Disposable Set

Abstract

A disposable bag set for separating a complex fluid into discrete volumes includes a separation bag containing the complex fluid to be separated, a first bag in fluid communication with the separation bag and configured to receive a first component of the complex 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 configured to receive a product formed using the first component.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 18 / 367,555, filed September 13, 2023, and the benefit of U.S. Provisional Patent Application No. 63 / 406,879, filed September 15, 2022, the entire disclosures of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure generally relates to systems and methods for separating components of complex fluids. [Background technology]

[0003] This section provides background information related to the present disclosure that is not necessarily prior art.

[0004] Blood collection and processing plays a critical role in healthcare systems worldwide. In traditional large-scale blood collection, whole blood is withdrawn from a source or donor or patient or subject, separated into various blood components by centrifugation, filtration, or elutriation, and stored in sterile containers for future infusion into the patient for therapeutic use. The separated blood components typically include fractions containing red blood cells, white blood cells, platelets, and / or plasma. Separation of whole blood into components can be performed continuously during collection and / or after collection in batches. Summary of the Invention [Problem to be solved by the invention]

[0005] When separating whole blood, it is desirable to maximize the recovery of each blood component, and separation of blood into its various components under highly sterile conditions is important for many therapeutic applications. [Means for solving the problem]

[0006] This section provides a general overview of the disclosure and is not an exhaustive disclosure of the entire scope or all features.

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

[0008] In at least one exemplary embodiment, the disposable bag set further comprises a third bag in fluid communication with the separation bag and in fluid communication with neither the first bag nor the second bag, the third bag configured to receive a second component of the composite fluid from the separation bag, the second component being different from both the first component and the product.

[0009] In at least one exemplary embodiment, the disposable bag set further comprises a fourth bag in fluid communication with the separation bag and in fluid communication with none of the first bag, the second bag, and the third bag, the fourth bag configured to receive a third component of the composite fluid from the separation bag, the third component being different from any of the first component, the second component, and the product.

[0010] In at least one exemplary embodiment, the disposable bag set further comprises a tube assembly connecting the separation bag to the first bag, the second bag, and the fourth bag, the tube assembly including a first tube establishing fluid communication between the separation bag and a connector, a second tube establishing fluid communication between the connector and the first bag, a third tube establishing fluid communication between the connector and the third bag, and a fourth tube establishing fluid communication between the connector and the fourth bag.

[0011] In at least one exemplary embodiment, the disposable bag set further comprises a fifth bag in fluid communication with the separation bag and in fluid communication with none of the first bag, the second bag, and the third bag, the fifth bag configured to receive a fourth component of the composite fluid from the separation bag, the fourth component being different from any of the first component, the second component, the third component, and the product.

[0012] In at least one exemplary embodiment, a tube establishes fluid communication between the separation bag and the fifth bag, the tube including one of a clamp and a filter, the clamp configured to switch between an open position and a closed position, and in the closed position, the clamp configured to at least partially block movement through the tube.

[0013] In at least one exemplary embodiment, the filter is a leukoreduction filter for red blood cells.

[0014] In at least one exemplary embodiment, the complex fluid comprises whole blood, the first component comprises plasma, and the product formed using the first component comprises 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 white blood cells.

[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 comprises a sixth bag in fluid communication with the separation bag, the sixth bag configured to aid in the collection of the composite fluid.

[0019] In at least one exemplary embodiment, the disposable bag set further comprises a tube assembly connecting the separation bag to the sixth bag, the tube assembly having a first tube establishing fluid communication between the separation bag and a connector and a second tube establishing fluid communication between the sixth bag and the connector, the connector being coupled to a needle.

[0020] In at least one exemplary embodiment, the first tube includes a clamp configured to switch between an open position and a closed position, and in the closed position, the clamp is configured to at least partially block movement through the first tube.

[0021] In at least one exemplary embodiment, the second tube includes a clamp configured to switch between an open position and a closed position, and in the closed position, the clamp is configured to at least partially block movement through the second tube.

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

[0023] In at least one exemplary embodiment, a tube establishes 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 includes a separation bag containing the 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 with the separation bag, a third bag in fluid communication with the separation bag and either the first bag or the second bag, a fourth bag in fluid communication with the separation bag but not with any of the first bag, the second bag, or the third bag, and a fifth bag in fluid communication with the separation bag but not with any of the first bag, the second bag, the third bag, or the fourth bag. The first bag is configured to receive plasma from the whole blood held by the separation bag. The second bag is configured to receive cryoprecipitate formed using the plasma. The third bag is configured to receive platelets from the whole blood held by the separation bag, the fourth bag is configured to receive residual white blood cells from the whole blood held by the separation bag, and the fifth bag is configured to receive red blood cells from the whole blood held by the separation bag.

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

[0026] In at least one exemplary embodiment, the disposable bag set further comprises a first assembly of tubes connecting the separation bag to the first bag, the second bag, and the fourth bag, a fifth tube establishing fluid communication between the separation bag and the fifth bag, a sixth tube establishing fluid communication between the first bag and the second bag, and a second assembly of tubes connecting the separation bag to the sixth bag, wherein the first assembly of tubes includes a first tube establishing fluid communication between the separation bag and a connector, a second tube establishing fluid communication between the connector and the first bag, a third tube establishing fluid communication between the connector and the third bag, and a fourth tube establishing fluid communication between the connector and the fourth bag. The second tube assembly includes a first tube that establishes fluid communication between the separation bag and a connector, and a second tube that establishes fluid communication between the sixth bag and the connector, the connector being coupled to a 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.

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

[0029] [Figure 1] FIG. 1 is a perspective view of an exemplary rotor of an apparatus for separating complex fluids into separate volumes, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 2] FIG. 2 is a partial cross-sectional view along a diametric plane of an exemplary apparatus for separating a complex fluid into separate volumes, including, for example, the rotor illustrated in FIG. 1 , in accordance with at least one exemplary embodiment of the present disclosure. [Figure 3] FIG. 3 is a cross-sectional view along a radial plane of an exemplary first cavity of the rotor illustrated in FIG. 1 configured to receive and hold a separation bag holding a composite fluid, according to at least one exemplary embodiment of the present disclosure. [Figure 4] FIG. 4 is a top view of an exemplary disposable bag set used to separate complex fluids into separate volumes, for example, using the rotor illustrated in FIG. 1 , in accordance with at least one exemplary embodiment of the present disclosure. [Figure 5] FIG. 5 is a cross-sectional view along a radial plane of an exemplary second cavity of the rotor shown in FIG. 1 configured to receive and hold multiple satellite bags configured to receive one or more blood components separated from a composite fluid, according to at least one exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0030] Corresponding reference characters indicate corresponding parts shown in the several views of the drawings.

[0031] Exemplary embodiments will be described in more detail with reference to the accompanying drawings.

[0032] The exemplary embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope to those skilled in the art. Numerous specific details are set forth, such as examples of specific components, devices, and methods, to provide a thorough understanding of the embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details are not necessary, that the exemplary embodiments may be embodied in many different forms, and that none of these should be construed as limiting the scope of the present disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0033] The terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and thus specify the presence of stated features, entities, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein should not be construed as necessarily requiring performance in the particular order described or illustrated, unless specifically identified as such. It should also be understood that additional or alternative steps may be employed.

[0034] When an element or layer is referred to as "on," "engaged to," "connected to," or "coupled to" another element or layer, it may be directly on, directly engaged with, directly connected to, or directly coupled to the other element or layer, or intervening elements or layers may be present. Conversely, when an element is referred to as "directly on," "directly engaged with," "directly connected to," or "directly coupled to" another element or layer, no intervening elements or layers are present. Other terms used to describe relationships between elements should be interpreted similarly (e.g., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0035] Terms such as "first," "second," and "third" may be used herein to describe various elements, components, regions, layers, and / or sections, but these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only 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 herein, do not imply a sequence or order unless clearly indicated by context. Thus, a first element, first component, first region, first layer, or first section described below could also be referred to as a second element, second component, second region, second layer, or second section without departing from the teachings of the exemplary embodiments.

[0036] Spatial terms such as "inside," "outside," "beneath," "below," "lower," "upper," and "above" are used herein for ease of description when describing the relationship of one element or feature to another element(s) or feature(s), as shown in the figures. Spatial terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures were inverted, elements described as being "beneath" or "beneath" other elements or features would change accordingly to be "above" them. Thus, for example, the term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatial descriptions used herein should be interpreted accordingly.

[0037] Various components are referred to herein as "operably associated." As used herein, "operably associated" refers to components that are linked together in an operable manner and includes embodiments in which components are directly coupled as well as embodiments in which other components are disposed between the coupled components. "Operably associated" components can be "fluidically associated." "Fluidly associated" refers to components that are linked together so that fluid can be transported between them. The term "fluidly associated" includes embodiments in which another member is disposed between two fluidly associated members, embodiments in which members are directly connected, and the like. Fluidly associated members may include members that do not contact the fluid but that operate the system by contacting other members (e.g., a peristaltic pump that pumps fluid through a flexible tube by compressing the outside of the tube).

[0038] Exemplary embodiments will be described in more detail with reference to the accompanying drawings.

[0039] At least one embodiment of the present disclosure relates to an apparatus for parallel (i.e., simultaneous) separation of complex fluids or liquids (e.g., whole blood) separated into separate volumes, for example, by centrifugation. Apparatuses for separating whole blood are described, for example, in U.S. Patent Application No. 17 / 975,180, filed October 27, 2022, and published May 18, 2023, in U.S. Patent Application Publication No. 2023 / 0149668 (titled "Method and System for Selectively Coupling a Blood Collection Pressure Device," inventors: Jeremy Parsons and Jesse Jantzen); and / or U.S. Patent No. 11,013,850, issued May 25, 2021, (titled "Separation of Complex Fluids," inventors: Bruce W. Gibbs, Bruce Ellingbaugh, and Jeffrey J. Blakeslee), the entire contents of which are expressly incorporated herein by reference.

[0040] An exemplary rotor 100 for use in apparatus 200 for separating complex fluids into separate volumes is shown in FIG. 1. As shown, rotor 100 includes one or more separation cells 102. Each of separation cells 102 is configured to receive and hold a separation bag (also called a whole blood bag) 400 containing one volume of the complex fluid to be separated. As shown, in at least one exemplary embodiment, rotor 100 includes four separation cells 102, and rotor 100 is configured to receive four separation bags 400.

[0041] Each separation cell 102 has a container (also called a bucket) 104 defining a cavity 230 configured to receive and hold a separation bag 400. In at least one exemplary embodiment, each separation cell 102 has a hinged lid (also called a top or upper wall) 106 that allows access to the container 104 for placement or removal of the separation bag 400. The cavity (also called a separation chamber) 230 also has a lower wall 105 opposite the upper wall 104 and disposed on the turntable 130 side. In at least one exemplary embodiment, the upper and lower walls 104 converge toward a central central axis 226 to define the container 104. In other exemplary embodiments, the cavity 230 may include side walls connecting the upper and lower walls 104 and 105. Generally, the cavity 230 is shaped and sized to loosely accommodate the separation bag 400.

[0042] The rotor 100 further includes a central container 120 that includes a plurality of satellite containers 122 arranged about a central cavity 124. Each of the satellite containers 122 is configured to receive and hold one or more satellite bags 502. As shown, in at least one exemplary embodiment, the rotor 100 includes four satellite containers 122 arranged about the central cavity 124 to correspond to each of the four separation cells 102 shown. As described further below, each of the satellite bags 502 is configured to receive one or more separated components from a corresponding separation bag 400. Each separation bag and the satellite bags are collectively referred to as a bag system.

[0043] 2 is a partial cross-sectional view along a diameter plane of an apparatus 200 for separating a composite fluid into separate volumes, including the exemplary rotor illustrated in FIG. 1 . As shown, the rotor 100 is supported by a bearing assembly 202 to facilitate rotation of the rotor 100 about a first axis (also referred to as the axis of rotation) 204. The rotor 100 is connected to the bearing assembly 202 via a rotor shaft 206 that extends along a second axis (also referred to as the shaft axis or shaft longitudinal axis) 208. For example, as shown, the central vessel 120 is connected to an upper end 212 of the rotor shaft 206 such that the second axis 208 coincides with the first axis 204 and also coincides with a third axis (also referred to as the vessel axis or vessel longitudinal axis) 214 of the central vessel 120. The apparatus 200 includes a motor 220 that drives rotation of the rotor 100 about the axis of rotation 204. In at least one exemplary embodiment, as shown, motor 220 interacts with rotor 202 via a system comprised of belt 222 and pulley 210. Belt 222 is engaged in groove 224 of pulley 210, which is connected to rotor shaft 206.

[0044] Each separation cell 102 defines a central longitudinal axis 226. The separation cells 102 are mounted on the turntable 130 such that their respective central longitudinal axes 226 intersect the rotation axis 204 and are positioned the same distance from the rotation axis 204 and / or such that the angles between the central longitudinal axes 226 are substantially the same (e.g., about 90 degrees). The positioning of the separation cells 102 on the turntable 130 may be adjusted to balance the rotor 100, for example, so that weight on the turntable is evenly distributed when the separation cells 102 are empty.

[0045] The apparatus 200 includes a component transfer means for transferring at least one separated component from each separation bag 400 to one or more satellite bags 502 connected to the separation bag 400. In at least one exemplary embodiment, the component transfer means includes a squeezing system for squeezing the separation bag 400 received and held by each container 104 to transfer the separated components into the separation bag 400. The squeezing system includes one or more flexible partitions (also referred to as "bladders") 232 selectively coupled to one or more of the containers 104. The flexible partitions define expandable chambers 234 within the cavities 230. For example, as shown, the flexible partitions 232 are sized to line the bottom wall of each cavity 230, which is the wall closest to the turntable 130.

