Steerable Catheter and Dilator and System and Method for Implanting a Heart Implant

• US 20100022948A1
• Filed: 07/28/2009
• Published: 01/28/2010
• Est. Priority Date: 06/13/2008
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: St. John, Robert J., Conley, Eric W., Wilson, Jonathan E.
• Granted Patent: US 8,591,460 B2
• Time in Patent Office: Days
• US Class Current: 604/95.40
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A catheter according to one embodiment may be configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle. The catheter may comprise a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator, a first steerable actuator coupled to the shaft at a position on the shaft substantially corresponding to the annulus of the mitral valve when the distal end of the shaft is disposed within the left ventricle, and a handle assembly coupled to a proximal end of the shaft. The handle assembly may comprise a first actuator coupled to the first steerable actuator. The first actuator may be configured to apply a force to the first steerable actuator to deflect the shaft about a region proximate to the first steerable actuator.

Claims

1. A catheter configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle, said catheter comprising:

a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator;

a first steerable actuator coupled to said shaft at a position on said shaft substantially corresponding to said transseptal puncture site when a distal end of said shaft is disposed within said left ventricle; and

a handle assembly coupled to a proximal end of said shaft, said handle assembly comprising a first actuator coupled to said first steerable actuator, said first actuator configured to apply a force to said first steerable actuator to deflect said shaft about a region proximate to said first steerable actuator.

2. The catheter of claim 1, wherein said first actuator coupled to said shaft at said position corresponding to 1.5-4 inches from said distal end.

3. The catheter of claim 2, wherein said position corresponds to 3 inches from said distal end.

4. The catheter of claim 1, wherein said first steerable actuator comprises a first pull ring coupled to said shaft.

5. The catheter of claim 4, wherein said first actuator is coupled to said first pull ring shaft with at least a first wire.

6. The catheter of claim 5, wherein said first wire is disposed within a second lumen of said shaft.

7. The catheter of claim 1, wherein said first steerable actuator is configured to deflect said shaft to form a first curve up to 180 degrees.

8. The catheter of claim 7, wherein said first curve of said shaft comprises a radius of between 1.0 inches and 2.0 inches.

9. The catheter of claim 8, wherein said first curve of said shaft comprises a radius of between 1.25 inches and 1.75 inches.

10. The catheter of claim 1, further comprising at least a second steerable actuator coupled to said shaft proximate said distal end of said shaft.

11. The implant of claim 10, wherein said second steerable actuator comprises a second pull ring coupled to said shaft.

12. The catheter of claim 11, wherein said second steerable device is coupled to a second actuator disposed in said handle assembly, said second actuator configured to apply a force to said second actuator to deflect said shaft about a region between said first steerable actuator and said second steerable actuator.

13. The catheter of claim 12, wherein said second steerable actuator comprises a second pull ring.

14. The catheter of claim 13, wherein said second actuator is coupled to said second pull ring shaft with at least a second wire.

15. The catheter of claim 12, wherein said second steerable actuator is configured to deflect said shaft to form a second curve up to 180 degrees.

16. The catheter of claim 15, wherein said second curve of said shaft comprises a radius of between 1.0 inches and 2.0 inches.

17. The catheter of claim 16, wherein said second curve of said shaft comprises a radius of between 1.25 inches and 1.75 inches.

18. The catheter of claim 1, wherein said shaft comprises a plurality of segments, each segment having a different stiffness compared to adjacent segments.

19. The catheter of claim 18, wherein said plurality of segments comprises a first segment disposed proximate said distal end of said shaft, a second segment disposed adjacent to said first segment, and a third segment extend from said proximal end to said second segment, wherein said first segment is the lowest stiffness and said third segment is the highest stiffness of said plurality of segments.

20. The catheter of claim 19, wherein said first segment is 8 inches long and said second segment is 2.5 inches long.

21. The catheter of claim 19, wherein said first segment has a durometer of 25 D, said second segment has a durometer of 40 D, and said third segment has a durometer of 72 D.

22. The catheter of claim 1, wherein said shaft comprises a first section disposed proximate said distal end configured to provide kink resistance when deflecting said first section, a second section extending from said first section towards said handle assembly configured to provide kink resistance when deflecting said second section and a third section extending from a proximal end of said second spiral reinforced section to the handle assembly configured to increase the pushability and torsional strength of the shaft while reducing and/or minimizing kinking.

23. The catheter of claim 22, wherein first section comprises a spiral reinforced section.

24. The catheter of claim 23, wherein said first section comprises a length of 1-3 inches.

25. The catheter of claim 22, wherein said second section comprises a spiral reinforced section

26. The catheter of claim 25, wherein said second section comprises a length of 7.5 inches.

27. The catheter of claim 22, wherein said third section comprises a braided reinforced section.

28. The catheter of claim 1, further comprising a dilator configured to be received within said lumen of said shaft.

29. The catheter of claim 1, further comprising an implant configured to be received within said lumen of said shaft.