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 Helical-tipped lesion localization needle device and method of using the same

Details
Inventors: Rank, William R.; Nichols, Ronald L.; Schoenberger, Stephanie G.;
Assignee: Research Corporation Technologies, Inc. (Tucson, AZ)
Primary Examiner: Aschenbrenner; Peter A.
Assistant Examiner:
Attorney, Agent or Firm: Scully, Scott, Murphy & Presser

A lesion localization and marking wire and needle assembly for marking non-palpable lesions within the body. A marking device having a helically wound coil of wire attached to an end of the shaft which is insertable into the body through a needle or cannula for rotatingly anchoring the marking device into a lesion or tumor is provided. The needle or cannula is inserted into the body with the marking device positioned therein so that when the cannula is positioned proximate to a lesion the shaft of the marker is rotated to advance the marker into the lesion to mark it for subsequent surgical procedures. A second helical wire may be provided on the shaft which cooperates with a wire guide device attached to the needle to enable the physician to determine the depth of the marking device as it anchors into the lesion. In particular, the device is provided for marking for biopsy lesions of the breast.

DETAILED DESCRIPTION The present invention eliminates or substantially ameliorates the disadvantages encountered in the prior art through the provision of a lesion localization and marking device having a helically wound wire tip attached to a shaft which is inserted within the lumen of a cannula into the body and then rotated into a lesion to anchor the marker within the lesion tissue.
The device is simple to manufacture and inexpensive thereby making it a disposable unit, which may be packaged in a sterile packaging unit for one time use.
The lesion localization and marking device of the present invention consists of a marker having a shaft constructed of stainless steel or other biocompatable material which has secured to its distal end, or formed integrally thereon, a stainless steel wire which is helically.
wound about the end of the shaft.
The helically wound wire extends outwardly in a concentric manner from the end of the shaft and overhangs the shaft a predetermined distance.
The end of the helix is sharpened to facilitate insertion into a lesion within the body.
The helical wire is secured to the shaft by conventional means such as soldering.
The marking device, when used in conjunction with the needle assembly of the present invention, may be provided with a second helically wound wire which is secured to the shaft of the marker remote from the end having the first helically wound wire.
The second helically wound wire is secured to the shaft by soldering, or integrally formed as part of the shaft, and is dimensioned to have the same number of turns per centimeter as the first helically wound wire, thus having the same pitch or angle for each turn of coil.
The marking device is positioned within a hypodermic needle or cannula which essentially comprises a stainless steel tube having a cutting edge at one end and a thermoplastic gripping knob at its other end.
The gripping knob has a hole bored through the center which preferably aligns with the lumen of the cannula, and a second hole is bored through the knob parallel to the first hole and offset from the center of the lumen



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