[0046] The squeezing system includes a manifold 132 disposed near a periphery 134 of the turntable 130. For example, each of the expandable chambers 234 is fluidly connected to the manifold 132 by a supply channel 236. The manifold 132 has a generally circular shape or is arranged in a generally circular manner.

[0047] The compression system can include a hydraulic pump station 240 configured to pump hydraulic fluid into and / or out of each of the expandable chambers 234. The hydraulic fluid is selected to have a density greater than the density of the densest of the components in the complex liquid to be separated (e.g., red blood cells if the complex liquid is blood). As a result, during centrifugation, the hydraulic fluid in each expandable chamber 234, whatever its volume, generally remains in the outermost portion of each cavity 230.

[0048] As shown, in at least one exemplary embodiment, hydraulic pump station 240 is connected to expandable chamber 234 by a rotary seal 242 or fluid coupling through duct 244. The duct passes through rotor shaft 206 and further through bottom wall 105 (and / or, optionally, a side wall) of central vessel 120, radially from central vessel 120, through turntable 130, and to manifold 132. In at least one exemplary embodiment, hydraulic pump station 240 includes piston pump 245. Piston pump 245 includes piston 246 movable within hydraulic cylinder 248. Hydraulic cylinder 248 is fluidly connected to expandable chamber 234 via rotary seal 242 and duct 244. Piston 246 may be actuated by a stepper motor 250 configured to move a lead screw 252 coupled to a rod of piston 246.

[0049] The compression system also includes a hydraulic fluid reservoir 254. The hydraulic cylinder 248 is connected to the hydraulic fluid reservoir 254, and communication of the hydraulic cylinder 248 to the hydraulic fluid reservoir 254 is controlled by a valve 256. The valve 256 is configured to selectively allow hydraulic fluid to be introduced into and withdrawn from a hydraulic circuit formed by the hydraulic cylinder 248, the duct 244, and the expandable chamber 234. In at least one exemplary embodiment, a pressure gauge 258 is connected to the hydraulic circuit and configured to measure the hydraulic pressure therein.

[0050] In at least one exemplary embodiment, the apparatus 200 includes a first balancing means configured to (initially) balance the rotor 100 when the respective separation bags 400 disposed within the separation cells 102 have different weights. The first balancing means may include substantially the same components as the components of the component transfer means. For example, the first balancing means may include four hydraulically expandable chambers (similar to the hydraulically expandable chambers 234) interconnected by a manifold (similar to the manifold 132) and a hydraulic pumping station (similar to the hydraulic pumping station 240) for pumping hydraulic fluid into the hydraulic chambers through ducts (similar to the ducts 244) connected to the manifold. To initially balance the rotor 100 when the respective volumes of composite fluid contained within the four separation cells 102 have different weights, the hydraulic pumping station is controlled to pump a predetermined volume of hydraulic fluid selected to balance the rotor 100 into the interconnected hydraulic chambers at the start of the separation process. For example, for whole blood, determining this balancing volume takes into account the maximum difference in volume between two blood collections and the maximum difference in hematocrit between two blood collections. Under centrifugal force, the hydraulic fluid is distributed unevenly among the four separation cells 102 according to the difference in separation bag weights, balancing the rotor 100. To achieve the desired or optimal initial balance, the volumes of the cavities 230 of the separation cells 102 may be selected such that the cavities 230 are not full after a determined amount of hydraulic fluid is pumped into the interconnected expandable chambers 234, whatever the volume of the separation bags contained therein.

[0051] In at least one exemplary embodiment, the device 200 includes a second balancing means configured to balance the rotor 100 when the weights of the components transferred to the satellite bags 502 in the central container 120 are different. For example, if two blood collections have the same hematocrit but different volumes, the volume of plasma extracted from each blood collection will be different, and the same is also true when two blood collections have the same volume but different hematocrit. In at least one exemplary embodiment, the second balancing means includes flexible rectangular pouches 280 interconnected by tubing sections, as shown. For example, a tubing section connects two adjacent pouches 280 near their bottoms. The pouches 280 contain a volume of balancing liquid having a density close to that of the composite liquid. The pouches 280 are dimensioned to cover the inner surface of the central container 120 and to have an internal volume larger than the volume of the balancing liquid so that the balancing liquid can expand freely within the pouches 280. In operation, for example, if four satellite bags 502 adjacent to four pouches 280 each receive different volumes of plasma components, the four satellite bags 502 will be subjected to centrifugal force and press unevenly against the four pouches 280, resulting in the balancing liquid being unevenly distributed within the four pouches 280 to compensate for the weight differences within the satellite bags.

