Method of refractive eye surgery and device for implantation of the intraocular refractive lens

 

The invention relates to medicine, namely to ophthalmology. Method of refractive eye surgery involves an incision of the cornea, fixation and implantation of refractive lenses working tool. After incision of the cornea, anterior chamber is filled with viscoelastic low molecular weight and implanted refractive lens using a cannula provided with a source of vacuum. To fix this refractive lens work end of the cannula in the middle between the edge of the lens and the boundary of the optical part with the bend edges on the end of the cannula. Then top bend impose refractive lens in the incision of the cornea and install it in the rear chamber of the eye, then when removing the vacuum disconnect the cannula from the refractive lens and the reverse movement of the cannula is removed from the anterior chamber of the eye. The invention allows reducing the injury to the eye tissue in the surgical field, to speed up the operation and to improve its quality. 2 AD. and 1 C.p. f-crystals, 2 tab., 5 Il.

The invention relates to medicine, ophthalmology, and can be used for eye operations for implantation of the intraocular refractive lens in Peru the 2200517, publ. 20.03.2003,, class a 61 F 9/00). Pneumophila contains a rubber pneumovirus and conical suction Cup to hold the contact lenses. In the cone sucker has rod to limit the “suction” of the lens surface. Compression pneumovirus fingers or vacuum is created to attach to the suction Cup mount lenses, or pressure repulsive it after installation on the cornea.

However, for refractive surgery requires a more delicate, petite and precise dimensions, allowing you to work in a confined space, in the anterior chamber of the eye, where the average depth of 3 mm and a slight movement can cause irreversible and dangerous complications of the crystalline lens and corneal endothelium.

Also known device injector PRL (Ciba Vision Surgical, Dulith, USA), inside the cartridge is folded lens and method of ejection is implanted in the anterior chamber of the eye. The main disadvantage of the injector is that inside the cartridge lens can turn upside down and can be installed in the wrong position, thereby violating the concept of placing the lens is the distance from the anterior lens capsule, stick to it, cause disorders of the metabolism of the lens with further eustacia phakic posterior chamber intraocular lens (PRL, Ciba Vision) for the correction of ametropy. D. D. Dement'ev, E. Sixth Century, T. L. Fedaykin. Moscow scientific research ophthalmic center “New look”, Moscow, Russia).

The known method and device for episcleral sealing of the retina (RF patent No. 2197208, publ. 27.01.2003,, class a 61 F 9/007). The device contains a springing branches, work items which form the cylinder, through which the filling material is extruded by the piston in the retina. The piston is installed in the branches, provided with a limiter of its movement. The device provides reliable grip filling material, reduces the time of surgery, reduces tissue injuries of the eyeball.

However, for the introduction of intraocular refractive lens requires fixing it working tool, which also have formed through the corneal incision tunnel, while maintaining the integrity of the intraocular refractive lens and without damaging the surrounding tissue.

So the closest technical solution can be considered a method and a device for the implantation of intraocular lenses described in the patent of the Russian Federation (RF patent No. 2189803, class a 61 F 9/007), which is a prototype for the proposed method and device.

Known Ustronie material, is wedge-shaped at the distal end to the nearest needle with thread that secures the lens. A work element connected to the handle for promotion. The method, implemented with the use of this device, includes incision of the cornea in the form of sclerocorneal tunnel 3, 5, 4 mm, followed by the rear camera work item, injected a needle with thread No. 9 or No. 10 from non-absorbable monofilament material - Proline. After the maximum vcol needle in a work item of the device together with needle and thread is extracted from the cavity of the eyeball.

Thread connected with intra-ocular lens, which by pulling the threads are implanted in iridociliary furrow, fixed by pulling the thread from the sclera and tie beneath the flap of sclera. Known technical solution allows to reduce injuries and procedures to accelerate the implantation operation.

