Treatment device and control method of a treatment device

Abstract

The present disclosure provides a treatment device and a control method of a treatment device. A treatment device for treating a target tissue includes a drive source having a transducer configured to convert electric energy into mechanical vibration, an instrument having a blade connected to the drive source and configured to apply the mechanical vibration to the target tissue, and a control unit configured to control supply of electric energy to the drive source. The control unit is configured to automatically adjust the supply of electric energy to the drive source in response to detecting a change in a resonance frequency of the blade. The change in the resonance frequency of the blade occurs after the target tissue has been completely cut by the blade.

Description

Technical Field

[0001] According to some embodiments, this disclosure relates to an ultrasonic treatment apparatus for cutting target tissue. More specifically, this disclosure relates to an ultrasonic treatment apparatus configured to detect a complete incision in the target tissue. Methods for detecting incision completion via the ultrasonic treatment apparatus, and methods for controlling the ultrasonic treatment apparatus in response thereto, are also described herein. Background Technology

[0002] Ultrasonic treatment devices are configured to use ultrasonic mechanical vibrations to perform surgical treatments on various medical conditions. Ultrasonic vibrations can be used, for example, to cut, dissect, and / or cauterize a patient's soft tissue. Such ultrasonic treatment devices typically include a tissue contact member (also referred to herein as an "end effector") for applying ultrasonic vibrations to the tissue to be treated, an ultrasonic transducer for converting electrical energy into ultrasonic vibrations, and a transmission element for transmitting the ultrasonic vibrations from the ultrasonic transducer to the tissue contact member. Frictional heat generated between the vibrating tissue contact member and the tissue is used to cut through the tissue.

[0003] In some ultrasonic treatment devices, the tissue contact member can be a single-component instrument for applying ultrasonic vibrations to the tissue, such as a blade, a spherical coagulant, or a hook. In other ultrasonic treatment devices, the tissue contact member includes a multi-component instrument, such as a gripping device with a blade for applying ultrasonic vibrations to the tissue, and jaws capable of pivoting relative to the blade so that the tissue can be clamped between the blade and the jaws. The jaws can be configured to apply compressive forces to the tissue when ultrasonic vibrations are applied by the blade, thereby allowing for faster cutting and / or coagulation in some cases.

[0004] The jaws of a gripping instrument may include a pad for pressing against tissue. The pad may be made of a polymeric material (such as polytetrafluoroethylene (PTFE) or other polymeric resins) and include a surface designed to contact the tissue when the jaws grip it. This pad surface may also come into contact with the vibrating blade during use (e.g., once the blade has completely cut through the tissue). However, this contact between the pad and the vibrating blade can lead to wear or damage to the pad.

[0005] Once the tissue has been cut, pad wear can be reduced by stopping the ultrasonic vibrations. For example, some ultrasonic devices may include a processor configured to stop the ultrasonic vibrations in response to a detected change in ultrasonic impedance (“US impedance”). In some such examples, during ultrasonic treatment, the tissue denatures and hardens through frictional heat, and the US impedance increases. After the tissue has been cut, the blade and pad come into contact with each other, and the US impedance decreases. The completion of the incision can be detected by detecting the point (peak) at which the US impedance changes from an increase to a decrease.

[0006] However, depending on the type of tissue being treated, a “false” peak in the US impedance may appear before the actual “true” peak indicating the completion of the incision. False peaks in the US impedance may occur, for example, in some tissues with a layered structure consisting of two or more layers (e.g., the cervix). For instance, a false peak may be detected after only the first layer of tissue has been cut. In some such cases, when the processor detects a false peak, it may prematurely stop ultrasound vibrations before the tissue has been completely cut, resulting in an incomplete incision. Summary of the Invention

[0007] According to some embodiments, this disclosure provides an ultrasonic treatment apparatus configured to detect the completion of an incision in target tissue in a manner that overcomes the aforementioned difficulties. In some embodiments, a treatment apparatus for treating target tissue includes: a drive source having a transducer configured to convert electrical energy into mechanical vibrations; an instrument having a blade connected to the drive source and configured to apply the mechanical vibrations to the target tissue; and a control unit configured to operate the transducer to stop generating the mechanical vibrations using the transducer in response to detecting a change in the resonant frequency of the blade. In some embodiments, the instrument includes jaws movable relative to the blade, the instrument being configured to grasp the target tissue between a pad of the blade and the jaws. In some embodiments, after the target tissue has been completely cut by the blade, a change in the resonant frequency of the blade occurs when the blade contacts the pad of the jaws. In some embodiments, the control unit is configured to control the electrical power supply to the drive source and to automatically reduce or stop the electrical power supply to the drive source in response to detecting a change in the resonant frequency of the blade. In some embodiments, the control unit is configured to adjust the power supply to the drive source in response to detecting a change in the resonant frequency in addition to a change in the US impedance.

[0008] In some embodiments, detecting a change in the resonant frequency of the blade includes detecting a change from a first trend of the resonant frequency over time to a second trend of the resonant frequency over time. In some embodiments, the first trend is a decreasing trend of the resonant frequency, and the second trend is an increasing trend of the resonant frequency. In some embodiments, detecting a change in the resonant frequency of the blade includes detecting the occurrence of a peak value of the resonant frequency.

[0009] In some embodiments, the control unit is configured to determine the slope of the resonant frequency over a predetermined time period, determine a threshold, and compare the slope with the threshold. In some embodiments, the control unit is configured to update the slope and the threshold every predetermined time period. In some embodiments, the threshold is proportional to the resonant frequency at a specified time. In some embodiments, the threshold for a given predetermined time period is the product of the resonant frequency at the beginning of the given predetermined time period and a coefficient. In some embodiments, the threshold for a given predetermined time period is equal to the average resonant frequency over the given predetermined time period. In some embodiments, the threshold for a given predetermined time period is equal to the integral of the resonant frequency over the given predetermined time period.

[0010] In some embodiments, the control unit is configured to, for each time interval in a series of time intervals: determine the slope of the resonant frequency in the immediately preceding time interval; calculate a predicted value of the resonant frequency based on the slope of the resonant frequency; and compare the resonant frequency with the predicted value for the resonant frequency. In some embodiments, comparing the predicted value for the resonant frequency with the resonant frequency includes calculating the difference between the resonant frequency and the predicted value for the resonant frequency. In some embodiments, the control unit is further configured to compare the magnitude of the difference between the resonant frequency and the predicted value for the resonant frequency with a threshold. In some embodiments, detecting a change in the resonant frequency of the blade includes detecting that the magnitude of the difference exceeds the threshold. In some embodiments, if the magnitude of the difference does not exceed the threshold within a time interval, the control unit is configured to proceed to the next time interval in the series of time intervals.

[0011] In some embodiments, a method for controlling a disposal device using a control unit includes: generating mechanical vibration using a transducer; transmitting the mechanical vibration to a blade connected to the transducer; measuring the resonant frequency of the blade over time; and stopping the generation of the mechanical vibration using the ultrasonic transducer by the control unit in response to detecting a change in the resonant frequency of the blade. In some embodiments, detecting a change in the resonant frequency of the blade includes detecting a change from a first trend of the resonant frequency over time to a second trend of the resonant frequency over time by the control unit. In some embodiments, the first trend is a decreasing trend of the resonant frequency, and the second trend is an increasing trend of the resonant frequency. In some embodiments, detecting a change in the resonant frequency of the blade includes detecting the occurrence of a peak value of the resonant frequency.

[0012] In some embodiments, the method further includes, for each time interval in a series of time intervals: calculating the slope of the resonant frequency within the time interval, calculating a threshold; and comparing the slope with the threshold. According to some embodiments, these steps can be performed independently by the control unit. In some embodiments, detecting a change in the blade's resonant frequency includes detecting that the slope exceeds a threshold. In some embodiments, the threshold is proportional to the resonant frequency at a specified time. In some embodiments, the threshold for a given time interval is the product of the resonant frequency at the beginning of the given time interval and a coefficient. In some embodiments, the threshold for a given time interval is equal to the average resonant frequency within the given time interval. In some embodiments, the threshold for a given time interval is equal to the integral of the resonant frequency within the given time interval.

[0013] In some embodiments, the method further includes, for each time interval in a series of time intervals: determining the slope of the resonant frequency in the immediately preceding time interval; calculating a predicted value for the resonant frequency based on the slope of the resonant frequency; and comparing the resonant frequency with the predicted value for the resonant frequency. In some embodiments, comparing the predicted value for the resonant frequency with the resonant frequency includes calculating the difference between the resonant frequency and the predicted value for the resonant frequency. In some embodiments, detecting a change in the resonant frequency of the blade includes detecting that the magnitude of the difference between the resonant frequency and the predicted value for the resonant frequency exceeds a threshold. According to some embodiments, the foregoing steps can be performed independently by each control unit. Attached Figure Description

[0014] The foregoing summary of the invention and the following detailed description will be better understood when read in conjunction with the accompanying drawings. For the purposes of illustrating this disclosure, presently preferred embodiments are shown in the drawings, wherein the same reference numerals consistently indicate the same elements. However, it should be noted that aspects of this disclosure may be embodied in different forms and therefore should not be construed as limited to the embodiments shown herein. Elements shown in the drawings are not necessarily drawn to scale but may be exaggerated to highlight essential features of the subject matter. Furthermore, the drawings may be simplified by omitting elements that are not necessarily necessary for understanding the disclosed embodiments.

[0015] Figure 1A This is a perspective view of an example ultrasonic treatment device with a grasping instrument according to one embodiment.

[0016] Figure 1B yes Figure 1A An enlarged view of the gripper of the ultrasonic treatment device.

[0017] Figure 2AThis is a cross-sectional view showing tissue being cut by a gripping instrument of an ultrasonic treatment device according to one embodiment.

[0018] Figure 2B This shows what happens after the tissue has been cut. Figure 2A A cross-sectional view of the grasping device.

[0019] Figure 3A and Figure 3B These are graphs showing impedance versus time and resonant frequency during tissue cutting operations using an ultrasonic treatment device.

[0020] Figure 3C It shows the peak in the resonant frequency. Figure 3B The magnified portion of the graph.

[0021] Figure 3D and Figure 3E It has further annotations. Figure 3B and Figure 3C The graph, with further annotations, describes the change of resonant frequency over time during operation of the ultrasonic treatment device.

[0022] Figure 4 It is a graph showing the difference between the resonant frequency and the predicted frequency of a method for detecting incisions in tissue according to an example embodiment.

[0023] Figure 5 This is a schematic diagram outlining certain steps of a method for detecting tissue incisions using predicted frequencies according to some embodiments.

[0024] Figure 6 This is a flowchart illustrating certain steps of a method for detecting tissue incisions according to some embodiments, wherein a resonant frequency is compared with a predicted frequency.

[0025] Figure 7 It is a graph comparing the slope of the resonant frequency with a threshold according to another example embodiment.

[0026] Figure 8 It is a graph of the resonant frequencies with annotations according to another example embodiment, the annotations showing the difference in slope before and after the tissue incision.

[0027] Figure 9 This is a flowchart illustrating certain steps of a method for detecting tissue incisions according to another embodiment, wherein the slope of the resonant frequency is compared with a threshold that is updated at regular intervals.

[0028] Figure 10 This is a flowchart illustrating certain steps of a method for detecting tissue incisions according to another embodiment, wherein a second slope of the resonant frequency is compared with a threshold.

[0029] Figure 11 This is a flowchart illustrating certain steps of a method for detecting tissue incisions according to another embodiment, wherein the slope of the resonant frequency is compared with a threshold calculated based on the average value of the resonant frequency and updated at regular intervals.

[0030] Figure 12 This is a flowchart illustrating certain steps of a method for detecting tissue incisions according to another embodiment, wherein the slope of the resonant frequency is compared with a threshold calculated based on the integral value of the resonant frequency and updated at regular intervals. Specific Implementation

[0031] The subject matter will now be described more fully below with reference to the accompanying drawings, in which representative embodiments are illustrated. However, the subject matter may be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided for description and to enable those skilled in the art to implement them. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference in their entirety.

[0032] Figure 1A A perspective view of an example ultrasound treatment device 1 is provided. In some embodiments, the ultrasound treatment device 1 includes a housing 2 and a grasping device 3 (also referred to herein as an "end effector") located at the distal end of the ultrasound treatment device 1. The grasping device 3 is configured to contact target tissue and apply ultrasonic vibrations to the target tissue to, for example, cut and / or cauterize the target tissue. In some embodiments, the grasping device 3 is connected to the housing 2 via an elongated shaft 4. In some embodiments, the housing 2 includes a handle 5 configured to be held in the hand of a user (e.g., a surgeon or other operator) and a handle 6 movable relative to the handle 5. In some embodiments, the grasping device 3 is configured to open and close by movement of the handle 6 relative to the handle 5. For example, in some embodiments, moving the handle 6 away from the handle 5 causes the grasping device 3 to open, while moving the handle 6 toward the handle 5 causes the grasping device 3 to close.

[0033] The ultrasonic treatment device 1 also includes a drive source 7, which includes a transducer, such as an ultrasonic transducer for generating ultrasonic vibrations applied to target tissue by the grasping device 3. In some embodiments, the ultrasonic transducer is configured to convert electrical energy into mechanical vibrations, which can then be transmitted to the grasping device 3 via a shaft 4. In some embodiments, the ultrasonic transducer of the drive source 7 may include, for example, a piezoelectric element. When a voltage is applied to the piezoelectric element included in the vibrator, the piezoelectric element expands and contracts in the direction of the applied voltage, thereby converting electrical energy into mechanical vibrations. According to some embodiments, a control unit (not shown) is housed within a housing 2 and is configured to control the operation of the drive source 7. For example, the control unit may include one or more processors configured to control the power supply to the ultrasonic transducer.

[0034] Figure 1B Enlarged views of a gripping device 3 according to certain embodiments are provided. In some embodiments, the gripping device 3 generally includes a blade 8 (which may also be referred to herein as a “probe”) and jaws 9, the blade 8 being configured to apply ultrasonic vibrations to target tissue, and the jaws 9 being movable relative to the blade 8 between an open configuration (an example of which is shown) and a closed configuration. The blade 8 is operatively connected to a drive source 7 such that mechanical vibrations generated by a transducer are applied to the target tissue through the blade 8. In use, the tissue to be treated can be clamped between the blade 8 and the jaws 9, such that the tissue is pressed against the blade 8 through the jaws 9. In some embodiments, ultrasonic vibrations generated by the drive source 7 are transmitted to the blade 8, causing the blade 8 to mechanically vibrate during use at a frequency sufficient to treat the target tissue (e.g., cut the target tissue). In some embodiments, frictional heat generated between the vibrating blade 8 and the tissue is used to cut through the tissue.

