Circumferential ablation guide wire system and related method of using the same

• US 8,137,342 B2
• Filed: 12/21/2006
• Issued: 03/20/2012
• Est. Priority Date: 12/24/2005
• Status: Active Grant

• Current Assignee: Arthur W. Crossman
• Original Assignee: Arthur W. Crossman
• Inventors: Crossman, Arthur W.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): Scott, Amanda
• Application Number:
  US11/919,718
• Publication Number:
  US 20090093801A1
• Time in Patent Office: 1,916 Days
• Field of Search: 606 21- 42
• US Class Current: 606/41
• 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 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/1435 Spiral

Abstract

Device and method significantly that improves the safety and procedural success of the existing art by being able to be less traumatic to vascular tissue, improving atrial contact with the ablation surface, improving positioning and geometrical precision of the ablation pattern, improving steerability and deliverability of the ablation device and by improving localization and geometric precision of the ablation device. The risk of pulmonary vein fibrosis/stenosis will also be substantially lowered. Finally, expansion of the eligible atrial fibrillation population will inherently increase due to the improved components and methods of the present invention.

Claims

1. A tissue ablation system for treating atrial arrhythmia by ablating a circumferential region of tissue at a location where a pulmonary vein (PV) extends from an atrium of a heart of a subject, said system comprising:

a guide catheter comprising a shaft having a proximal portion and a distal portion;

a guide wire disposed in said guide catheter shaft having a proximal portion, distal portion and distal tip, said guide wire adapted to travel through said guide catheter to be inserted into the atrium;

an interface member disposed on said guide wire;

a first balloon disposed on said guidewire distally beyond said interface member;

said first balloon adapted to center or align said guide wire in the pulmonary vein (PV) and/or its pulmonary vein ostium (PVO) so that the interface member is coaxially aligned with the pulmonary vein ostium (PVO) to provide optimal coaxial alignment with the pulmonary vein ostium (PVO);

an actuator element disposed on said interface member; and

said interface member to be positioned to center and/or align said guide wire, said interface member and/or actuator element in the pulmonary vein (PV) and/or it'"'"'s pulmonary vein ostium (PVO) so that the interface member and/or actuator element is coaxially aligned with the pulmonary vein ostium (PVO) to provide optimal coaxial alignment with the pulmonary vein ostium (PVO).

2. The system of claim 1, wherein said first balloon having a compliance greater than the compliance of the pulmonary vein (PV) and/or the pulmonary vein ostium (PVO) so as to prevent rupture of the pulmonary vein (PV) and/or pulmonary vein ostium (PVO) from the forces exerted by an said first balloon when inflated.

3. The system of claim 1, wherein at least portions of said interface member having a compliance greater than the compliance of the pulmonary vein (PV) and/or pulmonary vein ostium (PVO) so as to prevent rupture of the pulmonary vein (PV) and/or pulmonary vein ostium (PVO) from the forces exerted by said interface member.

4. The system of claim 1, wherein said first balloon adapted to provide an anchoring function to provide leverage to push said interface member against the wall of the atrium for optimum contact to assure success.

5. The system of claim 4, wherein said anchoring function is enabled by surface area and/or hydrostatic forces.

6. The system of claim 4, wherein said anchoring function is enabled by pressure.

7. The system of claim 4, wherein said first balloon is comprised of a material that will be non-covalently chemically attractive to the endothelia surface.

8. The system of claim 1, wherein the material of said first balloon may provide for hydrophilic interaction, hydrostatic forces, hydrophobic interaction and/or molecular flash atomic polaric forces.

9. The system of claim 1, wherein said ablation element is a ring or circuit.

10. The system of claim 1, wherein said first balloon may be have a shape or inflated to a shape that may be contoured in any desired/required shape in the longitudinal (x-plane) or radial direction (y and z planes) or combination thereof to provide the entire geometric spectrum of potential shapes in the x, y and z planes.

11. The system of claim 1, wherein said first balloon having a portion that is non-compliant.

12. The system of claim 11, wherein said non-compliant portion comprising at least one of:

rib-like structure, ring-like structure, doughnut-like structure, or rim-like structure when inflated.

13. The system of claim 11, wherein said non-compliant portion serves to improve the centering and/or aligning of the guide wire in the pulmonary vein (PV) and/or its pulmonary vein ostium (PVO) so that said interface member is coaxially aligned with the pulmonary vein ostium (PVO) to provide optimal coaxial alignment with the pulmonary vein ostium (PVO).

14. The system of claim 11, wherein said non-compliant portion is sized to a radius of the sized to a radius of the of the pulmonary vein ostium (PVO) minus a clearance distance as required or desired.

15. The system of claim 14, wherein said non-compliant portion is sized according to anatomical and procedural requirements.

