Medical front ultrasonic transducer with flange provided with convex lugs and ultrasonic surgical instrument

Abstract

The invention provides a medical front ultrasonic transducer with a flange provided with a convex lug and an ultrasonic surgical instrument. The ultrasonic transducer comprises an ultrasonic amplitude-change pole, the flange, a piezoelectric ceramic stack and a rear cover plate which are coaxially arranged in sequence and pressed by a pre-tightening piece. The pre-tightening piece is used for adjusting the pre-tightening force between all parts in the transducer, and the pressing degree between the flange, the piezoelectric ceramic stack and the rear cover plate can be changed through rotating adjustment. The ultrasonic amplitude-change pole is of an integrated structure and comprises a base cylinder, a nose cylinder and a cutter bar cylinder, wherein the diameters of the three cylinder sections are sequentially reduced. Wherein the front end of the cutter bar cylinder is designed to be arc-shaped, and a plurality of cutting surfaces and cutting edges limited by the cutting surfaces are formed. The flange comprises an annular body and a plurality of convex lugs arranged on the annular body, the convex lugs are used for improving the mounting and positioning precision of the flange when the flange is assembled, and the thickness difference between the annular body and the convex lugs facilitates radial fixation during assembly.

Description

Technical Field

[0001] This application belongs to the technical field of medical devices, and more specifically, relates to a medical pre - placed ultrasonic transducer with a flange and lugs and an ultrasonic surgical instrument. Background Art

[0002] When the ultrasonic transducer is in the working state, it will generate high - frequency mechanical vibration, and its internal components often undergo small - amplitude axial rotation in the assembly. This unexpected relative movement will not only cause energy loss of mechanical energy but also significantly reduce the energy transfer efficiency.

[0003] In the prior art, the ultrasonic transducer is usually fixed by simple interference fit or thread fastening and other methods, but these traditional assembly methods are difficult to effectively suppress the small - amplitude rotation generated under high - frequency working conditions. Especially during long - term continuous operation, this micro - motion phenomenon will gradually intensify, leading to a series of problems such as contact surface wear and connection loosening, and ultimately resulting in the attenuation of the overall performance of the transducer. Summary of the Invention

[0004] The purpose of the embodiments of this application is to provide a medical pre - placed ultrasonic transducer with a flange and lugs and an ultrasonic surgical instrument, so as to solve the technical problem of low positioning accuracy during the assembly of the ultrasonic transducer in the prior art.

[0005] To achieve the above - mentioned purpose, the technical solution adopted in this application is: Provide a medical pre - placed ultrasonic transducer with a flange and lugs, including: An ultrasonic horn, a flange, a piezoelectric ceramic stack, and a rear cover plate that are coaxially arranged in sequence and compressed by a pre - tightening member; where The ultrasonic horn is a single component and includes a base cylinder, a nose cylinder, and a cutter bar cylinder with diameters decreasing from large to small. The front part of the cutter bar cylinder is arc - shaped and has a plurality of cutting surfaces and a cutting edge defined by the plurality of cutting surfaces; The flange includes an annular body and a plurality of lugs provided on the annular body. The thickness of the lugs is less than the thickness of the annular body. The annular body has an outer diameter and an inner diameter of the same size as the piezoelectric ceramic stack. The position of one of the lugs corresponds to the position of the cutting edge.

[0006] As a further improvement of the above - mentioned technical solution: Optionally, the nose cylinder is provided with two symmetric and parallel flat parts. The mid - lines of the two lugs are respectively located on the extension lines of the mid - lines of the two flat parts. The two flat parts respectively correspond to the concave surface and the convex surface of the front part of the arc. The cutting surface where the cutting edge is located is perpendicular to the extension plane of the flat part.

[0007] Optionally, the piezoelectric ceramic stack includes multiple piezoelectric ceramics, and a positive electrode sheet or multiple serially connected positive electrode sheets and a negative electrode sheet or multiple serially connected negative electrode sheets that are alternately arranged between the multiple piezoelectric ceramics. The lead wires of the positive electrode sheet or the multiple serially connected positive electrode sheets and the negative electrode sheet or the multiple serially connected negative electrode sheets are all led out from positions close to the flange.

[0008] Optionally, the number of piezoelectric ceramic sheets is 2, 4, or 6.

[0009] Optionally, the lead wire of the positive electrode sheet includes a strip-shaped electrode sheet extending from the positive electrode sheet, the lead wire of the negative electrode sheet includes a strip-shaped electrode sheet extending from the negative electrode sheet, and the lengths of the strip-shaped electrode sheets extending from the positive electrode sheet and the negative electrode sheet are both greater than or equal to the total length of the piezoelectric ceramic stack.

