Connecting device for connecting post-processing unit to single-sampling equipment

Abstract

A medical system may include a separation device configured to separate a material received from a source into two or more components; a post-treatment unit in fluid communication with the separation device and configured to isolate at least one of the two or more components; and a controller configured to manage operation of the separation apparatus to separate the material received from the source into two or more components, move the two or more components to the post-processing unit, and return isolated at least one of the two or more components to the separation apparatus.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Patent Application No. 18 / 780,699, filed July 23, 2024, and also claims the benefit of U.S. Provisional Application No. 63 / 529,932, filed July 31, 2023. The entire disclosure of the above applications is incorporated herein by reference. Technical Field

[0002] This disclosure relates to medical systems that include a post-processing unit for specialized blood component identification and isolation, or medical systems configured to receive or communicate with such a post-processing unit. Background Technology

[0003] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0004] Plasma-based therapies can be used to treat or mediate a variety of conditions, including sepsis and neurological disorders. Plasma conjugation therapy and plasma-based therapies typically involve extracting plasma from a subject or patient, processing the extracted plasma to remove one or more specific compounds or components, and returning the modified or altered plasma to the subject or patient. Extraction, processing, and return are often referred to as targeted plasma modification or secondary plasma treatment. In some variations, plasma conjugation therapy and plasma-based therapies may additionally or alternatively include the introduction of donated and processed plasma and / or saline solution into the subject or patient. The extraction and introduction of donated and processed plasma and / or saline solution is often referred to as plasma exchange.

[0005] Plasma exchange removes disease antagonists, but it often removes other essential components, including medications the subject or patient may be taking, essential proteins, etc. Plasma exchange can expose vulnerable subjects or patients to risks associated with donated plasma. Targeted plasma modification can reduce these risks. In targeted plasma modification, the subject's or patient's plasma typically bypasses adsorption or immunoadsorption columns for selective removal. For example, one or more ligands can be used to treat the column, selecting these ligands to bind to one or more specific compounds (e.g., proteins), thus removing only such specific compounds. Targeted plasma modification is typically performed using a dialysis machine; however, apheresis systems are generally more efficient. To use an apheresis system for targeted plasma modification, the column can be connected to or easily coupled to a replacement device that fluidly connects the subject or patient and the apheresis system. Summary of the Invention

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

[0007] In various respects, this disclosure provides a medical system.

[0008] In at least one exemplary embodiment, the medical system may include: a separation device configured to separate material received from a source into two or more components; a post-processing unit fluidly connected to the separation device and configured to isolate at least one of the two or more components; and a controller configured to manage the operation of the separation device to separate the material received from the source into two or more components, move the two or more components to the post-processing unit, and return at least one isolated component of the two or more components to the separation device.

[0009] In at least one exemplary embodiment, the medical system may further include a tube that establishes fluid communication between the separation device and the post-processing unit.

[0010] In at least one exemplary embodiment, the fluid communication between the separation device and the post-processing unit may be a first fluid communication between the separation device and the post-processing unit, and the medical system may also include a second fluid communication between the post-processing unit and the separation device to return at least one of the isolated components of two or more components to the separation device.

[0011] In at least one exemplary embodiment, the tube may be a first tube, and the medical system may also include a second tube that establishes a second fluid communication between the post-processing unit and the separation device to return at least one of the isolated components of two or more components to the separation device.

[0012] In at least one exemplary embodiment, the first pipe and the second pipe may be configured as a connecting device.

[0013] In at least one exemplary embodiment, the medical system may further include a third tube that establishes fluid communication between the separation device and the source.

[0014] In at least one exemplary embodiment, the first tube, the second tube, and the third tube may be configured as connecting devices.

[0015] In at least one exemplary embodiment, the second and third tubes may be configured as connecting devices.

[0016] In at least one exemplary embodiment, the post-processing unit may include a column.

[0017] In at least one exemplary embodiment, the post-processing unit may include a filter.

[0018] In various respects, this disclosure provides a treatment system.

[0019] In at least one exemplary embodiment, the treatment system may include a flow path that fluidly connects a separation device and a post-processing device, wherein the separation device is configured to separate material received from a source into two or more components, and the post-processing device is configured to isolate at least one of the two or more components.

[0020] In at least one exemplary embodiment, the flow path may be a first flow path, and the treatment system may also include a second flow path that fluidly connects the separation device and the post-processing device to return at least one of the isolated components of two or more components to the separation device.

[0021] In at least one exemplary embodiment, the first flow path and the second flow path may be configured as a connecting device.

[0022] In at least one exemplary embodiment, the treatment system may further include a third flow path that fluidly connects the separation device and the source fluid.

[0023] In at least one exemplary embodiment, the first flow path, the second flow path, and the third flow path may be configured as a connecting device.

[0024] In at least one exemplary embodiment, the second flow path and the third flow path may be configured as connecting devices.

[0025] In at least one exemplary embodiment, the post-processing device may include a column.

[0026] In at least one exemplary embodiment, the post-processing device may include a filter.

[0027] In various aspects, this disclosure provides a connection device for connecting a separation device and a post-processing unit.

[0028] In at least one exemplary embodiment, the connecting device may include a first tube assembly and a second tube assembly. The first tube assembly may include a first tube length having a first end and a second end, wherein the first end of the first tube length is connectable to a separation device, and the second end of the first tube length is connectable to a post-processing unit. The second tube assembly may include a second tube length having a first end and a second end, wherein the first end of the second tube length is connectable to the post-processing unit, and the second end of the second tube length is connectable to the separation device. The separation device may be configured to separate material received from a source into two or more components. The post-processing unit may be configured to isolate at least one of the two or more components.

[0029] In at least one exemplary embodiment, the first tube assembly may include one or more first clamps.

[0030] In at least one exemplary embodiment, the second tube assembly includes one or more second clamps.

[0031] In at least one exemplary embodiment, one or more first clamps are of a first color, and one or more second clamps are of a second color, wherein the second color is different from the first color.

[0032] In at least one exemplary embodiment, the connecting device may further include a third tube assembly, the third tube assembly including a third tube length, the third tube length being capable of being connected to the separation device and the source.

[0033] In at least one exemplary embodiment, the third tube assembly may include one or more third clamps.

[0034] In various aspects, this disclosure provides a connection device for connecting a separation device and a post-processing unit.

[0035] In at least one exemplary embodiment, the connecting device may include a first tube length, a second tube length, a third tube length, a fourth tube length, and a fifth tube length. The first tube length may have a first end and a second end, wherein the first end of the first tube length is connectable to a first bag. The second tube length may have a first end and a second end, wherein the first end of the second tube length is connectable to the second end of the first tube length, and the second end of the second tube length is connectable to a first end of a post-processing unit. The third tube length may have a first end and a second end, wherein the first end of the third tube length is connectable to the second end of the first tube length. The fourth tube length may have a first end and a second end, wherein the first end of the fourth tube length is connectable to the second end of the third tube length, and the second end of the fourth tube length is connectable to a second bag. The fifth tube length may have a first end and a second end, wherein the first end of the fifth tube length is connectable to the second end of the post-processing unit, and the second end of the fifth tube length is connectable to one or more other components of the separation device.

[0036] In at least one exemplary embodiment, the first tube length, the second tube length, and the third tube length may be combined and configured as a first different set of tubes.

[0037] In at least one exemplary embodiment, the fourth tube may be configured as a second set of different tubes.

[0038] In at least one exemplary embodiment, the fifth tube may be configured as a third set of different tubes.

[0039] In at least one exemplary embodiment, at least one of the first tube length, the second tube length, the third tube length, the fourth tube length, and the fifth tube length may include one or more clamps.

[0040] Further applicable areas will become apparent from the description provided herein. The descriptions and specific examples in this overview are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0041] The accompanying drawings described herein are for illustrative purposes only of the selected embodiments and do not represent all possible implementations, nor are they intended to limit the scope of this disclosure.

[0042] Figure 1 This is an illustration of an exemplary single-sample device according to at least one exemplary embodiment of the present disclosure; Figure 2 This is an example of an embodiment of the present disclosure for use in a single-sample device (similar to...) Figure 1 An illustration of an exemplary tube bag kit used in or with an exemplary single-sampling device; Figure 3 This is an embodiment of at least one exemplary model of the present disclosure for use in a medical system (similar to...) Figure 1 An illustration of an exemplary disposable kit used in or with a medical system (as shown in the exemplary apheresis device); Figure 4 This is an embodiment of at least one exemplary model of the present disclosure for use in a medical system (similar to...) Figure 1 An illustration of an exemplary tube bag kit for aligning a post-processing unit, used in or with a medical system in an exemplary single-apheresis device; and Figure 5 It is based on at least one exemplary embodiment of this disclosure, such as Figure 4 The illustration shows an exemplary tube bag assembly, which includes a post-processing unit and one or more additional tube lengths for aligning the post-processing unit, for use in a single-sample device (similar to...). Figure 1 It can be used in or with the exemplary single-sample device shown.

