Disposable set

Abstract

A set of disposable pouches for separating discrete volumes of a composite fluid, comprising: a separation pouch containing a composite fluid to be separated; a first pouch in fluid communication with the separation pouch, the first pouch configured to receive a first component of the composite fluid from the separation pouch; and a second pouch in fluid communication with the first pouch instead of the separation pouch, the second pouch configured to receive a product formed using the first component.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Patent Application No. 18 / 367,555, filed on September 13, 2023, which also claims the benefit of U.S. Provisional Application No. 63 / 406,879, filed on September 15, 2022. The entire disclosure of the above application is incorporated herein by reference. Technical Field

[0003] The present disclosure generally relates to systems and methods for separating components of a composite fluid. Background Art

[0004] This section provides background information related to the present disclosure but is not necessarily prior art.

[0005] Blood collection and processing play an important role in the global health care system. In conventional large-scale blood collection, whole blood is taken from a source or donor or patient or subject, separated into various blood components of whole blood via centrifugation, filtration or elutriation, and the blood components are stored in sterile containers for future transfusion into the patient for treatment. The separated blood components generally include parts containing red blood cells, white blood cells, platelets and / or plasma. Separating whole blood into components of whole blood can be performed continuously during collection, and / or, can be performed after batch collection. When separating whole blood, it is desirable to achieve the maximum ratio of different blood components. In addition, separating blood into various components of blood under highly sterile conditions is essential for many therapeutic applications. Summary of the invention

[0006] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0007] In various aspects, the present disclosure provides a disposable bag set for separating discrete volumes of a composite fluid. The disposable bag set may include: a separation bag, the separation bag containing the composite fluid to be separated; a first bag in fluid communication with the separation bag, the first bag being configured to receive a first component of the composite fluid from the separation bag; and a second bag in fluid communication with the first bag but not in fluid communication with the separation bag, the second bag being configured to receive a product formed using the first component.

[0008] In at least one exemplary embodiment, the disposable bag set further includes a third bag in fluid communication with the separation bag but not with the first bag or the second bag. The third bag can be configured to receive a second component of the composite fluid from the separation bag, wherein the second component is different from the first component and the product.

[0009] In at least one exemplary embodiment, the disposable bag set further includes a fourth bag in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, or the third bag. The fourth bag can be configured to receive a third component of the composite fluid from the separation bag, wherein the third component is different from the first component, the second component, and the product.

[0010] In at least one exemplary embodiment, the disposable bag set further includes a tube set connecting the separation bag to the first bag, the second bag, and the fourth bag. The tube set may include: a first tube segment, the first tube segment establishing fluid communication between the separation bag and the connector; a second tube segment, the second tube segment establishing fluid communication between the connector and the first bag; a third tube segment, the third tube segment establishing fluid communication between the connector and the third bag; and a fourth tube segment, the fourth tube segment establishing fluid communication between the connector and the fourth bag.

[0011] In at least one exemplary embodiment, the disposable bag set further includes a fifth bag in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, or the third bag. The fifth bag can be configured to receive a fourth component of the composite fluid from the separation bag, wherein the fourth component is different from the first component, the second component, the third component, and the product.

[0012] In at least one exemplary embodiment, the tubing segment establishes fluid communication between the separation bag and the fifth bag. The tubing segment may include one of a clamp and a filter, wherein the clamp is configured to move between an open position and a closed position. In the closed position, the clamp may be configured to at least partially block movement through the tubing segment.

[0013] In at least one exemplary embodiment, the filter can be an erythrocyte leukoreduction filter.

[0014] In at least one exemplary embodiment, the composite fluid may include whole blood, the first component may include plasma, and the product formed using the first component may include cryoprecipitate.

[0015] In at least one exemplary embodiment, the second component comprises platelets.

[0016] In at least one exemplary embodiment, the third component comprises residual leukocytes.

[0017] In at least one exemplary embodiment, the fourth component comprises red blood cells.

[0018] In at least one exemplary embodiment, the disposable bag set further includes a sixth bag in fluid communication with the separation bag. The sixth bag can be configured to assist in collecting the composite fluid.

[0019] In at least one exemplary embodiment, the disposable bag set further comprises a tube set connecting the separation bag to the sixth bag. The tube set may comprise a first tube section establishing fluid communication between the separation bag and the connector, and a second tube section establishing fluid communication between the sixth bag and the connector, wherein the connector is coupled to the needle.

[0020] In at least one exemplary embodiment, the first pipe segment includes a clamp. The clamp can be configured to move between an open position and a closed position. In the closed position, the clamp can be configured to at least partially block movement through the first pipe segment.

[0021] In at least one exemplary embodiment, the second pipe segment includes a clamp. The clamp can be configured to move between an open position and a closed position. In the closed position, the clamp can be configured to at least partially block movement through the first pipe segment.

[0022] In at least one exemplary embodiment, the tubing assembly further includes a needle stick protector disposed between the connector and the needle.

[0023] In at least one exemplary embodiment, a tubing segment may establish fluid communication between the first bag and the second bag.

