RU2395258C1 - Implant for correction of upper eye-lid position (versions) - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: versions of invention relate to ophthalmology. Implant contains hinged links with canals for passing suture threads. Each link has, as minimum, one straight and one curved canal for passing suture thread with transversal section made for tissue growing between thread and canal-forming flat guide surface for needle and chute-shaped surface with walls oriented at right angle or at acute angle with respect to flat guide surface. Chute bottom is adjacent to radius surface with outlet external groove for suture thread, oriented toward each other butt ends of hinged links being located with clearances for tissue growing between links. In other version of implant implementation links have coating made in accordance with nanotechnology. ^ EFFECT: application of claimed implants will allow to achieve planned lowering of upper eye-lid while looking straight ahead and down, obtain adequate correction or elimination of lagophthalmos, will ensure reliable fixation and holding of implant during term of implant placement, good cosmetic effect with minimal contouring, as well as convenience of application. ^ 21 cl, 4 dwg

Description

The invention relates to ophthalmology and can be used to correct the position of the upper eyelid and lagophthalmos of various origins.

In 1958, Illig K.M. suggested using gold implants to eliminate lagophthalmus and prevent complications caused by it (Illig K.M. A new method of lagophthalmos surgery. Klin Monatsbl Augenheilkd 1958; 132: 410-1).

The disadvantage of this model is its solidity, because of which, after implantation, difficulties arise when performing an eversion of the eyelid, if necessary, examination; the standard and initially specified radius of curvature does not provide its optimal adaptation to the tarsal plate; the absence of suture fixation with the underlying tissues leads to implant displacements. In general, this affects the engraftment, leads to its contouring, the appearance of corneal astigmatism, and can also lead to the development of aseptic inflammation, dislocation and rejection of the implant.

Subsequently, several implant models were proposed, including those made according to individual parameters, including some variations in its shape, thickness, number and location of suture fixation holes (US 6309418 B1, 10.30.2001; US 6482428 B1, 11/19/2002; US 7108718 B1, 09/19/2006).

Despite the possibility of suture fixation and, accordingly, greater stability, better adaptation and, as a result, a higher cosmetic effect, all of them retained the aforementioned disadvantages to one degree or another. The rigidity of the structure causes certain difficulties when conducting the suture thread through the holes for fixation.

The closest analogue of the invention is the implant DE 19741342 C1, 05/06/1999, containing articulated links with ligature channels.

The disadvantages of this implant include the insufficient size of the channels for suture fixation in the chain links, as well as their location relative to the surface, which causes difficulties when holding the needle and fixing the implant to the underlying tissues.

The ligature thread protrudes above the front surface of the link due to the lack of grooves for its immersion, which leads to its worst covering with tissues, can cause aseptic inflammation and proliferation of granulomatous tissue. The thread may bother the patient upon palpation of the implant.

The asymmetric arrangement of the holes in the implant of maximum mass and length leads to difficulties in fixing the marginal links associated with the oversize implant size of the tarsal plate, especially in patients with small eyelids.

The links on the periphery have the same height compared to the central and insufficiently rounded edges, which, when using an implant of maximum mass and, accordingly, length, is accompanied by significant contouring and tension of the skin along the edges of the implant and can lead to its rejection.

This group of inventions is aimed at solving the problem of creating implants that do not have the disadvantages of known designs.

The technical result of the invention is the achievement of a predetermined lowering of the upper eyelid when looking straight and down, achieving adequate correction or elimination of lagophthalmos, ensuring reliable fixation and retention of the implant during the term of the implant, a good cosmetic effect with minimal contouring, as well as ease of use.

The technical result is achieved through the formation of a connective tissue capsule around the links, including the spaces between them, and fibrovascular growth into the ligature channels and new eyelid biomechanics, due to the location of the links and individual anatomical adaptation of the chain of implant links to the tarsal plate in different directions of the gaze.

