrifugation cycle, the fixed plunger 36 may be configured to automatically descend to a specific or selected position. In a non-limiting example, as the centrifuge rotates to separate the plasma layer 94 into the upper chamber plasma layer 98 and the platelet-rich pellet layer 100, the fixed plunger 36 is configured to descend until the bottom surface 40 of the fixed plunger contacts the inner bottom wall surface 26 of the fractionation device 10 or the like.

[0059]

[0078] In other cases, the fixed plunger 36 can be manually lowered before or after this centrifugation cycle to separate the plasma layer 94 into the upper chamber plasma layer 98 and the platelet-rich pellet layer 100. To manually lower the fixed plunger 36, a threaded rod 30 can be engaged into the opening 28, and the internal rod 31 of the threaded rod 30 can be coupled or engaged with the post 37. The threaded rod 30 can then be rotated within the opening 28 to lower the fixed plunger 36. In other words, once the threaded rod 30 is removed from the fractionation apparatus, the internal rod 31 engaged with the post 37 pulls the fixed plunger 36 downward until it reaches a specific or selected position (for example, the bottom surface 40 of the fixed plunger contacts the bottom inner wall surface 26 of the fractionation apparatus 10aa). When the fixed plunger 36 reaches a specific or selected position, the internal rod 31 is disengaged or released from the post 37 (for example, by rotating the threaded rod 30 or by rotating the second knob 33).

[0060]

[0079] Method 2000 includes removing at least a portion or all of the upper chamber plasma layer 98 via the plasma layer collection tube 80 and a second port 78 in any block 2024. Method 2000 then includes optionally resuspending or mixing the platelet-rich pellet 100 in a portion of the upper chamber plasma layer 98 (any block 2026) and removing at least a portion of the platelet-rich pellet 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 pellet layer and / or leukocyte and platelet-rich pellet layer collection tube 84 and a third port 82 (any block 2028). In a non-limiting example, the platelet-rich pellet layer 100 may be mixed with at least a portion of the upper chamber plasma layer 98 using the platelet-rich pellet layer and / or leukocyte and platelet-rich pellet layer collection tube 84 before removal. In some cases, one or more markings 102 may be formed on the side wall 12 of the upper chamber 54 so that the user can determine the amount of upper chamber plasma layer 98 to be mixed with the platelet-rich pellet layer 100. Alternatively, at least a portion or all of the platelet-rich pellet layer 100 may be removed with or without the upper chamber plasma layer 98, or with or without a minimum amount of upper chamber plasma layer 98.

[0061]

[0080] In other cases, the technician or user of the fractionation apparatus 10 may desire to include at least part or all of the buffy coat layer or platelet and leukocyte layer 92 together with the plasma layer 94 in the upper chamber 54. In this case, method 2000 includes further rotating the threaded rod 30 in any block 2030 so that the leukocyte and platelet-rich red blood cell portion (e.g., at least part or all of the buffy coat layer or platelet and leukocyte layer 92) enters the upper chamber 54 of the fractionation apparatus 10 through the overflow window 72. A second scale line 102b may be used to determine the amount of plasma layer 94 (including platelets or platelet-poor) and buffy coat layer or leukocyte layer 92 (including platelets or platelet-poor) overflowing into the upper chamber 54. In a non-limiting example, the threaded rod 30 may be rotated until the bottom of the plasma layer 94 reaches the second scale line 102b, and the threaded rod 30 may be positioned so that the projection 34 faces the user. Next, the threaded rod 30 may be rotated (e.g., a quarter turn, a half turn, etc.) so that a certain amount of the buffy coat layer or leukocyte layer 92 enters the upper chamber 54. This causes the plasma layer 94 and at least a portion of the buffy coat layer or leukocyte layer 92 to overflow into the upper chamber 54, while minimizing the amount of red blood cells entering the upper chamber 54 from the erythrocyte layer or erythrocyte layer 90. In some cases, the orientation of the threads of the threaded rod 30 and / or the projection 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 layer or leukocyte layer 92 to overflow into the upper chamber 54.

[0062]

[0081] After rotating the threaded rod 30 to allow leukocyte and platelet-rich red blood cells to enter the upper chamber 54, the method continues by removing the threaded rod 30 from the fractionation apparatus 10 in any block 2032 and centrifuging the fractionation apparatus 10 to separate the plasma layer 94 and leukocyte-rich red blood cells located in the upper chamber 54 into one or more layers, including the upper chamber plasma layer 98 and the leukocyte and platelet-rich pellet layer 100 shown in Figure 16. The inclined portion 48 and one or more inclined recesses 62 on the side wall 12 of the fractionation apparatus 10 work in conjunction with the centrifuge to collect the leukocyte and platelet-rich pellet layer 100 into the lower region 58. During this second centrifugal cycle, a counterweight 200 in a second orientation (shown in Figure 18B) may be used to balance the fractionation apparatus 10 in the centrifuge.

