Ultrasonic vibration components, manufacturing methods thereof, and ultrasonic surgical devices

Abstract

The present disclosure provides an ultrasonic vibration component, a manufacturing method thereof, and an ultrasonic surgical device, wherein the ultrasonic vibration component is configured to vibrate under the excitation of ultrasonic waves and includes an ultrasonic transmission component and an end effector. The ultrasonic transmission component includes a proximal end and a distal end opposite to each other along its extension direction, the end effector is connected to the distal end, and the ultrasonic transmission component is configured to transmit the vibration from the proximal end to the distal end to vibrate the end effector. The end effector includes a first alloy material, and the ultrasonic transmission component includes a second alloy material, the tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the end effector is greater than the tensile strength of the ultrasonic transmission component, which can avoid cracks or fractures in the end effector during vibration, thereby improving the service life and safety of the ultrasonic vibration component.

Description

Technical Field

[0001] The disclosed embodiments relate to an ultrasonic vibration component, a manufacturing method thereof, and an ultrasonic surgical device. Background Art

[0002] Surgeons use ultrasonic surgical devices to cut tissues and achieve hemostasis through coagulation during surgery, thereby minimizing patient trauma. In ultrasonic surgical devices, piezoelectric elements are electrically excited to generate mechanical wave vibrations, which are transmitted and amplified through ultrasonic transmission elements, causing the front end of the ultrasonic surgical device to vibrate to achieve treatment. Summary of the invention

[0003] In a first aspect, the present disclosure provides an ultrasonic vibration component, which is configured to vibrate under the excitation of ultrasonic waves and includes an ultrasonic transmission element and an end effector. The ultrasonic transmission element includes a proximal end and a distal end opposite to each other along its extension direction, the end effector is connected to the distal end, and the ultrasonic transmission element is configured to transmit the vibration from the proximal end to the distal end to vibrate the end effector; the end effector includes a first alloy material, and the ultrasonic transmission element includes a second alloy material, the tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the end effector is greater than the tensile strength of the ultrasonic transmission element.

[0004] In at least some embodiments, the ultrasonic vibration component further includes: a connecting portion connected to the proximal end of the ultrasonic transmission element; the connecting portion is configured to vibrate under the excitation of the ultrasonic wave and transmit the vibration to the ultrasonic transmission element; the connecting portion includes a third alloy material, the tensile strength of the third alloy material is greater than the tensile strength of the second alloy material so that the tensile strength of the connecting portion is greater than the tensile strength of the ultrasonic transmission element, and the third alloy material is the same as or different from the first alloy material.

[0005] In at least some embodiments, the connecting portion includes a first connecting end and a second connecting end along its extension direction, the first connecting end is connected to the proximal end of the ultrasonic transmission element, and the second connecting end is far away from the ultrasonic transmission element; the ultrasonic transmission element has a plurality of vibration nodes distributed along its extension direction, the plurality of vibration nodes also include a nearest vibration node closest to the proximal end of the ultrasonic transmission element, and the distance between the first connecting end of the connecting portion and the nearest vibration node is less than or equal to 1 / 2 of the distance between two adjacent vibration nodes.

[0006] In at least some embodiments, the first connection end is located at a proximal vibration node of the ultrasonic transmission element.

[0007] In at least some embodiments, the end effector is configured to be detachably connected to the distal end of the ultrasonic transmission element; and / or the connection portion is configured to be detachably connected to the proximal end of the ultrasonic transmission element.

[0008] In at least some embodiments, the detachable connection includes a threaded connection or a snap connection.

[0009] In at least some embodiments, the specific strength of the first alloy material is greater than the specific strength of the second alloy material; and / or the specific strength of the third alloy material is greater than the specific strength of the second alloy material.

[0010] In at least some embodiments, the first alloy material and the third alloy material are the same and are both first titanium alloy materials; the second alloy material is a second titanium alloy material; and the tensile strength of the first titanium alloy material is 1.1 to 2.5 times that of the first titanium alloy material.

[0011] In at least some embodiments, the first titanium alloy material is at least one of TB6 titanium alloy and TC18 titanium alloy, and the second titanium alloy material is TC4 titanium alloy.

[0012] In at least some embodiments, the end effector is made of the first alloy material, the ultrasonic transmission element is made of the second alloy material, and the connecting portion is made of the third alloy material.

[0013] A second aspect of the present disclosure provides an ultrasonic surgical device, comprising the ultrasonic vibration component described above.

[0014] In at least some embodiments, the ultrasonic surgical device further includes: an ultrasonic generator connected to the ultrasonic vibration component and configured to generate the ultrasonic wave that causes the ultrasonic vibration component to vibrate; a transmission component sleeved on the ultrasonic transmission component, the transmission component including a first end and a second end opposite to each other along its extension direction, the first end being close to the distal end of the ultrasonic transmission component, and the second end being close to the proximal end of the ultrasonic transmission component; and an end effector, the end effector including the end effector and a closure member, the closure member being pivotally connected to the first end of the transmission component. The transmission component is configured to be movable along the extension direction of the ultrasonic transmission component to drive the closure member to pivot relative to the end effector. The closure member has an open position and a closed position, and the end effector has an open state and a clamped state. The closure member, the end effector, and the end effector are configured such that when the closure member is in the open position, at least a portion of the closure member is spaced apart from the end effector, and the end effector is in the open state; when the closure member is in the closed position, the closure member is adjacent to the end effector, and the end effector is in the clamped state.