[0043] In several views of the accompanying drawings, corresponding reference numerals indicate the corresponding parts. Detailed Implementation

[0044] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0045] Exemplary embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those skilled in the art. Numerous specific details, such as examples of specific components, devices, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that these specific details are not required, that exemplary embodiments may be implemented in many different forms, and that embodiments should not be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0046] 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 also include the plural forms unless the context clearly indicates otherwise. The terms “comprising,” “including,” “containing,” and “having” are inclusive and thus indicate the presence of the described features, integers, steps, operations, elements, and / or components, but do not exclude 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 requiring them to be performed in the particular order discussed or shown, unless specifically identified as such. It should also be understood that additional or alternative steps may be employed.

[0047] When an element or layer is referred to as being “on,” “joined to,” “connected to,” or “attached to” another element or layer, this element or layer may be directly on, joined to, or attached to the other element or layer, or there may be intermediate elements or layers present. Conversely, when an element is referred to as being “directly” on, joined to, connected to, or attached to another element or layer, there may be no intermediate elements or layers present. Other terms used to describe relationships between elements should be interpreted in a similar manner (e.g., “located between” versus “directly located between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and / or” includes any and all combinations of one or more of the associated items listed.

[0048] While the terms first, second, third, etc., may be used herein to describe various elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. When terms such as “first,” “second,” and other numerical terms are used herein, these terms do not imply order or sequence unless the context clearly indicates otherwise. Therefore, without departing from the teachings of exemplary embodiments, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment.

[0049] For ease of description, spatial relative terms such as “inside,” “outside,” “below,” “under,” “below,” “above,” and “above” are used herein to describe the relationship between one element or feature and another element or feature as shown in the figure. In addition to covering the orientation depicted in the figure, spatial relative terms may also be intended to cover different orientations of the device during use or operation. For example, if the device in the figure is flipped over, an element described as being “below” or “below” other elements or features may be oriented to be “above” other elements or features. Thus, the exemplary term “below” can cover both upper and lower orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein shall be interpreted accordingly.

[0050] Various components are referred to herein as “operably associated.” As used herein, “operably associated” means components that are operably connected together, and covers embodiments in which components are directly connected, as well as embodiments in which additional components are placed between connected components. “Operably associated” components can be “fluidly associated.” “Fluidally associated” means that components are connected together such that fluid can be transported between the components. “Fluidally associated” covers embodiments in which additional components are placed between two fluidly associated components and between directly connected components. Fluidly associated components may include components that do not contact the fluid but contact other components to manipulate a system (e.g., a peristaltic pump that pumps fluid through a flexible tube outside a compression tube).

[0051] In this application, including the definitions below, the terms "module" or "controller" may be replaced by the term "circuit". The term "module" may refer to, or may be part of, or may include: application-specific integrated circuits (ASICs); digital, analog, or mixed-signal analog / digital discrete circuits; digital, analog, or mixed-signal analog / digital integrated circuits; combinational logic circuits; field-programmable gate arrays (FPGAs); processor circuitry that runs code (shared processor circuitry, dedicated processor circuitry, or a group of processor circuitry); memory circuitry that stores code executed by the processor circuitry (shared memory circuitry, dedicated memory circuitry, or a group of memory circuitry); other suitable hardware components that provide the described functionality; or combinations of some or all of the foregoing, such as in a system-on-a-chip.

[0052] A module may include one or more interface circuits. In some exemplary embodiments, the interface circuit may include a wired or wireless interface connected to a local area network (LAN), the Internet, a wide area network (WAN), or a combination thereof. The functionality of any given module of this disclosure may be distributed among multiple modules connected via interface circuits. For example, multiple modules may allow load balancing. In another example, a server module (also referred to as a remote module or cloud module) may perform some functions on behalf of a client module.

[0053] The term "code," as used above, can include software, firmware, and / or microcode, and can refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuitry" encompasses a single processor circuitry that runs some or all of the code from multiple modules. The term "group of processor circuitry" encompasses processor circuitry combined with additional processor circuitry to run some or all of the code from one or more modules. References to multiple processor circuitry encompass multiple processor circuitry on a discrete die, multiple processor circuitry on a single die, multiple cores of a single processor circuitry, multiple threads of a single processor circuitry, or a combination of the above. The term "shared memory circuitry" encompasses a single memory circuitry that stores some or all of the code from multiple modules. The term "group of memory circuitry" encompasses memory circuitry combined with additional memory to store some or all of the code from one or more modules.

[0054] The term memory circuit is a subset of the term computer-readable medium. As used herein, the term computer-readable medium does not cover transient electrical or electromagnetic signals propagating through a medium (e.g., propagating on a carrier wave); therefore, the term computer-readable medium can be considered tangible and non-transitory. Non-limiting examples of non-transitory, tangible computer-readable media are non-volatile memory circuits (e.g., flash memory circuits, erasable programmable read-only memory circuits, or masked read-only memory circuits), volatile memory circuits (e.g., static random access memory circuits or dynamic random access memory circuits), magnetic storage media (e.g., analog or digital magnetic tape or hard disk drives), and optical storage media (e.g., CDs, DVDs, or Blu-ray discs).

[0055] The apparatus and methods described in this application can be implemented, in part or in whole, by a dedicated computer, which is created by configuring a general-purpose computer to perform one or more specific functions embodied in a computer program. The aforementioned functional blocks, flowchart components, and other elements serve as software specifications that can be translated into computer programs by skilled technicians or programmers through their daily work.

[0056] A computer program includes processor-executable instructions stored on at least one non-transitory, tangible, computer-readable medium. A computer program may also include stored data or depend on stored data. A computer program may encompass a basic input / output system (BIOS) for interacting with the hardware of a special-purpose computer, device drivers for interacting with specific devices of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0057] Computer programs may include: (i) descriptive text to be parsed, such as HTML (Hypertext Markup Language), XML (Extensible Markup Language), or JSON (JavaScript Object Notation); (ii) assembly code; (iii) object code generated from source code by a compiler; (iv) source code run by an interpreter; (v) source code compiled and run by a just-in-time (JIT) compiler; and so on. As an example only, source code may be written using syntax from a variety of languages, including C, C++, C#, Objective-C, Swift, Haskell, Go, SQL, R, Lisp, Java®, Fortran, Perl, Pascal, Curl, OCaml, JavaScript®, HTML5 (Hypertext Markup Language version 5), Ada, ASP (Active Server Pages), PHP (PHP: Hypertext Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, Visual Basic®, Lua, MATLAB, SIMULINK, and Python®.

[0058] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0059] This disclosure relates to medical systems that include a post-processing unit for specialized blood component identification and isolation, or medical systems configured to receive or communicate with such a post-processing unit. In at least one exemplary embodiment, the medical system may include an apheresis device similar to the apheresis device described in U.S. Patent No. 8,123,713, entitled "System and Method for Collecting Plasma Protein Components from Separated Blood Components," published February 28, 2012, and / or the apheresis device described in U.S. Patent No. 7,780,618, entitled "Extracorporeal Blood Processing Apparatus and Method with Pressure Sensing," published August 24, 2010, and / or the apheresis device described in U.S. Patent No. 7,780,618, entitled "Extracorporeal Blood Processing Apparatus and Method with Pressure Sensing," published July 7, 2020, and / or the apheresis device described in U.S. Patent No. 7,780,618, entitled "Separated Blood Components." The entire disclosures of the following U.S. patents are incorporated herein by reference: U.S. Patent No. 10,704,023, entitled “Blood Separation System with Shielded Extraction Port and Optical Control”, published September 6, 2016; and U.S. Patent No. 8,057,376, entitled “Blood Processing Apparatus with Sealed Diffuser in Optical Control Device”, published November 15, 2011.

