Patent Application
20160109337
1. Field
A method and system for indicating time on a reagent container, in particular, a method and system for indicating fixation time of a biological sample exposed to a fixation medium in a reagent container.
2. Background
In various settings, processing and testing of biological specimens is required for diagnostic purposes. Generally speaking, pathologists and other diagnosticians collect and study samples from patients, and utilize microscopic examination, and other devices to assess the samples at cellular levels. Numerous steps typically are involved in pathology and other diagnostic processes, including the collection of biological samples such as blood and tissue, processing the samples, preparation of microscope slides, staining, examination, re-testing or re-staining, collecting additional samples, re-examination of the samples, and ultimately the offering of diagnostic findings.
The collection of biological samples is typically performed by a healthcare provider (e.g. a laboratory technician) at a hospital or clinic. In particular, the provider collects the sample (e.g. blood or tissue) from the patient and then places the sample in a leak tight container. The container is then transported to a laboratory for processing. To prevent tissue deterioration during transport of the sample to a laboratory, the container is pre-filled with a fixative. To get the most optimal end-result, the sample should be fixated prior to the laboratory process. The time it takes to fixate the sample may depend, for example, upon the type of sample, dimensions and temperature. Typically, the fixation start time is determined by a technician and written on a container label at the time of collection and then the laboratory, upon receipt of the container, reviews the fixation start time to determine if the sample is fixed and ready for processing. Such a system, however, can lead to errors because it relies heavily on the accuracy of the technician. For example, the technician may incorrectly print the start time on the container, illegibly print the start time and/or the receiving technician may incorrectly determine the fixation time based on the start time.
The embodiments of the invention are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings in which like references indicate similar elements. It should be noted that references to “an” or “one” embodiment in this disclosure are not necessarily to the same embodiment, and such references mean at least one.
In the following paragraphs, the present invention will be described in detail by way of example with reference to the accompanying drawings. Throughout this description, the preferred embodiments and examples shown should be considered as exemplars, rather than as limitations on the present invention. Furthermore, reference to various aspects of the embodiments disclosed herein does not mean that all claimed embodiments or methods must include the referenced aspects.
During operation, a biological sample 108 is placed in container 102. In some embodiments, the fixation medium 106 may already be in container 102. Alternatively, the fixation medium 106 may be selected based on the type of biological sample 108 placed in an empty container 102, and then added to container 102. In the case where the fixation medium 106 is already in the container, the technician obtaining the biological sample 108 may select a container based upon the type of fixation medium already in the container. Once placed in container 102, the biological sample 108 is exposed to the fixation medium for a period of time sufficient for fixation to occur. The period of time may be different depending upon characteristics of the biological sample (e.g. type, size, density, etc.) as well as the type of fixation medium. It is important, however, that regardless of the period of time, the sample is completely fixated before the technician removes the biological sample for further processing. In other words, the biological sample can remain in the fixation medium after fixation without causing harm to the sample, but should not be taken out prior to fixation. In this aspect, it is important that the lab technician receiving the container 102 having biological sample 108 know the precise fixation time so that they don't have to wait extra time to ensure fixation, which in turn can unnecessarily delay further processing on the biological sample.
Container 102 therefore further includes a fixation indicator 110. Fixation indicator 110 provides an indication of a processing time or a fixation time of the biological sample 108 placed within fixation medium 106. The fixation time may be a period of time that is predetermined based on the type of biological sample and fixation medium within container 102. Representatively, fixation indicator 110 may indicate a period of time the biological sample 108 is exposed to fixation medium 106. In some embodiments, fixation indicator 110 may be configured to indicate a period of time equal to or less than a period of time required for fixation of the biological sample 108 within fixation medium 106. For example, where it is determined, based on the type of biological sample 108 and type of fixation medium 106 that it takes 24 hours for the fixation medium 106 to fix the biological sample 108, fixation indicator 110 may indicate a period of time of up to 24 hours. In this aspect, fixation indicator 110 is used to indicate to the technician receiving the container 102 with the biological sample 108 therein, whether the biological sample 108 has been in the fixation medium 106 long enough for fixation to be complete. Said another way, the fixation indicator 110 indicates whether the biological sample 108 has been in the fixation medium 106 for a period of time less than or equal to a predetermined period of time sufficient for completion of fixation. In other words, the processing time or the fixation time indicated by fixation indicator 110 can be directly tied to, and based on, the time it takes to fix a particular biological sample 108 within a particular fixation medium 106. This is in contrast to other time indicating systems which generally indicate whether, for example, an item such as a food product has expired or is no longer safe for human consumption or use. In addition, it should be understood that fixation indicator 110 may be adjusted to room temperature at, for example 22 degrees)(° C., but indicates time only. The time displayed by the fixation indicator 110 is therefore not associated with or affected by, for example, a temperature or any other conditions that may be associated with the sample, container, and/or fixation medium.
