ARTIFICIAL INTRAOCULAR LENS SUPPORTING DEVICE FOR APHAKIC PATIENT TREATMENT

TECHNICAL FIELD

[001] The subject matter in general relates to ophthalmology. The present inven tion discloses an artificial intraocular lens supporting device. More particularly, but not exclusively, the subject matter relates to artificial intraocular lens support ing device for aphakic patient treatment.

BACKGROUND ART

[002] Artificial intraocular lens is inserted in the natural capsular bag after cata ract extraction. Cataract is one of the leading eye problems faced by individuals. Generally, treatment for cataract includes removal of the natural lens and its re placement with an intraocular lens (IOL). The intraocular lens is placed within the capsular bag inside the eye. But in case of aphakic eyes due to trauma, inherent genetic disease with subluxation of natural lens or surgical complications, there is poor capsular support hence it is very difficult to put IOL in the natural capsular bag.

[003] Therefore in these cases it is required to suture or fix the modified IOL to the sclera. Various surgical techniques available to fix the IOL to the sclera are Trans-scleral fixation of IOL (TSFIOL), scleral fixation of IOL (SFIOL), Glued TSFIOL and Yamane technique.

Many prior art documents have earlier disclosed intraocular lens fixation. Refer ence may be made to:

[004] WO2019236016A1, invention relates to sutureless scleral intraocular lens fixation without introducing the lens haptic into the needle and without using a trocar. When performing the sutureless lens fixation to the sclera via scleral tun nel for the intraocular lens implantation for the eyes with no posterior capsular support. [005] WO 2011/065833 Al, invention relates to intraocular lenses (IOLs) with adjustable optical power that can be adjusted, for example, the surgery, or after the surgery in which the lens is implanted. These adjustable lenses can be used to correct the refractive error of the eye.

[006] WO2009143436A2, invention relates to an intraocular lens with a foldable optic. The IOL also includes multi-hinged haptics coupled to the foldable optic operable to position the IOL within an eye and method to correct the visual im pairment of an aphakic patient by implanting such an IOL.

[007] WO2017134056A1, invention relates to a supporting device for the inser tion of an intraocular lens without a capsular bag or sufficient capsular remnants for lens fixation, wherein said intraocular lens is made up of one optical part and two haptics. The device comprises: a piece manufactured with a biocompatible material, wherein the piece is configured to receive a portion of the haptic in its interior through the first end of the piece; and a thread made of biocompatible ma terial attached to the end of said piece located opposite the end designed to re ceive the haptic. The thread, when this device is in use, is configured to pull and position the optical part of the lens inside the intraocular cavity.

[008] US4477931A, invention relates to intraocular lens with flexible C-shaped support portions with protruding contact points for seating the lens in the lower groove portion formed by the anterior and posterior capsules of the eye. US6224628B1, invention relates to haptics for an intraocular lens attached to a flexible, deformable optic which is capable of being rolled for insertion through a small incision in the cornea.

[009] Siddharth Agrawal, Vinita Singh, Sanjiv Kumar Gupta, Nibha Misra, Rajat M Srivastava, Indian Journal of Ophthalmology Vol. 63 No. 8, 649-653, describes Transscleral fixation of closed loop haptic hydrophilic acrylic posterior chamber intraocular lens with 10-0 polypropylene suture in aphakic nonvitrectomized eyes. [010] In paediatric patients, with age their axial length also increases and it is highly expected for myopic shift (change in minus number) which mandates IOL exchange. However among the all above mentioned techniques, IOL exchange is possible only “in the bag insertion” of IOL and not for transclerally fixated device or lens which is most desirable in case of children. Hence, these one-time inser tion techniques are not recommended in children in concern of myopic shift (change in refractive number).

[Oil] Therefore, it is highly desirable to provide a device that gives the facility to exchange the IOL multiple times in the future with minimal surgical requirements and damage to eyes.

[012] Therefore, no prior art providing viable solution to above stated problems. The inventors of present invention have developed a simple novel device which acts as a platform for the foldable IOL to fix inside the eye. It is beneficial to the adults and more beneficial in case of children for exchanging IOL where change in IOL power (Myopic shift) is expected.

DISCLOSURE OF THE INVENTION

[013] Disclosing intraocular lens supporting device (100) for aphakic patient treatment. The device comprises central body and supporting part. Wherein, cen tral body comprising at least a pair of optic holder and supporting part comprising a pair of wing and a pair of haptic. Optionally, the device central body further comprises at least a pair of IOL haptic holder and supporting part comprising a pair of wing with at least one hole. The central body of the device may be circu lar, wherein the central space along with conventional three piece IOL implanta tion, fixated by optic capture or buttoning facilitates the passing of light. The cen tral body comprises an inner side surface and an outer side surface, wherein an inner side faces the central space and the outer side surface is away from the cen tral space of device. Each of the haptic and wing extend outwards from the central body. The wings of the device comprise empty space to facilitate the expansion and compression of the device. The wings of the device comprise holes to facili tate the tying suture between sclera and the device. In the device each of the wing further comprising haptic that extends outwards from the wing to facilitate the holding and providing additional support to the device. In the device wings are at angular position with respect to central body. In the device each of the optic hold ers extends inwards from the central body to facilitate the capturing of optic part

B of the conventional three piece IOL. In the device each of the IOL haptic holders extends outwards from the central body to hold the haptic of IOL in condition if IOL is not fixing to the device by means of optic capture or buttoning. The device is made from flexible material. The device is configured to provide the support for implanting IOL in aphakic patient (absence of lens) with poor capsular support in all age group.

BRIEF DESCRIPTION OF THE DRAWINGS

[014] The present invention will become more understandable from the descrip tion given herein and the accompanying drawings below. These are given by way of illustration only and therefore not limited to present invention and wherein: [015] Figure 1 illustrates artificial intraocular lens supporting device (100) for aphakic patient treatment.

[016] Figure 2 illustrates an alternate embodiment of wings (112) of the device (100).

[017] Figure 3 illustrates alternate embodiments of artificial intraocular lens sup porting device (100) with IOL haptic holder (302).

[018] Figure 4 illustrates the sectional view of the device (100) with height HI and width W 1.

[019] Figure 5A illustrates compression of the device (100).

[020] Figure 5B illustrates expansion of the device (100).

[021] Figure 6A illustrates artificial intraocular lens supporting device (100) fix ated to the sclera (602) by suturing along with conventional three piece IOL fixat ed to the device by means of optic capture or buttoning of the optic part (606) of IOL. This is the preferred way of fixation of IOL to the device.

[022] Figure 6B illustrates artificial intraocular lens supporting device (100) fix ated to the sclera (602) by suturing along with conventional three piece IOL fixat ed to the device by means of inserting haptic (608) of the IOL into the IOL haptic holder (302). This is the second line technique in case if optic capture or button ing is not happening. BEST MODE(S) FOR CARRYING OUT THE INVENTION [023] The following presents a simplified description of the invention in order to provide a basic understanding of some aspects of the invention. This description is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the inven tion. Its sole purpose is to present some concept of the invention in a simplified form.

[024] Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness. [025] Features that are described and/or illustrated with respect to one embodi ment may be used in the same way or in a similar way in one or more other em bodiments and/or in combination with or instead of the features of the other em bodiments.

[026] The terms and words used in the following description and claims are not limited to the bibliographical meanings, but, are merely used by the inventor to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to those skilled in the art that the following description of ex emplary embodiments of the present invention are provided for illustration pur pose only and not for the purpose of limiting the invention as defined by the ap pended claims and their equivalents.

