Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-06-09
2001-08-07
Manuel, George (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
Reexamination Certificate
active
06272372
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates, generally, to tools used in radiology. More particularly, it relates to a biopsy tool that helps radiologists using imaging techniques such as ultrasound or CT scanning to properly align a guide needle relative to a lesion or tumor in a breast or other soft tissue.
2. Description of the Prior Art
One commonly used biopsy tool is a spring-loaded, trigger-operated device that shears off and captures a tissue sample from a lesion or tumor so that the sample can be analyzed in a lab. A guide needle is first inserted into a breast or other soft tissue where a lesion is detected, using a preselected imaging technique such as ultrasound or CT scanning, so that the physician can see the guide needle and the lesion. The longitudinal axis of the guide needle is aimed directly at the lesion, and the distal end or tip of the guide needle is placed in close proximity to the lesion. The proximal end of the guide needle remains external to the breast or other soft tissue.
If the guide needle appears to be properly positioned relative to the lesion, the leading end of the biopsy tool is then inserted into the bore of the guide needle at its proximal end. When the trigger is pulled, the operative part of the biopsy tool extends quickly, under the bias of its propulsion spring, from the open distal end of the guide needle, enters into the lesion, shears off a tissue sample, captures the sheared off sample in a small compartment, and retracts. The physician withdraws the biopsy tool from the guide needle, removes the sample from the compartment, and re-introduces the tool into the guide needle for the taking of an additional sample. A physician will typically take four of five such samples in sequence to ensure that different parts of the lesion have been sampled and to provide sufficient tissue for the testing lab. Using the guide needle requires but one entry into the breast or soft tissue and allows multiple entries of the biopsy tool through the hollow bore of the guide needle.
There are several drawbacks to this well-known procedure. First of all, it is difficult to see the guide needle under ultrasonic, CT scanning, and other types of imaging. If the guide needle is improperly positioned with respect to the lesion, the spring-loaded biopsy tool inserted thereinto will be equally mis-positioned and the tissue-shearing mechanism will miss the lesion when the trigger is pulled. The guide needle has a rather large bore to accommodate the biopsy tool, so the patient is not pleased when it has to be withdrawn and re-inserted so that the physician may try to hit the lesion again.
Nor does the art provide any means for preventing migration of the guide needle after it has been successfully positioned in an optimal relationship with a lesion or tumor. Thus, if a patient has had to endure numerous guide needle re-entries until it is finally properly positioned, a migration of the needle tip away from the lesion can still result in a missed biopsy because the shearing mechanism of the biopsy tool may fall short of the lesion and shear healthy tissue.
What is needed, then, is a means for enhancing the visibility of the guide needle under ultrasound, CT scanning, or other imaging technique. If such a means could be found, it would ensure proper alignment and optimal placement of the guide needle relative to a lesion or tumor and thus would ensure consistent hitting of the lesion by the shearing mechanism of the spring-loaded biopsy tool. Repeated insertions of the large bore guide needle would then become unnecessary.
A means for anchoring the guide needle into position after it has been optimally positioned is also needed.
However, it was not obvious to those of ordinary skill in this art how the needed means could be provided, in view of the art considered as a whole at the time the present invention was made.
SUMMARY OF THE INVENTION
The long-standing but heretofore unfulfilled need for an innovation that overcomes the limitations of the prior art is now met by a new, useful, and nonobvious invention. The present invention includes an apparatus for properly positioning a guide needle in alignment and proper spacing relation to a lesion or tumor in a breast or other soft tissue mass.
The apparatus includes a hollow bore guide needle having a proximal end and a pointed distal end. An inflatable balloon means is secured to the guide needle adjacent the pointed distal end. The balloon means has a deflated configuration where its lies snugly against an exterior surface of the guide needle so that it does not interfere with insertion of the guide needle into a breast or other soft tissue. An inflation means is connected to the guide needle at the proximal end thereof for selectively inflating the balloon means, and the balloon means when inflated contains a preselected liquid fluid that is visible under ultrasound imaging or CT scanning when the balloon means is in its inflated configuration.
The inflation means includes a flexible, bulbous reservoir means for holding a predetermined amount of the preselected liquid fluid. An elongate tube means extends in fluid communication between the bulbous reservoir means and the balloon means so that the predetermined liquid fluid flows from the bulbous reservoir means into the balloon means when the bulbous reservoir means is compressed.
A locking means locks the balloon means into its inflated configuration. The locking means may be provided in the form of a clamp means that is attachable to a proximal end of the tube means. The clamp means has a closed position that prevents reverse liquid fluid flow through the tube means.
It is a primary object of this invention to advance the art of lesion or tumor biopsy.
A more specific object is to provide a means that enhances the visibility of a guide needle under ultrasound, CT scanning, or X-ray imaging.
Another object is to provide a means for anchoring a guide needle against movement.
These and other important objects, features, and advantages of the invention will become apparent as this description proceeds.
The invention accordingly comprises the features of construction, combination of elements and arrangement of parts that will be exemplified in the construction hereinafter set forth, and the scope of the invention will be indicated in the claims.
REFERENCES:
patent: 5301682 (1994-04-01), Debbas
patent: 5879357 (1999-03-01), Heaton et al.
Biopsy Sciences, LLC
Manuel George
Smith Ronald E.
Smith & Hopen , P.A.
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