MXPA06007200A - Method and apparatus for collecting and processing blood - Google Patents

Abstract

Method and apparatus are disclosed for collecting and separating whole blood into one or more components. A disposable blood separation fluid circuit (4) is provided which is adapted to cooperate with a reusable separation controller. The fluid circuit includes a fluid flow path (6) for communication with a blood source and an initial collection chamber in fluid communication with the fluid flow path. The fluid flow path is connected to a blood source;and a quantity of whole blood is collected from the source in the initial collection container. The source is then disconnected from the disposable fluid circuit. The disposable fluid circuit is mounted in associated with the reusable controller (2) and the collected blood is processed through the disposable fluid circuit assembly to separate it into the desired components.

Description

METHOD AND APPARATUS FOR COLLECTING AND PROCESSING BLOOD BACKGROUND OF THE INVENTION This application claims the priority and benefit of the application for provisional payee of the United States Serial No. 60 / 532,310, filed on December 23, 2003, which is hereby incorporated by means of this reference. The present invention relates to a method and apparatus for collecting and separating blood from one or more components. It is well known how to collect blood from healthy donors for posiérior administration to patients who need one or more components of the blood. Because patients often require only compose parts of the blood, it is now common to separate the collected blood from healthy donors into one or more components (commonly referred to as "apheresis"), such as red blood cells, platelets, or plasma. . Components of blood that are not immediately needed may be processed further for other applications, or unnecessary components may be returned to the donor. Apheresis can also be used as an idiopathic procedure to remove one or more components of the blood of a sick patient. The devices for blood processing or apheresis of those that are available in the current to carry out said blood collection processes, including the blood separation devices CS-3000®, Amicus®, Aufopheresis-C® and Alyx®, sold by Baxfer Healíhcare Corporación de Deerfield, Illinois, E. U. A. Available apheresis devices from other manufacturers include the Speciras® and Trima® from Gambro BCT of Lakewood, Colorado; the AS 1 04 of Fresenius Hemocare, Inc. of Redmond, Washington and the V-50 and other models of the Haremonefics Corporaíion de Brainíree, Massachusefís. These devices employ, typically, a pre-assembled, sterile fluid flow circuit, which is disposable, and a reusable, associated, or associated conirol module, which co-ordinates processing through the fluid circuit. In the devices identified above, the donor or other human subject remains physically connected to the disposition during a blood collection procedure, which can be as little as 20 to 25 minutes, or up to 90 minutes or so. Without misusing the time it is used, usually a blood processing, separate, or configu- ration module device is associated with each human subject (donor or patient), and the device remains connected to the fluid circuit for a period of time. the process. Although specialized devices have been proposed to collect blood from a donor and process it after the donor is disconnected, see, for example, the patent US No. 4,806,252, by Brown and co-inventors, there is still a need to develop an apparatus and versatile methods for collecting blood, in order to improve the efficiency of the use of the device, to reduce tying and to minimize the imposition on the time of delivery. donor and reduce inconvenience.

