RU2676601C2 - Method of implementation of automated continuous capsulorhexis and ring for its implementation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine, namely to ophthalmology. To perform automated continuous capsulorhexis, a flexible ring is used, which is installed in the cartridge. Then the cartridge is installed in the device for implantation of the ring in the corneal or scleral tunnel incision in the anterior chamber of the eye. After the tip of the cartridge appears in the anterior chamber, the ring is opened in the anterior chamber and is placed on the front capsule with the cutting edge down. Ring is supported on one side with a spatula behind the ear, on the other – with a thread through the injector. After the capsulorhexis circle is formed, the ring is explanted with a thread from the anterior chamber of the eye back into the cartridge.

EFFECT: group of inventions allows for automatic capsulorhexis, with stabilization using standard surgical instruments at the stage of cataract phacoemulsification in difficult cases.

3 cl, 6 dwg

Description

The invention relates to medicine, more specifically to ophthalmology, and can be used in cataract extraction. Used with a cartridge designed for use with devices used for intraocular implantation of an IOL. It can be used to automate the phase of cataract phacoemulsification surgery in complex cases.

The prior art method for the extraction of cataracts with implantation of an intraocular lens in the eyes after surgery for retinal detachment, with silicone oil tamponade, including two corneal paracentesis, the introduction of viscoelastic in the anterior chamber, corneal tunnel incision, anterior continuous circular capsulorexis (PNC- capsulorexis), hydrodissection, phacoemulsification of the nucleus of the native lens of the eye, aspiration of the lens mass, implantation of the intracapsular ring and intra ocular lens (IOL), leaching of viscoelastic and sealing of the corneal tunnel incision, characterized in that before performing the corneal tunnel incision, PNA-capsulorhexis is formed, and before implantation of the intracapsular ring, a viscoelastic tamponade of the anterior chamber and capsular bag is performed, then the posterior circle is performed a circle with a diameter of 3-3.5 mm of the central portion of the clouded posterior capsule of the native lens of the eye with a pitch between the perforations of 0.5 mm, the beginning I’m from the most dense fibrous area, then the bridges between the perforations are destroyed, and through the corneal tunnel incision, the formed flap is removed and the IOL is implanted, then the corneal tunnel incision is sealed, and then the viscoelastic is washed through the corneal paracentesis [patent RU 2300353, publ.: 10.06. 2007].

This solution describes a method for removing the back of this capsule (pouch) after removing the cloudy contents of the capsule to prevent clouding of this back of the capsule and reducing vision again in some patients because of the capsule, by first creating holes and then connecting these holes into one big one.

A solution is known according to the patent US 6159175. This solution describes a phacoemulsification tip, which, according to the creators, reduces the fluid flow during this operation. This tip crushes the lens core.

In our claimed invention, the instrument opens the lens capsule.

The lens is a substance that contains many closely connected lens fibers located in a sac. This pouch is secured with ligaments inside the eye. Cataracts are a condition in which the lens becomes cloudy, while a person sees through it worse.

US patent 6159175 describes a device for the extraction of nuclei and lens masses using the minimum, according to the authors, ultrasonic energy.

In the claimed invention, the tool helps to form a hole in the anterior capsule for subsequent removal of the cloudy lens, since during this operation, the cloudy contents of the capsule are removed for cataracts (phacoemulsification, FEC), and the capsule and its ligaments attaching to the processes of the ciliary body remain.

During this operation, a lens is implanted into this pouch instead of the removed contents. A similar solution is described in patent RU 2583594, publ.: 05/10/2016. it describes a method for cataract extraction with implantation of an intraocular lens in the eyes with tamponade of the vitreous cavity with silicone oil, including opening the eyeball, performing continuous circular anterior capsulorhexis, hydrodissection, hydrodelineation, fragmentation and removal of the lens nucleus, aspiration of the crystalline lens capsule, continuous circle implantation of an intraocular lens (IOL), characterized in that after removal of the lens and aspiration of the lens masses the anterior chamber the lens manhole and lens capsule bag are filled with viscoelastic, after which a regular plastic interface is installed in the form of a plastic funnel with a vacuum ring with an inner diameter of 12.5 mm and an outer diameter of 18.5 mm, then the interface is vacuum-fixed to the eye, on the eye surface, in “Funnel”, balanced salt solution (BSS) is poured in the volume from 3.0 to 5.0 ml, the next step is docking of the “docking” interface with the “working module” of the femtolaser device, the position of the posterior lens capsule is determined, and t The required parameters of the posterior capsulorexis, while the diameter of the posterior capsulorexis is set 1.5-2.0 mm less than the diameter of the existing anterior capsulorhexis, and the energy varies from 110% to 170%, then a femtolaser opening of the posterior capsule is performed, the incised disc of the posterior capsule is removed from the eye then an IOL is implanted in the capsular bag.

The solutions for patents RU 2583594 and US 9351879 are characterized in that a femtosecond laser is used to form a window in a capsule (pouch), while in the claimed invention, the capsule is mechanically dissected with a blade integrated into the ring.

A silicone ring-shaped device for assisting continuous curvilinear capsulorexis is known to provide guidance for accurate sizing and positioning for opening a capsule. [http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/content/tags/anteri-capsulotomy/silicone-ring-addresses-challenges-precise-caps?page=full], published: 07/01/2014. This ring only helps to make smooth capsulorexis. The surgeon himself makes it according to the generally accepted technique.

Its disadvantage is that it limits the rupture zone of the capsule and it does not always stick uniformly, therefore the capsule can tear unevenly, and any sense of such a ring is lost.

Known ring for capsulorhexis [https://www.aao.org/clinical-video/new-disposable-device-auto-capsulotomy], publ.: 11/30/2016., Which cuts through the technology of nanoimpulse.

The cutting element is a rigid ring for capsulorexis, which is surrounded by a thin transparent membrane, threaded through the corneal incision. Through pulses, a slow absorption in the anterior capsule occurs, and brief electrical impulses create an instant mechanical breakdown of the anterior capsule without cauterizing or burning tissue.

The technical problem is that this technology is quite expensive and requires high-precision equipment. The ring used alone does not do capsulorexis without the use of electro-pulse technology. In addition, in the well-known analogue, the ring is stabilized by suction using a vacuum and rexis is carried out by electric discharge, and in the device we have claimed, caplusorexis is performed by the cutting edge, when the ring is stabilized in the anterior chamber using standard surgical instruments.

The difference from the claimed invention is that the claimed solution makes capsulorexis on its own.

The closest analogue is a method of performing automated continuous capsulorhexis (US2011071524 A1, 03.24.2011, D1) a method of performing automated continuous capsulorhexis (description, 0009), characterized by using a hollow cap with a serrated blade inside, which is installed in the cartridge, then the cadtridge is installed in the device for implantation of the cap into the corneal or scleral tunnel incision in the anterior chamber of the eye; after the tip of the cartridge appears in the front chamber, the cap is opened in the front chamber and placed on the front capsule. In this case, the lid is attached to the leg, which partially remains in the cartridge and the lid is supported only on one side with the help of this leg. In the known method, in contrast to the claimed method, a flexible cap is used, inside of which there is one continuous serrated concentric blade; after inserting the cap into the cartridge, the cap folds into a tube; after implantation, the cap is placed on the front capsule with the cutting edge down so that a closed cavity is formed between the inner surface of the hollow cap and the front capsule; a vacuum is created in the cavity by pumping air through the leg, while part of the capsule is drawn into the inside of the cap, touches the blade and is cut by it. After the capsulorexis is formed by the cutting elements, the cap is explanted from the anterior chamber of the eye back into the cartridge.

The difference from the prototype is that after manual centering of the ring, it is pressed to the front of the capsule, while the ring is held on both sides: on the one hand with a spatula by the eye, on the other hand, support the thread through the injector. After the cutting part of the ring comes into contact with the capsule, the latter is cut under the influence of the physical force of light pressure with a spatula and the tip of the injector on the ring from above; after that, the ring is lifted with a spatula on one side and thread on the other; then you need to pull the thread and the ring will go back into the tip of the injector. The difference of the prototype is also that the prototype ring is not hollow and no vacuum is created in it, the capsule is not pulled by the vacuum to the prototype, the cutting of the capsule occurs only under the influence of light pressure. Due to this, there is no pressure on the capsular ligaments supporting it along with the lens in the eye, there is no risk of damage to them during cutting the capsule. The blade in the prototype has no teeth and evenly cuts the capsule, creating the same pressure around the entire circumference.

The technical problem of the prototype is that in it the ring in the injector is not refilled, but simply removed from the eye, which increases the risk of eye injury due to the prototype folding when passing through the corneal tunnel incision, injuring the edges of the incision.

The objective of the invention is to remedy these disadvantages of the known solutions, by creating an inexpensive and easy-to-use mechanical device.

The technical result of the invention is the possibility of automatic capsulorexis, with stabilization using standard surgical instruments at the stage of cataract phacoemulsification operation in complex cases. The specified technical result is achieved due to the fact that the claimed method of performing automated continuous capsulorhexis, characterized by using a ring that is installed in the cartridge, then a cadridge is installed in the device for implanting the ring into a corneal or scleral tunnel incision in the anterior chamber of the eye; after the tip of the cartridge appears in the front chamber, the ring is opened and placed on the front capsule in the front chamber, characterized in that a flexible ring is used, at the bottom of which there is a blade with an annular cutting edge or two semicircular blades forming an annular cutting edge; after inserting the ring into the cartridge, the ring folds into a tube; after implantation, the ring is placed on the anterior capsule with the cutting edge down; after manual centering of the ring, it is attached to the front of the capsule, while the ring is supported on two sides: on the one hand, with a spatula by the eye, and on the other, support the thread through the injector; after the cutting part of the ring comes into contact with the capsule, the latter is cut under the influence of light pressure with a spatula and the tip of the injector on the ring from above; after that, the ring is lifted with a spatula on one side and thread on the other; then they pull on the thread and the ring is inserted back into the tip of the injector; after the capsulorexis circumference is formed by the cutting elements, the ring is explanted from the anterior chamber of the eye back into the cartridge. Also claimed is a ring for the automated execution of continuous capsulorexis, used according to the method described above, characterized in that it contains a ring having an eye for manipulating the device in the anterior chamber and a thread for exploring the device on the other hand, the ring is flexible, a blade with an annular cutting edge or two semicircular blades forming an annular cutting edge.

It is permissible that it is made of silicone.

Brief Description of the Drawings

In FIG. 1 shows the ring device and cartridge where it is inserted.

In FIG. 2 stages from A to G show the process of "refueling" the ring into the cartridge.

In FIG. 3 shows the process of inserting a cartridge into an injector.

In FIG. 4 shows the sites of corneal paracentesis and the main incision.

In FIG. Figure 5 shows the eye in the longitudinal axis of the eye section with places of paracentesis and the main section.

In FIG. 6 shows the stages of implantation, operation and removal of the ring in the anterior chamber:

A - use a curved spatula to hold the ring by the ear, push the ring from behind with a pusher; B - the pusher pushes the ring into the front chamber, after the ring has completely straightened, center it over the capsule and press it with a spatula a little; B - after performing the anterior capsulorhexis, the ring is retracted by the thread back into the cartridge; G - remove the ring with the cartridge from the eye, evaluate the completeness of capsulorexis.

In the drawings: 1 - an eye for threading a thread, 2 - a sharp edge that runs along the bottom of the ring; has a built-in blade that cuts the front capsule mechanically, 3 - a small loop for supporting the ring in the anterior chamber of the eye with an instrument, 4 - a thread for explantation (removal) of the ring from the eye after the manipulation, 5 - a cartridge, 6 - a ring, 7 - injector pusher, 8 - injector, 9 - lens capsule, in which the lens is located, the impact will be on the front of the capsule, 10 - iris, 11 - paracentesis at 3 and 9 hours, 12 - main incision, 13 - cornea, 14 - ligaments on which the lens capsule is attached to itself lens inside, 15 - the tip of the cartridge in the main section at 11 o’clock.

The implementation of the invention

The device consists of a ring and standard auxiliary tools for implanting the device into the anterior chamber (cartridge and injector) and a surgical instrument to maintain the device in a normal position in the anterior chamber of the eye (wide spatula).

The device consists of a ring and an annular cutting edge on one side of the product, an eye on the top of the ring for better manipulation of the device in the front chamber and thread for exploring the device on the other side.

The device is designed to automate the phase of cataract phacoemulsification operation in complex cases. The device works as follows: A silicone ring is inserted into a special device (cartridge), which folds the ring into a “tube”. This cartridge is inserted into a device for implanting a ring into a corneal or scleral tunnel incision in the anterior chamber of the eye. After implantation, the ring opens in the anterior chamber and is placed on the front capsule with the cutting edge down. In this case, the ring for the safety of the manipulation is supported by a spatula through the second incision (paracentesis). After cutting the circumference of capsulorexis, the ring is explanted from the anterior chamber of the eye back into the cartridge.

The capsulorexis ring is flexible, a blade or two semicircular blades are soldered from below into this ring.

On one side of the ring 6 there is an eyelet 1 (see Fig. 1), into which a thread 4 is threaded. On the opposite side, there is also a larger eyelet 3. Nothing is threaded into it, it serves to better further fix the ring inside the anterior chamber. At the bottom of the ring is a cutting edge 2.

To insert the ring 6 into the eye, a special disposable device is used - cartridge 5. This is a device inside which there is a hollow tube, the diameter of which decreases in the direction from its beginning to the tip.

In FIG. 2 shows the steps in the process of “refilling” a ring into a cartridge.

It is carried out as follows.

Viscoelastic is introduced into the cavity of the injector - a viscous substance that performs the function of more controlled expansion and the location of the ring in the anterior chamber. Then the ring 6 is inserted into the initial wider part of the injector with the eye 3 without the thread 4 forward. Ring 6 is pushed with a pusher tool. This is a direct tool that pushes the ring further along the channel as a weapon ramrod, while the diameter of the channel decreases and the ring folds in half. Ring 6 is pushed almost to the tip of the cartridge.

Then the cartridge 5 is inserted into another, larger tube with an injector 8 (see. Fig. 3). The tip of the resulting device from the injector and cartridge is inserted into the eye so that the narrow tip 15 of the cartridge goes into a small incision in the cornea (see Fig. 5). In the cornea 13 in the area of the iris 10, three incisions are made - one of the main 12, through which the ring is inserted (its dimensions 2.2-2.5 mm) and two punctures 11 with dimensions of 1.2 mm.

Inside the lens capsule 9 (see Fig. 4), in which the lens is located, the impact will be carried out on the front of the capsule above the ligaments 14, on which the lens capsule 9 is attached with the lens itself inside. The tip 15 of the cartridge is introduced in the main section at 11 hours.

Inside the eye, the same substance is injected into the anterior chamber - viscoelastic so that the ring inside the eye behaves more stably and does not float in the intraocular fluid. Then the pusher, which is inside the injector, push the ring inside the eye. In this case, the ring 6 is already in a folded state at the tip 15 of the injector. They push it with a pusher 7 (see Fig. 3), which is located in the injector 8. As soon as the ring appears inside the eye (see Fig. 5) from the cartridge, a spatula (a tool with a flat narrow long plate at the end) must be placed inside eyes. Insert the same spatula into the ear, which is attached to the ring and help the ring to fully enter the eye cavity into the so-called anterior chamber of the eye (see Fig. 6 (A)).

After the ring has completely come out of the cartridge and straightened, you need to center the ring inside the eye. At the same time, the cutting part of the ring is still directed downward. After manual centering of the ring, it is grafted onto the front of the capsule (see Fig. 6 (B)). At the same time, the ring is held on both sides. On the one hand - with a spatula behind the eye, on the other - support the thread through the injector. After the cutting part of the ring comes into contact with the capsule, the latter is cut under the influence of light pressure with a spatula and the tip of the injector on the ring from above. After that, the ring is lifted with a spatula on one side and thread on the other. Then you need to pull the thread and the ring will go back into the tip of the injector. Then you need to continue pulling on the thread until the entire ring enters the cartridge back (see Fig. 6 (B)). After that, the cartridge is removed from the main incision, and the spatula is removed from paracentesis (see Fig. 6 (D)).

At the next stage, the cloudy lens is removed through the formed “window” in the capsule according to standard technology, then the lens, which is located inside the capsule, is also inserted into the eye with the help of an injector and a cartridge.

Claims (3)

1. A method of performing automated continuous capsulorexis, characterized by using a ring that is installed in the cartridge, then a cadridge is installed in a device for implanting the ring into a corneal or scleral tunnel incision in the anterior chamber of the eye; after the tip of the cartridge appears in the front chamber, the ring is opened and placed on the front capsule in the front chamber, characterized in that a flexible ring is used, at the bottom of which there is a blade with an annular cutting edge or two semicircular blades forming an annular cutting edge; after inserting the ring into the cartridge, the ring is folded in a tube; after implantation, the ring is placed on the anterior capsule with the cutting edge down; after manual centering of the ring, it is attached to the front of the capsule, while the ring is supported on two sides: on the one hand, with a spatula by the eye, and on the other, support the thread through the injector; after the cutting part of the ring comes into contact with the capsule, the latter is cut under the influence of light pressure with a spatula and the tip of the injector on the ring from above; after that, the ring is lifted with a spatula on one side and thread on the other; then they pull on the thread and the ring is inserted back into the tip of the injector; after the capsulorexis circumference is formed by the cutting elements, the ring is explanted from the anterior chamber of the eye back into the cartridge. 2. A ring for the automated execution of continuous capsulorhexis, used according to the method of claim 1, characterized in that it contains a ring having an eye for manipulating the device in the front chamber and a thread for explanting the device on the other hand, the ring is flexible, a blade is located below the ring with an annular cutting edge or two semicircular blades forming an annular cutting edge. 3. The ring according to claim 2, characterized in that it is made of silicone.

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