Prosthetic cardiac valve formed from pericardium material and methods of making same

Abstract

A prosthetic stented heart valve which includes a compressible and expandable stent structure having first and second opposite ends, an expanded outer periphery, and a compressed outer periphery that is at least slightly smaller than the expanded outer periphery when subjected to an external radial force. The valve further includes a valve segment comprising a dual-layer sheet formed into a generally tubular shape having at least one longitudinally extending seam, and a plurality of leaflets formed by attachment of an outer layer of the dual-layer sheet to an inner layer of the dual-layer sheet in a leaflet defining pattern. The valve segment is at least partially positioned within the stent structure. The valve may further include at least one opening in the outer layer of the dual-layer sheet that is spaced from both the first and second ends of the stent structure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:

FIG. 1 is a top view of a piece of material, such as pericardium material, that is folded over onto itself to make a dual-layer configuration, in one step of being formed into a cardiac valve in accordance with the invention, including a pattern of attaching two layers of material to create a leaflet configuration;

FIG. 2 is a front view of the piece of material of FIG. 1 formed into a tubular valve segment;

FIG. 3 is a front view of an assembly showing an exemplary initial placement of a stent over the valve segment of FIG. 2, with both the stent and valve segment positioned on a mandrel;

FIG. 4 is an end view of the assembly of FIG. 3 from the side of the heart into which the blood of a patient would normally flow;

FIGS. 5 and 6 are top views of exemplary templates that can be positioned on top of the material that will be made into a cardiac valve to provide a guide for stitching patterns that can be followed in making a valve;

FIG. 7 is a front view of an embodiment of a cardiac valve and stent assembly of the invention;

FIG. 8 is a front view of another embodiment of a cardiac valve and stent assembly of the invention;

FIG. 9 is a perspective view of a valve segment of the invention with a portion of the outer tube material removed;

FIG. 10 is a perspective view of a valve segment of the invention with a smaller portion of the outer tube material removed as compared to the embodiment of FIG. 9, thereby leaving a top portion of the valve segment intact;

FIG. 11 is perspective view of another valve segment of the invention with a portion of the outer tube material removed to allow a particular flow of fluid through the valve;

FIG. 12 is a cross-sectional side view of a cardiac valve of the invention positioned relative to a cardiac vessel;

FIG. 13 is a top view of an embodiment of a piece of dual-layer material having another leaflet and attachment pattern, which is capable of being formed into a cardiac valve in accordance with the invention;

FIGS. 14 and 15 are end views of a tubular valve made of the piece of material of FIG. 13, where FIG. 14 shows the valve with leaflets in their open position and FIG. 15 shows the valve with leaflets in their closed position;

FIG. 16 is a top view of another embodiment of a piece of dual-layer material having another alternative leaflet and attachment pattern;

FIGS. 17 and 18 are end views of a tubular valve made of the piece of material of FIG. 16, where FIG. 17 shows the valve with leaflets in their open position and FIG. 18 shows the valve with leaflets in their closed position;

FIG. 19 is a top view of three separate dual-layer material pieces having one embodiment of a leaflet pattern;

FIGS. 20 and 21 are end views of a tubular valve made of the three pieces of material of FIG. 19, which are attached to each other in the form of a tubular valve, where FIG. 20 shows the valve with leaflets in their open position and FIG. 21 shows the valve with leaflets in their closed position;

FIG. 22 is a top view of two separate dual-layer material pieces having one embodiment of a leaflet pattern;

FIGS. 23 and 24 are end views of a tubular valve made of the two pieces of material of FIG. 22, which are attached to each other in the form of a tubular valve, where FIG. 23 shows the valve with leaflets in their open position and FIG. 24 shows the valve with leaflets in their closed position;

FIG. 25 is a top view of an embodiment of a dual-layer material having another leaflet and attachment pattern;

FIG. 26 is a perspective view of the piece of material of FIG. 25 formed into a tubular valve segment;

FIG. 27 is a top view of a dual-layer material having another leaflet and attachment pattern; and

FIG. 28 is a perspective view of the piece of material of FIG. 27 formed into a tubular valve segment.

Claims

1. A prosthetic stented heart valve comprising: a compressible and expandable stent structure comprising first and second opposite ends, an expanded outer periphery, and a compressed outer periphery that is at least slightly smaller than the expanded outer periphery when subjected to an external radial force; anda valve segment comprising a dual-layer sheet formed into a generally tubular shape having at least one longitudinally extending seam, and a plurality of leaflets formed by attachment of an outer layer of the dual-layer sheet to an inner layer of the dual-layer sheet in a leaflet defining pattern;wherein at least a portion of the valve segment is positioned within at least a portion of the stent structure, and wherein the stent structure is attached to the outer layer of the valve segment at one or more of the first and second ends of the stent structure.

