Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-11-18
2001-03-20
Kamm, William E. (Department: 3762)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S437000, C600S473000, C424S009300, C424S009400, C424S009500, C424S009600
Reexamination Certificate
active
06205352
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to methods, compositions and apparatuses for detecting sentinel nodes, and more particularly to means for transcutaneously identifying sentinel nodes, which do not employ radioactive isotope marking agents.
BACKGROUND OF THE INVENTION
Due to the propensity of malignant tumors to metastasize through the lymphatic system, it has in the past been normal practice in some situations to remove all lymph nodes potentially harboring malignant cells metastasized from a tumor. Recently, the technique of interoperative lymphatic mapping has taken much of the guesswork out of determining which lymph nodes to remove. The at least one lymph node (typically 1-3 lymph nodes) which is the first to receive lymphatic drainage from the tumor (i.e., the sentinel node) is identified and biopsied. If the at least one sentinel node is free of malignant cells, then further lymph node biopsies can be avoided.
Sentinel nodes have been identified by injecting a marking agent into the tumor-bearing tissue and tracing the pathway of the marking agent through the lymphatic system. Visible marking agents have been employed to visually detect sentinel nodes with the naked eye, but such methods typically require significant surgical dissection to view the potential sentinel nodes and detect the presence of marking agent therein. Radioactive isotopes have also been employed as sentinel node marking agents. See, e.g., Kapteijn et al., “Localizing the sentinel node in cutaneous melanoma: gamma probe detection versus blue dye,” 4(2) Ann. Surg. Oncol. 156-60 (Mar. 1997) and U.S. Pat. No. 5,732,704 to Thurston et al. These techniques comprise injecting radioactive isotope compositions into the tumor bearing tissue and detecting the migration of the composition from the tumor and into the lymphatic system.
Although such radiochemistry techniques are an improvement over prior visible detection methods in that radioactive marking agents can be detected transcutaneously (regardless of the depth of the sentinel node within the tissue), radiochemistry techniques are less than ideal in a number of aspects. Patients and medical personnel are exposed to potentially harmful doses of ionizing radiation. Radioactive isotopes also pose environmental contamination and disposal issues.
Thus, there has been a need for a method of transcutaneously identifying a sentinel node without using radioactive isotopes.
All references cited herein are incorporated herein by reference in their entireties.
SUMMARY OF THE INVENTION
The invention addresses at least the foregoing deficiencies of the prior art in providing a method for identifying a sentinel node, comprising:
injecting tumor-bearing tissue with a marking composition comprising a marking agent;
radiating marking-agent-targeting energy into suspect tissues potentially harboring said sentinel node; and
detecting a lymph node first infiltrated by said marking agent to identify said sentinel node, said detecting being across a substantial thickness of said suspect tissues,
wherein said method is conducted without detecting radioactivity.
The invention also provides systems for performing the method of the invention and compositions for use in the method of the invention.
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Gulec, et al., “The Expanding Clinical Role for Intraoperative Gamma Probes,” Nuclear Medicine Annual 1997. pp. 209-237.
Kapteijn et al., “Localizing the Sentinel Node in Cutaneous Melanoma: Gamma Probe Detection Versus Blue Dye,” Annals of Surgical Oncology, 4(2), 1997, pp. 156-160.
Krag, M.D., et al. “The Sentinel Node in Breast Cancer,” The New England Journal of Medicine, No. 14, Oct. 1, 1998. 339:941-946.
Paganelli, Giovanni, “Sentinel node biopsy: role of nuclear medicine in conservative surgery of breast cancer,” Eur J Nucl Med, No. 2, Feb. 1998. 25:99-100.
Veronesi et al., “Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes,” Lancet, Jun. 28, 1997. 349:1864-1867.
Caesar Rivise Bernstein Cohen & Pokotilow Ltd.
Kamm William E.
Oncology Innovations, Inc.
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