Vascular implant and delivery system

• US 10,441,412 B2
• Filed: 10/07/2016
• Issued: 10/15/2019
• Est. Priority Date: 04/15/2009
• 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
• Primary Examiner(s): Dang, Phong Son H
• Application Number:
  US15/288,693
• Publication Number:
  US 20170035562A1
• Time in Patent Office: 1,103 Days
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Claims

1. A system for replacing a native valve, the system comprising:

a replacement valve for delivery to the native valve to be secured relative to a native valve annulus, the replacement valve comprising;

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame shaped to radially expand and collapse for deployment within the native valve annulus;

a plurality of distal anchors connected to the expandable frame and sized to contact the native valve on a first side of the native valve annulus, wherein when the expandable frame is in an expanded configuration within the native valve annulus;

at least a portion of each distal anchor extends proximally toward the proximal end of the expandable frame; and

a proximalmost portion of each distal anchor is positioned radially outward from the expandable frame; and

an anchoring feature configured to contact the native valve annulus, the anchoring feature being positioned proximal of locations at which the plurality of distal anchors are connected to the frame, wherein the anchoring feature comprises an enlarged portion of the expandable frame, the enlarged portion and the expandable frame is monolithic, the enlarged portion having a diameter greater than diameters of the proximal and distal ends of the expandable frame when the expandable frame is in an expanded configuration;

a valve body attached to the expandable frame; and

at least one locking feature extending from the expandable frame;

wherein radial expansion of the expandable frame causes the plurality of distal anchors to draw closer to the anchoring feature; and

a delivery device comprising;

an elongate inner tube having a proximal end and a distal end;

a locking mechanism positioned over the elongate inner tube, the locking mechanism comprising a receiving feature configured to engage the at least one locking feature of the replacement valve;

a cover configured to surround at least the receiving feature when the at least one locking feature of the replacement valve is engaged with the receiving feature; and

wherein the at least one locking feature of the replacement valve is configured to be disposed between the cover and a surface of the locking mechanism.

2. The system for replacing a native valve of claim 1, wherein the replacement valve is shaped such that, after the replacement valve has been delivered to the native valve and expanded, the anchoring feature is configured to contact tissue of the native valve annulus and at least some of the plurality of distal anchors are configured to tissue on the first side of the native valve annulus.

3. The system for replacing a native valve of claim 1, wherein the proximalmost portions of the distal anchors are proximal to where the distal anchors connect to the frame.

4. The system for replacing a native valve of claim 1, wherein the replacement valve is shaped such that, after the replacement valve has been delivered to the native valve and expanded, at least some of the plurality of distal anchors are configured to contact tissue on the first side of the native valve annulus and exert a proximally directed force.

5. The system for replacing a native valve of claim 1, wherein the proximalmost portions of the distal anchors extend substantially parallel with the longitudinal axis.

6. The system for replacing a native valve of claim 1, wherein the proximalmost portions of the plurality of distal anchors are atraumatic.

7. The system for replacing a native valve of claim 1, wherein the delivery device comprises a support tube having a proximal end and a distal end, the support tube being positioned over the elongate inner tube, wherein the locking mechanism is positioned at or adjacent the distal end of the support tube.

8. The system for replacing a native valve of claim 1, wherein the cover and the locking mechanism are configured to be moveable relative to each other.

9. The system for replacing a native valve of claim 1, wherein the cover comprises an elongate sheath.

10. The system for replacing a native valve of claim 1, wherein the receiving feature comprises a capture slot configured to engage the at least one locking feature of the replacement valve.

11. The system for replacing a native valve of claim 10, wherein the receiving feature comprises a plurality of guide slots configured to receive a portion of the replacement valve when the at least one locking feature is engaged with the capture slot, the capture slot being proximal to the one or more guide slots.

12. A system for replacing a native mitral valve, the system comprising:

a replacement mitral valve for delivery to a native mitral valve to be secured relative to a native mitral valve annulus, the native mitral valve positioned between a left atrium and a left ventricle, the replacement mitral valve comprising;

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame shaped to radially expand and collapse for deployment within the native mitral valve annulus;

a plurality of distal anchors connected to the expandable frame and sized to contact the native mitral valve on a ventricular side of the native mitral valve annulus, wherein when the expandable frame is in an expanded configuration within the native mitral valve annulus;

at least a portion of each distal anchor extends proximally toward the proximal end of the expandable frame; and

a proximalmost portion of each distal anchor is positioned radially outward from the expandable frame; and

an anchoring feature comprising an enlarged portion of the expandable frame configured to contact the native valve annulus, the enlarged portion and the expandable frame is monolithic, the enlarged portion having a diameter greater than diameters of the proximal and distal ends of the expandable frame when the expandable frame is in an expanded configuration, the enlarged portion being positioned proximal of locations at which the plurality of distal anchors are connected to the frame;

a valve body attached to the expandable frame;

at least one locking feature extending from the expandable frame;

wherein radial expansion of the expandable frame causes the plurality of distal anchors to draw closer to the anchoring feature; and

a delivery device comprising;

an elongate inner tube having a proximal end and a distal end;

a locking mechanism positioned over the elongate inner tube, the locking mechanism comprising a capture slot sized to receive and engage the at least one locking feature of the replacement mitral valve; and

a cover configured to surround at least the capture slot when the at least one locking feature of the replacement mitral valve is engaged with the capture slot;

wherein the at least one locking feature of the replacement mitral valve is configured to be disposed between the cover and a surface of the locking mechanism.

13. The system for replacing a native valve of claim 12, wherein the replacement mitral valve is shaped such that, after the replacement mitral valve has been delivered to the native mitral valve and expanded, the enlarged portion is configured to contact tissue of the native mitral valve annulus and at least some of the plurality of distal anchors are configured to contact tissue on the ventricular side of the native valve annulus.

14. The system for replacing a native valve of claim 12, wherein the replacement mitral valve is shaped such that, after the replacement mitral valve has been delivered to the native valve and expanded, at least some of the plurality of distal anchors are configured to contact tissue on the ventricular side of the native valve annulus and exert a proximally directed force.

15. The system for replacing a native valve of claim 12, wherein the delivery device comprises a support tube having a proximal end and a distal end, the support tube being positioned over the elongate inner tube, wherein the locking mechanism is positioned at or adjacent the distal end of the support tube.

16. The system for replacing a native valve of claim 12, wherein the cover and the locking mechanism are configured to be moveable relative to each other.

17. The system for replacing a native valve of claim 12, wherein the cover comprises an elongate sheath.

18. A system for replacing a native valve, the system comprising:

a replacement valve for delivery to the native valve to be secured relative to a native valve annulus, the replacement valve comprising;

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame shaped to radially expand and collapse for deployment within the native valve annulus;

a plurality of distal anchors connected to the expandable frame and sized to contact the native valve on a first side of the native valve annulus, wherein when the expandable frame is in an expanded configuration within the native valve annulus;

at least a portion of each distal anchor extends proximally toward the proximal end of the expandable frame; and

a proximalmost portion of each distal anchor is positioned radially outward from the expandable frame, and wherein the proximalmost portion of each distal anchor is atraumatic; and

an anchoring feature configured to contact the native valve annulus, the anchoring feature being positioned proximal of locations at which the plurality of distal anchors are connected to the frame, wherein the anchoring feature comprises an enlarged portion of the expandable frame, the enlarged portion and the expandable frame is monolithic, the enlarged portion having a diameter greater than diameters of the proximal and distal ends of the expandable frame when the expandable frame is in an expanded configuration;

a valve body attached to the expandable frame; and

at least one locking feature extending from the expandable frame;

wherein radial expansion of the expandable frame causes the plurality of distal anchors to draw closer to the anchoring feature; and

a delivery device comprising;

an elongate inner tube having a proximal end and a distal end;

a locking mechanism positioned over the elongate inner tube, the locking mechanism comprising a receiving feature configured to engage the at least one locking feature of the replacement valve;

a cover configured to surround at least the receiving feature when the at least one locking feature of the replacement valve is engaged with the receiving feature; and

wherein the at least one locking feature of the replacement valve is configured to be disposed between the cover and a surface of the locking mechanism.

19. A system for replacing a native valve, the system comprising:

a replacement valve for delivery to the native valve to be secured relative to a native valve annulus, the replacement valve comprising;

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame shaped to radially expand and collapse for deployment within the native valve annulus;

a plurality of distal anchors connected to the expandable frame and sized to contact the native valve on a first side of the native valve annulus, wherein when the expandable frame is in an expanded configuration within the native valve annulus;

at least a portion of each distal anchor extends proximally toward the proximal end of the expandable frame; and

a proximalmost portion of each distal anchor is positioned radially outward from the expandable frame; and

an anchoring feature configured to contact the native valve annulus, the anchoring feature being positioned proximal of locations at which the plurality of distal anchors are connected to the frame;

a valve body attached to the expandable frame; and

at least one locking feature extending from the expandable frame;

wherein radial expansion of the expandable frame causes the plurality of distal anchors to draw closer to the anchoring feature; and

a delivery device comprising;

an elongate inner tube having a proximal end and a distal end;

a locking mechanism positioned over the elongate inner tube, the locking mechanism comprising a receiving feature configured to engage the at least one locking feature of the replacement valve, wherein the receiving feature comprises a capture slot configured to engage the at least one locking feature of the replacement valve, and wherein the receiving feature comprises a plurality of guide slots configured to receive a portion of the replacement valve when the at least one locking feature is engaged with the capture slot, the capture slot being proximal to the one or more guide slots;

a cover configured to surround at least the receiving feature when the at least one locking feature of the replacement valve is engaged with the receiving feature; and

wherein the at least one locking feature of the replacement valve is configured to be disposed between the cover and a surface of the locking mechanism.