Method for driving ultrasonic surgical operating instrument

Abstract

The invention discloses a method for driving an ultrasonic surgical operating instrument, and a driving electric signal for driving the ultrasonic surgical operating instrument comprises electric signals with different amplitudes output in three time periods, transition time is set for at least one of the electric signal amplitude decreasing process from the first time period to the second time period and the electric signal amplitude increasing process from the second time period to the third time period, and the existing step change of the electric signal amplitude is replaced by a slower decreasing or slower increasing mode. Therefore, the ultrasonic energy transmitted to the tool bit has a certain buffer time during high and low power change, the control precision of an operator on an ultrasonic instrument is effectively improved, the tearing force generated by sudden change of the ultrasonic vibration energy of the tool bit is reduced, and particularly, the condition of tool breakage is avoided.

Description

[0001] This case is a divisional application of patent application No. 202210130249.9, filed on February 11, 2022, entitled "Method, Apparatus and Ultrasonic Surgical System for Driving Ultrasonic Surgical Instruments". Technical Field

[0002] This invention relates to the field of surgical instrument technology, and in particular to a method for driving ultrasonic surgical instruments. Background Technology

[0003] Ultrasonic surgical instruments, also known as ultrasonic soft tissue cutting / hemostasis systems, primarily utilize ultrasonic energy to facilitate the cutting and coagulation of soft tissues, resulting in minimal thermal damage. They are suitable for cutting soft tissues in the human body, excluding bone and fallopian tubes. Ultrasonic surgical instruments and signal generators are key components of an ultrasonic surgical system. The instruments include transducers and actuators. The actuators consist of a blade and a shearing head, connected to the transducer via a transmission medium. During operation, the signal generator outputs a drive electrical signal at a specific frequency and amplitude to the transducer. The transducer converts this signal into mechanical vibration. This vibration is transmitted and amplified through the transmission medium, reaching the blade in the actuator and causing it to vibrate at an ultrasonic frequency. The operator manipulates the blade and shearing head to apply appropriate pressure to the tissue, or directly applies the blade to the tissue.

[0004] Ultrasonic surgical instruments are frequently used for vascular closure due to their advantages in hemostasis and thermal damage control. The vascular closure process includes three stages: separation of the vascular muscle tissue layer, vascular closure and coagulation, and vascular transection. In different stages, the amplitude and frequency of the driving electrical signal output by the signal generator vary, thus altering the vibration amplitude and frequency of the cutting head. Combined with the hand force applied by the operator, this changes the force between the cutting head and the scissors, meeting the force requirements of each stage on the blood vessel. For the three stages of vascular closure, the driving electrical signal output by the signal generator in existing solutions is a step signal. The signal amplitude jumps instantaneously from a high point to a low point between the first and second stages, and from a low point to a high point between the second and third stages. This causes abrupt changes in the ultrasonic vibration energy of the cutting head, affecting not only the operator's force stability and control precision during vascular closure, but also the tearing force applied to the tissue, and potentially leading to cutting head breakage. Summary of the Invention

[0005] The technical problem to be solved by the present invention is that the control precision of existing ultrasonic surgical instruments is easily affected and the blade may break when used for vascular closure.

[0006] To address the aforementioned technical problems, the present invention provides a method for driving an ultrasonic surgical instrument, the method comprising: In response to a start signal, an electrical signal of a first amplitude range is output to the ultrasonic surgical instrument during a first time period to drive the end effector assembly in the ultrasonic surgical instrument. After the first time period ends, within a first set time interval, a first transitional electrical signal with decreasing amplitude is output to the ultrasonic surgical instrument to drive the end effector assembly. After the first set time interval ends, during the second time interval, an electrical signal of a second amplitude range is output to the ultrasonic surgical instrument to drive the end effector assembly, wherein the upper limit of the second amplitude range is less than the lower limit of the first amplitude range. After the second time period ends, a second transitional electrical signal with increasing amplitude is output to the ultrasonic surgical instrument within a second set time interval to drive the end effector assembly; After the second set time interval ends, an electrical signal of a third amplitude range is output to the ultrasonic surgical instrument during a third time period to drive the end effector assembly. The lower limit of the third amplitude range is greater than the upper limit of the second amplitude range. In the above, at least one of the first set time interval and the second set time interval is greater than zero.

[0007] In some embodiments of the present invention, if the first set time interval is greater than zero, the amplitude of the first transition electrical signal output to the ultrasonic surgical instrument within the first set time interval decreases according to the first nonlinear curve.

[0008] In some embodiments of the present invention, the first nonlinear curve is: A = (A 11 - A 12 )×sinΦ+ A 11 Φ∈(180°, 270°), where A is the amplitude of the first transition electrical signal. 11 A represents the amplitude of the electrical signal at the end of the first time interval. 12 This represents the amplitude of the electrical signal at the start of the second time period.

[0009] In some embodiments of the present invention, if the second set time interval is greater than zero, the amplitude of the second transition electrical signal output to the ultrasonic surgical instrument during the second set time interval increases according to the second nonlinear curve.

[0010] In some embodiments of the present invention, the second nonlinear curve is: C = (A 14 - A 13 )×sinΦ+ A13 Φ∈(0°, 90°), where C is the amplitude of the second transition electrical signal, A 13 A represents the amplitude of the electrical signal at the end of the second time period. 14 The amplitude of the electrical signal at the start of the third time period.

[0011] In some embodiments of the present invention, if the first set time interval is greater than zero, the amplitude of the first transition electrical signal output to the ultrasonic surgical instrument within the first set time interval decreases according to a first linear law.

[0012] In some embodiments of the present invention, if the second set time interval is greater than zero, the amplitude of the second transition electrical signal output to the ultrasonic surgical instrument decreases according to a second linear law within the second set time interval.

[0013] In some embodiments of the present invention, the difference between the upper and lower limits of the second amplitude range of the electrical signal output to the ultrasonic surgical instrument during the second time period is less than a set value.

[0014] In some embodiments of the present invention, the electrical signal output to the ultrasonic surgical instrument during the second time period is a periodic signal.

[0015] In some embodiments of the present invention, the periodic signal output to the ultrasonic surgical instrument during the second time period is a sine wave signal.

[0016] In some embodiments of the present invention, the sinusoidal signal output to the ultrasonic surgical instrument during the second time period is represented by the following function: B = A5 - set value × sin(π × τ / T); where B is the amplitude of the electrical signal output during the second time period, τ is a time variable, τ∈(0,T), T is the length of the second time period, and A5 is the upper limit of the amplitude of the electrical signal output during the second time period.

[0017] In some embodiments of the present invention, the method further includes: The change in current or voltage value fed back by the ultrasonic surgical instrument is obtained, and the change in current or voltage value is determined based on the impedance change of the end effector assembly; The amplitude of the electrical signal in each time period is adjusted according to the change in the current or voltage value. Each time period includes the first time period, the second time period, the third time period, the first set time interval, and / or the second set time interval.

[0018] In some embodiments of the present invention, the method further includes: The durations of the first time period, the second time period, and the third time period are determined based on the change in current or voltage values.

[0019] In some embodiments of the present invention, the method further includes: When the first set time interval is greater than zero, the length of the first set time interval is determined based on the change in the current or voltage value; and / or, When the second set time interval is greater than zero, the length of the second set time interval is determined based on the change in the current value or voltage value.

[0020] In some embodiments of the present invention, at least one of the electrical signals output during the first time period, the second time period, and the third time period has a frequency that is the resonant frequency of the ultrasonic surgical instrument.

[0021] The technical solution of the present invention has the following technical effects compared with the prior art: The present invention provides a method for driving ultrasonic surgical instruments. The driving electrical signal for driving the ultrasonic surgical instruments includes electrical signals with different amplitudes output in three time periods. In the process of the decrease in electrical signal amplitude from the first time period to the second time period and the increase in electrical signal amplitude from the second time period to the third time period, at least one process is provided with a transition time. The transition time is replaced by a slower decrease or a slower increase in electrical signal amplitude, so that the ultrasonic energy transmitted to the cutting head has a certain buffer time when the power changes from high to low. This effectively improves the operator's control precision of the ultrasonic instrument, reduces the tearing force caused by the sudden change in ultrasonic vibration energy of the cutting head, and especially avoids the occurrence of cutting head breakage. Attached Figure Description

[0022] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, which will help to understand the purpose and advantages of the present invention, wherein: Figure 1 This is a schematic diagram of the overall structure of the ultrasonic surgical instrument according to one embodiment of the present invention; Figure 2 This is a schematic diagram of the structure of the transmission component according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the ultrasonic energy generation and transmission process of an ultrasonic surgical instrument according to an embodiment of the present invention; Figure 4 This is a flowchart of a method for driving an ultrasonic surgical instrument according to an embodiment of the present invention; Figures 5a-5e This is a waveform diagram of the driving electrical signal described in an embodiment of the present invention; Figure 6This is a curve showing the change in vessel wall thickness during the vessel closure process described in an embodiment of the present invention; Figure 7 This is a waveform diagram of the driving electrical signal described in an embodiment of the present invention; Figure 8 This is a flowchart illustrating the adjustment of electrical signals in a method for driving an ultrasonic surgical instrument according to an embodiment of the present invention; Figure 9 This is a waveform diagram of the driving electrical signal according to another embodiment of the present invention; Figure 10a and Figure 10b This is a structural block diagram of the ultrasonic surgical system described in an embodiment of the present invention; Figure 11 This is an exploded view of the end effector assembly in a partially closed state according to an embodiment of the present invention; Figure 12 for Figure 11 An exploded view of the end effector assembly in its partially open state; Figure 13 This is a schematic diagram of the partially closed state of the end effector assembly according to an embodiment of the present invention; Figure 14a and Figure 14b A comparison diagram showing the deformation of the existing technology and the ultrasonic surgical instrument of the present invention when the end effector assembly clamps a blood vessel; Figures 15a-15c This is a comparison chart of the vascular closure test results between this solution and existing technical solutions. Detailed Implementation

[0023] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0024] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, the technical features involved in the different embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0025] In various embodiments of the present invention, "distal / side" refers to the end of the surgical instrument that is far from the operator when it is operated, while "proximal" refers to the end / side of the surgical instrument that is close to the operator when it is operated.

[0026] The following embodiments of this application generally relate to an ultrasonic surgical system that can be used to cut, coagulate, and / or clamp tissue during surgical procedures. Figures 1 to 3 The diagram shows a specific embodiment of the ultrasonic surgical system of this application. The ultrasonic surgical system includes ultrasonic surgical instruments, which include an operating component and a transducer 10. The operating component includes a handle assembly 20, a transmission component 30, and an end effector assembly 40 arranged sequentially from proximal to distal. The transducer 10 is inserted into the handle assembly 20, and the proximal end of the operating component is connected to and assembled with the distal end of the transducer 10. The ultrasonic surgical system also includes a signal generator 50 for generating and outputting a drive electrical signal. The transducer 10 is connected to the signal generator 50 via a cable, converting the power of the drive electrical signal output by the signal generator 50 into mechanical power, i.e., ultrasonic energy, which is then transmitted. The transmission component 30 transmits the ultrasonic energy to the end effector assembly 40. The handle assembly 20 is adapted for operation by a user, and the handle assembly 20 can control the movement of the end effector assembly 40 via the transmission component 30 for cutting / hemostasis operations. The handle assembly 20 can be shaped to be held by a user in a conventional manner. In one specific embodiment, the operating components of this ultrasonic surgical instrument manipulate the end effector assembly 40 to close via a trigger-like configuration.

[0027] Handle assembly 20 includes a main housing 21 and a handle 22, which extends downward from the main housing 21. Handle assembly 20 is adapted to be held by a medical practitioner during use to facilitate the grasping and manipulation of surgical instruments while isolating the practitioner from ultrasonic vibrations. A trigger 23 is mounted on handle assembly 20 for pivoting toward and away from handle 22, thereby causing the end effector assembly 40 to close. A button 24 is provided on handle assembly 20 for pressing toward the handle, thereby causing ultrasonic energy application to end effector assembly 40. End effector assembly 40 clamps tissue (i.e., applies pressure to tissue) during the closing action, while simultaneously performing tissue cutting / hemostasis under the action of ultrasonic energy; the force acting on the tissue and the ultrasonic energy can be referred to as the loading force. The proximal end of the main housing 21 is open, allowing transducer 10 to be inserted into the interior of the main housing 21.

[0028] The end effector assembly 40 includes a blade head 41 and a scissor head 42 (also called a clamping arm) pivotable relative to the blade head 41. The scissor head 42 has an open position and a closed position. In the open position, at least a portion of the scissor head 42 is spaced apart from the blade head 41. In the closed position, the scissor head 42 is close to the blade head 41 and is used to cut tissue located between the scissor head 42 and the blade head 41.

[0029] The transmission assembly 30 extends distally from the handle assembly 20. The transmission assembly 30 includes a central rod 31 for transmitting the ultrasonic energy of the transducer 10 to the cutter head 41, an inner sleeve 32 fitted onto the central rod 31, and an outer sleeve 33 fitted onto the inner sleeve 32. The outer sleeve 33 is axially fixed relative to the handle assembly 20. The cutter head 42 is pivotally connected to the outer sleeve 33. One end of the inner sleeve 32 is connected to the operating mechanism of the handle assembly 20, and the other end acts on the cutter head 42. The operating mechanism triggers the inner sleeve 32 to reciprocate axially relative to the outer sleeve 33, thereby driving the cutter head 42 to pivot about a pivot axis on the outer sleeve 33. A cutter head pad 43 is connected to the cutter head 42, and the cutter head 42 and the cutter head pad 43 are connected together to the distal ends of the outer sleeve 33 and the inner sleeve 32. A scissor pad 43 is mounted on the scissor head 42 to cooperate with the blade head 41. The pivoting motion of the scissor head 42 positions the scissor pad 43 substantially parallel to and in contact with the blade head 41, thereby defining the tissue treatment area. With this structure, the tissue is held between the scissor pad 43 and the blade head 41.

[0030] The center rod 31, outer sleeve 33, and inner sleeve 32 are connected to each other via a bayonet connector assembly 34, allowing them to rotate as a whole relative to the handle assembly 20 along with the transducer 10 using a knob 35. The center rod 31 extends into the main housing 21 of the handle assembly 20 via the knob 35. During use, the outer sleeve 33 and center rod 31 can be rotated using the knob 35, thereby adjusting the end effector assembly 40 and the connected shear head 42 to the desired orientation. During use, rotation of the knob 35 relative to the handle assembly 20 causes rotation of the outer sleeve 33, center rod 31, and the ultrasonic transducer 10 operably connected thereto relative to the handle assembly 20.

[0031] The reciprocating motion of the inner sleeve 32 drives the shear head 42 to open or close. A force limiting mechanism 36 is operatively connected to the inner sleeve 32 and includes a sleeve cap 361 that secures a distal washer 362, a distal wave spring 363, a proximal washer 364, and a proximal wave spring 365 to a collar 366. The collar 366 includes an axially extending lug that engages with a suitable opening in the proximal portion of the tubular inner sleeve 32. A circumferential groove in the inner sleeve 32 receives an O-ring 367 for engagement with the inner surface of the outer sleeve 33.

[0032] Based on the above description of the structure of the ultrasound surgical system, we can obtain the following: Figure 3 The diagram illustrates the ultrasonic energy transfer process. Signal generator 50 outputs a driving electrical signal, which is an electrical signal with a specific current and frequency. Transducer 10 converts the driving electrical signal into an ultrasonic vibration signal. This ultrasonic vibration signal (ultrasonic energy) can be transmitted to the central rod 31 via operation button 24. The central rod 31 is adapted to transmit ultrasonic energy from transducer 10 to the cutter head 41 located at the distal end of the central rod 31. The central rod 31 can be flexible, semi-flexible, or rigid. As is known to those skilled in the art, the amplitude and / or frequency of the vibration wave propagating along the length of the central rod 31 can be adjusted by changing the diameter of the central rod 31 or other corresponding features. For example, reducing the diameter, especially reducing the diameter near or at the vibration node of the central rod, can increase the amplitude of the mechanical vibration transmitted from the central rod 31 to the cutter head 41. Other features can also be provided on the central rod 31 to control the gain (positive or negative) of the longitudinal vibration transmitted along the central rod, and to adjust the vibration of the central rod 31 to the ideal resonant frequency of the system. Thus, the central rod 31 can have different cross-sectional dimensions, including a substantially uniform cross-section, or it can taper gradually at multiple locations along the central rod 31 to provide two or more segments with different cross-sections, or it can even be tapered along the entire length of the central rod.

[0033] The center rod 31 can be made of a variety of materials, particularly a variety of medically or surgically acceptable metallic materials, such as titanium, titanium alloys (e.g., Ti6Al4V), aluminum, aluminum alloys, or stainless steel. In some embodiments, such as those shown in the figures, the cutter head 41 and the center rod 31 are integrally formed, for example, milled from a metal rod to have the desired features. Alternatively, the center rod 31 and the cutter head 41 can be configured to comprise two or more separable components, which may have the same or different compositions, and the components are connected to each other by means such as bonding, welding, threaded connection, and / or other suitable methods known to those skilled in the art. For example, the cutter head 41 can be connected to the center rod 31 by a threaded connection, welding, or other coupling mechanism.

[0034] As an example, the signal generator 50 and transducer 10 of the embodiment shown in the figures are configured to generate a standing wave with a vibration frequency of approximately 55 kHz. However, other ultrasonic frequencies may also be used, such as those between approximately 20 kHz and approximately 120 kHz.

[0035] Based on the structure and working principle of the aforementioned ultrasonic surgical system, it can be determined that the driving electrical signal plays a crucial role, as it determines the ultrasonic vibration energy of the cutting head 41. Therefore, providing an appropriate driving electrical signal to enable the cutting head 41 to generate appropriate ultrasonic vibration energy at different stages of tissue manipulation is extremely important for the successful completion of surgical procedures. In the following embodiments of this application, a blood vessel is used as the manipulated tissue to illustrate in detail the working principle of the aforementioned ultrasonic surgical system for blood vessel closure.

[0036] This invention provides a method for driving an ultrasonic surgical instrument, such as... Figure 4 As shown, the method includes the following steps: S10: This step corresponds to the separation of the vascular muscle tissue layer, and includes: In response to the start signal, an electrical signal of a first amplitude range is output to the ultrasonic surgical instrument within a first time period to drive the end effector assembly in the ultrasonic surgical instrument. In this step, under the driving action of the electrical signal of the first amplitude range, the end effector assembly 40 generates high ultrasonic vibration energy at the blade 41, which meets the need for rapid drying of the blood vessel wall.

[0037] S20: This step corresponds to the vascular closure and coagulation stage, and includes: S201: After the first time period ends, a first transitional electrical signal with decreasing amplitude is output to the ultrasonic surgical instrument within a first set time interval to drive the end effector assembly. S202: After the first set time interval ends, during the second time interval, an electrical signal of a second amplitude range is output to the ultrasonic surgical instrument to drive the end effector assembly, wherein the upper limit of the second amplitude range is less than the lower limit of the first amplitude range. S203: After the second time period ends, a second transitional electrical signal with increasing amplitude is output to the ultrasonic surgical instrument within a second set time interval to drive the end effector assembly.

[0038] Above, at least one of the first set time interval and the second set time interval is greater than zero. When the first set time interval is zero, the end time of the first time period is taken as the start time of the second time period; when the second set time interval is zero, the end time of the second time period is taken as the start time of the third time period. In this step, the amplitude of the electrical signal driving the ultrasonic surgical instrument is lower than the amplitude of the electrical signal in step S10. Under the driving action of the electrical signal in the second amplitude range, the end effector assembly 40 generates lower ultrasonic vibration energy from the blade 41, which is suitable for the needs of blood vessel coagulation.

[0039] S30: This step corresponds to the blood vessel transection phase, which includes: After the second set time interval ends, an electrical signal with a third amplitude range is output to the ultrasonic surgical instrument during a third time period to drive the end effector assembly. The lower limit of the third amplitude range is greater than the upper limit of the second amplitude range. In this step, the amplitude of the electrical signal driving the ultrasonic surgical instrument is higher than the amplitude of the electrical signal in step S20. Under the driving action of the electrical signal with the third amplitude range, the end effector assembly 40 generates higher ultrasonic vibration energy at the blade 41, which meets the requirements of blood vessel transection.

