Deflectable sheath catheters

• US 8,267,932 B2
• Filed: 05/02/2011
• Issued: 09/18/2012
• Est. Priority Date: 07/14/1999
• Status: Expired due to Term

• Current Assignee: Cardiofocus Incorporated
• Original Assignee: Cardiofocus Incorporated
• Inventors: Baxter, Lincoln S., Arnold, Jeffrey M., Melsky, Gerald
• Primary Examiner(s): FARAH, AHMED M
• Application Number:
  US13/099,105
• Publication Number:
  US 20110245828A1
• Time in Patent Office: 505 Days
• Field of Search: 606/34, 606/37, 606/40, 606/41, 606/45, 606 47- 50, 607/96, 607/101, 607/102, 607/116, 607/119, 607/122
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• 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 2018/0097 Cleaning probe surfaces
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61B 2018/2266 with a lens, e.g. ball tipped
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: C08L 27/12 containing fluorine atoms

Abstract

The present invention provides devices and methods for the treatment of atrial fibrillation. In one embodiment a deflectable sheath catheter includes an elongate catheter body having proximal and distal ends, the distal end having a distal tip region that includes a plurality of flexible segments with varying degrees of stiffness. A handle portion can be located at the proximal end of the catheter body to provide a steering mechanism that causes the distal tip region to deflect according to a compound curve.

Claims

1. A cardiac ablation instrument assembly comprising:

a deflectable first catheter adapted for disposition within a heart having at least one lumen therein extending from a proximal end to a distal end, the catheter having a deflectable end section formed of a plurality of flexible polymeric segments, at least one polymeric segment having a different stiffness as compared to another polymeric segment of the deflectable end section thereby allowing the deflectable end section to form a compound curve upon deployment and deflection within the heart;

an elongate second catheter for disposition within a heart;

an expandable balloon member having a wall coupled to the elongate second catheter and sized for positioning proximate to a pulmonary vein;

a radio-frequency (RF) ablation element within the balloon member for creating at least one lesion proximate the pulmonary vein by being configured to convey a sufficient amount of energy through the balloon wall to create the at least one lesion; and

wherein the lumen is sized and configured to allow passage of the elongate second catheter, the balloon member, and the ablation element contained within the balloon member.

2. The assembly of claim 1, wherein the stiffness of a distal section of the first catheter decreases in a distal direction along at least a portion of the distal section.

3. The assembly of claim 1, wherein the polymeric segments comprise Pbax polymer.

4. The assembly of claim 1, wherein the elongate second catheter comprises at least one braided wire reinforcement layer.

5. The assembly of claim 4, wherein the elongate second catheter comprises at least one braided wire cladding surrounding at least a portion of the second catheter'"'"'s length.

6. The assembly of claim 4, wherein the reinforcement layer is continuous.

7. The assembly of claim 4, wherein the reinforcement layer is discontinuous.

8. The assembly of claim 4, wherein the reinforcement layer is varied to provide segments of different stiffness.

9. The assembly of claim 1, further comprising an actuator that effects deflection of the deflectable end section.

10. The assembly of claim 9, wherein the actuator further comprises a lock to fix the deflectable end section in a particular curve within its range of movement.

11. The assembly of claim 10, wherein the actuator further comprises a pull wire mechanically linking the deflectable end section to a proximal handle portion.

12. The assembly of claim 1, wherein the stiffness of the plurality of segments varies progressively over at least a portion of the deflectable end section.

13. The assembly of claim 1, wherein the deflectable end section includes at least one irrigation port.

14. The assembly of claim 1, wherein the deflectable end section includes at least one radiopaque band.

15. The assembly of claim 1, wherein the proximal end of the deflectable first catheter comprises a handle.

16. The assembly of claim 15, wherein the handle comprises at least one hemostasis valve.

17. The assembly of claim 1, wherein the deflectable end section further comprises a distal tip that is bent out of a plane of deflection.

18. The assembly of claim 1, wherein the deflectable end section has a distal taper.

19. The assembly of claim 1, wherein the RF ablation element comprises one or more conductive region(s).

20. A cardiac energy delivery instrument assembly comprising:

a deflectable first catheter adapted for disposition within a heart having at least one lumen therein extending from a proximal end to a distal end, the catheter having a deflectable end section formed of a plurality of flexible polymeric segments, at least one polymeric segment having a different stiffness as compared to another polymeric segment of the deflectable end section thereby allowing the deflectable end section to form a compound curve upon deployment and deflection within the heart;

an elongate second catheter for disposition within a heart;

an expandable balloon member having a wall coupled to the elongate second catheter and sized for positioning proximate to a pulmonary vein;

a radio-frequency (RF) energy delivery element within the balloon member for conveying energy through the balloon wall; and

wherein the lumen is sized and configured to allow passage of the elongate second catheter, the balloon member, and the energy delivery element contained within the balloon member.

21. The assembly of claim 20, further comprising an actuator that effects deflection of the deflectable end section, the actuator comprising a pull wire mechanically linking the deflectable end section to a proximal handle portion and a lock to fix the deflectable end section in a particular curve within its range of movement.

22. The assembly of claim 21, wherein the stiffness of a distal section of the first catheter decreases in a distal direction along at least a portion of the distal section.

23. The assembly of claim 21, wherein the elongate second catheter comprises at least one braided wire reinforcement layer.

24. The assembly of claim 21, wherein the reinforcement layer is varied to provide segments of different stiffness.

25. The assembly of claim 23, wherein the RF energy delivery element comprises one or more conductive region(s).