Detection of data input error in blood separation system

Abstract

To detect a data input error to a blood separation system.SOLUTION: A blood separation system comprises: a data input device; a blood separator; a pump system; and a control part. The control part compares data received by the data input device related to a blood supply source and / or a calculation value obtained from the data, with a target range, a maximum value and / or a minimum value. The control part requires re-input or confirmation of at least a part of the data when the data or the calculation value is outside of the target range, is smaller than the minimum value and / or is greater than the maximum value. On the other hand, the control part advances a blood separation procedure, when it is determined that, the data or calculation value is not at outside of the target range, is not smaller than the minimum value and / or is not greater than the maximum value, or there is no data input error.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 251,736, filed on October 4, 2021, the content of which is incorporated herein by reference.

Background Art

[0002] This disclosure relates to a blood separation system. More specifically, this disclosure relates to the detection of data input errors in a blood separation system.

[0003] Whole blood is typically separated into its components (e.g., red blood cells, platelets, and plasma) by centrifugation, such as in the AMICUS® separator of Fenwal, Incorporated, Lake Zurich, Illinois, a subsidiary of Fresenius Kabi AG, Bad Homburg, Germany, or other centrifuge devices, or by a rotary membrane separator, such as the AUTOPHERESIS - C® and AURORA® devices of Fenwal, Incorporated.

[0004] A blood separation system typically includes a touch screen or other data input device (e.g., a computer keyboard) that enables an operator to control the procedure, collect status information, and handle error conditions. The display portion of the system (e.g., an integrated touch screen or a separate computer screen) typically displays information and prompts the operator to perform various actions. These actions include providing information or data regarding the blood source, such as height and weight (in the case of a living body) and blood characteristics (e.g., pre - count of platelets), using a user input device. The data input device may also enable the operator to select one or more procedure parameters, such as the target volume of blood to be collected or the target volume of a separated blood component (e.g., plasma) to be collected.

[0005] One or more data entries provided by the operator are typically used by the system when performing a blood separation procedure. For example, the height and weight of a living subject can be used to estimate the subject's total blood volume, which can then be used to assess the amount of blood that can be safely collected from the subject. Therefore, since the proper execution of the procedure depends on accurate input from the operator, it is advantageous to minimize the possibility of input errors. [Overview of the project]

[0006] There are several embodiments of the subject matter that can be embodied separately or together in the apparatus and systems described and claimed below. These embodiments may be used alone or in combination with other embodiments of the subject matter described herein, and the description of these embodiments together is not intended to preclude the use of these embodiments separately or the claim of such embodiments separately or as a set in different combinations within the claims attached herein.

[0007] In one embodiment, the blood separation system comprises a data input device, a blood separator, a pump system, and a control unit. The data input device is configured to receive input data relating to a blood source, and the blood separator is configured to separate blood into two or more separated blood components. The pump system is configured to transport blood to the blood separator and to discharge at least a portion of at least one separated blood component from the blood separator. The control unit is configured to control the blood separator and the pump system to perform the blood separation procedure, and the control unit is further configured to compare at least a portion of the input data received by the data input device, or a calculated value derived from at least a portion of the input data received by the data input device, with a target range, a minimum value, and / or a maximum value. If at least a portion of the input data or the calculated value is outside the target range, less than the minimum value, and / or greater than the maximum value, the control unit requests re-entry of at least a portion of the input data and / or confirmation of at least a portion of the input data and / or different portions of the input data. If at least a portion of the input data or the calculated value is not outside the target range, not less than the minimum value, and / or greater than the maximum value, the control unit proceeds with the blood separation procedure instead. [Brief explanation of the drawing]

[0008] [Figure 1] This is a front perspective view of an exemplary blood separation system according to one aspect of the present disclosure.

[0009] [Figure 2] This is a rear perspective view of the blood separation system shown in Figure 1, with the rear door in the open position.

[0010] [Figure 3] Figure 1 is a front perspective view of the blood separation system, in which a fluid flow circuit is associated.

[0011] [Figure 4]Figures 4A and 4B show exemplary screens that may be displayed on the display unit or data input device of the blood separation system shown in Figure 1. [Modes for carrying out the invention]

[0012] The embodiments disclosed herein are intended to provide an illustrative description of the subject matter. However, they are merely illustrative, and the subject matter can be embodied in a variety of forms. Accordingly, the specific details disclosed herein should not be construed as limiting the subject matter as defined in the appended claims.

[0013] Figures 1 and 2 show an exemplary automated system 10 for processing blood and blood products. This type of system (similar to the AURORA® apparatus of Fenwall, Incorporated) is described and illustrated in U.S. Patent Application Publication 2016 / 0175509, which is incorporated herein by reference. While such systems are particularly suited for plasma exchange, the systems and methods described herein for detecting data entry errors can be used in substantially any automated component removal or blood processing system, including, but not limited to, those configured for red blood cell collection, plasma exchange therapy, red blood cell exchange, cell washing, etc.

[0014] A durable or reusable blood separation system 10 is used in combination with a separate fluid flow circuit (which may be disposable) to separate whole blood (which may be mixed with an anticoagulant) into separated plasma and concentrated cells. Figure 3 shows an exemplary fluid flow circuit 12 attached to the blood separation system 10, but it should be understood that the illustrated blood separation system 10 and fluid flow circuit 12 are merely examples of such systems and circuits, and blood processing systems and fluid flow circuits of different configurations may be provided without departing from the scope of this disclosure.

[0015] The illustrated system 10 includes a cabinet or housing 14, with some components located outside the cabinet 14 (e.g., associated with the front wall, surface, or panel of the cabinet 14), and additional components (including a programmable central processing unit or control unit) and interconnects located inside the cabinet 14, which can be accessed by opening the rear door 18 of the system 10, as shown in Figure 2. It should be understood that the illustrated system components and their locations are illustrative only, and additional or different components and different component arrangements can be incorporated into the system without departing from the scope of this disclosure.

[0016] Among the system components located outside the cabinet 14, one or more pumps or pump stations 20a-20c may be provided, and the pumps 20a-20c are configured to house the tubular lines of the fluid flow circuit 12. One of the pumps, pump 20a, may be associated with the source / recipient access line 22 of the fluid flow circuit 12 and may be provided as a source / recipient access pump that operates to draw blood from a blood source and return the fluid to the recipient (which may be the blood source). Another of the pumps, pump 20b, may be provided as an anticoagulant pump, which may be associated with the anticoagulant line 24 of the fluid flow circuit 12 and operates to add anticoagulant from the anticoagulant source or container of the fluid flow circuit 12 to the blood drawn from the blood duct within the source / recipient access line 22 before the blood enters the blood separation module or chamber 26 of the fluid flow circuit 12. A third pump 20c can be associated with a blood cell outlet line 28 and can be provided as an outlet pump that draws separated blood cells out of the blood separation chamber 26 and leads them to the collection and storage unit 30 after the blood has been separated into blood cells and substantially cell-free plasma within the blood separation chamber 26.

[0017] In the illustrated embodiments, pumps 20a to 20c are peristaltic pumps, but providing pumps with different configurations, such as diaphragm pumps or other pumps, is within the scope of this disclosure. Furthermore, additional or alternative pumps can be provided without departing from the scope of this disclosure. For example, a pump may be associated with the plasma outlet line 32 of the fluid flow circuit 12 to draw out the plasma separated from the blood separation chamber 26 after the blood has been separated into cellular blood components and plasma. The illustrated fluid flow circuit 12 uses a single fluid flow tube or channel to intermittently draw blood from the source and flow it to or return it to the recipient. However, the fluid flow circuit 12 could instead use separate draw-in and return channels or tubes, without departing from the scope of this disclosure.

[0018] In addition to the pumps 20a-20c, the external components of the system 10 may include one or more clamps or valves 34a-34d associated with the tubular lines of the fluid flow circuit 12. The clamps or valves 34a-34d can be configured in various ways and may operate to selectively allow and prevent the flow of fluid through the associated tubular lines. In the illustrated embodiment, one clamp or valve 34a may be provided as a blood source / recipient clamp, which may be associated with the inflow branch 22a of the source / recipient access line 22 of the fluid flow circuit 12, and selectively allow or prevent the flow of fluid through the inflow branch 22a of the source / recipient access line 22. Another clamp or valve 34b may be provided as a reinjection clamp or valve, which may be associated with the reinjection branch 22b of the source / recipient access line 22 downstream of the collection reservoir 30 of the fluid flow circuit 12, and selectively allow or prevent separated blood cells from flowing through the reinjection branch 22b. A third clamp or valve 34c may be provided as a plasma clamp or valve and associated with the plasma outlet line 32 to selectively allow or prevent the flow of separated plasma through the plasma outlet line 32 into the separated plasma container. A fourth clamp or valve 34d may be provided as a replacement fluid clamp or valve that can be associated with the replacement fluid line 36 of the fluid flow circuit 12 to selectively allow or prevent the flow of replacement fluid from a replacement fluid source (e.g., a bag or container at least partially filled with saline). Additional or alternative clamps or valves may also be provided without departing from the scope of the present disclosure.

[0019] The illustrated system 10 further includes one or more pressure sensors 38a and 38b that can be associated with the fluid flow circuit 12 to monitor the pressure in one or more tubular lines of the fluid flow circuit 12 during the operation of pumps 20a-20c and clamps or valves 34a-34d. In one embodiment, one pressure sensor 38a may be associated with a tubular line that draws blood from a blood source and / or directs the processed fluid to the fluid recipient, and the other pressure sensor 38b may be associated with a tubular line that leads blood into the blood separation chamber 26 or leads the separated fluid out of the blood separation chamber 26 to assess the pressure in the blood separation chamber 26. However, pressure sensors 38a and 38b may also be associated with other tubular lines without departing from the scope of the present disclosure. Pressure sensors 38a and 38b may transmit signals to the system control unit 16 indicating the pressure in one or more tubular lines being monitored by pressure sensors 38a, 38b. If the control unit 16 determines that an inappropriate pressure exists within the fluid flow circuit 12 (for example, high pressure due to a blockage in one of the piping lines), the control unit 16 may instruct one or more of the pumps 20a to 20c and / or one or more of the clamps or valves 34a to 34d to act to mitigate the inappropriate pressure condition (for example, by reversing the direction of operation of one of the pumps 20a to 20c and / or by opening or closing one of the clamps or valves 34a-34d). Additional or alternative pressure sensors may also be provided without departing from the scope of this disclosure.

