WO2001049334A1 - Implant intracorneen et methode de traitement des malformations de la cornee - Google Patents

Implant intracorneen et methode de traitement des malformations de la cornee Download PDF

Info

Publication number
WO2001049334A1
WO2001049334A1 PCT/BR2001/000002 BR0100002W WO0149334A1 WO 2001049334 A1 WO2001049334 A1 WO 2001049334A1 BR 0100002 W BR0100002 W BR 0100002W WO 0149334 A1 WO0149334 A1 WO 0149334A1
Authority
WO
WIPO (PCT)
Prior art keywords
cornea
substance
reactive
implant device
biocompatible polymer
Prior art date
Application number
PCT/BR2001/000002
Other languages
English (en)
Inventor
Paulo Ferrara De Almeida Cunha
Original Assignee
Ferrara Ophthalmics Ltda.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ferrara Ophthalmics Ltda. filed Critical Ferrara Ophthalmics Ltda.
Priority to AU21313/01A priority Critical patent/AU2131301A/en
Publication of WO2001049334A1 publication Critical patent/WO2001049334A1/fr

Links

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
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials

Definitions

  • the present invention relates to a device for corneal implant adapted to be implanted within the region of the stroma with the purpose of altering the corneal shape.
  • the present implant device is particularly suitable for the treatment of cornea deformities such as keratoconus, irregular astigmatisms due to cornea transplant and after Lasik and PRK refractive corneal surgeries, myopia and other ametropias.
  • cornea deformities such as keratoconus, irregular astigmatisms due to cornea transplant and after Lasik and PRK refractive corneal surgeries, myopia and other ametropias.
  • Background of the Invention Intrastromal implant devices are used in eye surgical procedures to repair deformities of the cornea and their primary function is to modify the cornea curvature.
  • Brazilian Patent PI 8705060 discloses a ring for implant in the cornea which comprises a solid or gelatinous polymeric body having a diameter that varies from the diameter of the cornea and an equally variable thickness, and is suitable for correcting myopia and other ametropias.
  • Document US 5,653,752 discloses a device for intrastromal corneal implant containing at least one portion adapted to be placed in the cornea so as to change the refractive properties of the eye and which comprises a flexible ring consisting of a plurality of coils. The thickness of the portion to be placed into the eye will depend upon the number of scoils inserted in the ring.
  • the ring defined therein comprises at least one outer layer of a physiologically compatible polymer having low modulus of elasticity and that may be hydratable and hydrophilic, and an inner layer formed by a polymer presenting high modulus of elasticity.
  • Polymers suitable for the inner layer may be selected from methyl methacrylate polymers, TEFLON, certain long-chained silicones, polycarbonates, polyolefins, elastomer polymers, among others.
  • polymers having low modulus of elasticity include biological polymers such as cross-linked dextran, cross-linked heparin and hyaluronic acid.
  • said rings may be lubricated while they are introduced into the eye, and suitable lubricants may be chosen from the group consisting of hyaluronic acid, methyl ethyl cellulose, dextran solutions, glycerine solutions, polysaccharides or oligosaccharides, these compounds being used exclusively as lubricants.
  • the present invention refers to a device for intracomeal implant, which comprises a solid or gelatinous body constituted by a biocompatible polymer having at least one outer surface, wherein said outer surface is coated with a material which is reactive to the biocompatible polymer and which is covalently linked to the body of the implant device, said reactive material having chemical characteristics that are similar to those of the fundamental substance of the cornea.
  • the invention further relates to a method of treating deformities of the cornea, which comprises the steps of providing a cavity in the corneal stroma and introducing into said cavity a device as defined above.
  • corneal implant devices produced from biocompatible polymers can present improved results when they include a coating applied to its outer surface consisting of a material that is reactive to said polymer and that has chemical characteristics similar to those of the fundamental substance of the cornea.
  • coating is intended to define the formation of a layer of the reactive material on the outer surface of the implant device by means of covalent chemical reactions between said reactive material and the polymer that constitutes the body of the implant.
