WO1998015238A1 - Device for stretching the crystalline capsule, capable of being charged with at least one active principle and for releasing said active principle, and its preparation - Google Patents
Device for stretching the crystalline capsule, capable of being charged with at least one active principle and for releasing said active principle, and its preparation Download PDFInfo
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- WO1998015238A1 WO1998015238A1 PCT/FR1997/001785 FR9701785W WO9815238A1 WO 1998015238 A1 WO1998015238 A1 WO 1998015238A1 FR 9701785 W FR9701785 W FR 9701785W WO 9815238 A1 WO9815238 A1 WO 9815238A1
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- hydrogel
- tensioning
- charged
- bioresorbable
- capsule according
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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
- 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
- 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
- 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
- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61L27/56—Porous materials, e.g. foams or sponges
-
- 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
- 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
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
- A61L2300/406—Antibiotics
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea
Definitions
- Device for tensioning the crystalline capsule capable of being loaded with at least one active principle and of releasing said active principle, and its preparation.
- the subject of the present invention is a device for tensioning the lens capsule, capable of being loaded with at least one active principle and of progressively releasing said active principle.
- Said device is perfectly bi-functional. After its implantation, charged, in the emptied capsular bag of the lens, it is able on the one hand, for many years, to avoid the retraction of said emptied bag and on the other hand, for a certain duration, to release gradually, at least one active ingredient. This release does not jeopardize his integrity. It does not bring into play the bioresorbable nature of all or even part of its structure.
- the shrinkage of the capsular bag is a relatively common complication associated with cataract surgery.
- a device for tensioning said bag generally a ring, made of polymethyl methacrylate (PMMA).
- PMMA polymethyl methacrylate
- surgeons have already demonstrated the beneficial effects of this type of device and several companies, including the companies Morcher and Cornéal market models.
- the main function of this device is as stated above to maintain the volume of the capsule emptied of the lens.
- a device of this type can also be requested for positioning and maintaining the intraocular lens (EP-A-0 507 292 and EP-A-0 478 929).
- the Applicant has developed an effective device, overcoming both the mechanical and biological complications of cataract surgery, that is to say, ensuring both the almost permanent tensioning of the lens capsule and the gradual release of at least one active ingredient.
- the specifications of such a device provided that it has adequate mechanical properties (in particular of rigidity) to exert sufficient force on the emptied bag, in order to avoid its retraction and that it can however be hydrated to be charged in principle (s) active (s); while presenting a simple structure, in one piece.
- the process of providing a satisfactory solution to such specifications was by no means obvious. Said satisfactory solution constitutes the subject of the invention currently claimed.
- the Applicant has therefore developed a device for tensioning the lens capsule, capable of being loaded with at least one active principle and of progressively releasing said active principle, of a new type.
- Said device typically, is a single piece, not bioresorbable (it is thus capable of ensuring the tensioning of the bag for many years) and all or part of its mass consists of at least one volume of hydrogel capable to be charged in principle (s) active (s); said hydrogel volume having at least one surface for exchange with the outside (exchange surface, through which the active principle (s) is (are) capable of) to be released).
- the release of active principle (s) does not imply the bioresorbable nature of the charged material involved.
- the integrity of the device is preserved.
- the release of the active ingredient does not affect the mechanical properties of said device.
- the device of the invention is therefore original in that in its one-piece, non-absorbable structure, rigid enough to provide the required tension on the empty bag, it includes a hydrogel (a hydrophilic structure) capable of being charged in principle (s ) active.
- - uncharged the hydrogel (s) constituting its structure or entering its structure having not been charged with at least one active principle.
- Said uncharged device can be implanted in the state or kept, in the state, in anticipation of a future loading and of an implantation, charged;
- - loaded the hydrogel (s) constituting its structure or entering its structure including at least one active principle (with a view to its subsequent release, after the implantation of said device in the crystalline cavity). Its two forms form an integral part of the present invention.
- the device of the invention - loaded or unloaded - exists according to two main variants, which are not exhaustive.
