Ultrasonic scalpel head manufacturing method, device and ultrasonic scalpel

Abstract

The present application belongs to the field of medical device technology, and in particular, relates to a manufacturing method, device and ultrasonic scalpel of an ultrasonic scalpel head, wherein the scalpel head includes a surface texture structure, and the method includes: determining a first dimension based on plane strain shear stress, a first direction axis coordinate value, a maximum value of contact normal stress, a friction coefficient, a normal line load, a comprehensive equivalent elastic modulus of a contact body, a circumferential coefficient and a first preset condition; determining a depth through a film thickness equation of a water vapor film based on a total thickness of a water vapor film and a surface water vapor film thickness outside a surface texture structure; determining a density of a surface texture structure based on a first dimension, a depth, a density friction curve and a second preset condition, wherein the density of a surface texture structure is the number of surface texture structures per unit area on a biological tissue surface; manufacturing a scalpel head of an ultrasonic scalpel based on the first dimension, depth and density of the surface texture structure; reducing the risk of biological tissue adhesion to the ultrasonic scalpel and improving cutting and coagulation efficiency.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular, relates to a method and device for manufacturing an ultrasonic scalpel head and an ultrasonic scalpel. Background Art

[0002] Currently, during surgery, the ultrasonic scalpel (i.e., ultrasonic surgical knife) applies periodic micro-vibrations to the biological tissue, causing cavitation, protein maturation, tissue fragmentation and other reactions in the biological tissue, thereby achieving the effects of coagulation and tissue cutting.

[0003] It is generally believed that the smoother the ultrasonic scalpel tip, the smaller the friction coefficient between the ultrasonic scalpel tip and biological tissue, the faster the cutting speed, the lower the heat of the blade tip, and the less likely biological tissue is to adhere. However, during ultrasonic surgery, the ultrasonic scalpel with a smooth blade tip rubs against biological tissue at high frequency and high speed, and there is still a situation where the blade tip heats up and causes biological tissue to adhere to the ultrasonic scalpel, causing greater thermal damage to the ultrasonic scalpel, or even making it impossible to continue the surgery, reducing the cutting and coagulation efficiency of the ultrasonic scalpel.

[0004] In the prior art, during ultrasonic scalpel surgery, there is a problem that biological tissue adheres to the ultrasonic scalpel, thereby reducing the cutting and coagulation efficiency of the ultrasonic scalpel. Summary of the invention

[0005] The present application provides a method and device for manufacturing an ultrasonic scalpel head and an ultrasonic scalpel, aiming to solve to a certain extent the problem of biological tissue adhesion to the ultrasonic scalpel during ultrasonic scalpel surgery, which reduces the cutting and coagulation efficiency of the ultrasonic scalpel.

[0006] In a first aspect, the present application provides a method for manufacturing an ultrasonic knife head, the knife head including a surface texture structure, and the manufacturing method includes:

[0007] Determine a first dimension of the surface texture structure along the first direction based on the plane strain shear stress corresponding to the axis coordinate value of the first direction, the axis coordinate value of the first direction, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circumferential coefficient and the first preset condition, wherein the first direction is a direction perpendicular to the movement direction of the cutter head on the surface of the biological tissue;

[0008] The total thickness of the water vapor film and the thickness of the surface water vapor film outside the surface texture structure, and the depth of the surface texture structure are determined by the film thickness equation of the water vapor film;

[0009] Determine the density of the surface texture structure based on the first size, depth, density friction curve and second preset condition of the surface texture structure, wherein the density of the surface texture structure is the number of the surface texture structures per unit area of ​​the cutter head surface;

[0010] A blade head of an ultrasonic surgical knife is manufactured based on the first size, depth and density of the surface texture structure.

[0011] In one embodiment, based on the plane strain shear stress corresponding to the axis coordinate value in the first direction, the axis coordinate value in the first direction, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circumferential coefficient and the first preset condition, determining the first size of the surface texture structure along the first direction includes:

[0012] Based on the normal line load, the comprehensive equivalent elastic modulus of the contact body, the preset curvature radius and the circular coefficient of the surface texture structure, the contact area radius is determined by a contact area radius calculation formula;

[0013] Based on the contact area radius, the shear stress of the plane strain corresponding to the first direction axis coordinate value, the first direction axis coordinate value, the maximum value of the contact normal stress and the preset friction coefficient, the tool head tissue contact model is cycled until the first preset condition is met, and the first size of the surface texture structure along the first direction is determined. The first preset condition is that the preset friction coefficient corresponding to the preset curvature radius is a minimum value.

[0014] In one embodiment, determining the maximum value of the contact normal stress includes:

[0015] Based on the comprehensive equivalent elastic modulus of the contact body, the normal line load, the preset curvature radius and the circular coefficient, the maximum value of the contact normal stress is determined by a calculation formula for the maximum value of the contact normal stress.

[0016] In one embodiment, it is characterized in that determining the comprehensive equivalent elastic modulus of the contact body comprises:

[0017] Based on the cutter head elastic modulus, the cutter head Poisson's ratio, the biological tissue elastic modulus and the biological tissue Poisson's ratio, the contact body comprehensive equivalent elastic modulus is determined by a contact body comprehensive equivalent elastic modulus calculation formula.

[0018] In one embodiment, determining the total thickness of the water vapor film includes:

[0019] Based on the water vapor film pressure, water vapor film density, water vapor film viscosity and entrainment velocity, the total thickness of the water vapor film is determined by a time-varying effect equation of the water vapor film.

[0020] In one embodiment, determining the plane strain shear stress includes:

[0021] Based on the vibration circular frequency, stress upper limit value, stress lower limit value and load variation function value of the ultrasonic surgical knife, the plane strain shear stress is determined by the ultrasonic knife vibration equation.

[0022] In one embodiment, determining the load change function value includes:

[0023] Based on the circumferential coefficient and the vibration frequency, vibration amplitude and vibration time of the ultrasonic surgical knife, the load change function value is determined by a load change function calculation formula.

