FORM 2
THE PATENTS ACT, 1970
(Act 39 of 1970)'
And
THE PATENTS RULE, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
Title: Inventive Implantable Foldable Ocular Capsular Device Scleralsight and
the Method thereof
1. Applicant(s):
(a) Name: Biotech Vision Care Pvt. Ltd.
(b) Nationality: Indian
(c) Address: Block 1, Abhishree Corporate Park, Opp. Swagat Bungalows
BRTS Stop, Bopal-Ambli Road, Ahmedabad- 380058, Gujarat, India
2. Preamble of description
The following specification particularly describes the invention and the manner in
which it is to be performed.

TITLE OF INVENTION
Inventive Implantable Foldable Ocular Capsular Device Scleralsight and the method thereof
FIELD OF INVENTION
The present invention relates to an inventive implantable foldable ocular capsular device Scleralsight and the description of the technique of implanting the same. More particularly the present invention provides the effective base support for Intraocular Lens (IOL) with insufficient capsule, capsular tears, trauma, aniridia, pseudoexfoliation, lens subluxation or loss of zonular integrity and also focuses on the techniques of its implantation.
BACKGROUND OF THE INVENTION
Cataract Surgery is one of the most successfully and most frequently performed surgical procedures in India and worldwide. Each year people achieve a significant improvement in their visual function due to this procedure. With the increasing demand for better visual outcomes post cataract surgery there is increase in usage of multifocal. This increased demand will require more ophthalmologists to be trained to perform cataract surgery as well as each trained ophthalmologist to perform more cataract Surgeries each year. In addition to the increase in demand for cataract surgery, there have been many technological advances that have increased patient expectations and requirements for the surgery. The procedure takes a short amount of time to perform, and patients expect quick recovery of visual function. The use of IOLs in cataract requires perfect technique, precise preoperative measurements, and choice of good IOL for patient satisfaction. In fact, almost all patients will typically require glasses for near

vision. The need for better range of vision among patients in the quest for more youthful vision without glasses through the use of multifocal lenses, presbyopia correcting lenses, toric lenses, and monovision lenses are only increasing.
Gradual wearing off and resultant erosion of the suture fixating the IOL'to the sclera is the most common complication of trans-scleral sutured IOLs. Common to all techniques for sutured scleral fixation is the need to cover, bury or rotate the suture knots created for fixation in order to prevent conjunctival erosion and subsequent endophthalmitis. Secondly, scleral fixation with sutures is a somewhat cumbersome surgery where there are long strands of thread that are in the operative field. It's a challenging and frustrating procedure for ophthalmologists to perform in many cases, whereas this technique is quite elegant and efficient. Sutures may erode through the scleral flaps and cause irritation. They may also become loose or break, causing either tilting or dislocation of the optic. A persistent suture extending between the intraocular and extraocular environments may provide a track for bacteria to enter the eye and establish endophthalmitis,
Even though fibrin glue seals the haptics to the sclera; however, studies have not yet been able to demonstrate whether it is stable in the long term and whether IOL tilt or decentration occurred with this technique. The present invention obviates the need of fibrin glue, it is more suitable in case of developing countries where cost of glue is a major concern due to financial setbacks.
The techniques used earlier described the use of partial thickness scleral flaps and a scleral niche created by a crescent knife to place the IOL haptics. Use of tunnels in

place of flaps as described in our technique, yields a more secure haptic placement and minimizes the chances of haptic movement. In addition, there might be a need to suture the flaps post-operatively in case of severe hypotony due to vitreous loss. There is a theoretical risk of haptic exposure in such cases when the partial thickness scleral flaps may not oppose well especially at the edge due to flap retraction in the scleral bed due to cautery etc. Also, the scleral flaps may not oppose well due to post-operative IOP fluctuation and may retract due to scarring etc. These issues can be completely avoided by the use of partial thickness scleral tunnels in place of partial thickness scleral flaps. Lastly, as our technique uses an intrascleral track created by tunnel-and-26G-needle-niche, it leaves the haptic 'trapped' in the sclera and fixes it securely without the use of glue or suture. Thus as these partial thickness scleral tunnels are self-sealing with the haptic ends snugly fitted in respective scleral niches, the chances of IOL displacement and haptic exposure are minimized.
Indications for suture-less glue-iess intrascleral fixation posterior chamber IOL fixation have widened. The most important and foremost scenario is that of deficient capsular support leading to surgical aphakia. The indication scenario, however, has changed. Early on, planned surgical aphakia or complicated cataract surgeries obviating IOL implantation at primary surgery were predominant indications. More recently, inadvertent delayed secondary subluxation of the lens-bag complex in conjunction with pseudo-exfoliation syndrome has increasingly gained importance.
The existing Scharioth-Agarwal technique claims to have good results because of absence of pseudo-phakodonesis, unlike a sutured IOL, which moves like a hammock as verified on high-speed videography and anterior segment OCT. However, the term 'glued IOL' is, technically incorrect, as fibrin glue does not have the tensile strength to

