CN100408118C - Systems and methods for reducing intraocular pressure - Google Patents
Systems and methods for reducing intraocular pressure Download PDFInfo
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- CN100408118C CN100408118C CNB018060463A CN01806046A CN100408118C CN 100408118 C CN100408118 C CN 100408118C CN B018060463 A CNB018060463 A CN B018060463A CN 01806046 A CN01806046 A CN 01806046A CN 100408118 C CN100408118 C CN 100408118C
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
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Abstract
The present invention provides systems and methods for reducing intraocular pressure, thereby to treat glaucoma and other disorders. The systems of the present invention include a shunt insertable across the clear cornea and a delivery device for inserting the shunt in the transcorneal position. The shunt has a body with a head at one end and a foot at the opposite end, and a channel therethrough permitting the passage of aqueous humor from the anterior chamber to the external surface of the cornea. A removable filter is positioned within the channel to regulate aqueous humor outflow and to resist the incursion of microorganisms.
Description
Background
Related application
The application relates to and requires the U.S. Provisional Patent Application of submitting on January 12nd, 2,000 60/175, the rights and interests of 658 " glaucoma pressure relieve valve and drug release devices " (Glaucoma Pressure Relief Valve andDrug Delivery Device), the reference in content of described patent application is incorporated into this.
Invention field
The present invention relates generally to reduce the system and method for intraocular pressure.In one embodiment, the present invention relates to discharge aqueous body fluid to alleviate the implantable device of the distinctive ocular hypertension power of glaucoma.
Description of Related Art
Eyeball is spheric structure basically, and its shape and color and luster are kept by give birth to liquid substance in filling in the outside collagen spheroid of interior sky.The inside of eyeball is divided into two chambeies, i.e. ante-chamber and back cavity.Eye lens and its support and relevant tissue are arranged between these two chambeies.Be filled with the spawn that is called vitreous humor in the back cavity, this material is considered to intraocular pressure (being called intraocular pressure (IOP)) not produced significantly influence.Different therewith, be filled with the aqueous liquid that is called aqueous body fluid (aqueous humor) in the ante-chamber, this liquid produces constantly and is absorbed.This liquid is exerted pressure to top cornea and all structures around it is exerted pressure.If the amount of the aqueous body fluid that produces is too much, then will rise with intraocular pressure in the ante-chamber.Normal IOP be the generation of aqueous body fluid and absorb again between normal equilibrium set up.
Aqueous body fluid produces and flows into ante-chamber at the rear of iris bottom.The absorption again of aqueous body fluid is earlier by the trabecula net, flows in the Sclera Cavity again, is absorbed to enter in the blood flow.The pressure of certain limit is considered to be generally the 10-21 millimetres of mercury normally in the ante-chamber.Pressure in the ante-chamber depends on speed that aqueous body fluid produces and the speed of discharging by trabecula net system.Obstruction in the discharge system may be the reason that intraocular pressure raises.Inappropriate treatment continue higher IOP and can cause being called glaucomatous symptom, and higher IOP may damage ocular nerve and affect one's power of vision, if can finally cause losing one's sight.
Glaucoma can adopt the whole bag of tricks to treat.Its Drug therapy is to manage to promote fluidic outflow or reduce fluidic generation and reduce IOP.Available drug treatment comprises Drug therapy topical ophthalmic or system.Yet the medication means may be failed, and this is because the complication that patient's compliance is poor, expense high or certain people know and the cause of side effect.Under the unsuccessful situation of medication, can take to have more the Therapeutic Method of intervention property to patient, promptly change normal anatomical structure or introduce implantable body fluid discharger to reduce excessive aqueous body fluid.For example, recommend to adopt laser surgery's art, thereby change the discharge of the anatomical structure reinforcement ante-chamber of trabecula net; Also can adopt other laser eye method for glaucomatous treatment.Although Drug therapy and laser interventional method are arranged, the glaucoma disease that continues to have higher intraocular pressure still needs a good surgical intervention method.
As an example, a kind of surgery interventional procedure of general type is intended to produce fistula or other passing away of eyes ante-chamber.Subconjunctival bag that the surgery that so just makes the aqueous body fluid inflow be commonly referred to " herpes " produces or hyposcleral bag, body fluid just can be absorbed in the blood flow more thus.This mode can make excessive liquid flow out ante-chamber, thereby reduces intraocular pressure.Yet relevant with this method is that some known limitation are arranged.At first, normal wound healing tends to hinder the size of the open of fistula and influence discharge bag, makes these methods have unacceptable mortality.In order to improve the operating success rate of this type, the doctor can recommend to adopt the auxiliary treatment that can regulate normal wound healing medicament.This treatment can increase the incidence rate of the second kind problem relevant with these steps again: the excessive or outflow excessively apace of aqueous body fluid.Well-knownly be, the too fast too much removal meeting of aqueous body fluid sharply reduces intraocular pressure and reaches dangerous lower limit, promptly a kind ofly is called hypotensive symptom, and this just produces dangerous complication on the multiple vision potentially.In order to prevent this problem, operative site must heal enough well, produces controlled aqueous body fluid and discharges.For this situation is taken place, normal wound healing is absolutely necessary.Therefore, those Therapeutic Method that suppress wound healing can increase and the relevant danger of excessive aqueous body fluid discharge.Three problem relevant with such conventional body fluid discharge method is: the danger of infection improves.Aqueous body fluid is discharged to the danger that infection is arranged in the herpes under sclera or the conjunctiva, and this is because the liquid environment that provides microorganism to invade.And, occur in the bag that is filled with liquid if infect, then microorganism can be reverse enters the ante-chamber of eyes by passing away, and it is also caused infection, and this is a much serious problem.
In order to solve some problem relevant, multiple managing the implantable device of excessive liquid from the ante-chamber discharge proposed once with the conventional surgical operation.Yet the above-mentioned operating problem of soft tissue that influences equally also influences the implantation surgical operation.Wound healing mechanism is still and works, even surgical operation comprises the ophthalmic implant is installed.In fact, artificial material can too stimulate partial wound healing, thereby causes the formation of too much scar tissue.And the outflow flow of control aqueous body fluid remains major issue, even relate to artificial apparatus in this process.The danger of infection is still arranged in addition.Having mechanical conduit microorganism can be transferred to from the outside under the situation of inside ofeye, wishing has certain mechanism can prevent reverse here infection.At last, the same with most people soma, eyes are limited to long-term existence artificial material endurance.Tissue around the local implant of settling can stimulate.Certainly, eyes are responsive especially.For the device that is implanted on the ocular surface, patient can feel that it is long-term, lasting and makes us uncomfortable foreign body.At last, because eye tissue is very fine, so the design of implant and place not adjacent, the following or top tissue of induced damage resistive fragility.Yet, even place suitably when implant begins, also can be shifted owing to partial tissue moves, perhaps the contraction owing to wound healing process is extruded.
Some that has various devices to claim in the prior art to provide in these problems or the solution of all problems.For example, the device of some prior art can make aqueous body fluid be diverted in implantation sclera or a subconjunctival reservoir or the discharging area.Yet as mentioned above, these devices are faced with and regulate the waterborne liquid outflow, opposing is infected and avoid local organization to stimulate and damage these problems.First problem occurs, the reason that promptly will regulate the aqueous liquid stream outflow is, the delivery flow of this liquid can depend on the mechanical property of implant basically reaching effective wound healing before biologically limit fluid flows out.At implant is in the discharge process of base, to the effusive mechanical resistance of aqueous body fluid and biology resistance active balance remain problem.The mechanism that the implanting device of prior art adopts multiple restriction waterborne liquid to flow out.In case wound has formed healing, each in these mechanism will be born responsibility.When combining with the caused limiting factor of wound healing, the restricted parts in the implant will exceedingly reduce the effusive speed of aqueous body fluid, may reach the degree that can not treat.The reason that second problem to occur be the intraocular infection probability is that the existence of implant provides antibacterial can enter the pipeline of ante-chamber inside.Introduced filter or valve or other conduit system in the discharger of some prior art, prevented that reverse infection from entering into ante-chamber.Yet these mechanism are to have circumscribedly, even be effectively on opposing the passing through of microorganism, they also can produce the hydraulics effect to the outflow of liquid, discharge and weaken effectively.At last, the reason that occurs the problem of local organization endurance in the device of some prior art is, the histio-irritative reaction of these external objects meetings, it is outstanding and come to an end so that local inflammation or device to take place, thereby may further cause this device easily to be discovered or uncomfortable sensation:, can be not suitable for using clinically owing to exist implant that these effects can take place to patient.
The device of placing by transparent cornea impels aqueous body fluid to discharge, and can be used to avoid implant some relevant limitation down with sclera or conjunctiva.Some device, for example U.S. Patent No. 3,788, and 327 and U.S. Patent No. 5,807,302 and U.S. Patent No. 5,743, device in 868 provides the conduit through cornea, and these conduits can be discharged to ante-chamber liquid on the surface of cornea, and (tear film) mixes with the tear film.Device described in the above-identified patent comprises and some relevant feature of problem such as trickle adjusting, microorganism restriction, the local organization compatibility and positional stability.As discussed previously, these problems also can influence this device through cornea.Therefore, still need a kind of biocompatible ante-chamber discharger, it can control the outflow of aqueous body fluid well, and no matter the behavior of wound healing how.Thereby still also need a kind of energy restriction micro-organisms enter the discharger that the protection inside ofeye is avoided infecting.In addition, also need a kind of can be fine concerning patient bearing and comfortable ophthalmology discharger.At last, the problem of positional stability also is not resolved satisfactorily.Need a kind of like this discharger in the art, it can be placed safely and reliably, and the worry of not having displacement, moving or be extruded.
Except the demand under such as glaucomatous state, also need temporary anterior body fluid to discharge or decompressor to lasting or durable ante-chamber discharger.For example, afterwards, in short a period of time (1 hour to 2 weeks), may exist IOP to raise in multistep ophthalmologic operation step (comprising that cataractopiesis and repairing retina break away from).And doctor physician may find it better is that the employing bypass is temporarily controlled the IOP in the glaucoma, gets down to the surgical procedure that is used for curing imbalance that other does not adopt long-term shunting afterwards again.Need a kind of like this device, it can satisfy the demand that the ante-chamber short-term is discharged under these and similar situation.
Also need to provide a kind of delivery system (delivery system) that is specially adapted to implant the discharger of process cornea and does not cause wound.This delivery system better should be able to be safely fixing discharger, and place this discharger by the surgeon.In the time of discharger will being implanted by cornea, this delivery system can also easily discharge described discharger.Also wish to make this delivery system, in order to avoid the delicate tissues of corneal epithelial and substrate causes additional injury.
The general introduction of invention
An object of the present invention is to provide the system that is used to reduce intraocular pressure.System of the present invention comprises that can see through transparent eyes cornea is inserted in the ante-chamber, so that therefrom discharge the diverter (shunt) of aqueous body fluid.This diverter comprises that what passage was arranged in one is columniform cylinder basically, can allow aqueous body fluid be discharged on the outer surface of transparency cornea from ante-chamber with it; Diverter comprises that also an invasion that rests top on the transparency cornea outer surface, rests the bottom on the cornea inner surface and be used for regulating the flow of the aqueous body fluid that therefrom flows through and make microorganism reduces to minimumly, can stay the elongate filter in the cylinder passage.In one embodiment, the opening that aqueous body fluid can flow through on the bottom enters cylindrical passage, and therefrom passes through, and flows to through the slit on the top on the surface of cornea.In one embodiment, top and bottom and cylinder form an integral body.In another embodiment, top, bottom or cylinder can be made by the polymer that can dewater.In certain embodiments, the outer surface of top or bottom can be made with the adhesion or the adhesion of cell and reduce to minimum.In certain embodiments, cylindrical outer surface can be made adhesion or the adhesion that promotes and organize or become attractive.The bottom specifically, its shape is convenient to see through cornea implantable shunt device.In certain embodiments, cylindrical circumference is littler than the circumference of top or bottom.By compressing or any other suitable manner can make elongate filter stay in the cylindrical passage.Elongate filter can be positioned at the near-end of cylinder feeder connection or wherein any other position.