[0020] System 10 also includes a separation actuator 40 that interacts with a portion of the fluid separation chamber 26 to operate the blood separation chamber 26. A chamber lock 42 may also be provided to hold the blood separation chamber 26 in place relative to the system cabinet 14 and to engage with the separation actuator 40. The configuration and operation of the separation actuator 40 depend on the configuration of the blood separation chamber 26. In the illustrated embodiment, the blood separation chamber 26 is provided as a rotating membrane separator, such as a separator of the type described in detail by U.S. Patent Nos. 5,194,145 and 5,234,608 or PCT Patent Application Publication WO2012 / 125457A1, all of which are incorporated herein by reference. When provided as a rotating membrane separator, the blood separation chamber 26 may include a tubular housing in which a microporous membrane is placed. An inlet allows blood to enter the housing (via a retraction branch 22a of the source / recipient access line 22), and a lateral outlet allows cellular blood components to exit the housing (via a blood cell outlet line 28). The bottom outlet allows the separated plasma to exit the housing (via the plasma outlet line 32) after the blood has been separated into cellular blood components and plasma.

[0021] In the illustrated embodiment, the separation actuator 40 is provided as a drive unit magnetically coupled to a rotor to which the membrane is attached, and the separation actuator 40 rotates the rotor and membrane around the central axis of the housing. The rotating rotor and membrane generate a Taylor vortex in the gap between the housing and the membrane, which tends to push cellular blood components away from the membrane and discharge them from the blood separation chamber 26 through a lateral outlet while the separated plasma passes through the membrane. Meanwhile, the separated plasma passes through the membrane toward the central axis of the housing and exits the blood separation chamber 26 through a bottom outlet. It should be understood that this disclosure is not limited to a particular blood separation chamber, and the illustrated and described fluid separation chamber 26 is merely illustrative. For example, in other embodiments, blood can be separated into plasma and blood cells using a centrifuge that separates blood components based on density rather than size.

[0022] System 10 can include alternative and / or additional components without departing from the scope of the present disclosure. For example, the illustrated system 10 includes a hemoglobin detector or optical sensor assembly 44 associated with the plasma outlet line 32, a hematocrit meter 46 associated with the reservoir 30, and a plasma weight meter 48 associated with a separate plasma container of the fluid flow circuit 12. The illustrated system 10 also includes a data input device 50 configured as a touch screen for inputting information to the control unit 16 and displaying the input information or information resulting from the control unit 16. Although a touch screen is illustrated (Figs. 4A and 4B show exemplary images that can be displayed on the touch screen), it should be understood that data input devices of different configurations can also be used without departing from the scope of the present disclosure.

[0023] According to one method of using the blood separation system 10 and the fluid flow circuit 12, blood is drawn from a blood source into the blood separation chamber 26 during a draw phase or mode, where it is separated into blood cells and plasma. The separated plasma is retained by the system 10, while the blood cells are returned to the fluid recipient during a return or reinfusion phase or mode. In one embodiment, the collection phase and the return phase are repeatedly alternated until a goal (e.g., the amount of collected separated plasma, regardless of the presence or absence of an anticoagulant) is achieved (draw blood from the blood source, separate the blood into plasma and blood cells, and then return the blood cells to the fluid recipient). All draw phases and all return phases may be the same or different from each other. For example, in the last draw phase, less blood can be drawn from the blood source than in the previous draw phase, and in the last return phase, a combination of blood cells and replacement fluid can be injected into the fluid recipient, while in the previous return phase, only the separated blood cells can be returned to the fluid recipient.

[0024] As described above, the execution of the blood separation procedure by the control unit 16 typically depends on data entered by the operator using the data input device 50. Figures 4A and 4B show exemplary images that may be displayed on the screen of the data input device 50, with Figure 4A showing a pre-processing image that requests various information from the operator. The illustrative screen in Figure 4A includes various fields 52a-52i for receiving and displaying data entered by the operator, which may include a first field 52a for providing a procedure ID, a second field 52b for providing a setup ID, a third field 52c for providing a blood source ID, a fourth field 52d for providing the sex of the human blood source, a fifth field 52e for providing the height of the human blood source, a sixth field 52f for providing the weight of the human blood source, a seventh field 52g for providing information about the blood of the blood source (e.g., hemoglobin or hematocrit level or pre-count of platelets), an eighth field 52h for providing treatment parameters (e.g., target saline volume), and a ninth field 52i for providing additional procedure parameters (e.g., target plasma collection volume, or target binding amount of collected plasma to anticoagulant). It should be understood that the data requested on the screen in Figure 4A is illustrative only, and the data input device 50 may request additional or different information from the operator.

