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

• US 5,018,530 A
• Filed: 06/15/1989
• Issued: 05/28/1991
• Est. Priority Date: 06/15/1989
• Status: Expired due to Fees

• Current Assignee: Research Corporation Technologies
• Original Assignee: Research Corporation Technologies
• Inventors: Nichols, Ronald L., Rank, William R., Schoenberger, Stephanie G.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Longo, Robin R.
• Application Number:
  US07/367,405
• Time in Patent Office: 712 Days
• Field of Search: 128/658, 128/753, 128/630, 128/749, 128/754, 604/164, 73/426, 73/428, 606/223-225, 606/104, 606/96, 606/180, 81/3.45
• US Class Current: 600/562
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

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.

Claims

1. 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 at least one notch in said cannula forming a cutout communicating with said lumen, said cutout being located proximate a second end of said cannula a predetermined distance from said first end;

a marking device positioned within said lumen, said marking device including a shaft and a helical wire including a first portion helically wound at said first end about said shaft and extending a predetermined distance from said shaft in a helical coil, said helical wire having a sharpened tip, said marking wire being axially slidable and rotatable within said cannula;

wherein said helical wire of said marking device includes a second portion which engages into said at least one cutout formed by said notch, whereby rotation of said marking device effects advancement of said marking device through said lumen, the advancement of said marking device being responsive to said helical wire rotatingly engaging into and contacting said at least one cutout.

2. A needle assembly according to claim 1, wherein said wire is wound about and secured to said shaft.

3. A needle assembly according to claim 1, wherein said cannula and said marking device are constructed of biocompatible material.

4. A needle assembly according to claim 3, wherein said cannula and said marking device are constructed of stainless steel.

5. A needle assembly according to claim 3, wherein said cannula and said marking device are constructed of a metal alloy.

6. A needle assembly according to claim 1, wherein said helical coil of said wire has a constant diameter along its length.

7. 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.

8. A needle assembly according to claim 7, wherein said first and second helical wires of said marking device are secured to said shaft by soldering.

9. A needle assembly according to claim 7, wherein said first helical wire extends past said shaft end a predetermined distance which is equal to the length of said second helical wire.

10. A needle assembly according to claim 9, wherein an end of said second helical wire remote from said first helical wire is positioned at a distance such that when said second end is rotated past said wire guide into said cannula, said first end of said shaft is positioned coaxial and adjacent to said cutting edge of said cannula.

11. A needle assembly according to claim 9, wherein said predetermined distance said first helical wire extends past said shaft end and the length of said second helical wire is between 0.5 and 2.0 cm.

12. A needle assembly according to claim 11, wherein said predetermined distance is 1 cm.

13. A needle assembly according to claim 7, wherein said second helical wire is positioned a predetermined distance from said first helical wire, such than when an end of said second helical wire closest to said first helical wire engages said wire guide of said knob, said sharpened tip of said first helical wire is positioned coaxial and adjacent to said cutting edge of said cannula.

14. A needle assembly according to claim 7, wherein said first and second helical wires have a constant diameter along their entire lengths.

15. A needle assembly according to claim 8, wherein said first and second helical wires have a diameter of approximately 0.02 cm and said shaft has a diameter of approximately 0.04 cm.

16. A needle assembly according to claim 7, wherein said cannula and wire marker are constructed of stainless steel.

17. A needle assembly according to claim 7, wherein said first and second helical wires are wound about said shaft an identical number of turns per centimeter.

18. A needle assembly according to claim 17, wherein said first and second helical wires are wound about said shaft between 6 and 15 turns per centimeter.

19. A needle assembly according to claim 18, wherein said first and second helical wires are wound about said shaft 8 turns per centimeter.

20. 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.

21. 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.

22. A method according to claim 21, wherein rotation continues until said first helical wire is embedded in said lesion and said second helical wire passes fully into said knob beyond said wire guide.