The patent's assignee is
News editors obtained the following quote from the background information supplied by the inventors: "This invention relates to the use of a portable florescence imaging device for florescence-guided surgery ('FGS'). In particular, the invention involves the use of a portable digital florescence imaging device in the florescent-guided surgery of cancer.
"The long-term survival of patients with solid tumor malignancies is typically dependent on complete surgical resection of the primary tumor. Additionally, accurate staging to determine an optimal strategy for post-surgical adjuvant treatment depends on the early identification of the presence and extent of metastatic disease. Therefore, complete visualization of primary and metastatic tumors within the operative field at the time of surgery is integral to the treatment of patients with solid cancers.
"Fluorescence-guided surgery enhances tumor identification and resection. Viewing of tumors glowing with fluorescence under excitatory light is a powerful adjunct to intraoperative tumor visualization over standard 'bright light' surgery ('BLS'). Labeling of primary and metastatic solid tumors using intracellular fluorescent labels has been accomplished through a variety of techniques, including retroviral transfection of genes coding for fluorescent proteins, fluorophores, and fluorescent antibodies. The label allows for greatly increased visual resolution when excited to fluoresce by a light source of the proper wavelength. Resolution is further increased by converting the emitted fluorescent light to a digital signal that can be viewed on a computer screen or other standard monitor. Fixed fluorescence imaging systems are typically used for this purpose.
"These fixed fluorescence imaging systems, although easily used in the laboratory for FGS on small experimental animals, are impractical for use in the hospital operating room and other clinical settings when treating human cancer patients. For example, the Olympus OV-100 small animal imaging system for in-vivo fluorescence molecular imaging is contained within a 50 cm.times.54 cm.times.100 cm. cabinet and requires introducing the entire animal into the device, yet has a field of view no greater than 6.3 cm. at a magnification of 0.14.times.. (http://www.metamouse.com/OV100%20brochure.pdf) Such a device cannot be used by the gowned-and-gloved surgeon, who ideally must be able to direct the device to the area of interest within the surgical field without breaking sterility. Intraoperative use by the surgeon is necessary to facilitate complete resection of the primary tumor and metastatic deposits while optimizing preservation of normal, non-cancerous tissue. Additionally, fixed imaging systems can induce significant background autofluorescence of non-labeled tissue, decreasing resolution and creating ambiguity regarding the boundary between labeled and non-labeled tissue. The value of using fluorescent labels lies in making this precise distinction. For example, to optimize the chance of curing a patient with a solid-tumor malignancy, all tissue containing cancerous cells must be resected while minimizing excision of non-labeled normal somatic cells to preserve the function of normal tissues and organs.
"In order for FGS to become routine in clinical settings and to enhance its use in the laboratory, an improved imaging system is needed.
"Citation of documents herein is not an admission by the applicant that any is pertinent prior art. Stated dates or representation of the contents of any document is based on the information available to the applicant and does not constitute any admission of the correctness of the dates or contents of any document."
As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors' summary information for this patent application: "Embodiments of the present invention relate to a system and method for using a portable digital fluorescence imaging device for fluorescence-guided surgery and for fluorescence-guided surgery of cancer. Generally, the system and method include the use of a portable probe directed toward a surgical field to excite a fluorescent label-containing tissue within the surgical field and display a real-time image visualization of the surgical field on a display.
"An embodiment includes a method for use of a portable imaging device for fluorescence-guided surgery. The method comprises directing a portable probe toward a surgical field, wherein the probe comprises a light source, a fluorescence detector, and a digital signal output. The method also includes exciting a fluorescent label-containing tissue within the surgical field in response to the light source of the portable probe illuminating the fluorescent label-containing tissue. The method then includes displaying a real-time image visualization of the surgical field on a screen in response to a computer in communication with the computer receiving image data of the fluorescent label-containing tissue from the digital signal output of the portable probe.
"It is understood that where 'screen,' 'monitor,' or other related term is used throughout this application, embodiments of the invention may use these or any type and number of displays for visualization during FGS.
"Another embodiment includes a portable digital imaging system for fluorescence-guided surgery. The system comprises a portable probe comprising a light source, a fluorescence detector, a digital signal output, a memory and a processor. The system also includes a computer in communication with the portable probe, the computer comprising a memory and a processor, and a display. The portable probe excites a fluorescent label-containing tissue within a surgical field in response to the light source of the portable probe illuminating the fluorescent label-containing tissue. Further, the computer displays a real-time image visualization of the surgical field on the screen in response to the computer receiving and processing a digital signal from the output of the portable probe.
"The foregoing and other features and advantages of the present invention will be apparent from the following more detailed description of the particular embodiments of the invention, as illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
"The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
"FIG. 1 is a schematic of an example handheld probe for real-time digital imaging of tissues containing fluorescent-labeled cells.
"FIG. 2 is a flowchart demonstrating the steps to practice the invention.
"FIG. 3 is a series of photographs demonstrating an example portable imaging system for use in FGS, contrasted with two corresponding fixed imaging systems.
"FIG. 4 is imaging of genetically-labeled MiaPaCa-2-GFP tumor using an example portable imaging system for use in FGS, contrasted with images taken with two corresponding fixed imaging systems.
"FIG. 5 is imaging of the BxPC3 tumor labeled with fluorescent anti-CEA antibody using an example portable imaging system for use in FGS, contrasted with images taken with two corresponding fixed imaging systems.
"FIG. 6 is imaging of the pancreatic PDOX.RTM. tumor labeled with fluorescent anti-CA19-9 antibody using an example portable imaging system for use in FGS contrasted with images taken with two corresponding fixed imaging systems"
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