Visual electrode ablation systems

• US 8,709,008 B2
• Filed: 05/09/2008
• Issued: 04/29/2014
• Est. Priority Date: 05/11/2007
• Status: Active Grant

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Original Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Inventors: Willis, N. Parker, Malchano, Zachary J., Rothe, Chris A., Saadat, Vahid, Peh, Ruey-Feng, Miller, David, Tam, Edmund
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): FOWLER, DANIEL WAYNE
• Application Number:
  US12/118,439
• Publication Number:
  US 20090030412A1
• Time in Patent Office: 2,181 Days
• Field of Search: 606/41, 606/27, 606/34
• US Class Current: 606/41
• CPC Class Codes: A61B 1/00089 Hoods
• CPC Class Codes: A61B 1/012 characterised by internal passages or accessories therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00809 measured thermochromatically
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

Visual electrode ablation systems are described herein which include a deployment catheter and an attached imaging hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. An electric current may be passed through the fluid such that it passes directly to the tissue region being imaged and the electrical energy is conducted through the fluid without the need for a separate ablation probe or instrument to ablate the tissue being viewed.

Claims

1. A tissue ablation apparatus adapted for deployment within a blood-filled environment, comprising:

a barrier or membrane projecting from a deployment catheter and defining a field when the barrier or membrane is expanded in the blood-filled environment from an insertion configuration to an expanded and deployed configuration, wherein the barrier or membrane further comprises a distal membrane which at least partially covers the field and further defines a central aperture in the distal membrane having a diameter which is less than an outer diameter of the barrier or membrane and through which fluid is permeable to an environment external to the barrier or membrane;

an imaging element positioned within or adjacent to the barrier or membrane and adapted to image a tissue surface adjacent to the barrier or membrane when the field is purged of blood via a purging fluid introduced through the deployment catheter, where the barrier or membrane is configured to maintain its deployed configuration prior to introduction of the purging fluid into the field; and

an electrode within the field or adjacent to the barrier or membrane and electrically coupled to the purging fluid and spaced from the aperture such that, in use, electrical energy from the electrode is conducted by the purging fluid into the tissue surface adjacent the aperture, and where the imaging element is positioned to provide for visualization of the tissue surface through the purging fluid while the electrode conducts the electrical energy.

2. The apparatus of claim 1 wherein the barrier or membrane defines a conical structure.

3. The apparatus of claim 1 wherein the transparent fluid comprises saline.

4. The apparatus of claim 1 wherein the barrier or membrane forms an expandable membrane defining an angled contact surface relative to the catheter.

5. The apparatus of claim 1 further comprising a handle coupled to a proximal end of the deployment catheter.

6. The apparatus of claim 1 wherein the imaging element comprises a CMOS imaging camera, CCD imaging camera, or optical fiber.

7. The apparatus of claim 6 wherein the barrier or membrane define one or more directional indicators visible through the field via the imaging element, wherein a handle coupled to the catheter further defines one or more directional indicators correlating to the directional indicators on the barrier or membrane such that articulation of a control on the handle articulates the deployment catheter in a corresponding direction.

8. The apparatus of claim 6 wherein the barrier or membrane define one or more gradations visible through the field via the imaging element.

9. The apparatus of claim 1 wherein the electrode is positioned within the barrier or membrane proximally of the field.

10. The apparatus of claim 1 wherein the electrode is configured as a support strut positioned along the barrier or membrane.

11. The apparatus of claim 1 wherein the electrode is configured as a ring electrode extending from a support member positioned within the field proximally of the aperture.

12. The apparatus of claim 1 wherein the electrode is configured as a ring electrode positioned upon a surface of the barrier or membrane proximal to the aperture.

13. The apparatus of claim 1 further comprising an electrocardiogram electrode positioned along an outer surface of the barrier or membrane for contacting the tissue region.

14. The apparatus of claim 1 further comprising one or more ultrasound transducers along an outer surface of the barrier or membrane for contacting the tissue region.

15. The apparatus of claim 1 wherein the deployment catheter comprises a proximal steering section configured to articulate within a plane and a distal steering section configured to articulate within at least four planes.

16. The apparatus of claim 1 further comprising at least one thermochromic indicator along a surface of the barrier or membrane for visually indicating a temperature change of the transparent fluid and/or tissue surface.

