System and method for implementing different versions of blood separation procedure

Abstract

To provide systems and methods for implementing different versions of a blood separation procedure.SOLUTION: A blood separation device has a controller configured to execute a first version and a second version of a blood separation procedure. Information regarding a blood source is analyzed to determine whether to implement the first version of the procedure or the second version. This may include an analysis of the age, weight, and / or sex of the blood source, along with whether the blood source has previously been the subject of a blood separation procedure. The second version may allow for a greater percentage of the blood or red blood cells of the blood source to be outside of the body of the blood source (in a fluid flow circuit mounted to the device) at any time during the procedure. The second version may also or alternatively allow for a higher blood cell separation efficiency than the first version, along with separation of the blood in a larger blood separation chamber.SELECTED DRAWING: None

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 327,869, filed April 6, 2022, and U.S. Provisional Patent Application No. 63 / 348,839, filed June 3, 2022, the contents of each of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to blood separation systems and methods. More particularly, the present disclosure relates to systems and methods for performing different versions of a blood separation procedure. [Background technology]

[0003] Various blood processing systems now allow for the collection of specific blood components, instead of whole blood, from blood sources such as, but not limited to, containers of previously drawn blood or other biological or non-biological sources. Blood is typically separated into its components (e.g., red blood cells, platelets, plasma) using a centrifuge or other centrifugal separation device, such as the AMICUS® separator from Fenwall Corporation, Lake Zurich, Illinois, an affiliate of Fresenius Kabi AG, Bad Homburg, Germany, or a rotating membrane-type separator, such as the AUTOPHERESIS-C® and AURORA® devices from Fenwall, Inc. In such systems, whole blood is drawn from the blood source, specific blood components or components are separated, removed, and collected, and the remaining blood components are returned to the blood source.

[0004] Removing only specific components is advantageous when the blood source is a human donor because it potentially shortens the time required for the donor's body to return to pre-donation levels, allowing donations to occur at more frequent intervals than when whole blood is withdrawn, thereby increasing the overall supply of blood components, such as plasma and platelets, available for transfer and / or therapy. Summary of the Invention

[0005] The present subject matter has several aspects that may be embodied individually or together in the devices and systems described and claimed below. These aspects can be used alone or in combination with other aspects of the subject matter described herein, and describing these aspects together is not intended to exclude using these aspects individually or claiming such aspects individually or in different combinations set forth in the claims appended hereto.

[0006] In one aspect, a method for performing a blood separation procedure is provided. The method includes selecting a first blood separation device configured to perform a first version of the blood separation procedure, a second blood separation device configured to perform a second version of the blood separation procedure, or a single blood separation device configured to perform both the first and second versions of the blood separation procedure. A determination is made as to whether a blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure and / or whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure. The first version of the blood separation procedure is performed on the blood source if the blood source is determined to be suitable for the first version of the blood separation procedure and / or if the blood source is determined to be not suitable for the second version of the blood separation procedure. Alternatively, the second version of the blood separation procedure is performed on the blood source if the blood source is determined to be suitable for the second version of the blood separation procedure and / or if the blood source is determined to be not suitable for the first version of the blood separation procedure.

[0007] In another aspect, a blood separation device includes a pump system, a clamp system, a separation actuator, and a controller. The controller is programmed with a first version and a second version of a blood separation procedure in which the pump system, the clamp system, and the separation actuator are activated to draw blood from a blood source, separate the blood into at least two blood components, and deliver at least a portion of one of the blood components to a recipient. The controller is configured to determine or be instructed that the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or to determine or be instructed that the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure. The controller performs the first version of the blood separation procedure on the blood source when the controller determines or is instructed that the blood source is eligible for the first version of the blood separation procedure and / or when the controller determines or is instructed that the blood source is not eligible for the second version of the blood separation procedure. Alternatively, the control unit performs the second version of the blood separation procedure on the blood source when it determines or is instructed that the blood source is suitable for the second version of the blood separation procedure and / or when it determines or is instructed that the blood source is not suitable for the first version of the blood separation procedure.

[0008] In yet another aspect, a blood separation device includes a pump system, a clamp system, a separation actuator, and a controller. The controller is configured to operate the pump system, the clamp system, and the separation actuator to perform a blood separation procedure in which a volume of blood having a volume of red blood cells is present in the fluid flow circuit. The controller is further configured to be instructed on a maximum percentage and / or maximum volume of a total blood volume of a blood source that may be present in the fluid flow circuit at any time during the blood separation procedure and / or a maximum percentage and / or maximum volume of a pre-procedure red blood cell volume of a blood source that may be present in the fluid flow circuit at any time during the blood separation procedure.

[0009] In another aspect, a computer-implemented method for performing a blood separation procedure using a first blood separation device configured to perform a first version of the blood separation procedure and a second blood separation device configured to perform a second version of the blood separation procedure, or a single blood separation device configured to perform both the first version of the blood separation procedure and the second version of the blood separation procedure, is provided. The method includes determining whether a blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure. The first version of the blood separation procedure is initiated for the blood source (or an operator is prompted to initiate the first version of the procedure) upon determining that the blood source is eligible for the first version of the blood separation procedure and / or upon determining that the blood source is not eligible for the second version of the blood separation procedure. The second version of the blood separation procedure is initiated for the blood source (or the operator is prompted to initiate the second version of the procedure) when the blood source determines that it is eligible for the second version of the blood separation procedure and / or when the blood source determines that it is not eligible for the first version of the blood separation procedure. [Brief explanation of the drawings]

[0010] FIG. 1 is a front perspective view of an exemplary blood separation device according to one embodiment of the present disclosure.

[0011] FIG. 2 is a rear perspective view of the blood separation device of FIG. 1 with the rear door in an open position.

[0012] FIG. 3 is a front perspective view of the blood separation device of FIG. 1 with its associated fluid flow circuits to form a blood separation system.

[0013] FIG. 4 is a front perspective view, with portions cut away for illustrative purposes, of the blood separation chamber of the fluid flow circuit of FIG.

[0014] FIG. 5 is a schematic diagram of the blood separation system of FIG. 3 in a blood collection mode.

[0015] FIG. 6 is a schematic diagram of the blood separation system of FIG. 3 in a blood component return mode.

[0016] FIG. 7 is a schematic diagram of the fluid flow circuit and fluid treatment system of FIG. 3 in a displacement fluid return mode.

[0017] 8A, 8B, 9A and 9B are diagrams illustrating exemplary screens that may be displayed on the display or data entry device of the blood separation device of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0018] The embodiments disclosed herein are intended to provide exemplary descriptions of the present subject matter. However, they are merely examples, and the present subject matter may be embodied in various forms. Accordingly, the specific details disclosed herein should not be construed as limiting the subject matter defined in the appended claims.

[0019] According to one aspect of the present disclosure, a durable or reusable blood separation device is used in combination with a separate fluid flow circuit (which may be disposable) to separate blood into two or more components. Figures 1 and 2 show an exemplary blood separation device 10, and Figure 3 shows an exemplary fluid flow circuit 12 attached to the blood separation device 10 (the combination is referred to herein as a "blood separation system"). It should be understood that the illustrated blood separation device 10 and fluid flow circuit 12 are merely exemplary of such devices and circuits, and that different configurations of blood separation devices and fluid flow circuits may be provided without departing from the scope of the present disclosure.

[0020] 1 is configured to process whole blood, it can also be used to process other plasma-containing fluids to separate plasma from a concentrate fluid (which may be a red blood cell concentrate or packed red blood cells when the plasma is concentrated, if the plasma-containing fluid comprises whole blood). The plasma-containing fluid can be derived from any fluid source, including a living donor or patient (e.g., a human donor) or a non-living source (e.g., a blood bag or fluid container).

[0021] The illustrated device 10 includes a cabinet or housing 14 with some components located outside the cabinet 14 (e.g., associated with the front wall or front face or front panel of the cabinet 14) and additional components (a central processing unit or control 16) and interconnects located inside the cabinet 14 and accessible by opening a rear door 18 of the device 10, as shown in Figure 2. It should be understood that the illustrated components and component locations are merely exemplary, and that additional or different components and different component arrangements may be incorporated into the device without departing from the scope of the present disclosure.

[0022] Among the components located outside of cabinet 14, one or more pumps or pump stations 20a-20c (collectively referred to herein as a "pump system") may be provided, and pumps 20a-20c are configured to accommodate the tubing lines of fluid flow circuit 12. One of the pumps, pump 20a, may be provided as a source / recipient access pump, which may be associated with source / recipient access line 22 of fluid flow circuit 12 and draws fluid from a fluid source (FIG. 5) and returns the fluid to a fluid recipient (FIGS. 6 and 7). Another of the pumps, pump 20b, may be provided as an anticoagulant pump, which may be associated with anticoagulant line 24 of fluid flow circuit 12 and operates to add anticoagulant from an anticoagulant source or reservoir 26 of fluid flow circuit 12 to fluid drawn from the fluid source in source / recipient access line 22 before the fluid enters blood separation module or chamber 28 of fluid flow circuit 12 (FIG. 5). The third pump 20c may be provided as a concentrate pump, which may be associated with the concentrate outlet line 30 and operates to draw the concentrate from the blood separation chamber 28 and direct the concentrate to the concentrate reservoir 32 after the fluid has been separated into concentrate and separated plasma within the blood separation chamber 28.

