Biopsy method and device

Surgery – Diagnostic testing – Sampling nonliquid body material

Reexamination Certificate

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Details

C604S116000, C378S037000, C382S123000

Reexamination Certificate

active

06176835

ABSTRACT:

TECHNICAL FIELD
This invention relates to a method and apparatus for facilitating biopsies, and particularly core breast biopsies.
BACKGROUND
A critical issue in the conducting of core biopsies is the accurate location of suspect tissue (hereinafter referred to as a lesion), and thereafter the accurate guiding of the biopsy needle to the lesion. Sophisticated methods and apparatus have been developed for core biopsies in connection with mammography.
Stereotactic breast biopsy involves the taking of a first radiographic image of a lesion in a breast, moving the breast or x-ray tube a known distance and then taking a second radiographic image of the lesion in the breast, so that the x, y and z coordinates of the lesion site in the breast may be calculated.
Once the location of the lesion has been confirmed, most biopsy needles and their associated biopsy guns are computer-controlled to drive the biopsy needle to the calculated position in the breast. The use of such equipment is expensive and time consuming, and cannot be justified in small practices.
New methods are required which avoid the high cost associated with computer-controlled equipment, and which may be conducted relatively quickly and efficiently, whilst maintaining accuracy of the biopsy.
Thus, it is an object of the present invention to provide a method and apparatus for core biopsies which reduces the abovementioned problems or at least which provides the public with a useful alternative.
Other objects of the present invention may become apparent from the following description which is given by way of example only.
STATEMENT OF INVENTION
According to one aspect of the present invention there is provided a biopsy method wherein a biopsy needle is guided to a calculated site of a target lesion, said method including the steps of:
identifying a location on the skin surface directly between the calculated site and a source of electromagnetic radiation, including a light source,
positioning a biopsy needle tip at the location,
monitoring shadows in the light from the light source on the skin surface, created by at least two guiding members on a biopsy gun to which the biopsy needle is attached, each said guiding member projecting from a side of the biopsy gun, in a parallel axis to the needle and at least two of the guiding members substantially perpendicular to one another, and
guiding the biopsy needle to the calculated site by minimising the shadows so that the needle remains substantially parallel to the electromagnetic radiation beam.
In a preferred method the biopsy needle may be in the plane of each guiding member such that the shadows are monitored in line with the needle.
In a preferred form of method of the present invention the electromagnetic radiation may be x-rays.
Preferably, the site of the target lesion may be calculated by stereotactic radiography.
In a further preferred form a biopsy method of the present invention may further comprise locating said biopsy needle at the location using a locator means.
According to a further aspect of the present invention there is provided a biopsy gun, said gun having at least two guiding members, each said guiding member projecting from a side of the biopsy gun, in a parallel axis to a needle attached to or held by the biopsy gun when in use, and each, or at least two, of said guiding members substantially perpendicular to one another.
In a further aspect of the present invention there is provided a biopsy gun attachment, securely attachable to a biopsy gun, said attachment having at least two guiding members, each said guiding member projecting from the gun attachment such that when the gun attachment is securely engaged on a biopsy gun the guiding members are in an axis parallel to a needle attached to or held by the biopsy gun when in use, and each, or at least two, of the guiding members are substantially perpendicular to one another.
Preferably, there may be two guiding members, substantially perpendicular to one another.
Preferably, each said guiding member may run substantially the length of the biopsy gun or the biopsy gun attachment.
Preferably, each guiding member may be in line with said needle, when attached to the biopsy gun, such that the needle would be in the plane of each guiding member.
In a further aspect of the invention there is provided a biopsy gun attachment including:
engagement means adapted to securely engage the biopsy gun attachment to a barrel of a biopsy gun,
a first guiding member projecting from the attachment, parallel to the axis of the barrel and extending substantially the length of the barrel, and
at least one further guiding member projecting from the attachment, parallel to the axis of the barrel and extending substantially the length of the barrel,
the or at least one of the further guiding members substantially perpendicular to the first guiding member, and each guiding member in line with a needle attached to or held by the biopsy gun when in use, such that the needle is in the plane of each guiding member.
Other aspects of the present invention may become apparent from the following description which is given by way of example only and with reference to the accompanying drawings.


REFERENCES:
patent: 4651732 (1987-03-01), Frederick
patent: 4821727 (1989-04-01), Levene et al.
patent: WO93/15660 (1993-08-01), None
patent: WO93/17620 (1993-09-01), None

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