[0060] Apheresis devices typically include one or more connectors configured to allow whole blood and / or blood components to move into and from a blood component separation device. The blood component separation device may be housed within the apheresis device and typically includes a centrifuge. For example, Figure 1 This is an illustration of an exemplary apheresis device 100. The apheresis device 100 can be used in a whole blood separation process, wherein whole blood is drawn from a donor, subject, patient, or source and supplied to a blood component separation device 104, in which the whole blood is separated into various compounds, components, or elements, some of which are collected and the remainder are returned to the donor, subject, patient, or source.

[0061] In at least one exemplary embodiment, whole blood can be drawn from a donor, subject, patient, or source and guided through a tubing kit 108 configured to be received by (e.g., mounted in) a blood component separation device 104. The tubing kit 108 may include, for example, an extracorporeal tubing loop 112 and a processing container 116, together defining a closed, sterile, disposable system. In at least one exemplary embodiment, the blood component separation device 104 may include a pump / valve / sensor assembly 120 interfaced with the extracorporeal tubing loop 112. In at least one exemplary embodiment, the blood component separation device 104 may include a centrifuge assembly 124 interfaced with the processing container 116. For example, the centrifuge assembly 124 may include a channel 128 in a rotatable rotor assembly 132, within which the processing container 116 may be fitted, the rotatable rotor assembly 132 being configured to provide the centrifugal force required to separate whole blood into one or more of its compounds, components, or elements.

[0062] In at least one exemplary embodiment, whole blood can flow from a donor, subject, patient, or source through an extracorporeal tubing loop 112 and into a rotating processing container 116. Within the processing container 116, the whole blood can be separated into one or more compounds, components, or elements, and at least one of the separated compounds, components, or elements can be removed from the processing container 116. For example, one or more separated compounds, components, or elements that were not retained for collection (e.g., for therapeutic treatment) can be removed from the processing container 116 and returned to the donor, subject, patient, or source via the extracorporeal tubing loop 112. In at least one exemplary embodiment, the flow of whole blood can be substantially continuous. In various other exemplary embodiments, the collection process using the exemplary apheresis device 100 may include a batching process (e.g., discontinuous inflow of whole blood and / or discontinuous outflow of separated blood components) or a smaller-scale batch or continuous red blood cell / plasma separation system, wherein blood compounds or components or elements are returned to the donor, subject, patient, or source.

[0063] The blood collection device 100 may include one or more processors configured to control the operation of the blood component separation device 104. The one or more processors may be part of a computer system. The computer system may include components or parts that enable a user or operator of the blood collection device 100 to interface with the computer system. For example, the blood collection device 100 may include memory and storage devices (e.g., RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.); communication / networking devices (e.g., wired forms (e.g., modems / network cards) and / or wireless forms (e.g., Wi-Fi)); input devices such as a keyboard, touchscreen, camera, and / or microphone; and / or output devices such as a display and audio system. In at least one exemplary embodiment, the blood collection device 100 may include a graphical user interface 136 utilizing a display, the graphical user interface 136 including, for example, an interactive touchscreen.

[0064] Figure 2 It is used in single-sample collection equipment (similar to) Figure 1 An illustration of an exemplary tube bag kit (or replacement kit) 201 used in or with an exemplary single-sampling device (100) shown. For example, Figure 2 The tube bag kit 201 shown can be used as Figure 1 The bag tube assembly 108 of the single-sampling device 100 shown is similar to... Figure 1 The shown bag tube kit 108, Figure 2 The tube bag kit 201 shown may include an external tubing circuit 213, wherein the external tubing circuit 213 includes a housing 200 and a plurality of tube assemblies (or collection assemblies or tube segments) 202, 204, 205, 207 and 209.

[0065] In at least one exemplary embodiment, the tubing assembly may include a blood removal-return tubing assembly 202, which provides, for example, one or more lines 212, 214, 216 for removing whole blood from a donor, subject, patient, or source, introducing the whole blood into the remainder of the external tubing circuit 213, and also returning blood compounds or components or elements or other fluids to the donor, subject, patient, or source. For example, the blood removal-return tubing assembly 202 may include a needle interface for drawing whole blood from a donor, subject, or patient, introducing the whole blood into the remainder of the external tubing circuit 213, and also returning blood compounds or components or elements or other fluids to the donor, subject, patient, or source. While a single-needle configuration is shown, it should be appreciated that other configurations may be suitable in various other exemplary embodiments, including, for example, the use of a dual-needle interface.

[0066] In at least one exemplary embodiment, the tubing assembly may include a blood inlet tubing assembly (or blood component tubing assembly) 204. A cartridge 200 may be disposed between the blood removal-return tubing assembly 202 and the blood inlet tubing assembly 204, wherein the blood inlet tubing assembly 204 provides an interface between the cartridge 200 and the processing container 217. The processing container 217 may be connected to... Figure 1 The processing container 116 shown is the same. Similar to... Figure 1 The external tubing circuit 112 and the processing container 116, Figure 2 The extracorporeal tubing loop 213 and the treatment container 217 can be pre-connected to form a closed, sterile, disposable assembly for single use.

[0067] The blood inlet tubing assembly 204 may include one or more tubing segments 218, 220, 222, 224, and 226, which are configured to deliver whole blood and / or one or more components to and from the processing container 217. For example, in at least one exemplary embodiment, as shown, the blood inlet tubing assembly 204 may include five tubing segments. The cartridge 200 may be configured to orient one or more of the different tubing assemblies within a predetermined spatial relationship for eventual engagement with the tubing bag kit 201 and / or other components of the apheresis device, including, for example, different valve components. In at least one exemplary embodiment, the cartridge 200 may be connected to or coupled to the anticoagulant tubing assembly 230, the ventilation bag 206, the plasma collection bag 208, the leukocyte collection bag 210, or any combination thereof.

[0068] When the extracorporeal tubing 213 is installed in a blood component separation device (similar to...) Figure 1 When used on the blood component separation device 104 shown, a saline solution can be used, for example, to perfuse the extracorporeal tubing circuit 213 via line 234. In at least one exemplary embodiment, line 234 may include a filter 236. The saline solution may flow through internal channels in cartridge 200 and through anticoagulant line 214 to reach the distal end of blood removal-return assembly 202. Then, during preparation for blood processing, the saline solution may flow upward along blood removal line 212 into other tubes and channels of extracorporeal tubing circuit 213. After preparation, an anticoagulant supply or bag (not shown) may be connected to the distal end of anticoagulant tubing assembly 230 in place of the saline solution supply or bag. The anticoagulant solution may flow through anticoagulant line 214 through filter 236 and first pump circuit 238 to reach the distal end of blood removal assembly 202. Pump circuit 238 and other pump circuits can be connected to the peristaltic pump in the blood component separation device, which controls the flow direction and rate of fluid by controlling the speed and direction of the peristaltic pump and the position of various valves.

[0069] Blood removal line 212 guides whole blood into cartridge 200, whereby the whole blood passes through a first pressure sensor 240 and a second pump circuit 242. A second pressure sensor 244 may be disposed between the second pump circuit 242 and its associated pump and a blood inflow line 218 leading to processing container 217, and may be configured to sense effective fluid pressure at the inlet leading to processing container 217. A red blood cell outlet line 220 of the blood component tubing assembly 204 may extend from processing container 217. The red blood cell outlet line 220 connects to a return circuit 246, which leads to a return reservoir 248. The return reservoir 248 may contact sensors located on the blood component separation device that detect low and high fluid levels. The blood component separation device can maintain fluid in reservoir 248 between these two levels by controlling the flow exiting the reservoir, through return pump circuit 250, and return pressure sensor 252. Ventilation bag 206 can be connected to reservoir 248 via ventilation tube 254, allowing aseptic airflow between reservoir 248 and ventilation bag 206. Fluid can flow into return line 216 in blood removal-return assembly 202. Blood removal-return assembly 202 may include anticoagulant line 214 for perfusion or anticoagulation. If needed, red blood cells can be aspirated and collected in collection bag (not shown) by replacing line 232. When needed, plasma can be aspirated from processing container 217 via plasma line 226 and sent to pump circuit 260. Valve 262 can redirect plasma to collection tube 264 leading to plasma collection bag 208 or to connection circuit or line 266 leading to reservoir 248. Excess plasma in reservoir 248 can be returned to donor, subject, patient, or source in the same manner as red blood cells. A bag containing replacement fluid (not shown) may be connected to a tip or Luer connector 256 on the replacement line 232, allowing the replacement fluid to enter the reservoir 248 via the return loop 246. In at least one exemplary embodiment, the replacement line 232 may be connected to the return loop 246 via a connector 258 and may be provided with a manual closure or clamp to guide the flow of blood compounds or components or elements and / or replacement fluid.