[0015] The third aspect of the present disclosure provides a method for manufacturing an ultrasonic vibration component, wherein the ultrasonic vibration component is configured to vibrate under the excitation of ultrasonic waves, and the manufacturing method includes: providing an end effector and an ultrasonic transmission element, wherein the ultrasonic transmission element includes a proximal end and a distal end opposite to each other along its extension direction; and connecting the end effector to the distal end of the ultrasonic transmission element. In the manufacturing method, the ultrasonic transmission element is configured to transmit the vibration from the proximal end to the distal end to vibrate the end effector; the end effector includes a first alloy material, and the ultrasonic transmission element includes a second alloy material, and the tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the end effector is greater than the tensile strength of the ultrasonic transmission element.

[0016] In at least some embodiments, the manufacturing method further includes: providing a connection portion; and connecting the connection portion to the proximal end of the ultrasonic transmission element, wherein the connection portion is configured to vibrate under the excitation of the ultrasonic wave and transmit the vibration to the ultrasonic transmission element. In the manufacturing method, the connection portion includes a third alloy material, the tensile strength of the third alloy material is greater than the tensile strength of the second alloy material so that the tensile strength of the connection portion is greater than the tensile strength of the ultrasonic transmission element, and the third alloy material is the same as or different from the first alloy material.

[0017] In at least some embodiments, the end effector is configured to be detachably connected to the distal end of the ultrasonic transmission element; and / or the connection portion is configured to be detachably connected to the proximal end of the ultrasonic transmission element.

[0018] In at least some embodiments, the detachable connection includes a threaded connection or a snap connection. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present disclosure, but are not intended to limit the present disclosure.

[0020] Figure 1 It is a schematic diagram of the structure of an ultrasonic surgical device provided according to an embodiment of the present disclosure;

[0021] Figure 2 A partial exploded view of an ultrasonic surgical device provided according to an embodiment of the present disclosure;

[0022] Figure 3 It is a schematic diagram of the structure of an ultrasonic knife provided according to an embodiment of the present disclosure;

[0023] Figure 4 It is a schematic diagram of the structure of a cutter head provided according to an embodiment of the present disclosure;

[0024] Figure 5 It is a schematic diagram of the structure of the connecting part provided according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0025] In order to make the purpose, technical solution and advantages of the embodiments of the present disclosure clearer, the technical solution of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings of the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0026] Unless otherwise defined, the technical terms or scientific terms used herein shall have the usual meanings understood by persons of ordinary skill in the field to which the present disclosure belongs. The words "first", "second" and similar words used in the patent application specification and claims of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "include" or "comprise" and the like mean that the elements or objects appearing before "include" or "comprise" include the elements or objects listed after "include" or "comprise" and their equivalents, and do not exclude other elements or objects. Words such as "connect" or "connected" and the like are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0027] In the present disclosure, an ultrasonic surgical device includes an ultrasonic generator (e.g., an ultrasonic transducer) for generating ultrasonic vibrations, wherein a piezoelectric element made of a piezoelectric material is provided in the ultrasonic transducer, and when the ultrasonic transducer is powered on, the piezoelectric element converts electrical energy into mechanical energy to generate ultrasonic vibrations. The ultrasonic surgical device also includes an instrument connected to the ultrasonic transducer, the instrument having an end effector mounted at a distal end, the end effector including, for example, an ultrasonic scalpel.

[0028] Ultrasonic scalpels can denature proteins in tissues to form viscous coagulants through high-frequency vibrations (e.g., 55,500 times per second). Pressure is applied to the tissue through the blade surface of the ultrasonic scalpel, causing the blood vessels to collapse and allowing the viscous coagulant to form a hemostatic seal. The operator controls the cutting speed and the degree of coagulation by adjusting the force applied to the tissue by the ultrasonic scalpel, the time of force application, and the deflection angle of the ultrasonic scalpel.

[0029] The vibration of the ultrasonic scalpel head is transmitted through the blade rod connected to the ultrasonic transducer. As the frequency of use of the blade head increases, the blade head of the ultrasonic scalpel may develop cracks or even be at risk of breaking when vibrating. In addition, the connection between the blade rod and the ultrasonic transducer may also be at risk of breaking due to long-term vibration.

[0030] To this end, at least one embodiment of the present disclosure provides an ultrasonic vibration component, which is configured to vibrate under the excitation of ultrasonic waves and includes an ultrasonic transmission element and an end effector. The ultrasonic transmission element includes a proximal end and a distal end opposite to each other along its extension direction, the end effector is connected to the distal end, and the ultrasonic transmission element is configured to transmit vibration from the proximal end to the distal end to vibrate the end effector. The end effector includes a first alloy material, and the ultrasonic transmission element includes a second alloy material, and the tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the end effector is greater than the tensile strength of the ultrasonic transmission element.

[0031] In the ultrasonic vibration component provided in at least one embodiment of the present disclosure, by making the tensile strength of the end actuator greater than the tensile strength of the ultrasonic transmission component, cracks or breakage of the end actuator during vibration can be avoided, thereby improving the service life and safety of the ultrasonic vibration component.

[0032] At least one embodiment of the present disclosure further provides an ultrasonic surgical device, including the aforementioned ultrasonic vibration component. Since the service life and safety of the ultrasonic vibration component are improved, the stability of the ultrasonic surgical device during use is further guaranteed, and surgical risks are avoided.

[0033] In the embodiments of the present disclosure, the “proximal end” refers to the side close to the operator who uses the ultrasonic vibration component or the ultrasonic surgical device, and the “distal end” refers to the side away from the operator.

[0034] The present disclosure is described below by specific embodiments. In order to keep the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and known components may be omitted. When any component of the embodiments of the present disclosure appears in more than one figure, the component may be represented by the same reference numeral in each figure.

[0035] Figure 1 It is a schematic diagram of the structure of an ultrasonic surgical device provided according to an embodiment of the present disclosure. Figure 2 It is a partial exploded view of an ultrasonic surgical device provided according to an embodiment of the present disclosure.

[0036] like Figure 1 and Figure 2As shown, the ultrasonic surgical device 100 provided by at least one embodiment of the present disclosure includes an ultrasonic knife 1 (i.e., an ultrasonic vibration component), an ultrasonic transducer 2 (i.e., an ultrasonic generator), a sleeve transmission component 3 (i.e., a transmission component) and an end actuator 4.

[0037] For example, a piezoelectric element (not shown) is provided in the ultrasonic transducer 2. When powered, the piezoelectric element is excited by the electric energy and vibrates to generate mechanical waves, such as longitudinal waves. Figure 1 As shown, the ultrasonic transducer 2 is connected to the ultrasonic scalpel 1, so that mechanical waves can be transmitted to the ultrasonic scalpel 1, so that the ultrasonic scalpel 1 vibrates under the excitation of ultrasound.

[0038] For example, the ultrasonic transducer 2 is disposed in a housing 5, and the housing 5 has a shape that can be conveniently held by an operator. The housing 5 has, for example, a hand-held portion to facilitate holding by the operator.

[0039] The housing 5 is also configured to isolate the operator from the vibration of the piezoelectric element contained in the transducer 50. For example, a separate accommodation space is provided in the housing 5 to facilitate the ultrasonic transducer 2 to be located in the accommodation space. In addition, the housing 5 can be integral or composed of a plurality of housing parts. In order to facilitate disassembly and assembly during maintenance, the housing 5 is preferably formed by combining a plurality of housing parts.

[0040] Figure 3 It is a schematic diagram of the structure of an ultrasonic knife provided according to an embodiment of the present disclosure.

[0041] For example, Figure 2 and Figure 3 As shown, the ultrasonic knife 1 includes a knife rod 10 (ie, an ultrasonic transmission element) and a knife head 20 (ie, an end effector).

[0042] The knife bar 10 includes a proximal end 101 and a distal end 102 opposite to each other along its extension direction (e.g., direction D shown in the figure). For example, the proximal end 101 is inserted into the housing 5 to be connected to the ultrasonic transducer 2, and the distal end 102 is connected to the knife head 20. The knife bar 10 can transmit the mechanical vibration generated by the ultrasonic transducer 2 from the proximal end 101 to the distal end 102 to vibrate the knife head 20.

[0043] For example, the cutter head 20 includes a first alloy material, the cutter bar 10 includes a second alloy material, and the tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the cutter head 20 is greater than the tensile strength of the cutter bar 10. Tensile strength refers to the maximum stress value that a material can withstand before breaking, which reflects the fracture resistance of the material. In the disclosed embodiment, when the tensile strength of the cutter head 20 is greater than the tensile strength of the cutter bar 10, the fatigue resistance of the cutter head 20 can be improved, thereby preventing the cutter head 20 from cracking or breaking during vibration, thereby improving the safety and stability of the operation.

[0044] In one example, the tensile strength of the first alloy material is 1.1 to 2.5 times that of the second alloy material. For example, the tensile strength of the second alloy material is 800 to 1000 MPa, and the tensile strength of the first alloy material is 880 to 2500 MPa.

[0045] For example, the specific strength of the first alloy material is greater than the specific strength of the second alloy material. Specific strength is the ratio of the tensile strength of a material to its apparent density. The higher the specific strength, the lighter the material used to achieve the corresponding strength. High-quality structural materials should have a high specific strength so that they can meet the strength requirements with a smaller cross-section as much as possible, while significantly reducing the weight of the structure itself.

[0046] For example, the cutter head 20 only includes the first alloy material, that is, the cutter head 20 is made of the first alloy material. The shank 10 only includes the second alloy material, that is, the shank 10 is made of the second alloy material. In this way, the production of the cutter head 20 or the shank 10 can be facilitated and the manufacturing process can be simplified.

