EP0734721A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Method of incorporating drugs into a polymer component of stents
Assignee: Abbott Cardiovascular Systems Inc
•
Filing: 1996-03-20
•
Granted: —
•
Expires: 2016-03-20
Abstract
Abstract The drug-loaded polymeric material containing a therapeutic drug can be applied to a structure of an intravascular stent. A therapeutically effective amount of a therapeutic drug is incorporated into such a layer of polymeric material, without significantly increasing the thickness of the stent, to avoid interfering with the function of the stent. The drug-loaded polymer coating of the stent can formed to include pores, can be multi-layered to permit the combination of a plurality of different drug containing materials in a single stent, and can include a rate controlling membrane to allow for controlled retention and delivery of selected drugs within the affected blood vessel upon implantation. The layer of polymeric material is manufactured by combining the selected polymeric material with a relatively high loading of the therapeutic drug in a thermal process, such as coextrusion of the therapeutic drug with the polymeric material. The therapeutic drug is dispersed and incorporated into the polymer as small particles, preferably having a maximum cross-sectional dimension of 10 microns.
Inventors
- 👤 Robert P. Eury
- 👤 Darlene Garguilo
- 👤 Plaridel Villareal
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 12:47
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/14; A61L31/16; A61L31/08; A61L31/10; A61L31/146; A61P; A61P3/00; A61P3/08; A61P43/00; A61P7/00; A61P7/02; A61P9/00; A61L2300/00; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/62; A61L2300/622; A61M; A61M25/00; A61M25/0043; A61M2025/0057
Claims Analysis
Total Claims: 36
Claim 1
Independent Claim
85 words
A method of incorporating a therapeutically effective amount of a therapeutic drug into a polymeric material for application to an intravascular stent, the method comprising the steps of: forming solid particles of a therapeutic drug to have a maximum cross-sectional dimension of about 10 microns; and uniformly dispersing said solid particles of said therapeutic drug in said polymeric material such that said particles of said therapeutic drug form up to 70% by weight of the total weight of the therapeutic drug and the polymeric material.
Claim 2
Dependent Claim
48 words
The method of claim 1, wherein said step of forming solid particles of said therapeutic drug comprises one or more of air milling crystals of said therapeutic drug, recrystallizing crystals of said therapeutic drug, ball milling crystals of said therapeutic drug, or grinding crystals of said therapeutic drug.
Claim 3
Dependent Claim
81 words
The method of claim 1, wherein said therapeutic drug is selected from the group consisting of heparin, D-phe-pro-arg-chloromethylketone, dipyridamole, hirudin, recombinant hirudin, thrombin inhibitor, angiopeptin, angiotensin converting enzyme inhibitors, calcium channel blockers, colchicine, fibroblast growth factor antagonists, fish oil, omega 3-fatty acid, low molecular weight heparin, histamine antagonists, inhibitors of HMG-CoA reductase, methotrexate, monoclonal antibodies, nitroprusside, phosphodiesterase inhibitors, prostacyclin and prostacyclin analogues, prostaglandin inhibitor, PDGF antagonists, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine, alpha-interferon, and genetically engineered epithelial cells, and mixtures thereof.
Claim 4
Dependent Claim
16 words
The method of claim 1, wherein said polymeric material has a relatively low thermal processing temperature.
Claim 5
Dependent Claim
20 words
The method of claim 1, wherein said polymeric material has a thermal processing temperature of not more than approximately 100°C.
Claim 6
Dependent Claim
38 words
The method of claim 1, wherein said polymeric material is selected from the group consisting of polycaprolactone, poly(ethylene-co-vinyl acetate), poly(vinyl acetate), silicone gum rubber, poly-DL-lactic acid (DL-PLA), poly-L-lactic acid (L-PLA), polyorthoesters, polyiminocarbonates, aliphatic polycarbonates, polyphosphazenes, and mixtures thereof.
Claim 7
Dependent Claim
30 words
The method of claim 1, wherein said particles of said therapeutic drug comprise up to 70% by weight of the total weight of the therapeutic drug and the polymeric material.
Claim 8
Dependent Claim
64 words
The method of claim 1, wherein said step of uniformly dispersing said solid particles of said therapeutic drug in said polymeric material comprises one or more of coextruding said particles of said therapeutic drug and said polymeric material, calendaring said particles of said therapeutic drug and said polymeric material together, or solvent casting said particles of said therapeutic drug together with said polymeric material.
Claim 9
Dependent Claim
23 words
The method of claim 1, further including the step of uniformly dispersing a porosigen in said polymeric material together with said therapeutic drug.
Claim 10
Dependent Claim
35 words
The method of claim 9, wherein said step of uniformly dispersing a porosigen in said polymeric material together with said therapeutic drug comprises coextruding said porosigen together with said therapeutic drug and said polymeric material.
Claim 11
Dependent Claim
24 words
The method of claim 9, further including the step of dissolving said porosigen in said polymeric material to leave pores in said polymeric material.
Claim 12
Dependent Claim
17 words
The method of claim 11, wherein said pores have a maximum cross-sectional dimension of about 10 microns.
Claim 13
Dependent Claim
17 words
The method of claim 11, wherein said pores have a maximum cross-sectional dimension of about one micron.
Claim 14
Dependent Claim
31 words
The method of claim 1, further including the step of applying a rate-controlling membrane over said polymeric material to control the release rate of said therapeutic drug from said polymeric material.
