Prosthetic valves with mechanically coupled leaflets
First Claim
Patent Images
1. A prosthetic valve comprising:
- a leaflet frame defining an annular shape having a leaflet frame inner surface, a leaflet frame outer surface opposite the leaflet frame inner surface, and at least two leaflet frame edges extending between the leaflet frame inner surface and the leaflet frame outer surface,the leaflet frame having a plurality of leaflet frame projections extending from each of one or more leaflet retention surfaces, wherein each leaflet frame projection includes a projection base portion and a projection head portion opposite the projection base portion, the plurality of leaflet frame projections being spaced apart from each other; and
one or more leaflets, each leaflet having a leaflet attachment region and a leaflet free edge,wherein the one or more leaflet retention surfaces includes at least a portion of the one or more of the leaflet frame edges, wherein each leaflet frame projection is coupled to the leaflet retention surface at the projection base portion, wherein each of the leaflet frame projections extends at least partially through the leaflet attachment region, and wherein the leaflets are retained on the leaflet frame.
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Accused Products
Abstract
Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with apertures located within the leaflet attachment region of a leaflet. Some embodiments are further directed toward pulmonary valved conduits incorporating such leaflet and leaflet frame constructs. Methods of making and using such prosthetic valve devices are also described amongst others.
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Citations
100 Claims
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1. A prosthetic valve comprising:
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a leaflet frame defining an annular shape having a leaflet frame inner surface, a leaflet frame outer surface opposite the leaflet frame inner surface, and at least two leaflet frame edges extending between the leaflet frame inner surface and the leaflet frame outer surface, the leaflet frame having a plurality of leaflet frame projections extending from each of one or more leaflet retention surfaces, wherein each leaflet frame projection includes a projection base portion and a projection head portion opposite the projection base portion, the plurality of leaflet frame projections being spaced apart from each other; and one or more leaflets, each leaflet having a leaflet attachment region and a leaflet free edge, wherein the one or more leaflet retention surfaces includes at least a portion of the one or more of the leaflet frame edges, wherein each leaflet frame projection is coupled to the leaflet retention surface at the projection base portion, wherein each of the leaflet frame projections extends at least partially through the leaflet attachment region, and wherein the leaflets are retained on the leaflet frame. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
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60. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet attachment region defines a plurality of leaflet apertures spaced apart from each other, each of the leaflet frame projections extending at least partially through a corresponding one of the plurality of leaflet apertures, wherein the one or more restraining elements are coupled to or unitary with the leaflet frame projections configured to impede decoupling of the leaflets from the leaflet frame, wherein the restraining element is integral to each of the leaflet frame projections, wherein the restraining element includes a projection head portion. - View Dependent Claims (61, 76, 79, 80, 91, 92, 98, 99, 100)
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62. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein a distance between adjacent leaflet frame projections is less than 2 mm.
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63. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein a distance between adjacent leaflet frame projections is at least 0.5 mm.
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64. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the plurality of leaflet frame projections are unitary with the leaflet frame.
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65. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet frame has a leaflet frame first edge, a leaflet frame second edge opposite the leaflet frame first edge, and optionally at least one leaflet frame internal edge, and wherein a leaflet retention surface is one or more of the leaflet frame second edge, the leaflet frame first edge, and the at least one leaflet frame internal edge. - View Dependent Claims (66)
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67. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region and a leaflet free edge; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet frame has a leaflet frame first edge, a leaflet frame second edge opposite the leaflet frame first edge, and optionally at least one leaflet frame internal edge, and wherein a leaflet retention surface is one or more of the leaflet frame second edge, the leaflet frame first edge, and the at least one leaflet frame internal edge, wherein the leaflet frame has a plurality of commissure posts and a set of leaflet window frame elements flanking each side of each commissure post, wherein each set of leaflet window frame elements and two of the plurality of commissure posts defines one of a plurality of leaflet windows. - View Dependent Claims (68, 69, 70, 71, 72, 73, 74)
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75. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet is formed of a leaflet material that is reinforced at the leaflet attachment region.
