Ultrasonic phacoemulsification 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] This application claims priority to U.S. Provisional Patent Application No. 63 / 232,447, filed 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 needle that is particularly suited for use with an associated ultrasonically vibrated surgical handpiece to facilitate efficient operation and use. [Background technology]

[0003] Phacoemulsification has become the technique of choice for the removal of damaged or diseased lenses from the eye. Typically, such surgery is required when a patient develops cataracts, a condition in which part of the eye's lens hardens and becomes opaque. Unless the damaged lens is removed and replaced with a properly selected artificial lens, blindness or severe vision impairment will result.

[0004] Phacoemulsification is the use of ultrasonic energy to emulsify the damaged lens and aspirate the resulting lens particles from the eye. One of the biggest advantages of using phacoemulsification is that the device itself is small, requiring a relatively small incision, which can result in less leakage of fluid from the eye capsule and shorter recovery time for the patient. To minimize the risk of damage to the eye tissue, it is desirable to limit the amount of ultrasonic energy used as much as possible. Often, prior to or during phacoemulsification, the lens nucleus (the hardest part of the lens) is chopped or split into smaller pieces. The smaller pieces require less energy for emulsification and reduce the time that ultrasonic energy is actually produced by the phacoemulsification device.

[0005] Typically, an infusion sleeve is fitted around the needle to supply irrigation fluid to the eye to maintain positive pressure within the eye as the emulsified nucleus and fluid are aspirated through the hollow lens.

[0006] Proper injection of fluids during such surgeries is extremely important. Maintaining an adequate amount of fluid prevents the breakdown of certain tissues within the eye and the associated damage or injury to delicate ocular structures. As an example, endothelial cells can be easily damaged during such breakdown, and since these cells do not regenerate, this damage is permanent. One advantage of using the smallest possible incision during such surgeries is that it can minimize leakage of fluids during and after surgery, prevent tissue breakdown, reduce healing time, and reduce postoperative astigmatism.

[0007] US Pat. No. 7,601,136, incorporated herein by reference, discloses a phacoemulsification needle and sleeve assembly.

[0008] Many phacoemulsification needles and tips are designed for use with handpieces that vibrate the needle longitudinally at a relatively low frequency. In addition to longitudinal vibration, certain handpieces impart a torsional motion to the needle at a vibration frequency of about 100 cycles per second. Other handpieces provide torsional vibration of the phacoemulsification tip at a frequency of about 32,000 cycles per second.

[0009] The use of torsional type handpieces requires different phacoemulsification needle tip designs than those used with longitudinal type handpieces. For example, needles have been designed with shaped, swaged, and angled tips to take advantage of the needle motion generated by the handpiece.

[0010] Many surgeons prefer phacoemulsification needles with a straight tip design that are commonly used with longitudinal handpieces. The majority of surgeons use longitudinal handpieces rather than torsional handpieces because torsional phacoemulsification equipment is often more expensive than longitudinal equipment, thus preventing them from taking advantage of the enhanced phacoemulsification results that can be obtained with torsional phacoemulsification systems.

[0011] U.S. Patent No. 10,952,895, the entirety of which is incorporated herein by reference, discloses that a needle tip in an off-axis position relative to the axis of the aspiration passageway extending through the needle body induces an eccentric motion or "wobble" during torsional phacoemulsification to improve the efficiency of 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 phacoemulsification when using longitudinal handpieces.

[0012] The use of an off-axis tip on a longitudinal handpiece appears to desirably produce a hybrid type phacoemulsification action without the use of more complicated and expensive torsional phacoemulsification devices. By forming a central aspiration passage in the needle body at an off-axis location, an eccentric or wobble type motion can be imparted to the phacoemulsification needle without flare at the tip. Similar results can be obtained using a straight phacoemulsification needle with an aspiration passage formed with a cross-sectional configuration different from that of the needle body. These results are further amplified when the passage is also disposed off-axis.

[0013] The present invention relates to an improved phacoemulsification surgical instrument assembly in which an improved phacoemulsification needle has an improved tip configuration to facilitate improved emulsification efficiency, improved aspiration, and / or minimization of the transfer of thermal energy to the site during the procedure. Summary of the Invention

[0014] The present invention relates to an improved ultrasonic phacoemulsification needle that is particularly suited for use with an associated vibrating surgical handpiece, which may be configured for torsional (i.e., rotational) ultrasonic motion, as well as linear or longitudinal motion, elliptical motion, or mixed motion, etc.

