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

A needle assembly for localization of lesions within the body, comprising:

• a needle cannula having a lumen, a cutting edge at a first end of said cannula, and a gripping knob secured at a second end of said cannula, said knob having a first hole formed therethrough in coaxial alignment with said lumen, and a second hole formed therethrough offset from said first hole and having a wire guide passing through and secured within said second hole in a direction parallel to said cannula, said wire being bent at a right angle perpendicular to said cannula to practically cover said first hole;
• a marking device positioned within said lumen and including a shaft having a diameter less than the inner diameter of said lumen, said marking device further including a first helical wire coiled about a first end of said shaft and secured thereto, said first wire extending beyond said first end of said shaft in a helical coil for a predetermined distance and terminating in a sharpened tip, said marking device further including a second helical wire coiled about said shaft and secured thereto a distance from said first helical wire towards a second end of said shaft, said first and second wires forming coils having an outer diameter substantially equal to each other and less than or substantially equal to the inner diameter of said lumen;
• wherein said second helical wire of said shaft engages said wire guide of said knob, whereby rotation of said marking device advances said shaft and said first and second wires through said lumen, the advancement of said shaft and said wires through said lumen being assisted by said second helical wire rotatingly contact said wire guide.

A method for marking no-=palpable lesions within the body, comprising steps of:

• puncturing the skin to enter the body with a marking needle assembly, said needle assembly including a cannula having a lumen, a cutting edge atone end of said cannula and a gripping mean on said cannula, said needle assembly further including a marking device positioned within said lumen, said marking device having a helical wire helically wound at one end a predetermined distance in a helical coil, and having a sharpened tip;
• said marking device being coaxially slideable and rotatable within said cannula;
• tracking said needle assembly inside said body;
• advancing said needle assembly to a point within proximity to a lesion within said body;
• rotating said marking device within said cannula to advance said marking device;
• determining the distance said marking device travels by the distance said marking device is advanced into said cannula;
• ceasing rotation of said marking device when said marking device is positioned within a determined proximal distance of said lesion;
• and
• removing said cannula from said body;
• wherein said marking device remains in position with respect to said lesion to mark said lesion for subsequent medical procedures.

A method for marking non-palpable lesions within the body, in particular the human breast, comprising the steps of:

• puncturing the skin to enter the body with a marking needle assembly, said needle assembly including a needle cannula having a lumen, a cutting edge at one end and a gripping knob at another end, said gripping knob having a first hole formed therethrough aligned with said lumen and a second hole formed therethrough offset and parallel to said first hole for receiving a wire guide, said wire guide bent at an angle perpendicular to said second hole and covering a part of said first hole, said needle assembly further including a marking device positioned within said lumen, said marking device having a shaft and a least two helically wound wires concentrically coiled about and secured to said shaft and spaced from each other a predetermined distance, a first helical wire secured at an end of said shaft and concentrically extending outwardly a predetermined length from said shaft and terminating in a sharpened end, and a second helical wire coiled about said shaft having an equal number of turns per centimeter as said first helical wire, a first end of said second helical wire engaging said wire guide while said sharpened end of said first helical wire is adjacent to said cutting edge of said cannula;
• tracking said needle assembly inside said body;
• advancing said needle assembly to a point adjacent to a lesion within said body;
• rotating said marking device within the lumen of said cannula to advance said marking device such that said wire guide draws said marking device through said lumen by engaging said second helical wire;
• determining the distance said first helical wire travels by the distance said second helical wire has travelled past said wire guide;
• ceasing rotation when said first helical wire marks said lesion;
• and
• removing said cannula from said body;
• wherein said first helical wire remains in position with respect to said lesion to mark said lesion for subsequent medical procedures.