Localization element with energized tip

• US 20030195433A1
• Filed: 10/15/2002
• Published: 10/16/2003
• Est. Priority Date: 04/16/2002
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Vivant Medical, Inc. (Johnson Controls International plc)
• Inventors: Su, Ted, Prakash, Mani, Kim, Steven, Turovskiy, Roman
• Granted Patent: US 6,752,767 B2
• Time in Patent Office: Days
• US Class Current: 600/564
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/183 characterised by the type of antenna
• 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

This invention is an improved tissue-localizing device with an electrically energized locator element for fixedly yet removably marking a volume of tissue containing a suspect region for excision. The electrical energizing of the locator element facilitates the penetration of the locator element in to subject'"'"'s tissue and minimizes resistance due to dense or calcified tissues. At least one locator element is deployed into tissue and assumes a predetermined curvilinear shape to define a tissue border containing a suspect tissue region along a path. Multiple locator elements may be deployed to further define the tissue volume along additional paths defining the tissue volume border that do not penetrate the volume. Delivery of electric current may be achieved through monopolar or bipolar electronic configuration depending on design needs. Various energy sources, e.g. radio frequency, microwave or ultrasound, may be implemented in this energized tissue-localizing device.

Claims

1. A tissue-localizing device comprising:

a sleeve having a lumen; and

a locator element at least partially disposed in the lumen of said sleeve in a slidable manner, said locator element having a distal portion and a distal end, the distal portion having a discrete electric conductive surface region at or near said distal end, the locator element further being adapted to penetrate tissue so that the distal portion of the locator element forms at least a partial loop that defines a volume of tissue when said locator element is deployed in tissue.

2. A tissue-localizing device as in claim 1 wherein said locator element has a cross-section with a width greater than its height.

3. A tissue-localizing device as in claim 1 wherein said locator element has a non-circular cross-section.

4. A tissue-localizing device as in claim 1 wherein said locator element is comprised of a shape memory alloy.

5. A tissue-localizing device as in claim 1 further comprising:

an insulating layer at least partially covering said locator element.

6. A tissue-localizing device as in claim 1 wherein said sleeve is electric conductive.

7. A tissue-localizing device as in claim 6 wherein said sleeve further comprises a cannula.

8. A tissue-localizing device as in claim 1 further comprising:

an insulating layer at least partially covering an inner surface of said sleeve.

9. A tissue-localizing device as in claim 1 wherein said locator element has a second electric conductive surface region electrically isolated from said first electric conductive surface region.

10. A tissue-localizing device as in claim 1 further comprising:

a power supply capable of supplying an alternating current with a frequency within a range of about ten kilohertz to about one hundred megahertz, to said first electric conductive region; and

an electric conductive path connecting said electric conductive surface region to said power supply.

11. A tissue-localizing device as in claim 10 further comprising:

an electric conducting member adapted for connection to tissue; and

a second electric conductive path connecting said power supply to said electric conducting member.

12. A tissue-localizing device as in claim 10 further comprising:

an electric conductive pad; and

a second electric conductive path connecting said power supply to said electric conductive pad.

13. A tissue-localizing device as in claim 10 wherein said power supply has an alternating current output power within a range of zero to about four hundred watts.

14. The tissue-localizing device as in claim 10 wherein said alternating current has a primary frequency in the range of about one hundred kilohertz to about one megahertz.

15. A tissue-localizing device comprising:

a sleeve having a lumen and an insulating liner covering the inner surface of said sleeve; and

an electric conductive locator element at least partially disposed in the lumen of said sleeve in a slidable manner, said locator element having a distal portion, the locator element further being adapted to penetrate tissue so that the distal portion of the locator element forms at least a partial loop that defines a volume of tissue when said locator element is deployed in tissue.

16. A tissue-localizing device as in claim 15 wherein said sleeve is electric conductive.

17. A tissue-localizing device as in claim 16 further comprising:

an insulating layer covering an outer surface of said sleeve with a distal end of said sleeve exposed.

18. A tissue-localizing device as in claim 16 further comprising:

an insulating layer partially covering said locator element with the distal end of the locator element exposed.

19. A tissue-localizing device as in claim 15 further comprising:

a power supply capable of supplying an alternating current, with at least a frequency within a range of about fifty kilohertz to about ten megahertz, to said locator element; and

an electric conductive path connecting said locator element to said power supply.