[0023] In the illustrated embodiment, pumps 20a-20c are peristaltic pumps; however, it is within the scope of this disclosure that pumps of different configurations, such as diaphragm pumps or other pumps, may be provided. Furthermore, additional or alternative pumps may be provided without departing from the scope of this disclosure. For example, a pump may be associated with plasma outlet line 34 of fluid flow circuit 12 to withdraw separated plasma from blood separation chamber 28 after the plasma-containing fluid has been separated into concentrate fluid and separated plasma. Additionally, as described in more detail herein, the illustrated embodiment utilizes a single fluid flow conduit or flow path for both intermittently drawing blood from the source and for flowing or returning fluid to the recipient. System 10 may utilize separate inlet and return flow paths or conduits without departing from the scope of this disclosure.

[0024] In addition to the pumps 20a-20c, the external components of the device 10 may include one or more clamps or valves 36a-36d (collectively referred to herein as a "clamp system") associated with the tubing lines of the fluid flow circuit 12. The clamps or valves 36a-36d may be variously configured and operated to selectively permit or prevent fluid flow through the associated tubing lines. In the illustrated embodiment, one clamp or valve 36a may be provided as a fluid source / recipient clamp, which may be associated with the inlet branch 22a of the source / recipient access line 22 of the fluid flow circuit 12 to permit (FIG. 5) or prevent (FIGS. 6 and 7) fluid flow through the suction branch 22a of the source / recipient access line 22. Another one of the clamps or valves 36b may be provided as a reinfusion clamp or valve associated with the reinfusion branch 22b of the source / recipient access line 22 downstream of the concentrate fluid reservoir 32 of the fluid flow circuit 12 to allow (FIGS. 6 and 7) or prevent (FIG. 5) the flow of concentrate fluid through the reinfusion branch 22b. The third clamp or valve 36c may be provided as a plasma clamp or valve associated with the plasma outlet line 34 to allow (FIG. 5) or prevent (FIGS. 6 and 7) the flow of separated plasma through the plasma outlet line 34 into the separated plasma container 38. The fourth clamp or valve 36d may be provided as a substitution fluid clamp or valve associated with the substitution fluid line 40 of the fluid flow circuit 12 to allow (FIG. 7) or prevent (FIGS. 5 and 6) the flow of substitution fluid from a substitution fluid source 42 (e.g., a bag or container at least partially filled with saline). Additional or alternative clamps or valves may be provided without departing from the scope of the present disclosure.

[0025] The illustrated apparatus 10 further includes one or more pressure sensors 43a and 43b that can be associated with fluid flow circuit 12 to monitor the pressure in one or more tubing lines of fluid flow circuit 12 during operation of pumps 20a-20c and clamps or valves 36a-36d. In one embodiment, one pressure sensor 43a can be associated with a tubing line that draws fluid from a fluid source and / or conducts processed fluid to a fluid recipient, and the other pressure sensor 43b can be associated with a tubing line that conducts fluid into or out of blood separation chamber 28 to assess the pressure within blood separation chamber 28, although pressure sensors 43a and 43b may be associated with other tubing lines without departing from the scope of this disclosure. Pressure sensors 43a and 43b can send signals to system controller 16 indicative of the pressure in one or more tubing lines being monitored by pressure sensors 43a, 43b. If controller 16 determines that improper pressure exists within fluid flow circuit 12 (e.g., high pressure due to a blockage in one of the plumbing lines), controller 16 can direct one or more of pumps 20a-20c and / or one or more of clamps or valves 36a-36d to take action to alleviate the improper pressure condition (e.g., by reversing the direction of operation of one of pumps 20a-20c and / or by opening or closing one of clamps or valves 36a-36d). Additional or alternative pressure sensors can be provided without departing from the scope of the present disclosure.

[0026] Apparatus 10 also includes a separation actuator 44 that interacts with a portion of blood separation chamber 28 to actuate blood separation chamber 28. A chamber lock 46 may also be provided to hold blood separation chamber 28 in place relative to cabinet 14 and engage separation actuator 44. The configuration and operation of separation actuator 44 depend on the configuration of blood separation chamber 28. In the illustrated embodiment, blood separation chamber 28 is provided as a rotating membrane separator, such as the type described in detail in U.S. Pat. Nos. 5,194,145 and 5,234,608, or PCT Patent Application Publication No. WO 2012 / 125457 A1, all of which are incorporated herein by reference. When provided as a rotating membrane separator, blood separation chamber 28 may include a tubular housing 48 ( FIG. 4 ) having a microporous membrane 50 disposed therein. The inlet 52 allows fluid to enter the housing 48 (via the suction branch 22a of the source / recipient access line 22), while the side outlet 54 allows concentrated fluid to exit the housing 48 (via the concentrated fluid outlet line 30), and the bottom outlet 56 allows the separated plasma to exit the housing 48 (via the plasma outlet line 34) after the fluid has been separated into concentrated fluid and plasma.

[0027] In the illustrated embodiment, the separation actuator 44 is provided as a drive magnetically coupled to a rotor 58 to which the membrane 50 is attached, and the separation actuator 44 rotates the rotor 58 and membrane 50 about the central axis of the housing 48. The rotating rotor 58 and membrane 50 generate Taylor vortices within a gap 60 between the housing 48 and the membrane 50, which tend to transport concentrated fluid (which may be cellular blood components) from the membrane 50 and discharge it from the blood separation chamber 28 through a side outlet 54, while the separated plasma passes through the membrane 50 toward the central axis of the housing 48 and exits the blood separation chamber 28 through a bottom outlet 56. It should be understood that the present disclosure is not limited to a particular blood separation chamber, and the illustrated and described blood separation chamber 28 is merely exemplary. For example, in other embodiments, a plasma-containing fluid can be separated into plasma and concentrated fluid using a centrifugal device that separates fluid components based on density rather than size.

[0028] Apparatus 10 may include alternative and / or additional components without departing from the scope of the present disclosure. For example, the illustrated apparatus 10 includes a hemoglobin detector or optical sensor assembly 62 associated with plasma outlet line 34, a hemocytometer associated with reservoir 32, and a plasmameter associated with separated plasma container 38 of fluid flow circuit 12. The illustrated apparatus 10 also includes a data input device 64 configured as a touchscreen for inputting information to and displaying information from controller 16. While a touchscreen is illustrated ( FIGS. 8A and 8B show exemplary images that may be displayed on the touchscreen), it should be understood that data input devices with different configurations (e.g., barcode readers) may be used without departing from the scope of the present disclosure.

[0029] According to one method of using the illustrated blood separation system, plasma-containing fluid is aspirated from a fluid source into blood separation chamber 28 during an aspiration phase or mode (FIG. 5), where the plasma-containing fluid is separated into concentrated fluid and separated plasma. The separated plasma is retained by device 10 (e.g., in separated plasma container 38 of fluid flow circuit 12), while the concentrated fluid is returned to a fluid recipient during a return or reinfusion phase or mode (FIG. 6). In one embodiment, the aspiration and return phases alternate repeatedly (aspirating from the fluid source, separating the fluid into plasma and concentrated fluid, and then returning the concentrated fluid to the fluid recipient) until a goal (e.g., collected volume of separated plasma) is achieved. All aspiration phases and all return phases may be identical or different from one another. For example, the final aspiration phase may aspirate less fluid from the fluid source than the previous aspiration phases, and the final return phase may infuse a combination of concentrated and replacement fluid into the fluid recipient, while the previous return phases may return only concentrated fluid to the fluid recipient.

[0030] FIG. 7 illustrates an exemplary stage or mode in which substitution fluid (e.g., saline) is delivered to a fluid recipient alone or with a quantity of concentrate fluid. In the stage of FIG. 7, a clamp or valve 36d associated with substitution fluid line 40 is opened to allow substitution fluid to flow from substitution fluid source 42. A clamp or valve 36a associated with suction branch 22a of source / recipient access line 22 may be in a closed state to prevent fluid flow therethrough, such that substitution fluid is directed into blood separation chamber 28. Substitution fluid is drawn from blood separation chamber 28 and placed into concentrate fluid reservoir 32 by operation of pump 20c associated with concentrate fluid outlet line 30. If concentrate fluid is present in concentrate fluid reservoir 32, the substitution fluid mixes with the concentrate fluid before being pumped to the fluid recipient by pump 20a associated with source / recipient access line 22, or the substitution fluid may be pumped alone to the fluid recipient. 7 is performed only once as a final return step (e.g., when the amount of concentrate fluid in concentrate reservoir 32 is at a sufficiently low level), where the concentrate and substitution fluid are returned to the fluid recipient. This can be advantageous to ensure that all concentrate fluid in concentrate reservoir 32 (along with any remaining in blood separation chamber 28) is flushed out of concentrate reservoir 32 and pumped to the fluid recipient.

