Method and apparatus for electrical energy control, ultrasonic treatment system, and storage medium

Abstract

The present application relates to an electric power control method and apparatus, an ultrasonic treatment system, and a storage medium. In an electric power control method of a medical device including an ultrasonic instrument having a vibration transmission member that ultrasonically vibrates, a power supply configured to supply electric power to the ultrasonic instrument, and a processor including a control unit operably connected to the power supply, the method includes controlling the supply of electric power to the ultrasonic instrument, obtaining a temperature value related to a temperature of the vibration transmission member, wherein the vibration transmission member is separate from the transducer, and controlling the power supply to reduce or stop the supply of electric power from the power supply based on a rate of change of the temperature value.

Description

Technical Field

[0001] The systems, apparatuses, and methods disclosed herein relate to medical devices, and more particularly to medical devices for ultrasound treatment. Background Technology

[0002] In the following discussion, certain structures and / or methods are referenced. However, these references should not be construed as an admission that these structures and / or methods constitute prior art. The applicant expressly reserves the right to demonstrate that these structures and / or methods are not prior art to this invention.

[0003] When cutting living tissue using ultrasonic vibration, the ultrasonic impedance (“US impedance”) is monitored, and a change in US impedance is detected as a sign that the cutting of the living tissue is complete. When this change is detected, ultrasonic vibration is stopped.

[0004] For example, U.S. Patent 8,749,116 discloses an ultrasonic treatment device comprising a treatment section to which ultrasonic vibrations are transmitted and jaws that can be opened and closed relative to the treatment section. In this ultrasonic treatment device, ultrasonic vibrations are generated in an ultrasonic transducer when vibration-generating electricity is transmitted from a power source to the vibration-generating section, and the generated ultrasonic vibrations are transmitted to the treatment section, which then treats a target, such as biological tissue, by using the transmitted ultrasonic vibrations. Here, the opening and closing direction of the jaws is perpendicular (transverse) to the transmission direction of the ultrasonic vibrations. When the ultrasonic vibrations are transmitted to the treatment section while the target is held between the treatment section and the jaws, frictional heat is generated between the target and the treatment section. Through this frictional heat, the target is condensed and simultaneously cut. Furthermore, in the ultrasonic treatment device, the ultrasonic impedance value of the vibration-generating electricity is detected over time, and it is determined whether the ultrasonic impedance value is within a range greater than or equal to a first default threshold and less than or equal to a second default threshold, wherein the second default threshold is greater than the first default threshold.

[0005] For example, U.S. Patent 9,848,903 discloses the calculation and detection of ultrasonic impedance values, as well as the calculation of the peak of the ultrasonic impedance value at which the cutting of the living tissue should be completed. However, the detection of the impedance peak itself does not always provide an accurate determination of when the cutting of the living tissue is completed.

[0006] Nevertheless, when monitoring ultrasonic impedance, spurious peaks may occur before the true peak, which is due to the completion of biopsy dissection. In this case, when the processor detects the spurious peak, it stops ultrasonic vibration, but the procedure is not yet complete, for example, the biopsy dissection is not finished. This can happen, for example, when treating biopsy with a layered structure consisting of two or more layers, and a spurious peak appears in the monitored ultrasonic impedance when the first layer is cut. Therefore, more accurate systems and methods are needed to detect the completion of the dissection process when treating biopsy using a medical device for ultrasonic treatment. Summary of the Invention

[0007] This application discloses systems and methods for controlling a medical device for ultrasonic treatment based on the temperature behavior of a vibration transmission member, such as the rate of temperature change at a point on the vibration transmission member of an end effector. In some embodiments, the control of the medical device for ultrasonic treatment is based on both the change in ultrasonic impedance during treatment and the temperature behavior of the vibration transmission member (such as the rate of temperature change at a point on the vibration transmission member). Detecting both the change in ultrasonic impedance and the rate of temperature change allows for the differentiation between spurious peaks (which are not associated with the completion of the cutting of the living tissue being treated) and true peaks (which are associated with the completion of the cutting of the living tissue being treated). Additionally, the completion of the ultrasonic treatment (such as a cutting procedure) can be based on the integrated temperature of the vibration transmission member. In another embodiment, strain values ​​are monitored to detect changes in the clinician's operation of the medical device for ultrasonic treatment (such as parameters related to the forward and backward longitudinal movement of the transmission rod), and these changes are then correlated with ultrasonic impedance to differentiate between spurious peaks (which may be caused by such clinician operation) and true peaks (which indicate the end of the treatment conditions). This application also discloses a medical device itself, which operates based on a method for detecting the completion of ultrasound treatment, and incorporates a method for detecting a true peak caused by the completion of cutting of living tissue by the medical device for ultrasound treatment.

[0008] The purpose of this disclosure is to provide a method for controlling electrical power in a medical device, the medical device including an ultrasound instrument having a vibration transmission member that vibrates ultrasonically, a power supply configured to supply electrical power to the ultrasound instrument, and a processor including a control unit operatively connected to the power supply. The method includes: controlling the electrical power supply to the ultrasound instrument, obtaining a temperature value related to the temperature of the vibration transmission member, wherein the vibration transmission member is separate from a transducer, and controlling the power supply to reduce or stop the electrical power supply based on the rate of change of the temperature value.

[0009] Another object of this disclosure is to provide a power control method for a medical device including an ultrasound instrument having an ultrasonically vibrating vibration transmission member, a power supply configured to provide power to an ultrasonic oscillator circuit for providing ultrasonic vibrations to the vibration transmission member to cut living tissue, and a processor including a control unit operatively connected to the power supply. The method includes: calculating a temperature change value per unit time based on the temperature of the vibration transmission member; identifying a peak value among a plurality of temperature rate change values, wherein the peak value is the maximum value among the plurality of temperature rate change values; determining whether the peak value is a false peak corresponding to incomplete cutting of the living tissue or a true peak corresponding to completed cutting of the living tissue; when the peak value is determined to be a true peak, controlling the power supply to reduce or stop providing power to the ultrasonic oscillator circuit; and when the peak value is determined to be a false peak, controlling the power supply to continue providing power to the ultrasonic oscillator circuit.

[0010] Another object of this disclosure is to provide an electrical power control device comprising a power supply and a processor, the power supply being configured to: be connected to an ultrasonic instrument having a vibration transmission member having ultrasonic vibration, and supply electrical power to the ultrasonic instrument; the processor comprising a control unit operatively connected to the power supply, the control unit being configured to: control the electrical power supply to the ultrasonic instrument, obtain a temperature value related to the temperature of the vibration transmission member, and control the power supply to reduce or stop the electrical power supply based on the rate of change of the temperature value.

[0011] Another object of this disclosure is to provide a medical control device comprising a power supply and a processor, the power supply being configured to: supply power to an ultrasonic oscillator circuit for providing ultrasonic vibrations to cut living tissue; the processor being operatively connected to the power supply and configured to: calculate a temperature change value per unit time based on the temperature of a vibration transmission member; identify a peak value among a plurality of temperature rate change values, the peak value being the maximum value among the plurality of temperature rate change values; determine whether the peak is a false peak corresponding to incomplete cutting of the living tissue or a true peak corresponding to complete cutting of the living tissue; when the peak is determined to be a true peak, control the power supply to reduce or stop supplying power to the ultrasonic oscillator circuit; and when the peak is determined to be a false peak, control the power supply to continue supplying power to the ultrasonic oscillator circuit.

[0012] Another object of this disclosure is to provide a non-transitory computer-readable storage medium storing instructions, wherein the instructions, when executed by a processor, instruct the processor to perform a power control method for a medical device, the medical device comprising: an ultrasound instrument having a vibration transmission member that vibrates ultrasonically; a power source configured to supply power to the ultrasound instrument; and a processor including a control unit operably connected to the power source, the method comprising: controlling the supply of power to the ultrasound instrument; obtaining a temperature value related to the temperature of the vibration transmission member; and controlling the power source based on the rate of change of the temperature value to reduce or stop the power supply.

[0013] Another object of this disclosure is to provide a non-transitory computer-readable storage medium storing instructions, wherein the instructions, when executed by a processor, instruct the processor to perform a power control method for a medical device, the medical device comprising: an ultrasound instrument having a vibration transmission member that vibrates ultrasonically; a power source configured to supply power to an ultrasound oscillator circuit for supplying ultrasonic vibrations to the vibration transmission member to cut living tissue; and a processor including a control unit operably connected to the power source, the method comprising: calculating a temperature change value per unit time based on the temperature of the vibration transmission member; identifying a peak value among a plurality of temperature rate change values, the peak value being the maximum of the plurality of temperature rate change values; determining whether the peak value is a spurious peak corresponding to incomplete cutting of the living tissue or a true peak corresponding to complete cutting of the living tissue; if the peak value is determined to be a true peak, controlling the power source to reduce or stop supplying power to the ultrasound oscillator circuit; and if the peak value is determined to be a spurious peak, controlling the power source to continue supplying power to the ultrasound oscillator circuit.

[0014] Further features and advantages will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practice of the invention. The objects and other advantages of the disclosed input device will be realized and obtained by means of the structures particularly pointed out in the written description, its claims, and the accompanying drawings. Attached Figure Description

[0015] The disclosed aspects will be described below in conjunction with the accompanying drawings, which are provided for illustrative purposes and not for limiting the disclosed aspects, wherein the same reference numerals denote the same elements.

[0016] Figure 1 A schematic diagram of a medical device according to an embodiment of the present disclosure is shown.

[0017] Figure 2 A schematic diagram of a controller according to an embodiment of the present disclosure is shown.

[0018] Figure 3 It is a graph showing the rate of increase (%) of temperature in a medical device according to an embodiment of the present disclosure over time (seconds).

[0019] Figure 4 This is a flowchart of the process for detecting the completion of tissue cutting according to an embodiment of the present disclosure.

[0020] Figure 5 This is a graph showing the ultrasonic impedance (kiloohms (KΩ)) in a medical device according to an embodiment of the present disclosure as a function of time (seconds).

[0021] Figure 6A This shows the rate of increase of temperature (%) in a medical device according to an embodiment of the present disclosure over time (seconds) and as shown in the figure. Figure 5 The graph of ultrasonic impedance (kiloohms (KΩ)) versus time (seconds).

[0022] Figure 6B yes Figure 6A Details of part A of the graph.

[0023] Figure 6C It is based on Figure 6A A block diagram illustrating the functional operation of the medical device in an embodiment.

[0024] Figure 7 This is a flowchart of the process for detecting the completion of tissue cutting according to another embodiment of the present disclosure.

[0025] Figure 8 This is a graph showing the integrated temperature (joules) in a medical device according to an embodiment of the present disclosure as a function of time (seconds).

[0026] Figure 9 This is a flowchart of the process for detecting the completion of tissue cutting according to another embodiment of the present disclosure.

[0027] Figure 10A This is a cross-section of a medical device according to an embodiment of the present disclosure.

[0028] Figure 10B It is shown Figure 10A The operation of the medical device is plotted, in which the peak characteristics of the ultrasonic impedance (kiloohms (KΩ)) in the medical device over time (seconds) (plot at (I)) are correlated with the peak characteristics of the strain (microstrain (με)) in the medical device over time (seconds) (plot at (II)).

[0029] Figure 11 This is a flowchart of the process for detecting the completion of tissue cutting according to another embodiment of the present disclosure.

[0030] In all the accompanying drawings, the sizes of the corresponding constituent elements have been appropriately adjusted for clarity. For ease of viewing, in some instances, only certain named features in the drawings are labeled with reference numerals. Detailed Implementation

[0031] Medical devices that can provide ultrasonic vibrations to apply heat to body tissue are used in a variety of surgical procedures, such as to cauterize blood vessels or to weld or seal tissue or lumens. One common type of device includes an end effector that generates ultrasonic vibrations at its site. The end effector includes a vibration transmission member and a pad that are moved to contact each other. As the living tissue is cut by ultrasonic vibrations in the vibration transmission member, a processor monitors the ultrasonic impedance. The processor detects the completion of the cutting of the living tissue based on changes in ultrasonic impedance and stops (or reduces) the ultrasonic vibrations.

[0032] After ultrasonic treatment begins, the living tissue denatures and hardens due to frictional heat, and the ultrasonic impedance increases. The living tissue is cut, and the vibration transmission component and the pad come into contact with each other. As the pad denatures due to the frictional heat generated by ultrasonic vibration, the ultrasonic impedance decreases. The completion of the cutting of the living tissue can be detected by detecting the point (peak) where the ultrasonic impedance changes from increasing to decreasing. Pad wear can be suppressed by accelerating the detection of the completion of the cutting of the living tissue. Therefore, excessive invasion of the living tissue can be suppressed.

[0033] However, depending on the type of live tissue, another peak (i.e., a "false peak") may appear before the peak (i.e., the "true peak") caused by the completion of live tissue cutting. When the processor detects a false peak, it reduces or stops ultrasound vibrations even though the live tissue has not been cut. In cases where the live tissue is a layered structure consisting of two or more layers (e.g., the cervix), a false peak may occur when the first layer is cut. Examples detect the completion of live tissue cutting by detecting peaks of changes in ultrasound impedance and by monitoring changes in the rate of temperature increase of the vibration transmission member. Some embodiments detect the completion of live tissue cutting by monitoring changes in the rate of temperature increase of the vibration transmission member without detecting impedance.

[0034] Therefore, one aspect of this disclosure describes a method for accurately detecting a true peak resulting from the completion of cutting of living tissue. This disclosure also describes controlling a medical device based on either the rate of temperature change at a location of the vibration transmission member of the end effector or based on changes in ultrasonic impedance and the rate of temperature change (such as the rate of temperature change at a location of the end effector) during the procedure. Detection of both the changes in ultrasonic impedance and the rate of temperature change allows for the differentiation between false peaks (which are not associated with the completion of cutting of the living tissue being treated) and true peaks (which are associated with the completion of cutting of the living tissue being treated). In another aspect, this disclosure also relates to a medical device for ultrasonic treatment that operates based on a method for detecting a true peak resulting from the completion of cutting of living tissue.

[0035] As used herein, the term "patient" includes any and all living organisms, and includes the term "subject." Patients can be humans and animals.

[0036] As used herein, the temperature of a vibration transmission component specifically indicates the temperature of its tip. The temperature of the vibration transmission component is treated in the same manner in the following description and examples. For example, the temperature may be calculated based on the current and voltage supplied to the vibration transmission component, or obtained through various known methods.

[0037] Figure 1 A schematic diagram of a medical device according to an embodiment of the present disclosure is shown. Figure 1 As shown, the medical device 1 for treating patient tissue includes a treatment instrument 2, and a controller 3 with a processor includes an input controller 4 (such as an actuation switch). The treatment instrument 2 may be, for example, a surgical energy fusion device used for applications such as welding biological tissue through the abdominal wall in the abdominal cavity, or for cutting in open surgery or laparoscopy.

[0038] The treatment instrument 2 has a handle 2A1, a shaft 2A2, and a treatment section consisting of an end effector 10, which is, for example, a pair of openable or pivotable gripping parts (including a first gripping part 11A and a second gripping part 11B) for grasping biological tissue for treatment. The gripping part as a whole is also referred to herein as the "treatment section" or "treatment unit" of the medical instrument. Note that in the following text, when referring to constituent elements having the same function and having reference numerals A and B respectively appended to the end of the reference numerals, the symbols A or B may be omitted. For example, the first gripping part 11A and the second gripping part 11B may each be referred to as a gripping part.

[0039] Handle 2A1 is connected to controller 3 via cable 2L. Handle 2A1 has an open / close actuator 2A3, such as a trigger, for the surgeon to operate the opening and closing of the treatment unit and is in a shape that the surgeon can easily fasten, for example, approximately L-shaped. The open / close actuator 2A3 is disposed at one end of handle 2A1 and integrated with the treatment unit to transmit the operation of the open / close actuator 2A3 to the treatment unit. On the other side of handle 2A1, a handhold 2A4 is provided for the clinician to hold while operating the treatment instrument 2.

[0040] Figure 2 A schematic diagram of a controller according to an embodiment of the present disclosure is shown. The controller 3 may include a processor 32, a display 36, an input unit 42, and a power supply 44.

[0041] The processor 32 may include a memory 34, a computing unit 46, and a control unit 40. The computing unit 46 and the control unit 40 are formed of integrated circuits including a CPU (Central Processing Unit), an ASIC (Application-Specific Integrated Circuit), or a FPGA (Field-Programmable Gate Array). The computing unit 46 and the control unit 40 may be formed of a single integrated circuit or may be formed of multiple integrated circuits.

