Percutaneous intervention ultrasonic elastography catheter needle

Abstract

The percutaneous intervention ultrasonic elastography catheter needle comprises an outer catheter, a puncture tip is arranged at the front end of the outer catheter, an ultrasonic assembly containing cavity is formed in the position, close to the puncture tip, of the outer catheter, an ultrasonic window is formed in the side face of the ultrasonic assembly containing cavity, and the outer catheter is provided with a first channel formed in the axial direction; the front end of the first channel is connected with the ultrasonic component accommodating cavity; the ultrasonic assembly is arranged in the ultrasonic accommodating cavity, and a scanning sound beam surface of the ultrasonic assembly corresponds to the position of the ultrasonic window; and the negative pressure passage is arranged to be connected with a negative pressure providing device so as to form / release negative pressure between the ultrasonic assembly and the in-vivo tissue. According to the percutaneous intervention ultrasonic elastography catheter needle, by controlling starting / stopping of negative pressure in the first channel, instant negative suction / release of tissue near the ultrasonic assembly can be achieved, and the ultrasonic elastography function can be achieved.

Description

Technical Field

[0001] The present application relates to the technical field of ultrasonic equipment, and in particular to a percutaneous interventional ultrasonic elastic imaging catheter needle. Background Art

[0002] There are differences in elasticity between different tissue structures. For example, some malignant tumor tissues are harder than fibrous tissues, fibrous tissues are usually harder than glandular tissues, and glandular tissues are harder than fat tissues. Since the elastic coefficients of different tissues are quite different, the type of tissue can be determined based on the detection of elasticity. An ultrasonic elastic imaging technology has been proposed. Its principle is to apply pressure to the same tissue to deform the tissue. By comparing the ultrasonic images formed by the ultrasonic echo signals before and after the pressure is applied, the information related to the elasticity of the tissue can be captured. The elastic parameters of the tissue can be obtained through data analysis to determine the type of tissue. The traditional pressure operation is to apply force on the surface of the skin to press the body part tightly. The deep subcutaneous tissue is affected by limited force and the detection error is large.

[0003] Existing percutaneous ultrasound examinations have the following defects because the probe is not close enough to the deep tissue: the tissue resolution is not high enough to accurately identify the boundary between tumors and normal tissues, resulting in inaccurate ultrasound interventional puncture surgery; it is impossible to obtain accurate tissue elastic imaging and tissue hardness indicators at zero distance, making it difficult to achieve accurate diagnosis and treatment with the help of ultrasound elastic imaging technology. Summary of the invention

[0004] In view of this, the present application proposes a percutaneous interventional ultrasound elastic imaging catheter needle, which can solve the above existing technical problems. The present application provides the following technical solutions:

[0005] According to the embodiment of the present application, the percutaneous interventional ultrasound elastic imaging catheter needle includes: an outer catheter, the front end of the outer catheter is a puncture tip, the outer catheter has an ultrasound component accommodating cavity at a position close to the puncture tip, the side position of the ultrasound component accommodating cavity has an ultrasound window, the outer catheter has a first channel arranged along the axial direction, the front end of the first channel is connected to the ultrasound component accommodating cavity; an ultrasound component, the ultrasound component is arranged in the ultrasound accommodating cavity, the scanning sound beam surface of the ultrasound component corresponds to the position of the ultrasound window; and a negative pressure passage, the negative pressure passage is configured to be connected to a negative pressure providing device to form / release negative pressure between the ultrasound component and the body tissue.

[0006] According to the percutaneous interventional ultrasound elastography catheter needle of the exemplary embodiment of the present application, the negative pressure passage includes a gap, which is configured to be located between the ultrasound component and the ultrasound accommodating cavity, and the rear end of the first channel is configured to be connected to the negative pressure providing device.

[0007] According to the percutaneous interventional ultrasound elastography catheter needle of the exemplary embodiment of the present application, the rear end of the first channel is configured to be detachably connected to the negative pressure providing device.

[0008] According to the percutaneous interventional ultrasound elastography catheter needle of an exemplary embodiment of the present application, the negative pressure passage includes a second channel arranged along the axial direction, the front end of the second channel is arranged to be adjacent to the ultrasound window, and the rear end of the second channel is arranged to be detachably connected to the negative pressure providing device.

