WO2011151837A1

WO2011151837A1 - Micro incision phaco needle assembly

Info

Publication number: WO2011151837A1
Application number: PCT/IN2011/000142
Authority: WO
Inventors: Ram Srikanth Mirlay
Original assignee: Ram Srikanth Mirlay
Priority date: 2010-05-31
Filing date: 2011-03-07
Publication date: 2011-12-08

Abstract

A phacoemulsification needle assembly (101) comprises a sleeve (103) and a bevel (104). The needle near the tip portion (102) has a plurality of projections (106) on the outer surface and a plurality of cross wires (209) and blades on the inner lumen for emulsifying and cutting the cataract inside an eye. The bevel (104) has an enlarged cross-section to provide a more surface area to create extra ultrasonic vibrations. The projections (106) also help in increasing the surface area. The bevel (104) has a sharp outer edge (108) and sharp teeth like projections on the inner edge (107). The phacoemulsification needle assembly (101) comprises a first cutting segment, a second cutting segment and a third cutting segment. The sharp outer edge (108) of the bevel (104) forms a first cutting segment. The teeth and th cross wires (209) form the second and the third cutting segments respectively.

Description

TITLE OF THE INVENTION:

MICRO INCISION PHACO NEEDLE ASSEMBLY

BACKGROUND

Technical field

[0001] The embodiments herein generally relate to the field of phacoemulsification in cataract surgery and particularly to phaco needles. The embodiments herein more particularly relate to a phacoemulsification surgical cutting needle tip used for removing a cataract nucleus from a mammalian eye by utilizing the ultrasonic movements of the Phaco needle, with smaller incision size, greater efficiency and less tissue trauma.

Description of the Related Art

[0002] In a mammalian cataract surgery, a machine called the phaco emulsification machine is used. The machine is used by an eye surgeon to emulsify a cataract inside an eye. The machine has a "phaco hand piece," as a part of it. A metallic tip is attached to the phaco hand piece called as the Phaco Needle; An incision is made in the cornea of the eye. The phaco needle is inserted in the eye. The cataract is emulsified and sucked in by the aspiration aperture of the needle.

[0003] But, the larger incisions cause a distortion in the cornea. The distortion is called Surgically Induced Astigmatism or SIA. In order to avoid SIA, smaller incisions, than the present incisions of size 2.5 to 3.2 mm, are becoming a trend. Since the incision accommodates the phaco tip, narrow, more efficient, smaller and incision profile shaped phaco tips are being designed. The narrow and smaller bore tips have less lumen volume. As a result, new problems and challenges have arisen in emulsifying and evacuating a cataract. The problems are as follows: less volume flows through a lumen per minute thereby increasing the surgical time. The vacuum hold on the cataract pieces is less or reduced as the open bore face (surface area) is less. As the broad face of the bevel gets narrower, the cataract pieces get stuck in the narrow lumen whenever sucked in by a vacuum of the machine.

[0004] These shortcomings result in a greater phaco surgical time thereby providing greater damage to tissue. Also the shortcomings further result in a prolonged tissue manipulation thereby increasing the risk of surgical complications. [0005] Hence there is a need to develop a phaco needle that provides less damage to the tissues with fewer complications and reduces the surgical time.

[0006] The above mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification.

OBJECTS OF THE EMBODIMENTS

[0007] The primary object of the embodiments herein is to provide a phacoemulsification needle tip with an Incision Profile Shaped (IPS) needle cross section so that the phacoemulsification needle tip has an oval shaped cross section that is perpendicular to long axis of needle, to provide a better fit to the slit like incision, which takes an oval shape when any instrument is passed through it.

[0008] Another object of the embodiments herein is to provide a phacoemulsification needle tip having a gentle bend (away from the bevel open face), at preset angles to long axis of the needle shaft, to increase the efficiency of the fragmentation process by an increased surface area of the needle bevel face and to increase the ultrasonic energy delivery to increase the Grip- area and 'Hold' on the cataract and to quicken the emulsification and fragmentation process of the cataract surgery.

[0009] Yet another object of the embodiments herein is to provide a phacoemulsification needle tip with an expanded "FACE" to provide the needle tip with a larger mouth that is longer than the lumen's cross-sectional area thereby providing a dynamic wide funnel design to enhance the ultrasound energy delivered to the cataract. However, the expansion is only in length-wise direction and not along the breadth wise direction, thereby enabling micro incision sizes.

