Transcatheter heart valve delivery system with reduced area moment of inertia

• US 8,771,344 B2
• Filed: 08/15/2013
• Issued: 07/08/2014
• Est. Priority Date: 04/09/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tran, Don, Wiemeyer, Nathan, Deshmukh, Susheel, Mendoza, Leonel, Rust, Matthew
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US13/967,894
• Publication Number:
  US 20140005769A1
• Time in Patent Office: 327 Days
• Field of Search: 606/108, 606/191, 606/194, 606/198, 606/200, 623/1.11, 623/1.23, 623/2.1, 623/2.11, 623/2.12
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A device for percutaneously repairing a heart valve of a patient including a self-expanding, stented prosthetic heart valve and a delivery system. The delivery system includes delivery sheath slidably receiving an inner shaft forming a coupling structure. A capsule of the delivery sheath includes a distal segment and a proximal segment. An outer diameter of the distal segment is greater than that of the proximal segment. An area moment of inertia of the distal segment can be greater than an area moment of inertia of the proximal segment. Regardless, an axial length of the distal segment is less than the axial length of the prosthesis. In a loaded state, the prosthesis engages the coupling structure and is compressively retained within the capsule. The capsule is unlikely to kink when traversing the patient'"'"'s vasculature, such as when tracking around the aortic arch, promoting recapturing of the prosthesis.

Claims

1. A method of loading a transcatheter delivery system with a prosthetic heart valve having a stent frame and a valve structure assembled to the stent frame and forming at least two valve leaflets, the prosthetic heart valve being radially self-expandable from a compressed arrangement to a natural arrangement, the method comprising:

receiving a delivery system including;

an inner shaft assembly including an intermediate portion forming a coupling structure,

a delivery sheath assembly defining a lumen sized to slidably receive the inner shaft assembly and including a shaft and a capsule extending distally from the shaft, the capsule including a distal segment and a proximal segment, wherein an outer diameter of the distal segment is greater than an outer diameter of the proximal segment; and

an axial length of the distal segment is less than an axial length of the stent frame;

coaxially disposing the prosthetic heart valve over the inner shaft assembly such that a proximal region of the prosthetic heart valve is adjacent the coupling structure; and

compressing the prosthetic heart valve to the compressed arrangement over the inner shaft assembly, including disposing the capsule segments over the prosthetic heart valve and crimping the prosthetic heart valve into engagement with the coupling structure to achieve a loaded state;

wherein the loaded state includes the distal segment encompassing and contacting a distal region of the prosthetic heart valve and the proximal segment encompassing and contacting a proximal region of the prosthetic heart valve;

wherein the prosthetic heart valve is entirely compressibly retained within the proximal and distal segments.

2. The method of claim 1, wherein the distal region of the prosthetic heart valve is an inflow region and the proximal region is an outflow region.

3. The method of claim 1, wherein the loaded state includes the distal segment encompassing an entirety of the valve structure and less than an entirety of the stent frame.

4. The method of claim 1, wherein a radial stiffness of the distal segment is greater than a radial stiffness of the proximal segment.

5. The method of claim 1, wherein an inner diameter of the distal segment is greater than an inner diameter of the proximal segment.

6. The method of claim 1, wherein an area moment of inertia of the distal segment is greater than an area moment of inertia of the proximal segment.

7. The method of claim 1, wherein a construction of the distal segment differs from a construction of the proximal segment.

8. A method of repairing a defective heart valve of a patient, the method comprising:

receiving a delivery system loaded with a radially self-expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including an inner shaft assembly coaxially received within a delivery sheath assembly having a capsule forming a distal segment and a proximal segment, the distal segment having an outer diameter greater than an outer diameter of the proximal segment, and an axial length of the distal segment is less than an axial length of the stent frame, wherein the distal segment is disposed over and compressively retains and contacts a distal region of the prosthetic heart valve and the proximal segment is disposed over and compressively retains and contacts a proximal region of the prosthetic heart valve such that the prosthetic heart valve is entirely compressibly retained within the capsule;

inserting the prosthetic heart valve into a bodily lumen while the prosthetic heart valve is constrained within the capsule;

manipulating the delivery system to guide the prosthetic heart valve through the patient'"'"'s vasculature and into the defective heart valve; and

withdrawing the capsule from the prosthetic heart valve to permit the prosthetic heart valve to self-expand and release from the delivery system and into engagement with the native heart valve.

9. The method of claim 8, wherein manipulating the delivery system to guide the prosthetic heart valve through the patient'"'"'s vasculature includes tracking the prosthetic heart valve around the patient'"'"'s aortic arch.

10. The method of claim 9, wherein tracking the prosthetic heart valve around the patient'"'"'s aortic arch includes the capsule not experiencing kinking when tracking across the patient'"'"'s aortic arch.

11. The method of claim 8, wherein prior to the step of withdrawing the capsule to permit the prosthetic heart valve to release from the delivery system, the method further comprising:

partially retracting the capsule from the prosthetic heart valve such that an exposed region of the prosthetic heart valve self-expands while a trailing region of the prosthetic heart valve remains constrained within the capsule; and

distally advancing the capsule over the exposed region to recapture the prosthetic heart valve relative to the delivery system.