Systems and methods for performing online extracorporeal photopheresis

Patent metadata

Field	Value
Publication number	US-9399093-B2
Application number	US-201313733607-A
Country	US
Kind code	B2
Filing date	Jan 3, 2013
Priority date	Jan 27, 2012
Publication date	Jul 26, 2016
Grant date	Jul 26, 2016

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 storage container adapted to receive mononuclear cells wherein at least a portion of said 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 independent of, and spaced apart and housed separately from, said separation device and having said mononuclear cell storage container received therein simultaneously with the processing chamber being received in the separation device for treating said mononuclear cells with a selected dose of light,
(d) a controller separate from the separation device and the irradiation device for communicating with and controlling both devices, the controller configured to i. dilute the mononuclear cells received in the storage container with a diluting solution comprising saline or plasma prior to activation of the irradiation device, ii. concentrate the irradiated diluted mononuclear cells by separating supernatant liquid, iii. combine the concentrated mononuclear cells with a wash solution, and iv. separate the combination into a concentrated washed cell product and supernatant liquid,
(e) wherein said disposable fluid circuit provides a sterile closed pathway between said processing chamber when mounted in said separation device and said storage container when mounted in said irradiation device.

2. 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.

3. The system of claim 2 wherein said separation component and said washing component comprise a centrifugation device.

4. The system of claim 3 wherein said separation component and said washing component comprise the same centrifugation device.

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

6. The system of claim 5 wherein the storage container comprises a port through which the photoactive agent is delivered to the storage container.

7. A method for performing an extracorporeal photopheresis procedure comprising the steps of:
a) obtaining a disposable fluid circuit comprising a separation chamber for separating a biological fluid into one or more components including a cell product, 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 an 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 separate from each of the apheresis device and the irradiation device for controlling both devices,
d) introducing from a source of biological fluid a volume of said biological fluid into said separation chamber and separating said cell product from said volume of biological fluid inside said separation chamber,
e) combining said separated cell product with a selected amount of an activation agent,
f) introducing said combined separated cell product and activation agent into said treatment container by action of said at least one pump of said apheresis device;
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;
i) withdrawing said treated cell product from said treatment container by the action of said at least one pump of said apheresis device;
j) concentratin aid treated cell product and separating supernatant liquid from said concentrated cells;
k) combining said concentrated treated cell product with a wash solution; and
l. separating said combination into a concentrated washed cell product and supernatant.

8. The method of claim 7 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.

9. The method of claim 7 comprising concentrating said treated cell product by subjecting the treated cell product to a centrifugal field.

10. The method of claim 9 further comprising resuspending said treated and concentrated cell product in a solution.

11. The method of Claim 7 wherein said wash solution is plasma.

12. The method of Claim 7 wherein said wash solution is saline.

13. The method of claim 7 wherein said cell product comprises mononuclear cells.

14. The method of claim 7 said activation agent comprises 8-methoxypsoralen and the controller is configured to automatically deliver a desired amount of photoactive agent to the treatment container.

15. The method of Claim 7 wherein said supernatant includes unbound activation agent.

16. The method of claim 7 wherein said light is in the ultraviolet range.

17. The method of claim 16 wherein said light is in the UV-A range.

18. The method of claim 7 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

• A61M1/3696

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

• A61M1/3693

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

• A61M1/3692

  Washing or rinsing blood or blood constituents · CPC title

• A61M1/3683

  using photoactive agents · CPC title

• B04B11/02

  Continuous feeding or discharging; Control arrangements therefor · CPC title