[0024] In various aspects, the present disclosure provides a disposable bag set for separating whole blood. The disposable bag set may include: a separation bag, the separation bag containing whole blood to be separated; a first bag in fluid communication with the separation bag; a second bag in fluid communication with the first bag but not in fluid communication with the separation bag; a third bag in fluid communication with the separation bag and the first bag or the second bag; a fourth bag in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, or the third bag; and a fifth bag in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, the third bag, or the fourth bag. The first bag may be configured to receive plasma from the whole blood contained in the separation bag. The second bag may be configured to receive a cryoprecipitate formed using plasma. The third bag may be configured to receive platelets from the whole blood contained in the separation bag. The fourth bag may be configured to receive residual white blood cells from the whole blood contained in the separation bag. The fifth bag may be configured to receive red blood cells from the whole blood contained in the separation bag.

[0025] In at least one exemplary embodiment, the disposable bag set further includes a sixth bag in fluid communication with the separation bag. The sixth bag can be configured to facilitate collection of whole blood.

[0026] In at least one exemplary embodiment, the disposable bag set further includes: a first tube set connecting the separation bag to the first bag, the second bag, and the fourth bag; a fifth tube segment establishing fluid communication between the separation bag and the fifth bag; a sixth tube segment establishing fluid communication between the first bag and the second bag; and a second tube set connecting the separation bag to the sixth bag. The first tube set may include: a first tube segment establishing fluid communication between the separation bag and the connector; a second tube segment establishing fluid communication between the connector and the first bag; a third tube segment establishing fluid communication between the connector and the third bag; and a fourth tube segment establishing fluid communication between the connector and the fourth bag. The second tube set may include: a first tube segment establishing fluid communication between the separation bag and the connector; and a second tube segment establishing fluid communication between the sixth bag and the connector, the connector being coupled to the needle.

[0027] Further areas of applicability will become apparent from the description provided herein.The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0029] Figure 1 is a perspective view of an exemplary rotor of an apparatus for separating discrete volumes of a composite fluid according to at least one exemplary embodiment of the present disclosure;

[0030] Figure 2 is a partial cross-sectional view taken along a diametric plane of an exemplary apparatus for separating discrete volumes of a composite fluid according to at least one exemplary embodiment of the present disclosure, the apparatus comprising, for example Figure 1 The rotor shown;

[0031] Figure 3 According to at least one exemplary embodiment of the present disclosure Figure 1 A cross-sectional view of an exemplary first cavity of the rotor shown, taken along a radial plane, the first cavity being configured to receive and retain a separation bag for containing a composite fluid;

[0032] Figure 4 is a top view of an exemplary disposable bag set according to at least one exemplary embodiment of the present disclosure, which can be used to use, for example Figure 1 The rotor shown is used to separate discrete volumes of composite fluids; and

[0033] Figure 5 According to at least one exemplary embodiment of the present disclosure Figure 1A cross-sectional view taken along a radial plane of an exemplary second cavity of a rotor is shown, the second cavity being configured to receive and hold a plurality of satellite bags configured to receive one or more blood components separated from a composite fluid.

[0034] Corresponding reference characters indicate corresponding parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0035] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0036] Exemplary embodiments are provided to make the present disclosure detailed and to fully convey the scope of the present disclosure to those skilled in the art. Many specific details (such as examples of specific components, devices and methods) are set forth to provide a detailed understanding of the embodiments of the present disclosure. It is apparent to those skilled in the art that specific details may not be used, and exemplary embodiments may be implemented in many different forms and should not be construed as limiting the scope of the present disclosure. In some exemplary embodiments, known processes, known device structures and known technologies are not described in detail.

[0037] The terms used herein are only used to describe specific exemplary embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "the" as used herein may also be intended to include plural forms. The terms "include", "comprise", "with" and "have" are inclusive, and therefore specify the presence of the features, integers, steps, operations, elements and / or parts, but do not exclude the presence or increase of one or more other features, integers, steps, operations, elements, parts and / or combinations thereof. The method steps, processes and operations described herein, unless specifically identified as an execution order, should not be interpreted as necessarily requiring the method steps, processes and operations to be performed in the specific order discussed or shown. It should also be understood that additional steps or alternative steps may be adopted.

[0038] When an element or layer is referred to as being "located on" or "engaged to," "connected to," or "coupled to" another element or layer, the element or layer may be directly located on or engaged to, connected to, or coupled to the other element or layer, or there may be intervening elements or layers. Conversely, when an element is referred to as being "directly located on" or "directly engaged to," "directly connected to," or "directly coupled to" another element or layer, there may be no intervening elements or layers. Other words used to describe the relationship between elements should be interpreted in a similar manner (e.g., "located between" and "directly located between," "adjacent" and "directly adjacent," etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the listed related items.

[0039] In this article, although the terms first, second, third, etc. can be used to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first", "second" and other numerical terms when used in this article do not mean sequence or order unless the context clearly indicates. Therefore, without departing from the teachings of exemplary embodiments, the first element, first component, first area, first layer or first section discussed below can be referred to as the second element, second component, second area, second layer or second section.

[0040] For ease of description, spatially related terms (such as "inside", "outside", "below", "below", "down", "above", "upper", etc.) may be used herein to describe the relationship between an element or feature as shown in the figure and one or more other elements or features. In addition to the orientation shown in the figure, spatially related terms may be intended to include different orientations of the device in use or in operation. For example, if the device in the figure is flipped, the element described as being "below" or "below" other elements or features will be oriented to be "above" other elements or features. Therefore, the exemplary term "below" may include an orientation above and below. The device may be oriented otherwise (rotated 90 degrees or in other orientations), and the spatially related descriptive terms used herein are interpreted accordingly.