  • the so formed covalent bonds provides anchorage points between the layer of reactive material and the body of the implant. Since it is composed by a substance that has chemical characteristics similar to those of the corneal tissue, the coated outer layer of the implant device according to the present invention becomes inert with respect to the corneal tissue, and therefore it does not stimulate possible immune responses after the device has been implanted into the eye. In this way, when the device as a whole is implanted into the eye, it becomes an integral part of the corneal tissue itself, thus becoming immunologically inert and reducing any possibility of rejection.
  • the implant device of the present invention has a solid or gelatinous body that may be produced from biocompatible polymers conventionally used for this purpose.
  • biocompatible polymers conventionally used for this purpose.
  • methacrylate polymers such as polymethylmethacrylate (PMMA) are used.
  • the reactive material coated on the biocompatible polymer body is preferably selected from the group consisting of chemical compounds containing carboxyl groups available for reacting with said polymer and to form covalent chemical bonds with same.
  • chemical compounds mucopolysaccharides, proteins, chondroitin sulfates and cheratan-sulfates may be used.
  • the compound used is hyaluronic acid or chondroitin sulfates, which comprise, for example, B-D-glycuronic acid and N-acethyl-B-D-galactosamine-sulfate copolymers, B-D-iduronic acid and N-acethyl-B-D-galactosamine-sulfate copolymers and B-D- glycuronic acid and B-D-N-acethyl-B-D-galactosamine-sulfate copolymers.
  • chondroitin sulfates comprise, for example, B-D-glycuronic acid and N-acethyl-B-D-galactosamine-sulfate copolymers, B-D-iduronic acid and N-acethyl-B-D-galactosamine-sulfate copolymers and B-D- glycuronic acid and B-D-N-acethyl-B-D-gal
  • PMMA When PMMA is used as the polymeric body of the implant device of the invention, the steps of carrying out chemical reaction between PMMA and the coating material may be illustrated by the schema given below.
  • the PMMA is first subjected to hydrolysis and is subsequently reacted with the chosen reactive material (in the case illustrated below, chondroitin sulfate acid is used).
  • the final shape and size of the corneal implant device according to the present invention will depend upon the purposes and desired results, that is to say, the specific corneal deformities to be corrected.
  • the amount and, consequently, the thickness of the reactive coating layer applied on the implant polymeric body are not a limiting parameter of the invention since they can be determined according to each specific case. It was found, however, that advantageous results can be achieved with a coating layer having thickness of 1 TA wherein the coating may cover the whole implant outer surface or only some areas that will effectively be in contact with the corneal tissue.
  • the implant device has the configuration of a ring such as the one defined in Brazilian Patent PI 8705060 or the one disclosed in Pat. US 5,792,161 , and it may have the shape of a spherical cap with transverse through orifice, or the structure of several concentric rings of different diameters connected to each other.
  • the implant device presented now provides excellent results of biocompatibility when used in surgical methods of correcting cornea deformities such as keratoconus, irregular astigmatisms due to cornea transplant and after Lasik and PRK refractive cornea surgeries, myopia and other ametropias.
  • This kind of method comprises the steps of forming a cavity in the corneal stroma, preferably in the form of a tunnel, and introducing in said cavity an implant device as defined above.
  • Said cavities may be produced by conventional surgical procedures according to the desired refractive correction.
  • PMMA rings in solid state were treated with a 25% solution of hyragin hydrate in 50% methanol saturated with CO2 for about 4 - 5 hours at 50° C.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un dispositif d'implant intracornéen comprenant un corps solide ou gélatineux constitué d'un polymère biocompatible possédant au moins une surface extérieure et d'une matière réactive au polymère biocompatible et liée par covalence au corps du dispositif d'implant appliqué sur ladite surface extérieure comme revêtement, ladite matière réactive possédant des caractéristiques chimiques semblables à celles de la substance fondamentale de la cornée.
PCT/BR2001/000002 2000-01-06 2001-01-05 Implant intracorneen et methode de traitement des malformations de la cornee WO2001049334A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU21313/01A AU2131301A (en) 2000-01-06 2001-01-05 Intracorneal implant, and a method of treating cornea deformities