In some other embodiment, system of the present invention comprises that can pass cornea places the implant that makes eyes ante-chamber discharge body fluid.This implant comprises top, bottom, the tubular conduit between bottom and top and filter, described conduit has the internal channel that links to each other with ante-chamber liquid, and the inside that described filter can be pressed in ante-chamber is reduced to minimum or hindered it and pass through with entering or it being entered of the outflow flow of regulating aqueous body fluid and restriction micro-organisms.
In also having some other embodiment, system of the present invention comprises the diverter through cornea, and described system also comprises the releasing device that is used for diverter is implanted the position of this process cornea.In certain embodiments, the diverter of implanting with releasing device through cornea has top, bottom, between top and bottom, have through wherein passage be columniform cylinder and filter basically, described filter places in the passage to regulate flow that aqueous body fluid flows through passage and further entering of restriction micro-organisms.In certain embodiments, releasing device comprises the tip that is suitable for fixed shunt dimensionally and is used for diverter is in place through the cornea outer surface inserts, described releasing device also comprises the plunger that can slide into amphi position from peri position, and the slip of this plunger can make diverter move and force it to see through the position that the cornea outer surface reaches the process cornea.
Another object of the present invention provides and reduces the ante-chamber fluid pressure, is the glaucoma of feature and the method for other disease thereby treat former cavity pressure higher.These methods comprise the steps, diverter through cornea is provided, the releasing device that diverter is placed the position of process cornea is provided, on the cornea outer surface, cuts a locating hole and be used for inserting diverter, re-use the position that releasing device is inserted into diverter the process cornea.In enforcement of the present invention, it is columniform cylinder, top, bottom and filter basically that the diverter that is provided has.A further object of the present invention provides temporary transient discharge ante-chamber liquid, thereby reduces the method for intraocular pressure.The temporary transient liquid discharge process that is interpreted as using a certain device to take place in as 1 hour to the time in several weeks of discharging in short-term, described device can take out after finishing between temporary transient ejection time or can be biodegradable, can be absorbed when finishing during temporary transient described again.This device can be implanted after the operating procedure that those IOP may raise subsequently, or to can be used as higher with IOP be the temporary transient rectification of the disease of feature.
Diverter of the present invention can be used for solving above-mentioned some problem that always exists in treating the higher ophthalmology technology of IOP.At first, this diverter, its releasing device and its using method are suitable for that transparent cornea is passed in the discharge system places, thereby has avoided discharging relevant difficulty under or the sclera following with conjunctiva.Secondly, regulate the outflow flow of aqueous body fluid by filtration system always, and do not involve the mechanism of wound healing, thereby can calculate predetermined outflow flow, hypotensive danger can be avoided so on the one hand, inadequate discharge can be avoided again on the other hand.The 3rd, filter can stop the invasion of antibacterial for body fluid provides a zigzag path; In addition, drive the slit on the top, its shape and size also can stop the intrusion of antibacterial; And top itself is by preventing that the material with cytoadherence (comprise and preventing and the microorganism adhesion) from making.The 4th, device is to be made by the fine material that bears by cornea.Top and bottom energy prevention and cytoadherence also prevent to scab on device, and cylinder is by promoting the material with cytoadherence to make, device being securely fixed on the process position of cornea simultaneously.Can more be expressly understood these and other purposes, features and advantages of the present invention from following explanation with accompanying drawing (parts that wherein identical numeral is identical).
Brief Description Of Drawings
Fig. 1 is the perspective view of one embodiment of the invention.
Fig. 2 is the exploded view of one embodiment of the invention, and the insertion path of filter is described.
Fig. 3 is the sectional view of one embodiment of the invention.
Fig. 4 is that explanation is installed dissection sectional view on the throne by diverter of the present invention.
Fig. 5 is the sketch map of one embodiment of the invention.
Fig. 6 A-D is the perspective view and the sectional view of a releasing device of explanation the present invention.
The perspective view and the sectional view of another releasing device of Fig. 7 A-B explanation the present invention.
Describe in detail
See Fig. 1 now, it is the perspective view of a diverter 10 of the present invention.In a representational embodiment, diverter 10 nearly 1 millimeters long, its external diameter is about 0.5 millimeter.Although this figure and below diverter 10 among each figure all be cylindrical configuration, what should understand is that the shape of other tubular conduit also is suitable for.For example, diverter 10 can be shape that more resembles spheroid or the shape that more resembles lenticular body.The diverter 10 of Fig. 1 is from its top or the figure that sees of outside.Diverter 10 is suitable for placing through cornea dimensionally.When diverter 10 was held in place, it was on the epithelial surface that top 12 will be positioned at outer corneal surface.As shown in this figure, top 12 can be the vaulted shape in garden, so that provide a successive transitional surface for install cornea from this.This shape also can be born by patient's eyelid well.Although this shape is seemingly good especially, also can design the top of other shape, same advantage is provided.For example, having the flat top 12 that the minimum level of circular edge stretches out equally also can be born by eyelid well.Adopt some normal experiments just can determine the shape of other appropriate designs.The bottom surface at top 12 (not shown) can be flat, or the form fit of the anterior corneal surface of suitably crooked and apparatus for placing.Top 12, cylinder 14 and bottom 18 these three parts can be exactly an incorporate unit when forming, and also can be that top 12 or bottom 18 are an integral body with cylinder when forming.In another embodiment, each parts can with other isolation of components.
Hydroxyethyl methylacrylate (HEMA) copolymer can be used for making each parts of diverter.In one embodiment, top 12 is made by slick material, and with the adhesion of preventing tissue and antibacterial, and it is high degree of hydration, can be by the moistening of tear institute.The surface component of HEMA polymer such as HEMA+ methacrylic acid (all know and can be used for preventing cytoadherence) can be contained in top 12 in prior art.As an example, polymethylacrylic acid 2-hydroxyl ethyl ester (PHEMA) can be used for the skin of diverter.In one embodiment, the basic material that can be used for the organizational integration layer coating (tissue integration layercoating) of this attraction cell can comprise HEMA and cyclohexyl methacrylate.In the outer field composition of this diverter, can comprise and be used to contact crystalline lens, its equilibrium water content is at least covalently cross-linked hydrogel, the especially acrylic acid of 15 weight % (better being at least 20 weight %) and methacrylic acid and two and the copolymer of the ester of polyol.The example of the polyol that this is suitable comprises ethylene glycol, diethylene glycol, 2,2'-ethylenedioxybis(ethanol)., 1,2-propylene glycol, glycerol, acetin, glucose etc.Acrylamide and conspicuous many other analogous composition combined polymerizations concerning the practitioner in the art that these esters can be further replace with vinyl pyrrolidone, acrylic acid and methacrylic acid, acrylamide, N-.The many concrete compositions of this hydrogel is known in prior art, and is wherein many all suitable, and only adopts normal experiment to be not difficult they are selected concerning those of skill in the art.Typical cross-linking agent is the diacrylate and the dimethylacrylate of above-mentioned dihydroxylic alcohols and polyhydric alcohol.In certain embodiments, the surface of cylinder 14 can comprise the organizational integration layer that contains cross linked polymer, described cross linked polymer for example is the compositions that contains HEMA and alkyl methacrylate (especially cyclohexyl methacrylate), the high compositions of concentration ratio HEMA of especially wherein used described alkyl methacrylate.This organizational integration layer can be slick, the formation pattern or porous.In one embodiment, diverter of the present invention is characterised in that its some physical characteristic, comprises reversible hydration, shape memory power, possess hydrophilic property or hydrophobic local surface areas, has the local surfaces and the local surfaces with different cytoadherences of different hydrabilities.
The slit 22 that runs through top 12 can further stop the intrusion of antibacterial.Slit 22 can allow by the aqueous body fluid outflow of diverter, flows on the transparent cornea, thereby enters the tear film.Although the slit of representing in this figure 22 is microscler holes, what should understand is that other slit structure also is fit to be used for allowing aqueous body fluid flow out and the intrusion of restricting bacterial.For example, can design the pattern of a plurality of tiny slits.Perhaps, for example, elongate slit difference shown in the figure can be used one or an a series of not oversize and band circular slit therewith.Those of ordinary skill can be expected other slit arrangement at an easy rate.
Further referring to Fig. 1, the cylinder 14 of diverter 10 and links to each other with them between top 12 and bottom 18.The bottom 18 can be made by solid HEMA polymer, and scribbles hydrogel, and the copolymer of HEMA and cyclohexyl methacrylate for example, this copolymer can be used for promoting the adhesion with cell.The coating 20 acceptant tissue attachment of bottom 18, bottom 18 just can firmly fix on the throne like this.This feature can prevent that diverter 10 from moving and displacement on the spot.And this feature can prevent that antibacterial from inwardly growing along the passage that passes cornea of placing diverter 10.In order further to promote the inside growth of tissue and adhering to of cell, can adopt the surface modification method, as make it have certain structure, roughening or introduce irregular pattern the coating 20 of bottom 18 is handled.With promote cell the HEMA of adhesion on the cylinder 14 polymer with prevent that these 2 in the HEMA polymer of cell adhesion on top 12 and bottom 18 from combining, just can make on the cornea that diverter 10 therefrom passes through attached to cylinder 14 securely, and also can prevent bacterial adhesion on top 12, in case may entering of antibacterial subsequently.
What prior art was understood is that the device of being made by HEMA can be born by eyes well.In addition, but thereby can dewater by the device that dehydrated polymer such as HEMA make and to reduce size, so that this implant is by little otch.This feature is convenient to insert diverter by locating hole or similar little access road, and to the disorganization minimum.After dehydration diverter 10 of the present invention was suitably placed, it can absorb moisture from tissue on every side, was swelling to its predetermined size.Can change the degree of dehydration, look used concrete hydrogel formulation and different.Even dehydration makes size reduce seldom, also be convenient to implant.And,, absorb moisture then and swell through implanting device on position of cornea at it through dehydration, it closely fixedly is fitted on the desired position.
Fig. 2 illustrates the perspective view of the diverter 10 that also can see internally from the bottom surface.Shown in this embodiment in, when after placing diverter 10 on the anatomical structure, bottom 18 is positioned on the inner face or endothelium of cornea, and reaches in the ante-chamber.In this figure, also can see cylinder 14 and top 12.Diverter 10 has individual passage 24, it by bottom 18 and cylinder 14 reach the top below.Shown in previous figure, the slit (not shown) on the top 12 can allow the aqueous body fluid that flows through passage 24 flow out.There is individual filter 28 to regulate aqueous body fluid and flows to the flow of eyes outside, and therefore in passage 24, provide zigzag path, can stop antibacterial to pass through from ante-chamber.In one embodiment, filter 28 can be made with titanium.Other material also is applicable to filter 28 as pottery and polymer.In certain embodiments, filter 28 is compressible in the passage 24 of cylinder 14.Filtering 28 can be a permanent components that forms diverter 10.Perhaps, can not influence in diverter 10 is equipped with the inlet that can join with passage 24 through the position of corneas some embodiments at those, filter 28 can be removed and replace.For example, removable top 12 can join with filter 28, can remove and replaces thereby filter 28.As another example, a localized inlet (not shown) can be equipped with in top 12, so that join with filter 28, and can not influence the position at top 12.In certain embodiments, this inlet at top 12 and its adnexa can form an integral body with above-mentioned slit system.The practitioner of prior art is not difficult to adopt other setting.Filter can place in the outer rigid cap.After the organizational integration layer was with cylinder 14 fix in position, this outer housing can be inserted on the diverter cylinder 14 or from wherein removing, and did not influence outer fixing in eyes.
As shown in Figure 2, filter 28 can be made cylinder, is convenient to insert in the passage 24 through interference fit.In this embodiment, passage 24 has slick wall 30.Representative dimensions is about the wall that 0.02 * 0.02 inch filter 28 nestles up passage 24, is firmly fixed at wherein.Shown filter 28 comprises the pore network that the aperture is about 0.5 micron.The aperture should be suitable for fluid flow is controlled to be about 2 mul/min dimensionally.Be enough to reduce the excessive intraocular pressure relevant with this flow that provides the proper flow resistance to obtain by the aperture of manufacturing and the length of flow path, prevent that simultaneously eye pressure is low excessively with glaucoma.Although the arrangement of above-mentioned aperture and flow-path-length it seems that to system of the present invention be particularly advantageous, what should understand is that other arrangement of aperture and flow-path-length also can be suitable.What it is also to be understood that is, the hydraulics feature of metal, pottery or polymer can change, and the specification of the filter of being made by these materials also can change, but all within the scope of the invention, as long as the aqueous body fluid that purpose can provide constant, foreseeable and pathophysiology is required of filter flows out flow, stop simultaneously that microorganism is reverse to be passed through.