[0070] White blood cells and platelets can flow out of processing container 217 through cell line 268 and into cell separation chamber 270. The contents of cell separation chamber 270 can flow out of the separation chamber through an outlet. In cartridge 200, fluid from cell separation chamber 270 can pass through red-green light sensor 272, which can be used to control the periodic flushing of white blood cells leaving cell separation chamber 270 into white blood cell collection bag 210. Selected cells can flow through pump circuit or common line 274, which is connected to a peristaltic pump on the blood component separation device. Pump circuit 274 can be connected to a valved channel in cartridge 200. The blood component separation device can control valve 276 to guide white blood cells or other selected cells into collection tube 278 and then into white blood cell collection bag 210, or to guide white blood cells or other selected cells into connection circuit or line 280 and then into reservoir 248. For platelet collection, excess white blood cells in reservoir 248 can be returned to the donor, subject, patient, or source in the same manner as red blood cells and plasma. Alternatively, for mesenchymal stem cell (MNC) collection, where platelets are typically returned to the donor, subject, patient, or source, mesenchymal stem cells can be drawn into collection tube 278 for storage in white blood cell collection bag 210.

[0071] During blood removal, whole blood can be transferred from a donor, subject, patient, or source to the blood removal line 212 of the blood removal tubing assembly 202. The blood can be pumped by a blood component separation device, for example, via pump circuit 242 through the blood inflow line 218 of the cartridge 200 and the blood component tubing assembly 204, into the processing container 217. Separation processing can then occur substantially continuously in the processing container 217 (i.e., blood flows substantially continuously within the processing container 217), separation can be performed continuously, and the separated components can flow out of the processing container 217. After separation processing in the processing container 217, any uncollected blood components can be transferred from the processing container 217 to the cartridge 200 and through the cartridge 200 into the reservoir 248 of the cartridge 200, which can be filled to a predetermined level. The blood component separation device can initiate a blood return sub-mode, in which components can be returned to the donor, subject, patient, or source via return line 216. The cycle between the blood removal sub-mode and the blood return sub-mode can continue until the predetermined amount of blood components has been harvested.

[0072] Figure 3 It is used in single-collection systems (similar to) Figure 1The illustration shows an exemplary disposable kit 300 used in or with an exemplary blood collection device 100. The disposable kit 300 includes a processing container 304 and a separation chamber 308. In at least one exemplary embodiment, the disposable kit 300 can be used to provide a disposable blood processing kit, wherein the processing container 304 can be used as... Figure 1 The processing container 116 and separation chamber 308 shown can be used as such Figure 2 The cell separation chamber 270 is shown.

[0073] The processing container 304 may have a generally annular flow path including an inlet portion 312 and an opposing outlet portion 316. An inlet pipe 320 may be connected to the inlet portion 312 and configured to deliver fluid into the processing container 304 for separation into components (e.g., separating whole blood into blood components). In at least one exemplary embodiment, a disposable kit 300 may be used in a centrifuge that rotates the processing container 304 and, as a result of centrifugal force, separates the liquid into one or more components. In this case, the substance entering the inlet portion 312 (e.g., whole blood) may flow around the processing container 304 and stratify according to density differences in response to the rotation of the centrifuge. The outlet portion 316 may include outlets for the components of the separated liquid.

[0074] When the separated complex fluids include whole blood, line 324 can be used as a red blood cell line, line 328 as a plasma line, and line 332 as a white blood cell or leukocyte line to remove the separated components from processing container 304. Each component separated in processing container 304 can be collected in only one area of ​​processing container 304 (i.e., outlet portion 316) and removed.

[0075] In at least one exemplary embodiment, the components separated in processing container 304 may be further processed to separate additional components. In this case, the outlet of line 332 may be connected to separation chamber inlet 336 to transfer intermediate-density components to chamber 308. When the fluid being separated includes whole blood, the portion transferred to chamber 308 may include a white membrane layer. The white membrane layer may include leukocytes, or mesenchymal stem cells may be transferred to separation chamber 308. The components initially separated in processing container 304 may be further separated in cell separation chamber 308. For example, cell separation chamber 308 may be used to separate leukocytes from plasma and platelets in the white membrane layer. For example, such further separation may be performed by a saturated fluidized bed that forms particles in cell separation chamber 308. Plasma and platelets may flow out of cell separation chamber 308 through outlet 340. Leukocytes or mesenchymal stem cells may be retained in chamber 308. In other exemplary embodiments, other components may be separated, including, for example, granulocytes from erythrocyte components.

[0076] Figure 4 It is used in single-sample collection equipment (similar to) Figure 1 The illustration shows an exemplary tubular bag kit (or connecting device) 2100 used in or with a single-sampling device in an exemplary single-sampling system for aligning a post-processing unit (or post-processing assembly or post-processing device). The post-processing unit may include a filter, an adsorption column, or a combination of a filter and an adsorption column. The filter further identifies and isolates compounds or components or elements in the fluid based on whether they are larger or smaller than a specific size, and the adsorption column identifies and isolates compounds or components or elements in response to a specific size range. That is, the filter will identify and isolate all compounds or components or elements larger than a certain filter size, or alternatively, identify and isolate all compounds or components or elements smaller than a certain filter size, while the adsorption column will only identify and isolate those compounds or components or elements having a specific size, without identifying and isolating larger or smaller compounds or components or elements.

[0077] The tube bag kit 2100 can be configured to integrate a post-processing unit and a single-collection device (e.g. Figure 1 The illustrated apheresis system is fluidly associated (e.g., connected). In at least one exemplary embodiment, the tubing kit 2100 may be coupled to another tubing kit that connects the donor or subject or patient or source to the corresponding apheresis device. For example, in at least one exemplary embodiment, ends 2138 and 2186 of the tubing kit 2100 may be coupled to opposite sides of a post-processing unit, and end 2188 of the tubing kit 2100 may be coupled to... Figure 2 The red blood cell outlet tubing 220 of the tubing kit 201 shown or along Figure 2The illustrated tubing kit 201 has a red blood cell outlet line 220. During use, line 234 of the (first) tubing kit 201 can be closed (e.g., using one or more valves or clamps) to divert plasma (and / or other compounds or components or elements) collected from a donor, subject, patient, or source to the red blood cell outlet line 220 and the end 2188 of the (second) tubing kit 2100, wherein, as described in further detail below, the tubing kit 2100 directs the collected plasma (and / or other compounds or components or elements) to a post-processing unit. The tubing kit 2100 can also be configured such that, during perfusion and / or flushing of the post-processing unit, effluent from the post-processing unit is directed to a waste bag 2170 or to a buffer or plasma bag 2110 for return to the donor, subject, patient, or source. Buffer bag 2110 can be configured to compensate for any imbalances in pump flow rate and ensure that modified or treated components (e.g., plasma) are always available for return to the donor, subject, patient, or source. For example, buffer bag 2110 can provide a free surface to the fluid, for instance, to prevent pressurization or vacuum due to flow imbalances. Buffer bag 2110 can be configured to provide a consistent head to the downstream pump.

[0078] Refer again Figure 4 In at least one exemplary embodiment, the tubing kit 2100, which fluidly associates the post-processing unit and the single-collection device, may include a first assembly 2102 of one or more adjacent tubing segments, a second assembly 2104 of one or more adjacent tubing segments, and a third assembly 2106 of one or more adjacent tubing segments. The first assembly 2102 may include one or more tubing segments connected to a buffer bag 2110. The second assembly 2104 may include one or more tubing segments connected to a waste bag 2170. In at least one exemplary embodiment, the post-processing unit may be disposed between the first assembly 2102 and the third assembly 2106, and the third assembly 2106 may be coupled to the single-collection system. More specifically, the third assembly 2106 may be coupled to another tubing kit (e.g., such as...). Figure 2 The tube bag kit 201 shown is another tube bag kit that can be connected to the single collection system.

[0079] In at least one exemplary embodiment, a first set 2102 may be configured as a first assembled set, a second set 2104 may be configured as a second assembled set, and a third set 2106 may be configured as a third assembled set. In at least one exemplary embodiment, during storage and transportation of the tubular kit 2100, the first assembled set, the second assembled set, and the third assembled set may be configured as different components. In at least one exemplary embodiment, the first set 2102 and the second set 2104 may be configured as a first assembled set, and the third set 2106 may be configured as a second assembled set. In at least one exemplary embodiment, during storage and transportation of the tubular kit 2100, the first assembled set and the second assembled set may be configured as different components. In each case, the first set 2102 may include a first tubular segment 2120, which may be coupled to a second tubular segment 2130 and a third tubular segment 2140. The first set 2102 may include a fourth tubular segment 2150, which may be coupled to the third tubular segment 2140 remotely from the first tubular segment 2120.

