Percutaneous clip for repairing a heart valve

• US 10,524,792 B2
• Filed: 12/04/2015
• Issued: 01/07/2020
• Est. Priority Date: 12/04/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hernandez, Cristobal R., Bak-Boychuk, Gregory, Karapetian, Emil
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US14/959,903
• Publication Number:
  US 20160157862A1
• Time in Patent Office: 1,495 Days
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

A leaflet clip has an elongated member including a proximal end portion and a distal end portion, and first and second clipping arms movable between an open position and a closed position. The clipping arms include respective proximal end portions coupled to the proximal end portion of the elongated member, and respective distal end portions extending distally and radially outward relative to the elongated member. The leaflet clip further includes a tubular member coaxially disposed about the elongated member. Axial motion of the tubular member with respect to the elongated member or axial motion of the elongated member with respect to the tubular member causes corresponding movement of the clipping arms between the open and closed positions.

Claims

1. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extending axially and radially outward relative to the elongated member;

a tubular member coaxially disposed about the elongated member; and

a leaflet engagement mechanism disposed on the distal end portion of the elongated member, the leaflet engagement mechanism comprising a fabric covering configured to engage the first and second native leaflets as the clipping arms are moved from the open position to the closed position, the fabric covering comprising a natural or synthetic fibrous material that is woven, braided, or any combination thereof;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions.

2. A method, comprising:

positioning a leaflet clip adjacent a commissure of a heart valve such that a first clipping arm of the leaflet clip is adjacent a first leaflet of the heart valve and a second clipping arm of the leaflet clip is adjacent a second leaflet of the heart valve and an elongated member of the leaflet clip is positioned between the leaflets; and

moving a sheath disposed coaxially over the elongated member axially with respect to the elongated member or moving the elongated member axially with respect to the sheath such that the sheath extends over the elongated member and the clipping arms, and causes the clipping arms to move from an open position to a closed position, thereby capturing the first leaflet between the first clipping arm and the elongated member and capturing the second leaflet between the second clipping arm and the elongated member.

3. The method of claim 2, wherein the heart valve is a mitral valve, an aortic valve, or a tricuspid valve.

4. The method of claim 2, further comprising positioning a leaflet clip adjacent each commissure of the heart valve.

5. A method, comprising:

positioning a leaflet clip adjacent a commissure of a heart valve such that a first clipping arm of the leaflet clip is adjacent a first leaflet of the heart valve and a second clipping arm of the leaflet clip is adjacent a second leaflet of the heart valve and an elongated member of the leaflet clip is positioned between the leaflets;

moving a sheath disposed coaxially over the elongated member axially with respect to the elongated member or moving the elongated member axially with respect to the sheath such that the sheath causes the clipping arms to move from an open position to a closed position, thereby capturing the first leaflet between the first clipping arm and the elongated member and capturing the second leaflet between the second clipping arm and the elongated member; and

actuating a leaflet engagement mechanism disposed on the elongated member to engage the first and second leaflets between the respective first and second clipping arms and the elongated member.

6. The method of claim 5, wherein actuating the leaflet engagement mechanism comprises causing a covering of the elongated member to expand radially such that the covering engages the first and second leaflets.

7. The method of claim 5, wherein actuating the leaflet engagement mechanism comprises moving one or more protuberances disposed on the elongated member proximally with respect to the first and second clipping arms.

8. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extendable axially and radially outward relative to the elongated member;

a tubular member coaxially disposed about the elongated member;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions;

wherein when the leaflet clip is implanted, the tubular member is configured to extend over the elongated member and the clipping arms, and retain the clipping arms in the closed position on opposite sides of the first and second leaflets to anchor the leaflet clip in place; and

a plurality of protuberances disposed on the second end portion of the elongated member and axially spaced apart from one another, the protuberances being configured to engage leaflets of a heart valve between the protuberances and the clipping arms as the clipping arms are moved from the open position to the closed position.

9. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extendable axially and radially outward relative to the elongated member; and

a tubular member coaxially disposed relative to the elongated member;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions;

wherein when the leaflet clip is implanted, the tubular member is configured to retain the clipping arms in the closed position on opposite sides of the first and second leaflets to anchor the leaflet clip in place; and

wherein the is elongated member further comprises a polymeric or fabric covering configured to engage the native leaflets of a heart valve as the clipping arms are moved from the open position to the closed position.