- the entire mass of said device is made of non-bioresorbable hydrogel.
- a single hydrogel, not bioresorbable, capable of being charged in principle (s) active (s) and giving the device the required mechanical properties constitutes the entire mass of said device.
- Such a device is directly cut from a block of such a hydrogel.
- the one-piece mass of the device consists of at least two hydrogels, of different nature, chemically linked. We may thus wish to bring and deliver to the lens capsule at least two active ingredients which are not very compatible.
- Such a device can also be cut from a block made up of different hydrogels.
- the entire mass of the device of the invention which is not in hydrogel is not capable of being charged in principle (s) active (s).
- Part of said mass is made of a non-bioresorbable hydrophobic material. Such material cannot be loaded in active principle (s). Its presence may be appropriate to strengthen the structure of the device of the invention, to strengthen its mechanical properties.
- the arrangement of the part (or even parts) of hydrogel, capable of being charged (s) in active principle (s) and of the part (or even of the parts) of hydrophobic material (s) is obviously such that the said active principle (s) can be released.
- the volume (s) of hydrogel capable of being charged has at least one surface for exchange with the outside.
- the devices of the invention in accordance with this second variant - part of their mass is made of a hydrophobic material - also have a one-piece structure.
- the hydrophobic (s) and hydrophilic (s) (hydrogel (s)) materials entering into their structure are linked chemically, not mechanically. (In any event, whatever the variant embodiment of the devices of the invention, their structure does not include an attachment).
- a hydrophilic, crosslinked, advantageously acrylic copolymer is recommended.
- Said copolymer is obtained from at least one hydrophobic monomer advantageously acrylic and from at least one hydrophilic monomer advantageously acrylic.
- the hydrophilic monomer gives said copolymer its hydrophilic properties while the hydrophobic monomer gives it a certain mechanical resistance.
- Such copolymers must be crosslinked so that the device has the required mechanical properties.
- hydrogel a crosslinked copolymer obtained from a mixture of at least one hydrophobic monomer chosen from methacrylates or alkyl acrylates (alkyl, generally C ⁇ -C ⁇ ), advantageously methacrylates C 1 -C 2 alkyl and at least one hydrophilic monomer chosen from hydroxyalkyl methacrylates or acrylates (hydroxyalkyl, generally C 2 -C 8 ), advantageously hydroxyethyl methacrylate (HEMA), hydroxypropyl methacrylate (HPMA), hydroxybutyl methacrylate (HBMA), hydroxyhexyl methacrylate (HHMA).
- hydrophobic monomer chosen from methacrylates or alkyl acrylates (alkyl, generally C ⁇ -C ⁇ )
- methacrylates C 1 -C 2 alkyl advantageously methacrylates C 1 -C 2 alkyl
- hydrophilic monomer chosen from hydroxyalkyl methacrylates or acrylates (hydroxyalkyl, generally C 2 -
- MMA methyl methacrylate
- EMA ethyl methacrylate
- PMA -propyl methacrylate
- BMA, n-BMA butyl methacrylate
- HMA, n-HMA -hexyl methacrylate
- DMA n-dodecyl methacrylate
- hydrophilic (non-acrylic) monomers can also be used to prepare hydrogels suitable for the purposes of the invention.
- N-vinyl pyrrolidone and acrylamide are examples of suitable crosslinkers.
- Crosslinking is obtained by the conventional intervention of a crosslinking agent during the implementation of the copolymerization reaction.
- suitable crosslinkers there may be mentioned, in a nonlimiting manner, ethylene glycol dimethacrylate, dibutanediol dimethacrylate and hexanediol dimethacrylate. Crosslinking is generally carried out in the absence of oxygen. It is then easier to control it and we obtain purer products.
- Crosslinked copolymers obtained from mixtures of monomers: C 1 -C 2 alkyl methacrylate / hydroxyethyl methacrylate (HEMA) C 1 -C 12 alkyl methacrylate / hydroxypropyl methacrylate (HPMA) are particularly preferred.
