Systems and methods for deriving recommended storage parameters for collected blood components

• US 5,639,382 A
• Filed: 06/07/1995
• Issued: 06/17/1997
• Est. Priority Date: 12/23/1991
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Brown, Richard I.
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/483,733
• Time in Patent Office: 741 Days
• Field of Search: 210/85-87, 210/143, 210/645, 210/739, 210/929, 210/321.67, 210/96.1, 210/257.1, 210/512.1, 210/767, 210/787, 210/789, 604/4-6, 604/265-67, 128/DIG. 13, 128/760, 128/771, 364/413.07, 364/479, 364/564, 364/554, 364/555, 364/567, 364/569, 364/413.05, 422/44
• US Class Current: 210/739
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3624 Level detectors; Level control
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 1/385 taking into account of the patient characteristics
• CPC Class Codes: A61M 2202/0071 product to be retained or harvested, e.g. by pheresis
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 21/2405 Feed mechanisms for settling tanks
• CPC Class Codes: B01D 21/245 Discharge mechanisms for the sediments
• CPC Class Codes: B01D 21/26 : Separation of sediment aided by centrifugal force or centripetal forcecentrifuges B04B; cyclones B04C
• CPC Class Codes: B01D 21/262 : by using a centrifuge
• CPC Class Codes: B01D 21/302 : Active control mechanisms with external energy, e.g. with solenoid valve
• CPC Class Codes: B01D 21/34 : Controlling the feed distribution; Controlling the liquid level ; Control of process parameters
• CPC Class Codes: B01D 2221/10 : Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues apparatus for dental treatment A61C17/065
• CPC Class Codes: B04B 13/00 : Control arrangements specially designed for centrifuges; Programme control of centrifuges control arrangements for feed, charge, or discharge B04B11/00
• CPC Class Codes: B04B 5/0442 : with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: B04B 7/08 : Rotary bowls centrifugal casting machines B22D

Abstract

Systems and methods recommend storage parameters for a prescribed number of platelets in a prescribed gas permeable container and in association with a specified storage medium. The systems and methods receiving as input selected storage criteria information. The systems and methods generate as output, based upon the selected storage criteria information received, recommended storage parameters comprising a recommended number of selected storage containers (Plt_BAG) to be used and a recommended volume of storage medium (Plt_MED) to be used.

Claims

1. A system for collecting platelets for storage comprising

a process controller,

a separation device constructed and arranged for separating blood into plasma and platelets,

the process controller and separation device together operative in a collection mode to convey anticoagulated blood containing plasma and platelets from a donor into the separation device for separating into a plasma yield and a concentrated platelet yield, and

at least one storage container having gas permeability,

the process controller and separation device together operative in a resuspension mode to resuspend the concentrated platelet yield for storage with a volume of plasma drawn from the plasma yield in the at least one storage container,

the process controller including a resuspension processing element including an input operative to receive storage criteria input values comprising

a value representing number of platelets in the concentrated platelet yield (Yld),

a value representing a measured mean platelet volume of the platelets in the concentrated platelet yield (MPV) (in fl),

a targeted platelet volume value for the storage container or containers (Plt_TVol) (in ml), taking into account the gas permeability of the storage container or containers, and

a desired thrombocytocrit value (Tct) (expressed as a percentage) for platelets during storage, and

the resuspension processing element further including an element coupled to the input that is operative to derive, based upon the storage criteria input values, storage criteria output values comprising

a platelet storage volume (Plt_VOL) (in ml), derived as follows:

space="preserve" listing-type="equation">Plt.sub.VOL =Yld×

MPV

a number of storage containers to be used (Plt_BAG) based upon a number value BAG derived as follows;

##EQU32## and where Plt_BAG =1 when BAG≦

1, otherwise Plt_BAG ={BAG+1}, where {BAG +1} is the integer part of the quantity {BAG+1}, and

a volume of plasma (Plt_MED) (in ml) to be drawn from the plasma yield for transfer to each storage container, to serve as storage medium Plt_MED for the platelets, derived as follows;

##EQU33##

2. A system according to claim 1

wherein the process controller includes an element that is operative to derive, at least in part during the collection mode, the number of platelets in the concentrated platelet yield (Yld) for use as one of the storage criteria input values.