17. A tissue ablation system adapted for ablating a target tissue region within a blood-filled environment, the target tissue region disposed along a tissue surface, the ablation system comprising:

a deployment catheter having a fluid lumen, an electrode, and an imaging element;

a barrier or membrane projecting from the deployment catheter and defining a visualization field when the barrier or membrane is expanded, wherein the barrier or membrane further comprises a distal membrane which at least partially covers the field and further defines a central aperture in the distal membrane having a diameter which is less than an outer diameter of the barrier or membrane and through which fluid is permeable to an environment external to the barrier or membrane;

a fluid source in fluid communication with the fluid lumen so as to direct fluid distally through the fluid lumen and into the visualization field extending between the imaging element and the target tissue, where the barrier or membrane is configured to maintain its expanded configuration prior to introduction of the fluid into the visualization field;

an imaging monitor coupled to the imaging element so as to image the tissue surface through the fluid within the visualization field; and

an electrical energy source coupled to the electrode, the electrode coupled to the fluid from the lumen so that the fluid within the visualization field conducts ablating electrical energy to the target tissue region, and where the imaging element is positioned to provide for visualization of the tissue surface through the fluid while the electrode conducts the electrical energy.

18. The system of claim 17 wherein the deployment catheter has a flexible intracardial catheter body, and further comprising a steering system coupled to the deployment catheter so as to selectively bend the catheter body and reposition the visualization field when the distal end of the deployment catheter is disposed in a chamber of a heart.

19. A tissue ablation apparatus adapted for deployment within a blood-filled environment, comprising:

a barrier or membrane projecting from a deployment catheter and defining a visualization field when the barrier or membrane is in an expanded and deployed configuration;

a distal membrane which at least partially covers the visualization field, wherein the distal membrane further defines a central aperture having a diameter which is less than an outer diameter of the distal membrane and through which fluid is permeable to an environment external to the barrier or membrane;

an imaging element positioned within or adjacent to the visualization field and adapted to image a tissue surface adjacent to the barrier or membrane within a field of view of the imaging element when the visualization field is purged of blood via a transparent fluid, where the barrier or membrane is configured to maintain its deployed configuration prior to introduction of the transparent fluid into the visualization field; and

an electrode positioned within or adjacent to the visualization field such that the electrode is spaced from the aperture and energy discharged from the electrode is directed through the transparent fluid and into the tissue surface being visualized, and where the imaging element is positioned to provide for visualization of the tissue surface through the transparent fluid while the electrode conducts the energy.

20. The apparatus of claim 19 wherein the barrier or membrane defines a conical structure.

21. The apparatus of claim 19 wherein the transparent fluid comprises saline.

22. The apparatus of claim 19 wherein the barrier or membrane forms an expandable membrane defining an angled contact surface relative to the catheter.

23. The apparatus of claim 19 further comprising a handle coupled to a proximal end of the deployment catheter.

24. The apparatus of claim 23 wherein the barrier or membrane define one or more directional indicators visible through the visualization field via the imaging element, wherein the handle further defines one or more directional indicators correlating to the directional indicators on the barrier or membrane such that articulation of a control on the handle articulates the deployment catheter in a corresponding direction.

25. The apparatus of claim 19 wherein the barrier or membrane define one or more gradations visible through the visualization field via the imaging element.

26. The apparatus of claim 19 wherein the electrode is positioned within the barrier or membrane proximally of the visualization field.

27. The apparatus of claim 19 wherein the electrode is configured as a support strut positioned along the barrier or membrane.

28. The apparatus of claim 19 wherein the electrode is configured as a ring electrode extending from a support member positioned within the visualization field proximally of the aperture.

29. The apparatus of claim 19 wherein the electrode is configured as a ring electrode positioned upon a surface of the barrier or membrane proximal to the aperture.

30. The apparatus of claim 19 further comprising an electrocardiogram electrode positioned along an outer surface of the barrier or membrane for contacting the tissue region.

31. The apparatus of claim 19 further comprising one or more ultrasound transducers along an outer surface of the barrier or membrane for contacting the tissue region.

