Steerable catheter and dilator and system and method for implanting a heart implant

• US 8,591,460 B2
• Filed: 07/28/2009
• Issued: 11/26/2013
• Est. Priority Date: 06/13/2008
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Wilson, Jonathan E., St. John, Robert J., Conley, Eric W.
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US12/510,929
• Publication Number:
  US 20100022948A1
• Time in Patent Office: 1,582 Days
• Field of Search: 604/95.04, 604/523, 604/528
• US Class Current: 604/95.04
• 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, comprising:

a handle;

a shaft comprising a proximal end and a distal end, said proximal end coupled to said handle; and

first and second steerable actuators coupled to said shaft so as to define a first region between said first steerable actuator and said proximal end, a second region between said first and second steerable actuators, and a third region between said distal end and said second steerable actuator;

wherein;

said handle comprises first and second actuators coupled to said first and second steerable actuators, respectively, said first actuator configured to apply a force to said first actuator and deflect said shaft in said second region, said second actuator configured to apply a force to said second actuator and deflect said shaft in said third region;

said first region comprises a spiral reinforced section extending from said first steerable actuator towards said handle;

said first region further comprises a braided reinforced section extending from a proximal end of said spiral reinforced section towards said handle; and

said first region remains substantially straight during the deflection of one or both of said second and third regions.

2. The catheter of claim 1, wherein:

said shaft further comprises a lumen; and

said catheter further comprises a dilator configured to be received within said lumen.

3. The catheter of claim 1, wherein:

said shaft further comprises a lumen; and

said catheter further comprises an implant configured to be received within said lumen.

4. The catheter of claim 1, wherein said first steerable actuator is configured to deflect said second region of said shaft to form a first curve up to 180 degrees, and said second steerable actuator is configured to deflect said third region of said shaft to form a second curve of up to 180 degrees.

5. The catheter of claim 1, wherein said second actuator comprises a second pull ring coupled to said shaft.

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

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

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

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

10. The catheter of claim 1, wherein said second steerable actuator is configured to deflect said third region of said shaft to form a second curve of up to 180 degrees.

11. The catheter of claim 10, wherein said second curve comprises a radius of between 1.0 inches and 2.0 inches.

12. The catheter of claim 11, wherein said second curve comprises a radius of between 1.25 inches and 1.75 inches.

13. The catheter of claim 1, wherein:

said catheter is configured to extend through a transseptal puncture site, a left atrium, a mitral valve, and into a left ventricle;

said shaft comprises at least one lumen configured to receive at least one of an implant and a dilator; and

said first steerable actuator is coupled to said shaft at a position on said shaft substantially corresponding to said transseptal puncture site when said shaft is disposed through said transseptal puncture site, through said left atrium, and through said mitral valve, such that the distal end of said shaft is disposed within said left ventricle.

14. The catheter of claim 13, wherein said position corresponds to 1.5 to 4 inches from said distal end.

15. The catheter of claim 14, wherein said position corresponds to 3 inches from said distal end.

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

17. The catheter of claim 16, wherein said first actuator is coupled to said first pull ring with at least a first wire.

18. The catheter of claim 17, wherein said shaft comprises a first lumen configured to receive at least one of an implant and a dilator and a second lumen, wherein the first wire is disposed within the second lumen.

19. The catheter of claim 1, wherein:

said first region is adjacent said second region;

said second region is adjacent said first and third regions;

said third region is adjacent said second region;

the first, second and third regions have first, second, and third stiffnesses, respectively; and

the first stiffness differs from the second stiffness, the second stiffness differs from the first stiffness and third stiffness, and the third stiffness differs from the second stiffness.

20. The catheter of claim 19, wherein the third stiffness is lower than the first stiffness and second stiffness, and the third stiffness is higher than the first stiffness and second stiffness.

21. The catheter of claim 20, wherein said third section is 8 inches long and the second section is 2.5 inches long.

22. The catheter of claim 20, wherein said third section has a durometer of 25 D, said second section has a durometer of 40 D, and said first section has a durometer of 72 D.