Stents, Valved-Stents, and Methods and Systems for Delivery Thereof

• US 20110022157A1
• Filed: 10/27/2008
• Published: 01/27/2011
• Est. Priority Date: 10/25/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Hefti, Jean-Luc, Essinger, Jacques, Delaloye, Serge, Delaloye, Stephane
• Granted Patent: US 8,647,381 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section (102) a second stent section (104) a third stent section (106) and a fourth stent section (108).

Claims

1-58. -58. (canceled)

59. An aortic replacement valve for use within a human body comprising:

a stent component comprising

a first end and a second end, wherein the first end is the proximal end of the replacement valve for positioning within or adjacent the ventricle of the heart of the human body and the second end is the distal end for positioning within or adjacent the aorta of the human body,

the stent component further comprising a plurality of sections including;

a first stent section defining an at least partly conical body, wherein the first stent section defines the proximal end of the stent component;

a second stent section in communication with the first stent section and defining an at least partly conical body, wherein the conical body of the first stent section slopes outwardly in the direction of the first end, and wherein the conical body of the second stent section slopes outwardly in the direction of the second end;

a distal stent section defining an at least partly conical body, wherein the distal stent section defines the second end and includes a plurality of stabilization arches projecting distally to stabilize the aortic replacement valve within the aorta.

60. The replacement valve of claim 59, wherein the distal section comprises a third stent section and a fourth stent section, wherein:

the third stent section is in communication with the second stent section,

the third stent section comprises valve fixation arches and is configured to house at least a portion of the valve component,

the fourth stent section is in communication with the third stent section,

the fourth stent section comprises the stabilization arches and defines the second end.

61. The replacement valve of claim 60, wherein the third stent section includes valve fixation elements.

62. The replacement valve according to claim 59, wherein the outward slope of the first stent section is defined by an angle α

2 relative to a longitudinal axis of the replacement valve of between about 5 degrees to about 30 degrees.

63. The replacement valve according to claim 59, wherein the outward slope of the second stent section is defined by an angle α

1 relative to a longitudinal axis of the replacement valve of between about 10 degrees to about 80 degrees.

64. The replacement valve according to claim 59, wherein the end of the second stent section forms an inwardly bent tip bent toward the longitudinal axis at an angle (α

3) of between about 0 degrees to about 180 degrees.

65. The replacement valve according to claim 60, wherein an angle α

4 represents an offset angle between a longitudinal axis of the stabilization arches of the fourth section of the stent in the expanded configuration and the stabilization arches of the fourth section of the stent component in the expanded configuration, wherein α

4 is between about 0 degrees to about 60 degrees.

66. The replacement valve according to claim 60, wherein an angle α

5 represents an offset angle from a longitudinal axis of the stabilization arches of the fourth section of the stent in the expanded configuration and the stabilization arches of the fourth section of the stent component in the expanded configuration, wherein angle α

5 is between about 0 degrees to about 20 degrees.

67. The replacement valve according to claim 59, further comprising attachment elements provided at the first end for removably attaching the stent component to a delivery device.

68. The replacement valve according to claim 59, wherein the first stent section is configured to create a form fit with an inflow tract of a native aortic valve for preventing migration of the replacement valve towards the ascending aorta and/or wherein the second stent section is configured to create a form fit with an outflow tract and native leaflets of a native aortic valve for preventing migration of the replacement valve towards the left ventricle.

69. The replacement valve according to claim 60, wherein the fourth stent section is configured to engage the ascending aorta to orient the replacement valve and an associated delivery system longitudinally within an aorta/aortic annulus and prevent tilting of the replacement valve when implanted.

74. A method for replacing an aortic valve within a human body, the method comprising:

covering a stent-valve with a sheath in order to maintain the stent-valve in a collapsed configuration;

inserting the stent-valve still in the collapsed configuration into the human body via direct access through a wall of the heart;

partially expanding the stent-valve by sliding the sheath towards the left ventricle of the heart, wherein said sliding of the sheath towards the left ventricle causes expansion of a distal end of the stent-valve while the proximal end of the stent-valve remains constrained by the sheath; and

further sliding the sheath towards the left ventricle of the heart in order to substantially release the entire stent-valve such that the stent-valve is allowed to expand to an expanded configuration.

