Anchored RF ablation device for the destruction of tissue masses

• US 8,512,333 B2
• Filed: 05/08/2006
• Issued: 08/20/2013
• Est. Priority Date: 07/01/2005
• Status: Active Grant

• Current Assignee: Acessa Health Inc. (Hologic Incorporated)
• Original Assignee: Halt Medical, Inc. (Hologic Incorporated)
• Inventors: Epstein, Gordon, Lee, Bruce, Cohen, Jeffrey M., Hagmann, Adam, Spero, Richard
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/429,921
• Publication Number:
  US 20070006215A1
• Time in Patent Office: 2,661 Days
• Field of Search: 606 41- 50, 607101-102
• US Class Current: 606/41
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/0094 Types of switches or controllers
• CPC Class Codes: A61B 2018/1405 Electrodes having a specific shape
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1869 : with an instrument interstitially inserted into the body, e.g. needles

Abstract

The inventive ablation element comprises an elongated cannula having a proximal end and a distal end. The cannula defines an internal lumen within the cannula and a cannula axis. A plurality of conductors contained within the lumen, each of the conductors has a proximal end proximate the proximal end of the cannula, and a distal end proximate the distal end of the cannula. A plurality of ablation stylets each has a proximal end and a distal end, and each coupled at the respective proximal end of the stylet to the distal end of a respective conductor, the stylets comprise a deflectable material, the conductors together with their respective stylets being mounted for axial movement. A trocar point defined proximate the distal end of the cannula. A deflection surface positioned between the trocar point and the proximal end of the cannula, the deflection surface being configured and positioned to deflect, in response to axial movement of the stylets in a direction from the proximate end of the cannula to the distal end of the cannula, at least some of the stylets laterally with respect to the cannula axis in different directions along substantially straight paths, the paths defining an ablation volume.

Claims

1. An ablation instrument, comprising:

(a) an elongated support member having a proximal portion and a distal portion, said elongated support member defining an elongated support surface, and an elongated support member axis;

(b) at least one conductor extending along at least a portion of the length of said elongated support member surface and mounted for axial movement of at least a portion of said conductor;

(c) a plurality of ablation stylets, each of said stylets being made of metal and having an elongated exposed metal distal portion, said exposed metal distal portion having a length roughly commeasurate with the region to be ablated, said stylets being supported proximate the distal portion of said elongated support member, said stylets comprising a resiliently deflectable material, and said stylets being mounted for axial movement of at least a portion of said stylets;

(d) a head positioned to receive the distal portion of said stylets, said head comprising a head end; and

(e) open deflection surfaces positioned proximate said head end and proximate said distal portion of said elongated support member, said deflection surfaces being configured and positioned, in response to advancement of said stylets toward said head end, to deflect at least some of said stylets laterally and only forwardly with respect to said elongated support axis causing said stylets to exit said deflection surfaces and move along substantially straight external paths external to said elongated support member and said head.

2. An ablation instrument as in claim 1, further comprising a countersurface cooperating with said deflection surfaces and defining respective countersurface portions in facing spaced relationship to respective ones of said deflection surfaces.

3. An ablation instrument as in claim 2, wherein said countersurface comprises a low friction nonmetallic material.

4. An ablation instrument as in claim 1, wherein said stylets are deflected with a strain between 3.5% and 4.5%.

5. An ablation instrument as in claim 1, wherein said ablation stylets are secured to each other in a unitary structure comprising a support member having a plurality of mounting surfaces each configured to engage a respective ablation stylet.

6. An ablation instrument as in claim 5, wherein said head is a trocar comprising a trocar point and said deflection surfaces comprise a number of ramps defined proximate the proximal end of said trocar point, the distal ends of said stylets being positionable proximate to said ramps.

7. An ablation instrument as in claim 6, wherein said conductor is an electrical conductor, said stylets are electrical conductors, and each of said stylets are configured to assume a substantially straight configuration in the absence of external forces.

8. An ablation instrument as in claim 1, further comprising:

(g) an anchor mounted for movement between an internal position disposed within said elongated support member and an anchoring position extending laterally from said elongated support member through points external of said lumen.

9. An ablation instrument as in claim 8, wherein said anchor comprises at least two pointed members mounted for movement in directions which have vector components which extend away from the axis of said elongated support member and away from each other.