Fig. 3 is illustrated to be the cross section of a diverter 10 of the present invention.The figure shows aqueous body fluid and flow through cylinder 14 liquid path that slit 22 is discharged on top 12 again by passage 24 from ante-chamber.Shown in this figure is the unit that top 12, cylinder 14 and bottom 18 are integrated into.This figure has illustrated that also a linear slit 22 runs through top 12.Shown slit 22 axially runs through top 12.Also it is contemplated that other slit arrangement.For example, can provide an irregular slit path.The combination of a plurality of slits or slit and other shape perforation also can be provided.In this figure, there is the coating 20 of surface imperfection to be applied in the outside of cylinder 14.Illustrated filter 28 is arranged in passage 24 securely.As shown in the drawing, filter 28 is in occupation of the middle part of passage 24.Filter 28 also can be suitable in other position.For example, the position shown in the figure is compared therewith, filters 28 can be for an end more approaching or apart from farther.
Fig. 4 illustrates diverter 10 and is positioned at the dissection cross section of the anatomical position that passes cornea 104 at it.As previously mentioned, the surface of described diverter embodiment can be made by different materials of different nature, specifically is, as mentioned above, the sedimentary surface of cytoadherence or anti-protein and the surface that can attract cytoadherence arranged can have the capability of doing sth.The top 12 that can see this device rests on the surface 118 of cornea.The diverter 10 that is provided therefrom passes, and making flow of liquid in the ante-chamber 108 cross this diverter is on the outer surface of eyes outside cornea 104.The liquid that enters diverter 10 inner passages leaves this device, flows on the outer corneal surface 118, then mixes with the tear film.This figure has shown that the top 12 of diverter 10 contacts with outer corneal surface 118.This figure has shown that also shunt base 18 contacts with the inner surface 122 of cornea, but this contact is not to be necessary concerning reaching gratifying location.In a representational location, diverter 10 of the present invention can be positioned at transparency cornea above, it is covered by the upper eyelid when neutrality is stared.The diverter 10 of some embodiments of the present invention can be configured to across at tear film on the cornea outer surface 118 and the corneal stroma between the ante-chamber 108.In certain embodiments, diverter 10 comprises following parts at least: (a) cylinder 14, and it is made by hydrogel and has an outer surface that directly contacts with matrix organization; (b) top 12, and it stretches out in cornea outside, have contact with the tear film and with eyelid (not shown) the inner surface outer surface of Intermittent Contact at least; (c) bottom 18, it reaches in the ante-chamber 108.In described embodiment, in the adhesion and wettability of pair cell, the outer surface of cylinder 14 has different character with top 12 at least.In a good especially embodiment, the outer surface pair cell at top 12 is inadhesive, it can be well by tear institute's moistening and be high degree of hydration, and the outer surface hydrability of cylinder 14 is less and the pair cell height adheres to.Fig. 4 also schematically illustrates other anatomical structure.Illustrated crystalline lens 100 separates ante-chamber 108 and back cavity 102.Crystalline lens 100 next doors be the ciliary projection 114 of corpus ciliare 112, its structure is that pipe produces aqueous body fluid.In crystalline lens 100 fronts are irises 120.
Fig. 5 schematically shows an embodiment of diverter 10 of the present invention.In the embodiment illustrated, be penetrated with the passage 24 that a diameter is about the 0.017-0.018 inch in the cylinder 14.In the illustrated embodiment, the length of passage 24 is about 0.048 inch.There is individual filter 28 to be arranged in passage 24.The vertical height of filter 28 is about 0.020 inch.Better be that filter configuration is become can hold back microorganism such as antibacterial, virus, fungus and its spore.Shown bottom 18 has tapered edge 16, so that insert diverter 10 by cornea.Tapered edge 16 inclination 45s shown in this figure, the distance of inclination is about 0.008 inch.The whole vertical height of bottom 18 is about 0.013 inch.Also it is contemplated that the bottom 18 of other size and dimension,, simultaneously bottom 18 is kept suitably being arranged in ante-chamber so that insert diverter 10 by cornea.For example, bottom 18 can have folding or pleating structure, and its size is reduced to minimum when dehydration, and is expanded to bigger when rehydration.In some other embodiment, bottom 18 can be Frusto-conical shape or reverse Frusto-conical shape, can it is folding so that its insertion.As shown in the drawing, in certain embodiments, bottom 18 is bigger than cylinder 14.Although in this figure, filter 28 is depicted as the far-end that is positioned at passage 24 imports, filter 28 on other position also within the scope of the invention.For example, filter 28 can be positioned at the import that is bordering on passage 24, and perhaps it can occupy the position of making in the passage, and also its aperture and liquid path length can be made is enough to make filter 28 to occupy whole passage 24 basically.
In certain embodiments, diverter 10 of the present invention can be made by the polymer with shape memory power, described polymer can be transformed into and is suitable for the deformed shape inserted by little otch, then returns previously selected shape because of hydration or temperature action.For example, can be during beginning with its softening temperature T
sBe higher than room temperature but better insert through cornea by entering otch (for example any other of knowing of slit, cutting mouth, aperture or technology skilful person enters otch) near the diverter 10 of the partial dehydration state of part flow arrangement temperature, then after rehydration and temperature raise, be expanded to and present its predetermined size and shape.
The method of making diverter of the present invention can be included in the disposable mould to be made, and perhaps machining is made, and the form with curable compositions applies the organizational integration layer again.For example, corneal implant or diverter can have casting in the single-piece silicone mold of cavity with the mixture of HEMA, methacrylic acid, dimethylacrylate cross-linking agent and radical initiator and get in one, this cavity is that the die head with reservation shape impresses formation.Perhaps, can machining making corneal implant is diverter, then the organizational integration layer is applied on the outer surface of diverter.The organizational integration layer is a kind of curable compositions, and it comprises copolymer, monomer HEMA, dimethylacrylate cross-linking agent, radical initiator and the volatile solvent of HEMA and alkyl methacrylate.Should expect at an easy rate by those of ordinary skill in the related art practitioner by other method that these system and methods manufacturing corneal implant are diverter.