16. The system of claim 11, wherein said non-compliant portion is integral, removably coupled, or fixed together with the remaining portion of said first balloon that is not said non-compliant portion of said first balloon.

17. The system of claim 11, wherein said non-compliant portion may be part of the inflation material of said first balloon or may not be part of the inflation function of said first balloon.

18. The system of claim 11, wherein said non-compliant portion being located on the proximal portion said first balloon.

19. The system of claim 11, wherein said wherein said non-compliant portion being a spiral structure, x-shapcd structure, zigzag structure, or grid-like structure.

20. The system of claim 1, further comprising a non-traumatic tip compartment, said non-traumatic compartment disposed at or proximal to said distal wire tip.

21. The system of claim 20, wherein said non-traumatic compartment comprises an inflatable balloon or compartment, as well as a J-tip, non-traumatic tip, or other type of non-traumatic tip.

22. The system of claim 20, wherein said first balloon and/or non-traumatic tip compartment may have at least one the following shapes:

olive, bulbous, rounded, spherical, hemispherical, conical, oval, tapered, beveled, chamfered, graduated and/or multi-faceted, or any combination thereof.

23. The system of claim 20, wherein said first balloon and/or non-traumatic tip compartment may have has at least one the following shapes:

semi-elliptical, semi-spherical, hemispherical, semi-oval, partly rounded or partly olive, or any combination thereof.

24. The system of claim 20, wherein said first balloon and/or non-traumatic tip compartment may have a size that is manipulated by varying the compliance of the material and inflation pressure.

25. The system of claim 1, and wherein a segment of said distal portion of said guide wire that is located distally beyond said interface member provides a distal extension.

26. The system of claim 1, wherein said actuator element delivers an energy source to the intended region of tissue.

27. The system of claim 26, wherein said energy source creates an ablated region or portion that circumscribes the PV and/or PVO as desired or required.

28. The system of claim 27, wherein the difference between radius of the actuator element, designated as ‘

RAE,’ and

the radius of the PVO, designated as ‘

RPVO,’

equals the distance as ‘

d’

defining the ablation region.

29. The system of claim 1, wherein a lumen of said guide wire may be utilized for accommodating a communication channel or wire for delivering energy from an ablation actuator to the ablation element of said interface member.

30. The system of claim 1, wherein a lumen of said guide wire may be utilized for inflating said first balloon or delivering inert gas, radiographic contrast, or fluid.

31. The system of claim 1, wherein said guide wire implements a multi-lumen guide wire structure.

32. The system of claim 1, wherein said interface member comprises a plurality of panels folded or collapsed over causing said interface member to be in a deflated or restricted state and unfolded or un-collapsed causing said interface member to be in an inflated or expanded state.

33. The system of claim 32, wherein said plurality of panels may be individual segments or one continuous surface.

34. The system of claim 32, wherein said interface member in said inflated or expanded state has shape comprising:

bell-shaped, olive shaped, hemispherical shaped, ellipsoid shaped or multifaceted shaped, cone shaped, or oval shaped.

35. The system of claim 32, wherein said interface member in said inflated or expanded state has its wall that that may be angled a variety of degrees relative to the longitudinal axis of said guide wire at the location of said interface member to accommodate successful ablation of the tissue region.

36. The system of claim 35, wherein said actuator element has a circuit that runs along the longitudinal axis and radially across to the rim of said interface member.

37. The system of claim 35, wherein said actuator element has a circuit that runs along the wall of said interface member toward the rim of said interface member.

38. The system of claim 35, wherein said actuator element has a circuit that is wireless or hard wired.

39. The system of claim 32, wherein said interface member may be compressible to pass-through a sheath to pass through a sheath in a compressed state and expandable after it passes through the sheath.

40. The system of claim 1, further comprising:

a delivery catheter comprising a shaft having a proximal portion and a distal portion;

said delivery catheter travels coaxially through said guide catheter, said guide wire travels coaxially through said delivery catheter;

a proximal hub slidably disposed on said delivery catheter at distal portion of said delivery catheter, said proximal hub having a plurality of proximal spokes attached to said proximal hub; and

a distal huh slidably disposed on said delivery catheter and in contact with said proximal hub, said distal hub having a plurality of distal spokes attached to said distal huh;

wherein when a force is applied in a distal direction to said proximal hub;

said proximal hub is pushed as close to the distal hub as possible, or as desired, thereby causing the proximal and distal set of spokes to be deployed and flare outward relative to the longitudinal axis of said proximal hub and distal hub, and

wherein when a force is applied in a proximal direction to said proximal hub;

said proximal hub pulled away or slid away from said distal hub as much as possible, or as desired, thereby causing the proximal and distal set of spokes to be in a to collapse in a non-deployed state.

41. The system of claim 40, wherein said ablation element may be folded, collapsed, or arranged on the under side of the proximal spokes and/or distal spokes.

