RU2279262C1 - Method and device for implanting intraocular refractive lens - Google Patents

Abstract

FIELD: medicine; medical engineering.

SUBSTANCE: method involves dilating pupil with mydriatic preparations, making eye incision after applying anesthesia, filling anterior chamber with viscoelastic material and implanting refractive lens into the anterior chamber by means of cannula connected to vacuum source and fixing the refractive lens. Contacting end of the cannula is placed on upper surface of haptic lens part close to optical part. Vacuum fixation is carried out with rarefaction of 100-600 mm of mercury column. Initial lens shape is retained. The lens is sequentially introduced into anterior and posterior eye chamber in horizontal plane above crystalline lens surface. The haptic lens part is placed under iris. Device has cannula as tube curved at an angle with contact end face made from biologically inert material having tension strength of 27 Mpa and has handle connected to rarefaction source. Hollow tube of cannula having round or oval cross-section of 0.5-2.5 mm large diameter and 0.05 mm thick wall is bent at an angle of 110-160°. The cannula is set on bearing surface with its contact end having radial fold curved with radius equal to or greater than 2 times tube diameter. The tube has restrictor on 7-14 mm long segment having conic funnel. It is connected to hollow cylindrical handle having external diameter not less than 5 mm, rough surface and end connecting pipes for making connection to cannula mouth and flexible hose connected to rarefaction source.

EFFECT: high reliability, safety and effectiveness of lens implantation.

5 cl, 6 dwg

Description

The invention relates to medicine, to ophthalmic surgery, and can be used in ophthalmic surgery for implantation of a refractive lens into the anterior and posterior chamber of the eye.

A known method and device, pneumatic tweezers for installing a contact lens (RF patent No. 2200517, publ. March 20, 2003, class A 61 F 9/00). The pneumatic tweezers contain rubber pneumatic pear and a cone-shaped suction cup to hold the contact lens. There is a rod in the suction cup cone to limit the magnitude of the “suction” surface of the lens. When the pneumatic pear is compressed with fingers, either a vacuum is created to attach the lens to the suction cup, or the pressure to repel it after installation on the cornea.

However, refractive surgery requires an order of magnitude finer, smaller and more precise instrument sizes, allowing you to work in a limited space, in the anterior chamber of the eye, where an average depth of 3 mm and slight movements can cause irreversible and formidable complications from the transparent lens and endothelium of the cornea.

The closest technical solution can be considered a method and device for implantation of intraocular lenses described in the patent of the Russian Federation (Method of refractive eye surgery and device for installing lenses RF patent No. 2242956, publ. 12/27/2004, class. A 61 F 9/007) , which is a prototype for the proposed method and device.

A known method for implanting a refractive lens includes a corneal incision, fixation and implantation of an intraocular refractive lens with a working tool. After expanding the pupil with mydriatics, after anesthesia, a corneal incision is made (Clear cornea - 3 mm), after which the anterior chamber is filled with low molecular weight viscoelastic and an intraocular refractive lens is implanted using a cannula connected to a vacuum source of 40-60 mm Hg. The intraocular refractive lens is fixed with the working end of the cannula in the middle between the edge of the lens and the boundary of the optical part, with the edge bent to the end of the cannula. Then, the intraocular refractive lens is inserted into the corneal incision with the apex of the bend and placed in the anterior chamber of the eye, after which, when the vacuum is removed, the cannula is disconnected from the intraocular refractive lens and the cannula is removed from the anterior chamber of the eye by reverse movement.

It is also known a device used in ophthalmic surgery for implantation of an intraocular refractive lens, containing a working element for fixing and passing through the incision of the cornea into the anterior chamber of the eye of the intraocular refractive lens. The working element is made in the form of a cannula - a tube bent at an angle of 120-130 °, oval, enlarged after bending the section, the funnel-shaped working end of which is 0.4-0.6 mm long, has an ellipse section with small and large axes 0.8-0 , 9 mm and 1.8-2 mm, respectively. The cannula is made of a biologically inert material, with a tensile strength characteristic of at least 27 MPa, and the funnel-shaped working end face of the cannula is lined with polymer material along its edge and inner surface, with a tensile strength characteristic of 2.9-3 MPa, as well as a handle for moving the cannula made in the form of a vacuum syringe connected by a bell with a cannula. The cannula can be made of material - low-pressure polyethylene HDPE or stainless steel, and the facing material of the working end of the cannula is polyurethane methacrylate.