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77. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet frame projections extend in a direction that is substantially parallel with a central longitudinal axis of the prosthetic valve, further comprising a leaflet frame jacket coupled to the leaflet frame and having a lip that projects inward and is configured to impede the leaflets decoupling from the leaflet frame. - View Dependent Claims (78)
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81. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet attachment region defines a plurality of leaflet apertures spaced apart from each other, each of the leaflet frame projections extending at least partially through a corresponding one of the plurality of leaflet apertures, wherein the one or more restraining elements are coupled to or unitary with the leaflet frame projections configured to impede decoupling of the leaflets from the leaflet frame, wherein the restraining element is a deformable locking bar restraining element comprising; a deformable locking bar including a bar base end and a bar free end opposite the bar base end, the deformable locking bar extending from a leaflet retention surface at the bar base end, the deformable locking bar having a length that spans a distance between the bar base end and at least one leaflet frame projection so as to impede decoupling of a respective leaflet from the respective leaflet frame projections. - View Dependent Claims (82, 83, 84, 95)
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85. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet attachment region defines a plurality of leaflet apertures spaced apart from each other, each of the leaflet frame projections extending at least partially through a corresponding one of the plurality of leaflet apertures, wherein the one or more restraining elements are coupled to or unitary with the leaflet frame projections configured to impede decoupling of the leaflets from the leaflet frame, wherein the restraining element is an attachable locking bar restraining element comprising; an attachable locking bar including a bar-shaped element, the attachable locking bar having a length that spans a distance between at least two leaflet frame projections, wherein the attachable locking bar extends over the at least two leaflet frame projections and coupled thereto so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.
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86. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet attachment region defines a plurality of leaflet apertures spaced apart from each other, each of the leaflet frame projections extending at least partially through a corresponding one of the plurality of leaflet apertures, wherein the one or more restraining elements are coupled to or unitary with the leaflet frame projections configured to impede decoupling of the leaflets from the leaflet frame, wherein the restraining element is an attachable locking bar restraining element comprising; an attachable locking bar including a bar-shaped element with a retention hook at each end; and a pair of locking clips spaced apart and coupled to a leaflet retention surface, wherein each of the locking clips is operable to couple with a respective retention hook of the locking bar, the attachable locking bar having a length that spans a distance between the pair of locking clips, wherein at least one leaflet frame projection is located between the pair of locking clips, wherein the attachable locking bar extends over a projection head portion of the at least one leaflet frame projection so as to impede decoupling of a respective leaflet from respective leaflet frame projections. - View Dependent Claims (87, 88, 96)
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89. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet frame projections comprise a shape memory material, wherein the leaflet frame projections define a first shape suitable to allow the advancement of the leaflet attachment region onto the leaflet frame projections and wherein the leaflet frame projections define a second shape that is suitable to impede decoupling of the leaflet attachment region from the leaflet frame projections.
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90. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet frame projections comprise a plastically deformable material, wherein the leaflet frame projections define a first shape suitable to allow the advancement of the leaflet attachment region onto the leaflet frame projections and wherein the leaflet frame projections define a second shape by plastically deforming that is suitable to impede decoupling of the leaflet attachment region from the leaflet frame projections.
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93. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet frame is operable to have a first diameter and a second diameter that is lamer than the first diameter suitable for use as a transcatheter prosthetic valve, wherein when the leaflet frame is at the first diameter opposing leaflet frame projections abut each other so as to prevent further compression of leaflet frame elements preventing the crushing of the leaflet. - View Dependent Claims (94)
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97. A prosthetic valve comprising:
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a plurality of leaflets, each leaflet having a leaflet attachment region; a leaflet frame defining an annular shape having one or more leaflet frame edges, the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame, wherein the leaflet attachment region defines a plurality of leaflet apertures spaced apart from each other, each of the leaflet frame projections extending at least partially through a corresponding one of the plurality of leaflet apertures, wherein the one or more restraining elements are coupled to or unitary with the leaflet frame projections configured to impede decoupling of the leaflets from the leaflet frame, wherein the restraining element is a cap that covers at least a portion of one or more leaflet frame projections suitable to impede decoupling of the leaflet attachment region from the one or more leaflet frame projections.
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Specification