BRIEF DESCRIPTION OF THE PRESENT INVENTION In accordance with the present invention, a method and apparatus for collecting and separating whole blood in one or more components are provided, with improved efficiency and with reduced inconveniences. The method includes providing a disposable fluid separation circuitry which is adapted to cooperate with a reusable separation control controller or module which is also suitable for other blood separation applications and processes. The fluid circuit includes a stream of fluid flow for communication with a blood source, such as a recipient with blood from a human subject, a donor or a patient, and an initial collection chamber, in fluid communication with the patient. flow. According to the method of the present invention, the fluid flow path is connected to a blood source, such as a healthy human donor, although the method of the present invention is not limited to collecting and separating whole blood from humans in general or healthy donors, in particular. A quantity of blood was collected from the source into the initial collection chamber. Then the fluid circuit was disconnected from the source. In case of a healthy donor, the donor may leave the blood collection room or cen- tury behind and the presence or time of the donor is no longer necessary. The disposable fluid circuit is then blanked in association with a reusable controller, if it is not mounted in the controller at the time of collection. Whole blood collected in the initial collection vessel is processed through the disposable fluid circuit assembly to separate it from the desired components. In accordance with this procedure, the coninuous connection of the source to the blood collection fluid circuit during the entire procedure is not required; It is only required during the initial collection period, during which whole blood is collected in the initial collection chamber. Nor is it required to dedicate a controller to each donor or patient, and a controller can be used to process blood from many different sources. According to other aspects of the present invention, the initial collection chamber preferably includes an amount of anicoagulant to mix it with the blood, or it can be dosed into the blood, as it was collected into the initial collection chamber) inhibit the coagulation of whole blood when it is processed posioriorly through the assembly of fluid circuit. The amount of blood collected in the initial collection chamber can be an amount as desired by the user, consisting of the health of the donor or the patient; but it is to be expected that the amount of blood collected will be a typical "unit" of whole blood. A "unit" may be defined by the particular collecting agency, or as defined by any applicable regulatory body, any applicable rule or any applicable line. It is expected that normally 200 and 750 mL of whole blood will be collected in the initial collection chamber and, more specifically, around 405 to 550 mL and, more specifically, about 500 mL of whole blood. These scales may differ in different countries or regions, or between different blood collection agencies. In accordance with yet another aspect of the present invention, it is not necessary that the reusable controller or the reusable device be in the immediate vicinity of the human during the collection or processing of the blood, and may even run in completely different localities than where it is located. carries out the collection.

BRIEF DESCRIPTION OF THE DRAWING FIGURES Figure 1 is a perspective view of a blood separation controller or conirol module, and a disposable fluid circuit assembly, of the type incorporated in, and which is can be used in relation to the present invention, so that the fluid circuit assembly is mounted in the controller. Figure 2 is a perspective view of the apparatus of Figure 1, after the fluid circuit assembly is assembled, in association with the reusable controller. Fig. 3 is a perspective view of a reulilizable blood separator conirol module or module and a disposable fluidic disposable fluid assembly, of the type incorporated in, and that may be employed in connection with the present invention, before the fluid circuit assembly is mounted on the controller. Figure 4 is a perspective view of the apparatus of Figure 3, after the disposable fluid circuit assembly is assembled, in association with the reusable controller.

DETAILED DESCRIPTION The present invention is described herein in the recording of the Baxfer Aylx® blood collection and separation system. However, the present invention is not limited to a particular system or to a system made by a particular manufacturer. It may be used in connection with, or using other blood collection and separation systems, now available or that may be developed and still used, for a variety of procedures to process blood.