[0010] Yet another object of the embodiments herein is to provide a phacoemulsification needle tip with features on the outer surface of the shaft near the edge to increase the energy delivered for emulsification thereby increasing efficiency, reducing the emulsification process and reducing the cataract surgery time, especially during the "Intra-nuclear" emulsification stage of the surgery.

[0011] Yet another object of the embodiments herein is to provide a phacoemulsification needle tip in which the intra-lumen of the needle is fixed or arranged with (super) sharp blades or cross wires, with the sharp edges to provide a second cutting device, (the first cutting device being the needle's front end) to break up the smaller cataract pieces quickly and to create more ultrasonic energy.

[0012] Yet another object of the embodiments herein is to provide a phaco emulsification needle with the presence of thin, vibrating, sharp cutting blade like devices such as sharp, thin and strong cross-wires which are arranged just inside the bevel of the needle as part of the tip and fixed at the time of manufacture.

[0013] Yet another object of the embodiments herein is to provide a phaco emulsification needle with the gently curved, open-face bevel, having, teeth like serrations on its inner lip to provide a help in crushing and cutting the cataract pieces as they are sucked in by the vacuum of the machine and to increase the phaco / ultra sound energy delivered to the cataract by increasing the surface area of the ultrasound energy delivery.

[0014] Yet another object of the embodiments herein is to provide a phaco emulsification needle in which the outer surface of the needle shaft is provided with the features such as tiny depressions or pits or buttons like knobs and roughened surface irregularities, to increase the phaco/ultra sound energy delivery to the cataract, thereby increasing the efficiency of surgery. The features are present up to at least one mm from bevel.

[0015] These and other objects and advantages of the embodiments herein will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings. SUMMARY

[0016] The various embodiments herein provide a incision phaco needle assembly According to one embodiment herein, a micro incision phaco needle assembly comprises an outer sleeve and an phaco needle which is arranged inside the outer sleeve. A bevel is formed at a tip portion of the phaco needle. A plurality of projections is formed on an outer surface of the phaco needle near the tip portion. A plurality of cutting elements is arranged inside the phaco needle along an axis of the phaco needle.

[0017] The bevel is formed in an oval shape. The bevel has an outer edge and an inner edge. The outer edge of the bevel is smooth and sharp. The smooth and sharp outer edge forms a first cutting segment. The inner edge of the bevel has a plurality of sharp teeth. The plurality of sharp teeth in the inner edge of the bevel forms a second cutting segment. The bevel is extended along a length direction to provide an area which is more than a cross sectional area of the phaco needle. The bevel has a dynamic long funnel shape to increase an ultrasound energy delivered to a cataract.

[0018] The plurality of projections formed on an outer surface of the phaco needle is selected from a group comprising of pits, buttons, fins, grooves, sintered portion, and sand blasted portion and a combination thereof. The fins are spikes or flat vertical plates and angulated plates and combination thereof. The plurality of cutting elements arranged inside the phaco needle is selected form a group comprising of cross wires or blades. The plurality of cutting elements arranged inside the phaco needle is a third cutting segment. The plurality of cutting elements is mounted at an angle of 45° from an inner surface of the phaco needle. The plurality of the cutting elements is arranged in parallel to each other. The plurality of the cutting elements is arranged perpendicular to each other. The plurality of cutting elements is angled and arranged in a forward direction to form an arrow head like structure pointing forwardly along a longitudinal direction of the phaco needle.

[0019] The tip portion has a bending with an angle of 50-450 to a longitudinal axis of the phaco needle. The phaco needle has an oval shaped cross section with its long axis being arranged along a horizontal direction in the front portion for a distance of 8mm. The phaco needle has a circular cross section beyond the 8 mm distance with a transition zone arranged in between.