[0041] Various components are referred to herein as being "operably associated". As used herein, "operably associated" refers to components that are connected together in an operably manner, and includes embodiments in which the components are directly connected, as well as embodiments in which additional components are placed between the connected components. "Operably associated" components may be "fluidically associated". "Fluidically associated" refers to components that are connected together so that fluid can be transported between them. "Fluidically associated" includes embodiments in which an additional component is disposed between two fluidically associated components, as well as additional components disposed between directly connected components. Fluidically associated components may include components that do not contact the fluid but contact other components to operate the system (e.g., a peristaltic pump that pumps fluid through a flexible tube by compressing the outside of the tube).

[0042] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0043] At least one embodiment of the present disclosure relates to an apparatus for separating discrete volumes of composite fluids or liquids (e.g., whole blood) in parallel (or simultaneously), for example, by centrifugation. Apparatus for separating whole blood is described, for example, in U.S. application Ser. No. 17 / 975,180, filed Oct. 27, 2022, published on May 18, 2023 as U.S. Publication No. 2023 / 0149668, entitled “Methods and Systems for Selectively Connecting Blood Collection Pressure,” and listing Jeremy Parsons and Jesse Janzen as inventors; and / or, U.S. Pat. No. 11,013,850, issued on May 25, 2021, entitled “Compound Fluid Separation,” and listing Bruce W. Gibbs, Bruce Ellingboe, and Jeffrey J. Blakeslee as inventors, the entire disclosure of which is incorporated herein by reference.

[0044] Figure 1 An exemplary rotor 100 for use in an apparatus 200 for separating discrete volumes of a composite fluid is shown. As shown, the rotor 100 includes one or more separation units 102, each of which is configured to receive and hold a separation bag (separation bag may also be referred to as a whole blood bag) 400, which contains a volume of the composite fluid to be separated. As shown, in at least one exemplary embodiment, the rotor 100 may include four separation units 102, and the rotor 100 may be configured to receive four separation bags 400.

[0045] The separation units 102 may each include a container (the container may also be referred to as a barrel) 104 defining a cavity 230, the cavity 230 being configured to receive and hold a corresponding separation bag 400. In at least one exemplary embodiment, each separation unit 102 includes a hinged lid (the hinged lid may also be referred to as a top or upper wall) 106, which enables access to the container 104 to place or remove the separation bag 400. The cavity (the cavity may also be referred to as a separation compartment) 230 may also include a lower wall 105 disposed opposite the upper wall 104 and closer to the turntable 130. In at least one exemplary embodiment, the upper wall 104 and the lower wall 105 may converge toward the central middle axis 226 to define the container 104. In other exemplary embodiments, the cavity 230 may include a side wall connecting the upper wall 104 and the lower wall 105. Generally, the shape and size of the cavity 230 may be designed to loosely accommodate the separation bag 400.

[0046] The rotor 100 also includes a central container 120 that includes a plurality of satellite containers 122 arranged around a central cavity 124. The satellite containers 122 are each configured to receive and hold one or more satellite bags 502. As shown, in at least one exemplary embodiment, the rotor 100 may include four satellite containers 122 that are arranged around the central cavity 124 and correspond to each of the four illustrated separation units 102. As discussed further below, each satellite bag 502 is configured to receive one or more separated components from a corresponding separation bag 400. The corresponding separation bags and satellite bags may be collectively referred to as a bag system.

[0047] Figure 2 is a partial cross-sectional view taken along a diametric plane of an apparatus 200 for separating discrete volumes of a composite fluid, the apparatus comprising Figure 1 1. An exemplary rotor is shown. As shown, the rotor 100 can be supported by a support assembly 202 to facilitate the rotation of the rotor 100 around a first axis (the first axis can also be referred to as an axis of rotation) 204. The rotor 100 can be connected to the support assembly 202 via a rotor shaft 206, which extends along a second axis (the second axis can also be referred to as an axis axis or an axis longitudinal axis) 208. For example, as shown, the central container 120 can be connected to the upper end 212 of the rotor shaft 206 so that the second axis 208 coincides with the first axis 204 and the third axis (the third axis can also be referred to as the container axis or the container longitudinal axis) 214 of the central container 120. The device 200 can include a motor 220 that facilitates the rotation of the rotor 100 around the axis of rotation 204. In at least one exemplary embodiment, as shown, the motor 220 can interact with the rotor 202 via a belt 222 and a pulley 210 system, wherein the belt 222 is engaged in a groove 224 of the pulley 210, and the pulley 210 is connected to the rotor shaft 206.

[0048] Each separation unit 102 can define a middle longitudinal axis 226. The separation units 102 can be mounted on the turntable 130 such that the corresponding middle longitudinal axis 226 intersects the rotation axis 204, each separation unit 102 is located at the same distance from the rotation axis 204, and / or the angles between different middle longitudinal axes 226 are substantially the same (e.g., about 90 degrees). The positioning of the separation units 102 on the turntable 130 can be adjusted so that when the separation units 102 are empty, the weight on the turntable 130 is evenly distributed, for example, to balance the rotor 100.