[0052] In at least one exemplary embodiment, the device 200 includes a controller 290 including a control unit and memory. The control unit includes, for example, a microprocessor, a controller, and / or the like. The memory may include, for example, a computer-readable memory. The memory provides the control unit with information and programmed instructions regarding various separation protocols (e.g., protocols for separating plasma and blood cell components, and / or protocols for separating plasma, platelet, and red blood cell components) and the operation of the device in accordance with such separation protocols. The control unit is programmed to receive, directly or via the memory, information regarding the centrifugation speeds at which the rotor 100 should be rotated during various stages of the separation process (e.g., the component separation stage, the plasma component expression stage, the platelet suspension in the plasma fraction stage, the platelet component expression stage, etc.) and / or information regarding the various transfer flow rates at which the separated components should be transferred from the separation bag 400 to the satellite bag 502. Information regarding the various transfer flow rates can be expressed, for example, as hydraulic fluid flow rates in the hydraulic circuit and / or as rotational speeds of stepper motors 250 of hydraulic pumping stations 240. The control unit may be programmed to receive information from pressure gauges 258 directly or via memory and / or to control motors 220 and / or stepper motors 250 of hydraulic pumping stations 240 to operate the separation apparatus according to a selected separation protocol.

[0053] 3 is a cross-sectional view of one of the separation cells 102 taken along a radial plane. As shown, one or more sensors 310, 312 may be incorporated into the upper wall 106 and / or lower wall 105 of the container 104. For example, in at least one exemplary embodiment, the separation cell 102 includes a bag sensor (also referred to as a first sensor) 310 and a tube sensor (also referred to as a second sensor) 312. The sensors 310, 312 may be formed or mounted along the central longitudinal axis 226 of the container 104. The bag sensor 310 may be located farther from the axis of rotation 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 faces the upper triangular portion of the separation bag 400, and the tube sensor 312 faces the proximal end of one or more tubes 702, 716 connecting the separation cell 102 and the multiple satellite bags 502. The bag sensor 310 may be configured to detect blood cells in the liquid. The tube sensor 312 may be configured to detect the presence or absence of liquid in the tube as well as to detect blood cells in the liquid. Each of the sensors 310, 312 includes a photocell including, for example, an infrared LED and a photodetector. In at least one exemplary embodiment, power is supplied to the sensors 310, 312 through a slip ring array 270 mounted around the lower portion of the rotor shaft 206, as shown in FIG. 2 .

[0054] 3 , the container 104 has one or more pins 410 and one or more corresponding recesses 412 for securing the separation bag 400 within the separation cell 102. The pins 410 protrude from an inner surface 414 of the lid 106 near an open edge or top 416 of the separation cell 102. The recesses 412 are formed in an inner surface 418 of the lower wall 105 of the container 104. In at least one exemplary embodiment, the pins 410 are spaced apart and sized to be received in one or more holes 420 in an upper edge (e.g., two upper corners) of the separation bag 400.

[0055] The device 200 is configured for use with a set of bags (also referred to as a bag assembly or bag set or disposable bag set or disposable set) 500. The separation bag 400 may be used sequentially for collection separate or remote from the device 200 and for separation within the device 200, while a satellite bag 502 is used within the device 200 to receive the separated components. FIG. 4 is a top view of an exemplary disposable bag set 500 used to separate separate volumes of complex fluids, for example, using the rotor illustrated in FIG. 1. The disposable bag set 500 includes the separation bag 400 configured to receive one of the separate volumes of whole blood from a source or donor or patient or subject, and one or more satellite bags 502 configured to receive the separated components from the separation bag 400.

[0056] In at least one exemplary embodiment, the satellite bag 502 includes a first bag 602 configured to receive and store a first component from the combined fluid of the separation bag 400 and a second bag 612 configured to receive and store a second component (different from the first component) from the combined fluid of the separation bag 400. The first component may include platelets, and the first bag 602 may be a platelet collection bag (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 subsequently separated from the second component. For example, the third component may be cryoprecipitate prepared from plasma, and the third bag 622 may be a plasma-cryoprecipitate bag or a plasma-cryoprecipitate-reduced bag.

[0057] In at least one exemplary embodiment, satellite bag 502 includes, in addition to first bag 602, second bag 612, and third bag 622, a fourth bag 632. Fourth bag 632 is configured to receive and store a fourth component (different from the first and second components) from the composite fluid of separation bag 400. For example, the fourth component may include red blood cells (RBCs), and fourth bag 632 may be a red blood cell collection bag (also referred to as a red blood cell storage bag).

