WO2020139212A1

WO2020139212A1 - A sutureless scleral fixation cannula

Info

Publication number: WO2020139212A1
Application number: PCT/TR2018/050936
Authority: WO
Inventors: Ertuğrul Can
Original assignee: Ondokuz Mayis Üni̇versi̇tesi̇ Rektörlük Özel Kalem Vergi̇ Numarasi
Priority date: 2018-12-28
Filing date: 2018-12-28
Publication date: 2020-07-02
Also published as: TR201820995A2

Abstract

The present invention relates to a sutureless scleral fixation cannula that allows for a controlled and sutureless implantation of intraocular lenses (IOL) to sclera through ciliary sulcus in surgeries involving posterior chamber intraocular lens (IOL) implantation by means of scleral fixation. By means of the implementation of the embodiment wherein the present invention comprises needles at both ends, the tunnel creation procedure is facilitated. Inventive sutureless scleral fixation cannula (10) is used in the treatment of eye (20) diseases and in implantation of posterior chamber intraocular lens (30) (IOL) following the removal of a patient's own crystalline lens through a surgical operation due to any reason.

Description

A SUTURELESS SCLERAL FIXATION CANNULA

Technical Field

The present invention relates to a sutureless scleral fixation cannula that allows for a controlled and sutureless implantation of intraocular lenses (IOL) to sclera through ciliary sulcus in surgeries involving posterior chamber intraocular lens (IOL) implantation by means of scleral fixation.

The present invention relates particularly to a sutureless scleral fixation cannula having needles at both ends thereof, used in posterior chamber intraocular lens (IOL) implantation surgeries .

State of the Art

Cataract is the deterioration of eyesight due to the clouding of lens (eye lens) which is the second layer that makes images seem smaller by diffracting rays and eventually gaining opacity thereupon. Although the condition of cataract arises as an age- associated problem, it can also be observed in people of all age groups due to various reasons. Cataracts left untreated at young ages may cause severe amblyopia up to the level of blindness.

Delayed treatments in this regard may occasionally result in intraocular inflammations and severe eye pressure. Treatment of cataract generally involves the removal of a person's natural eye lens and its replacement with an artificial one. In sutural cataract surgery, following the injection of anesthetic agent to the eye, a large incision is made around the cornea and the sclera so that a gap is created through which the lens can be extracted. Person's lens is extracted through this gap and subsequently the same gap is used for the insertion of artificial unfoldable rigid lens into or before the hyaloid membrane and concordantly this gap is closed with the adequate amount of stitches by means of suturing. In failed cataract surgeries, lenses cannot be inserted into the eye by means of standard methods. In such cases therefore, the lens must be sutured to the eye so that it can retain its position. Furthermore, the complete extraction of eye lens can occasionally be necessary in vitreoretinal eye surgeries. Again, in such cases artificial lenses cannot be inserted through standard methods. To that end, lens is inserted to the eye by being sutured to the sclera by means of conventional methods. In the recent years, this procedure was tried to perform in a sutureless manner by means of various assistive instruments. Various methods were developed in line with this purpose. However, all of these are exceptionally difficult methods and the eye becomes severely traumatized during the surgery. Moreover, with the exception of surgeries performed by highly talented and experienced ophthalmologists, obtaining satisfactory results is not an easy matter. Due to these reasons, lenses are inserted to the eye by being sutured to the sclera by means of conventional methods. One of the crucial stages of cataract surgery is the implantation of intraocular lenses (IOL) . Despite of the advanced surgical techniques of modern day, insufficiency of posterior capsular support associated with diseases that may result in traumatic cataracts, phacodoneses and lens luxation renders posterior chamber IOL implantation nearly impossible. Therefore, anterior chamber intraocular lens (IOL) implantation or posterior chamber scleral fixated intraocular lens (IOL) implantation constitutes options for alternative surgery. Because of its improved refractive properties observed during the recent years, posterior chamber scleral fixated IOL implantation is opted for anterior chamber IOL implantation.

In surgeries of scleral fixated posterior IOL implantation, intraocular lenses are implanted into the ciliary sulcus through two different methods which are known as sutured (sutural) and unsutured (sutureless) . In the sutured method, subsequently after a patient's own crystalline lens is removed through surgical means due to any sort of reason, a posterior intraocular lens (IOL) is implanted as a substitution. If the posterior capsule of the crystalline lens remains intact, then the posterior chamber IOL can be implanted into the capsule without any additional procedure. In cases where this capsule is partially damaged or in case when it suffers extensive damage, then the intraocular lenses are implanted to the posterior chamber by means of fixating it either to the sclera or the iris. While these procedures are being carried out, haptic portion of the intraocular lens is inserted to the ciliary sulcus and particularly during the process of scleral fixation, surgical suture is also run through the ciliary sulcus and crossed from the sclera. Initially in this procedure, depending on the preference of the surgeon, an incision usually wider than

1,5 mm is made in the cornea. Subsequently, the rear end of the first suture is ligated to one of the haptics of the lens.

Analogously, the second suture is also ligated to the other haptic. Surgeon then gains access to the anterior chamber by means of running the needle of the first suture through the incision made on the cornea and subsequently the needle is advanced below the iris and eventually reaches to the ciliary sulcus. The space located below the iris where it enters into connection with the sclera is named as the ciliary sulcus. After the point of the needle is advanced further, surgeon runs it through the sclera and exerts, preferably in line with the 9 o'clock position (this localization varies depending on the preference of the surgeon) . Same procedures are performed for the second suture as well. Surgeon then gains access to the anterior chamber by means of running the needle of the second suture through the incision made on the cornea and subsequently the needle is advanced below the iris and eventually reaches to the ciliary sulcus. After the point of the needle is advanced further, surgeon runs it through the sclera and exerts, preferably in line with the 3 o'clock position (this localization varies depending on the preference of the surgeon) .

Subsequently the posterior chamber intraocular lens (IOL) is implanted to the anterior chamber through the incision made on the cornea and then inserted to the posterior chamber. Meanwhile the settling of haptics belonging to the posterior chamber intraocular lens (IOL) into the ciliary sulcus is enabled by means of pulling needles and their sutures that are egressed from the sclera. In the sutureless method which is the second one in this field, haptic portion of the intraocular lens (IOL) is impaled into the sclera instead of the ciliary sulcus and no surgical suture is used in this procedure. In the sutureless method, subsequently after its implemented under topical, peribulbar, retrobulbar or preferably general anesthesia, conjunctival peritomy is performed in accordance with the egress points of intraocular lens (IOL) haptics and cauterization is performed in order to stop the bleeding when necessary.

Preferably, an infusion cannula or an anterior chamber provider can be implanted in order to ensure the intraocular tonus, wherein this implantation is inserted into an optimal quadrant in order not to aggravate the forming of scleral flaps and to prevent it from hindering further surgical manipulations. Two limbal-based scleral flaps having partial thickness and is of

2.5 - 3 mm in size (these proportions may vary depending on the preference) are formed 1.5 or 2 mm away from the limbus with an angle of 180 degrees on a basis of reciprocity. Again preferably, procedures such as pars plana vitrectomy or anterior vitrectomy through the path of anterior chamber can be performed. Depending on the preference two reciprocal sclerotomies with an angle of 180 degrees to one another can be performed in flap locations, 1.5 or 2 mm away from the limbus by means of 20, 22, 23, 24, 25, 26 or 27-gauge needles or with surgical blades. Furthermore, a tunnel is created within the sclera in order for the impaling of haptics at the end of the procedure. While the intraocular lens placed inside the cartridge and the injector is being implanted into the anterior chamber (intraocular lens implantation can be performed without using an injector by inserting it to the anterior chamber directly by means of folding it with forceps), 25-gauge (can be 24-27 gauge as well) microforceps are inserted into the anterior chamber through the sclerotomy with assistance of the other hand. End portion of the anterior haptic is retained by means of the microforceps and pulled outside through the location of sclerotomy. Analogously, other haptic is also drawn outside through the other sclerotomy location. Haptic ends are impaled into previously created tunnels. Subsequently the scleral flaps are closed wherein this closure procedure is performed either through suturing or preferably by using biological wound glues. Conjunctiva is similarly sutured or adhered by using biological wound glue. Apart from the technique mentioned above, intraocular lens (IOL) haptics can also be impaled into the sclera by means of pulling out using 25-gauge or 27-gauge needles instead of microforceps without the utilization of suture. Both of these have advantages, as well as disadvantages when subjected to comparison. In the sutureless scleral fixation procedure and the method where microforceps are utilized, certain probabilities where intraocular ciliary body may suffer damage or intraocular lens (IOL) haptics may break quite easily rise to the surface. In methods where surgical needles are utilized, inserting haptics through the needle cavity while inside the intraocular space is quite difficult. Moreover, in both methods specifically after the implantation of the first haptic, implantation of the second haptic becomes significantly harder and surgical operations such as this are generally performed by highly experienced ophthalmologists. Additionally, sclerotomies incised in these methods are relatively thicker and depending on the vitreous exudate certain risks involving post operative hypotony and infection are present. The present invention relates to a sutureless scleral fixation cannula having a double-ended needle that eliminates abovementioned disadvantages present in the state of the art.

Brief Description and Objects of the Invention

Within the present invention, sutureless scleral fixation cannula that has needle on at least one of its ends and that is used in scleral fixation posterior chamber intraocular lens (IOL) implantation surgeries.

It is therefore an object of the present invention to allow for implanting of intraocular lenses (IOLs) to the sclera in a sutureless, easier, more controlled and more secure manner by means of the inventive sutureless scleral fixation cannula.

It is thus another object of the present invention to eliminate risks that involve the damaging of intraocular ciliary body or breaking of intraocular lens haptics through enabling the implantation of intraocular lenses (IOLs) to the sclera in a sutureless manner by means of the inventive sutureless scleral fixation cannula.

It is therefore an object of the present invention to provide ease of implementation for the surgeon through eliminating the need for procedures involving needles and suturing and thereby eliminating the difficulty experienced in the stage involving the implantation of the second haptic by means of the inventive sutureless scleral fixation cannula.

It is thus another object of the present invention to ensure incising thinner sclerotomies and to reduce risks of post operative hypotony and infection associated with vitreous exudate resultant of thicker sclerotomies by means of the inventive sutureless scleral fixation cannula.

Description of the Figures

In order for understanding the present invention's structural properties and advantages it offers together with its complementary elements better, it should be subjected to an evaluation in company with the figures described below.

Figure 1: Illustrates the general schematic view of the inventive scleral fixation cannula having a needle at one end .

Figure 2: Illustrates the general schematic view of the inventive scleral fixation cannula having needles at both ends .

Figure 3: Illustrates the general schematic view of the eye.

Figure 4: Illustrates the general schematic view of intraocular lens (IOL) .

Figure 5: Illustrates the general schematic view of the eye before cannula implementation.

Figure 6: Illustrates the general schematic view of the eye during when scleral fixation cannula is being implemented.

Figure 7: Illustrates the general schematic view of the eye during the stage of intraocular entry with the needle subsequently after the scleral tunnel is created (a: single needle, b: double needle) .

Figure 8: Illustrates another general schematic view of the eye during the stage of egressing with needle from the primary incision.

Figure 9: Illustrates the general schematic view of the implantation of lens haptic inside the cannula (a: single needle, b: double needle) .

Figure 10: Illustrates the general schematic view of haptics impaled inside the sclera. Figure 11: Illustrates the frontal part of the cannula filled with rigid material without needle in another embodiment of the present invention.

Figure 12: Illustrates the cannula having curved needle only one frontal part in another embodiment of the present invention .

Figure 13: Illustrates the cannula having blunt needle only one frontal part in another embodiment of the present invention .

Description of Elements/Portions/Parts That Constitutes the Invention

In order for providing a better description towards the inventive sutureless fixation cannula developed with this invention, parts and portions within the figures were enumerated and parts and portions corresponding to each number are provided below :

10. Sutureless fixation cannula

11. Anterior needle

12. Tube

13. Posterior needle

20. Eye

21. Lens

22. Sclera

23. Sclera entry point

24. Second point

30. Intraocular Lens (IOL)

31. Anterior haptic

32. Optic Detailed Description of the Invention

The present invention relates to a sutureless scleral fixation cannula (10) having one needle on at least one of the frontal or rear ends that allows for implanting intraocular lenses (30) (IOL) in to the sclera (22) through the ciliary sulcus in a more controlled and sutureless manner in surgeries involving implantation of posterior chamber intraocular lenses by means of scleral fixation. Inventive sutureless scleral fixation cannula (10) is used in the treatment of eye (20) diseases and in implantation of posterior chamber intraocular lens (IOL) following the removal of a patient's own crystalline lens through a surgical operation due to any reason.

The inventive sutureless scleral fixation cannula (10); comprises a tube (12) that enables the implantation of the intraocular lens (30) (IOL) into the sclera (22) by means of grasping it with a needle and needle/needles on at least one of the ends that allows for creating tunnel within the sclera (22) and that allows for entering into the eye (20) .

In an embodiment of the present invention, sutureless scleral fixation cannula (10) comprises a needle only at the frontal end (Figure 1 ) .

In another embodiment of the present invention, sutureless scleral fixation cannula (10) comprises needles at both frontal and rear ends (Figure 2) . One out of anterior needle (11) and posterior needle (13) included in the inventive sutureless scleral fixation cannula (10) has a curved form while the other one has a straight form wherein the posterior needle (13) is preferable of curved and the anterior needle (11) is of straight form. The anterior needle (11) and/or the posterior needle (13) of the inventive sutureless scleral fixation cannula (10) is of round in shape and has tapered point. Needles that are mentioned above can also be of standard cutting, reverse cutting, spatula needle and/or of tapercut needle in characteristics.

In the inventive sutureless scleral fixation cannula (10), the tube is made out of thermoplastic material, polymer or metal. In the present invention, preferably stainless steel, titanium, aluminum and nitinol are used for metal materials. In the present invention, preferably polyvinyl chloride (PVC) , polyethylene (PE) , low-density polyethylene (LDPE) , high-density polyethylene (HDPE) , polytetrafluoroethylene (Teflon) , polypropylene (PP) , polyethylene terephthalate (PET, PETE), natural rubber, polybutadiene, nitrile rubber, silicon rubber or ethylene vinyl acetate is used for polymer materials.

Sclerotomy Procedure with Single-Needle Sutureless Scleral Fixation Cannula

While the inventive sutureless scleral fixation cannula (10) described above is being administered to the patient, after the patient is anesthetized with topical, peribulbar, retrobulbar or preferably with general anesthesia, conjunctival peritomy is performed in accordance with the egress points of the intraocular lens (30) (IOL) haptics and cauterization is performed in order to stop the bleeding when necessary.

Depending on the preference, scleral (22) tunnel can be created directly without performing conjunctival peritomy. Again, depending on the preference, an infusion cannula or an anterior chamber provider can be implanted in order to ensure the eye

(20) tonus (intraocular tonus) . Two reciprocal sclera entry points (23) with an angle of 180 degrees to one another are marked 1.5 or 2 mm away from the Limbus using surgical marker pen or a different tool. Two scleral entry points (23) illustrated in Figure 5 are primary points and they show the locations of sclerotomies (sclerotomy points) . Subsequently, from this marking point the secondary points (24) (Figure 6) are reciprocally marked 3-4 mm away so that it will be parallel to the limbus. This distance provides assistance in determining of the scleral tunnel's length and its direction should be the same with the haptic of the intraocular lens (30) (IOL) . Then entry is performed with the anterior needle (11) through the second point (24) and the scleral tunnel is created towards the sclera entry point (23) . The point of the anterior needle (11) is pulled outside from the sclera entry point (23) as it is shown in Figure 6 and the sclerotomy is performed by means of reentering through the same point (Figure 7) . Clear cornea incision is made and the point of the anterior needle (11) is pulled outside of the eye (20) through this incision (Figure 8) .

Subsequently, the anterior needle (11) portion of the sutureless scleral fixation cannula (10) is cut. Intraocular lens (30)

(IOL) (preferably trilobate) that is placed inside the cartridge and injector is slightly pushed as so its anterior haptic (31) remains outside. Special attention should be paid in order to retain the optic (32) inside the cartridge in the meanwhile.

Point of the anterior haptic (31) demonstrated in Figure 9a is inserted into the tube (12) of the sutureless scleral fixation cannula (10) and it is ensured that approximately the half of the anterior haptic (31) is inserted into the tube (12) .

Subsequently the intraocular lens (30) (IOL) is implanted into the anterior chamber. After this stage, the tube (12) is grabbed outside by its rear portion by means of forceps and pulled slowly wherein the proper implantation of the intraocular lens

(30) (IOL) and settling of anterior haptic (31) running into the scleral tunnel by going through the eye (20) are ensured.

Procedures mention above are implemented for the posterior haptic in the same manner on the opposite side as well and finally as it is demonstrated in Figure 10, after IOL (30) centering is performed by using forceps on both of the extraocular tubes outside of the eye (20), these tubes (12) are then removed by means of pulling them through the second points

(24) using once again the forceps and thus it is ensured that both of the haptics remains impaled within the sclera (22) . If conjunctival peritomy is performed, then the peritomy is closed. The surgery 30 is concluded subsequently after the necessary antibiotic and steroid treatment is administered.

In an embodiment of the present invention, while the sutureless scleral fixation cannula (10) is being implemented as it is shown in the Figure 11, the tunnel is created in the sclera (22) between the sclera entry point (23) and the second point (24) by using 20, 21, 23, 24, 25, 26, 27 or 30 gauge surgical blade or surgical needle and instead of needle, the sutureless scleral fixation cannula (11) of which first portion is rigidified by using metal or silicon filling material is inserted through this tunnel .

In a preferred embodiment of the present invention, while the sutureless scleral fixation cannula (10) as shown in Figure 12 is being implemented, the tunnel is created by entering through the entry point (23) to the sclera (22) by using curved surgical needle (11) and entry is gained into the eye in accordance with the said curve without getting out through the second hole.

In another preferred embodiment of the present invention, the sutureless scleral fixation cannula (10) comprises blunt pointed curved surgical needle only at the frontal part which is illustrated in Figure 13. While the sutureless scleral fixation cannula (10) shown in Figure 13 is being implemented, tunnel is created on the sclera through the entry point (23) by using 20, 21, 23, 24, 25, 26, 27- and 30-gauge surgical blade or needle and the exit point of the tunnel remains in the eye (20) . Through this tunnel, instead of needle, first portion of the curved sutureless scleral fixation cannula (10) rigidified with the filling having the same raw material with metal or the tube (12) is implanted.

Sclerotomy Procedure with Double-Needle Sutureless Scleral Fixation Cannula

While the scleral fixation cannula (10) is being implemented, tunnel is created by entering from the sclera (22) as illustrated in Figure 3, through the sclera entry point (23) by means of curved posterior needle (13) and egressed from the second point (24) . Subsequently, sclerotomy procedure is performed by entering into the sclera (22) through the sclera entry point (23) by using the anterior needle (11) . While the inventive sutureless scleral fixation cannula (10) is being administered to the patient, after the patient is anesthetized with topical, peribulbar, retrobulbar or with general anesthesia, conjunctival peritomy is performed in accordance with the egress points of the intraocular lens (30) (IOL) demonstrated in Figure 4, haptics and cauterization is performed in order to stop the bleeding when necessary. During the sclerotomy procedure, depending on the preference, scleral (22) tunnel can be created directly without performing conjunctival peritomy. During the procedure, again depending on the preference, an infusion cannula or an anterior chamber provider can be implanted in order to ensure the eye (20) tonus

