Ultrasonic lens emulsification aspiration needle

Abstract

The surgical instrument assembly includes a phacoemulsification needle for use with a phacoemulsification handpiece. The needle includes a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle further includes an emulsification tip connected to a distal end of the needle shaft portion. In one form, the tip has five sidewalls defining a periphery of an opening in communication with the aspiration passage, three of the sidewalls defining a first thickness and two of the sidewalls converging at a location in a vertical plane extending through the longitudinal shaft axis and having a second thickness greater than the first thickness.

Description

Technical Field

[0001] [Priority Claim] This application claims priority to U.S. Provisional Patent Application No. 63 / 232,447 filed on August 12, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates generally to surgical instruments used in ophthalmic surgery, and more particularly to an improved ultrasonic phacoemulsification aspiration needle that is particularly suitable for use with associated ultrasonic vibrating surgical handpieces to facilitate efficient operation and use.

Background Art

[0003] Ultrasonic phacoemulsification aspiration has become the optimal technique for removing damaged or diseased lenses from the eyeball. Generally, such surgery is required when a patient develops cataracts, a condition in which part of the lens of the eyeball becomes hardened and opaque. Unless the damaged lens is removed and replaced by a properly selected intraocular lens, it will result in blindness or severe visual impairment.

[0004] Ultrasonic phacoemulsification aspiration is the use of ultrasonic energy to emulsify the damaged lens and aspirate the resulting lens particles from the eyeball. One of the greatest advantages of using ultrasonic phacoemulsification aspiration is that the device itself is small, requiring a relatively small incision, which can result in less fluid leakage from the ocular capsule and shorter patient recovery time. In order to minimize the risk of damage to ocular tissues, it is desirable to limit the amount of ultrasonic energy used as much as possible. In many cases, prior to or during ultrasonic phacoemulsification aspiration, the lens nucleus (the hardest part of the lens) is chopped or divided into small pieces. The small pieces require less energy for emulsification and reduce the actual time during which ultrasonic energy is generated by the ultrasonic phacoemulsification aspiration device.

[0005] Generally, when the emulsified lens nucleus and fluid are drawn through a hollow lens, an injection sleeve is fitted around the needle to supply perfusion fluid to the eyeball in order to maintain positive pressure inside the eyeball.

[0006] Properly injecting fluid during such surgery is extremely important. Maintaining a sufficient amount of fluid prevents the breakdown of certain tissues within the eyeball and the resulting damage or injury to the delicate structures of the eye. For example, endothelial cells are easily damaged during such breakdown, and since these cells do not regenerate, this damage is permanent. One of the advantages of using the smallest possible incision during such surgery is that it minimizes fluid leakage during and after the surgery, prevents tissue breakdown, shortens healing time, and reduces postoperative astigmatism.

[0007] U.S. Patent No. 7,601,136, incorporated herein by reference, discloses an ultrasonic phacoemulsification needle and sleeve assembly.

[0008] Many ultrasonic phacoemulsification needles and tips are designed to be used with handpieces that vibrate the needle longitudinally at relatively low frequencies. In addition to longitudinal vibration, certain handpieces impart a torsional motion to the needle at a vibration frequency of approximately 100 cycles per second. There are also handpieces that provide torsional vibration of the ultrasonic phacoemulsification tip at a frequency of approximately 32,000 cycles per second.

[0009] The use of a twisted handpiece requires a different ultrasonic phacoemulsification needle tip design than that used with a longitudinal handpiece. For example, needles have been designed with tips that are shaped, swaged, and angled to take advantage of the needle movement generated by the handpiece.

[0010] Many surgeons prefer phacoemulsification needles with a straight tip design, which are commonly used with longitudinal handpieces. The majority of surgeons use longitudinal handpieces rather than twisted handpieces because twisted phacoemulsification devices are often more expensive than longitudinal ones, thus missing out on the enhanced phacoemulsification results that can be obtained with twisted phacoemulsification systems.

[0011] U.S. Patent No. 10,952,895, incorporated herein by reference in its entirety, discloses that a needle tip positioned off-axis with respect to the axis of the suction passage extending through the needle body causes eccentric motion or "wobble" during torsional ultrasonic phacoemulsification, improving the efficiency of ultrasonic phacoemulsification while maintaining a straight tip configuration. It has also been found that forming the tip in such an off-axis position improves the efficiency of ultrasonic phacoemulsification when using a longitudinal handpiece.

[0012] The use of an off-axis tip in a longitudinal handpiece appears to desirablely produce a hybrid type of ultrasonic phacoemulsification action without the need for more complex and expensive torsional ultrasonic phacoemulsification devices. By forming the central suction passage within the needle body at an off-axis position, the ultrasonic phacoemulsification needle can be given eccentric or oscillating motion without tip flare. Similar results can be obtained using a straight ultrasonic phacoemulsification needle with a suction passage formed with a different cross-sectional structure from that of the needle body. These results are further amplified when the passage is also located off-axis.

[0013] The present invention relates to an improved ultrasonic phacoemulsification surgical instrument assembly having an improved tip structure, for the purpose of promoting improved emulsification efficiency, improved aspiration, and / or minimizing the transfer of thermal energy to the treatment site. [Overview of the project]

[0014] The present invention relates to an improved ultrasonic phacoemulsification needle, particularly suitable for use with an associated vibratory surgical handpiece, the handpiece may be configured for torsional (i.e., rotational) ultrasonic motion, and linear or longitudinal motion, elliptical motion, or mixed motion, etc.

[0015] According to a broad embodiment of the present invention, an ultrasonic phacoemulsification needle comprises a needle shaft having a defined longitudinal axis and an internal suction passage. The needle comprises an emulsification tip connected to the distal end of the needle shaft. The emulsification tip has five side walls defining the outer circumference of an opening communicating with the suction passage. Three of the side walls define a first thickness, and the remaining two side walls converge in a vertical plane extending along the longitudinal shaft axis and have a second thickness greater than the first thickness. Preferably, the first thickness is about 100 microns. Furthermore, the second thickness is preferably about 150 microns to about 170 microns.

[0016] In a preferred embodiment of the present invention, the five sides define the perimeter of a substantially pentagon that is symmetrical with respect to the aforementioned plane.

[0017] In another preferred embodiment of the present invention, the emulsifying tip has a distal edge positioned at an acute angle to a plane extending perpendicularly through the longitudinal axis of the needle shaft. Preferably, the acute angle is about 20 to 40 degrees, and more preferably about 30 degrees.

[0018] In yet another preferred embodiment of the present invention, for improved safety during needle operation, adjacent side walls of the five side walls converge at a convex corner.

[0019] In yet another preferred embodiment of the present invention, the opening defines a longitudinal opening axis that is parallel to the longitudinal shaft axis and offset from the longitudinal shaft axis.

[0020] According to a preferred embodiment of the present invention, the emulsifying tip extends along the longitudinal shaft axis for a length of approximately 1.95 mm to approximately 2.05 mm.

[0021] According to a broad embodiment of the present invention, an ultrasonic phacoemulsification needle comprises a needle shaft having a defined longitudinal axis and an internal suction passage. The needle comprises an emulsification tip connected to the distal end of the needle shaft. The emulsification tip has five side walls defining the outer circumference of an opening communicating with the suction passage. Two of the side walls converge at rounded corners in a vertical plane extending along the longitudinal shaft axis. Preferably, all side walls have the same nominal thickness, preferably about 100 microns. Furthermore, the second thickness is preferably about 150 to 170 microns.

[0022] According to another broad embodiment of the present invention, an ultrasonic phacoemulsification needle comprises a needle shaft portion having a defined longitudinal axis and an internal suction passage. The needle comprises an emulsification tip connected to the distal end of the needle shaft portion. The emulsification tip has six sidewalls defining the outer circumference of an opening communicating with the suction passage. A first pair of sidewalls are substantially parallel to each other. A second pair of sidewalls are substantially parallel to each other. A third pair of sidewalls extends from one of the first pair of sidewalls to one of the second pair of sidewalls. Preferably, all sidewalls have the same nominal thickness, preferably about 100 microns. Furthermore, the second thickness is preferably about 150 to about 170 microns.

[0023] According to a preferred embodiment of the present invention, the opening is substantially rectangular.

[0024] In another preferred embodiment of the present invention, a first pair of sidewalls defines a first thickness, and one of a second pair of sidewalls defines a second thickness that is substantially greater than the first thickness.

[0025] According to a broad aspect of the present invention, an ultrasonic phacoemulsification aspiration needle defines a longitudinal axis and includes a needle shaft portion having an internal aspiration passage. The needle includes an emulsification tip connected to the distal end of the needle shaft portion. The emulsification tip has four side walls that define the outer periphery of an opening in communication with the aspiration passage. The opening has a pentagonal shape.

[0026] In a preferred embodiment of the present invention, the opening defines a longitudinal opening axis that is parallel to the longitudinal shaft axis and offset from the longitudinal shaft axis. Furthermore, the opening is symmetric with respect to a plane extending through both the longitudinal opening axis and the longitudinal shaft axis.

[0027] In another preferred embodiment of the present invention, the opening defines a longitudinal opening axis that is parallel to the longitudinal shaft axis and offset from the longitudinal shaft axis. Furthermore, the opening is asymmetric with respect to a plane extending through both the longitudinal opening axis and the longitudinal shaft axis.

[0028] According to a preferred embodiment of the present invention, the proximal end of the needle shaft portion is provided with means for being removably attached to a vibrating handpiece. Preferably, the needle is combined with the vibrating handpiece.

[0029] According to another broad aspect of the present invention, an ultrasonic phacoemulsification aspiration needle defines a longitudinal axis and includes a needle shaft portion having an internal aspiration passage. The needle includes an emulsification tip connected to the distal end of the needle shaft portion, which has five side walls defining the outer periphery of an opening in communication with the aspiration passage. The aspiration passage has a pentagonal cross-sectional shape in a plane perpendicular to the longitudinal shaft axis.

