EPICARDIAL CLIP

• US 20100004504A1
• Filed: 07/01/2008
• Published: 01/07/2010
• Est. Priority Date: 07/01/2008
• Status: Active Grant

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: LOMBARDI, PIERLUCA, ANDERSON, EVAN, JURAVIC, MARK S., LAMBERTI, JOE, CHIN, ALBERT K., STEWART, MICHAEL C., WANG, TAMMY, CALLAS, PETER TACHI, LAU, LIMING
• Granted Patent: US 8,647,254 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 reshaping the annulus of the mitral valve of a 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, an oblique sinus, and an atrioventricular groove, the clip comprising:

a curved member having a first end and a second end, the member forming;

a) an anterior segment configured to be positioned in the transverse sinus of the heart;

b) a posterior segment configured to be positioned on or inferior to the atrioventricular groove of the heart; and

c) a lateral segment extending between the anterior segment and the posterior segment, the lateral segment including a curve such that the first end of the member is positioned on or above the plane of the mitral valve and the second end of the member is positioned on or below the plane of the mitral valve;

wherein the transverse sinus is a pericardial cavity of the heart located posterior to the aorta and pulmonary trunk and anterior to the superior vena cava; and

wherein the atrioventricular groove is a natural junction between the left atrium and the left ventricle of the heart on a posterior side of the heart.

2. The epicardial clip of claim 1, wherein the curve is a helical curve.

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

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

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

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

7. The epicardial clip of claim 6, wherein the compliant material is an over-mold.

8. The epicardial clip of claim 6, wherein the compliant material is silicone.

9. The epicardial clip of claim 6, wherein the compliant material includes a flat section on the posterior segment.

10. The epicardial clip of claim 6, wherein the compliant material includes a rounded section on the anterior segment.

11. The epicardial clip of claim 6, wherein a fabric sheath covers the compliant material.

12. The epicardial clip of claim 11, wherein the fabric sheath promotes tissue growth thereon.

13. The epicardial clip of claim 11, wherein the fabric sheath promotes tissue growth therein.

14. 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 includes a component that occupies the transverse sinus from an inferior aspect of the transverse sinus to a superior aspect of the transverse sinus.

15. The epicardial clip of claim 14, wherein the component of the anterior segment includes a double-arm member including a first arm and a second arm forming a U-shape.

16. The epicardial clip of claim 14, wherein the component of the anterior segment includes a superior arm portion connected to an inferior arm portion.

17. The epicardial clip of claim 16, wherein the inferior arm portion includes an elastic band stretched between a first anchor point and a second anchor point.

18. The epicardial clip of claim 16, wherein the inferior arm portion is positioned at the inferior aspect of the transverse sinus.

19. The epicardial clip of claim 18, wherein the superior arm portion is positioned at the superior aspect of the transverse sinus.

20. The epicardial clip of claim 14, wherein the curved member includes a coupler for coupling the anterior segment to the lateral segment.

21. The epicardial clip of claim 20, wherein the coupler has an imaginary longitudinal axis, and wherein the anterior segment is rotatable about the imaginary longitudinal axis of the coupler.

22. The epicardial clip of claim 21, wherein the anterior segment is rotatable through an angle of at least 30 degrees.

23. The epicardial clip of claim 21, wherein the anterior segment is rotatable through an angle of at least 60 degrees.

24. The epicardial clip of claim 14, wherein the anterior segment is positioned in the transverse sinus and the posterior segment is positioned at or below the atrioventricular groove.

25. The epicardial clip of claim 14, wherein the component of the anterior segment lies in an imaginary plane and the posterior segment lies in another imaginary plane, wherein the component of the anterior segment does not lie in the imaginary plane of the posterior segment.

26. The epicardial clip of claim 14, wherein the posterior segment includes an over-mold covering.

27. An epicardial clip for reshaping the annulus of the mitral valve of a heart, the heart including a left atrium, a left ventricle, a transverse sinus, and an atrioventricular groove, the mitral valve lying in a plane between the left atrium and the left ventricle of the heart, the clip comprising:

a curved member having a first end and a second end, the member forming;

i) an anterior segment positioned on or superior to the plane of the mitral valve;

ii) a posterior segment positioned on or inferior to the plane of the mitral valve; and

iii) a lateral segment extending between the anterior segment and the posterior segment, the lateral segment including a curve extending around a lateral portion of the heart.

