CA2422763C - A device for use in eye surgery - Google Patents
A device for use in eye surgery Download PDFInfo
- Publication number
- CA2422763C CA2422763C CA002422763A CA2422763A CA2422763C CA 2422763 C CA2422763 C CA 2422763C CA 002422763 A CA002422763 A CA 002422763A CA 2422763 A CA2422763 A CA 2422763A CA 2422763 C CA2422763 C CA 2422763C
- Authority
- CA
- Canada
- Prior art keywords
- sealing device
- plug part
- capsular bag
- lens
- eye
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Classifications
-
- 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
- A61F2/1662—Instruments for inserting intraocular lenses into the eye
-
- 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
- A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
- A61F2/1616—Pseudo-accommodative, e.g. multifocal or enabling monovision
-
- 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
Abstract
The present invention relates to a method of manufacturing an intraocular le ns inside a capsular bag (28;73) after that the natural lens has been removed a nd to a sealing device (21;41;61;71) comprising a plug part (23;43;63;77) adapt ed to seal a rhexis (30:75) of a lens-forming liquid material injected through the rhexis (30;75) and adapted to replace the natural lens and form an intraocular lens implant. According to the invention said plug part (23;43;63;77) has a slightly larger area than the capsulorhexis (30;75) and is made of a deformable polymer. Also according to the invention the sealing device (21;41;61;71) comprises an adjusting means (25;45;65), connected to t he plug part (23;43;63;77), said adjusting means (25;45;65) having the function of positioning said plug part (23;43;63;77) to a desired location.
Description
A device for use in eye surgery Field of invention The present invention relates to a sealing device comprising a plug part adapted to seal a capsulorhexis of a capsular bag used in surgical processes involving insertion of lens-forming liquid to replace the natural lens and forming an intraocular lens implant. It also relates to a method providing visual correction including manufacturing an intraocular leiis inside a capsular bag after that the natural lens has been removed.
Background of the invention A technique for removing a catarcteous and/or presbyopic natural lens from the capsular bag of the eye and replacing it by a lens-forming liquid material injected directly into the capsular bag is under development.
The liquid material is a partially polymerized material, which can undergo a curing process in the eye and thereby form a solid lens implant. The lens implant acts as a substitute for the natural lens and aims to substantially restore the features of the natural lens of the young eye. Materials and methods suitable for injection and subsequent formation of an IOL (Intra Ocular Lens) are disclosed in the patent applications WO 00/22460, WO 00/22459 and WO 99/47185. The defect natural lens matrix can be removed by a conventional surgical method involving an ultrasound probe, such as a phacoemulsification method involving aspiration. In order to facilitate the removal of the lens matrix and the refilling witli lens fonning liquid material, a capsulotomy i.e. a capsulorhexis is prepared in the anterior wall of the capsular bag. The capsulorhexis is prepared from a circular or essentially circular capsultomy in the capsular bag wall, typically with a diameter of fioin about 0.5 to about 2.5 mm. An injection syringe needle is inseited through an incision in the eye and through the capsulorhexis into the capsular bag so the lens-forming liquid material can be injected into the capsular bag.
It has been identified as a problenl in capsular bag filling processes that during the injection and before the final lens is f.ormed liquid material can leak through the capsulorhexis. For this purpose a plug is proposed in the Japanese patent specification JP97-308946. Tliis plug is adapted to be attached to the SUBSTITUTE SHEET (RULE 26) injection syringe needle and inserted to the eye and positioned in the riglit position in the rhexis when the syringe needle is inserted. A problem with this plug is that it is clainped and/or glued in the rhexis. Since the plug is relatively large and adapted to stay in the rhexis permanent optical problems could arise. Furtherinore, it needs a relatively large opening in the eye to be implaiited. The plug comprises also a filling tube, which has to be cut off after filling. The tube could cause a leak. The size of tlie plug may also influence the free movement of the capsule that is needed for an even deformation of the capsule during accommodation. In the hzternational Patent Application published as WO 00/49976 (University of Miaini), a more siinple plug construction is suggested that attempts to act as a valve during the surgical process.
Also this plug suffers fiom the drawback that it perinanently locates parts of its structure outside the capsular bag after finalizing the surgery. The curved flexible member is permanently protruding from the capsular bag tlirough its hub like attaclunent point to the flexible discoid flap-valve mezilber. Consequently, the protruding parts may risk to compromise surrounding delicate eye tissues, including the iris, while they also risk generating unwanted optical side effects. It is therefore obvious that it is need for improvements in plug parts or sealing means for a capsulorhexis that has been introduced in a capsular filling process.
Description of the invention It is an object of the invention to provide a sealing device for a capsulorliexis of the capsular bag of the eye that effectively prevents a liquid inserted into the capsular bag to lealc out through the capsulorhexis.
It is also an object of the present invention to provide a sealing device for a capsulorhexis that leaves no permanent parts outside the capsular bag after the lens iinplantation process is finalized.
Another object is to provide a sealing device having means by which its location can be controlled after its insertion tluoughout the capsule filling process and lens forming process.
Still a fiu-ther object of the invention is to provide a sealing device for the capsular bag that can contribute to coinpensate for refractive errors and/or wavefront aberrations of the optical parts of the eye.
These objects are obtained with a sealing device having a plug part made of a deformable polymer that is capable of admitting the entrance of an injection SUBSTITUTE SHEET (RULE 26) ~
device for injecting a lens-forming liquid material tluough the capsulorhexis, while having slightly larger area than the capsulorhexis, so as to obtain a sealing effect from being pressed in a tight sealing position with the imler capsular bag from the pressure exerted by the injected liquid material. The sealing device fiu-ther comprises an anteriorly protruding removable adjusting means comiected to the plug part. By the adjustinent means, tlie plug part can be displaced exactly to the desired location by surgeon. It is an important characteristic of the preseiitly invented sealing device that it is free from any features protruding out from the capsular bag subsequent to the surgical process. This is due to that its adjustinent means is readily removable through surgical incision of the eye wllen the surgeon so decides. The highly simplified construction of the sealing device that leaves no perinanent parts outside capsular bag protruding out in posterior chainber of the eye resides from the finding that the fluid lens forining material is capable of exerting a sufficient pressure on the deforinable sealing device so it together with the capsular bag wall can act sufficiently sealing without the need of additional securing means.
Preferably, said plug part is essentially disc-shaped and suitably said plug part is adapted to be placed at the inside of the capsular bag, covering the whole capsulorhexis. It is suitable that the plug part has a somewhat larger diameter than the capsulorhexis to enable a safe sealing effect. A suitable plug diaineter is accordingly in the range of about 0.5 to about 2.5 mm. However, in certain embodiments described below the plug part can have a considerably larger extension. The plug part of the sealing device is adapted to permanently remain in the eye, but can alternatively, be removed after the lens forining process in the capsular bag is completed and the lens forining material is satisfyingly cLUed. In such case, the adjustment means are not removed, but employed to carefully loose the plug part and transfer it out of the eye.
The plug part is made of a suitable soft, flexible, biocompatible material that is sufficiently thin to follow the accormnodation movements of the capsular bag.
Normally that means that the plug part will have a thicluiess in the range of about 5 to 250 micrometers. In order to avoid any problems of material incoinpatibility, or eventually any optical side effects, it is preferable that the ph.ig part is made of a similar niaterial to the lens forining material. Preferably the plug part is made from a silicon material to comply with an injectable lens forming silicon material.
For the condition that the capsulorhexis is placed in the visual field, it is greatly preferable SUBSTITUTE SHEET (RULE 26) that the plug part is made of a material having essentially the saine refractive index as the material inserted in the capsular bag. This is important especially if the plug part is to be left in the capsular bag after that the lens-forining process is coinpleted.
Hereby, the sealing device does not affect the visual quality. Suitable silicone materials can be found ainong the terpolymers mentioned in PCT/EP99/07781 and PCT/EP99/07780, or the high refractive index silicones, for example, disclosed in US Patents Nos. 5,236,970 and 5,444,106, optionally without UV absorbers and other additives regarded unsuitable for the present teclulical application.
Also various medical grades of conventional polydimethylsiloxanes (PDMS) are suitable within certain einbodiments of the invention. The plug part can be prepared with conventional molding processes for silicones, which together with other suitable silicones tllan the aforementioned are well known to persons skilled in this teclniology.
The adjusting means typically is one or several thin flexible wire(s) that is non-permanently attached to the plug part. In a suitable embodiment, the thin wire penetrates the plug part from the anterior to the posterior side and then penetrates the plug part from the posterior to the anterior side. The distance between the two penetrating positions and their locations on the plug part are selected so that it can be comfortably ma.nipulated, either with a microforceps, or with other suitable means, also from outside of the eye. It is to be understood that the th.in wire can be of such a length that it protrudes out of the eye through the corneoscleral incision.
