CA2473355A1 - Sustained release ophthalmological device and method of making and using the same - Google Patents
Sustained release ophthalmological device and method of making and using the same Download PDFInfo
- Publication number
- CA2473355A1 CA2473355A1 CA002473355A CA2473355A CA2473355A1 CA 2473355 A1 CA2473355 A1 CA 2473355A1 CA 002473355 A CA002473355 A CA 002473355A CA 2473355 A CA2473355 A CA 2473355A CA 2473355 A1 CA2473355 A1 CA 2473355A1
- Authority
- CA
- Canada
- Prior art keywords
- pharmaceutical agent
- implant
- sustained release
- combination
- release medium
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/147—Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
- A61K9/0051—Ocular inserts, ocular implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1694—Capsular bag spreaders therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
- A61F2002/1683—Intraocular lenses having supporting structure for lens, e.g. haptics having filiform haptics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/901—Method of manufacturing prosthetic device
Abstract
An ophthalmological implant and method of making and using the same. One preferred implant (78) is prepared to include an implant member (82). A region (84) includes a pharmaceutical agent and an overlying barrier layer (80) of a bioerodible material, a biodegradable material a bioavailable material or a mixture thereof.
Claims (20)
1) A method for providing a sustained release of a dose of a pharmaceutical agent, comprising the steps of:
a) providing a biocompatible ophthalmological implant; and b) applying to the implant a sustained release medium and a pharmaceutical agent.
a) providing a biocompatible ophthalmological implant; and b) applying to the implant a sustained release medium and a pharmaceutical agent.
2) The method of claim 1, wherein the opthalmological implant is selected from an endocapsular tension ring or an intraocular lens.
3) The method of claim 1 or 2 wherein the pharmaceutical agent is selected from an antimicrobial, an antithrombotic, an antiseptic, an antifungal, a chelating, an anticoagulant, antibiotic, an anti-inflammatory, a steroid, an antiglaucomatous or a combination thereof.
4) The method of any of claims 1 through 3, wherein the sustained release medium and the pharmaceutical layer is applied fro defining multi-layered structure, a structure having the pharmaceutical agent dispersed in the sustained release medium or a combination thereof.
5) The method of claim 4, wherein the sustained release medium is applied to define a barrier layer over at least one region of a pharmaceutical agent.
6) The method of any of claims 1 through 5, wherein the sustained release medium comprises a material provided in a state selected from solid, semi-solid, liquid, gel, amorphous solid, crystalline solid, freeze dried, spray-dried, or supercooled.
7) The method of any of claims 1 through 6, wherein the pharmaceutical agent is selected from 5-fluorouracil (5-FU), cyclosporine A
(CsA), vancomycin, ganciclovir, fluocinolone acetonide, dexamethasone, daunorubicin, indomethacin, timolol, mitomycin-C, or mixtures thereof.
(CsA), vancomycin, ganciclovir, fluocinolone acetonide, dexamethasone, daunorubicin, indomethacin, timolol, mitomycin-C, or mixtures thereof.
8) The method of any of claims 1 through 7, wherein the implant includes a surface defining a plurality of wells, divots, pores, grooves, other types of crevices, or a combination thereof for holding the pharmaceutical agent.
9) The method of any of claims 1 through 8, further comprising the step of providing the implant, having the sustained release medium and the pharmaceutical agent applied thereto, to a health care provider for performing cataract surgery.
10) The method of any of claims 1 through 9, wherein the implant is fabricated from polymethylmethacrylate.
11) The method of any of claims 1 through 10, wherein over a major portion of its length, the outer surface of the implant, having the sustained release medium and the pharmaceutical agent applied thereto, is selected from a smooth surface an irregular surface, a stepped surface, a tapered surface, a surface having no slope or a combination thereof.
12) The method of any of claims 1 through 11, wherein at least one of the sustained release mediums, the pharmaceutical agent, or a combination of both, is applied to the implant by a step including, spraying, dipping, swabbing, brushing, rolling, curtain coating, doctor blading, vapor deposition or combinations thereof.
13) A device provided according to any of the claims 1 through 12.
14) A therapy employing a device prepared according to any of claims 1 through 13.
15) The method of any of claims 1 through 14, wherein the pharmaceutical agent is applied to the implant along the length of the implant as a continuous layer or an intermittent layer.
