Device for the treatment and extracorporeal circulation of blood or blood components

• US 8,400,298 B2
• Filed: 08/04/2008
• Issued: 03/19/2013
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Rada, Hiram
• Primary Examiner(s): PHAM, TOAN NGOC
• Application Number:
  US12/809,032
• Publication Number:
  US 20100315231A1
• Time in Patent Office: 1,688 Days
• Field of Search: 340/540, 340/573.1, 340/691.1, 340/691.6, 340/693.9, 340/3.1, 340/3.3, 210/85, 210/142, 210/203, 210/295, 210/348, 220/500, 294/28
• US Class Current: 340/540
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3451 the difference in weight between both ultra-filtrate and substitution reservoir being used as control signal
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The invention relates to a medical device for providing a plurality of extracorporeal blood or plasma treatments, apt to receive at least one disposable article that can be connected to extracorporeal circuit, each disposable article being equipped with storage means containing information about the disposable article, the device comprising a first receiving station (2) for disposable articles (100) with a first reading means (3) for the associated article, a second receiving station (3) for disposable articles (100) with a second reading means (3) for the associated article, a memory comprising information concerning at least one treatment protocol designed to be executed by the device, and information concerning a configuration of the disposable articles necessary for each treatment protocol at each receiving station, a control unit (10) for comparing the stored configuration of articles concerning a treatment protocol with the configuration of articles once it is installed.

Claims

1. A medical device for providing a plurality of extracorporeal blood or plasma treatments in a filtration unit having a primary compartment and a secondary compartment, which are separated by a semipermeable membrane, the primary compartment being able to be connected to a primary extracorporeal blood circuit, the secondary compartment being able to be connected to a secondary circuit, the primary circuit and the secondary circuit defining an extracorporeal circuit, the device being apt to receive at least one disposable article that can be connected to the extracorporeal circuit, each disposable article being equipped with storage means containing information about the disposable article, the device comprising:

a first receiving station for disposable articles, which is able to collect a first disposable article,

a first reading means associated to the first station for identifying a disposable article received at the first station,

at least a second station for receiving disposable articles, which is able to collect a second similar disposable article,

at least a second reading means associated to the second station for identifying a disposable article received at the second station,

a device storage means for storing;

information concerning at least one treatment protocol designed to be executed by the device,

information concerning a configuration of the disposable articles necessary for each treatment protocol at each receiving station,

a control unit connected to the device storage means, comprising;

means for receiving information concerning the treatment protocols to be executed,

means for receiving information read by at least one of the reading means, and

means for checking, as a function of this information, whether the configuration of the disposable article or articles received complies with the stored configuration for the treatment to be executed.

2. The device according to claim 1, wherein the configuration of the disposable articles necessary for each protocol comprises at least one of the following elements for each protocol:

the number of necessary articles, the nature of each necessary article, the function of each necessary article, the position of each necessary article at each receiving station.

3. The device according to claim 1, wherein the first receiving station comprising first fastening means for articles, wherein at least the second receiving station for articles comprises second fastening means for articles that are identical to the first fastening means for articles.

4. The device according to claim 1, wherein the disposable article received at the first receiving station comprises first fastening means to a receiving station, at least the second disposable article received at the second receiving station comprises second fastening means to a receiving station that are identical to the first fastening means of the station.

5. The device according to claim 1, wherein the control unit (10) comprises means for sending, as a function of said information, an alarm signal when the configuration of the disposable article or articles received does not comply with the configuration of the selected treatment.

6. The device according to claim 1, comprising display means, and wherein the control unit comprises means for controlling, as a function of said information, said display means for displaying an alarm or warning signal comprising at least one of the following information:

a necessary article is missing in the device,

an unnecessary article is present in the device,

a necessary article is present but is installed in an incorrect receiving station,

a necessary article is present in the device,

a present article requires a particular use, optionally wherein the particular use is a preparation previous to the use of the article.

7. The device according to claim 1, wherein the device storage means are able to store all the information received by the reading means associated to the receiving stations.

8. The device according to claim 1, wherein at least one reading means is integrated into the associated receiving station.

9. The device according to claim 1, wherein at least one reading means is close to the associated receiving station.

10. The device according to claim 1, wherein at least one receiving station is a weighing means for weighing the disposable article to be received.

11. The device according to claim 1, wherein at least one reading means is a contactless reading means.

12. The device according to claim 11, wherein the contactless reading means is at least one of the following readers:

a radiofrequency reading means, an optical reader, a magnetic reader.

13. The device according to claim 1, wherein the disposable articles belong to one of the following categories:

container comprising a medical liquid,

empty container designed to receive used liquid,

dialyzer,

set containing at least one filter with various accesses and lines connected to the accesses of the filter so as to form at least partially the extracorporeal circuit,

blood or plasma filter, absorption cartridge,

ultrafilter,

plasma filter.

