Self-actuating breast lesion probe and method of using

• US 4,616,656 A
• Filed: 03/19/1985
• Issued: 10/14/1986
• Est. Priority Date: 03/19/1985
• Status: Expired due to Term

• Current Assignee: Mitek Surgical Products, Inc. (Johnson & Johnson)
• Original Assignee: James E. Nicholson, Roland F. Gatturna
• Inventors: Nicholson, James E., Gatturna, Roland F.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/713,613
• Time in Patent Office: 574 Days
• Field of Search: 128/418, 128/784-785, 128/774, 128/630.1, 128/653, 128/303.16, 128/303.17, 604/164-169
• US Class Current: 600/300
• CPC Class Codes: A61B 10/00 Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis vaccination prophylaxis, vaccination therapy A61B17/20; Sex determination; Ovulation-period determination menstruation tables G06C3/00; Throat striking implements
• 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation

Abstract

A probe sheath and probe wire having a memory hook and soft flexibility are used to locate a small presymptomatic breast lesion, wherein the wire is sheathed within the sheathing cannula and both are inserted into the body tissue and directed to the site of the lesion. Thereafter the wire is extended through the sheath to assume its memory configuration and its location is determined mammographically. If re-positioning is necessary the wire may be retracted into the sheath and then extended and re-anchored after the wire and sheath are directed to a new position. When the probe wire location is acceptable the cannula is removed and the probe wire is left as a marker for surgical excision of the lesion.

Claims

1. A method of locating a lesion, especially a method for locating a presymptomatic, non-palpable breast lesion, comprising the steps of:

(A) mammographically determining the probable location of such lesion;

(B) selecting a probe wire that has at its distal end a relatively small memory hook and a predetermined degree of soft flexibility;

(C) sheathing the probe wire in a needle cannula whereat the wire assumes the straight configuration of the cannula and the distal ends of the wire and cannula are in a predetermined relationship as evidenced by observation of graduated scale markings on the proximal portion of the wire;

(D) maintaining such determined relationship and initially inserting the assembled cannula and probe wire unit into the body tissue to a depth whereat said distal endsd are at about the site of said lesion;

(E) mammographically determining if placement of such distal ends is within a predetermined spacing with regard to the lesion;

(F) repositioning the unit and mammographically determining each aforedescribed placement of said unit until the desired accuracy is achieved;

(G) solely moving the probe wire forwardly to an extent, as determined by further observation of said graduated scale markings, whereby to only free the distal end portion having the memorty hook and whereby the distal end of the probe wire assumes the hook configuration to thereby anchor itself in the tissue;

(H) mammographically determining the spatial relationship of the anchored end of the probe wire to the lesion with regard to a desired accuracy thereof;

(I) relying on said characteristic of soft flexibility of the probe wire, manually actuating the probe wire to release and easily slide from its anchored position in the tissue to a fully sheathed location within the cannula at said predetermined relationship of the distal ends without injury to the tissue when said desired accuracy has not been effected; and

(J) repositioning the unit as aforedescribed, reanchoring the probe wire as aforedescribed, and repeating the aforedescribed mammographic determinations until the desired accuracy of the spatial relationship of the anchored end of the probe wire to the lesion site is effected.

2. The method of claim 1 comprising the additional steps of:

(K) completely withdrawig and removing the cannula needle; and

(L) fixing the probe wire by clamping a lock means onto the wire and simultaneously in a position whereat one surface of the lock means bears on the body containing the lesion;

whereby, during subsequent transportation and handling of the body, to further inhibit dislodgement of the probe wire and to prevent the body tissue from covering the proximal portion of the probe wire that may have become non-sterile.

3. The method of claim 1 wherein the depth of unit insertion, as described in (D), guided by observation of graduated scale markings on the cannula needle.

4. A method of lesion excision comprising:

locating the lesion by the method of claim 1; and

during surgical removal of the lesion, being guided by observation of graduated scale markings on the distal portion of the anchored probe wire.

5. A probe unit adapted for location of a lesion, and especially for location of a presymptomatic, non-palpable breast lesion, comprising:

(A) a tubular needle cannula adapted for insertion into a body to the site of said lesion;

(B) a probe wire in the form of a simple straight wire closely fitted within, and freely slidable through, said cannula;

(C) said probe wire possessing a memory hook shape at its distal end whereby such end assumes the straight configuration of the cannula when sheathed therein and being dimensioned so as to pierce the body tissue while simultaneously assuming its normal hook configuration when pushed through the cannula to thereby anchor itself in the tissue at the lesion when the probe unit of cannula and probe wire therein has previously been inserted into the body at about the lesion site;

(D) said probe wire possessing the further characteristic of a predetermined degree of soft flexibility whereby said wire is adapted to be manually actuated to release and easily slide from a said anchored location to a fully sheathed disposition within the cannula and without undue destruction of surrounding tissue;

(E) whereby the probe unit may be relocated within the body and the probe wire reanchored within the tissue until a desired accuracy is attained with respect to lesion location; and

(F) the cannula needle being completely withdrawable from the body and operative association with the probe wire.