[0047] In one example, the cutter head 20 is made of a titanium alloy material, and the cutter bar 10 is made of an aluminum alloy material. The density of titanium alloy is generally around 4.51 g / cm3, and its specific strength (strength / density) is much greater than that of aluminum alloy material, and it can be used to produce parts with high unit strength, good rigidity, and light weight. In the range of 150°C to 500°C, titanium alloy still has a very high specific strength, while the specific strength of aluminum alloy decreases significantly at 150°C. The operating temperature of titanium alloy can reach 500°C, while that of aluminum alloy is below 200°C. Therefore, titanium alloy has the advantages of high strength, low density, high thermal strength, and corrosion resistance. In addition, titanium alloy has excellent corrosion resistance to human body fluids, is non-toxic, and has good affinity with muscle tissue, making it suitable for use as a cutter head material.

[0048] In another example, the cutter head 20 is made of a first titanium alloy material, the cutter bar 10 is made of a second titanium alloy material, and the tensile strength of the first titanium alloy material is 1.1 to 2.5 times the tensile strength of the second titanium alloy material; preferably 1.1 to 1.5 times. For example, the tensile strength of the first titanium alloy material is 880 to 1500 MPa, and the tensile strength of the second titanium alloy material is 800 to 1000 MPa.

[0049] For example, the first titanium alloy material is at least one of TB6 titanium alloy and TC18 titanium alloy, and the second titanium alloy material is TC4 titanium alloy.

[0050] The nominal chemical composition of TC4 titanium alloy is Ti-6Al-4V, and its main components are aluminum and vanadium. In TC4 titanium alloy, the mass percentage of aluminum is 5.5-6.8%, the mass percentage of vanadium is about 3.5-4.5%, and the balance is Ti. TC4 titanium alloy has good toughness, plasticity and high temperature deformation properties, can be well processed by hot pressure, and can be quenched to strengthen the alloy. The strength after heat treatment is about 50%-100% higher than that of the annealed state; it has high high temperature strength and can work for a long time at a temperature of 400C°-500C°. Compared with aluminum alloy or magnesium alloy, it is more suitable as a tool bar material.

[0051] The nominal composition of TB6 titanium alloy is Ti-10V-2Fe-3Al, and its main components are vanadium, aluminum and iron. In TB6 titanium alloy, the mass percentage of vanadium is about 10%, the mass percentage of aluminum is about 3%, the mass percentage of iron is about 2%, and the balance is Ti. The room temperature elastic modulus of TB6 titanium alloy is 104GPa, and the β phase transition temperature is 800C°±15C°, which is about 200C° lower than that of TC4 titanium alloy, providing a lower metal hot working temperature, so that this alloy can be forged at a lower temperature than TC4 titanium alloy when forged with normal pressure, which greatly reduces the die life and cost. The flow stress of TB6 titanium alloy forged near the phase transition point is equivalent to the flow stress of TC4 titanium alloy forged at 935C°, so the requirements for die materials during isothermal deformation are lower than those of TC4 titanium alloy, which is very suitable for hot die forging or isothermal forging, and is suitable for the production of forgings, bars, plates, etc. The forging precision provided by hot die forging or isothermal forging is higher than that of conventional die forging, which not only avoids the waste of manufacturing materials, but also reduces the processing amount, thereby reducing the cost of forgings. Compared with the 800Mpa tensile strength of TC4 titanium alloy, the tensile strength of TB6 titanium alloy can reach 1000-1310Mpa, thereby improving the fatigue resistance of the cutter head 20 and avoiding cracks or fractures in the cutter head.

[0052] The nominal composition of TC18 titanium alloy is Ti-5Al-5Mo-5V-1Cr-1Fe, and its main components are aluminum, molybdenum, vanadium, chromium and iron. In TB6 titanium alloy, the mass percentage of aluminum is 4.4-5.7%, the mass percentage of molybdenum is 4.0-5.5%, the mass percentage of vanadium is 4.0-5.5%, the mass percentage of chromium is 0.5-1.5%, the mass percentage of iron is 0.5-1.5%, and the balance is Ti. TC18 has approximately equal amounts of α phase and β phase in the annealed state, and is the titanium alloy with the highest strength in the annealed state. The tensile strength of TC18 can reach 1270-1480Mpa, which is significantly better than the tensile strength of TC4 titanium alloy. In addition, replacing TC4 titanium alloy with TC18 titanium alloy can reduce weight by 15%-20%, and TC18 is suitable for use as a tool head material.

[0053] In the embodiment of the present disclosure, the cutter head 20 can be made of TB6 titanium alloy, or TC18 titanium alloy, or both, which can improve the tensile strength of the cutter head 20. When the cutter head 20 is made of TB6 titanium alloy and TC18 titanium alloy, the weight percentages of TB6 titanium alloy and TC18 titanium alloy can be the same or different, which is not limited in the embodiment of the present disclosure.

[0054] For example, Figure 1 and Figure 2 As shown, the sleeve transmission assembly 3 is sleeved on the knife rod 10 of the ultrasonic knife 1. The extension direction of the sleeve transmission assembly 3 is the same as the extension direction of the knife rod 10, for example, both are the D direction shown in the figure. The sleeve transmission assembly 3 includes a first end 31 and a second end 32 opposite to each other along the D direction, the first end 31 is close to the distal end 102 of the knife rod 10, and the second end 32 is close to the proximal end 101 of the knife rod 10.

