Unstented Heart Valve with Formed in Place Support Structure

• US 20110213460A1
• Filed: 03/22/2011
• Published: 09/01/2011
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Granted Patent: US 9,510,941 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30672 : temporary
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• 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 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0059 : temporary
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

An implantable prosthetic valve has an in situ formable support structure. The valve comprises a prosthetic valve, having a base and at least one flow occluder. A first flexible component is incapable of retaining the valve at a functional site in the arterial vasculature. The first component extends proximally of the base of the valve. A second flexible component is incapable of retaining the valve at a functional site in the arterial vasculature. The second component extends distally of the base of the valve. At least one rigidity component combines with at least one of the first and second flexible components to impart sufficient rigidity to the first or second components to retain the valve at the site.

Claims

1-27. -27. (canceled)

28. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable carrier element and a replacement valve endovascularly to a vicinity of the native heart valve, the replacement valve configured to allow the flow of blood through the replacement valve in a first direction and prevent the flow of blood through the replacement valve in a second direction;

expanding the carrier element from a collapsed delivery configuration to a first expanded configuration in the vicinity of the native heart valve;

evaluating the position of the carrier element;

at least partially collapsing the carrier element from the first expanded configuration to a moveable configuration;

repositioning the carrier element in the moveable configuration in the vicinity of the native heart valve; and

expanding the carrier element from the moveable configuration to a second expanded configuration to secure the carrier element in the vicinity of the native heart valve.

29. The method of claim 28, wherein the carrier element is at least partially secured within the vicinity of the native heart valve when in the first expanded configuration.

30. The method of claim 28, wherein the carrier element is expanded to the first and second expanded configurations using an inflation media.

31. The method of claim 28, wherein the carrier element is expanded to the first expanded configuration using a preinflation media and expanded to the second expanded configuration using a preinflation media, the method further comprising substituting the preinflation media with a permanent inflation media.

32. The method of claim 28, wherein repositioning of the carrier element includes at least one of rotating or translating the carrier element.

33. The method of claim 28, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during expansion of the carrier element to the first expanded configuration.

34. The method of claim 28, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during expansion of the carrier element to the second expanded configuration.

35. The method of claim 28, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during collapsing of the carrier element.

36. The method of claim 28, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during repositioning of the carrier element

37. The method of claim 28, wherein the carrier element is configured to conform to the patient'"'"'s anatomy upon expansion.

38. The method of claim 28, wherein the only native anatomical feature displaced by the carrier element is the native valve.

39. The method of claim 28, wherein proximal and distal ends of the carrier element form a seal with respective native anatomical features proximate opposing sides of the native valve.

40. The method of claim 28, wherein a length of the carrier element in the first and second expanded configurations is less than a length of the carrier element in the collapsed delivery configuration.

41. The method of claim 28, wherein the carrier element has a non-cylindrical profile in the first and second expanded configurations.

42. The method of claim 28, wherein a proximal portion of the carrier element extends further radially outwardly than a central portion of the carrier element.

43. The method of claim 28, wherein repositioning the carrier element includes moving at least three control wires removeably coupled to the carrier element.

44. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable first carrier element and a first replacement valve endovascularly to a vicinity of the native heart valve, the first replacement valve configured to allow the flow of blood through the first replacement valve in a first direction and prevent the flow of blood through the valve in a second direction;

expanding the first carrier element from a collapsed delivery configuration to an expanded configuration in the vicinity of the native heart valve;

evaluating the position of the first carrier element;

at least partially collapsing the first carrier element from the expanded configuration to a moveable configuration;

completely removing the first carrier element and exchanging the first carrier element with a second carrier element having a second replacement valve, the second replacement valve configured to allow the flow of blood through the second replacement valve in the first direction and prevent the flow of blood through the second replacement valve in the second direction, the second carrier element having at least one of a different diameter, length or style than the first carrier element; and

expanding the second carrier element from a collapsed delivery configuration to an expanded configuration to secure the second carrier element in the vicinity of the native heart valve.