System and method of the present invention preferably uses a kind of releasing device, and this device is suitable for diverter or other discharger are fixed, and can place it near on the precalculated position of cornea, again it is seen through anterior corneal surface and inserts, and occupies the position through cornea.In certain embodiments, releasing device comprises that is inserted a tip, is suitable for removably diverter being fixed and diverter is seen through the insertion of cornea outer surface being in place.Described releasing device also comprises the inserter that can slide into amphi position from peri position, and the slip of this inserter from the peri position to the amphi position can make diverter move and force it to see through outer corneal surface to reach position through cornea by inserting tip.When delivery system being used for device is discharged into its predetermined position through cornea, better earlier on anterior corneal surface, produce little the entering wound or it is extended to and even, insert diverter or discharger afterwards again of a locating hole or other to reduce resistance by corneal stroma.In certain embodiments, releasing device of the present invention can be well-suited for the operator and indicate diverter placement correctly already.
Fig. 6 A represents a kind of releasing device 200 that is suitable for diverter insertion of the present invention is reached process cornea position.Have ergonomic structure at the releasing device 200 shown in this figure, it have near-end major axis (proximal elongate shaft) 206, clamping zone 210, comprise the inserter of tip spare 212 slidably and insert tip 214.Axle 206 and clamping zone 210 are formed by body shell 202, and more handy light plastic material is made.The fore-end of releasing device 200 comprises the far-end housing 226 of hollow, and slidably tip sheet 212 can move forward and backward therein.Clamping zone 210 has been characterised in that a proximal protrusion thing 204 and a distal projection thing 208, between these two thrusts, can releasing device 200, allow axle 206 be positioned on operator's the first rear fabric space (first dorsal webspace) with the clamping of a lip pencil clamper.The lip pencil clamper is particularly suitable for accurately handling inserting tip 214, although the clamper of other type can be used for device 200 for the operator.At the end that inserts tip 214 individual patchhole 218 is arranged, can place diverter (not shown) therein.
Fig. 6 B represents the cross section of releasing device 200 end portion of the present invention, and wherein slidably tip sheet 212 has moved forward.Slidably tip sheet 212 can be along non-movable piston 220 coaxial slips.Fig. 6 B has shown that slidably tip sheet 212 is positioned at position the preceding with respect to the fixed position of the plunger in end housing 226 220.In this position, at the end 230 of plunger with insert between the patchhole 218 in the tip 214 and just form a cavity, this cavity is suitable for holding removably diverter 10 dimensionally.In this figure, can see that diverter 10 is arranged in the slidably insertion tip 214 of tip spare 212, just in time in the inside of patchhole 218.In this figure, the shown insertion tip 214 that is positioned at tip sheet 212 terminal positions contacts with the surface of cornea 228.Place like this, the front of diverter 10 is inserted tip 214 with end haply and is flushed, and the back of diverter 10 leans against on the end 230 of plunger 220.And, when this position, form a back cavity 222 in the back at tip spare 212 backs 228 slidably with in the front of fixing back barrier 224.This back cavity 222 provide one can be by the space that enters towards the moving slidably tip spare 212 of trying hard to recommend of rear.Make it terminal when inserting tip 214 and contacting when the operator pushes ahead releasing device 200, be used for slidably tip spare 212 with regard to above-mentioned masterpiece towards the rear is arranged with anterior corneal surface 228.The surface 228 of cornea hampers the terminal tip 214 that inserts and moves forward, and forces slidably that tip spare 212 retreats.Different therewith, the fixed-site of plunger 220 is in releasing device 200.Therefore, when forcing that slidably tip spare 212 slides backward relatively, in operator's hands, continue to push away forward, just can advance plunger 220 to move forward relatively by making releasing device 200.Plunger 220 continues to move forward with the diverter 10 that contacts with the end 230 of plunger 220, and the surface 228 that just forces diverter to see through cornea reaches its position through cornea.The little insertion point or the locating hole that provide the bottom (not shown) of a diverter to enter just can be so that diverter 10 see through the surface 228 of cornea.The axial length of sliding cavity 222 is identical haply with the length of diverter 10.It is too dark that this design can prevent that diverter 10 from pushing in the eyes.
Slidably the mobile backward degree of tip spare 212 can be referring to Fig. 6 C.In this figure, can see insertion tip 214 at the end of end housing 226, slidably tip spare 212 is near being pushed in the end housing 226.This figure has also shown the end 230 that can see plunger by the patchhole 218 of end insertion tip 214, and this shows that the end 230 of plunger flushes with the end that inserts tip 214 haply after slidably tip spare 212 is promoted fully backward.
Fig. 6 D represents when diverter 10 pushes the position that occupies its process cornea of striding corneal stroma 232 two sides through anterior corneal surface, the cross section of each structure member position of releasing device.Slidably tip spare 212 is on its position that retreats fully, its back 228 with the back barrier 224 of plunger near.220 of plungers are immovable in end housing 226.And moving forward of releasing device 200 promoted slidably tip spare 212 and moved backward with respect to plunger 220.Keeping just being pushed through anterior corneal surface 228 with terminal 230 diverters that contact 10 of plunger, better is by a locating hole or otch or insertion point, occupies its position through cornea at last.Further forward releasing device 200 is exerted pressure and can be met obstructions because no longer movably slidably the end of tip spare 212 insert tip 214 and be pressed on the anterior corneal surface 228.When running into this resistance, the operator understands and can not further exert pressure again.
Also it is contemplated that and adopt other mechanism to inform that operator's diverter 10 has reached correct position.For example, back cavity 222 can have breach or dummy slider (not shown), and after tip spare 212 slidably moved fully backward, described breach or dummy slider can cooperate with associated components on the tip spare 212 slidably.The engagement of these members that cooperatively interact can produce hear or sense of touch on appreciable " card is taken " sound, tell the operator slidably tip spare 212 fully to retrodisplacement, thereby diverter 10 has placed fully forwardly.The engagement of mating component may be nonvolatil, and so slidably tip spare just can not be replied its position in front, perhaps can engagement can be unclamped with latch, knob or kindred organization.Practitioner in these fields can expect at an easy rate that other can inform the structure of operator about the same purpose of diverter position.In certain embodiments, whole slidably tip spare 212 or insertion tip 214 can be made with material transparent, and plunger can be made with opaque or bright-coloured painted material.This arrangement can make the operator examine easily to know these members relative position each other.Perhaps, all end members are all made with material transparent, and the operator just can easily see the surface of cornea by the transparent region of releasing device 200 like this.