[0025] The image in Figure 4B can be considered a summary or confirmation screen that displays various data inputs after the operator has entered all the data using the screen in Figure 4A. The screen in Figure 4B includes nine fields 54a to 54i, which correspond to the nine fields 52a to 52i (each), plus an additional field 54j that does not display data entered by the operator, which in the example shown is the ratio of anticoagulant to whole blood, but displays a central setpoint or a value set by the administrator. Field 54j can instead display a calculated value derived from one or more inputs provided by the operator using the data entry device 50, or the screen may have one or more additional fields, each presenting a different calculated value. The calculated value may be any of several possible values, including but not limited to the anticoagulant-to-whole blood ratio, the body mass index of the human source (a body mass index that can be calculated using the height and weight of the blood source), the total blood volume of the source (which can be estimated using the height and weight of the human blood source according to known or new approaches such as the use of the Lemmens-Bernstein-Brodoski equation), the total 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 that a summary or confirmation screen may display multiple calculated values, and / or present multiple summary or confirmation screens (each displaying one or more calculated values).

[0026] The control unit 16 calculates or receives a calculated value of the data input by the operator using the data input device 50. To more surely ensure that the operator has not committed a data input error, the control unit 16 compares at least a part of the input data and / or one or more of the calculated values with the corresponding maximum value, the corresponding minimum value, and / or the target range of the corresponding value. For example, the input body weight can be compared with the maximum body weight value, the minimum body weight value, and / or the range of body weight values. In another example, the input height can be compared with the maximum height value, the minimum body weight value, and / or the range of height values. In yet another example, the input target collection amount (for example, the amount of collected plasma, or the amount of collected plasma combined with an anticoagulant) can be compared with the maximum collection amount, the minimum collection amount, and / or the range of collection amounts. In another example, the calculated body mass index can be compared with the maximum body mass index, the minimum body mass index, and / or the range of body mass indices. In yet another example, the calculated total blood volume can be compared with the maximum total blood volume, the minimum total blood volume, and / or the range of total blood volumes. When the data input or the calculated value is smaller than the corresponding minimum value of the comparison target, larger than the corresponding maximum value of the comparison target, and / or outside the target range of the corresponding value of the comparison target (such data input and calculated values are hereinafter referred to as "suspicious" values), it indicates that the operator may have committed a data input error.

[0027] If there is a potential data entry error, the control unit 16 may prevent the blood separation procedure from starting and may attempt to determine whether there was a data entry error by responding in one of several ways before the blood separation procedure begins. This may include the control unit 16 requesting re-entry of each suspicious value (for example, via an image appearing on the display unit or screen). For example, if the entered blood source weight, entered blood source height, and hematocrit value are all identified as suspicious values ​​by the control unit 16, the control unit 16 may request the operator to re-enter the blood source weight, blood source height, and hematocrit value. Alternatively, instead of requesting re-entry of each suspicious value, the control unit 16 may instead request confirmation of each suspicious value.

[0028] According to an alternative approach, instead of requiring re-entry or confirmation of each questionable value, the control unit 16 can instead request re-entry of only one or more (but not all) of the questionable values. For example, if the entered weight of the blood source is greater than the maximum weight value, less than the minimum weight value, and / or outside the target range for weight values, the result may be a questionable weight value, a questionable body mass index, and a questionable total blood volume (since the body mass index and total blood volume are calculated using the entered weight value). Since the body mass index and total blood volume are calculated values, not entered data, the control unit 16 can only request the operator to re-enter the weight of the blood source. Alternatively, the control unit 16 can request confirmation of one or more of the questionable values, rather than requiring re-entry of fewer than all of them (for example, in the previous example, instead of requesting re-entry of the weight value, it could request confirmation that the entered weight value is correct).

[0029] Another approach is that the control unit 16 may instead request re-entry of at least one valid value (referred to herein as an "acceptable" value). For example, an operator may enter an acceptable weight and height for a blood source, but this could result in a questionable body mass index. In this case, both the entered weight and height are acceptable, but the control unit 16 may request re-entry of one or both values ​​to determine whether one or both values ​​were entered correctly. Alternatively, instead of requesting re-entry of one or more acceptable values, the control unit 16 may request confirmation of such values ​​(for example, in the previous example, instead of requesting re-entry, it might request confirmation that the entered weight and / or height values ​​are correct).

[0030] Alternatively, the control unit 16 may instead request re-entry or confirmation of all input values, regardless of whether a particular input is questionable or not.

[0031] Once the operator has finished re-entering or confirming the requested values, the control unit 16 recalculates the calculated values ​​affected by the re-entered values ​​that differ from the corresponding initial values ​​(for example, if the re-entered weight of the blood source differs from the weight initially entered, the control unit 16 recalculates the body mass index). If at least one re-entered value differs from the initially entered value, the control unit 16 may be configured to request re-entry of some or all of the other entered values ​​before recalculating the calculated value, in order to ensure that the operator has not committed any other data entry errors that may not have been initially identified by the control unit 16.