[0009] According to the percutaneous interventional ultrasound elastography catheter needle of the exemplary embodiment of the present application, the second channel is configured to be used for inserting a working instrument when the negative pressure providing device is not connected.

[0010] The percutaneous interventional ultrasound elastography catheter needle according to the exemplary embodiment of the present application further includes: an ultrasound guide wire connected to the ultrasound component, wherein the ultrasound guide wire is disposed in the first channel.

[0011] The percutaneous interventional ultrasound elastography catheter needle according to the exemplary embodiment of the present application further includes: a first negative pressure control module, which is arranged on the outer catheter and is used to control the start / stop of the negative pressure state in the first channel.

[0012] According to the exemplary embodiment of the present application, the percutaneous interventional ultrasound elastography catheter needle also includes: a handle, which is configured to wrap the rear end of the outer catheter for easy holding by the user, and the handle has an operation button, which is coupled to the first negative pressure control module for easy user operation and control.

[0013] According to the percutaneous interventional ultrasound elastography catheter needle of the exemplary embodiment of the present application, a sealing plug is provided at the rear end of the first channel.

[0014] The percutaneous interventional ultrasound elastography catheter needle according to the exemplary embodiment of the present application further includes: a second negative pressure control module, which is arranged on the outer catheter and is used to control the start / stop of the negative pressure state in the second channel.

[0015] According to the percutaneous interventional ultrasound elastography catheter needle of the exemplary embodiment of the present application, a pulsed negative pressure with a vacuum degree of 1% to 99% can be provided between the ultrasound component and the body tissue through the negative pressure passage.

[0016] The percutaneous interventional ultrasound elastography catheter needle of the embodiment of the present application is provided with a negative pressure passage, so that the instantaneous negative suction / release of tissue near the ultrasound component can be achieved by controlling the start / stop of the negative pressure in the negative pressure passage. In the negative suction state, the body tissue is subjected to a slight deformation by force, and in the release state, the body tissue returns to its original shape. Therefore, by comparing and analyzing the different ultrasound images in these two states, parameters related to the tissue elasticity before and after the deformation of the body tissue can be obtained, and information such as the hardness of the body tissue can be obtained through data analysis to realize the ultrasound elastography function. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the present application or related technologies, the drawings required for use in the embodiments or related technical descriptions are briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 is a stereoscopic view of a percutaneous interventional ultrasound elastography catheter needle according to an exemplary embodiment of the present application;

[0019] Figure 2 yes Figure 1 A front view of a percutaneous interventional ultrasound elastography catheter needle is shown;

[0020] Figure 3A yes Figure 1 A cross-sectional view of a percutaneous interventional ultrasound elastography catheter needle is shown;

[0021] Figure 3B yes Figure 3A A partial enlarged view of the boxed area;

[0022] Figure 3C yes Figure 1 The schematic diagram of the partial enlargement of the front section of the catheter needle of the percutaneous interventional ultrasound elastic imaging catheter needle in the non-negative suction state;

[0023] Figure 3D yes Figure 1 The schematic diagram of the partial enlargement of the front section of the catheter needle of the percutaneous interventional ultrasound elastic imaging catheter needle in the negative suction state is shown;

[0024] Figure 4 yes Figure 1 A side view of a percutaneous interventional ultrasound elastography catheter needle is shown;

[0025] Figure 5 yes Figure 1 A perspective view of some components in a percutaneous interventional ultrasound elastography catheter needle is shown;

[0026] Figure 64 is a cross-sectional view of a front section of a catheter needle of a percutaneous interventional ultrasound elastography catheter needle according to another exemplary embodiment of the present application.