32. The apparatus of claim 19 wherein the deployment catheter comprises a proximal steering section configured to articulate within a plane and a distal steering section configured to articulate within at least four planes.

33. The apparatus of claim 19 further comprising at least one thermochromic indicator along a surface of the barrier or membrane for visually indicating a temperature change of the transparent fluid and/or tissue surface.

34. A tissue ablation apparatus adapted for ablating a tissue region within an isolated region contained in a blood-filled environment, comprising:

a barrier or membrane projecting from a deployment catheter and defining a therapy field when the barrier or membrane is in an expanded and deployed configuration;

a distal membrane which at least partially covers the therapy field, wherein the distal membrane further defines a central aperture having a diameter which is less than an outer diameter of the distal membrane and which is permeable to an environment external to the barrier or membrane;

an electrode positioned within or adjacent to the therapy field and spaced from the aperture; and

an imaging element positioned within or adjacent to the barrier or membrane and adapted to image a tissue surface adjacent to the barrier or membrane when the therapy field is purged of blood via the electrolytic fluid, and,

wherein the aperture is positionable against a tissue region to be ablated such that the electrolytic fluid introduced through the catheter and into the therapy field forms a conductive path between the electrode and the tissue region through the aperture,

wherein the barrier or membrane is configured to maintain its deployed configuration prior to introduction of the electrolytic fluid into the therapy field,

wherein energy delivered through the electrolytic fluid to the tissue region is contained temporarily within the therapy field of the barrier or membrane, and

wherein the imaging element is positioned to provide for visualization of the tissue region through the electrolytic fluid while the electrode conducts the energy.

35. The apparatus of claim 34 wherein the electrolytic fluid comprises saline.

36. The apparatus of claim 34 wherein the electrode is positioned within the barrier or membrane proximally of the therapy field.

37. The apparatus of claim 34 wherein the electrode is configured as a support strut positioned along the barrier or membrane.

38. The apparatus of claim 34 wherein the electrode is configured as a ring electrode extending from a support member positioned within the therapy field proximally of the aperture.

39. The apparatus of claim 34 wherein the electrode is configured as a ring electrode positioned upon a surface of the barrier or membrane proximal to the aperture.

40. The apparatus of claim 34 wherein the distal membrane defines a surface area at least twice as large as a cross sectional area of the deployment catheter.

41. A tissue ablation apparatus adapted for ablating a tissue region within a blood-filled environment, comprising:

a barrier or membrane projecting from a deployment catheter and defining a therapy field when the barrier or membrane is in an expanded and deployed configuration;

a distal membrane which at least partially covers the therapy field, wherein the distal membrane further defines a central aperture having a diameter which is less than an outer diameter of the distal membrane and which is permeable to an environment external to the barrier or membrane;

an imaging element positioned within or adjacent to the barrier or membrane and adapted to image a tissue surface adjacent to the barrier or membrane when the therapy field is purged of blood via an electrolytic fluid introduced through the deployment catheter, where the barrier or membrane is configured to maintain its deployed configuration prior to introduction of the electrolytic fluid into the therapy field;

an electrode positioned within or adjacent to the therapy field and spaced from the aperture, and

wherein energy delivered from the electrode and through the electrolytic fluid within the therapy field enters the tissue region uniformly over an area isolated by the barrier or membrane against the tissue region, and

wherein the imaging element is positioned to provide for visualization of the tissue region through the electrolytic fluid while the electrode conducts the energy.

42. The apparatus of claim 41 wherein the electrolytic fluid comprises saline.

43. The apparatus of claim 41 wherein the tissue region area isolated by the barrier or membrane is at least twice as large as a cross sectional area of the deployment catheter.

44. The apparatus of claim 41 wherein the electrode is positioned within the barrier or membrane proximally of the therapy field.

45. The apparatus of claim 41 wherein the electrode is configured as a support strut positioned along the barrier or membrane.

46. The apparatus of claim 41 wherein the electrode is configured as a ring electrode extending from a support member positioned within the therapy field proximally of the aperture.

47. The apparatus of claim 41 wherein the electrode is configured as a ring electrode positioned upon a surface of the barrier or membrane proximal to the aperture.

48. The apparatus of claim 41 wherein the imaging element comprises a CMOS imaging camera, CCD imaging camera, or optical fiber.