20. A tissue-localizing device as in claim 15 further comprising:

a power supply capable of supplying a RF energy to said locator element; and

an electric conductive path connecting said locator element to said power supply.

21. A tissue-localizing device as in claim 16 further comprising:

a power supply capable of supplying an alternating current with a frequency within a range of about three kilohertz to about three hundred gigahertz to said locator element; and

a first electric conductive path connecting said locator element to said power supply; and

a second electric conductive path connecting said sleeve to said power supply.

22. A tissue-localizing device comprising:

a sleeve having a first electric conductive region and a lumen; and

a locator element at least partially disposed in the lumen of said sleeve in a slidable manner, said locator element having a distal portion and a distal end, the distal end having a second electric conductive region, the locator element further being adapted to penetrate tissue so that the distal portion of the locator element forms at least a partial loop that defines a volume of tissue when said locator element is deployed in a mammalian tissue.

23. A tissue-localizing device as in claim 22 further comprising:

a power supply capable of generating a RF electric current;

a first electric conductive path connecting said power supply to said first electric conductive region; and

a second electric conductive path connecting said power supply to said second electric conductive region.

24. A tissue-localizing device comprising:

a locator element having a distal portion and an electric conductive surface region, said locator element further being adapted to penetrate tissue so that the distal portion of the locator element forms at least a partial loop that defines a volume of tissue when said locator element is deployed in tissue; and

a power supply capable of generating a RF electric current;

an electric conductive member adapted for connection to tissue;

a first electric conductive path connecting said power supply to said electric conductive region.

a second electric conductive path connecting said power supply to said electric conductive member.

25. A tissue-localizing device as in claim 24 wherein said distal end of said locator element has a sharp edge, and wherein said sharp edge has a conductive surface.

26. A method of placing a locator element in a mammalian tissue, comprising the steps of:

a.) penetrating through tissue with a sleeve containing a locator element at least partially disposed in a lumen defined by said sleeve, said locator element having a distal portion and a distal end, wherein said distal portion having an electric conductive surface limited to said distal end of the locator element.

b.) advancing said locator element through said sleeve and penetrating the tissue so that the distal portion of the locator element forms at least a partial loop such that said locator element when fully deployed substantially surrounds a volume of tissue.

27. A method of placing a locator element in tissue as in claim 26, further comprising the step of:

delivering an alternating current to said electric conductive surface.

28. A method of placing a locator element in a mammalian tissue, comprising the steps of:

a.) connecting an electric conducting pad to a surface on a mammalian body;

b.) penetrating through a tissue on said mammalian body with a sleeve containing a locator element at least partially disposed in a lumen defined by said sleeve, said locator element having a distal portion, the distal portion having an electric conductive surface region;

c.) advancing said locator element through said sleeve and penetrating the tissue so that the distal portion of the locator element forms a partial loop such that said locator element when fully deployed substantially surrounds a volume of tissue next to the sleeve; and

d.) energizing said locator element with an electric current while said locator element is being advanced through the tissue.

29. A method of placing a locator element in a mammalian tissue, comprising the steps of:

a.) penetrating into a tissue with a sleeve containing a locator element at least partially disposed in a lumen defined by said sleeve, said locator element having a distal portion, the distal portion further having a first electric conductive region, wherein said sleeve further having a second electric conductive region;

b.) advancing said locator element through said sleeve and penetrating the tissue so that the distal portion of the locator element forms at least a partial loop such that said locator element when fully deployed substantially surrounds a volume of tissue next to the sleeve; and

c.) allowing a current to flow between said fist electric conductive region and said second electric conductive region.

30. A method of placing a locator element in a mammalian tissue, comprising the steps of:

a.) penetrating through tissue with a sleeve containing a locator element at least partially disposed in a lumen defined by said sleeve, said locator element having a distal portion, the distal portion having an electric conductive surface region, said locator element further being adapted to penetrate tissue so that the distal portion of the locator element forms at least a partial loop that defines a volume of tissue when said locator element is deployed in tissue;

b.) advancing the locator element into the tissue; and

c.) applying an alternating current to said electric conductive region.

31. The method of claim 30 wherein steps (b) and (c) are performed simultaneously.