Microfabricated instrument for tissue biopsy and analysis

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Reexamination Certificate

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C030S278000, C030S289000, C083S167000, C083S856000, C083S915500, C422S082050, C422S105000, C600S564000, C606S172000

Reexamination Certificate

active

06319474

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to preparing tissue samples for pathological study, particularly to a microfabricated instrument for tissue biopsy and analysis, and more particularly to a microfabricated biopsy/histology system using a combined tissue cutter and specimen treatment chamber, thus minimizing specimen handling.
The process of preparing tissue samples for pathological study, known as histology, requires skill and experience. The current process used for preparing samples for histological analysis is labor intensive, somewhat of an art form, and requires expensive equipment and large quantities of chemicals. In the traditional process, a piece of tissue is embedded in paraffin wax, and thin ribbons are sliced off using a microtome, then mounted onto glass slides, treated with chemicals, and viewed with a microscope. Large quantities of chemicals are required to fix, dehydrate, and stain the tissue. In addition, the large tissue samples removed from a patient causes substantial discomfort.
Recently, micro-biopsy tools have been developed to enable removing only a small amount of tissue or other material in a minimally invasive manner, and reduce risks, costs, injury, and patient discomfort associated with traditional biopsy procedures. Such micro-biopsy tools are described and claimed in copending U.S. application Ser. No. 08/887,780 filed Jul. 3, 1997 entitled “Micro-biopsy/Precision Cutting Devices”, now U.S. Pat. No. 5,928,161 assigned to the same assignee. These micro-biopsy tools are formed from silicon and anisotropic etching of silicon, resulting in extremely sharp edges, ideally suited for slicing soft tissues.
The present invention significantly simplifies specimen slicing and subsequent chemical treatment, and combines these operations into one complete histology instrument. The sample is sliced to a precise thickness with a micromachined silicon cutter, trapped in a chamber such that the sample lies flat against a glass surface, treated with appropriate chemicals, and viewed through the glass, all without directly handling the specimen after it has been sliced. The system of this invention may be used to slice and process fresh tissue samples or samples embedded in paraffin wax. The system of this invention has three components: a cutter for directly performing a microbiopsy or slicing a thin section from previously biopsied tissue, and specimen chamber for capturing, treating, and viewing the thin cut section, and flow channels for exposing the specimen to a variety of chemicals. The cutter is formed by anisotropic etching of silicon and enables slicing very thin specimens (about 2 &mgr;m or greater).
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a microfabricated instrument for tissue biopsy and analysis.
A further object of the invention is to provide a microfabricated instrument for acquiring specimens for DNA analysis.
A further object of the invention is to provide a microfabricated biopsy/histology system.
Another object of the invention is to provide a biopsy/histology system, which combines sample cutting, sample analysis, and sample viewing in a single instrument thus minimizing sample handling.
Another object of the invention is to provide an instrument induding a silicon cutter having a cutting edge formed by anisotropic etching of the silicon.
Another object of the invention is to provide a biopsy/histology instrument that utilizes a silicon member bonded to a glass member, with the silicon member including a specimen tissue cutter and the glass member induding microchannels for small volumes of chemicals for treating cut tissue specimens.
Other objects and advantages will become apparent from the following description and accompanying drawings. The present invention is a microfabricated biopsy/histology instrument which has several advantages over the conventional procedures, including minimal specimen handling, smooth cutting edges with atomic sharpness capable of slicing very thin specimens (approximately 2 &mgr;m or greater), microliter volumes of chemicals for treating the specimens, low cost and thus disposable, and ease of use. The system of this invention has three components: 1) a cutter for directly performing a microbiopsy or slicing a thin section from previously biopsied tissue, 2) a specimen chamber for capturing, treating, and viewing the thin section, and 3) flow channels for exposing the specimen to a variety of chemicals. The system also includes means for causing the cut specimen to lie flat in the specimen chamber.


REFERENCES:
patent: 4271740 (1981-06-01), Yamazaki et al.
patent: 5842387 (1998-12-01), Marcus et al.
patent: 6003419 (1999-12-01), Irita et al.

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