[0042] In some embodiments, any of the various parameters used to estimate the current temperature may be stored in memory 34, for example, in a lookup table stored in memory 34. These parameters may include, for example, the specific heat capacity of the treatment portion, the thermal resistance of the treatment portion, the thermal conductivity of the treatment portion, or the contact area between body tissue and the treatment portion. The lookup table may include values ​​for corresponding parameters for different treatment portions. For example, the lookup table may include parameters for muscle tissue, adipose tissue, blood vessels, intestinal wall, or other tissue types. In such embodiments, estimating the current temperature may include determining the type of tissue undergoing surgery and determining the corresponding parameter value in the lookup table for estimating the current temperature. Alternatively, the surgery name may be used as the basis for entering the lookup table. Calculation unit 46 is configured to calculate the estimated current temperature and other parameters required for calculating the estimated current temperature and the rate of temperature change (which may need to estimate the current temperature). In such embodiments, for example, estimating the current temperature may include determining the type of biological tissue undergoing surgery and determining the corresponding parameter value in the lookup table for estimating the current temperature. Control unit 40 is configured to control power supply 44 and display 36 using parameters calculated by calculation unit 46 based on commands provided by processor 32. Temperature can be determined, sensed, or calculated by suitable apparatus and methods, for example, as disclosed in U.S. Provisional Patent Application 63 / 042,594, filed June 23, 2020, entitled “A METHOD FOR CONTROLLING A MEDICALDEVICE AND A MEDICAL DEVICE IMPLEMENTING THE SAME,” the entire contents of which are incorporated herein by reference.

[0043] In some embodiments, the data associated with various parameters is the value of the contact area calculated using the size and shape of the end effector (particularly the disposal portion of the end effector) and how the end effector is used (e.g., in relation to surgery), and this data is pre-stored in memory. Furthermore, since the contact area changes as the end effector grasps and re-grasps tissue during the surgical procedure, the various parameters can also change accordingly during the surgical procedure, and the readily available data for these parameters in memory allows for dynamic updates during the surgical procedure.

[0044] like Figure 1As shown, the controller 3 has a display section 36 for displaying treatment conditions, etc., and a setting operation section 35 for the surgeon to set treatment conditions, etc., on the front panel. In some embodiments, the input controller 4 can be connected to the controller 3 via a cable 4L. The clinician can turn the power output from the controller 3 to the treatment instrument 2 on or off by the input controller 4 (e.g., by pressing the pedal of the foot switch of the input controller 4). The foot switch is not a necessary component, and any input controller can be used, such as a switch operated by the clinician's hand or other alternative input controllers.

[0045] In some embodiments, the controller 3 includes a processor 32 that controls the application of power to the treatment instrument 2 via a power supply 44 to maintain the temperature at the end effector 10 within a safe and effective range. In some embodiments, the processor 32 may control input provided by a clinician (e.g., via an input controller 4) to turn the power to the treatment instrument 2 on or off.

[0046] In some embodiments, the control unit 40 may be configured to increase or decrease the gripping force of the treatment instrument 2 or its end effector 10 on a portion of the tissue being operated on.

[0047] Figure 3 It is a graph showing the rate of increase (%) of temperature in a medical device according to an embodiment of the present disclosure over time (seconds). Figure 3 The illustration shows that, according to some embodiments, the completion of a biopsy can be detected by the rate of change (ΔT, %) of the temperature increase of the vibration transmission component during the procedure. Incomplete cuts 303 (dot-line-circle) have a value less than a threshold (ΔT). th The first temperature change rate (ΔT1) at the incomplete cut 303 is a false peak, where the temperature increase rate temporarily decreases before it increases again. The completed cut 304 (dashed circle) has a temperature change rate greater than the threshold (ΔT). th The second rate of temperature change (ΔT2). The peak of the rate of temperature increase at the completed cut 304 is the true peak. Then, after the cut is completed, the rate of temperature increase will decrease (arrow 305).

[0048] Figure 4 This is a flowchart of the process for detecting the completion of tissue cutting according to an embodiment of the present disclosure. In operation S401, ultrasonic treatment begins. In operation S402, it is determined whether a peak has been detected in the rate of change of temperature increase of the vibration transmission member during treatment. If "no", the treatment continues in operation S402. If "yes", it is determined whether the change in the rate of temperature increase over a certain period of time is greater than a threshold (ΔT). th(S403). If "No", the procedure continues in S402. If "Yes", it is determined that the cutting of the living tissue has been completed, and the procedure is stopped (or reduced) (S404).

[0049] Figure 5 This is a graph showing the ultrasonic impedance (kiloohms (kΩ)) in a medical device according to an embodiment of the present disclosure as a function of time (seconds). Reference Figure 5 According to embodiments of this disclosure, the ultrasonic impedance of the ultrasonic transmission component can be monitored simultaneously. Figure 5 As shown, when monitoring ultrasonic impedance, the impedance will typically increase (arrow 501) until the cut is complete, and then decrease (arrow 502) until it stops or the power is reduced. However, a false impedance peak 503 (dotted circle) may be detected, where there is a temporary drop in impedance followed by another increase in impedance until the true impedance peak 504 (dashed circle).

[0050] Figure 6A This illustrates, according to an embodiment of the present disclosure, the time-based transfer of data from a medical device... Figure 3 The graph of temperature increase rate (%) over time (seconds) and its origin Figure 5 The graph is a superposition of the ultrasonic impedance (kiloohms (KΩ)) versus time (seconds). Figure 6B yes Figure 6A Details of section A of the graph. In this embodiment, the temperature change per unit time is calculated based on the temperature of the vibration transmission component. To determine if the first peak is a false impedance peak 503, the rate of temperature change (ΔT) at the corresponding time interval is analyzed. For example, as described above, the rate of temperature change (ΔT) is calculated and compared with a threshold (ΔT). th (This is a comparison.) In the temperature behavior corresponding to the ultrasonic impedance peak, if the increase (ΔT) from the minimum temperature increase rate of the vibration transmission component is less than the threshold (ΔT)... th If the peak of the ultrasonic impedance is not found to be a false peak, then the peak is identified as a false peak. However, in the temperature behavior corresponding to the ultrasonic impedance peak, if the increase (ΔT) from the minimum temperature increase rate of the vibration transmission component is greater than the threshold (ΔT), then the peak is considered a false peak. th If the peak of the ultrasonic impedance is such that the peak is determined to be the true peak, then... (Reference) Figure 6A and Figure 6B The first temperature change rate (ΔT1) at the pseudo-impedance peak at 503, obtained at the time associated with the temperature at 505, is less than the threshold (ΔT). th The second temperature change rate (ΔT2) at the true peak at 504, obtained at a time correlated with the temperature at 506, is greater than the threshold (ΔT). th ).

[0051] Figure 6C It is based on Figure 6AA block diagram illustrating the functional operation of the medical device in an embodiment.

[0052] Figure 6C Function blocks can be, for example, made by Figure 2 The processor 32 operates. In embodiment 600, the generator 610 can be controlled by a field-programmable gate array (FPGA) 620, programmable circuitry, or other integrated circuit, and can control a handheld device 630, for example... Figure 1 Treatment instrument 2.

[0053] Generator 610 may include an ultrasonic oscillator circuit 613 (e.g., an amplifier circuit), an output current detection circuit 611, an output voltage detection circuit 612, and analog-to-digital converters (ADCs) 614 and 615. The ultrasonic oscillator circuit 613 outputs an ultrasonic oscillation signal to the handheld device 630. The output current detection circuit 611 detects the current from the ultrasonic oscillation signal from the ultrasonic oscillation signal from the ultrasonic oscillator circuit 613. The output voltage detection circuit 612 detects the voltage from the ultrasonic oscillation signal from the ultrasonic oscillator circuit 613. The output current detection circuit 611 and the output voltage detection circuit 612 output analog signals corresponding to their respective detected values ​​to the corresponding analog-to-digital converters 614 and 615.

[0054] FPGA 620 may include an impedance calculation block 621 for calculating impedance, a power calculation block 622 for calculating the amount of power supplied, a frequency detection block 623 for detecting the vibration frequency of the medical device, a temperature (t) / T increase rate estimation block 624 for calculating the increase (ΔT) from the minimum temperature increase rate of the vibration transmission component, and an output control block 625 for controlling the output of the ultrasonic oscillator circuit 613 of generator 610. The ADCs 614 and 615 of generator 610 each output to the impedance calculation block 621, the power calculation block 622, the frequency detection block 623, and the output control block 625. The power calculation block 622 and the frequency detection block 623 output to the temperature (t) / T increase rate estimation block 624. The minimum and peak values ​​of the temperature increase rate are detected at the temperature (t) / T increase rate estimation block 624. Output control block 625 receives results from temperature (t) / T increase rate estimation block 624 and impedance calculation block 621, and uses these results, along with values ​​from ADCs 614 and 615, to control ultrasonic oscillator circuit 613. As described above, if temperature (t) / T increase rate estimation block 624 determines that the increase (ΔT) from the minimum temperature increase rate of the vibration transmission member is less than a threshold, it is determined to be a false peak, and output control block 625 controls ultrasonic oscillator circuit 613 to continue operating. If temperature (t) / T increase rate estimation block 624 determines that the increase (ΔT) from the minimum temperature increase rate of the vibration transmission member is greater than a threshold, it is determined to be a true peak, and output control block 625 controls ultrasonic oscillator circuit 613 to reduce or stop operation and stop transmitting oscillations to handheld device 630.

[0055] Figure 7 This is a flowchart of the process for detecting the completion of tissue cutting according to an embodiment of the present disclosure. In operation S701, ultrasonic treatment begins. In operation S702, based on the power supplied to the vibration transmission member, it is determined whether a peak has been detected in the ultrasonic impedance of the vibration transmission member during treatment. If "no", the treatment continues in operation S702. If "yes", in operation S703, it is determined whether a peak has been detected in the rate of change of temperature increase of the vibration transmission member during treatment. If "no", the treatment continues in operation S702. If "yes", it is determined whether the change in the rate of temperature increase over a certain period of time is greater than a threshold T. th (S704). If “No”, the procedure continues with S702. If “Yes”, it is determined that the cutting of the living tissue has been completed, and the procedure is stopped (or reduced) (S705). It should be understood that operation S702 can be performed after or simultaneously with operations S703 and S704.

[0056] Figure 8This is a graph showing the integrated temperature over time in a medical device according to an embodiment of the present disclosure. (Reference) Figure 8 In some embodiments, the presence of cut tissue can be detected solely by the integrated temperature of the vibration transmission component. In other embodiments, integrated temperature can be used in addition to the aforementioned rate of temperature increase and / or impedance change. The cutting of living tissue can be detected by calculating the temperature at the tip of the medical device (e.g., at...). Figure 1 The integrated temperature is determined by the amount of energy (e.g., joules (J)) at the distal end of the vibration transmission member of the end effector 10. This can be calculated by integrating the temperature of the vibration transmission member. The memory 34 can include information about the protein denaturation temperatures of various tissues to determine whether the tissue has been cut. At time t1, while supplying ultrasonic energy, line 801 begins integrating the temperature of the vibration transmission member. At time t2, when the calculated integrated temperature reaches the threshold at line 802, the output is stopped (or reduced) and the treatment ends.

[0057] Figure 9 This is a flowchart of the process for detecting the completion of tissue cutting according to an embodiment of the present disclosure. In operation S901, ultrasonic treatment begins. In operation S902, it is determined whether a peak has been detected in the ultrasonic impedance of the vibration transmission member during treatment. If "no", the treatment continues in operation S902. If "yes", in operation S903, it is determined whether a peak has been detected in the rate of change of temperature increase of the vibration transmission member during treatment. If "no", the treatment continues in operation S902. If "yes", it is determined whether the change in the rate of temperature increase over a certain period of time is greater than a threshold T. th (S904). If “No”, the procedure continues in S902. If “Yes”, it is determined that the cutting of the living tissue has been completed, and the procedure is stopped (or reduced) (S905). It should be understood that operation S902 can be performed after or simultaneously with operations S903 and S904.

[0058] Figure 10A This is a cross-section of a medical device according to an embodiment of the present disclosure. Figure 10B It is shown Figure 10A A diagram illustrating the operation of the medical device. (Reference) Figure 1 and Figures 10A-10B , Figure 1The shaft 2A2 of the medical device 1 can extend internally to the handle 2A1. The internal portion of the shaft 2A2 can include an inner shaft 51 and a slider 52 that enables longitudinal movement of the inner shaft 51. A force sensor 1001 (e.g., a strain sensor) can be mounted at the end of the slider 52 for detecting the hand-held force of a clinician operating the medical device. A change in hand-held force indicates that a back-and-forth movement of the shaft is being generated. The force sensor 1001 (e.g., a strain sensor) is used to detect strain after the output begins, which indicates stress in the long axis direction generated by the longitudinal movement of the shaft. In other words, a higher strain detected by the force sensor 1001 means that the clinician is squeezing the open / close actuator 2A3 more forcefully. This is combined with detecting the rate of change of temperature increase, as in... Figure 7 In the examples, if the change in the dependent variable (i.e., the deformed value) exceeds a certain range or a certain rate of change, it is identified as a spurious peak. For example, a clinician might want to continue cutting, so they grip harder. Figure 10B In the middle, part (I) shows the rate of change of temperature increase, similar to Figure 7 Examples show a false peak 1003 and a true peak 1004. Part (II) shows the results of... Figure 10A The force sensor 1001 detects the strain value. If the strain at the corresponding time (e.g., as indicated by line 1005) exceeds a threshold, a peak 1003 appears simultaneously with the deformation value in the strain, thus identifying a false peak.

[0059] Figure 11 This is a flowchart of the process for detecting the completion of tissue cutting according to an embodiment of the present disclosure. In operation S1101, ultrasonic treatment begins. In operation S1102, it is determined whether a peak has been detected in the rate of change of temperature increase of the vibration transmission member during treatment. If "no", the treatment continues in operation S1102. If "yes", it is determined whether the change in the rate of temperature increase over a certain period of time is greater than a threshold T. th (S1103). If "No", the process continues to operation S1102. If "Yes", in operation S1104, it is determined that... Figure 10A The force sensor 1001 detects whether the change in strain value exceeds a threshold. If "yes", the procedure continues in operation S1102. If "no", it is determined that the cutting of the living tissue has been completed, and the procedure stops (or is reduced) (S1105). It should be understood that operation S1104 can be performed before or simultaneously with operations S1102 and S1103.

[0060] Although the invention has been described in conjunction with the exemplary embodiments described above, those skilled in the art will understand that additions, deletions, modifications, and substitutions not specifically described may be made without departing from the spirit and scope of the invention as defined by the appended claims.

[0061] The foregoing description is provided to enable those skilled in the art to practice the various configurations described herein. While the subject matter has been specifically described with reference to various accompanying drawings and configurations, it should be understood that these drawings and configurations are for illustrative purposes only and should not be considered as limiting the scope of the subject matter.

[0062] There are many other ways to implement the subject matter. The various functions and elements described herein may be distinguished differently from those shown without departing from the scope of the subject matter. Various modifications to these configurations will be apparent to those skilled in the art, and the general principles defined herein can be applied to other configurations. Therefore, those skilled in the art can make many changes and modifications to the subject matter without departing from its scope.

[0063] It should be understood that the specific order or hierarchy of steps in the disclosed process is an illustration of an exemplary method. It should be understood that the specific order or hierarchy of steps in the process can be rearranged based on design preferences. Some steps may be performed simultaneously. The appended method claims present the elements of the various steps in a sample order and are not intended to limit one to the specific order or hierarchy presented.

[0064] In some embodiments, any provision of this document may be subordinate to any independent provision or any dependent provision. In one aspect, any provision (e.g., a dependent or independent provision) may be combined with any other provision (e.g., a dependent or independent provision). In one aspect, a claim may include some or all of the words (e.g., steps, operations, means, or components) recorded in a provision, sentence, phrase, or paragraph. In one aspect, a claim may include some or all of the words recorded in one or more provisions, sentences, phrases, or paragraphs. In one aspect, some words may be removed from individual provisions, sentences, phrases, or paragraphs. In one aspect, additional words or elements may be added to provisions, sentences, phrases, or paragraphs. In one aspect, the subject matter may be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject matter may be implemented using additional components, elements, functions, or operations.

[0065] Therefore, for example, a reference to "piston assembly" includes a reference to one or more piston assemblies, and a reference to "magnet" includes a reference to one or more magnets.

[0066] In one or more respects, the terms “about,” “basically,” and “approximately” may provide industry-accepted tolerances for the relevance between their respective terms and / or items, such as from less than one percent to five percent.

[0067] As used in this article, the term “substantially” refers to the complete or nearly complete scope or degree of an action, characteristic, nature, state, structure, item, or result.

[0068] It should be understood that the range format is used for convenience and brevity only, and therefore should be flexibly interpreted to include not only the values ​​explicitly listed as range boundaries, but also all individual values ​​or subranges covered within that range, as if each value and subrange were explicitly listed. For example, the numerical range “approximately 0.5 to 10 cm” should be interpreted to include not only the explicitly listed values ​​of approximately 0.5 cm to approximately 10.0 cm, but also the individual values ​​and subranges within the indicated range. Therefore, what is included in this numerical range are individual values ​​such as 2, 5, and 7, and subranges such as 2 to 8, 4 to 6, etc. The same principle applies to ranges that list only one value. Furthermore, this interpretation should apply regardless of the width of the range or the characteristics described.

[0069] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Although any methods, apparatuses, and materials similar to or equivalent to those described herein may be used in the practice or testing of this disclosure, representative methods, apparatuses, and materials are described below.

[0070] Unless otherwise stated, references to singular elements are not intended to mean "one and only one," but rather "one or more." Male pronouns (e.g., his) include female and neuter pronouns (e.g., her and its), and vice versa. The term "some" refers to one or more. Underlined and / or italicized headings and subheadings are used for convenience only, do not limit the subject matter, and are not mentioned in connection with the interpretation of the description of the subject matter. All structural and functional equivalents of elements in various configurations throughout the description of this disclosure that are known or will be known later by one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the subject matter. Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the foregoing description.

[0071] The techniques described herein can be implemented in hardware, software, firmware, or any combination thereof, unless explicitly described as being implemented in a particular manner. Any feature described as a module or component may also be implemented together in an integrated logic device or separately as a discrete but interoperable logic device. If implemented in software, the technique may be implemented at least in part by a non-transitory processor-readable storage medium comprising instructions that, when executed, perform one or more of the methods described above.

[0072] Non-transitory processor-readable storage media may include random access memory (RAM) (such as synchronous dynamic random access memory (SDRAM), read-only memory (ROM), non-volatile random access memory (NVRAM), electrically erasable programmable read-only memory (EEPROM), flash memory, and other known storage media. Additionally or alternatively, these techniques may be implemented at least in part by a processor-readable communication medium that carries or conveys code in the form of instructions or data structures and can be accessed, read, and / or executed by a computer or other processor. For example, a carrier wave may be used to carry computer-readable electronic data, such as data used in sending and receiving emails or accessing networks such as the Internet or a local area network (LAN). Many modifications to this configuration may be made without departing from the scope or spirit of the claimed subject matter.

[0073] Although the detailed description contains many details, these details should not be construed as limiting the scope of the subject matter, but merely as illustrating different examples and aspects of the subject matter. It should be understood that the scope of the subject matter includes some embodiments not discussed in detail above. Various other modifications, alterations, and variations can be made to the arrangement, operation, and details of the methods and apparatus of the subject matter disclosed herein without departing from the scope of this disclosure. Unless otherwise stated, references to singular elements are not intended to mean "one and only one," but rather "one or more." Furthermore, an apparatus or method need not be designed to address every problem (or possess every achievable advantage) that can be solved by the different embodiments of this disclosure to be included within the scope of this disclosure. The word "may" and its derivatives as used herein should be understood to mean "possibly" or "optionally," rather than an affirmative capability.

[0074] Relevant application data

[0075] This application is based on and in accordance with priority of U.S. Provisional Application 63 / 153,548, filed on February 25, 2021, pursuant to 35 U.SC §119, the entire contents of which are incorporated herein by reference.

Claims

1. An electrical power control apparatus comprising: a power source configured to: connect to an ultrasonic oscillator circuit for providing ultrasonic vibrations to a vibration transmitting member that ultrasonically vibrates, and provide power to the ultrasonic oscillator circuit; and a processor including a control unit operably connected to the power source, the control unit configured to: calculate a temperature change value per unit time based on a temperature of the vibration transmitting member; identify a peak value among a plurality of temperature change values, the peak value being a maximum value among the plurality of temperature change values; determine whether the peak value is a false peak or a true peak; in a case where it is determined that the peak value is a true peak, control the power source to reduce or stop providing power to the ultrasonic oscillator circuit; and in a case where it is determined that the peak value is a false peak, control the power source to continue providing power to the ultrasonic oscillator circuit.

2. The apparatus of claim 1, wherein, in a case where the peak value is less than a temperature change threshold value, determine the peak value as a false peak.

3. The apparatus of claim 1, wherein, in a case where the peak value is greater than the temperature change threshold value, determine the peak value as a true peak.

4. The apparatus according to claim 1, the control unit further configured to: determining a plurality of ultrasonic impedance values corresponding to an ultrasonic impedance of the vibration transmission member, wherein an ultrasonic impedance of the vibration transmitting member is based on power supplied to the vibration transmitting member; identify a first ultrasonic impedance value among the plurality of ultrasonic impedance values, the first ultrasonic impedance value being a maximum value among the plurality of ultrasonic impedance values; and determine that the first ultrasonic impedance value corresponds to the peak value.

5. The apparatus according to claim 1, the control unit further configured to: calculate an integrated temperature value by integrating a temperature of the vibration transmitting member; determine that the integrated temperature value is greater than an integrated temperature threshold value; in a case where it is determined that the integrated temperature value is greater than the integrated temperature threshold value, control the power source to reduce or stop providing power to the ultrasonic oscillator circuit; and in a case where it is determined that the integrated temperature value is less than the integrated temperature threshold value, control the power source to continue providing power to the ultrasonic oscillator circuit.

6. An electrical power control apparatus comprising: a power source configured to: connect to an ultrasonic instrument having a vibration transmitting member that ultrasonically vibrates, and supply electrical power to the ultrasonic instrument; and a processor including a control unit operably connected to the power source, the control unit configured to: control the supply of the electrical power to the ultrasonic instrument, obtain a temperature value related to a temperature of the vibration transmitting member, wherein the temperature value is a temperature change value per unit time of the vibration transmitting member; detect a peak where the temperature change value changes from increasing to decreasing; and in a case where a period where the temperature change value decreases after the peak is longer than a threshold value, control the power source to reduce or stop the supply of electrical power.

7. The control apparatus according to claim 6, further comprising: a generator including: an ultrasonic oscillator circuit configured to provide an ultrasonic oscillation signal to a handpiece, an output current detection circuit configured to detect a current of the ultrasonic oscillation signal output by the ultrasonic oscillator circuit, ​ ​ ​ an output voltage detection circuit configured to detect a voltage of the ultrasonic oscillation signal output by the ultrasonic oscillator circuit, a first analog-to-digital converter (ADC) configured to convert an analog current value from the output current detection circuit into a digital current value, a second ADC configured to convert an analog voltage value from the output voltage detection circuit into a digital voltage value, and an integrated circuit configured to control the ultrasonic oscillator circuit of the generator, the integrated circuit including: an impedance calculation block configured to calculate an impedance value based on: the digital current value from the first ADC, and the digital voltage value from the second ADC, a power calculation block configured to calculate an amount of power that has been supplied by the ultrasonic oscillator circuit based on: the digital current value from the first ADC, and the digital voltage value from the second ADC, a frequency detection block configured to detect a vibration frequency of the vibration transmission member based on: the digital current value from the first ADC, and the digital voltage value from the second ADC, a temperature increase rate estimation block configured to calculate an amount of increase from a minimum value of a temperature increase rate of the vibration transmission member based on: the calculated power from the power calculation block, and the detected frequency from the frequency detection block, and an output control block configured to control the ultrasonic oscillation signal of the ultrasonic oscillator circuit of the generator based on: the digital current value from the first ADC, the digital voltage value from the second ADC, the calculated impedance value from the impedance calculation block, and the estimated amount of increase from the minimum value of the temperature increase rate of the vibration transmission member from the temperature increase rate estimation block.

8. The control device according to claim 7, wherein: the temperature increase rate estimation block is further configured to detect a minimum value and a peak value of the temperature increase rate, and the amount of increase from the minimum value of the temperature increase rate of the vibration transmission member is a difference between the peak value and the minimum value.

9. The control device of claim 8, wherein, the temperature increase rate estimation block is further configured to: determine whether the peak value is a false peak corresponding to an incomplete cutting of living tissue or a true peak corresponding to a completed cutting of living tissue, the output control block is further configured to, in a case where it is determined that the peak value is a true peak, control the ultrasonic oscillator circuit to stop or reduce the ultrasonic oscillation signal, and the output control block is further configured to, in a case where it is determined that the peak value is a false peak, control the ultrasonic oscillator circuit to maintain the ultrasonic oscillation signal.

10. The control device of claim 9, wherein, in a case where the amount of increase is less than a temperature change threshold value, the temperature increase rate estimation block is further configured to determine the peak value as a false peak.

11. The control device according to claim 6, the control unit is further configured to: detect a minimum value of the temperature change value; in a case where an amount of increase from the minimum value to the peak is greater than a threshold value, control the power supply to reduce or stop the supply of electric power of the power supply.

12. The control device of claim 6, the control unit further configured to: obtain an integrated value of temperature of the vibration transmission member; and control the power source to reduce or stop supply of electrical energy if the integrated value exceeds a threshold value.

13. The control device of claim 6, the control unit further configured to: obtain an ultrasonic impedance value; detect a peak where the ultrasonic impedance value changes from increasing to decreasing; and control the power source to reduce or stop supply of electrical energy based on the change in the ultrasonic impedance value and the peak.

14. An ultrasonic treatment system comprising the electrical energy control device of claim 6, further comprising: a controller comprising: the processor, and an input controller comprising an actuation switch; and a treatment instrument comprising: a treatment portion comprising an end effector configured to grasp living tissue for treatment, a handle connected to the controller via a cable, the handle comprising: an open / close actuator configured to operate opening and closing of the treatment portion, the open / close actuator being arranged at one end of the handle and configured to transmit operation of the open / close actuator to the treatment portion, and a hand-held portion configured to be hand-held when operating the treatment instrument, and a shaft.

15. The ultrasonic treatment system of claim 14, wherein: the shaft extends into the handle and comprises: an inner portion within the handle, and an outer portion outside the handle, the inner portion of the shaft comprises: an inner shaft, and a slider configured to effect longitudinal movement of the inner shaft, and a force sensor is provided at an end portion of the slider, the force sensor being configured to detect a strain value indicative of stress in a long axis direction resulting from longitudinal movement of the shaft when the power source is providing electrical power for ultrasonic vibration.

16. The ultrasonic treatment system of claim 15, wherein: the strain value detected by the force sensor is proportional to a user’s hand-held force, such that a higher strain value corresponds to a user squeezing the open / close actuator harder, and the processor is further configured to cause the power source to reduce or stop providing electrical power for ultrasonic vibration if a change in the value of the force sensor is below a strain threshold value.

17. A non-transitory computer-readable storage medium storing instructions, wherein, the instructions, when executed by the processor, cause the processor to perform a method of electrical energy control for a medical device, the medical device comprising: an ultrasonic instrument having a vibration transmission member that ultrasonically vibrates; a power source configured to supply electrical energy to the ultrasonic instrument; and a processor comprising a control unit operably connected to the power source, the method comprising: controlling supply of the electrical energy to the ultrasonic instrument; obtaining a temperature value related to temperature of the vibration transmission member, wherein the temperature value is a temperature change value of the vibration transmission member per unit time; detecting a peak where the temperature change value changes from increasing to decreasing; and In a case where a period in which the temperature change value decreases after the peak is longer than a threshold value, the power supply is controlled to reduce or stop the supply of electric power from the power supply.

18. A non-transitory computer-readable storage medium storing instructions, wherein, The instructions, when executed by a processor, cause the processor to perform a method for electric power control of a medical device, the medical device comprising: an ultrasonic instrument having a vibration-transmitting member that ultrasonically vibrates; a power supply configured to provide electric power to an ultrasonic oscillator circuit for providing ultrasonic vibrations to the vibration-transmitting member to cut living tissue; and a processor including a control unit operably connected to the power supply, the method comprising: calculating a temperature change value per unit time based on a temperature of the vibration-transmitting member; identifying a peak value in a plurality of temperature change values, the peak value being a maximum value in the temperature change values; determining whether the peak value is a false peak or a true peak; in a case where it is determined that the peak value is a true peak, controlling the power supply to reduce or stop the supply of electric power to the ultrasonic oscillator circuit; and in a case where it is determined that the peak value is a false peak, controlling the power supply to continue the supply of electric power to the ultrasonic oscillator circuit.

Images