Crystalline lens nucleus softening apparatus

Abstract

The present invention relates to an apparatus for softening a crystalline lens nucleus (100) in a cataract phacoemulsification treatment comprising an electric current pulse generator (11) to supply a pulse current to a handpiece (12), wherein the pulse current generates a pulsatile magnetic field, and to hydrodissect the lens nucleus with iron oxide nanoparticle solution to loosen the lens nucleus as well as to infiltrate the lens nucleus (14) with the iron oxide nanoparticles (13), characterised in that the needle tip (24) of the handpiece (12) conducts the generated pulsatile magnetic field to the lens nucleus which causes vibration of iron oxide nanoparticles which emanates a mechanical force to break interdigitating bonds between lens fibers, leading to a controlled softening and fragmenting of the lens nucleus, wherein the electric current pulse generator (11) is configured to produce pulse currents with adjustable voltage and frequency parameters, and the iron oxide nanoparticle solution (13) further comprises a superparamagnetic property functionalised with a biocompatible coating.

Description

[0001] CRYSTALLINE LENS NUCLEUS SOFTENING APPARATUS

[0002] FIELD OF INVENTION

[0003] The present invention generally relates to an apparatus for softening and fragmenting the crystalline lens nucleus of a human eye.

[0004] BACKGROUND OF THE INVENTION

[0005] The eye is the sensory organ of the visual system whereby visible light from an object is converted into electrical impulses which are conducted via the visual pathway to the brain for the procession into visual perception. The eye is a globe-like structure consisting 2 segments jointed together at the limbus. The outer coat of the anterior segment is the cornea which is a transparent tissue making up 1 / 6 of the total surface of the eye. The outer coat of the posterior segment is the sclera with the optic nerve exiting from the posterior pole medially. The sclera constitutes the remaining 5 / 6 of the total surface of the eye. The middle coat of the posterior segment is the uveal tissue consisting of the iris, ciliary body and choroid. The choroid is the vascular layer which supplies part of the oxygen and nourishment requirement to the outer retina. The inner coat of the posterior segment is the sensory retina and retinal pigment epithelium.

[0006] The crystalline lens is biconvex in shape. It is suspended by hundreds of fine cables known as zonules to the processes of the ciliary body. The lens consists of the lens capsule, the cortex, and the nucleus. The lens capsule is a thin membrane that is divided into anterior and posterior capsule. The cortex is the soft part of the lens tissue whereas the nucleus is the hard part of the lens structure. The lens is capable of changing its shape in a young person by a process known as accommodation. As one ages, this ability is lost rendering one’s difficulty in near vision. The nucleus and cortex are made of minute lens fibers which are tightly packed with interdigitation system such as ball and socket, groove and tongue interlocking system. The lensfibres are formed by the epithelial cells at the equatorial region of the lens capsule. The lens fibres are laid in concentric layers with the older fibres situated at the centre of the nucleus. The cavity of the anterior segment is filled with aqueous humour and it is divided by the iris into anterior and posterior chambers. The posterior cavity is known as vitreous humour cavity which is filled with gel-like substance.

[0007] The cornea and crystalline lens form the major part of the refractive power of the eye by focusing light rays onto the fovea of the retina. As human ages, the crystalline lens turns cloudy and becomes opaque, resulting in cataract formation. Thus, light rays are impeded to enter the retina, causing one’s inability to see. On the whole, cataract is the commonest cause of reversible blindness. Basically, cataract operation entails removing part of the anterior capsule, the whole cortex and the nucleus of the crystalline lens and replaces it with an artificial lens. There are a few ways of doing it but phacoemulsification is the main treatment in most cases. This is because in phacoemulsification, the wound incision is small and therefore wound healing and recovering process is much faster than conventional extracapsular cataract extraction.

[0008] In phacoemulsification, the anterior chamber is entered via a corneal incision. The anterior capsule of the lens is opened to form a capsulotomy. The nucleus is loosened from the cortex by a process called hydrodissection. The nucleus is then divided into small pieces. With the phacoemulsification handpiece, the hard nucleus fragments are emulsified with the help of ultrasound. These emulsified nucleus materials can then be aspirated out easily.

