EP4392089A1 - Collecte de plasma basée sur fluide extracellulaire de donneur - Google Patents

Collecte de plasma basée sur fluide extracellulaire de donneur

Info

Publication number
EP4392089A1
EP4392089A1 EP22861843.5A EP22861843A EP4392089A1 EP 4392089 A1 EP4392089 A1 EP 4392089A1 EP 22861843 A EP22861843 A EP 22861843A EP 4392089 A1 EP4392089 A1 EP 4392089A1
Authority
EP
European Patent Office
Prior art keywords
donor
plasma
volume
anticoagulant
blood
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22861843.5A
Other languages
German (de)
English (en)
Other versions
EP4392089A4 (fr
Inventor
Amit J. PATEL
Samantha M. PLANAS
Walter T. WATTS
Kyungyoon Min
Daniel R. Boggs
Thomas J. GNIADEK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fenwal Inc
Original Assignee
Fenwal Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fenwal Inc filed Critical Fenwal Inc
Publication of EP4392089A1 publication Critical patent/EP4392089A1/fr
Publication of EP4392089A4 publication Critical patent/EP4392089A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/38—Removing constituents from donor blood and storing or returning remainder to body, e.g. for transfusion
    • A61M1/382—Optimisation of blood component yield
    • A61M1/385—Optimisation of blood component yield taking into account of the patient characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3496—Plasmapheresis; Leucopheresis; Lymphopheresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • A61M1/361—Physical characteristics of the blood, e.g. haematocrit, urea before treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0415—Plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers

Definitions

  • a control circuit may be configured to control operation of the system, the control circuit coupled to the touchscreen and configured to receive a weight of a donor.
  • the control circuit may be configured to calculate an extracellular fluid amount of the donor based at least on the weight of the donor and to calculate a target volume for plasma product and/or raw plasma based at least in part on the extracellular fluid amount.
  • the control circuit may be configured to control the system to operate draw and return phases to withdraw whole blood from a donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor.
  • the control circuit may be configured to operate the draw and return phases until a volume of plasma product in the collection container equals the target volume for plasma product and/or raw plasma.
  • a method for collecting plasma comprises (a) determining the weight of a donor; (b) calculating a donor extracellular fluid amount based, at least in part, on the weight of the donor; (c) calculating a target plasma volume to collect based, at least in part, on a calculated percentage of donor extracellular fluid amount; (d) withdrawing whole blood from the donor through a venous-access device and a first line, the first line connected to a blood component separation device; (e) introducing anticoagulant into the withdrawn whole blood through an anticoagulant line; (f) separating the withdrawn whole blood into a plasma component and at least a second blood component; (g) collecting the plasma component from the blood component separation device and into a plasma collection container; (h) continuing steps (d) through (g) until the target plasma volume to collect is reached in the plasma collection container.
  • a system for collecting plasma from a donor in which the system comprises: a blood separator for separating the whole blood into a plasma product and a second blood component comprising red blood cells, a donor line for introducing whole blood from the donor to the blood separator, a first pump for controlling flow through the donor line, an anticoagulant line coupled to an anticoagulant source for combining anticoagulant with the whole blood, and a second pump for controlling flow through the anticoagulant line.
  • a touchscreen is provided for receiving input from an operator to a controller programmed to control operation of the system.
  • the targeted volume of pure plasma to be collected may be a multiple or fraction of the donor’s weight.
  • TVP may be a multiple of the donor’s total blood volume, TBV, with the TBV of the donor being determined based on the donor’s weight and height, using well established methodology, such as the Lemmens equation or Nadler’s formula.
  • the hematocrit of the donor may be determined prior to the collection phase of each cycle, either by calculation or on the basis of a signal from a sensor or the like that is indicative of the donor’s hematocrit. Further, the amount of plasma product in the plasma collection container may be determined by, e.g., a weigh scale associated with the plasma collection container or an optical sensor that directly measures the volume.
  • a modified nomogram that utilizes the donor’s hematocrit to calculate a target volume/weight for a plasma product having the maximum volume of raw plasma permitted by the FDA nomogram.