[0063]

[0082] Method 2000 includes, in any block 2034, 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. Method 2000 then optionally includes resuspending or mixing the leukocyte and platelet-rich pellet 100 within a portion of the upper chamber plasma layer 98 (in any block 2036), and removing at least a portion of the leukocyte and platelet-rich pellet 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 pellet layer and / or the leukocyte and platelet-rich pellet layer collection tube 84 and the third port 82 (in any block 2038). In some cases, the leukocyte and platelet-rich pellet layer 100 may be mixed with at least a portion of the upper chamber plasma layer 98 using the platelet-rich pellet layer and / or the leukocyte and platelet-rich pellet layer collection tube 84 before removal. In some cases, one or more markings may be formed on the side wall 12 of the upper chamber 54 so that the user can determine the amount of upper chamber plasma layer 98 to be mixed with the leukocyte and platelet-rich pellet layer 100. Alternatively, at least a portion or all of the leukocyte and platelet-rich pellet layer 100 may be removed, with or without the upper chamber plasma layer 98, or with or without a minimum amount of upper chamber plasma layer 98.

[0064]

[0083] Various embodiments of this disclosure may also include permutations of the various elements described in the claims, such that each dependent claim is a multiple dependent claim incorporating each limitation and independent claim of a preceding dependent claim. Such permutations are explicitly within the scope of this disclosure.

[0065]

[0084] The foregoing description of the disclosed embodiments is provided to enable those skilled in the art to manufacture or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Accordingly, the invention is not limited to the embodiments shown herein, and the broadest scope should be given that is consistent with the principles and novel features disclosed herein.

Claims

1. The side walls are generally cylindrical, An upper wall connected to the upper part of the aforementioned side wall, A bottom wall connected to the lower part of the aforementioned side wall, It is an internal partition, The inclined portion that contacts the aforementioned side wall, An internal partition having a vertical portion that contacts the upper wall, An upper chamber defined within the fractionation device by the aforementioned internal partition, the aforementioned upper wall, and the aforementioned upper part of the side wall, A lower chamber defined within the fractionation device by the internal partition, the upper plunger surface of the fixed plunger engaged with the side wall, and the lower part of the side wall, The lower region of the upper chamber defined by the inclined portion of the internal partition adjacent to the side wall, The threaded opening that penetrates the bottom wall, A fractionation device equipped with the following features.

2. An input channel extending from the upper wall to the lower chamber, An overflow window is formed in the vertical portion of the internal partition, providing a fluid path between the input channel and the upper chamber, The fractionation apparatus according to claim 1, further comprising:

3. The fractionation apparatus according to claim 2, wherein the input channel is partially defined by the vertical portion of the internal partition and the upper portion of the side wall.

4. The fractionation apparatus according to claim 3, further comprising one or more recesses in the side wall of the input channel to limit the horizontal cross-section of the input channel.

5. The fractionation apparatus according to claim 3, further comprising a plurality of ports penetrating the upper wall.

6. A first port opening to the input channel, Within the input channel and below the first port, a recess in the side wall causes a portion of the side wall to extend toward the vertical portion of the internal partition, The fractionation apparatus according to claim 5, further comprising:

7. The fractionation apparatus according to claim 6, further comprising a lipid layer collection tube extending from the first port toward the lower chamber.

8. A second port adjacent to the vertical portion of the internal partition and opening into the upper chamber, A plasma layer collection tube extending from the second port to a position within the upper chamber, The fractionation apparatus according to claim 7, further comprising:

9. A third port adjacent to the side wall and located above the lower region of the upper chamber, opening into the upper chamber, A leukocyte and platelet layer collection tube extending from the third port to a position above the lower region of the upper chamber, The fractionation apparatus according to claim 8, further comprising:

10. The fractionation apparatus according to claim 1, wherein the lower region of the upper chamber, defined by the inclined portion of the internal partition adjacent to the side wall, comprises a flat portion configured to collect a platelet-rich pellet layer or a pellet layer rich in leukocytes and platelets.

11. The fractionation apparatus according to claim 1, wherein the side wall is made of an optically transparent material.

12. The fractionation apparatus according to claim 1, further comprising a threaded rod having threads of a size that engages with the threaded opening.