28. The epicardial clip of claim 27, wherein the curve is a helical curve.

29. The epicardial clip of claim 27, wherein the plane of the mitral valve intersects at least one of the lateral segment and the posterior segment.

30. The epicardial clip of claim 27, wherein the anterior segment includes a curved portion having a curvature opposite that of the curvature of the lateral segment.

31. The epicardial clip of claim 27, wherein the anterior segment includes a curved portion having a curvature generally perpendicular to a curvature of the curve of the lateral segment.

32. The epicardial clip of claim 31, wherein the curved portion of the anterior segment follows a curvature of an aorta extending from the heart.

33. The epicardial clip of claim 27, wherein the anterior segment includes a curved portion having a curvature generally perpendicular to the plane of the mitral valve.

34. The epicardial clip of claim 33, wherein the curved portion of the anterior segment follows a curvature of a floor of the transverse sinus.

35. The epicardial clip of claim 27, wherein the anterior segment is positioned in the transverse sinus.

36. The epicardial clip of claim 27, wherein the posterior segment is positioned on or inferior to the atrioventricular groove.

37. The epicardial clip of claim 27, wherein at least a portion of the member is covered with a biocompatible covering.

38. The epicardial clip of claim 37, wherein the biocompatible covering is a silicone material.

39. The epicardial clip of claim 27, wherein the clip further includes one or more pads extending from the member to contact an exterior surface of the heart.

40. The epicardial clip of claim 27, wherein the anterior segment is proximate the first end of the member, and wherein the clip further includes a bulbous member disposed at the first end of the member.

41. The epicardial clip of claim 27, further comprising a compliant material encasing at least a portion of the member.

42. The epicardial clip of claim 41, wherein the posterior segment and the lateral segment are encased with the compliant material, and wherein the anterior segment is not encased with the compliant material.

43. The epicardial clip of claim 27, further comprising a fabric material covering at least a portion of the member.

44. The epicardial clip of claim 27, further comprising a bioabsorbable covering material covering at least a portion of the member.

45. An epicardial clip for reshaping the annulus of the mitral valve of a heart, wherein the epicardial clip may be defined in an imaginary coordinate system having an origin, an x-axis extending from the origin, a y-axis extending from the origin and perpendicular to the x-axis, and a z-axis extending from the origin and perpendicular to both the x-axis and the y-axis, the clip comprising:

a curved member having a first end and a second end, the first end of the member positioned at the origin;

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

the anterior segment beginning at the origin and extending in a positive x-direction along the x-axis;

the lateral segment extending from the anterior segment including a straight portion extending in a positive y-direction and a curve portion extending to the posterior segment;

the posterior segment extending from the lateral segment in a negative x-direction.

46. The epicardial clip of claim 45, wherein the lateral segment generates a coordinate change in a z-direction.

47. The epicardial clip of claim 45, wherein the posterior segment generates a coordinate change in an x-direction, a coordinate change in a y-direction, and a coordinate change in a z-direction.

48. An epicardial clip for reshaping the annulus of the mitral valve of a heart, wherein the epicardial clip may be defined in an imaginary coordinate system having an origin, an x-axis extending from the origin, a y-axis extending from the origin and perpendicular to the x-axis, and a z-axis extending from the origin and perpendicular to both the x-axis and the y-axis, the clip comprising:

a curved member having a first end and a second end, the first end of the member positioned at the origin;

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

the anterior segment beginning at the origin and extending in the x-direction along the x-axis;

the lateral segment including a helical curve extending from the anterior segment and generating a coordinate change in the z-direction between the anterior segment and the posterior segment; and

the posterior segment extending from the lateral segment and generating a coordinate change in the x-direction, a coordinate change in the y-direction and a coordinate change in the z-direction.

49. The epicardial clip of claim 48, wherein the coordinate system further includes an x-y plane parallel to both the x-axis and the y-axis, an x-z plane parallel to both the x-axis and the z-axis, and a y-z plane parallel to both the y-axis and the z-axis, wherein the posterior segment does not lay in the x-y plane, the x-z plane, or the y-z plane of the coordinate system.

50. The epicardial clip of claim 48, wherein the posterior segment includes an arc.

51. The epicardial clip of claim 48, wherein the anterior segment includes a straight portion.

52. The epicardial clip of claim 48, wherein the lateral segment has a radius of curvature in the range of about 5 to 70 millimeters.

53. The epicardial clip of claim 48, wherein the lateral segment has a radius of curvature in the range of about 30 to 46 millimeters.

54. The epicardial clip of claim 48, 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.

55. The epicardial clip of claim 48, wherein the distance across the clip between the anterior segment and the posterior segment is closest between the first end of the curved member and the second end of the curved member.

56. A clip positioned around an epicardial surface of a heart interior of the pericardium surrounding 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 clip comprising:

a curved member having a first end and a second end, the member forming;

a) an anterior segment extending from the first end;

b) a posterior segment extending from the second end; and

c) a lateral segment extending between the anterior segment and the posterior segment, the lateral segment including a curve;

wherein when the curved member is viewed from above, the member has a U-shape.

57. The clip of claim 56, wherein when the curved member is viewed laterally, an acute angle is defined between the anterior segment and the posterior segment.

58. The clip of claim 56, wherein the curve is a helical curve.

59. The clip of claim 56, 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.

60. The clip of claim 56, wherein the anterior segment is configured to be positioned in the transverse sinus of the heart posterior to the aorta and pulmonary trunk and anterior to the superior vena cava.

61. The clip of claim 56, wherein the posterior segment is configured to be positioned on or inferior to the atrioventricular groove of the heart.

62. A method of epicardial treatment of mitral regurgitation associated with the mitral valve of a heart, the anatomy of the heart including an aorta, a pulmonary trunk, a superior vena cava, a transverse sinus, a left atrial appendage, and an oblique sinus, the method comprising:

providing a clip having an anterior segment, a posterior segment, and a lateral segment extending between the anterior segment and the posterior segment;

positioning the anterior segment in the transverse sinus of the heart; and

positioning the posterior segment on or inferior to the atrioventricular groove of the heart;

wherein the clip reshapes the annulus of the mitral valve.

63. The method of claim 62, wherein the posterior segment applies pressure on the posterior wall of the left ventricle, improving coaptation of the mitral valve.

64. The method of claim 62, wherein the lateral segment extends around a lateral side of the heart below the left atrial appendage of the heart.

65. The method of claim 62, wherein the lateral segment extends around a lateral side of the heart above the left atrial appendage of the heart.

66. The method of claim 62, wherein the mitral valve lies in a plane, and wherein the anterior segment extends above the plane of the mitral valve.

67. The method of claim 62, wherein the mitral valve lies in a plane, and wherein the posterior segment extends below the plane of the mitral valve.

68. The method of claim 62, further comprising a pad extending from the clip, wherein the pad applies pressure on the posterior wall of the left ventricle, improving coaptation of the mitral valve.

69. A method of epicardial treatment of mitral regurgitation associated with the mitral valve of a heart of a patient, the anatomy of the heart including a right atrium, a right ventricle, a left atrium, a left ventricle, an aorta, a pulmonary trunk, a superior vena cava, a transverse sinus, an oblique sinus, an atrioventricular groove, right pulmonary veins, left pulmonary veins, pericardium, and a left atrial appendage, the method comprising:

providing a thoracoscopic port in the right chest of the patient;

advancing an endoscopic device through the thoracoscopic port;

incising the right pericardium to gain access to a pericardial cavity;

advancing a visualization cannula into the transverse pericardial sinus via a path anterior to the superior vena cava and posterior to the ascending aorta;

tracking a distal end of a snare catheter from the transverse sinus into the oblique sinus while a proximal end of the snare catheter remains exterior of the chest of the patient through the thoracoscopic port;

repositioning the visualization cannula into the oblique sinus;

retrieving the distal end of the snare catheter;

withdrawing the distal end of the snare catheter out of the thoracoscopic port exterior of the chest of the patient;

providing a clip having a first leg, a second leg and a central portion between the first leg and the second leg;

loading the clip onto the proximal end and the distal end of the snare catheter exterior of the thoracoscopic port;

advancing the clip, disposed in a delivery tube, through the thoracoscopic port;

deploying the clip from the delivery tube, thereby expanding the clip;

advancing a portion of the clip into the transverse sinus and a portion of the clip into the oblique sinus or at or inferior to the atrioventricular groove;

securing the snare catheter to the first leg of the clip and the second leg of the clip; and

excising excess lengths of the snare catheter.

70. The method of claim 69, wherein the thoracoscopic port is located in the third intercostal space.

71. The method of claim 69, wherein the thoracoscopic port is located in the fifth intercostal space.

72. The method of claim 69, wherein the right pericardium is incised 1-2 cm anterior to the right phrenic nerve.

73. The method of claim 69, wherein the snare catheter is crimped to the first leg of the clip and the snare catheter is crimped to the second leg of the clip.