Degenerative Valvular Disease Specific Annuloplasty Rings

• US 20090177276A1
• Filed: 09/11/2008
• Published: 07/09/2009
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Adzich, Vaso, Carpentier, Alain F., Adams, David H.
• Granted Patent: US 7,959,673 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture

Abstract

Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases, such as fibroelastic deficiency (FED), Marfan'"'"'s or Barlow'"'"'s. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes. A bulge on the sewing cuff forms a step on the outflow side for ease of suturing, which may be indicated by a suture line.

Claims

1. A method of implanting an annuloplasty ring at a patient'"'"'s valve annulus afflicted by a degenerative heart valve disease, comprising:

measuring the size of the valve annulus;

referencing the characteristic shape of the annulus of a heart valve afflicted by the degenerative heart valve disease;

selecting an annuloplasty ring having a size and shape that corresponds to the characteristic shape of the degenerative heart valve disease for that annulus size; and

implanting the selected annuloplasty ring at the patient'"'"'s valve annulus.

2. The method of claim 1, wherein the step of referencing comprises echocardiographic and intraoperative measurements of the patient'"'"'s valve annulus.

3. The method of claim 2, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and the measurements include transverse diameter, antero-posterior diameter, and at least three oblique dimensions extending from the geometric center of the annulus to the posterior aspect of the annulus.

4. The method of claim 1, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and the degenerative heart valve disease manifests as mitral valve regurgitation.

5. The method of claim 1, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and wherein the ring defines a major axis and a minor axis and is selected to have a size and shape symmetric about the minor axis that preserves or restores full leaflet mobility to the patient'"'"'s mitral valve.

6. The method of claim 5, wherein the size and shape of the ring addresses the problems of excess tissue and related valve dysfunction commonly seen in degenerative valvular diseases.

7. The method of claim 6, wherein the size and shape of the ring conforms to the annulus shape for Barlow'"'"'s disease for rings having a size of 34 mm or larger.

8. The method of claim 1, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and wherein the ring has an anterior segment opposite a posterior segment, and two side segments, and varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

9. The method of claim 1, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and the ring generally defines a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and for rings having a size of 34 mm or larger the D-shape diminishes and becomes generally more circular.

10. The method of claim 1, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and wherein the ring has an anterior segment opposite a posterior segment, and two side segments, and the ring is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

11. The method of claim 10, wherein the ratio C/D is about 3:

1.

12. A method of manufacturing an annuloplasty ring, comprising:

referencing the characteristic shape of the annulus of a heart valve afflicted by a degenerative heart valve disease; and

forming the annuloplasty ring with a size and shape that corresponds to the characteristic shape of the annulus.

13. The method of claim 12, wherein the characteristic shape of the annulus of the heart valve afflicted by the degenerative heart valve disease is obtained partly by echocardiographic and intraoperative measurements of an afflicted annulus.

14. The method of claim 13, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and the measurements include transverse diameter, antero-posterior diameter, and at least three oblique dimensions extending from the geometric center of the annulus to the posterior aspect of the annulus.

15. The method of claim 12, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and the degenerative heart valve disease manifests as mitral valve regurgitation.

16. The method of claim 12, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming the ring to have a major axis and a minor axis and a size and shape symmetric about the minor axis that preserves or restores full leaflet mobility to the patient'"'"'s mitral valve.

17. The method of claim 16, wherein the size and shape of the ring addresses the problems of excess tissue and related valve dysfunction commonly seen in degenerative valvular diseases.

18. The method of claim 17, wherein the size and shape of the ring conforms to the annulus shape for Barlow'"'"'s disease for rings having a size of 34 mm or larger.

19. The method of claim 12, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming an anterior segment opposite a posterior segment, and two side segments, and varying the flexibility around the ring periphery with the posterior segment being more flexible than the anterior segment.

20. The method of claim 12, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming generally a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and for rings having a size of 34 mm or larger reducing the prominence of the D-shape such that the ring is more circular.

21. The method of claim 12, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming an anterior segment opposite a posterior segment, and two side segments, and forming the ring to be three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

22. The method of claim 21, wherein the ratio C/D is about 3:

1.

23. A mitral annuloplasty ring, comprising:

a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, wherein the periphery is defined in plan view by four circular arcs, one for each segment, connected at points of tangency.

24. The mitral annuloplasty ring of claim 23, wherein the ring defines:

a horizontal line segment a1-a2 having a length A along the major axis of the ring, and

wherein two of the four circular arcs defining the ring body periphery consist of portions of two congruent circles c2, c3 that include points a1 and a2, respectively, and both have a center along line segment a1-a2 and include a point b1 at the center of line segment a1-a2.