(intraocular tonus) . Two reciprocal sclera entry points (23) with an angle of 180 degrees to one another are marked 1.5 or 2 mm away from the Limbus using surgical marker pen or a different tool. Two scleral entry points (23) illustrated in Figure 5 demonstrate locations where sclerotomy (sclerotomy point) will be performed as well as the starting point of the scleral tunnel. Subsequently, by means of entering through the sclerotomy point (23) by using the posterior needle (13) illustrated in Figure 6, the needle is advanced staying close to the surface as so 3-5 mm parallel to limbus or partially parallel to limbus and then the posterior needle (13) is egressed from the sclera so that the body (tube) (12) portion remains impaled within the sclera. The direction of this advancement should be the same with the direction of the intraocular lens (30) (IOL) haptic. Then, by using the anterior needle (11) illustrated in Figure 7, entry gained into the eye through the sclerotomy point (23) . Clear cornea incision is made and the point of the anterior needle (11) is pulled outside of the eye (20) through this incision as demonstrated in Figure

8. Subsequently, the anterior needle (11) of the sutureless scleral fixation cannula (10) is cut. Intraocular lens (30)

(24) using once again the forceps and thus it is ensured that both of the haptics remains impaled within the sclera (22) . If conjunctival peritomy is performed, then the peritomy is closed.

The surgery is concluded subsequently after the necessary antibiotic and steroid treatment is administered.

Claims

1. The present invention is a sutureless scleral fixation cannula (10) that allows for a controlled and sutureless implantation of intraocular lenses (IOL) to sclera through ciliary sulcus in surgeries involving posterior chamber intraocular lens (30) (IOL) implantation by means of scleral fixation, characterized by comprising a tube (12) that enables the implantation of the intraocular lens (30) (IOL) into the sclera (22) by means of grasping it with a needle and needle/needles on at least one of the ends that allows for creating tunnel within the sclera (22) and that allows for entering into the eye (20) .

2. A sutureless scleral fixation cannula (10) according to

Claim 1, characterized by comprising needle only at the frontal end.

3. A sutureless scleral fixation cannula (10) according to

Claim 1, characterized by comprising needles both at the frontal and rear ends.

4. A sutureless scleral fixation cannula (10) according to

Claim 1, characterized in that needles are anterior needle (11) and/or posterior needle (13) .

5. A sutureless scleral fixation cannula (10) according to

Claim 4, characterized in that one out of the anterior needle (11) and posterior needle (13) has a curved from whereas the other one has a straight form.

6. A sutureless scleral fixation cannula (10) according to

Claim 4, characterized in that anterior needle (11) has a straight form and posterior needle (13) has a curved form.

7. A sutureless scleral fixation cannula (10) according to

Claim 1, characterized in that needle/needles are of round in shape and has tapered point .

8. A sutureless scleral fixation cannula (10) according to

Claim 1, characterized in that needle/needles are standard cutting, reverse cutting, spatula needle and/or tapercut needle .

9. A sutureless scleral fixation cannula (10) according to

Claim 1, characterized in that tube is made out of thermoplastic, polymer or metal material.

10. A sutureless scleral fixation cannula (10) according to

Claim 9, characterized in that mentioned polymer is polyvinyl chloride (PVC) , polyethylene (PE) , low-density polyethylene (LDPE) , high-density polyethylene (HDPE) , polytetrafluoroethylene (Teflon), polypropylene (PP) , polyethylene terephthalate (PET, PETE) , natural rubber, polybutadiene, nitrile rubber, silicon rubber or ethylene vinyl acetate.

11. A sutureless scleral fixation cannula (10) according to

Claim 9, characterized in that stainless steel, titanium, aluminum or nitinol is used as metal materials.