[0015] In accordance with one broad aspect of the invention, a phacoemulsification needle includes a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle includes an emulsifying tip connected to a distal end of the needle shaft portion. The emulsifying tip has five sidewalls defining a periphery of an opening in communication with the aspiration passage. Three of the sidewalls define a first thickness and the remaining two of the sidewalls have a second thickness that converges at a location in a vertical plane extending through the longitudinal shaft axis and is greater than the first thickness. Preferably, the first thickness is about 100 microns. Further, the second thickness is preferably about 150 microns to about 170 microns.

[0016] In one preferred form of the invention, the five sides define a substantially pentagonal perimeter having symmetry about the aforementioned plane.

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

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

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

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

[0021] According to one broad aspect of the invention, a phacoemulsification needle includes a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle includes an emulsifying tip connected to a distal end of the needle shaft portion. The emulsifying tip has five sidewalls defining an outer periphery of an opening in communication with the aspiration passage. Two of the sidewalls converge at a rounded corner at a location in a vertical plane extending through the longitudinal shaft axis. Preferably, all of the sidewalls have the same nominal thickness, preferably about 100 microns. Additionally, the second thickness is preferably between about 150 microns and about 170 microns.

[0022] In accordance with another broad aspect of the invention, a phacoemulsification needle includes a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle includes an emulsifying tip connected to a distal end of the needle shaft portion. The emulsifying tip has six sidewalls defining a periphery of an opening in communication with the aspiration passage. A first pair of the sidewalls are substantially parallel to one another. A second pair of the sidewalls are substantially parallel to one another. A third pair of the sidewalls extends from one of the first pair of sidewalls to one of the second pair of sidewalls. Preferably, the sidewalls all have the same nominal thickness, preferably about 100 microns. Moreover, the second thickness is preferably between about 150 microns and about 170 microns.

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

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

[0025] In accordance with one broad aspect of the invention, a phacoemulsification needle includes a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle includes an emulsifying tip connected to a distal end of the needle shaft portion. The emulsifying tip has four sidewalls defining a periphery of an opening in communication with the aspiration passage. The opening has a pentagonal shape.

[0026] In one preferred form of the invention, the opening defines a longitudinal opening axis that is parallel to and offset from the longitudinal shaft axis, and the opening is symmetrical about a plane extending through both the longitudinal opening axis and the longitudinal shaft axis.

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

[0028] According to one preferred form of the invention, the proximal end of the needle shaft portion is provided with means for removably attaching to a vibrating handpiece. Preferably, the needle is combined with a vibrating handpiece.

[0029] In accordance with another broad aspect of the invention, a phacoemulsification needle includes a needle shaft portion defining a longitudinal axis and having an internal aspiration passageway. The needle includes an emulsifying tip connected to a distal end of the needle shaft portion having five sidewalls defining a periphery of an opening in communication with the aspiration passageway. The aspiration passageway has a pentagonal cross-sectional shape in a plane perpendicular to the longitudinal shaft axis.

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

[0031] In yet another broad form of the invention, a phacoemulsification needle includes a needle shaft portion defining a longitudinal axis and having an internal aspiration passage. The needle includes an emulsification tip connected to a distal end of the needle shaft portion having five side walls defining an outer periphery of an opening in communication with the aspiration passage. A lower or bottom wall of the tip extends outwardly at a first acute angle α1 relative to a vertical plane extending perpendicular to the central axis, and upper walls 22I, 26I extend at a lesser acute angle relative to plane P2 compared to angle α2.

[0032] In the accompanying drawings which form a part of this specification, like numerals are used to represent like parts throughout. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a front and bottom isometric view of a first illustrative embodiment of a phacoemulsification needle of the present invention. [Diagram 2] FIG. 2 is a right side elevational view of the device shown in FIG. [Diagram 3] FIG. 3 is a front elevational view of the device shown in FIG. [Figure 4] FIG. 4 is a cross-sectional view of the instrument shown in FIG. 1 taken along a vertical plane 4-4 in FIG. 3, which extends through the central longitudinal axis of the instrument. [Diagram 5] FIG. 5 is a greatly enlarged, fragmentary, right-side elevational view of only the distal portion of the instrument shown in FIG. [Figure 6]FIG. 6 is a greatly enlarged, fragmentary, cross-sectional view of only the distal portion of the instrument shown in FIG. [Figure 7] FIG. 7 is another front elevational view of the device shown in FIG. [Figure 8] FIG. 8 is a greatly enlarged, fragmentary, isometric view from the front and right side of only the distal portion of the instrument shown in FIG. [Figure 9] FIG. 9 is a front and top isometric view of the device shown in FIG. [Figure 10] FIG. 10 is a greatly enlarged, fragmentary, cross-sectional view of only the distal portion of the instrument shown in FIG. [Figure 11] FIG. 11 is a greatly enlarged isometric wireframe view of only the distal portion of the instrument shown in FIG. 1, viewed from the front and above. [Figure 12] FIG. 12 is an isometric wireframe view of the device shown in FIG. 1 from the right and above. [Figure 13] FIG. 13 is a cross-sectional view of the device shown in FIG. [Figure 14] FIG. 14 is another cross-sectional view of the device shown in FIG. [Figure 15] FIG. 15 is a greatly enlarged, fragmentary, cross-sectional view of the tip of the instrument shown in FIG. [Figure 16] FIG. 16 is a front elevational view of a second illustrative embodiment of a phacoemulsification needle of the present invention. [Figure 17] FIG. 17 is a right side elevational view of the device shown in FIG. [Figure 18] FIG. 18 is a bottom and rear isometric view of the device shown in FIG. [Figure 19] FIG. 19 is a greatly enlarged, fragmentary, right-side elevational view of the tip of the instrument shown in FIG. [Figure 20] FIG. 20 is a cross-sectional view of the instrument shown in FIG. 16 taken along a vertical plane 20-20 in FIG. 16, which extends through the central longitudinal axis of the instrument. [Figure 21]FIG. 21 is a greatly enlarged, fragmentary, cross-sectional view of only the distal portion of the instrument shown in FIG. [Figure 22] FIG. 22 is another front elevational view of the device shown in FIG. [Figure 23] FIG. 23 is a fragmentary, greatly enlarged, isometric view from above and to the right of the device shown in FIG. [Figure 24] FIG. 24 is an isometric view from above and front of the device shown in FIG. [Diagram 25] FIG. 25 is a greatly enlarged, fragmentary, cross-sectional view of the device shown in FIG. [Figure 26] FIG. 26 is a greatly enlarged fragmentary wireframe isometric view of the device shown in FIG. [Figure 27] FIG. 27 is a wireframe isometric view from above and to the right of the device shown in FIG. [Figure 28] FIG. 28 is another isometric view from the front and right side of the device shown in FIG. [Figure 29] FIG. 29 is a greatly enlarged, fragmentary, isometric view from the front and right side of the device shown in FIG. [Diagram 30] FIG. 30 is a fragmentary, greatly enlarged, cross-sectional view of the device shown in FIG. [Diagram 31] FIG. 31 is a front and right side isometric view of a third illustrative embodiment of a phacoemulsification needle of the present invention. [Diagram 32] FIG. 32 is a fragmentary, greatly enlarged, isometric view of the instrument shown in FIG. 31, seen from the front and left side. [Diagram 33] FIG. 33 is a front elevational view of the device shown in FIG. [Diagram 34] FIG. 34 is a fragmentary isometric view from the front and left side of the device shown in FIG. [Diagram 35] FIG. 35 is another fragmentary isometric view of the instrument shown in FIG. 31 from the front and left side. [Diagram 36]FIG. 36 is a fragmentary isometric view from the front and left side of another embodiment of the device shown in FIG. [Figure 37] FIG. 37 is another fragmentary isometric view of the device shown in FIG. 36, seen from the front and left side. [Figure 38] FIG. 38 is a greatly enlarged, fragmentary, front elevational view of the instrument shown in FIG. [Figure 39] FIG. 39 is a greatly enlarged, fragmentary, isometric view, seen from the front and left side, of the instrument shown in FIG. [Diagram 40] FIG. 40 is a greatly enlarged, fragmentary, front elevational view of a fourth illustrative embodiment of a phacoemulsification needle of the present invention. [Diagram 41] FIG. 41 is a greatly enlarged, fragmentary, isometric view, seen from the front and left side, of the device shown in FIG. [Diagram 42] FIG. 42 is a greatly enlarged, fragmentary, front elevational view of a fifth illustrative embodiment of a phacoemulsification needle of the present invention. [Diagram 43] FIG. 43 is a greatly enlarged, fragmentary, front elevational view of a sixth illustrative embodiment of a phacoemulsification needle of the present invention. [Diagram 44] FIG. 44 is a greatly enlarged, fragmentary, isometric view, seen from the front and left side, of the device shown in FIG. [Diagram 45] FIG. 45 is a greatly enlarged, fragmentary, front elevational view of a seventh illustrative embodiment of a phacoemulsification needle of the present invention. [Figure 46] FIG. 46 is a greatly enlarged, fragmentary, isometric view from the front and right side of the device shown in FIG. [Figure 47] FIG. 47 is a greatly enlarged, fragmentary, front elevational view of an eighth illustrative embodiment of a phacoemulsification needle of the present invention. [Figure 47A] FIG. 47A is a greatly enlarged, fragmentary, front elevational view of a variation of the eighth illustrated embodiment of FIG. [Figure 48]FIG. 48 is a cross-sectional view of the instrument shown in FIG. 47 taken along a vertical plane P1 in FIG. 47 that extends through the central longitudinal axis of the instrument. [Figure 49] FIG. 49 is a greatly enlarged front elevational view of a ninth illustrative embodiment of a phacoemulsification needle of the present invention. [Figure 49A] FIG. 49A is a greatly enlarged front elevational view of a variation of the ninth illustrated embodiment of FIG. [Figure 50] FIG. 50 is a greatly enlarged fragmentary right side elevational view of the tenth illustrated embodiment of the phacoemulsification needle of the present invention. [Figure 51] FIG. 51 is a greatly enlarged fragmentary detail view of the distal portion of the needle tip circled in FIG. [Figure 52] FIG. 52 is a greatly enlarged fragmentary detail view of the distal portion of the needle tip circled in FIG. 50, but shows a variation of the embodiment having a rounded distal-most end of the tip. [Diagram 53] FIG. 53 is a greatly enlarged front elevational view of the surgical needle of FIG. 52. [Figure 54] FIG. 54 is a greatly enlarged fragmentary plan view of the surgical needle of FIG. [Figure 55] FIG. 55 is a greatly enlarged, fragmentary, cross-sectional view of a variation of the instrument shown in FIG. 50 taken along a central vertical plane extending through the central longitudinal axis of the instrument, FIG. 55 showing the instrument having a downward bend located near the tip. [Figure 56] FIG. 56 is a greatly enlarged, fragmentary, side elevational view of another variation of the device shown in FIG. 50, with FIG. 56 showing in hidden lines some of the internal features of the device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] While the present invention is susceptible of embodiment in various forms, presently preferred embodiments are shown in the drawings and will be described below. It will be understood that the present disclosure is to be considered as an example of the invention, and that it is not intended to limit the invention in its broadest form to only the specific embodiments shown.

