Adaptive apheresis apparatus

• US 5,637,082 A
• Filed: 02/22/1996
• Issued: 06/10/1997
• Est. Priority Date: 02/22/1996
• Status: Expired due to Term

• Current Assignee: Haemonetics Corporation
• Original Assignee: Haemonetics Corporation
• Inventors: Bernt, Stephen, Viviano, Stephen, Pages, Etienne
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/604,864
• Time in Patent Office: 474 Days
• Field of Search: 604/4, 604/5, 604/6, 210/645, 210/647, 210/782
• US Class Current: 604/6.11
• 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 1/304 Treatment chamber used as reservoir, e.g. centrifuge bowl or filter with movable membrane
• 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 1/361 before treatment
• 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 1/3698 Expressing processed fluid out from the turning rotor using another fluid compressing the treatment chamber; Variable volume rotors
• CPC Class Codes: A61M 1/385 taking into account of the patient characteristics
• CPC Class Codes: A61M 2202/0415 Plasma
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes lymphocytes A61M2202/0407
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

Automated apheresis apparatus and methods avoid unneeded collection and return of blood components. An operator "dials in" a desired amount of one or more blood components, whereupon the invention calculates the number of cycles necessary to achieve the target and directly implements an appropriate apheresis procedure. The invention may vary the volume of the separation chamber instead of, or in addition to, modifying the number of collection cycles in order to reach a target collection point. The invention may utilize a return procedure whereby, prior to the final collection cycle, only a portion of the contents of the separation chamber is returned to the donor; the returned portion is calculated such that filling the partly empty separation chamber on the last collection cycle results in just meeting the collection target. The invention may also monitor, in real-time, the amount of desired product actually collected during an apheresis cycle, and based thereon calculate the number of cycles necessary to reach the target level. Finally, the invention may continuously compare overall blood collection volumes with the volume of blood product actually obtained in order to compute (or verify) a machine collection efficiency for each type of blood product collected.

Claims

1. Apheresis apparatus comprising:

a. means for withdrawing blood from a donor, said means comprising a phlebotomy needle and a pump;

b. means for separating the withdrawn blood into a plurality of components;

c. means for obtaining the concentration, in the donor'"'"'s blood, of a selected cellular blood component;

d. control means, coupled to the withdrawal and separating means, for collecting a predetermined amount of the selected blood component based on the obtained concentration, the control means operating the withdrawing means and the separating means in cycles each comprising;

i. operation of the pump to withdraw, through the phlebotomy needle, an amount of blood from the donor and provision thereof to the separating means, which separates the withdrawn blood into the plurality of components, the amount of blood being sufficient to fill the separating means;

ii. collection, from the separating means, of the selected blood component; and

iii. return of blood components remaining in the separating means to the donor, the apparatus exhibiting, for the selected blood component, a collection efficiency factor specifying a collectable quantity of the selected blood component per unit volume of blood, the control means being configured to calculate, based on the collection efficiency factor, the obtained concentration and the amount of blood collected during a cycle, the number of cycles needed to collect the predetermined amount of the selected blood component.

2. The apparatus of claim 1 wherein the means for obtaining the concentration comprises at least one line sensor coupled to the control means, the apparatus exhibiting, for the selected blood component, a collection efficiency factor specifying a collectable percentage of the selected blood component given the concentration, the control means being configured to calculate, based on the collection efficiency factor and the amount of blood collected during a cycle, the number of cycles needed to collect the predetermined amount of the selected blood component.

3. The apparatus of claim 2 wherein the control means calculates the number of cycles based on a plurality of time-separated concentration measurements.

4. The apparatus of claim 1 wherein the means for obtaining the concentration comprises means for acquiring data entered by a user.

5. The apparatus of claim 1 wherein the selected blood component is chosen from the group consisting of red blood cells, buffy coat and platelets.