  • a calculated volume/weight of raw plasma is compared to the maximum volume/weight for the raw plasma permitted by the FDA nomogram. If the calculated volume/weight of raw plasma is less than the maximum permitted volume/weight, the volume/weight of the plasma product to be collected is adjusted upward from the maximum volume /weight permitted by the FDA nomogram for the plasma product by an amount equal to the difference plus the additional amount of anticoagulant that is added to process the additional volume/weight of plasma.
  • the Vpp for the procedure is recalculated before each extraction/separation phase is commenced, based on a value for the hematocrit of the donor determined prior to the start of each draw phase, and the target volume for the plasma product adjusted accordingly.
  • VRP may be determined based on a calculated value for the donor’s total plasma volume, based on Vb and the donor’s hematocrit.
  • VPP whole blood is withdrawn from the donor; anticoagulant is added to the whole blood in an amount consistent with the ACR; plasma product is separated from the whole blood; and plasma product is transferred to a collection container.
  • anticoagulant is added to the whole blood in an amount consistent with the ACR; plasma product is separated from the whole blood; and plasma product is transferred to a collection container.
  • the programmable controller is further configured to determine a target amount for the plasma product to be collected in the plasma collection container in accordance with any of the methods described herein, and to terminate the collection phase upon receiving a signal that the amount of plasma product in the plasma collection container equal to the target amount of the plasma product determined by the controller.
  • the controller may be configured to calculate the hematocrit of the donor prior to the collection phase of each cycle. Alternatively, or additionally, the controller may receive a signal from a sensor or the like that is indicative of the donor’s hematocrit. Further, the amount of plasma product in the plasma collection container may be determined by, e.g., the weigh scale associated with the plasma collection container or an optical sensor that directly measures the volume.
  • Fig.1 is a perspective view of an exemplary plasmapheresis instrument suitable for use in the system and method of the present application.
  • FIG. 3 is a perspective view of the front panel of the plasmapheresis system of Fig. 1 showing the components of the disposable set that are mounted thereto.
  • FIG. 4 is a schematic view showing operation of the plasmapheresis system in the collection phase.
  • Fig. 9 is a table that shows the volume of plasma product that may be collected from a donor, based on the donor’s weight and hematocrit, that results in the maximum permissible volume of pure plasma permitted by the FDA nomogram.
  • Fig. 10 is a table showing the inputs to a programmable controller for performing a hypothetical plasmapheresis procedure in accordance with the method of the present application.
  • Figs. 15A and 15B are charts plotting percentage of ECFV removed as plasma against incremental plasma volume achieved over a prior nomogram.
  • Three peristaltic pumps are located on the front panel of the hardware component 10, including an AC pump 54, a blood pump 56, and a cell pump 58.
  • the AC pump 54 delivers anticoagulant solution (AC) at a controlled rate into the blood line 38 as whole blood enters the set from the donor.
  • the blood pump 56 delivers anticoagulated whole blood to the separator during the collection phase of the procedure and returns concentrated cellular components and, if desired, replacement fluid to the donor during the reinfusion phase of the procedure.
  • the cell pump 58 delivers concentrated cellular components from the separator 14 to a reservoir during the collection phase.
  • the volume of pure/raw plasma contained within the volume of plasma product permitted under the FDA nomogram can be determined based upon the hematocrit of the donor.
  • the results of such calculations are set forth in Fig. 7, which shows the volume of pure/raw plasma based on donor hematocrit that is contained within a plasma product volume limit set by the FDA nomogram.
  • a target volume of pure plasma may be collected directly from the weight of the donor.
  • the weight of the donor may be multiplied by an established constant “Ki” (such as 10 mL/kg).
  • the weight of the donor may be segregated into weight categories or ranges (e.g., at least three categories, at least six categories, etc.), with a fixed volume established for each category (as in the FDA nomogram discussed above, in which the ranges of donor weight are divided into three categories).
  • a donor’s plasma volume may be estimated based on the donor’s total blood volume, and a volume of plasma that may be harvested consistent with donor safety and comfort may be based on this estimation.
  • Methods utilizing donor parameters may be used to estimate a donor’s total blood volume.
  • the donor’s total blood volume may be determined using one or more of Lemmens equation (that uses the donor’s body mass index to determine a total blood volume), Nadler’s equations (that take into account the height, sex and weight of the donor), Gilcher’s Rule of Five (that takes into account sex, weight and morphology (obese, thin, normal or muscular), or the standards of the International Counsel for Standardization in Haematology (“ICSH) as set forth in Br. J.