[0032] If there are no more questionable values ​​after the requested values ​​have been re-entered or verified (i.e., the operator initially made a data entry error and corrected it when given a second opportunity to enter the data, or the operator verified that the questionable values ​​were correct), the control unit 16 may proceed with the selected blood separation procedure. If questionable values ​​remain, the control unit 16 may again request the operator to re-enter or verify one or more values, which may be the same as or different from values ​​previously re-entered or verified by the operator, until there are no more questionable values ​​or the control unit 16 determines that there were no data entry errors. The control unit 16 may be configured to continue with the selected procedure after determining that there were no data entry errors, even though at least one questionable value remains. The exact approach taken by the control unit 16 when determining whether it is acceptable to continue despite the presence of one or more questionable values ​​(i.e., how the control unit 16 determines that there were no data entry errors, or that all remaining questionable values ​​are to be ignored and / or treated as acceptable values) may vary without departing from the scope of this disclosure. For example, in an exemplary embodiment, the control unit 16 may be configured to ignore the presence of a suspicious value and / or treat the suspicious value as an acceptable value, and to proceed with the procedure only after the operator re-enters the same value as the value initially entered and then verifies that the initial / re-entered value is correct.

[0033] The specific minimum, maximum, and target ranges of the values ​​compared to the input or calculated values ​​may change without departing from the scope of this disclosure. For example, the acceptable range of collected volume may be generated by selecting a target value (e.g., 900 mL) and a specific margin or degree of variation from that target value that is considered to encompass all acceptable values ​​(e.g., 100 mL above or below the target value, or 10% above or below the target value).

[0034] The minimum, maximum, and / or target ranges of values ​​used by the control unit 16 to identify potential data entry errors may be fixed / hardcoded or adjustable / customizable. If one or more of the values ​​are adjustable, the control unit 16 may allow operators (which may include only specific operators or only a subset of operators, such as a center administrator) to adjust such values, which includes the control unit 16 limiting the extent to which the operators can adjust the values. Alternatively, instead of allowing operators 16 to adjust one or more of the minimum, maximum, and target ranges of values ​​(or in addition to that), the control unit 16 may be configured to automatically adjust such values. If one or more values ​​are adjustable, machine learning principles and / or data management systems may be used to implement an appropriate adjustment scheme.

[0035] As an example of machine learning, the control unit 16 may be configured to retain one or more characteristics of multiple previous blood sources from which blood has been drawn by the system 10. If a particular characteristic consistently differs from an expected value, the control unit 16 can use the retained characteristic when adjusting one or more values, or when determining the extent to which the operator can change one or more values. For example, the control unit 16 may retain input data regarding the height of blood sources from which blood has been previously separated by the system 10. If previous blood sources tend to be relatively tall, and the accurately entered height is often higher than the initial maximum height, the control unit 16 may determine that it is appropriate to automatically increase the maximum height value, and the specific extent of the adjustment is based on the data retained by the control unit 16. In this same exemplary situation, the control unit 16 may instead (or additionally) allow the operator to make a larger adjustment to the maximum height value than initially permitted by the control unit 16.

[0036] Regarding the data management system (which may be, for example, a central database or server at the center), it can retain one or more characteristics of a larger population of previous blood sources, such as people who donated blood at the center. If a particular characteristic consistently differs from an expected value, the data management system can transmit data to the control unit 16 based on the retained characteristic, and the control unit 16 can use this data when adjusting one or more values. For example, the data management system can retain input data regarding the weight of blood sources from which blood was previously separated at the center (which may include one or more blood sources from which blood was not previously separated by system 10). If previous blood sources tend to have relatively low weights, and the accurately entered weights are frequently lower than the minimum weight value, the control unit 16 can determine (based on the data from the data management system) that it is appropriate to automatically reduce the minimum value. The specific degree of adjustment is based on the data received by the control unit 16. In this same exemplary scenario, the control unit 16 can use the data received from the data management system instead (or in addition) to determine whether it is acceptable for the operator to make a larger adjustment to the minimum weight value than was initially permitted by the control unit 16.

[0037] The techniques described herein can be used to prevent over-collection or over-sampling, as such situations can be dangerous to the blood source. These techniques can also be used to prevent under-collection, which is not dangerous to the blood source but is undesirable for the blood collection center.

[0038] manner Appearance 1. A blood separation system comprising: a data input device configured to receive input data relating to a blood supply source; a blood separator configured to separate blood into two or more separated blood components; a pump system configured to transport blood to the blood separator and discharge at least a portion of at least one separated blood component from the blood separator; and a control unit configured to control the blood separator and the pump system to perform a blood separation procedure, wherein the control unit is configured to compare at least a portion of the data input by the data input device, or a calculated value obtained from at least a portion of the input data received by the data input device, with a target range, a minimum value, and / or a maximum value; and if at least a portion of the input data or the calculated value is outside the target range, less than the minimum value, and / or greater than the maximum value, to request re-input of at least a portion of the input data and / or another portion of the input data, or to request confirmation of at least a portion of the input data and / or another portion of the input data; and if at least a portion of the input data or the calculated value is not outside the target range, not less than the minimum value, and / or greater than the maximum value, to proceed with the blood separation procedure.

[0039] Appearance 2. The blood separation system according to embodiment 1, wherein at least a portion of the input data includes the input height and input weight of the blood source.

[0040] Appearance 3. The blood separation system according to embodiment 2, wherein the target range includes a range of heights, the minimum value includes the minimum height, the maximum value includes the maximum height, and the control unit is configured to compare the input height of the blood supply source with the height range, the minimum height, and / or the maximum height.

[0041] Appearance 4. The blood separation system according to embodiment 2, wherein the target range includes a range of weights, the minimum value includes the minimum weight, the maximum value includes the maximum weight, and the control unit is configured to compare the input weight of the blood supply source with the range of weights, the minimum weight, and / or the maximum weight.

[0042] Appearance 5. The blood separation system according to embodiment 2, wherein the calculated value includes a body mass index of the blood source, derived from the input height and weight of the blood source; the target range includes a range of body mass indices; the minimum value includes the minimum body mass index; the maximum value includes the maximum body mass index; and the control unit is configured to compare the input body mass index of the blood source with a range of body mass indices, the minimum body mass index, and / or the maximum body mass index.

[0043] Appearance 6. The blood separation system according to Embodiment 1, wherein at least a portion of the input data includes the hemoglobin level of the blood source, the target range includes the hemoglobin level, the minimum value includes the minimum hemoglobin level, the maximum value includes the maximum hemoglobin level, and the control unit is configured to compare the input hemoglobin level with the hemoglobin level range, the minimum hemoglobin level, and / or the maximum hemoglobin level.

[0044] Appearance 7. A blood separation system according to Embodiment 1, wherein at least a portion of the input data includes the hematocrit level of a blood source, the target range includes the hematocrit level, the minimum value includes the minimum hematocrit level, the maximum value includes the maximum hematocrit level, and the control unit is configured to compare the input hematocrit level with the hematocrit level range, the minimum hematocrit level, and / or the maximum hematocrit level.

[0045] Appearance 8. The blood separation system according to Embodiment 1, wherein at least a portion of the input data includes a pre-count of platelets in a blood source, the target range includes a range of pre-counts of platelets, the minimum value includes the minimum pre-count of platelets, the maximum value includes the maximum pre-count of platelets, and the control unit is configured to compare the input pre-count of platelets with the range of pre-counts of platelets, the minimum pre-count of platelets, and / or the maximum pre-count of platelets.

[0046] Appearance 9. The blood separation system according to Embodiment 1, wherein the calculated value includes a target collection volume, the target range includes a range of collection volumes, the minimum value includes a minimum collection volume, the maximum value includes a maximum collection volume, and the control unit is configured to compare the input collection volume with the range of collection volumes, the minimum collection volume, and / or the maximum collection volume.

[0047] Appearance 10. The blood separation system according to embodiment 9, wherein the target collection volume includes the amount of collected plasma, or the amount of collected plasma combined with an anticoagulant.

[0048] Appearance 11. The blood separation system according to Embodiment 1, wherein the calculated value includes the total blood volume of the blood supply source, the target range includes the total blood volume range, the minimum value includes the minimum total blood volume, the maximum value includes the maximum total blood volume, and the control unit is configured to compare the input total blood volume of the blood supply source with the total blood volume range, the minimum total blood volume, and / or the maximum total blood volume.

[0049] Appearance 12. The blood separation system according to Embodiment 1, wherein the calculated value includes the total plasma volume of the blood source, the target range includes the total plasma volume range, the minimum value includes the minimum total plasma volume, the maximum value includes the maximum total plasma volume, and the control unit is configured to compare the input total plasma volume of the blood source with the total plasma volume range, the minimum total plasma volume, and / or the maximum total plasma volume.

[0050] Appearance 13. The blood separation system according to Embodiment 1, wherein the calculated value includes the extracellular fluid volume of the blood source, the target range includes the extracellular fluid volume range, the minimum value includes the minimum extracellular fluid volume, the maximum value includes the maximum extracellular fluid volume, and the control unit is configured to compare the input extracellular fluid volume of the blood source with the extracellular fluid volume range, the minimum extracellular fluid volume, and / or the maximum extracellular fluid volume.

[0051] Appearance 14. The blood separation system according to any one of embodiments 1 to 13, wherein the control unit is configured not to allow adjustment of the target range, minimum value, and / or maximum value.

[0052] Appearance 15. The blood separation system according to any one of embodiments 1 to 13, wherein the control unit is configured to allow adjustment of the target range, minimum value, and / or maximum value.

[0053] Appearance 16. The blood separation system according to embodiment 15, wherein the control unit is configured to allow an operator or a subset of operators to adjust a target range, a minimum value, and / or a maximum value.

[0054] Appearance 17. The blood separation system according to embodiment 16, wherein the control unit is configured to limit any adjustments that may be made by the operator or a subset of operators to a target range, a minimum value, and / or a maximum value, on at least in part to one or more characteristics of a previous blood source held by the control unit.

[0055] Appearance 18. The blood separation system according to embodiment 16, further comprising a data management system configured to transmit data to a control unit, wherein the control unit is configured to restrict any adjustments that may be made by an operator or a subset of operators to a target range, a minimum value, and / or a maximum value, based at least in part on the data transmitted to the control unit by the data management system.

[0056] Appearance 19. The blood separation system according to embodiment 18, wherein the data transmitted from the data management system to the control unit is based at least in part on the characteristics of one or more blood sources that have not been previously separated by the blood separation system.

[0057] Appearance 20. The blood separation system according to embodiment 15, wherein the control unit is configured to automatically adjust a target range, a minimum value, and / or a maximum value based at least in part on the characteristics of one or more blood sources previously separated by the blood separation system, which are held by the control unit.

[0058] Appearance 21. The blood separation system according to embodiment 15, further comprising a data management system configured to transmit data to a control unit, wherein the control unit is configured to automatically adjust target ranges, minimum values, and / or maximum values ​​based at least in part on the data transmitted to the control unit by the data management system.

[0059] Appearance 22. The blood separation system according to embodiment 21, wherein the data transmitted from the data management system to the control unit is based at least in part on one or more characteristics of blood sources that have not been previously separated by the blood separation system.

[0060] Appearance 23. The blood separation system according to any one of embodiments 1 to 22, wherein the control unit is configured to request re-entry of all input data when at least a portion of the input data or the calculated value is outside the target range, less than the minimum value, and / or greater than the maximum value.

[0061] Appearance 24. The blood separation system according to any one of embodiments 1 to 23, wherein the control unit is configured to request re-entry of at least a portion of the input data or the calculated value when it is outside the target range, less than the minimum value, and / or greater than the maximum value, and to request re-entry of the different portion of the input data when the re-entered data is different from at least a portion of the input value.

[0062] Appearance 25. The blood separation system according to any one of embodiments 1 to 24, wherein the control unit determines whether input data and / or calculated values ​​that are outside the target range, less than a minimum value, and / or greater than a maximum value are acceptable, and proceeds with the blood separation procedure when it is determined that all input data and / or calculated values ​​that are less than a minimum value and / or greater than a maximum value are acceptable, and the determination of whether input data and / or calculated values ​​that are less than a minimum value and / or greater than a maximum value are acceptable is performed after at least one input data and / or calculated value has been re-entered and / or verified at least once.

[0063] It will be understood that the embodiments and examples described above illustrate some applications of the principles of the subject matter. Numerous modifications can be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including combinations of features individually disclosed or claimed herein. For these reasons, the scope of this specification is not limited to the above description but is as set forth in the following claims, and the claims may cover the features of this specification, including combinations of features individually disclosed or claimed herein.

Claims

1. 1. A blood separation system comprising: a data input device configured to receive data input from an operator regarding a blood source, the input data including one or more physical dimensions of the blood source and / or one or more numbers characterizing components of blood in the blood source; a blood separator configured to separate the blood into two or more separated blood components; a pump system configured to deliver blood to the blood separator and to discharge at least a portion of at least one separated blood component from the blood separator; a controller configured to control the blood separator and the pump system to perform a blood separation procedure; The control unit further includes: comparing at least a portion of the data entered by the data entry device or a calculated value determined from the at least a portion of the entered data received by the data entry device with a target range, minimum value, and / or maximum value; when the at least a portion of the entered data or the calculated value is outside the target range, is less than the minimum value, and / or is greater than the maximum value, requesting re-entry by an operator of the at least a portion of the entered data and / or another portion of the entered data, or requesting confirmation by an operator of the at least a portion of the entered data and / or another portion of the entered data; A blood separation system configured to proceed with the blood separation procedure when the at least a portion of the input data or the calculated value is not outside the target range, is not less than the minimum value, and / or is not greater than the maximum value.

2. 10. The blood separation system of claim 1, wherein the at least some of the input data includes an input height of the blood source and an input weight of the blood source.

3. the target range includes a range of heights, the minimum value includes a minimum height, and the maximum value includes a maximum height; 3. The blood separation system of claim 2, wherein the controller is configured to compare the input height of the blood source with the height range, the minimum height, and / or the maximum height.

4. the target range includes a range of weights, the minimum value includes a minimum weight, and the maximum value includes a maximum weight; 3. The blood separation system of claim 2, wherein the controller is configured to compare the input weight of the blood source to the weight range, the minimum weight, and / or the maximum weight.

5. the calculated value includes a body mass index of the blood source determined from an input height of the blood source and an input weight of the blood source; the target range comprises a range of body mass indexes, the minimum value comprising a minimum body mass index and the maximum value comprising a maximum body mass index; 3. The blood separation system of claim 2, wherein the control unit is configured to compare the input body mass index of the blood source with the body mass index range, the minimum body mass index, and / or the maximum body mass index.

6. the at least some of the input data includes a hemoglobin level of the blood source; the target range comprises a range of hemoglobin levels, the minimum value comprising a minimum hemoglobin level and the maximum value comprising a maximum hemoglobin level; 2. The blood separation system of claim 1, wherein the control unit is configured to compare the input hemoglobin level with the range of hemoglobin levels, the minimum hemoglobin level, and / or the maximum hemoglobin level.