[0049] The apparatus 200 includes a component transfer device for transferring at least one separated component from each separation bag 400 to one or more satellite bags 502 connected to the corresponding separation bag 400. In at least one exemplary embodiment, the component transfer device includes a pressing system for pressing the separation bag 400 received by and held in the corresponding container 104 and transferring the separated component to the separation bag 400. The pressing system may include one or more flexible membranes (flexible membranes may also be referred to as "bladders") 232, which are selectively coupled to one or more of the containers 104 to define an expandable chamber 234 within the cavity 230. For example, as shown, the flexible membrane 232 may be sized to be along the bottom wall of the corresponding cavity 230, wherein the bottom wall is closest to the turntable 130.

[0050] The extrusion system can include a manifold 132 disposed about a perimeter 134 of the turret 130. For example, each expandable chamber 234 can be fluidly connected to the manifold 132 via a supply channel 236. The manifold 132 can have a generally circular shape or arrangement.

[0051] The squeezing system may include a hydraulic pumping station 240 configured to pump hydraulic fluid into and / or out of each expandable chamber 234. The hydraulic fluid may be selected to have a density greater than the density of the densest component in the composite fluid to be separated (when the composite fluid is whole blood, the densest component will be red blood cells). As a result, during centrifugation, the hydraulic fluid within each expandable chamber 234, regardless of its volume, will generally remain in the outermost portion of each cavity 230.

[0052] As shown, in at least one exemplary embodiment, a hydraulic pump station 240 can be connected to the expandable chamber 234 through a rotary seal or fluid coupling 242, through a conduit 244; the conduit 244 extends through the rotor shaft 206 and also extends through the bottom wall 105 (and / or optionally, one or more side walls) of the central container 120, and extends radially from the central container 120 through the turntable 130, where the conduit 244 connects with the manifold 132. In at least one exemplary embodiment, the hydraulic pump station 240 can include a piston pump 245. The piston pump 245 can include a piston 246 that can move in a hydraulic cylinder 248. The hydraulic cylinder 248 can be fluidly connected to the expandable chamber 234 via the rotary seal 242 and the conduit 244. The piston 246 can be actuated by a stepper motor 250, which is configured to move a lead screw 252 that is connected to the rod of the piston 246.

[0053] The extrusion system may also include a hydraulic liquid reservoir 254. The hydraulic cylinder 248 may be connected to the hydraulic liquid reservoir 254, and access of the hydraulic cylinder 248 to the hydraulic liquid reservoir 254 may be controlled by a valve 256. The valve 256 may be configured to selectively allow hydraulic liquid to be introduced into or withdrawn from a hydraulic circuit defined by the hydraulic cylinder 248, the conduit 244, and the expandable chamber 234. In at least one exemplary embodiment, a pressure gauge 258 may be connected to the hydraulic circuit and may be configured to measure the hydraulic pressure in the hydraulic circuit.

[0054] In at least one exemplary embodiment, the apparatus 200 includes a first balancing device configured to (initial) balance the rotor 100 when the weights of the separation bags 400 placed in the separation units 102 are different. The first balancing device may include structural elements that are substantially the same as the elements of the component transfer device. For example, the first balancing device may include four expandable hydraulic chambers (similar to the hydraulic chamber 234) that are interconnected by a manifold (similar to the manifold 132) and a hydraulic pump station (similar to the hydraulic pump station 240) for pumping hydraulic liquid into the hydraulic chambers through a conduit (similar to the conduit 244) connected to the manifold. In order to initially balance the rotor 100 (the four separation units 102 of the rotor 100 may contain four discrete volumes of composite fluids with different weights), the hydraulic pump station may be controlled to pump a predetermined volume of hydraulic liquid into the interconnected hydraulic chambers at the beginning of the separation process, the predetermined volume of hydraulic liquid being so selected to balance the rotor 100. For example, for whole blood, the determination of the equilibrium volume may take into account the maximum difference in volume between two blood donations and the maximum difference in hematocrit between two blood donations. Under the action of centrifugal force, the hydraulic liquid will be unevenly distributed in the four separation units 102 according to the weight difference of the separation bags, and the rotor 100 will be balanced. In order to achieve the desired or optimal initial balance, the volume of the cavity 230 of the separation unit 102 can be selected so that no matter how the volume of the separation bag contained in the cavity 230 is, the cavity 230 will not be filled after a determined amount of hydraulic liquid is pumped into the interconnected expandable chambers 234.

[0055] In at least one exemplary embodiment, the apparatus 200 may include a second balancing device configured to balance the rotor 100 when the weights of the components in the satellite bags 502 transferred to the central container 120 are different. For example, when two blood donations have the same hematocrit and different volumes, the volume of plasma extracted from each blood donation may be different, and when two blood donations have the same volume and different hematocrits, the hematocrit of plasma extracted from each blood donation may also be different. In at least one exemplary embodiment, as shown, the second balancing device may include flexible rectangular storage bags 280 interconnected by tube segments. For example, the tube segment may connect two adjacent storage bags 280 through its bottom. The storage bag 280 may contain a volume of balancing liquid having a density close to that of the composite liquid. The size of the storage bag 280 may be designed to be along the inner surface of the central container 120, and the internal volume of the storage bag is greater than the volume of the balancing liquid, so that the balancing liquid can expand freely in any of the storage bags 280. In operation, for example, if the four satellite bags 502 respectively adjacent to the four storage bags 280 contain different volumes of plasma components, the four satellite bags 502 will be unevenly pressed against the four storage bags 280 under the action of centrifugal force, which will cause the balancing liquid to become unevenly distributed in the four storage bags 280 and compensate for the weight differences in the satellite bags.