[0031] 7 may be performed at other times, such as early in a procedure, at multiple scheduled times during a procedure, and / or at any time upon request from the operator, and / or may use different paths between the substitution fluid source 42 and the fluid recipient. For example, when substitution fluid is pumped to the fluid recipient early in a procedure, it may be advantageous for the substitution fluid to bypass the blood separation chamber 28 and the concentrate fluid reservoir 32. In this case, the clamp or valve 36d associated with the substitution fluid line 40 and the clamp or valve 36a associated with the suction branch 22a of the source / recipient access line 22 may be opened to allow fluid flow therethrough, and the clamp or valve 36b associated with the reinfusion branch 22b may be closed to prevent fluid flow. Pump 20a associated with source / recipient access line 22 can be activated (with the other two pumps 20b and 20c stopped) to draw replacement fluid from replacement fluid source 42 through replacement fluid line 40, suction branch 22a, and finally, through source / recipient access line 22 to the fluid recipient.

[0032] The illustrated fluid flow circuit 12 and procedure is a "single-needle" variation, in which the same blood source access (e.g., needle) is used for both drawing blood from the blood source and returning fluid to the blood source. In other embodiments, two blood source / recipient accesses are incorporated into the fluid flow circuit, allowing for a "two-needle" variation of the procedure, in which blood can be drawn from the blood source (via a first needle or blood source access) and fluid can be simultaneously delivered to the blood source or other recipient (via a second needle or recipient access). It should be understood that the present disclosure is not limited to either a single-needle or a two-needle procedure, or to any particular blood separation method (e.g., by a centrifuge or spinning membrane separator), or to any particular separation procedure (e.g., separating blood into plasma and cellular blood components, or separating blood into plasma, buffy coat, and red blood cells).

[0033] The execution of the blood separation procedure by the controller 16 depends on data received by the controller 16, which is typically received from a data management system or entered by the operator using the data input device 64. FIGS. 8A and 8B show example images that may be displayed on the screen of the data input device 64, with FIG. 8A showing a pre-processing image requesting various information from the operator. The example screen of FIG. 8A includes various fields 66a-66i for receiving and displaying data entered by the operator, including: a first field 66a for providing a procedure ID, a second field 66b for providing a blood donation setting ID, a third field 66c for providing a blood source ID, a fourth field 66d for providing the gender of the human blood source, a fifth field 66e for providing the height of the human blood source, a sixth field 66f for providing the weight of the human blood source, a seventh field 66g for providing information about the blood of the blood source (e.g., hemoglobin or hematocrit level or platelet precount), an eighth field 66h for providing a procedure parameter (e.g., target saline volume), and a ninth field 66i for providing additional procedure parameters (e.g., target plasma collection volume or target combined volume of collected plasma and anticoagulant). It should be understood that the data requested in the screen of FIG. 8A is merely exemplary, and that the data input device 64 may request additional or different information from the operator.

[0034] The image of FIG. 8B can be thought of as a summary or confirmation screen displaying various data entries after they have all been entered by the operator using the screen of FIG. 8A. In addition to nine fields 68a-68i corresponding to the nine fields 66a-66i (respectively), the screen of FIG. 8B includes an additional field 68j that does not display data entered by the operator but rather a value set by a center or administrator. In the illustrated example, this is the anticoagulant-to-whole blood ratio. Alternatively, field 68j may display a calculated value derived from one or more inputs provided by the operator using data input device 64, or the screen may include one or more additional fields, each displaying a different calculated value. This calculated value may be any of many possible values, including, but not limited to, the anticoagulant to whole blood ratio, the body mass index of the human source (which may be calculated using the height and weight of the blood source), the total blood volume of the source (which may be estimated using the height and weight of the human blood source according to known or new approaches, such as using the Lemmens-Bernstein-Brodsky equation), the total red blood cell or plasma volume of the source, the extracellular fluid volume of the source, and the estimated time required to complete the procedure. It is within the scope of this disclosure for multiple summary or confirmation screens (each displaying one or more calculated values) to be presented.

[0035] The controller 16 receives data from a data management system or data entered by an operator using the data input device 64 and calculates or is provided with calculated values. The controller 16 then controls the other components of the device 10 to perform the selected blood separation procedure.

[0036] According to one aspect of the present disclosure, the controller 16 is configured to perform two different versions of the same blood separation procedure, referred to herein as an “induction” or “mild” version and a “standard” version. The “induction” version of a given procedure is intended to be performed on blood sources that are unsuitable for the “standard” version for various reasons, and the “induction” version is intended to improve donor tolerance to the procedure by mitigating mild / moderate reactions. According to another aspect of the present disclosure, a blood source can “graduate” from the “induction” version of the procedure by successfully undergoing the “induction” version of the procedure one or more times to establish readiness for the “standard” version. Once such a blood source establishes readiness for the “standard” version of the procedure, that version may be implemented on that blood source for future iterations of the procedure.

[0037] An "introducing" version of a blood separation procedure may differ in many respects from a "standard" version. For example, the separation efficiency of the blood separation device 10 may be higher in the "standard" version than in the "introducing" version. In the procedure described above (separating cellular blood components from plasma), this difference manifests itself in a relatively high blood cell separation efficiency when performing the "standard" version of the procedure, and a lower blood cell separation efficiency when performing the "introducing" version of the procedure.

[0038] According to another possible difference, a greater percentage of blood and / or red blood cells from the blood source may be present in fluid flow circuit 12 at any particular time during a “standard” version of the procedure than during an “introduction” version. For example, as described above, it is possible to calculate the total blood volume or pre-procedure red blood cell volume of the blood source. When performing the “introduction” version of the procedure, controller 16 may operate other components of blood separation device 10 to allow no more than 14% of the calculated total blood volume and / or pre-procedure red blood cell volume of the blood source to be present in fluid flow circuit 12 at any particular time. When performing a “standard” version of the same procedure, controller 16 may operate other components of blood separation device 10 to allow a greater percentage (e.g., no more than 16%) of the calculated total blood volume and / or pre-procedure red blood cell volume of the blood source to be present in fluid flow circuit 12 at any particular time. Alternatively, different limits may be placed on the volume of source blood or red blood cells that may be present in fluid flow circuit 12 at any particular time during the procedure, with larger limits (e.g., 250 mL of red blood cells or 600 mL of blood) in a "standard" version of the procedure than in an "introduction" version of the procedure (e.g., 200 mL of red blood cells or 500 mL of blood).

[0039] It should be understood that 14% and 16% are merely exemplary and that other percentages can be used as limits for the "introductory" and "standard" versions of the procedure. According to one aspect of the present disclosure, a blood collection center or facility can set a range of percentages that can be used during a procedure. For example, the blood collection center can set a range of 12-16% of the calculated total blood and / or red blood cell volume of the blood source as the maximum allowable volume of blood and / or red blood cells that can be present in fluid flow circuit 12 at any particular time during the procedure. The operator can then instruct controller 16 (e.g., using data input device 64) which percentage within the predetermined range to employ when performing one of the versions of the blood separation procedure, as shown by icon 66j in FIG. 9A .

[0040] Similarly, it should be understood that 200 mL and 250 mL of red blood cells and 500 mL and 600 mL of blood are merely exemplary, and other volumes may be used as limits for the "introductory" and "standard" versions of the procedure. According to one aspect of the present disclosure, a blood collection center or facility may be able to set a range of maximum volumes that may be used during a procedure. For example, the blood collection center may set a maximum allowable volume of red blood cells in the range of 150-250 mL and / or a maximum allowable volume of blood in the range of 450-600 mL that may be present in fluid flow circuit 12 at any particular time during the procedure. The operator may then instruct controller 16 (e.g., using data input device 64) which volume within the predetermined range to use when performing one of the versions of the blood separation procedure, as shown by icon 66k in FIG. 9B .

[0041] According to yet another possible variation, a relatively large blood separation chamber 28 (allowing for a larger extracorporeal fluid volume) may be used when performing a “standard” version of a blood separation procedure, and a relatively small blood separation chamber 28 (accounting for a smaller extracorporeal fluid volume) may be used when performing an “introduction” version of the same procedure. The specific sizes and configurations of such “standard” and “introduction” blood separation chambers may vary without departing from the scope of the present disclosure. However, in exemplary embodiments, the sizes of the “standard” and “introduction” blood separation chambers may be selected based on the allowable extracorporeal fluid volume for the associated version of the procedure (e.g., an “introduction” blood separation chamber may allow for no more than 14% of the volume of source blood present in fluid flow circuit 12 at any time when performing an “introduction” version of the procedure, and a “standard” blood separation chamber may allow for no more than 16% of the volume of source blood present in fluid flow circuit 12 at any time when performing a “standard” version of the procedure).