[0058] In at least one exemplary embodiment, satellite bag 502 includes, in addition to first bag 602, second bag 612, and third bag 622, and an optional fourth bag 632, a fifth bag 642. Fifth bag 642 is configured to receive and store a fifth component (different from the first, second, and fourth components) from the composite fluid of separation bag 400. For example, the fifth component may include white blood cells, and fifth bag 642 may be a residual white blood cell bag 642.

[0059] The separation bag 400 is connected to one or more satellite bags 502 by a tubing 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 702 is coupled to (or integrally formed with) the separation bag 400. The first end of the first tube 702 is coupled to (or integrally formed with) the separation bag 400 by a first connector (also referred to as a first coupling) 712. The first connector 712 may include a breakable connector. A second end of the first tube 702, opposite the separation bag 400, is coupled to (or integrally formed with) a second connector (also referred to as a second coupling) 704. The second connector 704 couples the first tube 702 to a first end of a second tube 706, a second end of the second tube 706 opposite the first end being coupled to (or integrally formed with) the first bag 602. The first connector 704 also couples the first tube 702 to a first end of a third tube 708, a second end of the third tube 708 opposite the first end being coupled to (or integrally formed with) the second bag 612. The first connector 704 also couples the first tube 702 to a first end of a fourth tube 710, a second end of the fourth tube 710 opposite the first end being coupled to (or integrally formed with) the fifth bag 642. The first connector 704 may be a cross connector.

[0060] A first end of the fourth tube 714 is coupled to (or integrally formed with) the second bag 612, and a second end of the fourth tube 714 opposite the first end is coupled to (or integrally formed with) the third bag 622. A first end of the fifth tube 716 is coupled to (or integrally formed with) the separation bag 400, and a second end of the fifth tube 716 is coupled to (or integrally formed with) the fourth bag 632. The fifth tube 716 includes a filter 722 and / or a first clamp 720. The filter 722 may be a red blood cell leukoreduction filter configured to remove white blood cells from the red blood cell product. For example, in at least one exemplary embodiment, the filter 722 is a red blood cell leukoreduction filter configured to remove a sufficient number of white blood cells from the red blood cell product, e.g., to meet standards defined by various regulatory agencies. The first clamp 720 is configured to toggle between a first or open position, a second or intermediate position, and / or a third or closed position. In the first position, the first clamp 720 applies no or minimal pressure to the fifth tube 716, allowing fluid to flow freely therethrough. In the intermediate position, the first clamp 720 applies a closing pressure to the fifth tube 716, at least partially blocking fluid flow therethrough. In the closed position, the first clamp 720 applies a closing pressure to the fifth tube 716, completely blocking fluid flow therethrough. The first clamp 720 may be positioned at any point along the fifth tube 716. For example, in at least one exemplary embodiment, the first clamp 720 is positioned closer to the second end of the fifth tube 716 (and the fourth bag 632) than to the first end of the fifth tube 716. In other embodiments, the first clamp 720 is positioned closer to the first end of the fifth tube 716 (and the separation bag 400) than to the second end of the fifth tube 716. In yet other embodiments, the first clamp 720 is positioned approximately midway along the fifth tube 716 between the first and second ends.Although not shown, it should be understood that in various embodiments, the first tube 702, the second tube 706, the third tube 708, and / or the fourth tube 710 may similarly include one or more clamps and / or one or more filters.

[0061] In at least one exemplary embodiment, the fifth tube 716 includes a first section 716A and a second section 716B joined by a third connector (also referred to as a third coupling) 718. This configuration can allow fluid to flow through the tube and filter only when the connector 718 is in an open state, as configured by, for example, an operator, user, or administrator. In at least one exemplary embodiment, the connector 718 includes a breakable part or member. While illustrated as including two or more tube sections 716A, 716B, it should be understood that in at least one exemplary embodiment, the fifth tube 716 may be a single tube, omitting the third connector 718. Similarly, while illustrated as a single tube, it should be understood that in various embodiments, the first tube 702, the second tube 706, the third tube 708, and / or the fourth tube 710 may include one or more tube sections joined by one or more connectors.

[0062] In at least one exemplary embodiment, the disposable bag set 500 may further include a sixth bag 644. The sixth bag 644 may be a sample / diversion bag configured to divert 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 adapter 646. The sample tube holder / Luer adapter 646 may be configured to withdraw (collect) one or more samples from the diverted volume within the sixth bag 644. The sample tube holder / Luer adapter 646 is coupled to (or integrally formed with) a first end of a sixth tube 750. The interior volume of the sixth bag 644 is coupled to (or integrally formed with) a first end of a seventh tube 752. The second end opposite the first end of the sixth tube 750 and the second end opposite the first end of the seventh tube 752 are joined together by a fourth connector (also referred to as a fourth coupling) 754.