It is also known device used in eye operations for implantation PRL - tweezers-Dementieva, the work item which is made in the form of two branches with work surfaces, facing each other, which fix the lens for haptic without touching the optical part. The tweezers is equipped with a handle for reciprocating the damage to the optical lens part PRL implantation. However, this pattern can lead to dangerous complications minor errors surgeon: this is an injury of the anterior lens capsule and the corneal endothelium. During the reverse movement of the tweezers possible loss of PRL.

The technical challenge which sent a group of inventions is to reduce injury to the eye tissue in the surgical field, acceleration and improvement of the quality of the operation.

The technical problem solved by the fact that in a method that includes incision of the cornea, fixation and implantation of refractive lenses working tool according to the invention, expanding the pupil by mediatique, after anesthesia, an incision of the cornea (Clear cornea - 3 mm), after which the anterior chamber is filled with viscoelastic low molecular weight and implanted refractive lens using a cannula provided with a source of vacuum 40-60 mm RT.art., to fix this refractive lens work end of the cannula in the middle between the edge of the lens and the boundary of the optical part with the bend edges on the end of the cannula, then the top bend impose refractive lens in the incision of the cornea and install it in the rear chamber of the eye, then when removing the vacuum disconnect the cannula from the refractive lens of Antichi refractive lens, containing the work item for capturing and holding through an incision of the cornea into the anterior chamber of the eye refractive lens and the handle according to the invention the work item is executed in the form of a cannula, which is a tube bent at an angle 120-130°, oval, enhanced after bending section, a funnel-shaped working end of which a length of 0.4-0.6 mm has a cross-section of an ellipse with minor and major axes of 0.8-0.9 mm and 1.8-2 mm, respectively, while the cannula is made of a biologically inert material with the characteristic tensile strength of not less than 27 MPa, and a funnel-shaped working end of the cannula along its edge and the inner surface lined with a polymeric material with a characteristic tensile strength of 2.9 to 3 MPa, and the handle to move the cannula is made in the form of a vacuum syringe connected socket with the cannula.

In addition, the cannula is made from a material - high density polyethylene HDPE or stainless steel, and the lining material of the working end of the cannula - polyurethanemetacrylate.

The technical result obtained with the implementation of the method and of the device is as follows:

- implantable intraocular refractive lens is not subjected to mechanical clamp magistratures refractive lens inside the cartridge and consequently improper installation;

- decreases the possibility of injury as implantable intraocular refractive lens and surrounding tissues of the eye;

- operation time is reduced compared to other methods because implantation occurs in one movement;

the simplicity of the method allows to master the operation of a wide range of ophthalmic surgeons;

- unification arm device with a vacuum syringe makes the device compact and convenient to the hand of the surgeon;

- the proposed device is inexpensive and disposable, which eliminates the need for sterilization, and the threat of infection of the patient is reduced.

When compared to the prototype revealed that the claimed method differs fixation of the lenses using a vacuum the size 40-60 mm RT.art., performing the bending edge of the lens and use it in the promotion of the lens through the tunnel to the moment of placement of the lens and the end surface of the lens with the end of the cannula upon removal of the vacuum. The claimed device is design work item, the characteristics of the material of the cannula and sizes, as well as the implementation arm for movement in the form of a vacuum syringe.

The essence of the invention is as follows.

Fixing the lens to the end of the cannula is at maximum size, selected experimentally. We tested different forms of the working end of the cannula. So, for example, tested construction: plastic tube, reinforced by a stainless steel tube with a soft work end cylindrical or oval.

