Anchored RF ablation device for the destruction of tissue masses

• US 20070006215A1
• Filed: 05/08/2006
• Published: 01/04/2007
• Est. Priority Date: 07/01/2005
• Status: Active Grant

• Current Assignee: Acessa Health Inc. (Hologic Incorporated)
• Original Assignee: American Capital Limited
• Inventors: Spero, Richard, Hagmann, Adam, Lee, Bruce, Cohen, Jeffrey, Epstein, Gordon
• Granted Patent: US 8,512,333 B2
• Time in Patent Office: Days
• US Class Current: 717/171
• 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 element, comprising:

(a) an elongated cannula having a proximal end and a distal end, said cannula defining an internal lumen within said cannula and a cannula axis;

(b) a plurality of conductors contained within said lumen, each of said conductors having a proximal end proximate the proximal end of said cannula, and a distal end proximate the distal end of said cannula;

(c) a plurality of ablation stylets each having a proximal end and a distal end, and each coupled at the respective proximal end of said stylet to the distal end of a respective conductor, said stylets comprising a deflectable material, said conductors together with their respective stylets being mounted for axial movement;

(d) a trocar point defined proximate the distal end of said cannula; and

(e) a deflection surface positioned between said trocar point and said proximal end of said cannula, the deflection surface being configured and positioned to deflect, in response to axial movement of said stylets in a direction from said proximate end of said cannula to said distal end of said cannula, at least some of said stylets laterally with respect to said cannula axis in different directions along substantially straight paths, said paths defining an ablation volume.

2. An ablation element as in claim 1, wherein said conductor is selected from the group consisting of electrical conductors, radio frequency conductors, microwave conductors and optical conductors.

3. An ablation element as in claim 1, wherein each of said conductors are integral with its respective ablation stylet.

4. An ablation element as in claim 1, wherein the solid contents of said lumen consist essentially of said conductors.

5. An ablation element as in claim 1, wherein each of said stylets are configured to assume a substantially straight configuration in the absence of external forces.

6. An ablation element as in claim 1, further comprising:

(f) a motor member or members coupled to said conductors to drive axial movement of said stylets in directions from said proximal end of said cannula to said distal end of said cannula, and from said distal end of said cannula to said proximal end of said cannula through a plurality of positions.

7. An ablation element as in claim 1, wherein said trocar point is defined at the distal end of a trocar member, said trocar member having an outside surface, 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.

8. An ablation element as in claim 7, wherein said deflection surface comprises 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 and within said trocar surface.

9. An ablation element as in claim 8, wherein said conductors are electrical conductors, said stylets are electrical conductors, and each of said stylets are configured to assume a substantially straight configuration in the absence of external forces.

10. An ablation element as in claim 9, wherein said deflection surface comprises a plurality of channels guiding said distal ends of said stylets to said ramps.

11. An ablation element as in claim 9, wherein said cannula is secured to said trocar member with the outside surface of said cannula proximate to the outside surface of said trocar member.

12. An ablation element as in claim 1, further comprising:

(f) an anchor mounted for movement between an internal position disposed within said trocar surface and an anchoring position extending laterally from said trocar surface through points external of said lumen; and

(g) a drive member disposed within said lumen and coupled to said anchor to drive said anchor between said internal position and said anchoring position.

13. An ablation element as in claim 9, wherein said anchor comprises at least two pointed members mounted for movement in directions which have vector components which extend away from the axis or said cannula and away from each other.

14. An ablation element as in claim 13, wherein said pointed members extend in a direction with vector component that extends in a direction opposite to the direction in which said trocar point extends.

15. An ablation element as in claim 1, wherein said conductors bear against each other at least along a portion of their length within said cannula.

16. An ablation element, comprising:

(a) an elongated cannula having a proximal end and a distal end, said cannula defining an internal lumen within said cannula and a cannula axis;

(b) a plurality of conductors contained within said lumen, each of said conductors having a proximal end proximate the proximal end of said cannula, and a distal end proximate the distal end of said cannula;

(c) a plurality of ablation stylets each having a proximal end and a distal end, and each coupled at the respective proximal end of said stylet to the distal end of a respective conductor, said stylets comprising a deflectable material, said conductors together with their respective stylets being mounted for axial movement;

(d) a front end defined proximate the distal end of said cannula; and

(e) a deflection surface positioned between said front end and said proximal end of said cannula, the deflection surface being configured and positioned to deflect, in response to axial movement of said stylets in a direction from said proximate end of said cannula to said distal end of said cannula, at least some of said stylets laterally with respect to said cannula axis in different directions along substantially straight paths, said paths defining an ablation volume.

17. An ablation element as in claim 16, wherein said conductors bear against each other at least along a portion of their length within said cannula.

18. An ablation element as in claim 16, wherein said conductors are driven by a drive mechanism which allows said conductors to move independently.

19. An ablation element as in claim 16, wherein said conductors have a length, a width and a thickness, said width being greater than said thickness.

20. An ablation element as in claim 16, wherein said conductors terminate in a point oriented to allow deflection by said deflection surface.

21. An ablation element as in claim 16, wherein said conductors extend in different directions when they exit the deflection surface and extend to a variable extent.

22. An ablation element as in claim 16, wherein said conductors are driven by a drive circuit which varies the amount of energy supplied to the stylets and/or the length of the stylets and/or the length of the stylets and/or the time during which power is supplied to the stylets and/or the angular orientation of the ablation element.

23. An ablation element as in claim 22, 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.

24. An ablation element, comprising:

(a) an elongated cannula having a proximal end and a distal end, said cannula defining an internal lumen within said cannula and a cannula axis;

(b) a plurality of conductors contained within said lumen, each of said conductors having a proximal end proximate the proximal end of said cannula, and a distal end proximate the distal end of said cannula;

(c) a plurality of ablation stylets each having a proximal end and a distal end, and each coupled at the respective proximal end of said stylet to the distal end of a respective conductor, said stylets comprising a deflectable material, said conductors together with their respective stylets being mounted for axial movement;

(d) a front end defined proximate the distal end of said cannula;

(e) an anchor mounted for movement between an internal position disposed within said trocar surface and an anchoring position extending laterally from said trocar surface through points external of said lumen; and

(f) a drive member disposed within said lumen and coupled to said anchor to drive said anchor between said internal position and said anchoring position, wherein said anchor comprises at least two pointed members mounted for movement in directions which have vector components which extend away from the axis or said cannula and away from each other.

25. An ablation element as in claim 24, wherein said front end is a trocar point defined at the distal end of a trocar member, said trocar member having an outside surface, 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.

26. An ablation element as in claim 25, wherein said trocar member bears a deflection surface, said deflection surface comprising 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 and within said trocar surface.

27. An ablation element as in claim 24, wherein said anchors extend in directions which have vector components which extend away from the distal end of said of ablation element.

28. An ablation element as in claim 24, wherein said anchors are deployed in response to rotary motion.

29. An ablation element as in claim 24, wherein said anchors are deployed by bearing against a deflection surface.

30. An ablation element as in claim 24, wherein said anchors are made of a springy material which assumes a curved configuration when not subjected to external forces.

In accordance with a particularly preferred embodiment of the invention, it is contemplated that a graphical user interface and a pair of electrical switches, for example a joystick and a pushbutton, will be used to switch between operating parameter options for the inventive catheter which are displayed on a graphical user interface or other information conveying device such as an audio cue generator. The surgeon navigates, for example, using a joystick looking at or hearing electronically generated audio signal, such as a voice, presenting various options and selects that option by pushing the electrical switch. In principle, this can be done on a single switch incorporating joystick and pushbutton features.

Optionally, the electrical switches which operate the system may be recessed partially or fully in order to minimize the likelihood of unintentional actuation. Additional protection is provided by requiring two motions within a relatively short period of time in order to achieve a change in the control of the system.

In accordance with a particularly preferred version of the invention, this is achieved by having a human voice present options and acknowledge instructions. This allows the surgeon to operate without having to look away from visual displays guiding the operation, the patient, instruments and so forth, thus removing potential losses of information.

In accordance with the invention it is contemplated that laser manufacturing techniques are used to manufacture the anchors and perhaps the anchor deflection surfaces.

Preferably, the point of the trocar is milled to a point with three surfaces. Stylets are milled and orientation which cooperates with the deflection surfaces which deflect them. A cooperating low friction insulator ring, for example, made of Teflon, cooperates with the deflection surfaces to deflect hypotube electrode stylets.

The present invention contemplates the use of rearwardly deployed anchoring stylets which act as retractable barbs for maintaining the position of the trocar point during forward deployment of the radiofrequency (RF) electrode ablation stylets.

In accordance with the present invention, a stylet operating member, optionally a stylet push member, which may be a tube, is positioned on one side of a tubular compression/tension operator, for example on the inside of the compression/tension operator. Similarly, in accordance with the present invention, and anchor member operating member, optionally an anchor poll member, which may be a tube, is positioned on the other side of a tubular compression/tension operator, for example on the outside of the compression/tension operator. Such outside placement is particularly advantageous in the case where the anchoring member is of relatively wide dimension and large size.

In accordance with a preferred embodiment of the invention, the compression tension operator is secured at the proximal end to the handle of the ablation instrument and at the distal and to the anchoring member deflection surface and the hypotube electrode stylet deflection surface.

The invention contemplates a plurality of hypotube electrode stylets which are bound together as a unitary structure and advanced by a single push tube or wire.

It is also contemplated that the inventive instrument will include channels for flushing clean. In accordance with the inventive system, the frequency with which flushing should be performed is minimized through the use of a trocar font face which is substantially closed (except for a single undeflected hypotube which exits the front face of the trocar) and providing for exit of hypotubes through the cylindrical side wall of the trocar point.

In accordance with a particularly preferred embodiment of the invention, the anchor member is separate from the anchor push tube, and is connected it to by mating or other interlocking structure.

Deflection surfaces for both the hypotube stylets and anchors are selected to result in strains in the range of two to 8%, preferably about 4%, for example 3.5% to 4.5%, which represents a reasonable compromise between instrument longevity and a relatively large amount of deflection.

And insulation sleeve between the anchors and the hypotube stylets in order to allow separate electrical actuation and ablation with either or both of the anchors and the hypotube stylets.

The hypotube stylets contained thermocouples which are used to measure the temperature of a plated tissue. Thus ensuring that the tissue will be raised to the correct temperature for a sufficient period of time to a blatant tissue resulting in the creation of necrotic tissue which may be absorbed by the body.

In accordance with the preferred embodiment of the invention, hypotube stylets are deployed forwardly or distally while anchors are deployed in a proximal direction or rearwardly. Alternatively, the hypotube stylets may be deployed in a proximal direction or rearwardly, while anchors are deployed forwardly or distally.

31. An ablation element, comprising:

(a) an elongated cannula having a proximal end and a distal end, said cannula defining an internal lumen within said cannula and a cannula axis;

(b) a plurality of ablation stylets, each of ablation stylets having a proximal end and a distal end, said ablation stylets being joined to each other in the configuration where said distal ends of said ablation stylets are free to be deflected, said ablation stylets forming a unitary ablation stylet array, said unitary ablation stylet array being mounted for sliding movement with respect to said elongated cannula, and said ablation stylets comprising a deflectable material;

(c) an ablation stylet sliding member, said ablation stylet sliding member having a proximal end proximate the proximal end of said cannula, and a distal end positionable proximate the distal end of said cannula, said ablation stylet sliding member being mounted for sliding movement with respect to said cannula, and said ablation stylet sliding member being an effective conductor of energy; and

(d) a trocar point assembly defining a trocar point, said trocar point assembly being secured to said cannula proximate the distal end of said cannula, said trocar point assembly comprising;

(i) a plurality of tracks for receiving and guiding sliding movement of said ablation stylets; and

(ii) a plurality of stylet deflection surfaces positioned between said trocar point and said proximal end of said cannula, the stylet deflection surfaces being configured and positioned to deflect, in response to axial movement of said stylets in a direction from said proximate end of said cannula to said distal end of said cannula, at least one of said stylets away from said cannula axis and in different directions along substantially straight paths, said straight paths defining an ablation volume.

