Data management system and method for membrane separation systems

• US 9,764,075 B2
• Filed: 03/09/2012
• Issued: 09/19/2017
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Blickhan, Bryan, Min, Kyungyoon, Cork, William H.
• Primary Examiner(s): Bass, Dirk
• Assistant Examiner(s): BREWSTER, HAYDEN R
• Application Number:
  US14/003,294
• Publication Number:
  US 20130334139A1
• Time in Patent Office: 2,020 Days
• Field of Search: 210 85, 210645, 210650, 210782, 345520
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: A61M 1/0281 Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• 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 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3687 Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/38 Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: B01D 2313/08 : Flow guidance means within the module or the apparatus
• CPC Class Codes: B01D 2313/20 : Specific housing
• CPC Class Codes: B01D 2313/205 : characterised by the shape
• CPC Class Codes: B01D 2315/02 : Rotation or turning
• CPC Class Codes: B01D 61/18 : Apparatus therefor
• CPC Class Codes: B01D 63/06 : Tubular membrane modules
• CPC Class Codes: B01D 63/16 : Rotary, reciprocated or vibrated modules
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Claims

1. A method for providing identifying information on one or more storage containers of a processing kit for a blood product during processing of a quantity of whole blood having donor identification data associated therewith, with a blood processing system having a programmable controller with a user interface, the controller automatically performing the steps comprising:

prompting a user to load the one or more storage containers of the processing kit onto the blood processing system;

after confirmation that the user has loaded the one or more storage containers of the processing kit onto the blood processing system, prompting the user to retrieve data associated with the processing kit;

after confirmation that the user has retrieved the data associated with the processing kit, prompting the user to retrieve the donor identification data associated with the whole blood;

after confirmation that the user has retrieved the donor identification data associated with the whole blood, associating the donor identification data with the one or more storage containers of the processing kit, or prompting the user to associate the donor identification data with one or more of the storage containers of the processing kit;

processing the whole blood into a blood product received in the one or more storage containers of the processing kit;

prompting the user to retrieve the donor identification data associated with the storage containers of the processing kit and, after confirmation that the user has retrieved the donor identification data associated with the storage containers of the processing kit, comparing it to the donor identification data for the whole blood to verify the donor identification data associated with the data containers; and

after verification of the correct identification information associated with the storage containers, prompting the user to detach the one or more storage containers of the processing kit.

2. The method of claim 1 in which the whole blood is contained in a collection container that has donor identification data associated therewith and is part of an integrated system including the one or more storage containers of the processing kit.

3. The method of claim 1 in which the whole blood is contained in a collection container that has collection container data comprising the donor identification data associated therewith and is initially separate from the one or more storage containers of the processing kit and is connected to the one or more storage containers of the processing kit after retrieval of the collection container data.

4. The method of claim 1 wherein the identification data is associated with a bar code.

5. The method of claim 1 wherein the identification data is associated with a RFID tag.

6. The method of claim 1 wherein the identification data is associated with both a bar code and a RFID tag.

7. The method of claim 2 wherein the identification data for the collection container comprises one or more of a donor ID, container type, expiration date, collection time, collection volume, nurse ID and collection site.

15. The method of claim 1 wherein the step of prompting the user to retrieve data associated with the processing kit comprises prompting the user to scan the processing kit and the one or more storage containers.

16. The method of claim 1 further comprising printing labels for the one or more storage containers including the donor identification data.

17. The method of claim 1 wherein the association of the donor identification data with the one or more storage containers is carried out by automated data transfer from a whole blood collection container.

8. A blood processing system for processing whole blood or a whole blood component contained in a source container, the blood processing system including a processing kit having one or more storage containers and a programmable controller with a user interface programmed to facilitate the provision of identifying information on the one or more storage containers of the processing kit based on donor identification data associated with the source container, the programmable controller being further programmed to:

prompt the user to load the one or more storage containers of the processing kit onto the blood processing system;

after receiving confirmation that the user has loaded the one or more storage containers of the processing kit onto the blood processing system, prompt the user to retrieve data associated with the processing kit;

after receiving confirmation that the user has retrieved the data associated with the processing kit, prompt the user to retrieve donor identification data associated with the whole blood or whole blood component;

after receiving confirmation that the user has retrieved the donor identification data associated with the whole blood or whole blood component, associate the donor identification data with the one or more storage containers of the processing kit, or prompt the user to associate the donor identification data with one or more of the storage containers of the processing kit;

process the fluid in the source container into a blood product that is received in the one or more storage containers of the processing kit;

prompt the user to retrieve the identifying information associated with the storage containers of the processing kit after receiving confirmation that the user has retrieved the donor identification data associated with the storage containers of the processing kit, compare it to the donor identification data for the whole blood or whole blood product to verify the donor identification data associated with storage containers; and

after verification of the correct identification information associated with the storage containers, prompt the user to detach the one or more storage containers of the processing kit.

9. The blood processing system of claim 8 wherein the programmable controller is further configured to generate at least one label for attachment to one or more storage containers.

10. The blood processing system of claim 8 wherein the programmable controller is contained within a blood processing apparatus.

11. The blood processing system of claim 8 wherein the programmable controller is contained within a sterile connection device for connecting a source container to a processing kit.

12. The blood processing system of claim 8 wherein the source container contains a quantity of previously collected whole blood.

13. The blood processing system of claim 8 wherein the source container contains blood or blood components and the processing of the fluid includes a washing step.

14. The blood processing system of claim 8 wherein the blood processing system includes a memory storage unit for storing the donor identification data.

18. A method for providing identifying information on one or more storage containers of a processing kit for a blood product during processing of a quantity of whole blood having donor identification data associated therewith, with a blood processing system having a programmable controller with a user interface, the steps comprising:

the programmable controller prompting a user to load the one or more storage containers of the processing kit onto the blood processing system;

the user loading the one or more storage containers of the processing kit onto the blood processing system

the programmable controller, after confirming that the user has loaded the one or more storage containers of the processing kit onto the blood processing system, prompting the user to retrieve data associated with the processing kit;

the user retrieving data associated with the processing kit;

the programmable controller, after confirming that the user has retrieved the data associated with the processing kit, prompting the user to retrieve the donor identification data associated with the whole blood;

the programmable controller, after confirming that the user has retrieved the donor identification data associated with the whole blood, associating the donor identification data with the one or more storage containers of the processing kit, or prompting the user to associate the donor identification data with one or more of the storage containers of the processing kit;

the programmable controller operating the blood processing system to process the whole blood into a blood product received in the one or more storage containers of the processing kit;

the programmable controller, after confirming that the blood processing system to process the whole blood into a blood product received in the one or more storage containers of the processing kit, prompting the user to retrieve the donor identification data associated with the storage containers of the processing kit;

the user retrieving the donor identification data associated with the storage containers of the processing kit;

the programmable controller, after confirming that the user has retrieved the donor identification data associated with the storage containers of the processing kit, comparing it to the donor identification data for the whole blood to verify the donor identification data associated with the storage containers; and

the programmable controller, after verification of the correct identification information associated with the storage containers, prompting the user to detach the one or more storage containers of the processing kit.