Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-08-21
2004-01-27
Shaw, Shawna J. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C382S133000, C128S920000
Reexamination Certificate
active
06684092
ABSTRACT:
DESCRIPTION
The present invention relates to a system (method and apparatus) for facilitating pathological examination of a lesion in tissue, and relates, particularly, to a system for facilitating pathological examination of a lesion in tissue in which the lesion is scanned in order to generate images representing microscopic slices of the lesion.
Traditionally, pathological examination of a lesion in the tissue of a patient requires that a pathologist interpret slides prepared from sections of the lesion, i.e., histologically prepared sections or slices. These sections are taken from a biopsy specimen which surgically removes a portion or the entire lesion. This biopsy specimen is frequently called a tissue ellipse, since often it approximates that shape. The borders of the specimen are referred to as margins and may contain diseased or healthy tissue. After suitable processing, the tissue specimen or slices thereof are embedded in paraffin blocks. Histological sections (usually 5-6 microns thick) are then cut from the tissue slices with a microtome and stained for microscopic examination and interpretation by a pathologist.
Pathologists generally require that the histologically prepared sections from the tissue specimen represent a common suite or set of sections selected to provide information to diagnose the type of pathologic lesion and its extent. This suite of sections generally includes at least one section along the major axis of the tissue ellipse (i.e., along the length of the ellipse), at least one to two sections on each side of the tissue ellipse transversing the major axis, and at least three to four sections from the center of the lesion. The number of slices in the suite increases with the size of the lesion. Typically, the slices are taken perpendicular with respect to a surface of the tissue. A description of the preparation of histological sections is shown, for example, in Appendix H of Ackerman's Surgical Pathology, eighth edition (1996).
The interpretation of the slides of the histologically prepared sections of the lesion is recorded by the pathologist in a diagnostic report. Typically, this report in addition to the diagnostic interpretation of the slides, includes specimen information, descriptions and comments. The recommended content of a surgical pathology report is described in Appendix A of Ackerman's Surgical Pathology, eighth edition (1996). The report is forwarded to the physician treating the patient and/or the physician who provided the biopsy to the pathologist.
The paraffin blocks containing the tissue left after preparing the histological sections, the slides, and the diagnostic report together represent an archival record of the pathologist's examination of the lesion. Not all parts of the archival record may be located at the same location, but are cross-referenced to each other. This archival record is retained, in case the pathological examination of the lesion ever needs to be reviewed, for at least a minimum retention time in compliance with regulatory requirements.
Confocal microscopes for scanning tissue can produce microscopic images of tissue sections. Such microscopic image sections may be made in-vivo in tissue without requiring a biopsy specimen of the lesion. Examples of confocal scanning microscopes are found in U.S. patent application Ser. No. 08/650,684, filed May 20, 1996 now U.S. Pat. No. 5,788,639, and Serial No. 60/025,076, filed Oct. 10, 1996, both by James M. Zavislan, now U.S. Pat. No. 5,788,639, and in Milind Rajadhyaksha et al., “In vivo Confocal Scanning Laser Microscopy of Human Skin: Melanin provides strong contrast,” The Journal of Investigative Dermatology, Volume 104, No. 6, June 1995, pages 1-7. For further information concerning the system of the Zavislan applications, see Milind Rajadhyaksha and James M. Zavislan, “Confocal laser microscope images tissue in vivo,” Laser Focus World, February 1997, pages 119-127. These systems have confocal optics which direct light to the patient's tissue and image the returned reflected light. Further, microscopic images of tissue sections can be produced by optical coherence tomography or interferometry, such as described in Schmitt et al., “Optical characterization of disease tissues using low-coherence interferometry,” Proc. of SPIE, Volume 1889 (1993).
It is a feature of the present invention to generate confocal images representing microscopic sections of a lesion to provide information traditionally available to a pathologist by viewing, under a microscope, slides of a suite of histologically prepared sections of a lesion, and also to enable the storage of such confocal images and their transfer from one location to a pathologist at a remote location for their interpretation.
It is another feature of the present invention to facilitate the pathological examination of lesions especially where images of microscopic sections are obtained electronically and under computer control, which provides for the transmission of such electronic images in a coordinated manner providing more pathological information and enabling such information to be communicated telepathologically to various selected locations. The system of the present invention is therefore more effective in medical imaging than other similar systems heretofore proposed in other areas of medicine, for example, U.S. Pat. No. 4,860,112, issued to Nichols et al., describes a teleradiology system for transmitting scanned x-ray images to various locations. U.S. Pat. No. 5,005,126, issued to Haskin, describes a system for transferring diagnostic image information picked off from the internal analog video signal of imaging equipment, such as a CAT scanner or MRI. U.S. Pat. No. 4,945,410, issued to Walling, describes a satellite communication system for transmitting medical images, produced using a high resolution camera taking a video picture of a photograph, such as an x-ray, from remote satellite locations to a central headquarters, and also for sending back diagnostic analysis to the remote stations.
An object of the present invention is to provide an improved system for facilitating pathological examination of a lesion in tissue in which the lesion is optically scanned to generate images representing a suite of microscopic sections traditionally viewed by a pathologist for examination of a lesion.
Another object of the present invention is to provide an improved system for facilitating pathological examination of a lesion in which an electronic file structure is generated which contains at least images of microscopic sections of the lesion, a macroscopic picture of the lesion, and information referencing the location in the macroscopic picture where the images were scanned.
A further object of the present invention is to provide an improved system for facilitating pathological examination of a lesion in tissue in which the electronic file structure may be sent from a first location, where the data comprising the electronic file was generated, to a second location, where pathological examination of the lesion responsive to the data in the electronic file structure is performed.
A still further object of the present invention is to provide an improved system and method for facilitating pathological examination of a lesion in tissue in which the electronic file structure may further include data representing a diagnostic report about the pathological examination of the lesion, and such file structure may be sent to both the physician treating the patient having the lesion and to archival storage as a document.
Briefly described, the present invention may be embodied in a system for facilitating pathological examination of a lesion located in tissue. The system uses a computer system in which both a camera for producing a digital macroscopic picture of the lesion and an imager are coupled to the computer system. The imager is responsive to the computer system and has optics for generating images representing microscopic sections of the lesion which provide sufficient information for pathologica
Lucid Inc.
Lukacher Kenneth J.
Shaw Shawna J.
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