Preshaped localization catheter, system, and method for graphically reconstructing pulmonary vein ostia

• US 20060253116A1
• Filed: 05/05/2006
• Published: 11/09/2006
• Est. Priority Date: 05/05/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Koblish, Josef V., Avitall, Boaz
• Granted Patent: US 8,535,303 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 2017/003 Steerable
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 6/06 Diaphragms
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• 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

Abstract

Catheters, systems, 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 catheter body, which includes a proximal shaft portion and a distal shaft portion, and a tracking element carried by the distal shaft portion. The proximal section is pre-shaped to form a curve having an apex sized to be inserted into the vessel ostium, and a distal section configured to contact the adjacent tissue when the curve apex is inserted within the vessel ostium. The method may comprise inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent the vessel ostium, and determining a location of the tracking element(s) within a coordinate system while the distal section is in contact with the first tissue site.

Claims

1. A catheter for performing a medical procedure on tissue adjacent an ostium of an anatomical vessel, comprising:

an elongated flexible catheter body including a proximal shaft portion and a distal shaft portion having a proximal section pre-shaped to form a curve having an apex sized to be inserted into the vessel ostium, and a distal section configured to contact with the adjacent tissue when the curve apex is inserted within the vessel ostium; and

at least one tracking element carried by the distal shaft portion.

2. The catheter of claim 1, wherein the distal section is configured to be placed into a non-radial relationship with the vessel ostium when the curve apex is inserted into the vessel ostium.

3. The catheter of claim 1, wherein the distal shaft portion further has a medial section pre-shaped to form another curve that bends in a direction opposite to the curve.

4. The catheter of claim 3, wherein the curve is a simple curve, and the other curve is a complex curve that bends in a direction opposite to and out-of-plane with the simple curve.

5. The catheter of claim 4, wherein the at least one tracking element comprises at least three tracking elements, a first of which is carried by the proximal section, a second of which is carried by the medial section, and a third of which is carried by the distal section.

6. A catheter system for performing a medical procedure on tissue adjacent an ostium of an anatomical vessel, comprising:

the catheter of claim 1;

and

a catheter navigation subsystem configured for determining locations of the at least one tracking element within a coordinate system.

7. The catheter system of claim 6, wherein the catheter navigation subsystem is a graphical navigation subsystem configured for graphically reconstructing the vessel ostium based on the determined locations of at least one tracking element.

8. The catheter system of claim 6, wherein the catheter comprises a therapeutic or diagnostic element carried by the distal section, and the catheter navigation subsystem is configured for determining a location of the diagnostic or therapeutic element based on the determined location of the at least one tracking element.

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

inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent the vessel ostium; and

determining a location of the at least one tracking element within a coordinate system while the distal section is in contact with the first tissue site.

10. The method of claim 7, further comprising:

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

determining another location of the at least one tracking element within the coordinate system while the distal section is in contact with the second tissue site.

11. A method of performing a medical procedure adjacent an anatomical vessel using a catheter having a proximal section and a distal section, comprising:

forming the proximal section into a curve having an apex;

inserting the curve apex into the vessel ostium to place the distal section in contact with a first tissue site adjacent an ostium of the vessel; and

determining a location of the distal section within a coordinate system while contacting the first tissue site.

12. The method of claim 11, further comprising:

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

determining another location of the distal section within the coordinate system while contacting the second tissue site.

13. The method of claim 11, wherein the distal section is placed into a non-radial relationship with the vessel ostium when the curve apex is inserted into the vessel ostium.

14. The method of claim 11, wherein the distal shaft portion further has a medial section, the method further comprising forming the medial section into another curve that bends in a direction opposite the curve.

15. The method of claim 14, wherein the curve is a simple curve, and the other curve is a complex curve that bends in a direction opposite to and out-of-plane with the simple curve.

16. The method of claim 11, wherein the catheter carries at least one tracking element, and the location determination comprises transmitting signals to or from the tracking element.

17. The method of claim 11, further comprising graphically reconstructing the vessel ostium based on the determined location of the distal section.

18. The method of claim 11, wherein the catheter comprises a therapeutic or diagnostic element carried by the distal section, and the method further comprises determining a location of the diagnostic or therapeutic element based on the determined location of the distal section.

19. The method of claim 18, wherein the therapeutic or diagnostic element comprises a tissue ablative element, and the method further comprises delivering ablation energy to the ablative element to create a lesion at the first tissue site.

20. The method of claim 19, further comprising graphically generating a mark representing the lesion at the first tissue site.

21. The method of claim 18, wherein the therapeutic or diagnostic element comprises a tissue mapping element, and the method further comprises receiving mapping signals from the mapping element to create a mapping data point at the first tissue site.

22. The method of claim 11, wherein the proximal section is formed into the curve using a steering mechanism.

23. The method of claim 11, wherein the proximal section is pre-shaped and is formed into the curve by removing a sheath from the proximal section.

24. The method of claim 11, wherein the vessel is a pulmonary vein.