Systems and methods for controlling the return phase of a blood separation procedure

• US 9,498,567 B2
• Filed: 09/29/2014
• Issued: 11/22/2016
• Est. Priority Date: 09/29/2014
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Patel, Amit J., Planas, Samantha M.
• Primary Examiner(s): Kim, John
• Application Number:
  US14/500,166
• Publication Number:
  US 20160089486A1
• Time in Patent Office: 785 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/029 Separating blood components present in distinct layers in a container, not otherwise provided for containers for storing blood or blood components A61J1/05; sampling or analysing blood by separating blood components G01N33/491
• CPC Class Codes: A61M 1/262 rotating
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• 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 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/305 Control of inversion point between collection and re-infusion phase
• 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 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/38 : Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 1/382 : Optimisation of blood component yield
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3393 : by weighing the reservoir

Abstract

A method is provided for controlling the return phase of a blood separation procedure having a draw phase in which blood is drawn through an access or donor line, is separated, and a fluid, such as a cellular concentrate, is flowed into a reservoir, and a return phase in which fluid is flowed from the reservoir through the donor line. The method comprises flowing fluid from the reservoir through the donor line in a steady state return; monitoring the donor line for the presence of air; and, upon detecting air in the donor line, determining the amount of fluid remaining in the reservoir. Then, either i) the donor line is purged, if the amount of fluid remaining in the reservoir exceeds a predetermined amount, and the steady state return of fluid from the reservoir through the donor line is resumed; or ii) if the amount of fluid remaining in the reservoir does not exceed the predetermined amount, the return phase is ended by terminating the flow of fluid from the reservoir through the donor line.

Claims

1. In a blood separation procedure having at least a first and a second draw phase in which blood is drawn through a donor line, is separated and a fluid is flowed into a reservoir and a first return phase after the first draw phase in which fluid is flowed from the reservoir through the donor line, a method for controlling the first return phase of the procedure comprising:

a) flowing fluid from the reservoir through the donor line;

b) monitoring the donor line for the presence of air; and

c) upon detecting air in the donor line, determining whether the amount of fluid remaining in the reservoir exceeds a predetermined amount and i) if the amount of fluid remaining in the reservoir exceeds a predetermined amount, purging the donor line and resuming flowing fluid from the reservoir through the donor line until the reservoir is substantially empty, or ii) if the amount of fluid in the reservoir does not exceed the predetermined amount, ending the first return phase by terminating flowing fluid from the reservoir through the donor line and commencing the second draw phase.

2. The method of claim 1 further comprising purging the donor line upon commencement of the second draw phase.

3. The method of claim 1 further comprising terminating the blood separation procedure upon the termination of the flow of fluid from the reservoir through the donor line.

4. The method of claim 1 in which an air detector is associated with the donor line for monitoring the donor line for the presence of air.

5. The method of claim 1 in which the amount of fluid in the reservoir is determined by weighing the reservoir.

6. The method of claim 1 in which the predetermined amount of fluid is greater than 0.0 mL.

7. A blood processing system for processing whole blood or a whole blood component, the processing system comprising a fluid flow circuit having a donor line and a reservoir in fluid communication with the donor line, and a hardware component having an air detector associated with the donor line, a weigh scale associated with the reservoir, and a controller with a user interface, the controller being configured to perform the method of claim 1.