Using the known method and device can reduce injuries of eye tissue in the surgical field and improves the quality of the operation.

In development of the methodology and devices for the operation of implanting an intraocular refractive lens, it is necessary to improve the contact end face of the cannula and the conditions for fixing the lens with vacuum in the absence of tissue injuries.

The technical task of the proposed invention is to increase the reliability, safety and efficiency of the operation of implantation of a refractive lens.

The technical problem is solved in that in a method for implanting an intraocular refractive lens, including expanding the pupil with mydriatics, cutting the cornea after anesthesia, filling the anterior chamber with viscoelastic and implanting a refractive lens into the anterior chamber using a cannula connected to a vacuum source and fixing the refractive lens between the lens edge the boundary of the optical part, according to the invention, the working end of the cannula is installed on the upper surface of the haptic part of the lens, close to the boundary of the optical part, fixed with a vacuum value of 100-600 mm RT.article and, preserving the initial shape of the lens, they are carried out in a horizontal plane above the lens surface sequentially in the front and rear cameras of the eye, setting the haptic part of the lens under the iris of the eye.

The technical problem is also solved by the fact that in the device for implantation of a refractive lens containing a cannula in the form of a tube bent at an angle, with a contact end face made of a biologically inert material, with a tensile strength characteristic of at least 27 MPa, and equipped with a handle connected to the source vacuum, according to the invention, the cannula in the form of a hollow tube of round or oval cross-section with an inner diameter of 0.5 mm-2.5 mm, with a wall thickness of at least 0.05 mm, is bent at an angle of 110-160 °, while the cannula is mounted with a contact end ohm - "hoof" on the supporting, conditionally horizontal surface "aa", which is curved to a height "h" to it, along a radius "r" equal to at least 2 tube diameters, while the tube is equipped with a length of 7-14 mm a conical limiter, with a diameter of 2-5 mm, and after bending it is connected to a hollow cylindrical handle with an outer diameter of at least 5 mm having a rough surface, and end fittings for connecting to the cannula socket and with a flexible hose in communication with a vacuum source. The working end - the “hoof” has in cross section a circle with a diameter of 1.0 to 2.0 mm or an ellipse with small and large axes of 0.6-0.9 mm and 1.5-2.5 mm, respectively.

As a vacuum source, the Legacy or Millennium phacoemulsifier system is used.

As a vacuum source, a handle made in the form of a cylinder made of transparent material can be used, with a nozzle for connection with a cannula from one end and a flange from another, a spring-loaded piston is placed inside the cylinder, with a rod equipped with a support disk, the surface area is comparable with flanging, while the compression spring is made of steel wire, while the parameters of the compression spring are selected from the condition of creating a vacuum of 100-600 mm Hg

The claimed group of inventions meets the requirement of "unity of invention", since the proposed method is implemented by the proposed device, and both objects are aimed at solving the same problem, with a single technical result. The technical result obtained by implementing the method and device is as follows:

- the implantable lens is not subjected to bending, the risk of damage to the lens is excluded;

- improved conditions for the passage of the lens through the incision;

- the possibility of implanting a lens in the front and rear cameras of the eye;

- reduces the possibility of injury as an implantable lens and surrounding eye tissue;

- the operation time is reduced compared to other methods, since the front haptic part of the lens is implanted under the iris in one motion;

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

- the unification of the handle of the device with a vacuum syringe with a spring-loaded rod expands the possibilities of using various sources of vacuum in various energy situations;

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

The device was manufactured in the experimental-technical production of the MTC “Eye Microsurgery”, operations were carried out in the experiment on rabbits and in the clinic, which confirms the compliance of the proposed technical solution with the criterion of the invention “industrial applicability”.

When comparing with the prototype, it was revealed that the claimed method differs in the size of the vacuum, the installation location of the working end of the cannula and the plan for promoting the lens in the cameras of the eye.

The claimed device is distinguished by the shape and design features of the cannula and the working end, which allows us to consider the proposal of the applicant meets the criteria of the invention of "novelty."

The essence of the invention is as follows.

During testing, it turned out that the vacuum must be reduced, since with an unexpected detachment of the lens from the cannula in the anterior chamber of the eye, there was a risk of absorption of the contents of the anterior chamber of the eye (moisture and viscoelastic) and trauma to eye structures (the anterior lens capsule, iris and endothelial cells).

The best results during experimental testing were obtained with the use of a phacoemulsifier, since the necessary vacuum is automatically provided by pressing the pedal with the foot, freeing the surgeon's hands. Experimentally worked out vacuum value of 100-600 mm Hg proved to be necessary and sufficient for safe and reliable fixation of the lens, and a decrease in vacuum of more than 600 mm Hg led to the loss of contact between the surface of the lens and the working end of the cannula. Reducing the magnitude of the vacuum compared with the prototype allowed for the implementation of a new design of the cannula. This design also made it possible to mount the working end on the lens surface near the optical part of the lens without bending its edge onto the end face of the cannula. The end face of the cannula, made in the form of a "hoof", with a bend to a height of "h", made it possible to fix the lens in the horizontal plane "aa", parallel to the cannula tube. This design made it possible to advance the lens into the anterior chamber, then into the posterior chamber of the eye, placing the haptic part of the lens under the iris (Figure 1.). The characteristics and dimensions of the working end face of the cannula, the tube limiter worked out depending on the magnitude of the vacuum and the size of the surgical field. If it is not possible to use a phacoemulsifier, a backup version of the cannula evacuation tool in the form of a vacuum syringe is provided. It is a cylinder made of transparent material, with a fitting for connecting to the cannula from one end and a flange from the other, a spring-loaded piston is placed inside the cylinder, with a rod equipped with a support disk, the surface area is comparable with the flanging, while the compression spring is made of steel wire, where its compression parameters are selected from the condition of creating a vacuum of 100-600 mm Hg.

Operations were performed in the ophthalmology clinic of the Moscow Clinical Hospital.

We give a clinical example. Patient K., 10 years old, was admitted to the clinic on January 21, 2004 with a diagnosis of High myopia OD, anisometropia, OD sph. - 15.50 = cyl. - 1.50 ax 177, OS sph. - 0.50 = cyl. - 0.75 ax 8. 01/22/2004 operation on the right eye - implantation of an intraocular refractive lens.

The progress of the operation. Medically dilated pupil. Under local anesthesia, a corneal incision was made at 12 hours 2.5 mm in size. Low molecular weight viscoelastic is introduced into the anterior chamber. Using a vacuum, the intraocular refractive lens is fixed to the end of the cannula. Using the cannula, the lens is drawn through the corneal incision and the anterior chamber of the eye, while simultaneously installing the front haptic part of the lens under the iris of the eye, then the vacuum is disconnected and the cannula is removed from the anterior chamber of the eye by reverse movement. With the help of a spatula, the rear lens haptic is set under the iris. The anterior chamber is washed with saline. In the anterior chamber, a drug-constricting pupil (myocol) is introduced and peripheral iridectomy is performed using tweezers and scissors microiris. At the site of the corneal incision, a BSS solution is injected into the stroma to hydrate and seamlessly adapt the edges of the wound. Installation of an antibiotic solution in the conjunctival sac. Aseptic blindfold.

The day after the operation, the eye is calm, the cornea is transparent, the moisture of the anterior chamber is clean, the pupil reacts vividly to light, there is no contact with the anterior surface of the lens, there is a pink reflex from the fundus. Refraction was OD sph. - 0.50 = cyl. - 1.00 ax 178. Thus, a result of 15.00 diopters was obtained.

The invention of the device is illustrated by drawings, where figure 2 gives a General view of the device. Figure 3 shows the connection of the cannula with the lens. Figure 4 - design of the cannula. Figure 5 - connection of the cannula with a handle and a vacuum source - phacoemulsifier system. Figure 6 shows a backup version of the evacuation of the cannula.

In figure 2, the cannula in the form of a tube 1, bent at an angle of 110-160 °, is equipped with a stopper 2, and a working end-hoof 3 mounted on a conditionally horizontal surface "aa". The cannula is equipped with a bell 4 mounted on the fitting 5 of the handle 6, in communication with a vacuum source.

Figure 3 shows the bend of the hoof 3 mounted on the haptic part of the lens 7, while the radius of the bend of the hoof is not less than two diameters of the tube.

Figure 4 shows the design of the cannula, the stopper 2, mounted on a length of 7-14 mm from the working end, it is made with a conical funnel 100-150, which fixes and promotes the intraocular lens and limits the excessive movement of the cannula into the anterior chamber of the eye.

The cannula is made in the form of a tube of round or oval cross section with an inner diameter of 0.5-2.5 mm and a wall thickness of at least 0.05 mm. The working end face, the “hoof” 3, has a cross section of a circle with a diameter of 1.0 to 2.0 mm or an ellipse with minor and major axes 0.6-0.9 mm and 1.5-2.5 mm, respectively.

