Stability device for use with percutaneous delivery systems

• US 10,327,897 B2
• Filed: 03/30/2016
• Issued: 06/25/2019
• Est. Priority Date: 02/11/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Madrid, Gilbert, Winston, Matthew T., Sok, Sam, Le, Thanh Huy, Tran, Tri D., Le, Kim, Franklin, Michael D.
• Primary Examiner(s): Ton, Martin T
• Application Number:
  US15/085,842
• Publication Number:
  US 20160206425A1
• Time in Patent Office: 1,182 Days
• Field of Search: 604528
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A delivery system for stabilizing a catheter shaft across an aortic arch can include one or more stabilizing members configured to fix or stabilize the position of the catheter relative to the aortic arch of a patient.

Claims

1. A prosthetic heart valve delivery device, comprising:

an elongate catheter tube having a first end portion, a second end portion, a first lumen, a second lumen, and a third lumen, wherein the first lumen is radially centrally disposed, the second lumen is disposed radially outwardly from the first lumen, and the third lumen is disposed radially outwardly from the first lumen and is directly opposed to the second lumen such that a first plane bisecting the second lumen also bisects the third lumen;

an elongate flexible member disposed in the second lumen of the catheter tube; and

an elongate stability member formed of nitinol and disposed in and axially moveable relative to the third lumen of the catheter tube and the flexible member in a direction parallel to a central longitudinal axis of the catheter tube, wherein the stability member comprises a C-shape cross-sectional profile in a second plane perpendicular to the central longitudinal axis of the catheter tube and perpendicular to the first plane, and wherein the stability member is relatively stiffer than the catheter tube and the flexible member.

2. The device of claim 1, wherein the first end portion of the catheter tube is a distal end portion, the second end portion of the catheter tube is a proximal end portion, and the stability member is disposed near the distal end portion of the catheter tube and is axially movable in the third lumen of the catheter tube between a first position and a second position proximal relative to the first position.

3. The device of claim 2, wherein the flexible member and the stability member are configured such that the flexible member and the stability member are axially overlapped relative to each other with the stability member in the first position and are axially offset relative to each other with the stability member in the second position, and wherein the catheter tube is relatively straighter with the stability member in the first position than in the second position.

4. The device of claim 2, wherein the flexible member is fixedly coupled to the distal end portion of the catheter tube.

5. A method of positioning the device of claim 1, comprising:

inserting the first end portion of the delivery device into a patient'"'"'s vasculature;

positioning the stability member in a first position within the third lumen of the catheter tube so that the first end portion of the delivery device is in a first configuration; and

positioning the stability member in a second position within the third lumen of the catheter tube so that the first end portion of the delivery device is in a second configuration,

wherein the first end portion of the delivery device is relatively straighter in the first configuration than in the second configuration.

6. The method of claim 5, further comprising bending the first end of the catheter tube with the flexible member.

7. The method of claim 5, further comprising advancing a prosthetic heart valve through the patient'"'"'s vasculature to the patient'"'"'s native aortic valve using the delivery device.

8. A prosthetic heart valve delivery device, comprising:

an elongate catheter tube having a first end portion, a second end portion, a first lumen, a second lumen, and a third lumen, wherein the first lumen is radially centrally disposed, wherein the second lumen is disposed radially outwardly from the first lumen and has a C-shape cross-sectional profile in a first plane perpendicular to the length of the catheter tube, wherein the third lumen is disposed radially outwardly from the first lumen, and wherein the third lumen is directly opposed to the second lumen such that a second plane perpendicular to the first plane bisects the second lumen and bisects the third lumen;

an elongate stability member disposed in and axially moveable relative to the second lumen of the catheter tube so as to adjust the stiffness of the catheter tube, wherein the stability member has a C-shape cross-sectional profile in the first plane, and wherein the stability member is formed of nitinol; and

an elongate flexible member disposed in the third lumen of the catheter tube, wherein the flexible member is a flat ribbon and is relatively more flexible than the stability member.

9. The device of claim 8, wherein the flexible member and the stability member are configured such that positioning the flexible member and the stability member in an axially overlapping configuration relative to each other causes the catheter tube to move from a curved configuration to a straighter configuration and such that positioning the flexible member and the stability member in an axially offset configuration relative to each other causes the catheter tube to bend from the straighter configuration to the curved configuration.