[027] It is to be understood that the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[028] By the term “substantially” it is meant that the recited characteristic, pa rameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy lim itations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

[029] It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

Embodiments

[030] Embodiments disclose a device to implant intraocular lens supporting de vice for aphakic patient treatment. The device comprises central body and sup porting part. Wherein, central body further comprising at least a pairs of optic holder and supporting part comprising a pair of wing and a pair of haptic. Alterna tively device central body further comprise at least a pairs of optic holder and at least a pair of IOL haptic holder and supporting part comprising a pair of wing with at least one hole and a pair of haptic. Central body forms a boundary of cen tral space which accommodates the optic part of the conventional three piece IOL. The central body of the device may be circular, wherein the central space along with conventional three piece IOL facilitates the passing of light. The central body comprises an inner side surface and an outer side surface, wherein an inner side faces the central space and the outer side surface is away from the central space of device. Each of the haptic and wing extend outwards from the central body. The wings of the device comprise empty space to facilitate the expansion and compression of the device. The wings of the device comprise holes to facili tate the tying suture between sclera and the device. In the device each of the wing further comprising haptic that extends outwards from the wing to facilitate the holding and providing additional support to the device. In the device wings are at angular position with respect to central body. In the device each of the optic hold ers extends inwards from the central body to facilitate the capturing or buttoning of optic part of conventional three piece IOL. In the device each of the IOL haptic holders extends outwards from the central body to facilitate the holding of the haptic of the IOL in case if IOL is not fixing to the device by means of optic cap ture or buttoning. The device is made from flexible material. The device is con figured to provide the support for implanting IOL in aphakic patient (absence of lens) with poor capsular support in all age group. [031] Referring to the figures, and more particularly to Figure 1, a device (100) is provided for implanting IOL in aphakic patient with poor capsular support. The device comprises central body and supporting part. Wherein, central body (104) further comprising at least a pair of optic holder (110) and supporting part com prises, at least a pair of wings (112), at least a pair of haptic (114) and central body forms (104) a boundary of a central space (102). The central body (104) of the device may be circular, wherein the central space along with IOL facilitates the passing of light. The central body (104) comprises an inner side surface (106) and an outer side surface (108), wherein an inner side (106) faces the central space (102) of device and the outer side (108) surface is away from the central space (102) of device. Each of the haptic (114) and wings (112) extend outwards from the central body (104). The wings of the device comprise empty space (116) to facilitate the expansion and compression of the device. The wings (112) of the device comprise holes (202) to facilitate the tying suture between sclera and the device. In the device (100) each of the wings (112) further comprising haptic (114) that extends outwards from the wing to facilitate the holding and providing additional support to the device. In the device (100) wings (112) are at angle theta with respect to the plane of central region (104). In the device (100) each of the optic holders (110) extends inwards from the central body (104) to facilitate the capturing or buttoning of optic part of IOL. The device (100) is made from flexi ble material. The device is configured to provide the support for implanting IOL in aphakic patient (absence of lens) with poor capsular support in all age group. [032] In an embodiment, the central body (104) is encircling the central space (102). The central body (104) is circular in shape and encircles the cental space (102). In an embodiment, the central space (without optic holder) (102) is circular and has a diameter ranging between 5 mm and 7 mm. In a preferred embodiment, the diameter of the central space (102) is about 6 mm and the diameter between the inner edges of the optic holder (110) is 5 mm. In the device (100) the space between two adjacent optic holders is termed as the inter-holder groove and max imum diameter between two opposite inter-holder grooves is 6 mm. [033] It may be appreciated that the central body (104) need not be circular, and may be of a different shape, such as an oblong shape, rhomboidal, rectangular , square as an example. In other words, the central space (102) could be of any shape that serves the purpose of the invention and not limited to the circular shape. Consequently, the longest distance between two extreme points of central space (102) may be between 5 mm and 7 mm, and about 6 mm preferably.

[034] In an embodiment, wings (112) are arced shape and extended outwards from the central body (104). In the device 100 two wings are placed opposite to each other. Each wing 112 of the device (100) comprises empty space (116) to facilitate the expansion and compression of the width of the device (100).

[035] Referring to Figure 2, in an embodiment each of the wing (112) of the de vice (100) comprise at least one hole (202) to facilitate the tying suture between sclera (602) and the device. It may be appreciated that the hole (202) needs not be circular, and may be of a different shape, such as an oblong shape as an example. In other words, the hole (202) could be of any shape that serves the purpose of the invention and not limited to the circular shape.

[036] In an embodiment, the distance between holes (202) of two opposite wings (112) is between 9.5 mm and 12.5 mm.

[037] In a preferred embodiment, the distance between holes (202) of two parallel wings (112) is 11 mm.