3. A system for collecting platelets for storage comprising

a process controller,

a separation device that is constructed and arranged for separating platelets from blood,

the process controller and separation device together operative in a collection mode to convey anticoagulated blood from a donor into the separation device for separation into a platelet yield,

at least one storage container having gas permeability,

a source of a platelet storage medium that includes bicarbonate,

the process controller and separation device together operative in a suspension mode to suspend the platelet yield for storage with a volume of the platelet storage medium drawn from the source in the at least one storage container,

the process controller including a suspension processing element including an input operative to receive storage criteria input values comprising

a value representing number of platelets in the concentrated platelet yield (Yld),

a value representing a measured mean platelet volume of the platelets in the concentrated platelet yield (MPV) (in fl),

a targeted platelet volume value for the storage container or containers (Plt_TVOL) (in ml), taking into account the gas permeability of the storage container or containers, and

a desired thrombocytocrit value (Tct) (expressed as a percentage) for platelets during storage, and

the suspension processing element further including an element coupled to the input that is operative to derive, based upon the storage criteria input values, storage criteria output values comprising

a platelet storage volume (Plt_VOL) (in ml), derived as follows:

space="preserve" listing-type="equation">Plt.sub.VOL =Yld×

MPV

a number of storage containers to be used (Plt_BAG) based upon a number value BAG derived as follows;

##EQU34## and where Plt_BAG =1 when BAG≦

1, otherwise Plt_BAG ={BAG+1}, where {BAG+1} is the integer part of the quantity {BAG+1}, and

a volume of storage medium (Plt_MED) (in ml) to be drawn from the source for transfer to each storage container, derived as follows;

##EQU35##

4. A system according to claim 3

wherein the process controller includes an element that is operative to derive, at least in part during the collection mode, the number of platelets in the concentrated platelet yield (Yld) for use as one of the storage criteria input values.

5. A system for processing concentrated platelets for storage in at least one gas permeable storage container comprising

a process controller,

a separation device constructed and arranged for separating blood into plasma and concentrated platelets,

the process controller and the separation device together operable in a collection mode for conveying anticoagulated blood containing plasma and platelets from a donor into the separation device for separating into a plasma yield and a concentrated platelet yield having a number of platelets (Yld), and

at least one storage container having gas permeability,

the process controller and the separation device together further operable in a resuspension mode to resuspend the concentrated platelet yield for storage with a volume of plasma drawn from the plasma yield in the at least one storage container, and including means for converting the number of platelets (Yld) to a platelet storage volume (Plt_VOL) (in ml) by multiplying the number of platelets (Yld) by a value representing a measured mean platelet volume of the platelets in the concentrated platelet yield (MPV) (in fl),

means for designating a platelet storage volume for the storage container or containers (Plt_TVOL) (in ml), taking into account the gas permeability of the storage container or containers, and

means for designating a thrombocytocrit value (Tct) (expressed as a percentage) for platelets during storage taking into account bicarbonate consumption by platelets per day of storage, and

means for deriving a value representing the number of storage containers to be used (Plt_BAG) based upon a number value BAG derived as follows:

##EQU36## where Plt_BAG =1 when BAG≦

1, otherwise Plt_BAG ={BAG+1}, were {BAG+1} is the integer part of the quantity {BAG+1}, and

means for deriving a value representing the volume of plasma (Plt_MED) (in ml) to be drawn from the plasma yield for transfer to the storage container or containers, to serve as storage medium for the platelets, as follows;