[0056] In at least one exemplary embodiment, the device 200 may include a controller 290, which includes a control unit and a memory. The control unit may include, for example, a microprocessor, a controller, etc. The memory may include, for example, a computer-readable memory. The memory may provide the control unit with information and programming instructions related to various separation protocols (e.g., protocols for separating plasma components and blood cell components and / or protocols for separating plasma components, platelet components, and red blood cell components) and related to the operation of the device based on these separation protocols. The control unit may be programmed to receive information related to one or more centrifugal speeds at which the rotor 100 rotates during various stages of the separation process (e.g., component separation stage, plasma component expression stage, stage in which platelets are suspended in the plasma portion, platelet component expression stage, etc.), directly or through the memory, and / or information related to various transfer flows at which the separated components will be transferred from the separation bag 400 to the satellite bag 502. The information related to the various transfer flows may be expressed, for example, as a hydraulic fluid flow in a hydraulic circuit, and / or, the speed of the stepper motor 250 of the hydraulic pump station 240. The control unit may be programmed to receive information from the pressure gauge 258 directly or via a memory and / or information for controlling the motor 220 of the hydraulic pump station 240 and / or the stepper motor 250 to operate the separation device in accordance with the selected separation protocol.

[0057] Figure 31 is a cross-sectional view of one of the separation units 102 taken along a radial plane. As shown, one or more sensors 310, 312 can be incorporated into the upper wall 106 and / or the lower wall 105 of the container 104. For example, in at least one exemplary embodiment, the separation unit 102 can include a bag sensor (the bag sensor can also be referred to as a first sensor) 310 and a tube sensor (the tube sensor can also be referred to as a second sensor) 312. The sensors 310, 312 can be formed or mounted along the middle longitudinal axis 226 of the container 104. The bag sensor 210 can be positioned farther from the rotation axis 204 than the tube sensor 312. In at least one exemplary embodiment, when the separation bag 400 is placed in the container 104 and the lid 106 is closed, the bag sensor 310 can face the upper triangular portion of the separation bag 400, and the tube sensor 312 can face the proximal end of one or more tubes 702, 716 that join the separation unit 102 and the plurality of satellite bags 502 together. The bag sensor 310 can be configured to detect blood cells in the fluid. The tube sensor 312 can be configured to detect the presence of liquid in the tube and to detect blood cells in the liquid. Each of the sensors 310, 312 can include, for example, a photocell including an infrared LED and a light detector. In at least one exemplary embodiment, power can be supplied by a slip ring array 270 (e.g., a 3D optical fiber) mounted around the lower portion of the rotor shaft 206. Figure 2 ) are supplied to sensors 310, 312.

[0058] like Figure 3 As further shown in FIG. 1 , the container 104 may include one or more pins 410 and one or more corresponding recesses 412 for securing the separation bag 400 within the separation unit 102. The pins 410 may protrude from an inner surface 414 of the lid 106 near an opening edge or top 416 of the separation unit 102. The recesses 412 may be defined in an inner surface 418 of the lower surface 105 of the container 104. In at least one exemplary embodiment, the pins 410 may be spaced apart and sized to be received in one or more corresponding holes 420 in an upper edge (e.g., two upper corners) of the separation bag 400.

[0059] The apparatus 200 is configured for use with a set of bags (which may also be referred to as a collection of bags or a bag set or a disposable bag set or a disposable set) 500. The separation bag 400 may be used continuously for collection separate from or away from the apparatus 200 and also for separation within the apparatus 200, while the satellite bag 502 may be within the apparatus 200 for receiving the separated components. Figure 4 is a top view of an exemplary disposable bag set 500 that can be used to, for example, Figure 1The rotor 100 is shown to separate discrete volumes of complex fluids. The disposable bag set 500 includes a separation bag 400 configured to receive discrete volumes of whole blood from a source or donor or patient or subject and one or more satellite bags 502 configured to receive separated components from the separation bag 400.

[0060] In at least one exemplary embodiment, the satellite bag 502 may include a first bag 602 configured to receive and store a first component in the composite fluid from the separation bag 400, and a second bag 612 configured to receive and store a second component (different from the first component) in the composite fluid from the separation bag 400. The first component may include platelets, and the first bag 602 may be a platelet collection bag (an interim platelet unit (IPU) bag). The second component may include plasma, and the second bag 612 may be a plasma collection bag. The satellite bag 502 may also include a third bag 622 configured to receive and store a third component that is subsequently separated from the second component. For example, the third component may be a cryoprecipitate prepared from plasma, and the third bag 622 may be a plasma cryoprecipitate bag or a plasma cryoprecipitate reduction bag.

[0061] In at least one exemplary embodiment, the satellite bag 502 may further include a fourth bag 632 in addition to the first bag 602, the second bag 612, and the third bag 622. The fourth bag 632 may be configured to receive and store a fourth component (different from the first component and the second component) in the composite fluid from the separation bag 400. For example, the fourth component may include red blood cells (RBCs), and the fourth bag 632 may be a red blood cell collection bag (the fourth bag may also be referred to as a red blood cell storage bag).