[0020] According to one embodiment herein, the phaco emulsification needle assembly comprises a needle and a bevel on tip of the needle. The bevel has an outer edge and an inner edge. The outer edge is sharp. The outer edge is a first cutting segment. The inner edge has a plurality of sharp teeth. The plurality of sharp teeth is second cutting segment. The sleeve has a plurality of projections on an outer surface. The plurality of projections is present at a distance upto at least 2 mm from the bevel. The plurality of projections are selected from a group comprising of pits, buttons, fins, grooves, sintered portion, and sand blasted portion and combination thereof. The fins include spikes and flat, vertical and angulated plates and combination thereof. The grooves are arranged in a parallel and a perpendicular direction to one another. The phaco needle has a plurality of cross wires at an inner surface. The sleeve has a plurality of blades at an inner surface. The sleeve has a plurality of knives at an inner surface. The plurality of cross wires is a third cutting segment. The plurality of cross wires is at an angle of 45° from the inner surface of the sleeve. The plurality of cross wires is available in multiples of 2. The sleeve is inclined at an angle of 5° to 45° from a longitudinal axis. The sleeve has an oval cross section. The sleeve has a circular cross section. The plurality of projections, the plurality of cross wires and the plurality of teeth increase an ultrasonic vibration during a phaco emulsification cataract surgery.

[0021] The various embodiments herein provide a phacoemulsification needle assembly which is to be attached to a phaco hand piece. According to one embodiment of the present invention, the phaco emulsification needle assembly comprises an elongated shaft. The shaft. includes a tip portion at one end. The tip portion is inclined at an angle of 5° to 45° from a longitudinal axis of the shaft. A plurality of projections exists on an outer surface of the shaft. The plurality of projections is at a distance of at least 2 mm from the tip portion of the shaft. The plurality of projections are selected from a group comprising of pits, buttons, fins, grooves, sintered portion, and sand blasted portion and combination thereof. The fins include spikes and fiat, vertical and angulated plates and combination thereof. The grooves are arranged in a parallel and a perpendicular direction to one another. A plurality of cross wires and blades are introduced at an inner surface of the shaft on an opposite end. The plurality of cross wires and blades are arranged at an angle of 45° from a shaft surface. The plurality of cross wires and blades are available in multiples of 2. The tip portion constitutes a bevel at an extreme end. The bevel has an enlarged cross-section. The bevel comprises an outer edge and an inner edge. The outer edge of the bevel is substantially sharp in nature. A plurality of sharp teeth resides on the inner edge of the bevel. The shaft and the tip portion are oval in cross section. The plurality of projections, the plurality of cross wires and the plurality of teeth increase an ultrasonic vibration during a phaco emulsification cataract surgery.

[0022] According to one embodiment herein, a phaco emulsification needle assembly comprises a first cutting segment, a second cutting segment and a third cutting segment. The first cutting segment is at a bevel end of the needle assembly. The first cutting segment includes a sharp outer edge of the bevel end. The second cutting segment is at an inner edge of the bevel end of the needle assembly. The second cutting segment includes a plurality of sharp teeth like projections. The third cutting segment is at an inner surface of a lumen of the needle assembly. The third cutting segment includes a plurality of cross wires and blades. The plurality of cross wires and blades are at an angle of 45° from a lumen surface. The plurality of cross wires is in multiples of 2.

[0023] According to one embodiment herein, a phaco needle assembly has a silicon sleeve with oval shaped cross section and irrigation holes. The needle tip is integrally attached to the phaco handpiece. The tip of the Needle comprises a specially designed bevel. The Needle comprises an oval shaped cross section perpendicular to a longer axis of the needle throughout the length, except at the emulsifying and cutting end provided at the tip portion. The needle includes special features provided on the outer surface of the shaft, near the bevel, in the tip portion, to create extra ultrasonic vibration thereby increasing the ultrasonic energy delivered for emulsifying the cataracts. The special features are provided in an area extending from 2mm from the edge of the (bevel) tip portion on to the shaft. The special features include pits, buttons, fins, grooves, sintered portion, and sand blasted portion. One or more ofthese features are provided in various shapes and designs individually or in combination. The fins are in the form of spikes, flat vertical, angulated plates, etc. The features are formed integrally with the needle shaft during the time of manufacture as a single piece.

[0024] The tip comprises a gentle bending (away from the open face of the bevel) with an angle of 5° to 45°. The angle is 5°, 10°, 15°, 20°, 30° and 45° to the long axis of the needle shaft/sleeve. The bevel has a length-wise stretched out and expanded area or "FACE" that provides a 'mouth' with an area wider than the cross sectional area of the lumen in the needle shaft. The extra surface area is arranged only along the longitudinal direction of the tip so that the width of the tip is maintained as same as that of the shaft/sleeve of the phaco needle, to ensure that a same incision size is be retained, without enlarging the incision for inserting the needle. The bevel has a smooth outer edge and a rough inner edge provided with super sharp spike teeth, thereby forming another second cutting surface. The bevel of the needle is the first cutting device.

