Endolumenal Prosthesis with Bioresorbable Portions

• US 20080215129A1
• Filed: 07/25/2005
• Published: 09/04/2008
• Est. Priority Date: 07/25/2005
• Status: Active Grant

• Current Assignee: Invatec Technology Center GmbH (Medtronic Plc)
• Original Assignee: Invatec S.P.A. (Medtronic Plc)
• Inventors: Schaffner, Silvio, Venturelli, Andrea
• Granted Patent: US 8,870,940 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

The present invention relates to an endolumenal prosthesis comprising a tubular body adapted to convert from a contracted condition to an expanded condition. The tubular body develops along a longitudinal axis and comprises: a plurality of coils and at least one bridge. The coils develop along a substantially circumferential direction and the bridge connects two coils. The coils are realised in a persistent material, while the bridge is realised in a bioabsorbable material.

Claims

1-44. -44. (canceled)

45. An endolumenal prosthesis, comprising a tubular body adapted to convert from a contracted condition to an expanded condition, said tubular body being developed along a longitudinal axis (X-X), said tubular body comprising:

a plurality of coils that develop in a substantially circumferential direction, and at least one bridge, that connects two coils,

wherein said at least one bridge is made of a bioabsorbable material and said coils are made of a persistent material.

46. An endolumenal prosthesis according to claim 45 wherein said endolumenal prosthesis is of the self-expandable type.

47. An endolumenal prosthesis according to claim 45 wherein said endolumenal prosthesis is of the balloon-expandable type.

48. An endolumenal prosthesis according to claim 45 wherein said coils define closed courses.

49. An endolumenal prosthesis according to claim 45 wherein said coils develop according to a substantially circumferential direction (C).

50. An endolumenal prosthesis according to claim 45 wherein said at least one bridge connects two adjacent coils.

51. An endolumenal prosthesis according to claim 45 wherein said at least one bridge connects two non-adjacent coils.

52. An endolumenal prosthesis according to claim 45 wherein said at least one bridge has a substantially straight line development and an extension oriented in an approximately axial direction.

53. An endolumenal prosthesis according to claim 45 wherein said at least one bridge develops in a substantially circumferential direction (C).

54. An endolumenal prosthesis according to claim 53, wherein said at least one bridge forms a pseudo-coil.

55. An endolumenal prosthesis according to claim 45 wherein a plurality of bridges 12 is included between two coils.

56. An endolumenal prosthesis according to claim 45 wherein said bridge has a slightly sloping direction in relation to the axial direction.

57. An endolumenal prosthesis according to claim 45 wherein all the bridges included between two coils are parallel with each other.

58. An endolumenal prosthesis according to claim 45 wherein following the endolumenal prosthesis longitudinally in the direction of the X-X axis bridges exist, which alternate in directions having opposite slopes in relation to the X-X axis direction.

59. An endolumenal prosthesis according to claim 45 wherein at least one of said coils comprises fixation actuators in a point wherein a bridge branches off.

60. An endolumenal prosthesis according to claim 59, wherein said fixation actuators comprise a hole made in the width of the coil.

61. An endolumenal prosthesis according to claim 59, wherein said fixation actuators comprise shaped protrusions positioned externally on the width of the coil.

62. An endolumenal prosthesis according to claim 59, wherein said fixation actuators comprise an incised line on the surface of the coil.

63. An endolumenal prosthesis according to claim 59, wherein said fixation actuators comprise a highly porous level on the surface of the coil.

64. An endolumenal prosthesis according to claim 60, wherein said bridge comprises a profile that locally replicates with great precision the contour of the profile of the coil and portions which are complementary to said fixation actuators, adapted to provide shape coupling between the coil and the respective bridge.

65. An endolumenal prosthesis according to claim 46 wherein at least one coil is made of superelastic material or in hardened pseudoelastic material.

66. An endolumenal prosthesis according to claim 46 wherein at least one coil is made of shape memory material.

67. An endolumenal prosthesis according to claim 66, wherein said shape memory material is NiTinol.

68. An endolumenal prosthesis according to claim 47 wherein at least one coil is made of stainless steel.

69. An endolumenal prosthesis according to claim 68, wherein said stainless steel is of the type classified as AISI 316 L.