Figure 5 shows the connection of the cannula 1 with a socket 4 with a fitting 5, of a handle 6 having a rough surface (notch). The handle is made hollow and other fitting 11 is connected by a flexible hose 12 to a vacuum source, for example, the Millennium phacoemulsifier.

Figure 6 shows a backup version of the evacuation of the cannula. As a source of vacuum, a handle in the form of a cylinder 13 of transparent material, with a fitting 14, can be used for connection with the cannula 1, from one end and a flange 15 from the other. Inside the cylinder, a spring-loaded piston 16 is placed, with a rod 17 provided with a support disk 18, with a surface area comparable to the flanging, the compression spring 19 is made of steel wire and its parameters are selected to create a vacuum of 100-600 mm Hg. The source of vacuum can be a syringe with a spring-loaded rod, the property of the spring provides a given vacuum (Fig.6). For example, in a cylinder with a diameter of 10 mm, a length of 50 mm, with a piston stroke of 40 mm, a portion of air is squeezed out when compressing a spring with a force of 450 g and moving the piston to the nozzle of the connection with the cannula. When the end face of the cannula is applied to the lens and the stem is released, the compression spring opens, releasing the piston inside the cylinder from the nozzle with the cannula, creating a vacuum of 325 mmHg. (0.427 atm), while the lens is firmly attached. After installing the intraocular refractive lens in the posterior chamber of the eye by pressing the rod, the remaining portion of the air pushes the lens away from the cannula. In this case, the cylinder plays the role of a handle, and the transparent wall of the cylinder allows visual control over the operation of the device. In this example, a spring of steel wire with a diameter of 1 mm, a spring winding diameter of 10 mm with a pitch of 3 mm was selected, while the spring is zanevin and heat treated at a temperature of 400. The dependence of the required vacuum on the spring parameters allows the use of various cylinder and spring sizes.

The operation of the device consists in fixing the lens with the working end face of the cannula using a vacuum, advancing the lens into the anterior and then posterior chambers of the eye and placing the haptic part of the lens under the iris of the eye. When removing the vacuum, the lens detaches from the working end of the cannula, and the cannula is removed from the surgical field.

Information sources

1. RF patent No. 2200517, publ. March 20, 2003, class A 61 F 9/00.

2. RF patent No. 2242956, publ. December 27, 2004, class And 61 F 9/007 is a prototype of the method and device.

Claims (5)

1. A method for implanting an intraocular refractive lens, comprising expanding the pupil with mydriatics, cutting the cornea after anesthesia, filling the anterior chamber with viscoelastic and implanting the refractive lens into the anterior chamber using a cannula connected to a vacuum source and fixing the refractive lens, characterized in that the contact end face of the cannula is installed on the upper surface of the haptic part of the lens close to the boundary of the optical part, they are fixed with a vacuum of 100-600 mm Hg. and, preserving the initial shape of the lens, they are carried out in a horizontal plane above the lens surface sequentially in the front and rear cameras of the eye, setting the haptic part of the lens under the iris of the eye. 2. A device for implantation of a refractive lens, comprising a cannula in the form of an angle-bent tube with a contact end, made of a biologically inert material with a tensile strength characteristic of at least 27 MPa and equipped with a handle connected to a vacuum source, characterized in that the cannula is in the form a hollow tube of round or oval cross-section with an inner diameter of 0.5 - 2.5 mm, with a wall thickness of at least 0.05 mm, is bent at an angle of 110-160 °, while the cannula is mounted with a contact end face on a supporting surface made with with a radius equal to at least 2 diameters of the tube, the tube being equipped with a stopper made with a conical funnel over a length of 7-14 mm, and after bending it is connected to a hollow cylindrical handle with an outer diameter of at least 5 mm having a rough surface, and end fittings for connection with a cannula socket and with a flexible hose in communication with a vacuum source. 3. The device according to claim 2, characterized in that the contact end has in cross section a circle with a diameter of 1.0 to 2.0 mm or an ellipse with minor and major axes 0.6-0.9 mm and 1.5-2, 5 mm respectively. 4. The device according to claim 2, characterized in that the Legacy or Millennium phacoemulsifier system is used as a vacuum source. 5. The device according to claim 2, characterized in that the handle connected to the vacuum source is made in the form of a cylinder of transparent material, with a fitting for connecting to the cannula from one end and flanging from the other, a spring-loaded piston with a rod equipped with a support disk is placed inside the cylinder while the compression spring is made of steel wire.

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