[0009] The challenge in phacoemulsification is to divide the hard nucleus into small pieces safely and easily. The various surgical techniques such as divide and conquer as well as phacochop require excessive manipulation in the anterior segment of the eye. These manoeuvres can lead to severe complication like posterior capsular rupture which makes intraocular lens implantation impossible or worse still causes nucleus drop into the vitreous cavity. These are serious complications which will affect visual outcome and in the worst-case scenario, it may lead to blindness due to a train of subsequent complications. The excessive manipulation and excessive use ofultrasonic energy will also cause endothelial cell loss, resulting in a damaged nontransparent cornea.

[0010] To overcome this problem of safe nucleus fragmentation, Femtosecond laser assisted cataract surgery (FLACS) is invented primarily for this purpose. FLACS is a surgical procedure for cataract removal that uses an ultra-fast laser to perform key steps of the surgery with precision to divide the nucleus without much manipulation in the eye. The femtosecond laser is utilized to create incisions, open the lens capsule (capsulorhexis), and fragment the cataractous lens. FLACS machine, however, is expensive and laser machine is costly to maintain. The FLACS machine also adds extra flow time of the operation and therefore it will increase the overall operational time. To address this dilemma, the present novel device is invented. This invention can seamlessly integrate into the phacoemulsification system and hence total operation time is not prolonged.

[0011] A United States patent US2019105519A1 discloses an invention that relates ultrasound directed cavitational method and system for ocular treatments. This method and system utilize ultrasound beams to create various spot-size cavitation ranging from 50 micron to 200 micron for ocular treatment. The present invention does not use ultrasound, nor does it cause cavitation.

[0012] Another US patent US2015265725A1 discloses an invention that relates to a method and composition for hyperthemally treating tumor cells in a patient under conditions that affect tumor stem cells or tumor cells. The tumor may be located at a site affecting body fluids, including the ocular cavity. Microwaves are used to treat intraocular tumors. Regardless of the route of administration of the nanoparticles, once in the body, they are attracted selectively more to a magnet that is positioned in the localized area. Using the eye as a non-limiting example only, the conforming magnet can be placed externally on, or provided on a small probe to an accessible ocular lesion, or the conforming magnet may be implanted on an internal lesion such as under the conjunctiva, over the sclera, and so on. The invention discloses targeting hyperthermal treatment of tumor cells by using hyperthermal effect of nanoparticles with magnetic field. However, no thermal energy is produced in the present invention.In terms of the mechanism, the invention in US2015265725A1 uses magnetic nanoparticles for thermal ablation, and not for mechanical effects. On the other hand, the present invention utilizes magnetic energy for mechanical softening of the crystalline lens nucleus. Furthermore, the scope of US2015265725A1 applies broadly to oncological treatment, including ocular tumors and does not disclose specific ophthalmic application, specifically for lens nucleus softening in cataract surgery.

[0013] The present invention provides a teaching related to an apparatus for softening the nucleus of crystalline lens. In conventional phacoemulsification which is a type of cataract surgery, a significant obstacle to surgeons is to divide the nucleus into small fragments so that phacoemulsification can be safely performed with low ultrasound energy and short exposure time. Hence, it is essential to overcome the difficulty of nuclear fragmentation, especially in hard and subluxated nucleus. This invention uses targeted magnetic energy to break the bonds of the lens fibres, thus minimal manipulation of the handpiece needle in the posterior chamber of the eye is required, thereby reducing stress to the eye and to surgeon as well. This also effectively reduces the risk of rupture of the posterior capsule and endothelial cell loss. It also shortens the operation time and ensures a happy and safe outcome for the patient.

[0014] SUMMARY OF THE PRESENT INVENTION

[0015] The main objective of the present invention is to provide a teaching which relates to simplifying and improving the process of lens nucleus fragmentation by softening the lens nucleus. This invention circumvents the present difficult techniques of lens nucleus fragmentation. The present invention will provide an easy and simplify way to fragment the lens nucleus with the help of nano technology thereby reducing the serious complications of phacoemulsification. Consequently, it will reduce stress on the surgeon and most importantly achieve a good visual recovery for the patient.

