Phacoemulsification device

Abstract

The invention relates to a device for softening the lens nucleus (100) in phacoemulsification treatment, which device comprises a current pulse generator (11) for supplying pulsed current to a handpiece (12), wherein the pulsed current generates a pulsating magnetic field; and water separation of the lens nucleus with an iron oxide nanoparticle solution to loosen the lens nucleus and to infiltrate the lens nucleus (14) with iron oxide nanoparticles (13), characterized in that the needle tip (24) of the handpiece (12) conducts the generated pulsating magnetic field to the lens nucleus, which causes the iron oxide nanoparticles to vibrate, the vibrations emitting mechanical forces to break the cross-linking bonds between the lens fibers, resulting in controlled softening and fragmentation of the lens nucleus, wherein the current pulse generator (11) is configured to generate pulsed current with adjustable voltage and frequency parameters, and the iron oxide nanoparticle solution (13) also has superparamagnetic properties functionalized with a biocompatible coating.

Description

Technical Field

[0001] The present invention relates to a device for softening and breaking the lens nucleus of the human eye. Background Technology

[0002] The eye is the sensory organ of the visual system, where visible light from objects is converted into electrical impulses, which are then transmitted to the brain via the visual pathway for visual perception. The eye is a spherical structure composed of two segments connected at the limbus. The outermost layer of the anterior segment is the cornea, a transparent tissue that makes up one-sixth of the eye's total surface area. The outermost layer of the posterior segment is the sclera, through which the optic nerve emerges from the posterior pole medially. The sclera constitutes the remaining five-sixths of the eye's total surface area. The middle layer of the posterior segment is the uvea, composed of the iris, ciliary body, and choroid. The choroid is a vascular layer that supplies some of the oxygen and nutrients needed for the outer retina. The innermost layer of the posterior segment is the sensory retina and retinal pigment epithelium.

[0003] The lens is biconvex in shape. It is suspended from the projections of the ciliary body by hundreds of thin cords called suspensory ligaments. The lens consists of the lens capsule, cortex, and nucleus. The lens capsule is a thin membrane divided into anterior and posterior capsules. The cortex is the soft part of the lens tissue, while the nucleus is the rigid part of the lens structure. In young people, the lens can change its shape through a process called accommodation. As we age, this ability is lost, resulting in poor near vision. The nucleus and cortex are composed of tiny lens fibers, which are tightly packed in an interlocking system such as a ball-and-socket or tongue-and-groove system. Lens fibers are formed by epithelial cells in the equatorial region of the lens capsule. The lens fibers are laid out in concentric layers, with older fibers located at the center of the nucleus. The anterior cavity is filled with aqueous humor and is divided into anterior and posterior chambers by the iris. The posterior cavity is called the vitreous cavity, which is filled with a gel-like substance.

[0004] The cornea and lens form the main refractive power of the eye by focusing light onto the fovea of ​​the retina. As people age, the lens becomes cloudy and loses its transparency, leading to the formation of cataracts. As a result, light is blocked from reaching the retina, causing blindness. In general, cataracts are the most common cause of reversible blindness. Essentially, cataract surgery involves removing part of the anterior capsule, the entire cortex, and the nucleus of the lens, and replacing it with an artificial lens. Several methods can be used to do this, but in most cases, phacoemulsification is the primary treatment. This is because phacoemulsification involves a small incision, resulting in a much faster healing and recovery process compared to conventional extracapsular cataract extraction.

[0005] In phacoemulsification, the anterior chamber is accessed through a corneal incision. The anterior capsule of the lens is opened to create a capsulotomy. The nucleus is loosened from the cortex through a process called hydrolysis. The nucleus is then fragmented into smaller pieces. Using a phacoemulsification handpiece, the hard nucleus fragments are emulsified with the aid of ultrasound. These emulsified nucleus materials can then be easily aspirated.

[0006] The challenge of phacoemulsification is safely and easily breaking the hard nucleus into smaller pieces. Various surgical techniques, such as fractionation and phacoemulsification nucleus splitting, require over-manipulation in the anterior segment of the eye. These operations can lead to serious complications, such as posterior capsule rupture, making intraocular lens implantation impossible, or worse, the nucleus falling into the vitreous cavity. These are serious complications that will affect visual outcomes and, in the worst case, can lead to blindness due to a series of subsequent complications. Over-manipulation and overuse of ultrasound energy can also cause endothelial cell loss, resulting in a damaged, opaque cornea.