10. An ablation instrument as in claim 1, wherein said stylets comprise an alloy comprising nickel and titanium alloy.

11. An ablation element as in claim 10, wherein said stylets are secured to each other at least along a portion of their length to form a stylet assembly.

12. An ablation element as in claim 10, further comprising a plurality of anchor members and an anchor member deploying operator mounted for axial movement independent of said at least one conductor.

13. An ablation element as in claim 1, wherein the parameters of stylet length, stylet power, stylet actuation time and/or angular orientation are controlled by a computer in response to a computer program having an input comprising feedback information from the tissue area being operated on and/or a preset program.

14. An ablation element as in claim 1, wherein said head end is a trocar point defined at the distal end of said head, said head comprising a trocar member, said trocar member having an outside surface, said support member comprising a cannula, said cannula having an outside surface, said trocar member having a proximal end secured proximate to the distal end of said elongated cannula, and the outside surface of said cannula and the outside surface of said trocar point defining a trocar surface, and wherein said stylets are made of a nickel titanium alloy and are deflected to a strain of less than 8%.

15. An ablation element as in claim 14, wherein said trocar member bears said deflection surfaces, said deflection surfaces comprising a number of ramps, said ramps extending partially around said ablation stylets, said ramps being defined proximate the proximal end of said trocar point, the distal ends of said stylets being positionable proximate to said ramps and within said trocar surface, and wherein said stylets are hollow and comprise an alloy comprising nickel and titanium, and have distal ends configured to tangentially engage a respective one of said deflection surfaces.

16. An ablation element as in claim 15, further comprising a graphical user interface and a pair of electrical switches, one of said switches for switching between operating parameter options for the ablation element and the other of said switches for selecting one of said options.

17. An ablation element as in claim 16, wherein a human voice presents options, allowing a surgeon to operate without requiring the surgeon to look away from visual displays guiding the operation, the patient, instruments and so forth, thus removing potential losses of information.

18. An ablation element as in claim 15, further comprising a cooperating low friction insulator ring, for example, made of Teflon, in facing spaced relationship to said deflection surfaces and cooperating with the deflection surfaces to deflect said stylets.

19. An ablation element as in claim 15, wherein an insulation sleeve is positioned between the anchors and the stylets in order to allow separate electrical actuation and ablation with either the anchors or the stylets or both the anchors and the stylets.

20. An ablation element as in claim 1, further comprising anchors deployed by bearing against a deflection surface configured to deploy them in an outward and rearward direction, and wherein said anchors comprise an alloy comprising nickel and titanium.

21. An ablation element as in claim 20, wherein said anchors are made of a springy material which assumes a straight configuration when not subjected to external forces.

22. An ablation element as in claim 20, wherein deflection surfaces for both the hypotube stylets and anchors are configured to result in strains in the range of 3.5% to 4.5%.

23. An ablation element as in claim 1, wherein said stylets which are bound together as a unitary structure and advanced by a single push tube or wire.

24. An ablation element as in claim 1, wherein the stylets contain thermocouples which are connected to measure the temperature of ablated tissue.

25. An ablation instrument, comprising:

(a) an elongated support member having a proximal portion and a distal portion, said elongated support member defining an elongated support member axis;

(b) at least one conductor extending along at least a portion of the length of said elongated support member and mounted for axial movement of at least a portion of said conductor;

(c) a plurality of ablation stylets, each of said stylets being made of metal and having an elongated exposed metal distal portion, said exposed metal distal portion having a length roughly commeasurate with the region to be ablated, said stylets being supported proximate the distal portion of said elongated support member, said stylets comprising a resiliently deflectable material, and said stylets being mounted for axial movement of at least a portion of said stylets;

(d) a head positioned to receive the distal portion of said stylets, said head comprising a head end;

(e) a plurality of alignment channels, each of said stylets each being positioned within a single alignment channel; and

(f) a plurality of open deflection surfaces, each of said open deflection surfaces communicating with a respective alignment channel to receive its respective stylet, said deflection surfaces being positioned proximate said head end and proximate said distal portion of said elongated support member, said deflection surfaces being configured and positioned, in response to advancement of said stylets toward said head end, to deflect at least some of said stylets causing said stylets to exit said deflection surfaces and move along substantially straight external paths external to said head.