[0035] Figure 2A and 2B Cross-sectional views of the gripping instrument 3 during the cutting of target tissue 11 are provided, according to some examples. Figure 2A As shown, the target tissue 11 is positioned between and held by the blade 8 and jaws 9 of the instrument 3. In some embodiments, the jaws 9 include a pad 10 configured to abut against the target tissue 11 during use. The pad 10 may be made, for example, of a polymer or resin material (e.g., PTFE). As discussed, the blade 8 is configured to vibrate at an ultrasonic frequency such that the friction between the blade 8 and the target tissue 11 is sufficient to cut through the target tissue 11. Figure 2B As shown, after the target tissue 11 has been cut (e.g., cut into slices 11a, 11b), the blade 8 may come into contact with the pad 10. In some instances, the contact between the pad 10 and the vibrating blade 8 may cause excessive heat buildup in the pad 10 due to friction between the two components. This excessive heat may in turn cause wear and / or damage to the pad 10.

[0036] In some embodiments, once the target tissue has been cut, wear on the pad 10 can be reduced by stopping the ultrasonic vibrations. Stopping the ultrasonic vibrations reduces the amount of friction and heat generated by the contact between the blade 8 and the pad 10. In some embodiments, the ultrasonic treatment apparatus according to embodiments of the present disclosure can be configured such that the ultrasonic transducer automatically stops operating when a complete cut in the tissue is detected. For example, the ultrasonic treatment apparatus according to embodiments of the present disclosure may include a control unit having one or more processors (not shown) configured to automatically stop the ultrasonic transducer when a complete cut in the target tissue has been detected. For example, the control unit may be configured to automatically reduce or stop the power supply to the transducer unit when a complete cut has been detected.

[0037] As previously mentioned, according to some examples, US impedance can be used to determine whether target tissue has been cut. In some such examples, during ultrasonic treatment, the tissue denatures and hardens through frictional heat, and the US impedance increases. After the tissue has been cut, the blade and pad come into contact with each other, and the US impedance decreases. According to some examples, by detecting the point (peak) where the trend of US impedance changes from increasing to decreasing, it may be possible to detect the completion of the incision.

[0038] Figure 3A This is a graph showing impedance over time during tissue cutting using an ultrasonic treatment device, according to an example. Time T0 represents the start time of ultrasonic treatment, and time T2 represents the time when the tissue is completely cut by the ultrasonic treatment device. As shown, the impedance typically increases to point P2 at T2 as the tissue is cut, and then generally decreases. Therefore, by being able to detect the occurrence of point P2 (peak impedance), it may be possible to determine when the incision is complete.

[0039] However, as Figure 3A As further shown, a small ("false") peak impedance (point P1) may appear at time T1 before the "true" peak impedance (point P2) is reached at time T2. For example, when the target tissue being cut has a layered structure, this layering causes a decrease in impedance after only a portion of the tissue (e.g., the first layer) is cut but before a complete incision is made, which may result in a small peak. For some devices based on impedance measurement control, the detection of false peaks may cause the device to prematurely stop ultrasonic vibrations before the tissue is completely cut through, resulting in an incomplete incision.

[0040] Some embodiments of this disclosure utilize resonant frequencies and / or values ​​derived from resonant frequencies as a substitute for or supplement to impedance to determine when tissue has been completely cut. A resonant frequency (which may also be referred to as the "resonant frequency") is the frequency at which the system will exhibit a local maximum response (e.g., the local maximum resonant magnitude). The resonant frequency is a unique frequency that can vary depending on the material, size, temperature, etc., of the blade. It has been surprisingly found that, in some embodiments, the resonant frequency can avoid spurious peaks that may occur in impedance measurements, even in the case of layered tissue. Therefore, the resonant frequency (and / or values ​​derived from the resonant frequency) can provide a more accurate detection of tissue cutting than impedance.

[0041] The resonant frequency of the vibrating blade is inversely related to the blade's temperature. As the blade's temperature increases, the resonant frequency decreases, and conversely, as the blade's temperature decreases, the resonant frequency increases. In some embodiments, when the vibrating blade contacts tissue, frictional heat is generated between the blade and the tissue, causing the blade's resonant frequency to decrease. When the tissue is fully cut, the blade contacts a pad (e.g., a pad placed on the jaws)... Figure 2B (As shown). In some embodiments, because the pad is at a lower temperature than the blade, the blade temperature momentarily decreases when the blade initially contacts the pad, resulting in a momentary increase in the resonant frequency. Further contact between the vibrating blade and the pad eventually causes the blade temperature to rise again due to frictional heating, resulting in another decrease in the resonant frequency.

[0042] In some embodiments, the resonant frequency can be measured or detected by a control unit of the ultrasonic treatment apparatus. In some embodiments, the ultrasonic treatment apparatus can be configured to detect the resonant frequency in a manner described in U.S. Patent No. 7,983,865, which is incorporated herein by reference in its entirety. In some embodiments, the control unit may include a resonant frequency detection circuit that can be configured to detect the resonant frequency based on the phase difference between the voltage and current of the ultrasonic transducer. In some embodiments, the phase of the output voltage and the phase of the output current are detected, and the phase difference between the output voltage and current is calculated. A scan is performed to detect a resonant point (frequency) where the phase difference between the voltage and current is zero. In some embodiments, the control unit is configured to turn on the ultrasonic transducer at the detected resonant frequency.