[0024] In the second aspect, the present application provides an ultrasonic knife, comprising a handle, a transducer, a sleeve assembly, an ultrasonic knife rod, a jaw, a jaw gasket arranged on the inner side of the jaw, and a knife head arranged at the distal end of the ultrasonic knife rod, the knife head comprising a working surface opposite to the jaw gasket, the working surface being provided with an array-distributed surface texture structure, the surface tissue structure comprising at least one of a semi-ellipsoidal pit structure, a regular tetrahedral pit structure, a cylindrical pit structure or an inclined groove pit structure, and the knife head is manufactured using any manufacturing method as described in the first aspect.

[0025] In one embodiment, the inclined groove-shaped pit structure is a plurality of inclined grooves arranged at a preset interval width along a first direction, and the angle between the groove and the first direction is less than 90°. The surface tissue structure also includes a composite configuration pit structure, and the composite configuration pit structure is a pit having a cross-sectional shape of a preset geometric shape arranged in an array between two of the inclined grooves, and the preset geometric shape is a rectangle, an inverted triangle, a semi-ellipse or a semicircle.

[0026] In a third aspect, the present application provides a manufacturing device for an ultrasonic knife head, the knife head including a surface texture structure, and the manufacturing device includes:

[0027] A first determination module is used to determine a first dimension of the surface texture structure along the first direction based on a plane strain shear stress corresponding to a first direction axis coordinate value, a first direction axis coordinate value, a maximum contact normal stress, a friction coefficient, a normal line load, a comprehensive equivalent elastic modulus of a contact body, a circular coefficient and a first preset condition, wherein the first direction is a direction perpendicular to a movement direction of the cutter head on a biological tissue surface;

[0028] A second determination module is used for determining the total thickness of the water vapor film and the thickness of the surface water vapor film outside the surface texture structure, and determining the depth of the surface texture structure by using the film thickness equation of the water vapor film;

[0029] A third determination module is used to determine the density of the surface texture structure based on the first size, depth, density friction curve and second preset condition of the surface texture structure, wherein the density of the surface texture structure is the number of the surface texture structures per unit area of ​​the tool head surface;

[0030] A manufacturing module is used to manufacture a blade head of an ultrasonic surgical knife based on the first size, depth and density of the surface texture structure.

[0031] It can be understood that the beneficial effects of the second to third aspects mentioned above can be found in the relevant description of the first aspect mentioned above, and will not be repeated here.

[0032] Compared with the prior art, the embodiments of the present invention have the following beneficial effects:

[0033] The ultrasonic scalpel head of the present application includes a surface texture structure. Compared with the prior art, the manufacturing method of the present application overcomes the technical prejudice that the smoother the ultrasonic scalpel head is, the lower the friction coefficient can be. The first size, depth and density of the surface texture structure are determined by various surgical process parameters of the ultrasonic scalpel, various biological tissue parameters, density friction curve, first preset conditions and second preset conditions. Therefore, while the surface texture structure is set on the ultrasonic scalpel head, the friction coefficient between the ultrasonic scalpel head and the biological tissue can be reduced, the heat generation of the ultrasonic scalpel head is reduced, the thermal damage of the ultrasonic scalpel head is reduced, and the risk of biological tissue adhesion to the ultrasonic scalpel during the operation is reduced, thereby improving the cutting and coagulation efficiency of the ultrasonic scalpel head, and improving surgical efficiency and surgical safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0035] Figure 1 It is a schematic flow chart of a method for manufacturing an ultrasonic scalpel head provided in one embodiment of the present application;

[0036] Figure 2 It is a schematic diagram of the force of the ultrasonic knife head in contact with biological tissue provided by an embodiment of the present application;

[0037] Figure 3 This is a schematic flow chart of determining a first dimension of a surface texture structure along a first direction based on the shear stress of the plane strain corresponding to the axis coordinate value in the first direction, the axis coordinate value in the first direction, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circular coefficient and the first preset condition in step S100 provided in an embodiment of the present application;

[0038] Figure 4 It is a schematic diagram of a curve showing a change in the wear rate of an ultrasonic scalpel head as a function of the normal clamping force provided in an embodiment of the present application;

[0039] Figure 5 It is a schematic diagram of a sinusoidal micro-vibration amplitude-time curve of an ultrasonic knife head provided in an embodiment of the present application;

[0040] Figure 6 is a schematic diagram of density friction curves corresponding to various densities and friction coefficients of a surface texture structure provided in an embodiment of the present application;

[0041] Figure 7 is a schematic diagram of a depth friction curve corresponding to each depth of a surface texture structure and a friction coefficient provided in an embodiment of the present application;

[0042] Figure 8 is a schematic diagram of a first-dimension friction curve corresponding to each first dimension and friction coefficient of a surface texture structure provided by an embodiment of the present application;

[0043] Fig. 9 is a schematic diagram of a curve showing a change in contact area ratio and axial normal stress under different friction coefficients provided in an embodiment of the present application;

[0044] Fig.10 It is a cross-sectional schematic diagram of a cutting head provided with a semi-ellipsoidal surface texture structure in contact with biological tissue provided by an embodiment of the present application;

[0045] Fig.11 It is a schematic diagram of the structure of the ultrasonic scalpel head provided in an embodiment of the present application;

[0046] Fig.12 is a schematic diagram of the shape of each surface texture structure provided in the embodiments of the present application, Fig.12 The surface texture structure of (1) is semi-ellipsoidal. Fig.12 The surface texture structure of (2) is a regular tetrahedral pyramid. Fig.12 The surface texture structure of (3) is cylindrical. Fig.12 The surface texture structure of (4) is in the shape of inclined grooves. Fig.12 5) is a depth diagram showing that the surface texture structure is in the shape of an inclined groove;

[0047] Fig.13 is a schematic diagram of a structure in which the surface texture structure provided in the embodiment of the present application is a composite structure, wherein: Fig.13 1) is a composite pit structure, 2) is a cross-sectional view of the composite pit structure;

[0048] Fig.14 It is a schematic diagram of the structure of the manufacturing device provided in the embodiment of the present application. DETAILED DESCRIPTION

[0049] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present application. However, it should be clear to those skilled in the art that the present application may also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present application.