The essence of the proposed group of inventions is expressed in the aggregate of essential features, in which the first version of the implant for correcting the position of the upper eyelid, containing articulated links with channels for suture threads, differs from the closest analogue in that each link has at least one straight or curved a channel for conducting a suture thread with a cross section made for the germination of tissue between the thread and forming the channel, a flat guide surface under the needle and the surface in the form of a groove and with walls oriented to a flat guide surface at a right angle or at an acute angle, while the bottom of the gutter is mated with a radius surface with an output outer groove for the suture thread, and the ends of the articulated joints oriented towards each other are located with gaps for the tissue to grow between the links.

In particular cases of its implementation or use, the implant according to the first embodiment contains:

- oriented toward each other ends of articulated joints, located with gaps for tissue germination, each gap for tissue germination is 1-1.5 mm;

- the output outer groove for the suture thread, having a section on the surface of the link and a section on the side surface of the link, the cross-sectional size of the section on the surface of the link equal to the diameter of the suture thread or greater than the diameter of the suture thread, and the cross-sectional size of the section on the side surface of the link exceeds the diameter of the suture threads 1.5 times;

- the central link and the side links symmetrically located on both sides of the central link, while the end surfaces of the extreme lateral links have curves located in the plane of the axial hinges, and the sections of links adjacent to the axial hinges have reduced thickness and curves located in planes perpendicular to the plane axial joints;

- links, each of which has two straight and / or curved channels for suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link;

- links, each of which has two straight and / or curved channels for conducting suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link made with an additional groove for the suture thread, mated with radial surfaces with channel grooves for suture;

- can be made of platinum and / or gold;

- have a drug coating;

- have a drug coating, which is equipped with a removable protective film;

- have at least one rough and / or uneven surface;

- have a porous bio-integrable, for example, hydroxyapatite coating.

The second version of the implant for correcting the position of the upper eyelid, containing pivotally connected links with channels for suture threads, differs from the closest analogue in that each link has at least one straight or curved channel for suture threads with a cross section made for germination tissue between the thread and the channel forming a flat guide surface under the needle and the surface in the form of a gutter with walls oriented to the flat guide surface at a right angle or at an acute angle m, while the bottom of the gutter is connected by a radius surface with the output outer groove for the suture thread, and the ends of the pivotally connected links oriented towards each other are located with gaps for the tissue to grow between the links and have a coating made by nanotechnology.

In particular cases of its implementation or use, the implant according to the second embodiment contains:

- a coating made by nanotechnology, located at least in one straight or curved channel for conducting suture thread;

- a coating made by nanotechnology, located on the surface of at least one link or on the surfaces of at least one link, and the coating can be arranged in stripes;

- the output outer groove for the suture thread, which has a section on the surface of the link and a section on the lateral surface of the link, the cross-sectional size of the section on the surface of the link equal to the diameter of the suture thread or greater than the diameter of the suture thread, and the cross-sectional size of the section on the side surface of the link exceeds 1 5 diameters of suture thread;

- the central link and the side links symmetrically located on both sides of the central link, while the end surfaces of the extreme lateral links have curves located in the plane of the axial hinges, and the sections of links adjacent to the axial hinges have reduced thickness and curves located in planes perpendicular to the plane axial joints;

- may have links, each of which has two straight and / or curved channels for suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link;

- may have links, each of which has two straight and / or curved channels for conducting suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link made with an additional groove for the suture thread conjugated by radius surfaces with channel grooves for suture threads.

The connection of these features with the technical result of the invention is manifested in the fact that the articulated joints of the implant allow it to adapt to the curvature of tarsal plastic.

The execution of each link with at least one straight or curved ligature channel ensures reliable fixation of the links during suture fixation and fibrovascular ingrowth of surrounding tissues and the use of needles of the most suitable shape and size.

The implementation of each channel for conducting a suture with a flat guide surface under the needle and a surface in the form of a groove with walls oriented to the flat guide surface at right or acute angles reduces the needle displacement during suturing and the graft displacement relative to the ligature when the implant is in the tissues.

The conjugation of the radial surface of the bottom of the gutter with the output of the outer ligature groove eliminates the protrusion of the seam above the surface of the link and, accordingly, reduces the irritating effect on the tissue.

The symmetrical arrangement of the lateral links and ligature channels relative to the central link allows for full suture fixation in case of mismatch between the length of the implant and the tarsal plate.