25. The mitral annuloplasty ring of claim 24, wherein the ring further defines:

a vertical line segment b1-b2 extending from center point b1 and having a length B′

=(0.3125·

A),

a vertical line segment b1-b3 opposite b1-b2, wherein the line segment b2-b3 defines the minor axis of the ring and has a length B;

wherein a third one of the four circular arcs defining the ring body periphery consists of an arc T1-T4 that is tangent at both ends to the outer circles c2 and c3 and includes point b2; and

wherein a fourth one of the four circular arcs defining the ring body periphery consists of an arc T2-T3 that is tangent at both ends to the outer circles c2 and c3 and includes point b3.

26. The mitral annuloplasty ring of claim 25, wherein the lengths A and B of the ring body are selected from the groups consisting of:

A is 34 mm, B is about 23.5 mm;

A is 36 mm, B is about 25.5 mm;

A is 38 mm, B is about 27.2 mm; and

A is 40 mm, B is about 28.7 mm.

27. The mitral annuloplasty ring of claim 23, wherein the ring body further includes varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

28. The mitral annuloplasty ring of claim 23, wherein the ring body further includes a three-dimensional periphery with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

29. The mitral annuloplasty ring of claim 28, wherein the ratio C/D is about 3:

1.

30. A method of forming a mitral annuloplasty ring, comprising:

shaping a ring body having a periphery with an anterior segment opposite a posterior segment, and two side segments,

wherein the periphery is defined in plan view by four circular arcs, one for each segment, connected at points of tangency.

31. The method of claim 30, wherein the step of shaping comprises geometrically constructing the periphery by the steps of:

drawing a horizontal line segment a1-a2 having a length A of the major axis of the ring being constructed;

draw two congruent circles c2, c3 including points a1 and a2, respectively, and both including a center point b1 along line a1-a2,

wherein two of the four circular arcs defining the ring body periphery consist of portions of circles c2 and c3.

32. The method of claim 31, further including the steps of:

drawing a vertical line segment b1-b2 from point b1 and having a length B′

=(0.3125·

A),

drawing a vertical line segment b1-b3 opposite b1-b2, wherein the line segment b2-b3 defines the minor axis of the ring being constructed and has a length B;

drawing arc T1-T4 tangent at both ends to the outer circles c2 and c3 and including point b2; and

drawing arc T2-T3 tangent at both ends to the outer circles c2 and c3 and including point b3,

wherein the other two of the four circular arcs defining the ring body periphery are arcs T1-T4 and T2-T3.

33. The method of claim 32, wherein the lengths A and B of the ring body are selected from the groups consisting of:

A is 34 mm, B is about 23.5 mm;

A is 36 mm, B is about 25.5 mm;

A is 38 mm, B is about 27.2 mm; and

A is 40 mm, B is about 28.7 mm.

34. The method of claim 30, further including forming the ring body to have varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

35. The method of claim 30, wherein the step of shaping further includes shaping the ring body to have a three-dimensional periphery with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

36. The method of claim 35, wherein the ratio C/D is about 3:

1.

37. A mitral annuloplasty ring for correcting a patient'"'"'s mitral valve annulus afflicted by a degenerative heart valve disease, comprising:

a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, the ring body having a size and shape that corresponds to the characteristic shape of the heart valve afflicted by the degenerative heart valve disease for that annulus size.

38. The mitral annuloplasty ring of claim 37, wherein the characteristic shape of the annulus of the heart valve afflicted by the degenerative heart valve disease is obtained partly by echocardiographic and intraoperative measurements of an afflicted annulus.

39. The mitral annuloplasty ring of claim 38, wherein the patient'"'"'s valve annulus is the mitral valve annulus, and the measurements include transverse diameter, antero-posterior diameter, and at least three oblique dimensions extending from the geometric center of the annulus to the posterior aspect of the annulus.

40. The mitral annuloplasty ring of claim 37, wherein the degenerative heart valve disease manifests as mitral valve regurgitation.

41. The mitral annuloplasty ring of claim 37, wherein the ring body defines a major axis and a minor axis has a size and shape symmetric about the minor axis that preserves or restores full leaflet mobility to the patient'"'"'s mitral valve.

42. The mitral annuloplasty ring of claim 41, wherein the size and shape of the ring body addresses the problems of excess tissue and related valve dysfunction commonly seen in degenerative valvular diseases.

43. The mitral annuloplasty ring of claim 42, wherein the size and shape of the ring body conforms to the annulus shape for Barlow'"'"'s disease for rings having a size of 34 mm or larger.

