WO2023066077A1 - 一种超声手术刀、手术用能量器械及其功率调节方法 - Google Patents

一种超声手术刀、手术用能量器械及其功率调节方法 Download PDF

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Publication number
WO2023066077A1
WO2023066077A1 PCT/CN2022/124534 CN2022124534W WO2023066077A1 WO 2023066077 A1 WO2023066077 A1 WO 2023066077A1 CN 2022124534 W CN2022124534 W CN 2022124534W WO 2023066077 A1 WO2023066077 A1 WO 2023066077A1
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Prior art keywords
ultrasonic
load
energy
power
working state
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PCT/CN2022/124534
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English (en)
French (fr)
Inventor
张军
吴智鑫
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安速康医疗(苏州)有限公司
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Priority to CA3234799A priority Critical patent/CA3234799A1/en
Priority to KR1020247013741A priority patent/KR20240060714A/ko
Priority to AU2022371213A priority patent/AU2022371213A1/en
Priority to EP22882687.1A priority patent/EP4403120A1/en
Priority to JP2024521078A priority patent/JP2024537221A/ja
Publication of WO2023066077A1 publication Critical patent/WO2023066077A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • H—ELECTRICITY
    • H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02M—APPARATUS FOR CONVERSION BETWEEN AC AND AC, BETWEEN AC AND DC, OR BETWEEN DC AND DC, AND FOR USE WITH MAINS OR SIMILAR POWER SUPPLY SYSTEMS; CONVERSION OF DC OR AC INPUT POWER INTO SURGE OUTPUT POWER; CONTROL OR REGULATION THEREOF
    • H02M3/00—Conversion of dc power input into dc power output
    • H02M3/22—Conversion of dc power input into dc power output with intermediate conversion into ac
    • H02M3/24—Conversion of dc power input into dc power output with intermediate conversion into ac by static converters
    • H02M3/28—Conversion of dc power input into dc power output with intermediate conversion into ac by static converters using discharge tubes with control electrode or semiconductor devices with control electrode to produce the intermediate ac
    • H02M3/325—Conversion of dc power input into dc power output with intermediate conversion into ac by static converters using discharge tubes with control electrode or semiconductor devices with control electrode to produce the intermediate ac using devices of a triode or a transistor type requiring continuous application of a control signal
    • H02M3/335—Conversion of dc power input into dc power output with intermediate conversion into ac by static converters using discharge tubes with control electrode or semiconductor devices with control electrode to produce the intermediate ac using devices of a triode or a transistor type requiring continuous application of a control signal using semiconductor devices only
    • H—ELECTRICITY
    • H03—ELECTRONIC CIRCUITRY
    • H03B—GENERATION OF OSCILLATIONS, DIRECTLY OR BY FREQUENCY-CHANGING, BY CIRCUITS EMPLOYING ACTIVE ELEMENTS WHICH OPERATE IN A NON-SWITCHING MANNER; GENERATION OF NOISE BY SUCH CIRCUITS
    • H03B28/00—Generation of oscillations by methods not covered by groups H03B5/00 - H03B27/00, including modification of the waveform to produce sinusoidal oscillations
    • H—ELECTRICITY
    • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K7/00—Constructional details common to different types of electric apparatus
    • H05K7/14—Mounting supporting structure in casing or on frame or rack
    • H—ELECTRICITY
    • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K7/00—Constructional details common to different types of electric apparatus
    • H05K7/20—Modifications to facilitate cooling, ventilating, or heating
    • H—ELECTRICITY
    • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K7/00—Constructional details common to different types of electric apparatus
    • H05K7/20—Modifications to facilitate cooling, ventilating, or heating
    • H05K7/2039—Modifications to facilitate cooling, ventilating, or heating characterised by the heat transfer by conduction from the heat generating element to a dissipating body
    • H05K7/20509—Multiple-component heat spreaders; Multi-component heat-conducting support plates; Multi-component non-closed heat-conducting structures
    • H—ELECTRICITY
    • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K9/00—Screening of apparatus or components against electric or magnetic fields
    • H05K9/0073—Shielding materials
    • H05K9/0081—Electromagnetic shielding materials, e.g. EMI, RFI shielding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00026—Conductivity or impedance, e.g. of tissue
    • A61B2017/0003—Conductivity or impedance, e.g. of tissue of parts of the instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320074—Working tips with special features, e.g. extending parts blade

Definitions

  • the invention relates to the field of medical equipment, in particular to an ultrasonic scalpel, an energy device for operation and a power adjustment method thereof.
  • Ultrasonic scalpels provide ultrasonic energy in various endoscopic and conventional operations, and are mainly used for hemostatic separation of soft tissues and tissue coagulation. With the popularization of minimally invasive surgery, ultrasonic scalpel has become a conventional surgical instrument and is widely used.
  • the ultrasonic knife head works under the action of an ultrasonic generator. When the ultrasonic knife head acts on the surgical site, the doctor presses the excitation button to make the ultrasonic knife head continue to output power. During the operation, the ultrasonic knife head often leaves the surgical site for a short time. At this time, the continuity of the doctor's operation makes the activation button still in the pressed state even when the cutter head leaves the operation site.
  • the cost of the ultrasonic scalpel is relatively expensive, therefore, the ultrasonic scalpel is not used as a disposable instrument, but the cutter of the ultrasonic scalpel has a certain service life, which determines that the ultrasonic scalpel cannot be used indefinitely. How to reduce the cost of using the ultrasonic scalpel has become a problem that needs to be solved urgently.
  • the object of the present invention is to provide an ultrasonic scalpel, an energy device for surgery and a power adjustment method thereof, which can automatically adjust the output power of the ultrasonic scalpel according to the current load condition, so as to reduce unnecessary life loss.
  • the present invention provides an ultrasonic scalpel, comprising a hand-held component, a control module, an ultrasonic generator and an ultrasonic knife head, the hand-held component is provided with an excitation button, and the ultrasonic scalpel also includes the following modules:
  • a load detection module configured to detect the load condition of the ultrasonic cutter head, the load detection module is electrically connected to the input terminal of the control module;
  • a power conversion module its input side is electrically connected to the output end of the control module, and its output side is electrically connected to the ultrasonic generator;
  • the control module is configured to receive the detection signal of the load detection module, and when the excitation button is pressed, the control module controls the power conversion module to adjust the output power of the ultrasonic generator.
  • the ultrasonic generator includes at least a first working state and a second working state, wherein, in the first working state, the ultrasonic generator The output power value of the ultrasonic generator is less than the output power value of the ultrasonic generator in the second working state; if the excitation button is pressed and the ultrasonic cutter head has no load, the control module controls the the power conversion module to adjust the operation of the ultrasonic generator in the first working state; if the excitation button is pressed and the ultrasonic cutter head has a load, the control module controls the power conversion module to adjust the The ultrasonic generator operates in the second working state.
  • the output power range of the ultrasonic generator in the first working state is 0.01-3W; the output power range of the ultrasonic generator in the second working state is 3-40W.
  • the activation button is electrically connected to the input terminal of the control module, and when the ultrasonic scalpel is powered on, the load
  • the detection module detects the load status of the ultrasonic scalpel according to a preset frequency or delay interval
  • the control module controls the power conversion module to adjust the power of the ultrasonic generator. The output power becomes smaller;
  • the control module controls the power conversion module to adjust the power of the ultrasonic generator.
  • the output power becomes larger;
  • the output power of the ultrasonic generator is zero.
  • the load detection module includes a resonance signal acquisition unit, an impedance calculation unit, and a determination unit, wherein,
  • the resonance signal acquisition unit is configured to acquire the voltage and current of the circuit of the ultrasonic scalpel in a resonance state
  • the impedance calculation unit is configured to calculate the resonance impedance according to the voltage and current signals collected by the resonance signal collection unit;
  • the determination unit is configured to determine the load condition of the ultrasonic scalpel according to the calculation result of the impedance calculation unit, including: comparing the calculation result with a preset impedance threshold, if the calculated resonance impedance is greater than or equal to If the preset impedance threshold is set, it is determined that the load condition of the ultrasonic scalpel is on-load; if the calculated resonance impedance is less than the preset impedance threshold, it is determined that the load condition of the ultrasonic scalpel is no-load.
  • the load detection module includes a resonance signal acquisition unit and a determination unit, wherein,
  • the resonance signal acquisition unit is configured to acquire the resonance frequency when the circuit of the ultrasonic scalpel is in a resonance state
  • the determination unit is configured to determine the load status of the ultrasonic scalpel according to the two signal acquisition results of the resonance signal acquisition unit before and after, including: changing the difference between the two signal acquisition results and the preset frequency Threshold value comparison, if the resonant frequency collected twice before and after is on the rise and the absolute value of the difference is greater than or equal to the preset frequency change threshold, then it is determined that the load condition of the ultrasonic scalpel is changed from loaded to unloaded; If the resonant frequencies collected twice before and after show a downward trend and the absolute value of the difference is greater than or equal to the preset frequency change threshold, it is determined that the load status of the ultrasonic scalpel is changed from no-load to loaded.
  • the power conversion module is a DC/DC conversion unit, which is electrically connected to the ultrasonic power amplifier module, and the DC/DC conversion unit is controlled by the Module control to output different voltage values;
  • the ultrasonic power amplifier module drives the ultrasonic generator to output power in the first working state
  • the ultrasonic power amplifier module drives the ultrasonic generator to output power in the second working state, wherein the second voltage threshold is greater than or equal to the first voltage threshold.
  • the handheld component includes a handle housing, a transducer assembly and a power cord, wherein the control module and the transducer assembly are set In the receiving chamber of the handle housing, the transducer assembly is arranged in the receiving chamber so as to be rotatable around an axis;
  • One end of the power cord is connected to the transducer assembly in the accommodation cavity, and the other end of the power cord passes out from the lower part of the handle housing to the outside of the accommodation cavity.
  • the transducer assembly includes a transducer housing, and the transducer housing and the ultrasonic generator are fixed to each other, so
  • the transducer housing has a hollow cavity, at least the rear part of the ultrasonic generator is accommodated in the hollow cavity, and the transducer assembly also includes a conductive member fixed on the outside of the transducer housing;
  • the conductive member has at least a conductive part, and the ultrasonic generator is electrically connected to the conductive part, and an electric connection element is fixedly arranged in the accommodation cavity of the handle shell, and the electric connection element abuts against On the conductive part, during the process of the transducer assembly rotating around its own axis relative to the handle housing, the electrical connection element is always in contact with the conductive part to maintain electrical connection.
  • the ultrasonic power amplifier module is connected to the ultrasonic generator through a conductive member;
  • the ultrasonic scalpel also includes a cutter, the blade of the cutter is detachably fixedly connected to the ultrasonic generator, and the transducer is configured to convert the energy delivered by the ultrasonic generator, and convert The final energy is delivered to the tool.
  • the present invention provides an energy device for surgery, comprising:
  • an energy generating device configured to generate energy
  • the said hand-held part is provided with an activation button
  • a load detection module configured to detect the load status of the surgical energy instrument, the load status is an unloaded status or a loaded status
  • a control module the input terminals of which are respectively electrically connected to the excitation button and the load detection module; the control module is configured to receive the detection signal of the load detection module, and when the excitation button is pressed, the control Module output control signal;
  • a power conversion module which is electrically connected to the output terminal of the control module, and the power conversion module is configured to adjust the working state of the energy generating device when triggered by a control signal of the control module;
  • the energy generating device includes at least a first working state and a second working state, wherein the output power value of the energy generating device in the first working state is smaller than that of the energy generating device in the second working state output power value; if the activation button is pressed and the load detection module detects that there is no load at present, the control module controls the power conversion module to adjust the energy generating device to operate in the first working state ; If the activation button is pressed, and the load detection module detects that there is a load, the control module controls the power conversion module to adjust the energy generating device to run in the second working state; if the activation If the key is not pressed, the output power of the energy generating device is zero.
  • the power conversion module is a DC/DC conversion unit, which is electrically connected to the power amplifier module, and the DC/DC conversion unit is controlled by the control module output different voltage values under the control of
  • the power amplifier module drives the energy generating device to output power in the first working state
  • the power amplifier module drives the energy generating device to output power in the second working state, wherein the second voltage threshold is greater than or equal to the first voltage threshold.
  • the load detection module includes a resonance signal acquisition unit, an impedance calculation unit, and a determination unit, wherein,
  • the resonance signal acquisition unit is configured to acquire the voltage and current of the circuit of the surgical energy instrument in a resonance state
  • the impedance calculation unit is configured to calculate the resonance impedance according to the voltage and current signals collected by the resonance signal collection unit;
  • the determination unit is configured to determine the load status of the surgical energy device according to the calculation result of the impedance calculation unit, including: comparing the calculation result with a preset impedance threshold, and if the calculated resonance impedance is greater than or If it is equal to the preset impedance threshold, it is determined that the load condition of the surgical energy device is on-load; if the calculated resonance impedance is less than the preset impedance threshold, it is determined that the load condition of the surgical energy device is no-load.
  • the load detection module detects The load status of the surgical energy device.
  • the surgical energy instrument is an ultrasonic scalpel
  • the energy generating device is an ultrasonic generator
  • the ultrasonic generator is arranged inside or outside the hand-held part; or
  • the energy instrument for surgery is a laser knife, the energy generating device is a laser generator, and the laser generator is arranged inside or outside the hand-held part; or,
  • the energy instrument for surgery is an electric knife
  • the energy generating device is an electric signal generator
  • the electric signal generator is arranged inside or outside the hand-held component.
  • the surgical energy instrument further includes a knife arranged on the front side of the hand-held part
  • the load detection module includes a biosensor
  • the biosensor It is set at the end of the knife away from the hand-held part. If the biosensor detects that it is in contact with an object or is close to the object within a preset distance threshold, it will output the detection result carried by the surgical energy instrument, otherwise it will output The detection result of no-load of the energy instrument for operation.
  • the present invention provides a method for adjusting the power of an energy device for surgery.
  • the adjusted energy device for surgery includes an activation button and an energy generating device, and the control mode of the activation button for energy output is configured as follows: if the When the activation button is pressed, the energy generating device outputs energy, if the activation button is released, the energy generating device stops outputting energy, and when the activation button is pressed, the energy generating device
  • the output power of the device is adjusted according to the load condition of the device, and the power adjustment method includes:
  • the activation button is pressed, and the load condition of the apparatus is no-load, then adjust the output power of the energy generating device to the output power corresponding to the first working state; if the activation button is pressed, and the If the load condition of the device is loaded, then adjust the output power of the energy generating device to the output power corresponding to the second working state, wherein the output power value of the energy generating device in the first working state is less than that in the first working state The output power value of the energy generating device in the second working state.
  • the power adjustment method is applicable to the following surgical energy devices:
  • the energy instrument for surgery is an ultrasonic scalpel
  • the energy generating device is an ultrasonic generator
  • the ultrasonic generator is arranged inside or outside the hand-held part; or
  • the energy instrument for surgery is a laser knife, the energy generating device is a laser generator, and the laser generator is arranged inside or outside the hand-held part; or,
  • the energy instrument for surgery is an electric knife
  • the energy generating device is an electric signal generator
  • the electric signal generator is arranged inside or outside the hand-held component.
  • the present invention also provides an ultrasonic scalpel, including an ultrasonic scalpel handle with an ultrasonic generator function, and the ultrasonic scalpel handle includes:
  • Handle shell gear button, handle
  • the head of the handle shell is provided with a handle connecting mechanism, which is used to connect with the tool;
  • a cavity is arranged in the handle shell, and a transformer, a transducer, a first PCB board, and a second PCB board are arranged in the cavity;
  • the first PCB board is arranged on the top of the cavity
  • the transformer is arranged at the end of the cavity
  • the second PCB board is arranged at the handshake position of the cavity
  • Both the first PCB board and the second PCB board can be set as a control board or a power board;
  • the gear button is set on the front part of the handle shell, which is used to switch between high and low power gears;
  • the handle is arranged on the front part of the handle shell, and it is used to control the opening and closing of the tool clamp.
  • the surgical energy device When the surgical energy device is in the no-load state, it will automatically run the low power output mode to reduce the unnecessary amplitude of the ultrasonic scalpel tool under no-load state, prolong the service life of the tool, and reduce the single use of the ultrasonic scalpel cost;
  • FIG. 1 is a schematic structural view of an ultrasonic scalpel provided by an exemplary embodiment of the present disclosure
  • FIG. 2 is a schematic diagram of the overall structure of the ultrasonic scalpel handle provided by an exemplary embodiment of the present disclosure
  • Fig. 3 is an exploded schematic view of the structure of the ultrasonic scalpel handle provided by an exemplary embodiment of the present disclosure
  • Fig. 4 is a schematic diagram of the internal structure of the ultrasonic scalpel handle provided by an exemplary embodiment of the present disclosure
  • Fig. 5 is a schematic diagram of the connection between the transducer assembly and the electrical connection element in the ultrasonic scalpel handle provided by an exemplary embodiment of the present disclosure
  • FIG. 6 is a schematic diagram of the overall structure of a transducer assembly provided by an exemplary embodiment of the present disclosure
  • FIG. 7 is a schematic exploded view of the structure of the transducer assembly of FIG. 6;
  • Figure 8 is a front view of the transducer assembly of Figure 6;
  • Fig. 9 is a schematic cross-sectional view along A1-A1 in Fig. 8;
  • Fig. 10 is an enlarged schematic diagram of D in Fig. 8;
  • Fig. 11 is a schematic diagram of the overall structure of the ultrasonic scalpel handle provided by another exemplary embodiment of the present disclosure.
  • Fig. 12 is an exploded schematic diagram of the structure of the ultrasonic scalpel handle provided by another exemplary embodiment of the present disclosure.
  • Fig. 13 is a schematic diagram of the overall structure of a transducer assembly provided by another exemplary embodiment of the present disclosure.
  • Fig. 14 is an exploded schematic diagram of the structure of the transducer assembly of Fig. 13;
  • Figure 15 is a front view of the transducer assembly of Figure 13;
  • Figure 16 is a schematic cutaway view along the A2-A2 direction in Figure 15;
  • Figure 17 is a left side view of the transducer assembly of Figure 13;
  • Fig. 18 is a schematic diagram of the connection structure between the transducer assembly and the power connection element provided by another exemplary embodiment of the present disclosure
  • Fig. 19 is a schematic diagram of the internal structure of the ultrasonic scalpel handle provided by an exemplary embodiment of the present disclosure.
  • Fig. 20 is a schematic circuit diagram of an energy device for surgery provided by an exemplary embodiment of the present disclosure
  • Fig. 21 is a schematic diagram of the output power adjustment logic of the surgical energy device provided by an exemplary embodiment of the present disclosure.
  • Fig. 22 is a schematic diagram of a flow chart for determining the load status of an apparatus provided by an exemplary embodiment of the present disclosure.
  • the reference signs include: 1, ultrasonic scalpel handle; 11, handle shell; 11a, shell-left; 11b, shell-right; 11c, top cover; 11d, perspective window;
  • Transducer assembly 121, transducer housing; 1211, front housing; 1212, rear housing; 1213, middle housing; 121a, spur gear;
  • Ultrasonic generator 1221. Horn shaft; 1222. Horn core; 1223. Retaining ring; 1224. First electric wire/second electric wire;
  • 123 conductive part; 1231, first conductive ring (first conductive part); 1232, second conductive ring (second conductive part); 1233, barrier ring; 1234, insulating sleeve; 1235, positioning boss; 123O , the board body; 123a, the first conductive sheet; 123b, the second conductive sheet; 123c, the first perforation; 123d, the second perforation;
  • Electric connection element 131, first electric connection element; 132, second electric connection element; 13a, first elastic electric connection piece; 13b, second elastic electric connection element.
  • the ultrasonic scalpel During the surgical operation of the ultrasonic scalpel, it is necessary for the ultrasonic generator to reach a certain output power in order to achieve the hemostatic separation and tissue coagulation of the soft tissue. Therefore, the current ultrasonic scalpel is equipped with a rated or multiple output powers. Many ultrasonic scalpels have a high-power button and a low-power button on the handle. Press the high-power button, and the ultrasonic scalpel works in a high-power mode.
  • the ultrasound in the no-load state The range of the output power of the ultrasonic generator is 6-9W, which is usually suitable for cutting and separating soft tissues; press the low power button, and the ultrasonic scalpel works in a low power mode, and the output power of the ultrasonic generator in the no-load state in this mode ranges from 3-7.6W, usually suitable for coagulation of soft tissue. If it is lower than the output power in the low-power mode, then the tissue cannot be operated on. Therefore, it is not easy to think of adjusting the ultrasonic generator output power of the ultrasonic scalpel to be lower than that in the low-power mode (3W) in the prior art. below) output power.
  • an ultrasonic scalpel including a hand-held part, an ultrasonic generator, an ultrasonic knife head and a control module.
  • the input terminal of the control module is electrically connected; the ultrasonic scalpel also includes the following modules:
  • a load detection module configured to detect a load condition of the ultrasonic scalpel, the load detection module being electrically connected to an input terminal of the control module;
  • a power conversion module whose input side is electrically connected to the output end of the control module, and whose output side is electrically connected to the ultrasonic generator, the power conversion module is configured to adjust the ultrasonic generator under the control of the control module to make it output different sound power;
  • the working state of the ultrasonic generator includes at least a first working state and a second working state, wherein the first working state corresponds to the situation when the ultrasonic cutter head is unloaded; the second working state corresponds to the ultrasonic cutter head having a load situation, the output power value of the ultrasonic generator in the first working state is less than the output power of the ultrasonic generator in the second working state; as shown in Figure 21, specifically, in the When the ultrasonic scalpel is powered on, if the excitation button is pressed and the load detection module detects that the ultrasonic scalpel is unloaded, the control module controls the power conversion module to adjust the ultrasonic generation The working state of the device is the first working state; if the excitation button is pressed and the load detection module detects that the ultrasonic scalpel is loaded, the control module controls the power conversion module to adjust the ultrasonic generation The working state of the ultrasonic generator is the second working state; if the excitation button is not pressed, the output power of the ultrasonic generator is zero.
  • the amplitude of the tool of the ultrasonic scalpel is greater, resulting in a shortened service life of the tool.
  • the service life of the tool is equal to service life.