[0030] In yet another broad aspect of the present invention, an ultrasonic phacoemulsification aspiration needle comprises a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle includes an emulsification tip connected to the distal end of the needle shaft portion, which has five side walls defining the outer periphery of an opening in communication with the aspiration passage. The emulsification tip has an intermediate passage formed therein that is offset from the longitudinal shaft axis. Preferably, the intermediate passage is semicircular and is centered along a vertical plane extending through the longitudinal shaft axis.

[0031] In yet another broad aspect of the present invention, an ultrasonic phacoemulsification aspiration needle comprises a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle includes an emulsification tip connected to the distal end of the needle shaft portion, which has five side walls defining the outer periphery of an opening in communication with the aspiration passage. The lower wall or bottom wall of the tip extends outward at a first acute angle α1 with respect to a vertical plane extending perpendicular to the central axis, and the upper walls 22I, 26I extend at an acute angle that is smaller than the angle α2 with respect to the plane P2.

[0032] In the accompanying drawings, which form part of the present specification, like numerals are employed throughout to represent like parts. [Brief Description of the Drawings]

[0033] [Figure 1] Figure 1 is an isometric view from the front and below of the first illustrated embodiment of the ultrasonic phacoemulsification surgical needle of the present invention. [Figure 2] Figure 2 is a right side elevational view of the instrument shown in Figure 1. [Figure 3] Figure 3 is a front elevational view of the instrument shown in Figure 1. [Figure 4] Figure 4 is a cross-sectional view of the instrument shown in Figure 1, taken along vertical plane 4-4 in Figure 3, extending through the central longitudinal axis of the instrument. [Figure 5] Figure 5 is a greatly enlarged fragmentary right side elevational view of only the tip portion of the instrument shown in Figure 1. [Figure 6]Figure 6 is a greatly enlarged, fragmentary cross-sectional view of only the tip of the instrument shown in Figure 4. [Figure 7] Figure 7 is another front elevation view of the device shown in Figure 1. [Figure 8] Figure 8 is a greatly enlarged, fragmentary isometric view of only the distal portion of the device shown in Figure 1, taken from the front and the right side. [Figure 9] Figure 9 is an isometric view of the device shown in Figure 1, from the front and above. [Figure 10] Figure 10 is a greatly enlarged, fragmentary cross-sectional view of only the distal portion of the instrument shown in Figure 1. [Figure 11] Figure 11 is a greatly enlarged isoangled wireframe view of only the distal portion of the device shown in Figure 1, viewed from the front and above. [Figure 12] Figure 12 is an isometric wireframe view of the device shown in Figure 1, viewed from the right and above. [Figure 13] Figure 13 is a cross-sectional view of the device shown in Figure 1. [Figure 14] Figure 14 is another cross-sectional view of the device shown in Figure 1. [Figure 15] Figure 15 is a greatly enlarged, fragmentary cross-sectional view of the tip of the instrument shown in Figure 1. [Figure 16] Figure 16 is a front elevation view of a second illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 17] Figure 17 is a right-side elevation view of the device shown in Figure 16. [Figure 18] Figure 18 is an isometric view of the device shown in Figure 16, viewed from below and behind. [Figure 19] Figure 19 is a greatly enlarged, fragmentary right-side elevation view of the tip of the instrument shown in Figure 17. [Figure 20] Figure 20 is a cross-sectional view of the device shown in Figure 16, along the vertical plane 20-20 in Figure 16, extending through the longitudinal axis of the center of the device. [Figure 21]Figure 21 is a greatly enlarged, fragmentary cross-sectional view of only the tip of the instrument shown in Figure 20. [Figure 22] Figure 22 is another front elevation view of the device shown in Figure 16. [Figure 23] Figure 23 is a fragmentary, greatly enlarged isometric view of the apparatus shown in Figure 16, viewed from above and to the right. [Figure 24] Figure 24 is an isometric view of the device shown in Figure 16, viewed from above and from the front. [Figure 25] Figure 25 is a greatly enlarged, fragmentary cross-sectional view of the apparatus shown in Figure 16. [Figure 26] Figure 26 is a greatly enlarged, fragmentary wireframe isometric view of the device shown in Figure 16. [Figure 