75. The method of claim 74, further comprising sliding the sheath in the opposite direction prior to said full expansion in order to recapture the stent-valve within the sheath.

76. A method for cardiac valve replacement comprising:

releasing a distal end of a stent-valve from a sheath, wherein the distal end comprising a radiopaque marker;

rotating the stent-valve, if necessary, to orient the stent-valve appropriately with respect to the coronary arteries;

releasing arches of the stent-valve from the sheath, in order to cause the arches to contact the aorta;

releasing a first conical crown of the stent-valve from the sheath, in order to cause the first conical crown to contact native valve leaflets; and

releasing a second crown of the stent-valve from the sheath, in order to cause the second crown to contact an annulus/inflow tract, wherein the second crown comprises the proximal section of the stent-valve and said releasing of the second crown comprises fully releasing the stent-valve from the sheath.

77. A method for cardiac valve replacement comprising:

releasing a distal end of a valved-stent from a sheath, wherein the distal end comprises a radiopaque marker and a plurality of arches;

rotating the valved-stent, if necessary, to orient the stent-valve appropriately with respect to the coronary arteries;

releasing the arches of the valved-stent from the sheath, in order to cause the arches to contact an area above a native valve;

releasing a first conical crown portion of the valved-stent from the sheath, in order to cause the first conical crown to contact the native valve leaflets; and

releasing a second crown portion of the valved-stent from the sheath, in order to cause the second crown to contact an annulus/inflow tract of the native valve, wherein the second crown is the proximal section of the stent-valve and said releasing the second crown comprises fully releasing the stent-valve from the sheath.

78. A method for replacing a worn or diseased valve comprising:

implanting a replacement valve by direct access through a wall of the heart, wherein the replacement valve comprises;

a valve component; and

a stent component to which the valve component is affixed thereto, the stent component comprising;

a longitudinal axis;

a first section including a substantially conical shape having a narrow end, a broad end and a predetermined first height; and

a second section including a substantially conical shape having a narrow end, a broad end and a predetermined second height;

wherein;

a center of each of the first section and the second section are arranged to align substantially with the longitudinal axis;

the narrow ends of the first section and second section are arranged to meet forming an annular groove to receive the annulus of worn or diseased cardiac valve at an implantation site of the heart,

the first height of the first section is greater than the second height of the second section; and

positioning the replacement valve so that the annular groove receives the annulus of the worn or diseased cardiac valve.

79. A method of implanting a replacement valve into a heart of a mammal comprising:

delivering a replacement valve to an implantation site of the heart of the mammal, wherein;

the implantation site comprises a release location and a final location; and

the release location is spaced apart from the final location in a blood upflow direction; and

releasing the replacement valve at the release location;

wherein;

the replacement valve slides into the final location upon at least one beat of the heart subsequent to the replacement valve being released at the release location.

80. A method of implanting a replacement valve into a heart of a mammal comprising:

delivering a replacement valve to an implantation site of the heart of the mammal, wherein;

the implantation site comprises a release location and a final location; and

the release location is spaced apart from the final location; and

releasing the replacement valve at the release location;

wherein;

the replacement valve slides into the final location upon at least one beat of the heart subsequent to the replacement valve being released at the release location.

81. The method according to claim 80, wherein the release location is spaced apart from the final location at a predetermined distance.

82. A method implanting a replacement valve into a heart of a mammal comprising:

delivering a replacement valve to an implantation site of the heart of the mammal, wherein;

the implantation site comprises a release location and a final location; and

the release location is spaced apart from the final location at a predetermined distance in a blood upflow direction; and

releasing the replacement valve at the release location;

wherein;

the replacement valve slides into the final location upon at least one beat of the heart subsequent to the replacement valve being released at the release location.

83. The method of implanting a replacement valve according to claim 82, wherein upon the replacement valve sliding into the final location, the replacement valve is substantially positioned to the final location.

84. The method according to claim 82, wherein the predetermined distance comprises a range.

85. The method according to claim 84, wherein the range comprise between about 3 mm and about 20 mm.

86. The method according to claim 84, wherein the range comprises between about 7 mm to about 11 mm.

87. The method according to claim 84, wherein the range comprises between about 8 mm to about 12 mm.

88. The method according to claim 84, wherein the range comprises between about 9 mm to about 13 mm.