Claim 15
Dependent Claim
34 words
The method of claim 14, wherein said step of applying a rate-controlling membrane over said polymeric material comprises forming said rate-controlling membrane to include a uniform dispersion of a porosigen in said rate-controlling membrane.
Claim 16
Dependent Claim
24 words
The method of claim 15, further including the step of dissolving said porosigen in said rate-controlling membrane to leave pores in said rate-controlling membrane.
Claim 17
Dependent Claim
32 words
The method of claim 9 or claim 15, wherein said porosigen is selected from the group consisting of sodium chloride, lactose, sodium heparin, polyethylene glycol, polyethylene oxide/polypropylene oxide copolymers, and mixtures thereof.
Claim 18
Dependent Claim
27 words
The method of claim 1, further including the step of forming said polymeric material containing said therapeutic drug as a sheet at least about 25 microns thick.
Claim 19
Dependent Claim
25 words
The method of claim 18, further including the step of laminating said sheet of polymeric material containing said therapeutic drug to an intravascular stent structure.
Claim 20
Dependent Claim
20 words
The method of claim 19, further including the step of removing excess polymeric material laminated to said intravascular stent structure.
Claim 21
Dependent Claim
53 words
A polymeric material containing a therapeutic drug for application to an intravascular stent for carrying and delivering said therapeutic drug within a blood vessel in which said intravascular stent is placed, comprising: a polymeric material having a relatively low thermal processing temperature; and particles of a therapeutic drug incorporated in said polymeric material.
Claim 22
Dependent Claim
20 words
The polymeric material of claim 21, wherein said polymeric material has a thermal processing temperature no greater than about 100°C.
Claim 23
Dependent Claim
39 words
The polymeric material of claim 21, wherein said polymeric material is selected from the group consisting of polycaprolactone, poly(ethylene-covinyl acetate), poly(vinyl acetate), silicone gum rubber, poly-DL-lactic acid (DL-PLA), poly-L-lactic acid (L-PLA), polyorthoesters, polyiminocarbonates, aliphatic polycarbonates, polyphosphazenes, and mixtures thereof.
Claim 24
Dependent Claim
24 words
The polymeric material of claim 21, wherein said particles of said therapeutic drug can have a maximum cross-sectional dimension of up to 50 microns.
Claim 25
Dependent Claim
84 words
The polymeric material of claim 21, wherein said therapeutic drug is a drug selected from the group consisting of heparin, D-phe-pro-arg-chloromethylketone, dipyridamole, hirudin, recombinant hirudin, thrombin inhibitor, angiopeptin, angiotensin converting enzyme inhibitors, calcium channel blockers, colchicine, fibroblast growth factor antagonists, fish oil, omega 3-fatty acid, low molecular weight heparin, histamine antagonists, inhibitors of HMG-CoA reductase, methotrexate, monoclonal antibodies, nitroprusside, phosphodiesterase inhibitors, prostacyclin and prostacyclin analogues, prostaglandin inhibitor, PDGF antagonists, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine, alpha-interferon, and genetically engineered epithelial cells, and mixtures thereof.
Claim 26
Dependent Claim
31 words
The polymeric material of claim 21, wherein said particles of said therapeutic drug comprise up to 70% by weight of the total weight of the therapeutic drug and the polymeric material.
Claim 27
Dependent Claim
31 words
The polymeric material of claim 21, wherein said particles of said therapeutic drug comprise up to 40% by weight of the total weight of the therapeutic drug and the polymeric material.
Claim 28
Dependent Claim
16 words
The polymeric material of claim 21, further comprising a porosigen uniformly dispersed in said polymeric material.
Claim 29
Dependent Claim
30 words
The polymeric material of claim 28, wherein said porosigen is selected from the group consisting of sodium chloride, lactose, sodium heparin, polyethylene glycol, polyethylene oxide/polypropylene oxide copolymers, and mixtures thereof.
Claim 30
Dependent Claim
26 words
The polymeric material of claim 21, wherein said polymeric material comprises a surface defining pores with a maximum cross-sectional dimension of less than about 10 microns.
Claim 31
Dependent Claim
11 words
The polymeric material of claim 21, further including a rate-controlling membrane.
Claim 32
Dependent Claim
43 words
The polymeric material of claim 31, wherein said rate-controlling membrane is formed to include a uniform distribution of a porosigen, said porosigen being selected from the group consisting of sodium chloride, lactose, sodium heparin, polyethylene glycol, polyethylene oxide/polypropylene oxide copolymers, and mixtures thereof.
Claim 33
Dependent Claim
24 words
The polymeric material of claim 31, wherein said rate-controlling membrane comprises a surface defining pores with a maximum cross-sectional dimension of about ten microns.
Claim 34
Dependent Claim
24 words
The polymeric material of claim 31, wherein said rate-controlling membrane comprises a surface defining pores with a maximum cross-sectional dimension of about one micron.
Claim 35
Dependent Claim
25 words
The polymeric material of claim 21, wherein said polymeric material containing said therapeutic drug is formed as a sheet at least about 25 microns thick.
Claim 36
Dependent Claim
24 words
The polymeric material of claim 35, wherein said sheet of polymeric material containing said therapeutic drug further is laminated to an intravascular stent structure.
References Cited (Backward Citations)
WO1995003036A1
Cited
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.