US6299604B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Coated implantable medical device
Assignee: Cook Medical Technologies LLC
•
Filing: 1999-08-20
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Granted: 2001-10-09
•
Expires: 2019-08-20
Abstract
Abstract A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer is includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.
Inventors
- 👤 Anthony O. Ragheb
- 👤 Brian L. Bates
- 👤 Neal E. Fearnot
- 👤 Thomas G. Kozma
- 👤 William D. Voorhees, III
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:22
CPC Classifications
A; A61; A61L; A61L29/00; A61L29/08; A61L29/085; A61L29/14; A61L29/16; A61L31/00; A61L31/08; A61L31/10; A61L31/14; A61L31/16; A61F; A61F2250/00; A61F2250/0058; A61F2250/0067; A61F2250/0068; A61L2300/00; A61L2300/40; A61L2300/416; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/608; A61L2420/00; A61L2420/08
Claims Analysis
Total Claims: 29
Claim 1
Independent Claim
130 words
An implantable medical device ( 10 ), comprising: a structure ( 12 ) adapted for introduction into a patient, the structure ( 12 ) having at least one surface and being composed of a base material ( 14 ); at least one coating layer ( 16 ) posited on one surface of the structure ( 12 ); and at least one layer ( 18 ) of a first bioactive material posited over at least a portion of the at least one coating layer ( 16 ), wherein said at least one coating layer ( 16 ) provides for a controlled release of the bioactive material from the at least one coating layer ( 16 ), and wherein said first bioactive material ( 18 ) comprises paclitaxel and has cytotoxic properties.
Claim 2
Dependent Claim
130 words
An implantable medical device ( 10 ), comprising: a structure ( 12 ) adapted for introduction into a patient, the structure ( 12 ) having at least one surface and being composed of a base material ( 14 ); at least one coating layer ( 16 ) posited on one surface of the structure ( 12 ); and at least one layer ( 18 ) of a first bioactive material posited over at least a portion of the at least one coating layer ( 16 ), wherein said at least one coating layer ( 16 ) provides for a controlled release of the bioactive material from the at least one coating layer ( 16 ), and wherein said first bioactive material ( 18 ) comprises paclitaxel and has cytotoxic properties.
Claim 3
Dependent Claim
29 words
The device ( 10 ) of claim 1 wherein said coating layer has a surface energy density to increase adhesion of said first bioactive material to said coating layer.
Claim 4
Dependent Claim
61 words
The device ( 10 ) of claim 1 further comprising at least one porous layer ( 20 ) posited over the bioactive material layer ( 18 ), wherein said at least one porous layer ( 20 ) is composed of a polymer and said polymer provides for a controlled release of the bioactive material through said at least one porous layer.
Claim 5
Dependent Claim
25 words
The device ( 10 ) of claim 3 , wherein the non-porous material is at least one of an adsorbent material and an absorbent material.
Claim 6
Dependent Claim
30 words
The device ( 10 ) of claim 4 , wherein the at least one coating layer ( 16 ) of the adsorbent material has a thickness of approximately 230,000 Angtroms.
Claim 7
Dependent Claim
20 words
The device ( 10 ) of claim 1 , wherein the coating layer ( 16 ) comprises a non-porous material.
Claim 8
Dependent Claim
23 words
The device ( 10 ) of claim 1 , wherein the at least one coating layer ( 16 ) comprises a parylene derivative.
Claim 9
Dependent Claim
30 words
The device ( 10 ) of claim 7 , wherein the at least one coating layer ( 16 ) has a thickness in a range from 50,000 to 500,000 Angstroms.
Claim 10
Dependent Claim
30 words
The device ( 10 ) of claim 7 , wherein the at least one coating layer ( 16 ) has a thickness in a range from 100,00 to 500,000 Angstroms.
Claim 11
Dependent Claim
26 words
The device ( 10 ) of claim 7 , wherein the at least one coating layer ( 16 ) has a thickness of approximately 200,000 Angstroms.
Claim 12
Dependent Claim
19 words
The device ( 10 ) of claim 1 , wherein the bioactive material layer includes a chimeric monoclonal antibody.
Claim 13
Dependent Claim
49 words
The device ( 10 ) of claim 1 , wherein the polymer is selected from the group consisting of a polyamide, polymers of parylene or derivatives thereof, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone based polymers, polymers of methane, tetrafluoroethylene or tetramethyidisiloxane or a polymer derived from photopolymerizeable monomers.
Claim 14
Dependent Claim
23 words
The device of claim 1 , wherein said paclitaxel is in a concentration of between 0.06 mg/mm 2 and 60 mg/mm 2 .
Claim 15
Dependent Claim
23 words
The device of claim 1 , wherein said paclitaxel is in a concentration of between 1.5 mg/mm 2 and 5 mg/mm 2 .
Claim 16
Dependent Claim
19 words
The device of claim 1 , wherein said paclitaxel is in a concentration of about 1.8 mg/mm 2 .
Claim 17
Dependent Claim
18 words
The device of claim 1 , wherein said paclitaxel is in an amount of at least 35 μg.