The wire is preferably made of less flexible material than the material of the plug part and the capsular bag and is attached to the plug part in a maiu-ier that is easily can be removed when the lens forining material is introduced, or when then lens forining process is finalized. Typically suitable materials for the wire are different brands of nylons that are well known in siugical processes and not discussed in further detail.
In one aspect of the invention, the plug part of the sealing device is provided with a contacting zneans that establishes an iinproved contact between the anterior surface of the plug part and the iiuier (posterior) wall of the capsular bag, so to prevent or hinder any displacements of the plug part from forces exerted on the capsular bag wall during the accommodation process. Further, substantial problezns to obtain a correct accommodation process may arise if the capsulorhexis to be sealed has a large extension, such as exceeding several millimeters. In order to SUBSTITUTE SHEET (RULE 26) ensure correct accoinmodation processes, the forces exerted on the capsular bag needs to be transmitted correctly without any dead zones incapable of participating in the process. Wlien a very soft lens material is employed which has sufficiently low elasticity modulus as to form accoininodating lens, this type of dead zones 5 and/or large plug part displacements during accommodation, may eventually cause that lens material does not correctly participate in the accommodation, or at worst will bulge out anteriorly witli uncontrollable consequences. To comply with any such unwanted effects, the plug part preferably is provided with contact means to improve the contact between the plug part and the capsular bag wall. Suitable contact means can be accomplished by providing plug part with an anterior surface that, at least partially, admits an enhanced friction to the inner wall of the capsular bag. As an example, this can be accomplished with the provision of a peripheral ring-shaped roughened anterior surface adapted to improve contact the iiuier wall of the capsular bag. Hereby, the contact between the sealing device and the inner wall of the capsular bag is improved. Friction enhancing processes and roughening processes are well lalown to silicon experts and are not elaborated on herein in any detail. Suitably, the whole area designated to contact the capsular bag inner wall is modified or treated accordingly which means that typically that about 5 to 50 % of the total surface is modified or treated.
In another aspect of the invention, the plug part of the sealing device has an anteriorly extending ring in the middle with a diaineter fitting into the capsulorhexis from below. The ring is adapted to stabilize the correct position of the sealing device.
According to a special embodiment, the plug part has a cut admitting passage of the lens-forining material. Hereby, the sealing device can be more easily retained in its position during the injection of lens forming material.
Suitably, the cut is provided with an overlapping part adapted to seal the cut when the injection is completed, in order to prevent from undesired leakage of injected lens-forming material through the cut.
The inventive sealing device can suitably be positioned in a capsulorhexis of about 1 min in diaineter positioned off the optical axis of the eye, i.e.
outside the normal visual field. Alternatively, the capsulorhexis includes the optical axis. In such case, it is of importance that the plug part is perfectly optically clear and that it does not contribute to any optical side effects. Preferably, the plug part is then made SUBSTITUTE SHEET (RULE 26) of a material that has the same or essentially the saine refractive index as the lens forming material.
In anotller embodiment of the invention, the sealing device is designed to have specific predetermined optical characteristics and to be used in the visual field of eye. The sealing device will then have such an extension that it extends over the whole, or substantially the wliole, visual field of the eye and can individually tailored for a patient to correct for optical deficiencies, including refractive errors or aberrations typically arriving from individual irregularities of the corneal surfaces.
In a surgical correction process, aiming to malce use of the optical characteristics of the sealing device, a larger part of the anterior capsular bag can be surgically excised, such as about 2 to 6 imn of the capsular bag surrounding the optical axis. A
sealing device having suitable extension to comply with an accordingly excised capsular bag can the be employed in a capsular bag lens filling process that admits visual correction of optical errors also from other parts of the eye, such as the corneal surfaces. The plug part of the sealing device can then be provided with a refractive power or with optical surfaces that can correct for aberrations, such as astigmatism and/or spherical aberration. Typically such a sealing device having lens power can be made in material having different refractive index tlian the injectable lens forming material and be provided with at least one surface deviating from perfect sphericity, i.e. being aspheric to reduce or eliminate aberrations.
The present invention also relates to a method of perfonning visual correction that involves the manufacturing of an intraocular lens inside the capsular bag of the eye. The method comprises the steps of:
- inserting a sealing device in a capsulorhexis, said plug part being adapted to cover the capsulorhexis from the inside of the capsular bag;
- adjusting the location of said sealing device with an adjusting means operable from the outside of the capsular bag;
- delivering a lens-forming material through the capsulorhexis into the capsular bag by using a delivering means and by displacing and/or deforming the plug part to adinit passage for the material;
- removing the delivering means out from the eye, whereby the plug part retains its sealing position, thereby preventing displacement of the lens-forming liquid material out fiom the capsular bag .
SUBSTITUTE SHEET (RULE 26) In one embodiment, the method coinprises removing the sealing device tluough the capsulorhexis wllen the lens-forming process is completed. Otlierwise, only the adjusting means is removed when the plug part has been positioned to seal capsulorhexis by the inserted lens-forining material in the capsular bag.
Suitably the method coinprises deforining the plug part so as to obtain a shape insertable through the capsulorhexis. Preferably the method comprises controlling the position of said plug part by means of the adjusting means.
In one embodiment the method coinprises inserting the lens-forming material to the capsular bag through a cut in the plug part and through the capsulorllexis.
The method can also coinprise a step where an agent that coLulteracts secondary cataract is introduced in the capsular bag before introducing the lens forming material. Such agents typically are typically introduced witli an injection syringe that can displace or deform the plug part sufficiently to insert a for injection needle in the capsular bag. The plug part provides a sufficiently sealed enviromnent that the injected agent is prevented from coming in contact witlz other ocular tissues than the iiuler wall of the capsular bag during the secondary cataract treatment.
Suitable agents are cytotoxic or antiproliferative agents that counteracts growth of epithelial cells that can coinpromise the transparency of the postsurgical capsular bag.
An exainple of such an agent is 5-fluorouracil, but munerous other agents are conceivable to the slcilled person. Alternatively an agent capable of blocking epithelial cell adhesiveness would be a useful such as the calcium chamiel blocker mibefradil.
In a special einbodiment the method furtller comprises zneasuring the error of refraction of the eye and designing the plug to fiu-ther compensate for error of refraction. In this embodiment, the method also can coinprise measuring one or several aberrations of the cornea by a corneal topographic method or with conducting a wavefront analysis of the aphalcic eye during the slugical process, for exainple witli a Hartmamz-Scalick sensor equipment, or the similar. The method can also involve estimations of the aberrations that will be generated in a wave front arriving from the lens to be formed in the capsular bag. Preferably, the results from these optical measurements can be employed to design the surface of the plug to coinpensate for the aberration of the eye, or alternatively to select a sealing device having plug part that will provide the best optical outcome for an individual, ainong SUBSTITUTE SHEET (RULE 26) a plurality of sealing devices in a kit with different refractive values and/or aberrations.
It is obvious that the present invention provides a highly advantageous sealing device for use in ophthalmic surgery that admits a high degree of versatility and readily can be adapted for numerous different surgical conditions due to its simplified construction and its adaptability to its ocular enviromnent. The following part aims to exemplify some specific einbodiments of sealing devices that aims to be illustrative, but not liiniting for the scope of invention.
Brief description of the drawings Fig. la is a schematic view from above of a sealing device according to a first embodiment of the invention.
Fig. lb is a side view of the sealing device in Fig. la inserted into a capsular bag.
Fig. 2 is a view from above of a second embodiment of the sealing device according to the invention.
Fig. 3 is a view from above of a third einbodiment of the sealing device according to the invention.
Fig. 4 is a side view of a sealing device according to the invention inserted into a capsular bag.
Detailed description of the embodiments Fig. 1 a is a schematic view from above of a sealing device 21 according to a first embodiment of the invention. The sealing device 21 comprises an essentially disc-shaped plug part 23 and an adjusting means 25. The plug part 23 is made of a defonnable polymer such as a silicon material. In this embodiment the adjusting ineans 25 is a nylon thread attached at its middle to the center of the plug part 23.
For exainple, the tbread can pass tluough two holes in the plug part 23 leaving the adjusting means 25 with two thread ends 26a and 26b pointing out from the plug part 23 on the same side. This thread 25 could of cotirse be attached to the plug part 23 in some other way and it can be made from anotller material than nylon. It is also possible to only attach one end of the thread to the plug part 23 leaving only one end pointing out from the plug part 23. The nylon thread used in this embodinlent has a suitable stiffiiess so it enables manipulation of the plug part. The material of the can have a refractive index compatible with the lens material ai.id it should SUBSTITUTE SHEET (RULE 26) follow the deformation of the capsular bag if the sealing inea.ns is adapted to be left in the rhexis.