[0062] In at least one exemplary embodiment, the satellite bag 502 may further include a fifth bag 642 in addition to the first bag 602, the second bag 612, the third bag 622, and the optional fourth bag 632. The fifth bag 642 may be configured to receive and store a fifth component (different from the first component, the second component, and the fourth component) in the composite fluid from the separation bag 400. For example, the fifth component may include leukocytes, and the fifth bag 642 may be a residual leukocyte bag 642.

[0063] The separation bag 400 can be connected to one or more satellite bags 502 by a tube system including one or more tubes 702, 706, 708, 710, 714, 716 and one or more connectors 704, 712, 718. For example, in at least one exemplary embodiment, a first end of a first tube segment 702 can be coupled to the separation bag 400 (or integrally formed with the separation bag). The first end of the first tube segment 702 can be coupled to the separation bag 400 by a first connector (the first connector can also be referred to as a first coupler) 712. The first connector 712 can include a frangible connector. The second end of the first tube segment 702 away from the separation bag 400 can be coupled to a second connector (the second connector can also be referred to as a second coupler) 704 (or integrally formed with the second connector). The second connector 704 can couple the first tube segment 702 to a first end of a second tube segment 706, wherein the second end of the second tube segment 706 away from the first end can be coupled to the first bag 602 (or integrally formed with the first bag). The first connector 704 may also couple the first tube segment 702 to a first end of a third tube segment 708, wherein a second end of the third tube segment 708 away from the first end may be coupled to (or integrally formed with) the second bag 612. The first connector 704 may also couple the first tube segment 702 to a first end of a fourth tube segment 710, wherein a second end of the fourth tube segment 710 away from the first end may be coupled to (or integrally formed with) the fifth bag 642. The first connector 704 may include a cross connector.

[0064] The first end of the fourth tube segment 714 can be coupled to the second bag 612 (or formed integrally with the second bag), wherein the second end of the fourth tube segment 714 away from the first end can be coupled to the third bag 622 (or formed integrally with the third bag). The first end of the fifth tube segment 716 can be coupled to the separation bag 400 (or formed integrally with the separation bag), wherein the second end of the fifth tube segment 716 can be coupled to the fourth bag 632 (or formed integrally with the fourth bag). The fifth tube segment 716 can include a filter 722 and / or a first clamp 720. The filter 722 can be a red blood cell leukocyte reduction filter configured to remove white blood cells from the red blood cell product. For example, in at least one exemplary embodiment, the filter 722 can be a red blood cell leukocyte reduction filter configured to remove a sufficient number of white blood cells from the red blood cell product to meet requirements defined, for example, by various regulatory agencies. The first clamp 720 can be configured to move between a first or open position and / or a second or intermediate position and / or a third or closed position. In the first position, the first clamp 720 may not apply pressure to the fifth tube segment 716 or apply minimal pressure to the fifth tube segment, and the fluid may flow freely through the fifth tube segment. In the intermediate position, the first clamp 720 may apply a closing pressure to the fifth tube segment 716 to at least partially block the fluid from flowing through the fifth tube segment. In the closed position, the first clamp 720 may apply a closing pressure to the fifth tube segment 716 to completely block the fluid from flowing through the fifth tube segment. The first clamp 720 may be positioned at any point along the fifth tube segment 716. For example, in at least one exemplary embodiment, the first clamp 720 may be disposed closer to the second end of the fifth tube segment 716 (and the fourth bag 632) than the first end of the fifth tube segment 716. In other embodiments, the first clamp 720 may be disposed closer to the first end of the fifth tube segment 716 (and the separation bag 400) than the second end of the fifth tube segment 716. In other embodiments, the first clamp 720 may be disposed between the first end and the second end along approximately half of the fifth tube segment 716. Although not shown, it should be understood that in various embodiments, the first tube segment 702, the second tube segment 706, the third tube segment 708, and / or the fourth tube segment 710 may similarly include one or more clamps and / or one or more filters.

[0065] In at least one exemplary embodiment, the fifth pipe segment 716 may include a first segment 716A and a second segment 716B joined by a third connector (the third connector may also be referred to as a third coupler) 718. This configuration may allow fluid to flow through the tube and filter only when the connector 718 is in an open state, for example, as set by an operator or user or administrator post-processing. In at least one exemplary embodiment, the connector 718 may include a fragile component or member. Although shown as including two or more pipe segment sections 716A, 716B, it should be understood that in at least one exemplary embodiment, the fifth pipe segment 716 may be a single pipe segment, omitting the third connector 718. Similarly, it should be understood that, although shown as a single pipe segment, in various embodiments, the first pipe segment 702, the second pipe segment 706, the third pipe segment 708, and / or the fourth pipe segment 710 may include one or more pipe segment sections joined by one or more connectors.

[0066] In at least one exemplary embodiment, the disposable bag set 500 may also include a sixth bag 644. The sixth bag 644 may be a sample / transfer bag configured to transfer a small amount of blood from a source or donor or patient or subject. The sixth bag 644 may include a sample tube holder / Luer connector 646. The sample tube holder / Luer connector 646 may be configured to remove one or more samples from the transfer volume in the sixth bag 644. The sample tube holder / Luer connector 646 may be coupled to a first end of a sixth tube segment 750 (or may be integrally formed with the first end of the sixth tube segment), and the internal volume of the sixth bag 644 may be coupled to a first end of a seventh tube segment 752 (or may be integrally formed with the first end of the seventh tube segment), wherein the second end of the sixth tube segment 750 away from the first end and the second end of the seventh tube segment 752 away from the first end are coupled together by a fourth connector (the fourth connector may also be referred to as a fourth coupling) 754.

[0067] The fourth connector 754 can connect the sixth pipe segment 750 and the seventh pipe segment 752 to the first end of the eighth pipe segment 756. The fourth connector 754 can be a Y-shaped connector. The eighth pipe segment 756 can include a second clamp 758. The second clamp 758 can be configured to move between a first or open position and / or a second or intermediate position and / or a third or closed position. In the first position, the second clamp 758 can not apply pressure to the eighth pipe segment 756 or apply a minimum pressure to the eighth pipe segment, and the fluid can flow freely through the eighth pipe segment. In the intermediate position, the second clamp 758 can apply a closing pressure to the eighth pipe segment 756 to at least partially block the fluid from flowing through the eighth pipe segment. In the closed position, the second clamp 758 can apply a closing pressure to the eighth pipe segment 756 to completely block the fluid from flowing through the eighth pipe segment. The second clamp 758 can be positioned at any point along the eighth pipe segment 756. For example, in at least one exemplary embodiment, the second clamp 758 may be disposed closer to the second end of the eighth tube segment 756 (and the fifth connector 760) than the first end of the eighth tube segment 756. In other embodiments, the second clamp 758 may be disposed closer to the first end of the eighth tube segment 756 (and the sixth bag 644) than the second end of the eighth tube segment 756. In other embodiments, the second clamp 758 may be disposed along approximately half of the eighth tube segment 756 between the first end and the second end.

[0068] The second end of the eighth tube segment 756 can be coupled to the fifth connector 760. The fifth connector 760 can also be coupled to a needle stick protector (NIP) 762 and a ninth tube segment 764. The needle stick protector 762 can be coupled to (or integrally formed with) a needle 770, which can be used to extract whole blood from a source or donor or patient or subject. The first end of the ninth tube segment 764 can be coupled to the separation bag 400, and the second end of the ninth tube segment 764 away from the first end is coupled to the fifth connector 760. The ninth tube segment 764 can include a third clamp 766. The third clamp 766 can be configured to move between a first or open position and / or a second or intermediate position and / or a third or closed position. In the first position, the third clamp 766 can not apply pressure to the ninth tube segment 764 or apply minimal pressure to the ninth tube segment, and the fluid can flow freely through the ninth tube segment. In the intermediate position, the third clamp 766 can apply a closing pressure to the ninth tube segment 764 to at least partially block the flow of fluid through the ninth tube segment. In the closed position, the third clamp 766 can apply a closing pressure to the ninth tube segment 764 to completely block the flow of fluid through the ninth tube segment. The third clamp 766 can be positioned at any point along the ninth tube segment 764. For example, in at least one exemplary embodiment, the third clamp 766 can be disposed closer to the second end of the ninth tube segment 764 (and the fifth connector 760) than the first end of the ninth tube segment 764. In other embodiments, the third clamp 766 can be disposed closer to the first end of the ninth tube segment 764 (and the separation bag 400) than the second end of the ninth tube segment 764. In other embodiments, the third clamp 766 can be disposed between the first end and the second end along approximately half of the ninth tube segment 764.

[0069] As will be appreciated by those skilled in the art, the separation bag 400 and the satellite bag 502 (including the first bag 602, the second bag 612, the third bag 622, the fourth bag 632 and / or the fifth bag 642) may include one or more holes or openings for supporting, positioning and / or hanging the bag, including, for example, one or more holes 420 in the separation bag 400 for receiving the pin 410 of the container 104. The separation bag 400 and the satellite bag 502 (including the first bag 602, the second bag 612, the third bag 622, the fourth bag 632 and / or the fifth bag 642) may be configured to receive one or more identification tags. For example, as shown, the separation bag 400 may include a first tag 800, the first bag 602 may include a second tag 802, the second bag 612 may include a third tag 812, the third bag 622 may include a fourth tag 822, the fourth bag 632 may include a fifth tag 832, and the fifth bag 642 may include a sixth tag 842.

[0070] Figure 5is a cross-sectional view taken along a radial plane of one of the satellite containers 122. As shown, the satellite container 122 includes a cavity 512 configured to receive a plurality of satellite bags 502, including a first bag 602, a second bag 612, a third bag 632, a fourth bag 642, and a fifth bag 644.

[0071] The foregoing description of the embodiments has been provided for the purpose of illustration and description. This is not intended to be exhaustive or to limit the present disclosure. Even if not specifically shown or described, the individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable where applicable and can be used in selected embodiments. The individual elements or features of a particular embodiment may also be changed in many ways. Such changes are not considered to depart from the present disclosure, and all such modifications are intended to be included within the scope of the present disclosure.

