Low profile delivery system for transcatheter heart valve

• US 10,456,253 B2
• Filed: 06/10/2015
• Issued: 10/29/2019
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Le, Thanh Huy, Tran, Tri D., Cayabyab, Ronaldo C., Taylor, David M., Vidal, Antonio O., Bowes, Robert
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US14/736,117
• Publication Number:
  US 20150272733A1
• Time in Patent Office: 1,602 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• 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 25/1011 Multiple balloon catheters

Abstract

A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus.

Claims

1. An apparatus for delivering a prosthetic valve through the vasculature of a patient comprising:

a steerable guide catheter having a handle portion and an elongated guide tube extending from the handle portion, the elongated guide tube having a distal end portion comprising a steerable section, the guide catheter further comprising a first adjustment mechanism on the handle portion and a pull wire operatively connecting the first adjustment mechanism to the steerable section for changing the curvature of the steerable section via manual adjustment of the first adjustment mechanism, the guide catheter further comprising a second adjustment mechanism coupled to the handle portion; and

a balloon catheter sized to slidably extend through the guide catheter, the balloon catheter comprising an elongated shaft extending coaxially through the guide tube and the handle portion, the shaft comprising a proximal end portion and a distal end portion, the balloon catheter further comprising an inflatable balloon mounted on the distal end portion of the shaft;

wherein the second adjustment mechanism comprises a rotatable component, wherein rotation of the rotatable component causes the shaft of the balloon catheter and the inflatable balloon to move longitudinally relative to the guide tube and the handle portion while the guide tube remains stationary upon rotation of the rotatable component;

wherein the second adjustment mechanism comprises a securement mechanism configured to selectively retain the shaft of the balloon catheter to prevent longitudinal sliding movement of the shaft relative to the second adjustment mechanism and release the shaft to permit longitudinal sliding movement of the shaft relative to the second adjustment mechanism and the guide tube without rotation of the rotatable component of the second adjustment mechanism.

2. The apparatus of claim 1, wherein the first adjustment mechanism comprises a rotatable knob that is rotatable about a longitudinal axis of the shaft of the balloon catheter, wherein rotation of the rotatable knob is effective to increase and decrease tension in the pull wire to change the curvature of the steerable section.

3. The apparatus of claim 1, wherein the guide catheter further comprises a flex indicator that moves relative to the handle portion upon manual adjustment of the first adjustment mechanism.

4. The apparatus of claim 3, wherein the handle portion comprises visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

5. The apparatus of claim 3, wherein:

the first adjustment mechanism comprises a rotatable knob that is rotatable about a longitudinal axis of the shaft of the balloon catheter, wherein rotation of the rotatable knob is effective to increase and decrease tension in the pull wire to change the curvature of the steerable section; and

the flex indicator moves proximally and distally within the handle upon rotation of the rotatable knob.

6. A method of implanting a prosthetic valve within a native aortic valve, comprising:

providing an apparatus as claimed in claim 1 and a prosthetic valve crimped coaxially on the shaft of the balloon catheter proximal to the balloon;

inserting the prosthetic valve and the distal end portions of the balloon catheter shaft and the guide tube into the vasculature of a patient;

after the prosthetic valve has been inserted into the vasculature, moving the balloon catheter shaft relative to the guide tube to position the balloon within the prosthetic valve.

7. The method of claim 6, further comprising:

after moving the balloon catheter shaft relative to the guide tube to position the balloon within the prosthetic valve, positioning the prosthetic valve within the native aortic valve; and

inflating the balloon to radially expand the prosthetic valve to a deployed configuration.

8. The method of claim 6, wherein the distal end portion of the guide tube comprises a flared end that contacts an adjacent end of the crimped prosthetic valve when the balloon catheter shaft is moved relative to the guide tube.

9. The method of claim 6, further comprising adjusting the first adjustment mechanism to change the curvature of the steerable section as the steerable section is advanced through the aortic arch.

10. An apparatus for delivering a prosthetic valve through the vasculature of a patient comprising:

a steerable guide catheter having a handle portion and an elongated guide tube extending from the handle portion, the elongated guide tube having a distal end portion comprising a steerable section, the guide catheter further comprising a rotatable adjustment knob on the handle portion and a pull wire operatively connecting the adjustment knob to the steerable section for changing the curvature of the steerable section via manual adjustment of the adjustment knob; and

a balloon catheter comprising an elongated shaft extending coaxially through the guide tube, the shaft comprising a proximal end portion and a distal end portion, the balloon catheter further comprising an inflatable balloon mounted on the distal end portion of the shaft;

wherein the guide catheter further comprises a flex indicator that moves relative to the handle portion upon manual adjustment of the adjustment knob;

wherein the rotatable knob is rotatable about a longitudinal axis of the shaft of the balloon catheter, wherein rotation of the rotatable knob is effective to increase and decrease tension in the pull wire to change the curvature of the steerable section; and

the flex indicator moves proximally and distally within the handle portion upon rotation of the rotatable knob.

11. The apparatus of claim 10, wherein the handle portion comprises visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

12. The apparatus of claim 10, wherein the flex indicator comprises a pin that moves proximally and distally within the handle portion upon rotation of the rotatable knob.