[0040] Figures 5a-5e Schematic diagrams of various signal waveforms for the electrical signals used to drive the ultrasonic surgical instruments in the above method are provided. Overall, the driving electrical signals include a first time-segment signal S1, a second time-segment signal S2, and a third time-segment signal S3. Under different electrical signal driving, the operation of the end effector assembly 40 corresponds to different stages of blood vessel closure. Specifically: The end effector assembly 40 performs the separation of the muscle tissue layer of the blood vessel: The end effector assembly 40 is driven by a first time period signal S1 to perform the separation of the muscle tissue layer of the blood vessel. During this stage, the blood vessel wall is rapidly dried. The output electrical signal within the first amplitude range has a high amplitude during the first time period. The end effector assembly 40 has high energy, enabling rapid separation of the muscle tissue layer. The start time of the first time period is t. 10 The end time of the first time period is t. 11.

[0041] The end effector assembly 40 performs the vascular closure and coagulation phase: from the end time t of the first time period. 11 up to the start time t of the third time period 30 Specifically, the second time period signal S2 and the transition signal segment between the second time period signal S2 and the first time period signal S1 and the third time period signal S3 collectively drive the end effector assembly 40 to perform vascular closure and coagulation. During this stage, the second time period signal S2 outputs an electrical signal with a second amplitude range within the second time period. The upper limit of the second amplitude range is less than the lower limit of the first amplitude range. The start time of the second time period is t. 20 The end time of the second time period is t. 21 During this stage, the output electrical signal has a low amplitude to avoid excessive energy in the end effector assembly 40, which could lead to carbonization of the blood vessel wall and affect the closure effect.

[0042] The end effector assembly 40 performs the blood vessel transection phase: the end effector assembly 40 is driven to perform blood vessel transection by the third time period signal S3. During the third time period, an electrical signal with a third amplitude range is output, the lower limit of which is greater than the upper limit of the second amplitude range, and the start time of the third time period is t. 30 The end time of the third time period is t. 31 During this stage, the output electrical signal has a high amplitude, and the end effector assembly 40 has high energy, which can quickly sever the blood vessel.

[0043] As shown in the figure, the starting time t of the second time period 20 The end time t of the first time period 11 The first set time interval Δt1 between the decrease in the amplitude of the power supply signal, and / or the start time t of the third time interval. 30 The end time t of the second time period 21 There is a second set time interval Δt2 between the rise in the amplitude of the power supply signal. That is, when the amplitude of the driving signal changes, at least one stage cancels the step change, improving the step transition to a transition within a certain transition time period. For example... Figure 5a The figure shows the scenario where a transition time is set when the signal changes from the first time period signal S1 to the second time period signal S2, as shown in the figure: at the end time t of the first time period 11 The amplitude of the electrical signal is A 11 At the start time t of the second time period 20 The amplitude of the electrical signal is A 12 When the amplitude of the electrical signal is A 11 Change to A 12During the process, a transition time of Δt1 is given as the first set time interval. For example... Figure 5b The figure shows the scenario where a transition time is set when the signal changes from the second time period S2 to the third time period S3, as shown in the figure: at the end time t of the second time period 21 The amplitude of the electrical signal is A 13 At the start time t of the third time period 30 The amplitude of the electrical signal is A 14 When the amplitude of the electrical signal is A 13 Change to A 14 During the process, a transition time of △t2 is given as the second set time interval. Figures 5c-5e Let t be the start time of the second time interval. 20 The previous and the end time t of the second time period 21 The following scenarios all involve setting transition times. In the waveforms shown in the attached figures, the electrical signal amplitudes of the first time period signal S1, the second time period signal S2, and the third time period signal S3 remain constant. The electrical signal amplitude of the third time period signal S3 differs from that of the first time period signal S1 (e.g., ...). Figure 5a and Figure 5b (as shown) or the same (e.g.) Figures 5c-5e (As shown) are all acceptable. However, in practical applications of this method, the amplitude of the electrical signal may fluctuate to some extent at each stage, meaning it is not stable at amplitude A. 11 Or A 12 A 13 Or A 14 This will be further described in detail in subsequent embodiments. When the electrical signal amplitudes of the first time period signal S1, the second time period signal S2, and the third time period signal S3 remain constant, and the electrical signal amplitude of the third time period signal S3 is the same as the electrical signal amplitude of the first time period signal S1, then A 13 =A 12 A 14 =A 11 At this point, we can obtain the following: Figures 5c-5e The signal waveform is shown. In this embodiment, the above figures are mainly used to illustrate the existence of the first set time interval Δt1 and / or the second set time interval Δt2. The preferred embodiment is to set time intervals for both stages of change to achieve a slow transition of the electrical signal amplitude change.

[0044] In the above-described scheme of this embodiment, a first predetermined time interval Δt1 is set separately between the first time period signal S1 and the second time period signal S2 for transition, or a second predetermined time interval Δt2 is set separately between the second time period signal S2 and the third time period signal S3 for transition, or a transition time is set simultaneously when the two stages change, so that the step change signals in the two stages are partially or completely adjusted to transition within a certain duration, thereby so that the ultrasonic energy transmitted to the blade head 41 has a certain buffer when the power changes between high and low, which can effectively improve the operator's control precision of the ultrasonic instrument, reduce the impact of sudden changes in tissue tearing force, and avoid the occurrence of blade breakage.

[0045] In the above scheme, when the first set time interval Δt1 and the second set time interval Δt2 exist, the change process of the electrical signal amplitude can follow a linear change process (e.g., Figure 5d As shown), it can also follow a nonlinear change process (such as...). Figures 5a-5c and Figure 5e (As shown).

[0046] For large-diameter blood vessels, in order to minimize the operation time while providing sufficient loading force to successfully complete the closure and hemostasis process during the operation of the end effector assembly 40, it is preferable that the loading force is adapted to the changes in the vessel wall thickness. Therefore, it is preferable that the transition process between the second time period signal S2 and the first time period signal S1 and the third time period signal S3 also follows a nonlinear law, thereby better matching the changes in vessel wall thickness to complete the closure and cutting of the vessel. That is, if the first set time interval Δt1 is greater than zero, within the first set time interval Δt1, the amplitude of the first transition electrical signal output to the ultrasonic surgical instrument decreases according to the first nonlinear curve law; if the second set time interval Δt2 is greater than zero, within the second set time interval Δt2, the amplitude of the second transition electrical signal output to the ultrasonic surgical instrument increases according to the second nonlinear curve law, so that the vessel wall thickness change curve during the closure process is as follows: Figure 6 As shown. Specifically, the waveforms of the first transition electrical signal and the second transition electrical signal provided in this embodiment are preferably... Figure 7 As shown, the first nonlinear curve is: A = (A 11 -A 12 )×sinΦ+A 11 Φ∈(180°, 270°), where A is the amplitude of the first transition electrical signal. 11 A represents the amplitude of the electrical signal at the end of the first time interval. 12The amplitude of the electrical signal at the start of the second time interval is Φ, which is 180° at the start of the first set time interval Δt1 and 270° at the end of the first set time interval Δt1. The second nonlinear curve is: C = (A 14 -A 13 )×sinΦ+A 13 Φ∈(0°, 90°), where C is the amplitude of the second transition electrical signal, A 13 A represents the amplitude of the electrical signal at the end of the second time period. 14 The amplitude of the electrical signal at the start of the third time period is Φ, which is 0° at the start of the second set time interval Δt2 and 90° at the end of the second set time interval Δt2. Figure 7 In the second time period, signal S2 is an electrical signal with a constant amplitude, therefore A 13 =A 12 If the signal S2 in the second time period is Figure 9 When the electrical signal shown has a fluctuating amplitude, A 13 With A 12 They can be different. In this scheme, the amplitude change of the driving electrical signal from the first time period signal S1 to the second time period signal S2 follows a sinusoidal curve. Similarly, the amplitude change of the electrical signal from the second time period signal S2 to the third time period signal S3 also follows a sinusoidal curve, allowing it to better adapt to the changes in vessel wall thickness during the vascular closure process. In this scheme, Figure 7 The driving electrical signal in this paper is illustrated using a current signal as an example. In practical applications, since current and voltage can be converted according to Ohm's law, the voltage change law can be obtained by combining the impedance change law and the current change law. Therefore, the present invention can be realized by using either driving current or driving voltage as the driving electrical signal, and the choice can be made according to the actual situation.

[0047] like Figure 7 The driving electrical signal shown, preferably when the ultrasonic surgical system closes a blood vessel, exhibits the following amplitude changes in the three stages: The end effector assembly 40 performs the separation of the vascular muscle tissue layer during this stage: A constant amplitude drive signal is output to rapidly dry the vessel wall. The duration of this stage is determined based on the time required for the vascular muscle tissue layer to complete separation, and whether separation is complete is determined by the impedance feedback from the end effector assembly 40. During this stage, the cutter head 41 generates ultrasonic energy with constant power, which, combined with the force applied by the operator, separates the vascular muscle tissue layer without causing significant thermal damage.

[0048] The end effector assembly 40 drives the vascular closure and coagulation phase: the amplitude of the driving electrical signal can be a constant amplitude output, causing the blood vessel to coagulate. The duration of this phase can be determined based on the time it takes for the blood vessel to complete coagulation, and whether the blood vessel has completed coagulation can be determined based on the impedance fed back by the end effector assembly 40.

[0049] The drive end effector assembly 40 performs the blood vessel severing stage: the drive electrical signal is output with a constant amplitude (which may be the same as or different from the constant amplitude during the separation of the blood vessel from the muscle tissue layer) until the blood vessel is severed.

[0050] The duration of the signals in each of the three stages described above can be determined based on the impedance changes fed back by the end effector assembly 40 during vascular closure. Therefore, preferably, as... Figure 8 As shown, the method for driving ultrasonic surgical instruments may further include the following steps: S40: Obtain the change in current or voltage value fed back by the ultrasonic surgical instrument, the change in current or voltage value being determined based on the change in impedance fed back by the end effector assembly 40. (Combined with...) Figure 3 In addition to the aforementioned principle of ultrasonic energy generation and transmission in the ultrasonic surgical system, during the vascular closure process, changes in the properties of the vascular wall (such as the wall thickness of the vascular vessel, the tissue characteristics of the vascular vessel, etc.) cause a change in the impedance of the end effector assembly 40. This impedance change can be fed back to the transducer 10 along the transmission path of ultrasonic vibration, causing a change in the current value or voltage value of the transducer 10. This step is performed in real time during the vascular closure process, wherein the amount of change in the current value or voltage value is provided by the transducer 10.

[0051] S50: Adjust the amplitude of the electrical signal within each time period according to the change in current or voltage value. Each time period includes the first time period, the second time period, the third time period, the first set time interval, and / or the second set time interval. In this step, the time period to be adjusted is determined based on the current operation stage performed by the end effector assembly 40. For example, in the stage where the end effector assembly 40 performs separation of the muscle tissue layer of a blood vessel, the amplitude of the electrical signal output in the first time period is adjusted according to the change in current or voltage value; in the stage where the end effector assembly 40 performs vascular closure and coagulation, the amplitude of the electrical signal output in the second time period is adjusted according to the change in current or voltage value.

[0052] Furthermore, the above method may also include the following steps: determining the duration of the first time period, the second time period, and the third time period based on the change in current or voltage value. Similar to step S50, in this step, the adjusted time period is determined based on the current operation stage being performed by the end effector assembly 40. That is, during the vascular closure process, the amplitude of the output electrical signal is adjusted in real time based on the change in current or voltage value fed back by the ultrasonic surgical instrument, or the waveform of the electrical signal is adjusted in real time.

[0053] Preferably, the above method further includes a step S60 of adjusting the duration of the transition electrical signal during the stage of adjusting the end effector assembly 40 to perform vascular closure and coagulation, specifically: When the first set time interval Δt1 is greater than zero, the above method includes S601: determining the time length of the first set time interval Δt1 based on the change in the current value or voltage value.

[0054] When the second set time interval Δt2 is greater than zero, the above method includes S602: determining the time length of the second set time interval Δt2 based on the change in the current value or voltage value.

[0055] In addition, in specific implementation, the first set time interval △t1 and the second set time interval △t2 can be equal or not equal. If they are equal, it can simplify the design of the waveform. If they are not equal, the difference between them is within a certain allowable error range, and the allowable error range can be determined according to empirical values ​​or experimental calibration methods.

[0056] As mentioned earlier, during the vascular closure and coagulation phase of the ultrasonic surgical system, the impedance value of the end effector assembly 40 changes due to alterations in vascular tissue characteristics. Therefore, the second time-segment signal S2 is designed to be a fluctuating signal, meaning the ultrasonic energy of the blade 41 has small fluctuations. This allows the end effector assembly 40 to better reflect impedance changes during vascular closure. A smaller fluctuation range avoids unnecessary tearing of the blood vessel or tissue caused by blade energy fluctuations. Preferably, the difference between the upper limit A5 and the lower limit A6 of the second amplitude range of the second time-segment signal S2 is less than a set value. Figure 9Taking the waveform diagram shown as an example, the electrical signal output during the second time period is preferably a periodic signal. Specifically, the periodic signal can be represented by the following function: B = A5 - set value × sin(π × τ / T); where B is the amplitude of the electrical signal output during the second time period, τ is a time variable, τ∈(0,T), and T is the length of the second time period. As the vascular closure and coagulation stage requires the end effector assembly 40 to continuously apply low energy to the blood vessel to ensure complete coagulation, the ultrasonic energy and duration of the blade 41 need to be well-matched during this stage. That is, the amplitude and duration of the signal in the second time period need to be well-matched to avoid excessively high amplitude or excessively long duration of the signal in the second time period, which could cause vascular carbonization and affect the closure and coagulation effect. Under this premise, the selection of the set value in the above formula should be compatible with the low energy value required by the blade 41 during the vascular coagulation stage, and can be obtained through calibration experiments or empirical values. In this step, the amplitude of the electrical signal S2 in the second time period is designed based on the impedance perturbation law of the vascular closure process. The periodic fluctuation of the signal in the form of a sine wave can better reflect the impedance changes during the vascular closure and coagulation process.

[0057] This invention also provides a signal generator for driving ultrasonic surgical instruments, such as... Figures 10a-10b The diagram shows the connection relationship between the signal generator 50 and other components when used in an ultrasonic surgical system. The signal generator 50 includes a processor chip 501 (such as a microcontroller, PLC, DSP, etc.). The processor chip 501 has pre-set program information for generating various preset waveform signals. After the signal generator 50 responds to a start signal, the processor chip 501 runs the program information to execute the method steps provided in the above method embodiment, causing the signal generator 50 to output the following: Figures 5a-5e or Figure 7 , Figure 9 The driving electrical signal shown is sent to the ultrasonic surgical instrument. The processor chip 501, through preset program information, can directly output a waveform signal that meets the requirements of the driving electrical signal; that is, the amplitude and duration of each stage of the electrical signal meet the driving requirements of the ultrasonic surgical instrument. Alternatively, as... Figure 10bAs shown, the processor chip 501 is connected to a signal conditioning circuit 502. After running the program information, the processor chip 501 outputs a preset waveform signal (as an initial electrical signal). The signal conditioning circuit 502 processes the preset waveform signal into a driving electrical signal. In this scheme, the amplitude of the preset waveform signal can be relatively small. The signal conditioning circuit 502 can have a signal amplification function, amplifying the small-amplitude initial electrical signal into a driving electrical signal that meets the driving requirements. The function of the signal conditioning circuit 502 is adapted to the initial electrical signal output by the processor chip 501 and the driving requirements. In addition to amplification, it can also have transformation and filtering functions.

[0058] Furthermore, the signal generator 50 further includes an impedance detection circuit 503, which is connected to the transducer 10 in the ultrasonic surgical instrument. The impedance detection circuit 503 detects the change in current or voltage value fed back by the transducer 10, converts the change in current or voltage value into a digital signal, and feeds it back to the processor chip 501. The change in current or voltage value is determined based on the impedance change of the end effector assembly 40. The processor chip 501 adjusts the amplitude of the drive electrical signal based on the digital signal fed back by the impedance detection circuit 503. Furthermore, the processor chip 501 can also adjust the duration of the first time period, the second time period, and the third time period in the drive electrical signal based on the digital signal fed back by the impedance detection circuit 503; determine the duration of the first set time period based on the change in current or voltage value when the first set time interval is greater than zero; and / or determine the duration of the second set time interval based on the change in current or voltage value when the second set time interval is greater than zero.

[0059] The signal generator that drives the ultrasonic surgical instrument can output a driving electrical signal to the end effector assembly 40 in the ultrasonic surgical instrument. Under the drive of the driving electrical signal, the blade 41 in the end effector assembly 40 generates ultrasonic energy that is adapted to different stages of the blood vessel closure process. Combined with the clamping force applied by the operator after operating the end effector assembly 40, the blood vessel closure is completed quickly.

[0060] This invention also provides an ultrasonic surgical system, which includes ultrasonic surgical instruments and the signal generator 50 provided in the above embodiments. The ultrasonic surgical instruments include a transducer 10 and an operating component; the transducer 10 receives a driving electrical signal output by the signal generator 50 and converts the driving electrical signal into an ultrasonic vibration signal; the operating component is equipped with a central rod 31 and an end effector assembly 40 for manipulating tissue disposed at the distal end of the central rod 31; the ultrasonic vibration signal is transmitted from the central rod 31 to the end effector assembly 40, and the ultrasonic energy generated by the end effector assembly 40 acts on the manipulated tissue. In this embodiment, the manipulated tissue is a blood vessel, but the ultrasonic surgical system can be applied to the cutting, coagulation, and / or clamping of other tissues besides blood vessels.

[0061] like Figure 10b As shown, the ultrasonic surgical system may also include a start signal switch 50A (such as an operation button 24, a foot switch connected to the signal generator 50, etc.). After the signal generator 50 receives the start signal from the start signal switch 50A (in the figure, the signal receiving end of the processor chip 501 is taken as the signal receiving end of the signal generator 50), the processor chip 501 can run the preset internal program information and output a preset waveform signal. After the preset waveform signal is processed by the signal conditioning circuit 502, it forms a driving electrical signal that is input to the transducer 10. After the blade 41 in the end effector assembly 40 undergoes ultrasonic vibration, it cooperates with the shear head 42 to clamp the tissue. The impedance change of the end effector assembly 40 is fed back to the transducer 10, causing a change in the current or voltage value of the transducer 10. The impedance detection circuit 503 can detect the change in the current or voltage value, process the change in the current or voltage value into a digital signal, and feed it back to the processor chip 501. The processor chip 501 can determine the impedance change based on the change in the current or voltage value and adjust the initial waveform according to the impedance change to change the amplitude of the driving electrical signal to change the ultrasonic energy of the end effector assembly 40. This allows the end effector assembly 40 to generate ultrasonic energy that adapts to the changes in the characteristics of the operated tissue at any stage of operation, thus better meeting the operational needs of the operated tissue.

[0062] Furthermore, the driving current waveforms proposed in the above embodiments of the present invention are expressed according to the effective value of the current. The effective value is a value used to measure the magnitude of alternating current. The specific calculation process is as follows: the heat generated by alternating current passing through a resistor in one cycle is equal to the heat generated by direct current passing through the same resistor in the same time period. The magnitude of this direct current is the effective value of the alternating current. Therefore, the effective value can be calculated based on the instantaneous value of the current. In specific applications, either the instantaneous value or the effective value can be selected as a variable for display. It has been verified that when the driving electrical signal controlling the blade head 41 in the above embodiments of this application is used to close and stop bleeding in large-diameter blood vessels, when the signals at each stage operate at the resonant frequency, and when the two ends of the second time period signal S2 are both achieved by using sine wave curves to realize the electrical signal transition, the ultrasonic vibration energy of the blade head 41 can achieve the maximum power output per unit time while meeting the needs of blood vessel closure, thereby shortening the entire closure process time.