  • Lemmens equation that uses the donor’s body mass index to determine a total blood volume
  • Nadler’s equations that take into account the height, sex and weight of the donor
  • Gilcher’s Rule of Five that takes into account sex, weight and
  • the 10 displays the input data for a hypothetical plasmapheresis procedure for a donor weighing 190 lbs. (86.4 kg) and having an initial hematocrit of 44.
  • the simplified FDA nomogram would limit the volume of plasma to be collected from such a donor to 800 mL, and the total collection volume for the plasma product to 880 mL.
  • the FDA nomogram limit on the volume of raw plasma that may be collected is for illustrative purposes only. As set forth above, other methodologies may be used to determine the amount of raw plasma that may be safely extracted from a donor that would differ from that indicated by the FDA nomogram.
  • the volume of raw plasma to be collected and the total target volume of plasma product to be collected are determined in accordance with the methodologies described above, based on the donor’s initial hematocrit.
  • the initial target volume for the plasma product to be collected is 889 mL, which is the same as indicated by the table of Fig.9 for a donor having a weight of 175 lbs. and up and a hematocrit of 44 in order to harvest the FDA limit of 800 mL of raw plasma from the donor.
  • the red blood cells and “non-RBC” blood components are returned to the donor, so that at the end of the first return cycle the donor’s hematocrit has increased to 45.6%, as calculated by the controller based on a blood volume being decreased by the amount of raw plasma collected, while the quantity of red blood cells in the total blood volume remains the same as at the start of the procedure.
  • the controller can also account for the volume of anticoagulant that is reinfused in each return phase along with the red blood cells, as well as the residual anticoagulant in the donor’s whole blood being drawn in cycles 2 and following, when determining the new hematocrit value for the next cycle.
  • the volume of raw plasma and the total target volume of plasma product to be collected for the procedure are then recalculated based on the donor’s new, increased hematocrit and raw plasma volume. This provides for a new total target collection volume of 891 mL.
  • the second collection phase is then performed, resulting in a total of 430 mL of plasma product comprising 386 mL of raw plasma being collected over the first two collection phases (Cycle 2 draw end).
  • the red blood cells and “non-RBC” blood components are again returned to the donor, after which the donor’s hematocrit is calculated to be 47.2%.
  • a target collection volume for the plasma product when the target collection volume for the plasma product is recalculated for each collection phase, a target collection volume for the plasma product of 894 mL is obtained, which is required in order to collect the target volume of raw plasma of 800 mL.
  • 889 mL of plasma product would have been collected if the target collection volume is determined based only on the donor’s initial hematocrit, or 880 mL if the target collection volume is based on the simplified FDA nomogram. In both cases, less than the target volume of 800 mL would have been collected.
  • FIG. 12 a plot of volume of plasma collected (along the X-axis versus IgG concentration (along the Y-axis) that was developed empirically is shown.
  • a 9% drop of the donor’s IgG is seen from the baseline of zero plasma collected (at the start of the procedure) to 200 mL of plasma collected, and a drop of an additional 4% from 200 mL to 800 mL collected. This was attributable to a shift of interstitial fluid equal to approximately 9% of the donor’s initial total blood volume (after 200 mL of plasma being collected) to approximately 13% of the donor’s initial total blood volume (after 800 mL of plasma being collected).
  • changes over time in donor-specific parameters may be used to adjust a target volume of plasma product and/or raw plasma collected for that donor. Accounting for changes may, in some embodiments, improve donor safety and/or product consistency.
  • a change in donor hematocrit from one donation to another may be used as a surrogate marker for changes in hydration status of that particular donor over time (e.g., across different encounters at the donation center).
  • the controller may be configured to recalculate or adjust a target volume of plasma product and/or raw plasma calculated at a prior donation event based on a change in donor weight, hematocrit, etc. at a subsequent donation event.
  • anticoagulant may be introduced into the disposable kit prior to the commencement of the plasmapheresis procedure in pre-processing steps, such as for priming the disposable kit, performing one or more pre-cycles, or for performing other pre-procedure steps.
  • pre-processing steps such as for priming the disposable kit, performing one or more pre-cycles, or for performing other pre-procedure steps.
