TWO-PART EXPANDABLE HEART VALVE
First Claim
1. A two-part prosthetic heart valve, comprising:
- an expandable tubular primary stent sized to contact a heart valve annulus in an expanded state and having a plurality of discrete mating features;
an expandable secondary stent configured to be coupled to the primary stent and having a plurality of discrete mating features that mate with the mating features on the primary stent;
a plurality of valve leaflets attached to the secondary stent for occluding blood flow in one direction; and
at least one guidewire coupled to the primary stent and slideably engaged to the secondary stent for ensuring proper rotational alignment during advancement of the secondary stent toward the primary stent.
1 Assignment
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Accused Products
Abstract
Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The one-piece stents may include an annulus anchoring section, a sinus section with the membranes attached over sinus apertures, and a rigid outflow section. The two-piece stent may include a primary stent to provide a tubular base at the annulus, and a secondary stent having the membranes that couples within the primary stent. Lockout tabs to secure the stents in their expanded shapes are provided. Also, alignment structure may be provided to ensure concentric unfurling. Anchoring barbs at the stent edges or in the stent body secure the valve within the annulus. Methods of implantation are also provided.
229 Citations
20 Claims
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1. A two-part prosthetic heart valve, comprising:
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an expandable tubular primary stent sized to contact a heart valve annulus in an expanded state and having a plurality of discrete mating features;
an expandable secondary stent configured to be coupled to the primary stent and having a plurality of discrete mating features that mate with the mating features on the primary stent;
a plurality of valve leaflets attached to the secondary stent for occluding blood flow in one direction; and
at least one guidewire coupled to the primary stent and slideably engaged to the secondary stent for ensuring proper rotational alignment during advancement of the secondary stent toward the primary stent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of delivering a two-part prosthetic heart valve, comprising:
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providing an expandable tubular primary stent sized to contact a heart valve annulus in an expanded state and having a plurality of discrete mating features;
providing an expandable secondary stent configured to be coupled to the primary stent and having a plurality of discrete mating features that mate with the mating features on the primary stent to couple the secondary stent thereto;
providing at least one guidewire threaded through the secondary stent and coupled to the primary stent to ensure proper rotational alignment between the secondary stent and the primary stent;
expanding the primary stent within the heart valve annulus;
advancing the secondary stent along the at least one guidewire so that the secondary stent couples to the primary stent. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification