Patient photopheresis treatment apparatus and method

• US 4,578,056 A
• Filed: 10/29/1984
• Issued: 03/25/1986
• Est. Priority Date: 10/29/1984
• Status: Expired due to Term

• Current Assignee: McNeilab, Inc. (Johnson & Johnson)
• Original Assignee: Extracorporeal Medical Specialties Incorporated (Johnson & Johnson)
• Inventors: King, Martin J., Troutner, Vernon H.
• Primary Examiner(s): Skogquist, Harland S.
• Application Number:
  US06/665,833
• Time in Patent Office: 512 Days
• Field of Search: 604/4, 604/5, 604/6, 604/20
• US Class Current: 604/6.08
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/362223 the interface being evacuated interfaces to enhance contact
• 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 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• 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 2202/0415 Plasma

Abstract

Provided are apparatus and methods of use for extracorporeally treating a patient whereby blood is withdrawn from the patient, separated into a leukocyte enriched portion which, in contact with a photoactivatable reagent, is irradiated and all blood portions being returned to the patient. The preferred apparatus is suitably modified with appropriate tubing sets, valves, pumps, centrifuge and controlling means to perform the patient treatment in three operational phases.

Claims

1. Apparatus for use in a patient treatment system wherein blood, in contact with a photoactivatable reagent, is collected from said patient, centrifuged to provide a leukocyte enriched portion which is irradiated for activating said reagent, all portions including the irradiated portion being returned to said patient, said apparatus comprising:

infusion pump means for controlling the addition of anticoagulation agent means to said patient'"'"'s blood;

receiving means for receiving an irradiation cassette adapted to provide said photoactivating irradiation;

continuous centrifuge means for separating patient blood into at least a plasma portion and a leukocyte enriched portion, said centrifuge means including a revolution sensor for monitoring rotation;

blood pump means for pumping blood from said patient to said centrifuge, said blood pump means including revolution counter means and having known pumping characteristics whereby blood volume pumped may be determined;

central control means for regulating said infusion pump means, said receiving means, said continuous centrifuge means and said blood pump means whereby blood withdrawn from said patient, is contacted with said anticoagulant agent means, separated into a leukocyte enriched portion which, while in contact with said photoactivatable reagent, is irradiated prior to its return to the patient.

2. The patient treatment apparatus as set forth in claim 1 further comprising:

a first valve for controlling flow of non-leukocyte enriched fluids from said blood pump to a return container adapted for returning said fluid to said patient;

a second valve for controlling and directing the infusion of said fluid from said return container to said patient; and

a third valve for directing the flow of plasma and leukocyte enriched blood portion, and the flow of excess plasma from said centrifuge to separate containers.

3. A blood collection and separation tubing set for use in a patient treatment system wherein blood is collected from said patient, centrifuged to provide a leukocyte enriched portion which, in contact with a photoactivatabable reagent, is irradiated for activating said reagent, all blood portions including the irradiated portion being returned to said patient, said collection tubing set comprising:

a first container for receiving leukocyte enriched blood and plasma;

a second container for receiving excess plasma and nonleukocyte enriched fluid;

a return container having an inlet for receiving the contents of said second container and an outlet for returning same to said patient; and

tubing means for sterilly connecting said foregoing containers and adapted for optional connection to an anticoagulation container for providing anticoagulation means to said patient blood.

4. A blood treatment tubing set for use in a patient treatment system wherein blood is collected from said patient, centrifuged to provide a leukocyte enriched blood portion which, in contact with a photoactivatable reagent, is irradiated for activating said reagent, all blood portions including the irradiated portion being returned to said patient, said treatment tubing set comprising:

irradiation cassette means for receiving said leukocyte enriched blood portion and adapted to apply photoactivating radiation thereto;

a blood reservoir for receiving said leukocyte enriched blood passing through said irradiation cassette means and for returning blood to said cassette means whereby said leukocyte enriched blood may be irradiated again; and

tubing means for sterilly connecting said blood reservoir and said irradiation cassette means and adapted to receive said leukocyte enriched blood to be irradiated.