As shown in FIG. 1, the system includes a rehydratable conirol or conirol module 2 for carrying out a blood separation process, in cooperation with a spherilized fluid circuit assembly and, preferably, although not necessarily, integral, pre-assembled and disposable, indicated generally at 4. The controller or reusable controller module and the disposable circuit assembly are described in greater detail in one or more of the following patents or patent applications, each of which which is incorporated in this description by means of this reference: U.S. Patent No. 6,325,775 and applications of TCP No. PCT / US02 / 31317; PCT / US02 / 31319, PCT / US03 / 33311 and PCT / US03 / 07944. As noted earlier, the invention can also be used with other apheresis systems, such as the Amicus® separator (US Pat. No. 5,370,802), the Autopheresis C® separator (shown in US Pat. 5,135,667 and 5,194,145), the Haemoneíics V-50 separator, the Gambro Specíra® and Trima® separators and others that were mentioned previously. Each of the United States patents referred to in this paragraph is incorporated herein by means of this reference. As seen in Figure 1, the disposable fluid circuit assembly 4 includes a fluid path, generally designated with the number 6, in the form of a plaster tube. flexible, which ferminates in a needle 8 to access the source of blood, as a blood vessel of a human subject. In typical application, the blood source will be a human subject and, more typically, will be a healthy donor that provides blood or blood components for subsequent administration to a patient. However, unless specified in the claims, the present invention is not limited to use with a particular source of whole blood or a healthy donor. The stream of fluid flow continues from the needle, through the fluid circuit and into other components of the fluid circuit, located downstream, such as the processing chambers 10 and the bags 12-22 to process, in order to separate Blood collected to one or more blood components, such as red blood cells, platelets and plasma. The disposable fluid circuit may include a camera 24 of initial collection, such as a flexible plastic container or bag, in fixed fluid communication with the flow path 6. In Figures 1 and 2 a tube 26, which joins the fluid path 6 in an appropriate joint , such as a T-site, Y-site, or V-site, or other connector arrangement 28, extends to the initial collection container. The initial collection chamber could also be directly in line in the stream of fluid flow 6, so that the blood collected from the source flows towards the initial collection chamber. The cenyrifugal processing chamber 10 itself could also be enough volume to serve as an initial collection chamber, if desired; although it may be preferred for other reasons (such as the reduced extracorporeal blood volume, in other procedures in which the processing chamber is used), having a much smaller volume processing chamber, than would be desired for the present invention . If the separation chamber were to have sufficient volume, it would be preferred for said chamber to be a standard chamber for the particular separation system, such as a standard Haemonetics separator, which does not require substantial modification of the controller or control module. Other connection arrangements could be provided for the initial collection chamber, of course, without departing from the present invention. It is desirable that a collection volume be provided to collect an initial amount of blood directly from the source., so that significant processing will take place, and the particular construction of said collection chamber, whether it be a separate initial collection vessel, a separation chamber or some other structure that defines the initial collection chamber, is within range of the present invention. According to the present invention, the disposable fluid circuit assembly 4, in the case of a source of human blood, can be connected by insertion of the needle 8 into the blood vessel of the holder, typically a vein with blood, such as it is used in normal procedures of blood collection or apheresis. The fluid circuit assembly can already be mounted on the controller or control module 2 the moment it is connected to the human subject. However, it may be more economical for the disposable fluid circuit assembly not to be monialized in the coniferous module or module, re-cleanable, at the time it is connected to the source, or during the subsequent collection of blood from the source. In a well known and understood manner, whole blood can be collected from the human subject and allowed to flow into the initial collection chamber. In the situation where the chamber 10 is a separate bag, as shown in Figure 1, the blood flow to the chamber can be diverted by a closing jaw in the fluid flow path, downstream of the connection site 28 for the tube 26. Whole blood received within the initial collection chamber is also preferably mixed with anticoagulant 32 contained in the initial collection chamber, to prevent blood coagulation. Of course anticoagulant could be added from a separate container, and dosed into the blood as it exludes from the subject, if desired. It is suggested that it would be more convenient for the user or collection agency to have a quantity of anticoagulant contained in the initial collection chamber, to mix with the blood as it was collected from the human body.