Claims

1. A disposable bag set for separating discrete volumes of a composite fluid, the disposable bag set comprising: a separation bag containing a composite fluid to be separated; a first bag in fluid communication with the separation bag, the first bag being configured to receive a first component of the composite fluid from the separation bag; and A second bag is in fluid communication with the first bag and not in fluid communication with the separation bag, the second bag being configured to receive a product formed using the first component.

2. The disposable bag set according to claim 1, wherein: The disposable bag set also includes: A third bag is in fluid communication with the separation bag but not with the first bag or the second bag, the third bag being configured to receive a second component of the composite fluid from the separation bag, the second component being different from the first component and the product.

3. The disposable bag set according to claim 2, wherein: The disposable bag set also includes: A fourth bag in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, or the third bag, the fourth bag being configured to receive a third component of the composite fluid from the separation bag, the third component being different from the first component, the second component, and the product.

4. The disposable bag set according to claim 3, wherein: The disposable bag set also includes: A tube assembly connecting the separation bag to the first bag, the second bag, and the fourth bag, the tube assembly comprising: a first tube segment, the first tube segment establishing fluid communication between the separation bag and a connector; a second tube segment establishing fluid communication between the connector and the first bag; a third tube segment establishing fluid communication between the connector and the third bag; and A fourth tube segment establishes fluid communication between the connector and the fourth bag.

5. The disposable bag set according to claim 3, wherein: The disposable bag set also includes: a fifth bag in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, or the third bag, the fifth bag being configured to receive a fourth component of the composite fluid from the separation bag, the fourth component being different from the first component, the second component, the third component, and the product.

6. The disposable bag set according to claim 5, wherein: A tubing segment establishes fluid communication between the separation bag and the fifth bag, the tubing segment including one of a clamp and a filter, the clamp being configured to move between an open position and a closed position, wherein the clamp is configured to at least partially block movement through the tubing segment.

7. The disposable bag set according to claim 6, wherein: The filter is an erythrocyte leukoreduction filter.

8. The disposable bag set according to claim 5, wherein: The composite fluid comprises whole blood, the first component comprises plasma, and the product formed using the first component comprises cryoprecipitate.

9. The disposable bag set according to claim 8, wherein: The second component comprises platelets.

10. The disposable bag set according to claim 9, wherein: The third component comprises residual leukocytes.

11. The disposable bag set according to claim 10, wherein: The fourth component comprises red blood cells.

12. The disposable bag set according to claim 3, wherein: The disposable bag set also includes a sixth bag in fluid communication with the separation bag and configured to facilitate collection of the composite fluid.

13. The disposable bag set according to claim 12, wherein: The disposable bag set also includes: A tube assembly connecting the separation bag to the sixth bag, the tube assembly comprising: a first tube segment that establishes fluid communication between the separation bag and a connector; and A second tubing segment establishes fluid communication between the sixth bag and the connector, the connector being coupled to a needle.

14. The disposable bag set according to claim 13, wherein: The first pipe segment includes a clamp configured to move between an open position and a closed position, in which the clamp is configured to at least partially block movement through the first pipe segment.

15. The disposable bag set according to claim 13, wherein: The second pipe segment includes a clamp configured to move between an open position and a closed position, in which the clamp is configured to at least partially block movement through the first pipe segment.

16. The disposable bag set according to claim 13, wherein: The tube assembly also includes: A needle stick protector is disposed between the connector and the needle.

17. The disposable bag set according to claim 1, wherein: A tubing segment establishes fluid communication between the first bag and the second bag.

18. A disposable bag set for separating whole blood, the disposable bag set comprising: a separation bag containing whole blood to be separated; a first bag in fluid communication with the separation bag, the first bag being configured to receive plasma from whole blood contained in the separation bag; a second bag in fluid communication with the first bag and not in fluid communication with the separation bag, the second bag being configured to receive a cryoprecipitate formed using plasma; a third bag in fluid communication with the separation bag and the first bag or the second bag, the third bag being configured to receive platelets from the whole blood contained in the separation bag; a fourth bag in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, or the third bag, the fourth bag being configured to receive residual leukocytes from the whole blood contained in the separation bag; as well as A fifth bag is in fluid communication with the separation bag but not in fluid communication with the first bag, the second bag, the third bag, or the fourth bag, the fifth bag being configured to receive red blood cells from the whole blood contained in the separation bag.

19. The disposable bag set according to claim 18, wherein: The disposable bag set also includes: A sixth bag is in fluid communication with the separation bag and is configured to facilitate collection of whole blood.

20. The disposable bag set according to claim 19, wherein: The disposable bag set also includes: A first tube set connecting the separation bag to the first bag, the second bag and the fourth bag, the first tube set comprising: a first tube segment, the first tube segment establishing fluid communication between the separation bag and a connector; a second tube segment establishing fluid communication between the connector and the first bag; a third tube segment establishing fluid communication between the connector and the third bag; and a fourth tube segment, the fourth tube segment establishing fluid communication between the connector and the fourth bag; a fifth tube segment, the fifth tube segment establishing fluid communication between the separation bag and the fifth bag; a sixth tube segment, the sixth tube segment establishing fluid communication between the first bag and the second bag; and A second tube set connecting the separation bag to the sixth bag, the second tube set comprising: a first tube segment that establishes fluid communication between the separation bag and a connector; and A second tubing segment establishes fluid communication between the sixth bag and the connector, the connector being coupled to a needle.

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