Fig. 7 A represents another embodiment of releasing device 200 of the present invention.The profile of the releasing device of describing among the profile of this embodiment and Fig. 6 A-D 200 is similar, and for example it has extend back body shell 202 that forms axle (not shown) and the clamping zone 210 that is formed through the ergonomics design by a proximal protrusion thing 204 and a terminal process thing 208.In the embodiment illustrated, partly have a patchhole 218 at the least significant end that inserts tip 214, diverter (not shown) can insert wherein removably.Yet in the embodiment illustrated, with respect to releasing device 200, fixed tip sheet 244 and insertion tip 214 are fixed.In place one starter 240 is housed near clamping zone 210.Starter 240 is arranged in the incision breach 242 that passes end housing 226, is slidably.Starter breach 242 can move forward starter 240 with respect to end housing 226.As shown in the drawing, starter is positioned at the place near clamping zone 210, although also can select any other position easily to starter mechanism 240.Starter 240 can have coarse, wrinkling or irregular surface, makes it be used for easily handling concerning the operator.
Releasing device 200 among Fig. 7 B presentation graphs 7A is along the longitudinal cross-section of A-A ' line.Although body shell 202 is depicted as hollow, can be solid or any structure easily near body shell 202 positions of starter axle 250 at this.Yet end housing 226 is enough empty, and slidably plunger 248 can move axially therein.In the embodiment illustrated, end housing 226 also has the starter breach 242 of an incision, and starter axle 250 can move therein.As shown in the drawing, the moving forward of starter axle 250 also forces plunger 248 slidably to move forward with respect to the position of end housing 226.This figure has represented to be present in the chamber 216 in the insertion tip 214 of fixing tip sheet 224.This chamber 216 is suitable for holding removably diverter of the present invention (not shown) dimensionally.When using the releasing device 200 shown in this figure to insert and placing diverter, the operator can advance the foremost position of starter 240 to starter breach 242, thereby advance starter axle 250 and its fixed slidably plunger 248, so slidably plunger 248 just enters in the chamber 216, thereby diverter (not shown) is moved.When discharging diverter, the insertion tip 214 of releasing device 200 is suitable for contacting with outer corneal surface.Operator ' is lived releasing device 200, and it inserts tip 214 and contacts in the precalculated position with anterior corneal surface, and the operator pushes ahead starter 240 simultaneously then, and diverter is inserted in the specified zone of cornea.As previously mentioned, various materials all can be used to make releasing device 200.Especially, the end component of releasing device can be made with material transparent.Slidably plunger 248 also can be made with material transparent, so that see diverter.Perhaps, insert tip 214 and/or fixed tip sheet 244 and can make, and slidably plunger 248 usefulness can be made by bright-coloured painted opaque material, make its relative position to be clear that with material transparent.
With reference to above-mentioned each figure, people can know some method that reduces the ante-chamber fluid pressure by the present invention.In a kind of enforcement of the present invention, provide diverter to discharge aqueous body fluid, and the releasing device that provides is suitable for inserting this diverter.This diverter is suitable for discharging aqueous body fluid with predetermined flow, also can be used to prevent the intrusion of microorganism.After appropriate anaesthetization is provided, select to insert the position of discharging diverter.Can drive a locating hole, this locating hole can extend through outer corneal surface, and can extend through corneal stroma and further stretch into ante-chamber.The size of locating hole can be determined based on surgical judgment and each patient's anatomical structure by each operator.Can use any in the multiple apparatus that pin, trocar, scalpel or ophthalmology practitioner know to open locating hole or similar insertion point.Diverter can be inserted in the releasing device by the operator, and diverter also can insert in the releasing device in its manufacture process in advance.Although the size for diverter has disclosed some exemplary size herein, what should understand is the diverter size that can use in a certain scope, to adapt to the situation that meeting becomes with the patient's eyes anatomical structure.What it is also to be understood that is the releasing device that various sizes can be provided, and is used for cooperating the diverter of different size, and perhaps a kind of releasing device of size can be suitable for implanting the diverter of various different sizes.Because diverter is fixed in the insertion tip of releasing device, so the operator can advance releasing device towards outer corneal surface.When releasing device arrives the precalculated position of cornea, use the mechanism of the releasing device of propelling and mobile diverter, just can force diverter to reach its position through cornea.After diverter was suitably had good positioning in cornea, it just can be discharged to aqueous body fluid on the surface of cornea.When the drop of aqueous body fluid is seen at the top of implanting device, just can confirm diverter appropriate location.
What should understand is, this device can be implanted after the step that those IOP may raise subsequently, or to can be used as with the IOP rising be the temporary transient rectification of the disease of feature.In the temporary transient rectification behind retina surgical operation, cataractopiesis or other intervention property ophthalmologic operation, this installed implantable 2 hours to 1 month or is stable up to IOP.Different therewith, the permanent or secular implant of use apparatus of the present invention then can be used for treating the glaucoma of diabetic.
What should understand is, above-mentioned description, its accompanying drawing and explanation only be to of the present invention for example, they are some illustrative embodiment.What it is also to be understood that is, under the situation that does not depart from the scope of the invention, can make changes and improvements to each parts of diverter and structure and delivery system thereof and method for releasing.And the present invention should be understood as that by following claims and limited.
Claims (20)
1. a transparency cornea that sees through eyes inserts the diverter in the eyes ante-chamber, and it comprises:
One is columniform cylinder basically, and the passage from this cylindrical proximal extension to far-end is wherein arranged, and is used for being discharged to aqueous body fluid on the outer surface of transparency cornea from ante-chamber;
A top, it is positioned at cylindrical far-end, leans against on the outer surface of transparency cornea, and this top has through first opening that wherein is fluid connection with described passage, and aqueous body fluid is flowed out;
A bottom, it is positioned at cylindrical near-end, leans against on the inner surface of cornea, and this bottom has through second opening that wherein is fluid connection with passage, makes in the aqueous body fluid flow channel;
A filter, it is used to regulate the flow of the aqueous body fluid that flows through passage and makes entering of microorganism reduce to minimum in passage;
Wherein said diverter to small part is made by the polymer that can dewater, the dehydration of described like this diverter reduces the size of described diverter, so that implant by the little otch on the cornea, and the hydration of described diverter makes described diverter be arranged in described cornea securely.