[0016] The embodiment of the present invention discloses a crystalline lens nucleus softening apparatus in a cataract phacoemulsification treatment which comprises an electric current pulse generator to supply a pulse current to a handpiece, wherein thepulse current generates a pulsatile magnetic field in the handpiece, the handpiece that is connected to the electric current pulse generator by a cable, and a hydrodisection using a syringe cannula to channel an iron oxide nanoparticle solution to a hardened crystalline lens nucleus so as to loosen the lens nucleus prior to the application of a needle tip of the handpiece coming into contact with the lens nucleus. The present invention is further characterised in that the needle tip of the handpiece conducts the generated pulsatile magnetic field to the loosened lens nucleus thereby causing vibration of the iron oxide nanoparticles in the nucleus interior, thereby emanating a mechanical force to break interdigitating bonds between the lens fibers, leading to a controlled softening and breaking of the lens nucleus into tiny fragments.

[0017] Accordingly, the present invention also discloses that the electric current pulse generator is configured to produce pulse currents with adjustable voltage and frequency parameters, and the iron oxide nanoparticle solution contains a superparamagnetic property functionalised with a biocompatible coating to enhance its penetration into the lens nucleus.

[0018] The embodiment of the present invention also discloses the electric current generator is set to produce direct current (DC) from 0-12 V, preferably 4-6V.

[0019] Another aspect of the present invention is that the electric current pulse generator produces a square wave with an adjustable duty cycle ranging from 1 -100% and pulse frequency ranging from 1 Hz to 1000 Hz, preferably 300-400 Hz.

[0020] In an aspect of the present invention embodiment, the softened lens nucleus is rendered aspirable and emulsifiable using minimal ultrasonic energy during phacoemulsification.

[0021] In an aspect of the present invention where the handpiece further comprises a casing, a cable outlet, a solenoid coil, a needle tip, a channelling inlet, and a channelling outlet. The handpiece is further characterised in that the casing protects the internal component, the cable supplies electrical pulse current, the solenoid coil is made from soft iron, the needle tip conducts the pulsatile magnetic field generated by thesolenoid coil to a loosened lens nucleus and the channelling inlet is connected to a solution drip tubing to supply a constant flow of balanced salt solution and the channelling outlet is for the continuous delivery of the balanced salt solution into the anterior chamber.

[0022] An embodiment of the present invention where the needle tip is bent to 70 degrees.

[0023] An embodiment of the present invention where the balanced salt solution maintains anterior chamber stability and prevents overheating during operation.

[0024] Another embodiment of the present invention is that the solenoid coil of the handpiece is capable to generate a magnetic field strength of 2-5 mTesla, preferably 3 mTesla. This is to ensure minimal collateral damage to adjacent ocular tissues.

[0025] In another aspect, the present invention discloses the use of the iron oxide nanoparticle solution is from a group of superparamagnetic iron oxide nanoparticles of 10-20 nm in size.

[0026] Accordingly, the iron oxide nanoparticle solution is functionalised with coating from a group of materials such as dextran or polyethylene glycol (PEG) so as to enhance stability, biocompatibility, and easy penetration into the hardened crystalline lens nucleus.

[0027] Another aspect of the present invention discloses a use of an iron oxide nanoparticle solution in a preparation of medicament for a cataract phacoemulsification treatment, characterised in that the iron oxide nanoparticle solution is channelled into a crystalline lens nucleus for breaking interdigitating bonds between lens fibers of the lens nucleus.

[0028] The present invention consists of features and a combination of parts hereinafter fully described and illustrated in the accompanying drawings, it is understood that various changes in the details may be made without departing from the scope of the invention or sacrificing any of the advantages of the present invention.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] To further clarify various aspects of some embodiments of the present invention, a more particular description of the invention will be rendered by references to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the accompanying drawings in which:

[0030] Figure 1 is an illustration showing an apparatus for softening a crystalline lens nucleus.