27] Figure 27 is a wireframe isometric view of the device shown in Figure 16, viewed from above and the right side. [Figure 28] Figure 28 is another isometric view of the device shown in Figure 16, viewed from the front and the right side. [Figure 29] Figure 29 is a greatly enlarged, fragmentary isometric view of the device shown in Figure 16, viewed from the front and the right side. [Figure 30] Figure 30 is a fragmentary, greatly enlarged cross-sectional view of the apparatus shown in Figure 16. [Figure 31] Figure 31 is an isometric view from the front and right side of a third illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 32] Figure 32 is a fragmentary, greatly enlarged isometric view of the device shown in Figure 31, viewed from the front and left side. [Figure 33] Figure 33 is a front elevation view of the device shown in Figure 31. [Figure 34] Figure 34 is a fragmentary isometric view of the device shown in Figure 31, viewed from the front and left side. [Figure 35] Figure 35 is another fragmentary isometric view of the device shown in Figure 31, viewed from the front and left side. [Figure 36]Figure 36 is a fragmentary isometric view of another embodiment of the device shown in Figure 31, viewed from the front and left side. [Figure 37] Figure 37 is another fragmentary isometric view of the device shown in Figure 36, viewed from the front and left side. [Figure 38] Figure 38 is a greatly enlarged, fragmentary front elevation view of the device shown in Figure 31. [Figure 39] Figure 39 is a greatly enlarged, fragmentary isometric view of the device shown in Figure 31, viewed from the front and left side. [Figure 40] Figure 40 is a greatly enlarged fragmentary front elevation view of a fourth illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 41] Figure 41 is a greatly enlarged, fragmentary isometric view of the device shown in Figure 40, viewed from the front and left side. [Figure 42] Figure 42 is a greatly enlarged fragmentary front elevation view of a fifth illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 43] Figure 43 is a greatly enlarged, fragmentary front elevation view of a sixth illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 44] Figure 44 is a greatly enlarged, fragmentary isometric view of the device shown in Figure 43, viewed from the front and left side. [Figure 45] Figure 45 is a greatly enlarged fragmentary front elevation view of a seventh illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 46] Figure 46 is a greatly enlarged, fragmentary isometric view of the device shown in Figure 45, viewed from the front and the right side. [Figure 47] Figure 47 is a greatly enlarged fragmentary front elevation view of an eighth illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 47A] Figure 47A is a greatly enlarged, fragmentary front elevation view of a modified example of the eighth embodiment shown in Figure 47. [Figure 48]Figure 48 is a cross-sectional view of the device shown in Figure 47, along the vertical plane P1 in Figure 47, which extends through the longitudinal axis of the center of the device. [Figure 49] Figure 49 is a greatly enlarged front elevation view of the ninth illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 49A] Figure 49A is a greatly enlarged front elevation view of a modified example of the ninth embodiment shown in Figure 49. [Figure 50] Figure 50 is a greatly enlarged, fragmentary right-hand elevation view of a tenth illustrated embodiment of the ultrasonic phacoemulsification and aspiration surgical needle of the present invention. [Figure 51] Figure 51 is a greatly enlarged, fragmentary detail view of the distal portion of the needle tip, which is circled in Figure 50. [Figure 52] Figure 52 is a greatly enlarged, fragmentary detail view of the distal portion of the needle tip circled in Figure 50, but Figure 52 shows a modified embodiment having a rounded distal end of the tip. [Figure 53] Figure 53 is a greatly enlarged front elevation view of the surgical needle shown in Figure 52. [Figure 54] Figure 54 is a greatly enlarged, fragmentary plan view of the surgical needle shown in Figure 52. [Figure 55] Figure 55 is a greatly enlarged, fragmentary cross-sectional view of a modified version of the instrument shown in Figure 50, along a central vertical plane extending through the longitudinal axis of the instrument's center, and Figure 55 shows an instrument having a downward-bent portion located close to the tip. [Figure 56] Figure 56 is a greatly enlarged, fragmentary side elevation view of another modification of the apparatus shown in Figure 50, where some internal features of the apparatus are shown with hidden lines. [Modes for carrying out the invention]

[0034] While various embodiments of the present invention are possible, currently preferred embodiments are shown in the drawings and described below. This disclosure should be considered illustrative of the present invention and it should be understood that it is not intended to limit the most extensive embodiments of the present invention to the specific embodiments shown.

[0035] A surgical instrument or ultrasonic phacoemulsification needle 10 of a first illustrated embodiment according to the present invention is shown in Figures 1 to 15, the needle 10 having a threaded proximal end 11 (Figure 1) for connection to a fitting thread in a vibrating handpiece, and including an elongated needle shaft portion 14 defining a longitudinal axis 12 (Figure 15). The shaft portion 14 defines an internal suction passage 16 (Figure 15), through which suction is performed during ultrasonic phacoemulsification. In many of the accompanying figures, only the distal portion of the needle 10 is shown, and it will be understood that the proximal end 11 of the needle disclosed herein may have various means or structures suitable for attachment to a vibrating handpiece, such as fitting screws, clamps, locks, friction fits, etc. A suitable proximal end structure of a needle is described in U.S. Patent No. 8,764,782, which is incorporated herein by reference in its entirety.

[0036] Referring to Figure 8, the ultrasonic lens emulsification needle 10 of the present invention further comprises an emulsification tip 20 connected to the distal end of the needle shaft portion 14 opposite to the proximal end 11. Notably, the emulsification tip 20 has a generally pentagonal cross-sectional structure and includes five side walls (or hereafter simply referred to as "walls") 22, 24, 26, 28, and 30 defining the outer circumference of the opening 34. The opening 34 of the tip 20 is connected to the suction passage 16 of the needle shaft portion 14 to facilitate the aspiration of emulsified tissue through the needle 10 when exposed to vacuum.

[0037] As shown in Figure 15, the emulsifying needle 10 of the present invention preferably includes a first thickness T1 of at least one of the walls 22, 24, 26 and a substantially larger second thickness T2 of at least one of the other walls 28, 30, which result in ultrasonic phacoemulsification and aspiration associated with the torsional motion, longitudinal motion, elliptical motion, and / or mixed ultrasonic motion of the needle 10. Preferably, each of the walls 28, 30 converges at a position in a vertical plane "P1" extending through the longitudinal shaft axis 12 and has symmetry with respect to this vertical plane "P1" (as shown in Figure 3). More preferably, this plane "P1" extends through the bottom of the needle tip portion 20. Preferably, each of the walls 22, 24, 26 has the same nominal thickness T1 of about 100 microns, and each of the converging lower or bottom walls 28, 30 has the same nominal thickness T2 of about 150 to 170 microns. In the illustrated preferred embodiment of the instrument 10, adjacent walls 22, 24, 26, 28, and 30 of the tip 20 defining the opening 34 are advantageously connected by rounded, convexly curved corners for improved safety in the eyeball. Referring to Figure 6, the emulsifying tip 20 preferably extends along the longitudinal shaft axis 12 for a length "L" of about 1.95 mm to about 2.05 mm.

[0038] Referring to Figure 6, the emulsifying tip 20 has a distal end positioned at an acute angle α of approximately 20 to 40 degrees, more preferably about 30 degrees, with respect to a plane "P2" that extends perpendicular to the longitudinal axis 12 of the needle shaft portion 14. This configuration facilitates efficient use and is particularly suitable for use with ultrasonic instruments configured to move ultrasonically in linear and / or torsional modes.

[0039] Referring to Figure 15, the opening 34 defines a longitudinal opening axis 36 that is substantially parallel to and offset from the longitudinal axis 12 of the needle shaft portion 14, in order to improve the emulsifying or cutting action of the thickened and converging bottom walls 28, 30 during the vibrating motion of the needle 10. In some embodiments, although not preferred or illustrated, the opening axis 36 may be coaxial with the axis 12 of the needle body 14.

[0040] A desirable feature of the ultrasonic lens emulsification needle of the present invention is that there are no sharp edges on the outside of the needle 10. The distal edge anterior to the emulsification tip 20 is preferably rounded and smooth, without sharp edges. The outer circumference of the tip 20 is preferably also free of sharp edges.

[0041] The specific configuration of the needle 10 of the present invention can vary depending on the intended use. The needle shaft 14 may be straight, as in the illustrated embodiment, or it may be bent into a Kelman structure for cutting during a surgical procedure. Alternatively, the needle shaft 14 may be bent into a red-star (reverse Kelman bend) for pre-cutting during the procedure. Other bending structures can also be conceived.

[0042] Referring to Figures 5 and 8, the outer surface of the tip 20 may have a sandblasted finish to eliminate or at least reduce the potential for sharp edges, for improved safety of the instrument 10 in the eyeball. Such a sandblasted finish or other conventional or unconventional finishing method may be applied to the needles of the embodiments discussed below.

[0043] A surgical needle of a second embodiment according to the present invention, represented by the number 10A and shown in Figures 16 to 30, functions similarly to the needle 10 of the first illustrated embodiment already described in Figures 1 to 15. The numbered features of the needle 10A of the second embodiment shown in Figures 16 to 30 are similar to the features of the needle 10 of the first embodiment, which share the same number but do not have the "A" at the end. The surgical needle 10A of the second embodiment differs from the first illustrated embodiment described above in that it includes an emulsifying tip 20A having a generally pentagonal cross-sectional structure and includes five side walls (or simply "walls") 22A, 24A, 26A, 28A, and 30A of equal thickness defining the outer circumference of the opening 34A.

[0044] As shown in Figures 22 and 30, the walls 22A, 24A, 26A, 28A, and 30A share a nominal thickness T1 of approximately 100 microns. Preferably, each of the walls 28A and 30A converges in a position in a vertical plane "P1" extending through the longitudinal shaft axis 12A, and is symmetrical with respect to this vertical plane "P1" (as shown in Figure 16). More preferably, this plane "P1" extends through the bottom of the needle tip 20A. In the illustrated preferred embodiment of the instrument 10A, adjacent walls 22A, 24A, 26A, 28A, and 30A of the tip 20A defining the opening 34A are connected at rounded convex-curved corners, advantageously for improved safety in the eye. Preferably, the corners are rounded with R0.2 to R0.50. In one undesirable embodiment, one or more of the corners are bent at a 90-degree angle.