32. An ablation element as in claim 31, further comprising:

(e) an anchors, said anchor having a proximal end and a distal end, said anchor having an end free to be deflected, said anchor forming a unitary anchoring array, said unitary anchoring array being mounted for sliding movement with respect to said elongated cannula, and said anchor comprising a deflectable material;

(f) an anchor sliding member, said anchor sliding member being mounted for sliding movement with respect to said cannula, and said anchor sliding member being an effective conductor of energy; and

wherein said trocar point assembly further comprises;

(iii) an anchor deflection surface positioned between said trocar point and said proximal end of said cannula, the anchor deflection surface being configured and positioned to deflect, in response to axial movement of said anchor, said anchor away from said cannula axis to act as a barb.

33. An ablation element as in claim 32, wherein a graphical user interface and a pair of electrical switches, for example a joystick and a pushbutton, will be used to switch between operating parameter options for the inventive catheter which are displayed on a graphical user interface or other information conveying device such as an audio cue generator, the surgeon navigates, for example, using a joystick looking at or hearing electronically generated audio signal, such as a voice, presenting various options and selects that option by pushing the electrical switch, optionally using a single switch incorporating joystick and pushbutton features.

34. An ablation element as in claim 32, wherein electrical switches which operate the system may be recessed partially or fully in order to minimize the likelihood of unintentional actuation, with optional additional protection is provided by requiring two motions within a relatively short period of time in order to achieve a change in the control of the system.

35. An ablation element as in claim 34, wherein a human voice present options and acknowledge instructions, allowing the surgeon to operate without having to look away from visual displays guiding the operation, the patient, instruments and so forth, thus removing potential losses of information.

36. An ablation element as in claim 32, wherein laser manufacturing techniques are used to manufacture the anchors and perhaps the anchor deflection surfaces.

37. An ablation element as in claim 32, wherein the point of the trocar is milled to a point with three surfaces. Stylets are milled and orientation which cooperates with the deflection surfaces which deflect them. A cooperating low friction insulator ring, for example, made of Teflon, cooperates with the deflection surfaces to deflect hypotube electrode stylets.

38. An ablation element as in claim 32, wherein rearwardly deployed anchoring stylets which act as retractable barbs for maintaining the position of the trocar point during forward deployment of the radiofrequency (RF) electrode ablation stylets.

39. An ablation element as in claim 32, wherein a stylet operating member, optionally a stylet push member, which may be a tube, is positioned on one side of a tubular compression/tension operator, for example on the inside of the compression/tension operator, and in accordance with the present invention, and anchor member operating member, optionally an anchor poll member, which may be a tube, is positioned on the other side of a tubular compression/tension operator, for example on the outside of the compression/tension operator and such outside placement is particularly advantageous in the case where the anchoring member is of relatively wide dimension and large size.

40. An ablation element as in claim 32, wherein the compression tension operator is secured at the proximal end to the handle of the ablation instrument and at the distal and to the anchoring member deflection surface and the hypotube electrode stylet deflection surface.

41. An ablation element as in claim 32, wherein a plurality of hypotube electrode stylets which are bound together as a unitary structure and advanced by a single push tube or wire.

42. An ablation element as in claim 32, wherein channels for flushing clean and the frequency with which flushing should be performed is minimized through the use of a trocar font face which is substantially closed (except for a single undeflected hypotube which exits the front face of the trocar) and providing for exit of hypotubes through the cylindrical side wall of the trocar point.

43. An ablation element as in claim 32, wherein the anchor member is separate from the anchor push tube, and is connected it to by mating or other interlocking structure.

44. An ablation element as in claim 32, wherein deflection surfaces for both the hypotube stylets and anchors are selected to result in strains in the range of two to 8%, preferably about 4%, for example 3.5% to 4.5%, which represents a reasonable compromise between instrument longevity and a relatively large amount of deflection.

45. An ablation element as in claim 32, wherein an insulation sleeve is positioned between the anchors and the hypotube stylets in order to allow separate electrical actuation and ablation with either or both of the anchors and the hypotube stylets.

46. An ablation element as in claim 32, wherein the hypotube stylets contain thermocouples which are used to measure the temperature of ablated tissue, thus ensuring that the tissue will be raised to the correct temperature for a sufficient period of time to ablate tissue resulting in the creation of necrotic tissue which may be absorbed by the body.

47. An ablation element as in claim 32, wherein hypotube stylets are deployed forwardly or distally while anchors are deployed in a proximal direction or rearwardly, or the hypotube stylets may be deployed in a proximal direction or rearwardly, while anchors are deployed forwardly or distally.