  • the operator is usually accustomed to pressing the activation button first, and then clamping the tissue, or, after the tissue is cut, the activation button is released after a delay, because it is difficult to ensure that the activation button is pressed while touching the tissue. Or release the excitation button while leaving the tissue.
  • the ultrasonic scalpel is not loaded but still outputs the standard load power, and research has found that under the same output power, the no-load
  • the tool amplitude of the ultrasonic scalpel under the state condition is greater than that of the ultrasonic scalpel under the load state.
  • the time when no-load state is detected and adjusted to the first working state with lower power can basically be regarded as the service life of the ultrasonic scalpel extended by the technical solution of this embodiment, assuming that every The actual operation time of the ultrasonic scalpel on the tissue is 10s, the time from pressing the excitation button in advance to finding the tissue for operation is 2s, and the time from the operation to releasing the excitation button is 1s, which is equivalent to the technical solution of this embodiment.
  • the service life of the ultrasonic scalpel is extended by about 30%.
  • the present invention does not limit the number of activation keys, which may be one or more.
  • the activation keys include two, which are respectively a high-power activation key and a low-power activation key.
  • the high power for cutting such as 6-9W
  • the low power such as 3-7.6W
  • the ultrasonic generator is adjusted to output in the first working state, and the corresponding output power of the ultrasonic generator can be 0.01W, or It is any value within the range of greater than 0.01W and not greater than 3W, that is, the power output under no-load condition is less than the low power setting value for condensation.
  • the output power of the ultrasonic generator corresponding to the second working state can be set to any value within the range of not less than 3W and not greater than 45W, for example, the output power of the ultrasonic generator is 0.01W at no-load , the output power of the ultrasonic generator jumps to 3W when the load is detected, or, the output power of the ultrasonic generator is 0.1W when the load is detected, and the output power of the ultrasonic generator jumps to 4.5W when the load is detected, or, no load When the output power of the ultrasonic generator is 0.2W, the output power of the ultrasonic generator jumps to 3.6W when the load is detected.
  • the high-power excitation button and/or the low-power excitation button can also be adjusted in multiple levels, such as the low-power
  • the activation button can be selected from 1-4 gears, the 4th gear power is about 5-7.6W, the 3rd gear power is about 4.3-6.5W, the 2nd gear power is about 3.6-5.4W, and the 1st gear power is about 3-4.5W.
  • the setting values of the above multiple gears are defined as the starting point of the output power of the ultrasonic generator jumping when the ultrasonic cutter head is detected to be loaded. As the load carried by the ultrasonic knife head of the ultrasonic scalpel increases, the actual output power of the ultrasonic generator increases, and the actual maximum output power of the ultrasonic generator of the ultrasonic scalpel is set to 45W.
  • the output power setting value of the first working state of this embodiment ranges from 0.01 to 3W, and can further be selected from 0.1 to 3W. 3W or 0.5 to 3W.
  • the first working state with different power values and the second working state with different power ranges can be set.
  • the above and below descriptions about the front and rear directions are all defined with reference to the direction observed by the operator when holding the ultrasonic scalpel for operation.
  • the position where the scalpel acts on the surgical site is the front, and the position where the ultrasonic scalpel is close to the human body of the operator (doctor) is the rear.
  • the ultrasonic scalpel system shown in Figure 1 it includes an ultrasonic scalpel, and a power adapter 3 for powering the ultrasonic scalpel; wherein, the ultrasonic scalpel includes an ultrasonic scalpel handle 1, and is detachably mounted on the ultrasonic scalpel Knife 2 on handle 1.
  • the ultrasonic scalpel handle 1 includes a handle housing 11 and a transducer assembly 12, the handle housing 11 includes a fixedly connected housing-left 11a and a housing-right 11b, and a top cover 11c at the top, which There is a housing cavity, the transducer assembly 12 is housed in the housing cavity as a whole and can be arranged to rotate around its own axis, and the control module 16 is optionally arranged in the housing cavity, as shown in Figure 4 and Figure 19 stated.
  • the transducer assembly 12 includes a transducer housing 121 and an ultrasonic generator 122 fixedly arranged with each other.
  • the transducer housing 121 has a hollow cavity.
  • the device housing 121 is fixed.
  • the ultrasonic generator 122 is an integral component, which includes a horn shaft 1221 and a horn core 1222 arranged in sequence along the axial direction, and the horn shaft 1221 and the horn core A retaining ring 1223 is also formed at the position where 1222 meets, the horn core 1222 and retaining ring 1223 are all accommodated in the hollow cavity of the transducer housing 121, and the front part of the horn shaft 1221 protrudes from the hollow cavity Outside and connected with the cutter 2 by the connecting screw 124 at the front.
  • the transducer assembly 12 also includes a conductive member 123 fixed on the outside of the transducer housing 121.
  • the conductive member 123 has at least a conductive part, and the ultrasonic generator 122 is electrically connected to the above-mentioned conductive part.
  • the receiving cavity is also fixedly provided with a connecting element 13, and the connecting element 13 abuts against the conductive part.
  • the conductive member 123 is fixedly arranged on the outer peripheral portion of the transducer housing 121, and the conductive portion is in the shape of a ring.
  • the axis of the conductive part extends in line with the axis of the transducer assembly 12 .
  • the conductive part includes a first conductive part and a second conductive part that are insulated from each other and are annular. , the two conducting wires are respectively electrically connected to the two conducting parts.
  • the conductive member 123 includes two conductive rings made of conductive materials—the first conductive ring 1231 and the second conductive ring 1231.
  • Two conductive rings 1232 The end of the first electric wire 1224 is fixed on the first conductive ring 1231 to realize electrical connection, and the end of the second electric wire 1224 is fixed on the second conductive ring 1232 to realize electrical connection.
  • the first conductive ring 1231, the second conductive ring 1232 and the barrier ring 1233 are relatively fixedly sleeved on the outer circumference of the transducer housing 121, specifically, each conductive ring and the barrier ring 1233 are provided There is a circumferential limiting structure for limiting the relative rotation of the two, and a positioning structure for limiting the rotation of the conductive component 123 and the axial movement of the conductive component 123 is also provided between the conductive component 123 and the transducer housing 121 .
  • the transducer housing 121 includes a front housing 1211, a middle housing 1213 and a rear housing 1212 arranged in sequence along the front and rear directions, and the gap between the front housing 1211 and the middle housing 1213 is A rubber gasket 125 and a rubber ring 126 are arranged between to realize sealing, and a rubber ring 126 is arranged between the middle housing 1213 and the rear housing 1212 to realize sealing, and at the same time, the ultrasonic generator accommodated in the transducer housing 121 122 is sealed in the transducer housing 121.
  • the conductive member 123 is fixedly mounted on the middle housing 1213 and located at the front of the rear housing 1212 .
  • the conductive member 123 also includes an insulating sleeve 1234, which is fixedly sleeved on the outer peripheral portion of the middle housing 1213, and the first conductive ring 1231, the barrier ring 1233 and the second conductive ring 1232 are sleeved on the insulating sleeve 1232.
  • a power connection element 13 is also arranged in the handle housing 11, the power connection element 13 is located on the outer side of the transducer assembly 12, and the power connection element 13 is against the transducer housing 121 on the outer peripheral portion of the outer peripheral part and contact with the conductive part, specifically, the power connection element 13 includes a first power connection element 131 and a second power connection element 132 that are independent of each other, and the first power connection element 131 and the second power connection element 131 are independent of each other.
  • the elements 132 are all made of metal and have certain elasticity along their length direction. The two elements are arranged at intervals along the front and rear directions of the handle housing 11 .
  • the second electric connection element 132 elastically abuts against the outer peripheral portion of the second conductive ring 1232 inwardly along the radial direction of the transducer housing 121 .
  • the power connection element 13 is arranged in the handle housing 11 and is located at the upper position, which is located above the transducer assembly 12, so that the power connection element 13 can abut against the transducer downwards. On the outer peripheral portion of the component 12 to maintain electrical connection more stably.
  • the conductive member 123 is fixedly arranged at the rear end of the transducer housing 121, and the transducer
  • the rear part of the housing 121 itself can be set as open, and the conductive member 123 closes the transducer housing 121 from the rear end.
  • the conductive part is arranged at the rear of the conductive member 123
  • the electric connection element 13 is arranged in the handle housing 11 and behind the transducer assembly 12 , and the electric connection element 13 resiliently leans forward against the conductive part.
  • the conductive portion includes a first conductive portion and a second conductive portion that are insulated from each other, and the ultrasonic generator 122 has two electric wires—the first electric wire and the second electric wire (not shown in the figure) , the first electric wire is electrically connected to the first conductive part, and the second electric wire is electrically connected to the second conductive part.
  • the power connecting element 13 also includes a first elastic connecting member 13a and a second elastic connecting member 13b which are independent from each other and insulated from each other. The first elastic connecting member 13a abuts against the first conductive part and the second elastic connecting member 13a The piece 13b abuts against the second conductive portion.
  • first conductive part and second conductive part are disc-shaped or ring-shaped with the axis of the transducer assembly 12 as the center of rotation, so that when the transducer assembly 12 rotates around its own axis , the first elastic electrical connection member 13a and the second elastic electrical connection member 13b can be held against the first conductive portion and the second conductive portion respectively.
  • the conductive member 123 includes a board body 123O, and a first conductive sheet 123a and a second conductive sheet 123b fixed on the board body 123O and made of metal material, wherein the first conductive sheet 123a is round Disc-shaped, the second conductive piece 123b is in the shape of a ring and is arranged on the circumferential outside of the first conductive piece 123a, and the first conductive piece 123a and the second conductive piece 123b are arranged at intervals along the radial direction of the conductive member 123, that is There is a certain distance between the outer peripheral wall of the first conductive sheet 123 a and the inner peripheral wall of the second conductive sheet 123 b in the radial direction of the conductive member 123 .
  • the above-mentioned first conductive sheet 123a constitutes a first conductive portion
  • the second conductive sheet 123b constitutes a second conductive portion.
  • the board body 123O is provided with a first through hole 123c and a second through hole 123d penetrating along its own thickness direction, and the first electric wire is passed through the first through hole 123c and fixed on the first conductive sheet 123a by welding.
  • the second electrical wire is passed through the second through hole 123d and fixed on the second conductive sheet 123b by welding to realize the electrical connection.
  • the first elastic connecting member 13a and the second elastic connecting member 13b are elastic pieces made of metal material, the lower end of the first elastic connecting member 13a, the second elastic connecting member The lower ends of the parts 13b are respectively fixedly arranged in the handle housing 11, the upper end of the first elastic connecting part 13a presses forward against the rear side of the first conductive sheet 123a, and the upper end of the second elastic connecting part 13b Press forward against the rear side of the second conductive sheet 123b.
  • the load detection module includes a resonance signal acquisition unit, an impedance calculation unit, and a determination unit.
  • the resonance signal acquisition unit refer to the current and voltage sampling processing unit shown in FIG. 20 .
  • the current and voltage sampling processing unit is configured to sample the output voltage and current of the ultrasonic generator, based on which, the impedance calculation unit calculates the resonance impedance, and then The judging unit judges the load condition of the ultrasonic scalpel according to the calculation result of the resonance impedance, as shown in FIG.
