Single needle recirculation system for harvesting blood components

• US 5,437,624 A
• Filed: 08/23/1993
• Issued: 08/01/1995
• Est. Priority Date: 08/23/1993
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Langley, Robert W.
• Primary Examiner(s): KRUTER, JEROME
• Application Number:
  US08/110,432
• Time in Patent Office: 708 Days
• Field of Search: 604/4-6
• US Class Current: 604/6.05
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• 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 1/301 Details
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• 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 2202/0415 Plasma
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

A single needle system for withdrawing donated blood, processing the blood to harvest components such as platelets, and returning processed blood to the donor through the single needle. Processing is performed by a centrifuge which separates blood components into stratified layers with a buffy coat containing platelets and white blood cells stably interfacing a red blood cell layer. Blood is withdrawn during a draw cycle and returned to the donor during a return cycle. A recirculation system is provided so that blood flows at a reduced rate through the processing system during the return cycle in order to minimize return cycle time while maintaining the stable position of the interface between buffy coat and red blood cell layers. A storage bag receives processed blood during the draw cycle and blood is squeezed from the bag during the return cycle, a portion returned to the donor and another portion entering the recirculation path. A pressure sensor is located in the return path to indicate an empty storage bag upon a precipitous drop in pressure. In that manner an immediate switch to the draw cycle is made to further minimize return cycle time. To still further minimize the return cycle time, flow resistance in the return path is minimized with more than 80% of the flow resistance in the return path associated with the needle.

Claims

1. A system for separating and collecting blood components during both a draw cycle and a return cycle, said system for drawing and returning blood to a donor through a single lumen needle, comprising

a connector having at least three branches, a first branch connected to said single lumen needle;

a constant volumetric flow rate inlet pump with an inlet and an outlet;

an inlet line connected to a second branch of said connector and to said inlet pump for supplying blood to the inlet side of said pump;

a centrifuge apparatus with a separation vessel connected to the outlet side of said inlet pump for separating blood components into stratified layers within said vessel;

a collection bag connected to said separation channel for receiving and holding a collected component of the donated blood;

a return path including a return line connected to a third branch of said connector;

a flexible storage bag with an inlet connected to said separation vessel for receiving and holding the processed donated blood other than collected components, said storage bag having an outlet connected to said return line;

a pressure application member in communication with said flexible storage bag for applying pressure to the external sides of said storage bag during said return cycle to force the accumulated fluids in said storage bag into said return line;

a return valve in fluid communication with said return line to open said return line during said return cycle to allow a first portion of said accumulated fluids to be returned to said donor, a second portion of said accumulated fluids passing through said connector to said inlet line for establishing and maintaining a recirculation path for blood during said return cycle;

a sensing device in communication with said return path for producing a signal upon detecting an empty storage bag;

a control device connected to said sensing device, said return valve and said inlet pump, said control device including means for minimizing the time duration of said return cycle.

2. The system of claim 1 wherein said means for minimizing the time duration of said return cycle includes interface control means for establishing the volumetric flow rate of said second portion at a value sufficient to stably maintain the interface position of said stratified layers.

3. The system of claim 2 wherein said interface control means includes means for setting the recirculation volumetric flow rate of said inlet pump on said return cycle substantially lower than the draw volumetric flow rate established during said draw cycle.

4. The system of claim 3 wherein said recirculation flow rate approaches a minimum value sufficient to stably maintain said interface position.

5. The system of claim 4 wherein said recirculation flow rate is 50% or less of said draw flow rate.

6. The system of claim 4 wherein said means for minimizing the time duration of said return cycle further includes

means for closing said return valve thereby ending said return cycle upon receiving said signal detecting an empty storage bag.

7. The system of claim 6 wherein said sensing device monitors pressure in said return path and detects an empty storage bag by a precipitous drop in pressure.

8. The system of claim 6 wherein said means for minimizing the duration of said return cycle further includes said return path wherein the resistance to the flow of blood through the return path is minimal, except for the flow resistance of said needle, said return path including said needle, said connector, said return line, and said storage bag.

9. The system of claim 8 wherein said return line is of a larger diameter than other tubing in said system.

10. The system of claim 8 in which the flow resistance of said needle is more than 80% of the total flow resistance in the return path.