[0043] Figure 3B-3E This is based on an example shown with Figure 3A The graph shown illustrates the resonant frequency measured simultaneously with the impedance measurement over time. (Example:) Figure 3D and 3EAs specifically shown, during the first interval 101, the resonant frequency exhibits a general decreasing trend. During this time period, starting from time T0, ultrasonic treatment is applied to the tissue, and the frictional contact between the vibrating blade of the ultrasonic treatment device and the tissue causes the blade temperature to rise. As mentioned above, since the resonant frequency is inversely correlated with temperature, the resonant frequency decreases with increasing temperature, resulting in... Figure 3D The downward trend is shown during the first interval 101. As the tissue is fully cut, the blade experiences a temperature decrease, resulting in an increase in the resonant frequency. This is shown during the second interval 102. In some embodiments, this temperature decrease occurs when the blade contacts the pad immediately after cutting the tissue. At this time, the pad may be at a lower temperature than the blade, such that when contact is made between the blade and the lower-temperature pad, the blade temperature decreases (e.g., due to heat transfer from the blade to the pad). Figure 3D and 3E As shown, the second interval 102 can be much shorter than the first interval 101. For example, according to some embodiments, the first interval 101 can be greater than 1-2 seconds, while the second interval 102 can be less than 0.25 seconds. The continuous contact between the vibrating blade and the pad causes the temperature to rise again due to friction between the blade and the pad. This rise in temperature leads to a further decrease in the resonant frequency, as shown in the third interval 103.

[0044] Figure 3B-3E The resonant frequency graph shows a single peak at point P3. Point P3 appears at the boundary between the second interval 102 and the third interval 103, where the resonant frequency changes from an increasing trend to a decreasing trend. Point P4 appears before point P3 at the boundary between the first interval 101 and the second interval 102, where the resonant frequency changes from a decreasing trend to an increasing trend. Point P4 can represent a local minimum in the resonant frequency. Now, specifically refer to... Figure 3B and 3C Point P4 is usually associated with the peak in the impedance ( Figure 3A The time T2 coincides with the occurrence of point P2. Therefore, in some embodiments, the point at which the resonant frequency changes from a decreasing trend to an increasing trend (e.g., point P4 at the boundary between the first interval 101 and the second interval 102) can be used as an indicator to determine when the incision in the tissue has been completed, as an alternative to or supplement to the peak in the detection impedance. In some embodiments, the detection of a peak in the resonant frequency (e.g., point P3) can be used as an indicator to determine when the incision in the tissue has been completed. Furthermore, unlike impedance measurements, the resonant frequency does not exhibit small peaks or “false” peaks before point P3. For example, although Figure 3A The impedance plot shows a false peak (point P1) at time T1, but in Figure 3BThe resonant frequency plot does not show a corresponding peak at time T1. Therefore, according to some embodiments, the use of the resonant frequency can avoid the problem of detecting false peaks.

[0045] Some embodiments of this disclosure include methods for detecting completion of an incision using an ultrasonic treatment device by using a resonant frequency and / or a value calculated or derived from the resonant frequency. In some embodiments, the method includes comparing a measured value of the resonant frequency of the blade of the ultrasonic treatment device with a predicted value for the resonant frequency at regular time intervals. In some such embodiments, the predicted value of the resonant frequency is calculated based on the slope of the measured resonant frequency over a previous time interval. In some embodiments, a linear prediction of the resonant frequency is calculated at regular time intervals, the slope of the linear prediction being equal to the slope of the measured resonant frequency over a previous (e.g., immediately preceding) time interval. In some embodiments, the difference between the predicted value of the resonant frequency and the measured resonant frequency at a given time is calculated, and if the value or magnitude of the difference exceeds a predetermined threshold, it is determined that the tissue has been completely cut by the ultrasonic treatment device. In some embodiments, once completion of the incision is detected, the ultrasonic treatment device may be configured to automatically stop operation of the ultrasonic transducer.

[0046] Figure 4 A graph illustrating the measured resonant frequency, the predicted resonant frequency at regular time intervals, and the difference between the measured and predicted values, according to an example embodiment, is shown. In this example, the predicted resonant frequency is a linear prediction calculated at regular intervals (e.g., 0.5-second intervals). In some embodiments, the slope of each linear prediction is equal to the slope calculated based on the measured resonant frequency at the end of the immediately preceding time interval. In this way, the linear prediction is updated at each time interval. For example, the slope (ΔF) of the predicted line... line The difference between the measured resonant frequencies of the immediately preceding time interval T1 and the time interval T1 can be calculated as: ΔF line =((F0-F T1 ) / T1), where F0 is the resonant frequency measured at the beginning of the time interval, and F T1 It is the resonant frequency measured at time T1 (the end of the time interval).

[0047] In some embodiments, the difference between the predicted line and the measured resonant frequency at a given time is calculated. When the value or magnitude of this difference exceeds a certain threshold, it indicates that the measured resonant frequency has substantially deviated from the predicted value for the resonant frequency. In some embodiments, this deviation indicates that the resonant frequency has reached a turning point (e.g., a change from a decreasing trend to an increasing trend), indicating that the tissue has been completely cut. In some embodiments, the threshold may be a predetermined constant value. In other embodiments, the threshold may be variable. For example, the threshold may be a function of one or more values ​​of the measured resonant frequency (such as the initial resonant frequency).

[0048] Figure 5 This is a diagram outlining the general steps of a method according to some embodiments. In some embodiments, during the output phase, the control unit of the ultrasonic treatment apparatus drives the ultrasonic transducer and performs a scanning process to detect a resonant point (frequency) where the phase difference between the voltage (V) and the current (I) becomes zero. When the scanning process is successful, locking is completed, and the control unit drives the ultrasonic vibrator at the detected resonant frequency. After an initial time interval T0 of T seconds, after output and locking, a first line (line 1) representing the predicted resonant frequency for time interval T1 is calculated. The slope of line 1 can be calculated as described above, for example, by dividing the difference between the measured resonant frequencies between the start and end points of time interval T0 by T seconds. Throughout the time interval T1, the value of line 1 is compared with the measured resonant frequency. For example, if the difference between the value of line 1 and the measured resonant frequency remains below a threshold at a given time, the process continues. If the difference between the value of line 1 and the measured resonant frequency exceeds the threshold, the process can be stopped.

[0049] After another T seconds, at the beginning of time interval T2, the slope is updated based on the measured resonant frequency from the previous time interval T1, and a new second line (line 2) representing the predicted resonant frequency for time interval T2 is calculated. This new line (line 2) is then compared with the measured resonant frequency, and the difference is again compared with a threshold. If the threshold has not been exceeded during time interval T2, the slope is updated again at the beginning of time interval T3 based on the measured resonant frequency from the previous time interval T2, and a new third line (line 3) representing the predicted resonant frequency for time interval T3 is calculated. Line 3 is then compared with the measured resonant frequency, and the difference is again compared with a threshold. This process can continue every T seconds until the threshold is exceeded.

[0050] Figure 6This is a flowchart illustrating the steps for detecting an incision completed using an ultrasonic treatment device according to another embodiment. After output step 602, time t is initialized and set to 0 at locking step 604. At step 606, the resonant frequency F is measured. At step 608, time t is compared with the duration T1 of a specified time interval until time t exceeds T1. Then, the process proceeds to step 610, where the predicted resonant frequency line (F) is calculated. line The slope ΔF line In some embodiments, ΔF line =(F0-F T1 ) / T1, where F0 is the resonant frequency measured at time t=0, and F T1 It is the resonant frequency measured at time t = T1. At ΔF line After the calculation, F line The value of is set to be equal to F, which is the initial value, and in reset step 612, time t is reset to t = 0. At step 614, F line Calculated as F line(n) =F line(n-1) -ΔF line , where n is the sampling interval and is less than T1.

[0051] At step 616, time t is compared with T1. If time t does not exceed T1 at step 616, the process proceeds to step 618, where the predicted resonant frequency F is calculated. line The difference between the measured resonant frequency F and the actual resonant frequency F. In some embodiments, this difference is a relative difference. In some embodiments, the predicted resonant frequency F is calculated. line The relative difference (e.g., percentage difference) between the measured resonant frequency F and the measured resonant frequency F. In some such embodiments, the relative difference can be expressed by the formula (F... line The relative difference is calculated as -X / F. This relative difference, or the magnitude of the relative difference, can then be compared to a threshold X. In some embodiments, the threshold X is a predetermined constant value. In other embodiments, the threshold X can be a function of one or more other variables or fixed parameters. In some embodiments, the threshold X can be stored, for example, in the memory or processor of a control unit. In some embodiments, if the relative difference is in the range of -X to X (e.g., -X ≤ (F / F)), the relative difference is calculated as -X / F. line If -F) / F≤X), then the process returns to step 614. In some embodiments, a new predicted resonant frequency F is calculated for the next sampling point. line(n) And obtain the new measured resonant frequency F. (n) Then use the new F line(n) and F (n) Proceed to steps 616 and 618. However, if the relative difference falls outside the range of -X to X (e.g., (F...line If -F) / F>X), the process proceeds to step 622, indicating that the incision has been completed. In some embodiments, the ultrasonic treatment device can automatically stop operating once the incision completion has been detected.

