USRE32969E - Injectionable visoelastic ophthalmic gel - Google Patents
Injectionable visoelastic ophthalmic gel Download PDFInfo
- Publication number
- USRE32969E USRE32969E US07/116,579 US11657987A USRE32969E US RE32969 E USRE32969 E US RE32969E US 11657987 A US11657987 A US 11657987A US RE32969 E USRE32969 E US RE32969E
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- United States
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- 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.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/52—Hydrogels or hydrocolloids
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- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
Definitions
- This invention relates to ophthalmic surgery and treatment. More particularly, this invention relates to a composition particularly suitable for use as an adjunct in ophthalmic surgery.
- ophthalmic surgical procedures are carried out in a viscoelastic medium so as to prevent mechanical damage and denudation of the tissue surfaces.
- Sodium hyaluronate is currently widely used as the viscoelastic substance, presenting both positive and negative facets in ophthalmic surgical procedures.
- the hyaluronate has been reported as protecting the corneal endothelium; however, great care must be exercised in the use of hyaluronate, and in many instances, undesirable post-operative pressure increases have been noted, with dilation and, in some instance, adhesion development between the posterior capsule and the iris.
- a further object of the present invention is to provide an improved injectionable viscoelastic solution which may be employed without postoperative complications in such anterior segment surgical procedures as cataract removal, corneal transplants, penetrating keratoplasty, correctional treatment of bullous rhegmatogenous retinal detachment and the like.
- an improved viscoelastic gel comprising:
- an acrylamide polymer selected from polyacrylamide and polymethacrylamide
- the polyacrylamides found to be effective in the present compositions are polymers having a molecular weight of from about 1 to 6 million, produced by the polymerization of acrylamide, methacrylamide, or mixtures thereof by methods known to the art.
- the polymers Preferably, have a molecular weight on the order of about 5 million. Inclusion of the polymer in the gel formulation is maintained within from about 2 to about 5 percent by weights, preferably from about 3.5 to about 4.5 percent by weight, and most preferably about 4.0 percent by weight.
- a particularly suitable formulation is a 4.0 percent by weight polymer gel containing 0.49 percent by weight sodium chloride, 0.075 percent by weight potassium chloride, 0.048 percent by weight calcium chloride, 0.03 magnesium chloride hexahydrate and 0.17 sodium citrate dihydrate as the buffering agent.
- sodium citrate dihydrate is preferred as a gel buffer
- other pharmaceutically acceptable buffering agents such as sodium phosphates and sodium borates may be advantageously employed.
- composition is formulated by autoclaving at sterilization temperatures an 8-10 percent by weight of the polymer and admixing the sterile gel with the premixed salt solution. It has been found that compounding of the polymer with the salt constituents prior to sterilization results in a rise in pH above an acceptable level.
- the viscoelastic gels of the present invention are, as previously stated, particularly useful in ocular surgical procedures as a surgical adjunct, exhibiting:
- the gel when utilized in standard testing for biocompatibility and irritation determinations, produced no adverse reactions in the ocular tissues of the test animals.
- the gel when utilized in standard testing for biocompatibility and irritation determinations, produced no adverse reactions in the ocular tissues of the test animals.
Abstract
Description
______________________________________ sodium chloride 0.4-8.6 potassium chloride 0.075-0.3 calcium chloride 0.04-0.33 magnesium chloride 0.02-0.04 hexahydrate sodium acetate 0.3-0.4 buffer 0.15-0.20 water remainder ______________________________________
______________________________________ Component Percent by Weight ______________________________________ polyacrylamide 4.0 sodium chloride 0.049 potassium chloride 0.075 calcium chloride 0.048 magnesium chloride 0.030 hexahydrate sodium acetate 0.390 sodium citrate dihydrate 0.170 water remainder ______________________________________
______________________________________ Component Percent by Weight ______________________________________ polymethacrylamide 4.0 sodium chloride 0.049 potassium chloride 0.075 calcium chloride 0.048 magnesium chloride 0.030 hexahydrate sodium acetate 0.390 sodium citrate dihydrate 0.170 water remainder ______________________________________
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/116,579 USRE32969E (en) | 1982-10-14 | 1987-08-24 | Injectionable visoelastic ophthalmic gel |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US43441282A | 1982-10-14 | 1982-10-14 | |
US06/625,249 US4540568A (en) | 1982-10-14 | 1984-06-27 | Injectionable viscoelastic ophthalmic gel |