Fig. lb is a side view of the sealing device 21 shown in Fig. la inserted into a capsular bag 28. The plug part 23 of the sealing device 21 is inserted inside the capsular bag and it is adapted to cover a rhexis 30 in the capsular bag from below.
The nylon threads 26a, 26b are extending anteriorly from the sealing device 21 and preferably they are long enough to protrude out of the eye. Thus, the sealing device 21 can be controlled and Icept in the desired location from outside the eye.
The sealing tlevice 21 is adapted to be inserted into the eye before the lens-forming liquid material is injected and after that the natural lens has been removed.
When the lens-forming material is injected, a delivering means, here an injection syringe is used. The injection syringe needle is inserted through the eye and through the capsulorhexis by sufficiently displacing and/or deforming the sealing device so the needle is admitted into the capsular bag. After the injection the syringe needle is removed out from the capsular bag and the eye and the presstu=e exerted by the fluid lens-forming material provides the sealing device to retain its original position and shape in front of the rhexis thus preventing the lens-forniing material to leak out. The lens-forining material can now be cured into the final lens implant and the wire can be removed from the eye witli for exainple a forceps.
To be noted is that the injection syringe not actually needs to be inserted all the way into the capsular bag. It is enough to inject the lens-forming material outside the rhexis in a direction towards the rhexis. Then the material will force itself through the sealing device and into the capsular bag. If a small ainount of the material would be left in the anterior charnber of the eye it will easily be flushed out by the rinsing liquid as used during the surgical procedure.
The liquid material can be a silicon material that will cure in ambient body tenlperature or that will cure through another curing mechanism by means of photosensitizers activated by light of a selected wavelength as further described in PCT/EP99/0778 1. When the lens-forming fluid has filled the capsular bag the sealing device 21 is pressed against the imler wall arotmd the rhexis of the capsular bag by the lens implant. If the sealing device 21 is adapted to be left in the capsular bag only the adjusting means 25 is removed. Otlierwise, the wllole sealing means 21 is removed. The plug part 23 could be deformed by an instrument operated from outside the eye such that it can be removed through the rliexis. The position and the SUBSTITUTE SHEET (RULE 26) size of the rhexis could be the same as described for the first embodiment but if the plug part is adapted to be left in tlie rhexis the rhexis preferably is positioned so as to include the optical axis. The rhexis is also preferably larger than one n1m in diameter and thus the plug part also has to be larger than in the fu' st einbodiment to 5 cover the whole rhexis. In fact the plug part preferably covers the whole path of light that is admitted by the pupil. In the case where the plug part 23 is left in the eye the plug part 23 material should also have essentially the same refractive index as the lens-forming material. When the sealing device 21 is left in the rhexis 30 the plug part 23 preferably is made of such a material and has such dimensions that it 10 follows the deformation of the capsular bag as described above. The plug part 23 in this embodiment preferably can be designed to further correct for refractive error in the eye. It can also be designed to correct for aberration defects of the optical surfaces of the eye, such as spherical aberration.
It is also possible to excise a larger part of the capsular bag wall than demonstrated in Fig. lb and thereby provide a larger opening of the capsular bag and use a larger sealing device that can extend over the whole visual field. A considerable possibility to provide visual correction that is complementary to what is possible from the injected lens is thereby provided.
Fig. 2 is a view from above of a sealing device 41 accord'uig to a second einbodiment of the invention. This second embodiment of the sealing device 41 principally follows the first embodiment of the sealing device. It comprises a plug part 43 and an adjusting means 45. The materials and the dimensions are the same and the use of the sealing device is also the same. The difference is that the plug part 43 is provided with a roughened surface 47 on the part of the surface contacting the inner wall of the capsular bag. The purpose of this roughened stuface 47 is to keep the sealing device 41 in the desired location covering the rhexis. The plug part 43 comprises also a cut 49 along a radius of the disc-shaped plug part 43. The purpose of the cut 49 is to make it easier for the injection syringe needle to come through the rhexis during the injection and to minimize the lealcage of the injected material through the rhexis during the injection. Preferably the plug part 43 also is provided with an overlapping part 51 under the cut 49. The puipose of the SUBSTITUTE SHEET (RULE 26) overlapping part 51 is to prevent the material from lealcing out through the cut. 49 after the needle has been removed. As explained above it is not necessary to insert the injection syringe needle all the way tluough the rhexis to insert the lens-forming material. However, the cut 49 also in this case simplifies the inj ection.
Fig. 3 is a view from above of a sealing device 61 according to a third embodiment of the invention. Also this third embodiment of the sealing device principally follows the first einbodiment of the sealing device. It comprises a plug part 63 and an adjusting means 65. The materials and the dimensions are the saine and the use of the sealing device is also the saine. The difference is that the plug part 63 comprises on the surface from wliich the adjusting means 65 protrudes an anteriorly protruding ring 67 with a slightly smaller diameter than the diameter of the rhexis. This ring 67 is adapted to fit into the rhexis when the plug part 63 has been located in the capsular bag so as to keep the sealing device 61 in the correct position sealing the rhexis from the inside of the capsular bag.
Fig. 4 is a side view of a sealing device 71 of any of the above mentioned kind inserted into a capsular bag 73 tluough a rhexis 75. The rhexis 75 is in this case located off the optical axis A of the eye. The rhexis 75 has here a dianleter of only about 1 mm and a plug part 77 of the sealing device 71 has thus a s1ig11tly larger diaineter. The sealing device 71 could in this case either be left in the capsular bag 73 since it is located off the optical axis and not will disturb the vision or be removed from the eye. The removing of the sealing device 71 is easier in this case when the sealing device is smaller.
Of course the different described features in all these embodiments can be coinbined in all possible ways.
SUBSTITUTE SHEET (RULE 26)
Background of the invention A technique for removing a catarcteous and/or presbyopic natural lens from the capsular bag of the eye and replacing it by a lens-forming liquid material injected directly into the capsular bag is under development.
The liquid material is a partially polymerized material, which can undergo a curing process in the eye and thereby form a solid lens implant. The lens implant acts as a substitute for the natural lens and aims to substantially restore the features of the natural lens of the young eye. Materials and methods suitable for injection and subsequent formation of an IOL (Intra Ocular Lens) are disclosed in the patent applications WO 00/22460, WO 00/22459 and WO 99/47185. The defect natural lens matrix can be removed by a conventional surgical method involving an ultrasound probe, such as a phacoemulsification method involving aspiration. In order to facilitate the removal of the lens matrix and the refilling witli lens fonning liquid material, a capsulotomy i.e. a capsulorhexis is prepared in the anterior wall of the capsular bag. The capsulorhexis is prepared from a circular or essentially circular capsultomy in the capsular bag wall, typically with a diameter of fioin about 0.5 to about 2.5 mm. An injection syringe needle is inseited through an incision in the eye and through the capsulorhexis into the capsular bag so the lens-forming liquid material can be injected into the capsular bag.
It has been identified as a problenl in capsular bag filling processes that during the injection and before the final lens is f.ormed liquid material can leak through the capsulorhexis. For this purpose a plug is proposed in the Japanese patent specification JP97-308946. Tliis plug is adapted to be attached to the SUBSTITUTE SHEET (RULE 26) injection syringe needle and inserted to the eye and positioned in the riglit position in the rhexis when the syringe needle is inserted. A problem with this plug is that it is clainped and/or glued in the rhexis. Since the plug is relatively large and adapted to stay in the rhexis permanent optical problems could arise. Furtherinore, it needs a relatively large opening in the eye to be implaiited. The plug comprises also a filling tube, which has to be cut off after filling. The tube could cause a leak. The size of tlie plug may also influence the free movement of the capsule that is needed for an even deformation of the capsule during accommodation. In the hzternational Patent Application published as WO 00/49976 (University of Miaini), a more siinple plug construction is suggested that attempts to act as a valve during the surgical process.
Also this plug suffers fiom the drawback that it perinanently locates parts of its structure outside the capsular bag after finalizing the surgery. The curved flexible member is permanently protruding from the capsular bag tlirough its hub like attaclunent point to the flexible discoid flap-valve mezilber. Consequently, the protruding parts may risk to compromise surrounding delicate eye tissues, including the iris, while they also risk generating unwanted optical side effects. It is therefore obvious that it is need for improvements in plug parts or sealing means for a capsulorhexis that has been introduced in a capsular filling process.
Description of the invention It is an object of the invention to provide a sealing device for a capsulorliexis of the capsular bag of the eye that effectively prevents a liquid inserted into the capsular bag to lealc out through the capsulorhexis.