  • anticoagulant used for these purposes is ultimately directed to the plasma product collection container, it may be accounted for in determining the volume contained in the plasma collection container that results in the target volume of raw plasma being collected. This may be done, for example, by measuring the weight of the “full” container of anticoagulant and the weight of the container of anticoagulant prior to the commencement of the first draw cycle and adding that volume of anticoagulant to the target volume of plasma product.
  • the controller can be configured to automatically perform the steps necessary to account for the anticoagulant introduced into the plasma collection container separately from the anticoagulated plasma.
  • Extracellular fluid refers to body fluid outside the cells of the donor. In some cases, extracellular fluid makes up about one third of body fluid and the remaining two thirds of body fluid may be intracellular fluid. Extracellular fluid may comprise interstitial fluid, blood plasma, lymph, and transcellular fluids (e.g., cerebrospinal fluid, fluid in the gastrointestinal tract, etc.).
  • Extracellular fluid may comprise interstitial fluid, blood plasma, lymph, and transcellular fluids (e.g., cerebrospinal fluid, fluid in the gastrointestinal tract, etc.).
  • setting a target plasma volume to collect to be a percentage of donor extracellular fluid volume may improve the consistency of risk across different donors. Significant donor hypotensive adverse events may correlate with relative ECFV removed.
  • setting a target plasma volume to collect to be a percentage of donor extracellular fluid volume may improve the consistency of the collected plasma product.
  • setting a target plasma volume to collect based on donor extracellular fluid volume may provide incremental plasma at a comparable significant hypotensive adverse event (SHAE) rate to other methods of setting a target plasma volume to collect.
  • HSE hypotensive adverse event
  • the vascular system comprises both extracellular fluid (e.g., plasma) and intracellular fluid (within red blood cells).
  • Extracellular fluid volume (ECFV) comprises (1) extravascular fluid volume (ISFV), which in some cases is about 20% of body mass and (2) intravascular fluid volume, plasma (PV), which in some cases is about 4% of body mass.
  • ISFV extravascular fluid volume
  • PV intravascular fluid volume
  • Extracellular fluid amount can be estimated or calculated in any of a number of different ways.
  • extracellular fluid volume (ECFV) of the donor may be based on the weight (BM) and height (H) of the donor such that:
  • ECFV (L) 0.6032 X BM° 6469 (kg) x H° 7236 (m) [11] where H is expressed in meters.
  • ECFW (kg) 0.135 x BM (kg) + 7.35 kg [15] where ECFW and BM are expressed in kilograms.
  • ECFV (L) 0.583 x BM° 678 [17] where ECFV is expressed in Liters and BM is expressed in kilograms.
  • the weight used in the equation may be lean body weight instead of total body weight, along with an appropriate constant.
  • Lean body weight may be the difference between total body weight and body fat weight.
  • Lean body weight may be calculated from height and total body weight using formulas by Boer, James or Hume, etc. For example, the Boer formula is:
  • a percentage of extracellular fluid amount may be calculated as a target raw plasma amount to be collected.
  • a control circuit may be configured to calculate a target raw plasma volume to collect as a percentage of the extracellular volume, the percentage being preferably between about 4 % and about 7%, between about 5 % and about 6%, at least about 5%, less than about 5.5%, about 5.6% or about 5.25%.
  • the control circuit may further be programmed to set the target raw plasma amount to collect based on a maximum plasma volume or weight (e.g., no more than 1000 mL).
  • extracellular fluid amount may be the primary parameter used to calculate the target raw plasma amount to collect, while other parameters or equations may be used to confirm the calculated amount is within a range of acceptable amounts.
  • a system for collecting plasma may comprise a separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container.
  • the system may comprise a donor line to introduce the whole blood from the donor to the separator, flow through the donor line being controlled by a first pump.
  • the system may comprise an anticoagulant line coupled to an anticoagulant source, flow through the anticoagulant line being controlled by a second pump to combine anticoagulant with the whole blood from the donor based on an anticoagulant ratio.
  • the system may comprise a touchscreen configured to receive input from an operator and a control circuit configured to control operation of the system.
  • the control circuit may be configured to determine the amount of raw plasma in the collection container meets the target amount for raw plasma by weighing an amount of plasma product in the collection container and calculating the volume of raw plasma in the collection container based at least on the weight of plasma product and a percentage of anticoagulant in the collection container.
