Method and device for driving ultrasonic surgical instruments, and ultrasonic surgical system

Abstract

This invention provides a method for driving the transducer of an ultrasonic surgical instrument. [Solution] The method includes: supplying a drive signal having a first amplitude range for a first period in response to a start signal to drive a transducer of an ultrasonic surgical instrument; supplying a first transition signal having an amplitude decreasing at a first predetermined interval after the first period; supplying a drive signal having a second amplitude range for a second period after a first predetermined interval, wherein the upper limit of the second amplitude range is lower than the lower limit of the first amplitude range; supplying a second transition signal having an amplitude increasing at a second predetermined interval after the second period; and supplying a drive signal having a third amplitude range for a third period after a second predetermined interval, wherein the lower limit of the third amplitude range is higher than the upper limit of the second amplitude range.

Description

[Technical Field]

[0001] This application claims priority to Chinese Patent Application No. 202210130249.9, filed on 11 February 2022. The entire disclosure of the aforementioned patent application is incorporated herein by reference.

[0002] This application relates to the field of surgical instruments, and more specifically to methods and devices for driving ultrasonic surgical instruments, as well as ultrasonic surgical systems. [Background technology]

[0003] Ultrasonic surgical instruments, also called ultrasonic soft tissue cutting and / or coagulation systems, primarily use ultrasonic energy to facilitate soft tissue cutting and coagulation, thereby stopping bleeding, minimizing thermal damage, and are suitable for cutting human soft tissues except bone and fallopian tubes. Ultrasonic surgical instruments and ultrasonic generators are the main components of an ultrasonic surgical system. Ultrasonic surgical instruments include transducers and effectors. The effector comprises a blade and jaw assembly, and the effector is connected to the transducer through a transmission medium. When in operation, the generator outputs a drive signal to the transducer according to a specific frequency and amplitude, and the transducer converts the drive signal into mechanical vibrations. The mechanical vibrations are transmitted and amplified by the transmission medium and then transmitted to the blade of the effector, thereby causing the blade to vibrate at an ultrasonic frequency. The surgeon can operate on the tissue portion by collaboratively manipulating the blade and jaw assembly to form a suitable pressure, or by directly applying the blade to the tissue portion.

[0004] Due to their advantages in hemostasis and burns, ultrasonic surgical instruments are often used to seal blood vessels. The process of sealing blood vessels involves three stages: separating the muscular tissue layer of the vessel, sealing and coagulating the vessel, and cutting the vessel. Since the amplitude and frequency of the drive signal output from the generator are different at each stage, the vibration amplitude and frequency of the blade also change. Combined with the hand force applied by the surgeon, the force acting between the blade and jaw assembly changes, which satisfies the requirement of applying force to the blood vessel at different stages. According to the three stages of sealing blood vessels, the drive signal output by the generator of existing solutions is a step signal. The amplitude of the signal jumps instantaneously from a high point to a low point when moving from the first stage to the second stage, and the amplitude of the signal jumps instantaneously from a low point to a high point when moving from the second stage to the third stage. This can cause a rapid change in the ultrasonic vibration energy of the blade, affecting not only the stability of the force applied by the surgeon and the operational precision in the process of sealing blood vessels, but also the tearing force acting on the tissue, potentially damaging the blade. [Overview of the project] [Means for solving the problem]

[0005] This application provides a method and device for driving ultrasonic surgical instruments, as well as an ultrasonic surgical system. This method is Steps include supplying a drive signal having a first amplitude range for a first period to drive the transducer of an ultrasonic surgical instrument in response to a start signal, The steps include supplying a first transition signal having an amplitude that decreases at a first predetermined interval to drive a transducer after a first period, Steps include: supplying a drive signal having a second amplitude range for a second period to drive a transducer after a first predetermined interval, wherein the upper limit of the second amplitude range is lower than the lower limit of the first amplitude range; The steps include supplying a second transition signal having an amplitude that increases at a second predetermined interval to drive a transducer after a second period, The steps include: supplying a drive signal having a third amplitude range for a third period to drive a transducer after a second predetermined interval, wherein the lower limit of the third amplitude range is higher than the upper limit of the second amplitude range; At least one of the first predetermined interval and the second predetermined interval is greater than zero (i.e., greater than zero).

[0006] In addition, this application provides a generator for driving an ultrasonic surgical instrument. The generator comprises a processor chip, which is preloaded with program information, and when the generator responds to a start signal, the processor chip executes the program information to perform the method for driving an ultrasonic surgical instrument according to the above solution, thereby the generator outputs a drive signal to the ultrasonic surgical instrument.

[0007] Furthermore, in this application, an ultrasonic surgical system is provided, comprising an ultrasonic surgical instrument and generator according to the above solution method. Ultrasonic surgical instruments consist of a transducer and a surgical assembly. The transducer receives the drive signal output by the generator and converts the drive signal into an ultrasonic vibration signal. The surgical assembly comprises a waveguide and an end-effector assembly positioned at the distal end of the waveguide and used for surgically treating tissue. The ultrasonic vibration signal is transmitted from the waveguide to the end effector assembly, and the ultrasonic energy generated by the end effector assembly acts on the tissue being operated on.

[0008] This specification concludes with claims that particularly point out and distinctly claim the disclosure, but the disclosure is believed to be well understood from the detailed description of its specific embodiments when read in conjunction with the accompanying drawings. Similar numbers are used within the drawings to identify similar elements, unless the context indicates otherwise. Additionally, some of the figures may be simplified by omitting certain elements to more clearly show other elements. Even if so omitted, unless explicitly stated in the corresponding detailed description, it does not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments.

Brief Description of the Drawings

[0009] [Figure 1] It is a schematic diagram of the integrated structure of an ultrasonic surgical instrument according to an embodiment of the invention of this application. [Figure 2] It is a schematic structural diagram of a transmission assembly according to an embodiment of this application. [Figure 3] It is a schematic diagram of the generation and transmission process of ultrasonic energy of an ultrasonic surgical instrument according to an embodiment of this application. [Figure 4] It is a flowchart of a method for driving an ultrasonic surgical instrument according to an embodiment of the invention of this application. [Figure 5a] It is a schematic diagram of the waveform of a driving signal according to an embodiment of this application. [Figure 5b] It is a schematic diagram of the waveform of a driving signal according to an embodiment of this application. [Figure 5c] It is a schematic diagram of the waveform of a driving signal according to an embodiment of this application. [Figure 5d] It is a schematic diagram of the waveform of a driving signal according to an embodiment of this application. [Figure 5e] It is a schematic diagram of the waveform of a driving signal according to an embodiment of this application. [Figure 6] It is a diagram showing a curve of the change in blood vessel wall thickness in the process of sealing a blood vessel according to an embodiment of this application. [Figure 7]This is a schematic diagram showing the waveform of the drive signal according to the embodiment of this application. [Figure 8] This flowchart shows the adjustment of a signal in a method for driving an ultrasonic surgical instrument according to one embodiment of the present application. [Figure 9] This is a schematic diagram showing the waveform of a drive signal according to another embodiment of this application. [Figure 10a] This is a structural block diagram of an ultrasonic surgical system according to an embodiment of the disclosure. [Figure 10b] This is a structural block diagram of an ultrasonic surgical system according to an embodiment of the disclosure. [Figure 11] This is an exploded view of a partially closed end effector assembly according to one embodiment of the present application. [Figure 12] Figure 11 is an exploded view of the end effector assembly, shown in a partially opened state. [Figure 13] This is a schematic diagram of a partially closed end effector assembly according to one embodiment of the present application. [Figure 14a] This is a comparative diagram of the deformation of the conventional technology and the ultrasonic surgical instrument of this application when an end effector assembly clamps a blood vessel. [Figure 14b] This is a comparative diagram of the deformation of the conventional technology and the ultrasonic surgical instrument of this application when an end effector assembly clamps a blood vessel. [Figure 15a] This is a comparative diagram of experimental results for sealing blood vessels between the present invention and the prior art. [Figure 15b] This is a comparative diagram of experimental results for sealing blood vessels between the present invention and the prior art. [Figure 15c] This is a comparative diagram of experimental results for sealing blood vessels between the present invention and the prior art. [Modes for carrying out the invention]