[0027] In the figure:

[0028] Outer catheter 1; puncture tip 101; ultrasonic component accommodating cavity 102; ultrasonic window 103; first channel 104; second channel 105; first negative pressure control module 106, sealing plug 107; pore 1071, negative pressure connection port 1072; ultrasonic component 2; damping layer 201; crystal layer 202; sound-permeable membrane 203; ultrasonic guide wire 204; handle 3; operation button 301; gap 4; working instrument 5; body tissue 7; remaining space 8; negative pressure providing device 9. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical solutions and advantages of this application clearer, the technical solutions in this application will be clearly and completely described below in conjunction with the drawings in this application. Obviously, the described embodiments are part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0030] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms such as "installation" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0031] like Figure 1 As shown, the percutaneous interventional ultrasound elastic imaging catheter needle according to the exemplary embodiment of the present application mainly includes: an outer catheter 1, an ultrasound component 2 and a negative pressure channel. Figure 2 As shown in FIG. 1 , the term “front end” used herein refers to the end farther from the operator; and the term “rear end” refers to the end closer to the operator. The front end of the outer catheter 1 is a puncture tip 101. The outer catheter 1 has an ultrasonic component accommodating cavity 102 (see FIG. 1 ) at a position close to the puncture tip 101. Figure 3A and Figure 3B). An ultrasound window 103 is provided at a side position of the ultrasound component accommodating cavity 102. The outer catheter 1 has a first channel 104 arranged along the axial direction, and the front end of the first channel 104 is connected to the ultrasound component accommodating cavity 102. The ultrasound component 2 is arranged in the ultrasound accommodating cavity 102, and the scanning sound beam surface of the ultrasound component 2 corresponds to the position of the ultrasound window 103. The negative pressure passage is configured to be connected to the negative pressure providing device 9, and is used to form / release negative pressure between the ultrasound component 2 and the body tissue 7. The percutaneous interventional ultrasound elastic imaging catheter needle also includes an optional handle 3, which is configured to wrap the rear end of the outer catheter 1 for easy holding by the user.

[0032] When the percutaneous interventional negative pressure ultrasound catheter according to the embodiment of the present application starts ultrasound examination, the needle percutaneously punctures into the tissue or close to the edge of the tissue, so that the ultrasound component 2 is wrapped by the body tissue 7 or is extremely close to the body tissue 7. There was originally a small amount of air or tissue fluid between the ultrasound component 2 and the body tissue 7, and this part of air or tissue fluid was originally contained and confined in the ultrasound containing cavity 102. After this small amount of air or tissue fluid is sucked out by negative pressure, there is no other isolation between the ultrasound component 2 and the body tissue. From the above, it can be seen that when the ultrasound containing cavity 102 switches between the negative pressure / pressure release states, this will cause the tissue to change shape / restore shape, which can provide the probe with elastic imaging conditions.

[0033] It should be noted that the negative pressure providing device 9 can be a device externally connected to the percutaneous interventional ultrasound elastic imaging catheter needle, and specifically, an existing commercially available vacuum pump can be used. The negative pressure providing device 9 can provide a negative pressure with a vacuum degree of 1% to 99% for the negative pressure passage. Within this numerical range, the vacuum degree can specifically be 1%, 5%, 10%, 20%, 30%, 50%, 70%, 80%, 90%, 95% and 99%, etc. Selecting such a negative pressure providing device 9 can make the percutaneous interventional ultrasound elastic imaging catheter needle widely applicable to the adsorption of different types of in vivo tissues. The negative pressure providing device 9 can provide a pulsed negative pressure. In other words, the negative pressure is not continuous for a long time, but instantaneous, and the duration of the working phase and the intermittent phase can be precisely controlled.

[0034] Figure 3A for Figure 1 A cross-sectional view of a percutaneous interventional ultrasound elastography catheter needle is shown; Figure 3B for Figure 3A A partial enlarged view of the box in the middle. Figure 3A and Figure 3B As shown, in the percutaneous interventional ultrasound elastic imaging catheter needle according to the embodiment of the present application, the ultrasound component 2 may include a damping layer 201, a crystal layer 202 and an acoustic permeable membrane 203 stacked in sequence, and the acoustic permeable membrane 203 is aligned with the ultrasound window 103. The acoustic permeable membrane 203 is dustproof and waterproof, and can protect the ultrasound component 2. Figure 3A As shown in FIG. B , the percutaneous interventional ultrasound elastic imaging catheter needle according to the embodiment of the present application may further include: an ultrasound guide wire 204 connected to the ultrasound component 2, and the ultrasound guide wire 204 is arranged in the first channel 104. This arrangement does not hinder the negative pressure extraction operation of the first channel 104, nor does it hinder the surgical operation of the working instrument 5 in the second channel 105.