[0063] A fourth connector 754 can couple the sixth tube 750 and the seventh tube 752 to a first end of an eighth tube 756. The fourth connector 754 can be a Y-connector. The eighth tube 756 can include a second clamp 758. The second clamp 758 is configured to switch between a first or open position, a second or intermediate position, and / or a third or closed position. In the first position, the second clamp 758 applies no or minimal pressure to the eighth tube 756, allowing fluid to flow freely therethrough. In the intermediate position, the second clamp 758 applies a closing pressure to the eighth tube 756, at least partially blocking fluid flow therethrough. In the closed position, the second clamp 758 applies a closing pressure to the eighth tube 756, completely blocking fluid flow therethrough. The second clamp 758 can be positioned at any point along the eighth tube 756. For example, in at least one exemplary embodiment, the second clamp 758 is positioned closer to the second end of the eighth tube 756 (and the fifth connector 760) than to the first end of the eighth tube 756. In other embodiments, the second clamp 758 is positioned closer to the first end of the eighth tube 756 (and the sixth bag 644) than to the second end of the eighth tube 756. In yet other embodiments, the second clamp 758 is positioned approximately midway along the eighth tube 756 between the first and second ends.

[0064] A second end of the eighth tubing 756 is coupled to a fifth connector 760. The fifth connector 760 is also coupled to a needle injury protector (NIP) 762 and a ninth tubing 764. The needle injury protector 762 is coupled to (or integrally formed with) a needle 770 used to draw whole blood from a source, donor, patient, or subject. A first end of the ninth tubing 764 is coupled to the separation bag 400, and a second end of the ninth tubing 764 opposite the first end is coupled to the fifth connector 760. The ninth tubing 764 can include a third clamp 766. The third clamp 766 is configured to switch between a first or open position, a second or intermediate position, and / or a third or closed position. In the first position, the third clamp 766 applies no or minimal pressure to the ninth tube 764, allowing fluid to flow freely therethrough. In the intermediate position, the third clamp 766 applies a closing pressure to the ninth tube 764, at least partially blocking fluid flow therethrough. In the closed position, the third clamp 766 applies a closing pressure to the ninth tube 764, completely blocking fluid flow therethrough. The third clamp 766 may be positioned at any point along the ninth tube 764. For example, in at least one exemplary embodiment, the third clamp 766 is positioned closer to the second end of the ninth tube 764 (and the fifth connector 760) than to the first end of the ninth tube 764. In other embodiments, the third clamp 766 is positioned closer to the first end of the ninth tube 764 (and the separation bag 400) than to the second end of the ninth tube 764. In yet another embodiment, the third clamp 766 is positioned approximately midway along the ninth tube 764 between the first and second ends.

[0065] As will be appreciated by those skilled in the art, the separation bag 400 and the satellite bag 502 (first bag 602, second bag 612, third bag 622, fourth bag 632, and / or fifth bag 642) may be provided with one or more holes or openings for supporting, positioning, and / or suspending the bags, such as one or more holes 420 formed in the separation bag 400 to receive pins 410 on the container 104. The separation bag 400 and the satellite bag 502 (first bag 602, second bag 612, third bag 622, fourth bag 632, and / or fifth bag 642) may be configured to receive one or more identification labels. For example, as shown, separation bag 400 may have a first label 800, first bag 602 may have a second label 802, second bag 612 may have a third label 812, third bag 622 may have a fourth label 822, fourth bag 632 may have a fifth label 832, and fifth bag 642 may have a sixth label 842.

[0066] 5 is a cross-sectional view along a radial plane of one of the satellite vessels 122. As shown, the satellite vessel 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.

[0067] The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the present disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment and, even if not specifically shown or described, may be interchangeable and used in selected embodiments, where applicable. The same may be modified in many ways. Such modifications should not be considered a departure from the present disclosure, and all such variations are intended to be included within the scope of the present disclosure.

Claims

1. 1. A disposable bag set for separating complex fluids into separate volumes, the disposable bag set comprising: a separation bag containing the composite fluid to be separated; a first bag in fluid communication with the separation bag, the first bag configured to receive a first component of the complex fluid from 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 configured to receive a product formed using the first component; Equipped with Disposable bag set.

2. 10. The disposable bag set of claim 1, further comprising a third bag in fluid communication with the separation bag and not in fluid communication with either the first bag or the second bag, the third bag configured to receive a second component of the composite fluid from the separation bag, the second component being different from either the first component or the product. Disposable bag set.