[0031] Figure 2 is an image showing an electric current pulse generator.

[0032] Figure 3 is an image showing a handpiece.

[0033] Figure 4 is an image showing an iron oxide nanoparticle solution.

[0034] Figure 5 is an illustration showing that the electric current pulse generator is configured to produce pulse currents with adjustable voltage and frequency parameters.

[0035] Figure 6 is an illustration showing a handpiece of the crystalline lens nucleus softening apparatus where (a) is the assembled view of the handpiece and (b) is the internal view of the handpiece.

[0036] Figure 7 is an illustration showing a method of using the crystalline lens nucleus softening apparatus.

[0037] Figure 8 is an illustration showing the image of a crystalline lens condition, where (a) is before softening and (b) is after softening using the present invention.Reference numerals

[0038] 11 - electric current pulse generator

[0039] 12 - handpiece

[0040] 13 - iron oxide nanoparticle solution

[0041] 14 - hardened crystalline lens nucleus

[0042] 21 - casing

[0043] 22 - cable outlet

[0044] 23 - solenoid coil

[0045] 24 - needle tip

[0046] 25 - channelling inlet

[0047] 26 - channelling outlet

[0048] 100 - an apparatus for softening a crystalline lens nucleus

[0049] 200 - a method for using an apparatus for softening a crystalline lens nucleus 201 - step of performing capsulotomy

[0050] 202 - step of channelling an iron oxide nanoparticle solution to a crystalline lens nucleus by performing hydrodissection on the lens nucleus

[0051] 203 - step of infusing a balanced salt solution from a solution drip tubing into the anterior chamber

[0052] 204 - step of supplying a pulsatile current to the handpiece electrically connected to an electric current pulse generator using a cable

[0053] 205 - step of conducting the pulsatile magnetic field to the lens nucleus

[0054] 206 - step of vibration of the iron oxide nanoparticlesDETAILED DESCRIPTION OF THE INVENTION

[0055] The most crucial and difficult step in phacoemulsification is nucleus fragmentation. Most of the complications of phacoemulsification occur at this stage of operation because it requires skilful manipulation with surgical instrumentation. The demand of dexterity is high and the learning curve is steep. The present invention is to circumvent these problems so that even a novice surgeon can perform the phacoemulsification with ease and good visual results. The invention of the crystalline lens nucleus softening apparatus is solely dedicated to soften the lens nucleus with an ergonomically designed instrument. The embodiment concept of the present invention therefore focuses on improvement of phacoemulsification procedure.

[0056] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that current invention may be practised without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.

[0057] The present invention teaches a method of breaking the interdigitating system of hardened crystalline lens nucleus fibres. When the crystalline lens fibres are unlocked and loosened, it causes the lens nucleus to soften. Therefore, the present invention utilizes iron oxide nanoparticles presented with a pulse magnetic field to generate a vibration force sufficiently strong enough to break the interlocking system of the lens fibers.

[0058] As shown in Figure 1 , the present invention discloses an apparatus for softening a crystalline lens nucleus (100) that comprises three main components that include an electric current pulse generator (11 ), a handpiece (12), and an iron oxide nanoparticle solution (13) to softening a crystalline lens nucleus (14). Images of the electric current pulse generator (11), the handpiece (12) and the iron oxide nanoparticle solution (13) are shown in Figures 2, 3 and 4 respectively.The electric current pulse generator (11 ) supplies a pulse current to a handpiece (12), wherein the pulse current generates a pulsatile magnetic field in the handpiece (12). The handpiece (12) is connected to the electric current pulse generator (11) by a cable. A syringe cannula is utilised to infuse an iron oxide nanoparticle solution (13) to a crystalline lens nucleus (14) by performing a hydrodissection which also helps to loosen the lens nucleus prior to the application of a needle tip (24) of the handpiece (12) into contact with the loosened lens nucleus.

[0059] The electric current pulse generator (11) is a power source of the system which generates a direct current (DC) of 0-12 V, preferably 4-6 V and a pulse frequency up from 1 to 1000 Hz, preferably 300 - 400 Hz. The output wave front is a square wave which has a rapid rise and fall pattern. Meanwhile, the duty cycle can be varied from 1-100% preferably 80%. This is also built in safety measures that protect the apparatus from overheating and switch voltage surge. These parameters are adjustable via a touch screen setting according to the severity of each case. Figure 5 is an illustration showing that the electric current pulse generator is configured to produce pulse currents with adjustable voltage and frequency parameters.

[0060] Moving forward to Figure 6, where Figure 6(a) shows the assembled view of the handpiece (12), while Figure 6(b) shows the separated view of the handpiece (12). From Figure 6, the present invention discloses that the handpiece (12) further comprises a casing (21), a cable outlet (22), a solenoid coil (23), a needle tip (24), a channelling inlet (25), and a channelling outlet (26).

[0061] These components are crucial to the handpiece (12) as each of the components plays a vital role in ensuring safety, effectiveness, and precision of the crystalline lens nucleus softening and fragmentation. The functions of these components include:

[0062] 1. A casing (21) is essential for protecting the internal parts, ensuring the handpiece (12) remains durable and sterile. Furthermore, it ensures the device’s ergonomic for ease of handling during surgery.2. A cable (22) is vital for supplying electrical pulse current. This allows the handpiece (12) to be properly connected to the electric current pulse generator (11).

[0063] 3. The main component of the handpiece (12) is a solenoid coil (23) which generates a pulse magnetic field. It enables appropriate energy delivery to soften the lens nucleus efficiently. By ensuring controlled oscillations of the iron oxide nanoparticles, it enhances safety, reduces risks of tissue damage, and supports effective lens nucleus softening. The solenoid coil's responsiveness and precision make it as an indispensable part of the handpiece (12).

[0064] In the present invention, a solenoid coil (23) which is made of a soft iron core is housed inside the casing (21) with the cable outlet (22). The solenoid coil (23) is made from soft iron of 99.8% purity of iron. Both ends of the soft iron has a smaller diameter than the middle part of the core. Traversing the centre of the soft iron core is a fluid channel with a 0.4 mm diameter. The channelling inlet (25) is connected to a drip tubing. The other end of the soft iron core is tapered to form into a needle with a diameter of 1.0 mm. The channelling outlet (26) is at the needle tip (24). The soft iron is plated with nickel to prevent rusting. The utilization of soft iron in the present invention is due to its low retentivity and low coercivity. Low magnetic retentivity of soft iron enhances the efficiency of the handpiece (12). The high magnetic permeability allows strong magnetization, while low retentivity ensures rapid demagnetization. These properties enable the handpiece (12) to generate a maximum output of a pulse magnetic field at a given electric current.

[0065] 4. A needle tip (24) is the part which directly involve in the procedure. The design and functionality of the needle tip (24) are critical for energy delivery to facilitate the softening and fragmentation of the crystalline lens nucleus by conducting the generated pulsatile magnetic field to a lens nucleus. Preferably, the needle tip (24) is bent to 70 degrees. The pulse magnetic field is conducted to the crystalline lens nucleus through the needle tip (24), in which the magnetic field strength generated by the solenoid coil (23) of the handpiece (12) is around 2-5 mTesla, preferably 3 mTesla which ensures minimal collateral damage to adjacent ocular tissues. The high flux of magnetic field activity at the needle tip (24) will generate nanoparticle vibration forceat the lens fiber level. The force generated is ultra-small and will not be felt by the surrounding tissue and therefore danger of collateral damage to the surrounding tissue is negligible. However, at the lens fibre level, there are billions of nanoparticles vibrating at high frequency, thus the force generated is deemed sufficient to break the ultrafine bondage. This explicitly illustrates the use of targeted force provided by nanoparticles to work on ultrafine cellular structure.

[0066] 5. A channelling inlet (25) is connected to a solution drip tubing to supply a continuous flow of balanced salt solution to the anterior chamber. The balanced salt solution bottle is hung with a drip stand. The height of the bottle is adjustable to maintain an optimum anterior chamber stability. It is crucial to maintain the anterior chamber for the working of the handpiece needle. The continuous flow of the balanced salt solution prevents anterior chamber collapse and ensures stability of the eye during the softening procedure. It can also effectively prevent overheating during operation as the continuous flow of balanced salt solution through the handpiece (12) is designed to cool the heat generated by the solenoid coil (23). The channelling inlet (25) has a diameter of 3 mm.

[0067] 6. The continuous flow of balanced salt solution which can be added with appropriate strength of iron oxide nanoparticle solution will replenish the iron oxide nanoparticles in the lens nucleus thereby increase the efficacy of the procedure.

[0068] The whole handpiece can be sterilized by steam autoclave or ethylene oxide.

[0069] The iron oxide nanoparticle is a form of a superparamagnetic nanoparticle in nature measuring 10-20 nm in size. The nano size is desirable as it can easily infiltrate into the nucleus. Other than that, as a pulse magnetic field is not a form of energy per se, it will only generate a mechanical force when it acts on a ferromagnetic substance. Hence, the iron oxide nanoparticles are chosen for their favourable properties in ocular applications as it has a superparamagnetic property in nature which allows them to generate a stronger magnetic force under an external magnetic field when compared to a non-superparamagnetic nanoparticle. The vibration force generated by the nanoparticles is precisely targeted to the nucleus lens fibers with a magnitudestrong enough to break the lens fibers interdigitation system. Therefore, the magnetic field will not post a collateral damage to the surrounding tissues such as the trabecular meshwork and endothelial cell particularly. Besides that, they are also biocompatible and non-toxic to ocular tissues including the corneal endothelial cell and sensory retina. The iron oxide nanoparticle can be coated with biocompatible materials like dextran or polyethylene glycol (PEG) to improve penetration and stability.

[0070] Accordingly, the particle size of the iron oxide nanoparticles used in the present invention ranges from 10-20 nm in a spherical morphology. The interfiber space is around 100 nm, therefore nanoparticles bigger than this will be unable to penetrate into interfiber space. Nanoparticles smaller than 10 nm will not be able to generate sufficient momentum to break the bondage of the lens fibers. Therefore, the optimum size of the nanoparticles is synthesized around 10-20 nm. Most of the nanoparticles are aspirated from the eye during the procedure and the remnant of the nanoparticles are eliminated via the circulatory system and phycocytosis by the macrophages of the reticuloendothelial system of the body.

[0071] In another embodiment of the present invention that discloses the iron oxide nanoparticle solution (13) is functionalised with coating material from a group of dextran or polyethylene glycol (PEG) to enhance stability, biocompatibility, and easy penetration into the hardened crystalline lens nucleus (14).

[0072] These types of coatings are utilised to enhance the stability, biocompatibility, and facilitated diffusion of iron oxide nanoparticles into the lens nucleus. The specific coating and surface modification employed in this invention are as follows:

[0073] 1. Dextran coating which enhances biocompatibility and prevents nanoparticle aggregation, thus improving the functionality and stability in biological environments. This can be achieved as dextran provides a hydrophilic surface, facilitating dispersion in aqueous solutions such as balanced salt solutions used during ocular surgery.2. Polyethylene glycol (PEG) functionalisation of the iron oxide nanoparticles is to enhance stability of the nanoparticles in solution form and to facilitate penetration into the interfibre space.

[0074] The present invention is characterised in that the needle tip (24) of the handpiece (12) conducts the generated pulsatile magnetic field to the lens nucleus which causes vibration of the iron oxide nanoparticles in the interfibre space thereby generating a mechanical force to break the interdigitating bonds between lens fibres of the lens nucleus (14), leading to a controlled softening and breaking of the lens nucleus into tiny fragments. The electric current pulse generator (11) is configured to produce pulse currents with adjustable voltage and frequency parameters, and the iron oxide nanoparticle solution (13) further comprises a superparamagnetic property functionalised with a biocompatible coating to enhance penetration into the lens nucleus.

[0075] As shown in Figure 7, the embodiment of the present invention discloses a method for using an apparatus (200) for softening a crystalline lens nucleus comprising the following steps:

[0076] 201 , A 2.75 mm corneal incision is made at the limbus of the eye. Viscoelatic substance is injected into the anterior chamber and anterior capsulotomy is done to make an opening on the anterior capsule. Continuous curvilinear capsulorhexis (CCC) is preferred to create a smooth, continuous edge which is resistant to tearing during the procedure. The CCC allows good intraocular lens centration and reduces posterior capsular tear during the procedure.

[0077] 202, Iron oxide nanoparticle solution is employed for hydrodissection of the lens nucleus. The hydrodissection will result in loosening the nucleus from the cortex and at the same time to enable the nanoparticles to infiltrate into lens nucleus.

[0078] 203, Infusing a balanced salt solution from a solution drip tubing into the anterior chamber by using the handpiece (12). The outflow of the balanced salt solution is through the corneal wound.204, supplying a pulsatile current to the handpiece solenoid coil (23) which is connected to an electric current pulse generator (11) using a cable. The electric current pulse generator (11 ) is switched on by a foot switch controlled by the surgeon. A pulse magnetic field is then generated by the solenoid coil (23) of the handpiece (12). It is then conducted to the needle tip (24).

[0079] 205, conducting the pulsatile magnetic field to the loosened lens nucleus (205) using a needle tip (24) of the handpiece (12) to cause vibration of the iron oxide nanoparticles (206) in the interfibre space of the lens nucleus (13). The vibrations of the nanoparticles break the interdigitations of the lens fibres thereby resulting in softening and fragmentation of the lens nucleus. In this step, the needle tip is gently placed on the lens nucleus surface with light touch so that the needle tip penetrates the lens nucleus slightly without unduly force applied. After a few seconds of application, a softening consistency of the lens nucleus will be felt at the site of application. Once the breaking of interlocking lens fibers caused by the vibrating nanoparticles is done, the loosened lens nucleus becomes soft in consistency. This process eliminates manual fragmentation, thereby it reduces surgical risks and enhances precision.

[0080] Accordingly, the method for using the apparatus (200) for softening a crystalline lens nucleus is characterised in that the infusing of the balanced salt solution into the handpiece (12) is done through the channelling inlet (25) of the handpiece (12), and the vibration of the iron oxide nanoparticles (206) is caused by the pulsatile magnetic field, which emanates a mechanical force to break interdigitating bonds between lens fibers of the lens nucleus, leading to a controlled softening and breaking of the lens nucleus into tiny fragments.

[0081] When softening at the spot is done, the needle is then placed to another adjacent spot and the whole procedure is repeated in that fashion, starting from the periphery and moving to the centre of the lens nucleus. This manoeuvre is preferred because the peripheral lens fibers are softer and easier to soften compared to the denser central nucleus.When the lens nucleus is completely softened and fragmented, the handpiece (12) is withdrawn from the anterior chamber. The nucleus fragments and cortex are then aspirated with or without ultrasonic power. The whole procedure is completed with intraocular lens implantation and clearance of the viscoelastic substance.

[0082] The significance of softening the lens nucleus using a pulsed magnetic field enhanced patient safety, and improved surgical outcomes, and can be applied to complex cases with hard cataracts, shallow anterior chambers, or subluxated lenses. Moreover, the softening technique simplifies the procedure, making it easier for less experienced surgeons to perform with higher safety margin thereby reducing intraoperative stress, shortening surgery time as it minimizes the need for multiple manual manipulations and ultimately reducing ultrasonic power.

[0083] The embodiment of the present invention further provides advantages where the crystalline lens nucleus softening apparatus (100) does not require manual breaking of the nucleus, therefore removing the steps of flipping, chopping or splitting nucleus into halves and quadrants. As the present invention uses minimal to no ultrasound energy, the endothelial cell loss is reduced. The procedure using the present invention is predictable and reproducible in all types of cataracts. And the present invention also reduced the intraoperative complications like posterior capsule tear, drop nucleus, vitreous loss and endothelial cell loss.