[0010] The following detailed description illustrates examples of embodiments of the present disclosure solely for the purpose of enabling those skilled in the art to manufacture and use the present invention. As such, the detailed description and illustrations of these embodiments are purely illustrative and are not intended to limit the scope or protection of the present disclosure in any way. Furthermore, it should be noted that the drawings are not to scale and, in some cases, details not necessary for understanding the present disclosure have been omitted.

[0011] It should be noted that in the description of this application, orientations or positional relationships indicated by “center,” “top,” “bottom,” “left,” “right,” “vertical,” “horizontal,” “inside,” “outside,” and similar terms are orientations or positional relationships based on the accompanying drawings, and are merely for the purpose of facilitating and simplifying the description of this application. They are not intended to indicate or imply that the indicated device or element has a particular orientation, or that it must be manufactured and operated in a particular orientation, and therefore should not be understood as limiting this application. Furthermore, the terms “first,” “second,” and “third” are used for illustrative purposes only and should not be understood as indicating or implying relative importance.

[0012] In the description of this application, unless otherwise specified and limited, “attached,” “related,” “connected,” and similar phrases should be understood in a broad sense, for example, that a connection can be a fixed connection, a detachable or integrated connection, a direct connection, an indirect connection through an intermediate medium, or internal communication between two elements. The specific meaning of the above terms in this application can be understood by those skilled in the art according to certain conditions. In addition, the technical features relating to the different embodiments of this application described below can be combined with each other, insofar as they do not contradict each other.

[0013] In various embodiments of this application, “distal end / side” refers to the end / side of a surgical instrument that is farther from the surgeon when the surgical instrument is being manipulated, and “proximal end / side” refers to the end / side that is closer to the surgeon when the surgical instrument is being manipulated.

[0014] The following embodiments of this application relate generally to an ultrasonic surgical system which may be used to transversely cut tissue, coagulate tissue, and / or clamp tissue during surgery. Figures 1 to 3 show schematic diagrams of a particular embodiment of the ultrasonic surgical system of this application. The ultrasonic surgical system comprises an ultrasonic surgical instrument. The ultrasonic surgical instrument comprises a surgical assembly and a transducer 10. The surgical assembly comprises a handle assembly 20, a transmission assembly 30, and an end effector assembly 40, which are arranged sequentially from the proximal end to the distal end. By inserting the transducer 10 into the handle assembly 20, the proximal end of the surgical assembly is connected to the distal end of the transducer 10 and assembled together with the distal end. The ultrasonic surgical system further comprises a generator 50 configured to supply ultrasonic energy. The transducer 10 is operably connected to the generator 50 via a cable, which converts electrical energy from the generator 50 into ultrasonic vibrations, which are further transmitted to the end effector assembly 20. The handle assembly 20 is designed for the surgeon to operate the surgical instrument. For example, the handle assembly 20 is adapted to actuate the end effector assembly 40 through the transmission assembly 30 to perform cutting and / or coagulation operations. The handle assembly 20 can be grasped by the surgeon in various ways. In one particular embodiment, the surgical assembly of the ultrasonic surgical instrument is configured in a trigger-like arrangement for controlling the opening and closing of the end effector assembly 40.

[0015] The handle assembly 20 comprises a main housing 21 and a handgrip 22 extending downward from the main housing 21. The handle assembly 20, and in particular its handgrip 22, is adapted to be held by a medical professional, thereby facilitating the gripping and manipulation of the instrument while isolating the operator from ultrasonic vibrations during use. A trigger 23 is supported in the handle assembly 20 to pivot toward and toward the handgrip 22 in order to cause the clamp arm assembly 42 located at the distal end of the transmission assembly 30 to pivot. The handle assembly 20 includes a hand switch 24, which is used to control the operation of the instrument by being pushed toward the handgrip 22, for example, allowing the ultrasonic generator to output and vibrate the ultrasonic blade 41. The end effector assembly 40 clamps the tissue (i.e., applies pressure to the tissue) when the end effector assembly 40 is closed, and at the same time performs tissue cutting and coagulation under the action of ultrasonic energy. The force acting on the tissue in the form of ultrasonic energy can be defined as a load force. The proximal end of the main housing 21 is open to receive an ultrasonic transducer 10 to be inserted therein.

[0016] The end effector assembly 40 comprises a blade 41 and a jaw assembly 42 (also called a clamp arm) which can be actuated to pivot toward or away from the ultrasonic blade 41 in order to close or open the end effector assembly 40. The jaw assembly 42 can be actuated to move between an open position and a closed position. In the open position, at least a portion of the jaw assembly 42 is actuated to move away from the blade 41. In the closed position, the jaw assembly 42 biases against the tissue clamped between the jaw assembly 42 and the blade 41.

[0017] The transmission assembly 30 may be configured as an elongated shaft extending distally from the handle assembly 20 of the instrument. The transmission assembly 30 comprises a waveguide 31 for transmitting ultrasonic energy supplied by the transducer 10 to the blade 41, an inner tube 32 attached to the waveguide 31, and an outer tube 33 attached to the inner tube 32. The outer tube 33 is mounted axially with respect to the handle assembly 20, and the jaw assembly 42 is pivotally connected to the outer tube 33. The proximal portion of the inner tube 32 is coupled to the actuation mechanism of the handle assembly 20, and the distal portion is coupled to the jaw assembly 42. The inner tube 32 is actuated via the actuation mechanism to reciprocate axially with respect to the outer tube 33, and further actsuated to the jaw assembly 42 to pivot around the outer tube 33. The jaw assembly 42 includes a clamp pad 43. The jaw assembly 42, together with the clamp pad 43, is coupled to the distal ends of the outer tube 33 and the inner tube 32. The clamp pad 43 is supported on the jaw assembly 42 so as to coincide with the blade 41, and the pivoting of the jaw assembly 42 positions the clamp pad 43 substantially parallel to the blade 41 and in contact with the blade 41, thereby defining the tissue treatment area. This structure clamps the tissue between the clamp pad 43 and the blade 41.

[0018] The proximal ends of the waveguide 31, outer tube 33, and inner tube 32 are connected to each other through a bayonet connector assembly located within the main housing 21, thereby allowing the waveguide 31, outer tube 33, and inner tube 32 as a whole to rotate together with the ultrasonic transducer 10 with respect to the handle assembly 20 using a knob 35. The waveguide 31 penetrates into the main housing 21 of the handle assembly 20 through the knob 35. During use, the outer tube 33 and waveguide 31 can be rotated through the rotation of the knob 35, thereby allowing the end effector assembly 40 and the jaw assembly 42 connected thereto to be adjusted to the desired direction. During use, the rotation of the knob 35 with respect to the handle assembly 20 causes the outer tube 33, waveguide 31, and the ultrasonic transducer 10 operably connected thereto to rotate with respect to the handle assembly 20.

[0019] The reciprocating motion of the inner tube 32 opens and closes the jaw assembly 42. A force limiting mechanism 36 is operably connected to the inner tube 32 and includes a tube collar cap 361. A distal washer 362, a distal wave spring 363, a proximal washer 364, and a proximal wave spring 365 are secured to a collar 366 by the tube collar cap 361. The collar 366 has axially extending lugs, which engage with appropriate openings in the proximal portion of the tubular inner tube 32. The inner tube 32 receives an O-ring 367 in an outer groove, which is used to engage with the inner surface of the outer tube 33.

[0020] Based on the above description of the structure of the ultrasonic surgical system, a schematic diagram of the ultrasonic energy transfer process, as shown in Figure 3, can be obtained. The generator 50 outputs a drive signal, which is a signal having a specific current and frequency. The transducer 10 converts the drive signal into an ultrasonic vibration signal, and the ultrasonic vibration signal (ultrasonic energy) can be transmitted to the waveguide 31 by the surgical hand switch 24. The waveguide 31 is suitable for transmitting ultrasonic energy from the transducer 10 to the blade 41 located at the distal end of the waveguide 31, and the waveguide 31 may be flexible, semi-flexible, or rigid. As is known to those skilled in the art, the amplitude and / or frequency of the vibration waves propagating along the longitudinal direction of the waveguide 31 can be adjusted by changing the diameter of the waveguide 31 or other corresponding characteristics. For example, the amplitude of the mechanical vibrations transmitted from the waveguide 31 to the blade 41 can be increased by reducing the diameter, in particular the diameter of the vibration nodes of the waveguide or the diameter near the vibration nodes of the waveguide. Other features may also be provided on the waveguide 31 to control the gain (positive or negative) of longitudinal vibrations transmitted along the waveguide and to adjust the vibration of the waveguide 31 to an ideal resonant frequency for the system. In this way, the waveguide 31 may have different cross-sectional sizes, a substantially uniform cross-section, be tapered at multiple locations along the waveguide 31 to provide two or more cross-sections with different cross-sections, or be tapered along the entire length of the waveguide.

[0021] In various embodiments, the waveguide 31 may be made from a variety of materials, in particular a variety of medically and surgically acceptable metals such as titanium, titanium alloys (e.g., Ti6Al4V), aluminum, aluminum alloys, or stainless steel. In some embodiments, such as those shown in the drawings, the blade 41 and waveguide 31 are formed as a single unit, for example, machined from a single metal rod milled to provide the desired characteristics. Alternatively, the waveguide 31 and ultrasonic blade 41 may comprise two or more separable components of the same material but of different compositions, the components being joined to each other, for example, by adhesive, welding, threaded studs, and / or other preferred methods known to those skilled in the art. For example, the ultrasonic blade 41 may be connected to the waveguide by screw connections, welded joints, or other bonding mechanisms.

[0022] For example, the generator 50 and transducer 10 in the depicted embodiment are configured to generate standing vibration waves having a frequency of approximately 55 kHz. However, various other ultrasonic frequencies, such as between approximately 20 and 120 kHz, may be employed.

[0023] Various embodiments of this application provide a method for driving an ultrasonic surgical instrument. As shown in Figure 4, the method includes the following steps.

[0024] In S10, this step is to separate the muscular layer of the blood vessels, and this The procedure includes the step of supplying a drive signal having a first amplitude range for a first period to drive a transducer of an ultrasonic surgical instrument in response to a start signal. In this step, the transducer is actuated by the drive signal having the first amplitude range, which causes the blade 41 to vibrate with relatively high ultrasonic vibration energy, rapidly drying the blood vessel wall.

[0025] In S20, this step is for sealing and / or coagulation of blood vessels, and this S201: After a first period, a first transition signal having an amplitude that decreases at a first predetermined interval is supplied to drive the transducer. S202: A step of supplying a drive signal having a second amplitude range for a second period to drive a transducer after a first predetermined interval, wherein the upper limit of the second amplitude range is lower than the lower limit of the first amplitude range, S203: The step of supplying a second transition signal having an amplitude that increases at a second predetermined interval to activate a transducer after a second period.

[0026] The first predetermined interval and / or the second predetermined value are greater than zero (i.e., greater than zero). For example, if the first predetermined interval is determined to be zero, the end of the first period is determined to be the start of the second period; alternatively, if the second predetermined interval is determined to be zero, the end of the second period is determined to be the start of the third period. In this step, the amplitude of the drive signal for driving the transducer of the ultrasonic surgical instrument is lower than the amplitude of the drive signal in step S10, which causes the blade 41 to vibrate with a lower ultrasonic vibration energy to perform vascular sealing or coagulation.

[0027] In S30, this step is for cutting the blood vessel, and this The step includes supplying a drive signal having a third amplitude range for a third period to activate a transducer after a second predetermined interval, wherein the lower limit of the third amplitude range is higher than the upper limit of the second amplitude range. In this step, the amplitude of the drive signal for driving the transducer is higher than the amplitude of the drive signal in step S20, which causes the blade 41 to vibrate with high ultrasonic vibration energy to cut the blood vessel.

[0028] Figures 5a to 5e are schematic diagrams showing various signal waveforms of the signals used to drive the ultrasonic surgical instrument in the method described above. Generally, all drive signals include a first signal S1 in the first period, a second signal S2 in the second period, and a third signal S3 in the third period. Under different signal drives, the operation of the end effector assembly 40 corresponds to different stages of vascular sealing.

[0029] More specifically, for the step of separating the muscular layer of the blood vessel, the transducer is driven by a first signal S1 in a first period, and the end effector assembly 40 is activated to perform the separation of the muscular layer of the blood vessel. In this stage, the blood vessel wall is rapidly dried. The drive signal in the first period is given a relatively high amplitude, supplying relatively high energy to the end effector assembly 40 to facilitate the separation of the muscular layer. As shown in the figure, t 10 refers to the start time of the first period, t 11 This refers to the end time of the first period.

[0030] The step of sealing or coagulating the blood vessels is performed at the end time of the first period t 11 Starting from the beginning of the third period t 30 Up to this point. At this stage, the transducer is driven by a second signal S2, a transition signal between the second signal S2 and the first signal S1, and a transition signal between the second signal S2 and the third signal S3, which causes the end effector assembly 40 to vibrate, sealing or coagulating the blood vessels. At this stage, the second signal S2 is given a second amplitude range, the upper limit of which is lower than the lower limit of the first amplitude range. The start time of the second period is t 20 The end time of the second period is t 21 The drive signal in the second period is given a low amplitude, supplying relatively low energy to the end effector assembly 40 to facilitate the sealing or coagulation of the blood vessels and prevent carbonation of the blood vessel walls caused by excessive energy in the end effector assembly 40.