##EQU37##

6. A system for processing platelets for storage in at least one gas permeable storage container comprising

a process controller,

a separation device constructed and arranged for separating platelets from blood,

a source of a platelet storage medium that includes bicarbonate,

the process controller and the separation device together operable in a collection mode for conveying anticoagulated blood from a donor into the separation device for separation into components including platelet yield having a number of platelets (Yld), and

at least one storage container having gas permeability,

the process controller and the separation device together further operable in a suspension mode to suspend the platelet yield for storage with a volume of platelet storage medium drawn from the source into the at least one storage container, and including

means for converting the number of platelets (Yld) to a platelet storage volume (Plt_VOL) (in ml) by multiplying the number of platelets (Yld) by a value representing a measured mean platelet volume of the platelets in the concentrated platelet yield (MPV) (in fl),

means for designating a platelet storage volume for the storage container or containers (Plt_TVOL) (in ml), taking into account the gas permeability of the storage container or containers, and

means for designating a thrombocytocrit value (Tct) (expressed as a percentage) for platelets during storage taking into account bicarbonate consumption by platelets per day of storage, and

means for deriving a value representing the number of storage containers to be used (Plt_BAG) based upon a number value BAG derived as follows:

##EQU38## where Plt_BAG =1 when BAG≦

1, otherwise Plt_BAG ={BAG+1}, where {BAG+1} is the integer part of the quantity {BAG+1}, and

means for deriving a value representing the volume of platelet storage medium (Plt_MED) (in ml) to be drawn from the source for transfer to the storage container or containers, as follows;

##EQU39##

7. A method for harvesting concentrated platelets for storage in at least one gas permeable storage container comprising the steps of

conveying in a collection mode anticoagulated blood containing plasma and platelets from a donor into a separation device for separating into a plasma yield and a concentrated platelet yield having a number of platelets (Yld),

operating in a resuspension mode to resuspend the concentrated platelet yield for storage with a volume of plasma drawn from the plasma yield in the at least one storage container, including the steps of

converting the number of platelets (Yld) to a platelet storage volume (Plt_VOL) (in ml) by multiplying the number of platelets (Yld) by a value representing a measured mean platelet volume of the platelets in the concentrated platelet yield (MPV) (in fl),

designating a platelet storage volume for the storage container or containers (Plt_TVOL) (in ml), taking into account the gas permeability of the storage container or containers, and

designating a thrombocytocrit value (Tct) (expressed as a percentage) for platelets during storage taking into account bicarbonate consumption by platelets per day of storage, and

deriving a value representing the number of storage containers to be used (Plt_BAG) based upon a number value BAG derived as follows:

##EQU40## where Plt_BAG =1 when BAG≦

1, otherwise Plt_BAG ={BAG+1}, where {BAG+1} is the integer part of the quantity {BAG+1}, and

deriving a value representing the volume of plasma (Plt_MED) (in ml) to be drawn from the plasma yield for transfer to the storage container or containers, to serve as storage medium Plt_MED for the platelets, as follows;

##EQU41##

8. A method for harvesting platelets for storage in at least one gas permeable storage container comprising the steps of

conveying in a collection mode anticoagulated blood from a donor into a separation device for separating into a platelet yield having a number of platelets (Yld),

operating in a suspension mode to suspend the concentrated platelet yield for storage with a volume of platelet storage medium having bicarbonate drawn from a source in the at least one storage container, including the steps of

converting the number of platelets (Yld) to a platelet storage volume (Plt_VOL) (in ml) by multiplying the number of platelets (Yld) by a value representing a measured mean platelet volume of the platelets in the platelet yield (MPV) (in fl),

designating a platelet storage volume for the storage container or containers (Plt_TVOL) (in ml), taking into account the gas permeability of the storage container or containers, and

designating a thrombocytocrit value (Tct) (expressed as a percentage) for platelets during storage taking into account bicarbonate consumption by platelets per day of storage, and

deriving a value representing the number of storage containers to be used (Plt_BAG) based upon a number value BAG derived as follows:

##EQU42## where Plt_BAG =1 when BAG≦

1, otherwise Plt_BAG ={BAG+1}, where {BAG+1} is the integer part of the quantity {BAG+1}, and

deriving a value representing the volume of storage medium plasma (Plt_MED) (in ml) to be drawn from the source for transfer to the storage container or containers, as follows;

##EQU43##