[038] Referring to Figure 3 in an embodiment the device (100) comprising at least a pair of IOF haptic holder (302). In the device (100) each of the IOF haptic holders (302) extends outwards from the central body to facilitate the holding of haptics of conventional three piece IOF in case if IOF is not fixated by means of optic capture or buttoning (figure 6B).

[039] In the device (100) each of the IOF haptic holders (302) extends outwards from the central body (104) to facilitate the holding of the haptic of the conven tional three piece IOF (608) in case IOF is not fixated by means of optic capture or buttoning. In the device (100) proximal part of IOF haptic holder (302) is in contact with the outer surface (108) of central body (104). [040] In an embodiment in the device (100) two IOL haptic holders (302) are placed opposite to each other.

[041] Referring now to Figure 4, in an embodiment, the device (100) has a height (thickness) HI between 0.1mm and 1mm.

[042] In a preferred embodiment, the height HI of the device (100) is about 0.3 mm.

[043] Referring to Figure 4, in an embodiment in the device (100) supporting part comprising wings (112) are at angular position with respect to central body (104). In an embodiment, each of the wings (112) forming an angle theta to the plane of the optic capture region (104), wherein the value of angle theta is ranging between 5° and 15.

[044] In a preferred embodiment, the value of angle theta is 5.

[045] In the device (100) each of the wing (112) further comprises haptic (114) that extends outwards from the wing (112) to facilitate the holding and providing additional support to the device.

[046] In a preferred embodiment in the device (100) the proximal end of the wing is in contact with the central body (104) and the distal end of the wing is in con tact with the haptic (114).

[047] It may be appreciated that the haptic (114) may be of a different shape that serves the purpose of the invention and not limited to the semi-circular and arc shape.

[048] In an embodiment in the device (100) the IOL haptic holder (302) may have any shape configuration for instance circular, rectangle etc. to facilitate the hold ing of the IOL haptic part (608).

[049] In an embodiment the IOL haptic holder (302) can be “D” or “C” shape configuration or having “Groove in lock” configuration.

[050] In the device (100) each of the optic holders (110) extends inwards from the central body (104) to facilitate the capturing or buttoning of IOL optic part (606). In an embodiment, at least a portion of each of the optic holders (110) is in con tact with the inner side surface (106) of the central body (104) and other end faced towards the central space (102). Each of the optic holders (110) extends from the central body (104).

[051] In a preferred embodiment, the number of the optic holders (110) is be tween two and six.

[052] In an embodiment, the number of the optic holders (110) can be more than six.

[053] In an embodiment of the optic holders (110), wherein the optic holders (110) has a rectangular shape.

[054] In an embodiment of the optic holders (110), wherein each of the optic holders (110) resemble a triangular or isosceles trapezoid shape, wherein the longer base of the trapezoid is in contact with the inner side surface (106) of the central body (104).

[055] In an embodiment of the optic holders (110), wherein each of the optic holders (110) resembles an isosceles trapezoid shape. In this embodiment, the base of the trapezoid is in contact with the inner side surface (106) of the central body (104), and the extended part is concave.

[056] In an embodiment, the width of the optic holders (110) may be between 0.5 mm and 1 mm.

[057] In an embodiment, the width of the optic holders (110) is 0.5 mm.

[058] In an embodiment, the length of the device (100) may be between 10.0 mm and 15.0 mm.

[059] Figure 5 A illustrates compression of the device (100) of Figure 1 after im planting in the eye. In an embodiment, implantation of the device (100) in the eye with smaller ciliary sulcus (in smaller eye as in children) results in compression of the device (100). The force created due to compression of the device (100) is transferred to the wings (112) resulting in a decrease in the length of the gap (116). In an embodiment, the two ends of the gap (116) come close to each other when the device (100) is in compressed form. Further, the compression of the de vice (100) may result in closing of the gap (118) may be associated with mild downward bowing of the device . [060] Referring to Figure 5B illustrates expansion of the device (100) of Figure 1 after implanting in the eye. In an embodiment, implantation of the device (100) in eye with larger ciliary sulcus (larger eye as in adults) resulting in expansion of the device (100). The force created due to expansion of the device (100) is transferred to the wings (112) resulting in an increase in the length of the gap (116). In an embodiment, the two ends of the gap (116) get away to each other when the de vice (100) is in expanded form. Further, the expansion of the device (100) may result in widening of the gap (116). The device (100) can be expand upto 15 mm without distortion of the central body (104).