  • the anticoagulant ratio may be equal to a volume of whole blood divided by a volume of anticoagulant.
  • the anticoagulant ratio may be equal to (a volume of whole blood plus a volume of anticoagulant) divided by a volume of anticoagulant.
  • the anticoagulant ratio may be expressed as the inverse of these equations (e.g., 16 parts whole blood to 1 part AC or 1 part AC to 16 parts whole blood).
  • the method comprises calculating a target plasma volume to collect based, at least in part, on a calculated percentage of donor extracellular fluid amount.
  • the percentage may be about 5.2%, about 5.4%, about 5.6%, less than about 6.0%, more than about 5.0%, more than about 4%, or other percentages.
  • a database of a donor population was used to analyze the amount of plasma volume that could be obtained using the equation from Bird 2003.
  • the database of the donor population was used to analyze ECFV distribution by gender and with genders combined. Distributions in percentage of ECFV removed as plasma for the FDA 1992 nomogram were charted.
  • SHAE rate was also modeled using a Kaplan-Meir survival analysis to model SHAE rates as a function of the percentage of blood volume removed as plasma in place of the traditional time variable.
  • Such an analysis was used to predict SHAE rates under the ECFV nomogram using Bird 2021 and with ⁇
  • ) 0.052, ⁇
  • ) 0.054 and ⁇
  • ) 0.56 separately for female donors and male donors.
  • Probability of a SHAE as a function of percentage of ECFV removed as plasma was charted based on the Kaplan-Meier analysis. Given the probability curves, the distributions of the percentage of ECFV removed were then generated for various nomograms.
  • Bin-wise multiplication of the SHAE probability and the percentage of donors in each bin then produced the bin-wise contributions to the overall SHAE rate. Summing these contributions gave the overall modeled SHAE rate.
  • modeled SHAE rate was 0.189 for females, 0.048 for males and 0.119 combined, assuming equal proportions of female and male donations.
  • Modeled SHAE rates for the previous total blood volume nomogram were 0.240 for females, 0.072 for males and 0.156 combined.
  • Observed SHAE rate from the database (542 SHAEs in 488,628 procedures) were 0.184 for females, 0.048 for males and 0.111 combined.
  • PECFV percentage difference in ECFV values
  • An input device may be configured to receive input data from an operator (e.g., via a touchscreen, nearby smartphone, etc.).
  • the input device may be configured to receive input data over a network from a remote computer, such as a server computer configured to access and/or store donor data for a plurality of donors (e.g., donor ID, donor weight, donor height, donation history, digital image of donor, etc.).
  • the minimum Het may be used as the constant C.
  • the average Het over a predetermined population may be used for the constant C.
  • the average Het of a population of donors may be initially unknown. Further, the minimum Het is a conservative estimate assigned by regulatory authority (FDA). For lower Het donors, using the average Het will collect more plasma than using the actual Het. Selecting the minimum Het as the constant C is a more conservative estimate for optimizing donor safety. According to the analysis, using the minimum Het as the constant C will result in collecting about 10 mL less plasma than using the actual donor Het, on average.
  • FDA regulatory authority
  • SHAE rates were also calculated for several data points, with the SHAE rate of the 5.65 point being estimated to be between 0.269% and 0.300%.
  • volume of Plasma Product f (weight, height, gender) * FH (x%, ac_ratio, C) [29.1]
  • the method may further comprise determining whether the collected plasma product (comprising raw plasma and anticoagulant) has reached the target amount of plasma product to collect. This determination may be made at various times during the processing of blood from withdrawal to mixing with anticoagulant to separation to return of red blood cells to the donor. The determination may be made by receiving a signal from a weigh scale which weighs the plasma product collection container. The determination may comprise converting a weight of the plasma product to a volume of plasma product. The determination may comprise comparing the volume of plasma product measured to the target amount of plasma product to collect. The determination may comprise determining the collected plasma product has reached the target amount of plasma product to collect when the collected plasma product equals or approximately equals the target amount of plasma product or a value derived from the target amount of plasma product.
  • the control circuit of the plasma collection machine may be programmed with one or more of a number of different nomograms.
