Methods and devices for the localization of lesions in solid tissue

• US 6,336,904 B1
• Filed: 04/06/1999
• Issued: 01/08/2002
• Est. Priority Date: 04/07/1998
• Status: Expired due to Term

• Current Assignee: Atossa Therapeutics, Inc.
• Original Assignee: Pro-Duct Health, Inc. (Hologic Incorporated)
• Inventors: Nikolchev, Julian N.
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/287,087
• Time in Patent Office: 1,008 Days
• Field of Search: 600/562, 600/567, 600/151, 600/564, 424/9.1
• US Class Current: 600/562
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/4887 Locating particular structures in or on the body
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Lesions, biopsy sites, and other target sites in solid tissue are localized by positioning an illumination source adjacent the lesion in the solid tissue. Usually, the illumination source is positioned using a localization wire which is percutaneously introduced to the lesion. Alternatively, the illumination source may be provided by an implantable capsule which is introduced using a cannula or needle. In both cases, the illumination may be visually or optically detected and used to guide a surgical procedure to the lesion. Kits comprising the localization wire illumination capsule, and instructions for use are also described.

Claims

1. A method for localizing a target site in solid tissue, said method comprising:

percutaneously introducing an illumination source through solid tissue to the target site in the solid tissue;

emitting illumination from the illumination source into the tissue; and

detecting the emitted illumination to mark the target site.

2. A method as in claim 1, further comprising removing a portion of the solid tissue in the region of the emitted illumination.

3. A method as in claim 2, wherein the removing step comprises manually cutting tissue while detecting the emitted illumination, wherein the direction of cutting is based at least in part on the position within the tissue of the emitted illumination.

4. A method as in claim 1, wherein the introducing step comprises anchoring a wire in the tissue, wherein the wire carries the illumination source.

5. A method as in claim 4, wherein the illumination source in the wire comprises an optical fiber having a light dispersive element thereon and wherein the emitting step comprises transmitting light through the optical fiber from an external source.

6. A method as in claim 4, wherein the illumination source comprises a light-generating element and the emitting step comprises transmitting electrical energy through the wire to produce light from the element.

7. A method as in claim 1, wherein the illumination source is a point source.

8. A method as in claim 7, wherein the point source emits radiation isotropically.

9. A method as in claim 1, wherein the emitting step comprises emitting infrared radiation from the illumination source.

10. A method as in claim 1, wherein the detecting step comprises direct visual observation without electronic enhancement.

11. A method as in claim 1, wherein the detecting step comprises electronic detection of the emitted light.

12. A method as in claim 11, wherein the detecting step further comprises video display of the emitted light.

13. A method as in claim 1, wherein the solid tissue is breast tissue.

14. A method as in claim 1, wherein the target site comprises a lymph node.

15. A method as in claim 14, wherein the lymph node has been previously labeled with a marker and wherein the introducing step comprises aligning the illumination source with the marker.

22. A kit comprising:

a localization wire having an anchor and an illumination source; and

instructions for use according to claim 1.

16. A device for localizing a target site in solid tissue, said device comprising:

a wire having a proximal end, a distal end, and an anchor near the distal end; and

an illumination source on the wire which emits visually observable illumination.

17. A device as in claim 16, wherein the illumination source is a point source.

18. A device as in claim 16, wherein the illumination source comprises an optical fiber disposed axially on or within the wire, the optical fiber is adapted to transmit light from an external source and to emit the transmitted light in a generally isotropic pattern from a point on the wire.

19. A device as in claim 17, wherein the illumination source comprises a light-generating element.

20. A device as in claim 19, wherein the light-generating element is a light emitting diode.

21. A device as in claim 16, further comprising a scintillation counter on or coupled to the wire, said scintillation counter having a detection head located in a fixed relationship to the illumination source.

23. A method for localizing a biopsy site, said method comprising the steps of percutaneously removing tissue from a target site;

and placing a detectable marker that emits illumination at or near the site from which tissue was removed.

24. A method for localizing a biopsy site, said method comprising the steps of percutaneously removing tissue from a target site;

placing a detectable marker at or near the site from which tissue was removed, said detectable marker comprising a power source at an illumination source that emits illumination that can be detected, analyzing the removed tissue to determine if further removal of tissue is necessary, and when further removal is necessary, said method further comprising the steps of selectively activating the illumination and power sources, detecting the detectable marker and removing additional tissue in the region of the marker.