Delivery systems and methods of implantation for replacement prosthetic heart valves

• US 8,623,074 B2
• Filed: 02/15/2008
• Issued: 01/07/2014
• Est. Priority Date: 02/16/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US12/070,380
• Publication Number:
  US 20080228263A1
• Time in Patent Office: 2,153 Days
• Field of Search: 623/2.11, 623/2.13, 623/2.17, 623/1.24, 623/1.25, 623/1.26
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A delivery system and method for positioning and partially deploying a replacement valve at an implantation site, verifying the location of the replacement valve relative to the implantation site, and retrieving the partially deployed stent for repositioning relative to the implantation site.

Claims

1. A method of delivering a self-expanding replacement prosthetic valve to a valve implantation site with a delivery system, the method comprising:

attaching a first peak at a proximal end of the replacement valve to an engagement member of a delivery component of the delivery system by which the replacement valve can be manipulated to move in a direction of the delivery system, the replacement valve providing a distal end opposite the proximal end;

surrounding the engagement member with a covering structure of the delivery system at a location of attachment of the engagement member to the first peak;

compressing the replacement valve within a sheath and onto a distal portion of the delivery system with the proximal end of the replacement valve being engaged with the delivery component and the distal end of the replacement valve being free from engagement with any component of the delivery system;

wherein following the step of compressing, the covering structure is within the sheath;

advancing a guidewire of the delivery system to the implantation site;

advancing the delivery system with the compressed replacement valve over the guidewire to the implantation site;

at least partially deploying the replacement valve from the sheath, wherein the deployment includes an expansion of the delivery component from a position as attached to the compressed replacement valve to an expanded position as such delivery component moves along with a self-expansion of the replacement valve, and wherein the deployment further includes releasing the distal end of the replacement valve from the sheath so that it is free to expand radially;

verifying the placement of the replacement valve;

at least partially recompressing the replacement valve and the delivery component within the sheath of the delivery system by controllably moving the delivery component relative to the sheath in a direction of the delivery system;

repositioning the delivery system with the compressed replacement valve relative to the implantation site;

at least partially redeploying the replacement valve;

verifying the placement of the replacement valve; and

releasing the replacement valve from the at least one delivery component of the delivery system, including withdrawing the covering structure from the engagement member.

2. The method of claim 1, further comprising the steps of resheathing the at least one delivery component with the sheath and removing the delivery system from the implantation site.

3. The method of claim 1, wherein the step of at least partially deploying the replacement valve from the sheath prior to the recompressing step comprises fully deploying the replacement valve from the sheath so that the replacement valve fully self-expands.

4. The method of claim 3, wherein the recompressing step comprises fully recompressing the replacement valve and repositioning the replacement valve within the sheath.

5. The method of claim 1, wherein the replacement valve provides a second peak at the distal end, and further wherein the replacement valve includes a stent supporting a valve structure, and even further wherein the stent forms the first and second peaks as each including an apex and opposing wire segments extending from the apex, and even further wherein the first and second peaks are exteriorly open and uncovered for receiving the delivery component.

6. The method of claim 5, wherein the stent forms a plurality of the first peaks that collectively define a proximal-most end of the replacement valve, and a plurality of the second peaks that collectively define a distal-most end of the replacement valve.

7. The method of claim 1, wherein the replacement valve provides a second peak at the distal end, the method further comprising:

selecting the first peak or the second peak for attachment to the delivery component.

8. The method of claim 1, wherein the replacement valve provides a second peak at the distal end, and further wherein the replacement valve includes a stent supporting a valve structure, the valve structure defining an inflow end and an outflow end, and further wherein the first peak is proximate the inflow end and is opposite the outflow end.

9. The method of claim 1, wherein the step of at least partially deploying the replacement valve from the sheath prior to the recompressing step includes fully deploying the replacement valve from the sheath with the covering structure continuing to surround the engagement member, apart from the sheath, at the location of attachment.

10. The method of claim 1, wherein the covering structure is a tube.

11. The method of claim 1, wherein the covering structure defines a covering structure portion surrounding the engagement member following the step of compressing, and further wherein the step of releasing the replacement valve includes:

deploying the distal end of the replacement valve from the sheath, including the engagement structure and the covering structure portion located outside of the sheath;

and then withdrawing the covering structure portion from the engagement member;

and then disengaging the engagement member from the first peak.