[0035] Figure 3C for Figure 1 The schematic diagram of the partial enlargement of the front section of the catheter needle of the percutaneous interventional ultrasound elastic imaging catheter needle in the non-negative suction state; Figure 3D It is a partially enlarged schematic diagram of the front section of the catheter needle of the percutaneous interventional ultrasound elastography catheter needle in a negative suction state according to an embodiment of the present application.

[0036] like Figure 3A and Figure 3B In the percutaneous interventional ultrasound elastography catheter needle shown, the negative pressure passage may include a gap 4, which is arranged to be located between the ultrasound component 2 and the ultrasound accommodating cavity 102, and the rear end of the first channel 104 is arranged to be detachably connected to the negative pressure providing device 9. The operating steps of the percutaneous interventional ultrasound elastography catheter needle of this embodiment when implementing ultrasound elastography are as follows: use the sharp puncture tip 101 to percutaneously puncture the subcutaneous tissue, and then push the percutaneous interventional ultrasound elastography catheter needle to a suitable depth. At this time, the ultrasound window 103 is located near the target desired in vivo tissue, and the front section of the outer catheter 1 and the surface of the ultrasound component 2 are wrapped by the in vivo tissue 7. There is only a narrow remaining space 8 between the outer catheter 1, the ultrasound component 2 and the in vivo tissue 7 (see Figure 3C , there is a residual space 8). There is a gap 4 between the ultrasonic component 2 and the outer catheter 1, and the gap 4 can allow air to pass through. The ultrasonic window 103 serves as a side opening of the outer catheter 1, so it actually forms a passage of "residual space 8-ultrasonic window 103-gap 4-first channel 104", so the air or tissue fluid in the residual space 8 can be sucked out by negative pressure through this passage. Then, the rear end of the first channel 104 is connected to the negative pressure providing device 9, and after the first channel 104 is pumped into a negative pressure state, the body tissue 7 is adsorbed on the ultrasonic window 103 and close to the ultrasonic component 2, and the original residual space 8 is filled (see Figure 3D, there is no remaining space 8). On the one hand, this makes the distance between the body tissue 7 and the ultrasonic component 2 almost zero, and can obtain accurate ultrasonic images with higher resolution (resolution up to 0.1mm); on the other hand, instantaneous negative pressure suction can give the body tissue a small force to cause the body tissue 7 to deform slightly, and then the negative pressure release can restore the body tissue 7 to its original state. Repeated negative pressure suction and release can produce continuous slight deformation. Therefore, the ultrasonic component 2 can capture parameters related to tissue elasticity by analyzing the echo signals before and after the slight deformation to reflect the hardness of the tissue, thereby realizing the ultrasonic elastic imaging function.

[0037] In the percutaneous interventional ultrasound elastic imaging catheter needle according to the embodiment of the present application, the size of the gap 4 is preferably, but not limitedly, 0.5 mm to 1.5 mm. The size of the gap is preferred mainly because if the gap is too large, the ultrasound component 2 is easy to shake and shift; if the gap is too small, it is difficult for the gas to flow smoothly.

[0038] Figure 4 for Figure 1 A side view of a percutaneous interventional ultrasound elastography catheter needle is shown; Figure 5 for Figure 1 A three-dimensional view of some components in a percutaneous ultrasound elastic imaging catheter needle is shown. Figure 4 and Figure 5 As shown, the rear end of the outer catheter 1 may be provided with a sealing plug 107. The sealing plug 107 has the function of sealing and preventing air leakage. The sealing plug 107 may be provided with a fine hole 1071 for the wire (including the ultrasonic wire 204, the wire connected to the first negative pressure control module 106, and the wire connected to the second negative pressure control module) to pass through, and a negative pressure connection port 1072 for the external negative pressure providing device 9.