  • each unit of the load detection module in this embodiment is only a unit divided by function, and does not limit its specific hardware composition division.
  • the impedance calculation unit can be divided into the current and voltage sampling processing unit in Figure 20, and also It can be divided into the control module (MCU or FPGA digital control center); the judgment unit can also be divided into multiple ways.
  • the load detection module includes a resonance signal acquisition unit and a determination unit, and the resonance signal acquisition unit is configured to collect the ultrasonic scalpel when the circuit is in resonance.
  • the resonant frequency in the state specifically, as shown in Figure 20, under the premise of the inherent function of the ultrasonic scalpel circuit to automatically adjust the operating frequency to make the system resonant, the current and voltage sampling processing unit is configured to sample the output voltage and current of the ultrasonic generator , and then send the sampling results of voltage and current to the control module (MCU or FPGA digital control center) for data processing, and obtain the corresponding resonant frequency as the sampling result;
  • the control module MCU or FPGA digital control center
  • the determination unit is configured to determine the load status of the ultrasonic scalpel according to the signal acquisition results of the resonance signal acquisition unit twice before and after, including: changing the difference between the resonance frequency of the two sampling before and after and the preset frequency Threshold value comparison, if the resonant frequency collected twice before and after is on the rise and the absolute value of the difference is greater than or equal to the preset frequency change threshold, then it is determined that the load condition of the ultrasonic scalpel is changed from loaded to unloaded; If the resonant frequencies collected twice before and after show a downward trend and the absolute value of the difference is greater than or equal to the preset frequency change threshold, it is determined that the load status of the ultrasonic scalpel is changed from no-load to loaded.
  • the ultrasonic scalpel also includes a knife set on the front side of the hand-held part, the load detection module includes a biosensor, and the biosensor is set on the end of the knife away from the hand-held part, if the biosensor detects When it comes into contact with the object or approaches the object within the preset distance threshold, the detection result of the ultrasonic scalpel is output, otherwise the detection result of the ultrasonic scalpel is output.
  • the load detection module detects the The load condition of the ultrasonic scalpel.
  • the output power of the ultrasonic generator is adjusted to the output power corresponding to the first working state, that is, it is in a standby state; once it is detected that the ultrasonic scalpel changes from the no-load state to the load state, the output power of the ultrasonic generator quickly returns to the normal level, that is, the minimum value of the power range in the second working state, and the output power of the ultrasonic generator is tuned and increased as the load increases.
  • the output power of the ultrasonic generator when it is detected that the ultrasonic scalpel is transferred from the no-load state to the loaded state, if the doctor does not adjust the output power during the no-load state, the output power of the ultrasonic generator will quickly return to the last time. Power level, if the doctor adjusts the output power during the no-load state, the output power of the ultrasonic generator is quickly increased to the new set power level.
  • the output power of the ultrasonic generator corresponding to the first working state cannot be zero.
  • the power conversion module is a DC/DC conversion unit, as shown in Figure 20, which is electrically connected to the ultrasonic power amplifier module, and the DC/DC conversion unit is controlled by the control module to output different voltage values ;
  • the ultrasonic power amplifier module drives the ultrasonic generator to output power in the first working state
  • the ultrasonic power amplifier module drives the ultrasonic generator to output power in the second working state, wherein the second voltage threshold is greater than or equal to the first voltage threshold.
  • the ultrasonic power amplifier module is connected with the ultrasonic generator through a conductive part, specifically, the conductive part can be a conductive shrapnel and a slip ring; the cutter bar of the cutter is fixedly connected with the ultrasonic generator, and the ultrasonic generator
  • the converter is configured to convert electrical energy into energy and deliver the converted energy to the tool.
  • a surgical energy device comprising:
  • an energy generating device configured to generate energy
  • the said hand-held part is provided with an activation button
  • a load detection module configured to detect the load status of the surgical energy instrument, the load status is an unloaded status or a loaded status
  • a control module whose input terminals are respectively electrically connected to the excitation button and the load detection module; the control module is configured to receive the detection signal of the load detection module and the trigger signal of the excitation button, and when the excitation button is activated In the case of pressing, the control module outputs a control signal;
  • a power conversion module which is electrically connected to the output terminal of the control module, and the power conversion module is configured to adjust the working state of the energy generating device under the control of the control module;
  • the working state of the energy generating device includes at least a first working state and a second working state, wherein the output power value of the energy generating device in the first working state is smaller than that in the second working state