5. Apparatus for use in an extracorporeal patient treatment system wherein blood is collected from said patient, centrifuged to provide a leukocyte enriched portion which, in contact with a photoactivatable reagent, is irradiated for activating said reagent, all blood portions including the irradiated portion being returned to said patient, said apparatus comprising:

infusion pump means for controlling the addition of an anticoagulation agent to said patient'"'"'s blood;

continuous centrifuge means for separating patient blood into at least plasma, and a leukocyte enriched portion;

a first tubing set including;

a first container for receiving said leukocyte enriched blood and plasma;

a second container for receiving excess plasma and non-leukocyte enriched fluids;

a return container having an inlet for receiving the contents of said second container and the contents of said centrifuge and an outlet for returning same to said patient and;

first tubing means for receiving said anticoagulation agent and for sterilly communicating blood sterilly from said patient to said centrifuge means, to said first container, to said second container and to said return container;

a second tubing set including;

irradiation cassette means for applying photoactivating radiation to said photoactivatable reagent; and

second tubing means for sterilly communicating blood between said first container and said cassette means

blood pump means for pumping blood from said patient, through said first tubing set and said centrifuge during a first operating phase, and for pumping leukocyte enriched blood through said second tubing set during a second operating phase, said blood pump means including monitor means wherby the volume pumped may be determined;

central control means for electronically communicating with;

a first valve associated with said return container inlet for controlling fluid flow into said container;

a second valve associated with said return container outlet for controlling and directing the return of fluids from said return container to said patient;

a third valve for controlling and directing blood portions from said centrifuge to said first or second container;

said blood pump means and said blood pump monitor means whereby the volume pumped may be monitored and the volume and direction of blood flow controlled;

said continuous centrifuge means for sensing rotation;

said infusion pump for regulating the addition of anticoagulation agent to said patient blood; and

manual control means for accepting a predetermined leukocyte enriched blood volume and plasma volume; and

memory means for providing treatment sequence procedures and operating parameters to said central control means;

whereby in accordance with said treatment sequence procedure and operating parameters from said memory means, said central control means controls the withdrawal of blood from a patient, the addition of anticoagulation agent thereto, the centrifugation thereof, and the collection and irradiation of predetermined plasma and leukocyte enriched blood portion, and the return of the blood portions to the patient.

6. The extracorporeal patient treatment apparatus set forth in claim 5 wherein said centrifuge means further comprises safety cover interlock means connected to said central control means for preventing operator access to said centrifuge while said centrifuge is rotating.

7. The extracorporeal patient treatment apparatus set forth in claim 5 wherein said second tubing set further comprises a reservoir container for receiving blood from said irradiation cassette means and for returning blood to said irradiation cassette means when blood flow through said irradiation cassette means is reversed.

8. The extracorporeal patient treatment apparatus set forth in claim 7 wherein said second tubing set further comprises a priming container adapted for connection with said second tubing set means for supplying a priming solution useful for removing air from said irradiation cassette means.

9. A method for treating a patient for use in an extracorporeal treatment system wherein blood is treated with a photoactivatable reagent, irradiated, and returned to the patient, said system including an electronic central control means for controlling the sequence of treatment steps and automatically monitoring the acquisition and treatent of blood volumes in accordance with preset indices, said method comprising the steps of:

(a) connecting said treatment system to said patient whereby blood may be withdrawn from and returned to said patient;

(b) withdrawing blood from said patient;

(c) infusing blood from said patient with an effective anticoagulant;

(d) pumping said anticoagulated blood to a continuous centrifuge for separating said blood into at least a plasma enriched portion and a leukocyte enriched portion;

(e) directing, in accordance with predetermined volume parameters, said plasma and said leukocyte enriched portion to a first container;

(f) further directing excess plasma, if any, and nonleukocyte enriched fluids from said centrifuge to a second container;

(g) returning the contents of said second container to the patient;

(h) performing steps b-g until the predetermined volume of leukocyte enriched blood portion has been obtained in said first container;

(i) connecting said first container to irradiation cassette means having a at least one radiation source and at least one chamber for receiving said leukocyte enriched blood and exposing it to radiation from said radiation source, said chamber substantially surrounding said radiation source;

(j) energizing said radiation source and passing the contents of said first container through said chamber of said irradiation cassette means whereby said reagent is photoactivated; and

then

(h) returning said irradiated leukocyte enriched blood portion to said patient.

10. The treatment method provided in claim 9 wherein the step of passing the contents in step (j) is performed until the amount of radiation reaches a predetermined level.

11. The treatment method provided in claim 10 wherein step (g) further includes the steps of emptying the centrifuge and combining the centrifuge contents with the contents of the second container and returning the combined contents to the patient.

12. The treatment method provided in claim 11 wherein the combining step includes transferring the contents of the second container and the contents of the centrifuge to a third container and then returning the combined contents to the patient.