Systems and methods for performing online extracorporeal photopheresis

Patent metadata

Field	Value
Publication number	US-9744288-B2
Application number	US-201615189752-A
Country	US
Kind code	B2
Filing date	Jun 22, 2016
Priority date	Jan 27, 2012
Publication date	Aug 29, 2017
Grant date	Aug 29, 2017

Abstract

Systems and methods for performing online extracorporeal photopheresis of mononuclear cells are disclosed. Whole blood is removed from a patient and introduced through a processing set into a separation chamber to separate the desired cell population from the blood. The separated cell population is processed through the set which is associated with a treatment chamber where the cells are treated. Once treated, the cells are returned to the patient. The processing set remains connected to the patient during the entire ECP treatment procedure and provides an online, sterile closed pathway between the separation chamber and the treatment chamber.

First claim

The invention claimed is:

1. An online extracorporeal photopheresis system comprising:
(a) a disposable fluid circuit comprising:
i. a processing chamber for separating whole blood into one or more components including mononuclear cells,
ii. at least one treatment container adapted to receive mononuclear cells wherein at least a portion of said treatment container is transparent to light of a selected wavelength,

(b) a freestanding separation device having said processing chamber received therein for effecting separation of said mononuclear cells from whole blood,
(c) a freestanding irradiation device having said at least one treatment container received therein with the processing chamber being received in the separation device for treating said mononuclear cells with a selected dose of light,
(d) a controller integral with the separation device for communicating with and controlling one or both of the separation device and the irradiation device, the controller configured to i. separate 1500-3000 ml of whole blood into one or more components including mononuclear cells, ii. dilute the mononuclear cells received in the treatment container with a diluting solution comprising saline or plasma prior to activation of the irradiation device, and iii reinfuse treated mononuclear cells to the patient through a venipuncture needle used to access the circulatory system of the patient during the separation of mononuclear cells from whole blood.

2. The system of claim 1 wherein the controller is configured to automatically deliver a desired amount of photoactive agent to the storage container.

3. The system of claim 1 wherein the at least one container comprises a port through which the photoactive agent is delivered to the container.

4. The system of claim 1 wherein the controller is further configured to iv. concentrate the irradiated diluted mononuclear cells by separating supernatant liquid, v. combine the concentrated mononuclear cells with a wash solution, and vi. separate the combination into a concentrated washed cell product and supernatant liquid.

5. The system of claim 1 further comprising a washing component for concentrating a treated desired cell population and separating said treated cell population into a concentrate of said treated cell population and a supernatant fluid.

6. The system of claim 5 wherein said separation component and said washing component comprise a centrifugation device.

7. The system of claim 6 wherein said separation component and said washing component comprise the same centrifugation device.

8. The system of claim 1 further comprising a tubing connecting the processing chamber to the at least one container.

9. A method for performing an extracorporeal photopheresis procedure comprising the steps of:
a) obtaining a disposable fluid circuit comprising a venipuncture needle for accessing the circulatory system of a patient, a separation chamber for separating a biological fluid into one or more cell products including mononuclear cells, and at least one treatment container adapted to receive said cell product, said circuit providing a sterile closed pathway between the separation chamber and the treatment container,
b) mounting said separation chamber onto a freestanding apheresis device and mounting said treatment container onto a freestanding irradiation device that is independent of, and spaced apart and separate from, said apheresis device so that said separation chamber and treatment container are simultaneously mounted in their respective devices with the disposable fluid circuit forming a closed fluid pathway between the apheresis device and the irradiation device, said apheresis device including at least one pump for effecting fluid flow through said circuit,
c) utilizing a controller integral with the apheresis device and the irradiation device for controlling one or both, of the apheresis device and the irradiation device, the controller configured to automatically perform the steps of:
d) introducing through the venipuncture needle 1500-3000 ml of biological fluid into said separation chamber and separating said cell product from said biological fluid inside said separation chamber,
e) introducing into said treatment container a selected amount of an activation agent,
f) combining said separated cell product and activation agent in said treatment container;
g) diluting the separated cell product with a diluting solution comprising saline or plasma;
h) treating said combined separated cell product combined and activation agent with light in said irradiation device; and
i) withdrawing said treated cell product from said treatment container by the action of said at least one pump of said apheresis device and reinfusing the treated cell product to the patient.

10. The method of claim 9 further comprising concentrating said treated cell product and separating supernatant liquid from said concentrated cells;
combining said concentrated treated cell product with a wash solution; and separating said combination into a concentrated washed cell product and supernatant.

11. The method of claim 9 further comprising returning said exposed cell product to said source, wherein at least a portion of said fluid circuit remains connected to said source for the duration of said treatment procedure.

12. The method of claim 10 comprising concentrating said treated cell product by subjecting the treated cell product to a centrifugal field.

13. The method of claim 10 wherein said wash solution is plasma.

14. The method of claim 10 wherein said wash solution is saline.

15. The method of claim 12 further comprising resuspending said treated and concentrated cell product in a solution.

16. The method of claim 9 wherein said activation agent comprises 8-methoxypsoralen and the controller is configured to automatically deliver a desired amount of photoactive agent to the treatment container.

17. The method of claim 10 wherein said supernatant includes unbound activation agent.

18. The method of claim 9 wherein said light is in the ultraviolet range.

19. The method of claim 18 wherein said light is in the UV-A range.

20. The method of claim 9 wherein the separated cell product comprises mononuclear cells having a total volume of approximately 15 ml and the diluting solution comprises approximately 200 ml of plasma.

Assignees

• Fenwal Inc

Inventors

• Min Kyungyoon
• Radwanski Katherine

Classifications

• A61M1/3693

  using separation based on different densities of components, e.g. centrifuging · CPC title

• A61M1/3696

  with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation · CPC title

• B04B11/02

  Continuous feeding or discharging; Control arrangements therefor · CPC title

• A61M1/3692

  Washing or rinsing blood or blood constituents · CPC title

• A61M1/3683

  using photoactive agents · CPC title