Due to the shape of the central link, the optimal distribution of the implant weight and the maximum load at the selected point are ensured, which helps to achieve a lower eyelid position with a lower implant weight.

Reducing trauma to surrounding tissues is achieved by rounding the end surfaces of the extreme lateral links located in the plane of the axial hinges, performing sections of links with reduced thickness adjacent to the axial hinges, and rounding located in planes perpendicular to the plane of the axial hinges.

The presence of curvatures and a smaller thickness of the surfaces of the sections of the links adjacent to axial joints located in planes perpendicular to the plane of the axial joints creates a smoother outer surface of the implant, which minimizes its competition, gives an optimal cosmetic effect and reduces the risk of implant eruption.

Reducing the irritating effect on the tissue contributes to:

- drug coating

- links having two straight and / or curved ligature channels with a distance between channels at the output ligature grooves, which is less than the distance between the channels on the opposite side of the link, and also links having two straight and / or curved ligature channels, with a distance between channels at the output ligature grooves, which is less than the distance between the channels on the opposite side of the link, made with an additional ligature groove, mated with radius surfaces with the grooves of the ligature channels.

For better preservation, the drug coating may be provided with a removable protective film.

Rough and / or uneven surfaces of links or surfaces of links with a porous bio-integrable (for example, hydroxyapatite) coating provide contact between the implant and tissues, which is also facilitated by the implementation of the implant of platinum and / or gold and a coating made by spraying. The coating, made by nanotechnology, even more reduces the irritating effect of the implant on the tissue due to its properties. The invention is illustrated by the drawing, in which Fig. 1 shows a general view of the implant for correcting the position of the upper eyelid, and Fig. 2, Fig. 3 and Fig. 4 are sections A-A, B-B and B-B shown respectively in Fig. 1. one. The upper eyelid position correction implant contains articulated links 1, 2, 3, 4 and 5 having at least two straight and / or curved ligature channels 6. Each ligature channel 6 is formed by a flat guide surface 7 under the needle and a surface in the form of a groove 8. The walls of the gutter 8 are oriented to a flat guide surface 7 at right or acute angles (Fig. 1 shows the location of the walls of the gutter 8 at sharp angles). The bottom of the groove 8 is conjugated by a radius surface 9 with an output outer ligature groove 10 located at the end of the channel 6. The ligature groove 10 extends to the edge of the link, while the depth and width of the groove to the edge of the link is not less than 1 diameter of the ligature thread, and the groove is deepened at the edge of the link is not less than 1.5 of the diameter of the ligature yarn.

An implant may have:

- the central link 3 and the lateral links 1, 2, 4 and 5 symmetrically located on both sides of the central link 3, while the end surfaces of the extreme lateral links 1 and 5 have curves 11 located in the plane of the hinges 12;

- links 1, 2, 3, 4 and 5 can have two straight and / or curved ligature channels 6 with a distance between channels at the output ligature grooves 10, which is less than the distance between channels 6 on the opposite side of links 1, 2, 3, 4 and 5;

- links 1, 2, 3, 4 and 5 can have two straight and / or curved ligature channels 6 with a distance between channels at the output ligature grooves 10, which is less than the distance between channels 6 on the opposite side of links 1, 2, 3, 4 and 5, made with an additional ligature groove (not shown), mated with radial surfaces with grooves 8 of the ligature channels 6, from which ligature grooves extend to the edge of the link, while the depth and width of the groove to the edge of the link is at least one diameter of the ligature thread , and the deepening of the ditches and edge level is not less than 1.5 times the diameter ligature filament;

- drug coating;

- drug coating, which is equipped with a removable protective film;

- have at least one rough and / or uneven surface;

- be made of biocompatible and bioinert material;

- be made of platinum and / or gold.

The implant can be used to correct the width of the palpebral fissure (when looking straight and down), to correct lagophthalmos of various origins, including neurogenic (acute and chronic paresis of the facial nerve), non-closure of the fissure with exophthalmos, in particular with endocrine ophthalmopathy, and also with retraction of the superior century. The following methods of placement and fixation of the implant are possible:

1) pretarsal production

2) fixation to septum orbitale,

3) placement of the implant in front of the upper extraconal space of the orbit.

1. Pretarsal fixation: a skin incision is made in the middle third of the fold of the upper eyelid; the blunt path exposes the tarsal plate; a pocket is formed sufficient to place an implant of the appropriate size in it, the weight of which is selected in the preoperative period; its suture fixation to the underlying tissues through channels is carried out; palpebral fibers of the circular muscle of the eye are sutured, a suture is applied to the edges of the skin incision.

Perhaps covering the implant with an aponeurosis of the upper eyelid levator or other biological or artificial coatings.

2. Fixation to septum orbitale: form a pocket between the circular muscle of the eye and septum orbitale, exposing the upper part of the tarsal plate, the implant is fixed to the upper part of the tarsal plate and to septum orbitale, the implant is covered with fibers of the circular muscle of the eye, a suture is applied to the edges of the skin incision.

3. Insertion of the implant in the front of the upper extraconal space of the orbit: a skin incision is made, a septum orbitale is secreted, after opening of which the implant is installed and fixed with sutures through the channels to the aponeurosis of the upper eyelid levator, septum orbitale, the circular muscle of the eye and skin are sutured in layers.

When installing the implant, its links 1, 2, 3, 4 and 5 due to the hinges 12 are located at an angle to each other, ensuring fit to the underlying tissue.

The fixation of links 1, 2, 3, 4 and 5 is carried out by a ligature, which is carried out through a direct or curved needle through straight and / or curved ligature channels 6.

Since each ligature channel 6 is formed by a flat guide surface 7 under the needle and a surface in the form of a groove 8 with walls oriented to the flat guide surface 7 at right or acute angles, the needle has support in all directions and does not move in the puncture.

After flashing, the ligature is placed in the output external ligature groove 10 located at the end of the channel 6. The radius surface 9, through which the bottom of the groove 8 is connected to the output external ligature groove 10, allows you to reduce the size of the part of the ligature protruding above link 1, 2, 3, 4 or 5, and, accordingly, minimize the irritating effect of the ligature on the tissue.

The ligature always has a smaller cross section compared to the needle and the channel for its conduct, therefore, each ligature channel 6 has a maximum cross-sectional size that exceeds the diameter of the thread.

This ratio of the channel and its location in the corners of the flat guide surface 7 minimizes the displacement of the implant.

The device is used as follows. Patient P., 43 years old, with a diagnosis of traumatic chronic paresis of the right facial nerve, paralytic lagophthalmus on the right, keratopathy, complains of progressive pain in the right eye and the inability to close the eye.

Objectively: The right eye. Non-closure of the palpebral fissure - 5 mm. Blinking movements less often than on the left eye. The conjunctiva is irritated, signs of xerosis. Schirmer test 1-3 mm. The cornea is smooth, transparent in the upper and central sections, in the lower sections, rough with subepithelial opacities. Norn test 5 seconds.

In accordance with the results of a preoperative examination using external tantalum weights of the upper eyelid, its optimal weight was calculated - 1.6 grams.

Technique for the operation. The treatment of the surgical field with a 10% aqueous solution of iodopyrone was performed. Local infiltration anesthesia with a solution of lidocaine 2% - 1 ml and 0.5% - 1 ml of marcaine in a ratio of 1: 1 was performed. In the middle third of the upper eyelid, a skin incision of 22 mm was made in the crease area. The tarsal plate is exposed bluntly, a pocket is formed that is sufficient to place an implant in it. An implant made of 999 gold was installed, weight - 1.6 grams. Its suture fixation (prolene 6/0) was carried out to the underlying tissues through the channels of the upper part in three places: the extreme links 2 and the central link 1. The implant was covered with palpebral fibers of the circular muscle of the eye. A continuous suture 7/0 prolene was applied to the edges of the skin incision. A tetracycline ointment is applied. Aseptic sealing.

3 months after the operation: there is no pain, the palpebral fissure is narrowed due to 2 mm of the lowering of the upper eyelid when looking directly, there is no closure of the eyelids, the cornea is transparent, smooth and shiny in all departments. Due to the profile of the chain of links and their optimal adaptation to the tarsal plate of the upper eyelid, no contouring is noted, the implant does not cause complaints.