[0010] Optionally, the positive electrode sheet or the multiple serially connected positive electrode sheets, the bridging portions of the positive electrode sheet brackets, and the strip-shaped electrode sheet extending from the positive electrode sheet are integrally formed from the following materials: gold sheet, silver sheet, copper sheet, or aluminum sheet; or aluminum sheet plated with gold, silver, or copper on the surface; or copper sheet plated with gold or silver on the surface; and / or the negative electrode sheet or the multiple serially connected negative electrode sheets, the bridging portions of the negative electrode sheet brackets, and the strip-shaped electrode sheet extending from the negative electrode sheet are integrally formed from the following materials: gold sheet, silver sheet, copper sheet, or aluminum sheet; or aluminum sheet plated with gold, silver, or copper on the surface; or copper sheet plated with gold or silver on the surface.

[0011] Optionally, a round hole is provided at the rear end of the rear cover plate to hide the head of the pre-tightening member.

[0012] Optionally, when the number of piezoelectric ceramic sheets is 6, the total length of the ultrasonic transducer is less than or equal to 61 mm; when the number of piezoelectric ceramic sheets is 4, the total length of the ultrasonic transducer is less than or equal to 57 mm; when the number of piezoelectric ceramic sheets is 2, the total length of the ultrasonic transducer is less than or equal to 53 mm.

[0013] Optionally, the base cylinder, the main body of the flange, the piezoelectric ceramic stack, and the rear cover plate have the same outer diameter size.

[0014] Optionally, the outer diameter of the piezoelectric ceramic stack is 6 mm.

[0015] Optionally, an adhesive is coated between each adjacent contact surface among the ultrasonic horn, the flange, multiple piezoelectric ceramics, the positive electrode sheet or the multiple serially connected positive electrode sheets, the negative electrode sheet or the multiple serially connected negative electrode sheets, and the rear cover plate.

[0016] Optionally, the outer sides of the ceramic sheets and electrode sheets of the piezoelectric ceramic stack are coated with insulating paint.

[0017] Optionally, the transducer is baked in an oven at a certain temperature for a period of time.

[0018] The beneficial effects of a medical pre - ultrasonic transducer with a flange and lugs provided by this application are as follows: The medical pre - ultrasonic transducer with a flange and lugs provided by this application includes a horn, a flange, a piezoelectric ceramic stack, and a rear cover plate that are coaxially arranged in sequence and compressed by a pre - tightening member. The pre - tightening member is used to adjust the pre - tightening force between the components inside the transducer, and the compression degree between the flange, the piezoelectric ceramic stack, and the rear cover plate can be changed by rotational adjustment. The horn is an integral structure, which includes a base cylinder, a nose cylinder, and a shank cylinder with diameters decreasing in sequence. The front end of the shank cylinder is designed in an arc shape, forming a plurality of cutting surfaces and cutting edges defined by these cutting surfaces. The flange includes an annular body and a plurality of lugs arranged thereon. The lugs are used to match with corresponding installation grooves during the assembly of the flange to improve the installation and positioning accuracy of the flange, and the thickness difference between the annular body and the lugs facilitates the radial fixation during assembly. The piezoelectric ceramic stack is made of a high - performance piezoelectric material after polarization treatment and can efficiently convert electrical energy into ultrasonic vibration energy. The rear cover plate is used to absorb the ultrasonic energy propagating backward, reduce energy reflection, support and protect the piezoelectric ceramic stack, and improve the acoustic impedance matching performance.

[0019] The ultrasonic surgical instrument provided by this application includes the above - mentioned medical pre - ultrasonic transducer. Therefore, it also has the advantages of the above - mentioned medical pre - ultrasonic transducer. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the embodiments of this application, the following will briefly introduce the drawings required for use in the embodiments or the description of the prior art. Obviously, the following - described drawings are only some embodiments of this application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0021] Figure 1 It is a schematic exploded view of the first medical pre - ultrasonic transducer with a flange and lugs provided by this application; Figure 2 It is a schematic three - dimensional view of the first medical pre - ultrasonic transducer with a flange and lugs provided by this application; Figure 3 It is a schematic cross - sectional view of the first medical pre - ultrasonic transducer with a flange and lugs provided by this application; Figure 4The front view structural schematic diagram of the flange of the medical pre - placed ultrasonic transducer with a flange having lugs provided by the present application; Figure 5 The side view structural schematic diagram of the flange of the medical pre - placed ultrasonic transducer with a flange having lugs provided by the present application; Figure 6 The front view structural schematic diagram of the second medical pre - placed ultrasonic transducer with a flange having lugs provided by the present application; Figure 7 The front view structural schematic diagram of the third medical pre - placed ultrasonic transducer with a flange having lugs provided by the present application.

[0022] Among them, each reference numeral in the figure: 1. Pre - tightening member; 2. Ultrasonic horn; 21. Base cylinder; 22. Nose cylinder; 221. Flat part; 23. Shank cylinder; 3. Flange; 31. Ring body; 32. Lug; 4. Piezoelectric ceramic stack; 41. Piezoelectric ceramic; 42. Positive electrode plate; 43. Negative electrode plate; 5. Rear cover plate. Detailed implementation manners

[0023] The embodiments of the present invention will be described in detail below. The examples of the embodiments are shown in the drawings, in which the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the drawings are exemplary and are intended to explain the present invention, but should not be construed as limiting the present invention.