[0042] According to another possible variation, when performing a “standard” version of a blood separation procedure, one or more steps of the procedure may be enhanced. For example, a blood draw step (shown in FIG. 5 ) performed in a “standard” version of a blood separation procedure may have a different duration than the same step in an “introduction” version of the same procedure. The controller 16 may also (or instead) operate the pump system to draw blood from the blood source at a different (typically higher) rate during the blood draw step in the “standard” version compared to the draw rate during “introduction.” This may include different minimum and / or maximum draw rates for each version of the procedure. In general, more blood may be drawn from the blood source during a blood draw step in a “standard” version of the procedure than during a blood draw step in an “introduction” version of the same procedure. In embodiments in which multiple blood draw steps are performed (typically “single-needle” procedures), it may be advantageous to have a particularly low blood draw rate (for donor comfort) in the first blood draw step in the “introduction” version of the procedure, with the blood draw rate increased in one or more subsequent blood draw steps.

[0043] Similarly, a fluid return step performed during a “standard” version of a blood separation procedure (as shown in FIGS. 6 and 7 ) may have a different duration than the same step during an “introduction” version of the same procedure. Controller 16 may also (or instead) operate the pump system to deliver fluid to the recipient (e.g., blood source) at a different rate during the fluid return step of the “standard” version compared to the fluid return rate in the “introduction” version. This may include different minimum and / or maximum return rates for each version of the procedure. Generally, more fluid may be delivered to the recipient during the fluid return step of the “standard” version of the procedure than during the fluid return step of the “introduction” version of the same procedure (because more blood may be drawn from the source during the “standard” version). In embodiments in which multiple fluid return steps are performed (typically “single-needle” procedures), it may be advantageous (for donor comfort) for the initial fluid return step of the “introduction” version of the procedure to have a particularly low return rate, with the return rate increasing in one or more subsequent fluid return steps.

[0044] According to one aspect of the present disclosure, parameters for one or both versions of the procedure may be configured when the device 10 is installed and set up, and / or may be adjusted by the operator before or at the start of the procedure. This may include ranges or limits on parameters that the operator can select (e.g., if the operator is limited to selecting a maximum extracorporeal blood volume from a range of values).

[0045] The criteria for designating a blood source for an "induction" or "standard" version of the blood separation procedure can vary without departing from the scope of the present disclosure. This screening process may include blood sources designated as eligible for the "induction" version, eligible for the "standard" version, not eligible for the "induction" version, or not eligible for the "standard" version. By way of example, the age of the blood source may be a factor in determining which version of the blood separation procedure to perform, with the "induction" version tending to be more appropriate for particularly young blood sources and particularly older blood sources. An additional or alternative factor may be the weight of the blood source, with the "induction" version tending to be more appropriate for lighter blood sources. The gender of the blood source may be another factor (which may be considered together with or independently of other factors), with the "induction" version often being more appropriate for female blood sources. Yet another factor may be the condition of the blood source on the day of the procedure (e.g., whether there is something about the condition of the blood source on the day of the procedure that suggests a gentler version may be recommended).

[0046] Yet another consideration is whether a blood separation procedure (or equivalent) has previously been performed on the blood source. If the blood source has not undergone this procedure (or equivalent), an "introduction" version of the procedure may be more appropriate than a "standard" version. If the blood source has previously undergone the procedure (or equivalent), it may be advantageous to consider the number of times blood has been drawn from the blood source. This may include the number of times blood has been drawn from the blood source within a certain period of time (e.g., to assess whether the blood source is an active and regular participant or whether participation has recently ended) and / or the average frequency or number of times blood has been drawn from the blood source within the relevant period of time.

[0047] The blood draw history of a blood source may be implemented as a factor in any of a number of ways. In one embodiment, the “history” element is treated as a status; for example, the blood source is classified as “new,” “expired,” or “regular.” A blood source that has never undergone a particular procedure (or an equivalent procedure) may be classified as a “new” blood source. A blood source that has undergone a particular procedure (or an equivalent procedure) in the past, but not recently (or not recently and regularly enough) may be classified as an “expired” blood source. A blood source that has recently undergone a particular procedure (or an equivalent procedure) regularly may be classified as a “regular” blood source. Different statuses may be assigned different numerical values ​​or “points” by the controller 16 when determining which version of a procedure to perform (e.g., 0 for a “new” blood source, 1 for an “expired” blood source, 2 for a “regular” blood source). A blood source with a “regular” status is more likely to be considered suitable for performing the “standard” version (because it has more “points”) than an “expired” or “new” blood source.

[0048] In another embodiment, the "history" factor may be treated as a number equal to the number of times blood has been drawn from the blood source in the past, or the number of times the blood source has undergone a particular procedure (or an equivalent procedure). When different types of procedures are included in the count, certain procedures (e.g., procedures identical to the particular procedure being implemented) may be given a higher numerical value or weight than other procedures (e.g., procedures similar to but different from the procedure being implemented). Similar to embodiments in which the "history" factor is treated as a status, a blood source that has undergone a particular procedure (or an equivalent procedure) more frequently may be more likely to qualify for the "standard" version of the blood separation procedure because it has more "points" or progresses toward the qualification threshold than a less experienced blood source.

[0049] When multiple factors (e.g., the blood source's age, sex, blood collection history) are considered in determining which version of the procedure to administer, they may be given the same or different weights. For example, the blood source's blood collection history may be more important (and therefore given more weight) than the blood source's age or sex. If the blood source's age and sex are typically appropriate for an "introduction" version of the procedure, those factors may be given more weight in a blood source that has successfully undergone a "standard" version of the procedure (or has successfully undergone a similar blood separation procedure).

[0050] Because some of the above factors may change during the life of the blood source, they may be periodically reevaluated to determine whether subsequent blood separation procedures should be performed according to the "introduction" version or the "standard" version. Indeed, it may be more common for a blood source to "graduate" from the "introduction" version of the procedure to the "standard" version (e.g., by undergoing the "introduction" version of the procedure a certain number of times), but it is also possible for a blood source to transition from the "standard" version to the "introduction" version (e.g., if the blood source loses significant weight).

[0051] The decision regarding which version of the blood separation procedure to implement (including whether to change the blood source from one version to another) can be made in any of a number of ways. For example, the controller 16 can determine which version of the procedure to implement based on information provided (e.g., by the operator via the data input device 64 or via the data management system) and then proceed to implement that version of the procedure without input from the operator. In another embodiment, the controller 16 can provide the operator with a recommended version of the procedure, and the operator has the option of implementing either the recommended version or a different version. This can involve providing the operator with an icon 70 ( FIG. 8B ) or button, and the appropriate parameters (e.g., aspiration and return rates, volume of blood processed per cycle, maximum allowable extracorporeal blood volume, maximum allowable extracorporeal red blood cell volume, etc.) are automatically implemented by the controller 16. In yet another embodiment, the operator can be allowed to select which version of the procedure to implement (e.g., using the icon 70 or button, etc.) without receiving input from the controller 16. In yet another embodiment, another authority (e.g., a “front desk” operator or a central controller) can be allowed to determine which version of the procedure to implement. Instructing the control unit 16 to execute one version or another of a procedure may be as simple as setting a single flag value in a procedure configuration file, or may be implemented in other ways without departing from the scope of this disclosure.

[0052] Although "introductory" and "standard" versions of blood separation procedures are described herein, it should be understood that the present disclosure is not limited to performing an "introductory" or "mild" version of a procedure and a "standard" version of the same procedure. For example, two "standard" versions of a blood separation procedure may be available, and one version may not be presented as a "mild" version of the procedure; rather, the two versions are substantially equivalent alternatives that differ in some respect. Indeed, the manner in which the two versions of a particular blood separation procedure differ may vary without departing from the scope of the present disclosure.

[0053] While the implementation of the "introductory" and "standard" versions of a given blood separation procedure is described above as being performed by a single blood separation device 10, it should be understood that multiple blood separation devices (which may be similar or different) may instead be used. According to this approach, a first device may be configured to perform a first version of the procedure (e.g., the "introductory" version), and a second device may be configured to perform a second version of the procedure (e.g., the "standard" version). Thus, a blood source may "graduate" from the first or "introductory" version to the second or "standard" version of the procedure by transitioning from use of the first device to use of the second device.