[0052] If time t exceeds T1 at step 616, the process proceeds to step 620, where the predicted resonant frequency F is calculated. line The difference between the measured resonant frequency F and the measured resonant frequency F is similar to step 618. In some embodiments, the resonant frequency F is predicted. line The relative difference (e.g., percentage difference) between the measured resonant frequency F and the measured resonant frequency F can again be expressed by the formula ((F line The relative difference is calculated as -F) / F). This relative difference can then be compared to a threshold X. If the relative difference is within the range of -X to X (e.g., -X ≤ (F) / X), then the relative difference is considered a threshold. line If -F) / F≤X), the process returns to step 610, where the slope ΔF is recalculated for the next time interval. line If the relative difference falls outside the range of -X to X (e.g., (F...) line If -F) / F>X), the process proceeds to step 622, indicating that the incision has been completed. Once the completion of the incision is detected, the ultrasonic treatment can automatically stop.

[0053] In another embodiment, detecting completion of an incision using an ultrasonic treatment device may include comparing the slope of a measured resonant frequency with a threshold. In some embodiments, completion of the incision is detected when the slope of the measured resonant frequency at a given time is equal to or exceeds the threshold. In some embodiments, the slope is the first derivative of the measured resonant frequency. In some embodiments, the slope of the measured resonant frequency may be determined at regular time intervals (e.g., every T seconds) and compared with a threshold. In some embodiments, the threshold may be calculated by multiplying the absolute value of the measured resonant frequency at a given time by a coefficient. Figure 7 This is a graph showing the slope and threshold of the resonant frequency according to such an example. In some embodiments, the threshold is also updated at regular time intervals (e.g., every T seconds) and may be proportional, for example, to the initial resonant frequency measured at the beginning of the time interval.

[0054] It has been found that, in some embodiments, the resonant frequency before the tissue is completely cut can have a different slope than the resonant frequency after the tissue has been completely cut. This is, for example, in... Figure 8The diagram shows that the slope of the resonant frequency after the tissue has been completely cut is steeper than the slope of the resonant frequency before the tissue has been completely cut. In some such embodiments, the completion of the incision can be detected in part by comparing a first slope of the resonant frequency within a first time interval to a threshold, and comparing a second slope of the resonant frequency within a second time interval to a threshold. The second time interval may be shorter than the first time interval. In some embodiments, the completion of the incision is indicated if the first slope exceeds the threshold and the second slope exceeds the threshold within a certain time period.

[0055] Figure 9 This is a flowchart illustrating steps for detecting an incision completed using an ultrasonic treatment device according to certain other embodiments, wherein the slope of the resonant frequency is compared with a threshold. After output step 902, time t is initialized and set to 0 at locking step 904. Steps 902 and 904 can be similar to those referenced above. Figure 6 Steps 602 and 604 are described. At step 906, the resonant frequency F is measured. At step 908, time t is compared to the duration T1 of a specified time interval until time t exceeds T1. When time t exceeds T1, the slope F' is calculated at step 910. In some embodiments, F' can be expressed by the equation F' = (F0 - F...). T1 The value is calculated using ) / T1, where F0 is the resonant frequency measured at time t = 0, and F T1 The resonant frequency is measured at time t = T1. At step 912, a threshold (F'Threshold) is determined. In some embodiments, F'Threshold is proportional to F0. For example, in some embodiments, F'Threshold is equal to F0 multiplied by a coefficient A. In some embodiments, F'Threshold is calculated based on the absolute value of the resonant frequency and updated every T1 seconds.

[0056] At step 914, F' is compared with F'Threshold. If F' does not exceed F'Threshold, then at step 916, time t is reset to 0, and the process returns to step 908 to begin a new time interval with a duration of T1 seconds, followed by an updated calculation of F' and F'Threshold. If at step 914, F' exceeds F'Threshold, the process proceeds to step 918, which indicates that the incision has been completed. Once incision completion is detected, the ultrasound treatment can automatically stop.

[0057] Figure 10 This illustrates certain embodiments. Figure 9 The flowchart shown is for a modified version of the process. Figure 10 The process shown can be similar to Figure 9The processing shown, except that after step 914, if F' is greater than F'Threshold, a second slope F” is calculated at step 920 and compared with F'Threshold. In some embodiments, F” can be calculated as F” = (F T2 -F T1 ) / T2, where F T1 It is the resonant frequency measured at time t = T1, and F T2 The resonant frequency is measured at time t = T2. If F” exceeds F'Threshold and time t is greater than a certain time T3, the completion of the cut is detected (step 918). Otherwise, the process returns to step 916, where time t is reset to 0, and returns to step 908 to begin another time interval.

[0058] The threshold F'Threshold is not necessarily limited to Figure 9 and 10 The embodiment shown. F'Threshold can be based on other calculations. In some embodiments, for example, F'Threshold can be the average value of the resonant frequency. Figure 11 The flowchart shown is similar to Figure 9 The flowchart shows that, except that F'Threshold calculated in step 912b is the average value of the resonant frequency, in some such embodiments, F'Threshold can be calculated using the following equation:

[0059]

[0060] Where n is the number of measurement samples during the time interval.