- HEMA hydroxyethyl methacrylate
- HPMA hydroxypropyl methacrylate
- the hydrophobic monomer retained may consist of methyl methacrylate (MMA), the polymer of which is to date the only material used for the manufacture of devices for tensioning the crystalline capsule.
- MMA methyl methacrylate
- said polymer could have been modified” to gain hydrophilicity - and thus be able to charge and gradually release active ingredients in the eye - without losing too much in mechanical properties.
- a person skilled in the art is capable of developing a hydrogel, from which can be cut a device for tensioning the suitable crystalline capsule.
- the least hydrophilic hydrogels release, once charged, their charge in active principle (s) over a longer period.
- Said less hydrophilic hydrogels are, however, those which can hardly be charged in active principle (s).
- a person skilled in the art will know how to adapt the characteristics of the hydrogel to the nature of the active ingredient (s) involved in order to optimize the release thereof (these).
- the thickness of the devices of the invention can be greater than that of devices of the same type of the prior art. Said thickness obviously remains compatible with their introduction into the emptied bag. It is in fact advisable on the one hand to be able to implant said devices and on the other hand that these, once implanted, exert on the walls of the crystalline cavity a sufficient tension force ... but not excessive.
- hydrogels whose nature has been specified above are suitable for representing 100% of the mass of the devices of the invention. They are obviously suitable for representing only part of said mass.
- the loading in principle (s) active (s) of the hydrogel (hydrogels) intervening (S) in the mass of the devices of the invention does not raise any particular difficulty. This is explained below in the presentation of a process for developing loaded devices of the invention.
- the volume (s) of hydrogel charged once the device of the invention placed in the crystalline cavity, will (will) release its (their) charge (s) ) of active principle (s) through the exchange surface (s) that it (s) present (s) with the outside. It may be desirable to intervene to modify (slow down) the kinetics of this exchange, of this release of active principle (s) (release which, in any event, is called to take place gradually, by broadcast).
- This technique of surface coating, to optimize a gradual controlled release of active ingredient is per se a known technique.
- two routes have more particularly been developed for generating a coating.
- a first route consisted in absorbing on the surface of a device of the invention a reaction mixture of acrylics, then in polymerizing this mixture. By interpenetration of the polymer networks, a more hydrophobic membrane capable of slowing the release of the active principle (s) is thus created on the surface of the volume (s) of hydrogel.
- the second route consisted in depositing on said surface of a device of the invention a bioresorbable polymer or copolymer. Such (co) polymers are perfectly known to those skilled in the art.
- Such poly- ⁇ -hydroxy acids are used in particular in the biomedical field, for, for example, the manufacture of osteosynthesis plates or bioresorbable sutures. It is judicious to choose as precursor of such a bioresorbable coating products soluble in solvents, in particular organic such as tetrahydrofuran and dioxane, in which the active active ingredients are insoluble.
- the devices of the invention, loaded with active principle (s) are then simply immersed in a relatively concentrated polymer solution, then removed.
- the charged devices of the invention may comprise on at least part (generally all) of their exchange surface: volume (s) of hydrogel (s) charged (s) / exterior, a surface coating, intended to slow the release of the active ingredient (s) present in the said volume (s) of hydrogel. It has also been noted that such a coating generally also affects the regularity of said release.
- a coating advantageously consists of a layer or membrane of a more hydrophobic polymer than the hydrogel which it covers (see the first route presented above) or of a bioresorbable polymer (see the second route presented above, preferred ).
- the devices for tensioning the lens capsule according to the invention are original in that a non-bioresorbable hydrogel capable of being charged with active principle (s) enters their non-biodegradable one-piece structure, or even constitutes said structure.
- s active principle
- they hardly present originality in terms of their geometry.
- they may have a cross section greater than that of the devices known from the prior art. They may also not have a uniform profile over their entire length. To gain flexibility, they can present a refined profile in at least one zone.
- they have overall shapes quite similar to those of said known devices and said shapes are suitably sized, relative to the dimensions of the eye so that the desired tensioning effect is ensured.