6. A probe unit as in claim 5 having in combintion therewith a fixing clamp comprised of:

(G) a member having a first aperture axially therethrough and adapted to accommodate the proximal portion of an anchored probe wire when a cannula needle is withdrawn from the body and removed from operative association with the wire;

(H) a threaded aperture disposed generally normal to and intersecting the first aperture;

(I) a clamping screw operatively associated with the threaded aperture; and

(J) a distal face of the member adapted to bear against the body surface through which the anchored probe wire would extend, whereupon the clamp screw would be adapted to lock the proximal portion of said wire and the body surface would be prevented from rising over said extending proximal probe wire portion that may have become non-sterile.

7. A probe unit as in claim 6 wherein the cannula needle has graduated scale markings thereon whereby to determine depth of cannula or probe unit insertion into the body.

8. A probe unit as in claim 6 wherein the probe wire has graduated scale markings on the proximal portion thereof whereby to determine alignment of the distal ends of the assembled cannula and probe wire and whereby to determine the extent to which the probe wire need be pushed through the cannula to only free the memory hook portion for its anchoring function.

9. A probe unit as in claim 6 wherein the probe wire has graduated scale markings on the distal portion thereof whereby during excision of a lesion the surgeon is guided.

10. A probe unit as in claim 5 wherein the cannula needle has graduated scale markings thereon whereby to determine depth of cannula or probe unit insertion into the body.

11. A probe unit as in claim 10 wherein the probe wire has graduated scale markings on the proximal portion thereof whereby to determine alignment of the distal ends of the assembled cannula and probe wire and whereby to determine the extent to which the probe wire need be pushed through the cannula to only free the memory hook portion for its anchoring function.

12. A probe unit as in claim 10 wherein the probe wire has graduated scale markings on the distal portion thereof whereby during excision of a lesion the surgeon is guided.

13. A probe unit as in claim 10 wherein the probe wire is coated with an inert material having predetermined lubricity and electrically insulative values.

14. A probe unit as in claim 5 wherein the probe wire has graduated scale markings on the proximal portion thereof whereby to determine alignment of the distal ends of the assembled cannula and probe wire and whereby to determine the extent to which the probe wire need be pushed through the cannula to only free the memory hook portion for its anchoring function.

15. A probe unit as in claim 14 wherein the probe wire has graduated scale markings on the distal portion thereof whereby during excision of a lesion the surgeon is guided.

16. A probe unit as in claim 14 wherein the probe wire is coated with an inert material having predetermined lubricity and electrically insulative values.

17. A probe unit as in claim 5 wherein the probe wire has graduated scale markings on the distal portion thereof whereby during excision of a lesion the surgeon is guided.

18. A probe unit as in claim 17 wherein the probe wire is coated with an inert material having predetermined lubricity and electrically insulative values.

19. A probe unit as in claim 5 wherein the probe wire is coated with an inert material having predetermined lubricity and electrically insulative values.

20. A probe wire adapted for use with a cannula needle for location of a lesion, and especially for location of a presymptomatic, non-palpable breast lesion, comprising:

a wire of the type possessing a relatively small memory hook at its distal end thereby being adapted to anchor in tissue at a lesion site when such end is pushed from a sheathing cannula needle that has been inserted into a body containing such lesion;

said wire being adapted to assume a straight configuration within a said cannula and being dimensioned so as to pierce the body tissue while simultaneously assuming its memory hook configuration to effect said anchor;

said wire havig a relatively soft flexibility characteristic whereby said distal end when anchored is adapted to be manually actuated to release and slide from such an anchored position to a sheathed location in said cannula without undue damage to the tissue;

said wire having graduated scale markings at its proximal portion whereby to facilitate location of the wire'"'"'s distal end with respect to the distal end of a cannula needle to be used therewith and whereby to determine the extent to which the wire need be pushed through a said cannula needle in order to free only the memorty hook portion for its anchoring function; and

said wire having graduated scale markings at its distal portion whereby with the wire properly located and anchored, the markings are adapted to guide a surgeon during excision of a said lesion.