  • the output power value of the energy generating device if the activation button is pressed and the load detection module detects that the surgical energy device is unloaded, the control module controls the power conversion module to adjust the energy generating device
  • the working state is the first working state; if the activation button is pressed and the load detection module detects that the surgical energy instrument is loaded, the control module controls the power conversion module to adjust the energy generation
  • the working state of the device is the second working state; if the activation button is not pressed, the output power of the energy generating device is zero.
  • the surgical energy device provided in this embodiment and the ultrasonic scalpel provided in the above embodiments belong to the same inventive concept, that is, to provide no-load protection for the surgical energy device/ultrasonic scalpel.
  • the load detection module of the surgical energy device in this embodiment is consistent with the load detection module and the power conversion module of the ultrasonic scalpel in the above embodiment, and is incorporated into this embodiment by reference, and will not be described again.
  • the surgical energy instrument in this embodiment can be an ultrasonic scalpel, then the energy generating device is an ultrasonic generator, and the ultrasonic generator is arranged inside or outside the hand-held component;
  • the energy instrument for surgery can be a laser knife, then the energy generating device is a laser generator, and the laser generator is arranged inside or outside the hand-held component;
  • the energy instrument for surgery may be an electric knife, and the energy generating device is an electric signal generator, and the electric signal generator is arranged inside or outside the hand-held component.
  • a method for adjusting the power of a surgical energy device includes an activation button and an energy generating device, and the control mode of the activation button for energy output is configured as : If the excitation button is pressed, the energy generating device outputs energy, if the excitation button is released, the energy generating device stops outputting energy, and when the excitation button is pressed, the energy generating device The output power of the energy generating device is adjusted according to the load condition of the device, and the power adjustment method includes:
  • the activation button is pressed, and the load condition of the apparatus is no-load, then adjust the output power of the energy generating device to the first working state; if the activation button is pressed, and the load condition of the apparatus If it is loaded, then adjust the output power of the energy generating device to the second working state, wherein the output power value of the energy generating device in the first working state is smaller than the value of the output power in the second working state
  • the output power value of the energy generating device is applicable to the following surgical energy devices:
  • the energy instrument for surgery is an ultrasonic scalpel
  • the energy generating device is an ultrasonic generator
  • the ultrasonic generator is arranged inside or outside the hand-held component
  • the energy instrument for surgery is a laser knife, the energy generating device is a laser generator, and the laser generator is arranged inside or outside the hand-held component;
  • the energy instrument for surgery is an electric knife
  • the energy generating device is an electric signal generator
  • the electric signal generator is arranged inside or outside the hand-held component.

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Abstract

一种超声手术刀、手术用能量器械及其功率调节方法，超声手术刀包括手持式部件、控制模块(16)、超声发生器(122)和超声刀头，还包括以下模块：负载检测模块，被配置为检测超声刀头的负载状况，负载检测模块与控制模块(16)的输入端电连接；功率变换模块，其输入侧与控制模块(16)的输出端电连接，其输出侧与超声发生器(122)电连接；控制模块(16)被配置为接收负载检测模块的检测信号，在激发按键被按压的情况下，控制模块(16)控制功率变换模块以调节超声发生器(122)的输出功率。超声手术刀根据自身负载情况自动调节超声发生器(122)的输出功率，在不影响手术效果的前提下，在空载状态下减小刀头不必要的振幅，延长刀具的使用寿命，降低超声手术刀的单次使用成本。

Description

一种超声手术刀、手术用能量器械及其功率调节方法 技术领域
本发明涉及医疗设备领域，尤其涉及一种超声手术刀、手术用能量器械及其功率调节方法。
背景技术
超声手术刀在各种腔镜手术和常规手术中提供超声能量，其主要用于软组织的止血性分离及组织凝结。随着微创外科手术的普及，超声手术刀已经成为一种常规的手术器械而被广泛应用。目前，超声刀头在超声发生器作用下进行工作，当超声刀头作用于手术部位时，医生通过按压激发按键使得超声刀头持续进行功率输出，手术期间会经常出现超声刀头短暂离开手术部位情况，而此时，医生的操作持续性使得激发按键即使在刀头离开手术部位的情况下依然处于被按压状态。
超声手术刀的成本比较贵，因此，超声手术刀并不作为一次性器械使用，但是超声手术刀的刀具具有一定的使用寿命，这决定了超声手术刀并不能无限次循环使用。如何降低超声手术刀的使用成本，成为目前亟需解决的难题。
发明内容
本发明的目的在于提供一种超声手术刀、手术用能量器械及其功率调节方法，能够自动地根据当前负载情况对超声刀头进行输出功率调节，以减少不必要的寿命损耗。
为达到上述目的，本发明采用的技术方案如下：
一方面，本发明提供了一种超声手术刀，包括手持式部件、控制模块、超声发生器和超声刀头，所述手持式部件上设有激发按键，所述超声手术刀还包括以下模块：
负载检测模块，其被配置为检测所述超声刀头的负载状况，所述负载检测模块与所述控制模块的输入端电连接；以及
功率变换模块，其输入侧与所述控制模块的输出端电连接，其输出侧与所述超声发生器电连接；
所述控制模块被配置为接收所述负载检测模块的检测信号，在所述激发按键被按压的情况下，所述控制模块控制所述功率变换模块以调节所述超声发生器的输出功率。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述超声发生器至少包括第一工作状态和第二工作状态，其中，在所述第一工作状态下所述超声发生器的输出功率值小于在所述第二工作状态下所述超声发生器的输出功率值；若所述激发按键被按压，且所述超声刀头未具有负载时，则所述控制模块控制所述功率变换模块以调节所述超声发生器运行在第一工作状态；若所述激发按键被按压，且所述超声刀头具有负载，则所述控制模块控制所述功率变换模块以调节所述超声发生器运行在第二工作状态。
优选地，超声发生器在第一工作状态下的输出功率范围为0.01-3W；超声发生器在第二工作状态下的输出功率范围为3-40W。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述激发按键与所述控制模块的输入端电连接，在所述超声手术刀接通电源的情况下，所述负载检测模块按照预设的频率或延时间隔来检测所述超声手术刀的负 载状况；
若所述激发按键被按压，且所述负载检测模块检测到所述超声刀头由带载状态转为空载状态，则所述控制模块控制所述功率变换模块以调节所述超声发生器的输出功率变小；
若所述激发按键被按压，且所述负载检测模块检测到所述超声刀头由空载状态转为带载状态，则所述控制模块控制所述功率变换模块以调节所述超声发生器的输出功率变大；
若所述激发按键未被按压，则所述超声发生器的输出功率为零。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述负载检测模块包括谐振信号采集单元、阻抗计算单元、判定单元，其中，
所述谐振信号采集单元被配置为采集所述超声手术刀的电路处于谐振状态下的电压和电流；
所述阻抗计算单元被配置为根据所述谐振信号采集单元所采集的电压和电流信号，来计算谐振阻抗；
所述判定单元被配置为根据所述阻抗计算单元的计算结果判断所述超声手术刀的负载状况，包括：将所述计算结果与预设的阻抗阈值比较，若计算得到的谐振阻抗大于或等于预设的阻抗阈值，则判定所述超声手术刀的负载状况为带载；若计算得到的谐振阻抗小于预设的阻抗阈值，则判定所述超声手术刀的负载状况为空载。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述负载检测模块包括谐振信号采集单元、判定单元，其中，
所述谐振信号采集单元被配置为采集所述超声手术刀的电路处于谐振状态下的谐振频率；