[0054] Additionally, while an "introductory" version and a "standard" version of a given blood separation procedure are described above, it should be understood that a single blood separation device may be configured to perform three or more different versions of a particular procedure (e.g., an "introductory" version, an "intermediate" version, and a "standard" version). Similarly, if three or more different versions of a particular procedure are available, then an equal number of similarly or differently configured blood separation devices may be provided, each configured to perform one of the versions of the procedure.

[0055] Aspects Aspect 1 A method for performing a blood separation procedure, the method comprising: selecting a first blood separation device configured to perform a first version of the blood separation procedure, a second blood separation device configured to perform a second version of the blood separation procedure, or a single blood separation device configured to perform both the first and second versions of the blood separation procedure; determining whether a blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not suitable for the first version of the blood separation procedure; performing the first version of the blood separation procedure on the blood source if it is determined that the blood source is suitable for the first version of the blood separation procedure and / or if it is determined that the blood source is not suitable for the second version of the blood separation procedure; and performing the second version of the blood separation procedure on the blood source if it is determined that the blood source is suitable for the second version of the blood separation procedure and / or if it is determined that the blood source is not suitable for the first version of the blood separation procedure.

[0056] Aspect 2 The method of embodiment 1, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure comprises assessing the age of the blood source.

[0057] Aspect 3 The method of embodiment 1 or embodiment 2, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure comprises assessing a weight of the blood source.

[0058] Aspect 4 The method of any one of aspects 1 to 3, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure comprises assessing the gender of the blood source.

[0059] Aspect 5 The method of any one of aspects 1 to 4, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure comprises assessing whether a blood separation procedure has previously been performed on the blood source.

[0060] Aspect 6 The method of embodiment 5, wherein assessing whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as a "new" blood source if a blood separation procedure has not previously been performed on the blood source.

[0061] Aspect 7 The method of embodiment 5 or embodiment 6, wherein assessing whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as an "expired" blood source if a predetermined amount of time has passed since the last time a blood separation procedure was performed on the blood source.

[0062] Aspect 8 The method of any one of aspects 5 to 7, wherein assessing whether a blood separation procedure has previously been performed on the blood source comprises classifying the blood source as a “regular” blood source if a blood separation procedure has been performed on the blood source more recently than a predetermined time.

[0063] Aspect 9 The method of any one of aspects 5 to 8, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes assigning one of a plurality of statuses to the blood source based at least in part on whether a blood separation procedure has previously been performed on the blood source, wherein each of the plurality of statuses is given a different value or weight when determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure.

[0064] Aspect 10 The method of any one of aspects 1 to 9, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure comprises assessing the number of times blood has been drawn from the blood source.

[0065] Aspect 11 11. The method of embodiment 10, wherein assessing the number of times blood is drawn from the blood source comprises assessing the number of times blood is drawn from the blood source within a period of time.

[0066] Aspect 12 12. The method of embodiment 11, wherein assessing the number of times blood is drawn from the blood source comprises assessing the average number of times blood is drawn from the blood source within the time period.

[0067] Aspect 13 The method of any one of aspects 10 to 12, wherein assessing the number of times blood has been drawn from the blood source includes determining the type of previous blood drawing procedure performed on the blood source while blood has been drawn from the blood source.

[0068] Aspect 14 The method of aspect 13, wherein determining the type of previous blood suction procedure includes selecting from multiple types of blood suction procedures when determining whether the blood source is eligible for a first version of the blood separation procedure or a second version of the blood separation procedure, and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and assigning different values ​​or weights to at least two different types of blood suction procedures.

[0069] Aspect 15 The method of aspect 14, wherein the first type of type of blood suction procedure is a blood separation procedure performed on the blood source and the second type of type of blood suction procedure is not a blood separation procedure performed on the blood source, and when determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, a greater value or weight is given to the first type of blood suction procedure than the second type of blood suction procedure.

[0070] Aspect 16

[0033] Aspect 16. The method of any one of aspects 1 to aspect 15, wherein the blood separation procedure comprises separating blood from a blood source into cellular blood components and plasma, and transporting at least a portion of the cellular blood components to a recipient.

[0071] Aspect 17 The method of embodiment 16, wherein the blood source is the recipient.

[0072] Aspect 18 The method of embodiment 16 or embodiment 17, wherein a blood cell separation efficiency of the first version of the blood separation procedure is different from a blood cell separation efficiency of the second version of the blood separation procedure.

[0073] Aspect 19 The method of any one of aspects 16 to 18, further comprising determining a pre-procedure volume of red blood cells of the blood source, wherein performing the blood separation procedure includes separating blood from the blood source in a fluid flow circuit, wherein when performing a first version of the blood separation procedure, at any time, a volume of red blood cells less than a selected percentage or a maximum volume of the pre-procedure volume of red blood cells is allowed to be present in the fluid flow circuit, and when performing a second version of the blood separation procedure, at least once, a volume of red blood cells different from the selected percentage or the maximum volume of the pre-procedure volume of red blood cells is allowed to be present in the fluid flow circuit.

[0074] Aspect 20 The method of any one of aspects 16 to 18, further comprising determining a total blood volume of the blood source, wherein performing the blood separation procedure includes separating blood from the blood source within the fluid flow circuit, wherein at any time during performance of the first version of the blood separation procedure, a volume of blood less than a selected percentage or a maximum volume of the total blood volume is allowed to be present within the fluid flow circuit, and wherein when performing the second version of the blood separation procedure, a volume of blood different from the selected percentage or the maximum volume of the total blood volume is allowed to be present within the fluid flow circuit at least once.

[0075] Aspect 21 The method of any one of aspects 1 to 20, wherein performing a first version of the blood separation procedure includes separating blood from the blood source in a first blood separation chamber, and performing a second version of the blood separation procedure includes separating blood from the blood source in a second blood separation chamber having a different volume than the first blood separation chamber.

[0076] Aspect 22 A method according to any one of aspects 1 to 21, wherein performing a first version of the blood separation procedure includes executing a first blood suction stage having a certain duration, a certain blood suction rate, and a certain blood suction volume, and performing a second version of the blood separation procedure includes executing a second blood suction stage having a different duration, blood suction rate, and / or blood suction volume than the first blood suction stage.

[0077] Aspect 23 A method as described in any one of aspects 1 to 22, wherein performing a first version of the blood separation procedure includes executing a first fluid return stage having a certain duration, a certain return rate, and a certain fluid return volume, and performing a second version of the blood separation procedure includes executing a second fluid return stage having a different duration, return rate, and / or fluid return volume than the first fluid return stage.

[0078] Aspect 24 A blood separation device, comprising: a pump system; a clamp system; a separation actuator; and a controller programmed with a first version and a second version of a blood separation procedure in which the pump system, the clamp system, and the separation actuator are activated to draw blood from a blood source, separate the blood into at least two blood components, and deliver at least a portion of one of the blood components to a recipient, wherein the controller determines or is instructed that the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determines that the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure. a blood separation device configured to perform a first version of a blood separation procedure on a blood source when the blood source is determined to be suitable for or is instructed to perform the first version of the blood separation procedure and / or when the blood source is determined to be unsuitable for or is instructed to perform the second version of the blood separation procedure on the blood source when the blood source is determined to be suitable for or is instructed to perform the second version of the blood separation procedure and / or when the blood source is determined to be unsuitable for or is instructed to perform the first version of the blood separation procedure on the blood source.

[0079] Aspect 25 25. The blood separation device of embodiment 24, wherein performance of the first version versus the second version of the blood separation procedure is based at least in part on the age of the blood source.

[0080] Aspect 26 26. The blood separation device of embodiment 24 or embodiment 25, wherein the implementation of the first version versus the second version of the blood separation procedure is based at least in part on the weight of the blood source.

[0081] Aspect 27 A blood separation device according to any one of aspects 24 to 26, wherein the implementation of the first version versus the second version of the blood separation procedure is based at least in part on the gender of the blood source.

[0082] Aspect 28 A blood separation device according to any one of aspects 24 to 27, wherein the implementation of the first version versus the second version of the blood separation procedure is based, at least in part, on whether a blood separation procedure has previously been performed on the blood source.

[0083] Aspect 29 A blood separation device as described in embodiment 28, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as a ``new'' blood source if a blood separation procedure has not previously been performed on the blood source.

[0084] Aspect 30 A blood separation device as described in embodiment 28 or embodiment 29, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as an ``expired'' blood source if a predetermined time has passed since the blood separation procedure was last performed on the blood source.

[0085] Aspect 31 A blood separation device as described in any one of aspects 28 to 30, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as a ``regular'' blood source if a blood separation procedure has been performed on the blood source more recently than a predetermined time.

[0086] Aspect 32 A blood separation device as described in any one of aspects 28 to 31, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes assigning one of a plurality of statuses to the blood source based at least in part on whether a blood separation procedure has previously been performed on the blood source, each of the plurality of statuses being given a different value or weight when determining whether the blood source is eligible for a first version of the blood separation procedure or a second version of the blood separation procedure and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure.

[0087] Aspect 33 A blood separation device according to any one of aspects 24 to 32, wherein the implementation of the first version versus the second version of the blood separation procedure is based, at least in part, on the number of times blood is drawn from the blood source.

[0088] Aspect 34 34. The blood separation device of embodiment 33, wherein the number of times blood is drawn from the blood source comprises the number of times blood is drawn from the blood source within a period of time.

[0089] Aspect 35 35. The blood separation device of embodiment 34, wherein the number of times blood is drawn from the blood source comprises an average number of times blood is drawn from the blood source within the period of time.

[0090] Aspect 36 A blood separation device described in any one of aspects 33 to 35, wherein evaluating the number of times blood has been drawn from the blood source includes determining the type of previous blood drawing procedure performed on the blood source while blood has been drawn from the blood source.

[0091] Aspect 37 A blood separation device as described in aspect 36, wherein determining the type of previous blood suction procedure includes selecting from multiple types of blood suction procedures when determining whether the blood source is eligible for a first version of the blood separation procedure or a second version of the blood separation procedure, and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and assigning different values ​​or weights to at least two different types of blood suction procedures.

[0092] Aspect 38 the first type of type of blood aspiration procedure is a blood separation procedure performed on the blood source and the second type of type of blood aspiration procedure is not a blood separation procedure performed on the blood source, and a greater value or weight is given to the first type of blood aspiration procedure than the second type of blood aspiration procedure when determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure; 38. A blood separation device according to embodiment 37.

[0093] Aspect 39 A blood separation device according to any one of aspects 24 to 38, wherein the blood separation procedure includes separating blood from a blood source into cellular blood components and plasma, and transporting at least a portion of the cellular blood components to a recipient.

[0094] Aspect 40 40. The blood separation device of embodiment 39, wherein the blood source is a recipient.

[0095] Aspect 41 A blood separation device according to embodiment 39 or embodiment 40, wherein a blood cell separation efficiency of the first version of the blood separation procedure is different from a blood cell separation efficiency of the second version of the blood separation procedure.

[0096] Aspect 42 A blood separation device described in any one of aspects 39 to 41, wherein the control unit is further configured to determine a pre-procedure volume of red blood cells of the blood source or to provide a pre-procedure volume of red blood cells of the blood source, and performing the blood separation procedure includes separating blood from the blood source in the fluid flow circuit, and when performing a first version of the blood separation procedure, at any time, a volume of red blood cells less than a selected percentage of the pre-procedure volume of red blood cells is allowed to be present in the fluid flow circuit, and when performing a second version of the blood separation procedure, at least once, a volume of red blood cells different from the selected percentage of the pre-procedure volume of red blood cells is allowed to be present in the fluid flow circuit.

[0097] Aspect 43 A blood separation device described in any one of aspects 39 to 41, wherein the control unit is further configured to determine the total blood volume of the blood source or to be provided with the total blood volume of the blood source, and performing the blood separation procedure includes separating blood from the blood source in the fluid flow circuit, and when performing a first version of the blood separation procedure, a volume of blood less than a selected percentage of the total blood volume is allowed to be present in the fluid flow circuit at any time, and when performing a second version of the blood separation procedure, a volume of blood different from the selected percentage of the total blood volume is allowed to be present in the fluid flow circuit at least once.

[0098] Aspect 44 A blood separation device described in any one of aspects 24 to 43, wherein performing a first version of the blood separation procedure includes separating blood from the blood source in a first blood separation chamber, and performing a second version of the blood separation procedure includes separating blood from the blood source in a second blood separation chamber having a different volume than the first blood separation chamber.

[0099] Aspect 45 A blood separation device described in any one of aspects 24 to 44, wherein performing a first version of the blood separation procedure includes performing a first blood suction stage having a certain duration, a certain blood suction rate, and a certain blood suction volume, and performing a second version of the blood separation procedure includes performing a second blood suction stage having a different duration, blood suction rate, and / or blood suction volume than the first blood suction stage.

[0100] Aspect 46 A blood separation device described in any one of aspects 24 to 45, wherein performing a first version of the blood separation procedure includes executing a first fluid return stage having a certain duration, a certain return rate, and a certain fluid return volume, and performing a second version of the blood separation procedure includes executing a second fluid return stage having a different duration, return rate, and / or fluid return volume than the first fluid return stage.

[0101] Aspect 47 A blood separation device described in any one of aspects 24 to 46, further comprising a data input device including a button or icon configured to be operated by an operator to instruct the control unit to perform a first version of the blood separation procedure.

[0102] Aspect 48 A blood separation device described in any one of aspects 24 to 46, further comprising a data input device configured to receive input data regarding the blood source, and wherein the control unit is configured to determine whether to perform a first version of the blood separation procedure versus a second version of the blood separation procedure based at least in part on the input data.

[0103] Aspect 49 A blood separation device comprising: a pump system; a clamp system; a separation actuator; and a controller configured to operate the pump system, the clamp system, and the separation actuator to perform a blood separation procedure in which a volume of blood having a volume of red blood cells is present in the fluid flow circuit, wherein the controller is further configured to receive instructions for a maximum percentage and / or maximum volume of the total blood volume of the blood source that may be present in the fluid flow circuit at any time during the blood separation procedure, and / or a maximum percentage and / or maximum volume of the pre-procedure red blood cell volume of the blood source that may be present in the fluid flow circuit at any time during the blood separation procedure.

[0104] Aspect 50 50. The blood separation device of embodiment 49, wherein a maximum percentage of the total blood volume of the blood source and / or a maximum volume that may be present in the fluid flow circuit at any time during the blood separation procedure is limited to a predetermined range.

[0105] Aspect 51 A blood separation device as described in aspect 50, further comprising a data input device configured to communicate with the control unit, the control unit being further configured to allow an operator to operate the data input device to select from a predetermined range a maximum percentage and / or maximum volume of the total blood volume of the blood source that may be present in the fluid flow circuit at any point during the blood separation procedure.

[0106] Aspect 52 A blood separation device described in any one of aspects 49 to 51, wherein the maximum percentage and / or maximum volume of pre-procedure red blood cell volume of the blood source that may be present in the fluid flow circuit at any point during the blood separation procedure is limited to within a predetermined range.

[0107] Aspect 53 A blood separation device as described in embodiment 52, further comprising a data input device configured to communicate with the control unit, the control unit being further configured to allow an operator to operate the data input device to select from a predetermined range a maximum percentage and / or maximum volume of pre-procedure red blood cell volume of the blood source that may be present in the fluid flow circuit at any point during the blood separation procedure.

[0108] Aspect 54 A computer-implemented method for performing a blood separation procedure using a first blood separation device configured to perform a first version of the blood separation procedure and a second blood separation device configured to perform a second version of the blood separation procedure, or a single blood separation device configured to perform both the first and second versions of the blood separation procedure, the method including: determining whether a blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure; initiating or prompting an operator to initiate the first version of the blood separation procedure on the blood source if it is determined that the blood source is eligible for the first version of the blood separation procedure and / or if it is determined that the blood source is not eligible for the second version of the blood separation procedure; and initiating or prompting an operator to initiate the second version of the blood separation procedure on the blood source if it is determined that the blood source is eligible for the second version of the blood separation procedure and / or if it is determined that the blood source is not eligible for the first version of the blood separation procedure.

[0109] Aspect 55 The method of embodiment 54, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure includes assessing the age of the blood source.

[0110] Aspect 56 The method of embodiment 54 or embodiment 55, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure includes evaluating the weight of the blood source.

[0111] Aspect 57 A method according to any one of aspects 54 to 56, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure includes assessing the gender of the blood source.

[0112] Aspect 58 A method according to any one of aspects 54 to 57, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure comprises assessing whether a blood separation procedure has previously been performed on the blood source.

[0113] Aspect 59 The method of embodiment 58, wherein assessing whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as a "new" blood source if a blood separation procedure has not previously been performed on the blood source.

[0114] Aspect 60 The method of embodiment 58 or embodiment 59, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as an "expired" blood source if a predetermined time has passed since the blood separation procedure was last performed on the blood source.

[0115] Aspect 61 A method as described in any one of aspects 58 to 60, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes classifying the blood source as a “regular” blood source if a blood separation procedure has been performed on the blood source more recently than a predetermined time.

[0116] Aspect 62 A method according to any one of aspects 58 to 61, wherein evaluating whether a blood separation procedure has previously been performed on the blood source includes assigning one of a plurality of statuses to the blood source based at least in part on whether a blood separation procedure has previously been performed on the blood source, each of the plurality of statuses being given a different value or weight when determining whether the blood source is eligible for a first version of the blood separation procedure or a second version of the blood separation procedure, and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure.

[0117] Aspect 63 A method according to any one of aspects 54 to 62, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure comprises evaluating the number of times blood has been drawn from the blood source.

[0118] Aspect 64 64. The method of embodiment 63, wherein assessing the number of times blood is drawn from the blood source comprises assessing the number of times blood is drawn from the blood source within a period of time.

[0119] Aspect 65 65. The method of embodiment 64, wherein assessing the number of times blood is drawn from the blood source comprises assessing the average number of times blood is drawn from the blood source within the period of time.

[0120] Aspect 66 A method as described in any one of aspects 63 to 65, wherein assessing the number of times blood has been drawn from the blood source includes determining the type of previous blood drawing procedure performed on the blood source while blood has been drawn from the blood source.

[0121] Aspect 67 The method of embodiment 66, wherein determining the type of previous blood suction procedure includes selecting from multiple types of blood suction procedures when determining whether the blood source is eligible for a first version of the blood separation procedure or a second version of the blood separation procedure, and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and assigning different values ​​or weights to at least two different types of blood suction procedures.

[0122] Aspect 68 the first type of type of blood aspiration procedure is a blood separation procedure performed on the blood source and the second type of type of blood aspiration procedure is not a blood separation procedure performed on the blood source, and a greater value or weight is given to the first type of blood aspiration procedure than the second type of blood aspiration procedure when determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure; 68. The method of embodiment 67.

[0123] Aspect 69 The method of any one of aspects 54 to 68, wherein the blood separation procedure includes separating blood from a blood source into cellular blood components and plasma, and transporting at least a portion of the cellular blood components to a recipient.

[0124] Aspect 70 The method of embodiment 69, wherein the blood source is the recipient.

[0125] Aspect 71 The method of embodiment 69 or embodiment 70, wherein the blood cell separation efficiency of the first version of the blood separation procedure is different from the blood cell separation efficiency of the second version of the blood separation procedure.

[0126] Aspect 72 A method according to any one of aspects 69 to 71, further comprising determining a pre-procedure volume of red blood cells in the blood source, wherein performing the blood separation procedure includes separating blood from the blood source in a fluid flow circuit, wherein when performing a first version of the blood separation procedure, at any time, a volume of red blood cells less than a selected percentage or maximum volume of the pre-procedure volume of red blood cells is allowed to be present in the fluid flow circuit, and when performing a second version of the blood separation procedure, at least once, a volume of red blood cells different from the selected percentage or maximum volume of the pre-procedure volume of red blood cells is allowed to be present in the fluid flow circuit.

[0127] Aspect 73 A method according to any one of aspects 69 to 71, further comprising determining a total blood volume of the blood source, wherein performing the blood separation procedure includes separating blood from the blood source within the fluid flow circuit, wherein at any time when performing the first version of the blood separation procedure, a volume of blood less than a selected percentage or a maximum volume of the total blood volume is allowed to be present in the fluid flow circuit, and when performing the second version of the blood separation procedure, a volume of blood different from the selected percentage or the maximum volume of the total blood volume is allowed to be present in the fluid flow circuit at least once.

[0128] Aspect 74 A method described in any one of aspects 54 to 73, wherein performing a first version of the blood separation procedure includes separating blood from the blood source in a first blood separation chamber, and performing a second version of the blood separation procedure includes separating blood from the blood source in a second blood separation chamber having a different volume than the first blood separation chamber.

[0129] Aspect 75 A method described in any one of aspects 54 to 74, wherein performing a first version of the blood separation procedure includes performing a first blood suction stage having a certain duration, a certain blood suction rate, and a certain blood suction volume, and performing a second version of the blood separation procedure includes performing a second blood suction stage having a different duration, blood suction rate, and / or blood suction volume than the first blood suction stage.

[0130] Aspect 76 A method described in any one of aspects 54 to 75, wherein performing a first version of the blood separation procedure includes performing a first fluid return stage having a certain duration, a certain return rate, and a certain fluid return volume, and performing a second version of the blood separation procedure includes performing a second fluid return stage having a different duration, return rate, and / or fluid return volume than the first fluid return stage.

[0131] It will be understood that the above-described embodiments and examples are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including combinations of features that are individually disclosed or claimed herein. For these reasons, it will be understood that the scope of the invention is not limited to the above description, but is set forth in the claims, and that the claims may be directed to features of the specification, including combinations of features that are individually disclosed or claimed herein.

Claims

1. A method implemented in a computer for performing a blood separation procedure using a first blood separation device configured to perform a first version of the blood separation procedure and a second blood separation device configured to perform a second version of the blood separation procedure, or a single blood separation device configured to perform both the first and second versions of the blood separation procedure, The aforementioned method, Determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, If it is determined that the blood source is suitable for the first version of the blood separation procedure, and / or if it is determined that the blood source is not suitable for the second version of the blood separation procedure, the first version of the blood separation procedure for the blood source is initiated, or the operator is prompted to initiate it. The procedure includes, if it is determined that the blood source is suitable for the second version of the blood separation procedure, and / or if it is determined that the blood source is not suitable for the first version of the blood separation procedure, initiating the second version of the blood separation procedure for the blood source or prompting the operator to initiate it. Each of the first and second versions of the blood separation procedure has a plurality of procedure parameters, and at least one of the plurality of procedure parameters of the first version of the blood separation procedure is different from the corresponding procedure parameter of the second version of the blood separation procedure. A method wherein the blood separation procedure includes the same steps whether it is performed in the first version or the second version.

2. The method according to claim 1, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, includes evaluating the age of the blood source.

3. The method according to claim 1, wherein determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, includes evaluating the weight of the blood source.

4. The method according to claim 1, wherein determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, includes evaluating the sex of the blood source.

5. The method according to claim 1, wherein determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, includes evaluating whether the blood separation procedure has been previously performed on the blood source.

6. The method of claim 5, wherein evaluating whether the blood separation procedure has been previously performed on the blood source includes classifying the blood source as a “novel” blood source if the blood separation procedure has not been previously performed on the blood source.

7. The method of claim 5, wherein evaluating whether the blood separation procedure has been previously performed on the blood source includes classifying the blood source as an “expired” blood source if a predetermined amount of time has elapsed since the blood separation procedure was last performed on the blood source.

8. The method of claim 5, wherein evaluating whether the blood separation procedure has been previously performed on the blood source includes classifying the blood source as a “regular” blood source if the blood separation procedure has been performed on the blood source more recently than a predetermined time.

9. Evaluating whether the blood separation procedure has been previously performed on the blood source includes assigning one of a plurality of statuses to the blood source, at least in part, based on whether the blood separation procedure has been previously performed on the blood source. When determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or when determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, each of the multiple statuses is given a different value or weight. The method according to claim 5.

10. The method according to claim 1, wherein determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, includes evaluating the number of times blood has been aspirated from the blood source.

11. The method according to claim 10, wherein evaluating the number of times blood has been drawn from the blood source includes evaluating the number of times blood has been drawn from the blood source within a certain period of time.

12. The method according to claim 11, wherein evaluating the number of times blood was drawn from the blood source includes evaluating the average number of times blood was drawn from the blood source during the period.

13. The method of claim 10, wherein evaluating the number of times blood has been aspirated from the blood source includes determining the type of previous blood aspiration procedure performed on the blood source between the times blood was aspirated from the blood source.

14. The method of claim 13, wherein determining the type of the preceding blood aspiration procedure includes selecting from a plurality of types of blood aspiration procedures when determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and assigning different values ​​or weights to at least two different types of blood aspiration procedures.

15. The first type of the blood aspiration procedure is the blood separation procedure performed on the blood source, A second type of the blood aspiration procedure is not the blood separation procedure performed on the blood source, When determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or when determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, a greater value or weight is given to the first type of blood aspiration procedure than to the second type of blood aspiration procedure. The method according to claim 14.

16. The aforementioned blood separation procedure is: The blood from the aforementioned blood source is separated into cellular blood components and plasma, The method according to claim 1, comprising transporting at least a portion of the cellular blood components to a recipient.

17. The method according to claim 16, wherein the blood source is the recipient.

18. The method according to claim 16, wherein the hemocytosis efficiency of the first version of the blood separation procedure is different from the hemocytosis efficiency of the second version of the blood separation procedure.

19. The procedure further includes determining the volume of red blood cells in the blood source prior to the procedure, The execution of the blood separation procedure includes separating blood from the blood source in the fluid flow circuit, When performing the first version of the blood separation procedure, it is permissible at any point in time for a volume of red blood cells in the fluid flow circuit to be less than a selected percentage or the maximum volume of red blood cells prior to the procedure. The method according to claim 16, wherein when performing the second version of the blood separation procedure, it is permissible at least once for a volume of red blood cells in the fluid flow circuit that is different from the selected percentage or maximum volume of red blood cells prior to the procedure.