10. The device of claim 8, wherein the first end portion of the catheter tube is a distal end portion, and the flexible member is fixedly coupled to the distal end portion of the catheter tube.

11. A method of positioning the device of claim 8, comprising:

inserting the first end portion of the delivery device into a patient'"'"'s vasculature;

advancing the first end portion of the delivery device through the patient'"'"'s vasculature to an implantation site;

positioning the stability member in a first position within the second lumen of the catheter tube so that the first end portion of the delivery device is in a first configuration; and

axially moving the stability member in the second lumen from the first position to a second position so that the first end portion of the delivery device is in a second configuration,

wherein the first end portion of the delivery device is more curved in the first configuration than in the second configuration.

12. The method of claim 11, further comprising advancing a prosthetic heart valve through the patient'"'"'s vasculature to the implantation site using the delivery device, wherein the implantation site is a native heart valve annulus.

13. A prosthetic heart valve delivery assembly comprising:

a prosthetic heart valve comprising an annular frame and a plurality of leaflets supported by the frame, wherein the frame is radially compressible to a compressed configuration and radially expandable from the compressed configuration to an expanded configuration; and

a delivery apparatus comprising a catheter tube, a valve catheter, an elongate flexible member, and a stability member, wherein the catheter tube has a first lumen, a second lumen, and a third lumen, the first lumen being radially centrally disposed on the catheter tube, the second lumen being disposed radially outwardly from the first lumen, the third lumen being disposed radially outwardly from the first lumen and circumferentially spaced relative to the second lumen and having a C-shape cross-sectional profile in a plane perpendicular to a central longitudinal axis of the catheter tube, and the valve catheter extending coaxially through the first lumen,

wherein the prosthetic heart valve is mounted to a distal end portion of the valve catheter in the compressed configuration,

wherein the flexible member is disposed in the second lumen of the catheter tube,

wherein the stability member is disposed in and axially moveable relative to the third lumen of the catheter tube, and wherein the stability member is formed of nitinol, comprises a C-shape cross-sectional profile in the plane perpendicular to the central longitudinal axis of the catheter tube, and is configured to be relatively stiffer than the catheter tube and the flexible member, and

wherein the flexible member and the stability member are configured such that positioning the flexible member and the stability member in an axially overlapping configuration relative to each other causes the catheter tube to move from a curved configuration to a straighter configuration and such that positioning the flexible member and the stability member in an axially offset configuration relative to each other causes the catheter tube to bend from the straighter configuration to the curved configuration.

14. The assembly of claim 13, wherein the prosthetic heart valve is balloon expandable.

15. The assembly of claim 13, wherein the prosthetic heart valve is self-expandable.

16. A method of positioning the assembly of claim 13, comprising:

inserting the distal end portion of the delivery apparatus together with the prosthetic heart valve into a patient'"'"'s vasculature;

positioning the stability member of the delivery apparatus in a first position within the third lumen of the catheter tube so that the distal end portion of the delivery apparatus is in a first configuration;

advancing the distal end portion of the delivery apparatus and the prosthetic heart valve through the patient'"'"'s vasculature; and

positioning the stability member of the delivery apparatus in a second position within the third lumen of the catheter tube so that the distal end portion of the delivery apparatus is in a second configuration,

wherein the distal end portion of the delivery apparatus is relatively straighter in the first configuration than in the second configuration.

17. The method of claim 16, wherein the first position of the stability member is distal relative to the second position of the stability member.

18. The method of claim 16, further comprising bending the distal end portion of the delivery assembly with the flexible member while the stability member is in the second position.

19. The method of claim 16, further comprising axially advancing the valve catheter relative to the first lumen of the catheter tube so that the prosthetic heart valve extends out of a distal end of the catheter tube.

20. The method of claim 16, wherein the step of positioning the stability member in the second position occurs when the distal end portion of the delivery apparatus is in the patient'"'"'s aorta, and the prosthetic heart valve is configured to be implanted in the patient'"'"'s native aortic valve.