US6042875A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Drug-releasing coatings for medical devices
Assignee: Schneider USA Inc
•
Filing: 1999-03-02
•
Granted: 2000-03-28
•
Expires: 2019-03-02
Abstract
Abstract The invention is directed to medical devices having a drug-releasing coating and methods for making such coated devices. The coating permits timed or prolonged pharmacological activity on the surface of medical devices through a reservoir concept. Specifically, the coating comprises at least two layers: an outer layer containing at least one drug-ionic surfactant complex overlying a reservoir layer containing a polymer and the drug which is substantially free of an ionic surfactant. Upon exposure to body tissue of a medical device covered with such coating, the ionically bound drug in the outer layer is released into body fluid or tissue. Following release of such bound drug, the ionic surfactant binding sites in the outer layer are left vacant. To maintain the pharmacological activity after delivery of the ionically bound drug, additional amounts of the drug are embedded or incorporated in the reservoir layer in a manner which allows the drug, which is substantially free of ionic surfactants, to complex with the vacant binding sites of the ionic surfactant of the outer layer. As a result, the surface of the medical device is enriched with the drug to provide sustained pharmacological activity to prevent the adverse reaction due to the presence of the medical device. The invention is further directed to medical devices with stabilized drug-releasing coatings. The coatings are stabilized by exposure to a low energy, relatively non-penetrating energy source, e.g., gas plasma or an electron beam energy source.
Inventors
- 👤 Ni Ding
- 👤 Jennifer E. Raeder-Devens
- 👤 Tuyethoa Thi Trinh
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 19:35
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/28; A61L27/34; A61L29/00; A61L29/08; A61L29/085; A61L29/14; A61L29/16; A61L31/00; A61L31/08; A61L31/10; A61L31/14; A61L31/16; A61L2300/00; A61L2300/20; A61L2300/23; A61L2300/236; A61L2300/258; A61L2300/40; A61L2300/41; A61L2300/412; A61L2300/414; A61L2300/42; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/608; A61L2300/61; A61L2300/80; A61L2300/802
Claims Analysis
Total Claims: 49
Claim 1
Independent Claim
113 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active material and b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material.
Claim 2
Independent Claim
113 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active material and b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material.
Claim 3
Dependent Claim
14 words
The method of claim 1 wherein the reservoir layer is formulated in a solvent.
Claim 4
Dependent Claim
20 words
The method of claim 2 wherein the method further comprises allowing the solvent of the reservoir layer composition to evaporate.
Claim 5
Dependent Claim
21 words
The method of claim 1 wherein formulation of the reservoir layer includes combining the biologically active material with a molten polymer.
Claim 6
Dependent Claim
20 words
The method of claim 1 wherein the reservoir layer composition and the outer layer composition are applied by spray coating.
Claim 7
Dependent Claim
16 words
The method of claim 1 wherein the polymer of the reservoir layer is an elastomeric material.
Claim 8
Dependent Claim
32 words
The method of claim 6 wherein the polymer of the reservoir layer is selected from the group consisting of silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers and EPDM rubbers.
Claim 9
Dependent Claim
29 words
The method of claim 1 wherein the biologically active material of the reservoir layer is in a particulate form having an average particle size of 1 to 100 microns.
Claim 10
Dependent Claim
21 words
The device of claim 8 wherein the ratio of reservoir layer thickness to average particle diameter is greater than about 3.
Claim 11
Dependent Claim
21 words
The device of claim 8 wherein the ratio of reservoir layer thickness to average particle diameter is greater than about 5.
Claim 12
Dependent Claim
39 words
The method of claim 1 wherein the biologically active material is selected from the group consisting of glucocorticoids, heparin, hirudin, angiopeptin, aspirin, growth factors, oligonucleotides, antiplatelet agents, anti-hypertensives, anti-coagulant agents, antimitotic agents, antioxidants, antimetabolite agents, anti-inflammatory agents and antibiotics.
Claim 13
Dependent Claim
12 words
The method of claim 11 wherein the biologically active material is heparin.