[0007] To overcome the problem of safe nucleus fragmentation, femtosecond laser-assisted cataract surgery (FLACS) was primarily invented for this purpose. FLACS is a surgical procedure for cataract extraction that uses an ultrafast laser to precisely perform key surgical steps to fragment the nucleus without requiring much manipulation of the eye. The femtosecond laser is used to create the incision, open the lens capsule (capsulotomy), and fragment the cataract lens. However, FLACS machines are expensive, and the laser machines have high maintenance costs. FLACS machines also add extra procedure time, thus increasing the overall surgery time. To address this dilemma, the novel device of this invention was invented. This invention can be seamlessly integrated into a phacoemulsification system, thus without extending the overall surgery time.

[0008] US Patent 2019105519A1 discloses an invention relating to an ultrasound-guided cavitation method and system for ocular treatment. The method and system utilize an ultrasound beam to generate cavitation with various spot sizes ranging from 50 micrometers to 200 micrometers for ocular treatment. This invention does not use ultrasound and does not induce cavitation.

[0009] Another US patent, US2015265725A1, discloses an invention relating to a method and composition for hyperthermic treatment of tumor cells in a patient under conditions affecting tumor stem cells or tumor cells. The tumor may be located in a site affecting bodily fluids, including the ocular cavity. Microwaves are used to treat intraocular tumors. Regardless of the route of administration, once inside the body, the nanoparticles are selectively and more readily attracted to magnets located in localized areas. Using only the eye as a non-limiting example, conformal magnets may be externally placed on accessible ocular lesions or positioned on small probes of accessible ocular lesions, or they may be implanted on internal lesions, such as under the conjunctiva, above the sclera, etc. This invention discloses targeted hyperthermic treatment of tumor cells using the thermal effect of a magnetic field on nanoparticles. However, no heat energy is generated in this invention. Mechanistically, the invention in US2015265725A1 uses magnetic nanoparticles for thermal ablation, rather than for mechanical effects. On the other hand, this invention utilizes magnetic energy for mechanical softening of the lens nucleus. Furthermore, US2015265725A1 has a broad scope applicable to cancer treatment, including eye tumors, and does not disclose specific ophthalmic applications, particularly for lens nucleus softening in cataract surgery.

[0010] This invention provides a teaching method relating to a device for softening the lens nucleus. In routine phacoemulsification, a cataract surgery, a major obstacle for surgeons is fragmenting the nucleus into small pieces, enabling safe phacoemulsification with low ultrasound energy and short exposure time. Therefore, overcoming the difficulty of nucleus fragmentation is crucial, particularly in hard and subluxated nuclei. This invention uses targeted magnetic energy to break the bonds in the lens fibers, thus requiring minimal manipulation of the handpiece needle in the posterior chamber of the eye, reducing stress on the eye and the surgeon. This also effectively reduces the risk of posterior capsule rupture and endothelial cell loss. It also shortens surgical time and ensures satisfactory and safe results for the patient. Summary of the Invention

[0011] The primary objective of this invention is to provide a teaching method that simplifies and improves the lens nucleus fragmentation process by softening the lens nucleus. This invention circumvents currently difficult lens nucleus fragmentation techniques. This invention will provide an easy and simplified method for fragmenting the lens nucleus with the aid of nanotechnology, thereby reducing serious complications of phacoemulsification. Therefore, it will reduce the burden on surgeons and, most importantly, achieve better visual recovery for patients.

[0012] This invention discloses a lens nucleus softening device for phacoemulsification of cataracts. The device includes a current pulse generator for: supplying a pulsed current to a handpiece, wherein the pulsed current generates a pulsating magnetic field within the handpiece, which is connected to the current pulse generator by a cable; and using a syringe cannula to guide a solution of iron oxide nanoparticles to the hardened lens nucleus to loosen the lens nucleus for a water separation operation before the tip of the handpiece contacts the lens nucleus. A further feature of this invention is that the tip of the handpiece conducts the generated pulsating magnetic field to the loosened lens nucleus, causing the iron oxide nanoparticles within the nucleus to vibrate, thereby generating a mechanical force that breaks the interlacing bonds between the lens fibers, resulting in controlled softening and fragmentation of the lens nucleus into tiny fragments.

[0013] Therefore, the present invention also discloses a current pulse generator configured to generate a pulse current with adjustable voltage and frequency parameters, and an iron oxide nanoparticle solution containing superparamagnetic properties functionalized by a biocompatible coating to enhance its permeability to the lens nucleus.

[0014] Embodiments of the present invention also disclose that the current generator is configured to generate direct current (DC) from 0 V to 12 V, preferably from 4 V to 6 V.

[0015] Another aspect of the invention is that the current pulse generator produces a square wave with an adjustable duty cycle in the range of 1% to 100% and a pulse frequency in the range of 1 Hz to 1000 Hz, preferably 300 Hz to 400 Hz.

[0016] In one aspect of the present invention, minimal ultrasonic energy is used during phacoemulsification to make the softened lens nucleus aspirable and emulsifiable.

[0017] In one aspect of the invention, the handheld device further includes a housing, a cable outlet, a solenoid coil, a needle tip, a flow inlet, and a flow outlet. The handheld device is further characterized in that the housing protects internal components, the cable supplies pulsed electrical current, the solenoid coil is made of soft iron, the needle tip guides the pulsating magnetic field generated by the solenoid coil to the loosened lens nucleus, the flow inlet is connected to a solution dropper to supply a constant flow of equilibrium salt solution, and the flow outlet is used to continuously deliver the equilibrium salt solution into the anterior chamber.

[0018] In one embodiment of the invention, the needle tip is bent to 70 degrees.

[0019] In one embodiment of the invention, a balanced salt solution maintains anterior chamber stability and prevents overheating during surgery.

[0020] Another embodiment of the invention is that the solenoid coil of the handheld component can generate a magnetic field strength of 2 to 5 millitalas, preferably 3 millitalas. This is to ensure minimal collateral damage to adjacent eye tissues.

[0021] In another aspect, the present invention discloses the use of an iron oxide nanoparticle solution derived from a group of superparamagnetic iron oxide nanoparticles with a size of 10 nm to 20 nm.

[0022] Therefore, iron oxide nanoparticle solutions are functionalized with a group of materials such as dextran or polyethylene glycol (PEG) coatings to enhance stability, biocompatibility, and ease of penetration into hardened lens nuclei.

[0023] Another aspect of the present invention discloses the use of iron oxide nanoparticle solution in the preparation of a medicament for phacoemulsification treatment of cataracts, characterized in that the iron oxide nanoparticle solution is guided into the lens nucleus to break the interlacing bonds between the lens fibers of the lens nucleus.

[0024] The present invention comprises the features and combinations of the parts fully described and illustrated below in the accompanying drawings. It should be understood that various changes in detail may be made without departing from the scope of the invention or sacrificing any of its advantages. Attached Figure Description

[0025] To further clarify various aspects of some embodiments of the invention, the invention will be described in more detail with reference to specific embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit its scope. The invention will be further described and explained in detail with reference to the accompanying drawings, in which: Figure 1 This is a diagram illustrating a device for softening the lens nucleus.

[0026] Figure 2 This is an image showing a current pulse generator.

[0027] Figure 3 It is an image showing the handheld device.

[0028] Figure 4 This is an image showing a solution of iron oxide nanoparticles.

[0029] Figure 5 This is a diagram illustrating a current pulse generator configured to produce pulsed currents with adjustable voltage and frequency parameters.

[0030] Figure 6 This is a diagram showing the handheld component of a lens nucleus softening device, wherein (a) is an assembled view of the handheld component and (b) is an internal view of the handheld component.

[0031] Figure 7 This is a diagram illustrating a method using a lens nucleus softening device.

[0032] Figure 8 These are illustrations showing the condition of the lens, where (a) is before softening and (b) is after softening using the present invention. Figure Labels

[0033] 11 – Current Pulse Generator 12 – Handheld 13–Iron oxide nanoparticle solution 14 – Hardened lens nucleus 21 – Shell 22 – Cable Outlet 23 – Solenoid Coil 24 – needle tip 25 – Flow Inlet 26 – Drainage Outlet 100 – Device for softening the lens nucleus 200 – Method using a device for softening the lens nucleus 201 – Steps for performing a cystotomy 202 – Step of directing iron oxide nanoparticle solution to the lens nucleus by water separation of the lens nucleus 203 – The procedure for infusing a balanced salt solution into the anterior chamber via a solution dropper. 204 – Steps for supplying pulsating current to a handheld device electrically connected to a current pulse generator using a cable 205 – Steps for transmitting a pulsating magnetic field to the lens nucleus 206 – Steps to vibrate iron oxide nanoparticles Detailed Implementation

[0034] The most critical and challenging step in phacoemulsification is nucleus fragmentation. Most complications of phacoemulsification occur at this stage of the procedure because it requires skilled manipulation with surgical instruments. It demands a high degree of dexterity and has a steep learning curve. This invention aims to circumvent these problems, enabling even novice surgeons to easily perform phacoemulsification with excellent visual outcomes. The lens nucleus softening device of this invention is entirely dedicated to softening the lens nucleus using ergonomically designed instruments. Therefore, the conceptual focus of this invention is on improving the phacoemulsification procedure.

[0035] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, those skilled in the art will understand that the invention can be practiced 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 invention.

[0036] This invention teaches a method for breaking the interlocking system of hardened lens nucleus fibers. When the lens fibers are unlocked and loosened, it causes the lens nucleus to soften. Therefore, this invention utilizes iron oxide nanoparticles exhibiting a pulsed magnetic field to generate a vibrational force strong enough to break the interlocking system of the lens fibers.

[0037] like Figure 1 As shown, this invention discloses an apparatus for softening the lens nucleus (100), comprising three main components: a current pulse generator (11), a handheld device (12), and an iron oxide nanoparticle solution (13) for softening the lens nucleus (14). Images of the current pulse generator (11), the handheld device (12), and the iron oxide nanoparticle solution (13) are shown in [images to be inserted here]. Figure 2 , Figure 3 and Figure 4 middle.

[0038] A pulse current generator (11) supplies a pulsed current to the handpiece (12), which generates a pulsating magnetic field in the handpiece (12). The handpiece (12) is connected to the pulse current generator (11) by a cable. The iron oxide nanoparticle solution (13) is infused into the lens nucleus (14) by performing water separation using a syringe cannula, which also helps to loosen the lens nucleus before the tip (24) of the handpiece (12) comes into contact with the loosened lens nucleus.

[0039] A current pulse generator (11) is the power supply for the system, generating direct current (DC) from 0 V to 12 V, preferably 4 V to 6 V, and pulse frequencies from 1 Hz to 1000 Hz, preferably 300 Hz to 400 Hz. The output wavefront is a square wave with a rapid rise and fall pattern. Simultaneously, the duty cycle can vary from 1% to 100%, preferably 80%. This is also based on safety measures protecting the device from overheating and switching voltage surges. These parameters can be adjusted via a touchscreen setting according to the severity of each situation. Figure 5 This is a diagram illustrating a current pulse generator configured to produce pulsed currents with adjustable voltage and frequency parameters.

[0040] Turn forward Figure 6 ,in Figure 6 (a) shows an assembled view of the handheld component (12), while Figure 6(b) shows a detached view of the handheld component (12). From Figure 6 As can be seen from the present invention, the handheld component (12) also includes a housing (21), a cable outlet (22), a solenoid coil (23), a needle tip (24), a flow inlet (25), and a flow outlet (26).

[0041] These components are crucial to the handpiece (12) because each of them plays a vital role in ensuring the safety, effectiveness, and precision of lens nucleus softening and fragmentation. The functions of these components include: 1. The housing (21) is necessary to protect the internal components, thereby ensuring that the handpiece (12) remains durable and sterile. In addition, it ensures the ergonomics of the device for easy handling during surgical procedures.

[0042] 2. The cable (22) is essential for supplying the electrical pulse current. This allows the handpiece (12) to be properly connected to the current pulse generator (11).

[0043] 3. The main component of the handpiece (12) is a solenoid coil (23) that generates a pulsed magnetic field. It enables appropriate energy delivery to efficiently soften the lens nucleus. By ensuring controlled oscillation of the iron oxide nanoparticles, it enhances safety, reduces the risk of tissue damage, and supports effective lens nucleus softening. The responsiveness and precision of the solenoid coil make it an indispensable part of the handpiece (12).