[0035] A first illustrated embodiment of a surgical instrument or phacoemulsification needle 10 according to the present invention is shown in Figures 1-15, with the needle 10 having a threaded proximal end 11 (Figure 1) for connection to a mating 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 aspiration passageway 16 (Figure 15) through which aspiration is conducted during phacoemulsification. It will be understood that in many of the accompanying figures, only the distal portion of the needle 10 is illustrated, and that the proximal end 11 of the needles disclosed herein may have a variety of means or structures suitable for attachment to a vibrating handpiece, such as by mating threads, a clamp, a lock, a friction fit, and the like. A suitable proximal end structure for the needle is described in U.S. Patent No. 8,764,782, which is incorporated herein by reference in its entirety.

[0036] 8, the phacoemulsification needle 10 of the present invention further comprises an emulsifying tip 20 connected to the distal end of the needle shaft portion 14 opposite the proximal end 11. Notably, the emulsifying tip 20 has a generally pentagonal cross-sectional configuration and includes five side walls (or simply referred to below as "walls") 22, 24, 26, 28, 30 that define the periphery of an opening 34. The opening 34 of the tip 20 connects to the aspiration passage 16 of the needle shaft portion 14 to facilitate aspiration of emulsified tissue through the needle 10 when exposed to a vacuum.

