An ultrasonic knife head amplitude intelligent testing device and detection method

Abstract

The application discloses an ultrasonic knife head amplitude intelligent testing device and method, which comprises a base plate for fixing the ultrasonic knife head, a sensing head for emitting and receiving testing laser, a mirror for reflecting the testing laser, a mirror adjusting mechanism for controlling the mirror movement, a sensing head adjusting mechanism for controlling the sensing head up and down movement, a main machine for controlling the sensing head adjusting mechanism and a controller, and a display for data display. The detection method comprises the following steps: S1, installing the ultrasonic knife head in place and starting the main machine; S2, presetting the relative position of the ultrasonic knife head, the sensing head and the mirror; and S3, performing laser on the specified region of the ultrasonic knife head, thereby confirming the position of the maximum amplitude and marking. The application has the beneficial effect that the ultrasonic knife head is fixed, the ultrasonic is continuously excited for a period of time after the system is powered on, the positioning and amplitude confirmation marking are automatically completed by the main machine, and the error caused by secondary processing is avoided.

Description

Technical Field

[0001] This invention relates to the field of testing equipment for medical devices, and in particular to an intelligent testing device and method for the amplitude of an ultrasonic scalpel tip. Background Technology

[0002] The basic principle of an ultrasonic cutting hemostat is to use ultrasonic waves generated by an ultrasonic frequency generator to cause the metal blade to mechanically oscillate at an ultrasonic frequency of 55.5 kHz. This causes water vaporization within biological tissue, protein hydrogen bond breakage, cell disintegration, and tissue cutting or coagulation to seal small blood vessels. The ultrasonic cutting hemostat mainly consists of an ultrasonic transducer, a blade, and a power generator. The blade includes an end effector mounted distally for tissue clamping. The end effector is typically connected to a handle and / or robotic surgical tool via a shaft. The blade is acoustically connected to the transducer within the handle via a waveguide extending through the shaft. Ultrasonic surgical devices with this property can be used for open surgical purposes, laparoscopic or endoscopic surgery, including robot-assisted procedures.

[0003] The amplitude of the ultrasonic scalpel tip is a crucial parameter during operation, representing a significant performance indicator of the ultrasonic system's output power. The output power is directly proportional to the square of the amplitude displacement. Insufficient amplitude can negatively impact cutting and coagulation, prolonging surgery time and potentially preventing effective tissue cutting and coagulation. Conversely, excessive amplitude reduces the tip's hand stability, shortens its lifespan, and increases the risk of breakage and misoperation during surgery. Therefore, it is essential to test the ultrasonic scalpel tip's amplitude before surgery. However, most existing ultrasonic scalpel amplitude testing devices measure the output end face of the curved section of the tip using a microscope or laser vibrometer, resulting in significant errors and placing a heavy burden on manual operators.

[0004] The most direct known method for measuring amplitude displacement is optical. For example, direct observation at the vibrating end face using a long-focal-length microscope is convenient for measuring amplitudes greater than 10 μm. For precise measurement of small amplitudes, laser interferometry can be used. Measuring the amplitude displacement of small vibrations using a feedback-modulated laser vibrometer does not require specialized instruments such as laser holograms or interferometers, but calibration and standardization of the amplitude displacement are difficult. Alternatively, amplitude can be measured using a vibration pickup, but this method also requires calibration. Sometimes, an older but effective method can be used to determine the displacement node of an amplitude transformer with larger amplitudes. This involves sprinkling a fine, lightweight powder on the surface of the transformer rod (i.e., the rod is placed horizontally), and then measuring the amplitude at the resonant frequency. However, the amplitude testing device cannot be flexibly adjusted to adapt to different measurement environments to achieve reusability.

[0005] Application No. 201821406121.6 discloses an ultrasonic scalpel tip amplitude measuring device, which comprises five units: a measurement unit, an image capture unit, a main measuring stage, a lifting rod, and a lifting platform. The measurement unit is directly mounted on the main measuring stage, and its deployment is controlled by a scale pop-up switch. The image capture unit, primarily composed of a CCD camera, is connected to the main measuring stage via a horizontally and vertically adjustable worktable. The lifting rod is connected to the main measuring stage via a groove of a certain depth. The lifting platform is directly fitted onto the lifting rod and secured using a coarse adjustment knob.

[0006] An online ultrasonic real-time amplitude measurement device is disclosed in 2020110296159. However, its application is geared towards torsional vibration, rather than vertical vibration.

[0007] The above solutions have the following main drawbacks, and existing ultrasonic amplitude measurement methods also have the following shortcomings: when the amplitude output face is a non-standard plane, if the instrument under test is replaced, the testing device cannot be flexibly adjusted to adapt to different measurement environments to achieve reusability; moreover, calibration and correction are difficult. Specifically, for example... Figure 5 As shown: The front end of the ultrasonic scalpel head 3 is curved, and the output end area is small. Manually aligning the sensing head 12 to be directly opposite the front end of the ultrasonic scalpel head 3 is very difficult, and recalibration is required every time the instrument under test is changed during batch testing, resulting in a significant amount of manual work. If the calibration fails as follows... Figure 6 The deflection shown will cause distortion in the amplitude test data, resulting in an A·sinθ component error in the actual amplitude A. This can easily lead to testing errors and repeatability errors. Furthermore, in the testing of other power ultrasound devices, such as ultrasonic bone scalpels, the structure and dimensions of the amplitude output end face will be as follows... Figure 7 and Figure 8 When the irregularity shown is smaller and conventional manual correction is not feasible, the testing method in this case becomes particularly convenient. Summary of the Invention

[0008] The purpose of this invention is to overcome the shortcomings of the prior art and provide an intelligent testing device and method for ultrasonic scalpel head amplitude. It fixes the ultrasonic scalpel head and continuously excites ultrasound for a period of time after the system is powered on. The host automatically completes the positioning and amplitude confirmation marking, avoiding errors introduced by secondary processing.

[0009] This invention is achieved through the following technical solution: an intelligent testing device for the amplitude of an ultrasonic scalpel tip, comprising...

[0010] The substrate has a limiting structure on its surface for fixing the ultrasonic scalpel head 3;

[0011] The sensing head 12 is equipped with a controller 10, which controls it to emit and receive test lasers.

[0012] Mirror 5 is used to reflect the test laser;

[0013] The reflector adjustment mechanism 6 is connected to the reflector 5 and controls the up-and-down movement and swing of the reflector 5.

[0014] The sensing head adjustment mechanism 11 is connected to the sensing head 12 and controls the up-and-down movement and swing of the sensing head 12.

[0015] The host 8 is connected to the sensor head adjustment mechanism 11 and the controller 10, and is used to control the sensor head adjustment mechanism 11 and the controller 10; and

[0016] Display 9 is used for data output display and is connected to host 8.

[0017] The host 8 controls the swing of the reflector 5 and the sensing head 12, and starts recording the amplitude of the ultrasonic scalpel head 3 when the controller 10 receives the test laser. The recording of the amplitude of the ultrasonic scalpel head 3 is stopped and the amplitude curve is saved and output after the test laser disappears.

[0018] A detection method for the ultrasonic scalpel tip amplitude intelligent testing device includes the following steps:

[0019] S1: Install the ultrasonic scalpel head 3 into place and start the main unit 8;

[0020] S2: Preset the relative positions of the ultrasonic scalpel head 3, the sensing head 12, and the reflector 5 to ensure that the laser emitted by the sensing head 12 can irradiate the designated area of ​​the ultrasonic scalpel head 3;

[0021] S3: The host 8 controls the controller 10 to make the sensing head 12 emit a test laser. At the same time, the sensing head 12 and the reflector 5 swing and / or rise and fall according to a preset program, so that the laser reflected by the reflector 5 illuminates the designated area of ​​the scanning ultrasonic scalpel head 3. The laser that enters the designated area of ​​the ultrasonic scalpel head 3 is reflected and returns along the original path, thereby confirming and marking the position of the maximum amplitude.

[0022] Compared with previous technologies, the beneficial effects of the present invention are as follows:

[0023] 1. Simple operation and setup, reducing human error;

[0024] 2. The measurement process is automated, and the data is automatically processed, with a result accuracy of up to 0.0001µm; the 392kHz sampling rate ensures the stability and reliability of the measurement.

[0025] 3. High efficiency, saving manpower;

[0026] 4. It has a wide range of applications, including therapeutic ultrasound such as ultrasonic cutting hemostatic scalpel, ultrasonic bone scalpel, ophthalmic phacoemulsification needle, ultrasonic aspiration, etc., as well as industrial ultrasound such as ultrasonic cleaning, welding, processing and treatment.

[0027] 5. Flexible operation and replacement, avoiding the need for repositioning every time the test piece is changed. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0029] Figure 2 This is a flowchart of the amplitude scanning test.

[0030] Figure 3 This is a graph showing the amplitude test results;

[0031] Figure 4 This is a magnified view of a portion of the amplitude test curve;

[0032] Figure 5 A schematic diagram of the front end of an ultrasonic scalpel head.

[0033] Figure 6 This is a schematic diagram of the deflection.

[0034] Figure 7 A view of the complex output end face of the ultrasonic scalpel head;

[0035] Figure 8 This is a magnified view of a portion of the complex output end face of the ultrasonic scalpel head.

[0036] Labeling Explanation: 1. Ultrasonic Generator, 2. Transducer Handle, 3. Ultrasonic Scalpel Head, 4. Positioning Block, 5. Reflector, 6. Reflector Adjustment Mechanism, 7. Adjustment Mechanism Controller, 8. Main Unit, 9. Display, 10. Controller, 11. Sensor Head Adjustment Mechanism, 12. Sensor Head. Detailed Implementation

[0037] The present invention will now be described in detail with reference to the accompanying drawings:

[0038] like Figure 1 As shown: An intelligent testing device for the amplitude of an ultrasonic scalpel tip, comprising:

[0039] The substrate has a limiting structure on its surface for fixing the ultrasonic scalpel head 3;

[0040] The sensing head 12 is equipped with a controller 10, which controls it to emit and receive test lasers.

[0041] Mirror 5 is used to reflect the test laser;

[0042] The reflector adjustment mechanism 6 is connected to the reflector 5 and controls the up-and-down movement and swing of the reflector 5.

[0043] The sensing head adjustment mechanism 11 is connected to the sensing head 12 and controls the up-and-down movement and swing of the sensing head 12.

[0044] The host 8 is connected to the sensor head adjustment mechanism 11 and the controller 10, and is used to control the sensor head adjustment mechanism 11 and the controller 10; and

[0045] Display 9 is used for data output display and is connected to host 8.

[0046] The host 8 controls the swing of the reflector 5 and the sensing head 12, and starts recording the amplitude of the ultrasonic scalpel head 3 when the controller 10 receives the test laser. The recording of the amplitude of the ultrasonic scalpel head 3 is stopped and the amplitude curve is saved and output after the test laser disappears.

[0047] Furthermore, it also includes an adjustment mechanism controller 7, through which the sensing head adjustment mechanism 11 and the reflector adjustment mechanism 6 are connected to the host 8.

[0048] The sensing head adjustment mechanism 11 is an electric push rod motor.

[0049] The reflector adjustment mechanism 6 is a serpentine tube.

[0050] Furthermore, the reflector 5 is a plane mirror, a hemispherical mirror, or a prism.

[0051] The substrate here is generally made of marble or bakelite, which can ensure the overall stability of the testing equipment during the testing process. When testing the ultrasonic scalpel head 3, it is generally installed on the ultrasonic generator 1 and provides power to the transducer handle 2. The transducer handle 2 converts the power into high-frequency mechanical vibration and transmits it to the front end of the ultrasonic scalpel head 3 connected to it. The ultrasonic scalpel head 3 is fixed on the substrate.

[0052] The reflector 5 is used to transmit the laser signal between the sensing head 12 and the output end of the ultrasonic scalpel head 3 under test. The reflector adjustment mechanism 6 and the sensing head adjustment mechanism 11 are finely adjusted by the host computer so that the laser signal emitted by the sensing head 12 can be directed to the front end of the ultrasonic scalpel head 3 under test through the reflector 5. The adjustment mechanism controller 7 can control the lifting and tilting of the reflector adjustment mechanism 6 and the lifting and deflecting of the sensing head adjustment mechanism 11, and can receive control signals from the host computer 8 via RS232 or USB communication interface. This process needs to ensure that the laser reflected by the reflector 5 illuminates the designated area of ​​the ultrasonic scalpel head 3 while the laser entering the designated area of ​​the ultrasonic scalpel head 3 returns along the same path after reflection, thereby confirming and marking the position of the maximum amplitude.

[0053] After the test is started, the system follows the preset scanning test procedure. The host 8 sends control commands to the adjustment mechanism controller 7 to control the lifting and tilting of the reflector adjustment mechanism 6, and adjusts the position and angle of the reflector 5. The horizontal direction is first scanned within a range of ±12° to determine the position of the maximum amplitude. Then, the vertical direction is scanned and the position of the maximum amplitude is determined in the same way. The maximum value is automatically marked on the interface of the display 9. This maximum value is the superposition of the two maximum points of the horizontal and vertical scans.

[0054] Generally, the limiting structure consists of a groove formed on the substrate and a positioning block 4 mounted on one side of the groove. The positioning block 4 is mainly used to assist in positioning and constraining the initial direction of the blade. The groove is a semi-circular, U-shaped, or V-shaped limiting groove. The curvature of the groove can fit perfectly with the outer sleeve of the ultrasonic scalpel head 3, and the impeller of the blade head 3 directly abuts against one end of the positioning block 4. These two degrees of freedom constraints can stabilize the blade head. The positioning block 4 also has a groove structure, which is a semi-circular, U-shaped, or V-shaped limiting groove.

[0055] The positioning block here can be directly set as a detachable and connectable plug, which is installed on the base plate to achieve the positioning of the tool bar.

[0056] The detection method of the ultrasonic scalpel tip amplitude intelligent testing device includes the following steps:

[0057] S1: Install the ultrasonic scalpel head 3 into place and start the main unit 8;

[0058] S2: Preset the relative positions of the ultrasonic scalpel head 3, the sensing head 12, and the reflector 5 to ensure that the laser emitted by the sensing head 12 can irradiate the designated area of ​​the ultrasonic scalpel head 3;

[0059] S3: The host 8 controls the controller 10 to make the sensing head 12 emit a test laser. At the same time, the sensing head 12 and the reflector 5 swing and / or rise and fall according to a preset program, so that the laser reflected by the reflector 5 illuminates the designated area of ​​the scanning ultrasonic scalpel head 3. The laser that enters the designated area of ​​the ultrasonic scalpel head 3 is reflected and returns along the original path, thereby confirming and marking the position of the maximum amplitude.

[0060] It should be noted that, in order to ensure that the test laser emitted by the sensing head 12 can illuminate the cutting head after being reflected by the reflector 5, the reflector adjustment mechanism 6 can be manually initially adjusted, and then the sensing head adjustment mechanism can be automatically adjusted to ensure that the laser reflected by the reflector 5 can illuminate the cutting head and be reflected back along the original path.

[0061] In S S3, the maximum amplitude scanning method of the reflector 5 is to first scan in the horizontal direction to determine the position of the maximum amplitude, and then scan in the vertical direction to determine the position of the maximum amplitude; then the position of the maximum amplitude that overlaps in the horizontal and vertical directions is the position of the confirmed maximum amplitude and marked.

[0062] In addition, in S3, when the sensor head 12 emits a test laser and the reflector 5 swings, when the test laser hits the front end of the ultrasonic scalpel head 3, the test laser is reflected back to the sensor head 12 through the same path, and the sensor head 12 detects the signal of the test laser. The computer host 8 then starts recording amplitude data.

[0063] The current testing method is as follows: The test process starts at T0. After the host is turned on and the ultrasonic scalpel head is powered on, the host issues a test command. The controller 10 emits a test laser through the sensor head 12, which is reflected by the reflector 5 onto the front end of the ultrasonic scalpel head 3 and then reflected back to the sensor head 12 along the same path. The host 8 controls the reflector control console 6 to move and adjust the position of the reflector 5. When a reflected laser signal is detected, the computer host 8 begins recording. Figure 3 As can be seen, the amplitude data reaches its maximum value at time T1, and returns to its minimum value at time T2, at which point the test automatically ends. Figure 4 This is a magnified view of a portion of the time axis after refinement. Within a relatively short time period, the output amplitude is the following sine curve:

[0064] Disp. = A·sin(ω·t)

[0065] Where: A is the zero-peak value of the amplitude, ω = 2·π·f, f is the resonant frequency, and t is the instantaneous time of the vibration.