[061] In an embodiment, the device (100) fixed with conventional three piece Intraocular lens (IOL) by optic capture or buttoning. The optical part of the IOL(606) is at the central space captured or buttoned by optic holder (110) of the device and haptics of the IOL (608) will be above the device [Figure 6A] . The device (100) can also fixed with conventional three piece IOL by means of insert ing haptic of the IOL(608) into the IOL haptic holder (302) of the device [Figure 6B]. Optic capture or buttoning of the IOL is the preferred and easier way of IOL fixation to the device than inserting IOL haptic (608) into the IOL haptic holder (302).

[062] In an embodiment, device (100) is made using non-biodegradable bio compatible materials. In an embodiment, the materials are selected from the group consisting of hydrophilic acrylic, hydrogel, hydrophobic acrylic, silicone, polyme thyl methacrylate (PMMA) and combination thereof. The device (100) could be made of any transparent or opaque and biocompatible material which serves the purpose of the invention. Further, the device 100 may be foldable, such that the device (100) could be easily held in an injector.

[063] In an preferred embodiment, device (100) is made using the hydrophilic acrylic material.

[064] Referring to Figure 6 the surgical technique consist of major two parts: Part I involves fixation of the artificial IOL supporting device (100) to the sclera (602) at the level of ciliary sulcus, 1.5 mm away from the limbus by means of polypro pylene suture (604) or by means of polymethyl methacrylate material or any other biocompatible materials. Part II involves implantation of conventional three piece foldable IOL comprising IOL optic part (606) and IOL haptic part (608) into the eye and then fixing on the artificial IOL supporting device (100) by means of but toning or optic capture of the optic part of the IOL (606).

[065] In an embodiment, conventional three piece IOL can be fixed to the device (100) by multiple ways and not limiting to optic capture or buttoning techniques. [066] In an embodiment, conventional three piece IOL can be also fixed to the device (100) by inserting IOL haptic (608) into the IOL haptic holder (302) of the device in case if IOL fixation is not happening through optic capture or buttoning of the IOL. But optic capture or buttoning is the preferred and easier way of IOL fixation in this device.

[067] The processes described above is described as a sequence of steps, this was done solely for the sake of illustration. Accordingly, it is contemplated that some steps may be added, some steps may be omitted, the order of the steps may be re arranged, or some steps may be performed simultaneously.

[068] Although embodiments have been described with reference to specific ex ample embodiments, it will be evident that various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the system and method described herein. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. [069] Many alterations and modifications of the present invention will no doubt become apparent to a person of ordinary skill in the art after having read the fore going description. It is to be understood that the phraseology or terminology em ployed herein is for the purpose of description and not of limitation. It is to be un derstood that the description above contains many specifications; these should not be construed as limiting the scope of the invention but as merely providing illu s- trations of some of the personally preferred embodiments of this invention. INDUSTRIAL APPLICABILITY

[071] The invention is to provide intraocular lens supporting device comes in sin gle size which can be expandable as well as compressible hence can be used uni versally in all age group. [072] Intraocular lens supporting device is an exchangeable IOL platform hence when there is a refractive surprise or high myopic shift in case of children, this facilitates IOL exchange and new IOL can be fixed with similar fashion [073] Elasticity of the intraocular lens supporting device protects from dislocation of IOL during trauma. During trauma, external force over the eye cause circum- ferential expansion of the eyeball which usually breaks the haptic of the conven tional PMMA TSFIOL since it is less expandable as compared to intraocular lens supporting device.

[074] Smaller corneal incision is needed as compared to sutured PMMA TSFIOL. [075] No pseudophakodonesis and hence less chance of pupillary capture as we see in case of PMMA TSFIOL.

[076] Intraocular lens supporting device is technically simple and easier to fix in side the eye.

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