6. The apparatus of claim 1 further comprising:

a. input means for obtaining information from an operator, the information including an amount of a selected blood component and at least one donor physiological characteristic;

b. output means for reporting information;

wherein

c. the control means is coupled to the withdrawal means, the separating means, the input means and the output means and is configured to;

i. calculate, from the at least one physiological characteristic, a maximum amount of the blood component that may be safely collected from the donor;

ii. compare the calculated amount with the operator-entered amount;

iii. provide an alert signal, over the output means, if the calculated amount exceeds the operator-entered amount; and

iv. if the calculated amount does not exceed the operator-entered amount, operate the withdrawing means and the separating means to separate, from withdrawn blood, the operator-entered amount of the selected blood component.

7. The apparatus of claim 6 wherein the at least one donor physiological characteristic comprises weight and sex.

8. The apparatus of claim 6 further comprising at least one collection container for collecting the at least one blood component.

9. The apparatus of claim 1 further comprising means for recomputing the collection efficiency factor after each cycle.

10. Apheresis apparatus comprising:

a. means for withdrawing blood from a donor, said means comprising a phlebotomy needle and a pump;

b. means for separating the withdrawn blood into a plurality of components;

c. means for obtaining the concentration, in the donor'"'"'s blood, of a selected blood component;

d. input means for obtaining, from an operator, a desired amount of the selected blood component; and

e. control means, coupled to the withdrawal and separating means, for collecting a predetermined amount of the selected blood component based on the obtained concentration, the control means operating the withdrawing means and the separating means in cycles each comprising;

i. operation of the pump to withdraw, through the phlebotomy needle, an amount of blood from the donor and provision thereof to the separating means, which separates the withdrawn blood into the plurality of components, the amount of blood being sufficient to fill the separating means;

ii. collection, from the separating means, of the selected blood component; and

iii. return of blood components remaining in the separating means to the donor,

the apparatus exhibiting, for the selected blood component, a collection efficiency factor specifying a collectable percentage of the selected blood component, the control means being configured to calculate, based on the collection efficiency factor, the obtained concentration and the amount of blood collected during a cycle, the number of cycles needed to collect the predetermined amount of the selected blood component, and the apparatus being further configured to collect operator-entered amounts of the selected blood component corresponding to non-integral numbers of cycles, each non-integral number including a mantissa portion, by

(i) in a penultimate cycle, during return of blood components remaining in the separating means to the donor, retaining in the separating means a fraction of the remaining blood components equal to the mantissa, and

(ii) in a final cycle, during withdrawal of blood from the donor, withdrawing only enough blood to fill the separating means.

11. The apparatus of claim 10 wherein the blood component is platelets.

12. The apparatus of claim 10 wherein the blood component is red blood cells.

13. The apparatus of claim 10 wherein the blood component is buffy coat.

14. The apparatus of claim 10 wherein the blood component is plasma.

15. Apheresis apparatus comprising:

a. means for withdrawing blood from a donor, said means comprising a phlebotomy needle and a pump;

b. variable-volume separation means for separating the withdrawn blood into a plurality of components, the separating means having a volume;

c. means for obtaining the concentration, in the donor'"'"'s blood, of a selected blood component;

d. control means, coupled to the withdrawal means and the separating means for collecting a predetermined amount of the selected blood component based on the obtained concentration, the control means operating the withdrawing means and the separating means in cycles each comprising;

i. operation of the pump to withdraw, through the phlebotomy needle, an amount of blood from the donor and provision thereof to the separating means, which separates the withdrawn blood into the plurality of components, the amount of blood being sufficient to fill the separating means;

ii. collection, from the separating means, of the selected blood component in the collection container; and

iii. return of blood components remaining in the separating means to the donor,

the control means also determining, based on the concentration of the selected blood component and the predetermined amount thereof an optimal separation-chamber volume and causing the separation chamber to assume the optimal volume.

16. The apparatus of claim 15 wherein the apparatus exhibits, for the selected blood component, a collection efficiency factor specifying a collectable quantity of the selected blood component per unit volume of blood, the control means calculating the optimal volume based on the collection efficiency factor and the obtained concentration.

17. The apparatus of claim 16 wherein the optimal volume facilitates collection of the predetermined amount of the selected blood component in an integral number of cycles and without variation of the volume.

18. The apparatus of claim 15 further comprising means for recomputing the machine collection efficiency after each cycle.