[0050] It should be understood that when used in the present specification and the appended claims, the term "comprising" indicates the presence of described features, integers, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or combinations thereof.

[0051] It should also be understood that the term “and / or” used in the specification and appended claims refers to any and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0052] In addition, in the description of the present application specification and the appended claims, the terms "first", "second", "third", etc. are only used to distinguish the descriptions and cannot be understood as indicating or implying relative importance.

[0053] References to "one embodiment" or "some embodiments" etc. described in the specification of this application mean that one or more embodiments of the present application include specific features, structures or characteristics described in conjunction with the embodiment. Therefore, the statements "in one embodiment", "in some embodiments", "in some other embodiments", "in some other embodiments", etc. that appear in different places in this specification do not necessarily refer to the same embodiment, but mean "one or more but not all embodiments", unless otherwise specifically emphasized in other ways. The terms "including", "comprising", "having" and their variations all mean "including but not limited to", unless otherwise specifically emphasized in other ways.

[0054] The ultrasonic scalpel is a surgical device that uses ultrasonic energy to cut and stop bleeding on soft tissue. The ultrasonic generator generates an alternating electrical signal of a certain frequency to excite the ultrasonic transducer. The transducer converts the electrical signal into an ultrasonic signal of the same frequency. The ultrasonic signal is transmitted to the tip of the blade through the ultrasonic blade rod, causing the tip of the blade to generate high-frequency vibration (for example, 55.5KHz). The tip of the blade acts on the soft tissue to denature the protein in the tissue to form a viscoelastic coagulant. When the soft tissue here is incised, the formed viscoelastic coagulant forms a hemostatic seal on the tissue.

[0055] At present, during the operation of ultrasonic scalpel, the ultrasonic blade applies periodic micro-vibration to the biological tissue, causing cavitation, protein maturation, tissue fragmentation and other reactions in the biological tissue, thereby achieving the effect of coagulation and tissue cutting. It is generally believed that the smoother the ultrasonic scalpel head, the smaller the friction coefficient between the ultrasonic scalpel head and the biological tissue, the faster the cutting speed, the lower the heat generation of the blade head, and the less likely the biological tissue is to adhere. However, during ultrasonic surgery, the ultrasonic scalpel with a smooth blade head rubs against the biological tissue at high frequency and high speed. There is still a situation where the blade head heats up and causes the biological tissue to adhere to the ultrasonic scalpel, causing greater thermal damage to the ultrasonic scalpel, or even making it impossible to continue the operation, reducing the cutting and coagulation efficiency of the ultrasonic scalpel.

[0056] In order to solve the above problems to a certain extent, the present application provides a method for manufacturing an ultrasonic knife head, the knife head includes a surface texture structure, and the manufacturing method includes: based on the plane strain shear stress corresponding to the first direction axis coordinate value, the first direction axis coordinate value, the maximum contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circumferential coefficient and the first preset condition, determine the first dimension of the surface texture structure along the first direction, the first direction is the direction perpendicular to the movement direction of the knife head on the surface of the biological tissue; based on the total thickness of the water vapor film and the surface water vapor film thickness outside the surface texture structure, determine the depth of the surface texture structure by the film thickness equation of the water vapor film; based on the first dimension, depth, density friction curve and the second preset condition of the surface texture structure, determine the density of the surface texture structure, the density of the surface texture structure is The number of surface texture structures per unit area of ​​the surface of the blade head; manufacturing the blade head of an ultrasonic surgical knife based on the first size, depth and density of the surface texture structure; compared with the prior art, the manufacturing method of the present application overcomes the technical prejudice that the smoother the ultrasonic scalpel blade head is, the lower the friction coefficient can be, and the first size, depth and density of the surface texture structure are determined by various surgical process parameters of the ultrasonic scalpel, various biological tissue parameters, density friction curve, first preset conditions and second preset conditions, so that while the surface texture structure is set on the ultrasonic scalpel head, the friction coefficient between the ultrasonic scalpel head and the biological tissue can be reduced, the heat generation of the ultrasonic scalpel head is reduced, the thermal damage of the ultrasonic scalpel head is reduced, and the risk of biological tissue adhesion to the ultrasonic scalpel during the operation is reduced, thereby improving the cutting and coagulation efficiency of the ultrasonic scalpel head, and improving the surgical efficiency and surgical safety.

[0057] The technical solution of the present application is described below through specific embodiments.

[0058] First, as Figure 1 As shown, the present application provides a method for manufacturing an ultrasonic knife head, comprising:

[0059] S100, based on the plane strain shear stress corresponding to the axis coordinate value in the first direction, the axis coordinate value in the first direction, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circular coefficient and the first preset condition, determine the first dimension of the surface texture structure along the first direction, where the first direction is the direction perpendicular to the movement direction of the cutting head on the surface of the biological tissue.

[0060] In this embodiment, if Figure 2 As shown, the first direction is set as the x-axis direction, the second direction is set as the direction perpendicular to the surface of the biological tissue, the second direction is set as the y-axis direction, and the movement direction of the blade head is set as the third direction, and the third direction is perpendicular to the plane where the x-axis and the y-axis are located. Step S100 specifically collects various surgical process parameters of the ultrasonic scalpel (for example, plane strain shear stress, maximum contact normal stress, friction coefficient, normal line load), comprehensive equivalent elastic modulus of the contact body, circumferential coefficient and other parameters, and determines the first dimension of the surface texture structure along the first direction under the first preset condition. According to the different cross-sectional shapes of the surface texture structure, the first dimension is the width or diameter.

[0061] In one embodiment, Figure 3 As shown, step S100, based on the shear stress of the plane strain corresponding to the axis coordinate value of the first direction, the axis coordinate value of the first direction, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circumferential coefficient and the first preset condition, determines the first size of the surface texture structure along the first direction, including:

[0062] S110, based on the normal line load, the comprehensive equivalent elastic modulus of the contact body, the preset curvature radius and the circular coefficient of the surface texture structure, the contact area radius is determined by a contact area radius calculation formula.

[0063] In one embodiment, the contact area radius is calculated as:

[0064]

[0065] in, is the contact area radius; is the normal line load (i.e. normal clamping force); A preset curvature radius for the surface texture structure; is the comprehensive equivalent elastic modulus of the contact body; is the circular coefficient.

[0066] S120, based on the contact area radius, the plane strain shear stress corresponding to the first direction axis coordinate value, the first direction axis coordinate value, the maximum value of the contact normal stress and the preset friction coefficient, the tool head tissue contact model is cycled until the first preset condition is met, and the first size of the surface texture structure along the first direction is determined, and the first preset condition is that the preset friction coefficient corresponding to the preset curvature radius is a preset minimum value.

[0067] In one embodiment, Figure 2 As shown, the blade moves under the simultaneous action of the normal clamping force and the micro-motion tangential force, and the contact normal stress distribution between the ultrasonic scalpel blade and the biological tissue is equivalent to the plane strain shear stress distribution; the micro-motion tangential force includes the contact normal stress and the plane strain shear stress, wherein the normal clamping force is the clamping force generated by the ultrasonic scalpel jaws when the ultrasonic scalpel jaws are closed and the ultrasonic scalpel jaws clamp the ultrasonic scalpel blade; the contact normal stress is the contact stress of the biological tissue acting on the ultrasonic scalpel blade when the jaws clamp the ultrasonic scalpel blade and the biological tissue is clamped between the jaws and the ultrasonic scalpel blade, and the contact normal stress is a time-varying static force; the plane strain shear stress is the shear stress given to the ultrasonic scalpel blade when the ultrasonic scalpel blade vibrates along the x-axis direction (i.e., the first direction) and the biological tissue undergoes elastic deformation, and the plane strain shear stress is a dynamic force related to the friction coefficient.

[0068] In one embodiment, the calculation formula of the blade tissue contact model is:

[0069]

[0070] in, is the plane strain shear stress; is the coordinate value of the first direction axis; is the maximum value of the contact normal stress; is the preset friction coefficient; is the contact area radius.

[0071] In this embodiment, the preset curvature radius of the specific surface texture structure is , Normal clamping force , comprehensive equivalent elastic modulus of contact body , Circumferential coefficient Substitute it into the contact area radius calculation formula, set the preset curvature radius R according to the width or diameter of the surface tissue structure required by the specific scene of the ultrasonic knife, and obtain the contact area radius of the surface texture structure on the biological tissue surface , and then the contact area radius , plane strain shear stress , first direction axis coordinate value , Maximum value of contact normal stress Substitute the cutter head tissue contact model to obtain the corresponding preset friction coefficient The cycle continues until the preset curvature radius is reached. Corresponding preset friction coefficient The preset minimum value is used to determine a first dimension of the surface texture structure along a first direction, that is, to determine a width or a diameter of the surface texture structure, wherein the preset minimum value is that the friction coefficient is less than or equal to 5.0.

[0072] In another embodiment, the blade head is stopped under the simultaneous action of the normal clamping force and the micro-movement tangential force, and the contact normal stress distribution between the ultrasonic blade head and the biological tissue is calculated as follows:

[0073]

[0074] in, is the contact normal stress corresponding to x; is the coordinate value of the first direction axis; is the maximum value of the contact normal stress; is the contact area radius.

[0075] In one embodiment, determining the maximum value of the contact normal stress in step S100 includes: determining the maximum value of the contact normal stress by a contact normal stress maximum value calculation formula based on the comprehensive equivalent elastic modulus of the contact body, the normal line load, the preset curvature radius and the circular coefficient.

[0076] In one embodiment, the maximum value of the contact normal stress is calculated as follows:

[0077]

[0078] in, is the maximum value of the contact normal stress; is the normal line load (i.e. normal clamping force); A preset curvature radius for the surface texture structure; is the comprehensive equivalent elastic modulus of the contact body; is the circular coefficient.

[0079] It should be noted that the comprehensive equivalent elastic modulus of the contact body is the comprehensive equivalent elastic modulus when the ultrasonic knife head contacts the biological tissue.

[0080] In one embodiment, determining the comprehensive equivalent elastic modulus of the contact body in step S100 includes: determining the comprehensive equivalent elastic modulus of the contact body through a calculation formula of the comprehensive equivalent elastic modulus of the contact body based on the elastic modulus of the tool head, the Poisson's ratio of the tool head, the elastic modulus of the biological tissue and the Poisson's ratio of the biological tissue.

[0081] In one embodiment, the calculation formula of the comprehensive equivalent elastic modulus of the contact body is:

[0082]

[0083] in, is the comprehensive equivalent elastic modulus of the contact body; is the elastic modulus of the ultrasonic knife head; is the elastic modulus of biological tissue; is the Poisson’s ratio of the ultrasonic scalpel tip; is the Poisson's ratio of biological tissue.

[0084] Understandably, Figure 4 is the variation curve of ultrasonic knife head wear rate with normal clamping force, such as Figure 4 As shown, the greater the normal clamping force applied to the ultrasonic knife head, the greater the wear rate of the knife head.

[0085] In one embodiment, the normal clamping force is set to 15-20N, and the corresponding blade wear rate is 0.9-1.4. Setting the normal clamping force within the range of this embodiment can stably clamp the biological tissue for cutting and coagulation while minimizing the blade wear rate, thereby increasing the service life of the ultrasonic blade and reducing the cost of surgery. Furthermore, the legal clamping force is set to 18N, and the corresponding blade wear rate is 1.3.

