USRE32969E - Injectionable visoelastic ophthalmic gel - Google Patents
Injectionable visoelastic ophthalmic gel Download PDFInfo
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- 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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- 229940100655 ophthalmic gel Drugs 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract description 14
- 229920002401 polyacrylamide Polymers 0.000 claims abstract description 11
- 229920000642 polymer Polymers 0.000 claims description 21
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 18
- 238000001356 surgical procedure Methods 0.000 claims description 18
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 16
- 239000011780 sodium chloride Substances 0.000 claims description 9
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 8
- 239000001110 calcium chloride Substances 0.000 claims description 8
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 8
- 239000001103 potassium chloride Substances 0.000 claims description 8
- 235000011164 potassium chloride Nutrition 0.000 claims description 8
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical group O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 8
- 229960000999 sodium citrate dihydrate Drugs 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 229940050906 magnesium chloride hexahydrate Drugs 0.000 claims description 6
- DHRRIBDTHFBPNG-UHFFFAOYSA-L magnesium dichloride hexahydrate Chemical compound O.O.O.O.O.O.[Mg+2].[Cl-].[Cl-] DHRRIBDTHFBPNG-UHFFFAOYSA-L 0.000 claims description 6
- 239000000872 buffer Substances 0.000 claims description 5
- 239000006172 buffering agent Substances 0.000 claims description 4
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims description 3
- 239000001632 sodium acetate Substances 0.000 claims description 3
- 235000017281 sodium acetate Nutrition 0.000 claims description 3
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 claims description 2
- 208000002177 Cataract Diseases 0.000 claims description 2
- 206010038848 Retinal detachment Diseases 0.000 claims description 2
- FQPSGWSUVKBHSU-UHFFFAOYSA-N methacrylamide Chemical compound CC(=C)C(N)=O FQPSGWSUVKBHSU-UHFFFAOYSA-N 0.000 claims description 2
- 208000019793 rhegmatogenous retinal detachment Diseases 0.000 claims description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 1
- 239000011575 calcium Substances 0.000 claims 1
- 229910052791 calcium Inorganic materials 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000011591 potassium Substances 0.000 claims 1
- 229910052700 potassium Inorganic materials 0.000 claims 1
- 239000003349 gelling agent Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 description 12
- 239000000499 gel Substances 0.000 description 11
- 210000001519 tissue Anatomy 0.000 description 10
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 238000012360 testing method Methods 0.000 description 4
- 210000002159 anterior chamber Anatomy 0.000 description 3
- 239000000470 constituent Substances 0.000 description 3
- 210000000871 endothelium corneal Anatomy 0.000 description 3
- 229960002337 magnesium chloride Drugs 0.000 description 3
- 229910001629 magnesium chloride Inorganic materials 0.000 description 3
- 239000012266 salt solution Substances 0.000 description 3
- ITUDPMUZMSYEHE-UHFFFAOYSA-M sodium acetate hexahydrate Chemical compound C(C)(=O)[O-].[Na+].O.O.O.O.O.O ITUDPMUZMSYEHE-UHFFFAOYSA-M 0.000 description 3
- WCDDVEOXEIYWFB-VXORFPGASA-N (2s,3s,4r,5r,6r)-3-[(2s,3r,5s,6r)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O)[C@H](O)[C@H]1O WCDDVEOXEIYWFB-VXORFPGASA-N 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 206010067482 No adverse event Diseases 0.000 description 2
- 238000013329 compounding Methods 0.000 description 2
- 229940014041 hyaluronate Drugs 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 239000008154 viscoelastic solution Substances 0.000 description 2
- 208000035965 Postoperative Complications Diseases 0.000 description 1
- 229920002385 Sodium hyaluronate Polymers 0.000 description 1
- 210000001742 aqueous humor Anatomy 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 210000003038 endothelium Anatomy 0.000 description 1
- 210000000981 epithelium Anatomy 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 229920000193 polymethacrylate Polymers 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 210000001525 retina Anatomy 0.000 description 1
- 230000002207 retinal effect Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 229940010747 sodium hyaluronate Drugs 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 235000011008 sodium phosphates Nutrition 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical class [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical class [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 239000003190 viscoelastic substance Substances 0.000 description 1
- 229940006076 viscoelastic substance Drugs 0.000 description 1
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
-
- 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 or corneal implants; 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.