keep an IOL haptic fixed in place but can only perhaps attach the scleral flap for about less than 24 hours. To validate this procedure as a glued IOL does not fully characterize the stability of the IOL fixation since it implies that the glue and nothing else is holding the lens in place whereas in reality the glue only helps in suture-less closure of the flaps and conjunctiva.
Vitrectomy is a pre-requisite for any technique of scleral fixated IOL especially when done for surgical aphakia. If the vitrectomy has not been adequately performed, there's a high risk of vitreous incarceration within the primary wound. A meticulous vitrectomy decreases the probability of vitreous traction leading to subsequent retinal detachment. A careful anterior vitrectomy through the limbal section was done with a slow rate of irrigation.
The natural capsular bag, a delicate structure that houses the natural lens, plays a crucial role in maintaining lens stability and refractive accuracy. However, factors such as capsular bag weakness, rupture, and Posterior Capsular Opacification (PCO) can impact surgical outcomes, posing challenges to IOL placement and vision restoration. In cases of compromised capsular support, the present surgical techniques restrict vision to the usage of monofocal lenses and this problem can be solved with an implantable capsular bag which will facilitate the implantation of all these advanced IOLs. Moreover the compromised capsular bag poses a challenge for the IOL implantation and various invasive techniques have to be used like sulcus fixation and scleral fixation to implant the IOL, which despite being tedious processes have quite some disadvantages like suture degradation, lesser stability etc.

In general practice, Posterior chamber IOLs are placed in the capsular bag. However, this may not be feasible in cases with insufficient capsule, capsular tears, trauma, aniridia, pseudo exfoliation, lens subluxation or loss of zonular integrity. In recent years, evolving techniques have enabled surgeons to perform intrascleral haptic fixation of posterior chamber IOLs with or without sutures. The present invention provides an Inventive Implantable Ocular Capsular Device (iBag) to sustain the IOL in addition with a new technique of intrascleral haptic fixation of mentioned three-piece foldable iBag with any IOL using scleral tunnels instead of flaps as described in literature.
Suture less intrascleral haptic fixation of a 3-piece posterior chamber IOL in eyes with insufficient capsular support was first reported by Scharioth et al in the Journal of Cataract and Refractive Surgery in 2007 wherein the IOL was placed in the ciliary sulcus. In 2007, Amar Agarwal and Soosan Jacob introduced a novel innovation to sutureless intrascleral posterior chamber IOL implantation wherein they made use of fibrin glue to secure the scleral flaps under which the lens haptics were tucked.
The prior arts mentioned do not disclose sutureless, glueless intrascleral fixation of a three-piece acrylic hydrophilic posterior chamber capsular bag in eyes with deficient capsular support using partial thickness scleral tunnels instead of flaps.
The current invention will solve this problem by being compatible with any technique and any advanced IOL can be placed which will be a reversible process in case the patient is not satisfied.

SUMMARY OF INVENTION
The main object of the present invention Inventive Implantable Foldable Ocular Capsular Device Scleralsight is to provide a suture-less, glue-less intrascleral fixation of a three-piece acrylic hydrophilic posterior chamber capsular bag in eyes with deficient capsular support using partial thickness scleral tunnels instead of flaps.
Yet another main object of the invention Inventive Implantable Foldable Ocular Capsular Device Scleralsight is to restore the normal anatomical structure of the eye lens, thereby stabilizing the effective lens position of an IOL so that refractive outcomes may be improved with cataract surgery for both monofocal and multifocal IOLs.
The other object of the present invention Inventive Implantable Foldable Ocular Capsular Device Scleralsight is to provide a foldable device which enables the surgeon to implant iBag in the same surgical incision done for phacoemulsification.
Another object of the present invention Inventive Implantable Foldable Ocular Capsular Device Scleralsight is to provide an integrated stable scaffold to facilitate any IOL exchange if needed in the future to accommodate refractive needs of the patient.
Other object of the present invention Inventive Implantable Foldable Ocular Capsular Device Scleralsight is to sustain the IOL in addition with a new technique of intrascleral