- They can in particular be in the form of open rings, of substantially circular or polygonal section with broken angles; they can also be in the form of a piece of propeller (the pitch of which is substantial), the cross section of which can also be substantially circular or polygonal with broken angles. They can also have the shape of a toothed wheel, of any section ...
- the device for tensioning the crystalline capsule consists of a ring open of substantially circular section or polygonal with broken angles, in hydroxyethyl methacrylate / methyl methacrylate (HEMA / MMA) or hydroxypropyl methacrylate / methyl methacrylate (HPMA / MMA), charged with at least one active principle and coated on its entire external surface d '' a bioresorbable layer of a copolymer of ⁇ -hydroxy acids.
- HEMA / MMA hydroxyethyl methacrylate / methyl methacrylate
- HPMA / MMA hydroxypropyl methacrylate / methyl methacrylate
- the device of the invention is therefore advantageous in that it is capable of effectively ensuring the tensioning of the crystalline capsule, for many years (up to 20 years and more ) while having, following its implantation, progressively delivered into said capsule at least one active principle.
- Said active ingredient is introduced and gradually released, in an original manner, via the volume (s) of charged hydrogel (s) constituting all or part of the mass of said device. Such a gradual release advantageously replaces repeated injections ...
- the devices of the invention In view of the biological complications associated with cataract surgery, recalled above, it is recommended to use the devices of the invention to gradually release at least one antibiotic and / or at least one antimitotic and / or at least one inducer of terminal cell differentiation.
- the hydrogel acting as a constituent of its mass close (s) separately or in combination, at least one antibiotic and / or at least one antimitotic and / or at least one cell differentiation inducer.
- the devices of the invention of which at least one hydrogel capable of being charged constitutes all or part of the mass, can obviously contain said charged hydrogel, in a more or less hydrated state, before their implantation. It is strongly recommended to install said loaded devices in the dry state.
- the advantage of installing such a dry device is obviously that the release kinetics of the active principle (s) is further limited by the rate of hydration of the material containing them.
- the deposition of a coating intended to slow the release of the said active principle (s) charged (s), on its surface, to obtain a charged device.
- the size of the device of the invention in such a block does not raise any particular difficulty.
- Said size is generally followed by a polishing, intended to eliminate any roughness, any sharp angle of the cut shape.
- Said cut and generally polished shape is then cleaned.
- the aim is to purify it, to extract from it any polymerization residue, the release of which into the eye (in particular during hydration of the hydrogel, which is advantageously introduced dry) would be harmful. .
- a form is obtained which it is possible to implant, advantageously hydrated, uncharged, for the tensioning of the lens capsule. If it is desired to load said form, it is advantageous to dry it beforehand, generally by heating under vacuum.
- the device of the invention which is not loaded is obtained which can be kept in the state for subsequent implantation after loading or which can be loaded immediately.
- said dry form is immersed in a solution containing the said active principle (s).
- a person skilled in the art perfectly masters such a step of loading a hydrogel.
- the charged device is extracted from the charging solution and can be used, implanted, as is.
- the method of the invention therefore comprises, at this level, advantageously a step of drying the loaded device.
- said method of the invention comprises an additional step intended to generate a coating on the surface of the charged device obtained.
- Techniques for depositing such a coating have been discussed upstream in the present text. They are in themselves perfectly known to those skilled in the art.
- Figure 1 is a plan view of a device for tensioning the lens capsule, according to the invention.
- Figure 2 is a section, taken along V-V of said figure 1.
- Figures 3 to 6 are sections, taken along V - V of plan views, similar to Figure 1, of other tensioning devices of the lens capsule according to the invention.
- the devices shown in said Figures 1 to 6, and in particular the device (1) of Figures 1 and 2, are open rings of polygonal section with broken angles.
- the device (1) according to Figures 1 and 2 has a one-piece structure in a hydrogel H, not bioresorbable, charged with an active principle (2).
- the active ingredient (2) is shown diagrammatically, which in fact is dispersed in the said hydrogel H.