It is also an object of the present invention to provide a sealing device for a capsulorhexis that leaves no permanent parts outside the capsular bag after the lens iinplantation process is finalized.
Another object is to provide a sealing device having means by which its location can be controlled after its insertion tluoughout the capsule filling process and lens forming process.
Still a fiu-ther object of the invention is to provide a sealing device for the capsular bag that can contribute to coinpensate for refractive errors and/or wavefront aberrations of the optical parts of the eye.
These objects are obtained with a sealing device having a plug part made of a deformable polymer that is capable of admitting the entrance of an injection SUBSTITUTE SHEET (RULE 26) ~
device for injecting a lens-forming liquid material tluough the capsulorhexis, while having slightly larger area than the capsulorhexis, so as to obtain a sealing effect from being pressed in a tight sealing position with the imler capsular bag from the pressure exerted by the injected liquid material. The sealing device fiu-ther comprises an anteriorly protruding removable adjusting means comiected to the plug part. By the adjustinent means, tlie plug part can be displaced exactly to the desired location by surgeon. It is an important characteristic of the preseiitly invented sealing device that it is free from any features protruding out from the capsular bag subsequent to the surgical process. This is due to that its adjustinent means is readily removable through surgical incision of the eye wllen the surgeon so decides. The highly simplified construction of the sealing device that leaves no perinanent parts outside capsular bag protruding out in posterior chainber of the eye resides from the finding that the fluid lens forining material is capable of exerting a sufficient pressure on the deforinable sealing device so it together with the capsular bag wall can act sufficiently sealing without the need of additional securing means.
Preferably, said plug part is essentially disc-shaped and suitably said plug part is adapted to be placed at the inside of the capsular bag, covering the whole capsulorhexis. It is suitable that the plug part has a somewhat larger diameter than the capsulorhexis to enable a safe sealing effect. A suitable plug diaineter is accordingly in the range of about 0.5 to about 2.5 mm. However, in certain embodiments described below the plug part can have a considerably larger extension. The plug part of the sealing device is adapted to permanently remain in the eye, but can alternatively, be removed after the lens forining process in the capsular bag is completed and the lens forining material is satisfyingly cLUed. In such case, the adjustment means are not removed, but employed to carefully loose the plug part and transfer it out of the eye.
The plug part is made of a suitable soft, flexible, biocompatible material that is sufficiently thin to follow the accormnodation movements of the capsular bag.
Normally that means that the plug part will have a thicluiess in the range of about 5 to 250 micrometers. In order to avoid any problems of material incoinpatibility, or eventually any optical side effects, it is preferable that the ph.ig part is made of a similar niaterial to the lens forining material. Preferably the plug part is made from a silicon material to comply with an injectable lens forming silicon material.
For the condition that the capsulorhexis is placed in the visual field, it is greatly preferable SUBSTITUTE SHEET (RULE 26) that the plug part is made of a material having essentially the saine refractive index as the material inserted in the capsular bag. This is important especially if the plug part is to be left in the capsular bag after that the lens-forining process is coinpleted.
Hereby, the sealing device does not affect the visual quality. Suitable silicone materials can be found ainong the terpolymers mentioned in PCT/EP99/07781 and PCT/EP99/07780, or the high refractive index silicones, for example, disclosed in US Patents Nos. 5,236,970 and 5,444,106, optionally without UV absorbers and other additives regarded unsuitable for the present teclulical application.
Also various medical grades of conventional polydimethylsiloxanes (PDMS) are suitable within certain einbodiments of the invention. The plug part can be prepared with conventional molding processes for silicones, which together with other suitable silicones tllan the aforementioned are well known to persons skilled in this teclniology.
The adjusting means typically is one or several thin flexible wire(s) that is non-permanently attached to the plug part. In a suitable embodiment, the thin wire penetrates the plug part from the anterior to the posterior side and then penetrates the plug part from the posterior to the anterior side. The distance between the two penetrating positions and their locations on the plug part are selected so that it can be comfortably ma.nipulated, either with a microforceps, or with other suitable means, also from outside of the eye. It is to be understood that the th.in wire can be of such a length that it protrudes out of the eye through the corneoscleral incision.
The wire is preferably made of less flexible material than the material of the plug part and the capsular bag and is attached to the plug part in a maiu-ier that is easily can be removed when the lens forining material is introduced, or when then lens forining process is finalized. Typically suitable materials for the wire are different brands of nylons that are well known in siugical processes and not discussed in further detail.
In one aspect of the invention, the plug part of the sealing device is provided with a contacting zneans that establishes an iinproved contact between the anterior surface of the plug part and the iiuier (posterior) wall of the capsular bag, so to prevent or hinder any displacements of the plug part from forces exerted on the capsular bag wall during the accommodation process. Further, substantial problezns to obtain a correct accommodation process may arise if the capsulorhexis to be sealed has a large extension, such as exceeding several millimeters. In order to SUBSTITUTE SHEET (RULE 26) ensure correct accoinmodation processes, the forces exerted on the capsular bag needs to be transmitted correctly without any dead zones incapable of participating in the process. Wlien a very soft lens material is employed which has sufficiently low elasticity modulus as to form accoininodating lens, this type of dead zones 5 and/or large plug part displacements during accommodation, may eventually cause that lens material does not correctly participate in the accommodation, or at worst will bulge out anteriorly witli uncontrollable consequences. To comply with any such unwanted effects, the plug part preferably is provided with contact means to improve the contact between the plug part and the capsular bag wall. Suitable contact means can be accomplished by providing plug part with an anterior surface that, at least partially, admits an enhanced friction to the inner wall of the capsular bag. As an example, this can be accomplished with the provision of a peripheral ring-shaped roughened anterior surface adapted to improve contact the iiuier wall of the capsular bag. Hereby, the contact between the sealing device and the inner wall of the capsular bag is improved. Friction enhancing processes and roughening processes are well lalown to silicon experts and are not elaborated on herein in any detail. Suitably, the whole area designated to contact the capsular bag inner wall is modified or treated accordingly which means that typically that about 5 to 50 % of the total surface is modified or treated.
In another aspect of the invention, the plug part of the sealing device has an anteriorly extending ring in the middle with a diaineter fitting into the capsulorhexis from below. The ring is adapted to stabilize the correct position of the sealing device.
According to a special embodiment, the plug part has a cut admitting passage of the lens-forining material. Hereby, the sealing device can be more easily retained in its position during the injection of lens forming material.
Suitably, the cut is provided with an overlapping part adapted to seal the cut when the injection is completed, in order to prevent from undesired leakage of injected lens-forming material through the cut.
The inventive sealing device can suitably be positioned in a capsulorhexis of about 1 min in diaineter positioned off the optical axis of the eye, i.e.
outside the normal visual field. Alternatively, the capsulorhexis includes the optical axis. In such case, it is of importance that the plug part is perfectly optically clear and that it does not contribute to any optical side effects. Preferably, the plug part is then made SUBSTITUTE SHEET (RULE 26) of a material that has the same or essentially the saine refractive index as the lens forming material.
In anotller embodiment of the invention, the sealing device is designed to have specific predetermined optical characteristics and to be used in the visual field of eye. The sealing device will then have such an extension that it extends over the whole, or substantially the wliole, visual field of the eye and can individually tailored for a patient to correct for optical deficiencies, including refractive errors or aberrations typically arriving from individual irregularities of the corneal surfaces.
In a surgical correction process, aiming to malce use of the optical characteristics of the sealing device, a larger part of the anterior capsular bag can be surgically excised, such as about 2 to 6 imn of the capsular bag surrounding the optical axis. A
sealing device having suitable extension to comply with an accordingly excised capsular bag can the be employed in a capsular bag lens filling process that admits visual correction of optical errors also from other parts of the eye, such as the corneal surfaces. The plug part of the sealing device can then be provided with a refractive power or with optical surfaces that can correct for aberrations, such as astigmatism and/or spherical aberration. Typically such a sealing device having lens power can be made in material having different refractive index tlian the injectable lens forming material and be provided with at least one surface deviating from perfect sphericity, i.e. being aspheric to reduce or eliminate aberrations.
The present invention also relates to a method of perfonning visual correction that involves the manufacturing of an intraocular lens inside the capsular bag of the eye. The method comprises the steps of:
- inserting a sealing device in a capsulorhexis, said plug part being adapted to cover the capsulorhexis from the inside of the capsular bag;
- adjusting the location of said sealing device with an adjusting means operable from the outside of the capsular bag;
- delivering a lens-forming material through the capsulorhexis into the capsular bag by using a delivering means and by displacing and/or deforming the plug part to adinit passage for the material;
- removing the delivering means out from the eye, whereby the plug part retains its sealing position, thereby preventing displacement of the lens-forming liquid material out fiom the capsular bag .
