Valvular prosthesis

• US 7,025,780 B2
• Filed: 02/24/2003
• Issued: 04/11/2006
• Est. Priority Date: 09/12/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): ALANKO, ANITA KAREN
• Application Number:
  US10/373,138
• Publication Number:
  US 20030149477A1
• Time in Patent Office: 1,142 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19, 623/900
• US Class Current: 623/2.13
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A valvular prosthesis and method of using the prosthesis are disclosed. A valve apparatus is located within a stent apparatus, such that the prosthesis is deformable between a first condition and a second condition, in which the prosthesis has a reduced cross-sectional dimension relative to the first condition, whereby implantation of the prosthesis is facilitated when in the second condition.

Claims

1. A valvular prosthesis comprising:

a stent apparatus;

a valve apparatus located within a stent apparatus to define a stented valve, the valve apparatus having inflow end and a generally sinusoidal outflow end, the inflow and outflow ends being spaced apart from each other by a length of a sidewall portion, the valve apparatus comprising an animal pulmonic heart valve that includes a plurality of leaflets attached to and extending from an interior part of the sidewall portion located within the stent apparatus, wherein each of the valve apparatus and the stent apparatus has a generally sinusoidal outflow end comprising axially extending posts with sinuses between adjacent posts, such that the plurality of stent posts are aligned substantially radially with and attached to corresponding posts of the valve apparatus;

the stented valve being deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension, whereby placement of the stented valve to a desired implantation position is facilitated when in the reduced cross-sectional dimension; and

the stent apparatus being self-expanding to urge the stented valve from the reduced cross-sectional dimension toward the expanded cross-sectional dimension thereof, whereby implantation is facilitated and the leaflets are movable between open and closed conditions to provide for substantially unidirectional flow of blood through the stented valve when in the expanded cross-sectional dimension thereof; and

an outer sheath of a substantially biocompatible material that covers at least a substantial portion of the stent apparatus and the valve apparatus.

2. The prosthesis of claim 1, the stent apparatus further comprising an annular base portion at an inflow end thereof, a plurality of spikes extending generally radially outwardly from the stent apparatus, at least a substantial portion of the plurality of spikes extending through the outer sheath, whereby, when the stented valve is implanted within tissue, at least some of the spikes engage the tissue to inhibit movement of the stented valve relative to the tissue.

3. A valvular prosthesis comprising:

a stent apparatus;

a valve apparatus located within a stent apparatus to define a stented valve, the valve apparatus having inflow end and a generally sinusoidal outflow end, the inflow and outflow ends being spaced apart from each other by a length of a sidewall portion, the valve apparatus comprising an animal pulmonic heart valve that includes a plurality of leaflets attached to and extending from an interior part of the sidewall portion located within the stent apparatus;

the stented valve being deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension, whereby placement of the stented valve to a desired implantation position is facilitated when in the reduced cross-sectional dimension; and

the stent apparatus being self-expanding to urge the stented valve from the reduced cross-sectional dimension toward the expanded cross-sectional dimension thereof, whereby implantation is facilitated and the leaflets are movable between open and closed conditions to provide for substantially unidirectional flow of blood through the stented valve when in the expanded cross-sectional dimension thereof; and

a sheath of a substantially biocompatible biological material covering the stent apparatus and at least a portion of the valve, the stent apparatus further comprising a plurality of spikes extending generally radially outwardly from the stent apparatus, at least a substantial portion of the plurality of spikes extending through the outer sheath, at least some of the spikes extending through the sheath whereby, when the stented valve is implanted within tissue, at least some of the spikes engage the tissue to inhibit movement of the stented valve relative to the tissue.

4. A valvular prosthesis comprising:

a stent apparatus comprising a plurality of stent posts extending generally axially from a stent base portion to define a substantially sinusoidal outflow end of the stent apparatus that includes a;

plurality of leaflets attached to and extending from an interior part of a sidewall

a pulmonic animal heart valve located within a stent apparatus, the heart valve having an inflow end and a generally sinusoidal outflow end with posts and sinuses that are aligned substantially radially with corresponding posts and sinuses of the stent apparatus with the inflow and;

outflow ends being spaced apart from each other by a length of the side wall

an outer sheath of a substantially biocompatible biological material that covers at least a substantial portion of the stent apparatus and the valve apparatus to define a stented valve;

the stented valve being deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension, whereby placement of the stented valve to a desired implantation position is facilitated when in the reduced cross-sectional dimension; and

the stent apparatus being self-expanding to urge the stented valve from the reduced cross-sectional dimension toward the expanded cross-sectional dimension thereof, whereby implantation is facilitated and the leaflets are movable between open and closed conditions to provide for substantially unidirectional flow of blood through the stented valve when in the expanded cross-sectional dimension thereof.

5. The prosthesis of claim 4, wherein an outflow end portion of the outer sheath defines a plurality of lobes that extend beyond the outflow end of the stented valve at respective posts of the valve apparatus.

6. The prosthesis of claim 4, wherein the stent apparatus further comprises an annular base portion at an inflow end thereof, a plurality of spikes extending generally radially outwardly from the stent apparatus, at least a substantial portion of the plurality of spikes extending through the outer sheath, whereby, when the stented valve is implanted within tissue, at least some of the spikes engage the tissue to inhibit movement of the stented valve relative to the tissue.