Surgery – Endoscope – With tool carried on endoscope or auxillary channel therefore
Reexamination Certificate
1996-07-08
2001-10-02
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
With tool carried on endoscope or auxillary channel therefore
C600S113000, C600S182000, C600S478000
Reexamination Certificate
active
06296608
ABSTRACT:
BACKGROUND OF THE INVENTION
This application relates to diagnosing and performing interventional procedures on tissue using endoscopically insertable catheters.
Lesions in body lumens such as the alimentary track may be diagnosed by inserting an endoscope into the alimentary track and inserting through a working channel of the endoscope a catheter having optical fibers for transmitting light to tissue located at a distal end of the catheter and for conveying light back from the tissue for analysis by a spectroscopic diagnosis system. If the spectroscopic diagnosis system determines an interventional procedure should be performed on the tissue, a biopsy of the tissue may be taken or the tissue may be otherwise removed or treated.
SUMMARY OF THE INVENTION
One aspect of the invention features a catheter for diagnosing and performing an interventional procedure on tissue. The catheter has an elongated catheter shaft, and optical fibers, extending through the catheter shaft, transmit light to tissue located at a distal end of the catheter shaft and convey light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue. An interventional device is located at the distal end of the catheter shaft for engaging tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue.
In various embodiments the catheter is constructed to be inserted through the working channel of an endoscope, and the interventional device is, for example, a scalpel, forceps jaws, a snare, a scissors, or a needle. An interventional needle can be used, for example, to cut the tissue, to apply an adhesive material to the tissue, to inject a chemical ablation fluid into the tissue, or to inject a marking fluid into the tissue so as to enable the tissue to be treated by another interventional device, which may be located on another catheter. Because the interventional device is located on the same catheter as the optical fibers, the physician can perform the interventional procedure on the tissue without having to remove the catheter from the patient's body. Moreover, the diagnosis and interventional procedure can be accomplished at multiple sites without having to remove the catheter from the patient's body. In various embodiments the interventional device is, for example, a scalpel, forceps jaws, a snare, a scissors, or a needle.
Another aspect of the invention features an assembly comprising an endoscope, a catheter shaft insertable through a working channel of the endoscope having optical fibers for transmitting light to tissue and from tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue, and an interventional device, insertable through a working channel of the endoscope, for performing the interventional procedure on the tissue.
Another aspect of the invention features a method for imaging and performing an interventional procedure on tissue. A catheter having an ultrasound imaging device located at its distal end is inserted through a working channel of an endoscope, for imaging a tissue structure located at a distal end of the endoscope, and the tissue structure is displayed in a manner that indicates-the depth of penetration of the tissue structure into the body of the living being. An interventional device, which is inserted through a working channel of the endoscope, performs interventional therapy on the tissue structure in a manner responsive to the displayed depth of penetration of the tissue structure.
This aspect of the invention enables the physician to determine the depth to which a tumor has grown into or through the wall of a lumen in order to determine whether the tumor can be removed safely from the lumen. The physician can rely on the ultrasound image display to determine how much tissue to remove in view of the depth of penetration of the tissue structure, and can also observe the ultrasound image of the tissue structure while performing the interventional procedure on the tissue structure so as to ensure that an appropriate amount of tissue is removed.
In general, the invention aids physicians in the accurate early diagnosis of patients with cancer or other abnormalities inside the body. Many cancers or other abnormalities can be treated efficiently if diagnosed and treated early enough in the least invasive manner. The invention helps physicians to locate suspect areas, diagnose accurately, and sample and treat tissue efficiently. The invention also provides high diagnostic accuracy and short procedural time by providing accurate data and avoiding unnecessary biopsies. Consequently, overall health care costs are low because of low lab analysis costs and minimal outpatient hospital visits.
Numerous other features, objects, and advantages of the invention will become apparent from the following detailed description when read in connection with the accompanying drawings.
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“Spectrascience Received 510(K) Premarket Notification Clearance from United States Food and Trust Administration for FiberopticBiopsy Forceps,” First! An Information Service of Individual, Inc., p. 5 (Dec. 16, 1996 at 08:56 EST, Bustiness Wire, File: b1216085.600).
Banik Michael S.
Daniels Douglas J.
Boston Scientific Corporation
Leubecker John P.
Testa, Hurwitz & Thibault, LLP
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