SUBSTITUTE SHEET (RULE 26) In one embodiment, the method coinprises removing the sealing device tluough the capsulorhexis wllen the lens-forming process is completed. Otlierwise, only the adjusting means is removed when the plug part has been positioned to seal capsulorhexis by the inserted lens-forining material in the capsular bag.
Suitably the method coinprises deforining the plug part so as to obtain a shape insertable through the capsulorhexis. Preferably the method comprises controlling the position of said plug part by means of the adjusting means.
In one embodiment the method coinprises inserting the lens-forming material to the capsular bag through a cut in the plug part and through the capsulorllexis.
The method can also coinprise a step where an agent that coLulteracts secondary cataract is introduced in the capsular bag before introducing the lens forming material. Such agents typically are typically introduced witli an injection syringe that can displace or deform the plug part sufficiently to insert a for injection needle in the capsular bag. The plug part provides a sufficiently sealed enviromnent that the injected agent is prevented from coming in contact witlz other ocular tissues than the iiuler wall of the capsular bag during the secondary cataract treatment.
Suitable agents are cytotoxic or antiproliferative agents that counteracts growth of epithelial cells that can coinpromise the transparency of the postsurgical capsular bag.
An exainple of such an agent is 5-fluorouracil, but munerous other agents are conceivable to the slcilled person. Alternatively an agent capable of blocking epithelial cell adhesiveness would be a useful such as the calcium chamiel blocker mibefradil.
In a special einbodiment the method furtller comprises zneasuring the error of refraction of the eye and designing the plug to fiu-ther compensate for error of refraction. In this embodiment, the method also can coinprise measuring one or several aberrations of the cornea by a corneal topographic method or with conducting a wavefront analysis of the aphalcic eye during the slugical process, for exainple witli a Hartmamz-Scalick sensor equipment, or the similar. The method can also involve estimations of the aberrations that will be generated in a wave front arriving from the lens to be formed in the capsular bag. Preferably, the results from these optical measurements can be employed to design the surface of the plug to coinpensate for the aberration of the eye, or alternatively to select a sealing device having plug part that will provide the best optical outcome for an individual, ainong SUBSTITUTE SHEET (RULE 26) a plurality of sealing devices in a kit with different refractive values and/or aberrations.
It is obvious that the present invention provides a highly advantageous sealing device for use in ophthalmic surgery that admits a high degree of versatility and readily can be adapted for numerous different surgical conditions due to its simplified construction and its adaptability to its ocular enviromnent. The following part aims to exemplify some specific einbodiments of sealing devices that aims to be illustrative, but not liiniting for the scope of invention.
Brief description of the drawings Fig. la is a schematic view from above of a sealing device according to a first embodiment of the invention.
Fig. lb is a side view of the sealing device in Fig. la inserted into a capsular bag.
Fig. 2 is a view from above of a second embodiment of the sealing device according to the invention.
Fig. 3 is a view from above of a third einbodiment of the sealing device according to the invention.
Fig. 4 is a side view of a sealing device according to the invention inserted into a capsular bag.
Detailed description of the embodiments Fig. 1 a is a schematic view from above of a sealing device 21 according to a first embodiment of the invention. The sealing device 21 comprises an essentially disc-shaped plug part 23 and an adjusting means 25. The plug part 23 is made of a defonnable polymer such as a silicon material. In this embodiment the adjusting ineans 25 is a nylon thread attached at its middle to the center of the plug part 23.
For exainple, the tbread can pass tluough two holes in the plug part 23 leaving the adjusting means 25 with two thread ends 26a and 26b pointing out from the plug part 23 on the same side. This thread 25 could of cotirse be attached to the plug part 23 in some other way and it can be made from anotller material than nylon. It is also possible to only attach one end of the thread to the plug part 23 leaving only one end pointing out from the plug part 23. The nylon thread used in this embodinlent has a suitable stiffiiess so it enables manipulation of the plug part. The material of the can have a refractive index compatible with the lens material ai.id it should SUBSTITUTE SHEET (RULE 26) follow the deformation of the capsular bag if the sealing inea.ns is adapted to be left in the rhexis.
Fig. lb is a side view of the sealing device 21 shown in Fig. la inserted into a capsular bag 28. The plug part 23 of the sealing device 21 is inserted inside the capsular bag and it is adapted to cover a rhexis 30 in the capsular bag from below.
The nylon threads 26a, 26b are extending anteriorly from the sealing device 21 and preferably they are long enough to protrude out of the eye. Thus, the sealing device 21 can be controlled and Icept in the desired location from outside the eye.
The sealing tlevice 21 is adapted to be inserted into the eye before the lens-forming liquid material is injected and after that the natural lens has been removed.
When the lens-forming material is injected, a delivering means, here an injection syringe is used. The injection syringe needle is inserted through the eye and through the capsulorhexis by sufficiently displacing and/or deforming the sealing device so the needle is admitted into the capsular bag. After the injection the syringe needle is removed out from the capsular bag and the eye and the presstu=e exerted by the fluid lens-forming material provides the sealing device to retain its original position and shape in front of the rhexis thus preventing the lens-forniing material to leak out. The lens-forining material can now be cured into the final lens implant and the wire can be removed from the eye witli for exainple a forceps.
To be noted is that the injection syringe not actually needs to be inserted all the way into the capsular bag. It is enough to inject the lens-forming material outside the rhexis in a direction towards the rhexis. Then the material will force itself through the sealing device and into the capsular bag. If a small ainount of the material would be left in the anterior charnber of the eye it will easily be flushed out by the rinsing liquid as used during the surgical procedure.
The liquid material can be a silicon material that will cure in ambient body tenlperature or that will cure through another curing mechanism by means of photosensitizers activated by light of a selected wavelength as further described in PCT/EP99/0778 1. When the lens-forming fluid has filled the capsular bag the sealing device 21 is pressed against the imler wall arotmd the rhexis of the capsular bag by the lens implant. If the sealing device 21 is adapted to be left in the capsular bag only the adjusting means 25 is removed. Otlierwise, the wllole sealing means 21 is removed. The plug part 23 could be deformed by an instrument operated from outside the eye such that it can be removed through the rliexis. The position and the SUBSTITUTE SHEET (RULE 26) size of the rhexis could be the same as described for the first embodiment but if the plug part is adapted to be left in tlie rhexis the rhexis preferably is positioned so as to include the optical axis. The rhexis is also preferably larger than one n1m in diameter and thus the plug part also has to be larger than in the fu' st einbodiment to 5 cover the whole rhexis. In fact the plug part preferably covers the whole path of light that is admitted by the pupil. In the case where the plug part 23 is left in the eye the plug part 23 material should also have essentially the same refractive index as the lens-forming material. When the sealing device 21 is left in the rhexis 30 the plug part 23 preferably is made of such a material and has such dimensions that it 10 follows the deformation of the capsular bag as described above. The plug part 23 in this embodiment preferably can be designed to further correct for refractive error in the eye. It can also be designed to correct for aberration defects of the optical surfaces of the eye, such as spherical aberration.
It is also possible to excise a larger part of the capsular bag wall than demonstrated in Fig. lb and thereby provide a larger opening of the capsular bag and use a larger sealing device that can extend over the whole visual field. A considerable possibility to provide visual correction that is complementary to what is possible from the injected lens is thereby provided.
Fig. 2 is a view from above of a sealing device 41 accord'uig to a second einbodiment of the invention. This second embodiment of the sealing device 41 principally follows the first embodiment of the sealing device. It comprises a plug part 43 and an adjusting means 45. The materials and the dimensions are the same and the use of the sealing device is also the same. The difference is that the plug part 43 is provided with a roughened surface 47 on the part of the surface contacting the inner wall of the capsular bag. The purpose of this roughened stuface 47 is to keep the sealing device 41 in the desired location covering the rhexis. The plug part 43 comprises also a cut 49 along a radius of the disc-shaped plug part 43. The purpose of the cut 49 is to make it easier for the injection syringe needle to come through the rhexis during the injection and to minimize the lealcage of the injected material through the rhexis during the injection. Preferably the plug part 43 also is provided with an overlapping part 51 under the cut 49. The puipose of the SUBSTITUTE SHEET (RULE 26) overlapping part 51 is to prevent the material from lealcing out through the cut. 49 after the needle has been removed. As explained above it is not necessary to insert the injection syringe needle all the way tluough the rhexis to insert the lens-forming material. However, the cut 49 also in this case simplifies the inj ection.