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Dermatology (AREA)
- Ophthalmology & Optometry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Dispersion Chemistry (AREA)
- Materials For Medical Uses (AREA)
Abstract
An improved injectionable viscoelastic gel for use in opthalmic surgical and treatment procedures, wherein the gelling agent is a high molecular weight polyacrylamide or polymethacrylamide.
Description
.Iadd.This is a continuation-in-part of Ser. No. 434,412, filed Oct. 14, 1982, now abandoned. .Iaddend.
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.
In surgical procedures involving ocular tissue such as, for example, anterior segment surgery, it is always necessary to protect the corneal endothelium from mechanical damage. Failure to provide adequate protection can result in irreparable damage to the tissue.
Presently, 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. Positively, 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.
It is an object of the present invention to provide an improved injectionable ocular surgical and treatment adjunct.
It is a further object of the present invention to provide an improved injectionable viscoelastic solution which is nonreactive with ocular tissues.
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.
These and other objects will become apparent from the disclosure which follows.
In accordance with the present invention, there is provided an improved viscoelastic gel comprising:
an acrylamide polymer selected from polyacrylamide and polymethacrylamide
sodium chloride
potassium chloride
calcium chloride
magnesium chloride hexahydrate
sodium acetate
buffer
water
In this particularly effective formulation, it has been found that the effectiveness thereof is achieved by compounding the constituents thereof within certain, well-defined ranges and by employing polyacrylamides and polymethacrylamides of certain, well-defined molecular weights.
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. Preferably, the polymers 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.
The remaining constituents of the formulation are present in the following amounts, based upon percent by weight:
______________________________________
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
______________________________________
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.
While 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.
The 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:
(a) protective properties for corneal endothelium, iris and retinal tissue;
(b) superior properties as an aqueous humor replacement;
(c) ability to maintain a deep anterior chamber during operative procedures;
(d) ability to separate effectively tissue surfaces and thereby minimize adhesion; and
(e) biocompatibility with intra ocular tissues.
The particular effectiveness of this specific formulation as an adjunct in ophthalmic surgery is a direct result of its balanced viscoelastic properties. The viscous nature thereof provides mechanical protection for tissues (iris, retina) and cell layers (corneal endo- and epithelium) which may be exposed to mechanical damage during surgery. Further, due to the physical properties of the formulation, the gel does not flow out of the anterior chamber, providing a deep anterior chamber during surgical manipulations.
The following example serves to illustrate the present invention.
An autoclaved polyacrylamide having a molecular weight of about 5 million was admixed with a premixed salt solution to yield the following homogenous gel composition:
______________________________________
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
______________________________________
The gel, when utilized in standard testing for biocompatibility and irritation determinations, produced no adverse reactions in the ocular tissues of the test animals.
An autoclaved polymethacrylate having a molecular weight of about 5 million was admixed with a premixed salt solution to yield the following homogenous gel composition:
______________________________________
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
______________________________________
The gel, when utilized in standard testing for biocompatibility and irritation determinations, produced no adverse reactions in the ocular tissues of the test animals.
Claims (9)
1. An injectionable viscoelastic gel particularly adapted for use in ophthalmic surgical procedures and treatments .[.which.]..Iadd., said .Iaddend.gel consisting essentially of from about 2 to about 5 percent by weight of a polymer selected from polyacrylamide and polymethacrylamide, said polymer having a molecular weight of from about 1 to about 6 million.[.;.]..Iadd., .Iaddend.from about 0.4 to about 8.6 percent by weight sodium chloride, from about 0.075 to about 0.3 percent by weight .[.postassium.]. .Iadd.potassium .Iaddend.chloride, from about 0.04 to about 0.33 percent by weight calcium chloride, from about 0.02 to about 0.04 percent by weight magnesium chloride hexahydrate, from about 0.3 to about 0.4 percent by weight sodium acetate, from about 0.15 to about 0.20 percent by weight of a buffer, remainder water.