3. 3. The disposable bag set of claim 2, further comprising a fourth bag in fluid communication with the separation bag and not in fluid communication with any of the first bag, the second bag, and the third bag, the fourth bag configured to receive a third component of the composite fluid from the separation bag, the third component being different from any of the first component, the second component, and the product. Disposable bag set.

4. 4. The disposable bag set according to claim 3, further comprising an assembly of tubes connecting the separation bag to the first bag, the second bag, and the fourth bag; The assembly of tubes is a first tube establishing fluid communication between the separation bag and a connector; a second tube establishing fluid communication between the connector and the first bag; a third tube establishing fluid communication between the connector and the third bag; a fourth tube establishing fluid communication between the connector and the fourth bag; having Disposable bag set.

5. 4. The disposable bag set of claim 3, further comprising a fifth bag in fluid communication with the separation bag and not in fluid communication with any of the first bag, the second bag, and the third bag, the fifth bag configured to receive a fourth component of the composite fluid from the separation bag, the fourth component being different from any of the first component, the second component, the third component, and the product. Disposable bag set.

6. The disposable bag set according to claim 5, a tube establishing fluid communication between the separation bag and the fifth bag, the tube including one of a clamp and a filter, the clamp configured to switch between an open position and a closed position, and in the closed position, the clamp configured to at least partially obstruct movement through the tube; Disposable bag set.

7. The disposable bag set according to claim 6, The filter is a leukocyte reduction filter for red blood cells. Disposable bag set.

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

9. The disposable bag set according to claim 8, the second component comprises platelets; Disposable bag set.

10. The disposable bag set according to claim 9, the third component comprises residual leukocytes; Disposable bag set.

11. The disposable bag set according to claim 10, the fourth component comprises red blood cells; Disposable bag set.

12. 4. The disposable bag set of claim 3, further comprising a sixth bag in fluid communication with the separation bag and configured to assist in the collection of the composite fluid. Disposable bag set.

13. 13. The disposable bag set according to claim 12, further comprising a tube assembly connecting the separation bag to the sixth bag; The assembly of tubes is a first tube establishing fluid communication between the separation bag and a connector; a second tube establishing fluid communication between the sixth bag and the connector; and the connector is coupled to a needle; Disposable bag set.

14. The disposable bag set according to claim 13, the first tube includes a clamp configured to switch between an open position and a closed position, and in the closed position, the clamp configured to at least partially block movement through the first tube. Disposable bag set.

15. The disposable bag set according to claim 13, the second tube includes a clamp configured to switch between an open position and a closed position, and in the closed position, the clamp is configured to at least partially block movement through the second tube. Disposable bag set.

16. The disposable bag set according to claim 13, The tubing assembly further includes a needle injury protector disposed between the connector and the needle. Disposable bag set.

17. The disposable bag set according to claim 1, a tube establishing fluid communication between the first bag and the second bag; Disposable bag set.

18. A disposable bag set for separating whole blood, the disposable bag set comprising: a separation bag containing the whole blood to be separated; a first bag in fluid communication with the separation bag and configured to receive plasma from the whole blood held by 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 configured to receive cryoprecipitate formed using the plasma; a third bag in fluid communication with the separation bag and the first bag or the second bag, the third bag configured to receive platelets from the whole blood retained by the separation bag; a fourth bag in fluid communication with the separation bag and not in fluid communication with any of the first bag, the second bag, and the third bag, the fourth bag being configured to receive residual white blood cells from the whole blood retained by the separation bag; a fifth bag in fluid communication with the separation bag and not in fluid communication with any of the first bag, the second bag, the third bag, and the fourth bag, the fifth bag being configured to receive red blood cells from the whole blood held by the separation bag; Equipped with Disposable bag set.

19. 20. The disposable bag set of claim 18, further comprising a sixth bag in fluid communication with the separation bag and configured to assist in the collection of the whole blood. Disposable bag set.

20. 20. The disposable bag set according to claim 19, further comprising a first tube assembly connecting the separation bag to the first bag, the second bag, and the fourth bag; The first tube assembly comprises: a first tube establishing fluid communication between the separation bag and a connector; a second tube establishing fluid communication between the connector and the first bag; a third tube establishing fluid communication between the connector and the third bag; a fourth tube establishing fluid communication between the connector and the fourth bag; and The disposable bag set further comprises: a fifth tube establishing fluid communication between the separation bag and the fifth bag; a sixth tube establishing fluid communication between the first bag and the second bag; a second tube assembly connecting the separation bag to the sixth bag; Equipped with The second tube assembly comprises: a first tube establishing fluid communication between the separation bag and a connector; a second tube establishing fluid communication between the sixth bag and the connector, the connector being coupled to a needle; and having Disposable bag set.

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