Experimentally it was found that to maintain the curved shape of the tube of the cannula and the strength of the structure during operation of sufficient strength characteristics of low pressure polyethylene brand HDPE. This brand material was selected from the same polymeric materials, such as collagen, polymethylmethacrylate (PMMA), the hydrogels. It features: tear strength of 40 MPa, a tensile strength of 27 MPa, modulus of elasticity in bending 550-700 MPa. When testing devices and methods of implantation of the intraocular refractive lens with equivalent results were used cannula made of stainless steel. However, it was determined that the working face must be formed in the form of a hollow spatula, tapered funnel with a hole sufficient to suction lenses by vacuum, and the outer surface without injuring the bend of the lens during its promotion. Was chosen as the material for the working end - polyurethanemetacrylate with strength when R is heometrycheskye dimensions experimentally selected in accordance with the size of incision and implanted lenses. In the device there are no mechanisms that would move inside the eye. To detach the intraocular refractive lens from the cannula does not require any manipulation in the anterior chamber of the eye. A smooth surface of the cannula eliminates the risk of tissue damage during the reverse movement of the tool. After implantation there is no contact of the cannula with the eye tissues, and also completely eliminates the contact of the cannula with the front surface of the lens capsule. Since the movement of the cannula is parallel to the lens and has a limiter after bending of the cannula, which limits the stroke of the cannula into the chamber of the eye during implantation of the lens, the possibility of subluxation of the crystalline lens. When passing through an incision in the cornea cannula his body does not allow emptied the anterior chamber of the eye that allows you to keep the anterior chamber of the eye in working condition. Completely eliminated the threat of turning the lens as the lens is in a fixed position. Possible visual control of the lens during the operation. Excluded the possibility of unwanted re lenses during the reverse movement of the cannula. The device is inexpensive and disposable, which eliminates the need for sterilization, and Hugo compact and convenient to the hand of the surgeon.

Our proposed method reduces the time of surgical intervention and avoids complications due to the fact that the working tool is fixed to the lens so that the cannula wrapped inside the lens and completely eliminated any possible contact with the anterior lens capsule and the corneal endothelium. The simplicity of the method allows to master the operation of a wide range of ophthalmic surgeons.

Method of refractive eye surgery, implantation of the intraocular refractive lens according to the invention is as follows. After local anesthesia, an incision of the cornea width of 3 mm with pre-medication Mediacom. After that, the anterior chamber is filled with viscoelastic low molecular weight and implanted intraocular refractive lens using a cannula provided with a vacuum 40-60 mm RT.art., fixed lens funnel work end in the middle, between the edge of the lens and the boundary of the optical part, with the bend edges on the end of the cannula, then the top bend insert the lens into the corneal incision and install it in the anterior chamber of the eye, then when removing the vacuum disconnect the cannula from the intraocular refractive lens and remove the cannula from the anterior chamber.

Conditions of fixation of intraocular refractive lens cannula should be such that the location of fixation must be exactly in the middle of haptic from its edges, the lens should be turned to the edge of the cannula, so that during the passage of the tunnel resistance promote increased contact between the lens and the cannula. Were tested samples of lenses - see table. 2.

On these models was carried out test series-suction cannula vacuum at different points. Several experiments at 30 mm RT.article showed that the cutting cannula or suction of the surface significantly. When a vacuum of 70 mm RT.article observed tipanie of the lens surface from the end of the cannula when it is moving. Thus, 40-60 mm RT.article optimally.

Experiments with prints end of the cannula on the surface of the lens, were selected as the optimal size of the flattened end of the cannula in the form of an oval. The selected combination of strength cannula (so it was not twisted and not bent”), dimensions of the channel, is with the cannula tested in a vacuum 40-60 mm RT.article The cavity before the piston was connected to a pressure sensor-vacuum were selected limiter-release movement of the piston in order that the construction and operation of the vacuum syringe provided the surgeon reliability of all parameters.

Were in ophthalmic clinic MNII “New look”. Here is clinical example: Patient M, 32, was admitted to the hospital with a diagnosis of Myopia of a high degree OU, anisometropia, OD sph. -13,75=cyl. - 2.5 ax 180. OS sph. -5,0=cyl. - 1.5 ax 180. 07.07.2003, produced by LASIK eye surgery on the left eye. 14.07.2003, the operation on the right eye - implantation of intraocular refractive lens.

