Low profile delivery system for transcatheter heart valve

• US 10,441,419 B2
• Filed: 11/20/2018
• Issued: 10/15/2019
• 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:
  US16/197,245
• Publication Number:
  US 20190083260A1
• Time in Patent Office: 329 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 method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient'"'"'s vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Claims

1. A method of delivery a prosthetic heart valve comprising:

inserting a delivery apparatus and a prosthetic heart valve into a patient'"'"'s vasculature, wherein the delivery apparatus comprises a steerable guide catheter, a balloon catheter, and a flex indicator, wherein the balloon catheter extends coaxially through the guide catheter, wherein the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and wherein the flex indicator is movably coupled to a handle of the guide catheter;

adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve relative to the patient'"'"'s native aortic valve, wherein adjusting the flexion includes rotating a knob relative to the handle of the guide catheter, wherein the flex indicator moves longitudinally relative to the knob and relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and wherein the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter; and

expanding the prosthetic heart valve into contact with the patient'"'"'s native aortic valve by inflating a balloon member disposed on the distal end portion of the balloon catheter.

2. The method of claim 1, wherein rotating the knob in a first direction relative to the handle of the guide catheter increases the flexion of the steerable section of the guide catheter, and wherein rotating the knob in a second direction relative to the handle of the guide catheter decreases the flexion of the steerable section of the guide catheter.

3. The method of claim 2, wherein the first direction is clockwise, and wherein the second direction is counterclockwise.

4. The method of claim 2, wherein rotating the knob in the first direction relative to the handle of the guide catheter results in the flex indicator moving toward a proximal end portion of the handle, and wherein rotating the knob in the second direction relative to the handle of the guide catheter results in the flex indicator moving toward a distal end portion of the handle.

5. The method of claim 1, wherein the handle of the guide catheter comprises an elongated slot, and wherein the flex indicator moves longitudinally in a direction parallel to a length of the slot when the flexion is adjusted.

6. The method of claim 1, wherein the one or more visual indicators include a first indicator and a second indicator, wherein the first indicator represents a non-flexed configuration of the steerable section, and wherein the second indicator represents a fully flexed configuration of the steerable section.

7. The method of claim 1, wherein adjusting the flexion includes increasing the flexion of the steerable section and decreasing the flexion of the steerable section.

8. A method of delivery a prosthetic heart valve comprising:

inserting a delivery apparatus and a prosthetic heart valve into a patient'"'"'s vasculature, wherein the delivery apparatus comprises a steerable guide catheter, a balloon catheter, and a flex indicator, wherein the balloon catheter extends coaxially through the guide catheter, wherein the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and wherein the flex indicator is movably coupled to a handle of the guide catheter;

adjusting a curvature of a steerable section of the guide catheter as the delivery apparatus and the prosthetic heart valve are advanced through the patient'"'"'s aortic arch, wherein adjusting the curvature includes rotating a knob relative to the handle of the guide catheter, wherein the flex indicator moves longitudinally relative to the knob and relative to the handle of the guide catheter as the curvature of the steerable section is adjusted, and wherein the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of the curvature of the steerable section of the guide catheter;

positioning the prosthetic heart valve within the patient'"'"'s native aortic valve; and

expanding the prosthetic heart valve into contact with the patient'"'"'s native aortic valve by inflating a balloon member disposed on the distal end portion of the balloon catheter.

9. The method of claim 8, wherein rotating the knob in a first direction relative to the handle of the guide catheter increases the curvature of the steerable section of the guide catheter, and wherein rotating the knob in a second direction relative to the handle of the guide catheter decreases the curvature of the steerable section of the guide catheter.

10. The method of claim 9, wherein rotating the knob in the first direction relative to the handle of the guide catheter results in the flex indicator moving toward a proximal end portion of the handle, and wherein rotating the knob in the second direction relative to the handle of the guide catheter results in the flex indicator moving toward a distal end portion of the handle.

11. The method of claim 8, wherein the handle of the guide catheter comprises an elongated slot, and wherein the flex indicator moves longitudinally within the slot when the curvature is adjusted.

12. The method of claim 8, wherein the one or more visual indicators include a first indicator and a second indicator, wherein the first indicator represents a non-curved configuration of the steerable section, and wherein the second indicator represents a curved configuration of the steerable section.

13. The method of claim 8, wherein adjusting the curvature includes increasing the curvature of the steerable section and decreasing the curvature of the steerable section.

14. The method of claim 13, wherein increasing the curvature of the steerable section occurs prior to decreasing the curvature of the steerable section.

15. A method of delivery a prosthetic heart valve comprising:

inserting a delivery apparatus and a prosthetic heart valve into a patient'"'"'s vasculature, wherein the delivery apparatus comprises a steerable guide catheter, a balloon catheter, an adjustment mechanism, and a flex indicator, wherein the balloon catheter extends coaxially through the guide catheter, wherein the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, wherein the adjustment mechanism is movably coupled to a handle of the guide catheter, and wherein the flex indicator is movably coupled to the handle of the guide catheter;

increasing a curvature of a steerable section of the guide catheter to move the prosthetic heart valve relative to the patient'"'"'s native anatomy by actuating an adjustment mechanism of the delivery apparatus, wherein actuating the adjustment mechanism includes rotating a knob of the adjustment mechanism relative to the handle of the guide catheter and relative to the flex indicator; and

decreasing the curvature of a steerable section of the guide catheter to move the prosthetic heart valve relative to the patient'"'"'s native anatomy by further actuating the adjustment mechanism of the delivery apparatus; and

expanding the prosthetic heart valve into contact with the patient'"'"'s native valve by inflating a balloon member of the balloon catheter,

wherein actuating the adjustment mechanism results in the flex indicator moving longitudinally relative to the knob of the adjustment mechanism and relative to one or more visual indicators disposed on the handle adjacent the flex indicator, and wherein a position of the flex indicator relative to the one or more indicators provides a visual indication of an amount of curvature of the steerable section.

16. The method of claim 15, wherein the one or more visual indicators include a first indicator and a second indicator, wherein the first indicator represents a non-curved configuration of the steerable section, and wherein the second indicator represents a curved configuration of the steerable section.