Display 204 may be formed by, for example, a window and/or transparent material within support member 202. A time scale 216 may be provided along a side of display 204. The time scale 216 may include numbers 210, 212, 214 which correspond to a predetermined period of time required for fixation of a biological sample. The migration medium 208 is specially designed to migrate through support member 202 at a rate which corresponds to the desired time scale such that the user can determine, based on the migration of the migration medium 208, a period of time the biological sample has been exposed to the fixation medium and, ultimately, whether the biological sample is fixated. For example, where it is determined that it takes 24 hours for a particular sample to be fixated within a fixation medium, time scale 216 may include time zero 210, time twelve 212 and time twenty-four 214, which correspond to hour increments. Once the biological sample is placed in the container upon which indicator 200 is attached and exposed to the fixation medium, the actuator 206 is pressed to activate the indicator. Once activated, the migration medium 208 starts to migrate through support member 202 and its progress is viewed through display 204. When the level of the migration medium 208 reaches time twelve 212, the user will understand that the biological sample has been exposed to the fixation medium for 12 hours. When the level of the migration medium 208 reaches time twenty-four 214, the user will understand that the biological sample has been exposed to the fixation medium for 24 hours. In embodiments, where the period of time required for fixation is twenty-four hours, the user will understand based on indicator 200 that the biological sample is fixed and ready to be removed from the container for the next processing step. Although time increments of zero, twelve and twenty-four hours are described in
The operation of fixation indicator 200 may be better understood in reference to
In some embodiments, identifier 420 may be a machine readable identifier. For example, identifier 420 may be a radio frequency identification (RFID) tag that can be read by a scanner or other type of reading device. It is further contemplated that identifier 420 may include optically readable data such as 1-D data, such as that found in a bar code, or 2-D data such as that which can be read optically by an optical reader (e.g. a CCD camera). In some embodiments, information obtained from identifier 420 may be used for automated identification and registration of the biological sample in a hospital or laboratory information system.
It should further be understood that an identifier or label such as identifier 420 could be attached to the container lid (e.g. lid 104) and contain any of the above-discussed types of information. For example, the identifier or label on the lid could provide sample processing information, patient information, fixation medium and/or time information, or sample specific information, for example, the maximum dimensions of the tissue sample to be fixed within the container.
Process 500 further includes associating the fixation indicator with the container (block 506). Representatively, the fixation indicator may have an adhesive backing as previously discussed such that it can be adhered directly to a surface of the container, for example, a side, top (e.g. lid) or bottom.
Once the fixation indicator is attached to the container, a biological sample may be placed within the container such that it is exposed to the fixation medium (block 508). The biological sample may be any type of sample in which fixation is required for further processing. For example, the biological sample may be a sample of mammalian tissue, for example, human tissue or animal tissue. The biological sample may be obtained from the mammal (e.g. using a biopsy procedure) and then placed within the container such that it is submersed in the fixation medium.
One the biological sample is exposed to the fixation medium, the fixation indicator is activated (block 510). It is important that activation occur immediately so that the period the biological sample is exposed to the fixation medium can be accurately tracked and monitored. For example, in some embodiments, the fixation indicator is activated simultaneously with placing the biological sample in the fixation medium. Alternatively, it is activated shortly thereafter. Activation may occur, for example, by pressing an actuator on the fixation indicator which causes migration of a migration medium within the indicator to migrate across the display as previously discussed. In other embodiments, the fixation indicator may be activated upon closing of the container, for example, the fixation indicator may include an actuator along the lid of the container which is pressed by the container lid to activate it.
With the fixation indicator activated and the fixation process under way within the container, the container may be transported to the desired lab for further processing. The fixation process may be monitored by a technician (or an information management system) to determine a fixation time of the biological sample (block 512). For example, in one embodiment, upon receiving the container, the laboratory technician looks at the fixation indicator display. If the migration medium visible through the display has reached the desired time on the time scale (or the “Fixation Complete” mark), the technician determines that the biological sample is fixed and may be removed from the container at any time for further processing. If, on the other hand, the desired mark on the time scale is not reached, the technician can determined the period of time remaining to fixation and leave the sample in the container for the additional period of time. For example, if the technician knows it takes 24 hours for fixation of the sample to be complete but the display shows the sample has only been exposed to the fixation medium for 12 hours, the technician determines the sample must remain in the fixation medium for another 12 hours. The fixation indicator can then be checked at any point to determine its progress.
It is further to be understood that although the technician may manually check the indicator, the fixation process may also be automatically tracked by a software based management system, for example, a hospital information system (HIS) or a laboratory information system (LIS). For example, the information management system may, through the aid of a scanner, determine that the fixation indicator has been activated and then register this information in the system. Since the system knows the time when the indicator was activated (and in turn when the biological sample was exposed to the fixation medium), the system can then track the period of time to fixation. In some cases, the system may be designed to automatically alert the technician when fixation is complete, such as using an audible or visible alarm.
It should be understood that the algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein or it may prove convenient to construct a more specialized device to perform the described processes disclosed herein. In addition, the invention is not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein.
A computer readable medium, which may be used to implement any of the processes disclosed herein on, for example a software application or other software based computing system, includes any mechanism for storing information in a form readable by a computer. For example, a computer readable medium includes read only memory (“ROM”), random access memory (“RAM”), magnetic disk storage media, optical storage media, flash memory devices or other type of machine-accessible storage media.
It should also be appreciated that reference throughout this specification to “one embodiment”, “an embodiment”, or “one or more embodiments”, for example, means that a particular feature may be included in the practice of the invention. Similarly, it should be appreciated that in the description various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects may lie in less than all features of a single disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment of the invention.
In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes can be made thereto without departing from the broader spirit and scope of the invention as set forth in the appended claims. For example, it should be understood that although information associated with the fixation indicator disclosed herein may be registered with an HIS or LIS, this is not required and therefore fixation time can be accurately monitored and determined independently and without such systems. In addition, although a fixation start time can optionally be determined and used by a technician to monitor sample fixation, it is not required therefore errors due to manual tracking of the fixation by the technician (such as by misprinting information) are eliminated. In this aspect, monitoring of sample fixation is more standardized. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.