[0045] The needle 10A of the second illustrated embodiment, when coupled with several vibrating handpieces, can provide more efficient ultrasonic phacoemulsification and aspiration compared to the needle of the first illustrated embodiment.

[0046] A surgical needle of a third embodiment according to the present invention, represented by the number 10B and shown in Figures 31 to 39, functions similarly to the needle 10 of the first illustrated embodiment already described in Figures 1 to 15. The numbered features of the needle of the third embodiment shown in Figures 31 to 39 are similar to the features of the needle of the first embodiment (without the "B" at the end) that share the same number. The surgical needle 10B of the third embodiment differs from the first illustrated embodiment described above in that the needle 10B includes an emulsifying tip 20B having six distinct walls 22B, 24B, 26B, 28B, 30B, and 32B. Referring now to Figure 38, as shown, the first pair of walls 22B, 26B are substantially parallel to each other, the second pair of walls 24B, 32B are also substantially parallel to each other, and the third pair of walls 28B, 30B are inclined toward each other and extend or connect from one of the first pairs to one of the second pairs. The opening 34B of the tip 20B has a substantially square structure with rounded corners.

[0047] In some forms of the needle 10B of the third embodiment shown in Figures 38 and 39, the walls 22B, 24B, 26B, and 32B have the same nominal thickness (T1) of about 100 microns, while the inclined converging walls 28B and 30B have a reduced thickness. In other forms of the needle 10B of the third embodiment shown in Figures 31 to 37, the walls 22B, 24B, and 26B have the same nominal thickness (T1) of about 100 microns, while the offset wall or bottom wall 32B has a substantially larger thickness (T2) of about 150 to about 250 microns for an improved sway or chopping effect during operation.

[0048] The needle 10B of the third illustrated embodiment, as a result of the truncated converging walls 28B and 30B, can provide safer ultrasonic phacoemulsification and aspiration when coupled with several vibrating handpieces compared to the needle 10 of the first illustrated embodiment.

[0049] A surgical needle of a fourth embodiment according to the present invention, denoted by the number 10C and shown in Figures 40 and 41, functions similarly to the needle 10 of the first illustrated embodiment already described. The numbered features of the needle 10C of the fourth embodiment illustrated in Figures 40 and 41 are similar to the features of the needle of the first embodiment, which share the same number but do not have the "C" at the end. The surgical needle 10C of the fourth embodiment differs from the first illustrated embodiment described above in that the needle 10C includes an emulsifying tip 20C that is substantially square, having four walls 22C, 24C, 26C, and 28C that define an opening 34C having an (internal) pentagonal structure. Compared to the preceding embodiments discussed above, the needle 10C is considered to have advantages in terms of low cost and high-quality manufacturability. The opening 34C further defines a longitudinal opening axis 36C that is parallel to the longitudinal axis 12C of the center of the needle shaft portion 14C, but offset from said axis.

[0050] Referring to Figure 40, it can be seen that the opening 34C is symmetrical with respect to a plane P1 that extends through both the longitudinal opening axis 36C and the longitudinal shaft axis 12C. The corners of the adjacent walls 22C, 26C that contact the bottommost wall 28C of the tip 20C are substantially thicker than the rest of the walls of the tip 20C in order to provide the opening 34C having a pentagonal structure.

[0051] A surgical needle of a fifth embodiment according to the present invention, represented by the number 10D and shown in Figure 42, functions similarly to the needle 10C of the fourth illustrated embodiment described immediately prior to this. The numbered features of the needle 10D of the fifth embodiment shown in Figure 42 are similar to the features of the needle of the fourth embodiment, which share the same number but do not have the "D" at the end. The surgical needle 10D of the fifth embodiment differs from the fourth illustrated embodiment described above in that the needle 10D includes an emulsifying tip 20D that defines the corners of adjacent walls 22D, 26D that are in contact with the bottommost wall 28D, which is substantially thinner than that of the preceding embodiments.

[0052] A surgical needle of a sixth embodiment according to the present invention, represented by the number 10E and shown in Figures 43 and 44, functions similarly to the needle 10D of the fifth illustrated embodiment described immediately prior to this. The numbered features of the needle 10E of the sixth embodiment illustrated in Figures 43 and 44 are similar to the features of the needle of the fifth embodiment, which share the same number but do not have the "E" at the end. The surgical needle 10E of the sixth embodiment differs from the fifth illustrated embodiment described above in that the needle 10E includes an emulsifying tip 20E having four side walls 22E, 24E, 26E, and 28E that define an opening 34E which is pentagonal in shape but lacks symmetry with respect to a plane P1 extending through both the longitudinal opening axis 36E and the longitudinal shaft axis 12E. Instead, the opening 34E is symmetrical with respect to a horizontal plane P3 that transverses perpendicular to the plane P1. This configuration facilitates efficient use and may be particularly suitable for use with certain vibrating instruments or handpieces.