45. The method of claim 44, wherein the and second replacement valves prevent the flow of blood through the valve in the direction and allows the flow of blood through the first and second replacement valves in the first direction during the expansion of the first and second carrier elements.

46. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable carrier element and a replacement valve endovascularly to a vicinity of the native heart valve; and

expanding the carrier element from a collapsed delivery configuration to an expanded configuration to secure the carrier element in the vicinity of the native heart valve,

wherein the replacement valve prevents the flow of blood through the valve in a first direction and allows the flow of blood through the replacement valve in a second direction during the expansion of the carrier element.

47. The method of claim 46, further comprising:

at least partially collapsing the carrier element from the expanded configuration to a moveable configuration;

repositioning the carrier element in the moveable configuration in the vicinity of the native heart valve; and

expanding the carrier element from the moveable configuration to the expanded configuration to re-secure the carrier element in the vicinity of the native heart valve.

48. The method of claim 47, wherein the carrier element is initially expanded to the expanded configuration using a preinflation media.

49. The method of claim 48, wherein the preinflation media is substituted with a permanent inflation media once the carrier element is re-secured in the vicinity of the native heart valve.

50. The method of claim 47, wherein repositioning of the carrier element includes at least one of rotating or translating the carrier element.

51. The method of claim 47, wherein the replacement prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during collapsing of the carrier element.

52. The method of claim 47, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during repositioning of the carrier element.

53. The method of claim 47, wherein repositioning the carrier element includes moving at least three control wires removeably coupled to the carrier element.

54. The method of claim 46, wherein the carrier element is expanded to the expanded configuration using an inflation media.

55. The method of claim 46, wherein the carrier element is configured to conform to the patient'"'"'s anatomy upon expansion.

56. The method of claim 46, wherein the only native anatomical feature displaced by the carrier element is the native valve.

57. The method of claim 46, wherein proximal and distal ends of the carrier element form a seal with respective native anatomical features proximate opposing sides of the native valve.

58. The method of claim 46, wherein a length of the carrier element in the first and second expanded configurations is less than a length of the carrier element in the collapsed delivery configuration.

59. The method of claim 46, wherein the carrier element has a non-cylindrical profile in the first and second expanded configurations.

60. The method of claim 46, wherein a proximal portion of the carrier element extends further radially outwardly than a central portion of the carrier element.

61. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable carrier element and a replacement valve endovascularly to a vicinity of the native heart valve, the replacement valve configured to allow the flow of blood through the replacement valve in a first direction and prevent the flow of blood through the valve in a second direction; and

expanding the carrier element from a collapsed delivery configuration to an expanded configuration to secure the carrier element in the vicinity of the native heart valve, the carrier element being configured to conform to the patient'"'"'s anatomy upon expansion.

62. The method of claim 61, further comprising:

at least partially collapsing the carrier element from the expanded configuration to a moveable configuration;

repositioning the carrier element in the moveable configuration in the vicinity of the native heart valve; and

expanding the carrier element from the moveable configuration to the expanded configuration to secure the carrier element in the vicinity of the native heart valve, wherein the carrier element re-conforms to the patient'"'"'s anatomy upon expansion.

63. The method of claim 62, wherein the carrier element is initially expanded to the expanded configuration using a preinflation media.

64. The method of claim 63, wherein the preinflation media is substituted with a permanent inflation media once the carrier element is re-secured in the vicinity of the native heart valve.

65. The method of claim 62, wherein repositioning the carrier element includes moving at least three control wires removeably coupled to the carrier element.

66. The method of claim 62, wherein repositioning of the carrier element includes at least one of rotating or translating the carrier element.

67. The method of claim 62, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during collapsing of the carrier element.

68. The method of claim 62, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during repositioning of the carrier element

69. The method of claim 61, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during expansion of the carrier element.

70. The method of claim 61, wherein the carrier element is expanded to the expanded configuration using an inflation media.

71. The method of claim 61, wherein the carrier element is configured to conform to the patient'"'"'s anatomy upon expansion.