[0039] like Figure 5 As shown, the percutaneous interventional ultrasound elastic imaging catheter needle according to the embodiment of the present application can also include a first negative pressure control module 106. The first negative pressure control module 106 is arranged on the outer catheter 1, and is used to control the start / stop of the negative pressure state in the first channel 104. In addition, the handle 3 can also have an operation button 301 (see Figure 1 3 ), the operation button 301 is coupled to the first negative pressure control module 106 for user operation and control.

[0040] In the percutaneous interventional ultrasound elastic imaging catheter needle according to the embodiment of the present application, the outer catheter 1 has a second channel 105 arranged along the axial direction. The front end of the second channel 105 is arranged to be adjacent to the ultrasound window 103, and the rear end of the second channel 105 is arranged to be detachably connected to the negative pressure providing device 9.

[0041] like Figure 1 and Figure 3A As shown, the second channel 105 can be used to insert the working instrument 5. The working instrument 5 can be a puncture needle, a biopsy needle or an ablation needle, or other slender instruments. The percutaneous interventional ultrasound elastic imaging catheter needle of this embodiment can provide a working channel for interventional diagnosis and treatment, which is convenient for performing surgical operations such as biopsy sampling, tumor ablation, lesion drug administration, and energy delivery. It should be noted that when the second channel 105 is used to insert the working instrument, the rear end of the second channel 105 is not connected to the negative pressure providing device 9.

[0042] On the other hand, the second channel 105 can also be used as a negative pressure channel. It should be noted that when the second channel 105 is used as a negative pressure channel, the working device 5 is not inserted therein, and the rear end of the second channel 105 is connected to the negative pressure providing device 9. When the negative pressure providing device 9 starts to work and the air is pumped to form a negative pressure, the opening at the front end of the second channel 105 can negatively absorb the nearby tissue to assist elastic ultrasound imaging. Specifically, when the rear end of the first channel 105 is connected to the negative pressure providing device 9 and the second channel 105 is pumped into a negative pressure state, the air or tissue fluid in the remaining space 8 can be negatively pressured and drawn out through the "remaining space 8 near the front end of the second channel 105 - the opening at the front end of the second channel 105 - the second channel 105" passage. At this time, the body tissue 7 near the ultrasound window 103 is deformed by the instantaneous negative suction pressure from the second channel 105. Subsequently, the negative pressure is removed from the second channel 105, and the body tissue 7 also returns to its original state. Based on this, the ultrasound component 2 can achieve ultrasonic elastic imaging.

[0043] The percutaneous interventional ultrasound elastic imaging catheter needle according to the embodiment of the present application can also include: a second negative pressure control module (not shown, its specific structure and setting method are the same as the first negative pressure control module, only the arrangement position is separated from the position of the first negative pressure control module). The second negative pressure control module can be arranged on the outer catheter 1 to control the start / stop of the negative pressure state in the second channel 105.

[0044] Figure 6 It is a cross-sectional view of the front section of the catheter needle of the percutaneous interventional ultrasound elastography catheter needle according to another embodiment of the present application. In this embodiment, the negative pressure passage only includes a second channel 105 arranged along the axial direction. The front end of the second channel 105 is arranged to be adjacent to the ultrasound window 103, and the rear end of the second channel 105 is arranged to be detachably connected to the negative pressure providing device 9. In this embodiment, the first channel 104 is mainly used to lay the ultrasound wire 204, and the negative pressure providing device 9 is not externally connected, that is, it is not used as a negative pressure channel. In this embodiment, the sound-permeable membrane 203 can completely cover the entire ultrasound window 103, completely isolating the body tissue 7 from the damping layer 201 and the crystal layer 202 of the ultrasound component, and also completely isolating the body tissue 7 from the first channel 104.

[0045] In summary, the percutaneous interventional ultrasound elastic imaging catheter needle of the exemplary embodiment of the present application is provided with a negative pressure passage, which can realize instantaneous negative suction / release of the body tissue near the ultrasonic component by controlling the start / stop of the negative pressure in the negative pressure passage. In the negative suction state, the body tissue is slightly deformed by force, and in the release state, the body tissue returns to its original shape. Therefore, by comparing and analyzing the different ultrasound images in these two states, the parameters related to the tissue elasticity before and after the body tissue deformation can be obtained, and the information such as the hardness of the body tissue can be obtained through data analysis to realize the ultrasound elastic imaging function. In addition, the negative pressure channel can be implemented as the first channel and / or the second channel, so the percutaneous interventional ultrasound elastic imaging catheter needle of the embodiment of the present application can flexibly realize ultrasound elastic imaging in a variety of ways, and has the advantage of wide application.