[0055] For example, Figure 1 As shown, the end effector 4 includes a cutting head 20 and a closure member 40, the closure member 40 is pivotally connected to the first end 31 of the sleeve transmission assembly 3, and the sleeve transmission assembly 3 is configured to be movable along the D direction to drive the closure member 40 to pivot relative to the cutting head 20. For example, the closure member 40 has an open position and a closed position, and the end effector 4 has an open state and a clamping state. The closure member 40, the cutting head 20 and the end effector 4 are configured as follows: when the closure member 40 is in the open position, at least a portion of the closure member 40 is spaced apart from the cutting head 20, and the end effector 4 is in the open state; when the closure member 40 is in the closed position, the closure member 40 is adjacent to the cutting head 20, and the end effector 4 is in the clamping state to clamp the tissue between the cutting head 20 and the closure member 40.

[0056] For example, the sleeve transmission assembly 3 includes an outer sleeve 311 and an inner sleeve 312, wherein the outer sleeve 311 is sleeved on the knife rod 10 and is fixed relative to the knife rod 10. The inner sleeve 312 is located between the outer sleeve 311 and the knife rod 10 along the radial direction of the knife rod 10 (i.e., the direction passing through the diameter of the knife rod 10), and is used as an actuator, which can move relative to the outer sleeve 311 or the knife rod 10, for example, it can be controlled to reciprocate along the D direction. For example, it can move forward and backward along the D direction, and the forward movement refers to the movement in the direction away from the ultrasonic transducer 2, and the backward movement refers to the movement in the direction close to the ultrasonic transducer 2.

[0057] For example, Figure 2 As shown, the closing member 40 includes a clamp arm 401 and a tissue pad 402 disposed on the side of the clamp arm 401 facing the cutter head 20. The clamp arm 401 and the tissue pad 402 are connected together to the outer sleeve 311 and the distal end of the inner sleeve 312, so that when the inner sleeve 312 moves forward and backward along the D direction, the clamp arm 401 is driven to rotate relative to the cutter head 20. For example, when the inner sleeve 312 moves in the D direction in a direction away from the ultrasonic transducer 2, the clamp arm 401 and the tissue pad 402 can be driven to open and separate from the cutter head 20, so that the end effector 4 is in an open state. When the inner sleeve 312 moves in the D direction in a direction close to the ultrasonic transducer 2, the clamp arm 401 and the tissue pad 402 can be driven to close in a direction close to the cutter head 20, generating the required tissue clamping force, so that the end effector 4 is in a clamping state.

[0058] In the embodiments of the present disclosure, only the sleeve transmission assembly is used as an example to describe the transmission assembly. It is understandable that in other embodiments, other transmission assemblies can also be used to drive the end actuator to perform actions, and the embodiments of the present disclosure do not limit this.

[0059] In the disclosed embodiment, the tissue pad 402 is arranged to be parallel to the plane of the cutter head 20. When the end effector 4 is in a clamping state, the tissue is clamped between the cutter head 20 and the tissue pad 402, so that the tissue pad 402 can increase the friction force to prevent the tissue from slipping off. For example, the surface of the tissue pad 402 can be smooth or have anti-slip features, such as a serrated structure. When the end effector 4 is in a closed state, since the tissue pad 402 is arranged between the clamp arm 401 and the cutter head 20, even if the cutter head 20 vibrates due to misoperation, the presence of the tissue pad 402 can prevent the clamp arm 401 from directly contacting the cutter head 20, thereby improving the wear resistance of the clamp arm 401.

[0060] In the embodiment of the present disclosure, the tissue pad 402 and the clamp arm 401 may be made of suitable materials known in the art, for example, the tissue pad 402 includes a polymer material, and the clamp arm 401 includes a metal, such as stainless steel or titanium.

[0061] Figure 4It is a schematic diagram of the structure of a cutter head provided according to an embodiment of the present disclosure.

[0062] For example, Figure 3 and Figure 4 As shown, the cutter head 20 includes a front end 201 and a rear end 202 along the D direction, the front end 201 is far away from the cutter rod 10 , and the rear end 202 is connected to the distal end 102 of the cutter rod 10 .

[0063] For example, the ultrasonic vibration generated by the ultrasonic transducer 2 is a longitudinal wave that vibrates along the proximal end 101 of the knife rod 10 toward the distal end 102 (in the embodiment, the length direction of the knife rod 10). A longitudinal wave is a wave in which the vibration direction of the particle is coaxial with the propagation direction (or parallel). A longitudinal wave is a type of wave (waves are divided into transverse waves and longitudinal waves), also known as a "sparse and dense wave". The propagation process of a longitudinal wave is that different dense and sparse parts appear along the direction of the wave. Figure 3 As shown, the tool bar 10 has a plurality of vibration nodes P distributed along the D direction, such as vibration nodes P1, P2, P3, ..., Pt-1, Pt, where t is a positive integer greater than or equal to 2. When the ultrasonic wave propagates on the tool bar 10, the vibration node of the tool bar 10 corresponds to the center between the sparse part and the dense part of the ultrasonic wave. That is, at the vibration node, the amplitude of the tool bar 10 is the smallest.