[0037] As seen in FIG. 15, the emulsification needle 10 of the present invention desirably 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 that effect phacoemulsification associated with torsional, longitudinal, elliptical, and / or mixed ultrasonic motion of the needle 10. Preferably, each of the walls 28, 30 converges at a location within a vertical plane "P1" that extends through the longitudinal shaft axis 12 and has symmetry about this vertical plane "P1" (as seen in FIG. 3). More preferably, this plane "P1" extends through the bottom of the needle tip 20. Preferably, each of the walls 22, 24, 26 have the same nominal thickness T1 of about 100 microns, and each of the converging lower or bottom walls 28, 30 have the same nominal thickness T2 of about 150 microns to 170 microns. In the illustrated preferred embodiment of device 10, adjacent ones of the walls 22, 24, 26, 28, 30 of tip 20 that define opening 34 are advantageously joined by rounded convexly curved corners for improved safety in the eye. With reference to Figure 6, emulsifying tip 20 preferably extends a length "L" along longitudinal shaft axis 12 of about 1.95 mm to about 2.05 mm.

[0038] 6, the emulsifying tip 20 has a distal end disposed at an acute angle α of about 20 degrees to 40 degrees, more preferably about 30 degrees, relative to a plane "P2" extending 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] 15, the aperture 34 defines a longitudinal aperture axis 36 that is substantially parallel to and offset from the longitudinal axis 12 of the needle shaft portion 14 to enhance the emulsifying or chopping action of the thickened and converging bottom walls 28, 30 during oscillating motion of the needle 10. Although not preferred or illustrated, in some embodiments the aperture axis 36 may be coaxial with the axis 12 of the needle body 14.

[0040] A desirable feature of the phacoemulsification needle of the present invention is the absence of sharp edges on the exterior of the needle 10. The front distal edge of the emulsification tip 20 is preferably rounded and smooth with no sharp edges. The periphery of the tip 20 is preferably 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 portion 14 can be straight, as in the illustrated embodiment, or the needle shaft portion 14 can be bent in a Kelman configuration for chopping during a surgical procedure. Alternatively, the needle shaft portion 14 can be bent in a Akastar (reverse Kelman bend) for pre-chopping during a procedure. Other bent configurations are also contemplated.

[0042] 5 and 8, the outer surface of tip 20 may have a sandblasted finish to eliminate or at least reduce the potential for sharp edges for improved safety of device 10 in the eye. Such sandblasted finishes or other conventional or non-conventional finishing methods may be applied to the needles of the embodiments discussed below.

[0043] A second embodiment of a surgical needle according to the present invention is shown in Figures 16-30, designated by the numeral 10A, and functions similarly to the first illustrated embodiment of the needle 10 previously described in Figures 1-15. The numbered features of the second embodiment of the needle 10A shown in Figures 16-30 are similar to the features of the first embodiment of the needle 10 that share the same numbers but without the suffix "A". The second embodiment of the surgical needle 10A differs from the first illustrated embodiment described above in that it includes an emulsifying tip 20A having a generally pentagonal cross-sectional configuration and includes five equal thickness side walls (or simply "walls") 22A, 24A, 26A, 28A, 30A that define the perimeter of an opening 34A.

[0044] As seen in Figures 22 and 30, the walls 22A, 24A, 26A, 28A, 30A share a nominal thickness T1 of about 100 microns. Preferably, each of the walls 28A, 30A converges at a location in a vertical plane "P1" that extends through the longitudinal shaft axis 12A and is symmetrical about this vertical plane "P1" (as seen in Figure 16). More preferably, this plane "P1" extends through the bottom of the needle tip 20A. In the illustrated preferred embodiment of the device 10A, adjacent ones of the walls 22A, 24A, 26A, 28A, 30A of the tip 20A that define the opening 34A are advantageously joined at rounded convexly curved corners for improved safety in the eye. Preferably, the corners are rounded with a radius of R0.2 to R0.50. In a non-preferred embodiment, one or more of the corners is a 90 degree bend.

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

[0046] A third embodiment of a surgical needle according to the present invention is shown in Figures 31-39, designated by the numeral 10B, and functions similarly to the first illustrated embodiment of the needle 10 previously described in Figures 1-15. The numbered features of the third embodiment of the needle illustrated in Figures 31-39 are similar to the features of the first embodiment of the needle that share the same numbers (without the suffix "B"). The third embodiment of the surgical needle 10B differs from the first illustrated embodiment described above in that the needle 10B includes an emulsifying tip 20B having six separate walls 22B, 24B, 26B, 28B, 30B, 32B. 38, as shown, the first pair of walls 22B, 26B are substantially parallel to one another, the second pair of walls 24B, 32B are also substantially parallel to one another, and the third pair of walls 28B, 30B are angled relative to one another and extend or connect from one of the first pair to one of the second pair. The opening 34B in the tip 20B has a substantially square configuration with rounded corners.

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

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

[0049] A fourth embodiment of the needle according to the present invention is shown in Figures 40 and 41, designated by the numeral 10C, and functions similarly to the first illustrated embodiment of the needle 10 already described. The numbered features of the fourth embodiment of the needle 10C shown in Figures 40 and 41 are similar to the features of the first embodiment of the needle that share the same numerals but without the suffix "C". The fourth embodiment of the needle 10C differs from the first illustrated embodiment described above in that the needle 10C includes a substantially square emulsifying tip 20C having four walls 22C, 24C, 26C, 28C that define an opening 34C having an (internal) pentagonal configuration. It is believed that the needle 10C may be advantageous in terms of low-cost, high-quality manufacturability compared to the preceding embodiments discussed above. Aperture 34C further defines a longitudinal aperture axis 36C that is parallel to but offset from the central longitudinal axis 12C of needle shaft portion 14C.

[0050] 40, it can be seen that the opening 34C is symmetrical about 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 meet the bottommost wall 28C of the tip 20C are substantially thicker than the remaining walls of the tip 20C to provide the opening 34C with a pentagonal configuration.

[0051] A fifth embodiment of a surgical needle according to the present invention is shown in FIG. 42, designated by the numeral 10D, and functions similarly to the fourth illustrated embodiment needle 10C just described. The numbered features of the fifth embodiment needle 10D illustrated in FIG. 42 are similar to the features of the fourth embodiment needles sharing the same numbers but without the suffix "D". The fifth embodiment of the surgical needle 10D differs from the fourth illustrated embodiment described above in that the needle 10D includes an emulsifying tip 20D that defines a corner of adjacent walls 22D, 26D that meets a bottommost wall 28D that is substantially thinner than the preceding embodiment.

[0052] A sixth embodiment of the needle according to the present invention is shown in Figures 43 and 44, designated by the numeral 10E, and functions similarly to the fifth illustrated embodiment of the needle 10D described immediately above. The numbered features of the sixth embodiment of the needle 10E shown in Figures 43 and 44 are similar to the features of the fifth embodiment of the needle that share the same numerals but without the suffix "E". The sixth embodiment of the needle 10E 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, 28E that define an opening 34E that is pentagonal in shape but lacks symmetry with respect to a plane P1 that extends through both the longitudinal opening axis 36E and the longitudinal shaft axis 12E. Instead, the opening 34E has symmetry with respect to a horizontal plane P3 that intersects perpendicularly to the plane P1. This configuration facilitates efficient use and may be particularly well suited for use with certain vibrating instruments or handpieces.

[0053] A seventh embodiment of a surgical needle according to the present invention is shown in Figures 45 and 46, designated by the numeral 10F, and functions similarly to the needle 10E of the sixth illustrated embodiment just described. The numbered features of the seventh embodiment of the needle 10F shown in Figures 45 and 46 are similar to the features of the needle of the sixth embodiment sharing the same numerals but without the suffix "F". The seventh embodiment of the surgical needle 10F differs from the sixth illustrated embodiment described above in that the needle 10F includes an emulsifying tip 20F that defines an opening 34F that is pentagonal in shape and has symmetry with respect to a plane P3 that is transverse to the plane P1 rather than perpendicular thereto.

[0054] An eighth embodiment of a surgical needle according to the present invention is shown in Figs. 47 and 48, represented by the numeral 10G, and functions similarly to the needle 10 of the first illustrated embodiment already described. The numbered features of the eighth embodiment of the needle 10G illustrated in Figs. 47 and 48 are similar to the features of the needle of the first embodiment sharing the same numerals but without the suffix "G". The eighth embodiment of the surgical needle 10G differs from the first illustrated embodiment described above in that the needle 10G includes an emulsifying tip 20G defining an intermediate passage 40G offset from the suction passage 16G of the needle body 14G (Fig. 48 only). The intermediate passage 40G creates a weighting effect on the tip 20G to enhance and / or adjust the swing or imbalance during the oscillation of the needle 10G. The intermediate passage 40G in the tip 20G is preferably drilled in a secondary step from the drilling of the suction passage 16G of the needle body 14G. The intermediate passage 40G preferably has a circular or semicircular valley configuration centered along an axis 44G offset from the central axis 12G of the aspiration passage 16G along a central vertical plane P1. However, it will be understood that the intermediate passage 40G may have other cross-sectional shapes, such as, for example, a square, oval, triangular, other polygonal or irregular shape. A variation of the eighth embodiment needle 10G is shown in FIG. 47A, in which the tip 20G includes two additional intermediate passages 40G located on either side of the plane P1, each of which has a semicircular shape.

[0055] A ninth embodiment of a needle according to the present invention is shown in FIG. 49, designated by the numeral 10H, and functions similarly to the needle 10 of the first illustrated embodiment previously described. The numbered features of the ninth embodiment of the needle 10H illustrated in FIG. 49 are similar to the features of the first embodiment of the needle that share the same numerals but without the suffix "H". The ninth embodiment of the needle 10H differs from the first illustrated embodiment previously described in that the needle 10H includes an aspiration passage 16H in the needle body having a pentagonal cross-sectional shape that is inset from the pentagonal cross-sectional shape of the walls 22H, 24H, 26H, 28H, 30H of the tip 20H. The aspiration passage 16H defines a central axis that is offset from the central axis of the opening defined by the walls 22H, 24H, 26H, 28H, 30H. A variation of the ninth embodiment needle 10H is shown in FIG. 49A, where the tip 20H includes two circular (top and bottom) and two pentagonal (left and right) intermediate passages located on either side of a vertical plane.

[0056] A tenth embodiment of a surgical needle according to the present invention is shown in Figures 50-54, designated by the numeral 10I, and functions similarly to the first illustrated embodiment of needle 10 previously described. The numbered features of the tenth embodiment of needle 10I shown in Figures 50-54 are similar to the features of the first embodiment of needles that share the same numbers but without the suffix "H." The tenth embodiment of the surgical needle 10I differs from the first illustrated embodiment described above in that the needle 10I includes a tip 20I having a pentagonal cross-sectional shape offset from the pentagonal cross-sectional shapes of the walls 22I, 24I, 26I, 28I, 30I, where the lower or bottom walls 28I, 30I extend at least outside the upper wall 24I at a different angle α1 with respect to a vertical plane P2 extending perpendicular to the central axis 12I of the needle body 14I and the central axis 36I of the offset tip 20I, compared to 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 apexes of the walls 28I and 30I meet at a sharp point 32I. The inventors believe that the steep angle of the lower walls 28I, 30I relative to the upper wall of the tip may provide improved trenching of the nucleus. In some configurations, the tip 20I may have seven walls in a heptagonal configuration for improved trenching. A variation of the tenth embodiment needle 10I is 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 variation of the tenth embodiment needle 10I is shown in FIG. 55, in which the lower or bottom walls 28I, 30I extend axially outward of the upper side walls 22I, 26I at an angle α3 of about 30 degrees (±3 degrees) relative to a vertical plane P2 extending perpendicular to the central axis 36I of the offset tip 20I. Additionally, the angle α2 (not shown) of the upper walls 22I, 26I relative to the plane P2 is about 0 degrees in this embodiment of the needle 10I. It can be seen that the needle 10I includes a bend 114I located proximate the tip 20I, and a needle body 14I. Although not shown, in some configurations, the angle α3 may be between 0 degrees (at a planar or flat distal end of the tip) and 90 degrees (perpendicular to the plane P2).

