Preshaped ablation catheter for ablating pulmonary vein ostia within the heart

• US 20060095030A1
• Filed: 11/04/2004
• Published: 05/04/2006
• Est. Priority Date: 11/04/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Avitall, Boaz, Koblish, Joe
• Granted Patent: US 8,409,191 B2
• Time in Patent Office: Days
• 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 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: C08L 2201/12 Shape memory

Abstract

Catheters and methods are provided for performing medical procedures, such as tissue ablation, adjacent the ostia of anatomical vessels, such as pulmonary veins. The catheter comprises an elongated flexible integrated catheter body having proximal and distal shaft portions and at least one operative element carried by the distal shaft portion. The distal shaft portion has a proximal section configured to be internally actuated (e.g., using a steering mechanism or pre-shaping the proximal section) to form a simple curve with an apex that can be inserted into the vessel ostium, an intermediate section pre-shaped to form a curve that bends opposite the simple curve, and a distal section configured to be placed into a non-radial relationship (tangential or oblique) with the vessel ostium when the apex of the simple curve is inserted into the vessel ostium. By this arrangement, the operative element is configured to be placed firmly in contact with tissue at a predefined radial location relative to the vessel ostium when the apex of the simple curve is inserted into the vessel ostium.

Claims

1. A catheter, comprising:

an elongated flexible integrated catheter body including;

a proximal shaft portion having a longitudinal axis,

a distal shaft portion having a proximal section configured to be internally actuated from a straight geometry to a simple curve that bends more than 70 degrees, an intermediate section pre-shaped to form a complex curve that bends in a direction opposite to and out-of-plane with the simple curve, and a distal section;

at least one operative element carried by the distal section.

2. The catheter of claim 1, wherein the at least one operative element comprises a tissue ablative element.

3. The catheter of claim 2, wherein the ablative element is a linear tissue ablative element.

4. The catheter of claim 1, wherein the at least one operative element comprises a diagnostic element.

5. The catheter of claim 1, further comprising a steering mechanism operable to internally actuate the proximal section to form the simple curve.

6. The catheter of claim 1, wherein the proximal section is pre-shaped to form the simple curve in the absence of an external force.

7. The catheter of claim 1, wherein the simple curve is eccentric and has a radius of curvature that is smallest at an apex of the simple curve.

8. The catheter of claim 1, wherein the simple curve bends more than 90°

.

9. The catheter of claim 1, wherein the simple curve bends more than 135°

.

10. The catheter of claim 1, wherein the simple curve bends less than 180°

.

11. The catheter of claim 1, wherein the proximal section is radio-opaque.

12. The catheter of claim 1, wherein the complex curve has a proximal curve that, when projected onto a plane of the simple curve, bends at least 90°

.

13. The catheter of claim 1, wherein the complex curve has a proximal curve that, when projected onto a plane of the simple curve, bends in the range of 90°

to 135°

.

14. The catheter of claim 1, wherein the complex curve has a distal curve that, when projected onto a plane perpendicular to the longitudinal axis, bends in the range of 60°

to 120°

.

15. The catheter of claim 1, wherein the complex curve has a distal curve that, when projected onto a plane perpendicular to the longitudinal axis, bends approximately 90°

.

16. The catheter of claim 1, wherein the distal section forms a distal tip of the catheter body.

17. The catheter of claim 1, wherein the distal section is substantially straight.

18. The catheter of claim 1, wherein the distal section is pre-shaped to form a simple curve having an apex that points away from a longitudinal axis of the proximal shaft portion.

19. The catheter of claim 1, wherein the smallest radius of curvature of the simple curve is within the range of 1.25 to 2.50 centimeters, and the smallest radius of curvature of the complex curve is within the range of 1.25 to 3.75 centimeters.

20. The catheter of claim 1, wherein the proximal section has a length within the range of 2.50 to 6.50 centimeters, the intermediate section has a length within the range of 0.50 to 2.00 centimeters, and distal section has a length within the range of 0.50 to 2.00 centimeters.

21. The catheter of claim 1, wherein the distal shaft portion includes a substantially straight shaft transition section between the proximal shaft portion and the proximal section of the distal shaft portion.

22. The catheter of claim 21, wherein the proximal shaft portion and the shaft transition section are collinear.

23. A method of performing a medical procedure adjacent an ostium of a vessel using the catheter of claim 1, comprising:

inserting an apex of the simple curve into the vessel ostium to place the at least one operative element in contact with a first tissue site adjacent the vessel ostium; and

performing the medical procedure on the first tissue site with the at least one operative element.

24. The method of claim 23, further comprising:

rotating the simple curve within the vessel ostium about the apex to place the operative element in contact with a second tissue site adjacent the vessel ostium; and

performing the medical procedure on the second tissue site with the at least one operative element.

25. The method of claim 23, wherein the at least one operative element comprises an ablative element, and performing the medical procedure comprises forming a lesion at the first tissue site with the ablative element.

26. A catheter, comprising:

an elongated flexible integrated catheter body including;

a proximal shaft portion having a longitudinal axis,

a distal shaft portion having a proximal section configured to be internally actuated to form a simple curve with an apex that can be inserted into an ostium of an anatomical vessel, an intermediate section pre-shaped to form a curve that bends opposite the simple curve, and a distal section configured to be placed into a non-radial relationship with the vessel ostium when the apex of the simple curve is inserted into the vessel ostium; and

at least one operative element carried by the distal section, and configured to be placed firmly in contact with tissue adjacent the vessel ostium when the apex of the simple curve is inserted into the vessel ostium.

27. The catheter of claim 26, wherein the at least one operative element comprises a tissue ablative element.

28. The catheter of claim 27, wherein the ablative element is a linear or curvilinear tissue ablative element.

29. The catheter of claim 26, wherein the at least one operative element comprises a diagnostic element.

30. The catheter of claim 26, further comprising a steering mechanism operable to internally actuate the proximal section to form the simple curve.

31. The catheter of claim 26, wherein the proximal section is pre-shaped to form the simple curve in the absence of an external force.

32. The catheter of claim 26, wherein the proximal section is radio-opaque.

33. The catheter of claim 26, wherein the distal section forms a distal tip of the catheter body.

34. The catheter of claim 26, wherein the non-radial relationship is a substantially tangential relationship.

35. The catheter of claim 26, wherein the non-radial relationship is an oblique relationship that falls within the range of −

30° and

30°

from the tangent.

36. The catheter of claim 26, wherein the vessel is a pulmonary vein in an adult human.

37. A method of performing a medical procedure adjacent an ostium of a vessel using the catheter of claim 26, comprising:

inserting the apex of the simple curve into the vessel ostium of a vessel to place the at least one operative element in contact with a first tissue site adjacent the vessel ostium; and

performing the medical procedure on the first tissue site with the at least one operative element.

38. The method of claim 37, further comprising:

rotating the curve within the vessel ostium about the apex to place the operative element in contact with a second tissue site adjacent the vessel ostium; and

performing the medical procedure on the second tissue site with the at least one operative element.

39. The method of claim 37, wherein the at least one operative element comprises an ablative element, and performing the medical procedure comprises forming a lesion at the first tissue site with the ablative element.

40-58. -58. (canceled)