Claim 18
Dependent Claim
34 words
The device of claim 1 , wherein said bioactive material includes at least 35 μg and includes at least up to a total of 400 μg of a mixture of paclitaxel and parylene N.
Claim 19
Dependent Claim
76 words
An implantable medical device ( 10 ), comprising: a structure ( 12 ) adapted for introduction into a patient, the structure ( 12 ) having at least one surface and being comprised of a base material ( 14 ); and at least one layer ( 18 ) of a bioactive material having cytotoxic properties posited on the at least one surface of the structure ( 12 ), wherein said bioactive material ( 18 ) comprises paclitaxel.
Claim 20
Dependent Claim
76 words
An implantable medical device ( 10 ), comprising: a structure ( 12 ) adapted for introduction into a patient, the structure ( 12 ) having at least one surface and being comprised of a base material ( 14 ); and at least one layer ( 18 ) of a bioactive material having cytotoxic properties posited on the at least one surface of the structure ( 12 ), wherein said bioactive material ( 18 ) comprises paclitaxel.
Claim 21
Dependent Claim
35 words
The device ( 10 ) of claim 18 , wherein said at least one surface has been treated and has a surface energy density to increase adhesion of said bioactive material to said base material.
Claim 22
Dependent Claim
23 words
The device of claim 18 , wherein said paclitaxel is in a concentration of between 0.06 mg/mm 2 and 60 mg/mm 2 .
Claim 23
Dependent Claim
23 words
The device of claim 18 , wherein said paclitaxel is in a concentration of between 1.5 mg/mm 2 and 5 mg/mm 2 .
Claim 24
Dependent Claim
19 words
The device of claim 18 , wherein said paclitaxel is in a concentration of about 1.8 mg/mm 2 .
Claim 25
Dependent Claim
18 words
The device of claim 18 , wherein said paclitaxel is in an amount of at least 35 μg.
Claim 26
Dependent Claim
34 words
The device of claim 18 , wherein said bioactive material includes at least 35 μg and includes at least up to a total of 400 μg of a mixture of paclitaxel and parylene N.
Claim 27
Dependent Claim
101 words
An implantable medical deice ( 10 ), comprising: a structure ( 12 ) adapted for introduction into a patient, the structure ( 12 ) having at least one surface and being composed of a base material ( 14 ); at least one adhesion promotion layer ( 30 ) posited on one surface of the structure ( 12 ); and at least one layer ( 18 ) of a first bioactive material having cytotoxic properties posited over at least a portion of the at least one adhesion promotion layer ( 30 ), wherein said first bioactive material ( 18 ) comprises paclitaxel.
Claim 28
Dependent Claim
101 words
An implantable medical deice ( 10 ), comprising: a structure ( 12 ) adapted for introduction into a patient, the structure ( 12 ) having at least one surface and being composed of a base material ( 14 ); at least one adhesion promotion layer ( 30 ) posited on one surface of the structure ( 12 ); and at least one layer ( 18 ) of a first bioactive material having cytotoxic properties posited over at least a portion of the at least one adhesion promotion layer ( 30 ), wherein said first bioactive material ( 18 ) comprises paclitaxel.
Claim 29
Dependent Claim
57 words
The device ( 10 ) of claim 25 further comprising at least one porous layer ( 20 ) posited over the bioactive material layer ( 18 ), wherein said at least one porous layer 20 includes a polymer and said polymer provides for a controlled release if the bioactive material thought said at least one porous layer.
References Cited (Backward Citations)
GB1307055A
Cited
US4101984A
Cited
US4343788A
Cited
US4479795A
Cited
US4769013A
Cited
US5197977A
Cited
US5108424A
Cited
US4677143A
Cited
US4872867A
Cited
US5019096A
Cited
WO1989011500A1
Cited
US5053048A
Cited
US5298255A
Cited
US5067491A
Cited
US5059166A
Cited
US5447724A
Cited
US5569463A
Cited
US5112457A
Cited
US5455040A
Cited
US5244654A
Cited
US5304121A
Cited
US5102402A
Cited
US5344411A
Cited
US5344444A
Cited
US5356433A
Cited
US5345933A
Cited
US5464450A
Cited
US5348873A
Cited
US5314688A
Cited
US5217493A
Cited
US5282823A
Cited
US5383927A
Cited
US5383928A
Cited
US5449382A
Cited
US5342348A
Cited
US5443458A
Cited
US5419760A
Cited
US5716981A
Cited
WO1995006487A2
Cited
US5380299A
Cited
US5457113A
Cited
US5554181A
Cited
EP0734721A2
Cited
US5609629A
Cited
EP0747069A2
Cited
WO1998017331A1
Cited
US5824049A
Cited
US5873904A
Cited
US5607475A
Cited
WO1997033552A1
Cited
WO1998036784A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-10-08 | 2005-04-09 | 2005-10-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-10-08 | 2009-04-09 | 2009-10-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-10-08 | 2013-04-09 | 2013-10-09 | $7700.00 | Window Closed / Lapsed |