[0046] The above specific implementations do not constitute a limitation on the protection scope of this application. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions may occur depending on design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and principles of this application should be included in the protection scope of this application.

Claims

1. A percutaneous interventional ultrasound elastic imaging catheter needle, characterized in that: include: An outer catheter (1), wherein the front end of the outer catheter (1) is a puncture tip (101), an ultrasonic component accommodating cavity (102) is provided at a position of the outer catheter (1) close to the puncture tip (101), an ultrasonic component accommodating cavity (102) is provided at a side position of the ultrasonic component accommodating cavity (102), and the outer catheter (1) has a first channel (104) arranged along the axial direction, and the front end of the first channel (104) is connected to the ultrasonic component accommodating cavity (102); An ultrasonic component (2), the ultrasonic component (2) being arranged in the ultrasonic accommodating cavity (102), the scanning sound beam surface of the ultrasonic component (2) corresponding to the position of the ultrasonic window (103); and A negative pressure passage is provided, wherein the negative pressure passage is configured to be connected to a negative pressure providing device (9) so as to form / release negative pressure between the ultrasonic component (2) and the body tissue (7).

2. The percutaneous interventional ultrasound elastography catheter needle according to claim 1, characterized in that: The negative pressure passage comprises a gap (4), wherein the gap (4) is arranged to be located between the ultrasonic component (2) and the ultrasonic accommodating cavity (102), and the rear end of the first channel (104) is arranged to be connected to the negative pressure providing device (9).

3. The percutaneous interventional ultrasound elastic imaging catheter needle according to claim 2, characterized in that: The rear end of the first channel (104) is configured to be detachably connected to the negative pressure providing device (9).

4. The percutaneous interventional ultrasound elastic imaging catheter needle according to claim 1, characterized in that: The negative pressure passage comprises a second channel (105) arranged along the axial direction, the front end of the second channel (105) is arranged to be adjacent to the ultrasonic window (103), and the rear end of the second channel (105) is arranged to be detachably connected to the negative pressure providing device (9).

5. The percutaneous interventional ultrasound elastography catheter needle according to claim 4, characterized in that: The second channel is configured to be used for inserting a working instrument (5) when the negative pressure providing device (9) is not connected.

6. The percutaneous interventional ultrasound elastography catheter needle according to claim 1, characterized in that: Also includes: An ultrasonic wire (204) connected to the ultrasonic component (2), wherein the ultrasonic wire (204) is disposed in the first channel (104).

7. The percutaneous interventional ultrasound elastography catheter needle according to claim 1, characterized in that: Also includes: A first negative pressure control module (106), wherein the first negative pressure control module (106) is arranged on the outer catheter (1) and is used to control the start / stop of the negative pressure state in the first channel (104).

8. The percutaneous interventional ultrasound elastic imaging catheter needle according to claim 7, characterized in that: Also includes: A handle (3), wherein the handle (3) is configured to wrap around the rear end of the outer catheter (1) for easy gripping by a user, and an operation button (301) is provided on the handle (3), wherein the operation button (301) is coupled to the first negative pressure control module (106) for easy operation and control by a user.

9. The percutaneous interventional ultrasound elastography catheter needle according to claim 2, characterized in that: A sealing plug (107) is provided at the rear end of the first channel (104).

10. The percutaneous interventional ultrasound elastography catheter needle according to claim 4, characterized in that: Also includes: A second negative pressure control module, the second negative pressure control module is arranged on the outer catheter (1) and is used to control the start / stop of the negative pressure state in the second channel (105).

11. The percutaneous interventional ultrasound elastography catheter needle according to any one of claims 1 to 10, characterized in that: Through the negative pressure passage, a pulsed negative pressure with a vacuum degree of 1% to 99% can be provided between the ultrasonic component (2) and the body tissue (7).

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