[0024] 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", 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 thus should not be construed as limiting the present invention.

[0025] In addition, the terms "first" and "second" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the present invention, "a plurality" means two or more unless otherwise specifically defined.

[0026] In the present invention, unless otherwise clearly specified or defined, terms such as "installed", "connected", "joined", "fixed", etc. shall be construed in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; 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 communication inside two components. 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.

[0027] In the present invention, unless otherwise clearly specified or defined, the first feature being "above" or "below" the second feature may include the direct contact between the first and second features, or may include the situation where the first and second features are not in direct contact but in contact through other features therebetween. Moreover, the first feature being "above", "over" and "on top of" the second feature includes that the first feature is directly above and obliquely above the second feature, or merely indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature being "under", "beneath" and "underneath" the second feature includes that the first feature is directly below and obliquely below the second feature, or merely indicates that the horizontal height of the first feature is lower than that of the second feature.

[0028] In the subsequent descriptions, suffixes such as "circuit", "component", "assembly" or "unit" are only used to facilitate the description of the present invention, and they have no specific meanings themselves. Therefore, they can be used interchangeably.

[0029] The present invention will be further described in detail below in conjunction with the specific embodiments and the accompanying drawings.

[0030] As Figures 1 to 3 shown, the present application provides a medical pre - ultrasonic transducer with a flange and lugs, which includes a horn 2, a flange 3, a piezoelectric ceramic stack 4, and a rear cover 5 that are coaxially arranged in sequence and pressed by a pre - tightening member 1.

[0031] Among them, the pre - tightening member 1 is a pre - tightening screw made of high - strength stainless steel. One end of it is connected to the internal thread of the horn 2, passes through the flange 3 and the piezoelectric ceramic stack 4 in sequence and finally presses against the rear cover 5. By screwing the pre - tightening member 1, the axial pressing of each internal component can be achieved. This pre - tightening screw has good wear resistance and corrosion resistance, and its main function is to precisely adjust the pre - tightening force between each internal component of the transducer. By rotating the adjustment, the pressing degree between the flange 3, the piezoelectric ceramic stack 4 and the rear cover 5 can be changed, so as to achieve precise control of the working state of the piezoelectric ceramic stack 4.

[0032] The ultrasonic horn 2 is of an integral structure, which includes a base cylinder 21, a nose cylinder 22 and a cutter bar cylinder 23, and these three cylinder segments with gradually decreasing diameters. The front end of the cutter bar cylinder 23 is designed in an arc shape, forming a plurality of cutting surfaces and cutting edges defined by these cutting surfaces. Additionally, the front end of the cutter bar cylinder 23 can also be designed in a straight line shape, and a plurality of cutting surfaces and cutting edges defined by these cutting surfaces are designed on the straight front end.

[0033] As Figure 4 and Figure 5 shown, the flange 3 includes an annular body 31 and a plurality of lugs 32 provided thereon. The thickness of the lugs 32 can be the same as the thickness of the annular body 31. In a preferred solution, the thickness of the lugs 32 is less than the thickness of the annular body 31. The outer diameter of the annular body 31 is consistent with the outer diameter of the piezoelectric ceramic stack 4, and the inner diameter of the annular body 31 is consistent with the inner diameter of the piezoelectric ceramic stack 4, which can enable the transducer to have better acoustic impedance matching characteristics, enable the transducer to generate a larger amplitude under the same current condition, and reduce the heat generation of the transducer. The lugs 32 are used to match with the corresponding mounting grooves during the assembly of the flange 3 to improve the mounting and positioning accuracy of the flange 3, and the thickness difference between the annular body 31 and the lugs 32 facilitates the realization of radial fixation during assembly. In particular, the position of one of the lugs 32 corresponds to the cutting edge of the ultrasonic horn 2. The specific corresponding relationship is that the midline of the lug 32, the midline of the cutting edge, and the midline of the entire transducer are approximately on the same straight line.

[0034] The piezoelectric ceramic stack 4 is made of a high-performance piezoelectric material after polarization treatment and can efficiently convert electrical energy into ultrasonic vibration energy.

[0035] The rear cover 5 is used to absorb the ultrasonic energy propagating backward, reduce energy reflection, support and protect the piezoelectric ceramic stack 4, and improve the acoustic impedance matching performance.

[0036] In a specific embodiment of the present application, the flange 3 is made of an aluminum alloy material. Compared with the titanium alloy material used for the ultrasonic horn 2, the aluminum alloy has a higher thermal conductivity coefficient, enabling the heat generated during the operation of the transducer to be more efficiently conducted to the external structural housing, thereby achieving rapid heat dissipation and ensuring that the transducer maintains a stable working state. In terms of manufacturing process, the aluminum flange 3 needs to undergo a special heat treatment process after preliminary machining, specifically including two process stages of solution treatment and aging treatment, to improve the mechanical properties such as strength and hardness of the flange 3.