Claim 14
Dependent Claim
17 words
The method of claim 1 wherein the reservoir layer is about 5 to about 200 microns thick.
Claim 15
Dependent Claim
17 words
The method of claim 13 wherein the reservoir layer is about 15 to about 50 microns thick.
Claim 16
Dependent Claim
18 words
The method of claim 1 wherein the ionic surfactant of the outer layer is a quaternary ammonium compound.
Claim 17
Dependent Claim
13 words
The method of claim 15 wherein the ionic surfactant comprises a tridodecymethylammonium ion.
Claim 18
Dependent Claim
17 words
The method of claim 1 wherein the outer layer is about 0.1 to about 10 microns thick.
Claim 19
Dependent Claim
21 words
The method of claim 1 which further comprises heat curing the reservoir layer composition after it is applied to the surface.
Claim 20
Independent Claim
140 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comnprising: a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active material; b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material; c) heat curing the reservoir layer composition after it is applied to the surface; and d) treating the reservoir layer with a low energy, relatively non-penetrating energy source.
Claim 21
Independent Claim
140 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comnprising: a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active material; b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material; c) heat curing the reservoir layer composition after it is applied to the surface; and d) treating the reservoir layer with a low energy, relatively non-penetrating energy source.
Claim 22
Dependent Claim
26 words
The method of claim 1 which further comprises treating the coating with a low energy, relatively non-penetrating energy source after the forming of the outer layer.
Claim 23
Independent Claim
146 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active materiall b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material; c) treating the coating with a low energy, relatively non-penetrating energy source after the forming of the outer layer; and d) heat curing the coating before the coating is treated with the energy source.
Claim 24
Independent Claim
146 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a reservoir layer over the surface by applying a reservoir layer composition comprising a polymer and a biologically active materiall b) forming an outer layer over the reservoir layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material; c) treating the coating with a low energy, relatively non-penetrating energy source after the forming of the outer layer; and d) heat curing the coating before the coating is treated with the energy source.
Claim 25
Dependent Claim
28 words
The method of claim 1 wherein the coating is constructed for maintaining the biologically active material on the surface of the device for at least about 24 hours.
Claim 26
Independent Claim
99 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a layer of the coating which comprises an ionic surfactant completed to the biologically active material on the surface, and b) exposing the layer to a low energy, relatively non-penetrating energy source.
Claim 27
Independent Claim
99 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a layer of the coating which comprises an ionic surfactant completed to the biologically active material on the surface, and b) exposing the layer to a low energy, relatively non-penetrating energy source.
Claim 28
Dependent Claim
24 words
The method of claim 23 wherein the energy source is selected from the group consisting of gas plasma, electron beam energy and corona discharge.
Claim 29
Independent Claim
129 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a layer of the coating which comprises an ionic surfactant complexed to the biologically active material on the surface, and b) exposing the layer to a low energy, relatively non-penetrating energy source; wherein the surface covered with the layer is heated at about 40° C. to 150° C. prior to exposing the coated surface to the low energy, relatively non-penetrating energy source.
Claim 30
Independent Claim
129 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a layer of the coating which comprises an ionic surfactant complexed to the biologically active material on the surface, and b) exposing the layer to a low energy, relatively non-penetrating energy source; wherein the surface covered with the layer is heated at about 40° C. to 150° C. prior to exposing the coated surface to the low energy, relatively non-penetrating energy source.
Claim 31
Dependent Claim
22 words
The method of claim 25 wherein the surface is heated at about 90° C. for about 30 seconds to about 16 hours.
Claim 32
Dependent Claim
30 words
The method of claim 24 wherein the layer is exposed to gas plasma generated from a gas selected from the group consisting of argon, helium, nitrogen, hydrogen and mixtures thereof.
Claim 33
Dependent Claim
14 words
The method of claim 27 wherein the gas plasma is generated from argon gas.
Claim 34
Dependent Claim
31 words
The method of claim 24 wherein the surface covered with the layer is exposed to gas plasma or the electron beam energy source for about 30 seconds to about 5 minutes.
Claim 35
Independent Claim
124 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a first layer of the coating over the surface by applying a first layer composition comprising a polymer, b) forming an outer layer over the first layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material, and c) exposing the coated surface to a low energy, relatively non-penetrating energy source.
Claim 36
Independent Claim
124 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a first layer of the coating over the surface by applying a first layer composition comprising a polymer, b) forming an outer layer over the first layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material, and c) exposing the coated surface to a low energy, relatively non-penetrating energy source.
Claim 37
Dependent Claim
24 words
The method of claim 30 wherein the energy source is selected from the group consisting of gas plasma, electron beam energy and corona discharge.
Claim 38
Dependent Claim
15 words
The method of claim 30, wherein the first layer further comprises a biologically active material.
Claim 39
Independent Claim
151 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a first layer of the coating over the surface by applying a first layer composition comprising a polymer, b) forming an outer layer over the first layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material, and c) exposing the coated surface to a low energy, relatively non-penetrating energy source; wherein the coated surface is heated at about 40° C. to 150° C. prior to exposing the coated surface to the low energy, relatively non-penetrating energy source.
Claim 40
Independent Claim
151 words
A method of making a medical device having at least a portion for insertion or implantation into the body of a patient, wherein the portion has a surface which is adapted for exposure to body tissue of the patient and wherein at least a part of the surface is covered with a coating to release at least one biologically active material therefrom, the method comprising: a) forming a first layer of the coating over the surface by applying a first layer composition comprising a polymer, b) forming an outer layer over the first layer by applying an outer layer composition comprising an ionic surfactant complexed to the biologically active material, and c) exposing the coated surface to a low energy, relatively non-penetrating energy source; wherein the coated surface is heated at about 40° C. to 150° C. prior to exposing the coated surface to the low energy, relatively non-penetrating energy source.
Claim 41
Dependent Claim
21 words
The method of claim 33 wherein the surface is heated at about 90° C. for about 1 to about 16 hours.
Claim 42
Dependent Claim
31 words
The method of claim 31 wherein the coated surface is exposed to gas plasma generated from a gas selected from the group consisting of argon, helium, nitrogen, hydrogen and mixtures thereof.
Claim 43
Dependent Claim
13 words
The method of claim 35 wherein gas plasma is generated from argon gas.
Claim 44
Dependent Claim
28 words
The method of claim 31 wherein the coated surface is exposed to gas plasma or the electron beam energy source for about 30 seconds to about 5 minutes.
Claim 45
Dependent Claim
20 words
The method of claim 30 wherein the first layer composition and the outer layer composition are applied by spray coating.
Claim 46
Dependent Claim
16 words
The method of claim 30 wherein the polymer of the first layer is an elastomeric material.
Claim 47
Dependent Claim
32 words
The method of claim 39 wherein the polymer of the first layer is selected from the group consisting of silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, and EPDM rubbers.
Claim 48
Dependent Claim
12 words
The method of claim 30 wherein the biologically active material is heparin.
Claim 49
Dependent Claim
13 words
The method of claim 30 wherein the ionic surfactant comprises a tridodecylmethylammonium ion.
References Cited (Backward Citations)
US3522346A
Cited
US3549409A
Cited
US3826678A
Cited
US4239664A
Cited
US4292965A
Cited
US4613665A
Cited
US4442133A
Cited
US4676975A
Cited
US4872867A
Cited
US4871357A
Cited
US4895566A
Cited
US4897433A
Cited
US5061738A
Cited
US5578079A
Cited
US5525348A
Cited
US5545208A
Cited
US5447724A
Cited
US5112457A
Cited
US5455040A
Cited
US5674192A
Cited
US5417969A
Cited
US5383927A
Cited
US5441759A
Cited
US5408999A
Cited
US5716981A
Cited
US5380299A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2003-03-28 | 2003-09-27 | 2004-03-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-03-28 | 2007-09-27 | 2008-03-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-03-28 | 2011-09-27 | 2012-03-28 | $7700.00 | Window Closed / Lapsed |