[0084] In another aspect of the invention, the softened lens nucleus is rendered aspirable and emulsifiable using minimal ultrasonic power during phacoemulsification. As shown in Figure 8, where Figure 8(a) shows the crystalline lens before softening, and Figure 8(b) is after softening using the present invention.

[0085] The present invention may be embodied in other specific forms without departing from its essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore indicated by the appended claims rather than by the foregoing description. All changes, which come within the meaning and range of equivalency of the claims, are to be embraced within their scope.

Claims

CLAIMS1. An apparatus for softening a crystalline lens nucleus (100) in a cataract phacoemulsification treatment comprising:an electric current pulse generator (11) to supply a pulse current to a handpiece (12), wherein the pulse current generates a pulsatile magnetic field in the handpiece (12);the handpiece (12) connected to the electric current pulse generator (11 ) by a cable; anda syringe with a cannula to deliver an iron oxide nanoparticle solution (13) to a hardened crystalline lens nucleus (14) of an eye to hydrodissect the lens nucleus before application of the needle tip (24) of the handpiece (12) into the loosened lens nucleus superficially,characterised in that the needle tip (24) of the handpiece conduct pulsatile magnetic field to the loosened lens nucleus which causes vibration of the iron oxide nanoparticles in the interfibre space which emanates a mechanical force to break interdigitating bonds between lens fibers of the lens nucleus (14), leading to a controlled softening and breaking of the lens nucleus into tiny fragments, wherein the electric current pulse generator (11) is configured to produce pulse currents with adjustable voltage and frequency parameters, and the iron oxide nanoparticle solution (13) further comprises a superparamagnetic property functionalised with a biocompatible coating to enhance penetration into the lens nucleus.

2. The apparatus according to claim 1 , wherein the electric current pulse generator (11 ) is set to produce direct current (DC) from 0-12 V.

3. The apparatus according to claim 1 , wherein the electric current pulse generator (11) produces a square wave with an adjustable duty cycle ranging from 1 -100% and pulse frequency ranging from 1 Hz to 1000 Hz.

4. The apparatus according to claim 1 , wherein the softened lens nucleus is rendered aspirable and emulsifiable using minimal ultrasonic power during phacoemulsification.

5. The apparatus according to claim 1 , wherein the handpiece (12) further comprises:a casing (21);a cable outlet (22);a solenoid coil (23);a needle tip (24);a channelling inlet (25); anda channelling outlet (26),characterised in that the casing (21 ) protects the internal component, the cable outlet (22) supplies electrical pulse, the solenoid coil (23) is made from soft iron, the needle tip (24) conducts the generated pulsatile magnetic field to a lens nucleus and the channelling inlet (25) is connected to a solution drip tubing to supply a balanced salt solution and the channelling outlet (26) is for the delivery of the balanced salt solution into the loosened lens nucleus.

6. The apparatus according to claim 5, wherein the needle tip (24) is bent to 70 degrees.

7. The apparatus according to claim 5, wherein the balanced salt solution maintains anterior chamber stability and prevents overheating during operation.

8. The apparatus according to claim 5, wherein the solenoid coil (23) of the handpiece (12) generates a magnetic field strength of 2-5 mTesla, ensuring minimal collateral damage to adjacent ocular tissues.

9. The apparatus according to claim 1 , wherein the iron oxide nanoparticle solution (13) is from a group of superparamagnetic iron oxide nanoparticles of 10-20 nm in size.

10. The apparatus according to claim 9, wherein the iron oxide nanoparticle solution (13) is functionalised with coating material from a group of dextran or polyethylene glycol (PEG) to enhance stability, biocompatibility, and easy penetration into the crystalline lens nucleus (14).

11. A use of an iron oxide nanoparticle solution (13) in a preparation of medicament for a cataract phacoemulsification treatment, characterised in that the iron oxide nanoparticle solution (13) is channelled into a crystalline lens nucleus for breaking interdigitating bonds between lens fibers of the lens nucleus.

Images