US20110022157A1 — Stents, Valved-Stents, and Methods and Systems fo…

Claim 1

Independent Claim 5 words

1 .- 58 . (canceled)

Claim 2

Dependent Claim 5 words

1 .- 58 . (canceled)

Claim 3

Dependent Claim 197 words

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.

Claim 4

Dependent Claim 197 words

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.

Claim 5

Dependent Claim 82 words

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.

Claim 6

Dependent Claim 18 words

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

Claim 7

Dependent Claim 44 words

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.

Claim 8

Dependent Claim 44 words

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.

Claim 9

Dependent Claim 43 words

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.

Claim 10

Dependent Claim 66 words

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.

Claim 11

Dependent Claim 67 words

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.

Claim 12

Dependent Claim 29 words

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.

Claim 13

Dependent Claim 78 words

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.

Claim 14

Dependent Claim 46 words

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.

Claim 15

Dependent Claim 89 words

70 . A system for replacing a valve within a human body comprising: a delivery device; and an aortic replacement valve according to claim 1 , and further comprising a central, longitudinal axis and at least one attachment element for removable attachment of the stent-valve to a delivery device, wherein the at least one attachment element is provided at the proximal end of the stent component, and wherein the proximal end is defined as the end positioned within or adjacent the left ventricle when delivered from a transapical approach.

Claim 16

Dependent Claim 25 words

71 . The system according to claim 70 , wherein the at least one attachment element is formed generally in the shape of a hook.

Claim 17

Dependent Claim 137 words

72 . The system according to claim 70 , wherein the delivery device comprises: an inner member comprising a guide wire lumen and a stent holder; and an outer member comprising a sheath; wherein the stent holder comprises a groove for receiving the attachment element of the stent component, and wherein the inner member and the outer member are co-axially positioned and slidable relative to one another in order to transition from a closed position to an open position, such that in the closed position the sheath encompasses at least a portion of the stent-valve still attached to the stent holder constraining expansion of the stent-valve, and such that in the open position the outer sheath does not constrain expansion of the stent-valve and the stent-valve detaches from the stent holder and expands to an expanded configuration.

Claim 18

Dependent Claim 31 words

73 . The system according to claim 70 , wherein release of the stent-valve from the stent holder is facilitated by rotation of the stent holder relative to the attachment element.

Claim 19

Dependent Claim 131 words

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.

Claim 20

Dependent Claim 131 words

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.

Claim 21

Dependent Claim 31 words

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.

Claim 22

Dependent Claim 134 words

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.

Claim 23

Dependent Claim 134 words

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.

Claim 24

Dependent Claim 150 words

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.

Claim 25

Dependent Claim 150 words

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.

Claim 26

Dependent Claim 187 words

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.

Claim 27

Dependent Claim 187 words

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.

Claim 28

Dependent Claim 95 words

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.

Claim 29

Dependent Claim 95 words

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.

Claim 30

Dependent Claim 90 words

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.

Claim 31

Dependent Claim 90 words

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.

Claim 32

Dependent Claim 24 words

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

Claim 33

Dependent Claim 98 words

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.

Claim 34

Dependent Claim 98 words

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.

Claim 35

Dependent Claim 34 words

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.

Claim 36

Dependent Claim 16 words

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

Claim 37

Dependent Claim 21 words

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

Claim 38

Dependent Claim 21 words

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

Claim 39

Dependent Claim 21 words

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

Claim 40

Dependent Claim 21 words

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

Claim 41

Dependent Claim 20 words

89 . The method according to claim 82 , further comprising providing a replacement valve according to claim 1 .

Claim 42

Dependent Claim 19 words

90 . The method according to claim 82 , further comprising providing a system according to claim 70 .

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

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