44. The mitral annuloplasty ring of claim 37, wherein the ring body has varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

45. The mitral annuloplasty ring of claim 37, wherein the ring body generally defines a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and for rings having a size of 34 mm or larger the D-shape diminishes and becomes generally more circular.

46. The mitral annuloplasty ring of claim 37, wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

47. The mitral annuloplasty ring of claim 46, wherein the ratio C/D is about 3:

1.

48. A mitral annuloplasty ring, comprising:

a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, the ring body in plan view defining a major axis A and a minor axis B extending across from the anterior segment to the posterior segment, the dimensional pairs B and A being selected from the groups consisting of;

A is about 34 mm and B is about 23.5 mm;

A is about 36 mm and B is about 25.5 mm;

A is about 38 mm and B is about 27.2 mm; and

A is about 40 mm and B is about 28.7 mm.

49. The mitral annuloplasty ring of claim 48, wherein the ratio of B/A is greater than or equal to 0.69 and less than or equal to 0.73.

50. The mitral annuloplasty ring of claim 48, wherein the axial elevation of the anterior segment is higher than the axial elevation of the posterior segment.

51. The mitral annuloplasty ring of claim 50, wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

52. The mitral annuloplasty ring of claim 51, wherein the ratio C/D is about 3:

1.

53. The mitral annuloplasty ring of claim 48, wherein the ring body has varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment.

54. The mitral annuloplasty ring of claim 48, wherein the ring body generally defines a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and wherein as the ring size increases the D-shape diminishes and becomes generally more circular.

55. A mitral annuloplasty ring, comprising:

a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, the ring body in plan view defining a major axis A and a minor axis B extending across from the anterior segment to the posterior segment, wherein A is about 34 mm and B is about 23.5 mm.

56. The mitral annuloplasty ring of claim 55, wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

57. The mitral annuloplasty ring of claim 56, wherein the ratio C/D is about 3:

1.

58. A mitral annuloplasty ring, comprising:

a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, the ring body in plan view defining a major axis A and a minor axis B extending across from the anterior segment to the posterior segment, wherein A is about 36 mm and B is about 25.5 mm.

59. The mitral annuloplasty ring of claim 58, wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

60. The mitral annuloplasty ring of claim 59, wherein the ratio C/D is about 3:

1.

61. A mitral annuloplasty ring, comprising:

a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, the ring body in plan view defining a major axis A and a minor axis B extending across from the anterior segment to the posterior segment, wherein A is about 38 mm and B is about 27.2 mm.

62. The mitral annuloplasty ring of claim 61, wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

63. The mitral annuloplasty ring of claim 62, wherein the ratio C/D is about 3:

1.

64. A mitral annuloplasty ring, comprising:

a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, the ring body in plan view defining a major axis A and a minor axis B extending across from the anterior segment to the posterior segment, wherein A is about 40 mm and B is about 28.7 mm.

65. The mitral annuloplasty ring of claim 64, wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

66. The mitral annuloplasty ring of claim 65, wherein the ratio C/D is about 3:

1.

67. A method of manufacturing mitral annuloplasty rings, comprising:

forming mitral annuloplasty rings of different sizes where each ring has a ring body defining a periphery with an anterior segment opposite a posterior segment, and two side segments, each ring body in plan view defining a major axis dimension A and a minor axis dimension B extending across from the anterior segment to the posterior segment, and each ring having an identified orifice size, wherein the ring bodies in plan view approximating a D-shape for smaller ring sizes and having gradually more circular shapes for larger ring sizes.

68. The method of claim 67, wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

69. The method of claim 68, wherein the ratio C/D is about 3:

1.

70. The method of claim 67, wherein the shapes of the ring bodies in plan view for different orifice sizes change to comply with predicted shapes of degenerative valvular disease for different annulus orifice sizes.

71. The method of claim 67, wherein the ratio B/A for each ring body increases with increasing ring orifice size.

72. The method of claim 67, wherein the dimensional pairs B and A are selected from the groups consisting of:

A is about 34 mm and B is about 23.5 mm;

A is about 36 mm and B is about 25.5 mm;

A is about 38 mm and B is about 27.2 mm; and

A is about 40 mm and B is about 28.7 mm.

73. A set of annuloplasty rings for correcting a heart valve annulus, comprising:

a set of rings each having a ring body able to resist deformation when subjected to the stress imparted thereon by the valve annulus and arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the valve annulus when the annuloplasty ring is implanted, each ring having an identified orifice size; and

wherein the proportional shapes of the ring bodies change with increasing orifice sizes of the rings in the set.