[0063] Based on the driving electrical signal in the above embodiments, the vibration time of the cutting head 41 can be effectively shortened, reducing the heat generated by the mechanical vibration of the cutting head 41. Compared with the existing cutting head 41 structure with a heat dissipation film (because the existing cutting head needs to vibrate for a longer time, it generates more heat, so the cutting head needs to have an additional heat dissipation film), this application can achieve the goal that the cutting head 41 does not need to be coated with a heat dissipation film. The heat dissipation film coated on the existing cutting head 41 not only increases the cost of the instrument, but also may fall off into the human body under high-frequency vibration, which may easily cause rejection by the human body. The above problems are effectively solved by eliminating the heat dissipation film in the cutting head 41 in this solution.

[0064] In conventional applications of the aforementioned ultrasonic surgical system (such as closure and coagulation of blood vessels with a diameter of approximately 5 mm or less), when the end effector assembly 40 clamps the blood vessel, the blade 41 and the shear head 42 need to work together to apply a loading force to the tissue. Specifically, as... Figure 11 and Figure 12The pivoting motion of the scissor head 42 relative to the blade head 41 is achieved by providing a pair of pivot points on the scissor head 42, which are respectively engaged with the outer sleeve 33 and the inner sleeve 32. The outer sleeve 33 is fixedly connected to the handle assembly 20. The scissor head 42 is pivotally connected to the outer sleeve 33 via a first through hole 421 on the scissor head 42 and a corresponding second through hole 331 on the outer sleeve 33. A fastening pin or rivet slides through the first through hole 421 and the second through hole 331 to pivotally connect the scissor head 42 to the outer sleeve 33. The inner sleeve 32 moves along the longitudinal axis of the outer sleeve 33. A pivot pin 422 on the scissor head 42 engages with a pivot hole 321 at the distal end of the inner sleeve 32. Thus, the reciprocating motion of the inner sleeve 32 relative to the outer sleeve 33 causes the scissor head 42 to pivot relative to the blade head 41. Movement of trigger 23 toward the handle moves the inner sleeve 32 proximally, thereby pivoting the scissor head 42 toward the blade head 41. The actuation provided by trigger 23 and the cooperating handle 22 facilitates convenient and efficient manipulation and positioning of the instrument, as well as the pivoting of the distal scissor head 42 toward the blade head 41, thereby effectively driving the tissue against the blade head 41. Movement of trigger 23 away from the handle 22 moves the inner sleeve 32 distally, thereby pivoting the scissor head 42 away from the blade head 41.

[0065] like Figure 13 As shown, multiple grooves or recesses for installing sealing support parts 39 are formed on the outer periphery of the central rod 31. The grooves are located at the nodes of the central rod 31. Since the ultrasonic amplitude at the node of the central rod 31 is zero, setting the sealing support part 39 at this position can effectively support the central rod 31 without affecting the ultrasonic transmission of the central rod 31. The sealing support part 39 is specifically a sealing ring set in the groove, and the sealing ring is made of flexible materials such as silicone. The sealing support part 39 located at the farthest node is closest to the end actuator assembly 40. This sealing support part 39 can also prevent tissue residue generated during the cutting of the end actuator assembly 40 from entering the transmission assembly 30 through the area between the central rod 31 and the inner sleeve 32.

[0066] When the end effector assembly 40 acts on the closure and coagulation of a larger diameter blood vessel, a greater force is required to operate the trigger 23 to clamp the blood vessel. The force of the shear head 42 in the Z-direction is greater, which causes the blade head 41 to tend to move in the Z-direction. The assembly gap between the inner and outer sheaths allows the blade head 41 to move in the Z-direction. Figure 13 As shown, the central rod 31, which is fastened or integral with the cutter head 41, abuts against the inner sleeve 32 through the sealing support part 39 without gap, and there is an assembly gap between the inner and outer sleeves. Figure 14aAs shown, the straight line formed by the pair of pivot points is tilted to the left (or, conversely, tilted to the right). At this point, the distal end F of the end effector assembly 40 is closed, while a large gap remains at its proximal end W. Because of this large gap at the proximal end W, if a blood vessel is clamped, the pressure is relatively low. This can easily lead to the distally clamped blood vessel being cut / stopped under pressure and energy, while the proximal clamped blood vessel remains uncut / unstopped. In other words, the end effector assembly 40 applies inconsistent force to larger diameter blood vessels, easily resulting in some blood vessels not being cut or coagulating.

[0067] In the above-described embodiments provided in this application, the driving electrical signal can control the cutter head 41 to output sufficiently high ultrasonic energy per unit time. This allows the operator to appropriately reduce the clamping force from the operator when controlling the movement of the cutter head 42, thereby alleviating the situation of poor loading force consistency of the end effector assembly 40.

[0068] To further ensure consistent loading of the blade 41 from proximal to distal end during coagulation of larger diameter blood vessels using the end effector assembly 40, the force on the blade 41 needs to gradually decrease from proximal to distal. Preferably, in this embodiment, an abutment portion is provided at the distal ends of the inner sleeve 32 and the outer sleeve 33. This abutment portion forms a support between the inner sleeve 32 and the outer sleeve 33, making the gap between the distal ends of the inner and outer sleeves close to zero. This prevents changes in the radial gap between the inner and outer sleeves without affecting their relative sliding motion. Specifically, when the blade 41 is subjected to a force from the shear head 42 along the Z-direction, the offset distance of the inner sleeve 32 along the Z-direction is close to zero, thus avoiding changes in the radial gap between the inner and outer sleeves. Figure 14bAs shown, when the scissor head 42 pivots towards the blade head 41 to close and stop bleeding in a larger diameter blood vessel, the blade head 41, supported by the distal ends of the inner sleeve 32 and the outer sleeve 33, experiences a decrease in its radial Z-direction offset, which is almost zero. At this point, the distal end F of the end effector assembly 40 is closed, and the gap at its proximal end W is small, allowing the force on the blade head 41 to gradually increase from the distal end to the proximal end. More specifically, the inner side of the abutment portion abuts against the outer wall of the inner sleeve 32 or is integrally formed with the outer wall of the inner sleeve 32, and the outer side of the abutment portion is integrally formed with the inner wall of the outer sleeve 33 or abuts against the inner wall of the outer sleeve 33. Thus, by providing the abutment portion on the distal side, the gap between the inner sleeve 32 and the outer sleeve 33 is further reduced. In some embodiments, the abutment portion is at least one clip P disposed between the inner sleeve 32 and the outer sleeve 33. By setting a clamp P independent of the inner sleeve 32 and the outer sleeve 33, the machining difficulty of the inner and outer sleeves 33 can be reduced. More specifically, the surface of the clamp P is shaped into an arc-shaped surface that matches the tube wall of the inner and outer sleeves 33, so that the clamp P has a large contact area with the outer tube wall of the inner sleeve 32 and the inner tube wall of the outer sleeve 33 to achieve stable support for the central rod 31. It is understood that the above implementation of the contact part is only an illustrative example, and in actual implementation, the clamp P can be replaced with other structural components that can achieve the same function.

[0069] The above solution in this embodiment, by improving the mechanical structure of the end effector assembly 40 and coordinating with the improved drive electrical signal, further shortens the time required to close larger diameter blood vessels and improves the consistency of the loading force of the end effector assembly 40. In implementing this solution, the ultrasonic surgical instrument provided in this embodiment and a prior art ultrasonic surgical instrument were used to perform closure and coagulation tests on 60 blood vessel sample models with a diameter of approximately 7 mm. The effectiveness of this solution is explained from two aspects: closure time and post-closure rupture pressure verification results. Specifically, the two instruments were used to perform closure and coagulation operations on multiple blood vessel sample models with a diameter of approximately 7 mm. After completing the entire closure and coagulation process, the rupture pressure at the closure point was measured. The closure time corresponding to different rupture pressure test results was statistically analyzed. The final verification results of this solution are as follows: Figure 15a As shown, the existing product verification results are as follows: Figure 15b As shown, the comparison results are as follows: Figure 15c As shown. Wherein: The ultrasonic surgical instruments provided in this solution have a closure time ranging from 2.8 to 7.2 seconds, with an average closure time of 6.067 seconds and a standard deviation of 0.928 seconds. After vascular closure, the average burst pressure at the closure site is 1186.1 mmHg, and the standard deviation of the burst pressure test results is 271.9 mmHg.

[0070] The closure time using existing products ranged from 5.4 to 19.4 seconds, with an average closure time of 11.225 seconds and a standard deviation of 3.485 seconds. After vascular closure, the average burst pressure at the closure site was 969.71 mmHg, with a standard deviation of 303.78 mmHg.

[0071] Based on the experimental results shown in the figure, when closing blood vessels with a diameter of approximately 7 mm, this method clearly achieves better closure results with a shorter closure time. Adopting this method can further improve the efficiency of blood vessel closure while ensuring the quality of closure.

[0072] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A method for driving an ultrasonic surgical instrument, characterized in that, The method includes: In response to a start signal, an electrical signal of a first amplitude range is output to the ultrasonic surgical instrument during a first time period to drive the end effector assembly in the ultrasonic surgical instrument. After the first time period ends, within a first set time interval, a first transitional electrical signal with decreasing amplitude is output to the ultrasonic surgical instrument to drive the end effector assembly. After the first set time interval ends, during the second time interval, an electrical signal of a second amplitude range is output to the ultrasonic surgical instrument to drive the end effector assembly, wherein the upper limit of the second amplitude range is less than the lower limit of the first amplitude range. After the second time period ends, a second transitional electrical signal with increasing amplitude is output to the ultrasonic surgical instrument within a second set time interval to drive the end effector assembly; After the second set time interval ends, an electrical signal of a third amplitude range is output to the ultrasonic surgical instrument during a third time period to drive the end effector assembly. The lower limit of the third amplitude range is greater than the upper limit of the second amplitude range. In the above, at least one of the first set time interval and the second set time interval is greater than zero.

2. The method for driving an ultrasonic surgical instrument according to claim 1, characterized in that: If the first set time interval is greater than zero, the amplitude of the first transition electrical signal output to the ultrasonic surgical instrument within the first set time interval decreases according to the first nonlinear curve.

3. The method for driving an ultrasonic surgical instrument according to claim 2, characterized in that: The first nonlinear curve is: A = (A 11 -A 12 )×sinΦ+A 11 Φ∈(180°, 270°), where A is the amplitude of the first transition electrical signal. 11 A represents the amplitude of the electrical signal at the end of the first time interval. 12 This represents the amplitude of the electrical signal at the start of the second time period.

4. The method for driving an ultrasonic surgical instrument according to claim 1, characterized in that: If the second set time interval is greater than zero, the amplitude of the second transition electrical signal output to the ultrasonic surgical instrument during the second set time interval increases according to the second nonlinear curve.

5. The method for driving an ultrasonic surgical instrument according to claim 4, characterized in that: The second nonlinear curve is: C = (A 14 -A13)×sinΦ+A 13 Φ∈(0°, 90°), where C is the amplitude of the second transition electrical signal, A 13 A represents the amplitude of the electrical signal at the end of the second time period. 14 The amplitude of the electrical signal at the start of the third time period.

6. The method for driving an ultrasonic surgical instrument according to claim 1, characterized in that: If the first set time interval is greater than zero, the amplitude of the first transition electrical signal output to the ultrasonic surgical instrument within the first set time interval decreases according to a first linear law.

7. The method for driving an ultrasonic surgical instrument according to claim 1, characterized in that: If the second set time interval is greater than zero, the amplitude of the second transition electrical signal output to the ultrasonic surgical instrument decreases according to a second linear law within the second set time interval.

8. The method for driving an ultrasonic surgical instrument according to claim 1, characterized in that: The difference between the upper and lower limits of the second amplitude range of the electrical signal output to the ultrasonic surgical instrument during the second time period is less than a set value.

9. The method for driving an ultrasonic surgical instrument according to claim 8, characterized in that: The electrical signal output to the ultrasonic surgical instrument during the second time period is a periodic signal.

10. The method for driving an ultrasonic surgical instrument according to claim 9, characterized in that: The periodic signal output to the ultrasonic surgical instrument during the second time period is a sine wave signal.

11. The method for driving an ultrasonic surgical instrument according to claim 10, characterized in that: The sinusoidal signal output to the ultrasonic surgical instrument during the second time period is represented by the following function: B = A5 - set value × sin(π × τ / T); where B is the amplitude of the electrical signal output during the second time period, τ is a time variable, τ∈(0,T), T is the length of the second time period, and A5 is the upper limit of the amplitude of the electrical signal output during the second time period.

12. The method for driving an ultrasonic surgical instrument according to claim 1, characterized in that, The method further includes: The change in current or voltage value fed back by the ultrasonic surgical instrument is obtained, and the change in current or voltage value is determined based on the impedance change of the end effector assembly; The amplitude of the electrical signal in each time period is adjusted according to the change in the current or voltage value. Each time period includes the first time period, the second time period, the third time period, the first set time interval, and / or the second set time interval.

13. The method for driving an ultrasonic surgical instrument according to claim 12, characterized in that, The method further includes: The durations of the first time period, the second time period, and the third time period are determined based on the change in current or voltage values.

14. The method for driving an ultrasonic surgical instrument according to claim 13, characterized in that, The method further includes: When the first set time interval is greater than zero, the length of the first set time interval is determined based on the change in the current or voltage value; and / or, When the second set time interval is greater than zero, the length of the second set time interval is determined based on the change in the current value or voltage value.

15. The method for driving an ultrasonic surgical instrument according to any one of claims 1-14, characterized in that: At least one of the electrical signals output during the first time period, the second time period, and the third time period has a frequency that is the resonant frequency of the ultrasonic surgical instrument.

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