Phacoemulsification needle, phacoemulsification handpiece, and method for manufacturing a phacoemulsification needle

Abstract

The present invention relates to an ultrasonic emulsification needle, an ultrasonic emulsification handle, and a manufacturing method of the ultrasonic emulsification needle. The ultrasonic emulsification needle includes a needle head; a base for connecting external components; and a body. The needle head is disposed at the distal end of the body, and the base is disposed at the proximal end of the body. The body includes a mode conversion portion, and the mode conversion portion includes a needle body portion, and the outer wall of the needle body portion is spiral. The ultrasonic emulsification needle provided by the present invention can realize the conversion of longitudinal vibration into longitudinal-torsional composite vibration without structural changes at the transducer, and the longitudinal-torsional composite vibration can be generated by using a longitudinal vibration transducer; further improve the conversion rate of vibration and increase the intensity of the longitudinal-torsional composite vibration at the distal end of the ultrasonic emulsification needle; its external structure and the lengths of various parts are variable, and different magnitudes of torsional amplitude components and aspiration effects can be obtained; at the same time, the contact area with the bushing is reduced, thereby reducing the frictional heat generation between the outer wall of the ultrasonic emulsification needle and the inner wall of the bushing, and further reducing the surgical risk.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a phacoemulsification needle, a phacoemulsification handle and a manufacturing method of the phacoemulsification needle. Background Art

[0002] Cataract is a visual impairment caused by the clouding of the lens in the eye, which blocks light from entering the eye. As the world's leading cause of blindness, the incidence rate in the elderly is extremely high. It is caused by the denaturation of lens protein, which changes it from transparent to cloudy, forming cataracts. At present, the most popular and effective way to treat this disease is phacoemulsification. Phacoemulsification uses high-frequency ultrasonic energy (usually with a frequency of 20kHz to 60kHz) to emulsify the diseased lens nucleus, then absorbs the emulsified nuclear material and implants an artificial lens to complete the operation.

[0003] Since Charles D. Kelman introduced the phacoemulsification surgery in 1967, the vibration mode of the phacoemulsification needle has gradually developed from longitudinal vibration along the long axis of the handle to vibration in a non-single longitudinal direction, giving rise to composite vibration modes such as torsional vibration and elliptical trajectory vibration that are more advantageous than single longitudinal vibration.

[0004] Traditional phacoemulsification uses vibration along the long axis of the handle, that is, longitudinal vibration. However, during longitudinal vibration, the hollow phacoemulsification needle tube will generate a repulsive force on the crystal when it hits the crystal and the needle retreats. This repulsive force offsets part of the negative pressure suction, causing the nucleus to vibrate or be pushed away from the needle tip, resulting in ultrasonic energy dissipation. While reducing the efficiency of the operation, the drifting fragments will damage the capsule and corneal endothelium with the perfusion fluid, increasing the incidence of complications. This repulsive force is inevitable in longitudinal ultrasonic vibration. And under the same nuclear fragmentation efficiency, longitudinal ultrasound generates more heat than torsional or elliptical ultrasound.

[0005] In order to solve the problem of longitudinal vibration, most ultrasonic emulsification handles now adopt the method of longitudinal torsional combination. There are two main methods to achieve longitudinal torsional combination:

[0006] (1) Modal conversion, that is, converting part of the longitudinal vibration into torsional vibration. The main method is to open an oblique groove on the front cover or the thick end of the horn. When the longitudinal wave is at the oblique groove position, it will be reflected. The reflected transverse wave and the reflected longitudinal wave will be transmitted to the next oblique groove to produce more complex stress changes, and finally a longitudinal-torsional composite vibration will be generated at the output end, as shown in patent applications US2009306583A1, CN107530102A, etc.;

[0007] (2) Modal coupling, that is, generating longitudinal vibration and torsional vibration separately and designing matching structures to make the two frequencies of the transducer equal. The methods include using axially polarized and tangentially polarized piezoelectric ceramics.

[0008] In the structure that realizes mode conversion at the front cover plate or the thick section of the horn, since the longitudinal vibration is converted into torsional vibration here before the longitudinal amplitude is amplified by the diameter change of the horn, the amplitude amplified by the thin section of the horn is more in the torsional direction. From the effect presented by the needle tip, the longitudinal displacement is small and tends to pure rotation, and the effective longitudinal-torsional compound effect cannot be achieved. The limitation of the method of mode coupling lies in the high manufacturing cost (the price of tangentially polarized piezoelectric ceramic sheets is extremely high), relatively low yield, and immature assembly process, etc. Therefore, it is necessary to design a new longitudinal-torsional compound ultrasonic emulsification device. Summary of the Invention

[0009] Based on this, the present invention provides an ultrasonic emulsification needle aiming at at least one of the problems of insufficient longitudinal vibration conversion rate, difficult processing, high cost, etc. of the ultrasonic emulsification needle with longitudinal-torsional compound vibration at present.

[0010] An ultrasonic emulsification needle includes a needle head; a base for connecting external components; a main body, the needle head is arranged at the distal end of the main body, the base is arranged at the proximal end of the main body, the main body includes a mode conversion part, and the mode conversion part includes a needle body part, and the outer wall of the needle body part is spiral.

[0011] Further, the mode conversion part includes a front transition part and a rear transition part, the front transition part is located at the distal end of the needle body part, and the rear transition part is located at the proximal end of the needle body part.

[0012] Further, the main body further includes a needle body transition part, and the needle body transition part is a transition structure between the mode conversion part and the base.

[0013] Further, the base includes a first interface end, a clamping part and a support disk, the support disk is arranged between the clamping part and the first interface end, the base is connected to the external components through the first interface end, the clamping part is used to be stressed to facilitate the assembly between the ultrasonic emulsification needle and the external components, and the support disk is used to abut against the external components to define the axial distance between the ultrasonic emulsification needle and the external components.