16) The method of any of claims 1 through 12, wherein the pharmaceutical agent is applied to the implant by producing a mixture that includes at least one porogenic agent, compacting or shaping the mixture to its desired form, treating the product obtained in such a way that the porogen is removed, and introducing pharmaceutical agent where the porogen used to be.
17) The method of any of claims 1 through 12 or 15-16, further comprising the step of implanting the implant into an eye of a human, a dog or a horse.
18) The method of any of claims 1 through 12 or 15-17, wherein the implant includes an arc-shaped "J-loop", an arc-shaped "C-loop", a complete circumferential support member, a partial circumferential support member, a plate, a radial support member, a pararadial support member, a tangential support member, a circumferential support member, or a combination thereof.
19) A method for providing a medicated member, comprising the steps of:
a) providing a member selected from an ear tag post, a suture, a stent, orthopedic implant member, breathing tube, syringe needle, intraveneous needle, or a body piercing member post; and b) coating the member with a sustained release medium and a pharmaceutical agent selected from the group consisting of an anti-inflammatory, a steroid, an antibiotic or a combination thereof, wherein the sustained release medium is provided as a barrier layer that has an outer surface, which is (i) tapered, stepped, free of slope or a combination thereof, and which is (ii) diposed over a pharmaceutical agent layer, a mixture with a pharmaceutical agent dipersed throughout, or a combination thereof;
wherein the member is configured to have an outer surface that is selected from a smooth surface, an irregular surface defined for providing a cavity for receiving the pharmaceutical agent, or a combination thereof; and further wherein the sustained release medium is a material selected from biodegradable material, a bioerodable material, a bioavailable material or a combination thereof.
a) providing a member selected from an ear tag post, a suture, a stent, orthopedic implant member, breathing tube, syringe needle, intraveneous needle, or a body piercing member post; and b) coating the member with a sustained release medium and a pharmaceutical agent selected from the group consisting of an anti-inflammatory, a steroid, an antibiotic or a combination thereof, wherein the sustained release medium is provided as a barrier layer that has an outer surface, which is (i) tapered, stepped, free of slope or a combination thereof, and which is (ii) diposed over a pharmaceutical agent layer, a mixture with a pharmaceutical agent dipersed throughout, or a combination thereof;
wherein the member is configured to have an outer surface that is selected from a smooth surface, an irregular surface defined for providing a cavity for receiving the pharmaceutical agent, or a combination thereof; and further wherein the sustained release medium is a material selected from biodegradable material, a bioerodable material, a bioavailable material or a combination thereof.
20) A device prepared according to the method of claim 19.
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US34946502P | 2002-01-18 | 2002-01-18 | |
US60/349.465 | 2002-01-18 | ||
US39769802P | 2002-07-22 | 2002-07-22 | |
US60/397,698 | 2002-07-22 | ||
US10/346,671 | 2003-01-17 | ||
US10/346,671 US7090888B2 (en) | 2002-01-18 | 2003-01-17 | Sustained release ophthalmological device and method of making and using the same |
PCT/US2003/001388 WO2003061625A2 (en) | 2002-01-18 | 2003-01-17 | Sustained release ophthalmological device and method of making and using the same |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2473355A1 true CA2473355A1 (en) | 2003-07-31 |
CA2473355C CA2473355C (en) | 2012-01-03 |
Family
ID=27617576
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2473355A Expired - Fee Related CA2473355C (en) | 2002-01-18 | 2003-01-17 | Sustained release ophthalmological device and method of making and using the same |
Country Status (4)
Country | Link |
---|---|
US (2) | US7090888B2 (en) |
CA (1) | CA2473355C (en) |
GB (1) | GB2399753B (en) |
WO (1) | WO2003061625A2 (en) |
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- 2003-01-17 WO PCT/US2003/001388 patent/WO2003061625A2/en not_active Application Discontinuation
- 2003-01-17 CA CA2473355A patent/CA2473355C/en not_active Expired - Fee Related
- 2003-01-17 US US10/346,671 patent/US7090888B2/en not_active Expired - Fee Related
- 2003-01-17 GB GB0415630A patent/GB2399753B/en not_active Expired - Fee Related
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2006
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GB2399753B (en) | 2006-04-19 |
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