[0086] In one embodiment, determining the plane strain shear stress in step S100 includes: determining the plane strain shear stress through the ultrasonic scalpel vibration equation based on the vibration circular frequency of the ultrasonic surgical scalpel, the stress upper limit value, the stress lower limit value and the load change function value.

[0087] In one embodiment, the ultrasonic knife vibration equation is calculated as follows:

[0088]

[0089] in, is the plane strain shear stress varying with time t and x-axis coordinate value; is the upper boundary of the dimensionally normalized computational domain; is the lower boundary of the dimensionally normalized computational domain; is the load variation function value of the ultrasonic knife output energy over time t; is the circular vibration frequency of the ultrasonic knife.

[0090] In one embodiment, determining the load change function value includes: determining the load change function value through a load change function calculation formula based on the circumferential coefficient and the vibration frequency, vibration amplitude, and vibration time of the ultrasonic surgical knife.

[0091] In one embodiment, the load change function calculation formula is:

[0092]

[0093] in, is the load variation function value of the ultrasonic knife output energy with the vibration time t; is the vibration frequency; is the vibration amplitude; is the circular coefficient.

[0094] It should be noted that, as shown in Figure 5, Figure 5 This is the sinusoidal micro-vibration amplitude-time curve of the ultrasonic knife head.

[0095] S200, the total thickness of the water vapor film and the surface water vapor film thickness excluding the surface texture structure, and the depth of the surface texture structure is determined by the film thickness equation of the water vapor film.

[0096] In one embodiment, the film thickness equation of the water vapor film is calculated as:

[0097]

[0098] in, is the total thickness of the water vapor film that changes with time t and x-axis coordinate value; is the thickness of the surface water vapor film outside the surface texture structure; is the depth of the surface texture structure, It is the collection of regions of surface texture structure.

[0099] In one embodiment, determining the total thickness of the water vapor film in step S200 includes: determining the total thickness of the water vapor film through a time-varying effect equation of the water vapor film based on the water vapor film pressure, the water vapor film density, the water vapor film viscosity and the entrainment velocity.

[0100] In one embodiment, the time-varying effect equation of the water vapor film is calculated as follows:

[0101]

[0102] in, is the water vapor film pressure; is the water vapor film density; is the water vapor film viscosity; is the entrainment speed; is the coordinate value of the first direction axis; is the total thickness of the water vapor film.

[0103] In this embodiment, step S200 determines the total thickness of the water vapor film through biological tissue parameters (such as water vapor film pressure, water vapor film density, and water vapor film viscosity) and surgical process parameters (such as suction speed), and then subtracts it from the surface water vapor film thickness outside the surface texture structure (i.e., the surface water vapor film thickness between two surface texture structures) to determine the depth of the surface texture structure.

[0104] S300, determining the density of the surface texture structure based on the first size, depth, density friction curve and second preset condition of the surface texture structure, where the density of the surface texture structure is the number of the surface texture structure per unit area of ​​the tool head surface.

[0105] In this embodiment, the second preset condition is that the preset friction coefficient corresponding to the density of the surface texture structure is a preset minimum value. Step S300 specifically obtains a density friction curve corresponding to each density of the surface texture structure and the friction coefficient based on the first size and depth of the surface texture structure and each density of the surface texture structure, such as Figure 6 As shown, Figure 6 The density friction curve diagram is a diagram showing the density of the surface texture structure and the friction coefficient corresponding to each density of the surface texture structure. According to the second preset condition, the density of the surface texture structure corresponding to the minimum friction coefficient is selected in the density friction curve. The density of the surface texture structure is the number of surface texture structures per unit area on the surface of the cutter head. According to the density friction curve, when the density of the surface texture structure is 4, the friction coefficient is the lowest, thereby maximizing the reduction of the wear rate of the cutter head and thereby increasing the service life of the cutter head.

[0106] In another embodiment, the third preset condition is that the preset friction coefficient corresponding to the depth of the surface texture structure is a preset minimum value, and based on the first size and density of the surface texture structure and each depth of the surface texture structure, a depth friction curve corresponding to each depth of the surface texture structure and the friction coefficient is obtained, such as Figure 7 As shown, Figure 7 The figure is a schematic diagram of the depth friction curve corresponding to each depth of the surface texture structure and the friction coefficient. According to the third preset condition, the depth of the surface texture structure corresponding to the minimum friction coefficient is selected in the depth friction curve. According to the depth friction curve, when the depth of the surface texture structure is 2μm, the friction coefficient is the lowest, thereby maximizing the reduction of the wear rate of the cutter head and thereby increasing the service life of the cutter head.

[0107] In another embodiment, the fourth preset condition is that the preset friction coefficient corresponding to the first size of the surface texture structure is a preset minimum value, and based on the depth, density and each first size of the surface texture structure, a first size friction curve corresponding to each first size of the surface texture structure and the friction coefficient is obtained, such as Figure 8 As shown, Figure 8 The first dimension friction curve schematic diagram is a first dimension friction curve corresponding to each first dimension of the surface texture structure and the friction coefficient. According to the fourth preset condition, the first dimension of the surface texture structure corresponding to the minimum friction coefficient is selected in the first dimension friction curve. According to the first dimension friction curve, when the first dimension of the surface texture structure is 50 μm, the friction coefficient is the lowest, thereby maximizing the reduction of the wear rate of the cutter head and thereby increasing the service life of the cutter head.

[0108] S400, manufacturing a blade of an ultrasonic surgical knife based on the first size, depth and density of the surface texture structure.

[0109] In this embodiment, step 400 specifically involves manufacturing the blade head of the ultrasonic surgical knife using a preset process according to the first size, depth and density of the surface texture structure. The preset process includes 3D printing, laser cutting or mechanical processing.

[0110] In one embodiment, if the surface texture structure is set as a cylindrical pit structure, according to the vibration amplitude 0.1μm, the circumference coefficient is 3.14, the vibration frequency The frequency is 55500Hz, the vibration time is 1 s, and the load change function value is determined is 1.087; after determining the load change function value, the upper boundary of the calculation domain is normalized according to the dimension =4, dimensionally normalized lower boundary of the computational domain -5, ultrasonic knife vibration frequency The plane strain shear stress is determined by using the ultrasonic knife vibration equation at 348540 Hz. ; Then according to the comprehensive equivalent elastic modulus of the contact body 2.1×10 11 Pa, normal clamping force The contact area radius is obtained by setting the curvature radius R to 18N. is 0.02 m, and the corresponding friction coefficient is less than 5.0; and the viscosity of the water vapor film is known 0.08 According to the above external conditions and various calculation formulas, the first size of the surface texture structure is determined to be 50 μm (i.e., the diameter of the cylindrical pit structure is determined to be 50 μm), the depth of the cylindrical pit structure is determined to be 2 μm, and the density of the cylindrical pit structure is determined to be 4 (i.e., the number of cylindrical pit structures per unit area on the surface of the tool head is 4). If the surface texture structure is set as a composite pit structure of angled grooves, according to the above external conditions and various calculation formulas, the first size of the surface texture structure is determined to be 200 μm (i.e., the spacing between two angled grooves), the depth of the cylindrical pit structure is determined to be 200 μm, and the density of the composite pit structure of angled grooves is determined to be 4 (i.e., the number of cylindrical pit structures between two angled grooves per unit area on the surface of the tool head is 4).

[0111] It should be noted that due to the different biological tissues of surgeries on different parts of the human body, the parameters of external conditions will change, and the first size, depth and density of the surface texture structure will change accordingly. There is no limitation on the first size, depth and density of the surface texture structure, and they are set according to surgical requirements.

[0112] In one embodiment, Fig. 9 As shown, Fig. 9 The curves of contact area ratio and axial normal stress under different friction coefficients are shown in Figure 1, where the contact area ratio is the ratio of the first contact area between the ultrasonic scalpel head without surface texture structure and the biological tissue surface to the second contact area between the ultrasonic scalpel head with surface texture structure and the biological tissue surface. The increase in friction coefficient will increase the adhesion area, resulting in an increase in the maximum value of the tangential force. When the ultrasonic scalpel head is in a micro-motion state, the friction coefficient of the contact surface between the scalpel head and the biological tissue will change due to surface wear, and the friction coefficient ranges from 4.0 to 7.0.

[0113] In one embodiment, when the contact surface of the cutter head and the biological tissue are in global slip, the friction coefficient is increased so that the maximum value of the shear stress increases, and the shear stress maintains an elliptical distribution. When the contact surface of the cutter head and the biological tissue are in local slip, the increase in the friction coefficient causes the peak value of the shear stress on the loading side and the peak value of the shear stress on the fixed side to increase and be closer to the edges of the contact areas at both ends. Therefore, when the cutter head is in a state of local slip, the increase in the friction coefficient will lead to an increase in micro-motion wear. At this time, if the friction coefficient is reduced again, the micro-motion wear of the cutter head can be reduced by increasing lubrication. Among them, global slip refers to the overall contact between the working surface of the ultrasonic cutter head and the biological tissue, and local slip refers to the partial contact between the working surface of the ultrasonic cutter head and the biological tissue.

[0114] In one embodiment, Fig.10 As shown, Fig.10 It is a cross-sectional schematic diagram of the contact between a cutting head having a surface texture structure with a semi-ellipsoidal spherical pit structure and biological tissue.

[0115] Compared with the prior art, the embodiments of the present invention have the following beneficial effects:

[0116] The ultrasonic scalpel head of the present application includes a surface texture structure. Compared with the prior art, the manufacturing method of the present application overcomes the technical prejudice that the smoother the ultrasonic scalpel head is, the lower the friction coefficient can be. The first size, depth and density of the surface texture structure are determined by various surgical process parameters of the ultrasonic scalpel, various biological tissue parameters, density friction curve and preset conditions. Therefore, while the surface texture structure is set on the ultrasonic scalpel head, the friction coefficient between the ultrasonic scalpel head and the biological tissue can be reduced, the heat generation of the ultrasonic scalpel head is reduced, the thermal damage of the ultrasonic scalpel head is reduced, and the risk of biological tissue adhesion to the ultrasonic scalpel during the operation is reduced, thereby improving the cutting and coagulation efficiency of the ultrasonic scalpel head, and improving the surgical efficiency and surgical safety.

[0117] In a second aspect, the present application provides an ultrasonic knife, such as Fig.11 As shown, it includes a handle (not shown in the figure), a transducer (not shown in the figure), a sleeve assembly (not shown in the figure), an ultrasonic knife rod 1, a jaw 2, a jaw gasket 3 arranged on the inner side of the jaw 2, and a knife head 4 arranged at the distal end of the ultrasonic knife rod 1, the knife head 4 includes a working surface 41 opposite to the jaw gasket 3, and the working surface 41 is provided with an array-distributed surface texture structure 42, such as Fig.12 As shown, the surface tissue structure 42 includes at least one of a semi-elliptical spherical pit structure, a regular tetrahedral pit structure, a cylindrical protrusion structure or an inclined groove pit structure, and the blade head 4 is manufactured by any manufacturing method as described in the first aspect. The ultrasonic scalpel blade head of this embodiment is not a smooth plane, which overcomes the prejudice that the smoother the blade head surface, the smaller the friction coefficient. While setting the surface texture structure, the friction coefficient between the ultrasonic scalpel blade head and the biological tissue is reduced, the heat generation of the ultrasonic scalpel blade head is reduced, the thermal damage of the ultrasonic scalpel blade head is reduced, and the risk of biological tissue adhesion to the ultrasonic scalpel during surgery is reduced, thereby improving the cutting and coagulation efficiency of the ultrasonic scalpel blade head, and improving surgical efficiency and surgical safety.

[0118] In one embodiment, Fig.12 Schematic diagram of the shape of each surface texture structure. Fig.12 The surface texture structure of (1) is a semi-elliptical spherical pit structure. Fig.12 The surface texture structure of (2) is a regular tetrahedral pyramidal pit structure. Fig.12 The surface texture structure of (3) is a cylindrical pit structure. Fig.12 The surface texture structure of (4) is a diagonal groove-shaped pit structure. Fig.12 The surface texture structure of (4) is a depth diagram of the inclined groove-shaped pit structure. Fig.12 1) where r is the first dimension of the semi-ellipsoidal pit structure, and h is the depth of the semi-ellipsoidal sphere; Fig.12 2) in which a is the first dimension of the regular tetrahedral pyramidal pit structure (i.e., the side length of the regular tetrahedral pyramid), and h is the depth of the regular tetrahedral pyramidal pit structure; Fig.12 3) where r is the first dimension of the cylindrical pit structure (i.e., the radius of the cylinder), and h is the depth of the cylindrical pit structure; Fig.12 4), a is the first dimension of the inclined groove-shaped pit structure (i.e., the preset interval width a between the two inclined grooves), and θ is the angle between the inclined groove and the first direction; Fig.12 In 5), h is the depth of the angled groove pit structure (i.e., the distance between the working surface of the tool head and the bottom of the angled groove); the angled groove pit structure is a plurality of angled grooves arranged along the first direction at a preset interval width, and the angle between the angled groove and the first direction is less than 90°, for example, the angle between the angled groove and the first direction is 75°.

[0119] In one embodiment, Fig.13 As shown, the surface tissue structure 42 also includes a composite configuration pit structure, which is a pit 422 with a cross-sectional shape of a preset geometric shape arranged in an array between two inclined grooves 421. The preset geometric shape is a rectangle, an inverted triangle, a semi-ellipse or a semicircle. The pit corresponding to the rectangle is a cylinder or a cube, the pit corresponding to the inverted triangle is an inverted quadrangular pyramid or an inverted cone, the pit corresponding to the semi-ellipse is a semi-elliptical sphere, and the pit corresponding to the semicircle is a hemisphere. Fig.13 The dimple of the preset geometric shape is a rectangular dimple. It should be noted that in this embodiment, no restrictions are imposed on the preset geometric shape and the dimple shape corresponding to the preset geometric shape, and the dimple shape is set according to the needs of the ultrasonic scalpel head. For example, the preset geometric shape can also be an arc, and the dimple corresponding to the arc is a spherical cap.

[0120] In one embodiment, the ultrasonic knife head further comprises a blade, an elbow blade, a clamping surface and a blunt head, wherein the blade is arranged on the lower surface of the blade head, i.e., the side opposite to the working surface; Fig.11 The front of the middle blade is set as an elbow blade. Fig.11 The back of the blade, i.e. the side opposite to the curved blade, is set as the clamping surface, and the blunt end is set at Fig.11 The left side of the middle blade; the working surface with a surface texture structure is used for large-area cutting and coagulation, the blade is used for biological tissue marking and cutting outward and downward, the curved blade is used for large-area cutting and coagulation in the other direction, the clamping surface is used for cutting, coagulation and grasping tissue, and the blunt head is used for point coagulation and precise dissection. The ultrasonic scalpel blade of this embodiment has a total of 5 functional surfaces, which can play different roles during the operation, thereby improving the efficiency of the operation.

[0121] In a third aspect, the present application provides a manufacturing device 100 for an ultrasonic knife head, wherein the knife head includes a surface texture structure, such as Fig.14 As shown, the manufacturing device includes:

[0122] A first determination module 110 is used to determine a first dimension of the surface texture structure along a first direction based on the plane strain shear stress corresponding to the first direction axis coordinate value, the first direction axis coordinate value, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circular coefficient and preset conditions, wherein the first direction is a direction perpendicular to the movement direction of the cutter head on the surface of the biological tissue;

[0123] The second determination module 120 is used to determine the depth of the surface texture structure by the film thickness equation of the water vapor film based on the total thickness of the water vapor film, the total thickness of the surface water vapor film other than the surface texture structure and preset conditions;

[0124] A third determination module 130 is used to determine the density of the surface texture structure based on the first size, depth and density friction curve of the surface texture structure and a preset condition, where the density of the surface texture structure is the number of the surface texture structure per unit area on the surface of the biological tissue;

[0125] The manufacturing module 140 is used to manufacture a blade of an ultrasonic surgical knife based on the first size, depth and density of the surface texture structure.

[0126] It should be noted that the information interaction, execution process and other contents between the above-mentioned devices are based on the same concept as the method embodiment of the present application. Their specific functions and technical effects can be found in the method embodiment part and will not be repeated here.

[0127] The technicians in the relevant field can clearly understand that for the convenience and simplicity of description, only the division of the above-mentioned functional units and modules is used as an example for illustration. In practical applications, the above-mentioned function allocation can be completed by different functional units and modules as needed, that is, the internal structure of the device can be divided into different functional units or modules to complete all or part of the functions described above. The functional units and modules in the embodiment can be integrated in a processing unit, or each unit can exist physically separately, or two or more units can be integrated in one unit. The above-mentioned integrated unit can be implemented in the form of hardware or in the form of software functional units. In addition, the specific names of the functional units and modules are only for the convenience of distinguishing each other, and are not used to limit the scope of protection of this application. The specific working process of the units and modules in the above-mentioned system can refer to the corresponding process in the aforementioned method embodiment, which will not be repeated here.

[0128] Those of ordinary skill in the art will appreciate that the units and algorithm steps of each example described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of this application.

[0129] In the embodiments provided in the present application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are merely schematic. For example, the division of the modules or units is only a logical function division. There may be other division methods in actual implementation, such as multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, indirect coupling or communication connection of devices or units, which can be electrical, mechanical or other forms.

