Epicardial clip

• US 9,724,194 B2
• Filed: 01/03/2014
• Issued: 08/08/2017
• Est. Priority Date: 07/01/2008
• Status: Active Grant

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: Stewart, Michael C, Juravic, Mark S, Callas, Peter Tachi, Lombardi, Pierluca, Lamberti, Joe, Chin, Albert K, Wang, Tammy, Lau, Liming, Anderson, Evan
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US14/146,927
• Publication Number:
  US 20140172084A1
• Time in Patent Office: 1,313 Days
• Field of Search: 600 37, 128898, 623 211, 623 212, 623 22, 623 234, 623 236, 623 237, 623 238
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

An epicardial clip for reshaping the annulus of the mitral valve of a heart. The epicardial clip includes a curved member having an anterior segment configured to be positioned in the transverse sinus of the heart, a posterior segment configured to be positioned on the posterior side of the heart, such as on or inferior to the atrioventricular groove, and a lateral segment extending between the anterior segment and the posterior segment. The lateral segment includes a curve such that the first end of the member is positioned at or above the plane of the mitral valve and the second end of the member is positioned at or below the plane of the mitral valve.

Claims

1. An epicardial clip for placement on the epicardial surface of a heart in order to reshape the annulus of the mitral valve of the heart, the mitral valve lying in a plane between the left atrium and the left ventricle of the heart, the anatomy of the heart includes an aorta, a pulmonary trunk, a superior vena cava, a transverse sinus, and an atrioventricular groove, the epicardial clip comprising:

a curved member having an anterior segment, a posterior segment and a lateral segment extending between the anterior segment and the posterior segment;

wherein the anterior segment is configured and dimensioned to at least partially occupy the transverse sinus epicardially and end at a location short of overlying the right atrium;

wherein the curved member is configured for positioning the anterior segment on or above a plane in which the mitral valve is located, and the posterior segment on or below the plane in which the mitral valve is located, and below a position of the anterior segment;

wherein said epicardial clip is configured to rotate about a longitudinal axis of said anterior segment on the epicardial surface of the heart at a location superior of an anterior annulus of the mitral valve, said epicardial clip configured to move said posterior segment toward or away from the apex of the heart while said anterior segment remains in contact with a base of the transverse sinus;

wherein said epicardial clip is non-flexible and having a permanent configuration, said permanent configuration is configured not to be readily bent to an ad hoc configuration; and

wherein said curved member comprises a helical curve.

2. The epicardial clip of claim 1, wherein when the curved member is viewed laterally, an acute angle is defined between the anterior segment and the posterior segment.

3. The epicardial clip of claim 1, wherein the anterior segment is straight.

4. The epicardial clip of claim 1, wherein the posterior segment is arced.

5. The epicardial clip of claim 1, further comprising a compliant material encasing at least a portion of the member.

6. The epicardial clip of claim 5, further comprising a fabric sheath covering the compliant material.

7. The epicardial clip of claim 6, wherein the fabric sheath promotes tissue growth thereon.

8. The epicardial clip of claim 6, wherein the fabric sheath is biocompatible.

9. The epicardial clip of claim 1, wherein the compliant material is an over-mold.

10. The epicardial clip of claim 1, wherein the compliant material is silicone.

11. The epicardial clip of claim 1, wherein the compliant material includes a flat section on the posterior segment.

12. The epicardial clip of claim 1, wherein the compliant material includes a rounded section on the anterior segment.

13. The epicardial clip of claim 1, further comprising a fabric sheath covering the member.

14. The epicardial clip of claim 1, wherein the member is configured to be placed on the epicardial surface of the heart such that the plane of the mitral valve intersects at least one of the lateral segment and the posterior segment.

15. The epicardial clip of claim 1, wherein the anterior segment comprises a curved portion configured to follow a curvature of a floor of the transverse sinus.

16. The epicardial clip of claim 1, wherein the anterior segment is located in an imaginary plane and the posterior segment is located in an imaginary plane, wherein the imaginary plane of the posterior segment is at an acute angle to the imaginary plane of the anterior segment.

17. The epicardial clip of claim 1, wherein the lateral segment has a radius of curvature in the range of about 5 to 70 millimeters.

18. The epicardial clip of claim 1, wherein the lateral segment has a radius of curvature in the range of about 30 to 46 millimeters.

19. The epicardial clip of claim 1, wherein the lateral segment includes a first curved portion, a second curved portion, and a straight portion intermediate the first curved portion and the second curved portion.

20. The epicardial clip of claim 1, wherein a distance across the clip between the anterior segment and the posterior segment is closest between a first end of the curved member and a second end of the curved member.

21. An epicardial clip for placement on the epicardial surface of a heart in order to reshape the annulus of the mitral valve of the heart, the mitral valve lying in a plane between the left atrium and the left ventricle of the heart, the anatomy of the heart includes an aorta, a pulmonary trunk, a superior vena cave, a transverse sinus, and an atrioventricular groove, the epicardial clip comprising:

a curved member having an anterior segment, a posterior segment and a lateral segment extending between the anterior segment and the posterior segment;

wherein the anterior segment is configured and dimensioned to at least partially occupy the transverse sinus epicardially and end at a location short of overlying the right atrium;

wherein the lateral segment is curved and configured for positioning, the anterior segment on or above a plane in which the mitral valve is located, and the posterior segment on or below the plane in which the mitral valve is located, and below a position of the anterior segment;

wherein said epicardial clip is configured to rotate about a longitudinal axis of said anterior segment on the epicardial surface of the heart at a location superior of an anterior annulus of the mitral valve, said epicardial clip configured to move said posterior segment towards or away from the apex of the heart while said anterior segment remains in at least partial contact with a base of the transverse sinus; and

wherein said epicardial clip member is configured to be in a final, usable configuration, said epicardial clip member is non-flexible relative to forces applied thereto by the heart.