- the entire external surface of said device (1) constitutes the exchange surface by which the active principle (2) is capable of being released.
- the devices of the invention according to FIGS. 3 to 6 typically have a part of their mass, having at least one surface for exchange with the outside, in a hydrogel H, not bioresorbable, charged with active principle ( 2) and the complementary part made of a non-bioresorbable hydrophobic material: M.
- Said hydrogels H and non-bioresorbable hydrophobic materials M of the different devices shown can be identical or different. Within of the same device, for example those according to FIGS. 4 to 6, it is in particular possible to involve two hydrophobic non-bioresorbable materials M.
- a device of the invention has been developed and tested as specified below.
- the material obtained is extracted in a methanol / water mixture: 50/50 by volume. This removes the residue from the polymerization.
- the mass of extractables was found to be 3.7%.
- the water content of the hydrated hydrogel prepared is 15.5% by mass.
- the dry implant is placed in a bottle containing 5 ml of physiological saline, this volume corresponding to the average volume of one eye.
- the solution is regularly replaced and the 5-FU is dosed in the solution thus recovered.
- the time required for full release of the loaded 5-FU is 9 days. Only
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Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP97944934A EP0946125A1 (en) | 1996-10-07 | 1997-10-07 | Device for stretching the crystalline capsule, capable of being charged with at least one active principle and for releasing said active principle, and its preparation |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR96/12174 | 1996-10-07 | ||
FR9612174A FR2754173B1 (en) | 1996-10-07 | 1996-10-07 | DEVICE FOR TENSIONING THE CRYSTALLINE CAPSULE, LIKELY TO BE CHARGED WITH AT LEAST ONE ACTIVE PRINCIPLE AND TO RELEASE THE ACTIVE PRINCIPLE, AND ITS PREPARATION |
Publications (1)
Publication Number | Publication Date |
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WO1998015238A1 true WO1998015238A1 (en) | 1998-04-16 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/FR1997/001785 WO1998015238A1 (en) | 1996-10-07 | 1997-10-07 | Device for stretching the crystalline capsule, capable of being charged with at least one active principle and for releasing said active principle, and its preparation |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP0946125A1 (en) |
FR (1) | FR2754173B1 (en) |
WO (1) | WO1998015238A1 (en) |
Cited By (8)
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US6187042B1 (en) | 1998-04-15 | 2001-02-13 | Alcon Laboratories, Inc. | Intraocular lens coating compositions |
US6210438B1 (en) * | 1998-04-15 | 2001-04-03 | Alcon Laboratories, Inc. | Bicomposite intraocular lens and method for its preparation |
US6416550B2 (en) | 1998-04-15 | 2002-07-09 | Alcon Manufacturing, Ltd. | Method of selecting an intraocular lens material |
WO2002064071A1 (en) * | 2001-02-13 | 2002-08-22 | The Lions Eye Institute Of Western Australia | Device and method for anterior segment drug delivery |
US6455318B1 (en) | 1998-04-15 | 2002-09-24 | Alcon Manufacturing, Ltd. | Collagen IV adhesion assay for intraocular lens materials |
US6482230B1 (en) | 1998-04-15 | 2002-11-19 | Alcon Manufacturing, Ltd. | Lens epithelial cell growth assay for intraocular lens materials |
US6491721B2 (en) | 1998-04-15 | 2002-12-10 | Alcon Manufacturing, Ltd. | Toric intraocular lens material |
WO2016079204A1 (en) | 2014-11-18 | 2016-05-26 | Pierre Coulon | Multifunctional capsular implant |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19724108C1 (en) | 1997-06-09 | 1998-11-19 | Morcher Gmbh | Capsule equatorial ring |