[0025] The phaco needle tip comprises a third sharp cataract fragment cutting system in the bore / lumen of the needle shaft. A plurality of cross wires is fixed to the inner surface of the lumen near the tip portion. For example, 2, 4, 6 or 8 cross wires are anchored to the wall of the lumen. The pluralities of cross wires are positioned at the point where the bevel narrows and becomes the shaft of the needle. The cutting wires are arranged at an angle of 45° to the lumen surface so that the wires cross each other in the center of the lumen. The wires are angled and arranged in a forward direction so that the arrangement of the wires resembles an arrow head pointing forward along the longitudinal axis of the needle shaft. One or more cross wires are placed in the lumen / bore of needle in many combinations. The wire cutting devices are of thin dimensions to provide sharp cutting edges. The thickness of the wires is dependent on the properties of the metal used for manufacturing.

[0026] According to one embodiment herein, the inner surface of the lumen is fixed with pluralities of super sharp blades with sharp edges facing the forward portion. The cross-wires and the blades are 2-8 in number. [0027] According to one embodiment herein, the arrow crossed wires and the secondary cutting blades are added to increase the ultrasonic energy delivered to the system.

[0028] According to one embodiment herein, the needle comprises a tip with oval shaped design. The needle has a dynamic long funnel design for the bevel of the tip to enhance the ultrasound energy delivered to the cataract and to aspirate the emulsified cataract faster. The tip of the needle contains a bevel surface provided with a smooth outer edge and a sharp/rough inner edge with tiny 'teeth' to provide a second cutting surface. The bore of the sleeve is provided with cross wires and blades to provide a third cutting surface. The needle is formed of three cutting as well as emulsifying surfaces to improve the cataract fragmentation process and to reduce the size of the cataract pieces, thereby decreasing the surgical time and increasing the efficiency. The outer surface of the needle has protrusions or fins or spikes or buttons or pits or grooves near the edge of the tip to improve the ultrasonic energy delivered for emulsification.

[0029] These and other aspects, of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

[0031] FIG. l illustrates a perspective view of the phaco emulsification needle assembly, according to one embodiment herein. [0032] FIG. 2 shows the sectional view of the micro incision phaco needle tip according to one embodiment herein.

[0033] FIG.3A shows a side sectional view of a tip portion indicating the cross wires and teeth in the phaco emulsification needle assembly, according to one embodiment herein.

[0034] FIG.3B shows a side view of a tip portion indicating the projections in the phaco emulsification needle assembly according to one embodiment herein.

[0035] FIG. 4 shows a front view of the bevel showing the three cutting segments in the phaco emulsification needle assembly, according to one embodiment herein.

[0036] FIG. 5 shows a side sectional view of a phaco needle tip with spikes, buttons and fins, according to one embodiment herein.

[0037] FIG. 6 shows a side sectional view of a phaco needle tip with a bent portion in a phaco emulsification needle assembly, according to one embodiment herein.

[0038] FIG. 7 A shows a front side view of a lumen provided with two cross wires in a phaco emulsification needle assembly, according to one embodiment herein.

[0039] FIG. 7B shows a side sectional view of a lumen provided with three knives (or cross wires) in a phaco emulsification needle assembly, according to one embodiment of the present invention.

[0040] FIG. 7C shows a front side view of the cross wires inside the lumen in a phaco emulsification needle assembly, according to one embodiment herein.

[0041] FIG. 8 shows a side sectional view of a phaco needle tip showing the bevel with super sharp teeth on inner edge and smooth sharp outer edge in phaco emulsification needle assembly, according to one embodiment herein. [0042] FIG. 9 shows a sectional side view of the micro incision phaco needle tip indicating the primary cutting surface, secondary cutting surface and tertiary cutting surface, according to one embodiment herein.

[0043] FIG.10 shows a front side view of a lumen with oval shaped cross section showing the cross wires forming a cross to cut through the cataract in a phaco emulsification needle assembly, according to an embodiment herein.

[0044] FIG. 1 1 shows a side sectional view of the cross wires arranged at an angle of 45^p angle to lumen forming an arrow head in the forward direction towards a bevel in a phaco emulsification needle assembly according to one embodiment herein.

[0045] FIG. 12A shows a side view of the micro incision phaco needle tip with a oval profile in the phaco needle assembly, according to an embodiment herein.

[0046] FIG. 12B shows a sectional view of a phaco needle assembly with an oval profile and a needle with an oval cross section showing a grip cutting and crushing teeth, according to one embodiment herein.

[0047] FIG. 13A shows a side view of the phaco needle, assembly having a flattened portion provided with threading for fixing the needle assembly to the phaco hand piece, according to an embodiment herein.

[0048] FIG. 13B shows a side view of the phaco hand piece indicating a circular cross section at p - q and a flattened oval cross section at r - s, according to an embodiment herein.

[0049] FIG. 13C shows a cross sectional view of a flattened phaco needle tip, according to an embodiment herein.

[0050] FIG. 14 shows a phaco needle assembly with a oval profile, according to an embodiment herein. [0051] Although specific features of the embodiments herein are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the embodiments herein. ^

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0052] In the following detailed description, a reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments herein are described in sufficient detail to enable those skilled in the art to practice the embodiments herein and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments herein. The following detailed description is therefore not to be taken in a limiting sense.

[0053] FIG.l illustrates a perspective view of the phacoemulsification needle assembly, according to one embodiment herein. With respect to FIG.l, the phaco emulsification needle assembly 101 has a tip portion 102 and a sleeve 103. The tip portion has a bevel 104. The bevel 104 is specially designed. The needle assembly 101 is oval shaped in cross section throughout the length, except at the bevel 104. The bevel 104 is cataract emulsifying and cutting end. The tip portion 102 is gently bent at an angle of 15°, 30°, 45° and 60° to the long axis of the sleeve 103. The tip portion has a bent portion 105 which is arranged away from an open face of the bevel 104. The bevel 104 has an oval shaped expanded face to gives a mouth portion with an area wider than the cross sectional area of the lumen of the sleeve 103. The area is expanded in the longitudinal direction of the bevel 104 and the width of the needle assembly 101 is maintained same as that of the shaft 103. The bevel 104 has a smooth outer edge 108 and a rough inner edge with super sharp teeth 107 thereby providing a cutting surface. The sleeve 103 has projections 106 provided on an outer surface. The projections 106 include pits, buttons, fins, grooves, sintered portion, and sand blasted portion. The projections 106 create an extra ultrasonic vibration thereby increasing the ultrasonic energy delivered for emulsifying the cataracts. The projections 106 are formed at an area of at least 2mm from the bevel 104 of the tip portion 102. The projections 106 are formed in various ¹ shapes and designs, individually or in combination. The fins are in the form of spikes or flat vertical plates. The grooves are arranged in a parallel or in a perpendicular direction to each other. The projections 106 are formed integrally with the needle shaft 103 as a single piece during the manufacturing process. The expanded area of the bevel tip leads to an increase in the bevel face volume and provides a larger grip on cataract and better suction hold.

[0054] FIG. 2 shows the sectional view of the micro incision phaco needle tip according to one embodiment herein. With respect to FIG.2, the phaco hand piece 201 has a needle assembly 101. The needle assembly 101 has a silicon sleeve 103. Silicon sleeve 103 has an irrigation hole 204 to expel out the saline 205 during a surgery. Phaco needle assembly 101 has a specially designed bevel 104. Bevel 104 has a smooth and sharp outer cutting edge 108. The inner edge 107 of bevel 104 has sharp teeth like projections. Inside a lumen of silicon sleeve 103 is present sharp cross cutting wires or knives or blades 209. On an outer surface of silicon sleeve 103 a plurality of projections or features 106 is present to increase the ultrasonic energy reaching the cataract. Phaco needle is fixed to phaco hand piece from point 211.

[0055] ^/ FIG.3A shows a sectional side view of the phacoemulsification needle assembly, according to one embodiment herein. With respect to FIG.3A, the phaco emulsification needle assembly 101 comprises a sleeve 103, a tip portion 102 and a bevel tip 104. The tip portion 102 is curved at an angle of 5° to 45°. The outer diameter 108 of the bevel tip 104 is sharp and helps in cutting the cataract. The inner diameter of the bevel includes teeth like projections 107 acting as a cutting segment. The sleeve 103 is composed of plurality of cross wires and blades 209 that cuts the cataract sucked in into further smaller pieces to be sucked in and ejected out easily thereby increasing the ultrasonic vibration energy by clearing the aspiration passage. The plurality of cross wires and blades are fixed to the inner surface of the lumen of the sleeve 103. The plurality of cross wires and the blades are present in multiples of 2. The cross wires are placed at an angle of 45° to the lumen surface crossing each other in the center of the lumen. The cross wires are angled and arranged in a forward direction towards the bevel to resemble an arrow head pointing forward along the longitudinal axis of the needle shaft. The cross wire cutting surfaces are of thin dimension to provide sharp cutting edges.

[0056] FIG.3B shows a side view of the phacoemulsification needle assembly, according to one embodiment herein. With respect to FIG.3B, the phaco emulsification needle assembly 101 constitutes a plurality of irregular or regular projections 106. The plurality of irregular projections comprises pits, buttons, fins, grooves, sintered portion, and sand blasted portion. The plurality of irregular projections 106 increases the surface area of the needle assembly and creates an extra ultrasonic vibration thereby increasing the ultrasonic energy delivered for emulsifying the cataracts.

[0057] FIG. 4 shows a front view of the bevel of the phacoemulsification needle assembly showing the three cutting segments, according to one embodiment herein. With respect to FIG. 4, the bevel 104 comprises an outer edge 108 and an inner edge 107. The outer edge 108 is composed of a sharp edge and acts as a first cutting segment. The inner edge 107 constitutes a plurality of teeth like projections. The plurality of teeth like projections acts as a second cutting segment. The teeth help to fracture the vacuum held cataract better than the phaco tips with the smooth bevel. A plurality of cross wires and blades 209 are integrated inside a lumen of the needle shaft near the tip portion. The plurality of cross wires and blades are fixed to the inner surface of the lumen. The pluralities of cross wires and the blades are in multiples of 2. At least 2 cross wires are anchored in the wall of the lumen. 2, 4, 6 or 8 cross wires are anchored to the wall of the lumen. The cross wires and blades are positioned at the point where the bevel narrows and becomes the shaft of the needle. The cross wires are arranged at an angle of 45° to the lumen surface crossing each other in the center of the lumen. The cross wires are angled . and arranged in a forward direction towards the bevel to resemble an arrow head pointing forward along the longitudinal axis of the needle shaft. The cross wires and blades form a third cutting segment of the phacoemulsification needle assembly. The cross wire cutting surfaces are of thin dimension to provide sharp cutting edges. The thickness of the wires is dependent on the properties of the metal used for manufacturing. The cross wires and blades are provided at the narrowing portion of the shaft. The cross wires further cut the cataract pieces that are to be sucked in by the vacuum thereby avoiding the retention or the accumulation of the cataract debris in the narrow portion of the lumen or the shaft. The cross wires also help in creating more ultrasonic energy by their presence in the vibrating part of the tip.

[0058] FIG. 5 shows the side view of phaco needle tip with spikes, buttons and fins, according to one embodiment herein. With respect to FIG.5, plurality of projections 106 is provided in an area extending 2mm from the tip portion of the phaco needle. The plurality of projections 106 includes the spikes, buttons and fins. The tip portion has the bevel provided with the sharp cutting outer edge 108 of the needle. The inner cross wires209 are arranged inside the phaco needle.

[0059] FIG. 6 shows the side view of the phaco needle tip with a bent sleeve 103, indicating the distance between the sleeves a→b and lumen c→d, according to one embodiment herein. The distance c→d is larger than the distance a→b.

[0060] FIG. 7A shows the cross-sectional view of the lumen with the presence of two cross cutting knives or cross wires, according to one embodiment herein. With respect to FIG. 7A, the cutting elements 209 arranged inside the phaco needle are the third cutting segment. The cutting elements 209 are blades or cross wires or knives.

[0061] FIG. 7B shows the side view of the lumen with the presence of three cross cutting knives (or cross wires), according to one embodiment herein. With respect to FIG. 7B, the cross cutting knives 701, 702 and 703 are placed one behind the other. The first knife 701 cuts a cataract piece sucked in. The cataract piece is then further cut by 702 and 703 knives, respectively, into smaller portions.

[0062] FIG. 7C shows the cross sectional view of the lumen with the presence of three cross cutting knives (or cross wires) 701, 702 and 703, showing the orientation of the knives, according to one embodiment herein. The cutting elements 701 and 702 are arranged perpendicular to each other and the cutting element 703 is arranged at an angle to the cutting element 701 and 702.