[0031] During the stage of cutting the blood vessel, the transducer is driven in a third period by a third signal S3, and the end effector assembly 40 is actuated to perform blood vessel cutting. At this stage, the drive signal is given a third amplitude range in the third period, the lower limit value of which is higher than the upper limit value of the second amplitude range. As shown in the figure, t 30 refers to the start time of the third period, and t 31 refers to the end time of the third period. The drive signal for the first stage is given a relatively high amplitude, supplying relatively high energy to the end effector assembly 40 to facilitate rapid cutting of the blood vessel.

[0032] As shown in the figure, a drive signal having a decreasing amplitude is supplied in a first predetermined interval Δt1 from the start time t 20 of the second period to the end time t 11 of the first period, and / or a drive signal having an increasing amplitude is supplied in a second predetermined interval Δt2 from the start time t 30 of the third period to the end time t 21 of the second period. That is, the amplitude of the drive signal changes more smoothly, avoiding a step change in the drive signal. Fig. 5A shows the situation of setting the transition time when the first signal S1 changes to the second signal S2. As shown in the figure, at the end time t[[ID=第十八]] 11 of the first period, the amplitude of the signal is A 11 , and at the start time t 20 of the second period, the amplitude of the signal is A 12 . In the process of the amplitude of the signal changing from A 11 to A 12 , the first predetermined interval Δt1 is defined as the transition time. Fig. 5b shows the situation of setting the transition time of the phase change from the second signal S2 to the third signal S3. As shown in the figure, at the end time t 21 of the second period, the amplitude of the signal is A 13 , and at the start time t 30 of the third period, the amplitude of the signal is A 14 . In the process of the amplitude of the signal changing from A 13 to A14 In the process of change, a second predetermined interval △t2 is defined as the transition time. Figures 5c to 5e show the transition time from the start time t of the second period. 20 The end time of the first and second period t 21 This shows the situation that is set after the above. Note that in the waveform shown in the figure above, the signal amplitudes of the first signal S1 in the first period, the second signal S2 in the second period, and the third signal S3 in the third period are all kept constant, and the signal amplitude of the third signal S3 may be different from (as shown in Figures 5a and 5b) or the same as (as shown in Figures 5c to 5e) the signal amplitude of the first signal S1 in the first period. However, in the actual application of this method, the signal amplitude will fluctuate to some extent at each stage, that is, amplitude A 11 Or A 12 , A 13 Or A 14 It is not stable, which will be further explained in the following embodiment. When the signal amplitudes of the first signal S1 in the first period, the second signal S2 in the second period, and the third signal S3 in the third period are all kept constant, and the signal amplitude of the signal S3 in the third period is the same as the signal amplitude of the first signal S1 in the first period, A 13 =A 12 , A 14 =A 11 In this case, the signal waveforms shown in Figures 5c to 5e can be obtained. In this embodiment, the above figures are mainly used to illustrate the existence of a first predetermined interval △t1 and / or a second predetermined interval △t2. An alternative solution is a predetermined interval for the change between two phases to achieve a slow transition of the amplitude change of the signal.

[0033] In this embodiment, the above solution is such that a first predetermined interval △t1 is set between a first signal S1 and a second signal S2 for the transition, or a second predetermined interval △t2 is set between a second signal S2 and a third signal S3 for the transition, or the transition time is set simultaneously for both phase changes, and the stepwise changing signals in the two phases are partially or completely adjusted to transition within a specific time period. Thus, this has a specific buffer when the ultrasonic energy transmitted to the blade 41 changes between high and low power, effectively improving the surgeon's surgical precision with respect to the ultrasonic instrument, reducing the impact of abrupt changes in tissue tearing force, and avoiding blade breakage.

[0034] In the above solution, when a first predetermined interval △t1 and a second predetermined interval △t2 are provided, the amplitude of the signal changes linearly (as shown in Figure 5d) or nonlinearly (as shown in Figures 5a to 5c and 5e).

[0035] To shorten the surgical time required to transversely cut large-diameter blood vessels and successfully seal or coagulate them, a load corresponding to the thickness of the blood vessel wall must be applied. For example, the amplitude of the transition signal between the second signal S2 and the first signal S1, and further, the amplitude of the transition signal between the second signal S2 and the third signal S3, changes nonlinearly, thereby allowing for coagulation and cutting of the blood vessel in accordance with the change in the thickness of the blood vessel wall. That is, when the first predetermined interval △t1 is greater than or above zero, the amplitude of the first transition signal supplied to the ultrasonic surgical instrument over the first predetermined interval △t1 decreases according to the first nonlinear curve, and when the second predetermined interval △t2 is greater than or above zero, the amplitude of the second transition signal supplied to the ultrasonic surgical instrument over the second predetermined interval △t2 increases according to the second nonlinear curve, so that the change in the thickness of the blood vessel wall in the sealing process follows the curve shown in Figure 6.

[0036] In particular, the waveforms of the first and second transition signals provided in this embodiment are shown in Figure 7. Here, the equation for the first nonlinear curve is A=(A 11 -A 12 ) × sinΦ + A 11 Φ∈(180°,270°), and A is the amplitude of the first transition signal, A 11 is the amplitude of the signal at the end of the first period, and A 12 Φ is the amplitude of the signal at the start time of the second period, the start time Φ of the first predetermined interval △t1 is 180°, and the end time Φ of the first predetermined interval △t1 is 270°. The second curve is given by C=(A 14 -A 13 ) × sinΦ + A 13 Φ∈(0°, 90°), C is the amplitude of the second transition signal, and A 13 is the amplitude of the signal at the end of the second period, and A 14 is the amplitude of the signal at the start time of the third period, the start time Φ of the second predetermined interval △t2 is 0°, and the end time Φ of the second predetermined interval △t2 is 90°. In Figure 7, the second signal S2 in the second period is a signal with a constant amplitude, and therefore A 13 =A 12 As shown in Figure 9, if the second signal S2 in the second period is a signal with a fluctuating amplitude, then A 13 and A 12 These can differ. In this solution, the amplitude change of the drive signal from the first signal S1 to the second signal S2 follows a sinusoidal curve, and similarly, the amplitude change of the signal from the second signal S2 to the third signal S3 follows a sinusoidal curve, so the amplitude change of the drive signal can be well adapted to the process of wall thickness change in the process of sealing blood vessels. In this solution, the drive signal in Figure 7 is illustrated using a current signal as an example. Since current and voltage can be converted according to Ohm's law, it will be understood that voltage can be obtained through conversion by combining impedance with current. Therefore, the drive signal provided in one of the embodiments of this application can also be configured as a current signal or a voltage signal.

[0037] As shown in Figure 7, when an ultrasonic surgical system is adapted for sealing blood vessels, the changes in the amplitude of the three-stage signal are as follows: The end effector assembly 40 is driven to perform a step of separating the muscular tissue layer of the blood vessel, and the drive signal is given a constant amplitude to rapidly dry the blood vessel wall. The duration of this step may be determined according to the time it takes to complete the separation of the muscular tissue layer of the blood vessel, and whether the separation of the muscular tissue layer of the blood vessel is complete may be determined according to the impedance fed back by the end effector assembly 40. In this step, ultrasonic energy with a constant output supplied by the blade 41, combined with the force applied by the operator, can separate the muscular tissue layer of the blood vessel without causing significant thermal damage.

[0038] The end effector assembly 40 is driven to perform a step of sealing and coagulating the blood vessel, and the amplitude of the drive signal may be given a constant amplitude to coagulate the blood vessel. The duration of this step may be determined according to the time it takes for the coagulation of the blood vessel to be completed, and whether the coagulation of the blood vessel is complete may be determined according to the impedance fed back by the end effector assembly 40.

[0039] The end effector assembly 40 is driven to perform the step of cutting a blood vessel, and a drive signal is given a constant amplitude (the constant amplitude may be the same as or different from the constant amplitude used in the step of separating the muscular layer of the blood vessel) until the blood vessel is cut laterally.

[0040] In the three stages described above, the duration of the signal at each stage may be determined according to the impedance changes fed back by the end effector assembly 40 during the process of sealing the blood vessel. Thus, as shown in Figure 8, the method for driving the ultrasonic surgical instrument may further include the following steps.

[0041] In S40, fluctuations in the current or voltage values ​​fed back by the ultrasonic surgical instrument are acquired, where the current or voltage fluctuations are determined according to the impedance fluctuations fed back by the end effector assembly 40. Referring to Figure 3 and the principle of ultrasonic energy generation and transmission in the ultrasonic surgical system, during the process of sealing the blood vessels, changes in the characteristics of the blood vessel wall (such as the thickness of the blood vessel wall and the tissue characteristics of the blood vessel) lead to changes in the impedance of the end effector assembly 40, which are fed back to the transducer 10 along the transmission path of ultrasonic vibrations, and can change the current or voltage values ​​of the transducer 10. This step is performed in real time during the execution of the process of sealing the blood vessels. At that time, the acquired current or voltage fluctuations are supplied by the transducer 10.

[0042] In S50, the amplitude of the signal in each period is adjusted according to the current value or voltage fluctuation, and each period includes a first period, a second period, a third period, a first predetermined interval and / or a second predetermined interval. In this step, the adjusted period is determined according to the current surgical stage performed by the end effector assembly 40, for example, when the end effector assembly 40 is performing the step of separating the muscle tissue layer of the blood vessel, the amplitude of the signal output in the first period is adjusted according to the current value or voltage fluctuation, and when the end effector assembly 40 is performing the step of sealing and coagulating the blood vessel, the amplitude of the signal output in the second period is adjusted according to the current value or voltage fluctuation.

[0043] Furthermore, the above method may include a step of determining the duration of the first, second, and third periods according to current or voltage fluctuations. Similar to step S50, in this step as well, the adjusted periods are determined according to the surgical stage currently being performed by the end effector assembly 40, i.e., the amplitude of the signal is adjusted in real time according to current or voltage fluctuations fed back by the ultrasonic surgical instrument, or the waveform of the signal is adjusted in real time during the process of sealing the blood vessels.

[0044] Alternatively, in the above method, step S60, which adjusts the duration of the transition signal, is further included in the step of adjusting the end effector assembly 40 to perform the step of sealing and coagulating the blood vessel, in particular, If the first predetermined interval △t1 is greater than zero (i.e., greater than zero), the above method includes S601: determining the time length of the first predetermined interval △t1 according to the current fluctuation or voltage fluctuation.

[0045] If the second predetermined interval △t2 is greater than zero (i.e., greater than zero), the above method includes S602: determining the time length of the second predetermined interval △t2 according to the current fluctuation or voltage fluctuation.

[0046] In addition, in the realization process, the first predetermined interval △t1 and the second predetermined interval △t2 may be equal or different. If the first interval is equal to the second interval, the waveform may be simplified. If the first interval is different from the second interval, the difference between the two intervals is within a certain tolerance range, which may be determined according to empirical values ​​or experimental calibration.

[0047] As described above, the impedance value of the end effector assembly 40 also changes due to changes in the vascular tissue characteristics during the stage of sealing and coagulating blood vessels by the ultrasonic surgical system. Therefore, the second signal S2 is designed as a volatile signal, i.e., the ultrasonic energy of the blade 41 has a small fluctuation range, so that the end effector assembly 40 can better reflect the impedance changes during the process of sealing blood vessels, and the small fluctuation range can avoid unnecessary rupture of blood vessels or tissues caused by energy fluctuations of the blade. Alternatively, the difference between the upper limit A5 and the lower limit A6 of the second amplitude range of the second signal S2 is smaller than the setpoint. Taking the waveform diagram shown in Figure 9 as an example, the signal supplied over the second period is configured as a periodic signal, in particular, the periodic signal can be expressed by the function B = A5 - setpoint × sin(π × τ / T), where B is the amplitude of the signal output during the second period, τ is a time variable, τ ∈ (0, T), and T is the duration of the second period. In the above, the end effector assembly 40 needs to act continuously on the blood vessels with low energy to completely coagulate them in the stage of sealing and coagulating the blood vessels. Therefore, in this stage, the ultrasonic energy and duration of the blade 41 need to be well matched, that is, the amplitude and duration of the signal in the second period need to be well matched, thereby avoiding carbonation of the blood vessels caused by excessively high amplitude or long duration of the signal in the second period, and affecting the sealing and coagulation effect. In this premise, the selection of the setting value in the above function is suited to the low energy value required by the blade 41 in the coagulation stage of the blood vessels, which can be obtained by calibration experiment or empirical value. In this step, the amplitude of the signal in the second signal S2 is designed according to the law of impedance disturbance in the process of sealing the blood vessels, and periodic fluctuations in sinusoidal mode can better reflect impedance changes in the process of sealing and coagulating the blood vessels.

[0048] Embodiments of this application further provide a generator for driving an ultrasonic surgical instrument. Figures 10a to 10b are schematic diagrams of the generator 50 and other components when the generator 50 is used in an ultrasonic surgical system. The generator 50 comprises a processor chip 501 (such as a single-chip microcomputer, PLC, DSP, and the like) which is preloaded with program information for generating various preset waveform signals. When the generator 50 responds to a start signal, the processor chip 501 executes the program information and performs the method steps provided in the above method embodiments, thereby causing the generator 50 to output a drive signal to the ultrasonic surgical instrument as shown in Figures 5a to 5e, or in Figures 7 and 9. The processor chip 501 can directly output a waveform signal that satisfies the requirements of the drive signal through the preset program information, i.e., the amplitude and duration of each stage of the signal satisfy the driving requirements of the ultrasonic surgical instrument. Alternatively, as shown in Figure 10b, the processor chip 501 is connected to a signal conditioning circuit 502, which outputs a preset waveform signal (as an initial signal) after executing program information, and the signal conditioning circuit 502 processes the preset waveform signal to create a drive signal. In this solution, the amplitude of the preset waveform signal may be small, and the signal conditioning circuit 502 may have a signal amplification function that can amplify the initial signal with a smaller amplitude to create a drive signal that meets the driving requirements. The functions of the signal conditioning circuit 502 are adapted to match the initial signal output by the processor chip 501 and the driving requirements, and in addition to amplification, the signal conditioning circuit may have conversion and filtering functions.

[0049] Furthermore, the generator 50 further comprises an impedance detection circuit 503. The impedance detection circuit 503 is connected to the transducer 10 of the ultrasonic surgical instrument. The impedance detection circuit 503 is used to detect current fluctuations or voltage fluctuations fed back by the transducer 10, convert the current fluctuations or voltage fluctuations into digital signals, and feed back the digital signals to the processor chip 501, where the current fluctuations or voltage fluctuations are determined according to the impedance fluctuations of the end effector assembly 40. The processor chip 501 adjusts the amplitude of the drive signal according to the digital signals fed back by the impedance detection circuit 503. Furthermore, the processor chip 501 may also adjust the time lengths of a first period, a second period, and a third period in the drive signal according to the digital signals fed back by the impedance detection circuit 503, determining the time length of the first predetermined interval according to the current fluctuations or voltage fluctuations when the first predetermined interval is greater than or equal to zero, and / or determining the time length of the second period according to the current fluctuations or voltage fluctuations when the second predetermined interval is greater than or equal to zero.

[0050] The above-described generator for driving the ultrasonic surgical instrument can output a drive signal to the end effector assembly 40 of the ultrasonic surgical instrument. The blade 41 within the end effector assembly 40 is driven by the drive signal to generate ultrasonic energy suitable for different stages in the process of sealing blood vessels, and combined with the clamping force applied by the surgeon to the end effector assembly 40, the sealing of blood vessels can be completed quickly.

[0051] Embodiments of this application further provide an ultrasonic surgical system. This system comprises an ultrasonic surgical instrument and a generator 50 provided in the above embodiment. The ultrasonic surgical instrument comprises a transducer 10 and a surgical assembly. The transducer 10 receives a drive signal output by the generator 50 and converts the drive signal into an ultrasonic vibration signal. The surgical assembly comprises a waveguide 31 and an end effector assembly 40 positioned at the distal end of the waveguide 31 and used to surgically treat tissue. The ultrasonic vibration signal is transmitted from the waveguide 31 to the end effector assembly 40, and the ultrasonic energy generated by the end effector assembly 40 acts on the tissue being treated. In embodiments of the present invention, blood vessels are taken as an example of tissue being treated, but the ultrasonic surgical system may be applied to cutting, coagulating, and / or clamping other tissues other than blood vessels.

[0052] As shown in Figure 10b, the ultrasonic surgical system may further include a start signal switch 50A (such as a surgical hand switch 24, a foot switch connected to the generator 50, and similar). When the generator 50 receives a start signal from the start signal switch 50A (in the figure, the signal receiving terminal of the processor chip 501 is used as the signal receiving terminal of the generator 50), the processor chip 501 can execute preset program information stored therein and output a preset waveform signal. The preset waveform signal is processed by the signal conditioning circuit 502 to form a drive signal, which is input into the transducer 10. After ultrasonic vibration, the blades 41 of the end effector assembly 40 work together with the jaw assembly 42 to clamp the tissue, and the impedance change of the end effector assembly 40 is fed back to the transducer 10, thereby causing a current or voltage fluctuation in the transducer 10. The impedance detection circuit 503 can detect the current or voltage fluctuation, process the current or voltage fluctuation into a digital signal, and feed the digital signal back to the processor chip 501. The processor chip 501 can determine impedance fluctuations according to current or voltage fluctuations, adjust the initial waveform according to the impedance fluctuations, and change the amplitude of the drive signal to change the ultrasonic energy of the end effector assembly 40. This allows the end effector assembly 40 to generate ultrasonic energy corresponding to characteristic fluctuations of the surgically treated tissue at any stage, and to successfully meet the operating requirements of the surgically treated tissue.

[0053] In addition, the drive current waveform proposed in the above embodiments of this application is expressed according to the RMS value of the current, where RMS is a value for measuring the magnitude of the alternating current. The specific calculation process is as follows: when the alternating current passes through the resistor, the heat generated in one cycle is equal to the heat generated by the direct current passing through the resistor in the same amount of time, and the magnitude of the direct current is the RMS value of the alternating current; therefore, the RMS value can be calculated according to the instantaneous value of the current. In specific applications, the instantaneous value or the RMS value may be selected as the variable to be displayed. In the above embodiments of this application, when the drive signal controls the operation of the blade 41, in the process of sealing and coagulating larger diameter blood vessels, it has been verified that the ultrasonic vibration energy of the blade 41 can achieve a maximum output value within a unit time, provided that the requirements for blood vessel sealing are met, when the signal in each stage operates at a resonant frequency and the ends of the second signal S2 in the second period form a sinusoidal curve to realize the signal transition.

[0054] Based on the drive signal in the above embodiment, the vibration duration of the blade 41 can be effectively shortened, and the heat generated by the mechanical vibration of the blade 41 can be reduced. Compared to the structure of an existing blade 41 equipped with a heat dissipation film (in the prior art, the blade needs to be vibrated for a long time, generating more heat, and the blade needs to be provided with an additional heat dissipation film), this application makes it possible to achieve a blade 41 without requiring the exterior to be coated with a heat dissipation film. The heat dissipation film coated on existing blades 41 not only increases the cost of the equipment but also has the potential to fall onto the human body under high-frequency vibration conditions, which can easily cause rejection reactions in the human body. In this solution, the blade 41 effectively solves the above problems after eliminating the heat dissipation film.

[0055] In the ultrasonic surgical system described above, when the end effector assembly 40 clamps a blood vessel, the blade 41 needs to be matched with the jaw assembly 42 to apply load force to the tissue in conventional use scenarios (such as sealing and coagulation of blood vessels with a diameter of approximately 5 mm or less). In particular, as shown in Figures 11 and 12, the pivot of the jaw assembly 42 with respect to the blade 41 is achieved by setting a pair of pivots on the jaw assembly 42 that engage with the outer tube 33 and the inner tube 32, respectively. The outer tube 33 is fixedly connected to the handle assembly 20. The jaw assembly 42 is pivotally connected to the outer tube 33 via a first through-hole 421 on the jaw assembly 42 and a corresponding second through-hole 331 on the outer tube 33. A fastening pin or rivet slides through the first through-hole 421 and the second through-hole 331, pivotally connecting the jaw assembly 42 to the outer tube 33. The inner tube 32 moves along the longitudinal axis of the outer tube 33. The pivot pin 422 of the jaw assembly 42 engages with the pivot hole 321 at the distal end of the inner tube 32. Thus, the reciprocating motion of the inner tube 32 relative to the outer tube 33 pivots the jaw assembly 42 relative to the blade 41. Movement of the trigger 23 toward the handgrip 22 moves the inner tube 32 proximal, thereby pivoting the jaw assembly 42 toward the blade 41. The pulling action provided by the trigger 23 and the cooperating handgrip 22 helps to conveniently and effectively operate and position the instrument, acting on the distal end of the instrument to pivot the jaw assembly 42 toward the blade 41, thereby effectively biasing and pushing the tissue toward the blade 41. Movement of the trigger 23 toward the handgrip 22 moves the inner tube 32 distal, thereby pivoting the jaw assembly 42 toward the blade 41.

[0056] As shown in Figure 13, multiple grooves or notches are formed on the outer circumference of the waveguide 31 for mounting sealing supports 39. The grooves are located at the nodes of the waveguide 31. Since the amplitude of the ultrasound at the nodes of the waveguide 31 is zero, the sealing supports 39 are provided at these locations to effectively support the waveguide 31 without affecting the ultrasound transmission of the waveguide 31. The sealing supports 39 are, in particular, sealing rubber rings configured within the grooves, and these sealing rubber rings are made from a flexible material such as silica gel. The sealing supports 39 located at the furthest nodes are closest to the end effector assembly 40, and the sealing supports 39 can also prevent tissue residue generated when the end effector assembly 40 is cut from entering the transmission assembly 30 through the region between the waveguide 31 and the inner tube 32.

[0057] When the end effector assembly 40 is used for sealing and coagulation of larger diameter vessels, a greater force is required to operate the trigger 23 to clamp the vessel. The force on the jaw assembly 42 in the Z direction is greater, and the blade 41 tends to move in the Z direction. An assembly gap between the inner and outer tubes would allow the blade 41 to move in the Z direction. As shown in Figure 13, the waveguide 31, which is fastened or integrated with the blade 41, abuts the inner tube 32 without gap through the sealing support 39, and an assembly gap is provided between the inner and outer tubes. As shown in Figure 14a, the straight line formed by the pair of pivots is inclined to the left (or it could also be considered that the straight line is inclined to the right). At this time, the distal end F of the end effector assembly 40 is closed, but there is still a large gap at the proximal end W of the end effector assembly. The large gap at the proximal end W results in lower pressure when the end effector assembly clamps the vessel. At this point, it is easy to see that the vessels clamped at the distal end have completed transverse severance / hemostasis due to the action of pressure and energy, but the vessels clamped at the proximal end have not. In other words, the force matching of the end effector assembly 40 acting on vessels with a larger diameter is poor, resulting in the problem that some vessels are not severed or do not coagulate easily.

[0058] In the embodiments provided by this application, the drive signal can be controlled so that the blade 41 outputs sufficiently high ultrasonic energy per unit time, so that the surgeon can appropriately reduce the clamping force from the surgeon when controlling the action of the jaw assembly 42, thereby reducing the decrease in load force consistency of the end effector assembly 40.

[0059] Furthermore, when the end effector assembly 40 seals and coagulates blood vessels with a larger diameter, it is necessary to gradually decrease the force applied to the blade 41 from the proximal end to the distal end in order to ensure consistent loading conditions on the blade 41 from the proximal end to the distal end. Alternatively, this embodiment provides contact portions at the distal ends of the inner tube 32 and the outer tube 33, which form a support between the inner tube 32 and the outer tube 33, thereby reducing the gap between the distal ends of the inner and outer tubes to near zero and preventing a change in the radial gap between the inner and outer tubes without affecting the relative sliding motion of the inner and outer tubes. That is, the displacement of the inner tube 32 along the Z direction becomes near zero when the blade 41 is subjected to a force applied by the jaw assembly 42 along the Z direction, preventing a change in the radial gap between the inner and outer tubes. As shown in Figure 14b, when the jaw assembly 42 pivots toward the blade 41 to seal and coagulate larger diameter vessels, the positional displacement of the blade 41 in the radial Z direction decreases to almost zero due to the support of the distal ends of the inner tube 32 and outer tube 33. At this time, the distal end F of the end effector assembly 40 is closed and the gap at the proximal end W of the end effector assembly is small, so the force on the blade 41 gradually increases from the distal end to the proximal end. More specifically, the inside of the contact portion abuts against or is integrally formed with the outer wall of the inner tube 32, and the outside of the contact portion is integrally formed with the inner wall of the outer tube 33 and abuts against the inner wall of the outer tube 33. In this way, the gap between the inner tube 32 and the outer tube 33 is further reduced by providing the contact portion on the distal end side. In some configurations, the contact portion is at least one clamp piece P positioned and configured between the inner tube 32 and the outer tube 33. By positioning the clamp piece P independently of the inner tube 32 and outer tube 33, the difficulty of machining the inner tube 33 and outer tube 33 can be reduced. More specifically, the surface of the clamp piece P is shaped as an arc-shaped surface that matches the walls of the inner tube and outer tube 33, thereby providing a large contact area between the clamp piece P and the outer wall of the inner tube 32 and the inner wall of the outer tube 33, and stably supporting the waveguide 31.The above-described implementation of the contact portion is merely a schematic diagram, and it should be understood that the clamp piece P can be replaced with other structural members that can achieve the same function in a specific implementation.

[0060] According to the solution described above in this embodiment, by improving the mechanical structure of the end effector assembly 40 and combining it with an improved drive signal, the time required to seal blood vessels with larger diameters is further reduced, and the load force consistency of the end effector assembly 40 is improved. In the process of realizing this solution, the ultrasonic surgical instrument provided in this embodiment and the ultrasonic surgical instrument of the prior art are selected to perform sealing and coagulation experiments on 60 blood vessel samples having a diameter of approximately 7 mm, and the effect of this solution is described in two aspects: the time required for the sealing work and the verification results of the rupture pressure of the sealed blood vessels. In particular, two instruments are used to perform sealing and coagulation on multiple blood vessel samples with a diameter of approximately 7 mm. After the entire sealing and coagulation process is completed, the rupture pressure at the location where the blood vessel is sealed is measured, and different times required for different sealing work corresponding to different rupture pressure experimental results are counted, respectively. Finally, the verification results of this solution are shown in Figure 15a, the verification results of existing products are shown in Figure 15b, and the comparison results are shown in Figure 15c.

[0061] The time required to perform the sealing operation of the ultrasonic surgical instrument provided by this solution ranges from 2.8 to 7.2 seconds, with an average sealing operation time of 6.067 seconds and a standard deviation of 0.928 seconds. After completing the vascular sealing operation, the average burst pressure at the sealed location of the vessel was 1186.1 mmHg, and the standard deviation obtained from the burst pressure experiment results was 271.9 mmHg.

[0062] The time required to perform sealing work on existing products ranged from 5.4 to 19.4 seconds, with an average sealing time of 11.225 seconds and a standard deviation of 3.485 seconds. After completing the sealing work on the blood vessels, the average burst pressure at the sealed location was 969.71 mmHg, and the standard deviation of the burst pressure was 303.78 mmHg.

[0063] According to the experimental results shown in the figure, when sealing a blood vessel with a diameter of approximately 7 mm, the solution of this application clearly allows for a shorter sealing time and better sealing results. With this solution, the efficiency of blood vessel sealing can be further improved, provided that the quality of the blood vessel sealing is ensured. [Explanation of Symbols]

[0064] F distal end P clamp piece W proximal end 10 transducers 20 Handle Assembly 21 Main Housing 22 Hand Grips 23 Trigger 24 Surgical hand switch 30 Transmission Assembly 31 Waveguides 32 Inner tube 33 Outer tube 35 Knobs 36. Force Limiting Mechanism 40 End Effector Assembly 41 Ultrasonic Blades 42 Clamp Arm Assembly 43 Clamp Pad 50 Generators 321 Pivot hole 331 Second through hole 361 Pipe Color Cap 362 Distal Washer 363 Distal Wave Spring 364 Proximal Washer 365 Proximal Wave Spring 366 Colors 367 O-type ring 421 First through hole 422 Pivot pin 501 Processor Chip 502 Signal conditioning circuit 503 Impedance detection circuit

Claims

1. A method for driving an ultrasonic surgical instrument, Steps include supplying a drive signal having a first amplitude range for a first period in response to a start signal to drive the transducer of the ultrasonic surgical instrument, The steps include, after the first period, supplying a first transition signal having an amplitude that decreases at a first predetermined interval to drive the transducer, A step of supplying a drive signal having a second amplitude range for a second period to drive the transducer after the first predetermined interval, wherein the upper limit of the second amplitude range is lower than the lower limit of the first amplitude range. The steps include, after the second period, supplying a second transition signal having an amplitude that increases at a second predetermined interval to drive the transducer, The steps include: after the second predetermined interval, supplying a drive signal having a third amplitude range for a third period to drive the transducer, wherein the lower limit of the third amplitude range is higher than the upper limit of the second amplitude range; A method wherein at least one of the first predetermined interval and the second predetermined interval is greater than zero.

2. The method according to claim 1, wherein, when the first predetermined interval is greater than zero, the amplitude of the first transition signal supplied to the ultrasonic surgical instrument at the first predetermined interval decreases according to a first nonlinear curve.

3. The first nonlinear curve is given by A = (A １１ -A １２ ) × sinΦ + A １１ , defined as Φ∈(180°, 270°), where A is the amplitude of the first transition signal, A １１ is the amplitude of the signal at the end of the first period, A １２ The method according to claim 2, wherein is the amplitude of the signal at the start of the second period.

4. The method according to claim 1, wherein, when the second predetermined interval is greater than zero, the amplitude of the second transition signal supplied to the ultrasonic surgical instrument at the second predetermined interval increases according to a second nonlinear curve.

5. The second non-linear curve is C = (A １４ − A １３ ) × sin Φ + A １３ , where Φ ∈ (0°, 90°) is defined, C is the amplitude of the second transition signal, A １３ is the amplitude of the signal at the end of the second period, and A １４ is the amplitude of the signal at the start of the third period, the method according to claim 4.

6. The method according to claim 1, wherein, when the first predetermined interval is greater than zero, the amplitude of the first transition signal supplied to the ultrasonic surgical instrument at the first predetermined interval decreases linearly.

7. The method according to claim 1, wherein if the second predetermined interval is greater than zero, the amplitude of the second transition signal output to the ultrasonic surgical instrument at the second predetermined interval increases linearly.

8. The method according to claim 1, wherein the difference between the upper and lower limits of the second amplitude range of the signal supplied to the ultrasonic surgical instrument during the second period is lower than a set value.

9. The method according to claim 8, wherein the signal supplied to the ultrasonic surgical instrument during the second period is a periodic signal.

10. The method according to claim 9, wherein the periodic signal supplied to the ultrasonic surgical instrument during the second period is a sinusoidal signal.

11. The sinusoidal signal supplied to the ultrasonic surgical instrument during the second period is function B = A ５ - Represented by the set value × sin(π × τ / T), where B is the amplitude of the signal during the second period, τ is a time variable, τ ∈ (0, T), and T is the duration of the second period, A ５ The method according to claim 10, wherein is the upper limit of the signal amplitude during the second period.

12. A step of acquiring current fluctuations or voltage fluctuations fed back by the ultrasonic surgical instrument, wherein the current fluctuations or voltage fluctuations are determined according to the impedance fluctuations of the end effector assembly. The method according to claim 1, further comprising the step of adjusting the amplitude of a signal in each period according to the current fluctuation or voltage fluctuation, wherein each period includes the first period, the second period, the third period, the first predetermined interval and / or the second predetermined interval.

13. The method according to claim 12, further comprising the step of determining the duration of the first period, the second period, and the third period according to the current fluctuation or voltage fluctuation.

14. If the first predetermined interval is greater than zero, the step of determining the time length of the first predetermined interval according to the current fluctuation or voltage fluctuation, and / or The method according to claim 13, further comprising the step of determining the time length of the second predetermined interval according to the current fluctuation or voltage fluctuation when the second predetermined interval is greater than zero.

15. The method according to any one of claims 1 to 14, wherein at least one of the signals over the first period, the second period, and the third period has a frequency that is the resonant frequency of the ultrasonic surgical instrument.

16. A generator for driving ultrasonic surgical instruments, The generator comprises a processor chip, the processor chip is preloaded with program information, and when the generator responds to a start signal, the processor chip executes the program information and outputs a drive signal to the ultrasonic surgical instrument by performing the method according to any one of claims 1 to 15.

17. The generator according to claim 16, further comprising a signal adjustment circuit, wherein the processor chip outputs a preset waveform signal after executing the program information, and the signal adjustment circuit processes the preset waveform signal to obtain the drive signal.

18. The generator further comprises an impedance detection circuit, which detects current or voltage fluctuations fed back by the ultrasonic surgical instrument, converts the current or voltage fluctuations into a digital signal, and is used to feed the digital signal back to the processor chip, wherein the current or voltage fluctuations are determined according to the impedance fluctuations of the end effector assembly. The generator according to claim 16 or 17, wherein the processor chip adjusts the amplitude of the drive signal according to the digital signal fed back by the impedance detection circuit.

19. The generator according to claim 18, wherein the processor chip adjusts the time lengths of the first period, second period, and third period of the drive signal according to the digital signal fed back by the impedance detection circuit.

20. The generator according to claim 19, wherein the processor chip determines the time length of the first predetermined interval according to the current fluctuation or voltage fluctuation when the first predetermined interval is greater than zero, and / or determines the time length of the second predetermined interval according to the current fluctuation or voltage fluctuation when the second predetermined interval is greater than zero.

21. An ultrasonic surgical system comprising an ultrasonic surgical instrument and a generator according to any one of claims 16 to 20, The aforementioned ultrasonic surgical instrument comprises a transducer and a surgical assembly, The transducer receives the drive signal supplied by the generator and converts the drive signal into ultrasonic vibrations. An ultrasonic surgical system comprising a waveguide and an end-effector assembly positioned at the distal end of the waveguide and used for surgically treating tissue, wherein ultrasonic vibrations are transmitted from the waveguide to the end-effector assembly, and ultrasonic energy generated by the end-effector assembly acts on the tissue being surgically treated.

22. The ultrasonic surgical system according to claim 21, further comprising a start signal switch, the output terminal of the start signal switch being connected to the input terminal of the generator, and the start signal switch transmitting a start signal to the generator when the start signal switch is triggered.

23. The impedance fluctuations of the end effector assembly are fed back to the transducer. The ultrasonic surgical system according to claim 21, wherein the transducer generates a current fluctuation or voltage fluctuation corresponding to the impedance fluctuation and transmits the current fluctuation or voltage fluctuation to the generator.

24. The surgical assembly further comprises an inner tube and an outer tube, The inner tube is attached to the waveguide, and the outer tube is attached to the inner tube. The distal end of the outer tube is connected to the jaw assembly, the distal end of the inner tube acts on the jaw assembly, the inner tube slides relative to the outer tube, and drives the jaw assembly to pivot relative to the blade. An ultrasonic surgical system according to any one of claims 21 to 23, wherein a contact portion is provided on the distal side of the inner tube and the outer sheath, and the contact portion prevents a change in the radial gap between the inner tube and the outer tube by forming a support portion between the inner tube and the outer tube, provided that it does not affect the relative sliding motion of the inner tube and the outer tube.

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