Fig. 3 is a view from above of a sealing device 61 according to a third embodiment of the invention. Also this third embodiment of the sealing device principally follows the first einbodiment of the sealing device. It comprises a plug part 63 and an adjusting means 65. The materials and the dimensions are the saine and the use of the sealing device is also the saine. The difference is that the plug part 63 comprises on the surface from wliich the adjusting means 65 protrudes an anteriorly protruding ring 67 with a slightly smaller diameter than the diameter of the rhexis. This ring 67 is adapted to fit into the rhexis when the plug part 63 has been located in the capsular bag so as to keep the sealing device 61 in the correct position sealing the rhexis from the inside of the capsular bag.
Fig. 4 is a side view of a sealing device 71 of any of the above mentioned kind inserted into a capsular bag 73 tluough a rhexis 75. The rhexis 75 is in this case located off the optical axis A of the eye. The rhexis 75 has here a dianleter of only about 1 mm and a plug part 77 of the sealing device 71 has thus a s1ig11tly larger diaineter. The sealing device 71 could in this case either be left in the capsular bag 73 since it is located off the optical axis and not will disturb the vision or be removed from the eye. The removing of the sealing device 71 is easier in this case when the sealing device is smaller.
Of course the different described features in all these embodiments can be coinbined in all possible ways.
SUBSTITUTE SHEET (RULE 26)
Claims (41)
1. A sealing device (21; 41; 61; 71) for use in ophthalmic surgery to replace a cataractous and/or presbyopic natural lens, comprising a flexible plug part (23; 43; 63; 77) adapted to seal a capsulorhexis (30; 75) of a capsular bag(28; 73), while admitting the entrance of injection device for injecting a lens-forming liquid material through the capsulorhexis (30;
75), said plug part (23;
43; 63; 77) having slightly larger area than the capsulorhexis(30; 75) and is made of a deformable polymer, wherein said sealing device (1; 21; 41; 61; 71) further comprises an anteriorly protruding removable adjusting means (25; 45; 65), connected to the plug part (23; 43;
63; 77) capable of positioning said plug part (23; 43; 63; 77) to a desired location.
75), said plug part (23;
43; 63; 77) having slightly larger area than the capsulorhexis(30; 75) and is made of a deformable polymer, wherein said sealing device (1; 21; 41; 61; 71) further comprises an anteriorly protruding removable adjusting means (25; 45; 65), connected to the plug part (23; 43;
63; 77) capable of positioning said plug part (23; 43; 63; 77) to a desired location.
2. A sealing device according to claim 1 characterized in that it is free from any parts protruding out from the capsular bag subsequent to the ophthalmic surgery.
3. A sealing device according to claim1, wherein said plug part(23; 43; 63;
77) is essentially disc-shaped.
77) is essentially disc-shaped.
4. A sealing device according to any one of claims 1 to 3, wherein said plug part (23; 43; 63; 77) is adapted to be placed at the inside of the capsular bag (28; 73), covering the whole capsulorhexis (30; 75).
5. A sealing device according to any one of claims 1 to 4, wherein said plug part (32; 43; 63; 77) being made of a suitable soft material and being thin enough for following the accommodation movements of the capsular bag.
6. A sealing device according to any one of claims 1 to 5, wherein said plug part (23; 43; 63; 77) is made of a silicon material.
7. A sealing device according to any one of claims 1 to 6, wherein said plug part (23; 43; 63) is made of a material having essentially the same refractive index as the material inserted in the capsular bag (73; 28).
8. A sealing device according to claim 1, wherein the plug part is provided with contacting means to capsular bag so as to ensure that a correct accommodating process is established.
9. A sealing device according to claim 8, wherein said contact means consists of a friction enhanced part of the anterior surface of the posterior plug.
10. A sealing device according to claim 9, having a roughened surface (47) on at least the surface contacting the inner wall of the capsular bag (73; 28).
11. A sealing device according to claim1, having an anteriorly extending ring (67) in the middle with a diameter fitting into the rhexis from below, the ring (67) being adapted to stabilize the position of the sealing device (61) in the rhexis.
12. A sealing device according to claim 1, wherein the removable adjusting means (25; 45; 65) is at least one flexible thread (25; 45) attached to the plug part (23; 43; 63).
13. A sealing device according to claim12, wherein the at least one thread (25; 45; 65) protrudes in an anterior direction from the plug part (23; 43; 63).
14. A sealing device according to claim13, wherein said at least one thread (25; 45; 65) is of such a length that it protrudes to outside the eye and can be manipulated from outside the eye.
15. A sealing device according to any one of claims 1 to 14, wherein the plug part (43) has a cut (49) admitting passage of the lens-forming material.
16. A sealing device according to claim 15, wherein the cut (49) is provided with an overlapping part(51) adapted to seal the cut (49) when the injection is completed.
17. A sealing device according to any one of claims 1 to 16, being adapted to be positioned in a rhexis (9; 75) of about 1 mm in diameter positioned off the optical axis of the eye.
18. A sealing device according to any one of the claims 1-17, being adapted to be positioned in a rhexis (30) of more than 1 mm in diameter positioned to include the optical axis of the eye.
19. A sealing device according to any one of claims 1 to 18, being adapted to remain in the capsular bag (28; 75) after the intraocular lens-forming process is completed.
20. A sealing device according to claim 18 or 19, wherein said plug part (23;
43) being optically clear.
43) being optically clear.
21. A sealing device according to claim 18, wherein said plug part (23; 43) covers the whole path of light that is admitted by the pupil.
22. A sealing device according to claim 21, being designed to compensate for aberration.
23. A sealing device according to any one of the claims 21 or 22, being designed to correct for error of refraction in the eye.
24. A sealing device according to any one of the claims 1-23, being adapted to be removed after the intraocular lens-forming process is completed.
25. Use of a sealing device (21; 41; 61; 71) for obtaining visual correction subsequent to surgically removing a natural lens of an eye, the sealing device having a plug part (23; 43; 63;
77) which can be inserted through a capsulorhexis (30; 75), said plug part (23; 43; 63; 77) being adapted to cover the capsulorhexis (30; 75) from the inside of the capsular bag (28; 73), the location of said plug part (23; 43; 63; 77) being adjustable with an adjusting means (25; 45; 65) operable from the outside of the capsular bag (28; 73); the plug part (23; 43;
63; 77) being displaceable and/or deformable to admit passage of a lens-forming material through the capsulorhexis (30; 75) into the capsular bag (28; 73) using a delivering means, wherein the plug part (23; 43; 63; 77) can retain its sealing position (30; 75) when the delivering means is removed from the eye to thereby prevent displacement of the lens-forming liquid material out from the capsular bag (28; 73).
77) which can be inserted through a capsulorhexis (30; 75), said plug part (23; 43; 63; 77) being adapted to cover the capsulorhexis (30; 75) from the inside of the capsular bag (28; 73), the location of said plug part (23; 43; 63; 77) being adjustable with an adjusting means (25; 45; 65) operable from the outside of the capsular bag (28; 73); the plug part (23; 43;
63; 77) being displaceable and/or deformable to admit passage of a lens-forming material through the capsulorhexis (30; 75) into the capsular bag (28; 73) using a delivering means, wherein the plug part (23; 43; 63; 77) can retain its sealing position (30; 75) when the delivering means is removed from the eye to thereby prevent displacement of the lens-forming liquid material out from the capsular bag (28; 73).
26. A use according to claim 25, wherein the sealing device (21; 41; 61; 71) can be removed through the capsulorhexis (30 ; 75) when the lens forming process is completed.
27. A use according to claim 25, wherein the plug part can seal the capsulorhexis (30; 75) by the influence of the lens-forming material in the capsular bag (7; 28; 73) so that the adjusting means (45; 65) can be removed.
28. A use according to any one of claims 25 to 27, wherein the adjusting means (25 ; 45; 65) can control the position of said plug part (23; 43; 63; 77).
29. A use according to any one of claims 25 to 28, wherein the plug part (43) can have a cut through which the lens-forming material can be delivered to the capsular bag (28) through the capsulorhexis (30).
30. A use according to any one of claims 25 to 29, wherein the plug part can at least partially compensate for an error of refraction of the eye.
31. A use according to any one of claims 25 to 30, wherein the plug part has at least one surface that is capable of compensating for at least one aberration wavefront arriving from the cornea of the eye.
32. A use according to any one of claims 25 to31, wherein the plug part together with said implanted lens can compensate for at least one aberration of the lens to be formed in the capsular bag.
33. A use according to claim 25, wherein the sealing device comprises an agent capable of counteracting the formation of a secondary cataract by epithelial cell growth on the capsular bag inner wall.
34. Use of a sealing device for visual correction in a patient by replacing a natural lens with a lens implant, wherein the sealing device comprises a flexible plug part and a removable adjusting means of a size sufficient to cover an excised area of the anterior capsular bag of the eye, with said adjusting means to a position where a peripheral anterior surface of said plug part contacts the inner (posterior) wall so as to sufficiently cover said excised area, the excised area having a sufficient size to surgically remove the natural lens, said plug part being capable of being temporarily displaced and/or deformed to deliver a lens filling material into the capsular bag by using a delivering means, said lens forming material being deliverable into the capsular bag to an extent that said material exerts a sufficient pressure on the posterior side of the plug part to seal the excised area so said lens material is prevented from being displaced from the capsular bag to the posterior chamber of the eye.