[0061] In other embodiments, F'Threshold can be the integral value of the resonant frequency. Figure 12 The flowchart shown is similar to Figure 9 The flowchart shows that, except that F'Threshold calculated in step 912c is the integral value of the resonant frequency, in some such embodiments, F'Threshold can be calculated using the following equation:

[0062]

[0063] An ultrasonic treatment apparatus according to embodiments of the present disclosure may be configured to detect the completion of an incision using any or more of the methods described herein, and to automatically stop operation of the ultrasonic transducer when the completion of the incision has been detected. In some embodiments, for example, in response to the detection of the completion of the incision, the power supply to the transducer may be automatically stopped or reduced. In some embodiments, the ultrasonic treatment apparatus may include, for example, a control unit for operating the ultrasonic transducer, the control unit being configured to implement one or more of the methods described herein for detecting the completion of the incision. The control unit may include one or more processors for controlling the operation of the ultrasonic transducer according to one or more of the described methods. The control unit may also include memory (e.g., one or more non-volatile storage devices or other non-transitory computer-readable storage media) for storing programs, modules, data structures, or subsets thereof for one or more processors to control and execute the various components and methods disclosed herein. In some embodiments, the ultrasonic treatment apparatus includes a storage medium (e.g., a non-transitory computer-readable medium) thereon storing computer-executable instructions that, when executed by a processor, perform one or more of the methods disclosed herein.

[0064] While certain embodiments of this disclosure have been described in conjunction with certain instruments and processes, the embodiments described herein are not necessarily limited to these specific uses. It should be understood that various changes, substitutions, and modifications may be made herein without departing from the spirit and scope of the invention as defined by the appended claims. It should also be apparent that various elements identified herein as belonging to specific embodiments may be included in other embodiments of the invention. Furthermore, the scope of this application is not intended to be limited to the specific embodiments of processes, machines, manufactures, and material compositions, means, methods, and steps described in the specification. As will be readily understood by those skilled in the art from the disclosure herein, according to the invention, processes, machines, manufactures, material compositions, means, methods, or steps existing or developed later can perform substantially the same function or achieve substantially the same results as the corresponding embodiments described herein.

[0065] Cross-references to related applications

[0066] This application claims priority and interest in U.S. Provisional Application 63 / 187,544, filed May 12, 2021, the entire contents of which are incorporated herein by reference.

Claims

1. A treatment apparatus for treating target tissue, comprising: A drive source having a transducer configured to convert electrical energy into mechanical vibration; An instrument having a blade connected to the drive source and configured to apply the mechanical vibrations to the target tissue, and A control unit is configured to operate the transducer to stop generating the mechanical vibration using the transducer in response to detecting a change in the resonant frequency of the blade. Detecting a change in the resonant frequency of the blade includes detecting a change from a first trend of the resonant frequency over time to a second trend of the resonant frequency over time. Wherein, the first trend is a decreasing trend of the resonant frequency, and the second trend is an increasing trend of the resonant frequency, or... The first trend is an increasing trend of the resonant frequency, and the second trend is a decreasing trend of the resonant frequency.

2. The treatment apparatus according to claim 1, wherein, The control unit is configured to control the power supply to the drive source and to automatically reduce or stop the power supply to the drive source in response to detecting a change in the resonant frequency of the blade.

3. The treatment apparatus according to claim 1, wherein, The control unit is configured to determine the slope of the resonant frequency over a predetermined time period, determine a threshold, and compare the slope with the threshold.

4. The treatment apparatus according to claim 3, wherein, The control unit is configured to update the slope and the threshold at predetermined time intervals.

5. The treatment apparatus according to claim 3, wherein, The threshold is proportional to the resonant frequency at a specified time.

6. The treatment apparatus according to claim 5, wherein, The threshold for a given predetermined time period is the product of the resonant frequency and the coefficient at the beginning of the given predetermined time period.

7. The treatment apparatus according to claim 3, wherein, The threshold for a given predetermined time period is equal to the average resonant frequency within the given predetermined time period.

8. The treatment apparatus according to claim 3, wherein, The threshold for a given predetermined time period is equal to the integral of the resonant frequency within the given predetermined time period.

9. The treatment apparatus according to claim 1, wherein, The control unit is configured to, for each time interval in a series of time intervals: Determine the slope of the resonant frequency in the immediately preceding time interval; The predicted value of the resonant frequency is calculated based on the slope of the resonant frequency; and The resonant frequency is compared with the predicted value for the resonant frequency.

10. The treatment apparatus according to claim 9, wherein, Comparing the predicted value for the resonant frequency with the resonant frequency includes calculating the difference between the resonant frequency and the predicted value for the resonant frequency.

11. The treatment apparatus according to claim 10, wherein, The control unit is also configured to compare the magnitude of the difference with a threshold.

12. The treatment apparatus according to claim 11, wherein, Detecting a change in the resonant frequency of the blade includes detecting that the magnitude of the difference exceeds the threshold, and Wherein, if the magnitude of the difference within the time interval does not exceed the threshold, the control unit is configured to proceed to the next time interval in the series of time intervals.

13. The treatment apparatus according to claim 1, wherein, The control unit is configured to stop generating the mechanical vibration in response to detecting a change in the resonant frequency and a change in the ultrasonic impedance.

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