  • the nomogram may be based on percentage or fraction of donor blood volume (BV), plasma volume (PV), extracellular fluid volume (ECFV) or weight (W) removed as plasma.
  • nomogram designation ECFV21 -5.70-1050-H 38/39 indicates a nomogram based on a target pure plasma of 5.70% of donor extracellular fluid volume using the Bird 2021 equation, not to exceed a maximum of 1050 mL of pure plasma, with hematocrit taken as the minimum allowable (38% for females, 39% for males) which calculating collection volume.
  • control circuit of the plasma collection device may be configured to estimate a physiological fluid amount of the donor based at least in part on one or more donor parameters and using any of the nomograms described in FIG. 18. Further, control circuit may be configured to calculate a target amount of plasma product comprising raw plasma and anticoagulant by multiplying a prestored constant by the estimated physiological fluid amount, the prestored constant being determined based on the respective nomogram described in FIG. 18.
  • a second embodiment includes the system of the first embodiment wherein the control circuit is configured to not use donor hematocrit in determining when the measured amount of plasma product meets the target amount of plasma product.
  • a third embodiment includes the system of the first embodiment wherein the control circuit is configured to not use donor hematocrit in calculating the target amount of plasma product.
  • a fourth embodiment includes the system of the first embodiment wherein the estimated physiological fluid amount is an extracellular fluid volume.
  • a fifth embodiment includes the system of the fourth embodiment, wherein the prestored constant is between about 0.050 and about 0.064.
  • a ninth embodiment includes the system of the first embodiment, wherein the estimated physiological fluid amount is a total blood volume.
  • An eleventh embodiment includes the system of the first embodiment, wherein the prestored constant is different for a male donor than for a female donor, donor gender data being received from the input device and used to select from a male prestored constant and a female prestored constant.
  • a twelfth embodiment includes the system of the first embodiment, wherein a weight and a height of the donor are received over a network from a donor management system, wherein the donor management system is used for qualification screening.
  • a method for collecting plasma includes (a) receiving one or more donor parameters selected from donor weight, donor height, donor body mass index and donor sex; (b) estimating a donor physiological fluid amount based, at least in part, on the one or more donor parameters, wherein the estimated donor physiological fluid amount is selected from total blood volume, total plasma volume and extracellular fluid volume; (c) calculating a target amount of plasma product to collect, the target amount of plasma product comprising raw plasma and anticoagulant, the target amount of plasma product calculated by multiplying the estimated donor physiological fluid amount by a prestored constant; (d) withdrawing whole blood from the donor through a venous-access device to a blood component separation device; (e) introducing anticoagulant into the withdrawn whole blood; (f) separating the withdrawn whole blood into a plasma product comprising raw plasma and anticoagulant and at least a second blood component; (g) collecting the plasma product from the blood component separation device into a plasma collection container; (h) determining whether the
  • An eighteenth embodiment includes the system of the seventeenth embodiment, wherein the prestored constant comprises a first constant for use with a male donor and a second constant different than the first constant for use with a female donor.
  • a nineteenth embodiment includes the system of the fifteenth embodiment, wherein actual donor hematocrit is not used in estimating donor physiological fluid amount, wherein actual donor hematocrit is not used in calculating a target amount of plasma product to collect.
  • a twenty-second embodiment includes the system of the twenty-first embodiment wherein the control circuit is configured to receive the weight and a height of the donor over a network from a donor management system, wherein the donor management system is used for qualification screening.
  • a twenty-third embodiment includes the system of the twenty-first embodiment, wherein the target amount for plasma product and/or raw plasma is calculated prior to initiating blood collection from the donor.
  • a twenty-fourth embodiment includes the system of the twenty-first embodiment, wherein the control circuit is configured to determine an amount of raw plasma in the collection container meets the target amount for raw plasma by weighing an amount of plasma product in the collection container and calculating a volume of raw plasma in the collection container based at least on the weight of plasma product and a percentage of anticoagulant in the collection container.
  • a twenty-sixth embodiment includes the system of the twenty-first embodiment, wherein the control circuit is configured to calculate the target volume of plasma product and/or raw plasma by calculating a percentage of the extracellular fluid amount of the donor.
  • a twenty-seventh embodiment includes the system of the twenty-first embodiment, wherein the control circuit is configured to perform the draw and return cycles at least three times and the control circuit is configured to determine a volume of whole blood to be drawn in a final draw phase which is different than a volume drawn in a prior draw phase.
