Replacement mitral valve, delivery system for replacement mitral valve and methods of use

• US 10,376,363 B2
• Filed: 04/28/2016
• Issued: 08/13/2019
• Est. Priority Date: 04/30/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent, Liao, Yen, Sanchez, Julio Cesar, Cooper, Alexander H., Rabito, Glen T., Vad, Siddharth, Pesce, Luca, Stewart, Kevin M., Landon, David Robert
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): Wei, Charles M
• Application Number:
  US15/141,684
• Publication Number:
  US 20160317301A1
• Time in Patent Office: 1,202 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.

Claims

1. A transseptal delivery system for replacement mitral valve implantation, the delivery system comprising:

a nose cone shaft having a proximal end and a distal end and a lumen extending therethrough;

a nose cone provided on the distal end of the nose cone shaft;

an inner retention shaft slideably positioned over the nose cone shaft, the inner retention shaft having a proximal end and a distal end;

an inner retention ring provided on the distal end of the inner retention shaft, the inner retention ring configured to receive struts at a proximal portion of a replacement mitral valve prosthesis;

a mid shaft slideably positioned over the inner retention shaft, the mid shaft having a proximal end and a distal end;

an outer retention ring provided on the distal end of the mid shaft, the outer retention ring configured to be positioned over the inner retention ring to hold the proximal portion of the replacement mitral valve prosthesis within the inner retention ring; and

an outer sheath assembly slideably positioned over the mid shaft and over the outer retention ring, the outer sheath assembly configured to radially restrain a distal portion of the replacement mitral valve prosthesis when the proximal portion of the replacement mitral valve prosthesis is held by the outer retention ring within the inner retention ring;

wherein the mid shaft comprises a longitudinally pre-compressed tube located within the outer sheath assembly, the longitudinally pre-compressed tube having a reduced length of about ⅛

, ⅙

, ¼

, ½

, or 1 inches from a natural state, wherein the longitudinally pre-compressed tube is configured to lengthen during bending of the delivery system so that deflection of the mid shaft does not substantially change the location of the outer retention ring relative to the inner retention ring; and

wherein the mid shaft provides a distal force on the outer retention ring.

2. The transseptal delivery system of claim 1, wherein the outer sheath assembly is configured to slide over the nose cone.

3. The transseptal delivery system of claim 1, further comprising a replacement heart valve prosthesis, wherein the replacement heart valve prosthesis comprises struts at a proximal portion thereof received within the inner retention ring and covered by the outer retention ring, and a distal portion covered by the outer sheath assembly.

4. The transseptal delivery system of claim 1, wherein the outer sheath assembly comprises a proximal segment and a distal segment, wherein the distal segment is configured to cover a replacement mitral valve, and wherein the distal segment is formed from two or more layers.

5. The trans septal delivery system of claim 1, wherein the outer sheath assembly comprises a distal segment configured to cover the replacement mitral valve, wherein the distal segment is formed from an inner polymer layer and an outer polymer layer, and wherein the distal segment further comprises:

a proximal section comprising a hypotube sandwiched between the inner and outer polymer layers; and

a distal section comprising an intermediate polymer layer sandwiched between the inner and outer polymer layers.

6. The transseptal delivery system of claim 5, wherein the distal section has a greater diameter than the proximal section.

7. The transseptal delivery system of claim 5, further comprising a polymer reinforcement in the distal section that at least partially overlaps the intermediate polymer layer.

8. The trans septal delivery system of claim 5, wherein the inner polymer layer and the outer polymer layer comprise ePTFE with generally longitudinally extending polymer chains, and the intermediate polymer layer comprises ePTFE having generally circumferentially extending polymer chains.

9. The transseptal delivery system of claim 5, wherein the hypotube comprises a plurality of circumferentially extending cuts along a longitudinal length thereof.

10. The transseptal delivery system of claim 1, wherein the longitudinally pre-compressed tube comprises a pre-compressed polymer tube.

11. The transseptal delivery system of claim 1, further comprising a spring within an interior of the outer retention ring and a cover at a distal end of the spring, wherein the spring is biased to position the cover at least partially over the inner retention ring.

12. The transseptal delivery system of claim 1, wherein the nose cone comprises an elongate hollow body that is distally tapered to facilitate bending of the nose cone when the nose cone is delivered over a guidewire and comes into contact with an internal body surface.

13. The transseptal delivery system of claim 1, further comprising a guide sheath comprising a distal tip having an open or openable wall, the distal tip being articulable to a plurality of shapes suitable for guiding components of the delivery system to the native mitral valve, wherein the outer sheath is configured to slide within a lumen of the guide sheath.

14. The transseptal delivery system of claim 1, further comprising a guidewire having an anchor assembly connected thereto, wherein the anchor assembly is configured to anchor to a heart wall.

15. The trans septal delivery system of claim 1, wherein the outer retention ring has a diameter greater than a diameter of the mid shaft.

16. The transseptal delivery system of claim 1, wherein the outer retention ring is a separate structural component attached to the mid shaft.

17. A flexible delivery system for replacement mitral valve implantation, the delivery system comprising:

an outer sheath comprising a distal segment configured to cover a replacement mitral valve, wherein the distal segment is formed from an inner polymer wall and an outer polymer wall, and wherein the distal segment further comprises;

a proximal section comprising a hypotube sandwiched between the inner polymer wall and the outer polymer wall; and

a distal section comprising an intermediate polymer layer sandwiched between the inner and outer polymer walls;

wherein a proximalmost end of the intermediate polymer layer is distal from a distalmost end of the hypotube; and

a tubular polymer reinforcement in the distal section that at least partially overlaps and is separate from the intermediate polymer layer;

wherein the distal section has a greater diameter than the proximal section and a transition between the distal section and the proximal section is a step;

wherein the intermediate polymer layer comprises a polymer tube separate from the inner polymer wall and the outer polymer wall;

wherein the hypotube comprises a slotted Nitinol hypotube separate from the inner polymer wall and the outer polymer wall;

wherein the inner polymer wall is continuous between the proximal section and the distal section;

wherein the outer polymer wall is continuous between the proximal section and the distal section; and

wherein the outer polymer wall and inner polymer wall are connected at a plurality of locations along the distal segment.

18. The flexible delivery system of claim 17, wherein the distal section has a greater diameter than the proximal section.

19. The flexible delivery system of claim 17, wherein the inner polymer wall and the outer polymer wall comprise ePTFE with generally longitudinally extending polymer chains, and the intermediate polymer layer comprises ePTFE having generally circumferentially extending polymer chains.