[0058] Yet another variation of the tenth embodiment needle 10I is shown in Figure 56, in which the lower or bottom walls 28I, 30I extend outwardly of at least the top wall 24I at a different angle α1 with respect to a vertical plane P2 extending perpendicular to the central axis 12I of the needle body 14I and the central axis 36I of the offset tip 20I, compared to the angle α2 of the top walls 22I, 26I with respect to the plane P2. Preferably, the lower or bottom walls 28I, 30I are angled at about 50 degrees (±3 degrees) with respect to the 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 angled at about 15 degrees (±3 degrees) with respect to the plane P2. Although not shown, in some forms, angle α2 can be from 0 degrees (the planar or flat distal end of the tip) to 90 degrees (perpendicular to plane P2), while angle α1 can be from 0 degrees (the planar or flat distal end of the tip) to 90 degrees (perpendicular to plane P2), or any combination of these ranges of α1 and α2.

[0059] The inventors have found that the needle design described herein exhibits better nucleus trackability, better flowability, no observable wobble, rebound or bubbles regardless of nucleus grade, no milky fluid when emulsifying grade 4 or 5 nuclei, improved nucleus sculpting or grooving, improved chamber stability, and better overall efficiency when compared to prior art phacoemulsification needles. It is currently believed that the pentagonal or pentagon-like shape of the needle tip described above creates a vortex that increases the amount of balanced salt solution inflow, providing enhanced trackability for the emulsified nucleus at the tip.

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

Claims

1. An ultrasonic phacoemulsification aspiration needle, comprising: a needle shaft portion defining a longitudinal shaft axis and having an internal aspiration passage; an emulsification tip connected to the distal end of the needle shaft portion; The emulsification tip has five side walls defining an outer periphery of an opening communicating with the aspiration passage, and two of the side walls converge at rounded corners located in a vertical plane extending through the longitudinal shaft axis. An ultrasonic phacoemulsification aspiration needle.

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

3. The ultrasonic phacoemulsification aspiration needle according to claim 2, wherein the thickness is about 100 microns.

4. Three of the five side walls define a first thickness T1, and the remaining two of the five side walls converge at a position in a vertical plane extending through the longitudinal shaft axis and have a second thickness T2 greater than the first thickness T1. The ultrasonic phacoemulsification aspiration needle according to claim 1.

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

6. The ultrasonic phacoemulsification aspiration needle according to claim 1, wherein an intermediate passage offset from the longitudinal shaft axis is formed in the emulsification tip.

7. The ultrasonic phacoemulsification aspiration needle according to claim 6, wherein the intermediate passage is semi-circular and is aligned along a vertical plane extending through the longitudinal shaft axis.

8. The emulsification tip has a distal edge defined by a converging pair of the five side walls arranged at a first acute angle α1 with respect to a plane extending perpendicularly through the longitudinal shaft axis. A second pair of the five side walls is arranged 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. The ultrasonic phacoemulsification aspiration needle according to claim 1.

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

10. The ultrasonic phacoemulsification aspiration needle according to claim 1, wherein adjacent ones of the five side walls converge at a convex corner.

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

12. The ultrasonic phacoemulsification aspiration needle according to claim 1, combined with a vibration handpiece.

13. The ultrasonic phacoemulsification 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.

14. An ultrasonic phacoemulsification aspiration needle, comprising: a needle shaft portion defining a longitudinal shaft axis and having an internal suction passage; an emulsification tip connected to the distal end of the needle shaft portion; wherein the emulsification tip has five side walls defining an outer periphery of an opening communicating with the suction passage, three of the side walls defining a first thickness T1, and the remaining two of the five side walls converging at a position in a vertical plane extending through the longitudinal shaft axis and having a second thickness greater than the first thickness of the five. The ultrasonic phacoemulsification aspiration needle.

15. An ultrasonic phacoemulsification aspiration needle, comprising: a needle shaft portion defining a longitudinal shaft axis and having an internal suction passage; an emulsification tip connected to the distal end of the needle shaft portion; wherein the emulsification tip has four side walls defining an outer periphery of an opening communicating with the suction passage, and the opening has a pentagonal shape. The ultrasonic phacoemulsification aspiration needle.

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