[0066] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An intelligent testing device for the amplitude of an ultrasonic scalpel tip, characterized in that: It includes The substrate has a limiting structure on its surface for fixing the ultrasonic scalpel head (3); The sensing head (12) is equipped with a controller (10) and is controlled by the controller (10) to emit and receive test lasers; Reflector (5), used to reflect the test laser; The reflector adjustment mechanism (6) is connected to the reflector (5) and controls the up-and-down movement and swing of the reflector (5); The sensing head adjustment mechanism (11) is connected to the sensing head (12) and controls the up-and-down movement and swing of the sensing head (12); The host (8) is connected to the sensing head adjustment mechanism (11) and the controller (10) for controlling the sensing head adjustment mechanism (11) and the controller (10); and The display (9) is used for data output display and is connected to the host (8); The host (8) controls the swing of the reflector (5) and the sensing head (12), and starts recording the amplitude of the ultrasonic scalpel head (3) when the controller (10) receives the test laser. The recording of the amplitude of the ultrasonic scalpel head (3) is canceled and the amplitude curve is saved and output after the test laser disappears. The host (8) controls the controller (10) to make the sensing head (12) emit a test laser. At the same time, the sensing head (12) and the reflector (5) swing and / or rise and fall according to the preset program, so that the laser reflected by the reflector (5) illuminates the designated area of ​​the scanning ultrasonic scalpel head (3), and the laser that enters the designated area of ​​the ultrasonic scalpel head (3) returns along the original path after reflection, thereby confirming and marking the position of the maximum amplitude. The maximum amplitude scanning method of the reflector (5) is to first scan in the horizontal direction to determine the position of the maximum amplitude, and then scan in the vertical direction to determine the position of the maximum amplitude; then the position of the maximum amplitude that overlaps in the horizontal and vertical directions is the position of the confirmed maximum amplitude and marked.

2. The intelligent testing device for ultrasonic scalpel head amplitude according to claim 1, characterized in that: It also includes an adjustment mechanism controller (7), through which the sensing head adjustment mechanism (11) and the reflector adjustment mechanism (6) are connected to the host (8).

3. The intelligent testing device for ultrasonic scalpel head amplitude according to claim 1, characterized in that: The sensing head adjustment mechanism (11) is an electric push rod motor.

4. The intelligent testing device for ultrasonic scalpel head amplitude according to claim 1, characterized in that: The reflector adjustment mechanism (6) is a serpentine tube.

5. The intelligent testing device for ultrasonic scalpel tip amplitude according to claim 1, characterized in that: The limiting structure is a groove formed on the substrate and a positioning block (4) installed on one side of the groove.

6. The intelligent testing device for ultrasonic scalpel head amplitude according to claim 5, characterized in that: The groove is a semi-circular, U-shaped, or V-shaped limiting groove.

7. The intelligent testing device for ultrasonic scalpel head amplitude according to claim 1, characterized in that: The reflector (5) is a plane mirror, a hemispherical mirror or a prism.

8. A detection method for the intelligent testing device for ultrasonic scalpel tip amplitude according to any one of claims 1-7, characterized in that: It includes the following steps: S1: Install the ultrasonic scalpel head (3) in place and start the main unit (8); S2: Preset the relative positions of the ultrasonic scalpel head (3), the sensing head (12), and the reflector (5) to ensure that the laser emitted by the sensing head (12) can irradiate the designated area of ​​the ultrasonic scalpel head (3); S3: The host (8) controls the controller (10) to make the sensing head (12) emit a test laser. At the same time, the sensing head (12) and the reflector (5) swing and / or rise and fall according to the preset program, so that the laser reflected by the reflector (5) illuminates the designated area of ​​the scanning ultrasonic scalpel head (3). The laser that enters the designated area of ​​the ultrasonic scalpel head (3) is reflected back along the original path, thereby confirming and marking the position of the maximum amplitude.

9. A detection method according to claim 8, characterized in that: In S3, the maximum amplitude scanning method of the reflector (5) is to first scan in the horizontal direction to determine the position of the maximum amplitude, and then scan in the vertical direction to determine the position of the maximum amplitude; then the position of the maximum amplitude that overlaps in the horizontal and vertical directions is the position of the confirmed maximum amplitude and marked.

10. A detection method according to claim 8, characterized in that: In S3, when the sensor head (12) emits a test laser and the reflector (5) swings, when the test laser hits the front end of the ultrasonic scalpel head (3), the test laser is reflected back to the sensor head (12) through the same path. The sensor head (12) detects the signal of the test laser and the computer host (8) begins to record the amplitude data.

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