Progress: Medication extended pupil. Under local anesthesia produced by an incision of the cornea 12 hours a size of 3 mm In front of the camera entered viscoelastic low molecular weight. With the help of vacuum intraocular refractive lens fixed to the end of the cannula. Using the cannula lens implanted in the anterior chamber of the eye, then the vacuum is disconnected and the cannula is removed from the anterior chamber, the reverse movement. With a spatula, haptica lens vpravlyaetsya under the iris. The front chamber is flushed with saline. In front of the camera enter constricting the pupil medication (miochol) Eomw injected BSS solution for seamless adaptation of the wound edges. In conductively bag Kapitsa antibiotic solution. Aseptic blindfold.

The next day after the operation, the eye is calm, the cornea is transparent, moisture anterior chamber clean, the pupil responds vividly to light, contact with the front surface of the lens no, fundus reflex rose. Refraction was OD sph. -0,75=cyl. -1.5 ax 180. Thus the result in 13,00 diopters.

The invention is illustrated in Fig.1, which shows a General view of the device, and Fig.2-3, where the given section and sections. Fig.4 - syringe, Fig.5 - lens. The cannula 1 is equipped with limiter 2 after bending and has a working funnel-shaped end 3 oval section 4 faced material - polyurethanemetacrylate. Cannula, made of tube with a diameter of 0.6-0.9 mm, bent at an angle 120-130°. The socket 5, the cannula is connected to the housing 6 of the vacuum syringe. Inside the housing 6 (Fig.5) of the syringe has a piston 7, the movement of which is restricted by the stopper 8 in the form of a bayonet. The piston has a rod 9 with the button and the housing 6 to the flange 10 for ease of holding in the fingers. As the vacuum source can be used as the delivery connected through a hollow handle with a socket cannula. In Fig.4 given the drawing of a vacuum syringe.

The device is trackware refractive lens in the anterior chamber of the eye (Fig.5).

Claims

1. Method of refractive eye surgery, including corneal incision, fixation and implantation of refractive lenses working tool, wherein expanding the pupil by mediatique, after anesthesia, an incision of the cornea, after which the anterior chamber is filled with viscoelastic low molecular weight and implanted refractive lens using a cannula provided with a source of vacuum 40-60 mm RT.art., why fix refractive lens work end of the cannula in the middle between the edge of the lens and the boundary of the optical part, with the bend edges on the end of the cannula, then the top bend impose refractive lens in the incision of the cornea and install it in the rear chamber of the eye, then when removing the vacuum disconnect the cannula from the refractive lens and the reverse movement of the cannula is removed from the anterior chamber of the eye.

2. Device for implantation of refractive lenses, containing the work item for capturing and holding through an incision of the cornea in the camera eye refractive lens, and the handle, characterized in that the working element is designed in the form of a cannula, which is a tube of oval cross-section, bent at an angle 120-130°, funnel RA is, the ri this cannula is made of a biologically inert material, with the characteristic tensile strength of not less than 27 MPa, funnel-shaped working end of the cannula along its edge and the inner surface lined with a polymeric material, with the characteristic tensile strength of 2.9 to 3 MPa, and the handle is used to move the cannula, and is designed as a vacuum syringe connected socket with the cannula.

3. The device according to p. 2, characterized in that the cannula is made in the form of a tube of polyethylene of low pressure PAMD, reinforced tube made of stainless steel.



 

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SUBSTANCE: method involves introducing 0.1-0.3 ml of photosensitizing gel preliminarily activated with laser radiation, after having removed neovascular membrane. The photosensitizing gel is based on a viscoelastic of hyaluronic acid containing khlorin, selected from group containing photolon, radachlorine or photoditazine in the amount of 0.1-2% by mass. The photosensitizing gel is in vitro activated with laser radiation having wavelength of 661-666 nm during 3-10 min with total radiation dose being equal to 100-600 J/cm2. The gel is introduced immediately after being activated. To compress the retina, vitreous cavity is filled with perfluororganic compound or air to be further substituted with silicon oil. The operation is ended with placing sutures on sclerotomy and conjunctiva areas. Compounds like chealon, viscoate or hyatulon are used as viscoelastic based on hyaluronic acid. Perfluormetylcyclohexylperidin, perfluortributylamine or perfluorpolyester or like are used as the perfluororganic compound for filling vitreous cavity.

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