42. The system of claim 41, wherein while said proximal and distal spokes are in a collapsed state the ablation element wire may be folded in an accordion-like manner and will not be visible.

43. The system of claim 41, wherein while said proximal and distal spokes are in the deployed or flared state the ablation element wire is caused to unfold or release to form a ring or rim;

and while said ablation element is energized said actuator element ablates the tissue region.

44. The system of claim 1, wherein said actuator element and said interface member circumscribes said guide wire.

45. A tissue ablation system for treating atrial arrhythmia by ablating a circumferential region of tissue at a location where a pulmonary vein (PV) extends from an atrium of a heart of a subject, said system comprising:

a guide catheter comprising a shaft having a proximal portion and a distal portion;

a guide wire disposed in said guide catheter shaft having a proximal portion, distal portion and distal tip, said guide wire adapted to travel through said guide catheter to be inserted into the atrium;

an interface member disposed on said guide wire;

a first balloon disposed on said guidewire distally beyond said interface member, said first balloon comprises distal end, distal portion, proximal end and proximal portion;

a non-compliance portion being located on said proximal portion of said first balloon, said proximal portion having a desired/required radius that may vary along its continuum;

said non-compliance portion is adapted to center or align said guide wire in the pulmonary vein (PV) and/or its pulmonary vein ostium (PVO) so that the interface member is coaxially aligned with the pulmonary vein ostium (PVO) to provide optimal coaxial alignment with the pulmonary vein ostium (PVO); and

an actuator element disposed on said interface member.

46. The system of claim 45, wherein said interface member to be positioned to center and/or align said guide wire, said interface member and/or actuator element in the pulmonary vein (PV) and/or it'"'"'s pulmonary vein ostium (PVO) so that the interface member and/or actuator element is coaxially aligned with the pulmonary vein ostium (PVO) to provide optimal coaxial alignment with the pulmonary vein ostium (PVO).

47. The system of claim 45, wherein the non-compliance portion can be a variety of lengths extending from or proximity thereto the proximal end of said first balloon as desired, or required being “

x”

distance distal from said proximal end of said first balloon.

48. The system of claim 45, wherein said non-compliance portion may have a shape or inflated to a shape that may be contoured in any desired/required shape in the longitudinal (x-plane) or radial direction (y and z planes) or combination thereof to provide the entire geometric spectrum of potential shapes in the x, y and z planes.

49. The system of claim 45, wherein said non-compliance portion may have at least one the following shapes:

olive, bulbous, rounded, spherical, hemispherical, conical, oval, tapered, beveled, chamfered, graduated and/or multi-faceted, or any combination thereof.

50. The system of claim 45, wherein said non-compliance portion may have has at least one the following shapes:

semi-elliptical, semi-spherical, hemispherical, semi-oval, partly rounded or partly olive, or any combination thereof.

51. The system of claim 45, wherein at least a portion other than said non-compliant portion is designated as high compliance portion;

and

said high compliance portion having compliance greater than said non-compliance portion so as to prevent rupture of the pulmonary vein (PV) and/or pulmonary vein ostium (PVO) from the forces exerted by said first balloon when inflated.

52. The system of claim 51, wherein a wall of said high compliance portion of said first balloon provides an anchoring function.

53. The system of claim 52, wherein said anchoring function is enabled by surface area and/or hydrostatic forces.

54. The system of claim 52, wherein said anchoring function is enabled by pressure.

55. The system of claim 52, wherein said wall of said high compliance portion comprises of a material that will be non-covalently chemically attractive to the endothelia surface.

56. The system of claim 52, wherein the wall of said high compliance portion comprises of a material that provides for hydrophilic interaction, hydrostatic forces, hydrophobic interaction and/or molecular flash atomic polaric forces.

57. The system of claim 45, wherein said first balloon 31 is positioned and inflated/expanded enabling said actuator element 61 to create a coaxial alignment with the pulmonary vein (PV) and/or pulmonary vein ostium (PVO) enabling a symmetric ablation region of the tissue of the pulmonary vein (PV) and/or pulmonary vein ostium (PVO).

58. The system of claim 57, wherein the radial distance from the actuator element radial to the pulmonary vein ostium (PVO) does not vary.

59. The system of claim 57, wherein an ablated region or portion of the tissue is created that circumscribes the PV and/or PVO as desired or required.

60. The system of claim 57, wherein the maximal diameter of the radius of the non-conformance portion of said first balloon is equal to the diameter of the radius of the PV minus ‘

y’

or ‘

z’

, wherein ‘

y’

or ‘

z’

is in the radial direction.

61. The system of claim 45, wherein at least a portion of said proximal portion of said first balloon comprises a neck or flair.

62. The system of claim 45, wherein said actuator element and said interface member circumscribes said guide wire.