所述判定单元被配置为根据所述谐振信号采集单元前后两次的信号采集结果判断所述超声手术刀的负载状况，包括：将前后两次的信号采集结果的差值与预设的频率变化阈值比较，若前后两次采集到的谐振频率呈上升趋势且差值的绝对值大于或等于预设的频率变化阈值，则判定所述超声手术刀的负载状况为由带载转为空载；前后两次采集到的谐振频率呈下降趋势且差值的绝对值大于或等于预设的频率变化阈值，则判定所述超声手术刀的负载状况为由空载转为带载。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述功率变换模块为DC/DC变换单元，其与超声功放模块电连接，所述DC/DC变换单元受所述控制模块的控制而输出不同的电压值；
若所述DC/DC变换单元输出的电压低于预设的第一电压阈值，则所述超声功放模块驱动所述超声发生器以所述第一工作状态输出功率；
若所述DC/DC变换单元输出的电压高于预设的第二电压阈值，则所述超声功放模块驱动所述超声发生器以所述第二工作状态输出功率，其中，第二电压阈值大于或等于第一电压阈值。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述手持式部件包括手柄外壳、换能器组件及电源线，其中，所述控制模块和所述换能器组件设置在所述手柄外壳的收容腔内，且所述换能器组件在所述收容腔中能够绕轴旋转地设置；
所述电源线的一端部在所述收容腔中与所述换能器组件连接，所述电源线的另一端自所述手柄外壳的下部穿出至所述收容腔外。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述换能器组件包括换能器壳体，所述换能器壳体与所述超声发生器相互固定设置，所述换能器壳体具有中空腔，所述超声发生器至少后部收容在所述中空腔中，所述换能器组件还包括固设于所述换能器壳体外侧的导电件；
所述导电件至少具有导电部，所述超声发生器与所述导电部之间固定地电连接，所述手柄外壳的收容腔中还固定地设置有接电元件，所述接电元件抵靠在所述导电部上，在所述换能器组件相对所述手柄外壳绕自身轴心线转动的过程中，所述接电元件始终与所述导电部接触而保持电连接。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述超声功放模块通过导电件与所述超声发生器连接；
所述超声手术刀还包括刀具，所述刀具的刀杆与所述超声发生器可拆卸地固定连接，所述换能器被配置为对所述超声发生器输送的能量进行转换，并将转换后的能量输送至刀具。
另一方面，本发明提供了一种手术用能量器械，包括：
能量发生装置，其被配置为发生能量；
手持式部件，所述手持式部件上设有激发按键；
负载检测模块，其被配置为检测所述手术用能量器械的负载状况，所述负载状况为空载状况或带载状况；
控制模块，其输入端分别与所述激发按键、负载检测模块电连接；所述控制模块被配置为接收所述负载检测模块的检测信号，在所述激发按键被按压的情况下，所述控制模块输出控制信号；
功率变换模块，其与所述控制模块的输出端电连接，所述功率变换模块被配置为在所述控制模块的控制信号触发下，调节所述能量发生装置的工作状态；
所述能量发生装置至少包括第一工作状态和第二工作状态，其中，在所述第一工作状态下所述能量发生装置的输出功率值小于在所述第二工作状态下所述能量发生装置的输出功率值；若所述激发按键被按压，且所述负载检测模块检测到当前未具有负载，则所述控制模块控制所述功率变换模块以调节所述能量发生装置运行在第一工作状态；若所述激发按键被按压，且所述负载检测模块检测到当前具有负载，则所述控制模块控制所述功率变换模块以调节所述能量发生装置运行在第二工作状态；若所述激发按键未被按压，则所述能量发生装置的输出功率为零。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述功率变换模块为DC/DC变换单元，其与功放模块电连接，所述DC/DC变换单元受所述控制模块的控制而输出不同的电压值；
若所述DC/DC变换单元输出的电压低于预设的第一电压阈值，则所述功放模块驱动所述能量发生装置以所述第一工作状态输出功率；
若所述DC/DC变换单元输出的电压高于预设的第二电压阈值，则所述功放模块驱动所述能量发生装置以所述第二工作状态输出功率，其中，第二电压阈值大于或等于第一电压阈值。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述负载检测模块包括谐振信号采集单元、阻抗计算单元、判定单元，其中，
所述谐振信号采集单元被配置为采集所述手术用能量器械的电路处于谐振状态下的电压和电流；
所述阻抗计算单元被配置为根据所述谐振信号采集单元所采集的电压和电流信号，来计算谐振阻抗；
所述判定单元被配置为根据所述阻抗计算单元的计算结果判断所述手术用能量器械的负载状况，包括：将所述计算结果与预设的阻抗阈值比较，若计算得到的谐振阻抗大于或等于预设的阻抗阈值，则判定所述手术用能量器械的负载状况为带载；若计算得到的谐振阻抗小于预设的阻抗阈值，则判定所述手术用能量器械的负载状况为空载。
进一步地，承前所述的任一技术方案或多个技术方案的组合，在所述手术用能量器械的电路导通的情况下，所述负载检测模块按照预设的频率或延时间隔来检测所述手术用能量器械的负载状况。
可选地，所述手术用能量器械为超声手术刀，所述能量发生装置为超声发生器，所述超声发生器设置在手持式部件内部或外部；或者，
所述手术用能量器械为激光刀，所述能量发生装置为激光发生器，所述激光发生器设置在手持式部件内部或外部；或者，
所述手术用能量器械为电刀，所述能量发生装置为电信号发生器，所述电信号发生器设置在手持式部件内部或外部。
进一步地，承前所述的任一技术方案或多个技术方案的组合，所述手术用能量器械还包括设置在手持式部件前侧的刀具，所述负载检测模块包括生物传感器，所述生物传感器设置在所述刀具上远离手持式部件的一端，若所述生物传感器检测到与物体接触或在预设的距离阈值内靠近物体，则输出所述手术用能量器械带载的检测结果，否则输出所述手术用能量器械空载的检测结果。
再一方面，本发明提供了一种手术用能量器械的功率调节方法，受调节的手术用能量器械包括激发按键和能量发生装置，所述激发按键对能量输出的控制模式被配置为：若所述激发按键被按压，则所述能量发生装置输出能量，若所述激发按键被松开，则所述能量发生装置停止输出能量，在所述激发按键被按压的情况下，所述能量发生装置的输出功率根据该器械的负载状况而被调节，所述功率调节方法包括：
若所述激发按键被按压，且所述器械的负载状况为空载，则调节所述能量发生装置的输出功率至第一工作状态对应的输出功率；若所述激发按键被按压，且所述器械的负载状况为带载，则调节所述能量发生装置的输出功率至第二工作状态对应的输出功率，其中，在所述第一工作状态下所述能量发生装置的输出功率值小于在所述第二工作状态下所述能量发生装置的输出功率值。
可选地，所述功率调节方法适用于以下手术用能量器械：
所述手术用能量器械为超声手术刀，所述能量发生装置为超声发生器，所述超声发生器设置在手持式部件内部或外部；或者，
所述手术用能量器械为激光刀，所述能量发生装置为激光发生器，所述激光发生器设置在手持式部件内部或外部；或者，
所述手术用能量器械为电刀，所述能量发生装置为电信号发生器，所述电信号发生器设置在手持式部件内部或外部。
本发明还提供了一种超声手术刀，包括自带超声发生器功能的超声手术刀手柄，所述超声手术刀手柄包括：
手柄外壳、档位按键、手把；
所述手柄外壳头部设置有手柄连接机构，其用于与刀具连接；
所述手柄外壳内设置有空腔，所述空腔内设置有变压器、换能器、第一PCB板、第二PCB板；
所述第一PCB板设置在所述空腔顶部；
所述变压器设置在所述空腔尾端；
所述第二PCB板设置在所述空腔的握手位置处；
所述第一PCB板、第二PCB板均可设置为控制板或功率板；
所述档位按键设置在所述手柄外壳的前部，其用于切换高低功率挡；
所述手把设置在所述手柄外壳的前部，其用于控制刀具钳夹的开合。
本发明提供的技术方案带来的有益效果如下：
a.在手术用能量器械处于空载状态下，自动运行低功率输出模式，减小超声手术刀刀具在空载状态下不必要的振幅，延长刀具的使用寿命，降低超声手术刀的单次使用成本；
b.根据自身负载情况自动调节超声发生器的输出功率，负载状况下正常输出标准功率，不影响手术效果。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请中记载的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本公开的一个示例性实施例提供的超声手术刀的结构示意图；
图2为本公开的一个示例性实施例提供的超声手术刀手柄的整体结构示意图；
图3为本公开的一个示例性实施例提供的超声手术刀手柄的结构分解示意图；
图4为本公开的一个示例性实施例提供的超声手术刀手柄的内部结构示意图；
图5为本公开的一个示例性实施例提供的超声手术刀手柄中换能器组件与接电元件的连接示意图；
图6为本公开的一个示例性实施例提供的换能器组件的整体结构示意图；
图7为图6的换能器组件的结构分解示意图；
图8为图6的换能器组件的正视图；
图9为沿图8中A1-A1向剖视示意图；
图10为图8中的D处放大示意图；
图11为本公开的又一个示例性实施例提供的超声手术刀手柄的整体结构示意图；
图12为本公开的又一个示例性实施例提供的超声手术刀手柄的结构分解示意图；
图13为本公开的又一个示例性实施例提供的换能器组件的整体结构示意图；
图14为图13的换能器组件的结构分解示意图；
图15为图13的换能器组件的正视图；
图16为沿图15中A2-A2向的剖切示意图；
图17为图13的换能器组件的左视图；
图18为本公开的又一个示例性实施例提供的换能器组件与接电元件的连接结构示意图；
图19为本公开的一个示例性实施例提供的超声手术刀手柄的内部结构示意图；
图20为本公开的一个示例性实施例提供的手术用能量器械的电路示意图；
图21为本公开的一个示例性实施例提供的手术用能量器械的输出功率调节逻辑示意图；
图22为本公开的一个示例性实施例提供的器械负载状况判别流程示意图。
其中，附图标记包括：1、超声手术刀手柄；11、手柄外壳；11a、外壳-左；11b、外壳-右；11c、顶盖；11d、透视窗；
12、换能器组件；121、换能器壳体；1211、前壳体；1212、后壳体；1213、中壳体；121a、直齿圈；
122、超声发生器；1221、变幅杆轴；1222、变幅杆芯；1223、挡圈；1224、第一接电导线/第二接电导线；
123、导电件；1231、第一导电环(第一导电部)；1232、第二导电环(第二导电部)；1233、隔挡圈；1234、绝缘套管；1235、定位凸台；123O、板本体；123a、第一导电片；123b、第二导电片；123c、第一穿孔；123d、第二穿孔；
124、连接螺钉；125、胶垫；126、胶环；127、前挡盖；128、后密封环；129、螺钉；
13、接电元件；131、第一接电元件；132、第二接电元件；13a、第一弹性接电件；13b、第二弹性接电件。
具体实施方式
为了使本技术领域的人员更好地理解本发明方案，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分的实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都应当属于本发明保护的范围。
需要说明的是，本发明的说明书和权利要求书及上述附图中的术语“第一”、“第二”等是用于区别类似的对象，而不必用于描述特定的顺序或先后次序。应该理解这样使用的数据在适当情况下可以互换，以便这里描述的本发明的实施例能够以除了在这里图示或描述的那些以外的顺序实施。此外，术语“包括”和“具有”以及他们的任何变形，意图在于覆盖不排他的包含，例如，包含了一系列步骤或单元的过程、方法、装置、产品或设备不必限于清楚地列出的那些步骤或单元，而是可包括没有清楚地列出的或对于这些过程、方法、产品或设备固有的其他步骤或单元。
在超声手术刀的手术操作过程中，需要超声发生器达到一定的输出功率，才能够实现其对软组织的止血性分离及组织凝结，因此，目前的超声手术刀都是被配置有额定的一种或多种输出功率，较多的超声手术刀的手柄上设有大功率键和小功率键，按下大功率键，则超声手术刀工作在大功率模式，此模式下空载状态的超声发生器输出功率的范围在6-9W，通常适用于对软组织切割和分离；按下小功率键，则超声手术刀工作在小功率模式，此模式下空载状态的超声发生器输出功率的范围在3-7.6W，通常适用于对软组织进行凝结。若低于小功率模式下的输出功率，则无法对组织起到手术的作用，因此，现有技术中不容易想到将超声手术刀的超声发生器输出功率调节至低于小功率模式下(3W以下)的输出功率。
在本发明的一个实施例中，提供了一种超声手术刀，包括手持式部件、超声发生器、超声刀头和控制模块，所述手持式部件上设有激发按键，所述激发按键与所述控制模块的输入端电连接；所述超声手术刀还包括以下模块：
负载检测模块，其被配置为检测所述超声手术刀的负载状况，所述负载检测模块与所述控制模块的输入端电连接；以及
功率变换模块，其输入侧与所述控制模块的输出端电连接，其输出侧与超声发生器电连接，所述功率变换模块被配置为在所述控制模块的控制下，调节所述超声发生器以使其输出不同的声功率；
所述超声发生器的工作状态至少包括第一工作状态和第二工作状态，其中，第一工作状态对应于所述超声刀头未负载时的情形；第二工作状态对应于超声刀头具有负载的情形，在所述第一工作状态下所述的超声发生器的输出功率值小于所述第二工作状态下所述超声发生器的输出功率；如图21所示，具体地，在所述超声手术刀接通电源的情况下，若所述激发按键被按压，且所述负载检测模块检测到所述超声手术刀空载，则所述控制模块控制 所述功率变换模块调节所述超声发生器的工作状态为第一工作状态；若所述激发按键被按压，且所述负载检测模块检测到所述超声手术刀带载，则所述控制模块控制所述功率变换模块调节所述超声发生器的工作状态为第二工作状态；若所述激发按键未被按压，则所述超声发生器的输出功率为零。