11. The system of claim 10 wherein the target hematocrit level is decreased as a percentage of inlet flow as inlet flow increases.

12. The system of claim 11 wherein the relationship of said target to inlet flow, Q_IN, is C₁ -C₂ Q_IN, where C₁ and C₂ are constant values.

13. The system of claim 6 wherein the relationship of said target to inlet flow, Q_IN, is C₁ -C₂ Q_IN, where C₁ and C₂ are constant values.

14. The system of claim 6 wherein the target hematocrit level is decreased as a percentage of inlet flow as inlet flow increases.

15. The system of claim 14 wherein the relationship of said target to inlet flow, Q_IN, is C₁ -C₂ Q_IN, where C₁ and C₂ are constant values.

16. The system of claim 4 wherein the target hematocrit level is decreased as a percentage of inlet flow as inlet flow increases.

17. The system of claim 16 wherein the relationship of said target to inlet flow, Q_IN, is C₁ -C₂ Q_IN, where C₁ and C₂ are constant values.

18. The system of claim 1 wherein said means for minimizing the time duration of said return cycle includes

means for closing said return valve thereby ending said return cycle upon receiving said signal detecting an empty storage bag.

19. The system of claim 11 wherein said sensing device monitors pressure in said return path and detects an empty storage bag by a precipitous drop in pressure.

20. The system of claim 19 wherein said means for minimizing the duration of said return cycle further includes said return path wherein the resistance to the flow of blood through the return path is minimal, except for the flow resistance of said needle, said return path including said needle, said connector, said return line, and said storage bag.

21. The system of claim 20 wherein said return line is of a larger diameter than other tubing in said system.

22. The system of claim 20 in which the flow resistance of said needle is more than 80% of the total flow resistance in the return path.

23. The system of claim 11 wherein the target hematocrit level is decreased as a percentage of inlet flow as inlet flow increases.

24. The system of claim 23 wherein the relationship of said target to inlet flow, Q_IN, is C₁ -C₂ Q_IN, where C₁ and C₂ are constant values.

25. The system of claim 1 wherein said means for minimizing the duration of said return cycle includes

return path means wherein the resistance to the flow of blood through the return path is minimal, except for the flow resistance of said needle, said return path including said needle, said connector, said return line, and said storage bag.

26. The system of claim 16 wherein said return line is of a larger diameter than other tubing in said system.

27. The system of claim 16 in which the flow resistance of said needle is more than 80% of the total flow resistance in the return path.

28. The system of claim 27 wherein the target hematocrit level is decreased as a percentage of inlet flow as inlet flow increases.

29. The system of claim 28 wherein the relationship of said target to inlet flow, Q_IN, is C₁ -C₂ Q_IN, where C₁ and C₂ are constant values.

30. The system of claim 1 wherein the target hematocrit level is decreased as a percentage of inlet flow as inlet flow Increases.

31. A method of separating and collecting blood components during both a draw cycle and a return cycle of a run phase, said method for drawing and returning blood to a donor through a single lumen needle, said method comprising the steps of:

providing a single lumen needle for insertion into the vein of a donor;

providing a connector having at least three branches, a first branch connected to said needle;

providing an inlet pump with an inlet and an outlet;

providing an inlet line connected to a second branch of said connector and to said inlet pump for supplying blood to the inlet side of said pump;

providing a centrifuge apparatus with a separation vessel connected to the outlet side of said pump, said vessel for separating blood components into stratified layers;

providing a collection bag connected to said separation vessel for receiving and holding a collected component of the donated blood;

providing a flexible storage bag with an inlet connected to said separation vessel for receiving and holding the processed donated blood other than the collected components, said storage bag having an outlet;

providing a return system including said storage bag and a return line connected to a third branch of said connector and to said outlet of said storage bag;

providing a pressure application member in communication with said return bag for applying pressure on the external sides of said return bag during said return cycle to force the fluids in said bag into said return line;

providing a sensing device in communication with said return system;

providing a return valve in fluid communication with said return line;

providing a control device for operating said return valve to close said valve during said draw cycle so that blood enters said inlet pump from said donor, is processed by said centrifuge to harvest blood components, and to send the processed blood to said storage bag, said control device operating said return valve to open said valve during a return cycle so that blood in said storage bag is squeezed into said return line, a first portion of blood in said return line passing through the first branch of said connector to said needle for return to the donor, a second portion of blood in said return line passing through the second branch of said connector to the inlet side of said pump for maintaining circulation of blood through said centrifuge apparatus to said storage bag and return line thereby providing a recirculation flow for reprocessing that portion of the blood not returned to the donor during the return cycle, said control device for minimizing return cycle time by reclosing said return valve thereby ending said return cycle and reinstituting said draw cycle when said sensing device indicates that said storage bag is empty, and

further minimizing return cycle time by providing return line flow resistance at a low level that produces return flow through said needle at a rate that is essentially independent of said recirculation flow.