14. The device according to claim 13, wherein the category of containers comprising a medical liquid is a bag, and wherein the disposable articles comprise at least one of the following bags:

a bag filled with dialysis liquid, a bag filled with perfusion liquid, a bag filled with anticoagulant, an empty bag for receiving used medical liquid during treatment.

15. The device according to claim 13, wherein at least one of the disposable articles is a container provided with at least two compartments, the compartments containing each a liquid for medical use, and wherein a mode of previous use of this container is the mixing of the liquids immediately before its use in the device.

16. The device according to claim 1, comprising:

a plurality of first receiving stations comprising first respective identical fastening means for fastening a first category of disposable articles,

at least a plurality of second receiving stations comprising second respective identical fastening means for fastening a second category of disposable articles, the second fastening means being different from the first fastening means,

wherein the first category and the second category of disposable articles are each included among one of the following categories;

container comprising a medical liquid,

empty container designed to receive used liquid,

dialyzer,

set comprising at least one filter containing various accesses and lines connected to the accesses of the filter so as to form at least partially the extracorporeal circuit,

blood or plasma filter, absorption cartridge,

ultrafilter,

plasma filter.

17. The device according to claim 1, wherein:

the first receiving station is designed to receive a container for perfusion liquid to be connected to the arterial line of the primary circuit,

the second receiving station is designed to receive a container for fresh dialysis liquid to be connected to the inlet of the secondary compartment of the filtration unit,

the device also comprising;

a third receiving station for disposable articles, similar to the first and second receiving stations and designed to receive a third disposable article, the third article being a container for perfusion liquid to be connected to the primary circuit upstream or downstream from the first compartment of the filtration unit,

at least one third reading means associated to the third station for identifying the disposable article received at the third station,

a fourth receiving station for disposable articles, similar to the first three receiving stations and designed to collect an empty fluid container to be connected to the outlet of the secondary compartment of the filtration unit.

18. The device according to claim 17, wherein the storage means comprise at least one of the following protocols:

first protocol of treatment by hemodiafiltration requiring the presence of four medical articles on the four corresponding receiving stations,

second protocol of treatment by hemodialysis requiring the presence of the first, second and fourth medical article on the corresponding first, second and third receiving station,

third protocol of treatment by hemofiltration requiring the presence of the four medical articles on the four corresponding receiving stations,

fourth protocol of treatment by ultrafiltration requiring the presence of the first and fourth medical article on the corresponding first and fourth receiving station,

fifth treatment protocol by plasma exchange requiring the presence of the first, second and fourth medical article on the corresponding first, second and fourth receiving station,

sixth protocol of treatment by hemoperfusion requiring the presence of the first medical article on the corresponding fourth receiving station.

19. The medical device according to claim 1, wherein at least one disposable medical article is installed in at least one receiving station.

20. The device according to claim 19, wherein the storage means for disposable articles is included among the following elements:

a read-only memory containing information on the article, a programmable or non-programmable random access memory, a random access memory where data concerning the development of the treatment can be written.

21. The medical device according to claim 19, wherein the storage means for disposable articles are fastened in a fixed manner to or into the disposable article.

22. The medical device according to claim 19, wherein the storage means comprise at least one of the following data concerning the disposable article associated thereto:

a nature of the article,

an effectiveness parameters of the article,

a function of the article,

a medical classification of the article,

a date of expiry of the article,

groups of patients who do not tolerate a use of the article or an administration of its content,

a manufacturer of the article,

a manufacturing date of the article,

modes of use of the article,

a volume contained in the articles of container type.

27. A control method for the device according to claim 1, wherein at least one disposable medical article is installed in at least one of the receiving stations, the device comprising an interface, the method comprising at least the following steps:

receiving by way of the interface the selection of an extracorporeal treatment among the plurality of possible treatments stored,

reading the storage means for each disposable article installed in the receiving station or stations by way of each reading means associated thereto,

comparing an installation configuration of the articles once they are installed in the receiving stations with the required stored configuration of disposable articles necessary for the selected treatment,

sending by way of the display means an alarm or warning signal when the configuration of the installed articles does not correspond to the required stored configuration.

28. The control method according to claim 27, wherein the sending of the signal comprises one of the following warnings:

a warning if a necessary article is missing in the device,

a warning if an unnecessary article is present in the device,

a warning if a necessary article is present but is installed in an incorrect receiving station,

a warning if a necessary article is present in the device,

a warning if a present article requires a particular use, optionally wherein the particular use is a preparation previous to the use of the article.