[0063] FIG. 8 shows the sectional view of the phaco needle tip showing the outer edge of the phaco needle tip with super sharp teeth on internal edge of bevel with smooth and sharp outer edge of bevel, according to one embodiment herein. With respect to FIG. 8, the bevel 104 has the inner edge having sharp teeth 107 and an outer smooth and sharp edge 108.

[0064] FIG. 9 shows the sectional side view of the micro incision phaco needle tip indicating the primary cutting surface, secondary cutting surface and tertiary cutting surface, according to one embodiment herein. With respect to FIG. 9, outer smooth and sharp edge 108 of bevel 104 forms the primary cutting surface. The inner jagged surface 107 of bevel 104 having teeth like sharp projections forming the secondary cutting surface. The cross wires 701 and 702 forms the tertiary cutting surface.

[0065] FIG.10 shows a cross sectional view of the lumen of the needle showing the cross wires forming a cross to cut through the cataract, according to an embodiment herein.

[0066] FIG. 11 shows a sectional view of the cross wires, showing the presence of cross wires in a 45° angle 1101 and forming an arrow head in the forward direction towards the bevel according to one embodiment herein.

[0067] FIG. 12A shows the perspective view of the micro incision phaco needle tip indicating oval profile perpendicular to long axis of the phaco needle assembly, showing an inner bore teeth, according to an embodiment herein. The needle comprises an oval shaped cross section throughout the length. The needle contains inner bore sharp teeth 107 for cutting the cataract while performing surgery. The needle forms a sleeve 103 with an oval cross section.

[0068] FIG. 12B shows the sectional view of the oval profiled phaco needle assembly and the oval cross sectional sleeve showing the grip cutting and crushing teeth, according to one embodiment herein. The grip cutting and crushing teeth help in emulsifying and cutting the cataract into small pieces. The grip cutting and crushing profile of the teeth helps to cut the cataract in less time thus reducing the time of surgery. [0069] FIG. 13A shows a side view of the phaco needle assembly with threading for fixing the needle assembly to the phaco hand piece, according to an embodiment herein. With respect to FIG. 13A, 1301 is the threading portion which is to be inserted in the phaco hand piece to fix the needle assembly to the hand piece.

[0070] FIG. 13B shows the side view of the phaco hand piece indicating a circular cross section at p - q and a flattened cross section at r - s, according to an embodiment of the present invention. With respect to FIG. 13B the needle has a circular cross section at the sleeve having threads around for fixing to a phaco hand piece. The circular cross sectional sleeve becomes flattened towards the tip region making a middle transition zone of circular sleeve flattening towards the needle.

[0071] FIG. 13C shows the cross section of the flattened phaco needle tip, according to an embodiment herein. The flattening phaco needle tip reduces the total area of making incision.

[0072] According to One embodiment herein, the needle also has a circular profile. The circular profile of the needle has a bevel with a circular cross section. The inner diameter of the circle has sharp teeth. The outer diameter of the bevel is sharp for cutting the cataract. FIG. 14 shows the circular profile of the phaco needle assembly, according to an embodiment of the present invention. With respect to FIG.14, the phaco needle tip 101 has a circular cross section with a circular cross sectional sleeve 103.

[0073] According to one embodiment herein, the phaco emulsification needle assembly is attached to a phaco hand piece and is detachable.

[0074] According to one embodiment herein, the bevel comprises an outer smooth edge and a rough -inner edge with super sharp teeth thereby providing a first cutting surface.

[0075] According to one embodiment herein, the inner surface of the lumen is fixed with pluralities of super sharp blades with sharp edges at forward portion. The blades may be 2-8 in number. [0076] According to one embodiment herein, the arrow crossed wire and the secondary cutting blades are added to increase the ultrasonic energy delivered to the system.

[0077] According to one embodiment herein, the inner surface of the tip portion of the needle is coated with a plastic layer to increase the flow of emulsate through the needle and thus increasing the efficiency of phaco machine. The coating is a Teflon coating.

[0078] As the broad face of the bevel gets narrower towards the shaft, the cataract pieces get stuck in the narrow lumen of the shaft before getting sucked in by the vacuum of the machine. It is here, just at narrowing portion of the tip that two more cutting wires like blades are erected and placed with the sharp edges facing the bevel. These further cut the pieces of the cataract , as they get sucked in and also help in creating more ultrasonic energy by their presence in the vibrating part of the tip.

[0079] According to one embodiment herein, the phaco needle can be made of many numbers of gauges, i.e., bore dimensions.

[0080] The to and fro vibration moment of the tips causes ultrasonic energy which emulsifies the cataracts. The roughened additional features on the tip shaft, near the bevel create extra ultrasonic vibrations to increase the energy delivered for emulsification. This extra energy shortens and fastens the emulsifications of cataract especially during the "Intra nuclear" (or inside the cataract) emulsification stage of the surgery.

[0081] The presence of a second sharp cataract fragment cutting system in the bore or lumen of the needle shaft increases the fragmentations of the cataract debris thereby improving the sucking speed of the debris and reducing the surgery time.

[0082] The arrow crossed wire is a third cutting device to provide an additional ultrasonic energy delivery system according to one embodiment of the present invention. [0083] The material for the micro incision phaco needle tip is the titanium alloys, according to one embodiment herein. The needle can be made up of any other surgically suitable material.

[0084] The phaco emulsification needle tip is used in all modifications of phaco cataract surgeries, including micro incision cataract surgery or M1CS tip for use in Bimanual Phaco that are sleeveless with irrigation through side port via irrigating second instrument or coaxial MICS.

[0085] The shaft or second cutting system and bevel may be separately manufactured and then joined together by means that are commercially feasible. The means can be screwing mechanism or welded together.

[0086] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments.

[0087] Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims. Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to -practice the invention with modifications. However, all such modifications are deemed to be within the scope of the claims.

[0088] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the embodiments described herein and all the statements of the scope of the embodiments which as a matter of language might be said to fall there between.

Claims

CLAIMS What is claimed is:

1. A micro incision phaco needle assembly comprising:

an outer silicon sleeve with oval profile in cross-section;

a phaco needle arranged inside the outer silicon sleeve;

an elongated bevel formed at a tip portion of the phaco needle;

a plurality of projections formed on an outer surface of the phaco needle near the tip portion; and

a plurality of cutting elements arranged inside the phaco needle along an axis of the phaco needle;

wherein the bevel is formed in an oval shape and wherein the phaco needle has an oval shaped cross section in perpendicular to a longitudinal axis of the phaco needle.

2. The assembly according to claim 1 , wherein the bevel has an outer edge and an inner edge.

3. The assembly according to claim 1 , wherein the outer edge of the bevel is smooth and sharp.

4. The assembly according to claim 1, wherein the smooth and sharp outer edge forms a first cutting segment.

5. The assembly according to claim 1, wherein the inner edge of the bevel has a plurality of sharp teeth.

6. The assembly according to claim 1, wherein the plurality of sharp teeth in the inner edge of the bevel forms a second cutting segment.

7. The assembly according to claim 1, wherein the bevel is extended along a length direction to provide an area which is more than a cross sectional area of the phaco needle.

8. The assembly according to claim 1 , wherein the bevel has a dynamic long funnel shape to increase an ultrasound energy delivered to a cataract.

9. The assembly according to claim 1, wherein the plurality of projections formed on an outer surface of the phaco needle is selected from a group comprising of pits, buttons, fins, grooves, sintered portion, and sand blasted portion and a combination thereof.

10. The assembly according to claim 9, wherein the fins are spikes or flat vertical plates and angulated plates and combination thereof.

11. The assembly according to claim 1, wherein the plurality of cutting elements arranged inside the phaco needle is selected form a group comprising of cross wires or blades or knives.

12. The assembly according to claim 1 , wherein the plurality of cutting elements arranged inside the phaco needle is a third cutting segment.

13. The assembly according to claim 1 , wherein the plurality of cutting elements are mounted at an angle of 45° from an inner surface of the phaco needle.

14. The assembly according to claim 1 , wherein the plurality of the cutting elements are arranged in parallel to each other.

15. The assembly according to claim 1, wherein the plurality of the cutting elements are arranged perpendicular to each other.

16. The assembly according to claim 1, wherein the plurality of cutting elements are angled and arranged in a forward direction to form an arrow head like structure pointing forwardly along a longitudinal direction of the phaco needle.

17. The assembly according to claim 1 , wherein the tip portion has a bending with an angle of 5°-45° to a longitudinal axis of the phaco needle.

18. The assembly according to claim 1 , wherein the phaco needle has an oval shaped cross section.

19. The assembly according to claim 1 , wherein the phaco needle has a circular cross section at one end and the oval shaped cross section at a distal end.