US5902598A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Sustained release drug delivery devices
Assignee: Control Delivery Systems Inc
•
Filing: 1997-08-28
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Granted: 1999-05-11
•
Expires: 2017-08-28
Abstract
Abstract A method and device for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect is provided. The method includes administering a sustained release drug delivery system to a mammalian organism in need of such treatment at an area wherein release of an effective agent is desired and allowing the effective agent to pass through the device in a controlled manner. The device includes an inner core or reservoir comprising the effective agent; a first coating layer, which is permeable to the passage of the effective agent; a second coating layer, which is essentially impermeable to the passage of the effective agent; and a third coating layer, which is permeable to the passage of the effective agent. The first coating layer covers at least a portion of the inner core. The second coating layer covers at least a portion of the first coating layer and inner core; however, at least a small portion of the first coating layer or inner core is not coated with the second coating layer. The second coating layer includes an impermeable film and at least one impermeable disc. The third coating layer essentially completely covers the second coating layer and the uncoated portion of the first coating layer or inner core.
Inventors
- 👤 Jianbing Chen
- 👤 Paul Ashton
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-28 14:53
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0087; A61K9/0092; A61K9/20; A61K9/0012; A61K9/0019; A61K9/0024; A61K9/0048; A61K9/0051; A61P; A61P19/00; A61P19/02; A61P25/00; A61P25/04; A61P27/00; A61P27/02; A61P29/00; A61P3/00; A61P3/08; A61P3/10; A61P31/00; A61P31/12; A61P31/14; A61P31/18; A61P31/20; A61P31/22; A61P35/00; A61P37/00; A61P37/02; A61P37/06
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
244 words
A method for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect comprising: administering a sustained release drug delivery system to a mammalian organism in need of such treatment, said drug delivery system comprising; (1) an inner core or reservoir comprising an effective amount of an agent to obtain a desired local or systemic physiological or pharmacological effect, (2) a first coating layer permeable to the passage of said agent, wherein said first coating layer covers at least a portion of said inner core, which provides control and sustained release of the agent, (3) a second coating layer, said second coating layer essentially impermeable to the passage of said agent, and said second coating layer covering at least 50% of the inner core and/or the first coating layer, wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer and said second coating layer comprises an impermeable film and at least one impermeable disc being different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (4) a third coating layer permeable to the passage of said agent, wherein said third coating layer essentially completely covers said second coating layer and the uncoated portion of the first coating layer or inner core, whereby said agent is able to pass through said third coating layer in a controlled manner.
Claim 2
Independent Claim
244 words
A method for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect comprising: administering a sustained release drug delivery system to a mammalian organism in need of such treatment, said drug delivery system comprising; (1) an inner core or reservoir comprising an effective amount of an agent to obtain a desired local or systemic physiological or pharmacological effect, (2) a first coating layer permeable to the passage of said agent, wherein said first coating layer covers at least a portion of said inner core, which provides control and sustained release of the agent, (3) a second coating layer, said second coating layer essentially impermeable to the passage of said agent, and said second coating layer covering at least 50% of the inner core and/or the first coating layer, wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer and said second coating layer comprises an impermeable film and at least one impermeable disc being different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (4) a third coating layer permeable to the passage of said agent, wherein said third coating layer essentially completely covers said second coating layer and the uncoated portion of the first coating layer or inner core, whereby said agent is able to pass through said third coating layer in a controlled manner.
Claim 3
Dependent Claim
20 words
A method for treating a mammalian organism as claimed in claim 1, wherein said third coating layer comprises polyvinyl alcohol.
Claim 4
Dependent Claim
21 words
A method for treating a mammalian organism as claimed in claim 2, wherein said second coating layer comprises ethylene vinyl acetate.
Claim 5
Dependent Claim
20 words
A method for treating a mammalian organism as claimed in claim 3, wherein said first coating layer comprises polyvinyl alcohol.
Claim 6
Dependent Claim
22 words
A method for treating a mammalian organism as claimed in claim 1, wherein said effective agent comprises fluocinolone acetonide, nimodipine or ganciclovir.
Claim 7
Independent Claim
225 words
A method for treating a mammalian organism for cytomegalovirus retinitis comprising: administering a sustained release drug delivery system to a mammalian organism in need of such treatment, said drug delivery system comprising; (1) an inner core or reservoir comprising an effective amount of ganciclovir effective to obtain a desired local or systemic physiological or pharmacological effect, (2) a first coating layer permeable to the passage of said agent, said first coating layer essentially completely covers said inner core, (3) a second coating layer, said second coating layer essentially impermeable to the passage of said ganciclovir, and said second coating layer covering at least 50% of the inner core and/or the first coating layer, wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer, and wherein said second coating layer comprises an impermeable film and at least one impermeable disc being a different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (4) a third coating layer permeable to the passage of said ganciclovir, wherein said third coating layer essentially completely covers said second coating layer and the uncoated portion of the first coating layer or inner core, whereby said ganciclovir is able to pass through said third coating layer in a controlled manner.
Claim 8
Independent Claim
225 words
A method for treating a mammalian organism for cytomegalovirus retinitis comprising: administering a sustained release drug delivery system to a mammalian organism in need of such treatment, said drug delivery system comprising; (1) an inner core or reservoir comprising an effective amount of ganciclovir effective to obtain a desired local or systemic physiological or pharmacological effect, (2) a first coating layer permeable to the passage of said agent, said first coating layer essentially completely covers said inner core, (3) a second coating layer, said second coating layer essentially impermeable to the passage of said ganciclovir, and said second coating layer covering at least 50% of the inner core and/or the first coating layer, wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer, and wherein said second coating layer comprises an impermeable film and at least one impermeable disc being a different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (4) a third coating layer permeable to the passage of said ganciclovir, wherein said third coating layer essentially completely covers said second coating layer and the uncoated portion of the first coating layer or inner core, whereby said ganciclovir is able to pass through said third coating layer in a controlled manner.
Claim 9
Independent Claim
245 words
A method for providing controlled and sustained administration of an agent effective in obtaining a desired local or systemic physiological or pharmacological effect comprising: surgically implanting a sustained release drug delivery system at a desired location, said drug delivery system comprising; (1) an inner core or reservoir comprising an effective amount of an agent effective in obtaining a desired physiological or pharmacological effect, and (2) a first coating layer permeable to the passage of said agent, wherein said first coating layer covers at least a portion of said inner core, which provides control and sustained release of the agent, (3) a second coating layer, said second coating layer essentially impermeable to the passage of said agent, and said second coating layer covering at least 50% of the inner core and/or the first coating layer, wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer and said second coating layer comprises an impermeable film and at least one impermeable disc being a different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (4) a third coating layer permeable to the passage of said agent, wherein said third coating layer essentially completely covers said second coating layer and the uncoated portion of the first coating layer or inner core, whereby said agent is able to pass through said third coating layer in a controlled manner.
Claim 10
Independent Claim
245 words
A method for providing controlled and sustained administration of an agent effective in obtaining a desired local or systemic physiological or pharmacological effect comprising: surgically implanting a sustained release drug delivery system at a desired location, said drug delivery system comprising; (1) an inner core or reservoir comprising an effective amount of an agent effective in obtaining a desired physiological or pharmacological effect, and (2) a first coating layer permeable to the passage of said agent, wherein said first coating layer covers at least a portion of said inner core, which provides control and sustained release of the agent, (3) a second coating layer, said second coating layer essentially impermeable to the passage of said agent, and said second coating layer covering at least 50% of the inner core and/or the first coating layer, wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer and said second coating layer comprises an impermeable film and at least one impermeable disc being a different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (4) a third coating layer permeable to the passage of said agent, wherein said third coating layer essentially completely covers said second coating layer and the uncoated portion of the first coating layer or inner core, whereby said agent is able to pass through said third coating layer in a controlled manner.
Claim 11
Dependent Claim
19 words
A method as claimed in claim 7, wherein said device is surgically implanted within the vitreous of the eye.
Claim 12
Dependent Claim
17 words
A method as claimed in claim 7, wherein said first and third coating layers comprise polyvinyl alcohol.
Claim 13
Dependent Claim
14 words
A method as claimed in claim 7 wherein said third coating layer is silicone.
Claim 14
Dependent Claim
16 words
A method as claimed in claim 9, wherein said second coating layer comprises ethylene vinyl acetate.
