APPARATUS AND METHODS FOR REPAIRING THE FUNCTION OF A DISEASED VALVE AND METHOD FOR MAKING SAME

• US 20100298927A1
• Filed: 07/30/2010
• Published: 11/25/2010
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Greenberg, Roy K.
• Granted Patent: US 8,979,924 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0017 Angular shapes

Abstract

An apparatus for repairing the function of a diseased valve includes an annular first support member expandable to a first diameter. An annular second support member is spaced axially apart from the first support member and is expandable to a second diameter that is independent of the first diameter. A tubular graft section interconnects the first and second support members. The graft section defines an annulus having a third diameter that is independent of each of the first and second diameters. A prosthetic valve is secured within the annulus of the graft section. The bioprosthetic valve has at least two valve leaflets that are coaptable to permit the unidirectional flow of blood. Methods for repairing the function of a diseased valve and for making the apparatus are also provided.

Claims

1-37. -37. (canceled)

38. An apparatus for repairing the function of a diseased valve, the apparatus comprising:

an annular first support member having longitudinally spaced proximal and distal first support member ends, the distal first support member end having a plurality of eyelets defining a distal first support member circumference;

an annular second support member having longitudinally spaced proximal and distal second support member ends, the proximal second support member end having a plurality of eyelets defining a proximal second support member circumference;

a tubular graft section having longitudinally spaced first and second graft ends and a graft neck annulus located longitudinally between the first and second graft ends, the first and second graft ends defining first and second graft end circumferences, respectively, and the graft neck annulus defining a graft neck circumference which is smaller than both of the first and second graft end circumferences;

the first graft end being directly attached to the distal first support member end with the distal first support member circumference being substantially coincident with the first graft end circumference;

the second graft end being directly attached to the proximal second support member end with the proximal second support member circumference being substantially coincident with the second graft end circumference; and

a prosthetic valve secured within the graft neck annulus, the prosthetic valve having at least two valve leaflets that are coaptable to permit the unidirectional flow of blood, and the prosthetic valve being longitudinally spaced from both of the first and second support members.

39. The apparatus of claim 38, wherein the distal first support member circumference has a different diameter than a diameter of the proximal second support member circumference.

40. The apparatus of claim 38, wherein at least one of the distal first support member circumference and proximal second support member circumference is located laterally inside the graft section.

41. The apparatus of claim 38, wherein the first graft end is directly attached to the distal first support member end with the distal first support member circumference located laterally inside the first graft end circumference, and the second graft end is directly attached to the proximal second support member end with the proximal second support member circumference located laterally outside the second graft end circumference.

42. The apparatus of claim 38, wherein the prosthetic valve has a longitudinally extending center valve axis, the graft neck annulus has a longitudinally extending center graft axis, and the prosthetic valve is secured within the graft neck annulus with the center valve axis being laterally offset from the center graft axis.

43. The apparatus of claim 38, wherein the prosthetic valve has a longitudinally extending center valve axis, the graft neck annulus has a longitudinally extending center graft axis, and the prosthetic valve is secured within the graft neck annulus with the center valve axis being substantially perpendicular to the center graft axis.

44. The apparatus of claim 38, wherein the graft section is supported only by the first and second support members.

45. The apparatus of claim 38, including an expandable ring encircling the graft neck annulus, positively establishing the graft neck circumference, and supporting the prosthetic valve secured within the graft neck annulus.

46. The apparatus of claim 38, wherein the second graft end includes a plurality of extension flaps that extend longitudinally toward the distal second support member end, the number and circumferential orientations of the extension flaps corresponding to the number and circumferential orientations of the valve leaflets.

47. The apparatus of claim 38, wherein the second graft end includes a plurality of extension struts that extend longitudinally toward the distal second support member end, the number and circumferential orientations of the extension struts corresponding to the number and circumferential orientations of the valve leaflets, with each extension strut being connected to one of the valve leaflets.

48. The apparatus of claim 47, wherein a first end of each extension strut is connected to the second graft end, and a second end of each extension strut, located longitudinally distal of the first end, is connected to a circumferentially extending strut ring located longitudinally between the proximal second member end and the distal second member end.

49. The apparatus of claim 38, wherein a diameter of the graft neck annulus is functionally independent from both a diameter of the first support member and a diameter of the second support member.

50. The apparatus of claim 38, wherein the first support member is at least partially located in a superior vena cava, the second support member is at least partially located in a inferior vena cava, and the prosthetic valve repairs the function of a native tricuspid valve.

51. The apparatus of claim 38, wherein the first support member is at least partially located in a chosen one of an inferior and a superior vena cavae, the second support member is at least partially located in a right atrium, and the prosthetic valve is located in the chosen one of the inferior and superior vena cavae and repairs the function of a native tricuspid valve.

52. A method for repairing the function of a diseased valve, the method comprising the steps of:

providing an apparatus including;

an annular first support member having longitudinally spaced proximal and distal first support member ends, the distal first support member end having a plurality of eyelets defining a distal first support member circumference,

an annular second support member having longitudinally spaced proximal and distal second support member ends, the proximal second support member end having a plurality of eyelets defining a proximal second support member circumference,

a tubular graft section having longitudinally spaced first and second graft ends and a graft neck annulus located longitudinally between the first and second graft ends, the first and second graft ends defining first and second graft end circumferences, respectively, and the graft neck annulus defining a graft neck circumference which is smaller than both of the first and second graft end circumferences,

the first graft end being directly attached to the distal first support member end with the distal first support member circumference being substantially coincident with the first graft end circumference,

the second graft end being directly attached to the proximal second support member end with the proximal second support member circumference being substantially coincident with the second graft end circumference, and

a prosthetic valve secured within the graft neck annulus, the prosthetic valve having at least two valve leaflets that are coaptable to permit the unidirectional flow of blood, and the prosthetic valve being longitudinally spaced from both of the first and second support members;

collapsing the apparatus radially;

loading the apparatus into a sheath for intravascular delivery;

inserting the apparatus, inside the sheath, into the vasculature;

advancing the apparatus, inside the sheath, to a location within the vasculature adjacent the diseased valve;

retracting the sheath;

expanding the first and second support members radially outward into engagement with the vasculature;

securing the apparatus to the vasculature; and

forming a seal between the first graft end and the vasculature when the apparatus is expanded;

wherein the prosthetic valve is suspended inside the graft neck annulus within the vasculature adjacent the diseased valve to assume the function of the diseased valve.

53. The method of claim 52, wherein the step of expanding the first and second support members radially outward includes the step of expanding the first and second support members such that the distal first support member circumference, when expanded, has a different diameter than a diameter of the proximal second support member circumference, when expanded.

54. The method of claim 52, wherein the prosthetic valve has a longitudinally extending center valve axis, the graft neck annulus has a longitudinally extending center graft axis, and the method includes the step of securing the prosthetic valve within the graft neck annulus with the center valve axis laterally offset from the center graft axis.

55. The method of claim 52, wherein the prosthetic valve has a longitudinally extending center valve axis, the graft neck annulus has a longitudinally extending center graft axis, and the method includes the step of securing the prosthetic valve within the graft neck annulus with the center valve axis substantially perpendicular to the center graft axis.

56. The method of claim 52, wherein the step of securing the apparatus to the vasculature includes the steps of:

providing at least one hook on each of the first and second support members; and

embedding at least one hook into a vessel wall of the vasculature.

57. The method of claim 52, wherein the step of the forming a seal between the first graft end and the vasculature when the apparatus is expanded includes the step of forming a seal between the first graft end and the vasculature with no portion of the first support member being interposed therebetween.

58. The method of claim 52, wherein the step of expanding the first and second support members radially outward into engagement with the vasculature includes at least one of the steps of:

self-expanding the first and second support members radially outward into engagement with the vasculature; and

balloon-expanding the first and second support members radially outward into engagement with the vasculature.

59. The method of claim 52, including the step of supporting each valve leaflet with a chosen one of an extension flap and an extension strut, the chosen extension flap or extension strut extending longitudinally toward the distal second support member end, the number and circumferential orientations of the chosen extension flaps or extension struts corresponding to the number and circumferential orientations of the valve leaflets.