[0080] The first tube segment 2120 may include a first tube length 2122 having a first end 2126 and a second end 2128. In at least one exemplary embodiment, the first tube segment 2120 may be referred to as a plasma line. Although a single tube length is shown, it should be appreciated that in various other exemplary embodiments, the first tube segment 2120 may be defined by two or more tube lengths or segments, which include one or more clamps (similar to the first clamp 2124) and / or one or more connectors configured, for example, to join two or more tube lengths or segments together.

[0081] The first pipe segment 2120 may include a first clamp 2124, which may be positioned at a point along the first pipe length 2122 between a first end 2126 and a second end 2128. The first clamp 2124 may 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 2124 may apply no pressure or a minimal pressure to the first pipe length 2122, allowing fluid to flow freely through the first pipe length 2122. In the intermediate position, the first clamp 2124 may apply a closing pressure to the first pipe length 2122 to at least partially prevent fluid from flowing through the first pipe length 2122. In the closed position, the first clamp 2124 may apply a closing pressure to the first pipe length 2122 to completely prevent fluid from flowing through the first pipe length 2122. The first clamp 2124 may be positioned at any point along the first pipe length 2122 between the first end 2126 and the second end 2128. For example, in at least one exemplary embodiment, the first clamp 2124 may be positioned approximately halfway along the length 2122 of the first tube between the first end 2126 and the second end 2128. In various other exemplary embodiments, the first clamp 2124 may be positioned closer to or more closely to the first end 2126 than to the second end 2128 along the length 2122 of the first tube. In still other exemplary embodiments, the first clamp 2124 may be positioned closer to or more closely to the second end 2128 than to the first end 2126 along the length 2122 of the first tube.

[0082] A first end 2126 of the first tube length 2122 may be coupled to a buffer bag 2110 receiving modified plasma. In at least one exemplary embodiment, the buffer bag 2110 may include a first port or opening 2112 and a first connector 2114 configured to engage the first end 2126 of the first tube length 2122 and the first opening 2112 together. Although the buffer bag 2110 is described as including the first connector 2114, it should be appreciated that in various exemplary embodiments, the first connector 2114 may be provided with a first assembly 2120. Although not shown, it should be appreciated that in various exemplary embodiments, the first end 2126 of the first tube length 2122 may extend into the buffer bag 2110. Although not shown, it should be appreciated that in various exemplary embodiments, the first end 2126 of the first tube length 2122 may be integrally formed with the buffer bag 2110. In each case, the buffer bag 2110 may include a second port or opening 2113 and optionally include a second connector 2115 that can be coupled to the apheresis device 100 (e.g., coupled to the apheresis device 100 via one or more other tube lengths 2252, 2254, 2256) to enable the return of the modified fluid (e.g., plasma) to the donor, subject, patient, or source. In at least one exemplary embodiment, the second port 2113 may be configured to receive a pointed connector, which is, for example, another tube bag kit connecting the donor, subject, patient, or source to the apheresis system (e.g., such as...). Figure 2 The tube bag kit 201 shown.

[0083] The second end 2128 of the first pipe length 2122 may be connected to the second pipe segment 2120 and the third pipe segment 2140. For example, a third connector 2129 may be configured to engage the second end 2128 of the first pipe length 2122 to the second pipe segment 2120 and the third pipe segment 2140. More specifically, the third connector 2129 may engage the second end 2128 of the first pipe length 2122 and the first end 2136 of the second pipe segment 2120 together, and also engage the second end 2128 of the first pipe length 2122 and the first end 2146 of the third pipe segment 2140 together. In at least one exemplary embodiment, the third connector 2129 may include a T-shaped connector.

[0084] The second pipe segment 2130 may include a second pipe length 2132 having a first end 2136 and a second end 2138. In at least one exemplary embodiment, the second pipe segment 2130 may be referred to as an outlet pipe. Although a single pipe length is shown, it should be appreciated that in various other exemplary embodiments, the second pipe segment 2130 may be defined by two or more pipe lengths or segments, which include one or more clamps (similar to the second clamp 2134) and / or one or more connectors configured, for example, to join the two or more pipe lengths or segments together.

[0085] For example, the first end 2136 of the second tube length 2132 can be connected to the first tube length 2122 via a third connector 2129. The second end 2138 of the second tube length 2132 can be connected to a processing unit. More specifically, for example, the second end 2138 of the second tube length 2132 can be connected to the first end of a post-processing unit via a fourth connector 2139. In at least one exemplary embodiment, the second tube segment 2130 (more specifically, the second end 2138 of the second tube length 2132) may include at least a portion of the fourth connector 2139.

[0086] The second pipe segment 2130 may include a second clamp 2134, which may be positioned at a point along the second pipe length 2132 between the first end 2136 and the second end 2138. Similar to the first clamp 2124, the second clamp 2134 may 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 2134 may apply no pressure or minimal pressure to the second pipe length 2132, allowing fluid to flow freely through the second pipe length 2132. In the intermediate position, the second clamp 2134 may apply a closing pressure to the second pipe length 2132 to at least partially prevent fluid flow through the second pipe length 2132. In the closed position, the second clamp 2134 may apply a closing pressure to the second pipe length 2132 to completely prevent fluid flow through the second pipe length 2132. The second clamp 2134 can be positioned at any point along the length 2132 of the second tube between the first end 2136 and the second end 2138. For example, in at least one exemplary embodiment, the second clamp 2134 may be positioned approximately halfway along the length 2132 of the second tube between the first end 2136 and the second end 2138. In various other exemplary embodiments, the second clamp 2134 may be positioned closer to the first end 2136 than the second end 2138 along the length 2132 of the second tube. In still some other exemplary embodiments, the second clamp 2134 may be positioned closer to the second end 2138 than the first end 2136 along the length 2132 of the second tube.

[0087] The third pipe segment 2140 may include a third pipe length 2142 having a first end 2146 and a second end 2148. In at least one exemplary embodiment, the third pipe segment 2140 may be referred to as an outlet pipe. Although a single pipe length is shown, it should be appreciated that in various other exemplary embodiments, the second pipe segment 2130 may be defined by two or more pipe lengths or segments, which include one or more clamps (similar to the third clamp 2144) and / or one or more connectors configured, for example, to join the two or more pipe lengths or segments together.

[0088] For example, the first end 2146 of the third pipe length 2142 can be connected to the first pipe length 2122 via the second connector 2129. The second end 2148 of the third pipe length 2142 can be connected to the fourth pipe segment 2150. More specifically, for example, the second end 2148 of the third pipe length 2142 can be connected to the first end 2156 of the fourth pipe segment 2150 via the fifth connector 2149. In at least one exemplary embodiment, the third pipe segment 2140 (more specifically, the first end 2156 of the fourth pipe segment 2150) may include at least a portion of the fifth connector 2149.

[0089] The third pipe segment 2140 may include a third clamp 2144 positioned along the third pipe length 2142 between the first end 2146 and the second end 2148. Similar to the first clamp 2124 and the second clamp 2134, the third clamp 2144 is movable 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 2144 may apply no pressure or minimal pressure to the third pipe length 2142, allowing fluid to flow freely through it. In the intermediate position, the third clamp 2144 may apply a closing pressure to the third pipe length 2142 to at least partially prevent fluid flow through it. In the closed position, the third clamp 2144 may apply a closing pressure to completely prevent fluid flow through it. The third clamp 2144 can be positioned at any point along the length 2142 of the third tube between the first end 2146 and the second end 2148. For example, in at least one exemplary embodiment, the third clamp 2144 may be positioned approximately halfway along the length 2142 of the third tube between the first end 2146 and the second end 2148. In various other exemplary embodiments, the third clamp 2144 may be positioned closer to the first end 2146 than the second end 2148 along the length 2142 of the third tube. In still some other exemplary embodiments, the third clamp 2144 may be positioned closer to the second end 2148 than the first end 2146 along the length 2142 of the third tube.

[0090] The fourth pipe segment 2150 may include a fourth pipe length 2152 having a first end 2156 and a second end 2158. In at least one exemplary embodiment, the fourth pipe segment 2150 and the third pipe segment 2140 together may be referred to as a waste pipeline. Although two segments are shown, it should be appreciated that in various other exemplary embodiments, the third pipe segment 2140 and / or the fourth pipe segment 2150 may be formed as a single pipe length to a segment, or alternatively, may still be formed as three or more pipe lengths or segments, which include one or more clamps (similar to the third clamp 2144) and / or one or more connectors configured, for example, to join the three or more pipe lengths or segments together.

[0091] For example, the first end 2156 of the fourth pipe segment 2150 can be connected to the second end 2149 of the third pipe length 2142 via the fifth connector 2149. In at least one exemplary embodiment, the fourth pipe segment 2150 (more specifically, the first end 2156 of the fourth pipe segment 2150) may include at least a portion of the fifth connector 2149. For example, the second end 2158 of the fourth pipe segment 2150 can be connected to the second collector 2104 via the sixth connector 2159. More specifically, the second end 2158 of the fourth pipe segment 2150 may be connected to the first end 2166 of the fifth pipe length 2162 of the second collection 2104. In at least one exemplary embodiment, the second end 2158 of the fourth pipe segment 2150 (more specifically, the second end 2158 of the fourth pipe segment 2150) may include at least a portion of the sixth connector 2159.

[0092] The second assembly 2108 may include a fifth pipe segment 2160. The fifth pipe segment 2160 may include a fifth pipe length 2162 having a first end 2166 and a second end 2168. In at least one exemplary embodiment, the fifth pipe segment 2160 may be referred to as a waste pipeline. Although a single pipe length is shown, it should be appreciated that in various other exemplary embodiments, the fifth pipe segment 2160 may be defined by two or more pipe lengths or segments, which include one or more clamps (similar to the fourth clamp 2164) and / or one or more connectors configured, for example, to join two or more pipe lengths or segments together.

[0093] The first end 2166 of the fifth pipe length 2162 may be connected to the first assembly 2102. More specifically, for example, the first end 2166 of the fifth pipe length 2162 may be connected to the second end 2152 of the fourth pipe segment 2150 via a sixth connector 2159. In at least one exemplary embodiment, the fifth pipe segment 2160 (more specifically, the first end 2166 of the fifth pipe segment 2160) may include at least a portion of the sixth connector 2159.

[0094] The second end 2168 of the fifth tube length 2162 may be coupled to the waste bag 2170. For example, in at least one exemplary embodiment, a portion of the second end 2158 of the fifth tube length 2162 may extend into the waste bag 2170. In at least one exemplary embodiment, the second end 2158 of the fifth tube length 2162 may be integrally formed with the waste bag 2170. In at least one exemplary embodiment, a coupling (not shown) may be configured to engage the second end 2158 of the fifth tube length 2162 and a port or opening of the waste bag 2170.

[0095] The fifth pipe segment 2160 may include a fourth clamp 2164, positioned along the fifth pipe length 2162 between the first end 2166 and the second end 2168. Similar to the first clamp 2124, the second clamp 2134, and the third clamp 2144, the fourth clamp 2164 is movable 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 fourth clamp 2164 may apply no pressure or minimal pressure to the fifth pipe length 2162, allowing fluid to flow freely through it. In the intermediate position, the fourth clamp 2164 may apply a closing pressure to the fifth pipe length 2162 to at least partially prevent fluid flow through it. In the closed position, the fourth clamp 2164 may apply a closing pressure to completely prevent fluid flow through it. The fourth clamp 2164 can be positioned at any point along the length 2162 of the fifth tube between the first end 2166 and the second end 2168. For example, in at least one exemplary embodiment, the fourth clamp 2164 may be positioned approximately halfway along the length 2162 of the fifth tube between the first end 2166 and the second end 2168. In various other exemplary embodiments, the fourth clamp 2164 may be positioned closer to the first end 2166 than the second end 2168 along the length 2162 of the fifth tube. In still some other exemplary embodiments, the fourth clamp 2164 may be positioned closer to the second end 2168 than the first end 2166 along the length 2162 of the fifth tube.

[0096] The third assembly 2106 may include a sixth pipe segment 2180. The sixth pipe segment 2180 may include a sixth pipe length 2182 having a first end 2186 and a second end 2188. In at least one exemplary embodiment, the sixth pipe segment 2180 may be referred to as an inlet extension line. Although a single pipe length is shown, it should be appreciated that in various other exemplary embodiments, the sixth pipe segment 2180 may be defined by two or more pipe lengths or segments, which include one or more clamps (similar to the fifth clamp 2174) and / or one or more connectors configured, for example, to join two or more pipe lengths together.

[0097] The first end 2186 of the sixth tube length 2182 may be connected to the post-processing unit 2210. More specifically, for example, the first end 2186 of the sixth tube length 2182 may be connected to the second end 2214 of the post-processing unit 2210 via a seventh connector 2183. In at least one exemplary embodiment, the sixth tube length 2182 (more specifically, the first end 2186 of the sixth tube length 2182) may include at least a portion of the seventh connector 2183.

[0098] The second end 2188 of the sixth tube length 2182 can be connected to one or more other tube segments (e.g., tube segments 2220, 2230) and / or another tube bag assembly (e.g., such as...) of the single-sampling system. Figure 2 The tube bag assembly 201 shown is another tube bag assembly that can be coupled to a single-sampling system. For example, in at least one exemplary embodiment, the sixth tube length 2180 (more specifically, the second end 2188 of the sixth tube length 2182) may include at least a portion of an eighth connector 2189 configured to engage the sixth tube length 2182 to one or more other tube segments (e.g., tube segments 2220, 2230) and / or another tube bag assembly (e.g., such as...) of the single-sampling system. Figure 2 The tube bag kit 201 shown is another tube bag kit that can be connected to the single collection system.

[0099] The sixth pipe segment 2180 may include a fifth clamp 2174 positioned along the sixth pipe length 2182 between the first end 2186 and the second end 2188. Similar to the first clamp 2124, the second clamp 2134, the third clamp 2144, and the fourth clamp 2164, the fifth clamp 2174 is movable 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 fifth clamp 2174 may apply no pressure or a minimal pressure to the sixth pipe length 2182, allowing fluid to flow freely through the sixth pipe length 2182. In the intermediate position, the fifth clamp 2174 may apply a closing pressure to the sixth pipe length 2182 to at least partially prevent fluid flow through the sixth pipe length 2182. In the closed position, the fifth clamp 2174 may apply a closing pressure to completely prevent fluid flow through the sixth pipe length 2182. The fifth clamp 2174 can be positioned at any point along the length 2182 of the sixth tube between the first end 2186 and the second end 2188. For example, in at least one exemplary embodiment, the fifth clamp 2174 may be positioned approximately halfway along the length 2182 of the sixth tube between the first end 2186 and the second end 2188. In other embodiments, the fifth clamp 2174 may be positioned closer to the first end 2186 than the second end 2188 along the length 2182 of the sixth tube. In still other embodiments, the fifth clamp 2174 may be positioned closer to the second end 2188 than the first end 2186 along the length 2182 of the sixth tube.

[0100] In at least one exemplary embodiment, the tubing kit 2100 may include a post-processing unit. In at least one exemplary embodiment, the tubing kit 2100 may include or be in communication with one or more other tubing segments. Figure 5 Is it like this? Figure 4 The illustration shows an exemplary tube bag assembly 2100, which includes a post-processing unit 2210 and one or more additional tube lengths 2220, 2230, 2250 for aligning the post-processing unit 2210, for use in a single-sample device (similar to...). Figure 1 The exemplary single-sample system shown is used or used in conjunction with a single-sample device. In at least one exemplary embodiment, as Figure 5 As shown, the tube bag assembly 2100 may also include a seventh tube segment 2220 and / or an eighth tube segment 2230 and / or a ninth tube segment 2250, or be in communication with the seventh tube segment 2220 and / or the eighth tube segment 2230 and / or the ninth tube segment 2250.

[0101] The seventh tube segment 2220 may include a seventh tube length 2222 having a first end 2226 and a second end 2228. In at least one exemplary embodiment, the seventh tube segment 2220 may be referred to as a plasma diversion line. Although a single tube length is shown, it should be appreciated that in various other exemplary embodiments, the seventh tube segment 2220 may be defined by two or more tube lengths or segments, which include one or more clamps (similar to the sixth clamp 2224) and / or one or more connectors configured, for example, to join two or more tube lengths or segments together.

[0102] For example, the first end 2226 of the seventh pipe length 2220 can be connected to the second end 2188 via the eighth connector 2189. For example, in at least one exemplary embodiment, the seventh pipe segment 2220 (more specifically, the first end 2226 of the seventh pipe length 2220) may include at least a portion of the eighth connector 2189.

[0103] For example, the second end 2228 of the seventh pipe length 2222 can be connected to the eighth pipe segment 2230 via the ninth connector 2225. More specifically, the second end 2228 of the seventh pipe length 2222 can be connected to the first end 2236 of the eighth pipe segment 2230. In at least one exemplary embodiment, the seventh pipe length 2222 (more specifically, the second end 2228 of the seventh pipe length 2222) may include at least a portion of the ninth connector 2225.

[0104] The seventh pipe segment 2220 may include a sixth clamp 2224, which is positioned along the seventh pipe length 2222 at a point between the first end 2226 and the second end 2228. Similar to the first clamp 2124, the second clamp 2134, the third clamp 2144, the fourth clamp 2164, and the fifth clamp 2174, the sixth clamp 2224 is movable 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 sixth clamp 2224 may apply no pressure or a minimal pressure to the seventh pipe length 2222, allowing fluid to flow freely through the seventh pipe length 2222. In the intermediate position, the sixth clamp 2224 may apply a closing pressure to the seventh pipe length 2222 to at least partially prevent fluid from flowing through the seventh pipe length 2222. In the closed position, the sixth clamp 2224 can apply a closing pressure to the seventh tube length 2222 to completely prevent fluid from flowing through the seventh tube length 2222. The sixth clamp 2224 can be positioned at any point along the seventh tube length 2222 between the first end 2226 and the second end 2228. For example, in at least one exemplary embodiment, the sixth clamp 2224 may be positioned approximately halfway along the seventh tube length 2222 between the first end 2226 and the second end 2228. In various other exemplary embodiments, the sixth clamp 2224 may be positioned closer to the first end 2226 than the second end 2228 along the seventh tube length 2222. In still some other exemplary embodiments, the sixth clamp 2224 may be positioned closer to the second end 2228 than the first end 2226 along the seventh tube length 2222.

[0105] The eighth pipe segment 2230 may include an eighth pipe length 2232 having a first end 2236 and a second end 2238. In at least one exemplary embodiment, the eighth pipe segment 2230 may be referred to as a waste pipeline. Although a single pipe length is shown, it should be appreciated that in various other exemplary embodiments, the eighth pipe segment 2230 may be defined by two or more pipe lengths or segments, which include one or more clamps (similar to the seventh clamp 2234) and / or one or more connectors configured, for example, to join two or more pipe lengths or segments together.

[0106] For example, the first end 2236 of the eighth pipe segment 2230 may be connected to the seventh pipe segment 2220 (more specifically, to the second end 2228 of the seventh pipe segment 2220) via the ninth connector 2225. In at least one exemplary embodiment, the eighth pipe segment 2230 (more specifically, the first end 2236 of the eighth pipe segment 2230) may include at least a portion of the ninth connector 2225.

[0107] The second end 2238 of the eighth tube length 2232 may be coupled to a waste bag or container 2240. For example, in at least one exemplary embodiment, a portion of the second end 2238 of the eighth tube length 2232 may extend into the bag 2240. In at least one exemplary embodiment, the second end 2238 of the eighth tube length 2232 may be integrally formed with the bag 2240. In at least one exemplary embodiment, a coupling (not shown) may be configured to engage the second end 2238 of the eighth tube length 2232 and a port or opening of the bag 2240.

[0108] The eighth pipe segment 2230 may include a seventh clamp 2234, which is positioned along the eighth pipe length 2232 at a point between the first end 2226 and the second end 2228. Similar to the first clamp 2124, the second clamp 2134, the third clamp 2144, the fourth clamp 2164, the fifth clamp 2174, and the sixth clamp 2224, the seventh clamp 2234 is movable 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 seventh clamp 2234 may apply no pressure or a minimal pressure to the eighth pipe length 2232, allowing fluid to flow freely through the eighth pipe length 2232. In the intermediate position, the seventh clamp 2234 may apply a closing pressure to the eighth pipe length 2232 to at least partially prevent fluid from flowing through the eighth pipe length 2232. In the closed position, the seventh clamp 2234 can apply a closing pressure to the eighth tube length 2232 to completely prevent fluid from flowing through the eighth tube length 2232. The seventh clamp 2234 can be positioned at any point along the eighth tube length 2232 between the first end 2236 and the second end 2238. For example, in at least one exemplary embodiment, the seventh clamp 2234 may be positioned approximately halfway along the eighth tube length 2232 between the first end 2236 and the second end 2238. In various other exemplary embodiments, the seventh clamp 2234 may be positioned closer to the first end 2236 than the second end 2238 along the eighth tube length 2232. In still other exemplary embodiments, the seventh clamp 2234 may be positioned closer to the second end 2238 than the first end 2236 along the eighth tube length 2232. In at least one exemplary embodiment, alternatively, the clamping action of the seventh clamp 2234 can be achieved using clamping scissors.

[0109] The ninth tube segment 2250 may include a ninth tube length 2252, a tenth tube length 2254, and / or an eleventh tube length 2256. The ninth tube length 2252 may have a first end 2262 and a second end 2272. The first end 2262 of the ninth tube length 2252 may be coupled to a second port or opening 2113 of the cushioning bag 2110. In at least one exemplary embodiment, the ninth tube length 2252 (more specifically, the first end 2262 of the ninth tube length 2252) may include at least a portion of the second connector 2115. Although not shown, it should be appreciated that in various other exemplary embodiments, a portion of the ninth tube length 2252 may extend into the cushioning bag 2110. For example, the ninth tube length 2252 (more specifically, the first end 2262 of the ninth tube length 2252) may include a pointed tip inserted into the cushioning bag 2110. The second end 2272 of the ninth tube length 2252 and the second end 2274 of the tenth tube length 2254 may each be coupled to the eleventh tube length 2256. For example, the eleventh connector 2282 can join the ninth tube length 2254, the tenth tube length 2254 and the eleventh tube length 2256 together.

[0110] The ninth pipe segment 2250 may include an eighth clamp 2292, which is positioned at a point along the ninth pipe length 2252 between the first end 2262 and the second end 2272. Similar to the first clamp 2124, the second clamp 2134, the third clamp 2144, the fourth clamp 2164, the fifth clamp 2174, the sixth clamp 2224, and the seventh clamp 2234, the eighth clamp 2292 is movable 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 eighth clamp 2292 may apply no pressure or a minimum pressure to the ninth pipe length 2252, allowing fluid to flow freely through the ninth pipe length 2252. In the intermediate position, the eighth clamp 2292 may apply a closing pressure to the ninth pipe length 2252 to at least partially prevent fluid from flowing through the ninth pipe length 2252. In the closed position, the eighth clamp 2292 can apply a closing pressure to the ninth tube length 2252 to completely prevent fluid from flowing through the ninth tube length 2252. The eighth clamp 2292 can be positioned at any point along the ninth tube length 2252 between the first end 2262 and the second end 2272. For example, in at least one exemplary embodiment, the eighth clamp 2292 may be positioned approximately halfway along the ninth tube length 2252 between the first end 2262 and the second end 2272. In various other exemplary embodiments, the eighth clamp 2292 may be positioned closer to the first end 2262 than the second end 2272 along the ninth tube length 2252. In still some other exemplary embodiments, the eighth clamp 2292 may be positioned closer to the second end 2272 than the first end 2262 along the ninth tube length 2252. In at least one exemplary embodiment, alternatively, the clamping action of the eighth clamp 2292 can be achieved using clamping scissors.

[0111] The tenth tube length 2254 may have a first end 2264 and a second end 2274. The first end 2264 of the tenth tube length 2254 may be coupled to a bag 2280. In at least one exemplary embodiment, the bag 2280 may be a ventilated bag. In at least one exemplary embodiment, the tenth tube length 2254 (more specifically, the first end 2264 of the tenth tube length 2254) may include at least a portion of a tenth connector 2282 that joins the bag 2280 and the tenth tube length 2254 together. Although not shown, it should be appreciated that in various other exemplary embodiments, a portion of the tenth tube length 2254 may extend into the bag 2280. For example, the tenth tube length 2254 (more specifically, the first end 2264 of the tenth tube length 2254) may include a pointed tip that inserts into the bag 2280.