2. A gel as defined in claim 1 wherein said polymer is polyacrylamide.
3. A gel as defined in claim 1 wherein said polymer is present in an amount of from about 3.5 to about 4.5 percent by weight.
4. A gel as defined in claim 1 wherein said polymer has a molecular weight of from about 4.5 to about 5.5 million.
5. A gel as defined in claim 1 wherein said buffer is sodium citrate dihydrate.
6. A gel as defined in claim 1 consisting essentially of about 4 percent by weight of said polymer having a molecular weight of about 5 million, about 0.049 percent by weight sodium chloride, about 0.075 percent by weight potassium chloride, about 0.048 percent by weight calcium chloride, about 0.03 percent by weight magnesium chloride hexahydrate, about 0.17 percent by weight sodium citrate dihydrate, remainder water. .Iadd.
7. A method for protecting ocular tissue during ophthalmic surgery which comprises
injecting into an ocular chamber prior to said surgery an amount of viscoelastic gel sufficient to prevent mechanical damage and denudation of said ocular tissue during said surgery, said viscoelastic gel comprising a polymer selected from polyacrylamide, polymethacrylamide and a copolymer of acrylamide and methacrylamide, said polymer having a molecular weight of from about 1 to 6 million, and a pharmaceutically acceptable diluent therefor. .Iaddend. .Iadd.8. The method of claim 7 wherein said surgical procedure is an anterior segment surgical procedure. .Iaddend. .Iadd.9. The method of claim 8 wherein said anterior segment surgical procedure is cataract removal, corneal transplant, keratoplasty or bullous
rhegmatogenous retinal detachment. .Iaddend. .Iadd.10. The method of claim 7 wherein said polymer is present in an amount between about 2 to about 5 percent by weight of said viscoelastic gel. .Iaddend. .Iadd.11. The method of claim 7 wherein said polymer is present in an amount between about 3.5 to about 4.5 percent by weight of said viscoelastic gel. .Iaddend. .Iadd.12. The method of claim 7 wherein said polymer is present in an amount between about 4.5 to about 5.5 percent by weight of said viscoelastic gel. .Iaddend. .Iadd.13. The method of claim 7 wherein said polymer is present in an amount between about 4 percent by weight of said viscoelastic gel. .Iaddend. .Iadd.14. The method of claim 7 wherein said polymer is polyacrylamide. .Iaddend. .Iadd.15. The method of claim 7 wherein said viscoelastic gel comprises
(a) 2 to 5 percent by weight of said polymer;
(b) 0.4 to 8.6 percent by weight sodium chloride;
(c) 0.075 to 0.3 percent by weight potassium chloride;
(d) 0.04 to 0.33 percent by weight calcium chloride;
(e) 0.02 to 0.04 percent by weight magnesium chloride hexahydrate;
(f) 0.3 to 0.4 percent by weight sodium acetate;
(g) 0.15 to 0.20 percent by weight buffering agent; and
(h) remainder water. .Iaddend. .Iadd.16. The method of claim 15, wherein said buffering agent is sodium citrate dihydrate. .Iaddend. .Iadd.17. The method of claim 7 wherein said viscoelastic gel consists essentially of about 4 percent by weight of said polymer having a molecular weight of about 5 million, about 0.49 percent by weight sodium chloride, about 0.075 percent by weight potassium chloride, about 0.048 percent by weight calcium, about 0.03 percent by weight magnesium chloride hexahydrate, about 0.17 percent by weight sodium citrate dihydrate, remainder water. .Iaddend.
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 |
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| 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 |
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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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