[0014] Further, the outer wall of the needle body part includes a plurality of first rotating surfaces rotating along the axial direction of the mode conversion part, the first rotating surfaces are planes rotating along the axial direction of the mode conversion part, and first transition surfaces are arranged between the first rotating surfaces, and the first transition surfaces are arc surfaces rotating along the axial direction of the mode conversion part.

[0015] Further, the rotation angle of the needle body part is greater than 0 degree and less than 360 degrees.

[0016] Further, the cross-sectional shape of the outer wall of the mode conversion part is oval, triangular, quadrilateral, pentagonal or hexagonal.

[0017] Further, the total length of the needle tip and the main body does not exceed 20 mm.

[0018] Further, the diameter of the needle tip is greater than the diameter of the main body.

[0019] Further, the needle tip is in the shape of a flared opening.

[0020] Further, a notch is provided on the needle tip, and the angle between the notch and the radial direction of the needle tip is greater than 0 degree and less than or equal to 60 degrees.

[0021] Further, the phacoemulsification needle is hollow to form an inner wall, and the inner wall includes a spiral structure.

[0022] Further, the spiral structure is provided on the inner wall of the mode conversion part.

[0023] Further, the spiral structure includes a plurality of second rotating surfaces that rotate along the axial direction of the mode conversion part. The second rotating surfaces are planes that rotate along the axial direction of the mode conversion part. Second transition surfaces are provided between the second rotating surfaces, and the second transition surfaces are arc surfaces that rotate along the axial direction of the mode conversion part.

[0024] The phacoemulsification needle provided by the present application includes a needle tip, a base and a main body. The base is used to connect external components. The distal end and the proximal end of the main body are respectively provided with the needle tip and the base, and a mode conversion part is provided on the main body. A needle body part is provided on the mode conversion part, and the outer wall of the needle body part is spiral. When the longitudinal vibration excited by the longitudinal vibration transducer is transmitted to the mode conversion part, due to the reflection of the stress wave by the spiral structure on the outer wall of the mode conversion part, the incident longitudinal wave, the reflected longitudinal wave and the reflected transverse wave are superimposed between the inclined walls. The superimposed stress wave generates vibration components in the axial and circumferential directions of the rotating mode conversion part, and the superimposed stress wave propagates to the distal end of the phacoemulsification needle to generate a composite vibration. The phacoemulsification needle provided by the present application can further improve the conversion rate of vibration, increase the intensity of the longitudinal-torsional composite vibration at the distal end of the phacoemulsification needle, is easy to process and manufacture, and has a more economical cost.

[0025] Further, a phacoemulsification handle is provided, which includes the phacoemulsification needle described above and an ultrasonic oscillator. The phacoemulsification needle is detachably connected to the ultrasonic oscillator through the base.

[0026] Further, the phacoemulsification handpiece further includes a bushing, the phacoemulsification needle is sleeved in the bushing, a bushing contact portion is provided at an end of the bushing, and an outer wall of the mode conversion portion contacts an inner wall portion of the bushing contact portion to form a slit interface.

[0027] Further, the ultrasonic vibrator includes a horn, the horn is located at a distal end of the ultrasonic vibrator, the phacoemulsification handpiece further includes a phacoemulsification handpiece housing, the horn is disposed at a distal end inside the phacoemulsification handpiece housing, a perfusion connector is further provided between the horn and the outside of the phacoemulsification handpiece housing, the perfusion connector is used to provide a connector channel for the flow of perfusion fluid, a first perfusion channel is defined between the horn and the phacoemulsification handpiece housing, a space between the phacoemulsification needle and the bushing forms a second perfusion channel, and the connector channel, the first perfusion channel, the second perfusion channel, and the slit interface are communicated.

[0028] In the phacoemulsification handpiece provided in this embodiment, the above-mentioned phacoemulsification needle is connected to the horn in the ultrasonic vibrator, a mode conversion portion is provided on the phacoemulsification needle, and the longitudinal vibration transmitted by the horn is converted into a longitudinal-torsional composite vibration through the mode conversion portion. Compared with the conventional solution of setting a mode conversion structure at the proximal end of the horn to convert the longitudinal vibration into a circumferential vibration, in the phacoemulsification handpiece provided in this embodiment, the longitudinal vibration is first amplified by the horn, and then the mode conversion is performed at the phacoemulsification needle after the longitudinal vibration is amplified. A certain longitudinal vibration amplitude is retained at the needle tip to generate a longitudinal-torsional composite vibration, which has both the impact effect of the longitudinal vibration and the cutting action of the torsional vibration. In addition, in the phacoemulsification handpiece provided in this application, the contact area between the phacoemulsification needle and the bushing during the vibration movement is reduced, and the frictional heat generation between the outer wall of the phacoemulsification needle and the inner wall of the bushing is reduced, thereby reducing the risk of surgery.

[0029] Further, a manufacturing method of a phacoemulsification needle is provided. The phacoemulsification needle includes a mode conversion portion for converting longitudinal vibration into composite vibration. The manufacturing method includes the following steps:

[0030] Fix a cylindrical needle blank, process the cylindrical needle blank so that a cross-sectional shape of an outer wall of a portion of the cylindrical needle blank corresponding to the mode conversion portion forms a desired shape;

[0031] Clamp two ends of a portion of the cylindrical needle blank corresponding to the mode conversion portion, and rotate the two ends in opposite directions with the axis of the cylindrical needle blank as a rotation axis to form the mode conversion portion.

[0032] Further, the step of processing the cylindrical needle blank includes extruding or cutting the outer wall of the part of the cylindrical needle blank corresponding to the mode conversion part along the axial direction of the cylindrical needle blank, so that the cross-sectional shape of the outer wall forms the desired shape.

[0033] Further, the cylindrical needle blank has a hollow cavity structure. By extruding the outer wall of the part of the cylindrical needle blank corresponding to the mode conversion part along the axial direction of the cylindrical needle blank, the cross-sectional shapes of the inner wall and the outer wall of the cylindrical needle blank form the desired shape.

[0034] In the manufacturing method of the phacoemulsification needle provided in this embodiment, first fix the cylindrical needle blank, and process the arc-shaped tube wall of the cylindrical needle blank so that the cross-sectional shape of the arc-shaped tube wall becomes the desired shape. Then clamp both ends of it and rotate them in opposite directions around its axis respectively, so that a spiral mode conversion part is formed in the axial direction of the cylindrical needle blank. Through the mode conversion part, the incident longitudinal wave, the reflected longitudinal wave and the reflected transverse wave are superimposed between the inclined walls, and the superimposed stress wave generates vibration components in the axial and circumferential directions of the rotating mode conversion part, thereby enhancing the composite vibration of the phacoemulsification needle. The manufacturing method of the phacoemulsification needle provided in this embodiment is easy to process and more economical in cost. Description of the Drawings

[0035] Figure 1 is a perspective view of the phacoemulsification needle according to Embodiment 1 of the present application;

[0036] Figure 2 is a partial cross-sectional view along the axis of the phacoemulsification needle according to Embodiment 1 of the present application;

[0037] Figure 3 is an A-A cross-sectional view of the mode conversion part of the phacoemulsification needles according to Embodiments 1 to 5 of the present application;

[0038] Figure 4 is a perspective view of a part of the mode conversion part (i.e., from the proximal end to the A-A position) of the phacoemulsification needles according to Embodiments 1 to 5 of the present application;

[0039] Figure 5 is a perspective view of a part of the phacoemulsification needles of the prior art and Embodiments 6 to 9 of the present application;

[0040] Figure 6 is a perspective view of a part of the phacoemulsification needles according to Embodiments 10 to 12 of the present application;

[0041] Figure 7 is a perspective view of a part of the phacoemulsification needles according to Embodiments 13 to 16 of the present application;

[0042] Figure 8 is a perspective view of the distal end of the phacoemulsification handle according to Embodiment 17 of the present application;

[0043] Figure 9 Axial sectional view along the distal end of the phacoemulsification handpiece according to the seventeenth embodiment of the present application;

[0044] Figure 10 Schematic diagram of the ultrasonic oscillator structure accommodated in the phacoemulsification handpiece housing according to the seventeenth embodiment of the present application;

[0045] Figure 11 Stereoscopic view of the perfusion fluid flow direction at the distal end of the phacoemulsification handpiece according to the seventeenth embodiment of the present application;

[0046] Figure 12 Front view of the perfusion fluid flow direction of the phacoemulsification handpiece according to the seventeenth embodiment of the present application;

[0047] Figure 13 Schematic diagram of the manufacturing process of the phacoemulsification needle according to the eighteenth embodiment of the present application;

[0048] Figure 14 Flow chart of the manufacturing method of the phacoemulsification needle according to the eighteenth embodiment of the present application. Detailed implementation manners

[0049] In order to make the above objects, features, and advantages of the present invention more obvious and understandable, the following will describe the detailed implementation manners of the present invention with reference to the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0050] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention.

[0051] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0052] In the present invention, unless otherwise clearly defined and limited, terms such as "mounted", "connected", "coupled", "fixed", etc. shall be construed in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0053] In the present invention, unless otherwise clearly defined and limited, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.

[0054] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it may be directly on the other element or there may also be an intermediate element. When an element is considered to be "connected" to another element, it may be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only embodiments.

[0055] It should be noted that the following proximal and near sides refer to the end close to the operator and far from the patient; the distal and far sides refer to the end far from the operator and close to the patient.

[0056] Figure 1The perspective view of the phacoemulsification needle according to the first embodiment of the present application is shown. The phacoemulsification needle 100 includes a needle head portion 101, a base 104 and a main body. The needle head portion 101 is disposed at the distal end of the main body, and the base 104 is disposed at the proximal end of the main body. Preferably, the phacoemulsification needle 100 is a hollow tube, forming an inner wall, and a suction tube cavity 106 is provided along the axial direction of the phacoemulsification needle 100. Further, a first interface end 105 is included on the base 104. Preferably, the base 104 further includes a clamping portion 1041 and a support disk 1042. Preferably, the first interface end 105 is an external thread, and the phacoemulsification needle 100 is fixed to an external component through the first interface end 105, such as connecting with a horn. Preferably, the cross-section of the clamping portion 1041 is hexagonal, which is used to receive force to facilitate the assembly between the phacoemulsification needle 100 and the external component; the support disk 1042 is used to abut against the external component to define the axial distance between the phacoemulsification needle 100 and the external component. For example, when the phacoemulsification needle 100 is connected to the horn, the phacoemulsification needle 100 and the horn are relatively rotated by clamping the clamping portion 1041, and the threaded engagement between the first interface end 105 and the horn is utilized to approach each other until the horn abuts against the support disk 1042, completing the connection between the phacoemulsification needle 100 and the horn, thereby ensuring a tight connection between the two. Specific details will be described in detail with reference to the accompanying drawings later. It should be noted that the clamping portion 1041 preferably has an external hexagonal structure for the purpose of facilitating the clamping of the phacoemulsification needle 100 by a fixture. Therefore, the clamping portion 1041 provided in this embodiment is not limited to the above structure, and those skilled in the art can design a clamping portion 1041 with a suitable structure according to actual needs.

[0057] For the phacoemulsification needle 100 provided by the present application, its main body includes a mode conversion portion, and at least a part of the outer wall of the mode conversion portion is spiral. The mode conversion portion is used to reflect the stress wave of the longitudinal vibration at the proximal end, so that the incident longitudinal wave, the reflected longitudinal wave and the reflected transverse wave are superimposed, and the superimposed stress wave propagates to the distal end of the phacoemulsification needle 100 to generate a composite vibration. Preferably, the main body further includes a needle body transition portion 102, and the needle body transition portion 102 is a transition structure between the mode conversion portion and the base 104. Preferably, the needle body transition portion 102 is cylindrical or frustum-shaped.

[0058] Specifically, the mode conversion part includes a needle body part 103, and the needle body part 103 is spiral. The rotation pitch of the needle body part 103 is determined by the number of spiral turns and the axial length of the rotating part. Preferably, the mode conversion part further includes a front transition part 1031 and a rear transition part 1032. The front transition part 1031 is located at the distal end of the needle body part 103, and the rear transition part 1032 is located at the proximal end of the needle body part 103. Further, the front transition part 1031 is used to connect the needle body part 103 to the needle head part 101. The rear transition part 1032 is used to connect the needle body part 103 and the needle body transition part 102 or the base 104. If there is no needle body transition part 102, the rear transition part 1032 is used to connect the needle body part 103 and the base 104. The specific structures and forming methods of the front transition part 1031 and the rear transition part 1032 will be described in detail later. Along the circumferential direction of the phacoemulsification needle 100, the outer wall of the needle body part 103 includes a plurality of first rotating surfaces 1033, and a first transition surface 1034 is arranged between the plurality of first rotating surfaces 1033. The first rotating surfaces 1033 and the first transition surface 1034 are arranged alternately and form a spiral rotating structure along the axial direction of the phacoemulsification needle 100. The setting of the first transition surface 1034 can reduce the friction between the phacoemulsification needle 100 and other components such as the following bushing 200. When the longitudinal vibration excited by the longitudinal vibration transducer is transmitted to the mode conversion part, due to the reflection of the stress wave by the spiral structure of the rotating outer wall, the incident longitudinal wave, the reflected longitudinal wave and the reflected transverse wave are superimposed between the inclined walls, and the superimposed stress wave generates vibration components in the axial and circumferential directions of the rotating mode conversion part. The superimposed stress wave propagates to the distal end of the phacoemulsification needle to generate a composite vibration.

[0059] Figure 2 A partial cross-sectional view of the phacoemulsification needle according to the first embodiment of the present application is shown in the transverse direction. As Figure 2As shown, the inner wall of the suction tube cavity 106 of the phacoemulsification needle 100 provided in this embodiment includes a spiral structure. Specifically, the spiral structure is provided on the inner wall of the mode conversion part. Along the circumferential direction of the inner wall of the phacoemulsification needle 100, the spiral structure includes a plurality of second rotating surfaces 1035, and second transition surfaces 1036 are provided between the plurality of second rotating surfaces 1035. The second rotating surfaces 1035 and the second transition surfaces 1036 are arranged alternately and form a spiral rotating structure along the axial direction of the phacoemulsification needle 100. It should be noted that the spiral shapes and parameters (such as pitch, etc.) of the spiral structures on the inner wall and outer wall of the phacoemulsification needle can be the same or different. By adding a spiral structure on the inner wall of the phacoemulsification needle 100, when the suction water flow passes through the mode conversion part, for example, the front transition part 1031 and the inner wall of the needle body part 103, an in-tube water vortex will be formed. The in-tube water vortex acts on the opening of the distal needle tip part 101 of the phacoemulsification needle, and then an opening water vortex is formed. The opening water vortex can effectively handle the lens nucleus block adsorbed on the needle tip during the operation. Specifically, compared with the suction force provided by the traditional cylindrical needle head that is horizontal to the axial direction of the needle body, the opening water vortex can provide a partial lateral force to drive the rotation of the nucleus block during the emulsification suction process, avoid blockage, improve the nucleus block grasping ability, and improve the emulsification efficiency.

[0060] Figure 3 FIG. shows the A-A cross-sectional view of the mode conversion part of the phacoemulsification needles of Embodiments 1 to 5 of the present application. Figure 4 FIG. shows a three-dimensional view of a partial mode conversion part (i.e., from the proximal end to the A-A position) of the phacoemulsification needles of Embodiments 1 to 5 of the present application. Combining Figures 3 to 4 As shown, the phacoemulsification needle 100 provided in this embodiment may include mode conversion parts with various cross-sectional shapes. Specifically, Figure 3 、 Figure 4 In the a to e drawings shown in, they respectively correspond to the phacoemulsification needles of Embodiments 1 to 5 of the present application. The cross-sectional shapes of the inner and outer walls of the needle body part 103 are hexagon, ellipse, triangle, quadrilateral, and pentagon in sequence. In the above embodiments, the cross-sectional shapes of the inner and outer wall profiles of the needle body part 103 are the same and are concentrically arranged. In other embodiments, the cross-sectional shapes of the inner and outer wall profiles of the needle body part 103 are different, thereby forming different rotating structures. For example, the cross-sectional shape of the outer wall is hexagon, while the cross-sectional shape of the inner wall is pentagon. Combining Figure 1 、 Figure 2As shown, taking Embodiment 1 as an example, a plurality of first rotating surfaces 1033 are provided on the outer wall of the needle body portion 103, and a first transition surface 1034 is provided between every two adjacent first rotating surfaces 1033; a plurality of second rotating surfaces 1035 are provided on the inner wall of the needle body portion 103, and a second transition surface 1036 is provided between every two adjacent second rotating surfaces 1035. Preferably, the first rotating surface 1033 and the second rotating surface 1035 are formed by rotating a plane, and the first transition surface 1034 and the second transition surface 1036 are formed by rotating an arc surface.

[0061] Further referring to Figure 4 , in Embodiments 1 to 5, the structure of the needle body portion 103 has the same rotation angle and rotation direction. Here, the rotation angle refers to an angle formed in a plane perpendicular to the axis of the mode conversion portion, by projecting the axis and the starting and ending points of the helix rotated from the proximal end to the distal end onto this plane, with the projection point of the axis as the vertex, and the connecting lines between the projection points of the starting and ending points and the projection point of the axis as the two sides. Too many helix turns are not conducive to generating longitudinal vibration and are also difficult to process. Preferably, the number of helix turns is less than 1 turn, that is, the rotation angle is between 0 degrees and 360 degrees.

[0062] Figure 5 Stereograms of the ultrasonic emulsification needle part of the prior art and Embodiments 6 to 9 of the present application are shown, where the needle body portion 103 has different rotation angles β. Figure 5 The attached drawings f - j shown in respectively correspond to the ultrasonic emulsification needles of the prior art, Embodiments 6 to 9. Among them, in the prior art, the rotation angle β of the part corresponding to the needle body portion 103 is zero, while in Embodiments 6 to 9, the rotation direction of the needle body portion 103 is the same, and the rotation angles β are different, such as 30°, 45°, 60°, 90°. The needle body portion 103 with a rotating shape can convert the longitudinal vibration transmitted by the proximal horn into circumferential vibration (also called torsional vibration).

[0063] Figure 6 Stereograms of the ultrasonic emulsification needle part of Embodiments 10 to 12 of the present application are shown, where the distal lengths of the ultrasonic emulsification needles are different. Here, the distal length refers to the length from the proximal end of the main body to the end of the needle head. Figure 6 The attached drawings k - m shown in respectively correspond to the ultrasonic emulsification needles of Embodiments 10 to 12. Combining Figures 1 - 6 As shown, the axial lengths of the needle head 101, the front transition portion 1031, the needle body portion 103, the rear transition portion 1032, and the needle body transition portion 102 of the above - mentioned ultrasonic emulsification needle can all be different. Preferably, the total length of the distal length does not exceed 20 mm, that is, the total length of the needle head 101, the front transition portion 1031, the needle body portion 103, the rear transition portion 1032, and the needle body transition portion 102 is not greater than 20 mm. Further, taking Figure 6Based on the lengths of the respective components of k, Figure 6 l of Figure 6 shortens the lengths of the front transition portion 1031 and the rear transition portion 1032 of k before shortening, so that the fold angles at the needle head portion 101 at the distal end and the needle body transition portion 102 at the proximal end when transitioning from the needle body portion 103 are larger. Figure 6 m of Figure 6 shortens the lengths of the front transition portion 1031 and the needle head portion 101 of k before shortening to match different bushing configurations. In this embodiment, the total length of the distal end length can also be changed by adjusting the lengths of other parts.

[0064] Figure 7 A perspective view of the phacoemulsification needle part of Embodiments 13 to 16 of the present application is shown, wherein the needle head portion 101 can be provided with different incisions. Figure 7 The accompanying drawings n - q shown therein respectively correspond to the phacoemulsification needles of Embodiments 13 to 16. Among them, Figure 7 the incision of the phacoemulsification needle of Embodiment 13 shown in n is a flat - mouth incision, while Figure 7 from o to Figure 7 the incisions of the phacoemulsification needles successively shown in q are bevel incisions, and their needle head portions 101 have different incision angles. Here, the "incision angle" is the radial angle between the plane where the bevel incision is located and the cross - section of the phacoemulsification needle 100. Preferably, the radial angle with the cross - section of the phacoemulsification needle 100 is greater than 0° and less than or equal to 60°, such as 30°, 45°, 60°. Preferably, the needle head portion 101 can be provided with a diameter larger than that of the main body. Further, the needle head portion 101 is in the shape of a flared opening. The phacoemulsification needles of Embodiments 14 to 16 can improve the grasping ability of the needle opening for the nuclear mass and reduce the occurrence of nuclear mass tremors.

[0065] Combined with Figures 3 - 7 the embodiments shown therein, the phacoemulsification needle 100 provided by the present application can be variably changed in terms of external shape structure, length, incision shape, spiral rotation angle, etc., thereby further expanding the scope of use of the phacoemulsification needle 100. Therefore, those skilled in the art can reasonably match the above - mentioned technical features according to actual needs to obtain the most suitable phacoemulsification needle 100.

[0066] The ultrasonic emulsification needle provided by the present application includes a needle head portion, a base, and a main body. The base is used to connect external components. The distal end and the proximal end of the main body are respectively provided with the needle head portion and the base, and a mode conversion portion is provided on the main body. A needle body portion is provided on the mode conversion portion, and the outer wall of the needle body portion is spiral. When the longitudinal vibration excited by the longitudinal vibration transducer is transmitted to the mode conversion portion, due to the reflection effect of the spiral structure on the outer wall of the mode conversion portion on the stress wave, the incident longitudinal wave, the reflected longitudinal wave, and the reflected transverse wave are superimposed between the inclined walls. The superimposed stress wave generates vibration components in the axial and circumferential directions of the rotating mode conversion portion, and the superimposed stress wave propagates to the distal end of the ultrasonic emulsification needle to generate a composite vibration. The ultrasonic emulsification needle provided by the present application can further improve the conversion rate of vibration, increase the intensity of the longitudinal-torsional composite vibration at the distal end of the ultrasonic emulsification needle, is easy to process and manufacture, and has a more economical cost.

[0067] The ultrasonic emulsification needle provided by some embodiments of the present application can realize the conversion of longitudinal vibration into longitudinal-torsional composite vibration without structural changes at the transducer. Using a longitudinal vibration transducer can generate longitudinal-torsional composite vibration. The needle body portion of the ultrasonic emulsification needle and the rotating structure of the inner wall of the ultrasonic emulsification needle can use different rotation angles and cross-sectional shapes. According to the requirements of surgical operations, the lengths of various parts of the ultrasonic emulsification needle can be adjusted to obtain different magnitudes of torsional amplitude components and aspiration effects.

[0068] Figure 8 The perspective view of the distal end of the ultrasonic emulsification handle according to the seventeenth embodiment of the present application is shown. Figure 9 The axial sectional view of the distal end of the ultrasonic emulsification handle according to the seventeenth embodiment of the present application is shown. Combining Figure 8 、 Figure 9 As shown, the ultrasonic emulsification handle provided in this embodiment includes the above ultrasonic emulsification needle 100, and further includes a bushing 200, an ultrasonic emulsification handle housing 300, and an ultrasonic oscillator 400.

[0069] Figure 10 The schematic structural diagram of the ultrasonic oscillator accommodated in the ultrasonic emulsification handle housing according to the seventeenth embodiment of the present application is shown. As Figure 10As shown, the ultrasonic oscillator 400 includes a horn 401, a longitudinal vibration transducer 402, a rear counterweight 403, and a threaded connector 404. The threaded connector 404 may specifically be a screw. The longitudinal vibration transducer 402 is used to generate longitudinal vibrations and includes electrode plates and piezoelectric ceramic plates. Among them, the electrode plates are preferably made of non-quenched beryllium copper alloy or carbon steel, and the piezoelectric ceramic is a ring structure made of lead zirconate titanate (PZT), and the surface of the piezoelectric ceramic is silver-plated to enhance conductivity. The longitudinal vibration transducer 402 is connected to a cable, and when powered on, it converts electrical energy into mechanical energy; the horn 401 is used to amplify and couple the mechanical energy and then transfer it to the ultrasonic emulsification needle 100; the rear counterweight 403 is used to achieve unobstructed single-directional radiation of vibrations. Further, the ultrasonic oscillator 400 is fixed inside the ultrasonic emulsification handle housing 300. The first interface end 105 at the proximal end of the ultrasonic emulsification needle 100 has an external thread, and the second interface end 3021 at the distal end of the horn 401 has an internal thread, and the first interface end 105 and the second interface end 3021 are in threaded cooperation. The internal thread 202 at the proximal end of the bushing 200 is in threaded cooperation with the external thread 3011 at the distal end of the ultrasonic emulsification handle housing 300. The ultrasonic emulsification needle 100 is accommodated in the bushing 200, and a partial contact is formed between the outer wall of the distal end of the ultrasonic emulsification needle 100 and the inner wall of the bushing 200, that is, the front transition portion 1031, the needle body portion 103, or the needle head portion 101 at the distal end of the ultrasonic emulsification needle 100 is not in full contact with the bushing contact portion 201 at the distal end of the bushing 200.

[0070] Figure 11 Fig. 4 shows a three-dimensional view of the flow direction of the perfusion fluid at the distal end of the ultrasonic emulsification handle according to the seventeenth embodiment of the present application. Figure 12 Fig. 5 shows a front view of the flow direction of the perfusion fluid of the ultrasonic emulsification handle according to the seventeenth embodiment of the present application. Combining Figures 10 - 12 As shown, a perfusion connector 501 is further provided outside the ultrasonic emulsification handle housing 300. The perfusion connector 501 is used to provide a connector channel for the flow of the perfusion fluid. A first perfusion channel 502 is defined between the horn and the ultrasonic emulsification handle housing 300. The perfusion connector 501 is used to connect the perfusion device to the first perfusion channel 502 through the connector channel. The space between the ultrasonic emulsification needle 100 and the bushing 200 forms a second perfusion channel 503. A hollow interface 505 is provided at the distal end of the bushing 200. The hollow interface 505 is used to communicate the second perfusion channel 503 with the outside. Referring to Figure 11 , the bushing contact portion 201 at the distal end of the bushing 200 contacts the needle body portion 103 of the ultrasonic emulsification needle 100. Referring to Figure 12, due to the spiral structure of the needle body portion 103, when the bushing contact portion 201 contacts the phacoemulsification needle 100 at the needle body portion 103, the contact between the two is not a full contact, thus forming a gap interface 504. Thereby, the connector channel, the first perfusion channel 502, the second perfusion channel 503, the hollow interface 505 or the gap interface 504 form a perfusion path 500 for the perfusion fluid to flow from the perfusion device into the patient's eye. In addition to flowing out of the conventional hollow interfaces 505 on both sides into the patient's eye, the perfusion fluid in the perfusion device can also flow out into the patient's eye from the gap interface 504, such as Figure 11 and Figure 12 in the directions 3A and 3B. Some studies have shown that the main source of heat generation in phacoemulsification is the frictional heat generated between the phacoemulsification needle and the bushing. The phacoemulsification needle 100 of the present invention is in partial contact with the bushing contact portion 201, generating less heat. Moreover, the presence of the gap interface 504 enables the perfusion fluid to carry away part of the heat, and the heat generation effect is significantly reduced compared to full-contact friction. In an alternative embodiment, if the front transition portion 1031 and the needle head portion 101 are spiral structures, the bushing contact portion 201 at the distal end of the bushing 200 can also contact the front transition portion 1031 and the needle head portion 101. Based on the mating distance of the bushing 200, the design length of the needle head portion 101, the front transition portion 1031, and the needle body portion 103, the bushing contact portion 201 contacts one of the above three.

[0071] The phacoemulsification handle provided in this embodiment connects the above phacoemulsification needle to the horn in the ultrasonic vibrator. A modal conversion portion is provided on the phacoemulsification needle, and the longitudinal vibration transmitted by the horn is converted into longitudinal-torsional composite vibration through the modal conversion portion. Compared with the traditional scheme of setting a modal conversion structure at the proximal end of the horn to convert longitudinal vibration into circumferential vibration, in the phacoemulsification handle provided in this embodiment, the longitudinal vibration is first amplified by the horn, and then modal conversion is performed at the phacoemulsification needle after the longitudinal vibration is amplified. A certain longitudinal vibration amplitude is retained at the needle tip to generate longitudinal-torsional composite vibration, which has both the impact effect of longitudinal vibration and the cutting action of torsional vibration. In addition, in the phacoemulsification handle provided in this application, the contact area between the phacoemulsification needle and the bushing during the vibration movement is reduced, reducing the frictional heat generation between the outer wall of the phacoemulsification needle and the inner wall of the bushing, thereby reducing the risk of the operation.

[0072] Figure 13 shows a schematic diagram of the manufacturing process of the phacoemulsification needle according to Embodiment XVIII of the present application, Figure 14 shows a flowchart of the manufacturing method of the phacoemulsification needle according to Embodiment XVIII of the present application. The phacoemulsification needle prepared in Embodiment XVIII is different from that in Embodiment I in that the cross-sectional shape of the needle body portion 103 is elliptical. Combining Figure 13 、 Figure 14As shown, this embodiment provides a method for manufacturing an ultrasonic emulsification needle, the ultrasonic emulsification needle includes a mode conversion part, and the mode conversion part is used to convert longitudinal vibration into composite vibration. The manufacturing method includes the following steps:

[0073] S181: Fix the cylindrical needle blank, process the cylindrical needle blank so that the cross-sectional shape of the outer wall of the part of the cylindrical needle blank corresponding to the mode conversion part forms a desired shape.