[0112] The ninth pipe segment 2250 may include a ninth clamp 2294, which is positioned at a point along the tenth pipe length 2254 between the first end 2264 and the second end 2274. Similar to the first clamp 2124, second clamp 2134, third clamp 2144, fourth clamp 2164, fifth clamp 2174, sixth clamp 2224, seventh clamp 2234, and eighth clamp 2292, the ninth clamp 2294 is movable 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 ninth clamp 2294 may apply no pressure or a minimal pressure to the tenth pipe length 2254, allowing fluid to flow freely through it. In the intermediate position, the ninth clamp 2294 may apply a closing pressure to the tenth pipe length 2254 to at least partially prevent fluid flow through it. In the closed position, the ninth clamp 2294 can apply a closing pressure to the tenth tube length 2254 to completely prevent fluid flow through the tenth tube length 2254. The ninth clamp 2294 can be positioned at any point along the tenth tube length 2254 between the first end 2264 and the second end 2274. For example, in at least one exemplary embodiment, the ninth clamp 2294 may be positioned approximately halfway along the tenth tube length 2254 between the first end 2264 and the second end 2274. In various other exemplary embodiments, the ninth clamp 2294 may be positioned closer to the first end 2264 than the second end 2274 along the tenth tube length 2254. In still some other exemplary embodiments, the ninth clamp 2294 may be positioned closer to the second end 2274 than the first end 2264 along the tenth tube length 2254.

[0113] In at least one exemplary embodiment, one or more of the different clamps 2124, 2134, 2144, 2164, 2174, 2234, 2292, 2294 may have one or more different colors to help the operator identify the appropriate sequence of events. Alternatively, in at least one exemplary embodiment, the clamping action of any of the clamps 2124, 2134, 2144, 2164, 2174, 2234, 2292, 2294 may be achieved using clamping scissors.

[0114] In various respects, this disclosure provides methods for using tube bag kits, which include post-processing units (similar to...) Figure 4 and Figure 5 The tube bag kit 2100 shown is for use in medical systems (similar to...) Figure 1The method can be used in conjunction with a medical system (as illustrated in the exemplary apheresis system). The method typically includes aligning the selected tube pouch kit with the medical system and / or the donor, subject, patient, or source, or aligning the selected tube pouch kit within the medical system and / or the donor, subject, patient, or source. In at least one exemplary embodiment, for example, when the post-processing unit of the selected tube pouch kit includes a filter, the method may include one or more flushing steps to remove or limit any blockages or obstructions in the post-processing unit.

[0115] In at least one exemplary embodiment, in a medical system (similar to...) Figure 1 The exemplary single-sampling system shown uses a tube bag kit (the tube bag kit includes a post-processing unit, similar to...) Figure 4 and Figure 5 The tube bag kit 2100 shown, or a method of using the tube bag kit with a medical system, may include dispensing blood components (e.g., plasma) from a tube of a length that can be coupled to a donor, subject, patient, or source (e.g., such as...). Figure 5 The tube length shown (2220) is introduced into the post-processing unit (e.g., such as...). Figure 5 The post-processing unit 2210 is shown. After post-processing, the method may include passing through another tube length (e.g., as shown). Figure 5 The tube shown (length 2256) can re-infuse one or more other blood components (e.g., red blood cells and / or white blood cells and / or platelets) to a donor, subject, patient, or source. In at least one exemplary embodiment, one or more other blood components (e.g., red blood cells and / or white blood cells and / or platelets) can be re-infused via a reservoir (e.g., such as...) Figure 2 The storage device 248 shown is then recycled to the donor, subject, patient, or source.

[0116] The foregoing description of embodiments has been provided for purposes of illustration and description. The embodiments are not intended to be exhaustive or limiting of this disclosure. Various elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable where applicable, and may be used in chosen embodiments even if not specifically shown or described. Embodiments may also be varied in many ways. Such variations should not be considered a departure from this disclosure, but all such modifications are intended to be included within the scope of this disclosure.

Claims

1. A medical system comprising: A separation device configured to separate material received from a source into two or more components; A post-processing unit, which is in fluid communication with the separation device and is configured to isolate at least one of the two or more components; as well as A controller configured to manage the operation of the separation device to separate the material received from the source into two or more components, move the two or more components to the post-processing unit, and return at least one isolated component of the two or more components to the separation device.

2. The medical system according to claim 1, wherein, The medical system also includes: A tube establishes fluid communication between the separation device and the post-processing unit.

3. The medical system according to claim 2, wherein, The fluid communication between the separation device and the post-processing unit is a first fluid communication between the separation device and the post-processing unit, and the medical system further includes: A second fluid communication exists between the post-processing unit and the separation device to return at least one of the isolated components of the two or more components to the separation device.

4. The medical system according to claim 3, wherein, The tube is the first tube, and the medical system also includes: A second pipe establishes a second fluid connection between the post-processing unit and the separation device to return at least one of the isolated components of the two or more components to the separation device.

5. The medical system according to claim 4, wherein, The first tube and the second tube are configured as a connecting device.

6. The medical system according to claim 4, wherein, The medical system also includes: A third tube establishes fluid communication between the separation device and the source.

7. The medical system according to claim 6, wherein, The first tube, the second tube, and the third tube are configured as a connecting device.

8. The medical system according to claim 6, wherein, The second tube and the third tube are configured as a connecting device.

9. The medical system according to claim 1, wherein, The post-processing unit includes columns.

10. The medical system according to claim 1, wherein, The post-processing unit includes a filter.

11. A treatment system comprising: A flow path fluidly connects a separation device and a post-processing device, the separation device being configured to separate material received from a source into two or more components, and the post-processing device being configured to isolate at least one of the two or more components.

12. The treatment system according to claim 11, wherein, The flow path is a first flow path, and the treatment system further includes: A second flow path fluidly connects the separation device and the post-processing device to return at least one of the isolated components of the two or more components to the separation device.

13. The treatment system according to claim 12, wherein, The first flow path and the second flow path are configured as a connecting device.

14. The treatment system according to claim 12, wherein, The treatment system also includes: A third flow path connects the separation device and the source fluid.

15. The treatment system according to claim 14, wherein, The first flow path, the second flow path, and the third flow path are configured as a connecting device.

16. The treatment system according to claim 14, wherein, The second flow path and the third flow path are configured as connecting devices.

17. The treatment system according to claim 11, wherein, The post-processing equipment includes a column.

18. The treatment system according to claim 11, wherein, The post-processing equipment includes a filter.

19. A connecting device for connecting a separation device and a post-processing unit, the connecting device comprising: The first tube assembly includes a first tube length, the first tube length having a first end and a second end, the first end of the first tube length being able to be connected to the separation device, and the second end of the first tube length being able to be connected to the post-processing unit. and The second tube assembly includes a second tube length having a first end and a second end. The first end of the second tube length can be connected to the post-processing unit, and the second end of the second tube length can be connected to the separation device. The separation device is configured to separate material received from the source into two or more components, and the post-processing unit is configured to isolate at least one of the two or more components.

20. The connecting device according to claim 19, wherein, The first tube assembly includes one or more first clamps.

21. The connecting device according to claim 20, wherein, The second tube assembly includes one or more second clamps.

22. The connecting device according to claim 21, wherein, The one or more first clamps are of a first color, and the one or more second clamps are of a second color, the second color being different from the first color.

23. The connecting device according to claim 19, wherein, The connecting device further includes: A third tube assembly, comprising a third tube length capable of being connected to the separation device and the source.

24. The connecting device according to claim 22, wherein, The third tube assembly includes one or more third clamps.

25. A connecting device for connecting a separation device and a post-processing unit, the connecting device comprising: A first tube length, the first tube length having a first end and a second end, the first end of the first tube length being able to be connected to a first bag; The second tube length has a first end and a second end, the first end of the second tube length can be connected to the second end of the first tube length, and the second end of the second tube length can be connected to the first end of the post-processing unit. The third tube length has a first end and a second end, and the first end of the third tube length can be connected to the second end of the first tube length. A fourth tube length having a first end and a second end, the first end of the fourth tube length being connectable to the second end of the third tube length, and the second end of the fourth tube length being connectable to a second bag; and The fifth tube length has a first end and a second end, the first end of the fifth tube length being connectable to the second end of the post-processing unit, and the second end of the fifth tube length being connectable to one or more other components of the separation device.

26. The connecting device according to claim 25, wherein, The first tube length, the second tube length, and the third tube length are combined and configured as a first set of different tubes.

27. The connecting device according to claim 26, wherein, The fourth tube is configured as a second set of different tubes.

28. The connecting device according to claim 27, wherein, The fifth tube is configured as the third set of different tubes.

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