Removable localizing wire

• US 8,170,648 B2
• Filed: 09/25/2006
• Issued: 05/01/2012
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Field, Steven E, Mulder, Brian R
• Primary Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US11/534,798
• Publication Number:
  US 20070021763A1
• Time in Patent Office: 2,045 Days
• Field of Search: 606/110, 606/113, 606/114, 606/116, 606/127, 606/128, 606/198, 600/434, 600/461, 600562-572, 600/414, 600/420, 600/431
• US Class Current: 600/431
• 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

Abstract

A localizing wire includes an anchor portion that can change shape from a collapsed shape to an expanded shape and thereby anchor within a tissue mass. The localizing wire has an exterior portion that can lie flat against the tissue mass. The localizing wire can be repositioned or withdrawn without the need for the reinsertion of an introducer.

Claims

1. A method of implanting and removing a localizing wire having a reconfigurable anchor into a tissue mass, comprising:

providing the reconfigurable anchor by contacting a distal end of the localizing wire with an intermediate portion of the localizing wire to define a geometric enclosure, the reconfigurable anchor having a release configuration wherein the geometric enclosure has a first completely bounded area, the reconfigurable anchor having an anchoring configuration wherein the geometric enclosure has a second completely bounded area, and wherein the first completely bounded area is smaller than the second completely bounded area;

inserting the reconfigurable anchor of the localizing wire into the tissue mass, the geometric enclosure of the reconfigurable anchor having a changeable shape such that the reconfigurable anchor displaces but does not puncture the tissue mass when the reconfigurable anchor changes from the release configuration to the anchoring configuration;

configuring the reconfigurable anchor into the anchoring configuration where the reconfigurable anchor anchors the localizing wire in the tissue mass by displacing the tissue mass without puncturing the tissue mass;

reconfiguring the reconfigurable anchor from the anchoring configuration to the release configuration, where the anchor does not anchor the localizing wire in the tissue mass; and

withdrawing the localizing wire with the reconfigurable anchor in the release configuration from the tissue mass.

2. The method according to claim 1, wherein the insertion of the localizing wire comprises inserting an introducer with a hollow interior into the tissue mass and inserting the localizing wire into the hollow interior of the introducer.

3. The method according to claim 2, and further comprising withdrawing the introducer away from the anchor after the inserting of the localizing wire in the tissue mass.

4. The method according to claim 3, wherein the withdrawing of the introducer comprises completely removing the introducer from the tissue mass.

5. The method according to claim 3, wherein the withdrawing of the introducer effects the reconfiguring the anchor from the release configuration to the anchoring configuration.

6. The method according to claim 2, wherein the withdrawal of the localizing wire is done without reinserting the introducer.

7. The method according to claim 2, wherein the inserting of the localizing wire into the introducer occurs prior to the inserting of the introducer into the tissue mass.

8. The method according to claim 2, wherein the configuring of the anchor into the anchoring configuration is effected by relatively moving the introducer and the localizing wire.

9. The method according to claim 8, wherein relatively moving the introducer and the localizing wire comprises moving the localizing wire relative to the introducer.

10. The method according to claim 2, wherein the inserting of the introducer comprises inserting a cannula into the tissue mass.

11. The method according to claim 1, and further comprising sliding a sheath on the localizing wire to configure the anchor.

12. The method according to claim 11, wherein the sheath is slid on the localizing wire toward the anchor and over at least a portion of the anchor to collapse the geometric enclosure from the second completely bounded area to the first completely bounded area to place the anchor in the release configuration.

13. The method according to claim 12, wherein the sheath is slid away from the anchor to place the anchor in the anchoring configuration.

14. The method according to claim 12, wherein the anchor is at least partially received within the sheath when the anchor is in the release configuration.

15. The method according to claim 1, and further comprising laying a portion of the localizing wire extending beyond an exterior of the tissue mass, and adjacent an insertion point of the localizing wire into the tissue mass, against the exterior of the tissue mass.

16. The method according to claim 15, and further comprising securing the portion of the localizing wire to the exterior of the tissue mass.

17. The method according to claim 16, and further comprising taping the portion of the localizing wire to the exterior of the tissue mass to secure the localizing wire to the exterior of the tissue mass.

18. The method according to claim 1, wherein a configuring of the anchor into the release configuration is done prior to the insertion of the localizing wire.

19. A method of marking a lesion in a tissue mass, the method comprising:

installing a localizing wire into a tube having at least one lumen, the localizing wire comprising a localizing thread and a localizing anchor, the localizing anchor defining a single enclosed perimeter having a collapsed enclosed shape delineating a first completely bounded area in the at least one lumen and an expanded enclosed shape delineating a second completely bounded area greater than the first completely bounded area outside the at least one lumen, the expanded enclosed shape resulting from a change in shape of the single enclosed perimeter from the collapsed enclosed shape;

inserting the tube into the tissue; and

moving one of the localizing wire and the tube to place the localizing anchor outside the at least one lumen at a first selected location relative to the lesion so that the localizing anchor expands from the first completely bounded area to the second completely bounded area to exert an expansive force against the tissue mass without puncturing the tissue mass.

20. The method according to claim 19, and retracting the localizing anchor into the at least one lumen to return the localizing anchor from the expanded enclosed shape to the collapsed enclosed shape.

21. The method according to claim 20, and repositioning the tube to relocate the localizing wire at a second selected location relative to the lesion.

22. The method according to claim 19, and withdrawing the tube from the tissue mass with the localizing anchor remaining in the first selected location and the localizing thread extending exterior of the tissue.

23. The method according to claim 22, and reinserting the tube into the tissue mass with the localizing thread extending through the at least one lumen.

24. The method according to claim 23, and retracting the localizing anchor into the at least one lumen to return the localizing anchor from the expanded enclosed shape to the collapsed enclosed shape.

25. The method according to claim 24, and withdrawing the tube with the localizing wire therein to remove the localizing wire from the tissue mass.

26. The method according to claim 19, wherein the tube comprises multiple lumens.

27. The method according to claim 26, and installing an imaging marker into one of the lumens.

28. The method according to claim 27, and moving one of the imaging marker and the tube to place the imaging marker at a selected location relative to the lesion.

29. The method according to claim 19, wherein the tube comprises at least one of a cannula and a sheath.