Centrifuge system and method with component tracking

Patent metadata

Field	Value
Publication number	US-11020522-B1
Application number	US-201916537103-A
Country	US
Kind code	B1
Filing date	Aug 9, 2019
Priority date	Sep 11, 2015
Publication date	Jun 1, 2021
Grant date	Jun 1, 2021

Abstract

Devices, methods, and systems are provided for priming, separating, and collecting blood components. At least one disposable component may be utilized, and a determination may be made as to whether such a disposable component is authentic, is new/unused or used, or both.

First claim

What is claimed is:

1. A method of operating an extracorporeal photopheresis system, said extracorporeal photopheresis system comprising a disposable photopheresis kit, a base unit, and a drug container comprising a drug that is used in the execution of an extracorporeal photopheresis procedure by said extracorporeal photopheresis system, said base unit comprising a plurality of pumps and a photoactivation module, said disposable photopheresis kit comprising a centrifuge bowl, a treatment bag, an irradiation bag, and tubing, said method comprising the steps of:
installing said disposable photopheresis kit relative to said base unit, comprising:
positioning said disposable photopheresis kit for engagement of said tubing by said plurality of pumps;
interconnecting said drug container with said treatment bag; and
disposing said irradiation bag in said photoactivation module;

sending a first signal from said extracorporeal photopheresis system to said drug container;
disposing said drug container in an unlocked configuration using said first signal only if said drug container was in a first locked configuration when said drug container receives said first signal;
requiring said drug container to be in said unlocked configuration for any execution of said extracorporeal photopheresis procedure using said drug container; and
disposing said drug container in a second locked configuration from a second signal received by said drug container from said extracorporeal photopheresis system after said drug container has been used for an execution of said extracorporeal photopheresis procedure, wherein said drug container is unable to be changed from said second locked configuration back to said unlocked configuration by any signal from said extracorporeal photopheresis system to reduce a potential of said drug container being used for execution of a subsequent extracorporeal photopheresis procedure.

2. The method of claim 1 , further comprising:
executing a first acquiring step comprising acquiring data on said drug container;
said extracorporeal photopheresis system determining if said drug container is either authentic or counterfeit using said data from said first acquiring step;
allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said drug container is authentic; and 2) that said drug container is in said unlocked configuration; and
precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said drug container is counterfeit; 2) that said drug container is not in said unlocked configuration; and 3) that said drug container is in said second locked configuration.

3. The method of claim 2 , further comprising:
reading data from each of said disposable photopheresis kit and said drug container for said extracorporeal photopheresis system to determine if a matched condition exists between said disposable photopheresis kit and said drug container;
wherein said allowing step further comprises allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said drug container is authentic; and 2) that said drug container is in said unlocked configuration; and 3) that said matched condition exists between said disposable photopheresis kit and said drug container;
wherein said precluding step further comprises precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said drug container is counterfeit; 2) that said drug container is not in said unlocked configuration; 3) that said drug container is in said second locked configuration; and 4) that said matched condition fails to exist between said disposable photopheresis kit and said drug container.

4. The method of claim 1 , further comprising:
reading data from each of said disposable photopheresis kit and said drug container for said extracorporeal photopheresis system to determine if a matched condition exists between said disposable photopheresis kit and said drug container;
allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said drug container is in said unlocked configuration; and 2) that said matched condition exists between said disposable photopheresis kit and said drug container; and
precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said drug container is not in said unlocked configuration; 2) that said drug container is in said second locked configuration; and 3) that said matched condition fails to exist between said disposable photopheresis kit and said drug container.

5. The method of claim 1 , further comprising:
executing a first acquiring step comprising acquiring data on said disposable photopheresis kit;
executing a first determining step comprising determining if said disposable photopheresis kit is of a first unused condition from said first acquiring step, wherein said first determining step is executed by said extracorporeal photopheresis system;
allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; and 2) that said drug container is in said unlocked configuration; and
precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said disposable photopheresis kit is of a first used condition using said first acquiring step; 2) that said drug container is not in said unlocked configuration; and 3) that said drug container is in said second locked configuration.

6. The method of claim 5 , further comprising:
said extracorporeal photopheresis system determining if said disposable photopheresis kit is either authentic or counterfeit from said first acquiring step;
wherein said allowing step further comprises allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; 2) that said drug container is in said unlocked configuration; and 3) that said disposable photopheresis kit is authentic; and
wherein said precluding step further comprises precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said disposable photopheresis kit is of said first used condition using said first acquiring step; 2) that said drug container is not in said unlocked configuration; and 3) that said drug container is in said second locked configuration; and 4) that sa

Assignees

• Mallinckrodt Hospital Products Ip Ltd

Inventors

• Briggs Dennis
• Do Simon
• Vandlik Mark
• Murphy Kevin

Classifications

• A61K35/17

  Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00) · CPC title

• A61K35/15

  Cells of the myeloid line, e.g. granulocytes, basophils, eosinophils, neutrophils, leucocytes, monocytes, macrophages or mast cells; Myeloid precursor cells; Antigen-presenting cells, e.g. dendritic cells (presenting a specific antigen A61K39/00; therapeutic combinations of antibodies, or fragments thereof, and blood-derived cells A61K39/00) · CPC title

• A61M1/362266

  Means for adding solutions or substances to the blood · CPC title

• A61M1/36225

  with blood pumping means or components thereof · CPC title

• A61M1/36224

  with sensing means or components thereof · CPC title