2. The prosthetic valve of claim 1, wherein the dual-layer sheet comprises a single sheet of material folded to provide a fold line along a first edge of the sheet, wherein the material on one side of the fold line comprises the outer layer of the dual-layer sheet and the material on the opposite side of the fold line comprises the inner layer of the dual-layer sheet.

3. The prosthetic valve of claim 2, wherein the inner layer of the dual-layer sheet has less surface area than the outer layer of the dual-layer sheet.

4. The prosthetic valve of claim 1, wherein the compressed outer periphery of the stent structure is sized for percutaneous insertion and implantation in an anatomical structure of a patient.

5. The prosthetic valve of claim 1, wherein the compressed outer periphery of the stent structure is configured for surgical sutureless insertion and implantation in an anatomical structure of a patient.

6. The prosthetic valve of claim 1, wherein the compressed outer periphery of the stent structure is configured for apical insertion and implantation in an anatomical structure of a patient.

7. The prosthetic valve of claim 1, wherein the dual-layer sheet further comprises multiple layers of material that are attached to each other along multiple longitudinally extending seams.

8. The prosthetic valve of claim 7, wherein each of the multiple layers of material comprises a leaflet formed by attachment of an outer layer of the dual-layer sheet to an inner layer of the dual-layer sheet in a leaflet defining pattern.

9. The prosthetic valve of claim 1, further comprising at least one opening in the outer layer of the dual-layer sheet that is spaced from both the first and second ends of the stent structure.

10. The prosthetic valve of claim 9, wherein the at least one opening in the outer layer of the dual-layer sheet comprises: a first opening that is configured for fluid communication with a right coronary artery when the prosthetic valve is positioned in the ascending aorta of a heart; anda second opening spaced circumferentially from the first opening for fluid communication with a left coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart.

11. The prosthetic valve of claim 9, wherein a first circumferential portion of the outer layer of the dual-layer sheet extends between the first end of the stent structure and the at least one opening, and wherein a second circumferential portion of the outer layer of the dual-layer sheet extends between the second end of the stent structure and the at least one opening.

12. The prosthetic valve of claim 1, wherein the leaflet defining pattern comprises at least a first leaflet-defining seam spaced from a second leaflet-defining seam.

13. The prosthetic valve of claim 12, wherein the first leaflet-defining seam is generally parallel to the second leaflet-defining seam to provide a leaflet having generally parallel sides.

14. The prosthetic valve of claim 12, wherein the first leaflet-defining seam is angled relative to the second leaflet-defining seam to provide a generally funnel-shaped leaflet.

15. The prosthetic valve of claim 12, further comprising at least a third leaflet-defining seam spaced from the second leaflet-defining seam, wherein the third leaflet-defining seam generally coincides with the longitudinally extending seam.

16. A prosthetic heart valve comprising: a valve segment comprising a dual-layer sheet formed into a generally tubular shape having at least one longitudinally extending seam, a plurality of leaflets formed by attachment of an outer layer of the dual-layer sheet to an inner layer of the dual-layer sheet in a leaflet defining pattern, a first opening in the outer layer of the dual-layer sheet that is configured for fluid communication with a right coronary artery when the prosthetic valve is positioned in the ascending aorta of a heart, and a second opening in the outer layer of the dual-layer sheet that is spaced circumferentially from the first opening for fluid communication with a left coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart.

17. The prosthetic heart valve of claim 16, further comprising a compressible and expandable stent structure comprising first and second opposite ends, an expanded outer periphery, and a compressed outer periphery that is at least slightly smaller than the expanded outer periphery when subjected to an external radial force, wherein at least a portion of the valve segment is positioned within at least a portion of the stent structure, and wherein the stent structure is attached to the outer layer of the valve segment at one or more of the first and second ends of the stent structure.

18. A method of manufacturing a prosthetic heart valve for percutaneous delivery and implantation at an implantation location of a patient, the method comprising the steps of: providing a dual-layer sheet of material;attaching an inner layer of the dual-layer sheet to an outer layer of the dual-layer sheet in a leaflet defining pattern;forming the dual-layer sheet into a tubular valve segment, with the inner layer of the dual-layer sheet facing toward the center of the segment;positioning the tubular valve segment at least partially within a compressible and expandable stent structure comprising first and second opposite ends, an expanded outer periphery, and a compressed outer periphery that is at least slightly smaller than the expanded outer periphery when subjected to an external radial force; andattaching the tubular valve segment to the stent structure at one or more of the first and second ends of the stent structure.

19. The method of claim 18, wherein the implantation location is the ascending aorta of a heart.

20. The method of claim 19, wherein the tubular valve segment further comprises: a first opening in the outer layer of the dual-layer sheet that is configured for fluid communication with a right coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart; anda second opening in the outer layer of the dual-layer sheet spaced circumferentially from the first opening for fluid communication with a left coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart.