AORTIC BIOPROSTHESIS AND SYSTEMS FOR DELIVERY THEREOF

• US 20120271398A1
• Filed: 09/10/2010
• Published: 10/25/2012
• Est. Priority Date: 11/02/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Delaloye, Stephane, Mantanus, Luc, Passerini, Reynald, Essinger, Jacques, Biadillah, Youseff, Hefti, Jean-Luc
• Granted Patent: US 10,376,359 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Embodiments of the present disclosure are directed to stents, valved-stents, and associated methods and systems for their delivery via minimally-invasive surgery.

Claims

1-34. -34. (canceled)

35. A replacement valve for use within a human body comprising:

a valve component; and

a stent component configured to house at least a portion of the valve component comprising a proximal end and a distal end, the stent component further comprising;

a lower anchoring crown comprising an at least partly conical body, wherein the lower anchoring crown defines the proximal end of the stent component;

an upper anchoring crown in communication with the lower anchoring crown and comprising an at least partly conical body, wherein the conical body of the lower anchoring crown slopes outwardly in the direction of the proximal end, and wherein the conical body of the upper anchoring crown slopes outwardly in the direction of the distal end; and

a distal stent section comprising an at least partly conical body, wherein the distal stent section is in communication with the upper anchoring crown.

36. The replacement valve of claim 35, the distal stent section comprising a plurality of stabilization arches for bearing against the ascending aorta for alignment of the stent-component with respect to the ascending aorta, each stabilization arch comprising:

a divergent portion that diverges away from the stent axis, in a direction towards the distal end; and

an arch apex inclined at an angle (alpha5) measured from the divergent portion in a direction towards the stent axis.

37. The replacement valve of claim 35, the distal stent section comprising an at least partly conical body, wherein the distal stent section comprises a commissural post section and/or stabilization arch section, wherein the commissural post section is in communication with the upper anchoring crown;

and wherein the stabilization arch section is in communication with commissural post section and defines an at least partly conical body, and wherein the stabilization arch section defines the distal end.

38. The replacement valve of claim 36, wherein the stabilization arches are configured to engage the ascending aorta to orient the stent component, the valve component, and an associated delivery system longitudinally within an aorta/aortic annulus thus preventing tilting of the stent component and the valve component when implanted.

39. The replacement valve of claim 36, wherein at least one of the stabilization arches comprises an asymmetric feature, preferably at least one arm of at least one arch comprises an additional pattern to distinguish the arm from the other.

40. The replacement valve of claim 35, wherein the valve comprises an attachment for removable attachment to a delivery device, preferably arranged at the lower anchoring crown, wherein the valve preferably has a lattice structure of interconnected open cells, the lattice structure including peripheral cells defining an end of the stent component, a first plurality of the peripheral cells being axially extended compared to a second plurality of the peripheral cells, to define a plurality of attachment elements projecting with respect to the second plurality of peripheral cells, each attachment element including an open portion defined by the extension of the respective peripheral cell.

41. The replacement valve, preferably according to claim 35, wherein the stent comprises at least one attachment element, wherein the at least one attachment element is formed generally in the form of an opening which is able to enlarge when the stent component expands.

42. The replacement valve of claim 40, wherein the conical body of the lower anchoring crown comprises cells whereof three cells are axially elongated to form openings which are able to enlarge when the stent component expands;

wherein the axial lengths of the elongations is between about 2 to about 3 mm.

43. The replacement valve of claim 35, wherein the conical body of the upper anchoring crown slopes outwardly from an inner diameter D2 to an outer diameter D1 in the direction of the distal end, wherein the axial length (L4) of the upper crown in the expanded configuration is between about 3 to about 4 mm and wherein the outward slope of the upper anchoring crown is defined by an angle α

1, and wherein 1 is between from about 40 degree to about 50 degree, preferably between from about 44 degree to about 46 degree.

44. The replacement valve of claim 35, wherein the upper and/or lower crown may include a cylindrical or only slightly outwardly sloping section, thus there being a trunk section between the at least partly conical body of the upper conical crown and the at least partly conical body of the lower conical crown.

45. The replacement valve of claim 44,

wherein the substantially cylindrical section has an axial length of between about 4 mm and about 6 mm;

and/or

wherein the axial length of the substantially cylindrical section is at least 50% of the axial length of at least one of the lower or upper anchoring crown; and

/or

wherein the axial length of the substantially cylindrical section is equal to or greater than the axial length of at least one of the first and second sections.

46. A system for replacing a valve within a human body comprising:

a delivery device; and

a replacement valve for use within a human body comprising;

a valve component, and

a stent component configured to house at least a portion of the valve component comprising a proximal end and a distal end, the stent component further comprising;

a lower anchoring crown defining an at least partly conical body, wherein the lower anchoring crown defines the proximal end of the stent component;

an upper anchoring crown in communication with the lower anchoring crown and defining an at least partly conical body, wherein the conical body of the lower anchoring crown slopes outwardly in the direction of the proximal end, and wherein the conical body of the upper anchoring crown slopes outwardly in the direction of the distal end; and

a distal stent section defining an at least partly conical body, wherein the distal stent section comprises a commissural post section and stabilization arch section, wherein the commissural post section is in communication with the upper anchoring crown; and

wherein the stabilization arch section is in communication with commissural post section and defines an at least partly conical, and wherein the stabilization arch section defines the distal end;

the stent component having a central, longitudinal axis and comprising at least one attachment element for removable attachment to a delivery device, wherein the at least one attachment element is located at a proximal end of the stent component, wherein the proximal end is defined as the end toward the left ventricle when delivered from a transapical approach.

47. The system according to claim 46, wherein the at least one attachment element is formed generally in the form of an opening which is able to enlarge when the stent component expands or Wherein the at least one attachment element is formed generally in the shape of a hook.

48. The system according to claim 46, wherein at least one of the stabilization arches comprises an asymmetric feature, preferably at least one arm of at least one arch comprises an additional pattern to distinguish the arm from the other.

49. The system according to claim 46, wherein the delivery device comprises:

an inner member comprising a guide wire lumen and a stent holder; and

an outer member comprising a sheath;

wherein the stent holder comprises at least one groove for receiving the attachment element of the stent component.

50. The system according to claim 46, wherein the stent holder comprises ramp surfaces to facilitate the release of the stent component after removing the sheath from the stent.

51. The system according to claim 46, wherein release of the stent-valve from the stent holder is facilitated by slight rotation of the stent holder relative to the attachment element.

52. A replacement valve for use within a human body comprising:

a valve component; and

a stent component configured to house at least a portion of the valve component comprising a proximal end and a distal end, the stent component further comprising;

a distal stent section defining the distal end and comprising a stabilization arch section and a commissural post section communicating with the stabilization arch section, the commissural post section defining supports for the valve component;

a proximal anchoring section defining the proximal end; and

a first crown section communicating with the distal stent section and with the proximal anchoring section, the first crown section comprising a first divergent portion that diverges outwardly in a direction towards the distal end, the first crown section having a free end.

53. The replacement valve of claim 52, wherein the first divergent portion comprises a narrow end communicating with the proximal anchoring section.

54. The replacement valve of claim 52, wherein the free end of the first crown section is proximal of the distal end.

55. The replacement valve of claim 52, wherein (i) the angle of divergence of the first divergent portion with respect to an axis of the valve is less than 60 degrees, and/or (ii) the axial length between the free end of the first crown section and the narrow end of the first divergent portion is less than 10 mm.

56. The replacement valve of claim 52, wherein the stent further comprises a tubular portion extending proximally from the narrow end of the first divergent portion, the tubular portion having a divergence in an inclusive range of 0 degrees (no divergence) to 10 degrees with respect to the axis of the valve.

57. The replacement valve of claim 56, wherein the tubular portion is generally cylindrical with a divergence of 0 degrees.

58. The replacement valve of claim 56, wherein the axial length of said tubular portion is at least 1 mm.

59. The replacement valve of claim 52, wherein the proximal anchor portion comprises a second crown section comprising a second diverging portion diverging outwardly in a direction towards the proximal end, the second crown portion having a free end.

60. The replacement valve of claim 59, wherein the free end of the second crown section defines the proximal end.

61. The replacement valve of claim 59, wherein the second diverging portion has an angle of divergence with respect to the axis in a range of 10 to 20 degrees.

62. The replacement valve of claim 52, further comprising at least one attachment element for attaching the valve to a stent holder of a delivery system.