13. A method for collecting blood or bone marrow aspirate (BMA) fractions, wherein the method is To provide a fractionation device, the fractionation device is The side walls are generally cylindrical, An upper wall connected to the upper part of the aforementioned side wall, A bottom wall connected to the lower part of the aforementioned side wall, It is an internal partition, The inclined portion that contacts the aforementioned side wall, An internal partition comprising a vertical portion in contact with the upper wall, An upper chamber defined within the fractionation device by the aforementioned internal partition, the aforementioned upper wall, and the aforementioned upper part of the side wall, A lower chamber defined within the fractionation device by the internal partition, the upper plunger surface of the fixed plunger engaged with the side wall, and the lower part of the side wall, The lower region of the upper chamber defined by the inclined portion of the internal partition adjacent to the side wall, It is equipped with a threaded opening that penetrates the bottom wall, The procedure involves collecting blood or bone marrow aspirate (BMA) from the patient, Pre-treating the blood or BMA from the patient, Inserting the blood or BMA into the lower chamber of the fractionation apparatus, In the first centrifugation cycle, the fractionation device is centrifuged to separate the blood or BMA into different layers. Engaging the threaded rod with the threaded opening, By rotating the threaded rod within the threaded opening, the fixed plunger rises within the lower chamber of the fractionation apparatus, and this is done until the plasma layer overflows into the upper chamber of the fractionation apparatus through the overflow window formed in the vertical portion of the internal partition, thereby providing a fluid path between the input channel and the upper chamber. To remove at least a portion of the plasma layer from the upper chamber of the fractionation apparatus, A method for collecting a blood or bone marrow aspirate (BMA) fraction containing [the specified substance].

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

15. When a BMA is used, the threaded rod is first rotated so that the lipid layer rises to the lipid layer collection tube extending from the first port toward the lower chamber, the first port opens to the input channel, and the method is performed. The method according to claim 13, further comprising removing at least a portion of the lipid layer from the fractionation apparatus via the lipid layer collection tube.

16. By rotating the threaded rod within the threaded opening, the fixed plunger rises within the lower chamber of the fractionation apparatus, and this is done until the plasma layer overflows into the upper chamber of the fractionation apparatus through the overflow window, after which the threaded rod is further rotated to allow the red blood cell portion, which is rich in white blood cells and platelets, to enter the upper chamber. After rotating the threaded rod so that the portion of red blood cells rich in white blood cells and platelets enters the upper chamber, the threaded rod is removed from the fractionation apparatus, and the fractionation apparatus is centrifuged in a second centrifugation cycle to separate the plasma layer and the portion of red blood cells rich in white blood cells and platelets into one or more layers containing a pellet rich in white blood cells and platelets. To remove at least a portion of the plasma layer from the upper chamber, To remove at least a portion of the leukocyte and platelet-rich pellets from the upper chamber, The method according to claim 13, further comprising:

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 apparatus via a second port opening into the upper chamber adjacent to the vertical portion of the internal partition, and a plasma layer collection tube extending 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 pellet is removed by a leukocyte and platelet layer collection tube extending from the third port to a position above the lower region of the upper chamber, via a third port adjacent to the side wall and opening into the upper chamber located above the lower region of the upper chamber.

19. The method according to claim 18, wherein at least a portion of the leukocyte and platelet-rich pellet 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, comprises a flat portion configured to collect the leukocyte and platelet-rich pellets, and at least a portion of the leukocyte and platelet-rich pellets collected in the lower region of the upper chamber is placed on the flat portion of the inclined portion of the internal partition.

21. The present invention further includes providing a counterweight configured 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, The method according to claim 16, wherein during the first centrifugal separation cycle, the counterweight is in the first orientation, and during the second centrifugal separation cycle, the counterweight is in the second orientation.

22. A fractionation device, The side walls are generally cylindrical, An upper wall connected to the upper part of the aforementioned side wall, A bottom wall connected to the lower part of the aforementioned side wall, It is an internal partition, The inclined portion that contacts the aforementioned side wall, An internal partition having a vertical portion that contacts the upper wall, An upper chamber defined within the fractionation device by the aforementioned internal partition, the aforementioned upper wall, and the aforementioned upper part of the side wall, A lower chamber defined within the fractionation device by the internal partition, the upper plunger surface of the fixed plunger engaged with the side wall, and the lower part of the side wall, The lower region of the upper chamber defined by the inclined portion of the internal partition adjacent to the side wall, A fractionation device comprising a threaded opening that penetrates the bottom wall, A centrifuge configured to receive the aforementioned fractionation device, A counterweight is configured to be positioned inside the centrifuge on the opposite side of the fractionation device so as to balance the fractionation device, and has a first center of gravity in a first direction and a second center of gravity in a second direction. Equipped with, During the first centrifugal separation cycle, the counterweight is in the first orientation, and during the second centrifugal separation cycle, the counterweight is in the second orientation. system.

Images