74. The set of annuloplasty rings of claim 73, wherein the annuloplasty rings are configured for implant in the mitral position and smaller rings in the set generally define a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and as the orifice sizes of the rings become larger the D-shape diminishes and becomes generally more circular.

75. The set of annuloplasty rings of claim 74, wherein the ring bodies are three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

76. The set of annuloplasty rings of claim 73, wherein the ring bodies are three-dimensional with opposite sides of the ring curving upward above a datum plane, and wherein the change in proportional shapes of the ring bodies is a change in the ratio of the heights of the opposite sides.

77. The set of annuloplasty rings of claim 73, wherein the annuloplasty rings are configured for implant in the mitral position and have an anterior segment opposite a posterior segment, and wherein the ring bodies are three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>

1.

78. The set of annuloplasty rings of claim 77, wherein the ratio C/D is about 3:

1.

79. The set of annuloplasty rings of claim 77, wherein the height C of the anterior segment rises up to at least 6 mm above the common datum plane.

80. The set of annuloplasty rings of claim 73, wherein the proportional shapes of the ring bodies change to comply with predicted shapes of a particular valvular disease for different annulus orifice sizes.

81. The set of annuloplasty rings of claim 80, wherein the annuloplasty rings are configured for implant in the mitral position and have an anterior segment opposite a posterior segment, and the valvular disease is Barlow'"'"'s valve.

82. The set of annuloplasty rings of claim 80, wherein the predicted shapes of a particular valvular disease have been calculated from echocardiographic and intraoperative measurements.

83. The set of annuloplasty rings of claim 82, wherein the annuloplasty rings are configured for implant in the mitral position and have an anterior segment opposite a posterior segment, and wherein the measurements include transverse diameter, antero-posterior diameter, and at least three oblique dimensions extending from the geometric center of the annulus to the posterior aspect of the annulus.

84. The set of annuloplasty rings of claim 73, wherein the annuloplasty rings are configured for implant in the tricuspid position.

85. A set of mitral annuloplasty rings comprising:

a set of rings each having a ring body able to resist deformation when subjected to the stress imparted thereon by the mitral valve annulus and arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted, each ring body in plan view defining a major axis A and a minor axis B extending across from an anterior segment to a posterior segment, and each ring having an identified orifice size; and

wherein the proportional shapes of the ring bodies change to comply with predicted shapes of degenerative valvular disease for different annulus orifice sizes.

86. The set of mitral annuloplasty rings of claim 85, wherein the plan view shape of the ring bodies is a more pronounced D-shape for smaller ring orifice sizes and becomes gradually more circular as the orifice size increases.

87. The set of mitral annuloplasty rings of claim 85, wherein the ratio B/A for each ring body changes with increasing ring orifice size.

88. The set of mitral annuloplasty rings of claim 85, wherein the ring bodies are three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, and wherein the ratio C/D changes with increasing ring orifice size.

89. The set of mitral annuloplasty rings of claim 85, wherein the ring bodies have varying flexibility around their peripheries, and wherein the relative flexibility between the anterior segment and the posterior segment changes with increasing ring orifice size.

90. The set of mitral annuloplasty rings of claim 85, wherein each ring further includes a suture-permeable covering over the ring body, and the covering has a smooth relatively flat inflow side and a stepped outflow side.

91. A set of mitral annuloplasty rings comprising:

a set of rings each having a ring body able to resist deformation when subjected to the stress imparted thereon by the mitral valve annulus and arranged around a flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted, each ring body in plan view defining a major axis A and a minor axis B extending across from an anterior segment to a posterior segment, and each ring having an identified orifice size; and

wherein the ratio B/A for each ring body changes with increasing ring orifice size.

92. The set of mitral annuloplasty rings of claim 91, wherein the ring bodies are generally D-shaped in plan view with a relatively straight anterior segment opposite a curved posterior segment, and wherein the shape of the ring bodies is a more pronounced D-shape for smaller rings and becomes gradually more circular with increasing ring orifice size.

93. The set of mitral annuloplasty rings of claim 91, wherein the ring bodies are three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, and wherein the ratio C/D changes with increasing ring orifice size.

94. The set of mitral annuloplasty rings of claim 91, wherein each ring further includes a suture-permeable covering over the ring body, and the covering has a smooth relatively flat inflow side and a stepped outflow side.

95. The set of mitral annuloplasty rings of claim 91, wherein the ring bodies each define a continuous periphery.

96. The set of mitral annuloplasty rings of claim 91, wherein the ring bodies each define a discontinuous periphery.