  • ECFV extracellular fluid volume
  • a method for collecting plasma includes (a) determining the weight of a donor; (b) calculating a donor extracellular fluid amount based, at least in part, on the weight of the donor; (c) calculating a target plasma volume to collect based, at least in part, on a calculated percentage of donor extracellular fluid amount; (d) withdrawing whole blood from the donor through a venous-access device and a first line, the first line connected to a blood component separation device; (e) introducing anticoagulant into the withdrawn whole blood through an anticoagulant line; (f) separating the withdrawn whole blood into a plasma component and at least a second blood component; (g) collecting the plasma component from the blood component separation device and into a plasma collection container; (h) continuing steps (d) through (g) until the target plasma volume to collect is reached in the plasma collection container.
  • a thirty-second embodiment includes the method of the thirty-first embodiment wherein the target plasma volume to collect is a target raw plasma volume.
  • ECFV extracellular fluid volume
  • ECFV extracellular fluid volume
  • ECFW extracellular fluid weight
  • BM weight of the donor
  • the system includes a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising concentrated cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container; a donor line configured to introduce the whole blood from the donor to the blood separator, flow through the donor line being controlled by a first pump; an anticoagulant line coupled to an anticoagulant source, flow through the anticoagulant line being controlled by a second pump to combine anticoagulant with the whole blood from the donor based on an anticoagulant ratio; an input device configured to receive input from an operator; and a control circuit programmed to control operation of the system, the control circuit coupled to the input device and programmed to receive at least a donor’s weight, to estimate the donor’s extracellular fluid amount based on the donor’s weight, to determine a target volume for plasma product and/or raw plasma based at least in part on the donor’s extracellular fluid amount, to control the system to operate draw and return phases to withdraw whole blood from the donor and
  • a thirty-seventh embodiment includes the system of the thirty-sixth embodiment wherein the control circuit is programmed to receive donor height, sex and hematocrit (Het) over a network from a donor management system used for qualification screening,
  • a thirty-eighth embodiment includes the system of the thirty-sixth embodiment , wherein the control circuit is further configured to operate the draw and return phases until a volume of raw plasma (VRP) in the collection container equals the target volume of raw plasma, the volume of raw plasma (VRP) based on a measured volume of plasma product (VPP).
  • VRP volume of raw plasma
  • ECFV extracellular fluid volume
  • ECFV extracellular fluid volume
  • a method for collecting plasma in which plasma product is collected in multiple collection phases between which separated red blood cells are reinfused to the donor includes a) determining a volume of whole blood (Vb) and hematocrit (Het) for a donor; b) determining a volume of raw plasma (VRP) that may be collected from the donor; c) determining a volume of plasma product (Vpp) that may be collected, wherein the plasma product comprises the raw plasma volume plus a volume of anticoagulant; d) withdrawing whole blood from the donor; e) introducing anticoagulant into the withdrawn whole blood at a specified ratio (ACR); f) separating the withdrawn whole blood into a plasma product and a second component comprising red blood cells; g) collecting the plasma product in a plasma collection container; h) after a desired amount of whole blood has been withdrawn from the donor, returning the red blood cells to the donor; and i) determining the Het of
  • a forty-fourth embodiment includes the method of forty-third embodiment wherein steps d)-j) are continued until a measured volume of plasma product in the collection container equals Vpp.
  • Vpp a volume of plasma product
  • VRP volume of raw plasma
  • VAC volume of anticoagulant
  • a forty-seventh embodiment includes the method of embodiment forty-six wherein steps c)-k) are repeated until a measured volume of plasma product in the collection container equals Vpp.
  • a forty-ninth embodiment includes the method of embodiment fortyeight wherein steps d)-k) are continued until a measured volume of plasma product in the collection container equals Vpp.
  • a fiftieth embodiment includes the method of any one of embodiments forty-eight and forty-nine wherein VRP is determined by establishing the VRP for each of a plurality of ranges of donor weight and selecting the VRP for the range of weight that is inclusive of the weight of the donor.
  • the ranges of donor weight may be in three categories from 110 to 149 lbs., 150 to 174 lbs., and 175 lbs. and up.