[0130] The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed on multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0131] It can be understood that the beneficial effects of the second to third aspects mentioned above can be found in the relevant description of the first aspect mentioned above, and will not be repeated here.

[0132] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0133] The embodiments described above are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, a person skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. Such modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application, and should all be included in the protection scope of the present application.

Claims

1. A method for manufacturing an ultrasonic scalpel head, characterized in that: The tool head includes a surface texture structure, and the manufacturing method includes: Determine a first dimension of the surface texture structure along the first direction based on the plane strain shear stress corresponding to the axis coordinate value of the first direction, the axis coordinate value of the first direction, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circumferential coefficient and the first preset condition, wherein the first direction is a direction perpendicular to the movement direction of the cutter head on the surface of the biological tissue; Based on the total thickness of the water vapor film and the thickness of the surface water vapor film outside the surface texture structure, determining the depth of the surface texture structure by using a film thickness equation of the water vapor film; Determine the density of the surface texture structure based on the first size, depth, density friction curve and second preset condition of the surface texture structure, wherein the density of the surface texture structure is the number of the surface texture structures per unit area of ​​the cutter head surface; A blade head of an ultrasonic surgical knife is manufactured based on the first size, depth and density of the surface texture structure.

2. The manufacturing method according to claim 1, characterized in that Based on the shear stress of the plane strain corresponding to the axis coordinate value in the first direction, the axis coordinate value in the first direction, the maximum value of the contact normal stress, the friction coefficient, the normal line load, the comprehensive equivalent elastic modulus of the contact body, the circumferential coefficient and the first preset condition, determining the first size of the surface texture structure along the first direction, including: Based on the normal line load, the comprehensive equivalent elastic modulus of the contact body, the preset curvature radius and the circular coefficient of the surface texture structure, the contact area radius is determined by a contact area radius calculation formula; Based on the contact area radius, the plane strain shear stress corresponding to the first direction axis coordinate value, the first direction axis coordinate value, the maximum value of the contact normal stress and the preset friction coefficient, the tool head tissue contact model is cycled until the first preset condition is met, and the first size of the surface texture structure along the first direction is determined. The first preset condition is that the preset friction coefficient corresponding to the preset curvature radius is a minimum value.

3. The manufacturing method according to claim 2, characterized in that: Determining the maximum value of the contact normal stress includes: Based on the comprehensive equivalent elastic modulus of the contact body, the normal line load, the preset curvature radius and the circular coefficient, the maximum value of the contact normal stress is determined by a calculation formula for the maximum value of the contact normal stress.

4. The manufacturing method according to any one of claims 1 to 3, characterized in that: Determining the comprehensive equivalent elastic modulus of the contact body includes: Based on the cutter head elastic modulus, the cutter head Poisson's ratio, the biological tissue elastic modulus and the biological tissue Poisson's ratio, the contact body comprehensive equivalent elastic modulus is determined by a contact body comprehensive equivalent elastic modulus calculation formula.

5. The manufacturing method according to claim 1, characterized in that: Determining the total thickness of the water vapor film comprises: Based on the water vapor film pressure, water vapor film density, water vapor film viscosity and entrainment velocity, the total thickness of the water vapor film is determined by a time-varying effect equation of the water vapor film.

6. The manufacturing method according to claim 1, characterized in that: Determining the plane strain shear stress comprises: Based on the vibration circular frequency, stress upper limit value, stress lower limit value and load variation function value of the ultrasonic surgical knife, the plane strain shear stress is determined by the ultrasonic knife vibration equation.

7. The manufacturing method according to claim 6, characterized in that: Determining the load change function value includes: Based on the circumferential coefficient and the vibration frequency, vibration amplitude and vibration time of the ultrasonic surgical knife, the load change function value is determined by a load change function calculation formula.

8. A manufacturing device for an ultrasonic knife head, characterized in that: The tool head includes a surface texture structure, and the manufacturing device includes: A first determination module is used to determine a first dimension of the surface texture structure along the first direction based on a plane strain shear stress corresponding to a first direction axis coordinate value, a first direction axis coordinate value, a maximum contact normal stress, a friction coefficient, a normal line load, a comprehensive equivalent elastic modulus of a contact body, a circular coefficient and a first preset condition, wherein the first direction is a direction perpendicular to a movement direction of the cutter head on a biological tissue surface; A second determination module is used to determine the depth of the surface texture structure by using a film thickness equation of the water vapor film based on the total thickness of the water vapor film and the thickness of the surface water vapor film outside the surface texture structure; A third determination module is used to determine the density of the surface texture structure based on the first size, depth, density friction curve and second preset condition of the surface texture structure, wherein the density of the surface texture structure is the number of the surface texture structures per unit area of ​​the tool head surface; A manufacturing module is used to manufacture a blade head of an ultrasonic surgical knife based on the first size, depth and density of the surface texture structure.

9. An ultrasonic scalpel, characterized in that: It includes a handle, a transducer, a sleeve assembly, an ultrasonic knife rod, a jaw, a jaw gasket arranged on the inner side of the jaw, and a knife head arranged at the distal end of the ultrasonic knife rod, the knife head includes a working surface opposite to the jaw gasket, the working surface is provided with an array-distributed surface texture structure, the surface texture structure includes at least one of a semi-ellipsoidal spherical pit structure, a regular tetrahedral pit structure, a cylindrical pit structure or an inclined groove pit structure, and the knife head is manufactured using the manufacturing method as claimed in any one of claims 1 to 7.

10. The ultrasonic scalpel according to claim 9, characterized in that: The inclined groove-shaped pit structure is a plurality of inclined grooves arranged along a first direction at a preset interval width, and the angle between the groove and the first direction is less than 90°. The surface texture structure also includes a composite configuration pit structure, and the composite configuration pit structure is a pit with a cross-sectional shape of a preset geometric shape arranged in an array between two of the inclined grooves, and the preset geometric shape is a rectangle, an inverted triangle, a semi-ellipse or a semicircle.

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