Expandable medical device for delivery of beneficial agent

• US 20060009838A1
• Filed: 09/07/2005
• Published: 01/12/2006
• Est. Priority Date: 10/16/2000
• Status: Active Grant

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Eigler, Neal L., Park, Kinam, Shanley, John F., Edelman, Elazer R.
• Granted Patent: US 8,187,321 B2
• Time in Patent Office: Days
• US Class Current: 623/1.160
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

An expandable medical device has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of said strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

Claims

1-48. -48. (canceled)

49. A method of forming an expandable medical device comprising:

(a) forming a substantially cylindrical expandable medical device body formed of a plurality of struts with a plurality of openings in the plurality of struts;

(b) forming a first solution of a first beneficial agent, first polymer carrier, and a first solvent;

(c) delivering the first solution into the opening;

(d) evaporating the first solvent to form a solid layer of first beneficial agent and first carrier; and

(e) repeating steps (c) and (d).

50. The method of claim 49, further comprising forming a second solution of a second beneficial agent, a second polymer carrier, and a second solvent and delivering the second solution into the opening on top of the layers of first beneficial agent.

51. The method of claim 49, wherein the first beneficial agent is an active drug.

52. The method of claim 49, wherein the first beneficial agent is an anti-proliferative.

53. The method of claim 49, wherein the first beneficial agent is an anti-inflammatory.

54. The method of claim 49, wherein the first beneficial agent is an antirestenotic.

55. The method of claim 49, wherein the first beneficial agent is a protein drug.

56. The method of claim 49, wherein the first beneficial agent is an anti-thombin.

57. The method of claim 49, wherein the first beneficial agent is an anti-platelet.

58. The method of claim 49, wherein the first beneficial agent is paclitaxel.

59. The method of claim 49, wherein the first beneficial agent is rapamycin.

60. The method of claim 49, wherein the first beneficial agent is heparin.

61. The method of claim 50, wherein the first beneficial agent is an anti-thrombotic and the second beneficial agent is an anti-proliferative.

62. The method of claim 50, wherein the first beneficial agent is an anti-proliferative and the second beneficial agent is an anti-inflammatory.

63. The method of claim 50, wherein the first and second beneficial agents are arranged to be delivered on a first side of the device body.

64. The method of claim 49, further comprising forming a second solution of a second solvent and a second polymer and delivering the second solution into the opening to form a barrier layer with the openings.

65. The method of claim 50, wherein the first beneficial agent is deposited in the openings to achieve a first release profile and the second beneficial agent is deposited in the openings to achieve a second release profile different from the first release profile.

66. The method of claim 49, wherein a thickness of the layers is 2 μ

m to 50 μ

m.

67. The method of claim 49, wherein an area of the openings is at least 0.0032 mm².

68. The method of claim 49, wherein a total depth of the openings is 125 μ

m to 140 μ

m.

69. An expandable medical device comprising:

a plurality of struts, said plurality of struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

at least one strut opening in at least one of the plurality of struts, the at least one strut opening extending through the strut; and

at least one beneficial agent in the at least one strut opening in a plurality of layers formed by a method comprising the steps of;

delivering a solution comprising first beneficial agent, a first polymer carrier and a first solvent, or the first beneficial agent and first solvent alone, into the at least one opening;

evaporating the solvent; and

repeating the process until each opening is partially or entirely filled.

70. The device of claim 69, further comprising forming a second solution of a second beneficial agent, a second polymer carrier, and a second solvent and delivering the second solution into the opening on top of the layers of first beneficial agent.

71. The device of claim 69, wherein the first beneficial agent is an active drug.

72. The device of claim 69, wherein the first beneficial agent is an anti-proliferative.

73. The device of claim 69, wherein the first beneficial agent is an anti-inflammatory.

74. The device of claim 69, wherein the first beneficial agent is an antirestenotic.

75. The device of claim 69, wherein the first beneficial agent is a protein drug.

76. The device of claim 69, wherein the first beneficial agent is an anti-thombin.

77. The device of claim 69, wherein the first beneficial agent is an anti-platelet.

78. The device of claim 69, wherein the first beneficial agent is paclitaxel.

79. The device of claim 69, wherein the first beneficial agent is rapamycin.

80. The device of claim 69, wherein the first beneficial agent is heparin.

81. The device of claim 70, wherein the first beneficial agent is an anti-thrombotic and the second beneficial agent is an anti-proliferative.

82. The device of claim 70, wherein the first beneficial agent is an anti-proliferative and the second beneficial agent is an anti-inflammatory.

83. The device of claim 70, wherein the first and second beneficial agents are arranged to be delivered on a first side of the device body.

84. The device of claim 69, further comprising forming a second solution of a second solvent and a second polymer and delivering the second solution into the opening to form a barrier layer with the openings.

85. The device of claim 70, wherein the first beneficial agent is deposited in the openings to achieve a first release profile and the second beneficial agent is deposited in the openings to achieve a second release profile different from the first release profile.

86. The device of claim 69, wherein a thickness of the layers is 2 μ

m to 50 μ

m.

87. The device of claim 69, wherein an area of the openings is at least 0.0032 mm².

88. The device of claim 69, wherein a total depth of the openings is 125 μ

m to 140 μ

m.