35. A use according to claim 34, wherein said excised area is intersected by the optical axis.
36. A use according to claim 35, wherein said excised area has a largest diameter that essentially extends over the visual field.
37. A use according to claim 34, wherein the adjustment means of the sealing device is removable from the eye after completing the introduction of lens forming material into the capsular bag.
38. A use according to claim 34, wherein the adjustment means of the sealing device is removable from the eye upon finalizing the lens forming process.
39. A use according to claim 34, wherein the sealing device comprises an agent capable of counteracting the formation of a secondary cataract by epithelial cell growth on the capsular bag inner wall.
40. A use according to claim 34, wherein the plug part has at least one surface that is capable of compensating for at least one aberration of a wavefront arriving from the cornea.
41. A use according to claim 40, wherein the plug part together with said implanted lens can compensate for at least on aberration of the lens to be formed in the capsular bag.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE0004393A SE0004393D0 (en) | 2000-11-29 | 2000-11-29 | A device for use in eye surgery |
| SE0004393-5 | 2000-12-29 | ||
| PCT/EP2001/013746 WO2002043630A2 (en) | 2000-11-29 | 2001-11-23 | A device for use in eye surgery |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2422763A1 CA2422763A1 (en) | 2002-06-06 |
| CA2422763C true CA2422763C (en) | 2009-11-03 |
Family
ID=20282022
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002422763A Expired - Fee Related CA2422763C (en) | 2000-11-29 | 2001-11-23 | A device for use in eye surgery |
Country Status (11)
| Country | Link |
|---|---|
| US (3) | US7182780B2 (en) |
| EP (1) | EP1337209B1 (en) |
| JP (1) | JP3992617B2 (en) |
| CN (1) | CN1216587C (en) |
| AT (1) | ATE419816T1 (en) |
| AU (2) | AU1705802A (en) |
| CA (1) | CA2422763C (en) |
| DE (1) | DE60137354D1 (en) |
| SE (1) | SE0004393D0 (en) |
| WO (1) | WO2002043630A2 (en) |
| ZA (1) | ZA200302001B (en) |
Families Citing this family (54)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060238702A1 (en) | 1999-04-30 | 2006-10-26 | Advanced Medical Optics, Inc. | Ophthalmic lens combinations |
| US7763069B2 (en) | 2002-01-14 | 2010-07-27 | Abbott Medical Optics Inc. | Accommodating intraocular lens with outer support structure |
| SE0201479D0 (en) | 2002-05-16 | 2002-05-16 | Pharmacia Groningen Bv | Kit and method in eye surgery |
| US7001426B2 (en) * | 2002-11-18 | 2006-02-21 | The Institute For Eye Research | One-piece minicapsulorhexis valve |
| US7662180B2 (en) | 2002-12-05 | 2010-02-16 | Abbott Medical Optics Inc. | Accommodating intraocular lens and method of manufacture thereof |
| US7905917B2 (en) * | 2003-03-31 | 2011-03-15 | Bausch & Lomb Incorporated | Aspheric lenses and lens family |
| WO2004090611A2 (en) * | 2003-03-31 | 2004-10-21 | Bausch & Lomb Incorporated | Intraocular lens and method for reducing aberrations in an ocular system |
| US7556378B1 (en) | 2003-04-10 | 2009-07-07 | Tsontcho Ianchulev | Intraoperative estimation of intraocular lens power |
| US20050131535A1 (en) | 2003-12-15 | 2005-06-16 | Randall Woods | Intraocular lens implant having posterior bendable optic |
| CA2561388C (en) | 2004-04-20 | 2017-10-10 | Wavetec Vision Systems, Inc. | Integrated surgical microscope and wavefront sensor |
| US8409278B2 (en) * | 2005-10-27 | 2013-04-02 | Gholam A. Peyman | External lens with flexible membranes for automatic correction of the refractive errors of a person |
| US9681800B2 (en) | 2005-10-27 | 2017-06-20 | The Arizona Board Of Regents On Behalf Of The University Of Arizona | Holographic adaptive see-through phoropter |
| US9671607B2 (en) | 2005-10-27 | 2017-06-06 | Gholam A. Peyman | Flexible fluidic mirror and hybrid system |
| US9016860B2 (en) | 2005-10-27 | 2015-04-28 | Gholam A. Peyman | Fluidic adaptive optic fundus camera |
| US9191568B2 (en) | 2005-10-27 | 2015-11-17 | Gholam A. Peyman | Automated camera system with one or more fluidic lenses |
| US20080161914A1 (en) | 2006-12-29 | 2008-07-03 | Advanced Medical Optics, Inc. | Pre-stressed haptic for accommodating intraocular lens |
| FR2913435B1 (en) * | 2007-03-07 | 2009-12-04 | Schonherr Textilmaschb Gmbh | A WEAVING COMB, A WEAVING WORK COMPRISING SUCH A COMB AND METHOD OF MANUFACTURING SUCH A COMB. |
| WO2008118938A1 (en) * | 2007-03-26 | 2008-10-02 | Theta Research Consultants, Llc | Method and apparatus for ophthalmic medication delivery and ocular wound recovery |
| US7594729B2 (en) | 2007-10-31 | 2009-09-29 | Wf Systems, Llc | Wavefront sensor |
| US8034108B2 (en) | 2008-03-28 | 2011-10-11 | Abbott Medical Optics Inc. | Intraocular lens having a haptic that includes a cap |
| US9125735B2 (en) * | 2008-04-04 | 2015-09-08 | Forsight Labs, Llc | Method of correcting vision using corneal onlays |
| US9943401B2 (en) | 2008-04-04 | 2018-04-17 | Eugene de Juan, Jr. | Therapeutic device for pain management and vision |
| US20100079723A1 (en) * | 2008-10-01 | 2010-04-01 | Kingston Amanda C | Toric Ophthalimc Lenses Having Selected Spherical Aberration Characteristics |
| WO2010054268A2 (en) | 2008-11-06 | 2010-05-14 | Wavetec Vision Systems, Inc. | Optical angular measurement system for ophthalmic applications and method for positioning of a toric intraocular lens with increased accuracy |
| AU2010266022B2 (en) | 2009-06-26 | 2015-04-23 | Johnson & Johnson Surgical Vision, Inc. | Accommodating intraocular lenses |
| US8876290B2 (en) | 2009-07-06 | 2014-11-04 | Wavetec Vision Systems, Inc. | Objective quality metric for ocular wavefront measurements |
| WO2011008606A1 (en) | 2009-07-14 | 2011-01-20 | Wavetec Vision Systems, Inc. | Determination of the effective lens position of an intraocular lens using aphakic refractive power |
| WO2011008609A1 (en) | 2009-07-14 | 2011-01-20 | Wavetec Vision Systems, Inc. | Ophthalmic surgery measurement system |
| US20110029074A1 (en) * | 2009-08-03 | 2011-02-03 | Abbott Medical Optics Inc. | Fixation of ophthalmic implants |
| WO2011017322A1 (en) | 2009-08-03 | 2011-02-10 | Abbott Medical Optics Inc. | Intraocular lens for providing accomodative vision |
| WO2011031557A1 (en) | 2009-08-27 | 2011-03-17 | Abbott Medical Optics Inc. | Fixation of opthalmic implants |
| WO2011050365A1 (en) | 2009-10-23 | 2011-04-28 | Forsight Labs, Llc | Conformable therapeutic shield for vision and pain |
| ES2649890T3 (en) | 2009-10-23 | 2018-01-16 | Nexisvision, Inc. | Corneal enervation for the treatment of eye pain |
| CA2786440C (en) | 2010-01-11 | 2018-02-27 | Abbott Medical Optics Inc. | Fixation of accommodating intraocular lenses |
| US10278810B2 (en) | 2010-04-29 | 2019-05-07 | Ojo, Llc | Injectable physiologically adaptive intraocular lenses (IOL's) |
| JP2013532519A (en) * | 2010-07-20 | 2013-08-19 | ザ・ジョンズ・ホプキンス・ユニバーシティ | Motion compensated surgical instrument system and surgical instrument |
| EP2422747B1 (en) * | 2010-08-26 | 2019-04-10 | Stevens, Julian Douglas | Intraocular implant |
| EP2672926B1 (en) | 2011-03-21 | 2017-05-31 | Adventus Technology, Inc. | Restoration of accommodation by lens refilling |