70. An endolumenal prosthesis according to claim 47 wherein at least one coil is made of Chromium-Cobalt alloy.

71. An endolumenal prosthesis according to claim 70, wherein said Chromium-Cobalt alloy is of the type classified as UNS R30035.

72. An endolumenal prosthesis according to claim 45, wherein at least one bridge is made of a bioabsorbable polymer.

73. An endolumenal prosthesis according to claim 72, wherein said bioabsorbable polymer is selected from the group composed of PDLA or poly-(D-lactic acid), PLLA or poly-(L-lactic acid), and PGA or poly-(glycolic acid).

74. An endolumenal prosthesis according to claim 72 wherein said bioabsorbable polymer is selected from the group composed of:

poly-caprolactone, poly-(lactide-co-glycolide), poly-(ethylene-vinyl acetate), poly-(hydroxybutyrate-co-valerate), poly-dioxanone, poly-orthoester, poly-anhydride, poly-(glycolic acid-co-trimethylene carbonate), poly-phosphoester, poly-phosphoester urethane, poly(amino acids), cyanoacrylates, poly-(trimethylene carbonate), poly-(iminocarbonate), copoly-(ether-esters) (e.g. PEO/PLA), poly-alkylene oxalates, poly-phosphazenes and biomolecules such as fibrin, fibrinogen, cellulose, starch, collagen, hyaluronic acid, poly-N-alkylacrylamides, poly-depsi-peptide carbonate, and poly-ethylene-oxide based polyesters.

75. An endolumenal prosthesis according to claim 45, wherein at least one bridge is made of a bioabsorbable metallic material.

76. An endolumenal prosthesis according to claim 45, wherein at least one bridge is made of a Magnesium alloy, preferably of the type classified as UNS M18430.

77. An endolumenal prosthesis according to claim 45, wherein at least one bridge is made of a binary mixture Calcium oxide (CaO) and Phosphorous pentoxide (or Phosphoric anhydride)(P₂O₅).

78. An endolumenal prosthesis according to claim 45, wherein at least one bridge forms a loop adapted to enclose a loop of a coil in order to form a chain connection.

79. An endolumenal prosthesis according to claim 45, wherein at least one bridge assumes the form of a beam having a mainly axial development and connected to more than two coils.

80. An endolumenal prosthesis according to claim 79 wherein said beam is positioned inside said coils and is connected to their radially internal surface.

81. An endolumenal prosthesis according to claim 80 wherein said radially internal surface of said coils comprises fixation actuators adapted to form a shape coupling with said beam.

82. An endolumenal prosthesis according to claim 79 wherein said endolumenal prosthesis comprises a plurality of beams which, when the endolumenal prosthesis is in its contracted condition, enter into contact with each other, thus forming a tubular structure positioned inside the coils.

83. An endolumenal prosthesis according to claim 82 wherein said tubular structure defines, at its distal end, an opening adapted to receive a guidewire.

84. An endolumenal prosthesis according to claim 78 wherein each of the beams comprises at its distal end, a keel.

85. An endolumenal prosthesis according to claim 84 wherein, when the endolumenal prosthesis is in its contracted condition, and the beams are in contact with one another, the plurality of keels creates a tip.

86. An endolumenal prosthesis according to claim 45, wherein at least one coil comprises a marker made of radiopaque material.

87. An endolumenal prosthesis according to claim 45, wherein the coils positioned at the distal end and proximal end respectively, comprise a marker made of radiopaque material.

88. An endolumenal prosthesis according to claim 45, wherein the parts made of bioabsorbable material are adapted to release a drug in a controlled manner over a prolonged period of time.

89. An endolumenal prosthesis according to claim 45, wherein each single loop of each single coil is connected by a bridge to the respective loop of the adjacent coil.

90. An endolumenal prosthesis according to claim 45, wherein the bridges made of persistent material alternate along the circumferential direction with bridges made for bioabsorbable material.

91. Device for the transport and delivery of an endolumenal prosthesis according to claim 82, comprising a catheter and a sheath adapted to supply a radial containing system for the endolumenal prosthesis, wherein

said catheter comprises, at its distal end, a shoulder adapted to provide an axial support for the tubular structure of the endolumenal prosthesis;

and

the length of said sheath extends further than that of said catheter by a length substantially equal to that of the endolumenal prosthesis.