As previously noted, when the source of blood is a human donor, it is expected that a typical "unit" of blood will be collected initially; being a unit as defined in accordance with the rules or practices of the particular agency involved in the collection, or as may be defined by any appropriate agency or regulation of the government or health. It is anticipated that typically about 200 to 750 mL of whole blood will be collected in the initial collection chamber, and preferably from 405 to 550 mL and, more commonly, about 500 mL of whole blood; although the exact volume or scale of volumes may vary between different collection organizations and / or in different countries or regions of the world. After the desired amount of whole blood is collected in the initial collection chamber, the blood source (donor or patient) can be disconnected from the fluid flow path. Since the presence of the source is no longer necessary, it is not necessary for the donor to remain connected to the facility, while additional blood processing or separation occurs; and you can leave the collection site and go to your business, if you wish. Consequently, the only time a human subject is required to be in the process of collecting blood is the time necessary for initial discrimination, connection and extraction, for example, by gravity, to the initial collection chamber. It is contemplated that a healthy donor is connected to the fluid circuit approximately between 7 and 10 minutes, which significantly reduces and minimizes the time that a human subject must devote to the collection procedure, and minimizes the inconveniences associated with the collection. It is well known and understood in the field of blood banks that one of the many obstacles to obtaining blood donors is the time and potential drawback to the donor when donating blood. Consequently, to the extent that progress can be made in reducing the time required for blood donation and reducing any perceived inconvenience to the donor, it will potentially be of significant benefit in increasing and maintaining blood donor groups. After the human or donor subject is disconnected from the fluid circuit, for example, by removing needle 8, tube 6 can be sealed and cut off from the fluid circuit., if so desired. Then the fluid circuit, if not already installed in the reusable controller or reusable control module, will be installed in it, in order to process the collected blood in the initial collection chamber, using a process such as that the controller can be programmed to perform. For example, the controller can be programmed to collect human red blood cells and plasma containing platelets. Alternately you can program the driver to pick up plates and plasma.

In any case, the blood may be processed through the controller in the manner that is most convenient and efficient for the collection agency, without concern for additional inconveniences or in terms of the time required of the donor or other source of blood. . Neither is it necessary for each donor or other source of blood, which has a controller or dedicated control module associated with it. Consequently, the controller may be located at the collection site when whole blood is being collected for convenient processing quickly after collection or, alternatively, the conirol module or module may be in a location that is different from where the blood was initially collected. of the human subject or another source of blood. As a result, a controller or control module can be used to process the collected blood of many different human subjects; thus significantly reducing the cost of capital required by blood collection centers or agencies, compared to situations where it is necessary to have a reusable controller or control module associated with each donor during the event or a significant portion of the collection and / or processing time. As another possible efficiency related to the present invention, it may be possible to connect more than one of the initial collection chambers to a given fluid circuit assembly, so that the collected blood may be processed from various donors, through the same disposable fluid circuit assembly. This can be achieved by providing additional connection sites, such as a Y-connector 28 in the fluid path 6, for connection to an initial collection chamber, to collect blood from another donor. Multiple collection sites 28 can be provided in fluid path 6, so that a plurality of initial collection chambers could be connected to process the whole blood collected from different donors. Instead of a connection site, one or more sealed branch pipe sections may be provided for connection to the collection chambers, by a sterile connecting device, allowing the blood to be processed in additional collection chambers, either serially or parallel, through the same fluid circuit. It is also possible to assemble several initial collection chambers in a single vessel for processing through the fluid circuit assembly. In summary, the present invention provides a novel and particularly unique method and apparatus for collecting and separating whole blood into one or more components; which has substantial benefit to reduce the amount of time of the source or donor, or the time of the human subject, required for connection to the separation apparatus; reducing any potential inconvenience for the donor and increasing the efficiency of the use of the devices and decreasing the capital requirements.

An alternate processing apparatus is shown in Figures 3 and 4. This embodiment differs from the version of Figures 1 and 2 in that a container previously connected is used, which is part of a standard Alyx®, a disposable fluid assembly or circuit apparatus, as the initial collection container; and it is not necessary to have additional container connected to the apparatus to function as an initial collection vessel. More specifically, in Figures 3 and 4, the container or bag 12, which is commonly referred to as an "in process" container, in the typical red blood cell collection procedures in the Alyx® system (described in one or more of the patents) and patent applications incorporated by reference above), serves as an initial collection vessel to receive the desired amount of blood from the blood source. In said fluid circuit arrangement, the access needle 8 can be connected, via the inlet tube 6, directly to the container 12 in process. A cannula of anticoagulant 32, such as ACD or another anticoagulant, may be placed in the container or bag in process prior to mixing with whole blood as it is harvested from the blood source. The amount of blood collected can be monitored automatically by means of a scale from which the container in process hangs.; if the system is installed in the control module 2 at the time of collection. Otherwise, the amount can be visually monitored by the operator, as is done in typical manual collection procedures of blood. When the desired amount of blood has been collected in the container in process, the inlet tube 6 can be sealed and cut to remove the needle 8. The jaw 30 (or the frangible, internal flow control member) can be opened, since Then the collected blood is processed through the fluid circuit assembly to separate the whole blood and collect the desired components of the blood. In this arrangement and this process, anticoagulated whole blood may be used to prime the remainder of the fluid circuit assembly; and it may not be necessary to have a separate container of saline as part of the previously assembled and previously sterilized fluid circuit assembly. Of course, because the system is disconnected from the blood source after the desired amount of blood is collected, saline is not required as a replacement fluid for the donor. Accordingly, the fluid circuit assembly in Figures 3 and 4 may be specially configured to practice the method of the present invention, by eliminating various parts or components that are normally employed in said disposable fluid circuit; but which are not necessary or are redundant for the method of the present invention. Although it has been described in terms of the Alyx® blood collection system, sold by Baxíer Healthcare Corporation, the invention can be applied, as was done earlier, in other systems and devices for collection of blood, without departing from the present invention, which is defined in the claims that follow

Claims (18)

1. - A method for collecting and separating blood from one or more components, characterized in that it comprises: providing a circuitry of disposable fluid for blood separation, adapted to cooperate with a reusable separation controller; the fluid circuit including a stream of fluid flow for communication with a source of blood; an initial collection chamber in fluid communication with the fluid flow path, and a blood processing chamber in fluid communication with the initial collection vessel; connecting the fluid flow path to a source of blood; collect a quantity of whole blood from the source, in the initial collection vessel; disconnect the source of the disposable fluid circuit; assemble the disposable fluid circuit, in association with the reusable controller; and process the collected blood through the disposable fluid circuit assembly and the processing chamber, to separate it to the desired components.

2. The method according to claim 1, further characterized in that the assembly occurs after the source of the fluid circuit is disconnected.

3. The method according to claim 1, further characterized in that the initial collection chamber includes an amount of anticoagulant.

4. The method according to claim 1, further characterized in that approximately 200 to 750 mL of whole blood is collected in the initial collection chamber.

5. The method according to claim 1, further characterized by collecting about 500 mL of whole blood in the initial collection chamber.

6. The method according to claim 5, further characterized in that a unit of whole blood is collected in the initial collection chamber.

7. The method according to claim 1, further characterized in that it includes connecting additional collection chambers of whole blood to the fluid flow path, to process it through the fluid circuit.

8. The method according to claim 1, further characterized in that the reusable device is not in the immediate vicinity of the source during collection or processing.

9. The method according to claim 1, further characterized in that the reusable device is in a different location from that in which the collection takes place.

10. The method according to claim 1, further characterized in that the source of blood is a human.

11. The method according to claim 7, characterized further by sequentially processing the blood in the initial collection chamber.

12. The method according to claim 7, further characterized in that the blood is processed simultaneously in the initial collection chamber.

13. The method according to claim 1, further characterized in that it includes gathering the blood from other sources of blood, and flowing the collected blood in the flow path to process it through the fluid circuit.

14. The method according to claim 1, further characterized in that approximately 405 to 550 mL of whole blood is collected in the initial collection chamber.

15. A disposable fluid circuit assembly for blood processing, characterized in that it comprises: a blood processing chamber and a plurality of associated fluid flow containers and tubes, adapted to process blood while in communication with a source of blood; further including the blood processing assembly: a container for initial collection, to receive a quantity of whole blood from the source, for processing after the communication with the blood source has ceased.

16. The assembly according to claim 15, further characterized in that the initial collection vessel has a volume sufficient to contain a unit of blood eniera

17. The assembly according to claim 15, further characterized in that the initial collection vessel has a volume between about 200 mL and about 750 mL.

18. The assembly according to claim 15, further characterized in that it comprises an amount of anticoagulant in the initial collection vessel.