US5843184A (en) * | 1998-01-26 | 1998-12-01 | Cionni; Robert J. | Endocapsular tension ring and method of implanting same |
FR2784287B1 (en) * | 1998-10-13 | 2000-12-08 | Georges Baikoff | SCLERAL EXPANSION SEGMENT |
FR2801192B1 (en) * | 1999-11-19 | 2002-08-09 | Corneal Ind | RING FOR CAPSULAR BAG AND ASSEMBLY CONSISTING OF SUCH A RING AND ITS INJECTOR |
DE102004027236B4 (en) * | 2004-06-03 | 2006-04-13 | Morcher Gmbh | Capsular equatorial ring |
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US4731080A (en) * | 1985-01-18 | 1988-03-15 | Galin Miles A | Coated intraocular lens |
EP0443809A2 (en) * | 1990-02-20 | 1991-08-28 | Ioptex Research Inc. | Coated intraocular lens and coatings therefor |
EP0478929A1 (en) * | 1990-09-29 | 1992-04-08 | Ipp Intellectual Property Protection Ag | Device for positioning an intraocular lens |
EP0507292A1 (en) * | 1991-04-04 | 1992-10-07 | Menicon Co., Ltd. | Device for inhibiting aftercataract |
WO1995003755A1 (en) * | 1993-08-02 | 1995-02-09 | Keravision, Inc. | Segmented preformed intrastromal corneal insert |
EP0732090A1 (en) * | 1995-03-15 | 1996-09-18 | LANGERMAN, David W. | Spare parts for use in ophthalmic surgical procedures |
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- 1996-10-07 FR FR9612174A patent/FR2754173B1/en not_active Expired - Fee Related
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- 1997-10-07 EP EP97944934A patent/EP0946125A1/en not_active Ceased
- 1997-10-07 WO PCT/FR1997/001785 patent/WO1998015238A1/en not_active Application Discontinuation
Patent Citations (6)
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US4731080A (en) * | 1985-01-18 | 1988-03-15 | Galin Miles A | Coated intraocular lens |
EP0443809A2 (en) * | 1990-02-20 | 1991-08-28 | Ioptex Research Inc. | Coated intraocular lens and coatings therefor |
EP0478929A1 (en) * | 1990-09-29 | 1992-04-08 | Ipp Intellectual Property Protection Ag | Device for positioning an intraocular lens |
EP0507292A1 (en) * | 1991-04-04 | 1992-10-07 | Menicon Co., Ltd. | Device for inhibiting aftercataract |
WO1995003755A1 (en) * | 1993-08-02 | 1995-02-09 | Keravision, Inc. | Segmented preformed intrastromal corneal insert |
EP0732090A1 (en) * | 1995-03-15 | 1996-09-18 | LANGERMAN, David W. | Spare parts for use in ophthalmic surgical procedures |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6187042B1 (en) | 1998-04-15 | 2001-02-13 | Alcon Laboratories, Inc. | Intraocular lens coating compositions |
US6210438B1 (en) * | 1998-04-15 | 2001-04-03 | Alcon Laboratories, Inc. | Bicomposite intraocular lens and method for its preparation |
US6416550B2 (en) | 1998-04-15 | 2002-07-09 | Alcon Manufacturing, Ltd. | Method of selecting an intraocular lens material |
US6455318B1 (en) | 1998-04-15 | 2002-09-24 | Alcon Manufacturing, Ltd. | Collagen IV adhesion assay for intraocular lens materials |
US6482230B1 (en) | 1998-04-15 | 2002-11-19 | Alcon Manufacturing, Ltd. | Lens epithelial cell growth assay for intraocular lens materials |
US6491721B2 (en) | 1998-04-15 | 2002-12-10 | Alcon Manufacturing, Ltd. | Toric intraocular lens material |
WO2002064071A1 (en) * | 2001-02-13 | 2002-08-22 | The Lions Eye Institute Of Western Australia | Device and method for anterior segment drug delivery |
WO2016079204A1 (en) | 2014-11-18 | 2016-05-26 | Pierre Coulon | Multifunctional capsular implant |
Also Published As
Publication number | Publication date |
---|---|
EP0946125A1 (en) | 1999-10-06 |
FR2754173A1 (en) | 1998-04-10 |
FR2754173B1 (en) | 1998-12-24 |
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