Chemistry: analytical and immunological testing – Condition responsive control
Reexamination Certificate
1993-09-15
2001-06-12
Ludlow, Jan (Department: 1743)
Chemistry: analytical and immunological testing
Condition responsive control
C422S024000, C604S006080, C250S453110, C250S455110, C250S492100
Reexamination Certificate
active
06245570
ABSTRACT:
TECHNICAL FIELD
As described in Kahn et al. U.S. Pat. No. 4,608,255 entitled Biocompatible Method for in Situ Production of Functional Platelets and Product Produced Thereby Lacking Immunogenicity, it is taught to expose blood products which contain substantial numbers of platelets to ultraviolet (U.V.) radiation, to eliminate or greatly decrease an immune response to the platelet preparation by alloimmunized patients. It is generally believed that this alloimmunization is caused by the residual lymphocytes present in the platelet concentrations prepared by standard procedures, which result in undesired immunological response on the part of the patient receiving the platelets. The ultraviolet irradiation of platelet preparations appears to disable the lymphocytes from causing such an undesired immune response. The result of this is to prolong the life of donated platelets in the blood stream of a patient, for example cancer patients undergoing chemotherapy or the like.
As described in the Kahn et al. patent, a platelet suspension in a plastic container, permeable to ultraviolet radiation, is exposed to an ultraviolet dosage. Specifically, a dosage of radiation of about 774 Joules per square meter for about 30 minutes is proposed, using polyethylene, polypropylene, or polyvinyl chloride bags. The ultraviolet radiation passes through the bag walls to irradiate platelets and other cells present, to provide a cell preparation for administration to the patient which elicits little or no undesirable immune response from the patient.
The process of Dr. Kahn has been further improved and refined, particularly through the improvements described in Miripol et al. U.S. Pat. Nos. 4,726,949; 4,952,812; and 4,866,282. Specifically, it was found that improvements in the results can be obtained with an increase in the overall energy of ultraviolet radiation exposure, while improvements in the apparatus for administering ultraviolet radiation to flexible containers of blood product are also disclosed.
In accordance with this invention, improvements are provided in a flexible, flat-collapsible, ultraviolet transparent container for holding the above blood product, any other blood or biological liquid product, or any other material, in sealed manner while it is irradiated with U.V. radiation. Additionally, an improved apparatus for administering such ultraviolet radiation is disclosed.
In the field of collecting and processing blood components for administration to patients, it is of course extremely important to provide proper identification and categorization of the various blood component portions. This has been customarily done in the past by printing indicia on the face and tubing of the bag which contains the blood components. However, with respect to the particular blood component at issue here which is to be irradiated with ultraviolet radiation, printed indicia on the bag will serve to block the ultraviolet irradiation of the contents thereof resulting in unsuccessful ultraviolet irradiation. Accordingly, it is highly preferable for the container to be free of indicia that would block the ultraviolet irradiation of the blood product contents thereof.
At the same time, it is desirable to have a quick and reliable means for indicating that the blood component within the container has or has not been treated with ultraviolet irradiation. Also, the indicia identifying the container desirably include a bar code so that the container and its contents may be tracked and categorized through a computerized inventory control system, which can reduce the danger of misidentification or loss that is more likely with a manual inventory control system.
Accordingly, there is a need for the container to be automatically and properly positioned in the irradiation device so that a bar code can be automatically read, while at the same time the bar code does not interfere with the ultraviolet irradiation of the contents of the container, and the bar code is not accidently positioned in an ultraviolet irradiation apparatus wrongly, or with a misidentification of the contents of the container, or the like.
The above technical issues are addressed and successfully dealt with in the container of this invention, especially when processed in apparatus as disclosed in this invention, to achieve the many advantages that are available when the above recited technical disadvantages are overcome.
DESCRIPTION OF THE INVENTION
In accordance with this invention, a container is provided for the irradiation of blood or other products. The container comprises a flexible, flat-collapsible wall defining a sealed blood product chamber. Access port means, typically a plurality of conventional access ports, are provided for communicating through the wall to the blood product chamber.
A flap is also provided, integral with the wall and spaced from the chamber. The flap preferably is made of the same, typically transparent plastic material that the rest of the container wall is made of, carrying a label on or within the plastic flap. The label, in turn, carries identifying indicia, typically including bar code indicia.
The container wall is made of a plastic material that is substantially transparent to the specific irradiation being used. In the case of ultraviolet radiation, a suitable plastic material for use is poly(ethylene vinyl acetate). Such materials are readily commercially available, and bags of such material are available from the Fenwal division of Baxter International Inc. of Deerfield, Ill.
It is preferred for the container, and particularly the flap of the container, to carry means for detecting and indicating exposure of the container to the irradiation. Ultraviolet exposure indicating tape or tabs are commercially available, for example from the U.V. Process Supply Co. of Chicago, Ill.
Additionally, it is preferred for the container, typically within the flap, to define alignment hole means spaced from the chamber for facilitating the orientation of the container with apparatus for irradiation, and also apparatus for bar code reading. Thus, a pair of pins may be appropriately positioned in the irradiation apparatus, and a container in accordance with this invention may be mounted on such a pair of pins by means of a pair of alignment holes appropriately positioned in the flap so that, when the container is so mounted on the alignment holes, the bar code on the flap is properly positioned to be read by a bar code reader, and the container is properly positioned for irradiation in the apparatus. The bag flap may also carry an area for receiving handwritten notes or other indicia for added comments and identification by the user.
Thus, a flexible, collapsible container is provided in which the wall of the container which defines a blood product chamber is at least substantially free of opaque indicia to facilitate the irradiation thereof, while the identifying and describing indicia, typically including a bar code, are positioned on a flap which is spaced from the blood product chamber defined by the container.
Additionally, the container can be quickly examined to determine whether it has been exposed to radiation or not by means of the means for detecting and indicating such exposure, and alignment hole means are provided for assuring proper alignment of the container for appropriate irradiation and bar code reading.
While the container of this invention may be used in conjunction with a large variety of different apparatus for irradiation, the container is preferably used with apparatus for irradiating with ultraviolet radiation a layer of blood product containing white cells, the layer being defined by the container as it lies on a tray within the apparatus. The apparatus comprises a housing which defines a chamber and a pair of ultraviolet light sources positioned on opposed sides of the chamber. The housing comprises a pair of housing sections which are moveable in hinged relation between opened and closed positions, each of the sections carrying one of the pair of ultra violet light sources. A manually remov
Grimm Daniel J.
Leuenberger Mark S.
Baxter International Inc.
Ellis Garrettson
Kolomayets Andrew G.
Ludlow Jan
Serewicz Denise M.
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