US07/116,579 USRE32969E (en) | 1982-10-14 | 1987-08-24 | Injectionable visoelastic ophthalmic gel |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US43441282A Continuation-In-Part | 1982-10-14 | 1982-10-14 | |
US06/625,249 Reissue US4540568A (en) | 1982-10-14 | 1984-06-27 | Injectionable viscoelastic ophthalmic gel |
Publications (1)
Publication Number | Publication Date |
---|---|
USRE32969E true USRE32969E (en) | 1989-06-27 |
Family
ID=27381848
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/116,579 Expired - Lifetime USRE32969E (en) | 1982-10-14 | 1987-08-24 | Injectionable visoelastic ophthalmic gel |
Country Status (1)
Country | Link |
---|---|
US (1) | USRE32969E (en) |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5505959A (en) * | 1990-10-04 | 1996-04-09 | Nestec S.A. | Pharmaceutical composition in gel form in a dispensing package |
US5629008A (en) * | 1992-06-02 | 1997-05-13 | C.R. Bard, Inc. | Method and device for long-term delivery of drugs |
US5631243A (en) * | 1990-07-03 | 1997-05-20 | Collagenesis Inc. | Collagen-based viscoelastic solution for visco-surgery |
US5639796A (en) * | 1991-02-12 | 1997-06-17 | C.R. Bard, Inc. | Injectable medical composition and method of use |
US5813411A (en) * | 1996-08-20 | 1998-09-29 | Menlo Care, Inc. | Method of deforming tissue with a swollen hydrogel |
US5855615A (en) * | 1996-06-07 | 1999-01-05 | Menlo Care, Inc. | Controller expansion sphincter augmentation media |
US6306418B1 (en) * | 1992-08-20 | 2001-10-23 | Robert Steven Bley | Controlled expansion sphincter augmentation media |
US6423332B1 (en) | 2000-05-26 | 2002-07-23 | Ethicon, Inc. | Method and composition for deforming soft tissues |
US20040167480A1 (en) * | 2003-02-21 | 2004-08-26 | Advanced Medical Optics, Inc. | Administration of multiple viscoelastic solutions with a multi-compartment syringe |
US7049346B1 (en) | 1996-08-20 | 2006-05-23 | Menlo Care Div Of Ethicon, Inc. | Swollen hydrogel for sphincter augmentation |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3868445A (en) * | 1972-11-30 | 1975-02-25 | Pharmacia Ab | Dosage unit containing a substance showing a topical effect on the eye, and a method of preparing same |
US3920810A (en) * | 1974-04-23 | 1975-11-18 | Burton Parsons And Company Inc | Polyacrylamide containing ophthalmic solutions |
US3978201A (en) * | 1972-11-27 | 1976-08-31 | Gennady Lvovich Khromov | Base for ophthalmological medicinal preparation on opthalmological medicinal film |
US4003991A (en) * | 1974-08-27 | 1977-01-18 | National Patent Development Corporation | Ophthalmic formulation |
-
1987
- 1987-08-24 US US07/116,579 patent/USRE32969E/en not_active Expired - Lifetime
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3978201A (en) * | 1972-11-27 | 1976-08-31 | Gennady Lvovich Khromov | Base for ophthalmological medicinal preparation on opthalmological medicinal film |
US3868445A (en) * | 1972-11-30 | 1975-02-25 | Pharmacia Ab | Dosage unit containing a substance showing a topical effect on the eye, and a method of preparing same |
US3920810A (en) * | 1974-04-23 | 1975-11-18 | Burton Parsons And Company Inc | Polyacrylamide containing ophthalmic solutions |
US4003991A (en) * | 1974-08-27 | 1977-01-18 | National Patent Development Corporation | Ophthalmic formulation |
Non-Patent Citations (4)
Title |
---|
Chem. Abst. 76:90019(j) (1972) Lemp et al. * |
Chem. Abst. 76:90019(j) (1972)-Lemp et al. |
Chem. Abst., 76:90018(h) (1972) Leong et al. * |
Chem. Abst., 76:90018(h) (1972)-Leong et al. |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5631243A (en) * | 1990-07-03 | 1997-05-20 | Collagenesis Inc. | Collagen-based viscoelastic solution for visco-surgery |
US5505959A (en) * | 1990-10-04 | 1996-04-09 | Nestec S.A. | Pharmaceutical composition in gel form in a dispensing package |
US5639796A (en) * | 1991-02-12 | 1997-06-17 | C.R. Bard, Inc. | Injectable medical composition and method of use |
US5733562A (en) * | 1991-02-12 | 1998-03-31 | C.R. Bard, Inc. | Injectable medical device and method of use |
US5629008A (en) * | 1992-06-02 | 1997-05-13 | C.R. Bard, Inc. | Method and device for long-term delivery of drugs |
US6306418B1 (en) * | 1992-08-20 | 2001-10-23 | Robert Steven Bley | Controlled expansion sphincter augmentation media |
US6592859B1 (en) * | 1992-08-20 | 2003-07-15 | Ethicon, Inc. | Controlled expansion sphincter augmentation media |
US5855615A (en) * | 1996-06-07 | 1999-01-05 | Menlo Care, Inc. | Controller expansion sphincter augmentation media |
US5813411A (en) * | 1996-08-20 | 1998-09-29 | Menlo Care, Inc. | Method of deforming tissue with a swollen hydrogel |
US7049346B1 (en) | 1996-08-20 | 2006-05-23 | Menlo Care Div Of Ethicon, Inc. | Swollen hydrogel for sphincter augmentation |
US6423332B1 (en) | 2000-05-26 | 2002-07-23 | Ethicon, Inc. | Method and composition for deforming soft tissues |
US20040167480A1 (en) * | 2003-02-21 | 2004-08-26 | Advanced Medical Optics, Inc. | Administration of multiple viscoelastic solutions with a multi-compartment syringe |
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