[0064] For example, Figure 3 As shown, the multiple vibration nodes P include the farthest vibration node P1 (ie, the farthest distance from the proximal end 101 of the knife rod 10) and the closest vibration node Pt (ie, the closest distance from the proximal end 101 of the knife rod 10).

[0065] For example, Figure 3 As shown, the ultrasonic knife 1 further includes a connecting portion 30, which is connected to the proximal end 101 of the knife rod 10. The connecting portion 30 is configured to vibrate under the excitation of ultrasonic waves and transmit the vibration to the knife rod 10.

[0066] When the ultrasonic surgical device 100 is in operation, the blade head 20 itself generates heat and there is friction between the blade head 20 and the tissue. The working environment is relatively harsh, so it is more likely to crack or break. The connecting portion 30 connects the blade rod 10 to the ultrasonic transducer 2. The heat generated during operation is low and there is almost no friction. Compared with the blade head 20, it is not easy to break. Even so, after repeated and long-term use, since the connecting portion 30 also vibrates, there is a potential risk of breakage when the fatigue limit of the material is exceeded.

[0067] Therefore, in order to avoid the above risks, in the present embodiment, the connection part 30 includes a third alloy material, and the tensile strength of the third alloy material is greater than the tensile strength of the second alloy material so that the tensile strength of the connection part 30 is greater than the tensile strength of the shank 10. By making the tensile strength of the connection part 30 greater than the tensile strength of the shank 10, the fatigue resistance of the connection part 30 can be improved, thereby preventing the connection part 30 from cracking or breaking during vibration, thereby improving the safety and stability of the operation.

[0068] In the disclosed embodiment, the third alloy material and the first alloy material may be the same or different. When the two are the same, the types of materials can be saved and the design difficulty can be reduced. For example, the third alloy material can be the first alloy material described above. In one example, the tensile strength of the third alloy material is 1.1 to 2.5 times the tensile strength of the second alloy material. For example, the tensile strength of the third alloy material is 800 to 1000 MPa, and the tensile strength of the first alloy material is 880 to 2500 MPa.

[0069] For another example, the specific strength of the third alloy material is greater than the specific strength of the second alloy material. For the definition and effect of the specific strength, please refer to the previous description and will not be repeated here.

[0070] For example, the connecting portion 30 only includes the third alloy material, that is, the connecting portion 30 is made of the third alloy material. The shank 10 only includes the second alloy material, that is, the shank 10 is made of the second alloy material. In this way, the manufacturing of the connecting portion 30 or the shank 10 can be facilitated, and the manufacturing process can be simplified.

[0071] In one example, the connecting portion 30 is made of a titanium alloy material, and the shank 10 is made of an aluminum alloy material. The technical effects of the titanium alloy material can be referred to the previous description, which will not be repeated here.

[0072] In another example, the connecting portion 30 is made of a first titanium alloy material, the shank 10 is made of a second titanium alloy material, and the tensile strength of the first titanium alloy material is 1.1 to 2.5 times the tensile strength of the first titanium alloy material; preferably 1.1 to 1.5 times. For example, the tensile strength of the first titanium alloy material is 880 to 1500 MPa, and the tensile strength of the second titanium alloy material is 800 to 1000 MPa. Further, for example, the first titanium alloy material is at least one of TB6 titanium alloy and TC18 titanium alloy, and the second titanium alloy material is TC4 titanium alloy. The main components and effects of these three alloys can be referred to the previous description, which will not be repeated here.

[0073] For example, the first titanium alloy material is at least one of TB6 titanium alloy and TC18 titanium alloy, and the second titanium alloy material is TC4 titanium alloy. In the embodiment of the present disclosure, the connecting portion 30 can be made of TB6 titanium alloy, or TC18 titanium alloy, or both, and the tensile strength of the connecting portion 30 can be improved. When the connecting portion 30 is made of TB6 titanium alloy and TC18 titanium alloy, the weight percentages of TB6 titanium alloy and TC18 titanium alloy can be the same or different, and the embodiment of the present disclosure does not limit this.

[0074] Figure 5 It is a schematic diagram of the structure of the connecting part provided according to an embodiment of the present disclosure.

[0075] For example, the extension direction of the connection portion 30 is the same as the extension direction of the knife bar 10, both of which are shown in the D direction. The connection portion 30 includes a first connection end 301 and a second connection end 302 along the D direction. The first connection end 301 is connected to the proximal end 101 of the knife bar 10, and the second connection end 302 is far away from the knife bar 10.

[0076] like Figure 5 As shown, the first connecting end 301 is located at the nearest vibration node Pt of the tool rod 10, thereby reducing the amplitude of the connection between the connecting part 30 and the tool rod 10, improving the stability of the connection, and avoiding the connection part and the tool rod from breaking at the connection.

[0077] In the embodiment of the present disclosure, the position of the first connection end 301 is only schematic. In other embodiments, the first connection end 301 may also be arranged near the nearest vibration node Pt, for example, the distance between the first connection end 301 and the nearest vibration node P2 is less than or equal to 1 / 2 of the distance between two adjacent vibration nodes P, which can also improve the stability of the connection between the connecting part and the knife rod.

[0078] In the embodiment of the present disclosure, the cutter head 20 is configured to be detachably connected to the distal end 102 of the cutter bar 10; and / or the connecting portion 30 is configured to be detachably connected to the proximal end 101 of the cutter bar 10, which not only facilitates the disassembly and assembly of the cutter head 20 and the connecting portion 30, but also facilitates subsequent maintenance or replacement. For example, the detachable connection includes a threaded connection or a clamping connection, and the embodiment of the present disclosure does not limit the specific connection method.

[0079] At least one embodiment of the present disclosure also provides a method for manufacturing an ultrasonic vibration component ultrasonic knife. Figures 1 to 5 The present disclosure provides a method for manufacturing an ultrasonic knife 1, wherein the ultrasonic knife 1 is configured to vibrate under the excitation of ultrasonic waves, and the manufacturing method includes:

[0080] S1: providing a cutter head 20 and a cutter rod 10, wherein the cutter rod 10 includes a proximal end 101 and a distal end 102 opposite to each other along a D direction;

[0081] S2: Connect the cutter head 20 to the distal end 102 of the cutter rod 10, wherein the cutter rod 10 is configured to transmit vibration from the proximal end 101 to the distal end 102 to cause the cutter head 20 to vibrate; the cutter head 20 includes a first alloy material, the cutter rod 10 includes a second alloy material, and the tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the cutter head 20 is greater than the tensile strength of the cutter rod 10.

[0082] In the manufacturing method of the ultrasonic vibration component provided in at least one embodiment of the present disclosure, by making the tensile strength of the blade head 20 greater than the tensile strength of the blade rod 10, cracks or breakage of the blade head 20 during vibration can be avoided, thereby improving the service life and safety of the ultrasonic blade 1.

[0083] For example, the above manufacturing method further includes:

[0084] S3: Providing a connecting portion 30;

[0085] S4: Connect the connecting portion 30 to the proximal end 101 of the knife rod 10, and the connecting portion 30 is configured to vibrate under the excitation of the ultrasonic wave and transmit the vibration to the knife rod 10. For example, the connecting portion 30 includes a third alloy material, the tensile strength of the third alloy material is greater than the tensile strength of the second alloy material so that the tensile strength of the connecting portion 30 is greater than the tensile strength of the knife rod 10, and the third alloy material is the same as or different from the first alloy material.

[0086] In this embodiment, by making the tensile strength of the connecting part 30 greater than the tensile strength of the shank 10, the fatigue resistance of the connecting part 30 can be improved, thereby avoiding cracks or breakages in the connecting part 30 during vibration, thereby improving the safety and stability of the ultrasonic vibration component during operation.

[0087] In the ultrasonic vibration component and its manufacturing method and ultrasonic surgical device provided in the embodiment of the present disclosure, by making the end effector include a first alloy material, the ultrasonic transmission element include a second alloy material, and the tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the end effector is greater than the tensile strength of the ultrasonic transmission element, it is possible to avoid cracks or fractures in the end effector during vibration, thereby improving the service life and safety of the ultrasonic vibration component. Further, optionally, by making the connection part include a third alloy material and the tensile strength of the third alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the connection part is greater than the tensile strength of the shank 10, it is possible to improve the fatigue resistance of the connection part, thereby avoiding cracks or fractures in the connection part during vibration, thereby improving the safety and stability of the ultrasonic vibration component and the ultrasonic surgical device.

[0088] In this article, there are a few points to note:

[0089] (1) The drawings of the embodiments of the present disclosure only relate to the structures related to the embodiments of the present disclosure, and other structures may refer to the general design.

[0090] (2) In the absence of conflict, the embodiments of the present disclosure and the features therein may be combined with each other to obtain new embodiments.

[0091] (3) The above description is merely an exemplary embodiment of the present disclosure and is not intended to limit the scope of protection of the present disclosure. The scope of protection of the present disclosure is determined by the appended claims.

[0092] The above are only specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present disclosure, which should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims

1. An ultrasonic vibration component, the ultrasonic vibration component is configured to vibrate under the excitation of ultrasonic waves and comprises an ultrasonic transmission member and an end effector, wherein: The ultrasonic transmission element includes a proximal end and a distal end opposite to each other along its extension direction, the end effector is connected to the distal end, and the ultrasonic transmission element is configured to transmit the vibration from the proximal end to the distal end to make the end effector vibrate. The end effector is made of a first alloy material, and the ultrasonic transmission element is made of a second alloy material. The tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the end effector is greater than the tensile strength of the ultrasonic transmission element. The specific strength of the first alloy material is greater than the specific strength of the second alloy material; Wherein, the ultrasonic vibration component also includes: A connecting portion connected to the proximal end of the ultrasonic transmission element and used to connect the ultrasonic transmission element to an ultrasonic transducer; wherein: The connecting portion is configured to vibrate under the excitation of the ultrasonic wave and transmit the vibration to the ultrasonic wave transmission member; The connecting portion is made of a third alloy material, the tensile strength of the third alloy material is greater than the tensile strength of the second alloy material so that the tensile strength of the connecting portion is greater than the tensile strength of the ultrasonic transmission element, and the specific strength of the third alloy material is greater than the specific strength of the second alloy material.