haptic fixation of three-piece foldable iBag with any IOL using scleral tunnels instead of flaps.
Yet another object of the present invention Inventive Implantable Foldable Ocular Capsular Device Scleralsight is to provide a reversible process for the IOL implantation in the iBag, wherein if the patient is not satisfied with the given lens, change of lens will be an easy option with this device.
The present invention Inventive Implantable Foldable Ocular Capsular Device Scleralsight is a foldable device which provides a suture-less, glue-less intrascleral fixation of a three-piece acrylic hydrophilic posterior chamber capsular bag in eyes with deficient capsular support using partial thickness scleral tunnels instead of flaps. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight of the present invention comprises is in cylindrical shape with overall outer diameter ranging from 6.0mm to 11mm, wall thickness of 0.2 mm and having the height of 1.4 mm with one side fully open surface (anterior side of the bag, 3) and one side 5.5 mm diameter annular open surface (posterior side of the bag, 6); Integrated with 0.1 mm thickness Polyvinylidene fluoride (PVDF) haptics (1, 2) to hold the iBag device in the anterior chamber of the eye in the desired position made of PVDF material for stronger support at the haptics portion 20 degree rim junction(5) connects the bottom annular surface with the cylindrical rim; along with a 5.5 mm diameter annular open surface (posterior side of the bag) to provide an uninterrupted light path to intraocular lenses, with the size of the annular open surface adjustable from 3.0 mm to 6.5 mm; One side featuring a 5.5 mm diameter annular open surface (posterior side of the bag) to provide an uninterrupted light path to intraocular lenses, with the size of the annular open surface adjustable from 3.0 mm to 6.5 mm, thus providing capsular support in eyes with

compromised capsular bag support for Intraocular lens implantation, utilizing partial thickness scleral tunnels instead of flaps by way of sutureless and glueless intrascleral fixation technique for a three-piece IOLs in the eyes.
BRIEF DESCRIPTION OF DRAWINGS OF INVENTION
The sketches illustrate the various embodiments of the present disclosure. The sketches are not scaled but represent exactly similar elements.
Figure 1 represents the implantable capsular bag (iBag) front view or anterior surface of the invention.
Figure 2 represents the implantable capsular bag (iBag) back view or posterior surface of the invention.
Figure 3 represents the implantable capsular bag (iBag) side view of the invention.
Figure 4 represents the implantable capsular bag (iBag) view of the invention.
Figure 5 describes the different parts of the implantable capsular bag (iBag) of the invention.
DETAILED DESCRIPTION OF THE INVENTION
The following paragraph describes the Inventive Implantable Foldable Ocular Capsular Device Scleralsight and its outcome and its advantages. The subject matter is explained with drawings at required places, where in like reference numerals are used.

The present invention provides an implantable ocular capsular bag that can be implanted in the eye to provide support for an IOL in the absence of a capsular bag. The invention especially concerns the device that is made for the human eye, which is useful for cataract surgery, where the capsular bag of the eye is compromised. This device is foldable, i.e., it can be injected with a regular injector system into the eye and it quickly unfolds to regain its shape. The iBag has been developed using biocompatible, implantable and transparent acrylic foldable (hydrophilic) material. It can be also developed using foldable hydrophobic material depending on the need.
Figure 1 and 2 represents the anterior and posterior surface of the device. Figure 3 represents the side view and figure 4 represents the isometric view of the implantable capsular bag (iBag).
The device disclosed in the present invention is in a cylindrical shape with overall outer diameter 7.40 mm, wall thickness of 0.2 mm and having the height of 1.4 mm as shown in the figure 5. The overall diameter can vary in between maximum 11 mm to minimum 6.0 mm size as per customer requirement to position the intraocular lenses inside the bag. The cylindrical shaped iBag containing one side fully open surface (anterior side of the bag, 3) and one side 5.5 mm diameter annular open surface (posterior side of the bag, 6) as shown in the figure 5. This annular open surface can vary from minimum 3.0 mm to maximum 6.5 mm as per the requirement. The annular open surface provides clear optic portion of the IOL to have unobstructed passing of light in to the inner part of eye. The annular bottom surface (4) having the 0.2 mm thickness as shown in the figure 5. There is a 0.4 mm open space given between cylinder rim and the bottom annular base surface (4) to accommodate the IOL haptics inside the bag. This structure allows the IOLs to rotate 160 degree according to the need of the patient. The iBag

device is integrated with 0.1 mm thickness Polyvinylidene fluoride (PVDF) haptics (1, 2) to hold the iBag device in the anterior chamber of the eye in the desired position as shown in the figure 5. This PVDF haptic material can be replaced with other alternative implantable materials like hydrophobic, hydrophilic, polypropylene (PP) and other suitable materials. At the haptics portion 20 degree rim junction (5) (both sides of the haptics) as shown in the figure 5, connects the .bottom annular surface with the cylindrical rim. This iBag structure supports to the patients to implant different type of intraocular lenses like monofocal, multifocal IOLs in the absence of capsular bag.
The overall diameter of the iBag structure is 11.80 mm with the inclusion of haptics which are made of PVDF material for stronger support and are devised according to use for various existing and the new proposed technique. The device can be designed and developed with variable overall dimensions ranging from 7.50 mm to 15.0 mm according to the suitable need for a particular eye.
The present invention can also be easily made up of any other type of biocompatible, implantable pliable material such as hydrophilic acrylic, hydrophobic acrylic, silicon material etc. The device can be easily implanted by using a regular injector system which is used in the intraocular lens implantation process without need of a special type of injector system.
The present novel technique of suture-less and glue-less intrascleral fixation of a three-piece implantable capsular bag (iBag) in eyes with deficient capsular support using partial thickness scleral tunnels instead of flaps comprises the method as mentioned below:

A standard 3 port pars plana vitrectomy is done. After tenotomy adjoining the 3 o' clock and 9 o' clock limbus, partial thickness scleral tunnels are created at these two diametrically opposite points 2 mm from the limbus. Two ab-externo sclerotomies - are created with 26 Gneedles on the bed of these partia thickness_sc]eral tunnels using the resistance of the Schiaroth's tunnel encountered at 2 mm distance as a guide marker. A scleral niche is made at edge of the tunnels using 26 G needles to accommodate the IOL haptic later, A 5.5 mm partial-thickness sclero-coheal incision is created at 12 o' clock. The haptics of a three-piece iBAG is then grasped by micro-vitreo-retinal (MVR) forceps and pulled out through the earlier marked point under the partial thickness scleral tunnel and then placed securely in scleral tunnel opposite the haptic. The technique uses the resistance of the Schiroth's tunnel created at 2 mm distance from the limbus which is adjacent to the two ab-externo sclerotomies which was used for exteriorisation of haptics. After securing the iBag in its position, then the desired IOL is placed in the iBag and secured in the slots given in the iBag. After securing the IOL in the iBag, ports are removed and secured and then the conjunctival flap is closed.

I/We claim:
1. An Inventive Implantable Foldable Ocular Capsular Device Scleralsight, comprising of:
is cylindrical shape with overall outer diameter ranging from 6.0 mm to 11 mm, wall thickness of 0.2 mm and having the height of 1.4 mm with one side fully open surface (anterior side of the bag, 3) and one side 5.5 mm diameter annular open surface (posterior side of the bag, 6);
Integrated with 0.1 mm thickness Polyvinylidene fluoride (PVDF) haptics (1, 2) to hold the iBag device in the anterior chamber of the eye in the desired position made of PVDF material for stronger support at the haptics portion 20 degree rim junction (5) connects the bottom annular surface with the cylindrical rim;
along with a 5.5 mm diameter annular open surface (posterior side of the bag) to provide an uninterrupted light path to intraocular lenses, with the size of the annular open surface adjustable from 3.0 mm to 6.5 mm;
One side featuring a 5.5 mm diameter annular open surface (posterior side of the bag) to provide an uninterrupted light path to intraocular lenses, with the size of the annular open surface adjustable from 3.0 mm to 6.5 mm,
thus providing capsular support in eyes with compromised capsular bag support for Intraocular lens implantation, utilizing partial thickness scleral tunnels instead of flaps by way of suture-less and glue-less intrascleral fixation technique for a three-piece IOLs in the eyes.
2. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight as claimed in Claim 1, wherein the construction material is biocompatible, implantable, and transparent acrylic foldable hydrophilic material, but not limited with hydrophobic, silicon, or other suitable biocompatible and implantable materials.

3. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight as claimed in Claim 1, wherein the overall dimensions of the device are developed in range of 7.50 mm to 15.0 mm to meet the needs of individual.patients.
4. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight as claimed in Claim 1, wherein the haptics are made of Polyvinylidene fluoride (PVDF) material, but not limited with hydrophobic, hydrophilic, polypropylene (PP), or other suitable materials.
5. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight as claimed in Claim 1, wherein the annular open surface on one side is adjustable in size from 3.0 mm to 6.5 mm to meet the needs of individual patients.
6. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight as claimed in Claim 1, wherein the iBag is compatible with a variety of IOLs, including monofocal, multifocal, and extended depth of focus (EDOF) IOLs, as well as c-loop, j-loop, modified c haptics, plate haptics, four-loop IOLs, three-piece IOLs, and reverse optic haptic (ROH) IOLs.
7. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight as claimed in Claim 1, wherein the suture-less and glue-less intrascleral fixation technique is adaptable to various types of three-piece IOLs implantation procedure and in the same surgical incision done for phacoemulsification.
8. The Inventive Implantable Foldable Ocular Capsular Device Scleralsight as claimed in Claim 1, wherein the technique is reversible suture-less and glue-less intrascleral fixation for three-piece IOL implantation, allowing for easy lens
replacement if patient satisfaction requires a change.