Claim 15
Dependent Claim
15 words
A method as claimed in claim 11, wherein said effective agent is ganciclovir or 5-fluorouracil.
Claim 16
Dependent Claim
16 words
A method as claimed in claim 11 wherein said effective agent is a low solubility steroid.
Claim 17
Dependent Claim
15 words
A method as claimed in claim 13, wherein said low solubility steroid is fluocinolone acetonide.
Claim 18
Dependent Claim
14 words
A method as claimed in claim 11 wherein said effective agent is a neuroprotectant.
Claim 19
Dependent Claim
12 words
A method as claimed in claim 15, wherein said neuroprotectant is nimodipine.
Claim 20
Dependent Claim
202 words
A sustained release drug delivery system comprising: (A) an inner core or reservoir comprising an effective amount of an agent effective in obtaining a desired local or systemic physiological or pharmacological effect, (B) a first coating layer permeable to the passage of said agent, wherein said first coating layer covers at least a portion of said inner core, which provides control and sustained release of the agent, (C) a second coating layer, said second coating layer impermeable to the passage of said effective agent, and said second coating layer covering at least 50% of the inner core and/or the first coating layer wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer and said second coating layer comprises an impermeable film and at least one impermeable disc being a different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (D) a third coating layer, said third coating layer permeable to the passage of said effective agent, wherein said third coating layer essentially completely covers the second coating layer and the uncoated portion of the first coating layer or inner core.
Claim 21
Dependent Claim
202 words
A sustained release drug delivery system comprising: (A) an inner core or reservoir comprising an effective amount of an agent effective in obtaining a desired local or systemic physiological or pharmacological effect, (B) a first coating layer permeable to the passage of said agent, wherein said first coating layer covers at least a portion of said inner core, which provides control and sustained release of the agent, (C) a second coating layer, said second coating layer impermeable to the passage of said effective agent, and said second coating layer covering at least 50% of the inner core and/or the first coating layer wherein at least a small portion of the inner core or first coating layer is not coated with said second coating layer and said second coating layer comprises an impermeable film and at least one impermeable disc being a different material from or having substantially greater hardness, thickness, malleability or response to heat curing than said impermeable film, and (D) a third coating layer, said third coating layer permeable to the passage of said effective agent, wherein said third coating layer essentially completely covers the second coating layer and the uncoated portion of the first coating layer or inner core.
Claim 22
Dependent Claim
19 words
A sustained release drug delivery system as claimed in claim 17, wherein said third coating layer comprises polyvinyl alcohol.
Claim 23
Dependent Claim
20 words
A sustained release drug delivery system as claimed in claim 18, wherein said second coating layer comprises ethylene vinyl acetate.
Claim 24
Dependent Claim
19 words
A sustained release drug delivery system as claimed in claim 19, wherein said first coating layer comprises polyvinyl alcohol.
Claim 25
Dependent Claim
20 words
A sustained release drug delivery system as claimed in claim 20, wherein said effective agent is ganciclovir or fluocinolone acetonide.
Claim 26
Dependent Claim
17 words
A sustained release drug delivery system as claimed in claim 17, wherein said effective agent is nimodipine.
Claim 27
Dependent Claim
18 words
A sustained release drug delivery system as claimed in claim 17, wherein the third coating layer comprises silicone.
Claim 28
Dependent Claim
25 words
A method for treating a mammalian organism according to claim 1, wherein said impermeable film is made of a composition different from said impermeable disc.
Claim 29
Dependent Claim
33 words
A method for treating a mammalian organism as claimed in claim 1, wherein said second coating layer covers all of the inner core and first coating layer except for a diffusion port opening.
Claim 30
Dependent Claim
22 words
A method for treating a mammalian organism as claimed in claim 1, wherein said impermeable disc is harder than said impermeable film.
Claim 31
Dependent Claim
18 words
The sustained release drug delivery system as claimed in claim 17, wherein said effective agent is a steroid.
Claim 32
Dependent Claim
17 words
The sustained drug delivery system as claimed in claim 17, wherein said effective agent is a neuroprotectant.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-05-10 | 2002-11-09 | 2003-05-11 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-05-10 | 2006-11-09 | 2007-05-11 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-05-10 | 2010-11-09 | 2011-05-11 | $7700.00 | Window Closed / Lapsed |