29. A method for installing disposable articles in a device according to claim 1, comprising the following steps:

selecting an extracorporeal treatment among the plurality of possible stored treatments,

installing the medical article or articles in the receiving station or stations,

reading the storage means for each disposable article installed in the receiving station or stations by way of each reading means associated thereto,

comparing the configuration of the articles installed in the receiving stations with the required stored configuration of disposable articles for the selected treatment,

if the configuration of the installed articles is not identical to the required stored configuration, sending an alarm or warning signal,

as a function of the sending of an alarm or warning message, add, remove or change at least one disposable medical article.

23. A kit of containers for liquids for medical use, this kit being designed to be used and fastened in a medical device so as to provide a plurality of extracorporeal blood or plasma treatments, and which comprises several receiving stations for containers having each a fastening means for containers, the fastening means for containers being identical, each station having an associated reading means for identifying the container to be received, and wherein:

Each container is equipped with a storage means for storing;

a. information concerning at least one treatment protocol designed to be executed by the device,

b. information concerning a configuration of the disposable containers necessary for each treatment protocol at each receiving station.

24. The kit of containers according to claim 23, comprising the following containers:

a container filled with dialysis liquid,

a container filled with perfusion liquid,

a container filled with anticoagulant,

an empty container for receiving used liquid.

25. A container comprising a first compartment containing a first fluid for medical use, at least a second compartment containing a second fluid for medical use, a fluid communication means between the first and second compartment, a closing means for the fluid communication means between the compartments, the closing means being removable so as to enable the communication between the two compartments, characterized in that at least one of the two compartments contains a storage means for storing:

a. information concerning at least one treatment protocol designed to be executed by the device,

b. information concerning a configuration of the disposable containers necessary for each treatment protocol at each receiving station, and in that the storage means is able, once the closing means has been removed from said fluid communication means, to switch from the first to the second compartment.

26. The container according to claim 25, comprising an auxiliary storage means fastened to the container, for storing:

a. information concerning at least one treatment protocol designed to be executed by the device,

b. information concerning a configuration of the disposable containers necessary for each treatment protocol at each receiving station.

30. A medical device for providing a plurality of extracorporeal blood or plasma treatments in a filtration unit having a primary compartment and a secondary compartment, which are separated by a semipermeable membrane, the primary compartment being able to be connected to a primary extracorporeal blood circuit, the secondary compartment being able to be connected to a secondary circuit, the primary circuit and the secondary circuit defining an extracorporeal circuit, the device being apt to receive at least one disposable article that can be connected to the extracorporeal circuit, each disposable article being equipped with storage means containing information about the disposable article, the device comprising:

a first receiving station for disposable articles, which is designed to receive a container for perfusion liquid to be connected to an arterial line of the primary circuit,

a first reading means associated to the first station for identifying a disposable article received at the first station,

at least a second station for receiving disposable articles, which is designed to receive a container for fresh dialysis liquid to be connected to an inlet of the secondary compartment of the filtration unit,

at least a second reading means associated to the second station for identifying a disposable article received at the second station,

a third receiving station for disposable articles, similar to the first and second receiving stations and designed to receive a third disposable article, the third article being a container for perfusion liquid to be connected to the primary circuit upstream or downstream from the primary compartment of the filtration unit,

at least one third reading means associated to the third station for identifying the disposable article received at the third station,

a fourth receiving station for disposable articles, similar to the first, second, and third receiving stations and designed to collect an empty fluid container to be connected to an outlet of the secondary compartment of the filtration unit;

a device storage means for storing;

information concerning at least one of the following treatment protocols designed to be executed by the device;

first protocol of treatment by hemodiafiltration requiring the presence of four medical articles on the four corresponding receiving stations,

second protocol of treatment by hemodialysis requiring the presence of the first, second and fourth medical article on the corresponding first, second and third receiving station,

third protocol of treatment by hemofiltration requiring the presence of the four medical articles on the four corresponding receiving stations,

fourth protocol of treatment by ultrafiltration requiring the presence of the first and fourth medical article on the corresponding first and fourth receiving station,

fifth treatment protocol by plasma exchange requiring the presence of the first, second and fourth medical article on the corresponding first, second and fourth receiving station,

sixth protocol of treatment by hemoperfusion requiring the presence of the first medical article on the corresponding fourth receiving station,

information concerning a configuration of the disposable articles necessary for each treatment protocol at each receiving station,

a control unit connected to the device storage means, comprising;

means for receiving information concerning the treatment protocols to be executed,

means for receiving information read by at least one of the reading means, and

means for checking, as a function of this information, whether the configuration of the disposable article or articles received complies with the stored configuration for the treatment to be executed.