72. The method of claim 61, wherein the only native anatomical feature displaced by the carrier element is the native valve.

73. The method of claim 61, wherein proximal and distal ends of the carrier element form a seal with respective native anatomical features proximate opposing sides of the native valve.

74. The method of claim 61, wherein a length of the carrier element in the first and second expanded configurations is less than a length of the carrier element in the collapsed delivery configuration.

75. The method of claim 61, wherein the carrier element has a non-cylindrical profile in the first and second expanded configurations.

76. The method of claim 61, wherein a proximal portion of the carrier element extends further radially outwardly than a central portion of the carrier element.

77. A method for replacing a patient'"'"'s native heart valve, the method comprising:

delivering an expandable carrier element and a replacement valve endovascularly through a delivery sheath to a vicinity of the native heart valve, the replacement valve configured to allow the flow of blood through the replacement valve in a first direction and prevent the flow of blood through the valve in a second direction, the carrier element being detachably coupled to at least three delivery apparatuses;

extending the carrier element out of the delivery sheath;

positioning the carrier element using the at least three delivery apparatuses;

expanding the carrier element from a collapsed delivery configuration to an expanded configuration in the vicinity of the native heart valve; and

removing the at least three delivery apparatuses.

78. The method of claim 77, wherein each of the at least three delivery apparatuses comprise an outer sleeve and an inner elongated member moveably positioned within the outer sleeve

79. The method of claim 78, wherein each of the elongated members lies on first and second imaginary planes and each of the elongated members are bendable along the first imaginary plane more than each of the elongated members is bendable along the second imaginary plane.

80. The method of claim 79, wherein the first imaginary plane is perpendicular to the second imaginary plane.

81. The method of claim 77, wherein the at least three delivery apparatuses are positioned at least partially between the carrier element and the native heart valve.

82. The method of claim 77, wherein the at least three delivery apparatuses include one or more radiopaque markers.

83. The method of claim 77, wherein the expanding carrier element is a self expanding stent.

84. The method of claim 77, wherein the expanding carrier element is an inflatable structure.

85. The method of claim 77, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction once the carrier element has been extended from the delivery sheath and during expansion of the carrier element.

86. The method of claim 77, wherein each of the at least three delivery apparatuses includes a wire.

87. A system for replacing a patient'"'"'s native heart valve, the system comprising:

a delivery sheath;

an expandable carrier element having a collapsed delivery configuration and an expanded configuration, the carrier element configured to be delivered endovascularly to a vicinity of the native heart valve in the collapsed delivery configuration using the delivery sheath and in the expanded configuration in the vicinity of the native heart valve;

a replacement valve coupled to the carrier element and configured to allow the flow of blood through the replacement valve in a first direction and prevent the flow of blood through the valve in a second direction; and

at least three delivery apparatuses releasably coupled to the carrier element and configured to position the carrier element in the vicinity of the native heart valve once the carrier element is extended out of the delivery sheath.

88. The system of claim 87, wherein each of the at least three delivery apparatuses comprise an outer sleeve and an inner elongated member moveably positioned within the outer sleeve

89. The system of claim 88, wherein each of the elongated members lies on first and second imaginary planes and each of the elongated members are bendable along the first imaginary plane more than each of the elongated members is bendable along the second imaginary plane.

90. The system of claim 89, wherein the first imaginary plane is perpendicular to the second imaginary plane.

91. The system of claim 87, wherein the at least three delivery apparatuses are positioned at least partially between the carrier element and the native heart valve.

92. The system of claim 87, wherein the at least three delivery apparatuses include one or more radiopaque markers.

93. The system of claim 87, wherein the expanding carrier element is a self expanding stent.

94. The system of claim 87, wherein the expanding carrier element is an inflatable structure.

95. The system of claim 87, wherein the replacement valve prevents the flow of blood through the replacement valve in the second direction and allows the flow of blood through the replacement valve in the first direction during expansion of the carrier element.

96. The system of claim 87, wherein each of the at least three delivery apparatuses includes a wire.