[0044] In this invention, a solenoid coil (23) made of a soft iron core is housed within a housing (21) having a cable outlet (22). The solenoid coil (23) is made of soft iron with an iron purity of 99.8%. The two ends of the soft iron have a smaller diameter than the middle portion of the core. A fluid channel with a diameter of 0.4 mm runs through the center of the soft iron core. A flow inlet (25) is connected to a dropper. The other end of the soft iron core tapers to form a needle with a diameter of 1.0 mm. A flow outlet (26) is located at the needle tip (24). The soft iron is plated with nickel to prevent rusting. Soft iron is used in this invention due to its low holding force and low coercivity. The low magnetic holding force of the soft iron improves the efficiency of the handpiece (12). High permeability allows for strong magnetization, while low holding force ensures rapid demagnetization. These characteristics enable the handpiece (12) to generate the maximum output of a pulsed magnetic field at a given current.

[0045] 4. The needle tip (24) is the component directly involved in the surgery. The design and functionality of the needle tip (24) are crucial for energy delivery to facilitate the softening and fragmentation of the lens nucleus by conducting the generated pulsating magnetic field to the lens nucleus. Preferably, the needle tip (24) is bent at 70 degrees. The pulsed magnetic field is conducted to the lens nucleus through the needle tip (24), wherein the magnetic field strength generated by the solenoid coil (23) of the handpiece (12) is approximately 2 to 5 millitalas, preferably 3 millitalas, which ensures minimal collateral damage to adjacent eye tissues. The high flux of magnetic field activity at the needle tip (24) will generate nanoparticle vibrational forces at the lens fiber level. The generated forces are extremely small and will not be felt by surrounding tissues, so the risk of collateral damage to surrounding tissues is negligible. However, there are billions of nanoparticles vibrating at high frequencies at the lens fiber level, so the generated forces are considered sufficient to break ultrafine bonds. This clearly demonstrates the use of targeted forces provided by nanoparticles to act on ultrafine cellular structures.

[0046] 5. The inlet (25) is connected to the solution dropper for supplying a continuous flow of balanced saline solution to the anterior chamber. The balanced saline solution bottle is suspended using a dropper holder. The height of the bottle is adjustable to maintain optimal anterior chamber stability. Maintaining the anterior chamber is crucial for the operation of the handpiece needle. The continuous flow of balanced saline solution prevents anterior chamber collapse and ensures eye stability during the softening procedure. It also effectively prevents overheating during the procedure, as the continuous flow of balanced saline solution through the handpiece (12) is designed to cool the heat generated by the solenoid coil (23). The inlet (25) has a diameter of 3 mm.

[0047] 6. A continuous flow of balanced salt solution, which can be added together with an iron oxide nanoparticle solution of appropriate strength, will replenish the iron oxide nanoparticles in the lens nucleus, thereby increasing the effectiveness of the procedure.

[0048] The entire handheld device can be sterilized by autoclaving or ethylene oxide.

[0049] Iron oxide nanoparticles are essentially superparamagnetic nanoparticles with dimensions ranging from 10 nm to 20 nm. The nanoscale size is desirable because it allows for easy penetration into the nucleus. Furthermore, since the pulsed magnetic field itself is not a form of energy, it will only generate mechanical force when acting on ferromagnetic materials. Therefore, iron oxide nanoparticles are chosen because of their advantageous properties for ophthalmic applications, as their inherent superparamagnetic nature compared to non-superparamagnetic nanoparticles allows them to generate a stronger magnetic force under an external magnetic field. The vibrational force generated by the nanoparticles precisely targets the lens fibers, and this force is strong enough to break the lens fiber interlacing system. Therefore, the magnetic field will not cause collateral damage to surrounding tissues, particularly trabecular meshwork and endothelial cells. In addition, they are biocompatible and non-toxic to ocular tissues including corneal endothelial cells and the sensory retina. Iron oxide nanoparticles can be coated with biocompatible materials such as dextran or polyethylene glycol (PEG) to improve permeability and stability.

[0050] Therefore, the spherical iron oxide nanoparticles used in this invention have a particle size in the range of 10 nm to 20 nm. The interfiber gap is approximately 100 nm, so nanoparticles larger than this will not be able to penetrate into the interfiber gap. Nanoparticles smaller than 10 nm will not generate sufficient momentum to break the bonds of the lens fibers. Therefore, the optimal size of the synthesized nanoparticles is approximately 10 nm to 20 nm. Most nanoparticles are aspirated from the eye during surgery, and the remaining nanoparticles are eliminated via the circulatory system and cleared by phagocytosis of macrophages in the reticuloendothelial system.