10. The leaflet clip of claim 9, wherein the first end portion of the elongated member comprises a retaining member configured to engage the tubular member and retain the tubular member in an extended position relative to the elongated member in which the tubular member extends over and retains the clipping arms in the closed position.

11. The leaflet clip of claim 9, wherein the clipping arms are integrally formed with a collar disposed on the first end portion of the elongated member.

12. The leaflet clip of claim 9, wherein the tubular member comprises first and second extension portions configured to contact the first and second clipping arms, respectively, upon axial movement of the tubular member.

13. The leaflet clip of claim 9, wherein the elongated member defines a lumen configured to receive a guidewire.

14. The leaflet clip of claim 9, wherein the second end portion of the elongated member has a diameter that is greater than a diameter of the first end portion of the elongated member such that when the first and second clipping arms are in the closed position and the first leaflet is disposed between the first clipping arm and the elongated member and the second leaflet is disposed between the second clipping arm and the elongated member, the leaflets are pinched between the clipping arms and the second end portion of the elongated member.

15. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extendable axially and radially outward relative to the elongated member; and

a tubular member coaxially disposed relative to the elongated member;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions;

wherein when the leaflet clip is implanted, the tubular member is configured to extend over the elongated member and the clipping arms, and retain the clipping arms in the closed position on opposite sides of the first and second leaflets to anchor the leaflet clip in place; and

wherein the first end portion of the elongated member comprises a retaining member configured to engage the tubular member and retain the tubular member in an extended position relative to the elongated member in which the tubular member extends over and retains the clipping arms in the closed position.

16. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extendable axially and radially outward relative to the elongated member; and

a tubular member coaxially disposed relative to the elongated member;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions;

wherein when the leaflet clip is implanted, the tubular member is configured to retain the clipping arms in the closed position on opposite sides of the first and second leaflets to anchor the leaflet clip in place; and

wherein the clipping arms are integrally formed with a collar disposed on the first end portion of the elongated member.

17. The leaflet clip of claim 16, wherein the is elongated member further comprises a polymeric or fabric covering configured to engage the native leaflets of a heart valve as the clipping arms are moved from the open position to the closed position.

18. The leaflet clip of claim 17, wherein the covering is retained on the elongated member by a first retaining member fixedly disposed on the elongated member proximal of a second retaining member, the second retaining member being movable relative to the first retaining member such that proximal movement of the second retaining member relative to the first retaining member causes radial expansion of the covering.

19. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extendable axially and radially outward relative to the elongated member; and

a tubular member coaxially disposed about the elongated member;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions;

wherein when the leaflet clip is implanted, the tubular member is configured to extend over the elongated member and the clipping arms, and retain the clipping arms in the closed position on opposite sides of the first and second leaflets to anchor the leaflet clip in place; and

wherein the tubular member comprises first and second extension portions configured to contact the first and second clipping arms, respectively, upon axial movement of the tubular member.

20. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extendable axially and radially outward relative to the elongated member; and

a tubular member coaxially disposed relative to the elongated member;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions;

wherein when the leaflet clip is implanted, the tubular member is configured to retain the clipping arms in the closed position on opposite sides of the first and second leaflets to anchor the leaflet clip in place; and

wherein the elongated member defines a lumen configured to receive a guidewire.

21. A leaflet clip for implanting on first and second native leaflets of a heart valve, comprising:

an elongated member including a first end portion and a second end portion;

first and second clipping arms movable between an open position and a closed position, the clipping arms including respective first end portions coupled to the first end portion of the elongated member and respective second end portions extendable axially and radially outward relative to the elongated member; and

a tubular member coaxially disposed relative to the elongated member;

wherein axial motion of the tubular member relative to the elongated member or axial motion of the elongated member relative to the tubular member causes corresponding movement of the clipping arms between the open and closed positions;

wherein when the leaflet clip is implanted, the tubular member is configured to retain the clipping arms in the closed position on opposite sides of the first and second leaflets to anchor the leaflet clip in place; and

wherein the second end portion of the elongated member has a diameter that is greater than a diameter of the first end portion of the elongated member such that when the first and second clipping arms are in the closed position and the first leaflet is disposed between the first clipping arm and the elongated member and the second leaflet is disposed between the second clipping arm and the elongated member, the leaflets are pinched between the clipping arms and the second end portion of the elongated member.