2. diverter as claimed in claim 1, at least one in wherein said top and the described bottom and described cylinder form an integral body.
3. diverter as claimed in claim 1, at least one in wherein said top, described bottom and the described cylinder comprises the described polymer that dewaters.
4. diverter as claimed in claim 1, wherein said filter can be removed from passage.
5. diverter as claimed in claim 1, the wherein said polymer that dewaters comprises hydrogel.
6. diverter as claimed in claim 5, wherein hydrogel is covalently cross-linked, it is base with the methacrylic acid derivative.
7. diverter as claimed in claim 1, wherein at least one outer surface is made and can be reduced to minimum with the adhesion of cell in the outer surface of the outer surface at top and bottom.
8. diverter as claimed in claim 1, wherein cylindrical outer surface are made the adhesion that can promote with tissue.
9. diverter as claimed in claim 1, wherein the bottom is configured as taper, is convenient to see through cornea and inserts this cornea diverter.
10. diverter as claimed in claim 1, wherein the bottom can become another kind of shape from a kind of shape dimensionally, is convenient to see through cornea and inserts this cornea diverter.
11. diverter as claimed in claim 1 wherein is to allow filter stay in the passage by compressing.
12. diverter as claimed in claim 1, its middle filtrator can be stayed the near-end in the passage.
13. one kind places the position through cornea to make the eyes ante-chamber discharge the implant of body fluid, it comprises:
A top, it is fit to be placed on the outside of cornea, and it has one first opening, allows aqueous body fluid flow out;
A bottom, it is fit to see through cornea inserts in the ante-chamber, and it abuts against on the inner face of cornea with also being fit to no wound, and it has can make therefrom effusive second opening of aqueous body fluid;
A tubular conduit, it is between bottom and top, and it has the internal channel that is fluid connection with first and second openings;
A filter, it is stayed in the internal channel and the filtration hole is provided, to regulate the outflow of aqueous body fluid and entering of restriction micro-organisms;
Wherein said implant to small part is made by the polymer that can dewater, the dehydration of described like this implant reduces the size of described implant, so that implant by the little otch on the cornea, and the hydration of described implant makes described implant be arranged in described cornea securely.
14. diverter as claimed in claim 1 is characterized in that, described first opening is set to further make entering of microorganism to reduce to minimum.
15. diverter as claimed in claim 14 is characterized in that, described first opening be shaped as slit.
16. implant as claimed in claim 13 is characterized in that, described first opening is set to further reduce entering of microorganism.
17. implant as claimed in claim 16 is characterized in that, described first opening be shaped as slit.
18. implant as claimed in claim 13 is characterized in that, the size of described filtration hole is about 0.5 micron.
19. diverter as claimed in claim 1 is characterized in that, described filter is an elongate filter.
20. implant as claimed in claim 13 is characterized in that, described top and tubular conduit have the outer surface that can prevent with cytoadherence.
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| US17565800P | 2000-01-12 | 2000-01-12 | |
| US60/175,658 | 2000-01-12 |
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| JP (1) | JP4290915B2 (en) |
| KR (1) | KR100778908B1 (en) |
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- 2001-01-05 KR KR1020027008954A patent/KR100778908B1/en not_active IP Right Cessation
- 2001-01-05 NZ NZ520099A patent/NZ520099A/en unknown
- 2001-01-05 CA CA002397166A patent/CA2397166A1/en not_active Abandoned
- 2001-01-05 IL IL15063001A patent/IL150630A0/en active IP Right Grant
- 2001-01-05 HU HU0301786A patent/HUP0301786A2/en unknown
- 2001-01-05 CZ CZ20022477A patent/CZ20022477A3/en unknown
- 2001-01-05 EP EP01942286A patent/EP1246656A2/en not_active Withdrawn
- 2001-01-05 JP JP2001551369A patent/JP4290915B2/en not_active Expired - Fee Related
- 2001-01-05 AU AU29283/01A patent/AU783775B2/en not_active Ceased
- 2001-01-05 MX MXPA02006889A patent/MXPA02006889A/en active IP Right Grant
- 2001-01-05 WO PCT/US2001/000350 patent/WO2001050943A2/en active IP Right Grant
- 2001-01-05 PL PL01362931A patent/PL362931A1/en not_active IP Right Cessation
- 2001-01-05 BR BR0107591-8A patent/BR0107591A/en not_active Application Discontinuation
- 2001-01-05 RU RU2002118596/14A patent/RU2262331C2/en not_active IP Right Cessation
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- 2002-07-05 ZA ZA200205386A patent/ZA200205386B/en unknown
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Also Published As
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| KR100778908B1 (en) | 2007-11-27 |
| WO2001050943A3 (en) | 2002-01-03 |
| MXPA02006889A (en) | 2003-05-23 |
| CA2397166A1 (en) | 2001-07-19 |
| PL362931A1 (en) | 2004-11-02 |
| BR0107591A (en) | 2004-07-27 |
| HUP0301786A2 (en) | 2003-10-28 |
| WO2001050943A2 (en) | 2001-07-19 |
| CN1620316A (en) | 2005-05-25 |
| AU2928301A (en) | 2001-07-24 |
| RU2262331C2 (en) | 2005-10-20 |
| JP2003520077A (en) | 2003-07-02 |
| ZA200205386B (en) | 2003-05-08 |
| NZ520099A (en) | 2005-03-24 |
| CZ20022477A3 (en) | 2003-02-12 |
| RU2002118596A (en) | 2004-01-20 |
| IL150630A (en) | 2011-01-31 |
| EP1246656A2 (en) | 2002-10-09 |
| AU783775B2 (en) | 2005-12-01 |
| IL150630A0 (en) | 2003-02-12 |
| JP4290915B2 (en) | 2009-07-08 |
| KR20020063003A (en) | 2002-07-31 |
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