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BRPI0000016-7 2000-01-06
BR0000016-7A BR0000016A (pt) 2000-01-06 2000-01-06 Dispositivo para implante intracorneano e processo para tratamento de deformidades da córnea

Publications (1)

Publication Number Publication Date
WO2001049334A1 true WO2001049334A1 (fr) 2001-07-12

Family

ID=3943297

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2001/000002 WO2001049334A1 (fr) 2000-01-06 2001-01-05 Implant intracorneen et methode de traitement des malformations de la cornee

Country Status (3)

Country Link
AU (1) AU2131301A (fr)
BR (1) BR0000016A (fr)
WO (1) WO2001049334A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007104068A1 (fr) * 2006-03-16 2007-09-20 Albert Daxer Implant cornéen
US9510938B2 (en) 2006-05-23 2016-12-06 Albert Daxer Corneal implant and method for correction of impaired vision in the human eye
CN109646716A (zh) * 2018-12-28 2019-04-19 深圳大学 人工角膜光学中心部及其制备方法和人工角膜

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4663233A (en) * 1985-10-24 1987-05-05 Universal High Technologies Lens with hydrophilic coating
BR8705060A (pt) 1987-08-25 1989-03-21 Inst Brasileiro De Microcirurg Anel para implante corneano intramelar na correcao de ametropias
US4851003A (en) * 1988-01-05 1989-07-25 Lindstrom Richard L Corneal implant lens with fixation holes
WO1991003990A1 (fr) * 1989-09-15 1991-04-04 Chiron Ophthalmics, Inc. Procede d'epithelialisation de lentilles synthetiques
US5080924A (en) * 1989-04-24 1992-01-14 Drexel University Method of making biocompatible, surface modified materials
WO1995003747A1 (fr) * 1993-08-02 1995-02-09 Keravision, Inc. Insert souple et segmente destine au stroma corneen
WO1996040005A1 (fr) * 1995-06-07 1996-12-19 Keravision, Inc. Implant radial destine a etre insere dans le stroma de la cornee et son procede d'insertion
US5653752A (en) 1995-02-28 1997-08-05 Keravision, Inc. Adjustable devices for corneal curvature adjustment
US5792161A (en) 1993-12-22 1998-08-11 De Almeida Cunha; Paulo Ferrara Device and method for implanting an intralamellar ring in the correction of ametropias
US5888243A (en) 1992-08-07 1999-03-30 Keravision, Inc. Hybrid intrastromal corneal ring

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4663233A (en) * 1985-10-24 1987-05-05 Universal High Technologies Lens with hydrophilic coating
BR8705060A (pt) 1987-08-25 1989-03-21 Inst Brasileiro De Microcirurg Anel para implante corneano intramelar na correcao de ametropias
US4851003A (en) * 1988-01-05 1989-07-25 Lindstrom Richard L Corneal implant lens with fixation holes
US5080924A (en) * 1989-04-24 1992-01-14 Drexel University Method of making biocompatible, surface modified materials
WO1991003990A1 (fr) * 1989-09-15 1991-04-04 Chiron Ophthalmics, Inc. Procede d'epithelialisation de lentilles synthetiques
US5888243A (en) 1992-08-07 1999-03-30 Keravision, Inc. Hybrid intrastromal corneal ring
WO1995003747A1 (fr) * 1993-08-02 1995-02-09 Keravision, Inc. Insert souple et segmente destine au stroma corneen
US5792161A (en) 1993-12-22 1998-08-11 De Almeida Cunha; Paulo Ferrara Device and method for implanting an intralamellar ring in the correction of ametropias
US5653752A (en) 1995-02-28 1997-08-05 Keravision, Inc. Adjustable devices for corneal curvature adjustment
WO1996040005A1 (fr) * 1995-06-07 1996-12-19 Keravision, Inc. Implant radial destine a etre insere dans le stroma de la cornee et son procede d'insertion

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007104068A1 (fr) * 2006-03-16 2007-09-20 Albert Daxer Implant cornéen
US8092526B2 (en) 2006-03-16 2012-01-10 Albert Daxer Cornea implant
US8377121B2 (en) 2006-03-16 2013-02-19 Albert Daxer Cornea implant
US9510938B2 (en) 2006-05-23 2016-12-06 Albert Daxer Corneal implant and method for correction of impaired vision in the human eye
CN109646716A (zh) * 2018-12-28 2019-04-19 深圳大学 人工角膜光学中心部及其制备方法和人工角膜
CN109646716B (zh) * 2018-12-28 2021-04-20 深圳大学 人工角膜光学中心部及其制备方法和人工角膜

Also Published As

Publication number Publication date
BR0000016A (pt) 2001-08-14
AU2131301A (en) 2001-07-16

Similar Documents

Publication Publication Date Title
CN107206119B (zh) 具有生物相容性层的医疗设备涂层
EP1670385B1 (fr) Nouveaux biomateriaux poreux
Pedley et al. Hydrogels in biomedical applications
US8147897B2 (en) Cross-linkable polyionic coatings for medical devices
US4971732A (en) Method of molding an intraocular lens
EP1196115B1 (fr) Implant oculaire convergent pour chambre anterieure
JPH06509731A (ja) 薬剤被覆した屈折性の目前室挿入体
JPH09503930A (ja) セグメント状の予備形成された角膜実質内挿入物
JPH08500035A (ja) 角膜実質内ハイブリッドリング
US20110125260A1 (en) Artificial cornea
JP2004534579A (ja) 多糖類生体材料及びその使用
JPH09503680A (ja) セグメント状のしなやかな角膜実質内挿入物
US7270678B2 (en) Surface modification of functional group-containing medical devices with catalyst-containing reactive polymer system
US4904272A (en) Crosslinked polyurethane medical prosthesis
CA1232406A (fr) Lentilles intraoculaires, methodes de fabrication et methodes et appareil pour l'implantation dans l'oeil humain
WO2001049334A1 (fr) Implant intracorneen et methode de traitement des malformations de la cornee
CN211243907U (zh) 一种复合型义眼台
IE63102B1 (en) Uncrosslinked hydrogel, process for its preparation and its uses as an article for medical and/or surgical purposes such as tubes, filaments, films, joints, implants and the like, particularly in ophthalmology
CN107920916B (zh) 眼内装置及其制备方法
WO2002043622A1 (fr) Prothese corneenne
JPH09182762A (ja) 人工角膜
WO2020175812A1 (fr) Implant comprenant une couche de revêtement pour ophtalmopathie
Chiang et al. A poly‐HEMA based aqueous humor draining device

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CR CU CZ DE DK DM DZ EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP