Method and device for driving an ultrasonic surgical instrument, and ultrasonic surgical system - Patents.com

Abstract

The method includes the steps of: in response to an initiation signal, supplying a drive signal having a first amplitude range for a first time period to drive a transducer of the ultrasonic surgical instrument; after the first time period, supplying a first transition signal having an amplitude that decreases for a first predetermined interval; after the first predetermined interval, supplying a drive signal having a second amplitude range for a second time period, where an upper limit of the second amplitude range is lower than a lower limit of the first amplitude range; after the second time period, supplying a second transition signal having an amplitude that increases for a second predetermined interval; and after the second predetermined interval, supplying a drive signal having a third amplitude range for a third time period, where 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 February 11, 2022. The entire disclosures of the above patent applications are incorporated herein by reference.

[0002] The present application relates to the field of surgical instruments, and more particularly to methods and devices for driving ultrasonic surgical instruments, and ultrasonic surgical systems. [Background technology]

[0003] Ultrasonic surgical instruments, also called ultrasonic soft tissue cutting and / or coagulation systems, mainly use ultrasonic energy to facilitate soft tissue cutting and coagulation to stop bleeding, and also cause less thermal damage, making them suitable for cutting human soft tissues except bone tissue and fallopian tubes. Ultrasonic surgical instruments and ultrasonic generators are the main components of ultrasonic surgical systems, and ultrasonic surgical instruments include a transducer and an effector. The effector includes a blade and a jaw assembly, and the effector is connected to the transducer through a transmission medium. Upon 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, causing the blade to vibrate at ultrasonic frequencies. The operator can operate on the tissue portion by cooperatively manipulating the blade and jaw assembly to form a suitable pressure, or operate by applying the blade directly to the tissue portion.

[0004] Due to its advantages in hemostasis and thermal injury, ultrasonic surgical instruments are often used to seal blood vessels. The process of sealing blood vessels includes three stages: separating the muscle tissue layer of the blood vessel, sealing and coagulating the blood vessel, and cutting the blood vessel. In different stages, the amplitude and frequency of the driving signal output from the generator are also different, so that the vibration amplitude and frequency of the blade are also changed. Combined with the hand-held force applied by the operator, the acting force between the blade and the jaw assembly changes, which meets the requirement of applying force to the blood vessel in different stages. According to the three stages of sealing the blood vessel, the driving signal output by the generator of the existing solution is a step signal. The amplitude of the signal jumps instantly from a high point to a low point when going from the first stage to the second stage, and the amplitude of the signal jumps instantly from a low point to a high point when going from the second stage to the third stage. This will cause the ultrasonic vibration energy of the blade to change suddenly, which will not only affect the stability of the force applied by the operator and the operating accuracy in the process of sealing the blood vessel, but also affect the tearing force acting on the tissue part, which may cause the blade to break. Summary of the Invention [Means for solving the problem]

[0005] In the present application, a method and device for driving an ultrasonic surgical instrument, and an ultrasonic surgical system are provided. The method includes: In response to the initiation signal, providing a drive signal having a first amplitude range for a first time period to the ultrasonic surgical instrument to drive a transducer of the ultrasonic surgical instrument; providing a first transition signal having an amplitude that decreases at a first predetermined interval to drive the transducer after the first period of time; after the first predetermined interval, providing a drive signal having a second amplitude range for a second period to drive the transducer, an upper limit of the second amplitude range being lower than a lower limit of the first amplitude range; after the second period of time, providing a second transition signal having an amplitude that increases at a second predetermined interval to drive the transducer; after the second predetermined interval, providing a drive signal having a third amplitude range for a third period to drive the transducer, the lower limit of the third amplitude range being higher than the upper limit of the second amplitude range; At least one of the first and second predetermined intervals is greater than (ie, greater than) zero.

[0006] Additionally, the present application provides a generator for driving an ultrasonic surgical instrument, the generator comprising a processor chip, the processor chip being 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, whereby the generator outputs a drive signal to the ultrasonic surgical instrument.

[0007] Further, in the present application, there is provided an ultrasonic surgical system comprising an ultrasonic surgical instrument and a generator according to the above solution, The ultrasonic surgical instrument includes 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 includes a waveguide and an end effector assembly disposed at a distal end of the waveguide and used to operate on tissue; The ultrasonic vibration signal is transmitted from the waveguide to an end effector assembly, and ultrasonic energy generated by the end effector assembly acts on the tissue being operated on.

[0008] While this specification concludes with claims that particularly point out and distinctly claim the present disclosure, it is believed that the disclosure will be best understood from the detailed description of specific embodiments thereof when read in conjunction with the accompanying drawings. Unless the context dictates otherwise, like numbers are used in the drawings to identify like elements of the drawings. In addition, some of the figures may be simplified by omitting certain elements to more clearly show other elements. Such omission does not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless it may be expressly stated in the corresponding detailed description. [Brief description of the drawings]

[0009] [Figure 1] 1 is a schematic diagram of an integrated structure of an ultrasonic surgical instrument according to one embodiment of the present invention; [Diagram 2] FIG. 2 is a schematic structural diagram of a transmission assembly according to an embodiment of the present application; [Diagram 3] FIG. 1 is a schematic diagram of an ultrasonic energy generation and transmission process of an ultrasonic surgical instrument according to an embodiment of the present application. [Figure 4] 1 is a flow chart of a method for driving an ultrasonic surgical instrument according to one embodiment of the present invention. [Figure 5a] 4 is a schematic diagram of a waveform of a driving signal according to an embodiment of the present application; [Figure 5b] 4 is a schematic diagram of a waveform of a driving signal according to an embodiment of the present application; [Figure 5c] 4 is a schematic diagram of a waveform of a driving signal according to an embodiment of the present application; [Figure 5d] 4 is a schematic diagram of a waveform of a driving signal according to an embodiment of the present application; [Figure 5e] 4 is a schematic diagram of a waveform of a driving signal according to an embodiment of the present application; [Figure 6] FIG. 2 illustrates a curve of the change in vessel wall thickness in the process of sealing a vessel according to an embodiment of the present application. [Figure 7]FIG. 2 is a schematic diagram illustrating a waveform of a driving signal according to an embodiment of the present application. [Figure 8] 1 is a flow chart illustrating conditioning a signal in a method for driving an ultrasonic surgical instrument according to an embodiment of the present application. [Figure 9] FIG. 13 is a schematic diagram showing a waveform of a driving signal according to another embodiment of the present application. [Figure 10a] FIG. 1 is a structural block diagram of an ultrasonic surgical system according to an embodiment of the present disclosure. [Figure 10b] FIG. 1 is a structural block diagram of an ultrasonic surgical system according to an embodiment of the present disclosure. [Figure 11] FIG. 2 is an exploded view of an end effector assembly in a partially closed state according to an embodiment of the present application. [Figure 12] FIG. 12 is an exploded view of the end effector assembly shown in FIG. 11 in a partially open state. [Figure 13] FIG. 2 is a schematic diagram of an end effector assembly in a partially closed state according to an embodiment of the present application. [Figure 14a] 1A-1C are comparative diagrams of deformations of ultrasonic surgical instruments of the prior art and the present application when the end effector assembly clamps a blood vessel. [Figure 14b] 1A-1C are comparative diagrams of deformations of ultrasonic surgical instruments of the prior art and the present application when the end effector assembly clamps a blood vessel. [Figure 15a] FIG. 1 is a comparison diagram of the experimental results of sealing blood vessels between the present application and the prior art. [Figure 15b] FIG. 1 is a comparison diagram of the experimental results of sealing blood vessels between the present application and the prior art. [Figure 15c] FIG. 1 is a comparison diagram of the experimental results of sealing blood vessels between the present application and the prior art. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The following detailed description describes examples of embodiments of the present disclosure solely for the purpose of enabling those skilled in the relevant art to make and use the present invention. As such, the detailed description and illustrations of these embodiments are purely exemplary in nature and are not intended to limit the scope of the present disclosure or its protection in any manner. It should also be understood that the drawings are not to scale and that in some cases details not necessary for understanding the present disclosure have been omitted.

[0011] In the description of this application, it should be noted that the orientations or positional relationships indicated by words such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and similar words are orientations or positional relationships based on the accompanying drawings, which are merely for ease and simplification of the description of this application, and are not intended to indicate or imply that the indicated devices or elements have a particular orientation or must be fabricated or operated in a particular orientation, and therefore cannot be understood as limiting this application. Furthermore, the words "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying a relative importance.

[0012] In the description of this application, unless otherwise specified or limited, the terms "attached", "associated", "connected" and similar expressions should be understood in a broad sense, for example, the connection may be a fixed connection, a detachable connection or an integral connection, a direct connection, an indirect connection through an intermediate medium, or an internal communication between two elements. The specific meanings of the above terms in this application may be understood by those skilled in the art according to specific conditions. In addition, the technical features related to different embodiments of this application described below may be combined with each other unless they are inconsistent with each other.

[0013] In various embodiments of the present application, the "distal end / side" refers to the end / side of a surgical instrument that is farther away from the operator when the surgical instrument is manipulated, and the "proximal end / side" refers to the end / side of a surgical instrument that is closer to the operator when the surgical instrument is manipulated.

[0014] The following embodiments of the present application generally relate to an ultrasonic surgical system that may be used to transect, coagulate, and / or clamp tissue during surgery. FIGS. 1 to 3 show schematic structural diagrams of one particular embodiment of the ultrasonic surgical system of the present application. The ultrasonic surgical system includes an ultrasonic surgical instrument. The ultrasonic surgical instrument includes a surgical assembly and a transducer 10. The surgical assembly includes a handle assembly 20, a transmission assembly 30, and an end effector assembly 40, which are sequentially arranged from a proximal end to a distal end. By inserting the transducer 10 into the handle assembly 20, the proximal end of the surgical assembly is connected to and assembled with the distal end of the transducer 10. The ultrasonic surgical system further includes a generator 50 configured to supply ultrasonic energy. The transducer 10 is operatively connected to a generator 50 through 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 an operator to manipulate 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 may be grasped by the operator in a variety of ways. In one particular embodiment, the operating assembly of the ultrasonic surgical instrument is 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 hand grip 22 extending downwardly from the main housing 21. The handle assembly 20, and in particular its hand grip 22, is adapted to be held by a medical practitioner, thereby facilitating gripping and manipulation of the instrument while isolating the operator from ultrasonic vibrations during use. A trigger 23 is supported on the handle assembly 20 to pivot toward and away from the hand grip 22 to cause pivoting of a clamp arm assembly 42 disposed at the distal end of the transmission assembly 30. The handle assembly 20 comprises a hand switch 24, which is used to be pressed toward the hand grip 22 to control the operation of the instrument, for example, to enable an ultrasonic generator to output and vibrate an ultrasonic blade 41. The end effector assembly 40 clamps (i.e., applies pressure to) tissue when the end effector assembly 40 closes, and simultaneously performs cutting and coagulation of the tissue under the action of ultrasonic energy. The force acting on the tissue in the form of ultrasonic energy may be defined as a load force. The proximal end of the main housing 21 is open to receive the ultrasound transducer 10 to be inserted therein.

[0016] The end effector assembly 40 includes a blade 41 and a jaw assembly 42 (also referred to as a clamp arm) that can be operatively actuated to pivot toward or away from the ultrasonic blade 41 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 away from the blade 41. In the closed position, the jaw assembly 42 biases against 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 away from the handle assembly 20 of the instrument. The transmission assembly 30 includes a waveguide 31 for transmitting ultrasonic energy provided 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 axially mounted with respect to the handle assembly 20, and a jaw assembly 42 is pivotally connected to the outer tube 33. A proximal portion of the inner tube 32 is coupled to an actuation mechanism of the handle assembly 20, and a distal portion is coupled to the jaw assembly 42. The inner tube 32 is actuated via an actuation mechanism to reciprocate axially with respect to the outer tube 33, further actuating the jaw assembly 42 to pivot about the outer tube 33. The jaw assembly 42 includes a clamp pad 43. The jaw assembly 42, along 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 in register with the blade 41, and the jaw assembly 42 pivots to position the clamp pad 43 substantially parallel to and in contact with the blade 41, thereby defining a tissue treatment area. With this configuration, tissue is clamped 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 together through a bayonet connector assembly disposed within the main housing 21, such that the waveguide 31, outer tube 33, and inner tube 32, as a whole, may be rotated with the ultrasonic transducer 10 relative to the handle assembly 20 using a knob 35. The waveguide 31 extends into the main housing 21 of the handle assembly 20 through the knob 35. In use, the outer tube 33 and the waveguide 31 may be rotated through rotation of the knob 35, which allows the end effector assembly 40 and the jaw assembly 42 connected thereto to be adjusted to a required orientation. In use, rotation of the knob 35 relative to the handle assembly 20 causes the outer tube 33, the waveguide 31, and the ultrasonic transducer 10 operably connected thereto to rotate relative to the handle assembly 20.

[0019] Reciprocating motion of the inner tube 32 opens and closes the jaw assembly 42. The force limiting mechanism 36 is operatively 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 includes axially extending lugs that engage with appropriate openings in the proximal portion of the tubular inner tube 32. The inner tube 32 receives an O-ring 367 in a circumferential groove that is used to engage 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 transmission process can be obtained as shown in FIG. 3. The generator 50 outputs a drive signal, which is a signal having a certain current and frequency. The transducer 10 converts the drive signal into an ultrasonic vibration signal, which can be transmitted to the waveguide 31 by the surgical hand switch 24. The waveguide 31 is suitable for transmitting the ultrasonic energy from the transducer 10 to the blade 41 located at the distal end of the waveguide 31, and the waveguide 31 can be flexible, semi-flexible, or rigid. As known to those skilled in the art, the amplitude and / or frequency of the vibration waves propagating along the length of the waveguide 31 can be adjusted by changing the diameter or other corresponding characteristics of the waveguide 31. For example, the amplitude of the mechanical vibration transmitted from the waveguide 31 to the blade 41 can be increased by reducing the diameter, especially the diameter of the vibration node of the waveguide or the diameter near the vibration node of the waveguide. Other features may also be provided on the waveguide 31 to control the gain (positive or negative) of the longitudinal vibration transmitted along the waveguide and to tune the vibration of the waveguide 31 to an ideal resonant frequency for the system. In this manner, the waveguide 31 may be tapered at multiple locations along the waveguide 31 to provide two or more cross sections having different cross-sectional sizes, or with a substantially uniform cross section, or with different cross sections, or may even be tapered along the entire length of the waveguide.

[0021] In various embodiments, the waveguide 31 may be made from various materials, particularly various medically and surgically acceptable metals, such as titanium, titanium alloys (e.g., Ti6Al4V), aluminum, aluminum alloys, or stainless steel. In some embodiments, such as the embodiment shown in the drawings, the blade 41 and the waveguide 31 are formed as a single unit, e.g., machined from a single metal bar that is milled to provide the desired characteristics. Alternatively, the waveguide 31 and the ultrasonic blade 41 may include two or more separable components of the same but of different composition, the components being bonded together, e.g., by adhesives, welding, threaded studs, and / or other suitable methods known to those skilled in the art. For example, the ultrasonic blade 41 may be connected to the waveguide by a threaded connection, a welded joint, or other coupling mechanism.

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

[0023] In various embodiments of the present application, a method for driving an ultrasonic surgical instrument is provided. As shown in FIG. 4, the method includes the following steps:

[0024] In S10, this step is to separate the muscular layer of the blood vessel, which is The method includes providing a drive signal having a first amplitude range for a first time period to drive a transducer of the ultrasonic surgical instrument in response to the initiation signal, the transducer being actuated by the drive signal having the first amplitude range, which causes the blade 41 to vibrate with a relatively high ultrasonic vibration energy to rapidly desiccate the wall of the blood vessel.

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

[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 taken as the start of the second period, and alternatively, if the second predetermined interval is determined to be zero, the end of the second period is taken as 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 seal or coagulate the blood vessel.

[0027] In S30, this step is for the cutting of the blood vessel, which After the second predetermined interval, the method includes providing a drive signal having a third amplitude range for a third period to actuate the transducer, the lower limit of the third amplitude range being higher than the upper limit of the second amplitude range, in which 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 and cut the blood vessel.

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

[0029] More specifically, for the step of separating the muscle 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 actuated to perform separation of the muscle layer of the blood vessel. In this step, the wall of the blood vessel is quickly dried. The drive signal in the first period is given a relatively high amplitude to provide a relatively high energy to the end effector assembly 40 to facilitate separation of the muscle layer. As shown in the figure, t 10 denotes the start time of the first period, and t 11 refers to the end time of the first period.

[0030] The step of sealing or coagulating the blood vessel begins at the end of the first period, t 11 The third period starts at time t 30 In this phase, the transducer is driven by the 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 and seal or coagulate the vessel. In this phase, 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 and the end time of the second period is t 21 The drive signal during the second period is given a low amplitude to provide relatively low energy to the end effector assembly 40 to facilitate sealing or coagulating the vessel and to prevent carbonation of the vessel wall caused by excessive energy of the end effector assembly 40.

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

[0032] As shown in the figure, the drive signal having a decreasing amplitude is applied from the start time t 20 to the end time t of the first period 11 and / or a drive signal having an increasing amplitude is provided for a first predetermined interval Δt1 until a start time t 30 to the end time t of the second period 21 The first signal S1 is supplied at a second predetermined interval Δt2 until the end of the first period t3. That is, the amplitude of the drive signal changes more smoothly, avoiding a step change in the drive signal. FIG. 5A illustrates the situation of setting the transition time when the first signal S1 changes to the second signal S2. As shown in the figure, the end time t 11 At this point, the amplitude of the signal is A 11 and the start time of the second period is t 20 At this point, the amplitude of the signal is A 12 If the signal amplitude is A 11 From A 12 In the process of changing to the third signal S3, the first predetermined interval Δt1 is defined as the transition time. Figure 5b shows the situation of setting the transition time of the change phase from the second signal S2 to the third signal S3. As shown in the figure, the end time t 21 At this point, the amplitude of the signal is A 13 and the start time of the third period is t 30 At this point, the amplitude of the signal is A 14 If the signal amplitude is A 13 From A14 In the process of changing to the second period, the second predetermined interval Δt2 is defined as the transition time. 20 and the end time of the second period t 21 It should be noted that in the waveforms shown in the above figures, 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 the signal amplitude of the first signal S1 in the first period (as shown in Figures 5a and 5b) or the same as the signal amplitude of the first signal S1 in the first period (as shown in Figures 5c to 5e). However, in the practical application of this method, the signal amplitude will fluctuate to some extent at each stage, i.e., the amplitude A 11 Or A 12 , A 13 Or A 14 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 the first predetermined interval Δt1 and / or the second predetermined interval Δt2. An alternative solution is a predetermined interval for the change between the two phases to realize a slow transition of the amplitude change of the signal.

[0033] According to the above solution of this embodiment, a first predetermined interval Δt1 is set between the first signal S1 and the second signal S2 for transition, or a second predetermined interval Δt2 is set between the second signal S2 and the third signal S3 for transition, or a transition time is set for both phase changes at the same time, and the step change signals in the two phases are partially or completely adjusted to transition within a certain time period. Therefore, this has a certain buffer when the ultrasonic energy transmitted to the blade 41 changes between high power and low power, which can effectively improve the operator's operating precision on the ultrasonic instrument, reduce the impact on the sudden change of tissue tearing force, and avoid the damage of the blade.

[0034] In the above solution, when a first predetermined interval Δt1 and a second predetermined interval Δt2 are provided, the amplitude of the signal varies linearly (as shown in FIG. 5d) or non-linearly (as shown in FIGS. 5a to 5c and 5e).

[0035] In order to shorten the operation time for transecting a large diameter vessel and successfully sealing or coagulating the vessel, a load force corresponding to the thickness of the vessel wall must be applied. For example, the amplitude of the transition signal between the second signal S2 and the first signal S1, and also between the second signal S2 and the third signal S3, change nonlinearly, so as to better match the change in the vessel wall thickness and coagulate and cut the vessel. That is, when the first predetermined interval Δt1 is greater than or above zero, the amplitude of the first transition signal provided to the ultrasonic surgical instrument for the first predetermined interval Δt1 decreases according to a first nonlinear curve, and when the second predetermined interval Δt2 is greater than or above zero, the amplitude of the second transition signal provided to the ultrasonic surgical instrument for the second predetermined interval Δt2 increases according to a second nonlinear curve, so that the change in the vessel wall thickness during the sealing process follows the curve shown in FIG. 6.

[0036] In particular, the waveforms of the first transition signal and the second transition signal provided in this embodiment are shown in FIG. 7. Here, the equation of the first nonlinear curve is A=(A 11 -A 12 )×sinΦ+A 11 , Φ∈(180°,270°), A is the amplitude of the first transition signal, and A 11 is the amplitude of the signal at the end of the first period, and A 12 is the amplitude of the signal at the start time of the second period, the start time Φ of the first predetermined interval Δt1 is 180°, and the end time Φ of the first predetermined interval Δt1 is 270°. The second curve is 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 Δt2 is 0°, and the end time Φ of the second predetermined interval Δt2 is 90°. In FIG. 7, the second signal S2 of the second period is a signal having a constant amplitude, so A 13 =A 12 If the second signal S2 in the second period is a signal having a fluctuating amplitude as shown in FIG. 13 and A 12 may be different. In this solution, the amplitude change of the drive signal from the first signal S1 to the second signal S2 follows a sine curve, and similarly, the amplitude change of the signal from the second signal S2 to the third signal S3 follows a sine curve, so that the amplitude change of the drive signal can well adapt to the process of wall thickness change in the process of sealing the blood vessel. In this solution, the drive signal in FIG. 7 is described by taking a current signal as an example. It will be understood that since the current and voltage can be converted according to Ohm's law, the voltage can be obtained through the conversion by combining the impedance with the current. Therefore, the drive signal provided in one of the embodiments of the present application can also be configured as a current signal or a voltage signal.

[0037] As shown in FIG. 7, when the ultrasonic surgical system is adapted for sealing a blood vessel, the amplitude changes of the three stages of the signal are as follows: The end effector assembly 40 is driven to perform a stage of separating the muscle tissue layer of the blood vessel, and the driving signal is given a constant amplitude to quickly dry the blood vessel wall. The duration of this stage can be determined according to the time when the muscle layer separation of the blood vessel is completed, and whether the muscle layer separation of the blood vessel is completed can be determined according to the impedance fed back by the end effector assembly 40. In this stage, the ultrasonic energy with a constant power supplied by the blade 41, combined with the force applied by the operator, can separate the muscle 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 at which coagulation of the blood vessel is completed, and whether coagulation of the blood vessel is completed 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 the blood vessel, and the drive signal is provided with a constant amplitude (which 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 transected.

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

[0041] In S40, the current or voltage value variation fed back by the ultrasonic surgical instrument is obtained, where the current or voltage variation is determined according to the impedance variation fed back by the end effector assembly 40. With reference to FIG. 3 and the principle of ultrasonic energy generation and transmission in an ultrasonic surgical system, during the process of sealing a blood vessel, the characteristic change of the blood vessel wall (such as the wall thickness of the blood vessel, the tissue properties of the blood vessel, etc.) leads to the impedance change of the end effector assembly 40, which can be fed back to the transducer 10 along the transmission path of the ultrasonic vibration and change the current or voltage value of the transducer 10. This step is performed in real time during the process of sealing a blood vessel. At that time, the obtained current or voltage variation is 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 a current operation stage performed by the end effector assembly 40, for example, when the end effector assembly 40 performs a stage of separating a muscle tissue layer of a 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 performs a stage 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 time lengths of the first period, the second period, and the third period according to the current or voltage fluctuation. Similar to step S50, in this step, the adjusted periods are also determined according to the surgical stage currently being performed by the end effector assembly 40, that is, the amplitude of the signal is adjusted in real time according to the current or voltage fluctuation fed back by the ultrasonic surgical instrument, or the waveform of the signal is adjusted in real time in the process of sealing the blood vessel.

[0044] Alternatively, in the above method, the step S60 of adjusting the duration of the transition signal may be further included in the step of adjusting the end effector assembly 40 to perform the steps of sealing and coagulating the blood vessel, in particular If the first predetermined interval Δt1 is greater than zero (ie, larger than zero), the above method includes: S601: determining a time length of the first predetermined interval Δt1 according to a current fluctuation or a voltage fluctuation.

[0045] If the second predetermined interval Δt2 is greater than zero (ie, larger than zero), the method includes: S602: determining a time length of the second predetermined interval Δt2 according to a current fluctuation or a voltage fluctuation.

[0046] In addition, in the process of realization, the first predetermined interval Δt1 and the second predetermined interval Δt2 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 experience or experimental calibration.

[0047] As described above, the impedance value of the end effector assembly 40 also changes due to the change in vascular tissue characteristics during the stage of sealing and coagulating a blood vessel 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 change in the process of sealing a blood vessel, and the small fluctuation range can avoid unnecessary tearing of the blood vessel or tissue caused by the energy fluctuation 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 set value. Taking the waveform diagram shown in FIG. 9 as an example, the signal provided over the second period is configured as a periodic signal, and in particular, the periodic signal can be represented by the function B=A5-set value×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 time length of the second period. In the above, since the end effector assembly 40 needs to continuously act on the blood vessel with low energy to completely coagulate the blood vessel in the stage of sealing and coagulating the blood vessel, 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 the carbonation of the blood vessel caused by the excessively high amplitude or long duration of the signal in the second period, which affects the sealing and coagulation effect. On this premise, the selection of the set value in the above function is adapted to the low energy value required by the blade 41 in the stage of coagulating the blood vessel, which can be obtained by calibration experiments or empirical values. 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 vessel, and the periodic fluctuation in the sine wave mode can better reflect the impedance change in the process of sealing and coagulating the blood vessel.

[0048] The embodiment of the present application further provides 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 includes 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 to perform the method steps provided in the above method embodiments, so that the generator 50 outputs a drive signal to the ultrasonic surgical instrument as shown in Figures 5a to 5e, or Figures 7 and 9. The processor chip 501 can directly output a waveform signal that meets the requirements of the drive signal through the preset program information, i.e., the amplitude and duration of each step of the signal meet the drive requirements of the ultrasonic surgical instrument. Alternatively, as shown in Fig. 10b, the processor chip 501 is connected with the signal conditioning circuit 502, the processor chip 501 outputs a preset waveform signal (as an initial signal) after executing the program information, and the signal conditioning circuit 502 processes the preset waveform signal into a driving 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, which can amplify the initial signal with a smaller amplitude into a driving signal that meets the driving requirements. The function of the signal conditioning circuit 502 is adapted to meet the initial signal output by the processor chip 501 and the driving requirements, and besides the amplification function, the signal conditioning circuit may have a conversion function and a filtering function.

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

[0050] The above generator for driving the ultrasonic surgical instrument can output a driving signal to an end effector assembly 40 of the ultrasonic surgical instrument. The blade 41 in the end effector assembly 40 is driven by the driving signal to generate ultrasonic energy suitable for different stages in the process of sealing the vessel, which, combined with the clamping force applied by the operator to the end effector assembly 40, can quickly complete the sealing of the vessel.

[0051] The embodiment of the present application further provides an ultrasonic surgical system. The system includes an ultrasonic surgical instrument and a generator 50 provided by the above embodiment. The ultrasonic surgical instrument includes a transducer 10 and a surgical assembly. The transducer 10 receives a driving signal output by the generator 50 and converts the driving signal into an ultrasonic vibration signal. The surgical assembly includes a waveguide 31 and an end effector assembly 40 arranged at a distal end of the waveguide 31 and used to operate on 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 to be operated on. In the embodiment of the present application invention, a blood vessel is taken as an example of a tissue to be operated on, but the ultrasonic surgical system may be applied to cutting, coagulating, and / or clamping other tissues other than blood vessels.

[0052] As shown in FIG. 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 the like). When the generator 50 receives a start signal from the start signal switch 50A (in the figure, the signal receiving end of the processor chip 501 is used as the signal receiving end of the generator 50), the processor chip 501 can execute the preset program information pre-stored therein and output a preset waveform signal. The preset waveform signal is processed by the signal conditioning circuit 502 to form a driving signal, which is input into the transducer 10. After ultrasonic vibration, the blade 41 of the end effector assembly 40 cooperates 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 fluctuation or a voltage fluctuation of the transducer 10. The impedance detection circuit 503 can detect the current fluctuation or the voltage fluctuation, process the current fluctuation or the voltage fluctuation into a digital signal, and feed back the digital signal to the processor chip 501. The processor chip 501 can determine the impedance variation according to the current value or voltage variation, adjust the initial waveform according to the impedance variation, and change the amplitude of the driving signal to change the ultrasonic energy of the end effector assembly 40, so that the end effector assembly 40 can generate ultrasonic energy corresponding to the characteristic variation of the operated tissue at any stage, and can well meet the operating requirements of the operated tissue.

[0053] In addition, the driving current waveform proposed in the above embodiment of the present application is expressed according to the effective value of the current, and the effective value is a value for measuring the magnitude of the AC current. The specific calculation process is that when an AC current passes through a resistor, the heat generated in one cycle is equal to the heat generated by a DC current passing through the resistor in the same time, and the magnitude of the DC current is the effective value of the AC current, so the effective value can be calculated according to the instantaneous value of the current. In specific applications, the instantaneous value or the effective value can be selected as the variable to display. When the driving signal in the above embodiment of the present application controls the operation of the blade 41, in the process of sealing and coagulating a blood vessel with a larger diameter, it has been verified that when the signal of each stage operates at a resonant frequency and both ends of the second signal S2 in the second period form a sinusoidal curve to realize the signal transition, the ultrasonic vibration energy of the blade 41 can achieve a maximum output value within a unit time on the premise of meeting the requirements of blood vessel sealing, so that the entire sealing process takes a short time.

[0054] Based on the driving 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 with the structure of the existing blade 41 with a heat dissipation film (the prior art needs to vibrate the blade for a long time, so more heat is generated and the blade needs to be additionally provided with a heat dissipation film), the present application can realize that the exterior of the blade 41 does not need to be coated with a heat dissipation film. The heat dissipation film coated on the existing blade 41 not only increases the cost of the instrument, but also may fall onto the human body under the condition of high-frequency vibration, which is easy to cause a rejection reaction in the human body. In this solution, the blade 41 effectively solves the above problems after omitting the heat dissipation film.

[0055] In the above-mentioned ultrasonic surgical system, when the end effector assembly 40 clamps a vessel, the blade 41 needs to be matched with the jaw assembly 42 to apply a load force to tissue in a conventional usage scenario (such as sealing and coagulating a vessel with a diameter of about 5 mm or less). In particular, as shown in FIG. 11 and FIG. 12, the pivoting 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 are engaged 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 through 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 to pivotally connect the jaw assembly 42 to the outer tube 33. The inner tube 32 moves along the longitudinal axis of the outer tube 33. A pivot pin 422 of the jaw assembly 42 engages a pivot hole 321 in the distal end of the inner tube 32. Thus, reciprocating movement 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 hand grip 22 moves the inner tube 32 proximally, thereby pivoting the jaw assembly 42 toward the blade 41. The pulling action provided by the trigger 23 and cooperating hand grip 22 helps to conveniently and effectively manipulate and position the instrument, and operates the jaw assembly 42 at the distal end of the instrument to pivot toward the blade 41, thereby effectively biasing and pushing tissue against the blade 41. Movement of the trigger 23 away from the hand grip 22 moves the inner tube 32 distally, thereby pivoting the jaw assembly 42 away from the blade 41.

[0056] As shown in FIG. 13, a number of grooves or notches are formed on the outer periphery of the waveguide 31 for mounting the sealing support 39. The grooves are disposed at the nodes of the waveguide 31. Since the amplitude of the ultrasonic waves at the nodes of the waveguide 31 is zero, the sealing support 39 is disposed at this position and can effectively support the waveguide 31 without affecting the ultrasonic transmission of the waveguide 31. The sealing support 39 is particularly a sealing rubber ring disposed in the groove, and the sealing rubber ring is made of a flexible material such as silica gel. The sealing support 39 disposed at the farthest node is closest to the end effector assembly 40, and the sealing support 39 can also prevent tissue residues generated during cutting of the end effector assembly 40 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 coagulating a vessel with a larger diameter, the trigger 23 needs to be operated with a larger force to clamp the vessel. The force of the jaw assembly 42 in the Z direction becomes larger, and the blade 41 has a tendency to move in the Z direction. If there is an assembly gap between the inner tube and the outer tube, the blade 41 will be allowed to move in the Z direction. As shown in FIG. 13, the waveguide 31 fastened or integrated with the blade 41 abuts the inner tube 32 without a gap through the sealing support 39, and an assembly gap is provided between the inner tube and the outer tube. As shown in FIG. 14a, the straight line formed by the pair of pivot joints is inclined to the left (or it can 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. There is a large gap at the proximal end W, and the pressure is low when the end effector assembly clamps the vessel. At this time, it is easy to see that the blood vessel clamped at the distal end has completed transecting / hemostasis under the action of pressure and energy, but the blood vessel clamped at the proximal end has not completed transecting / hemostasis, that is, the force consistency of the end effector assembly 40 acting on a blood vessel with a larger diameter is poor, resulting in the problem that some blood vessels are not cut or are not easily coagulated.

[0058] In the above embodiments provided by the present application, the drive signal can be controlled to cause the blade 41 to output sufficiently high ultrasonic energy per unit time, so that the operator can appropriately reduce the clamping force from the operator in controlling the action of the jaw assembly 42, and the decrease in the consistency of the load force of the end effector assembly 40 can be mitigated.

[0059] Furthermore, when the end effector assembly 40 seals and coagulates vessels with larger diameters, it is necessary to gradually decrease the force applied to the blade 41 from the proximal end to the distal end in order to make the loading situation of the blade 41 consistent from the proximal end to the distal end. Alternatively, this embodiment provides abutments 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, so that the gap between the distal ends of the inner tube and the outer tube is close to zero and the radial gap between the inner tube and the outer tube can be prevented from changing without affecting the relative sliding movement of the inner tube and the outer tube, i.e., the displacement of the inner tube 32 along the Z direction is close to zero when the blade 41 is subjected to the force applied by the jaw assembly 42 along the Z direction, which can prevent the radial gap between the inner tube and the outer tube from changing. As shown in FIG. 14b, when the jaw assembly 42 pivots toward the blade 41 to seal and coagulate a larger diameter vessel, the position displacement of the blade 41 in the radial Z direction decreases with the support of the distal ends of the inner tube 32 and the outer tube 33, and becomes almost zero. 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 that the force on the blade 41 gradually increases from the distal end to the proximal end. More specifically, the inner side of the abutment abuts against the outer wall of the inner tube 32 or is integrally formed with the outer wall of the inner tube 32, and the outer side of the abutment 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 an abutment on the distal end side. In some ways, the abutment is at least one clamp piece P arranged between the inner tube 32 and the outer tube 33. By arranging the clamp piece P independently of the inner tube 32 and the outer tube 33, it is possible to reduce the difficulty of processing the inner tube 33 and the outer tube 33. More specifically, the surface of the clamp piece P is shaped as an arc surface that matches the wall surfaces of the inner tube 32 and the outer tube 33, so that the clamp piece P has a large contact area with the outer wall of the inner tube 32 and the inner wall of the outer tube 33, and stably supports the waveguide 31.It can be understood that the above implementation of the abutment is merely a schematic diagram, and the clamp piece P can be replaced with other structural members capable of achieving the same function in a specific implementation.

[0060] According to the above solution in this embodiment, by improving the mechanical structure of the end effector assembly 40 and combining with the improved driving signal, the time required to seal a blood vessel with a larger diameter is further shortened, and the consistency of the loading force 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 carry out sealing and coagulation experiments on 60 blood vessel samples with a diameter of about 7 mm, and the effect of this solution is described from two aspects, consisting of the time required for the sealing operation and the verification results of the burst pressure of the sealed blood vessel. In particular, the two instruments are used to carry out the sealing and coagulation of multiple blood vessel samples with a diameter of about 7 mm. After the entire sealing and coagulation process is completed, the burst pressure at the position where the blood vessel is sealed is measured, and the different times required for different sealing operations corresponding to the different burst pressure experimental results are respectively counted. Finally, the verification result of this solution is shown in FIG. 15a, the verification result of the existing product is shown in FIG. 15b, and the comparison result is shown in FIG. 15c.

[0061] The time to perform the sealing operation of the ultrasonic surgical instrument provided by this solution is within the range of 2.8 to 7.2 seconds, the average time to perform the sealing operation is 6.067 seconds, and the standard deviation of the time to perform the sealing operation is 0.928 seconds. After completing the vessel sealing operation, the average burst pressure at the vessel sealed position is 1186.1 mmHg, and the standard deviation obtained by the burst pressure experiment result is 271.9 mmHg.

[0062] The time to perform the sealing operation of the existing product ranges from 5.4 to 19.4 seconds, the average time to perform the sealing operation is 11.225 seconds, and the standard deviation of the time to perform the sealing operation is 3.485 seconds. After completing the vessel sealing operation, the average burst pressure at the position where the vessel is sealed is 969.71 mmHg, and the standard deviation of the burst pressure is 303.78 mmHg.

[0063] According to the experimental results shown in the figures, when sealing a blood vessel with a diameter of about 7 mm, the solution of the present application can obviously use a shorter sealing time and obtain better sealing results. With this solution, the vessel sealing efficiency can be further improved under the premise of ensuring the quality of vessel sealing. [Explanation of symbols]

[0064] F Distal end P Clamp piece W Proximal end 10 Transducer 20 Handle Assembly 21 Main Housing 22 Hand Grip 23 Trigger 24 Surgical hand switch 30 Transmission Assembly 31 Waveguide 32 Inner tube 33 Outer tube 35 Knob 36 Force-Limiting Mechanism 40 End Effector Assembly 41 Ultrasonic Blade 42 Clamp arm assembly 43 Clamp Pad 50 Generator 321 Pivot hole 331 Second Through Hole 361 Tube Color Cap 362 Distal washer 363 Distal Wave Spring 364 Proximal washer 365 Proximal Wave Spring 366 Color 367 O-ring 421 First through hole 422 Pivot pin 501 Processor Chip 502 Signal conditioning circuit 503 Impedance detection circuit

Claims

1. 1. A method for driving an ultrasonic surgical instrument, comprising: in response to an initiation signal, providing a drive signal having a first amplitude range for a first time period to drive a transducer of the ultrasonic surgical instrument; providing a first transition signal having an amplitude that decreases at a first predetermined interval to drive the transducer after the first period of time; providing a drive signal having a second amplitude range for a second period to drive the transducer after the first predetermined interval, the upper limit of the second amplitude range being lower than the lower limit of the first amplitude range; after the second period of time, providing a second transition signal having an amplitude that increases at a second predetermined interval to drive the transducer; after the second predetermined interval, providing a drive signal having a third amplitude range for a third time period to drive the transducer, a lower limit of the third amplitude range being higher than an 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. 2. The method of claim 1, wherein an amplitude of the first transition signal supplied to the ultrasonic surgical instrument during the first predetermined interval decreases according to a first non-linear curve if the first predetermined interval is greater than zero.

3. The first nonlinear curve is A=(A １１ -A １２ ) × sinΦ + A １１ , Φ∈(180°, 270°), A is the amplitude of the first transition signal, and A １１ is the amplitude of the signal at the end of the first period, A １２ The method of claim 2 , wherein: x is the amplitude of the signal at the beginning of the second period.

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

5. The second nonlinear curve is 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, A １４ The method of claim 4 , wherein: is the amplitude of the signal at a start of the third period of time.

6. 10. The method of claim 1, wherein an amplitude of the first transition signal supplied to the ultrasonic surgical instrument during the first predetermined interval is linearly decreased when the first predetermined interval is greater than zero.

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

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

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

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

11. The sinusoidal signal provided to the ultrasonic surgical instrument during the second time period is determined according to a function B=A ５ - a set value × sin(π × τ / T), B is the amplitude of the signal during the second period of time, τ is a time variable, τ ∈ (0,T), T is the time length of the second period of time, and A ５ The method of claim 10 , wherein: n is an upper limit on the amplitude of the signal during the second period of time.

12. obtaining a current or voltage variation fed back by the ultrasonic surgical instrument, the current or voltage variation being determined according to an impedance variation of an end effector assembly; 2. The method of claim 1, further comprising: adjusting an amplitude of a signal in each period according to the current or voltage fluctuations, each period comprising the first period, the second period, the third period, the first predetermined interval, and / or the second predetermined interval.

13. The method of claim 12 , further comprising determining a time length of the first period, the second period, and the third period according to the current or voltage fluctuations.

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

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

16. 1. A generator for driving an ultrasonic surgical instrument, comprising:

16. A generator comprising a processor chip, the processor chip being preloaded with program information, and when the generator responds to a start signal, the processor chip executes the program information to perform the method of any one of claims 1 to 15, thereby causing the generator to output a drive signal to the ultrasonic surgical instrument.

17. 17. The generator of claim 16, wherein the generator further comprises a signal conditioning circuit, wherein the processor chip outputs a preset waveform signal after executing the program information, and the signal conditioning circuit processes the preset waveform signal into the drive signal.

18. The generator further comprises an impedance detection circuit, the impedance detection circuit being used to detect current or voltage fluctuations fed back by the ultrasonic surgical instrument, convert the current or voltage fluctuations into a digital signal, and feed back the digital signal to the processor chip, the current or voltage fluctuations being determined according to impedance fluctuations of an end effector assembly; 18. The generator of 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. 20. The generator of claim 18, wherein the processor chip adjusts the time lengths of the first period, the second period, and the third period of the drive signal according to the digital signal fed back by the impedance detection circuit.

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

21. 21. An ultrasonic surgical system comprising an ultrasonic surgical instrument and a generator according to any one of claims 16 to 20, The ultrasonic surgical instrument includes a transducer and a surgical assembly; The transducer receives a drive signal provided by the generator and converts the drive signal into ultrasonic vibrations; An ultrasonic surgical system, wherein the surgical assembly comprises a waveguide and an end effector assembly arranged at a distal end of the waveguide and used to operate on tissue, the ultrasonic vibrations being transmitted from the waveguide to the end effector assembly, and ultrasonic energy generated by the end effector assembly acts on the tissue being operated on.

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

23. feeding back impedance variations of the end effector assembly to the transducer; 22. The ultrasonic surgical system of claim 21, wherein the transducer generates current or voltage variations corresponding to the impedance variations and transmits the current or voltage variations to the generator.

24. The surgical assembly further comprises an inner tube and an outer tube; the inner tube is sleeved to the waveguide and the outer tube is sleeved to the inner tube; a distal end of the outer tube connected to a jaw assembly, a distal end of the inner tube acting on the jaw assembly, the inner tube sliding relative to the outer tube and driving the jaw assembly to pivot relative to the blade; 24. An ultrasonic surgical system according to any one of claims 21 to 23, wherein an abutment is provided on the distal side of the inner tube and the outer sheath, the abutment forming a support between the inner tube and the outer tube, thereby preventing a radial gap between the inner tube and the outer tube from changing, provided that the relative sliding movement of the inner tube and the outer tube is not affected.

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