Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-05-19
2002-05-28
Winakur, Erik F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C606S205000
Reexamination Certificate
active
06394964
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical diagnosis and treatment. More particularly, it pertains to a reusable and disposable biopsy forceps device having an optical fiber for optical biopsy and histopathological analysis of tissue.
BACKGROUND OF THE INVENTION
Numerous types of biopsy forceps have been developed for in vivo medical diagnosis and treatment of various conditions. Such devices are designed for sampling tissue within the body, for example in endoscopic, laparoscopic and vascular procedures to retrieve biopsy samples for analysis and identification of tissue types. These biopsy forceps devices generally include small cutting jaws at the distal end, operated remotely from the proximal end after the distal end of the device has been positioned or navigated to the site of interest.
One difficulty in using prior art biopsy forceps devices is in knowing for certain the exact positioning of the distal tip, in relation to the suspected disease area, especially when the area of interest is very small. Another difficulty of prior art biopsy forceps in combination with other endoscopic accessories is the exact positioning of both instruments. Various types of optical catheters or probes have been developed for use in locating or identifying sites within the body. A method of diagnosing in vivo using an optical guidewire is disclosed in U.S. Pat. No. 5,439,000, assigned to SpectraScience, Inc. An apparatus and method for identifying and obtaining a biopsy sample is disclosed in pending U.S. application Ser. No. 08/643,912, which licensed and assigned to SpectraScience, Inc. The application is entitled “Optical Biopsy Forceps and Method of Diagnosing Tissue.”
One type of prior art system for internal biopsy uses an optical catheter to locate the site, followed by replacement of the optical catheter with a biopsy forceps for taking a tissue sample. However, this can result in errors and uncertainties in the final placement of the biopsy jaws with respect to a previously identified small structure or targeted area since the exact site identified by the optical catheter is not treated with the biopsy forceps or other instruments to treat the site.
Other prior art systems have been proposed which use optical viewing or imaging and a cutting device in the same device, to visually locate and then biopsy a suspected area. However, such devices have been hampered by their thickness which is needed to accommodate the imaging system and the cutting actuation system, and which precludes their use in very small areas. Another shortcoming of such prior art systems is the offset or ‘parallax’ between the viewing axis or the imaging system and the cutting position of the biopsy jaws, such that the biopsy sample actually is taken from a zone slightly displaced from the zone being viewed by the optics. This can result in a loss of accuracy in the case of very small structures of interest.
Another difficulty in conventional devices is accessing the area from which the biopsy sample is to be taken. Often the area to be sampled requires treatment before the sample is taken. An optical catheter is used to locate the biopsy site, followed by replacement of the optical catheter with a medical instrument for treating the area. The instrument is removed, and biopsy forceps is inserted for taking a biopsy sample. However, this can result in errors and uncertainties in the final placement of the biopsy jaws with respect to a previously identified small structure or biopsy area.
Other biopsy devices allow for a biopsy sample to be pierced with a spike before the biopsy sample is taken. However, these devices are limited to the fixed instrument disposed within the forceps. If additional instruments and treatment is necessary for the biopsy area, the biopsy device must be removed from the body, and a different device inserted into the body. Removing the device to insert another poses additional problems in that the exact biopsy location will not be treated.
Accordingly, a better way to treat biopsy areas is needed. What is further needed is a device to accommodate multiple methods of treatment for an exact biopsy area. What is also needed is a better way to obtain a biopsy sample.
SUMMARY OF THE INVENTION
To overcome these and other problems, an integrated biopsy forceps device is provided, which is very thin, with an access lumen enabling the device to be used in very small areas of interest, and which allows for accurate alignment with repetitive withdrawal or introductions of various adjunctive medical instruments to treat the biopsy sampling area. A system is also provided where an integrated biopsy forceps device is coupled with an electro-optical diagnostic apparatus for optical biopsy to perform histopathological analysis of tissue.
The present invention, in one embodiment, provides a biopsy forceps which is adapted for tissue treatment and identification through the access lumen and by biopsy sampling. The forceps device includes an elongated catheter body for introduction into the body and navigation to an area of interest. The distal end of the forceps device has a pair of cutting jaws, and a lumen extends through the forceps device aligning with the closed cutting position of the cutting jaws. The proximal end has a handle portion for manipulating the forceps device and actuating the jaws.
In accordance with one aspect of the invention, there is provided a method of treating tissue at a site within a body. The method comprises introducing into the body a biopsy forceps which includes a flexible catheter body with an access lumen extending therethrough with the distal end of the lumen aligned with a biopsy sampling area adjacent the distal tip of the catheter body. Instruments such as an optical fiber, are inserted into the device and through the lumen to treat the sampling area as appropriate. The biopsy forceps additionally include cutting jaws mounted at the distal end of the catheter body for selective opening and closing in a biopsy cutting movement in the biopsy sampling area, and an actuator mechanism operatively connected to the jaws for selectively controlling the opening and closing of the cutting jaws. Then, tissue in the biopsy sampling area adjacent the distal end of the forceps is treated with the instruments inserted through the forceps or identified by the optical fiber coupled with the electro-optical diagnostic apparatus. Alternatively, the area is flushed with medicine or saline with or without the optical fiber inserted in the lumen. Then, a biopsy sample is cut from the location of the optical tissue analysis zone by actuating the actuator mechanism, and the biopsy sample is withdrawn from the body.
In one embodiment, the cutting jaws are mounted for pivoting about stationary pivot pins for cutting tissue placed there between, and coupled to and controlled by an inner tubular member forming the lumen that extends through the catheter body to the handle portion at the proximal end of the device. The inner tubular member extends through the handle and couples with an access portion on the handle portion. Instruments, medicine, or fluids are inserted into the access portion and through the lumen to treat, flush, or clean the biopsy sampling area. The inner tubular member is positioned coaxially with the jaws, so that the biopsy sample is taken exactly at the spot where treatment with instruments or fluids took place. In an alternative configuration, a second lumen is provided adjacent the lumen within the inner tubular member to provide additional access proximate the biopsy sampling area.
In another embodiment, the cutting jaws are mounted for pivoting about stationary pivot pins for cutting tissue placed therebetween, and controlled by control wires extending through the catheter body to the control handle and/or an inner member. Alternatively, the cutting jaws are rotatably coupled with a distal housing and are controlled by links. The links, in another embodiment, are operatively coupled with the actuator housing and the cutting jaws. The in
McMahon Brian T.
Pokorney James L.
Sievert, Jr. Chester E.
Townsend Greg L.
Wilson Scott R.
Schwegman Lundberg Woessner & Kluth P.A.
SpectraScience, Inc.
Winakur Erik F.
Wingood Pamela
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