ELUTING MEDICAL DEVICES
First Claim
Patent Images
1. A medical device comprising:
- a. an expandable member;
b. a coating comprising a therapeutic agent disposed around said expandable member;
c. a sheath disposed around said coating, wherein said sheath has a variably permeable microstructure that initially limits unintended transfer of therapeutic agent through said sheath when said sheath has a substantially closed microstructure;
d. wherein said coating and therapeutic agent are disposed substantially between the surface of the expandable member and the sheath; and
e. wherein when said expandable member and sheath are expanded, said sheath has an open microstructure and allows the transfer of said therapeutic agent to an area external to said sheath.
2 Assignments
0 Petitions
Accused Products
Abstract
The invention is directed to eluting medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and an outer sheath with a variably permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during expansion of the expandable member, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.
29 Citations
140 Claims
-
1. A medical device comprising:
-
a. an expandable member; b. a coating comprising a therapeutic agent disposed around said expandable member; c. a sheath disposed around said coating, wherein said sheath has a variably permeable microstructure that initially limits unintended transfer of therapeutic agent through said sheath when said sheath has a substantially closed microstructure; d. wherein said coating and therapeutic agent are disposed substantially between the surface of the expandable member and the sheath; and e. wherein when said expandable member and sheath are expanded, said sheath has an open microstructure and allows the transfer of said therapeutic agent to an area external to said sheath. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
-
-
56. A method of delivering a therapeutic agent to a desired location within a vessel or an implanted endoprosthesis comprising:
-
a. inserting a catheter in a vessel, said catheter comprising i. an expandable member comprising a coating with a therapeutic agent; ii. a sheath disposed around said expandable member, wherein said sheath has a variably permeable microstructure that substantially limits transfer of said therapeutic agent to an area external to said sheath when said sheath is in an unexpanded state and comprises a substantially closed microstructure; and iii. wherein said coating and therapeutic agent are disposed between the surface of the expandable member and the sheath; b. advancing said catheter to a desired location within said vessel; and c. expanding the expandable member and sheath at the desired location within said vessel, wherein the expansion of said sheath opens the microstructure of the sheath and allows transfer of said therapeutic agent from between the surface of the expandable member and the sheath to an area external to said sheath while preventing transfer of particles out of said sheath greater than about 25 microns in size. - View Dependent Claims (57, 58, 59, 60, 61, 62, 63, 64, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85)
-
- 65. The method of 56, wherein said sheath allows rapid transfer of said coating and therapeutic agent because said sheath rapidly wets out during expansion.
-
86. A balloon catheter comprising:
-
a. a balloon comprising a coating and a therapeutic agent on the outer surface of said balloon; b. a sheath disposed around said balloon wherein said sheath has a microstructure composed of nodes interconnected by fibrils and wherein said sheath possesses a variably permeable microstructure that substantially limits transfer of said therapeutic agent in an unexpanded state; c. wherein said coating and therapeutic agent are disposed between the surface of the balloon and the sheath; and d. wherein when said balloon and sheath are expanded, said sheath allows transfer of said coating through the outer sheath. - View Dependent Claims (87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114)
-
-
115. A system of delivering a therapeutic agent comprising:
-
a catheter comprising a distensible layer; a coating comprising a therapeutic agent disposed around said distensible layer; an outer sheath over said distensible layer and said coating, wherein said outer sheath has a variably permeable microstructure; and an expandable member, wherein said expandable member is on the distal end a catheter, wherein said expandable member can be placed within said catheter; wherein when said expandable member is expanded, said expandable member will distend said distensible layer and outer sheath allowing transfer of said coating and therapeutic agent to an area external to said outer sheath. - View Dependent Claims (116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132)
-
-
133. A medical device comprising:
-
a mass transport barrier; and a solubilized therapeutic agent; wherein said mass transport barrier has a first configuration that is substantially permeable to bodily fluids and impermeable to the solubilized therapeutic agent and a second configuration, that is substantially permeable to the solubilized therapeutic agent but impermeable to particles greater than about 25 μ
m. - View Dependent Claims (134, 135, 136)
-
-
137. A method of delivering a bioactive agent to biological target through a mass transport barrier, said method comprising:
-
a mass transport barrier; and a solubilized therapeutic agent; wherein said mass transport barrier has a first configuration that is substantially permeable to bodily fluids and impermeable to the solubilized therapeutic agent and a second configuration that is substantially permeable to the solubilized therapeutic agent but impermeable to particles greater than about 25 μ
m; andwherein upon an application of mechanical force to the mass transport barrier induces the change between the first and second configurations thereby allowing controlled permeation of the solubilized therapeutic agent through the mass transport barrier. - View Dependent Claims (138, 139, 140)
-
Specification