[0051] In another embodiment of the invention, an iron oxide nanoparticle solution (13) is disclosed to be functionalized with a coating material from a group of dextran or polyethylene glycol (PEG) to enhance stability, biocompatibility and ease of penetration into hardened lens nuclei (14).

[0052] These types of coatings are used to enhance the stability and biocompatibility of iron oxide nanoparticles and to promote their diffusion into the lens nucleus. Specific coatings and surface modifications used in this invention are as follows: 1. A dextran coating that enhances biocompatibility and prevents nanoparticle aggregation, thereby improving functionality and stability in biological environments. This is achieved by the hydrophilic surface provided by dextran, thus promoting dispersion in aqueous solutions such as balanced salt solutions used during ophthalmic surgery.

[0053] 2. Polyethylene glycol (PEG) functionalization of iron oxide nanoparticles is intended to enhance the stability of nanoparticles in solution and promote their penetration into the interfiber spaces.

[0054] The invention is characterized in that the tip (24) of the handheld device (12) conducts the generated pulsating magnetic field to the lens nucleus, which causes the iron oxide nanoparticles in the interfiber gaps to vibrate, thereby generating a mechanical force to break the interlacing bonds between the lens fibers of the lens nucleus (14), resulting in controlled softening and breakage of the lens nucleus into tiny fragments. The current pulse generator (11) is configured to generate a pulsed current with adjustable voltage and frequency parameters, and the iron oxide nanoparticle solution (13) also has superparamagnetic properties functionalized with a biocompatible coating to enhance permeability to the lens nucleus.

[0055] like Figure 7 As shown, an embodiment of the present invention discloses a method using a device (200) for softening the lens nucleus, the method comprising the following steps: 201. A 2.75 mm corneal incision is made at the limbus of the eye. Viscoelastic material is injected into the anterior chamber, and an anterior capsulotomy is performed to create an opening in the anterior capsule. Continuous circular capsulotomy (CCC) is preferred to produce a smooth, continuous edge that resists tearing during the procedure. CCC allows for good centering of the intraocular lens and reduces posterior capsule tearing during the procedure.

[0056] 202. A solution of iron oxide nanoparticles was used to separate the lens nucleus from the cortex. The separation of water caused the nucleus to loosen from the cortex, and at the same time allowed the nanoparticles to penetrate into the lens nucleus.

[0057] 203, The balanced salt solution is infused into the anterior chamber from the solution dropper using the handheld device (12). The balanced salt solution flows out through the corneal wound.

[0058] 204. A pulsating current is supplied to the handheld solenoid coil (23), which is connected by a cable to a current pulse generator (11). The current pulse generator (11) is turned on by a foot switch controlled by the surgeon. A pulsed magnetic field is then generated by the solenoid coil (23) of the handheld device (12). This is then conducted to the needle tip (24).

[0059] 205. Using the needle tip (24) of the handheld device (12), a pulsating magnetic field is conducted to the loosened lens nucleus (205) to induce vibration of iron oxide nanoparticles (206) in the interstices between the fibers of the lens nucleus (13). The vibration of the nanoparticles causes the interlocking of the lens fibers to break, resulting in softening and fragmentation of the lens nucleus. In this step, the needle tip is gently placed on the surface of the lens nucleus, touching it lightly so that the needle tip slightly penetrates the lens nucleus without applying excessive force. After a few seconds of application, a softened texture of the lens nucleus can be felt at the application site. Once the fragmentation of the interlocking lens fibers caused by the vibrating nanoparticles is complete, the loosened lens nucleus becomes soft. This process eliminates manual fragmentation, thus reducing surgical risks and increasing precision.

[0060] Therefore, the method for using the device (200) for softening the lens nucleus is characterized in that the balanced salt solution is infused into the handpiece (12) through the inlet (25) of the handpiece (12), and the iron oxide nanoparticles (206) are vibrated by a pulsating magnetic field, which exerts a mechanical force to break the interlacing bonds between the lens fibers of the lens nucleus, thereby causing the lens nucleus to soften in a controlled manner and break into tiny fragments.

[0061] Once softening is complete at the spot, the needle is then placed at another adjacent location, and the entire process is repeated in this manner, starting from the periphery and moving towards the center of the lens nucleus. This operation is preferred because the peripheral lens fibers are softer and easier to soften compared to the denser central nucleus.

[0062] Once 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 ultrasound power. The procedure concludes with intraocular lens implantation and removal of viscoelastic material.