| WO2014210186A2 (en) | 2013-06-26 | 2014-12-31 | Nexisvision, Inc. | Contact lenses for refractive correction |
| US10606066B2 (en) | 2011-06-21 | 2020-03-31 | Gholam A. Peyman | Fluidic light field camera |
| US11372230B2 (en) | 2011-06-21 | 2022-06-28 | Gholam A. Peyman | System for preventing motion sickness resulting from virtual reality or augmented reality |
| WO2013011511A1 (en) | 2011-07-18 | 2013-01-24 | Mor Research Applications Ltd. | A device for adjusting the intraocular pressure |
| RU2495652C1 (en) * | 2012-03-14 | 2013-10-20 | Федеральное государственное бюджетное учреждение "Межотраслевой научно-технический комплекс "Микрохирургия глаза" имени академика С.Н. Федорова" Министерства здравоохранения и социального развития Российской Федерации | Method for determining optimal diameter of graduated opening of posterior capsule |
| US9782291B2 (en) | 2012-06-08 | 2017-10-10 | Julian Douglas STEVENS | Intraocular implant and method for fixing same into an eye |
| US9681981B2 (en) | 2012-06-08 | 2017-06-20 | Julian Douglas STEVENS | Intraocular implant and method for fixing same into an eye |
| US9072462B2 (en) | 2012-09-27 | 2015-07-07 | Wavetec Vision Systems, Inc. | Geometric optical power measurement device |
| US11109957B2 (en) | 2014-09-22 | 2021-09-07 | Onpoint Vision, Inc. | Intraocular pseudophakic contact lens with mechanism for securing by anterior leaflet of capsular wall and related system and method |
| US11938018B2 (en) | 2014-09-22 | 2024-03-26 | Onpoint Vision, Inc. | Intraocular pseudophakic contact lens (IOPCL) for treating age-related macular degeneration (AMD) or other eye disorders |
| US10945832B2 (en) | 2014-09-22 | 2021-03-16 | Onpoint Vision, Inc. | Intraocular pseudophakic contact lens with mechanism for securing by anterior leaflet of capsular wall and related system and method |
| US10159562B2 (en) | 2014-09-22 | 2018-12-25 | Kevin J. Cady | Intraocular pseudophakic contact lenses and related systems and methods |
| US10299910B2 (en) | 2014-09-22 | 2019-05-28 | Kevin J. Cady | Intraocular pseudophakic contact lens with mechanism for securing by anterior leaflet of capsular wall and related system and method |
| US10709551B2 (en) | 2014-12-27 | 2020-07-14 | Jitander Dudee | Accommodating intraocular lens assembly |
| EP3681438A1 (en) | 2017-09-11 | 2020-07-22 | AMO Groningen B.V. | Methods and apparatuses to increase intraocular lenses positional stability |
| CN113101046B (en) * | 2018-11-12 | 2023-06-23 | 长春爱尔眼科医院有限公司 | Anterior capsulotomy guiding device for cataract surgery |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3302646A (en) * | 1964-01-10 | 1967-02-07 | Charles A Behney | Apparatus for treating eye infection |
| US4439198A (en) * | 1981-07-09 | 1984-03-27 | University Of Illinois Foundation | Biodegradable ocular insert for controlled delivery of ophthalmic medication |
| US4608050A (en) | 1983-07-21 | 1986-08-26 | Innovative Surgical Products, Inc. | Correction of defects in the eye and compositions therefor |
| US5236970A (en) | 1987-02-05 | 1993-08-17 | Allergan, Inc. | Optically clear reinforced silicone elastomers of high optical refractive index and improved mechanical properties for use in intraocular lenses |
| US4782820A (en) | 1987-10-22 | 1988-11-08 | Woods Randall L | Iris retaining device |
| JP3086263B2 (en) | 1990-12-25 | 2000-09-11 | 株式会社メニコン | Intraocular lens forming body |
| US5444106A (en) | 1992-04-21 | 1995-08-22 | Kabi Pharmacia Ophthalmics, Inc. | High refractive index silicone compositions |
| US5487394A (en) * | 1994-07-22 | 1996-01-30 | The Board Of Regents Of The University Of Texas System | Tungsten eye shields for electron beam treatment |
| JPH09308946A (en) | 1996-05-21 | 1997-12-02 | Sumitomo Metal Ind Ltd | Horizontal continuous casting mold |
| US5843184A (en) | 1998-01-26 | 1998-12-01 | Cionni; Robert J. | Endocapsular tension ring and method of implanting same |
| SE9800853D0 (en) | 1998-03-16 | 1998-03-16 | Pharmacia & Upjohn Bv | Intraocular lens |
| SE9803481D0 (en) | 1998-10-13 | 1998-10-13 | Pharmacia & Upjohn Ab | Photocurable siloxane polymers |
| CZ20011290A3 (en) | 1998-10-13 | 2001-11-14 | Pharmacia Groningen Bv | Injectable intraocular lenses |
| SE9900632D0 (en) | 1999-02-19 | 1999-02-19 | Juerg Schiffmann | Rotary piston machine |
| AU761684B2 (en) | 1999-02-22 | 2003-06-05 | University Of Miami | Minicapsulorhexis valve |
| US6413276B1 (en) * | 2000-04-26 | 2002-07-02 | Emmetropia, Inc. | Modified intraocular lens and method of correcting optical aberrations therein |
-
2000
- 2000-11-29 SE SE0004393A patent/SE0004393D0/en unknown
-
2001
- 2001-11-23 CN CN01817277.6A patent/CN1216587C/en not_active Expired - Fee Related
- 2001-11-23 EP EP01998288A patent/EP1337209B1/en not_active Expired - Lifetime
- 2001-11-23 AT AT01998288T patent/ATE419816T1/en not_active IP Right Cessation
- 2001-11-23 ZA ZA200302001A patent/ZA200302001B/en unknown
- 2001-11-23 WO PCT/EP2001/013746 patent/WO2002043630A2/en active Application Filing
- 2001-11-23 AU AU1705802A patent/AU1705802A/en active Pending
- 2001-11-23 AU AU2002217058A patent/AU2002217058B2/en not_active Ceased
- 2001-11-23 CA CA002422763A patent/CA2422763C/en not_active Expired - Fee Related
- 2001-11-23 DE DE60137354T patent/DE60137354D1/en not_active Expired - Lifetime
- 2001-11-23 JP JP2002545611A patent/JP3992617B2/en not_active Expired - Fee Related
- 2001-11-28 US US09/996,290 patent/US7182780B2/en not_active Expired - Lifetime
-
2005
- 2005-11-04 US US11/267,452 patent/US8303654B2/en not_active Expired - Fee Related
-
2012
- 2012-11-05 US US13/669,084 patent/US8945213B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1216587C (en) | 2005-08-31 |
| US8303654B2 (en) | 2012-11-06 |
| US8945213B2 (en) | 2015-02-03 |
| EP1337209A2 (en) | 2003-08-27 |
| US20130066363A1 (en) | 2013-03-14 |
| US20020107567A1 (en) | 2002-08-08 |
| ATE419816T1 (en) | 2009-01-15 |
| SE0004393D0 (en) | 2000-11-29 |
| CN1469728A (en) | 2004-01-21 |
| ZA200302001B (en) | 2004-03-12 |
| AU2002217058B2 (en) | 2006-06-01 |
| CA2422763A1 (en) | 2002-06-06 |
| DE60137354D1 (en) | 2009-02-26 |
| AU1705802A (en) | 2002-06-11 |
| JP3992617B2 (en) | 2007-10-17 |
| WO2002043630A2 (en) | 2002-06-06 |
| JP2004514501A (en) | 2004-05-20 |
| US20060058812A1 (en) | 2006-03-16 |
| WO2002043630A3 (en) | 2002-10-31 |
| US7182780B2 (en) | 2007-02-27 |
| EP1337209B1 (en) | 2009-01-07 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2422763C (en) | A device for use in eye surgery | |
| AU2002217058A1 (en) | A device for use in eye surgery | |
| CA2371844C (en) | Minicapsulorhexis valve | |
| AU2012259464B2 (en) | Accommodating intraocular lens | |
| CA1217001A (en) | Intraocular posterior chamber lens | |
| US20110029074A1 (en) | Fixation of ophthalmic implants | |
| US20060116761A1 (en) | One-piece minicapsulorhexis valve | |
| Hara et al. | Complications associated with endocapsular balloon implantation in rabbit eyes | |
| CA2786440A1 (en) | Fixation of accommodating intraocular lenses | |
| US7811267B2 (en) | Kit and method in eye surgery | |
| JP3940295B2 (en) | Auxiliary intracapsular lens | |
| Parel et al. | Intraocular implants for the surgical correction of presbyopia |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20141124 |