Claims (21)

1. An implant for correcting the position of the upper eyelid, containing articulated links with channels for conducting suture threads, characterized in that each link has at least one straight or curved channel for conducting suture thread with a cross section made for the tissue to grow between the thread and the generators channel with a flat guide surface under the needle and a surface in the form of a gutter with walls oriented to the flat guide surface at a right angle or at an acute angle, while the bottom of the gutter is conjugated usnoy outer surface of the outlet groove for the suture, and oriented towards each other ends pivotally connected units are arranged with clearances for germination tissue between the links. 2. The implant according to claim 1, characterized in that the ends of the pivotally connected links oriented towards each other are located with gaps for tissue germination, each gap for tissue germination is 1-1.5 mm. 3. The implant according to claim 1, characterized in that the output outer groove for the suture thread has a section on the surface of the link and a section on the lateral surface of the link, and the cross-sectional dimension of the section on the surface of the link is equal to the diameter of the suture thread or exceeds the diameter of the suture thread, and the size the cross section of the section on the side surface of the link exceeds the diameter of the suture thread by 1.5 times. 4. The implant according to claim 1, characterized in that it contains a central link and lateral links symmetrically located on both sides of the central link, while the end surfaces of the extreme lateral links have curvatures located in the plane of the axial joints, and sections of links adjacent to the axial joints have a reduced thickness and curvature located in planes perpendicular to the plane of the axial joints. 5. The implant according to claim 1, characterized in that each link has two straight and / or curved channels for suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link. 6. The implant according to claim 1, characterized in that each link has two straight and / or curved channels for conducting suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link made with an additional groove for a suture thread conjugated by radius surfaces with channel grooves for a suture thread. 7. The implant according to claim 1, characterized in that it is made of platinum and / or gold. 8. The implant according to claim 1, characterized in that it has a drug coating. 9. The implant according to claim 1, characterized in that it has a drug coating, which is equipped with a removable protective film. 10. The implant according to claim 1, characterized in that it has at least one rough and / or uneven surface. 11. The implant according to claim 1, characterized in that it has a protective coating. 12. The implant according to claim 11, characterized in that it has a protective coating that is sprayed. 13. The implant according to claim 1, characterized in that it is made with a porous bio-integrable, for example, hydroxyapatite coating. 14. An implant for correcting the position of the upper eyelid, containing articulated links with channels for suture thread, characterized in that each link has at least one straight or curved channel for suture thread with a cross section made for the germination of tissue between the thread and the generatrix channel with a flat guide surface under the needle and a surface in the form of a gutter with walls oriented to the flat guide surface at a right angle or at an acute angle, while the bottom of the gutter is conjugated a ical surface with an output outer groove for the suture thread, and the ends of the articulated joints oriented towards each other are located with gaps for tissue growth between the links and have a coating made by nanotechnology. 15. The implant according to 14, characterized in that the coating, made according to nanotechnology, is located in at least one straight or curved channel for holding the suture thread. 16. The implant according to 14, characterized in that the coating made according to nanotechnology is located on the surface of at least one link or on the surfaces of at least one link. 17. The implant according to clause 16, characterized in that the coating, made according to nanotechnology, is located in the form of strips. 18. The implant according to 14, characterized in that the output outer groove for the suture thread has a section on the surface of the link and a section on the side surface of the link, the cross-sectional dimension of the section on the surface of the link equal to the diameter of the suture thread or greater than the diameter of the suture thread, and the size the cross section of the section on the side surface of the link exceeds 1.5 suture diameter. 19. The implant according to clause 15, characterized in that it contains a central link and lateral links symmetrically located on both sides of the central link, while the end surfaces of the extreme lateral links have curvatures located in the plane of the axial hinges, and sections of the links adjacent to the axial hinges have a reduced thickness and curvature located in planes perpendicular to the plane of the axial joints. 20. The implant according to clause 16, wherein each link has two straight and / or curved channels for suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link. 21. The implant according to clause 16, wherein each link has two straight and / or curved channels for conducting suture threads, and the distance between the channels at the output grooves for suture threads is less than the distance between the channels on the opposite side of the link made with an additional groove for suture thread conjugated by radius surfaces with channel grooves for suture thread.

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