[0037] As Figure 1As shown, in a specific embodiment of the present application, two symmetric and parallel flat portions 221 are provided on the nose cylinder 22 of the ultrasonic horn 2. The midlines of the two lugs 32 are respectively located at the positions on the extension lines of the midlines of the two flat portions 221. The two flat portions 221 respectively correspond to the concave and convex surfaces of the arc-shaped front portion, and the cutting surface where the cutting edge is located is perpendicular to the extension plane of the flat portion 221 to ensure the best working orientation of the cutting edge during ultrasonic vibration.

[0038] As Figures 1 to 3 shown, in a specific embodiment of the present application, the piezoelectric ceramic stack 4 includes multiple piezoelectric ceramics 41 and one positive electrode plate 42 or multiple series-connected positive electrode plates 42 staggered between the multiple piezoelectric ceramics 41, and one negative electrode plate 43 or multiple series-connected negative electrode plates 43. Their arrangement order is: negative electrode plate 43, piezoelectric ceramic 41, positive electrode plate 42, piezoelectric ceramic 41, negative electrode plate 43... piezoelectric ceramic 41, negative electrode plate 43. The piezoelectric ceramic 41 is made of PZT-8 lead zirconate titanate material, with an outer diameter of 6 mm, an inner diameter of 2.5 mm, and a thickness of 2 mm. This material has the following characteristics: a relatively high electromechanical coupling coefficient, which can effectively realize the mutual conversion between electrical energy and mechanical energy with less energy loss during the conversion process; excellent mechanical strength, capable of withstanding a large pre-tightening force, which is beneficial to improving the acoustic impedance matching performance of the transducer; good temperature stability, and can maintain stable performance within a wide temperature range; fast response speed, capable of realizing rapid vibration; wide frequency response range, adapting to different working frequency requirements. The lead-out wires of one positive electrode plate 42 or multiple series-connected positive electrode plates 42 and one negative electrode plate 43 or multiple series-connected negative electrode plates 43 are all led out from the position close to the flange 3, which is convenient for circuit connection and improves the assembly reliability. It can also effectively prevent the lead-out wires from being broken due to welding or excessive mass and being at the position with a large amplitude of the transducer, ensuring the stable operation of the transducer.

[0039] As Figure 7 , Figure 6 and Figure 2As shown, in a specific embodiment of the present application, the number of piezoelectric ceramic sheets 41 can be flexibly configured according to different application requirements, such as 2 sheets, 4 sheets, or 6 sheets, etc. The specific configuration schemes of the piezoelectric ceramic 41 and the positive / negative electrode sheets include, but are not limited to: when 2 piezoelectric ceramic sheets 41 are used, the electrode sheet configuration scheme is 2 negative electrode sheets 43 and 1 positive electrode sheet 42, or 1 negative electrode sheet 43 and 2 positive electrode sheets 42; when 4 piezoelectric ceramic sheets 41 are used, the electrode sheet configuration scheme is 3 negative electrode sheets 43 and 2 positive electrode sheets 42, or 2 negative electrode sheets 43 and 3 positive electrode sheets 42; when 6 piezoelectric ceramic sheets 41 are used, the electrode sheet configuration scheme is 4 negative electrode sheets 43 and 3 positive electrode sheets 42, or 3 negative electrode sheets 43 and 4 positive electrode sheets 42. The piezoelectric ceramic stack 4 can adapt to the application requirements of different power outputs and frequency characteristics, and select the optimal number of piezoelectric ceramic sheets and electrode configuration scheme.

[0040] As Figures 1 to 3 shown, in a specific embodiment of the present application, the lead wire of the positive electrode sheet 42 includes a long strip-shaped electrode sheet extending from its body, and the lead wire of the negative electrode sheet 43 also includes a long strip-shaped electrode sheet extending from its body. The total length of these extended long strip-shaped electrode sheets is not less than the total axial length of the piezoelectric ceramic stack 4, so as to facilitate electrical connection with the terminals at the end of the transducer, and avoid the connection failure problem caused by insufficient electrode length.

[0041] As Figures 1 to 3 shown, in a specific embodiment of the present application, a positive electrode sheet 42 or multiple series-connected positive electrode sheets 42, the bridging part of each positive electrode sheet 42 bracket, and the long strip-shaped electrode sheet extending from the positive electrode sheet 42 are integrally formed by the following materials: gold sheet, silver sheet, copper sheet, or aluminum sheet; or aluminum sheet plated with gold, silver, or copper on the surface; or copper sheet plated with gold or silver on the surface, to meet the requirements of its structural toughness and conductivity.

[0042] As Figures 1 to 3 shown, in a specific embodiment of the present application, a negative electrode sheet 43 or multiple series-connected negative electrode sheets 43, the bridging part of each negative electrode sheet 43 bracket, and the long strip-shaped electrode sheet extending from the negative electrode sheet 43 are integrally formed by the following materials: gold sheet, silver sheet, copper sheet, or aluminum sheet; or aluminum sheet plated with gold, silver, or copper on the surface; or copper sheet plated with gold or silver on the surface, to meet the requirements of its structural toughness and conductivity.

[0043] As Figures 1 to 3As shown, in a specific embodiment of the present application, the rear cover plate 5 adopts a circular flat plate structure, and a circular hole is provided at the center position of its rear end for accommodating and hiding the head of the pre-tightening member 1. The rear cover plate 5 is made of high-density soft stainless steel material, which can absorb the ultrasonic energy propagating backward generated by the piezoelectric ceramic stack 4, reduce the energy reflection phenomenon, thereby improving the working efficiency and operation stability of the transducer; at the same time, it provides necessary support and protection for the piezoelectric ceramic stack 4. The thickness selection of the rear cover plate 5 needs to balance the following factors: appropriately increasing the thickness is beneficial to improving the ultrasonic energy absorption efficiency, but will cause an increase in the overall weight and volume of the transducer; while insufficient thickness will affect the energy absorption effect and may cause energy reflection problems.

[0044] In a specific embodiment of the present application, when the number of piezoelectric ceramic 41 is 6, the total length of the ultrasonic transducer is less than or equal to 61 mm; when the number of piezoelectric ceramic 41 is 4, the total length of the ultrasonic transducer is less than or equal to 57 mm; when the number of piezoelectric ceramic 41 is 2, the total length of the ultrasonic transducer is less than or equal to 53 mm. Compared with the traditional ultrasonic transducer, the structure is more compact, ensuring that the transducer can achieve a large range of direction adjustment after entering the human body, providing the necessary flexibility for surgical operations.

[0045] In a specific embodiment of the present application, the base cylinder 21, the body of the flange 3, the piezoelectric ceramic stack 4, and the rear cover plate 5 have the same outer diameter size. The unified outer diameter size simplifies the assembly process and improves the assembly efficiency; secondly, it can also ensure that each component naturally maintains coaxiality during the assembly process, avoiding assembly errors caused by size deviations.

[0046] In a specific embodiment of the present application, compared with the outer diameter range of 8 mm - 25 mm of the traditional ultrasonic transducer, the outer diameter of the piezoelectric ceramic stack 4 of the present application is 6 mm, which reduces the overall size and enables the transducer to achieve ultrasonic vibration output with multiple degrees of freedom. The small-size structure improves the movement flexibility of the transducer, enabling it to perform multi-angle operations in a narrow surgical space; on the premise of ensuring the output power, it meets the functional requirements of the multi-degree-of-freedom ultrasonic scalpel for precise cutting and effective blood coagulation in complex anatomical parts.

[0047] In a specific embodiment of the present application, epoxy adhesive is coated between adjacent contact surfaces such as the ultrasonic horn 2, the flange 3, the multi-piece piezoelectric ceramics 41, one positive electrode plate 42 or the series-connected positive electrode plates 42, one negative electrode plate 43 or multiple series-connected negative electrode plates 43, and the rear cover plate 5, etc., to enhance the connection stability of each contact part. In addition, the acoustic impedance matching characteristics of the contact interfaces of each component can be optimized, effectively reducing the impedance mismatch during the transmission of ultrasonic energy. Good acoustic impedance matching can improve the electromechanical coupling efficiency of the transducer, making the conversion of electrical energy into mechanical energy more sufficient; in addition, it also reduces the heat loss during the energy conversion process, effectively controlling the operating temperature rise of the transducer and ensuring its stable operation during a long surgical procedure.

[0048] In a specific embodiment of the present application, the outer sides of the ceramic sheets and electrode plates of the piezoelectric ceramic stack 4 are coated with insulating paint to effectively prevent the surface discharge phenomenon that may occur in the high-voltage electrode during operation, improving electrical safety; secondly, the insulating layer blocks the erosion of the external environment on the electrode material, enhancing the long-term reliability of the piezoelectric ceramic stack 4 in a humid surgical environment.

[0049] In a specific embodiment of the present application, the transducer needs to be subjected to heat curing treatment after assembly. The specific process parameters are as follows: Place the assembled transducer in a constant-temperature oven and keep it within the temperature range of 60°C - 100°C for 30 - 90 minutes to fully cure the epoxy adhesive and insulating paint, ensuring the bonding strength between components such as the ultrasonic horn 2, the flange 3, the piezoelectric ceramic stack 4, and the rear cover plate 5, and forming a uniform and dense insulating protective layer; also avoiding possible thermal damage to the piezoelectric ceramics 41, the positive electrode plate 42, and the negative electrode plate 43 caused by high temperature. By precisely controlling the baking temperature and time parameters, ensure that the adhesive and insulating paint achieve the best curing effect, thereby ensuring the structural stability and electrical reliability of the transducer during long-term use.