7. the at least some of the input data includes a hematocrit level of the blood source; the target range comprises a range of hematocrit levels, the minimum value comprising a minimum hematocrit level and the maximum value comprising a maximum hematocrit level; 2. The blood separation system of claim 1, wherein the control unit is configured to compare the input hematocrit level with the range of hematocrit levels, the minimum hematocrit level, and / or the maximum hematocrit level.

8. the at least some of the input data includes a pre-count of platelets in the blood source; the target range includes a range of platelet pre-counts, the minimum value includes a minimum platelet pre-count, and the maximum value includes a maximum platelet pre-count; 2. The blood separation system of claim 1, wherein the controller is configured to compare the input platelet precount with the platelet precount range, the minimum platelet precount, and / or the maximum platelet precount.

9. the calculated value includes a target collection volume; the target range includes a range of collection volumes, the minimum value includes a minimum collection volume, and the maximum value includes a maximum collection volume; The blood separation system of claim 1 , wherein the control unit is configured to compare the input collection volume with the collection volume range, the minimum collection volume, and / or the maximum collection volume.

10. 10. The blood separation system of claim 9, wherein the target collection volume comprises a volume of collected plasma or a combined volume of collected plasma and anticoagulant.

11. the calculated value includes a total blood volume of the blood source; the target range includes a range of total blood volume, the minimum value including a minimum total blood volume and the maximum value including a maximum total blood volume; 2. The blood separation system of claim 1, wherein the control unit is configured to compare the input total blood volume of the blood source with the total blood volume range, the minimum total blood volume, and / or the maximum total blood volume.

12. the calculated value includes the total plasma volume of the blood source; the target range includes a range of total plasma volume, the minimum value including a minimum total plasma volume and the maximum value including a maximum total plasma volume; 2. The blood separation system of claim 1, wherein the control unit is configured to compare the input total plasma volume of the blood source with the range of total plasma volumes, the minimum total plasma volume, and / or the maximum total plasma volume.

13. the calculated value includes the extracellular fluid volume of the blood supply; the target range comprises a range of extracellular fluid volumes, the minimum value comprising a minimum extracellular fluid volume, and the maximum value comprising a maximum extracellular fluid volume; 2. The blood separation system of claim 1, wherein the control unit is configured to compare the input extracellular fluid volume of the blood supply source with the extracellular fluid volume range, the minimum extracellular fluid volume, and / or the maximum extracellular fluid volume.

14. 14. The blood separation system of claim 1, wherein the control unit is configured to not allow adjustment of the target range, the minimum value, and / or the maximum value.

15. 14. The blood separation system of claim 1, wherein the control unit is configured to allow adjustment of the target range, the minimum value, and / or the maximum value.

16. 16. The blood separation system of claim 15, wherein the control unit is configured to allow an operator or a subset of operators to adjust the target range, the minimum value, and / or the maximum value.

17. 17. The blood separation system of claim 16, wherein the controller is configured to limit the adjustments that may be made to the target range, the minimum value, and / or the maximum value by the operator or a subset of operators based at least in part on one or more characteristics of a previous blood source maintained by the controller.

18. further comprising a data management system configured to transmit data to the controller; 17. The blood separation system of claim 16, wherein the controller is configured to limit the adjustments that may be made to the target range, the minimum value, and / or the maximum value by the operator or a subset of operators based at least in part on the data transmitted to the controller by the data management system.

19. 20. The blood separation system of claim 18, wherein the data transmitted from the data management system to the control unit is based, at least in part, on one or more characteristics of a blood source that has not previously had blood separated by the blood separation system.

20. 16. The blood separation system of claim 15, wherein the control unit is configured to automatically adjust the target range, the minimum value, and / or the maximum value based at least in part on one or more characteristics of a plurality of blood sources previously separated by the blood separation system that are maintained by the control unit.

21. further comprising a data management system configured to transmit data to the controller; 16. The blood separation system of claim 15, wherein the controller is configured to automatically adjust the target range, the minimum value, and / or the maximum value based at least in part on the data transmitted to the controller by the data management system.

22. 22. The blood separation system of claim 21, wherein the data transmitted from the data management system to the controller is based, at least in part, on one or more characteristics of a blood source that has not previously had blood separated by the blood separation system.

23. 2. The blood separation system of claim 1, wherein the control unit is configured to request re-input of all of the entered data when at least a portion of the entered data or the calculated value is outside the target range, less than the minimum value, and / or greater than the maximum value.

24. The control unit requesting re-input of at least a portion of the entered data when the at least a portion of the entered data or the calculated value is outside the target range, is less than the minimum value, and / or is greater than the maximum value; 2. The blood separation system of claim 1, configured to require re-entry of the different portion of the input data when the re-input data differs from the at least a portion of the input value.

25. The control unit determining whether input data and / or calculated values ​​that are outside the target range, less than the minimum value, and / or greater than the maximum value are acceptable; proceeding with the blood separation procedure when all entered data and / or all calculated values ​​less than said minimum value and / or greater than said maximum value are determined to be acceptable; 2. The blood separation system of claim 1, wherein the determination of whether input data and / or calculated values ​​less than the minimum value and / or greater than the maximum value are acceptable is made after at least one input data and / or calculated value has been re-entered and / or confirmed at least once.

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