[0074] In this embodiment, the desired shape is not particularly limited, such as a polygon, an ellipse, etc. Specifically, the wall surface of the cylindrical needle blank is processed along the axial direction of the cylindrical needle blank so that it forms at least partially axially extending planes. Refer to Figure 13 , taking the preparation of the ultrasonic emulsification needle of Embodiment 2 as an example, the cylindrical needle blank 110 is in the shape of a cylindrical hollow tube. Fix the cylindrical needle blank 110, such as clamping one end of the cylindrical needle blank 110, so that the other end for setting the needle head 101 is exposed for subsequent processing. Extrude the outer wall of the cylindrical needle blank 110. Specifically, use the clamping fixture to clamp at least part of the outer tube wall of the cylindrical needle blank 110 along the axial direction of the cylindrical needle blank 110. The clamping fixture can clamp the part of the cylindrical needle blank 110 corresponding to the main body of the ultrasonic emulsification needle 100 alone, or clamp the part of the cylindrical needle blank 110 corresponding to the needle head 101, or clamp the corresponding main body and the part of the needle head 101 at the same time.

[0075] At the same time, two clamping plates are symmetrically arranged outside the outer tube wall of the cylindrical needle blank 110. The number of clamping plates in this embodiment is not limited, and it can also be three, four, five, six, so as to obtain different cross-sectional shapes shown in Embodiments 1 to 17. Similarly, the position of the clamping plate relative to the cylindrical needle blank 110 and the length of the clamping plate in this embodiment are not limited and can be set as needed.

[0076] Continue to refer to Figure 13 , during preparation, apply two equal and opposite pressures of 1A and 1B to the needle body part 103 through the clamping plates to change the cross-sectional shape of part of the cylindrical needle blank 110. The needle body part 103 is extruded by the clamping plates to form at least partially axially extending planes, changing the original circular cross-section into an ellipse. Thus, the outer wall of the part of the cylindrical needle blank 110 that is extruded gradually becomes flat, while the unextruded part remains an arc surface. It should be noted that in the above-described embodiment, the cylindrical needle blank 110 is preferably a hollow tube, and both its inner and outer walls can be processed by the above extrusion method.

[0077] Another implementation provided by this application involves cutting the outer wall of the cylindrical needle blank 110 axially, and a planar wall surface can also be obtained in the same way. In addition, the cutting process is also applicable to the inner wall of the cylindrical needle blank 110. Therefore, this application is not limited to the above extrusion or cutting methods. As long as the cross-section of the inner wall and / or outer wall of the cylindrical needle blank 110 can form the expected shape, it is allowed by this application.

[0078] S182: Clamp the two ends of the part of the cylindrical needle blank corresponding to the mode conversion part, and rotate the two ends in the reverse direction with the axis of the cylindrical needle blank as the rotation axis to form the mode conversion part.

[0079] When at least part of the outer wall of the cylindrical needle blank 110 forms a planar structure axially, the clamping fixture releases the cylindrical needle blank 110, and the rotating fixture clamps the two ends of the cylindrical needle blank 110 corresponding to the mode conversion part. Continue to refer to Figure 13 , the rotating fixture clamps the part of the cylindrical needle blank 110 corresponding to the needle head part 101 and the needle body transition part 102, applies two equal and opposite torsional forces in the 2A direction and the 2B direction, and rotates. At the same time, according to the rotation angle β to be obtained, the magnitude of the torsional force is controlled. Finally, a needle body part 103 with a uniform rotation angle and a front transition part 1031 and a rear transition part 1032 with unequal rotation angles can be obtained.

[0080] Preferably, the rotation angle β of the needle body part 103 can be different. The rotation angle β is adjusted according to the rotation time and the magnitudes of the 2A and 2B forces. The rotation angle β is greater than 0° and less than 360°. Preferably, the rotation angle β is greater than 0° and less than 90°. Finally, the ultrasonic emulsification needle 100 is formed.

[0081] It should be noted that for the structure of the cylindrical needle blank 110 used to manufacture the ultrasonic emulsification needle 100 provided by the present invention, a hollow lumen can be provided in the middle, or it can be a solid structure. When it has a hollow lumen structure, the processing of its inner wall structure can refer to the above steps; when it is a solid structure, a through hole for the suction liquid to flow through can be obtained by drilling after the above steps are completed, and then the inner wall is processed. Those skilled in the art can make a reasonable design according to the actual situation.

[0082] Furthermore, in order to better achieve the processing effect, the above-mentioned extrusion, cutting, and torsion process steps are preferably carried out under high-temperature conditions.

[0083] Preferably, at the end of the ultrasonic emulsification needle 100, that is, at the end of the needle head part 101, a notch is processed, and the angle between the notch and the radial direction of the needle head part 101 is greater than 0° and less than or equal to 60°.

[0084] The manufacturing method of the phacoemulsification needle provided in this embodiment first fixes the cylindrical needle blank, processes the arc-shaped tube wall of the cylindrical needle blank, and after the cross-sectional shape of the arc-shaped tube wall becomes the desired shape, then clamps both ends thereof and rotates them in opposite directions around its axis respectively, so as to form a spiral mode conversion part in the axial direction of the cylindrical needle blank. Through the mode conversion part, the incident longitudinal wave, the reflected longitudinal wave, and the reflected transverse wave are superimposed between the inclined walls, and the superimposed stress wave generates vibration components in the axial and circumferential directions of the rotating mode conversion part, thereby enhancing the composite vibration of the phacoemulsification needle. The manufacturing method of the phacoemulsification needle provided in this embodiment is easy to process and more economical in cost.

[0085] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0086] The above-described embodiments only represent several implementation manners of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent should be subject to the appended claims.