[0063] The importance of using pulsed magnetic field softening of the lens nucleus lies in its enhanced patient safety and improved surgical outcomes, and its applicability to complex cases involving hard cataracts, shallow anterior chambers, or subluxated lenses. Furthermore, the softening technique simplifies the procedure, making it easier for less experienced surgeons to perform with greater safety margins, thereby reducing intraoperative stress and surgical time by minimizing the need for multiple manual manipulations and ultimately reducing ultrasound power.

[0064] Embodiments of the present invention also offer the advantage that the lens nucleus softening device (100) does not require manual nucleus fracturing, thus eliminating the steps of flipping, shredding, or splitting the nucleus into halves and quarters. Because the present invention uses minimal or no ultrasound energy, endothelial cell loss is reduced. The procedure using the present invention is predictable and reproducible in all types of cataracts. Furthermore, the present invention reduces intraoperative complications such as posterior capsule tear, detached nucleus, vitreous prolapse, and endothelial cell loss.

[0065] In another aspect of the invention, minimal ultrasonic power is used during phacoemulsification to make the softened lens nucleus aspirable and emulsifiable. For example... Figure 8 As shown, where Figure 8 (a) shows the lens before softening, and Figure 8 (b) is the lens after it has been softened using the present invention.

[0066] This 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. Therefore, the scope of the invention is indicated by the appended claims rather than by the foregoing description. All variations within the meaning and scope of equivalents of the claims will be included within their scope.

Claims

1. An apparatus for softening the lens nucleus (100) during phacoemulsification of cataracts, the apparatus comprising: A current pulse generator (11) is used to supply a pulsed current to a handheld device (12), wherein the pulsed current generates a pulsating magnetic field in the handheld device (12). Handheld device (12), which is connected to the current pulse generator (11) by a cable; as well as A syringe with a cannula for delivering an iron oxide nanoparticle solution (13) to the hardened lens nucleus (14) of the eye to dehydrate the lens nucleus before the needle tip (24) of the handpiece (12) is superficially applied to the loosened lens nucleus. The invention is characterized in that the tip (24) of the handheld device conducts a pulsating magnetic field to the loosened lens nucleus, which causes the iron oxide nanoparticles in the gaps between the fibers to vibrate. The vibration generates a mechanical force to break the interlacing bonds between the lens fibers of the lens nucleus (14), thereby causing the lens nucleus to soften in a controlled manner and break into tiny fragments. The current pulse generator (11) is configured to generate a pulsed current with adjustable voltage and frequency parameters, and the iron oxide nanoparticle solution (13) also has superparamagnetic properties functionalized with a biocompatible coating to enhance permeability to the lens nucleus.

2. The apparatus of claim 1, wherein the current pulse generator (11) is configured to generate direct current (DC) from 0 V to 12 V.

3. The apparatus according to claim 1, wherein the current pulse generator (11) generates a square wave with an adjustable duty cycle in the range of 1% to 100% and a pulse frequency in the range of 1 Hz to 1000 Hz.

4. The apparatus of claim 1, wherein minimal ultrasonic power is used during phacoemulsification to make the softened lens nucleus aspirable and emulsifiable.

5. The device according to claim 1, wherein the handheld component (12) further comprises: Shell (21); Cable outlet (22); Solenoid coil (23); needle tip (24); The flow entry point (25); and Drainage outlet (26). The device is characterized in that the housing (21) protects the internal components, the cable outlet (22) supplies electrical pulses, the solenoid coil (23) is made of soft iron, the needle tip (24) conducts the generated pulsating magnetic field to the lens nucleus, the flow inlet (25) is connected to a solution dropper to supply a balanced salt solution, and the flow outlet (26) is used to deliver the balanced salt solution to the loosened lens nucleus.

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

7. The device of claim 5, wherein the balanced salt solution maintains anterior chamber stability and prevents overheating during surgery.

8. The device according to claim 5, wherein the solenoid coil (23) of the handheld member (12) generates a magnetic field strength of 2 to 5 millitalas, thereby ensuring minimal collateral damage to adjacent eye tissues.

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

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

11. The use of iron oxide nanoparticle solution (13) in the preparation of a medicament for phacoemulsification therapy of cataracts, characterized in that, The iron oxide nanoparticle solution (13) is directed into the lens nucleus to break the interlacing bonds between the lens fibers of the lens nucleus.

Images