由于超声发生器的输出功率越大，则超声手术刀的刀具的振幅越大，导致刀具的使用寿命缩短，对于刀具与手柄一体结构的超声手术刀而言，刀具的使用寿命就等于超声手术刀的使用寿命。而在超声手术刀的实际使用中，术者通常习惯先按激发按键，再夹取组织，或者，在组织切割完毕后，激发按键延迟松开，由于很难确保接触组织的同时按下激发按键或离开组织的同时松开激发按键，因此，在使用过程中的一部分时间内，超声手术刀是没有负载但是依然按照带载的标准输出功率，而研究发现，在相同的输出功率下，空载状态条件的超声手术刀的刀具振幅要大于带载状态的超声手术刀的刀具振幅。若采用本实施例的技术方案，在检测到空载状态而调节为较小功率的第一工作状态的时间可以基本上认为是本实施例的技术方案延长的超声手术刀的使用寿命，假设每次超声手术刀实际对组织操作的时间为10s，提前按下激发按键至找到组织进行操作的时间为2s，操作完至松开激发按键的时间为1s，则相当于本实施例的技术方案将超声手术刀的使用寿命延长大概30％左右。
本发明不限定激发按键的数量，其可以为一个或多个，以举例来说，本实施例中，激发按键包括两个，分别为大功率激发按键和小功率激发按键，如上所述，分别为大功率激发按键对应设定用于切割的大功率(比如6-9W)，为小功率激发按键对应设定用于凝结的小功率(比如3-7.6W)；显然，无论被按压的是大功率激发按键还是小功率激发按键，上述当检测到所述超声手术刀空载，则调节所述超声发生器以第一工作状态输出，对应的超声发生器输出功率可以为0.01W，也可以为大于0.01W且不大于3W这一范围内的任意值，即空载状态下的功率输出小于用于凝结的小功率设定值。本实施例中，第二工作状态情形对应的超声发生器的输出功率可以设定为不小于3W且不大于45W这一范围内的任意值，比如，空载时超声发生器输出功率为0.01W，检测到带载时超声发生器的输出功率跃升为3W，或者，空载时超声发生器输出功率为0.1W，检测到带载时超声发生器的输出功率跃升为4.5W，或者，空载时超声发生器输出功率为0.2W，检测到带载时超声发生器的输出功率跃升为3.6W，具体地，大功率激发按键和/或小功率激发按键还可以分多档调节，比如小功率激发按键可选择为1-4档，4档功率大约为5-7.6W，3档功率大约为4.3-6.5W，2档功率大约为3.6-5.4W，1档功率大约为3-4.5W，以上多档的设定值定义为在检测到超声刀头带载时，超声发生器跃升的输出功率的起点。随着超声手术刀的超声刀头带载的负荷增大，则超声发生器的实际输出功率增大，设定超声手术刀的超声发生器实际能够输出的最大功率为45W。
本实施例中，对超声手术刀进行空载保护，即当判断当前为空载时，可把输出功率降到足够低，但因为不同刀头之间的差异性，每把刀头阻抗会有点区别，为了确保系统的可靠性和临界状态的稳定性，以及为了保证加载后功率不损失，本实施例的第一工作状态的输出功率设定值范围为0.01至3W，进一步可选为0.1至3W或者0.5至3W。在不同的实施例中，可以设定不同功率取值的第一工作状态和不同功率区间范围的第二工作状态。
为便于描述说明超声手术刀中各部件的相对位置关系，以上及以下关于前后方向的描述，均是以操作者在握持该超声手术刀进行操作时所观察到的方向进行参考定义的，其中超声手术刀作用于手术部位的位置为前，超声手术刀靠近操作者(医生)人体的位置为后。
参见图1所示的超声手术刀系统，其包括超声手术刀，以及向超声手术刀供能的电源适配器3；其中，超声手术刀包括超声手术刀手柄1，以及可拆卸地安装在超声手术刀手柄1上的刀具2。
参见各附图所示，超声手术刀手柄1包括手柄外壳11与换能器组件12，手柄外壳11包括固定连接配合的外 壳-左11a与外壳-右11b，以及位于顶部的顶盖11c，其具有一收容腔，换能器组件12整体地收容在该收容腔中且能够绕自身轴心线旋转地设置，所述控制模块16可选地设置在收容腔中，如图4和图19所述。换能器组件12包括相互固定地设置的换能器壳体121与超声发生器122，换能器壳体121具有中空腔，超声发生器122至少后部收容在上述中空腔中并相对换能器壳体121固定。
具体地，参见各附图所示，超声发生器122为一整体式元件，其包括沿轴向依次设置的变幅杆轴1221与变幅杆芯1222，变幅杆轴1221与变幅杆芯1222相接的位置处还形成有一挡圈1223，变幅杆芯1222及挡圈1223全部容置在换能器壳体121的中空腔中，变幅杆轴1221的前部伸出在中空腔外且通过前部的连接螺钉124与刀具2连接。
换能器组件12还包括固设于换能器壳体121外侧的导电件123，该导电件123至少具有导电部，超声发生器122与上述导电部之间固定地电连接，手柄外壳11的收容腔中还固定地设置有接电元件13，该接电元件13抵靠在导电部上，在超声发生器122相对手柄外壳11绕自身轴心线转动的过程中，接电元件13始终与导电部接触而保持电连接。
在本发明的一个超声手术刀的结构实施例中，参见图2至图10所示，导电件123固定地设于换能器壳体121的外侧周部上，该导电部呈圆环状，导电部的轴心线与换能器组件12的轴心线共线延伸。具体地，导电部包括相互绝缘设置且均呈圆环状的第一导电部与第二导电部，超声发生器122具有两个接电导线1224——第一接电导线与第二接电导线，两根接电导线分别与两个导电部之间电连接。
两个导电部在换能器壳体121的轴向上间隔地设置，在本实施例中，导电件123包括均由导电材料制成的两个导电环——第一导电环1231与第二导电环1232，以及设置在第一导电环1231与第二导电环1232之间且由绝缘材料制成的隔挡圈1233，第一导电环1231构成第一导电部、第二导电环1232构成第二导电环1232。第一接电导线1224的端部固设于第一导电环1231上实现电连接，第二接电导线1224的端部固设于第二导电环1232上实现电连接。
第一导电环1231、第二导电环1232及隔挡圈1233相对固定地套设在换能器壳体121的外侧周部上，具体地，每个导电环与隔挡圈1233之间均设置有用于限制两者相对转动的周向限位结构，导电件123整体与换能器壳体121之间还设置有用于限制导电件123旋转与限制导电件123沿轴向运动的定位结构。
在这里，参见图6、图7所示，换能器壳体121包括沿前后方向依次设置的前壳体1211、中壳体1213及后壳体1212，前壳体1211与中壳体1213之间设置有胶垫125与胶环126来实现密封，中壳体1213与后壳体1212之间设置有胶环126来实现密封，并同时将收容在换能器壳体121中的超声发生器122密封在该换能器壳体121中。导电件123固定地安装在中壳体1213上并位于后壳体1212的前部。
导电件123还包括绝缘套管1234，绝缘套管1234固定地套设在中壳体1213的外侧周部上，第一导电环1231、隔挡圈1233及第二导电环1232共同套设在绝缘套管1234的后部管段的外侧周部上，第一导电环1231的前部与绝缘套管1234之间、第一导电环1231的后部与隔挡圈1233的前部之间、隔挡圈1233的后部与第二导电环1232的前部之间、第二导电环1232的后部与后壳体1212的前部之间均通过定位凸台1235与凹槽的方式相互配合定位，如此，导电件123被固定在换能器壳体121上。
参见图3、图5所示，手柄外壳11中还设置有接电元件13，该接电元件13位于换能器组件12的周向外侧，接电元件13抵靠在换能器壳体121的外侧周部上并与导电部相互抵接，具体地，该接电元件13包括相互独立的 第一接电元件131与第二接电元件132，第一接电元件131与第二接电元件132均由金属材质制成且沿自身长度方向具有一定的弹性，两者沿手柄外壳11的前后方向间隔地设置，第一接电元件131沿换能器壳体121的径向向内弹性地抵靠在第一导电环1231的外侧周部上，第二接电元件132沿换能器壳体121的径向向内弹性地抵靠在第二导电环1232的外侧周部上。在换能器组件12整体相对手柄外壳11绕自身轴心线旋转的过程中，第一接电元件131与第一导电环1231之间、第二接电元件132与第二导电环1232之间始终接触而保持电连接。
参见图5所示，本实施例中，接电元件13设置在手柄外壳11中并位于上部位置，其位于换能器组件12的上方，使得接电元件13能够向下地抵靠在换能器组件12的外侧周部上以更稳定地保持电连接。
如此，仅需要将接电源线在手柄外壳11的内部去连接接电元件13，然后就可以将电源线从手柄外壳11的下部引出来接入电源，如此，换能器组件12在手柄壳体11中绕自身轴心线转动的过程中，电源线不会跟着旋转，这样就很好地避免了因电源线自手柄外壳11的后部伸出而带来的如手臂施力较大易劳累、电源线打结等一系列问题。
在本发明的超声手术刀的另一个结构实施例中，参见图11至图19所示，本实施例中，导电件123固定地设置在换能器壳体121的后端部，换能器壳体121自身的后部可设置为敞开式，导电件123从后端封闭该换能器壳体121。导电部设置在导电件123的后部，接电元件13设置在手柄壳体11中并位于换能器组件12的后方，接电元件13向前弹性地抵靠在导电部上。
具体地，导电部包括相互绝缘设置的第一导电部与第二导电部，超声发生器122具有两根接电导线——第一接电导线与第二接电导线(图中未示出)，第一接电导线与第一导电部之间电连接，第二接电导线与第二导电部之间电连接。接电元件13也包括相互独立而彼此绝缘设置的第一弹性接电件13a和第二弹性接电件13b，第一弹性接电件13a抵靠在第一导电部上且第二弹性接电件13b抵靠在第二导电部上。上述第一导电部、第二导电部是以换能器组件12的轴心线为旋转中心的圆盘状或圆环状，如此，当换能器组件12绕自身轴心线旋转的过程中，第一弹性接电件13a、第二弹性接电件13b能够分别保持抵靠在第一导电部、第二导电部上。
在本实施例中，导电件123包括板本体123O，以及固设于板本体123O上且由金属材质制成的第一导电片123a与第二导电片123b，其中，第一导电片123a为圆盘状，第二导电片123b呈圆环状且环设在第一导电片123a的周向外侧，第一导电片123a与第二导电片123b沿导电件123的径向间隔地设置，亦即第一导电片123a的外侧周壁与第二导电片123b的内侧周壁在导电件123的径向上具有一定的间距。上述第一导电片123a构成第一导电部，第二导电片123b构成第二导电部。
板本体123O上开设有沿自身厚度方向贯穿的第一穿孔123c与第二穿孔123d，第一接电导线穿设在第一穿孔123c中并通过焊接的方式固定在第一导电片123a上而实现电连接，第二接电导线穿设在第二穿孔123d中并通过焊接的方式固定在第二导电片123b上而实现电连接。
参见图12及附图18所示，第一弹性接电件13a和第二弹性接电件13b均为金属材质制成的弹片，第一弹性接电件13a的下端部、第二弹性接电件13b的下端部各自固定地设置在手柄外壳11中，第一弹性接电件13a的上端部向前抵压在第一导电片123a的后侧面上，第二弹性接电件13b的上端部向前抵压在第二导电片123b的后侧面上。
如此，仅需要将接电源线的两根导电线分别连接第一弹性接电件13a与第二弹性接电件13b，然后就可以将电源线从手柄外壳11的下部引出来接入电源，如此，换能器组件12在手柄壳体11中绕自身轴心线转动的过程中， 电源线不会跟着旋转，这样就很好地避免了因电源线自手柄外壳11的后部伸出而带来的如手臂施力较大易劳累、电源线打结等一系列问题。
下面针对负载检测模块检测超声手术刀负载状况的方案进行详细说明：
方案一、根据谐振阻抗来判断超声手术刀是否带载：所述负载检测模块包括谐振信号采集单元、阻抗计算单元、判定单元，谐振信号采集单元参见图20所示的电流电压采样处理单元，在超声手术刀电路的自动调整工作频率以使系统谐振的固有功能前提下，电流电压采样处理单元被配置为采样超声发生器的输出电压和电流，基于此，所述阻抗计算单元计算谐振阻抗，进而判定单元根据谐振阻抗的计算结果来判断所述超声手术刀的负载状况，如图22所示：将所述计算结果与预设的阻抗阈值比较，若计算得到的谐振阻抗大于或等于预设的阻抗阈值，则判定所述超声手术刀的负载状况为带载；若计算得到的谐振阻抗小于预设的阻抗阈值，则判定所述超声手术刀的负载状况为空载。
需要说明的是，本实施例中负载检测模块的各个单元只是按功能划分的单元，而不限定其具体的硬件组成划分，比如阻抗计算单元可以划分在图20中的电流电压采样处理单元，也可以划分在控制模块(MCU or FPGA数字控制中心)；判定单元同样可以有多种划分。
方式二、根据谐振频率的变化来判断超声手术刀是否带载：所述负载检测模块包括谐振信号采集单元、判定单元，所述谐振信号采集单元被配置为采集所述超声手术刀的电路处于谐振状态下的谐振频率，具体地，如图20，在超声手术刀电路的自动调整工作频率以使系统谐振的固有功能前提下，电流电压采样处理单元被配置为采样超声发生器的输出电压和电流，然后将电压和电流的采样结果输送至控制模块(MCU or FPGA数字控制中心)，进行数据处理，得到相应的谐振频率，作为采样结果；
所述判定单元被配置为根据所述谐振信号采集单元前后两次的信号采集结果判断所述超声手术刀的负载状况，包括：将前后两次采样的谐振频率的差值与预设的频率变化阈值比较，若前后两次采集到的谐振频率呈上升趋势且差值的绝对值大于或等于预设的频率变化阈值，则判定所述超声手术刀的负载状况为由带载转为空载；前后两次采集到的谐振频率呈下降趋势且差值的绝对值大于或等于预设的频率变化阈值，则判定所述超声手术刀的负载状况为由空载转为带载。
方式三、超声手术刀还包括设置在手持式部件前侧的刀具，所述负载检测模块包括生物传感器，所述生物传感器设置在所述刀具上远离手持式部件的一端，若所述生物传感器检测到与物体接触或在预设的距离阈值内靠近物体，则输出所述超声手术刀带载的检测结果，否则输出所述超声手术刀空载的检测结果。
在所述超声手术刀接通电源的情况下，针对以上任一中方式，所述负载检测模块按照预设的频率或延时间隔(毫秒或者微秒级别，比如100us-10ms)来检测所述超声手术刀的负载状况。当检测到超声手术刀为空载状态时，超声发生器的输出功率调整至第一工作状态对应的输出功率，即处于一种待机状态；一旦检测到超声手术刀由空载状态转为带载状态，则超声发生器的输出功率快速恢复到正常水平，即第二工作状态的功率区间范围最小值，并随着负载的增大而调谐增大超声发生器的输出功率。在一个优选实施例中，当检测到超声手术刀由空载状态转为带载状态时，如果医生在空载状态期间没有进行输出功率调节，则超声发生器的输出功率快速恢复到上次的功率水平，如果医生在空载状态期间进行了输出功率调节，则超声发生器的输出功率快速提升至新设定的功率水平。
针对方式一和方式二，由于需要采样谐振信号(电压和/或电流)，因此，第一工作状态情形对应的超声发生器的输出功率不能为零。
下面针对功率变换模块进行详细说明：