32. The method of claim 31 wherein the return system flow resistance, excluding flow resistance through said needle, is less than 20% of all flow resistance in said return system, said return system including flow resistance through said storage bag, said return line, said connector, and said needle.

33. The method of claim 32 further including the step of operating said inlet pump at a reduced speed during said return cycle relative to pump speed during said draw cycle to reduce the return cycle volumetric flow rate while maintaining the interface position.

34. The method of claim 33 further including the steps of

providing a plasma collection bag connected to said separation vessel for receiving and holding plasma, and

operating valves associated with the plasma collection to collect plasma during said draw cycle only.

35. The method of claim 34 further including the step of establishing a target hematocrit level as a decreasing function of the blood processing rate.

36. The method of claim 35 wherein said hematocrit target level is determined by C₁ -C₂ Q_IN where Q_IN is the inlet flow and C₁ and C₂ are constants.

37. The method of claim 31 further including a start-up phase independent of said run phase, said start-up phase designed to rid the collection system of saline solution in a minimal period of time, said method including start-up steps comprising:

providing a waste bag connected to receive saline solution during a prime divert period,

sensing when blood arrives at the entry of said waste bag and thereupon ending said prime divert period and entering a succession of start-up draw and return cycles;

during said start-up return cycle, halting operation of said inlet pump thereby causing all blood accumulated in said storage bag to be returned to said donor thereby creating no recirculation flow.

38. The method of claim 31 wherein said sensing device monitors pressure in said return system and further including the step of indicating an empty storage bag by a precipitous drop in pressure.

39. A method of separating and collecting harvested blood components utilizing a centrifuge apparatus for separating blood components and one single lumen needle for insertion into a circulatory system of a donor, comprising:

beginning a draw cycle of a predetermined duration;

withdrawing whole blood from the circulatory system of the donor through the single lumen needle during the draw cycle;

delivering the whole blood to the centrifuge apparatus at a first substantially constant predetermined flow rate during said draw cycle;

centrifuging the whole blood in the centrifuge apparatus during the draw cycle to separate the whole blood into stratified layers stably positioned within said centrifuge apparatus, the stratified blood providing at least one harvested blood component and a remaining blood component;

storing the remaining blood component in a storage reservoir during the draw cycle;

ending the draw cycle at the end of the predetermined duration;

beginning a return cycle;

returning a first portion of the remaining blood component stored in the storage reservoir to the circulatory system of the donor during a return cycle;

recirculating a second portion of the remaining blood component from the return storage reservoir to the centrifuge apparatus at a second predetermined flow rate during the return cycle, said second rate substantially lower than said first rate while maintaining the stability of the interface position of the stratified layers;

centrifuging the second portion of the remaining blood component during the return cycle;

sensing when the storage reservoir is substantially empty; and

ending the return cycle when the storage reservoir is substantially empty.

40. The method of claim 39 wherein:

the storage reservoir is a flexible bag held under pressure; and

the sensing step is performed by sensing the pressure in the bag, low pressure being indicative of a substantially empty flexible bag.

41. The method of claim 39 wherein the remaining blood component contains a fraction of at the least one harvested blood component, and the step of centrifuging the second portion of the remaining blood component further comprises separating the second portion of the remaining blood component into a further quantity of the at least one harvested blood component and third portion of the remaining blood component and returning the third portion of the remaining blood component to the circulatory system of the donor.

42. The method of claim 39 wherein the ending of the draw cycle step is substantially simultaneous with the beginning of the return cycle step.

43. The method of claim 39 further comprising beginning a subsequent draw cycle wherein the ending of the return cycle step is substantially simultaneous with the beginning of the subsequent draw cycle step.