[0050] In a specific embodiment of the present application, the base cylinder 21 is provided with internal threads for detachably connecting with a transducer or other external components. The nose cylinder 22 axially extends from the front end of the base cylinder 21, and two symmetric and parallel flat portions 221 are provided on its circumferential surface. The flat portion 221 is used for fitting and installing with the aluminum flange of the whole transducer to ensure the accurate positioning of the cutter head direction and facilitate the pre-tightening and fixing during assembly. The shank cylinder 23 extends from the front end of the nose cylinder 22, and its front part is in an arc structure. This arc structure can adjust the vibration mode of the cutter head so that it superimposes bending vibration on the basis of longitudinal vibration, thereby forming a longer effective cutting line. Compared with traditional longitudinal vibration cutting, the bending vibration can improve the cutting efficiency. The arc-shaped front part of the shank cylinder 23 is provided with a cutting edge defined by a plurality of cutting surfaces. Compared with the traditional cylindrical cutting edge, its edge width and cutting area are larger, and a better blood coagulation and sealing effect can be obtained. The cutting surface where the cutting edge is located is perpendicular to the extension plane of the flat portion 221 to precisely control the vibration direction of the arc-shaped front part. It should be noted that the perpendicular relationship between the cutting surface where the cutting edge is located and the extension plane of the flat portion 221, in addition to being strictly limited to intersecting at 90°, there are deviations within a certain angle range, such as intersecting at 85° or 100°, etc., which all belong to the equivalent replacement of the plane angle and should also be within the protection scope of the present application. The base cylinder 21, the nose cylinder 22, and the shank cylinder 23 are integrally formed of a metal material to ensure the mechanical strength and vibration transmission efficiency of the overall structure, and at the same time avoid energy loss caused by connection gaps.

[0051] In a specific embodiment of the present application, the total length of the ultrasonic horn 2 is optimized to be less than 42 mm. Its specific length can be 41mm, 40 mm, 39 mm, 38 mm, 37 mm, 36 mm, 37 mm, 36 mm, 35 mm, 34 mm, 33 mm, 32mm, 31 mm, 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, or 25 mm, etc.

[0052] Compared with the existing ultrasonic horn, the ultrasonic horn of the present application has a more compact structure, thereby improving the operation freedom of the instrument in a narrow surgical space. By shortening the overall dimensions of the base cylinder 21, the nose cylinder 22, and the shank cylinder 23, the horn can achieve more flexible angle adjustment within a limited surgical field of view while maintaining the ultrasonic energy transmission efficiency. Specifically, the shorter shank length enables the instrument end to adapt to more complex operation paths on the premise of ensuring the controllability of the vibration mode. This size optimization solves the problem of limited operation caused by the too long shank of the traditional ultrasonic scalpel. In addition, the integrally formed metal structure ensures sufficient mechanical strength while reducing the size, avoiding affecting the transmission stability of ultrasonic vibration due to the size reduction.

[0053] AsFigures 1 to 3 As shown, in a specific embodiment of the present application, the front part of the tool shank cylinder 23 adopts an arc structure to increase the radial vibration of the tool tip, thereby realizing the two-dimensional composite vibration of the tool tip to achieve a better cutting effect.

[0054] In a specific embodiment of the present application, the arc-shaped front part of the tool shank cylinder 23 is provided with a specific cutting surface structure, including a convex cutting surface located on the convex surface of the arc and a concave cutting surface located on the concave surface of the arc. Among them, the radius of the convex cutting surface is 75 mm, and the radius of the convex cutting surface is 10 mm. When the radius of the arc is too large, the tool vibration mode will change to short-wavelength bending vibration, which will not only reduce the energy transfer efficiency but also generate obvious sharp noise; when the radius of the arc is too small, the vibration mode will be too close to pure longitudinal vibration, resulting in insufficient cutting line length and affecting the actual cutting effect. This parameter selection not only ensures the working efficiency of the cutting edge of the tool tip but also can reduce its working noise.

[0055] The cutting edge is specifically formed by cutting the side surface of the tool shank cylinder 23 defined between the convex cutting surface and the concave cutting surface, thereby forming a double-sided cutting structure, enabling the tool to perform cutting operations using both the convex surface and the concave surface during vibration.

[0056] In a specific embodiment of the present application, at the front end of the arc-shaped front part, that is, the tool tip position, a plurality of chamfers are provided. Specifically, the chamfer R1 where the convex cutting surface meets the front end, the chamfer R2 where the concave cutting surface meets the front end, and the chamfer R3 where the cutting surface where the cutting edge is located meets the front end. The radius range of the aforementioned chamfers is controlled between 0.3 mm and 1.5 mm to effectively reduce the risk of accidental damage to non-target tissues during the operation while ensuring the cutting efficiency. It should be noted that when the chamfer radius is less than 0.3 mm, its protective effect is insufficient; when it exceeds 1.5 mm, it will affect the sharpness of the cutting edge and the energy transfer efficiency. The synergistic effect of the three chamfers enables the ultrasonic scalpel to improve the safety of surgical operations while maintaining the cutting performance.