Claims

1. An ultrasonic emulsification handle, characterized in that, it comprises: an ultrasonic emulsification needle and an ultrasonic oscillator, and the ultrasonic emulsification needle comprises: a needle head; a base for connecting external components; a main body, the needle head is arranged at the distal end of the main body, the base is arranged at the proximal end of the main body, the main body comprises a modal conversion part, the modal conversion part comprises a needle body part, and the outer wall of the needle body part is spiral; the ultrasonic emulsification needle is detachably connected to the ultrasonic oscillator through the base; the ultrasonic emulsification handle further comprises a bushing, the ultrasonic emulsification needle is sleeved in the bushing, a bushing contact part is arranged at the end of the bushing, and partial contact between the outer wall of the modal conversion part and the inner wall of the bushing contact part forms a slit interface.

2. The ultrasonic emulsification handle according to claim 1, characterized in that, the modal conversion part comprises a front transition part and a rear transition part, the front transition part is located at the distal end of the needle body part, and the rear transition part is located at the proximal end of the needle body part.

3. The ultrasonic emulsification handle according to claim 1, characterized in that, the main body further comprises a needle body transition part, and the needle body transition part is a transition structure between the modal conversion part and the base.

4. The ultrasonic emulsification handle according to claim 1, characterized in that, the base comprises a first interface end, a clamping part and a support disc, the support disc is arranged between the clamping part and the first interface end, the base is connected to the external component through the first interface end, the clamping part is used for receiving force to facilitate the assembly between the ultrasonic emulsification needle and the external component, and the support disc is used for abutting against the external component to define the axial distance between the ultrasonic emulsification needle and the external component.

5. The ultrasonic emulsification handle according to claim 1, characterized in that, the outer wall of the needle body part comprises a plurality of first rotating surfaces rotating along the axial direction of the modal conversion part, the first rotating surfaces are planes rotating along the axial direction of the modal conversion part, first transition surfaces are arranged between the first rotating surfaces, and the first transition surfaces are arc surfaces rotating along the axial direction of the modal conversion part.

6. The ultrasonic emulsification handle according to claim 1, characterized in that, the rotation angle of the needle body part is greater than 0 degree and less than 360 degrees.

7. The ultrasonic emulsification handle according to claim 1, characterized in that, the cross-sectional shape of the outer wall of the modal conversion part is oval, triangular, quadrilateral, pentagonal or hexagonal.

8. The ultrasonic emulsification handle according to claim 1, characterized in that, the total length of the needle head and the main body does not exceed 20 mm.

9. The ultrasonic emulsification handle according to claim 1, characterized in that, the diameter of the needle head is greater than the diameter of the main body.

10. The ultrasonic emulsification handle according to claim 9, characterized in that, the needle head is in the shape of a flared mouth.

11. The ultrasonic emulsification handle according to claim 1, characterized in that, a notch is arranged on the needle head, and the included angle between the notch and the radial direction of the needle head is greater than 0 degree and less than or equal to 60 degrees.

12. The ultrasonic emulsification handle according to any one of claims 1-11, characterized in that, the ultrasonic emulsification needle is hollow, forming an inner wall, and the inner wall includes a spiral structure.

13. The ultrasonic emulsification handle according to any one of claim 12, characterized in that, the spiral structure is arranged on the inner wall of the mode conversion part.

14. The ultrasonic emulsification handle according to claim 13, characterized in that, the spiral structure includes a plurality of second rotating surfaces rotating along the axial direction of the mode conversion part, the second rotating surface is a plane rotating along the axial direction of the mode conversion part, a second transition surface is arranged between the second rotating surfaces, and the second transition surface is an arc surface rotating along the axial direction of the mode conversion part.

15. The ultrasonic emulsification handle according to claim 1, characterized in that, the ultrasonic oscillator includes a horn, the horn is located at the distal end of the ultrasonic oscillator, the ultrasonic emulsification handle further includes an ultrasonic emulsification handle housing, the horn is arranged at the distal end inside the ultrasonic emulsification handle housing, a perfusion connector is further arranged between the horn and the outside of the ultrasonic emulsification handle housing, the perfusion connector is used to provide a connector channel for the flow of perfusion fluid, a first perfusion channel is defined between the horn and the ultrasonic emulsification handle housing, a second perfusion channel is formed in the space between the ultrasonic emulsification needle and the bushing, and the connector channel, the first perfusion channel, the second perfusion channel and the gap interface are communicated.

16. A manufacturing method of an ultrasonic emulsification handle, characterized in that, the ultrasonic emulsification handle includes an ultrasonic emulsification needle and an ultrasonic oscillator, the ultrasonic emulsification needle includes a mode conversion part for converting longitudinal vibration into composite vibration, and the manufacturing method includes the following steps: fixing a cylindrical needle blank, processing the cylindrical needle blank so that the cross-sectional shape of the outer wall of the part of the cylindrical needle blank corresponding to the mode conversion part forms a desired shape; clamping two ends of the part of the cylindrical needle blank corresponding to the mode conversion part, and reversely rotating the two ends with the axis of the cylindrical needle blank as the rotation axis to form the mode conversion part; wherein, the ultrasonic emulsification handle further includes a bushing, the ultrasonic emulsification needle is sleeved in the bushing, a bushing contact part is arranged at the end of the bushing, and the outer wall of the mode conversion part contacts with the inner wall part of the bushing contact part to form a gap interface.

17. The manufacturing method of the ultrasonic emulsification handle according to claim 16, characterized in that, the step of processing the cylindrical needle blank includes extruding or cutting the outer wall of the part of the cylindrical needle blank corresponding to the mode conversion part along the axial direction of the cylindrical needle blank so that the cross-sectional shape of the outer wall forms the desired shape.

18. The manufacturing method of the ultrasonic emulsification handle according to claim 16, characterized in that, the cylindrical needle blank is a hollow lumen structure, and by extruding the outer wall of the part of the cylindrical needle blank corresponding to the mode conversion part along the axial direction of the cylindrical needle blank, the cross-sectional shapes of the inner wall and the outer wall of the cylindrical needle blank form the desired shapes.

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