在本实施例中，所述功率变换模块为DC/DC变换单元，参见图20，其与超声功放模块电连接，所述DC/DC变换单元受所述控制模块的控制而输出不同的电压值；
若所述DC/DC变换单元输出的电压低于预设的第一电压阈值，则所述超声功放模块驱动所述超声发生器以所述第一工作状态输出功率；
若所述DC/DC变换单元输出的电压高于预设的第二电压阈值，则所述超声功放模块驱动所述超声发生器以所述第二工作状态输出功率，其中，第二电压阈值大于或等于第一电压阈值。
其中，所述超声功放模块通过导电件与所述超声发生器连接，具体地，所述导电件可以为导电弹片和滑环；刀具的刀杆与所述超声发生器固定连接，所述超声发生器被配置为对电能进行能量转换，并将转换后的能量输送至刀具。
在本发明的一个实施例中，提供了一种手术用能量器械，包括：
能量发生装置，其被配置为发生能量；
手持式部件，所述手持式部件上设有激发按键；
负载检测模块，其被配置为检测所述手术用能量器械的负载状况，所述负载状况为空载状况或带载状况；
控制模块，其输入端分别与所述激发按键、负载检测模块电连接；所述控制模块被配置为接收所述负载检测模块的检测信号及所述激发按键的触发信号，在所述激发按键被按压的情况下，所述控制模块输出控制信号；
功率变换模块，其与所述控制模块的输出端电连接，所述功率变换模块被配置为在所述控制模块的控制下，调节所述能量发生装置的工作状态；
所述能量发生装置的工作状态至少包括第一工作状态和第二工作状态，其中，在所述第一工作状态下所述能量发生装置的输出功率值小于在所述第二工作状态下所述能量发生装置的输出功率值；若所述激发按键被按压，且所述负载检测模块检测到所述手术用能量器械空载，则所述控制模块控制所述功率变换模块调节所述能量发生装置的工作状态为第一工作状态；若所述激发按键被按压，且所述负载检测模块检测到所述手术用能量器械带载，则所述控制模块控制所述功率变换模块调节所述能量发生装置的工作状态为第二工作状态；若所述激发按键未被按压，则所述能量发生装置的输出功率为零。
本实施例提供的手术用能量器械与上述实施例提供的超声手术刀属于同一发明构思，即为手术用能量器械/超声手术刀提供空载保护，本实施例中手术用能量器械的负载检测模块、功率变换模块与上述实施例中超声手术刀的负载检测模块、功率变换模块一致，通过引用的方式并入本实施例中，不再赘述。可选地，本实施例中的手术用能量器械可以为超声手术刀，则所述能量发生装置为超声发生器，所述超声发生器设置在手持式部件内部或外部；
所述手术用能量器械可以为激光刀，则所述能量发生装置为激光发生器，所述激光发生器设置在手持式部件内部或外部；
所述手术用能量器械可以为电刀，则所述能量发生装置为电信号发生器，所述电信号发生器设置在手持式部件内部或外部。
在本发明的一个实施例中，提供了一种手术用能量器械的功率调节方法，受调节的手术用能量器械包括激发按键和能量发生装置，所述激发按键对能量输出的控制模式被配置为：若所述激发按键被按压，则所述能量发生 装置输出能量，若所述激发按键被松开，则所述能量发生装置停止输出能量，在所述激发按键被按压的情况下，所述能量发生装置的输出功率根据该器械的负载状况而被调节，所述功率调节方法包括：
若所述激发按键被按压，且所述器械的负载状况为空载，则调节所述能量发生装置的输出功率至第一工作状态；若所述激发按键被按压，且所述器械的负载状况为带载，则调节所述能量发生装置的输出功率至第二工作状态，其中，在所述第一工作状态下所述能量发生装置的输出功率值小于在所述第二工作状态下所述能量发生装置的输出功率值。上述功率调节方法适用于以下手术用能量器械：
(1)所述手术用能量器械为超声手术刀，所述能量发生装置为超声发生器，所述超声发生器设置在手持式部件内部或外部；
(2)所述手术用能量器械为激光刀，所述能量发生装置为激光发生器，所述激光发生器设置在手持式部件内部或外部；
(3)所述手术用能量器械为电刀，所述能量发生装置为电信号发生器，所述电信号发生器设置在手持式部件内部或外部。
需要说明的是，在本文中，诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
以上所述仅是本申请的具体实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本申请的保护范围。

Claims (17)

  1. 一种超声手术刀，包括手持式部件、控制模块、超声发生器和超声刀头，所述手持式部件上设有激发按键，其特征在于，所述超声手术刀还包括以下模块：
    负载检测模块，其被配置为检测所述超声刀头的负载状况，所述负载检测模块与所述控制模块的输入端电连接；以及
    功率变换模块，其输入侧与所述控制模块的输出端电连接，其输出侧与所述超声发生器电连接；
    所述控制模块被配置为接收所述负载检测模块的检测信号，在所述激发按键被按压的情况下，所述控制模块根据该检测信号控制所述功率变换模块以调节所述超声发生器的输出功率。
  2. 根据权利要求1所述的超声手术刀，其特征在于，所述超声发生器至少包括第一工作状态和第二工作状态，其中，在所述第一工作状态下所述超声发生器的输出功率值小于在所述第二工作状态下所述超声发生器的输出功率值；若所述激发按键被按压，且所述超声刀头未具有负载，则所述控制模块控制所述功率变换模块以调节所述超声发生器运行在第一工作状态；若所述激发按键被按压，且所述超声刀头具有负载，则所述控制模块控制所述功率变换模块以调节所述超声发生器运行在第二工作状态。
  3. 根据权利要求1所述的超声手术刀，其特征在于，所述超声发生器在第一工作状态下的输出功率范围为0.01至3W；所述超声发生器在第二工作状态下的输出功率范围为3至45W。
  4. 根据权利要求1所述的超声手术刀，其特征在于，所述激发按键与所述控制模块的输入端电连接，在所述超声手术刀接通电源的情况下，所述负载检测模块按照预设的频率或延时间隔来检测所述超声手术刀的负载状况；
    若所述激发按键被按压，且所述负载检测模块检测到所述超声刀头由带载状态转为空载状态，则所述控制模块控制所述功率变换模块以调节所述超声发生器的输出功率变小；
    若所述激发按键被按压，且所述负载检测模块检测到所述超声刀头由空载状态转为带载状态，则所述控制模块控制所述功率变换模块以调节所述超声发生器的输出功率变大；
    若所述激发按键未被按压，则所述超声发生器的输出功率为零。
  5. 根据权利要求1所述的超声手术刀，其特征在于，所述负载检测模块包括谐振信号采集单元、阻抗计算单元、判定单元，其中，所述谐振信号采集单元被配置为采集所述超声手术刀的电路处于谐振状态下的电压和电流；
    所述阻抗计算单元被配置为根据所述谐振信号采集单元所采集的电压和电流信号，来计算谐振阻抗；
    所述判定单元被配置为根据所述阻抗计算单元的计算结果判断所述超声手术刀的负载状况，包括：将所述计算结果与预设的阻抗阈值比较，若计算得到的谐振阻抗大于或等于预设的阻抗阈值，则判定所述超声手术刀的负载状况为带载；若计算得到的谐振阻抗小于预设的阻抗阈值，则判定所述超声手术刀的负载状况为空载。
  6. 根据权利要求1所述的超声手术刀，其特征在于，所述负载检测模块包括谐振信号采集单元、判定单元，其中，所述谐振信号采集单元被配置为采集所述超声手术刀的电路处于谐振状态下的谐振频率；
    所述判定单元被配置为根据所述谐振信号采集单元前后两次的信号采集结果判断所述超声手术刀的负载状况，包括：将前后两次的信号采集结果的差值与预设的频率变化阈值比较，若前后两次采集到的谐振频率呈上升趋势且差值的绝对值大于或等于预设的频率变化阈值，则判定所述超声手术刀的负载状况为由带载转为空载；前后两次采集到的谐振频率呈下降趋势且差值的绝对值大于或等于预设的频率变化阈值，则判定所述超声手术刀的负载状况为由空载转为带载。
  7. 根据权利要求2所述的超声手术刀，其特征在于，所述功率变换模块为DC/DC变换单元，其与超声功放模 块电连接，所述DC/DC变换单元受所述控制模块的控制而输出不同的电压值；
    若所述DC/DC变换单元输出的电压低于预设的第一电压阈值，则所述超声功放模块驱动所述超声发生器以所述第一工作状态输出功率；
    若所述DC/DC变换单元输出的电压高于预设的第二电压阈值，则所述超声功放模块驱动所述超声发生器以所述第二工作状态输出功率，其中，第二电压阈值大于或等于第一电压阈值。
  8. 根据权利要求7所述的超声手术刀，其特征在于，所述手持式部件包括手柄外壳、换能器组件及电源线，其中，所述控制模块和所述换能器组件设置在所述手柄外壳的收容腔内，且所述换能器组件在所述收容腔中能够绕轴旋转地设置；
    所述电源线的一端部在所述收容腔中与所述换能器组件连接，所述电源线的另一端自所述手柄外壳的下部穿出至所述收容腔外。
  9. 根据权利要求8所述的超声手术刀，其特征在于，所述换能器组件包括换能器壳体，所述换能器壳体与所述超声发生器相互固定设置，所述换能器壳体具有中空腔，所述超声发生器至少后部收容在所述中空腔中，所述换能器组件还包括固设于所述换能器壳体外侧的导电件；
    所述导电件至少具有导电部，所述超声发生器与所述导电部之间固定地电连接，所述手柄外壳的收容腔中还固定地设置有接电元件，所述接电元件抵靠在所述导电部上，在所述换能器组件相对所述手柄外壳绕自身轴心线转动的过程中，所述接电元件始终与所述导电部接触而保持电连接。
  10. 一种手术用能量器械，其特征在于，包括：
    能量发生装置，其被配置为发生能量；
    手持式部件，所述手持式部件上设有激发按键；
    负载检测模块，其被配置为检测所述手术用能量器械的负载状况，所述负载状况为空载状况或带载状况；
    控制模块，其输入端与所述负载检测模块、激发按键电连接；所述控制模块被配置为接收所述负载检测模块的检测信号，在所述激发按键被按压的情况下，所述控制模块输出控制信号；
    功率变换模块，其与所述控制模块的输出端电连接，所述功率变换模块被配置为在所述控制模块的控制信号触发下，调节所述能量发生装置的输出功率；
    所述能量发生装置至少包括第一工作状态和第二工作状态，其中，在所述第一工作状态下所述能量发生装置的输出功率值小于在所述第二工作状态下所述能量发生装置的输出功率值；若所述激发按键被按压，且所述负载检测模块检测到当前未具有负载，则所述控制模块控制所述功率变换模块以调节所述能量发生装置运行在第一工作状态；若所述激发按键被按压，且所述负载检测模块检测到当前具有负载，则所述控制模块控制所述功率变换模块以调节所述能量发生装置运行在第二工作状态。
  11. 根据权利要求10所述的手术用能量器械，其特征在于，所述功率变换模块为DC/DC变换单元，其与功放模块电连接，所述DC/DC变换单元受所述控制模块的控制而输出不同的电压值；
    若所述DC/DC变换单元输出的电压低于预设的第一电压阈值，则所述功放模块驱动所述能量发生装置以所述第一工作状态输出功率；
    若所述DC/DC变换单元输出的电压高于预设的第二电压阈值，则所述功放模块驱动所述能量发生装置以所述第二工作状态输出功率，其中，第二电压阈值大于或等于第一电压阈值。
  12. 根据权利要求10所述的手术用能量器械，其特征在于，所述负载检测模块包括谐振信号采集单元、阻抗 计算单元、判定单元，其中，所述谐振信号采集单元被配置为采集所述手术用能量器械的电路处于谐振状态下的电压和电流；
    所述阻抗计算单元被配置为根据所述谐振信号采集单元所采集的电压和电流信号，来计算谐振阻抗；
    所述判定单元被配置为根据所述阻抗计算单元的计算结果判断所述手术用能量器械的负载状况，包括：将所述计算结果与预设的阻抗阈值比较，若计算得到的谐振阻抗大于或等于预设的阻抗阈值，则判定所述手术用能量器械的负载状况为带载；若计算得到的谐振阻抗小于预设的阻抗阈值，则判定所述手术用能量器械的负载状况为空载。
  13. 根据权利要求12所述的手术用能量器械，其特征在于，在所述手术用能量器械的电路导通的情况下，所述负载检测模块按照预设的频率或延时间隔来检测所述手术用能量器械的负载状况。
  14. 根据权利要求10-13中任一项所述的手术用能量器械，其特征在于，所述手术用能量器械为超声手术刀，所述能量发生装置为超声发生器，所述超声发生器设置在手持式部件内部或外部；或者，
    所述手术用能量器械为激光刀，所述能量发生装置为激光发生器，所述激光发生器设置在手持式部件内部或外部；或者，
    所述手术用能量器械为电刀，所述能量发生装置为电信号发生器，所述电信号发生器设置在手持式部件内部或外部。
  15. 根据权利要求10所述的手术用能量器械，其特征在于，所述手术用能量器械还包括设置在手持式部件前侧的刀具，所述负载检测模块包括生物传感器，所述生物传感器设置在所述刀具上远离手持式部件的一端，若所述生物传感器检测到与物体接触或在预设的距离阈值内靠近物体，则输出所述手术用能量器械带载的检测结果，否则输出所述手术用能量器械空载的检测结果。
  16. 一种手术用能量器械的功率调节方法，受调节的手术用能量器械包括激发按键和能量发生装置，若所述激发按键被按压，则所述能量发生装置输出能量，若所述激发按键被松开，则所述能量发生装置停止输出能量，其特征在于，在所述激发按键被按压的情况下，所述能量发生装置的输出功率根据该器械的负载状况而被调节，所述功率调节方法包括：
    若所述激发按键被按压，且所述器械的负载状况为空载，则调节所述能量发生装置的输出功率至第一工作状态对应的输出功率；若所述激发按键被按压，且所述器械的负载状况为带载，则调节所述能量发生装置的输出功率至第二工作状态对应的输出功率，其中，在所述第一工作状态下所述能量发生装置的输出功率值小于在所述第二工作状态下所述能量发生装置的输出功率值。
  17. 根据权利要求16所述的功率调节方法，其特征在于，适用于以下手术用能量器械：
    所述手术用能量器械为超声手术刀，所述能量发生装置为超声发生器，所述超声发生器设置在手持式部件内部或外部；或者，
    所述手术用能量器械为激光刀，所述能量发生装置为激光发生器，所述激光发生器设置在手持式部件内部或外部；或者，
    所述手术用能量器械为电刀，所述能量发生装置为电信号发生器，所述电信号发生器设置在手持式部件内部或外部。
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