2. The ultrasonic vibration assembly according to claim 1, wherein: The third alloy material is the same as or different from the first alloy material.

3. The ultrasonic vibration assembly according to claim 2, wherein the connecting portion includes a first connecting end and a second connecting end along its extension direction, the first connecting end is connected to the proximal end of the ultrasonic transmission element, and the second connecting end is far away from the ultrasonic transmission element; The ultrasonic transmission element has a plurality of vibration nodes distributed along its extension direction, and the plurality of vibration nodes also include a nearest vibration node that is closest to the proximal end of the ultrasonic transmission element, and the distance between the first connection end of the connection part and the nearest vibration node is less than or equal to 1 / 2 of the distance between two adjacent vibration nodes.

4. The ultrasonic vibration assembly according to claim 3, wherein the first connection end is located at the most proximal vibration node of the ultrasonic transmission element.

5. The ultrasonic vibration assembly according to claim 2, wherein: The end effector is configured to be detachably connected to the distal end of the ultrasonic transmission element; and / or The connecting portion is configured to be detachably connected to the proximal end of the ultrasonic transmission element. The ultrasonic vibration assembly according to claim 5 , wherein the detachable connection comprises a threaded connection or a snap connection.

7. The ultrasonic vibration assembly according to claim 2, wherein: The first alloy material and the third alloy material are the same and are both first titanium alloy materials; The second alloy material is a second titanium alloy material; The tensile strength of the first titanium alloy material is 1.1 to 2.5 times the tensile strength of the first titanium alloy material.

8. The ultrasonic vibration assembly according to claim 7, wherein: The first titanium alloy material is at least one of TB6 titanium alloy and TC18 titanium alloy, and the second titanium alloy material is TC4 titanium alloy.

9. An ultrasonic surgical device, comprising the ultrasonic vibration assembly according to any one of claims 1 to 8.

10. The ultrasonic surgical device according to claim 9, further comprising: an ultrasonic generator connected to the ultrasonic vibration component and configured to generate the ultrasonic wave that causes the ultrasonic vibration component to vibrate; A transmission assembly, sleeved on the ultrasonic transmission member, the transmission assembly comprising a first end and a second end opposite to each other along an extension direction thereof, the first end being close to a distal end of the ultrasonic transmission member, and the second end being close to a proximal end of the ultrasonic transmission member; as well as an end effector, the end effector comprising the end effector and a closure member, the closure member being pivotally connected to the first end of the transmission assembly; The transmission assembly is configured to move along the extension direction of the ultrasonic transmission member to drive the closing member to pivot relative to the end effector; wherein the closure member has an open position and a closed position, and the end effector has an open state and a clamped state; The closure member, the end effector and the end effector are configured as follows: When the closure member is in the open position, at least a portion of the closure member is spaced apart from the end effector, and the end effector is in the open state; When the closing member is in the closed position, the closing member is adjacent to the end effector, and the end effector is in the clamping state.

11. A method for manufacturing an ultrasonic vibration component, wherein the ultrasonic vibration component is configured to vibrate under the excitation of ultrasonic waves, the manufacturing method comprising: Providing an end effector and an ultrasonic transmission element, wherein the ultrasonic transmission element includes a proximal end and a distal end opposite to each other along its extension direction; as well as connecting the end effector to a distal end of the ultrasonic transmission member, wherein the ultrasonic transmission member is configured to transmit the vibration from the proximal end to the distal end to cause the end effector to vibrate; The end effector is made of a first alloy material, and the ultrasonic transmission element is made of a second alloy material. The tensile strength of the first alloy material is greater than the tensile strength of the second alloy material, so that the tensile strength of the end effector is greater than the tensile strength of the ultrasonic transmission element. wherein the specific strength of the first alloy material is greater than the specific strength of the second alloy material; Wherein, the manufacturing method further comprises: providing a connection portion; and Connecting the connection part to the proximal end of the ultrasonic transmission element, the connection part is used to connect the ultrasonic transmission element to an ultrasonic transducer and is configured to vibrate under the excitation of the ultrasonic wave and transmit the vibration to the ultrasonic transmission element; Wherein, the connecting part is made of a third alloy material, the tensile strength of the third alloy material is greater than the tensile strength of the second alloy material so that the tensile strength of the connecting part is greater than the tensile strength of the ultrasonic transmission element, and the specific strength of the third alloy material is greater than the specific strength of the second alloy material.

12. The method for manufacturing an ultrasonic vibration component according to claim 11, in, The third alloy material is the same as or different from the first alloy material.

13. The method for manufacturing an ultrasonic vibration component according to claim 12, wherein: The end effector is configured to be detachably connected to the distal end of the ultrasonic transmission element; and / or The connecting portion is configured to be detachably connected to the proximal end of the ultrasonic transmission element. 14 . The method for manufacturing an ultrasonic vibration component according to claim 13 , wherein the detachable connection comprises a threaded connection or a snap connection.

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