20. Further includes determining the total blood volume of the blood source, The execution of the blood separation procedure includes separating blood from the blood source in the fluid flow circuit, At any point in performing the first version of the blood separation procedure, it is permissible for a volume of blood less than a selected percentage or maximum volume of the total blood volume to be present in the fluid flow circuit. The method according to claim 16, wherein when the second version of the blood separation procedure is performed, it is permissible at least once for a volume of blood in the fluid flow circuit that is different from the selected percentage or maximum volume of the total blood volume.

21. Performing the first version of the blood separation procedure includes separating the blood from the blood source in a first blood separation chamber, The method according to any one of claims 1 to 20, wherein performing the second version of the blood separation procedure includes separating the blood from the blood source in a second blood separation chamber having a different volume from the first blood separation chamber.

22. Performing the first version of the blood separation procedure involves performing a first blood aspiration step having a certain duration, a certain blood aspiration rate, and a certain blood aspiration volume. The method according to any one of claims 1 to 20, wherein performing the second version of the blood separation procedure includes performing a second blood aspiration step having a different duration, blood aspiration rate, and / or blood aspiration volume than the first blood aspiration step.

23. Performing the first version of the blood separation procedure involves performing a first fluid return step having a certain duration, a certain return rate, and a certain fluid return volume, The method according to any one of claims 1 to 20, wherein performing the second version of the blood separation procedure includes performing a second fluid return step having a different duration, return rate, and / or fluid return volume than the first fluid return step.

24. A blood separation device, Pump system and, Clamp system and Separation actuator and The system comprises a pump system, a clamp system, and a control unit programmed with first and second versions of a blood separation procedure in which the pump system, the clamp system, and the separation actuator operate to draw blood from a blood source, separate the blood into at least two blood components, and deliver at least a portion of one of the blood components to a recipient. The control unit, It is determined or instructed that the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or it is determined or instructed that the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure. If it is determined or instructed that the blood source is suitable for the first version of the blood separation procedure, and / or if it is determined or instructed that the blood source is not suitable for the second version of the blood separation procedure, the first version of the blood separation procedure is performed on the blood source. The system is configured to perform the second version of the blood separation procedure on the blood source if it is determined or instructed that the blood source is suitable for the second version of the blood separation procedure, and / or if it is determined or instructed that the blood source is not suitable for the first version of the blood separation procedure. Each of the first and second versions of the blood separation procedure has a plurality of procedure parameters, and at least one of the plurality of procedure parameters of the first version of the blood separation procedure is different from the corresponding procedure parameter of the second version of the blood separation procedure. A blood separation apparatus wherein the blood separation procedure includes the same steps whether performed in the first or second version.

25. The blood separation apparatus according to claim 24, wherein the implementation of the first version versus the second version of the blood separation procedure is at least partially based on the age of the blood source.

26. The blood separation apparatus according to claim 24, wherein the implementation of the first version versus the second version of the blood separation procedure is at least partially based on the weight of the blood source.

27. The blood separation apparatus according to claim 24, wherein the implementation of the first version versus the second version of the blood separation procedure is at least partially based on the sex of the blood source.

28. The blood separation apparatus according to claim 24, wherein the implementation of the first version versus the second version of the blood separation procedure is at least in part based on whether the blood separation procedure has been previously performed on the blood source.

29. The blood separation apparatus according to claim 28, wherein evaluating whether the blood separation procedure has been previously performed on the blood source includes classifying the blood source as a "novel" blood source if the blood separation procedure has not been previously performed on the blood source.

30. The blood separation apparatus according to claim 28, wherein evaluating whether the blood separation procedure has been previously performed on the blood source includes classifying the blood source as an "expired" blood source if a predetermined amount of time has elapsed since the blood separation procedure was last performed on the blood source.

31. The blood separation apparatus according to claim 28, wherein evaluating whether the blood separation procedure has been previously performed on the blood source includes classifying the blood source as a “regular” blood source if the blood separation procedure has been performed on the blood source more recently than a predetermined time.

32. Evaluating whether the blood separation procedure has been previously performed on the blood source includes assigning one of a plurality of statuses to the blood source, at least in part, based on whether the blood separation procedure has been previously performed on the blood source. When determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or when determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, each of the multiple statuses is given a different value or weight. The blood separation apparatus according to claim 28.

33. The blood separation apparatus according to claim 24, wherein the implementation of the first version versus the second version of the blood separation procedure is at least partially based on the number of times blood has been aspirated from the blood source.

34. The blood separation apparatus according to claim 33, wherein the number of times blood has been aspirated from the blood source includes the number of times blood has been aspirated from the blood source within a certain period of time.

35. The blood separation apparatus according to claim 34, wherein the number of times blood was aspirated from the blood source includes the average number of times blood was aspirated from the blood source during the period.

36. The blood separation apparatus according to claim 33, wherein evaluating the number of times blood has been aspirated from the blood source includes determining the type of previous blood aspiration procedure performed on the blood source between the times blood was aspirated from the blood source.

37. The blood separation apparatus according to claim 36, wherein determining the type of the preceding blood aspiration procedure includes selecting from a plurality of types of blood aspiration procedures when determining whether the blood source is eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or when determining whether the blood source is not eligible for the first version of the blood separation procedure or the second version of the blood separation procedure, and assigning different values ​​or weights to at least two different types of blood aspiration procedures.

38. The first type of the blood aspiration procedure is the blood separation procedure performed on the blood source, A second type of the blood aspiration procedure is not the blood separation procedure performed on the blood source, When determining whether the blood source is suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, and / or when determining whether the blood source is not suitable for the first version of the blood separation procedure or the second version of the blood separation procedure, a greater value or weight is given to the first type of blood aspiration procedure than to the second type of blood aspiration procedure. The blood separation apparatus according to claim 37.

39. The aforementioned blood separation procedure is: The blood from the aforementioned blood source is separated into cellular blood components and plasma, The blood separation apparatus according to claim 24, further comprising transporting at least a portion of the cellular blood components to a recipient.

40. The blood separation apparatus according to claim 39, wherein the blood source is the recipient.

41. The blood separation apparatus according to claim 39, wherein the blood cell separation efficiency of the first version of the blood separation procedure is different from the blood cell separation efficiency of the second version of the blood separation procedure.

42. The control unit is further configured to determine the volume of red blood cells in the blood source before the procedure, or to provide the volume of red blood cells in the blood source before the procedure. The execution of the blood separation procedure includes separating blood from the blood source in the fluid flow circuit, When performing the first version of the blood separation procedure, it is permissible at any point in time for a volume of red blood cells in the fluid flow circuit to be less than a selected percentage of the volume of red blood cells before the procedure. The blood separation apparatus according to claim 39, wherein when performing the second version of the blood separation procedure, it is permissible at least once for a volume of red blood cells in the fluid flow circuit to be different from the selected percentage of the volume of red blood cells prior to the procedure.

43. The control unit is further configured to determine the total blood volume of the blood source, or to provide the total blood volume of the blood source. The execution of the blood separation procedure includes separating blood from the blood source in the fluid flow circuit, When performing the first version of the blood separation procedure, it is permissible at any point in time for a volume of blood less than a selected percentage of the total blood volume to be present in the fluid flow circuit. The blood separation apparatus according to claim 39, wherein when the second version of the blood separation procedure is performed, it is permissible at least once for a volume of blood different from the selected percentage of the total blood volume to be present in the fluid flow circuit.

44. Performing the first version of the blood separation procedure includes separating the blood from the blood source in a first blood separation chamber, The blood separation apparatus according to any one of claims 24 to 43, wherein performing the second version of the blood separation procedure includes separating the blood from the blood source in a second blood separation chamber having a different volume from the first blood separation chamber.

45. Performing the first version of the blood separation procedure involves performing a first blood aspiration step having a certain duration, a certain blood aspiration rate, and a certain blood aspiration volume. The blood separation apparatus according to any one of claims 24 to 43, wherein performing the second version of the blood separation procedure includes performing a second blood aspiration step having a different duration, blood aspiration rate, and / or blood aspiration volume than the first blood aspiration step.

46. Performing the first version of the blood separation procedure involves performing a first fluid return step having a certain duration, a certain return rate, and a certain fluid return volume, The blood separation apparatus according to any one of claims 24 to 43, wherein performing the second version of the blood separation procedure includes performing a second fluid return step having a different duration, return rate, and / or fluid return volume than the first fluid return step.

47. The blood separation apparatus according to any one of claims 24 to 43, further comprising a data input device including a button or icon configured to be operated by an operator to instruct the control unit to perform the first version of the blood separation procedure.

48. The blood separation apparatus according to any one of claims 24 to 43, further comprising a data input device configured to receive input data relating to a blood source, wherein the control unit is configured to determine, at least partially, whether to perform the first version of the blood separation procedure versus the second version of the blood separation procedure based on the input data.

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