[0053] The surgical needle of the seventh embodiment according to the present invention, denoted by the number 10F and shown in Figures 45 and 46, functions similarly to the needle 10E of the sixth illustrated embodiment described immediately prior to this. The numbered features of the needle 10F of the seventh embodiment illustrated in Figures 45 and 46 are similar to the features of the needle of the sixth embodiment, which share the same number but do not have the "F" at the end. The surgical needle 10F of the seventh embodiment differs from the sixth illustrated embodiment described above in that the needle 10F includes an emulsifying tip 20F that defines an opening 34F which is pentagonal in shape and symmetrical with respect to a plane P3 that is transverse to, rather than perpendicular to, plane P1.

[0054] The surgical needle of the eighth embodiment according to the present invention is represented by the number 10G and shown in Figures 47 and 48, and functions similarly to the needle 10 of the first illustrated embodiment already described. The numbered features of the needle 10G of the eighth embodiment shown in Figures 47 and 48 are similar to the features of the needle of the first embodiment, which share the same number but do not have the "G" at the end. The surgical needle 10G of the eighth embodiment differs from the first illustrated embodiment described above in that the needle 10G includes an emulsifying tip 20G that defines an intermediate passage 40G offset from the suction passage 16G of the needle body 14G (Figure 48 only). The intermediate passage 40G generates a weighting effect on the tip 20G to enhance and / or adjust for any oscillation or imbalance during the vibration of the needle 10G. The intermediate passage 40G in the tip 20G is preferably perforated in a secondary step from the perforation of the suction passage 16G of the needle body 14G. The intermediate passage 40G preferably has a circular or semicircular valley shape aligned with an axis 44G offset from the central axis 12G of the suction passage 16G along the central vertical plane P1. However, it will be understood that the intermediate passage 40G may have other cross-sectional shapes, such as a square, ellipse, triangle, other polygon, or irregular shape. A modification of the needle 10G of the eighth embodiment is shown in Figure 47A, in which the tip portion 20G includes two additional intermediate passages 40G located on either side of the plane P1, each having a semicircular shape.

[0055] A ninth embodiment of the surgical needle according to the present invention, represented by the number 10H and shown in Figure 49, functions similarly to the needle 10 of the first illustrated embodiment already described. The numbered features of the needle 10H of the ninth embodiment shown in Figure 49 are similar to the features of the needle of the first embodiment, which share the same number but do not have the "H" at the end. The surgical needle 10H of the ninth embodiment differs from the first illustrated embodiment described above in that the needle 10H includes a suction passage 16H of the needle body having a pentagonal cross-sectional shape inset from the pentagonal cross-sectional shape of the walls 22H, 24H, 26H, 28H, 30H of the tip 20H. The suction passage 16H defines a central axis offset from the central axis of the opening defined by the walls 22H, 24H, 26H, 28H, 30H. A modified example of the needle 10H of the ninth embodiment is shown in Figure 49A, in which the tip 20H includes two circular (up and down) and two pentagonal (left and right) intermediate passages located on both sides of the vertical plane.

[0056] A surgical needle of the tenth embodiment according to the present invention, denoted by the number 10I, is shown in Figures 50–54, and functions similarly to the needle 10 of the first illustrated embodiment already described. The numbered features of the needle 10I of the tenth embodiment illustrated in Figures 50–54 are similar to the features of the needle of the first embodiment, which share the same number but do not have the "H" at the end. The surgical needle 10I of the tenth embodiment differs from the first illustrated embodiment described above in that the needle 10I includes a tip 20I having a pentagonal cross-sectional shape inset from the pentagonal cross-sectional shape of the walls 22I, 24I, 26I, 28I, 30I, where the lower or bottom walls 28I, 30I extend at least outward from the upper wall 24I with respect to a vertical plane P2 that extends perpendicular to the central axis 12I of the needle body 14I and the central axis 36I of the offset tip 20I, at an angle α1 different from the angle α2 of the upper walls 22I, 26I with respect to the plane P2. Preferably, the lower or bottom walls 28I, 30I are at an angle of about 45 degrees with respect to the plane P2, and the upper side walls 22I, 26I are at an angle of about 15 degrees with respect to the plane P2. The vertices of walls 28I and 30I meet at a pointed point 32I. The inventors believe that the steep angle of the lower walls 28I, 30I relative to the upper wall of the tip can provide improved nucleus trenching. In some embodiments, the tip 20I may have seven walls in a heptagonal structure for improved trenching. Modifications of the needle 10I of the tenth embodiment are shown in Figures 52-54, in which the tip 20I includes a blunt, rounded apex 32I between the lower or bottom walls 28I, 30I.

[0057] Another modification of the needle 10I of the tenth embodiment is shown in Figure 55, where the lower or bottom walls 28I, 30I extend axially outward of the upper side walls 22I, 26I at an angle α3 of approximately 30 degrees (±3 degrees) with respect to a vertical plane P2 that extends perpendicular to the central axis 36I of the offset tip portion 20I. Furthermore, the angle α2 (not shown) of the upper walls 22I, 26I with respect to plane P2 is approximately 0 degrees in the needle 10I of this embodiment. It can be seen that the needle 10I includes a bent portion 114I located close to the tip portion 20I and the needle body 14I. Although not shown, in some embodiments, the angle α3 may range from 0 degrees (planar or flat distal end of the tip) to 90 degrees (perpendicular to plane P2).

