SUTURELESS HEART VALVE ATTACHMENT

• US 20090222084A1
• Filed: 05/11/2009
• Published: 09/03/2009
• Est. Priority Date: 10/02/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Friedman, Robert S.
• Granted Patent: US 8,142,497 B2
• Time in Patent Office: Days
• US Class Current: 623/2.380
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2210/0061 swellable

Abstract

A prosthetic heart valve having spaced apart anchoring flanges that change shape when the valve is implanted and contact the surrounding annulus to prevent migration of the valve. The heart valve may be non-expandable and the anchoring flanges may provide the primary anchoring structure of the valve. Alternatively, the valve may be expandable wherein the anchoring flanges supplement the inherent anchoring capacity of the valve structure. The anchoring flanges are at least partly made of a material that increases in size, i.e., swells, due to absorption of body fluids. For instance, the anchoring flanges may be formed of an inner material that swells upon contact with body fluids enclosed by a cover. The anchoring flanges may be provided on an anchoring sleeve that changes shape to provide the spaced apart annular flanges for securing the valve around a fibrous annulus. An anchoring sleeve for a prosthetic heart valve having an expandable frame surrounds a majority of the frame and may define an external hourglass configuration.

Claims

1. A non-expandable prosthetic heart valve for implantation at a heart valve annulus, comprising:

a non-expandable heart valve frame defining an orifice around an axis;

a valve member including at least one leaflet mounted to the frame and extending within the orifice, wherein the valve member permits blood flow in one axial direction through the orifice and occlude flow in the opposite direction; and

two axially spaced-apart flanges each surrounding the frame each at least partly made of a material that increases in size due to absorption of body fluids, wherein the flanges are configured with sufficient mechanical strength to provide the primary means for anchoring the prosthetic heart valve to the annulus.

2. The heart valve of claim 1, wherein each of the flanges comprises an inner swellable material enclosed within a cover.

3. The heart valve of claim 2, wherein the swellable material is selected from the group consisting of:

an isocyanate prepolymer,

a polyol resin/polyether polyol,

a hydrophilic acrylic resin base polymer, and

a biocompatible hydrogel comprising at least one polysaccharide.

4. The heart valve of claim 2, wherein the swellable material is capable of swelling between 10-20 times its original size if unconstrained.

5. The heart valve of claim 1, wherein the two axially spaced-apart flanges are provided on a single anchoring sleeve that surrounds the frame with a trough between the flanges.

6. The heart valve of claim 5, wherein the anchoring sleeve comprises an inner swellable material enclosed within a flexible cover having a biased structure so as to be flexible in the regions adjacent the flanges but not therebetween so as to maintain a radial restraint and form the trough.

7. The heart valve of claim 1, wherein the non-expandable heart valve frame defines a nominal radius and the flanges extend radially outward therefrom by at least about 10-12% of the nominal radius.

8. The heart valve of claim 7, wherein the flanges extend radially outward at least 3 mm from the nominal radius.

9. An expandable prosthetic heart valve for implantation at a heart valve annulus, comprising:

an expandable heart valve frame defining an orifice around an axis, the frame being convertible between a first compressed state and a second expanded state sized to contact a heart valve annulus;

a valve member including at least one leaflet mounted to the frame and extending within the orifice, wherein the valve member permits blood flow in one axial direction through the orifice and occludes flow in the opposite direction when the frame is in its second, expanded state; and

a pair of axially spaced apart annular flanges surrounding the frame each at least partly made of a material that increases in size due to absorption of body fluids, wherein the flanges are configured with sufficient mechanical strength to assist the frame in anchoring the prosthetic heart valve to the annulus.

10. The heart valve of claim 9, wherein the annular flanges are formed on a single anchoring sleeve.

11. The heart valve of claim 10, wherein the expandable heart valve frame defines a tubular shape in the second, expanded state, and wherein the anchoring sleeve defines a generally tubular shape that extends axially nearly the entire length of the heart valve frame.

12. The heart valve of claim 10, wherein the annular flanges are separated by a trough defining an hourglass configuration.

13. The heart valve of claim 9, wherein the expandable heart valve frame in the second, expanded state defines a nominal radius and the flanges extend radially outward from the frame by at least about 10-12% of the nominal radius.

14. The heart valve of claim 9, wherein the expandable heart valve frame in the second, expanded state defines a nominal radius and the flanges extend radially outward by at least 3 mm from the nominal radius.

15. A method of anchoring a prosthetic heart valve to a heart valve annulus, comprising:

providing a prosthetic heart valve including a heart valve frame defining an orifice and a one-way valve member mounted to the frame and extending within the orifice, the prosthetic heart valve further including a pair of axially spaced ribs surrounding the frame each at least partly made of a material that increases in size due to absorption of body fluids and being configured with sufficient mechanical strength to assist the frame in anchoring the prosthetic heart valve to the annulus; and

delivering the prosthetic heart valve to a heart valve annulus and maintaining a desired position of the prosthetic heart valve long enough for the anchoring sleeve to increase in size from absorption of body fluids and anchor the prosthetic heart valve to the annulus.

16. The method of claim 15, wherein the annulus is the aortic annulus between the left ventricle and the aortic sinus cavities, and the valve is delivered in antegrade fashion from the apex of the left ventricle using an access catheter having a size of between about 30-50 French.

17. The method of claim 15, wherein the axially spaced ribs are formed on a single anchoring sleeve including a trough therebetween in an hourglass configuration, and wherein the method includes positioning the trough over the target annulus to prevent migration of the valve.

18. The method of claim 17, wherein the step of delivering comprises delivering the heart valve using a catheter over a guide wire, and either balloon expanding the prosthetic heart valve or permitting it to self-expand such that the sleeve contacts the annulus, and holding the heart valve in place for sufficient time for the anchoring sleeve to increase in size from absorption of body fluids and anchor the prosthetic heart valve to the annulus.

19. The method of claim 17, wherein the anchoring sleeve changes shape immediately upon being exposed to body fluid, and the method includes balloon expanding the heart valve to register the trough with the target annulus and outwardly compress the sleeve between the frame and the target annulus.