RU2275174C2 - Artificial iridolenticular diaphragm and method for implanting it in aniridia and aphakia cases - Google Patents

Abstract

FIELD: medicine; medical engineering.

SUBSTANCE: device is manufactured as monolith disk-shaped diaphragm from flexible material. It has optical and haptic part. The haptic one has colored ring having internal diameter of 3.0-4.5 mm and external diameter of 9.0-10.0 mm, and supporting arc-shaped closed members as vertices of a figure symmetrically or asymmetrically arranged relative to pentagonal star rotation axis within a circle of 11.0-13.5 mm large diameter. To make point touch with surrounding tissues, the supporting members have rounded or sharp ends. Method involves applying the supporting members of haptic part for fixing iridolenticular diaphragm depending on whether lens bursa, capsule or iris residues are available or unavailable in the eye. The iridolenticular diaphragm is implanted via small tunnel incision in the cornea or sclera. Capsule bursa residue being available in the eye, supporting members of the iridolenticular diaphragm under implantation are leaned against the residues without additionally fixing them with sutures and thrust into the ciliary sulcus. Iris residues being available in meridians, closed ends of the iridolenticular diaphragm haptic part supporting members are preliminarily cut off and the supporting members are fixed in the meridians immediately to the iris in clips-like manner. No iris residues being available, the members are additionally sutured to sclera in one or two points. Intact capsule bursa being available, iridolenticular diaphragm is implanted after having completely cut-off the supporting members of the haptic part. Complete or partial lack of capsule or iris support being the case, iridolenticular diaphragm is implanted with suture fixation to sclera being used after having in advance built three sclera pockets in meridians corresponding to the supporting members arrangement in the haptic part of the iridolenticular diaphragm.

EFFECT: stable position and reliable diaphragm fixation; reduced risk of pre- and postoperative complications.

2 cl, 3 dwg

Description

The invention relates to medicine, and more particularly to ophthalmology, and is intended for the correction of aphakia with aniridia.

The known iris-lens diaphragm of the eye and the method of its implantation in aphakia and aniridia, described by Sobolev N.P. in the dissertation for the degree of Candidate of Medical Sciences (protection 01.12.03 at the State Scientific and Technical Center "Eye Microsurgery" named after academician S.N. Fedorov), as well as in the application for the invention of the Russian Federation No. 2001105824 dated 02.03.2001 (prototype). This iris-lens diaphragm is a two-component collagen copolymer implant and consists of the optical and haptic parts. The diaphragm element is made in the form of an opaque ring and is a photographic copy of the iris of the twin eye. The optical unit is a transparent optical cylinder that is inserted into the central hole of the haptic part, while the diameter of the optical unit is 5.0 mm, the diameter of the haptic part varies from 9.0 for intracapsular fixation and up to 11.0 mm for extracapsular fixation. In the absence of a capsular bag, such an iris-lens diaphragm is hemmed into scleral pockets at 3 points 1.5 mm from the limbus.

However, this iris-crystalline diaphragm (IHD) has significant drawbacks - the overall diameter is too large for extracapsular fixation, which causes a large contact area of the IHD support part with the ciliary zone and causes its constant irritation and hyperproduction of intraocular fluid by the ciliary processes, which leads to an increase in intraocular pressure and secondary glaucoma, as well as sluggish uveitis. In addition, the assembled ICD is rather cumbersome, heavy and too thick to be folded and implanted through a small incision. For the implantation of the described ICD in various situations (in the presence or absence of capsule support), the production of ICD of various diameters (9 or 11 mm) is required. In addition, the described IHD requires mandatory suture fixation to the sclera at 3 points in the absence of a lens bag, and then uniform tension of the hanging IHD threads for its correct centering, which is practically difficult and can lead to decentration of the complex. The required exclusively suture fixation of ICD cannot be considered reliable because of the possibility of resorption of sutures, as well as because of possible intraoperative bleeding from the vessels of the ciliary body when it is stitched for fixation of ICD. Therefore, the limited use of suture fixation through the use of other ICD fixation methods, taking into account the presence of capsule remnants or iris remnants, i.e. A more universal way of fixing them is required.

The aim of the invention is the creation of a more universal and safe model of ICD for the rehabilitation of patients with combined pathology of the iris and lens, the development of a reliable and universal method for its implantation and fixation in aniridia - aphakia.

The technical problem solved by the invention is the creation of an additional support for an elastic iris-crystalline diaphragm (IHD), taking into account the presence or absence of a capsular bag, its residues or the remains of the iris, allowing implantation of the IHD through a smaller surgical incision, reducing the contact area of the haptic part of the IHD with the vascular tissue of the eye to the point to prevent an increase in intraocular pressure and the development of uveitis, as well as having the ability to simulate for implantation in the case of intact capsules th lens bag.

The technical result of the invention is a stable position and reliable fixation of the elastic iris-lens diaphragm, taking into account the presence of capsule bag or iris in the eye and allowing to reduce intra- and postoperative complications in patients with aniridia and aphakia.

The specified technical problem is solved in that the iris-lens diaphragm is made of a monolithic disk-shaped of elastic material, contains the optical and haptic parts, in which the haptic part is made in the form of a colored ring with an inner diameter of 3.0-4.5 mm and an outer diameter of 9.0 -10.0 mm with supporting arcuate closed elements located at the periphery equidistant from each other in the form of the ends of the figure of a symmetrical or asymmetric relative axis of rotation of the “five-pointed star” with vertices within the circumference NOSTA 11,0-13,5 mm in diameter, while for a point of contact with the surrounding tissue supporting elements have rounded or pointed ends.

The invention is illustrated by drawings:

Figure 1 - IHD with supporting elements with rounded ends located symmetrically relative to the axis of rotation of the IHD;

Figure 2 - IHD with supporting elements with pointed ends located symmetrically relative to the axis of rotation of the IHD.

Figure 3 - IHD with supporting elements with pointed ends located asymmetrically relative to the axis of rotation of the IHD.

1 - haptic colored part, imitating the color of the iris of the paired eye,

2 - optical part of the IHD,

3 - supporting closed elements of the haptic part,

4 - the outer diameter of the diaphragm ring,

5 - the inner diameter of the diaphragmatic ring and the diameter of the optical part of the ICD,

6 - the diameter of the circle within which the vertices of the support elements are located.

The technical result is achieved by the fact that in the method of implanting a monolithic elastic iris-lens diaphragm (IHD) in case of aniridia - aphakia according to the invention, support elements (3 in Figs. 1, 2, 3) of its haptic part are used to fix IHD in the eye, namely, in the case of the presence of the remains of the capsular bag in the eye, the implantable ICD without additional suture fixation is placed on these residues with the emphasis of the supporting elements (3 in FIGS. 1, 2, 3) in the ciliary groove; in the presence of iris residues in some meridians, ICDs are implanted in such a way that in these meridians the crossed support elements are fixed directly to the iris, relying on it like a clip, and in other meridians at one or two points they can additionally be hemmed to the sclera; if there is a safe capsule bag, the ICD is implanted into it after preliminary cutting of the supporting elements (3 in Figs. 1, 2, 3); in the case of complete absence of capsular or rainbow support, the ICD is implanted using suture fixation to the sclera after the preliminary formation of three scleral pockets in the meridians corresponding to the location of the supporting elements (3 in Figs. 1, 2, 3) in the ICD haptic, and the ICD implantation in all of the above cases carried out through a small tunnel incision of the cornea or sclera.

The implantation method according to the invention is as follows. In the presence of the remains of the capsule bag in the eye around the entire perimeter after performing a tunnel corneal or scleral section 6-7 mm long, the elastic iridine-lens diaphragm (Figs. 1, 2, 3) is folded using capture-interception tweezers and inserted into the anterior chamber positioning so that the supporting elements (3 in FIGS. 1, 2, 3) of the haptic part of the ICD rested on the ciliary groove and rested on the remains of the capsule throughout the circle without additional suture fixation, one or two immersion interrupted sutures are applied to the tunnel incision. If there are residues of the capsule bag in the eye, only in some meridians try to position the irido-lens diaphragm in such a way as to maximize the use of the capsule remnants for seamless support of the ICD in the ciliary groove in these meridians, while in the meridians where the capsule bag is absent, respectively, to the projection points of the supporting haptic elements are formed after the conjunctiva 1-2 scleral pockets are cut into 1 / 3-1 / 2 of the thickness with the base to the limb, where IHD is sutured. To do this, after performing a tunnel corneal or scleral section 6-7 mm long, a needle with a 9-0 thread is held, pre-tied to one or two support elements (3 in Figs. 1, 2, 3), respectively, according to the future location of the IHD in the eye, through the front chamber and punctured in preformed scleral pockets, the elastic iris-crystalline diaphragm (Figs. 1, 2, 3) are folded with gripping-intercepting forceps and inserted into the front chamber, so that the supporting elements (3 in Fig. 1, 2, 3) of the haptic part of them They rested against the ciliary groove and rested on the capsule remnants in the corresponding meridians, and in the places of suture fixation, the threads are pulled and then fixed, one or two immersion interrupted sutures are applied to the tunnel incision, and the scleral pockets are sutured. If there are residues of the iris in the eye after performing a tunnel corneal or scleral incision 6-7 mm long, the elastic iris-crystalline diaphragm (Figs. 1, 2, 3) is folded with tweezers-pickups and inserted into the anterior chamber, placing so that the previously cut closed ends of the supporting elements (3 in FIGS. 1, 2, 3) of the haptic portion of the ICD rest on the remains of the iris according to the type of clip in 3-5 corresponding meridians without additional suture fixation, or in the presence of an iris only to support one or two elements in other meridians, suture fixation is performed in the scleral pocket according to the method described above, then one or two submerged nodal sutures are placed on the tunnel incision, the scleral pockets and the conjunctiva are sutured. In the presence of a traumatic or congenital cataract and, respectively, with complete or almost complete preservation of the capsule bag, ultrasonic, laser phacoemulsification or mechanical phacofragmentation is preliminarily performed through a corneal or scleral tunnel 5 mm long, after which completely supporting ones are cut off from the ICD (Figs. 1, 2, 3) elements (3 in FIGS. 1, 2, 3) from the rounded haptic part (4 in FIGS. 1, 2, 3), and the elastic iris-crystalline diaphragm is folded with gripping-intercepting forceps and inserted into the anterior chamber, positioning vn Three of the capsular bag. In the case of a complete absence of the capsule bag and the remains of the iris in the eye, according to the projection points of the three supporting elements of the haptic, points of future suture fixation are noted: in the projection for 6 hours, where after the conjunctiva is cut, the scleral pocket is 1/3-1 / 2 of the thickness with the base to the limb, and also in the projection 10 hours 45 minutes and 13 hours 15 minutes, which corresponds to the location of the scleral section 6-7 mm long 1.5-2 mm from the limb and 350 microns deep, one side of which the sclera is stratified upward at a given depth 1 mm for more complete adaptation wound at the end of the operation and in the opposite direction to the limb to form a scleral tunnel for implantation IHD. Then, the 9-0 thread is tied to the three support elements of the ICD, the needles of which are guided through the front chamber and, accordingly, are punctured in the preformed scleral pocket at 6 hours 1.5-2 mm from the limbus, at 10 hours 45 minutes and 13 hours 15 minutes at projections of the sclera incision, the elastic iridine-lens diaphragm is folded with grip-interceptor tweezers and inserted into the anterior chamber so that the support elements with the haptic part of the ICD fixed to them are located in the meridians corresponding to the needle needles, then I pull the threads Centering IHD, fixed to the sclera tunnel incision to impose two - three submersible nodal suture, and the conjunctiva and scleral pocket is sutured.

The invention is illustrated by examples:

Example 1. Patient K., 34 years old. History: 16 years ago, an OU keratotomy was performed. A year and a half ago, I received a blunt injury to the left eye, as a result of which the iris fell out due to a rupture of the keratotomy scar, PCO was made at the place of residence due to the injury, and after 4 months a traumatic cataract developed, which was also removed extracapsularly at the place of residence. Upon receipt of the diagnosis: OU - corneal scars after keratotomy. OS - post-traumatic aniridia, aphakia, traumatic retinopathy. There is a preserved rear capsule. However, it is not possible to form a capsular bag due to the fact that the front and back sheets stuck together due to the prescription of the operation. Visual acuity of the left eye = 0.01 s +12, OD = 0.2-0.3, right eye = 1.0. IOP of both eyes = 20 mm Hg.

On the left eye, a tunnel implantation of an elastic monolithic iris-crystalline diaphragm with a colored haptic (Fig. 1) was performed without additional suture fixation with support on a preserved capsule and with a stop of 5 points of support elements of the haptic part into a ciliary groove according to the invention. The operation and the postoperative period proceeded without complications. Visual acuity in the distance after surgery: 0.2 s cyl-3,0a × 78 ° = 0.4. IOP within normal limits.

When viewed a year after the operation: ICD is in a stable position, fibrosis of the posterior capsule has developed. Visual acuity OD: 0.3 n / k, IOP 22 mm Hg. A YAG laser discisation of the posterior capsule was performed, after which the vision rose to 0.5.

Example 2. Patient G., 17 years old. Upon receipt of the diagnosis: congenital cataract of both eyes, horizontal nystagmus, deep amblyopia. Visual acuity OD = 0.005 n / a, OS = 0.01-0.02 n / a.

An operation of tunnel ultrasonic phacoemulsification was performed with implantation of an elastic ICD with a colored haptic (Fig. 2) into a capsular bag after cutting off additional support elements from the haptic part according to the invention on the right eye, and after 3 months the same operation was performed on the left. Operations and the postoperative period were uneventful. Visual acuity in the distance in both eyes after surgery: 0.03 n / a, which is associated with deep amblyopia. This patient in the postoperative period twice with an interval of six months was given a course of complex conservative treatment of amblyopia with electro-, laser- and magnetostimulation. It was possible to achieve an increase in vision a year and a half after the operation to 0.06 on the right and to 0.09-0.1 on the left eye. ICDs are in the correct position in capsule bags. IOP 21 mm Hg.

Example 3. Patient B., 39 years old. A history of 2 years ago, a penetrating wound of the cornea with loss of the iris and the lens of the left eye, PHO at the place of residence. Upon receipt of the diagnosis: OS - central gross corneal scar, aniridia, aphakia, destruction of the vitreous body. In the meridian of 11-17 hours there are the remains of the capsule bag on the periphery. Visual acuity of the left eye is 0.04 n / a, right eye 1.0. IOP OD 19 mm Hg, OS 21 mm Hg.

An operation was performed on the left eye: a through corneal transplant with implantation of elastic ICD (Fig. 3) with partial vitrectomy according to the invention with suture fixation in the scleral pocket in the meridian for 20 hours and relying on the remains of the capsule at 11-17 hours. The operation and the postoperative period without complications. Visual acuity after surgery: 0.3 cyl-2.5 ax 47 ° = 0.5.

On examination after 1 year: the position of the IHD is stable, the visual acuity is the same, IOP of 20 mm Hg, the patient is satisfied with the cosmetic effect.

Example 4. Patient L., 48 years old. A history of penetrating corneoscleral wound of the eyeball a year ago with damage to the lens, due to which a PCF was performed with removal of the damaged lens and excision of part of the iris that fell into the wound at the place of residence. Upon receipt of a diagnosis of OD: aphakia, partial aniridia, traumatic retinopathy. The iris is kept within half a circle from 17 to 12 hours. Visual acuity of 0.01 s + 12.0 = 0.5. IOP = 22 mm Hg.

On the right eye, the operation of implanting a monolithic elastic ICD (Fig. 2) through a corneal tunnel incision according to the invention with the support of three support elements of the clip type on the remains of the iris in the meridians of 18, 20-30 and 11 hours and with suture fixation in the scleral pocket in 1.5 mm from the limb in the meridian 13-30 hours. Operation and postoperative period without complications. Visual acuity after surgery: 0.5 n / a.

When viewed after a year, the position of the IHD is stable, visual acuity is 0.6 n / k, IOP = 20 mm Hg. The cosmetic effect is satisfactory.

Thus, the use of the proposed design of IHD and the method of its implantation and fixation in the eyes with aniridia - aphakia allows us to provide a stable position and reliability of fixation of IHD in the eye, taking into account the presence or absence of capsule or iris residues, restore the anatomy of the eye, and reduce the risk of intraoperative hemorrhagic and postoperative hypertensive complications, eliminate the cosmetic defect of aniridia and contribute to a more complete social and professional rehabilitation of patients.

Claims (2)

1. Irido-crystalline diaphragm made of a monolithic disk-shaped of elastic material, containing optical and haptic parts, characterized in that the haptic part is made in the form of a colored ring with an inner diameter of 3.0-4.5 mm and an outer diameter of 9.0-10 , 0 mm, with supporting arcuate closed elements located at the periphery equidistant from each other in the form of the vertices of a figure symmetrical or asymmetric with respect to the axis of rotation of the "five-pointed star", within a circle of 11.0-13.5 mm, while for a point touch I support elements surrounding tissues have rounded or pointed top. 2. The method of implanting an artificial iris-lens diaphragm (IHD) in case of aniridia - aphakia, including the use of the support elements of its haptic part for fixing the IHD depending on the presence or absence of the lens bag, capsule or iris residues, characterized in that the IHD is implanted through a small tunnel incision of the cornea or sclera; in this case, in the case of the presence of the remains of the capsule bag in the eye, the supporting elements of the implantable ICD are supported on these residues without additional suture fixation and abut against the ciliary groove; in the presence of iris residues in the meridians, the closed ends of the supporting elements of the haptic part of the ICD are preliminarily cut off and ICD support elements are fixed in these meridians directly to the iris according to the clip type, and in those meridians where there are no iris residues, the support elements are additionally hemmed at one or two points to the sclera; if there is a safe capsule bag, ICD is implanted into it after preliminary complete cutting of the supporting elements of the haptic part; in the case of complete absence of capsular or rainbow support, ICDs are implanted using suture fixation to the sclera after the preliminary formation of three scleral pockets in the meridians corresponding to the location of supporting elements in the haptic part of the ICD.

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