[0058] Figure 56 shows yet another modification of the needle 10I of the tenth embodiment, in which the lower or bottom walls 28I, 30I extend at a different angle α1 with respect to a vertical plane P2 that extends perpendicular to the central axis 12I of the needle body 14I and the central axis 36I of the offset tip portion 20I, compared to the angle α2 of the upper walls 22I, 26I with respect to plane P2, at least outside the upper wall 24I. Preferably, the lower or bottom walls 28I, 30I are at an angle of about 50 degrees (±3 degrees) with respect to plane P2 (or about 40 degrees (±3 degrees) with respect to a plane perpendicular to P2 as shown), while the upper side walls 22I, 26I are at an angle of about 15 degrees (±3 degrees) with respect to plane P2. Although not shown in the figures, in some embodiments, angle α2 may range from 0 degrees (the planar or flat distal end of the tip) to 90 degrees (perpendicular to plane P2), while angle α1 may also range from 0 degrees (the planar or flat distal end of the tip) to 90 degrees (perpendicular to plane P2), and any combination of these ranges for α1 and α2 is possible.

[0059] The inventors have found that the needle design described herein exhibits, compared to conventional ultrasonic phacoemulsification needles, better nucleus conformability, better fluidity, absence of observable rattle, repulsion, or bubbles regardless of nucleus grade, absence of milky fluid when emulsifying grade 4 or 5 nuclei, improved nucleus sculpting or grooving, improved chamber stability, and better overall efficiency. Currently, it is believed that the pentagonal or pentagonal-like shape of the needle tip described above forms a vortex, increasing the amount of balanced saline solution flowing in, thereby improving the conformability of the emulsified nuclei at the tip.

[0060] From the above, it will be evident that numerous modifications and variations can be made without departing from the true spirit and scope of the novel concept of the present invention. It should be understood that no limitation to the most broad concept is intended or implied with respect to the specific embodiments illustrated herein. This disclosure is intended to encompass all such modifications within the claims by the appended claims.

Claims

1. An ultrasonic lens emulsification and aspiration needle, A needle shaft portion having an internal suction passage and defining the longitudinal shaft axis, An emulsifying tip is connected to the distal end of the needle shaft portion, Equipped with, The emulsifying tip has five side walls defining the outer circumference of an opening that communicates with the suction passage, two of which converge at rounded corners in a vertical plane extending through the longitudinal shaft axis. Ultrasonic phacoemulsification needle.

2. The ultrasonic lens emulsification and aspiration needle according to claim 1, wherein the five side walls have the same thickness.

3. The ultrasonic lens emulsification and aspiration needle according to claim 2, wherein the thickness is approximately 100 microns.

4. The ultrasonic lens emulsification needle according to claim 1, wherein three of the five side walls define a first thickness T1, and the remaining two of the five side walls converge in a vertical plane extending through the longitudinal shaft axis and have a second thickness T2 that is greater than the first thickness T1.

5. The ultrasonic lens emulsification and aspiration needle according to claim 1, wherein the suction passage has a pentagonal cross-sectional shape in a plane perpendicular to the longitudinal shaft axis.

6. The ultrasonic lens emulsification and aspiration needle according to claim 1, wherein the emulsifying tip has an intermediate passage formed therein that is offset from the longitudinal shaft axis.

7. The ultrasonic lens emulsification and aspiration needle according to claim 6, wherein the intermediate passage is semicircular and is aligned with a vertical plane extending through the longitudinal shaft axis.

8. The ultrasonic lens emulsification needle according to claim 1, wherein the emulsifying tip has a distal edge defined by a converging pair of the five side walls positioned at a first acute angle α1 with respect to a plane extending perpendicularly through the longitudinal shaft axis, the second pair of the five side walls positioned at a second acute angle α2 with respect to the plane, and the first acute angle α1 is greater than the second acute angle α2.

9. The ultrasonic lens emulsification and aspiration needle according to claim 1, wherein the emulsifying tip is sandblasted.

10. The ultrasonic lens emulsification and aspiration needle according to claim 1, wherein adjacent side walls among the five side walls converge at a convex corner.

11. The ultrasonic phacoemulsification needle according to claim 4, wherein the first thickness T1 is about 100 microns, and the second thickness T2 is about 150 microns to about 170 microns.

12. An ultrasonic crystalline lens emulsification and aspiration needle according to claim 1, combined with a vibrating handpiece.

13. The ultrasonic lens emulsification and aspiration needle according to claim 1, wherein the opening defines a longitudinal opening axis that is parallel to the longitudinal shaft axis and offset from the longitudinal shaft axis.

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