[0057] In a specific embodiment of the present application, the width of the cutting blade ranges from 0.35 mm to 0.45 mm. The setting of this size range is based on the consideration of the balance between cutting speed and tissue closure effect: when the cutting blade width is in the range of 0.35 mm to 0.40 mm, its narrower blade structure is conducive to increasing the cutting speed; and when the width increases to the range of 0.40 mm to 0.45 mm, the increased blade contact area can significantly improve the tissue closure effect. Experimental data show that the width range of 0.38 mm to 0.42 mm can achieve the best balance between cutting efficiency and hemostasis effect. This parameter design allows the surgeon to select the appropriate cutting blade width according to specific surgical needs, while ensuring surgical efficiency and meeting the processing requirements of different tissue characteristics. By precisely controlling the width parameters of the cutting blade, this embodiment achieves adjustable optimization of cutting performance while maintaining the efficiency of ultrasonic vibration energy transmission.

[0058] In a specific embodiment of the present application, a conical transition portion is provided between the nose cylinder 22 and the shank cylinder 23. The transition portion adopts a gradual structure, wherein the base portion is connected to the nose cylinder 22 having a diameter of 4.6 mm, and the tip portion forms a smooth transition with the shank cylinder 23 having a diameter of 1.6 mm. The conical transition portion can effectively improve the stress distribution while adjusting the transducer amplitude ratio, reduce the stress concentration phenomenon at the connection between the nose cylinder 22 and the shank cylinder 23, and thus improve the structural reliability of the instrument during operation. In order to further enhance the vibration transmission efficiency, an amplitude step of a specific size can be provided between the base cylinder 21 and the nose cylinder 22, which can increase the output amplitude of the transducer without increasing the overall size.

[0059] In a specific embodiment of the present application, the ultrasonic horn 2 is specifically made of titanium alloy rods and is integrally formed. This material selection is based on the excellent mechanical properties and biocompatibility characteristics of titanium alloy. Its elastic modulus is about 110GPa and its density is 4.5 grams per cubic centimeter, which can meet the strength-to-weight ratio requirements required for ultrasonic vibration transmission. Specifically, the base cylinder 21, the nose cylinder 22 and the shank cylinder 23 made of titanium alloy can control the overall weight within the range required for surgical operation while maintaining structural integrity. In addition, the biological inertness of titanium alloy allows it to directly contact human tissue, meeting the biosafety requirements of medical devices. This material selection takes into account the vibration performance, structural reliability and clinical applicability of the instrument. In other specific embodiments, the ultrasonic horn 2 can also be commonly used in the form of one-piece 3D printing.

[0060] In a specific embodiment of the present application, the ultrasonic horn 2 is heat-treated. The heat treatment process includes two stages: aging treatment and tempering treatment. By controlling parameters such as heating temperature, holding time and cooling rate, the microstructure of the titanium alloy material is optimized. The mechanical properties of the base cylinder 21, the nose cylinder 22 and the shank cylinder 23 after heat treatment are significantly improved, and their tensile strength is improved while maintaining sufficient toughness. In addition, the heat treatment process also eliminates the residual stress generated during the processing process, so that the horn maintains dimensional stability during long-term use and ensures the accurate transmission of ultrasonic vibration energy.

[0061] In a specific embodiment of the present application, the ultrasonic horn 2 is surface-treated. This surface treatment includes sputtering and coating the base cylinder 21, nose cylinder 22, and blade cylinder 23. This treatment effectively reduces tissue adhesion during surgery, improves the biocompatibility of the blade tip, and enhances its corrosion resistance, ensuring the long-term stability and reliability of the components in the surgical environment and providing a solid guarantee for the stable operation of the transducer.

[0062] The present application also provides an ultrasonic surgical instrument, comprising the medical front ultrasonic transducer of the aforementioned embodiment. Therefore, it also possesses the advantages of the medical front ultrasonic transducer of the aforementioned embodiment. Under 0.15A current drive excitation, the medical front ultrasonic transducer can produce an amplitude of 75μm at the blade tip, a frequency of approximately 46kHz, and an impedance of approximately 50Ωm. Actual cutting tests show that each cut takes approximately 3s to 4s to complete tissue severance, meeting the technical requirements of ultrasonic surgical scalpels in terms of performance.

[0063] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A medical pre - placed ultrasonic transducer with a flange and lugs, characterized in that, include: The following are coaxially arranged in sequence and compressed by a pre-tightening member (1): an ultrasonic horn (2), a flange (3), a piezoelectric ceramic stack (4), and a rear cover plate (5); wherein, The ultrasonic horn (2) is a single component and comprises a base cylinder (21), a nose cylinder (22) and a knife rod cylinder (23) with diameters from large to small, wherein the front portion of the knife rod cylinder (23) is arc-shaped and has multiple cutting surfaces and a cutting edge defined by the multiple cutting surfaces; The flange (3) includes an annular body (31) and a plurality of lugs (32) arranged on the annular body (31), the thickness of the lugs (32) is smaller than the thickness of the annular body (31), and the annular body (31) has an outer diameter and an inner diameter of the same size as the piezoelectric ceramic stack (4), and the position of one of the lugs (32) corresponds to the position of the cutting edge.