  • VRP is no greater than 28.6% of (1- Hct)*(V b ).
  • Vb is determined using one of Nadler’s equations, Gilcher’s Rule of Five, the standards of the ICSH, and any other generally accepted methodology.
  • VRP K2 * Vb.
  • an automated system for separating plasma from whole blood comprising a reusable hardware component and a disposable kit is provided.
  • the disposable kit further comprises i) a separator for separating whole blood into a plasma fraction and a concentrated cell fraction, the separator having an input having a blood line integrally connected thereto for transporting whole blood from a donor to the separator, a plasma output port integrally connected to a plasma collection container by a plasma line, and a concentrated cell outlet port integrally connected to a reservoir for receipt of concentrated cells prior to reinfusion to the donor; ii) an anticoagulant line integrally connected to the blood line and configured to be connected to a source of anticoagulant for transporting anticoagulant to the donor line, iii) a saline line configured to be attached to a source of saline for transporting saline to the blood line, and iv) a reinfusion line for transporting concentrated cells from the reservoir to the donor line.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un système et un procédé de collecte de plasma qui comprend un circuit de commande configuré pour commander le fonctionnement du système, le circuit de commande étant configuré pour recevoir un ou plusieurs paramètres de donneur. Le circuit de commande estime une quantité de fluide physiologique de donneur en se basant au moins en partie sur un ou plusieurs paramètres du donneur et calcule une quantité cible de produit plasmatique comprenant du plasma brut et un anticoagulant en multipliant une constante préalablement stockée par la quantité de fluide physiologique estimée. Le circuit de commande commande le système pour faire fonctionner les phases de prélèvement et de retour afin de transformer le sang total en produit plasmatique jusqu'à ce qu'une quantité mesurée de produit plasmatique dans le récipient de prélèvement corresponde à la quantité cible de produit plasmatique.
EP22861843.5A 2021-08-25 2022-05-03 Collecte de plasma basée sur fluide extracellulaire de donneur Pending EP4392089A4 (fr)

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US202163236743P 2021-08-25 2021-08-25
US202163244321P 2021-09-15 2021-09-15
US202163256762P 2021-10-18 2021-10-18
PCT/US2022/027484 WO2023027780A1 (fr) 2021-08-25 2022-05-03 Collecte de plasma basée sur fluide extracellulaire de donneur

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EP4392089A4 EP4392089A4 (fr) 2025-07-02

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JP (1) JP2024532293A (fr)
KR (1) KR20240072137A (fr)
AU (1) AU2022334246A1 (fr)
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CN114670635A (zh) * 2021-08-16 2022-06-28 北京新能源汽车股份有限公司 一种车辆的控制方法、装置及电动汽车
US20240325616A1 (en) 2023-03-28 2024-10-03 Fenwal, Inc. Systems and Methods For Controlling The Risk Of Citrate Reactions During Apheresis

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JPS61501494A (ja) 1984-03-21 1986-07-24 マクロ−リン、ウイリアム　フランシス 懸濁液からの物質の分離装置
EP0572656B1 (fr) 1991-12-23 1997-11-05 Baxter International Inc. Centrifugeuse a bol et bobine separables permettant d'acceder a la chambre de separation
US6730054B2 (en) * 1999-10-16 2004-05-04 Baxter International Inc. Blood collection systems and methods that derive estimated effects upon the donor's blood volume and hematocrit
JP2002282352A (ja) * 2001-03-26 2002-10-02 Terumo Corp 血液成分採取装置
US11386993B2 (en) * 2011-05-18 2022-07-12 Fenwal, Inc. Plasma collection with remote programming
US10792416B2 (en) * 2017-05-30 2020-10-06 Haemonetics Corporation System and method for collecting plasma
CN111465421B (zh) * 2017-10-25 2024-03-08 美国血液技术公司 用于收集血浆的系统和方法
KR102345761B1 (ko) 2018-05-21 2022-01-03 펜월, 인크. 혈장 수집 체적의 최적화를 위한 시스템

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EP4392089A4 (fr) 2025-07-02
WO2023027780A1 (fr) 2023-03-02
CA3229810A1 (fr) 2023-03-02
AU2022334246A1 (en) 2024-04-11
JP2024532293A (ja) 2024-09-05
KR20240072137A (ko) 2024-05-23

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