2. The medical pre - ultrasonic transducer with a flange and lugs according to claim 1, wherein, The nose cylinder (22) is provided with two symmetrical and mutually parallel flat portions (221), the midlines of the two lugs (32) are respectively located on the extension lines of the midlines of the two flat portions (221), the two flat portions (221) respectively correspond to the concave surface and the convex surface of the front portion of the arc, and the cutting surface where the cutting edge is located is perpendicular to the extension plane of the flat portions (221).

3. The medical pre - ultrasonic transducer with a flange and lugs according to claim 2, wherein, The piezoelectric ceramic stack (4) includes multiple piezoelectric ceramics (41) and a positive electrode sheet (42) or multiple positive electrode sheets (42) connected in series and a negative electrode sheet (43) or multiple negative electrode sheets (43) connected in series, which are staggered between the multiple piezoelectric ceramics (41). Lead wires of the positive electrode sheet (42) or the multiple positive electrode sheets (42) connected in series and the negative electrode sheet (43) or the multiple negative electrode sheets (43) connected in series are all led out from a position close to the flange (3).

4. The medical pre - placed ultrasonic transducer with a flange and lugs according to claim 3, characterized in that, The number of the piezoelectric ceramics (41) is 2, 4, or 6.

5. The medical pre - ultrasonic transducer with a flange and lugs according to claim 3, characterized in that, The lead wire of the positive electrode sheet (42) includes a long strip electrode sheet extending from the positive electrode sheet (42), and the lead wire of the negative electrode sheet (43) includes a long strip electrode sheet extending from the negative electrode sheet (43), and the lengths of the long strip electrode sheets extending from the positive electrode sheet (42) and the negative electrode sheet (43) are both greater than or equal to the total length of the piezoelectric ceramic stack (4).

6. The medical pre - placed ultrasonic transducer with a flange and lugs according to claim 3, characterized in that, The positive electrode sheet (42) or the plurality of positive electrode sheets (42) connected in series, the bridging portion of each positive electrode sheet (42) bracket, and the long strip electrode sheet extending from the positive electrode sheet (42) are formed integrally with the following materials: a gold sheet, a silver sheet, a copper sheet, or an aluminum sheet; or an aluminum sheet with gold, silver, or copper on the surface; or a copper sheet with gold or silver on the surface; and / or the negative electrode sheet (43) or the plurality of negative electrode sheets (43) connected in series, the bridging portion of each negative electrode sheet (43) bracket, and the long strip electrode sheet extending from the negative electrode sheet (43) are formed integrally with the following materials: a gold sheet, a silver sheet, a copper sheet, or an aluminum sheet; or an aluminum sheet with gold, silver, or copper on the surface; or a copper sheet with gold or silver on the surface.

7. The medical pre - placed ultrasonic transducer with a flange and lugs according to any one of claims 1 to 6, characterized in that, A round hole is provided at the rear end of the rear cover plate (5) to hide the head of the pre-tightening member (1).

8. The medical pre - placed ultrasonic transducer with a flange and lugs according to claim 4, characterized in that, When the number of piezoelectric ceramics (41) is 6, the total length of the ultrasonic transducer is less than or equal to 61 mm; when the number of piezoelectric ceramics (41) is 4, the total length of the ultrasonic transducer is less than or equal to 57 mm; when the number of piezoelectric ceramics (41) is 2, the total length of the ultrasonic transducer is less than or equal to 53 mm.

9. The medical pre - ultrasonic transducer with a flange and lugs according to any one of claims 1 to 6, characterized in that, The base cylinder (21), the body of the flange (3), the piezoelectric ceramic stack (4), and the rear cover plate (5) have the same outer diameter size.

10. The medical pre - ultrasonic transducer with a flange and lugs according to claim 9, characterized in that, The outer diameter of the piezoelectric ceramic stack (4) is 6 mm.

11. The medical pre - placed ultrasonic transducer with a flange and lugs according to any one of claims 3 to 6, characterized in that, An adhesive is coated between each adjacent contact surface among the ultrasonic horn (2), the flange (3), multiple piezoelectric ceramics (41), the one positive electrode plate (42) or the multiple serially-connected positive electrode plates (42), and the one negative electrode plate (43) or multiple serially-connected negative electrode plates (43), and the rear cover plate (5).

12. The flange-lugged medical pre-ultrasonic transducer according to claim 11, wherein, Insulating paint is smeared on the outside of the ceramic sheets and electrode sheets of the piezoelectric ceramic stack.

13. The medical pre - ultrasonic transducer with a flange and lugs according to claim 11, characterized in that, The transducer is baked in an oven at a certain temperature for a period of time.

14. An ultrasonic surgical instrument, characterized in that, It includes a medical pre-mounted ultrasonic transducer with a flange with lugs according to any one of claims 1 to 13.

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